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Fed Pract
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gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
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Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
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pedophilia
poker
porn
pornography
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recreational drug
sex slave rings
slot machine
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Texas hold 'em
UFC
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bunges
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butt
butt fuck
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buttfucked
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cock sucker
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Current Issue
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.

Current Issue Reference

Review of Efficacy and Safety of Spinal Cord Stimulation in Veterans

Article Type
Changed
Thu, 01/27/2022 - 15:41

Lower back pain (LBP) affects an estimated 9.4% of the global population and has resulted in more years lived with disability than any other health condition.1 LBP affects a wide range of populations, but US veterans have been shown to have significantly higher rates of back pain than nonveterans. The National Institutes of Health reports that 65.6% of veterans experience chronic pain; 9.1% of veterans experience severe, chronic pain.2 Chronic back pain is treated by a range of methods, including medications, surgery, physical therapy (PT), patient education, and behavioral therapy.3 However, chronic neuropathic back pain has been shown to have limited responsiveness to medication.4

Neuropathic pain is caused by lesions in the somatosensory nervous system, resulting in spontaneous pain and amplified pain responses to both painful and nonpainful stimuli.5 The most common location for neuropathic pain is the back and legs. Between 10% and 40% of people who undergo lumbosacral spine surgery to treat neuropathic radicular pain will experience further neuropathic pain.6 This condition is referred to as failed back surgery syndrome or postlaminectomy syndrome (PLS). While neuropathic back pain has had limited responsiveness to medication and repeated lumbosacral spine surgery, spinal cord stimulation (SCS) has shown promise as an effective form of pain treatment for those experiencing PLS and other spine disorders.7-10 In addition, SCS therapy has had a very low incidence of complications, which may be on the decline with recent technological advancements.11 Patients with a diagnosis of PLS, LBP, or complex regional pain syndrome (CRPS) who have not responded to medications, therapy, and/or injections for ≥ 6 months were eligible for a trial of SCS therapy. Trial leads were placed via the percutaneous route with the battery strapped to the waistline for 3 to 5 days and were removed in clinic. Patients who experienced > 60% pain relief and functional improvement received a SCS implant.

The effectiveness of SCS has been demonstrated in a nonveteran population, but it has not been studied in a veteran population.12 US Department of Veterans Affairs (VA) health care coverage is different from Medicare and private insurance in that it is classified as a benefit and not insurance. The goals of treatment at the VA may include considerations in addition to feeling better, and patient presentations may not align with those in the private sector.

We hypothesize that SCS is both a safe and beneficial treatment option for veterans with chronic intractable spine and/or extremity pain. The purpose of this study was to determine the efficacy and safety of SCS in a veteran population.

Methods

The efficacy and safety of SCS was determined via a retrospective study. Inclusion criteria for the study consisted of any Southeastern Louisiana Veterans Health Care System (SLVHCS) patient who had an SCS trial and/or implant from 2008 to 2020. Eligible veterans must have had chronic pain for at least 6 months and had previously tried multiple medications, PT, transcutaneous nerve stimulation, facet injections, epidural steroid injections, or surgery without success. For medication therapy to be considered unsuccessful, it must have included acetaminophen, nonsteroidal anti-inflammatory drugs, and ≥ 1 adjuvant medication (gabapentin, duloxetine, amitriptyline, lidocaine, and menthol). A diagnosis of chronic LBP, PLS, cervical or lumbar spondylosis with radiculopathy, complex regional pain syndrome, or chronic pain syndrome was required for eligibility. Patients whose pain decreased by > 60% and had functional improvement in a 3- to 5-day trial received SCS implantation with percutaneous leads by a pain physician or paddle lead by a neurosurgeon.

The SLVHCS Institutional Review Board approved this study. Electronic health records were reviewed to determine patient age, anthropometric data, and date of SCS implantation. Patients were then called and interviewed to complete a survey. After obtaining verbal consent to the study, subjects were surveyed regarding whether the patient would recommend the procedure to peers, adverse effects (AEs) or complications, and the ability to decrease opiates if applicable. A verbal Pain Outcome Questionnaire (POQ) assessment of activities of daily living also was given during the phone interview regarding pain levels before SCS and at the time of the phone interview.13 (eAppendix available at doi:10.12788/fp.0204) Following the survey, a chart review was performed to corroborate the given AEs or complications and opiate use information. Before and after results of the POQ were compared via a paired sample t test, and P values < .05 were considered significant. Analyses were performed by IBM SPSS, version 26.

The primary outcome measure for this study was whether veterans would recommend SCS to their peers; in our view, this categorical outcome measure seemed to be more valuable to share with future patients who might be candidates for SCS. Since VA health care coverage and goals of treatment may be different from a nonveteran population, we opted to use this primary measure to decrease the possibility of confounding variables.

Secondary outcome measures included changes in POC scores, improvements in activities of daily living, and decreases in use of opioid pain medications.

POQ responses were recorded during the telephone interviews (0 to 10 scale). A paired sample t test was conducted to compare pain levels before and after SCS implant. Pain levels were gathered in the single phone call. Patient opioid usage, if applicable, was assessed by converting medications to morphine milligram equivalent dosing (MMED). Since patients who were on chronic opioids took multiple formulations, we changed the total daily dose to all morphine; for this study, morphine was considered equivalent to hydrocodone, and oxycodone was 1.5x morphine.

 

 

Results

Of the 90 SLVHCS patients who received an SCS implant between 2008 and 2020, 76 were reached by telephone and 65 had their responses recorded in the study. Of the 11 patients who were not included, 5 had the SCS removed; it is unclear whether these veterans would have recommended the treatment. Four were unable to quantify pain and/or SCS effects, and 2 were excluded due to a dementia diagnosis years after the implant. The mean (SD) age of participants was 63.9 (10.3) years. Forty percent of patients had a diabetes mellitus diagnosis and 1 had prediabetes. Patients’ most common qualifying diagnosis for SCS was PLS (47.7%) followed by chronic LBP (26.2%). A percutaneous 2-lead technique was the most common type of SCS type used (60.0%) followed by 1-lead (21.5%). The most common SCS manufacturer was Boston Scientific (87.7%)(Table 1). Most veterans (76.9%) recommended SCS to their peers; 13.8% did not recommend SCS; 9.2% were undecided and stated that they were unable to recommend because they did not want to persuade a peer to get SCS (Figure).

Patient Demographics

Do Veterans Recommend SCS to Their Peers?

There was a statistically significant decrease in opioid use for the 40 veterans for whom pain medication was converted (P < .001)(Table 2). Six patients reported using opioids at some point but could not remember their dose, and no records were found in their chart review, so they were not included in the MMED analysis. In that group, 4 patients reported using opioids before SCS but discontinued the opioid use after SCS implantation, and 2 patients noted using opioids before SCS and concomitantly. Eighteen subjects reported no opioid use at any point before or after SCS (Table 3).

There were few life-threatening complications of SCS. Three veterans developed skin dehiscence; 2 had dehiscence at the battery/generator site, and 1 had dehiscence at the lead anchor site. Two patients with dehiscence also had morbid obesity, and the third had postoperative malnourishment. The dehiscence occurred 3 and 8 months postoperation. All 3 patients with dehiscence had the SCS explanted, though they were eager to get a new SCS implanted as soon as possible because SCS was their most successful treatment to date.

MMED and BMI Before and After Implantation and Patient Pain Outcome Questionnaire Responses


Twenty of the 64 veterans surveyed reported other complications of SCS, including lead migration, lack of pain coverage, paresthesia and numbness, soreness around generator site, SCS shocking patient when performing full thoracic spine flexion, and shingles at the battery site (Table 4). There were 11 explants among the 76 veterans contacted. The primary reason for explant was lack of pain coverage.

Complications and Adverse Effects


Patient concerns included pain with sitting in chairs due to tenderness around the implant, SCS helping with physical pain but not mental pain, SCS only working during the day and not helping with sleep, and patients lacking education regarding possible complications of SCS.

Discussion

In this nonrandomized retrospective review, SCS was shown to be an effective treatment for intractable spine and/or extremity pain. Veterans’ pain levels were significantly reduced following SCS implantation, and more than three-fourths of veterans recommended SCS to their peers. We used the recommendation of SCS to peers as the most important metric regarding the effectiveness of SCS, as this measure was felt to be more valuable to share with future patients; furthermore, categorical analysis has been shown to be more valuable than ordinal pain scales to measure pain.14 In addition to wanting to expand the available research to the general public, we wanted a measure that we could easily relay to our patient population regarding SCS.

The explant rate of 14.5% among surveyed veterans falls at the higher end of the normal ranges found in previous studies of long-term SCS outcomes.15-17 One possible reason for the higher rate is that we did not differentiate based on the reason for the explant (ie, no benefit, further surgery needed for underlying medical condition, or SCS-specific complications). Another possible contributing factor to the higher than expected explant rate is the geographic location in the New Orleans metro area; New Orleans is considered to have one of the highest rates of obesity in the United States and obesity typically has other diseases associated with it such as hypertension and diabetes mellitus.

 

 

Limitations

Limitations of the study include the relatively low number of subjects, subjective nature of the interview questions, and the patients’ answers. Typically the POQ has been used as a prospective assessment of pain; whether it is valid in a retrospective analysis is not clear. While there was a statistically significant decrease of opioid use after getting SCS, this study can only show correlation, not causation. During the study period, there has been a drastic change in opioid prescribing patterns and efforts to decrease the amount of opioids prescribed.

Subjects also were asked to rate their pain and quality of life before SCS. Some subjects had SCS implantation up to 10 years prior to the phone interview. The variable amount of time between SCS implantation and interview likely affected subjects’ responses. Chronic pain is a moving target. Patients have good days and bad days that would likely change opinions on SCS benefits on a single phone interview. Some patients needed battery replacements at the time of the interview (battery life averaged about 3 to 5 years in our study population) and were asked to report current levels of pain from the perspective of when their batteries were still functional, further affecting results.

Conclusions

SCS was shown to improve the quality of life of US veterans at SLVHCS across a wide variety of metrics, including activities of daily living, as well as mental and physical health. For veterans with chronic intractable pain who have tried and failed more conservative treatments, SCS is a great treatment.

Files
References

1. Hoy DG, Smith E, Cross M, et al. The global burden of musculoskeletal conditions for 2010: an overview of methods. Ann Rheum Dis. 2014;73(6):982-989 doi:10.1136/annrheumdis-2013-204344

2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021

3. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.

4. Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162-173. doi:10.1016/S1474-4422(14)70251-0

5. Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1-32. doi:10.1146/annurev.neuro.051508.135531

6. Wilkinson HA. The Failed Back Syndrome: Etiology and Therapy. 2nd ed. Harper & Row; 1991.

7. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188. doi:10.1016/j.pain.2007.07.028

8. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-107. doi:10.1227/01.neu.0000144839.65524.e0

9. Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AG, van Kleef M. Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. Neuromodulation. 2013;16(6):523-529. doi:10.1111/ner.12024

10. Kumar K, Rizvi S, Bnurs SB. Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction. Neurosurgery. 2011;69(3):566-5580. doi:10.1227/NEU.0b013e3182181e60

11. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. 2011;11(2):148-153. doi:10.1111/j.1533-2500.2010.00407.x

12. Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low back pain relief compared to traditional SCS-LUMINA Study. Pain Med. 2017;18(8):1534-1548. doi:10.1093/pm/pnw286

13. Gordon DB, Polomano RC, Pellino TA, et al. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010;11(11):1172-1186. doi:10.1016/j.jpain.2010.02.012

14. Kennedy DJ, Schneider B. Lies, damn lies, and statistic: a commentary. Pain Med. 2020;21(10):2052-2054. doi:10.1093/pm/pnaa287

15. Van Buyten JP, Wille F, Smet I, et al. Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study. Neuromodulation. 2017;20(7):642-649. doi:10.1111/ner.12642

16. Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation. 2015;18(7):603-609. doi:10.1111/ner.12312

17. Pope JE, Deer TR, Falowski S, et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation. 2017;20(6):543-552. doi:10.1111/ner.12634

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Casey A. Murphy, MDa,b,c; Randolph L. Roig, MDa,b,c; W. Bradley Trimbleb; Matthew Bennettb; and Justin Doughty, MDb
Correspondence:
Casey Murphy ([email protected])

Author affiliations 

aVeterans Affairs Medical Center, New Orleans, Louisiana
bLouisiana State University School of Medicine, New Orleans
cTulane University School of Medicine, New Orleans

Author disclosures

The authors report no actual or potential conflicts of interest and no outside funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The Southeastern Louisiana Veterans Health Care System Institutional Review Board approved this study. Patients provided verbal consent prior to completing the survey.

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Casey A. Murphy, MDa,b,c; Randolph L. Roig, MDa,b,c; W. Bradley Trimbleb; Matthew Bennettb; and Justin Doughty, MDb
Correspondence:
Casey Murphy ([email protected])

Author affiliations 

aVeterans Affairs Medical Center, New Orleans, Louisiana
bLouisiana State University School of Medicine, New Orleans
cTulane University School of Medicine, New Orleans

Author disclosures

The authors report no actual or potential conflicts of interest and no outside funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The Southeastern Louisiana Veterans Health Care System Institutional Review Board approved this study. Patients provided verbal consent prior to completing the survey.

Author and Disclosure Information

Casey A. Murphy, MDa,b,c; Randolph L. Roig, MDa,b,c; W. Bradley Trimbleb; Matthew Bennettb; and Justin Doughty, MDb
Correspondence:
Casey Murphy ([email protected])

Author affiliations 

aVeterans Affairs Medical Center, New Orleans, Louisiana
bLouisiana State University School of Medicine, New Orleans
cTulane University School of Medicine, New Orleans

Author disclosures

The authors report no actual or potential conflicts of interest and no outside funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The Southeastern Louisiana Veterans Health Care System Institutional Review Board approved this study. Patients provided verbal consent prior to completing the survey.

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Related Articles

Lower back pain (LBP) affects an estimated 9.4% of the global population and has resulted in more years lived with disability than any other health condition.1 LBP affects a wide range of populations, but US veterans have been shown to have significantly higher rates of back pain than nonveterans. The National Institutes of Health reports that 65.6% of veterans experience chronic pain; 9.1% of veterans experience severe, chronic pain.2 Chronic back pain is treated by a range of methods, including medications, surgery, physical therapy (PT), patient education, and behavioral therapy.3 However, chronic neuropathic back pain has been shown to have limited responsiveness to medication.4

Neuropathic pain is caused by lesions in the somatosensory nervous system, resulting in spontaneous pain and amplified pain responses to both painful and nonpainful stimuli.5 The most common location for neuropathic pain is the back and legs. Between 10% and 40% of people who undergo lumbosacral spine surgery to treat neuropathic radicular pain will experience further neuropathic pain.6 This condition is referred to as failed back surgery syndrome or postlaminectomy syndrome (PLS). While neuropathic back pain has had limited responsiveness to medication and repeated lumbosacral spine surgery, spinal cord stimulation (SCS) has shown promise as an effective form of pain treatment for those experiencing PLS and other spine disorders.7-10 In addition, SCS therapy has had a very low incidence of complications, which may be on the decline with recent technological advancements.11 Patients with a diagnosis of PLS, LBP, or complex regional pain syndrome (CRPS) who have not responded to medications, therapy, and/or injections for ≥ 6 months were eligible for a trial of SCS therapy. Trial leads were placed via the percutaneous route with the battery strapped to the waistline for 3 to 5 days and were removed in clinic. Patients who experienced > 60% pain relief and functional improvement received a SCS implant.

The effectiveness of SCS has been demonstrated in a nonveteran population, but it has not been studied in a veteran population.12 US Department of Veterans Affairs (VA) health care coverage is different from Medicare and private insurance in that it is classified as a benefit and not insurance. The goals of treatment at the VA may include considerations in addition to feeling better, and patient presentations may not align with those in the private sector.

We hypothesize that SCS is both a safe and beneficial treatment option for veterans with chronic intractable spine and/or extremity pain. The purpose of this study was to determine the efficacy and safety of SCS in a veteran population.

Methods

The efficacy and safety of SCS was determined via a retrospective study. Inclusion criteria for the study consisted of any Southeastern Louisiana Veterans Health Care System (SLVHCS) patient who had an SCS trial and/or implant from 2008 to 2020. Eligible veterans must have had chronic pain for at least 6 months and had previously tried multiple medications, PT, transcutaneous nerve stimulation, facet injections, epidural steroid injections, or surgery without success. For medication therapy to be considered unsuccessful, it must have included acetaminophen, nonsteroidal anti-inflammatory drugs, and ≥ 1 adjuvant medication (gabapentin, duloxetine, amitriptyline, lidocaine, and menthol). A diagnosis of chronic LBP, PLS, cervical or lumbar spondylosis with radiculopathy, complex regional pain syndrome, or chronic pain syndrome was required for eligibility. Patients whose pain decreased by > 60% and had functional improvement in a 3- to 5-day trial received SCS implantation with percutaneous leads by a pain physician or paddle lead by a neurosurgeon.

The SLVHCS Institutional Review Board approved this study. Electronic health records were reviewed to determine patient age, anthropometric data, and date of SCS implantation. Patients were then called and interviewed to complete a survey. After obtaining verbal consent to the study, subjects were surveyed regarding whether the patient would recommend the procedure to peers, adverse effects (AEs) or complications, and the ability to decrease opiates if applicable. A verbal Pain Outcome Questionnaire (POQ) assessment of activities of daily living also was given during the phone interview regarding pain levels before SCS and at the time of the phone interview.13 (eAppendix available at doi:10.12788/fp.0204) Following the survey, a chart review was performed to corroborate the given AEs or complications and opiate use information. Before and after results of the POQ were compared via a paired sample t test, and P values < .05 were considered significant. Analyses were performed by IBM SPSS, version 26.

The primary outcome measure for this study was whether veterans would recommend SCS to their peers; in our view, this categorical outcome measure seemed to be more valuable to share with future patients who might be candidates for SCS. Since VA health care coverage and goals of treatment may be different from a nonveteran population, we opted to use this primary measure to decrease the possibility of confounding variables.

Secondary outcome measures included changes in POC scores, improvements in activities of daily living, and decreases in use of opioid pain medications.

POQ responses were recorded during the telephone interviews (0 to 10 scale). A paired sample t test was conducted to compare pain levels before and after SCS implant. Pain levels were gathered in the single phone call. Patient opioid usage, if applicable, was assessed by converting medications to morphine milligram equivalent dosing (MMED). Since patients who were on chronic opioids took multiple formulations, we changed the total daily dose to all morphine; for this study, morphine was considered equivalent to hydrocodone, and oxycodone was 1.5x morphine.

 

 

Results

Of the 90 SLVHCS patients who received an SCS implant between 2008 and 2020, 76 were reached by telephone and 65 had their responses recorded in the study. Of the 11 patients who were not included, 5 had the SCS removed; it is unclear whether these veterans would have recommended the treatment. Four were unable to quantify pain and/or SCS effects, and 2 were excluded due to a dementia diagnosis years after the implant. The mean (SD) age of participants was 63.9 (10.3) years. Forty percent of patients had a diabetes mellitus diagnosis and 1 had prediabetes. Patients’ most common qualifying diagnosis for SCS was PLS (47.7%) followed by chronic LBP (26.2%). A percutaneous 2-lead technique was the most common type of SCS type used (60.0%) followed by 1-lead (21.5%). The most common SCS manufacturer was Boston Scientific (87.7%)(Table 1). Most veterans (76.9%) recommended SCS to their peers; 13.8% did not recommend SCS; 9.2% were undecided and stated that they were unable to recommend because they did not want to persuade a peer to get SCS (Figure).

Patient Demographics

Do Veterans Recommend SCS to Their Peers?

There was a statistically significant decrease in opioid use for the 40 veterans for whom pain medication was converted (P < .001)(Table 2). Six patients reported using opioids at some point but could not remember their dose, and no records were found in their chart review, so they were not included in the MMED analysis. In that group, 4 patients reported using opioids before SCS but discontinued the opioid use after SCS implantation, and 2 patients noted using opioids before SCS and concomitantly. Eighteen subjects reported no opioid use at any point before or after SCS (Table 3).

There were few life-threatening complications of SCS. Three veterans developed skin dehiscence; 2 had dehiscence at the battery/generator site, and 1 had dehiscence at the lead anchor site. Two patients with dehiscence also had morbid obesity, and the third had postoperative malnourishment. The dehiscence occurred 3 and 8 months postoperation. All 3 patients with dehiscence had the SCS explanted, though they were eager to get a new SCS implanted as soon as possible because SCS was their most successful treatment to date.

MMED and BMI Before and After Implantation and Patient Pain Outcome Questionnaire Responses


Twenty of the 64 veterans surveyed reported other complications of SCS, including lead migration, lack of pain coverage, paresthesia and numbness, soreness around generator site, SCS shocking patient when performing full thoracic spine flexion, and shingles at the battery site (Table 4). There were 11 explants among the 76 veterans contacted. The primary reason for explant was lack of pain coverage.

Complications and Adverse Effects


Patient concerns included pain with sitting in chairs due to tenderness around the implant, SCS helping with physical pain but not mental pain, SCS only working during the day and not helping with sleep, and patients lacking education regarding possible complications of SCS.

Discussion

In this nonrandomized retrospective review, SCS was shown to be an effective treatment for intractable spine and/or extremity pain. Veterans’ pain levels were significantly reduced following SCS implantation, and more than three-fourths of veterans recommended SCS to their peers. We used the recommendation of SCS to peers as the most important metric regarding the effectiveness of SCS, as this measure was felt to be more valuable to share with future patients; furthermore, categorical analysis has been shown to be more valuable than ordinal pain scales to measure pain.14 In addition to wanting to expand the available research to the general public, we wanted a measure that we could easily relay to our patient population regarding SCS.

The explant rate of 14.5% among surveyed veterans falls at the higher end of the normal ranges found in previous studies of long-term SCS outcomes.15-17 One possible reason for the higher rate is that we did not differentiate based on the reason for the explant (ie, no benefit, further surgery needed for underlying medical condition, or SCS-specific complications). Another possible contributing factor to the higher than expected explant rate is the geographic location in the New Orleans metro area; New Orleans is considered to have one of the highest rates of obesity in the United States and obesity typically has other diseases associated with it such as hypertension and diabetes mellitus.

 

 

Limitations

Limitations of the study include the relatively low number of subjects, subjective nature of the interview questions, and the patients’ answers. Typically the POQ has been used as a prospective assessment of pain; whether it is valid in a retrospective analysis is not clear. While there was a statistically significant decrease of opioid use after getting SCS, this study can only show correlation, not causation. During the study period, there has been a drastic change in opioid prescribing patterns and efforts to decrease the amount of opioids prescribed.

Subjects also were asked to rate their pain and quality of life before SCS. Some subjects had SCS implantation up to 10 years prior to the phone interview. The variable amount of time between SCS implantation and interview likely affected subjects’ responses. Chronic pain is a moving target. Patients have good days and bad days that would likely change opinions on SCS benefits on a single phone interview. Some patients needed battery replacements at the time of the interview (battery life averaged about 3 to 5 years in our study population) and were asked to report current levels of pain from the perspective of when their batteries were still functional, further affecting results.

Conclusions

SCS was shown to improve the quality of life of US veterans at SLVHCS across a wide variety of metrics, including activities of daily living, as well as mental and physical health. For veterans with chronic intractable pain who have tried and failed more conservative treatments, SCS is a great treatment.

Lower back pain (LBP) affects an estimated 9.4% of the global population and has resulted in more years lived with disability than any other health condition.1 LBP affects a wide range of populations, but US veterans have been shown to have significantly higher rates of back pain than nonveterans. The National Institutes of Health reports that 65.6% of veterans experience chronic pain; 9.1% of veterans experience severe, chronic pain.2 Chronic back pain is treated by a range of methods, including medications, surgery, physical therapy (PT), patient education, and behavioral therapy.3 However, chronic neuropathic back pain has been shown to have limited responsiveness to medication.4

Neuropathic pain is caused by lesions in the somatosensory nervous system, resulting in spontaneous pain and amplified pain responses to both painful and nonpainful stimuli.5 The most common location for neuropathic pain is the back and legs. Between 10% and 40% of people who undergo lumbosacral spine surgery to treat neuropathic radicular pain will experience further neuropathic pain.6 This condition is referred to as failed back surgery syndrome or postlaminectomy syndrome (PLS). While neuropathic back pain has had limited responsiveness to medication and repeated lumbosacral spine surgery, spinal cord stimulation (SCS) has shown promise as an effective form of pain treatment for those experiencing PLS and other spine disorders.7-10 In addition, SCS therapy has had a very low incidence of complications, which may be on the decline with recent technological advancements.11 Patients with a diagnosis of PLS, LBP, or complex regional pain syndrome (CRPS) who have not responded to medications, therapy, and/or injections for ≥ 6 months were eligible for a trial of SCS therapy. Trial leads were placed via the percutaneous route with the battery strapped to the waistline for 3 to 5 days and were removed in clinic. Patients who experienced > 60% pain relief and functional improvement received a SCS implant.

The effectiveness of SCS has been demonstrated in a nonveteran population, but it has not been studied in a veteran population.12 US Department of Veterans Affairs (VA) health care coverage is different from Medicare and private insurance in that it is classified as a benefit and not insurance. The goals of treatment at the VA may include considerations in addition to feeling better, and patient presentations may not align with those in the private sector.

We hypothesize that SCS is both a safe and beneficial treatment option for veterans with chronic intractable spine and/or extremity pain. The purpose of this study was to determine the efficacy and safety of SCS in a veteran population.

Methods

The efficacy and safety of SCS was determined via a retrospective study. Inclusion criteria for the study consisted of any Southeastern Louisiana Veterans Health Care System (SLVHCS) patient who had an SCS trial and/or implant from 2008 to 2020. Eligible veterans must have had chronic pain for at least 6 months and had previously tried multiple medications, PT, transcutaneous nerve stimulation, facet injections, epidural steroid injections, or surgery without success. For medication therapy to be considered unsuccessful, it must have included acetaminophen, nonsteroidal anti-inflammatory drugs, and ≥ 1 adjuvant medication (gabapentin, duloxetine, amitriptyline, lidocaine, and menthol). A diagnosis of chronic LBP, PLS, cervical or lumbar spondylosis with radiculopathy, complex regional pain syndrome, or chronic pain syndrome was required for eligibility. Patients whose pain decreased by > 60% and had functional improvement in a 3- to 5-day trial received SCS implantation with percutaneous leads by a pain physician or paddle lead by a neurosurgeon.

The SLVHCS Institutional Review Board approved this study. Electronic health records were reviewed to determine patient age, anthropometric data, and date of SCS implantation. Patients were then called and interviewed to complete a survey. After obtaining verbal consent to the study, subjects were surveyed regarding whether the patient would recommend the procedure to peers, adverse effects (AEs) or complications, and the ability to decrease opiates if applicable. A verbal Pain Outcome Questionnaire (POQ) assessment of activities of daily living also was given during the phone interview regarding pain levels before SCS and at the time of the phone interview.13 (eAppendix available at doi:10.12788/fp.0204) Following the survey, a chart review was performed to corroborate the given AEs or complications and opiate use information. Before and after results of the POQ were compared via a paired sample t test, and P values < .05 were considered significant. Analyses were performed by IBM SPSS, version 26.

The primary outcome measure for this study was whether veterans would recommend SCS to their peers; in our view, this categorical outcome measure seemed to be more valuable to share with future patients who might be candidates for SCS. Since VA health care coverage and goals of treatment may be different from a nonveteran population, we opted to use this primary measure to decrease the possibility of confounding variables.

Secondary outcome measures included changes in POC scores, improvements in activities of daily living, and decreases in use of opioid pain medications.

POQ responses were recorded during the telephone interviews (0 to 10 scale). A paired sample t test was conducted to compare pain levels before and after SCS implant. Pain levels were gathered in the single phone call. Patient opioid usage, if applicable, was assessed by converting medications to morphine milligram equivalent dosing (MMED). Since patients who were on chronic opioids took multiple formulations, we changed the total daily dose to all morphine; for this study, morphine was considered equivalent to hydrocodone, and oxycodone was 1.5x morphine.

 

 

Results

Of the 90 SLVHCS patients who received an SCS implant between 2008 and 2020, 76 were reached by telephone and 65 had their responses recorded in the study. Of the 11 patients who were not included, 5 had the SCS removed; it is unclear whether these veterans would have recommended the treatment. Four were unable to quantify pain and/or SCS effects, and 2 were excluded due to a dementia diagnosis years after the implant. The mean (SD) age of participants was 63.9 (10.3) years. Forty percent of patients had a diabetes mellitus diagnosis and 1 had prediabetes. Patients’ most common qualifying diagnosis for SCS was PLS (47.7%) followed by chronic LBP (26.2%). A percutaneous 2-lead technique was the most common type of SCS type used (60.0%) followed by 1-lead (21.5%). The most common SCS manufacturer was Boston Scientific (87.7%)(Table 1). Most veterans (76.9%) recommended SCS to their peers; 13.8% did not recommend SCS; 9.2% were undecided and stated that they were unable to recommend because they did not want to persuade a peer to get SCS (Figure).

Patient Demographics

Do Veterans Recommend SCS to Their Peers?

There was a statistically significant decrease in opioid use for the 40 veterans for whom pain medication was converted (P < .001)(Table 2). Six patients reported using opioids at some point but could not remember their dose, and no records were found in their chart review, so they were not included in the MMED analysis. In that group, 4 patients reported using opioids before SCS but discontinued the opioid use after SCS implantation, and 2 patients noted using opioids before SCS and concomitantly. Eighteen subjects reported no opioid use at any point before or after SCS (Table 3).

There were few life-threatening complications of SCS. Three veterans developed skin dehiscence; 2 had dehiscence at the battery/generator site, and 1 had dehiscence at the lead anchor site. Two patients with dehiscence also had morbid obesity, and the third had postoperative malnourishment. The dehiscence occurred 3 and 8 months postoperation. All 3 patients with dehiscence had the SCS explanted, though they were eager to get a new SCS implanted as soon as possible because SCS was their most successful treatment to date.

MMED and BMI Before and After Implantation and Patient Pain Outcome Questionnaire Responses


Twenty of the 64 veterans surveyed reported other complications of SCS, including lead migration, lack of pain coverage, paresthesia and numbness, soreness around generator site, SCS shocking patient when performing full thoracic spine flexion, and shingles at the battery site (Table 4). There were 11 explants among the 76 veterans contacted. The primary reason for explant was lack of pain coverage.

Complications and Adverse Effects


Patient concerns included pain with sitting in chairs due to tenderness around the implant, SCS helping with physical pain but not mental pain, SCS only working during the day and not helping with sleep, and patients lacking education regarding possible complications of SCS.

Discussion

In this nonrandomized retrospective review, SCS was shown to be an effective treatment for intractable spine and/or extremity pain. Veterans’ pain levels were significantly reduced following SCS implantation, and more than three-fourths of veterans recommended SCS to their peers. We used the recommendation of SCS to peers as the most important metric regarding the effectiveness of SCS, as this measure was felt to be more valuable to share with future patients; furthermore, categorical analysis has been shown to be more valuable than ordinal pain scales to measure pain.14 In addition to wanting to expand the available research to the general public, we wanted a measure that we could easily relay to our patient population regarding SCS.

The explant rate of 14.5% among surveyed veterans falls at the higher end of the normal ranges found in previous studies of long-term SCS outcomes.15-17 One possible reason for the higher rate is that we did not differentiate based on the reason for the explant (ie, no benefit, further surgery needed for underlying medical condition, or SCS-specific complications). Another possible contributing factor to the higher than expected explant rate is the geographic location in the New Orleans metro area; New Orleans is considered to have one of the highest rates of obesity in the United States and obesity typically has other diseases associated with it such as hypertension and diabetes mellitus.

 

 

Limitations

Limitations of the study include the relatively low number of subjects, subjective nature of the interview questions, and the patients’ answers. Typically the POQ has been used as a prospective assessment of pain; whether it is valid in a retrospective analysis is not clear. While there was a statistically significant decrease of opioid use after getting SCS, this study can only show correlation, not causation. During the study period, there has been a drastic change in opioid prescribing patterns and efforts to decrease the amount of opioids prescribed.

Subjects also were asked to rate their pain and quality of life before SCS. Some subjects had SCS implantation up to 10 years prior to the phone interview. The variable amount of time between SCS implantation and interview likely affected subjects’ responses. Chronic pain is a moving target. Patients have good days and bad days that would likely change opinions on SCS benefits on a single phone interview. Some patients needed battery replacements at the time of the interview (battery life averaged about 3 to 5 years in our study population) and were asked to report current levels of pain from the perspective of when their batteries were still functional, further affecting results.

Conclusions

SCS was shown to improve the quality of life of US veterans at SLVHCS across a wide variety of metrics, including activities of daily living, as well as mental and physical health. For veterans with chronic intractable pain who have tried and failed more conservative treatments, SCS is a great treatment.

References

1. Hoy DG, Smith E, Cross M, et al. The global burden of musculoskeletal conditions for 2010: an overview of methods. Ann Rheum Dis. 2014;73(6):982-989 doi:10.1136/annrheumdis-2013-204344

2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021

3. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.

4. Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162-173. doi:10.1016/S1474-4422(14)70251-0

5. Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1-32. doi:10.1146/annurev.neuro.051508.135531

6. Wilkinson HA. The Failed Back Syndrome: Etiology and Therapy. 2nd ed. Harper & Row; 1991.

7. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188. doi:10.1016/j.pain.2007.07.028

8. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-107. doi:10.1227/01.neu.0000144839.65524.e0

9. Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AG, van Kleef M. Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. Neuromodulation. 2013;16(6):523-529. doi:10.1111/ner.12024

10. Kumar K, Rizvi S, Bnurs SB. Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction. Neurosurgery. 2011;69(3):566-5580. doi:10.1227/NEU.0b013e3182181e60

11. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. 2011;11(2):148-153. doi:10.1111/j.1533-2500.2010.00407.x

12. Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low back pain relief compared to traditional SCS-LUMINA Study. Pain Med. 2017;18(8):1534-1548. doi:10.1093/pm/pnw286

13. Gordon DB, Polomano RC, Pellino TA, et al. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010;11(11):1172-1186. doi:10.1016/j.jpain.2010.02.012

14. Kennedy DJ, Schneider B. Lies, damn lies, and statistic: a commentary. Pain Med. 2020;21(10):2052-2054. doi:10.1093/pm/pnaa287

15. Van Buyten JP, Wille F, Smet I, et al. Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study. Neuromodulation. 2017;20(7):642-649. doi:10.1111/ner.12642

16. Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation. 2015;18(7):603-609. doi:10.1111/ner.12312

17. Pope JE, Deer TR, Falowski S, et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation. 2017;20(6):543-552. doi:10.1111/ner.12634

References

1. Hoy DG, Smith E, Cross M, et al. The global burden of musculoskeletal conditions for 2010: an overview of methods. Ann Rheum Dis. 2014;73(6):982-989 doi:10.1136/annrheumdis-2013-204344

2. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017;18(3):247-254. doi:10.1016/j.jpain.2016.10.021

3. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies Press; 2011.

4. Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015;14(2):162-173. doi:10.1016/S1474-4422(14)70251-0

5. Costigan M, Scholz J, Woolf CJ. Neuropathic pain: a maladaptive response of the nervous system to damage. Annu Rev Neurosci. 2009;32:1-32. doi:10.1146/annurev.neuro.051508.135531

6. Wilkinson HA. The Failed Back Syndrome: Etiology and Therapy. 2nd ed. Harper & Row; 1991.

7. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188. doi:10.1016/j.pain.2007.07.028

8. North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-107. doi:10.1227/01.neu.0000144839.65524.e0

9. Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AG, van Kleef M. Spinal cord stimulation for complex regional pain syndrome type I: a prospective cohort study with long-term follow-up. Neuromodulation. 2013;16(6):523-529. doi:10.1111/ner.12024

10. Kumar K, Rizvi S, Bnurs SB. Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction. Neurosurgery. 2011;69(3):566-5580. doi:10.1227/NEU.0b013e3182181e60

11. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. 2011;11(2):148-153. doi:10.1111/j.1533-2500.2010.00407.x

12. Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low back pain relief compared to traditional SCS-LUMINA Study. Pain Med. 2017;18(8):1534-1548. doi:10.1093/pm/pnw286

13. Gordon DB, Polomano RC, Pellino TA, et al. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010;11(11):1172-1186. doi:10.1016/j.jpain.2010.02.012

14. Kennedy DJ, Schneider B. Lies, damn lies, and statistic: a commentary. Pain Med. 2020;21(10):2052-2054. doi:10.1093/pm/pnaa287

15. Van Buyten JP, Wille F, Smet I, et al. Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study. Neuromodulation. 2017;20(7):642-649. doi:10.1111/ner.12642

16. Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation. 2015;18(7):603-609. doi:10.1111/ner.12312

17. Pope JE, Deer TR, Falowski S, et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation. 2017;20(6):543-552. doi:10.1111/ner.12634

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Rotating Hinge Distal Femur Replacement: A Turn for the Worse

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Thu, 01/27/2022 - 15:35

Preoperatively periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component is a rare event, and knowledge of this possible complication is important for arthroplasty surgeons.

The use of a rotating hinge distal femur replacement (DFR) for significant bone and soft tissue defects in the setting of total knee arthroplasty (TKA) revision has become increasingly more common. Although significant advancements have been made in modern DFR components, complications and failure rates remain high. The unanticipated early failure presented serves as the first reported case in the literature to our knowledge of a 180° rotation of a press-fit DFR.

Originally, DFRs were used primarily for oncology patients with substantial bone loss following large mass excisions. The utility of DFRs has grown to include massive bone loss in the setting of TKA revision, periprosthetic fractures, and periprosthetic joint infections.1-3 DFRs help restore the joint line in the setting of significant bone loss and contain a rotating hinge mechanism that provides functional movement despite the loss of soft tissue constraints around the knee.1-3

DFRs have been associated with early postoperative mobilization and decreased need for ambulatory devices at 1 year in revision TKA and periprosthetic and geriatric distal femur fractures.4-6 Advances in prosthetic design, biomechanics, and fixation technique have led to improved survival rates.3 Despite these improvements, the overall complication rate remains high at 30 to 40%.3-7 Commonly reported complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.3,4,7 Recent case studies also have reported on dislocation or disengagement of the rotating hinge.8-11

In this case report, we present a patient who had a DFR as the second stage of a 2-stage TKA revision due to a periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component. Although this is a rare event, knowledge of this possible complication is important for arthroplasty surgeons.

Case Presentation

A patient with a history of hypertension, osteopenia, and rheumatoid arthritis underwent a primary right TKA in 2007. Ten weeks postoperatively, the patient had a ground-level fall that resulted in a right periprosthetic supracondylar distal femur fracture that was treated with a distal femur locking plate. The patient healed, however, with a significant golf club deformity (Figure 1). The patient did well for more than a decade but in 2019 was admitted with pelvic inflammatory disease and adnexal abscess that was treated with broad-spectrum IV antibiotics. Shortly after this admission, the patient developed a right knee periprosthetic infection with cultures positive for Ureaplasma parvum.

Lateral Radiographs

The patient then underwent a 2-stage revision of the infected TKA. Stage 1 consisted of explant of the TKA components as well as removal of the distal femur plate and screws and placement of an articulating antibiotic cement spacer (Figure 2). The patient completed 6 weeks of IV antibiotics. Following completion of the antibiotic course, we obtained a serum erythrocyte sedimentation rate, C-reactive protein level, and white blood cell count, which were all within normal limits. A knee aspiration was performed and did not show signs of residual infection. Frozen histopathology was sent during the second stage of the revision and did not show infection. After the results of the frozen histopathology returned, the antibiotic spacer was removed, and the femoral canal was thoroughly debrided. Cement and fibrous tissue in the femoral canal were carefully removed. In the setting of significant bone loss and soft tissue compromise due to the previous infection and distal femur fracture, the Zimmer Biomet Orthopedic Salvage System (OSS) with porous coated press-fit elliptical femoral stem was utilized.

The femoral canal was reamed until good cortical chatter was obtained at 16 mm. Per the Biomet OSS guide, “For bowed (curved) long and short press-fit stems, the final flexible reamer shaft diameter may need to be larger than the definitive trial and implant diameter.” After trialing, size 15.5 mm was selected for implantation. Intraoperatively the final stem was noted to have good interference fit after insertion and was stable throughout knee range of motion and varus/valgus stress testing. The patient did well with mobilization while in the hospital postoperatively and was discharged home (Figure 3).

Five days after discharge, the patient kicked the repaired knee onto a chair for rest and elevation and experienced extreme pain and was unable to flex the knee. On presentation to the emergency department, the X-rays showed 180° rotation around the longitudinal axis of the femoral component without any other obvious component failure or fracture (Figure 4). The patient was taken back to surgery the following day. Intraoperatively, the femoral stem was found to be loose and rotated 180° (Figure 5). No failure or dislocation of the tibial or rotating hinge components were identified. The press-fit femoral stem was removed and replaced with a cemented stem (Figure 6).

Lateral Radiographs and Intraoperative Photograph


The postoperative course after the revision surgery was uneventful, and the patient is doing well clinically with no pain, functional range of motion of 5 to 105°, and has returned to regular activities without difficulty.

 

 

Discussion

Despite advancements in DFRs and increasing use in the setting of revision TKA, the procedure remains high risk with respect to postoperative complications.3-7 Vertesich and colleagues demonstrated that 43.3% of patients who underwent DFR for failed TKA developed at least 1 postoperative complication that required a return to the operating room.7Physicians need to be aware of the high rate of complications and counsel patients appropriately preoperatively.

Complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.4,7 Soft tissue failures include insufficiency or rupture of the extensor mechanism and patella dislocation.4,7 Structural failures include fracture of the hinge mechanism, dissociation of the component from the stem, rotating hinge-bushing failure, and dislocation of the hinge.4,7 In the acute postoperative period, the most common complications are infection and rotating-hinge dislocation/failure.3,12 There are various component options available for DFRs, including straight vs curved, cemented vs cementless/press-fit, and long vs short stems.13 Studies have sought to elucidate the ideal implant to decrease the rate of complications. Lu and colleagues demonstrated that curved press-fit short stems provided a stable interface without loosening over the short term (2 years) in 42 patients.13 No implant failures or incidences of aseptic loosening occurred in their study.13

The implant used in this case was a curved press-fit short-stem DFR. It was thought that this patient was young and with good enough bone quality that a press-fit short stem would be best in preserving bone stock. Both the technique guide and literature support reaming 0 to 2 mm greater than the planned stem size to accommodate the implant curvature.13 In this case, the intramedullary canal was reamed 0.5 mm larger than the curved stem that was implanted (16 mm and 15.5 mm, respectively). Intraoperatively during the index DFR, the component was stable and seemed to have a good press-fit interface. Despite this, obvious loosening of the component occurred with a relatively low-energy mechanism when the patient kicked the leg onto a chair, causing just enough force and femoral rotation to result in 180° rotation of the component.

Conclusions

We present this case report to make surgeons aware of this rare but serious complication. Although the final implant is a porous and curved stem, careful attention should be made during trialing to use the best-fitting implant to prevent this complication. If an adequate interference fit cannot be obtained, cementing the component may be required to prevent its loosening and catastrophic failure.

References

1. Sculco PK, Abdel MP, Hanssen AD, Lewallen DG. The management of bone loss in revision total knee arthroplasty: rebuild, reinforce, and augment. Bone Joint J. 2016;98-B(1 suppl A):120-124. doi:10.1302/0301-620X.98B1.36345

2. Harrison RJ Jr, Thacker MM, Pitcher JD, Temple HT, Scully SP. Distal femur replacement is useful in complex total knee arthroplasty revisions. Clin Orthop Relat Res. 2006;446:113-120. doi:10.1097/01.blo.0000214433.64774.1b

3. Smith EL, Shah A, Son SJ, et al. Survivorship of megaprostheses in revision hip and knee arthroplasty for septic and aseptic indications: a retrospective, multicenter study with minimum 2-year follow-up. Arthroplast Today. 2020;6(3):475-479. Published 2020 Jun 29. doi:10.1016/j.artd.2020.05.004

4. Wyles CC, Tibbo ME, Yuan BJ, Trousdale RT, Berry DJ, Abdel MP. Long-term results of total knee arthroplasty with contemporary distal femoral replacement. J Bone Joint Surg Am. 2020;102(1):45-51. doi:10.2106/JBJS.19.00489

5. Haidukewych GJ. Role of distal femoral replacement for periprosthetic fractures above a total knee arthroplasty: when and how?, J Orthop Trauma. 2019;33(suppl 6):S33-S35. doi:10.1097/BOT.0000000000001566

6. Hart GP, Kneisl JS, Springer BD, Patt JC, Karunakar MA. Open reduction vs distal femoral replacement arthroplasty for comminuted distal femur fractures in the patients 70 years and older: J Arthroplasty. 2017;32(1):202-206. doi:10.1016/j.arth.2016.06.006

7. Vertesich K, Puchner SE, Staats K, et al. Distal femoral reconstruction following failed total knee arthroplasty is accompanied with risk for complication and reduced joint function. BMC Musculoskelet Disord. 2019 Jan 31;20(1):47-54. doi:10.1186/s12891-019-2432-4

8. Biswas D, Haughom B, Mayle RE Jr, Della Valle CJ. Case report: Failure of rotating-hinge total knee prosthesis by disengagement of the hinge-post extension. Clin Orthop Relat Res. 2013;471(4):1389-1392. doi:10.1007/s11999-012-2736-2

9. Ward WG, Haight D, Ritchie P, Gordon S, Eckardt JJ. Dislocation of rotating hinge knee prostheses. A report of four cases. J Bone Joint Surg Am. 2005;87(5):1108-1112. doi:10.2106/JBJS.00837pp

10. Pacha-Vicente D, Malik A, Castellet-Feliu E, Nardi-Vilardaga J. Dislocation of rotating-hinge knee prostheses with antidislocation mechanism. J Arthroplasty. 2008;23(2):299-303. doi:10.1016/j.arth.2006.11.020

11. Manzano G, Schwarzkopf R. Posterior dislocation of the hinge-post extension in a rotating hinge total knee prosthesis. Case Rep Orthop. 2013;2013:756538. doi:10.1155/2013/756538

12. Vaishya R., Thapa, SS, Vaish A. Non-neoplastic indications and outcomes of the proximal and distal femur megaprosthesis: a critical review. Knee Surg Relat Res. 2020;32(1):18. Published 2020 Apr 9. doi:10.1186/s43019-020-00034-7

13. Lu M, Wang J, Xiao C, et al. Uncemented, curved, short endoprosthesis stem for distal femoral reconstruction: early follow-up outcomes. World J Surg Onc. 2018;16(1):183. doi:10.1186/s12957-018-1486-3

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations— including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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The authors report that they received verbal consent. The authors also report that the patient did not provide written informed consent to report this case in the literature. Details about the patient and the case have been changed to avoid identification.

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The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations— including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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The authors report that they received verbal consent. The authors also report that the patient did not provide written informed consent to report this case in the literature. Details about the patient and the case have been changed to avoid identification.

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Bryce N. Clinger, MDa; Kathryn C. Helmig, MDa; Scott Plaster, MDa; and Kenneth Yaw, MDb
Correspondence:
Bryce Clinger ([email protected])

Author affiliations

aDepartment of Orthopaedics and Rehabilitation, University of New Mexico, Albuquerque bDepartment of Orthopaedics, US Department of Veterans Affairs New Mexico Healthcare System, Albuquerque

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations— including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Ethics and consent

The authors report that they received verbal consent. The authors also report that the patient did not provide written informed consent to report this case in the literature. Details about the patient and the case have been changed to avoid identification.

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Related Articles

Preoperatively periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component is a rare event, and knowledge of this possible complication is important for arthroplasty surgeons.

Preoperatively periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component is a rare event, and knowledge of this possible complication is important for arthroplasty surgeons.

The use of a rotating hinge distal femur replacement (DFR) for significant bone and soft tissue defects in the setting of total knee arthroplasty (TKA) revision has become increasingly more common. Although significant advancements have been made in modern DFR components, complications and failure rates remain high. The unanticipated early failure presented serves as the first reported case in the literature to our knowledge of a 180° rotation of a press-fit DFR.

Originally, DFRs were used primarily for oncology patients with substantial bone loss following large mass excisions. The utility of DFRs has grown to include massive bone loss in the setting of TKA revision, periprosthetic fractures, and periprosthetic joint infections.1-3 DFRs help restore the joint line in the setting of significant bone loss and contain a rotating hinge mechanism that provides functional movement despite the loss of soft tissue constraints around the knee.1-3

DFRs have been associated with early postoperative mobilization and decreased need for ambulatory devices at 1 year in revision TKA and periprosthetic and geriatric distal femur fractures.4-6 Advances in prosthetic design, biomechanics, and fixation technique have led to improved survival rates.3 Despite these improvements, the overall complication rate remains high at 30 to 40%.3-7 Commonly reported complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.3,4,7 Recent case studies also have reported on dislocation or disengagement of the rotating hinge.8-11

In this case report, we present a patient who had a DFR as the second stage of a 2-stage TKA revision due to a periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component. Although this is a rare event, knowledge of this possible complication is important for arthroplasty surgeons.

Case Presentation

A patient with a history of hypertension, osteopenia, and rheumatoid arthritis underwent a primary right TKA in 2007. Ten weeks postoperatively, the patient had a ground-level fall that resulted in a right periprosthetic supracondylar distal femur fracture that was treated with a distal femur locking plate. The patient healed, however, with a significant golf club deformity (Figure 1). The patient did well for more than a decade but in 2019 was admitted with pelvic inflammatory disease and adnexal abscess that was treated with broad-spectrum IV antibiotics. Shortly after this admission, the patient developed a right knee periprosthetic infection with cultures positive for Ureaplasma parvum.

Lateral Radiographs

The patient then underwent a 2-stage revision of the infected TKA. Stage 1 consisted of explant of the TKA components as well as removal of the distal femur plate and screws and placement of an articulating antibiotic cement spacer (Figure 2). The patient completed 6 weeks of IV antibiotics. Following completion of the antibiotic course, we obtained a serum erythrocyte sedimentation rate, C-reactive protein level, and white blood cell count, which were all within normal limits. A knee aspiration was performed and did not show signs of residual infection. Frozen histopathology was sent during the second stage of the revision and did not show infection. After the results of the frozen histopathology returned, the antibiotic spacer was removed, and the femoral canal was thoroughly debrided. Cement and fibrous tissue in the femoral canal were carefully removed. In the setting of significant bone loss and soft tissue compromise due to the previous infection and distal femur fracture, the Zimmer Biomet Orthopedic Salvage System (OSS) with porous coated press-fit elliptical femoral stem was utilized.

The femoral canal was reamed until good cortical chatter was obtained at 16 mm. Per the Biomet OSS guide, “For bowed (curved) long and short press-fit stems, the final flexible reamer shaft diameter may need to be larger than the definitive trial and implant diameter.” After trialing, size 15.5 mm was selected for implantation. Intraoperatively the final stem was noted to have good interference fit after insertion and was stable throughout knee range of motion and varus/valgus stress testing. The patient did well with mobilization while in the hospital postoperatively and was discharged home (Figure 3).

Five days after discharge, the patient kicked the repaired knee onto a chair for rest and elevation and experienced extreme pain and was unable to flex the knee. On presentation to the emergency department, the X-rays showed 180° rotation around the longitudinal axis of the femoral component without any other obvious component failure or fracture (Figure 4). The patient was taken back to surgery the following day. Intraoperatively, the femoral stem was found to be loose and rotated 180° (Figure 5). No failure or dislocation of the tibial or rotating hinge components were identified. The press-fit femoral stem was removed and replaced with a cemented stem (Figure 6).

Lateral Radiographs and Intraoperative Photograph


The postoperative course after the revision surgery was uneventful, and the patient is doing well clinically with no pain, functional range of motion of 5 to 105°, and has returned to regular activities without difficulty.

 

 

Discussion

Despite advancements in DFRs and increasing use in the setting of revision TKA, the procedure remains high risk with respect to postoperative complications.3-7 Vertesich and colleagues demonstrated that 43.3% of patients who underwent DFR for failed TKA developed at least 1 postoperative complication that required a return to the operating room.7Physicians need to be aware of the high rate of complications and counsel patients appropriately preoperatively.

Complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.4,7 Soft tissue failures include insufficiency or rupture of the extensor mechanism and patella dislocation.4,7 Structural failures include fracture of the hinge mechanism, dissociation of the component from the stem, rotating hinge-bushing failure, and dislocation of the hinge.4,7 In the acute postoperative period, the most common complications are infection and rotating-hinge dislocation/failure.3,12 There are various component options available for DFRs, including straight vs curved, cemented vs cementless/press-fit, and long vs short stems.13 Studies have sought to elucidate the ideal implant to decrease the rate of complications. Lu and colleagues demonstrated that curved press-fit short stems provided a stable interface without loosening over the short term (2 years) in 42 patients.13 No implant failures or incidences of aseptic loosening occurred in their study.13

The implant used in this case was a curved press-fit short-stem DFR. It was thought that this patient was young and with good enough bone quality that a press-fit short stem would be best in preserving bone stock. Both the technique guide and literature support reaming 0 to 2 mm greater than the planned stem size to accommodate the implant curvature.13 In this case, the intramedullary canal was reamed 0.5 mm larger than the curved stem that was implanted (16 mm and 15.5 mm, respectively). Intraoperatively during the index DFR, the component was stable and seemed to have a good press-fit interface. Despite this, obvious loosening of the component occurred with a relatively low-energy mechanism when the patient kicked the leg onto a chair, causing just enough force and femoral rotation to result in 180° rotation of the component.

Conclusions

We present this case report to make surgeons aware of this rare but serious complication. Although the final implant is a porous and curved stem, careful attention should be made during trialing to use the best-fitting implant to prevent this complication. If an adequate interference fit cannot be obtained, cementing the component may be required to prevent its loosening and catastrophic failure.

The use of a rotating hinge distal femur replacement (DFR) for significant bone and soft tissue defects in the setting of total knee arthroplasty (TKA) revision has become increasingly more common. Although significant advancements have been made in modern DFR components, complications and failure rates remain high. The unanticipated early failure presented serves as the first reported case in the literature to our knowledge of a 180° rotation of a press-fit DFR.

Originally, DFRs were used primarily for oncology patients with substantial bone loss following large mass excisions. The utility of DFRs has grown to include massive bone loss in the setting of TKA revision, periprosthetic fractures, and periprosthetic joint infections.1-3 DFRs help restore the joint line in the setting of significant bone loss and contain a rotating hinge mechanism that provides functional movement despite the loss of soft tissue constraints around the knee.1-3

DFRs have been associated with early postoperative mobilization and decreased need for ambulatory devices at 1 year in revision TKA and periprosthetic and geriatric distal femur fractures.4-6 Advances in prosthetic design, biomechanics, and fixation technique have led to improved survival rates.3 Despite these improvements, the overall complication rate remains high at 30 to 40%.3-7 Commonly reported complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.3,4,7 Recent case studies also have reported on dislocation or disengagement of the rotating hinge.8-11

In this case report, we present a patient who had a DFR as the second stage of a 2-stage TKA revision due to a periprosthetic joint infection with a postoperative complication of 180° rotation of the press-fit femoral component. Although this is a rare event, knowledge of this possible complication is important for arthroplasty surgeons.

Case Presentation

A patient with a history of hypertension, osteopenia, and rheumatoid arthritis underwent a primary right TKA in 2007. Ten weeks postoperatively, the patient had a ground-level fall that resulted in a right periprosthetic supracondylar distal femur fracture that was treated with a distal femur locking plate. The patient healed, however, with a significant golf club deformity (Figure 1). The patient did well for more than a decade but in 2019 was admitted with pelvic inflammatory disease and adnexal abscess that was treated with broad-spectrum IV antibiotics. Shortly after this admission, the patient developed a right knee periprosthetic infection with cultures positive for Ureaplasma parvum.

Lateral Radiographs

The patient then underwent a 2-stage revision of the infected TKA. Stage 1 consisted of explant of the TKA components as well as removal of the distal femur plate and screws and placement of an articulating antibiotic cement spacer (Figure 2). The patient completed 6 weeks of IV antibiotics. Following completion of the antibiotic course, we obtained a serum erythrocyte sedimentation rate, C-reactive protein level, and white blood cell count, which were all within normal limits. A knee aspiration was performed and did not show signs of residual infection. Frozen histopathology was sent during the second stage of the revision and did not show infection. After the results of the frozen histopathology returned, the antibiotic spacer was removed, and the femoral canal was thoroughly debrided. Cement and fibrous tissue in the femoral canal were carefully removed. In the setting of significant bone loss and soft tissue compromise due to the previous infection and distal femur fracture, the Zimmer Biomet Orthopedic Salvage System (OSS) with porous coated press-fit elliptical femoral stem was utilized.

The femoral canal was reamed until good cortical chatter was obtained at 16 mm. Per the Biomet OSS guide, “For bowed (curved) long and short press-fit stems, the final flexible reamer shaft diameter may need to be larger than the definitive trial and implant diameter.” After trialing, size 15.5 mm was selected for implantation. Intraoperatively the final stem was noted to have good interference fit after insertion and was stable throughout knee range of motion and varus/valgus stress testing. The patient did well with mobilization while in the hospital postoperatively and was discharged home (Figure 3).

Five days after discharge, the patient kicked the repaired knee onto a chair for rest and elevation and experienced extreme pain and was unable to flex the knee. On presentation to the emergency department, the X-rays showed 180° rotation around the longitudinal axis of the femoral component without any other obvious component failure or fracture (Figure 4). The patient was taken back to surgery the following day. Intraoperatively, the femoral stem was found to be loose and rotated 180° (Figure 5). No failure or dislocation of the tibial or rotating hinge components were identified. The press-fit femoral stem was removed and replaced with a cemented stem (Figure 6).

Lateral Radiographs and Intraoperative Photograph


The postoperative course after the revision surgery was uneventful, and the patient is doing well clinically with no pain, functional range of motion of 5 to 105°, and has returned to regular activities without difficulty.

 

 

Discussion

Despite advancements in DFRs and increasing use in the setting of revision TKA, the procedure remains high risk with respect to postoperative complications.3-7 Vertesich and colleagues demonstrated that 43.3% of patients who underwent DFR for failed TKA developed at least 1 postoperative complication that required a return to the operating room.7Physicians need to be aware of the high rate of complications and counsel patients appropriately preoperatively.

Complications after DFR include infection, aseptic loosening, soft tissue failure, and structural failure.4,7 Soft tissue failures include insufficiency or rupture of the extensor mechanism and patella dislocation.4,7 Structural failures include fracture of the hinge mechanism, dissociation of the component from the stem, rotating hinge-bushing failure, and dislocation of the hinge.4,7 In the acute postoperative period, the most common complications are infection and rotating-hinge dislocation/failure.3,12 There are various component options available for DFRs, including straight vs curved, cemented vs cementless/press-fit, and long vs short stems.13 Studies have sought to elucidate the ideal implant to decrease the rate of complications. Lu and colleagues demonstrated that curved press-fit short stems provided a stable interface without loosening over the short term (2 years) in 42 patients.13 No implant failures or incidences of aseptic loosening occurred in their study.13

The implant used in this case was a curved press-fit short-stem DFR. It was thought that this patient was young and with good enough bone quality that a press-fit short stem would be best in preserving bone stock. Both the technique guide and literature support reaming 0 to 2 mm greater than the planned stem size to accommodate the implant curvature.13 In this case, the intramedullary canal was reamed 0.5 mm larger than the curved stem that was implanted (16 mm and 15.5 mm, respectively). Intraoperatively during the index DFR, the component was stable and seemed to have a good press-fit interface. Despite this, obvious loosening of the component occurred with a relatively low-energy mechanism when the patient kicked the leg onto a chair, causing just enough force and femoral rotation to result in 180° rotation of the component.

Conclusions

We present this case report to make surgeons aware of this rare but serious complication. Although the final implant is a porous and curved stem, careful attention should be made during trialing to use the best-fitting implant to prevent this complication. If an adequate interference fit cannot be obtained, cementing the component may be required to prevent its loosening and catastrophic failure.

References

1. Sculco PK, Abdel MP, Hanssen AD, Lewallen DG. The management of bone loss in revision total knee arthroplasty: rebuild, reinforce, and augment. Bone Joint J. 2016;98-B(1 suppl A):120-124. doi:10.1302/0301-620X.98B1.36345

2. Harrison RJ Jr, Thacker MM, Pitcher JD, Temple HT, Scully SP. Distal femur replacement is useful in complex total knee arthroplasty revisions. Clin Orthop Relat Res. 2006;446:113-120. doi:10.1097/01.blo.0000214433.64774.1b

3. Smith EL, Shah A, Son SJ, et al. Survivorship of megaprostheses in revision hip and knee arthroplasty for septic and aseptic indications: a retrospective, multicenter study with minimum 2-year follow-up. Arthroplast Today. 2020;6(3):475-479. Published 2020 Jun 29. doi:10.1016/j.artd.2020.05.004

4. Wyles CC, Tibbo ME, Yuan BJ, Trousdale RT, Berry DJ, Abdel MP. Long-term results of total knee arthroplasty with contemporary distal femoral replacement. J Bone Joint Surg Am. 2020;102(1):45-51. doi:10.2106/JBJS.19.00489

5. Haidukewych GJ. Role of distal femoral replacement for periprosthetic fractures above a total knee arthroplasty: when and how?, J Orthop Trauma. 2019;33(suppl 6):S33-S35. doi:10.1097/BOT.0000000000001566

6. Hart GP, Kneisl JS, Springer BD, Patt JC, Karunakar MA. Open reduction vs distal femoral replacement arthroplasty for comminuted distal femur fractures in the patients 70 years and older: J Arthroplasty. 2017;32(1):202-206. doi:10.1016/j.arth.2016.06.006

7. Vertesich K, Puchner SE, Staats K, et al. Distal femoral reconstruction following failed total knee arthroplasty is accompanied with risk for complication and reduced joint function. BMC Musculoskelet Disord. 2019 Jan 31;20(1):47-54. doi:10.1186/s12891-019-2432-4

8. Biswas D, Haughom B, Mayle RE Jr, Della Valle CJ. Case report: Failure of rotating-hinge total knee prosthesis by disengagement of the hinge-post extension. Clin Orthop Relat Res. 2013;471(4):1389-1392. doi:10.1007/s11999-012-2736-2

9. Ward WG, Haight D, Ritchie P, Gordon S, Eckardt JJ. Dislocation of rotating hinge knee prostheses. A report of four cases. J Bone Joint Surg Am. 2005;87(5):1108-1112. doi:10.2106/JBJS.00837pp

10. Pacha-Vicente D, Malik A, Castellet-Feliu E, Nardi-Vilardaga J. Dislocation of rotating-hinge knee prostheses with antidislocation mechanism. J Arthroplasty. 2008;23(2):299-303. doi:10.1016/j.arth.2006.11.020

11. Manzano G, Schwarzkopf R. Posterior dislocation of the hinge-post extension in a rotating hinge total knee prosthesis. Case Rep Orthop. 2013;2013:756538. doi:10.1155/2013/756538

12. Vaishya R., Thapa, SS, Vaish A. Non-neoplastic indications and outcomes of the proximal and distal femur megaprosthesis: a critical review. Knee Surg Relat Res. 2020;32(1):18. Published 2020 Apr 9. doi:10.1186/s43019-020-00034-7

13. Lu M, Wang J, Xiao C, et al. Uncemented, curved, short endoprosthesis stem for distal femoral reconstruction: early follow-up outcomes. World J Surg Onc. 2018;16(1):183. doi:10.1186/s12957-018-1486-3

References

1. Sculco PK, Abdel MP, Hanssen AD, Lewallen DG. The management of bone loss in revision total knee arthroplasty: rebuild, reinforce, and augment. Bone Joint J. 2016;98-B(1 suppl A):120-124. doi:10.1302/0301-620X.98B1.36345

2. Harrison RJ Jr, Thacker MM, Pitcher JD, Temple HT, Scully SP. Distal femur replacement is useful in complex total knee arthroplasty revisions. Clin Orthop Relat Res. 2006;446:113-120. doi:10.1097/01.blo.0000214433.64774.1b

3. Smith EL, Shah A, Son SJ, et al. Survivorship of megaprostheses in revision hip and knee arthroplasty for septic and aseptic indications: a retrospective, multicenter study with minimum 2-year follow-up. Arthroplast Today. 2020;6(3):475-479. Published 2020 Jun 29. doi:10.1016/j.artd.2020.05.004

4. Wyles CC, Tibbo ME, Yuan BJ, Trousdale RT, Berry DJ, Abdel MP. Long-term results of total knee arthroplasty with contemporary distal femoral replacement. J Bone Joint Surg Am. 2020;102(1):45-51. doi:10.2106/JBJS.19.00489

5. Haidukewych GJ. Role of distal femoral replacement for periprosthetic fractures above a total knee arthroplasty: when and how?, J Orthop Trauma. 2019;33(suppl 6):S33-S35. doi:10.1097/BOT.0000000000001566

6. Hart GP, Kneisl JS, Springer BD, Patt JC, Karunakar MA. Open reduction vs distal femoral replacement arthroplasty for comminuted distal femur fractures in the patients 70 years and older: J Arthroplasty. 2017;32(1):202-206. doi:10.1016/j.arth.2016.06.006

7. Vertesich K, Puchner SE, Staats K, et al. Distal femoral reconstruction following failed total knee arthroplasty is accompanied with risk for complication and reduced joint function. BMC Musculoskelet Disord. 2019 Jan 31;20(1):47-54. doi:10.1186/s12891-019-2432-4

8. Biswas D, Haughom B, Mayle RE Jr, Della Valle CJ. Case report: Failure of rotating-hinge total knee prosthesis by disengagement of the hinge-post extension. Clin Orthop Relat Res. 2013;471(4):1389-1392. doi:10.1007/s11999-012-2736-2

9. Ward WG, Haight D, Ritchie P, Gordon S, Eckardt JJ. Dislocation of rotating hinge knee prostheses. A report of four cases. J Bone Joint Surg Am. 2005;87(5):1108-1112. doi:10.2106/JBJS.00837pp

10. Pacha-Vicente D, Malik A, Castellet-Feliu E, Nardi-Vilardaga J. Dislocation of rotating-hinge knee prostheses with antidislocation mechanism. J Arthroplasty. 2008;23(2):299-303. doi:10.1016/j.arth.2006.11.020

11. Manzano G, Schwarzkopf R. Posterior dislocation of the hinge-post extension in a rotating hinge total knee prosthesis. Case Rep Orthop. 2013;2013:756538. doi:10.1155/2013/756538

12. Vaishya R., Thapa, SS, Vaish A. Non-neoplastic indications and outcomes of the proximal and distal femur megaprosthesis: a critical review. Knee Surg Relat Res. 2020;32(1):18. Published 2020 Apr 9. doi:10.1186/s43019-020-00034-7

13. Lu M, Wang J, Xiao C, et al. Uncemented, curved, short endoprosthesis stem for distal femoral reconstruction: early follow-up outcomes. World J Surg Onc. 2018;16(1):183. doi:10.1186/s12957-018-1486-3

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Nicotine and Nicotine Replacement Therapy Use During Myocardial Perfusion Imaging

Article Type
Changed
Thu, 01/27/2022 - 15:38

Chest pain is one of the most common concerns in patients presenting to the emergency department in the United States, accounting for approximately 7.6 million visits annually.1 Given the high mortality rate associated with acute coronary syndromes, prompt evaluation of chest pain is essential.2 Even in mild cases, recognition of newly onset or worsening coronary artery disease (CAD) is crucial to ensure that patients receive optimal medication therapy.

In symptomatic patients with risk factors for CAD, such as advanced age, hypertension, hyperlipidemia, obesity, and diabetes mellitus, myocardial perfusion imaging (MPI) is frequently used as a modality to assess the presence, location, and severity of ischemic or infarcted myocardium.2 MPI requires administration of a radiopharmaceutical before and after the patient undergoes a form of stress.2 This radiopharmaceutical is then detected in the myocardium with a nuclear camera, and images are obtained of the heart to assess myocardial blood flow.2

MPI can be performed using exercise-induced stress via a treadmill, or medication-induced stress (Table 1). In both strategies, healthy coronary arteries dilate to provide the myocardium with more blood flow to meet the increasing myocardial oxygen demand during this period of stress. While healthy vessels are able to dilate appropriately, coronary arteries with flow-limiting stenoses are unable to dilate to the same extent in response to stress.2 Because radioactive isotope uptake by the myocardium is directly related to arterial blood flow, MPI is able to demonstrate a mismatch in coronary blood flow between healthy and diseased coronary arteries indicated by differences in radioisotope uptake.2 The presence of such a mismatch, in conjunction with clinical history, potentially suggests the presence of CAD.

Pharmacologic Agents Used for Myocardial Perfusion Imaging


Prior to conducting MPI with a medication, certain substances should be avoided. For instance, methylxanthines, such as caffeine, aminophylline, and theophylline, antagonize adenosine receptors and can have major drug interactions with regadenoson, adenosine, and dipyridamole. Therefore, it is advised that these substances be stopped for at least 12 hours before testing.3 In some cases, other medications that can affect coronary blood flow, such as long-acting nitrates, β-blockers, and calcium channel blockers, are recommended to be avoided for 12 to 48 hours in order to obtain the most accurate depiction of underlying coronary disease.4

Because nicotine and nicotine replacement therapy (NRT) may have substantial effects on coronary circulation, a current area of controversy is whether these should be stopped prior to the use of a stress-inducing medication during MPI. To date, no formal drug interaction studies have been conducted between nicotine and regadenoson.5 Similarly, the ADVANCE MPI 2 Trial, which led to the US Food and Drug Administration approval of regadenoson, did not specify restrictions on the use of nicotine prior to stress testing in the protocol.6 However, as this trial was multicenter, investigators admit that individual study sites could have had their own restrictions on the use of nicotine prior to stress testing with regadenoson, but this information was not collected.6 The current review focuses on how the simultaneous use of nicotine or NRT during MPI with pharmacologic agents, such as regadenoson, may affect the accuracy of imaging results and the clinical impact of this interaction.

Nicotine Coronary Artery Effect

It is well documented that long-term cigarette smoking is a major risk factor for CAD.7 Compared with nonsmokers, cigarette smokers experience 2 times greater risk of morbidity and mortality from ischemic heart disease.7 There are several mechanisms by which nicotine induces damage to the myocardium (Figure). Nicotine has direct effects on both the sympathetic nervous system (SNS) and myocardial endothelium.8 Together, these factors result in reduced coronary blood flow, leading to less oxygen supply to meet an increased oxygen demand, resulting in myocardial ischemia.

Effect of Nicotine on Myocardium

Nicotine’s effect on coronary vasomotor tone occurs primarily through noradrenergic stimulation of α and β receptors associated with coronary vasoconstriction or vasodilation, respectively.9,10 These competing influences on coronary blood flow appear to manifest differently based on whether patients are at rest or in a stressed state. A study by Czerin and colleagues demonstrated that in healthy patients with relatively short smoking histories and in a healthy nonsmoker control group, coronary blood flow increased by 25% and 40%, respectively, with nicotine use at rest.9 However, when these patients were stressed with dipyramidole and while smoking during the examination, myocardial blood flow was reduced by 11% in the study group and 14% in the control group.9 This is likely because the patients studied had relatively healthy coronary arteries that were able to maximally dilate when stressed. In this scenario, nicotine’s dilatory effects are offset by nicotine’s α-receptor–mediated vasoconstriction effects.9 Of note, patients in the study group experienced a somewhat diminished increase in coronary blood flow at rest with nicotine use, suggesting that even a short smoking history may damage the myocardial endothelium, rendering it less responsive to nicotine’s vasodilatory effects.9

 

 



These principles similarly apply to patients with underlying moderate-to-severe cardiovascular disease (CVD). With nicotine use at rest, patients with significant CAD do not experience as dramatic of an increase in coronary blood flow, which typically decreases or remains the same despite increased myocardial work.10 This may be because patients with moderate-to-severe CAD often have flow-limiting stenoses and damaged endothelium that do not allow vessels to respond as efficiently to increased myocardial demand or to nicotine’s β-receptor–mediated vasodilatory effects.10,11 Moreover, when stressed, diseased coronary arteries are not able to further dilate and nicotine’s α-receptor–mediated vasoconstriction effects dominate.10,11

In a study by Quillen and colleagues of patients with moderate-to-severe CAD, the mean diameter of proximal coronary artery segments decreased by 5%, the distal coronary diameter decreased 8%, and the coronary vascular resistance increased by 21% while smoking at rest.12 The investigators did not analyze how parameters changed when these diseased coronary arteries were stressed using a medication during MPI. However, it can be predicted that coronary arteries would have constricted to a similar or greater degree than observed in Czerin and colleagues’ study, given that the underlying myocardium was diseased and more susceptible to nicotine’s vasoconstriction effects.9 Importantly, these studies have several limitations, most notably that they are older and have small sample sizes. Additionally, while statistically significant differences were found in the degree of changes in coronary circulation with nicotine use at rest and during stress, it is unclear whether this translates to a clinically significant and impactful finding.9-12

Nicotine Replacement Therapy and Stress Testing

Given the association between cigarette smoking and CAD, medical practitioners strongly encourage patients to quit smoking to reduce their risk of adverse cardiovascular outcomes. Various smoking cessation treatments are available for patients. Common, readily accessible forms of therapy include nicotine replacement products (Table 2).

Nicotine Replacement Products

Early studies of NRT in patients with underlying CVD found an increased risk of cardiovascular events, such as myocardial infarction, presumably due to the nicotine content of these products.13,14 However, the concentration of nicotine in NRT is substantially lower than that found in cigarettes and in some formulations, such as transdermal patches, nicotine is delivered over a prolonged period of time.15 For this reason, NRT is thought to be safe in patients with underlying CVD and stable ischemic heart disease. A recent systematic review and meta-analysis found that while NRT may be associated with tachycardia, it did not increase the risk of more serious cardiovascular adverse effects (AEs).16,17

Given the lower nicotine concentration in NRT products, the associated hemodynamic effect of nicotine also is thought to be less pronounced. In a study conducted by Tzivoni and colleagues in patients with CAD using transdermal nicotine patches, no differences in blood pressure, heart rate, ischemia, or arrhythmias were found from baseline to 2 weeks.18 These findings were further confirmed in a small study by Lucini and colleagues, which found that nicotine patches produced slight hemodynamic effects, but to a lesser extent than cigarette smoking.19 For the NRT gum formulation, while a small study found that 4 mg produced coronary vasoconstriction in patients with underlying CAD, a study by Nitenberg and Antony demonstrated that healthy and diseased coronary arteries did not significantly constrict while patients were using nicotine gum both before and after a cold pressor test, suggesting a lesser degree of coronary vasoconstriction than nicotine from cigarette smoking.20,21 Similar findings have been described with the nicotine intranasal spray in a study by Keeley and colleagues, which showed no additional AEs on myocardial demand or vasoconstriction when an intranasal nicotine spray was added to cigarette smoking.22 Importantly, a review of the transdermal and gum formulations found that these less pronounced hemodynamic effects were observed across different doses of NRT; however, further studies are needed to clarify the relationship between NRT dose and cardiovascular effects.23

Overall, NRT does not seem to activate the SNS to the same degree as nicotine obtained via cigarette smoking and likely does not increase the myocardial oxygen demand as much. Additionally, by containing a lower concentration of nicotine, NRT may not impair the myocardium’s ability to supply oxygen to coronary arteries to the same extent as nicotine from cigarette smoking. Therefore, the effects of NRT on MPI using a stress-inducing medication may not be as pronounced. However, due to study limitations, results should be interpreted cautiously.18-23

Conclusions

Because of the close relationship between cigarette smoking and CAD, many patients with underlying CVD are either current smokers or may be using NRT for smoking cessation. Therefore, the question of whether to refrain from nicotine use prior to MPI is clinically relevant. Currently, there is a lack of high-quality studies demonstrating the effects of nicotine and NRT on coronary perfusion. Because of this, the impact of nicotine and NRT use on the accuracy of MPI using stress-inducing medications remains uncertain. Nevertheless, given that nicotine and NRT may largely affect the accuracy of imaging results, several institutions have adopted protocols that prohibit patients from using these drugs on the day of nuclear stress testing.

There are currently no data specifying the number of hours to hold nicotine products prior to cardiac stress testing. It is generally recommended that other medications that affect coronary blood flow be held for 5 half-lives before conducting MPI.4 Following the same guidance for nicotine and NRT may present a reasonable approach to ensure accurate imaging results. Based on the discussed literature, patients should be instructed to refrain from cigarette smoking for at least 5 to 10 hours prior to MPI, given nicotine’s half-life of about 1 to 2 hours.24

The data for NRT are less clear. While use of NRT may not be an absolute contraindication to conducting MPI, it is important to consider that this may affect the accuracy of results. Given this uncertainty, it is likely ideal to hold NRT prior to MPI, based on the specific formulation of NRT and that product's half-life. Further robust studies are needed to analyze the impact of nicotine and NRT on the accuracy of nuclear stress testing using a medication.

References

1. Rui P, Kang K, Ashman JJ. National Hospital Ambulatory Medical Care Survey: 2016 emergency department summary tables. Published 2016. Accessed March 30, 2020. https://www.cdc.gov/nchs/data/nhamcs/web_tables/2016_ed_web_tables.pdf

2. Lange RA. Cardiovascular testing. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10th ed. McGraw Hill; 2017.

3. Mace S. Observation Medicine: Principles and Protocols. Cambridge University Press; 2017.

4. Currie GM. Pharmacology, part 4: nuclear cardiology. J Nucl Med Technol. 2019;47(2):97-110. doi:10.2967/jnmt.118.219675

5. Regadenoson; Package insert. Astellas Pharma US Inc; 2008.

6. Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007;14(5):645-658. doi:10.1016/j.nuclcard.2007.06.114

7. Hajar R. Risk factors for coronary artery disease: historical perspectives. Heart Views. 2017;18(3):109-114. doi:10.4103/HEARTVIEWS.HEARTVIEWS_106_17

8. Benowitz NL, Burbank AD. Cardiovascular toxicity of nicotine: implications for electronic cigarette use. Trends Cardiovasc Med. 2016;26(6):515-523. doi:10.1016/j.tcm.2016.03.001

9. Czernin J, Sun K, Brunken R, Böttcher M, Phelps M, Schelbert H. Effect of acute and long-term smoking on myocardial blood flow and flow reserve. Circulation. 1995;91:2891-2897. doi:10.1161/01.CIR.91.12.2891

10. Winniford MD, Wheelan KR, Kremers MS, et al. Smoking-induced coronary vasoconstriction in patients with atherosclerotic coronary artery disease: evidence for adrenergically mediated alterations in coronary artery tone. Circulation. 1986;73(4):662-667. doi:10.1161/01.cir.73.4.662

11. Klein LW, Ambrose J, Pichard A, Holt J, Gorlin R, Teichholz LE. Acute coronary hemodynamic response to cigarette smoking in patients with coronary artery disease. J Am Coll Cardiol. 1984;3(4):879-886. doi:10.1016/s0735-1097(84)80344-7

12. Quillen JE, Rossen JD, Oskarsson HJ, Minor RL Jr, Lopez AG, Winniford MD. Acute effect of cigarette smoking on the coronary circulation: constriction of epicardial and resistance vessels. J Am Coll Cardiol. 1993;22(3):642-647. doi:10.1016/0735-1097(93)90170-6

13. Dacosta A, Guy JM, Tardy B, et al. Myocardial infarction and nicotine patch: a contributing or causative factor?. Eur Heart J. 1993;14(12):1709-1711. doi:10.1093/eurheartj/14.12.1709

14. Ottervanger JP, Festen JM, de Vries AG, Stricker BH. Acute myocardial infarction while using the nicotine patch. Chest. 1995;107(6):1765-1766. doi:10.1378/chest.107.6.1765

15. Dollerup J, Vestbo J, Murray-Thomas T, et al. Cardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort study. Clin Epidemiol. 2017;9:231-243. Published 2017 Apr 26. doi:10.2147/CLEP.S127775

16. Mills EJ, Wu P, Lockhart I, Wilson K, Ebbert JO. Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals. Tob Induc Dis. 2010;8(1):8. Published 2010 Jul 13. doi:10.1186/1617-9625-8-8

17. Mills EJ, Thorlund K, Eapen S, Wu P, Prochaska JJ. Cardiovascular events associated with smoking cessation pharmacotherapies: a network meta-analysis. Circulation. 2014;129(1):28-41. doi:10.1161/CIRCULATIONAHA.113.003961

18. Tzivoni D, Keren A, Meyler S, Khoury Z, Lerer T, Brunel P. Cardiovascular safety of transdermal nicotine patches in patients with coronary artery disease who try to quit smoking. Cardiovasc Drugs Ther. 1998;12(3):239-244. doi:10.1023/a:1007757530765

19. Lucini D, Bertocchi F, Malliani A, Pagani M. Autonomic effects of nicotine patch administration in habitual cigarette smokers: a double-blind, placebo-controlled study using spectral analysis of RR interval and systolic arterial pressure variabilities. J Cardiovasc Pharmacol. 1998;31(5):714-720. doi:10.1097/00005344-199805000-00010

20. Kaijser L, Berglund B. Effect of nicotine on coronary blood-flow in man. Clin Physiol. 1985;5(6):541-552. doi:10.1111/j.1475-097x.1985.tb00767.x

21. Nitenberg A, Antony I. Effects of nicotine gum on coronary vasomotor responses during sympathetic stimulation in patients with coronary artery stenosis. J Cardiovasc Pharmacol. 1999;34(5):694-699. doi:10.1097/00005344-199911000-00011

22. Keeley EC, Pirwitz MJ, Landau C, et al. Intranasal nicotine spray does not augment the adverse effects of cigarette smoking on myocardial oxygen demand or coronary arterial dimensions. Am J Med. 1996;101(4):357-363. doi:10.1016/s0002-9343(96)00237-9

23. Benowitz NL, Gourlay SG. Cardiovascular toxicity of nicotine: implications for nicotine replacement therapy. J Am Coll Cardiol. 1997;29(7):1422-1431. doi:10.1016/s0735-1097(97)00079-x

24. Flowers L. Nicotine replacement therapy. Amer J Psych. 2017;11(6):4-7.

25. Adenosine; Package insert. Astellas Pharma US Inc; 1989.

26. Dipyridamole; Package insert. Boehringer Ingelheim Pharmaceuticals Inc; 2019.

27. Dobutamine; Package insert. Baxter Healthcare Corporation; 2012.

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Joanna Longueira, PharmDa; Emiliya Khazan, PharmD, BCPS, BCCPb; and Floyd Burke, MDb,c
Correspondence:
Joanna Longueira ([email protected])

Author affiliations

a Advent Health in Orlando, Florida
b Cardiovascular Section, Orlando Veteran Affairs Healthcare System
c Department of Medicine, University of Central Florida College of Medicine, Orlando

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects— before administering pharmacologic therapy to patients.

Ethics and consent

This study was deemed exempt from institutional review board approval.

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a Advent Health in Orlando, Florida
b Cardiovascular Section, Orlando Veteran Affairs Healthcare System
c Department of Medicine, University of Central Florida College of Medicine, Orlando

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects— before administering pharmacologic therapy to patients.

Ethics and consent

This study was deemed exempt from institutional review board approval.

Author and Disclosure Information

Joanna Longueira, PharmDa; Emiliya Khazan, PharmD, BCPS, BCCPb; and Floyd Burke, MDb,c
Correspondence:
Joanna Longueira ([email protected])

Author affiliations

a Advent Health in Orlando, Florida
b Cardiovascular Section, Orlando Veteran Affairs Healthcare System
c Department of Medicine, University of Central Florida College of Medicine, Orlando

Author disclosures

The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects— before administering pharmacologic therapy to patients.

Ethics and consent

This study was deemed exempt from institutional review board approval.

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Related Articles

Chest pain is one of the most common concerns in patients presenting to the emergency department in the United States, accounting for approximately 7.6 million visits annually.1 Given the high mortality rate associated with acute coronary syndromes, prompt evaluation of chest pain is essential.2 Even in mild cases, recognition of newly onset or worsening coronary artery disease (CAD) is crucial to ensure that patients receive optimal medication therapy.

In symptomatic patients with risk factors for CAD, such as advanced age, hypertension, hyperlipidemia, obesity, and diabetes mellitus, myocardial perfusion imaging (MPI) is frequently used as a modality to assess the presence, location, and severity of ischemic or infarcted myocardium.2 MPI requires administration of a radiopharmaceutical before and after the patient undergoes a form of stress.2 This radiopharmaceutical is then detected in the myocardium with a nuclear camera, and images are obtained of the heart to assess myocardial blood flow.2

MPI can be performed using exercise-induced stress via a treadmill, or medication-induced stress (Table 1). In both strategies, healthy coronary arteries dilate to provide the myocardium with more blood flow to meet the increasing myocardial oxygen demand during this period of stress. While healthy vessels are able to dilate appropriately, coronary arteries with flow-limiting stenoses are unable to dilate to the same extent in response to stress.2 Because radioactive isotope uptake by the myocardium is directly related to arterial blood flow, MPI is able to demonstrate a mismatch in coronary blood flow between healthy and diseased coronary arteries indicated by differences in radioisotope uptake.2 The presence of such a mismatch, in conjunction with clinical history, potentially suggests the presence of CAD.

Pharmacologic Agents Used for Myocardial Perfusion Imaging


Prior to conducting MPI with a medication, certain substances should be avoided. For instance, methylxanthines, such as caffeine, aminophylline, and theophylline, antagonize adenosine receptors and can have major drug interactions with regadenoson, adenosine, and dipyridamole. Therefore, it is advised that these substances be stopped for at least 12 hours before testing.3 In some cases, other medications that can affect coronary blood flow, such as long-acting nitrates, β-blockers, and calcium channel blockers, are recommended to be avoided for 12 to 48 hours in order to obtain the most accurate depiction of underlying coronary disease.4

Because nicotine and nicotine replacement therapy (NRT) may have substantial effects on coronary circulation, a current area of controversy is whether these should be stopped prior to the use of a stress-inducing medication during MPI. To date, no formal drug interaction studies have been conducted between nicotine and regadenoson.5 Similarly, the ADVANCE MPI 2 Trial, which led to the US Food and Drug Administration approval of regadenoson, did not specify restrictions on the use of nicotine prior to stress testing in the protocol.6 However, as this trial was multicenter, investigators admit that individual study sites could have had their own restrictions on the use of nicotine prior to stress testing with regadenoson, but this information was not collected.6 The current review focuses on how the simultaneous use of nicotine or NRT during MPI with pharmacologic agents, such as regadenoson, may affect the accuracy of imaging results and the clinical impact of this interaction.

Nicotine Coronary Artery Effect

It is well documented that long-term cigarette smoking is a major risk factor for CAD.7 Compared with nonsmokers, cigarette smokers experience 2 times greater risk of morbidity and mortality from ischemic heart disease.7 There are several mechanisms by which nicotine induces damage to the myocardium (Figure). Nicotine has direct effects on both the sympathetic nervous system (SNS) and myocardial endothelium.8 Together, these factors result in reduced coronary blood flow, leading to less oxygen supply to meet an increased oxygen demand, resulting in myocardial ischemia.

Effect of Nicotine on Myocardium

Nicotine’s effect on coronary vasomotor tone occurs primarily through noradrenergic stimulation of α and β receptors associated with coronary vasoconstriction or vasodilation, respectively.9,10 These competing influences on coronary blood flow appear to manifest differently based on whether patients are at rest or in a stressed state. A study by Czerin and colleagues demonstrated that in healthy patients with relatively short smoking histories and in a healthy nonsmoker control group, coronary blood flow increased by 25% and 40%, respectively, with nicotine use at rest.9 However, when these patients were stressed with dipyramidole and while smoking during the examination, myocardial blood flow was reduced by 11% in the study group and 14% in the control group.9 This is likely because the patients studied had relatively healthy coronary arteries that were able to maximally dilate when stressed. In this scenario, nicotine’s dilatory effects are offset by nicotine’s α-receptor–mediated vasoconstriction effects.9 Of note, patients in the study group experienced a somewhat diminished increase in coronary blood flow at rest with nicotine use, suggesting that even a short smoking history may damage the myocardial endothelium, rendering it less responsive to nicotine’s vasodilatory effects.9

 

 



These principles similarly apply to patients with underlying moderate-to-severe cardiovascular disease (CVD). With nicotine use at rest, patients with significant CAD do not experience as dramatic of an increase in coronary blood flow, which typically decreases or remains the same despite increased myocardial work.10 This may be because patients with moderate-to-severe CAD often have flow-limiting stenoses and damaged endothelium that do not allow vessels to respond as efficiently to increased myocardial demand or to nicotine’s β-receptor–mediated vasodilatory effects.10,11 Moreover, when stressed, diseased coronary arteries are not able to further dilate and nicotine’s α-receptor–mediated vasoconstriction effects dominate.10,11

In a study by Quillen and colleagues of patients with moderate-to-severe CAD, the mean diameter of proximal coronary artery segments decreased by 5%, the distal coronary diameter decreased 8%, and the coronary vascular resistance increased by 21% while smoking at rest.12 The investigators did not analyze how parameters changed when these diseased coronary arteries were stressed using a medication during MPI. However, it can be predicted that coronary arteries would have constricted to a similar or greater degree than observed in Czerin and colleagues’ study, given that the underlying myocardium was diseased and more susceptible to nicotine’s vasoconstriction effects.9 Importantly, these studies have several limitations, most notably that they are older and have small sample sizes. Additionally, while statistically significant differences were found in the degree of changes in coronary circulation with nicotine use at rest and during stress, it is unclear whether this translates to a clinically significant and impactful finding.9-12

Nicotine Replacement Therapy and Stress Testing

Given the association between cigarette smoking and CAD, medical practitioners strongly encourage patients to quit smoking to reduce their risk of adverse cardiovascular outcomes. Various smoking cessation treatments are available for patients. Common, readily accessible forms of therapy include nicotine replacement products (Table 2).

Nicotine Replacement Products

Early studies of NRT in patients with underlying CVD found an increased risk of cardiovascular events, such as myocardial infarction, presumably due to the nicotine content of these products.13,14 However, the concentration of nicotine in NRT is substantially lower than that found in cigarettes and in some formulations, such as transdermal patches, nicotine is delivered over a prolonged period of time.15 For this reason, NRT is thought to be safe in patients with underlying CVD and stable ischemic heart disease. A recent systematic review and meta-analysis found that while NRT may be associated with tachycardia, it did not increase the risk of more serious cardiovascular adverse effects (AEs).16,17

Given the lower nicotine concentration in NRT products, the associated hemodynamic effect of nicotine also is thought to be less pronounced. In a study conducted by Tzivoni and colleagues in patients with CAD using transdermal nicotine patches, no differences in blood pressure, heart rate, ischemia, or arrhythmias were found from baseline to 2 weeks.18 These findings were further confirmed in a small study by Lucini and colleagues, which found that nicotine patches produced slight hemodynamic effects, but to a lesser extent than cigarette smoking.19 For the NRT gum formulation, while a small study found that 4 mg produced coronary vasoconstriction in patients with underlying CAD, a study by Nitenberg and Antony demonstrated that healthy and diseased coronary arteries did not significantly constrict while patients were using nicotine gum both before and after a cold pressor test, suggesting a lesser degree of coronary vasoconstriction than nicotine from cigarette smoking.20,21 Similar findings have been described with the nicotine intranasal spray in a study by Keeley and colleagues, which showed no additional AEs on myocardial demand or vasoconstriction when an intranasal nicotine spray was added to cigarette smoking.22 Importantly, a review of the transdermal and gum formulations found that these less pronounced hemodynamic effects were observed across different doses of NRT; however, further studies are needed to clarify the relationship between NRT dose and cardiovascular effects.23

Overall, NRT does not seem to activate the SNS to the same degree as nicotine obtained via cigarette smoking and likely does not increase the myocardial oxygen demand as much. Additionally, by containing a lower concentration of nicotine, NRT may not impair the myocardium’s ability to supply oxygen to coronary arteries to the same extent as nicotine from cigarette smoking. Therefore, the effects of NRT on MPI using a stress-inducing medication may not be as pronounced. However, due to study limitations, results should be interpreted cautiously.18-23

Conclusions

Because of the close relationship between cigarette smoking and CAD, many patients with underlying CVD are either current smokers or may be using NRT for smoking cessation. Therefore, the question of whether to refrain from nicotine use prior to MPI is clinically relevant. Currently, there is a lack of high-quality studies demonstrating the effects of nicotine and NRT on coronary perfusion. Because of this, the impact of nicotine and NRT use on the accuracy of MPI using stress-inducing medications remains uncertain. Nevertheless, given that nicotine and NRT may largely affect the accuracy of imaging results, several institutions have adopted protocols that prohibit patients from using these drugs on the day of nuclear stress testing.

There are currently no data specifying the number of hours to hold nicotine products prior to cardiac stress testing. It is generally recommended that other medications that affect coronary blood flow be held for 5 half-lives before conducting MPI.4 Following the same guidance for nicotine and NRT may present a reasonable approach to ensure accurate imaging results. Based on the discussed literature, patients should be instructed to refrain from cigarette smoking for at least 5 to 10 hours prior to MPI, given nicotine’s half-life of about 1 to 2 hours.24

The data for NRT are less clear. While use of NRT may not be an absolute contraindication to conducting MPI, it is important to consider that this may affect the accuracy of results. Given this uncertainty, it is likely ideal to hold NRT prior to MPI, based on the specific formulation of NRT and that product's half-life. Further robust studies are needed to analyze the impact of nicotine and NRT on the accuracy of nuclear stress testing using a medication.

Chest pain is one of the most common concerns in patients presenting to the emergency department in the United States, accounting for approximately 7.6 million visits annually.1 Given the high mortality rate associated with acute coronary syndromes, prompt evaluation of chest pain is essential.2 Even in mild cases, recognition of newly onset or worsening coronary artery disease (CAD) is crucial to ensure that patients receive optimal medication therapy.

In symptomatic patients with risk factors for CAD, such as advanced age, hypertension, hyperlipidemia, obesity, and diabetes mellitus, myocardial perfusion imaging (MPI) is frequently used as a modality to assess the presence, location, and severity of ischemic or infarcted myocardium.2 MPI requires administration of a radiopharmaceutical before and after the patient undergoes a form of stress.2 This radiopharmaceutical is then detected in the myocardium with a nuclear camera, and images are obtained of the heart to assess myocardial blood flow.2

MPI can be performed using exercise-induced stress via a treadmill, or medication-induced stress (Table 1). In both strategies, healthy coronary arteries dilate to provide the myocardium with more blood flow to meet the increasing myocardial oxygen demand during this period of stress. While healthy vessels are able to dilate appropriately, coronary arteries with flow-limiting stenoses are unable to dilate to the same extent in response to stress.2 Because radioactive isotope uptake by the myocardium is directly related to arterial blood flow, MPI is able to demonstrate a mismatch in coronary blood flow between healthy and diseased coronary arteries indicated by differences in radioisotope uptake.2 The presence of such a mismatch, in conjunction with clinical history, potentially suggests the presence of CAD.

Pharmacologic Agents Used for Myocardial Perfusion Imaging


Prior to conducting MPI with a medication, certain substances should be avoided. For instance, methylxanthines, such as caffeine, aminophylline, and theophylline, antagonize adenosine receptors and can have major drug interactions with regadenoson, adenosine, and dipyridamole. Therefore, it is advised that these substances be stopped for at least 12 hours before testing.3 In some cases, other medications that can affect coronary blood flow, such as long-acting nitrates, β-blockers, and calcium channel blockers, are recommended to be avoided for 12 to 48 hours in order to obtain the most accurate depiction of underlying coronary disease.4

Because nicotine and nicotine replacement therapy (NRT) may have substantial effects on coronary circulation, a current area of controversy is whether these should be stopped prior to the use of a stress-inducing medication during MPI. To date, no formal drug interaction studies have been conducted between nicotine and regadenoson.5 Similarly, the ADVANCE MPI 2 Trial, which led to the US Food and Drug Administration approval of regadenoson, did not specify restrictions on the use of nicotine prior to stress testing in the protocol.6 However, as this trial was multicenter, investigators admit that individual study sites could have had their own restrictions on the use of nicotine prior to stress testing with regadenoson, but this information was not collected.6 The current review focuses on how the simultaneous use of nicotine or NRT during MPI with pharmacologic agents, such as regadenoson, may affect the accuracy of imaging results and the clinical impact of this interaction.

Nicotine Coronary Artery Effect

It is well documented that long-term cigarette smoking is a major risk factor for CAD.7 Compared with nonsmokers, cigarette smokers experience 2 times greater risk of morbidity and mortality from ischemic heart disease.7 There are several mechanisms by which nicotine induces damage to the myocardium (Figure). Nicotine has direct effects on both the sympathetic nervous system (SNS) and myocardial endothelium.8 Together, these factors result in reduced coronary blood flow, leading to less oxygen supply to meet an increased oxygen demand, resulting in myocardial ischemia.

Effect of Nicotine on Myocardium

Nicotine’s effect on coronary vasomotor tone occurs primarily through noradrenergic stimulation of α and β receptors associated with coronary vasoconstriction or vasodilation, respectively.9,10 These competing influences on coronary blood flow appear to manifest differently based on whether patients are at rest or in a stressed state. A study by Czerin and colleagues demonstrated that in healthy patients with relatively short smoking histories and in a healthy nonsmoker control group, coronary blood flow increased by 25% and 40%, respectively, with nicotine use at rest.9 However, when these patients were stressed with dipyramidole and while smoking during the examination, myocardial blood flow was reduced by 11% in the study group and 14% in the control group.9 This is likely because the patients studied had relatively healthy coronary arteries that were able to maximally dilate when stressed. In this scenario, nicotine’s dilatory effects are offset by nicotine’s α-receptor–mediated vasoconstriction effects.9 Of note, patients in the study group experienced a somewhat diminished increase in coronary blood flow at rest with nicotine use, suggesting that even a short smoking history may damage the myocardial endothelium, rendering it less responsive to nicotine’s vasodilatory effects.9

 

 



These principles similarly apply to patients with underlying moderate-to-severe cardiovascular disease (CVD). With nicotine use at rest, patients with significant CAD do not experience as dramatic of an increase in coronary blood flow, which typically decreases or remains the same despite increased myocardial work.10 This may be because patients with moderate-to-severe CAD often have flow-limiting stenoses and damaged endothelium that do not allow vessels to respond as efficiently to increased myocardial demand or to nicotine’s β-receptor–mediated vasodilatory effects.10,11 Moreover, when stressed, diseased coronary arteries are not able to further dilate and nicotine’s α-receptor–mediated vasoconstriction effects dominate.10,11

In a study by Quillen and colleagues of patients with moderate-to-severe CAD, the mean diameter of proximal coronary artery segments decreased by 5%, the distal coronary diameter decreased 8%, and the coronary vascular resistance increased by 21% while smoking at rest.12 The investigators did not analyze how parameters changed when these diseased coronary arteries were stressed using a medication during MPI. However, it can be predicted that coronary arteries would have constricted to a similar or greater degree than observed in Czerin and colleagues’ study, given that the underlying myocardium was diseased and more susceptible to nicotine’s vasoconstriction effects.9 Importantly, these studies have several limitations, most notably that they are older and have small sample sizes. Additionally, while statistically significant differences were found in the degree of changes in coronary circulation with nicotine use at rest and during stress, it is unclear whether this translates to a clinically significant and impactful finding.9-12

Nicotine Replacement Therapy and Stress Testing

Given the association between cigarette smoking and CAD, medical practitioners strongly encourage patients to quit smoking to reduce their risk of adverse cardiovascular outcomes. Various smoking cessation treatments are available for patients. Common, readily accessible forms of therapy include nicotine replacement products (Table 2).

Nicotine Replacement Products

Early studies of NRT in patients with underlying CVD found an increased risk of cardiovascular events, such as myocardial infarction, presumably due to the nicotine content of these products.13,14 However, the concentration of nicotine in NRT is substantially lower than that found in cigarettes and in some formulations, such as transdermal patches, nicotine is delivered over a prolonged period of time.15 For this reason, NRT is thought to be safe in patients with underlying CVD and stable ischemic heart disease. A recent systematic review and meta-analysis found that while NRT may be associated with tachycardia, it did not increase the risk of more serious cardiovascular adverse effects (AEs).16,17

Given the lower nicotine concentration in NRT products, the associated hemodynamic effect of nicotine also is thought to be less pronounced. In a study conducted by Tzivoni and colleagues in patients with CAD using transdermal nicotine patches, no differences in blood pressure, heart rate, ischemia, or arrhythmias were found from baseline to 2 weeks.18 These findings were further confirmed in a small study by Lucini and colleagues, which found that nicotine patches produced slight hemodynamic effects, but to a lesser extent than cigarette smoking.19 For the NRT gum formulation, while a small study found that 4 mg produced coronary vasoconstriction in patients with underlying CAD, a study by Nitenberg and Antony demonstrated that healthy and diseased coronary arteries did not significantly constrict while patients were using nicotine gum both before and after a cold pressor test, suggesting a lesser degree of coronary vasoconstriction than nicotine from cigarette smoking.20,21 Similar findings have been described with the nicotine intranasal spray in a study by Keeley and colleagues, which showed no additional AEs on myocardial demand or vasoconstriction when an intranasal nicotine spray was added to cigarette smoking.22 Importantly, a review of the transdermal and gum formulations found that these less pronounced hemodynamic effects were observed across different doses of NRT; however, further studies are needed to clarify the relationship between NRT dose and cardiovascular effects.23

Overall, NRT does not seem to activate the SNS to the same degree as nicotine obtained via cigarette smoking and likely does not increase the myocardial oxygen demand as much. Additionally, by containing a lower concentration of nicotine, NRT may not impair the myocardium’s ability to supply oxygen to coronary arteries to the same extent as nicotine from cigarette smoking. Therefore, the effects of NRT on MPI using a stress-inducing medication may not be as pronounced. However, due to study limitations, results should be interpreted cautiously.18-23

Conclusions

Because of the close relationship between cigarette smoking and CAD, many patients with underlying CVD are either current smokers or may be using NRT for smoking cessation. Therefore, the question of whether to refrain from nicotine use prior to MPI is clinically relevant. Currently, there is a lack of high-quality studies demonstrating the effects of nicotine and NRT on coronary perfusion. Because of this, the impact of nicotine and NRT use on the accuracy of MPI using stress-inducing medications remains uncertain. Nevertheless, given that nicotine and NRT may largely affect the accuracy of imaging results, several institutions have adopted protocols that prohibit patients from using these drugs on the day of nuclear stress testing.

There are currently no data specifying the number of hours to hold nicotine products prior to cardiac stress testing. It is generally recommended that other medications that affect coronary blood flow be held for 5 half-lives before conducting MPI.4 Following the same guidance for nicotine and NRT may present a reasonable approach to ensure accurate imaging results. Based on the discussed literature, patients should be instructed to refrain from cigarette smoking for at least 5 to 10 hours prior to MPI, given nicotine’s half-life of about 1 to 2 hours.24

The data for NRT are less clear. While use of NRT may not be an absolute contraindication to conducting MPI, it is important to consider that this may affect the accuracy of results. Given this uncertainty, it is likely ideal to hold NRT prior to MPI, based on the specific formulation of NRT and that product's half-life. Further robust studies are needed to analyze the impact of nicotine and NRT on the accuracy of nuclear stress testing using a medication.

References

1. Rui P, Kang K, Ashman JJ. National Hospital Ambulatory Medical Care Survey: 2016 emergency department summary tables. Published 2016. Accessed March 30, 2020. https://www.cdc.gov/nchs/data/nhamcs/web_tables/2016_ed_web_tables.pdf

2. Lange RA. Cardiovascular testing. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10th ed. McGraw Hill; 2017.

3. Mace S. Observation Medicine: Principles and Protocols. Cambridge University Press; 2017.

4. Currie GM. Pharmacology, part 4: nuclear cardiology. J Nucl Med Technol. 2019;47(2):97-110. doi:10.2967/jnmt.118.219675

5. Regadenoson; Package insert. Astellas Pharma US Inc; 2008.

6. Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007;14(5):645-658. doi:10.1016/j.nuclcard.2007.06.114

7. Hajar R. Risk factors for coronary artery disease: historical perspectives. Heart Views. 2017;18(3):109-114. doi:10.4103/HEARTVIEWS.HEARTVIEWS_106_17

8. Benowitz NL, Burbank AD. Cardiovascular toxicity of nicotine: implications for electronic cigarette use. Trends Cardiovasc Med. 2016;26(6):515-523. doi:10.1016/j.tcm.2016.03.001

9. Czernin J, Sun K, Brunken R, Böttcher M, Phelps M, Schelbert H. Effect of acute and long-term smoking on myocardial blood flow and flow reserve. Circulation. 1995;91:2891-2897. doi:10.1161/01.CIR.91.12.2891

10. Winniford MD, Wheelan KR, Kremers MS, et al. Smoking-induced coronary vasoconstriction in patients with atherosclerotic coronary artery disease: evidence for adrenergically mediated alterations in coronary artery tone. Circulation. 1986;73(4):662-667. doi:10.1161/01.cir.73.4.662

11. Klein LW, Ambrose J, Pichard A, Holt J, Gorlin R, Teichholz LE. Acute coronary hemodynamic response to cigarette smoking in patients with coronary artery disease. J Am Coll Cardiol. 1984;3(4):879-886. doi:10.1016/s0735-1097(84)80344-7

12. Quillen JE, Rossen JD, Oskarsson HJ, Minor RL Jr, Lopez AG, Winniford MD. Acute effect of cigarette smoking on the coronary circulation: constriction of epicardial and resistance vessels. J Am Coll Cardiol. 1993;22(3):642-647. doi:10.1016/0735-1097(93)90170-6

13. Dacosta A, Guy JM, Tardy B, et al. Myocardial infarction and nicotine patch: a contributing or causative factor?. Eur Heart J. 1993;14(12):1709-1711. doi:10.1093/eurheartj/14.12.1709

14. Ottervanger JP, Festen JM, de Vries AG, Stricker BH. Acute myocardial infarction while using the nicotine patch. Chest. 1995;107(6):1765-1766. doi:10.1378/chest.107.6.1765

15. Dollerup J, Vestbo J, Murray-Thomas T, et al. Cardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort study. Clin Epidemiol. 2017;9:231-243. Published 2017 Apr 26. doi:10.2147/CLEP.S127775

16. Mills EJ, Wu P, Lockhart I, Wilson K, Ebbert JO. Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals. Tob Induc Dis. 2010;8(1):8. Published 2010 Jul 13. doi:10.1186/1617-9625-8-8

17. Mills EJ, Thorlund K, Eapen S, Wu P, Prochaska JJ. Cardiovascular events associated with smoking cessation pharmacotherapies: a network meta-analysis. Circulation. 2014;129(1):28-41. doi:10.1161/CIRCULATIONAHA.113.003961

18. Tzivoni D, Keren A, Meyler S, Khoury Z, Lerer T, Brunel P. Cardiovascular safety of transdermal nicotine patches in patients with coronary artery disease who try to quit smoking. Cardiovasc Drugs Ther. 1998;12(3):239-244. doi:10.1023/a:1007757530765

19. Lucini D, Bertocchi F, Malliani A, Pagani M. Autonomic effects of nicotine patch administration in habitual cigarette smokers: a double-blind, placebo-controlled study using spectral analysis of RR interval and systolic arterial pressure variabilities. J Cardiovasc Pharmacol. 1998;31(5):714-720. doi:10.1097/00005344-199805000-00010

20. Kaijser L, Berglund B. Effect of nicotine on coronary blood-flow in man. Clin Physiol. 1985;5(6):541-552. doi:10.1111/j.1475-097x.1985.tb00767.x

21. Nitenberg A, Antony I. Effects of nicotine gum on coronary vasomotor responses during sympathetic stimulation in patients with coronary artery stenosis. J Cardiovasc Pharmacol. 1999;34(5):694-699. doi:10.1097/00005344-199911000-00011

22. Keeley EC, Pirwitz MJ, Landau C, et al. Intranasal nicotine spray does not augment the adverse effects of cigarette smoking on myocardial oxygen demand or coronary arterial dimensions. Am J Med. 1996;101(4):357-363. doi:10.1016/s0002-9343(96)00237-9

23. Benowitz NL, Gourlay SG. Cardiovascular toxicity of nicotine: implications for nicotine replacement therapy. J Am Coll Cardiol. 1997;29(7):1422-1431. doi:10.1016/s0735-1097(97)00079-x

24. Flowers L. Nicotine replacement therapy. Amer J Psych. 2017;11(6):4-7.

25. Adenosine; Package insert. Astellas Pharma US Inc; 1989.

26. Dipyridamole; Package insert. Boehringer Ingelheim Pharmaceuticals Inc; 2019.

27. Dobutamine; Package insert. Baxter Healthcare Corporation; 2012.

References

1. Rui P, Kang K, Ashman JJ. National Hospital Ambulatory Medical Care Survey: 2016 emergency department summary tables. Published 2016. Accessed March 30, 2020. https://www.cdc.gov/nchs/data/nhamcs/web_tables/2016_ed_web_tables.pdf

2. Lange RA. Cardiovascular testing. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10th ed. McGraw Hill; 2017.

3. Mace S. Observation Medicine: Principles and Protocols. Cambridge University Press; 2017.

4. Currie GM. Pharmacology, part 4: nuclear cardiology. J Nucl Med Technol. 2019;47(2):97-110. doi:10.2967/jnmt.118.219675

5. Regadenoson; Package insert. Astellas Pharma US Inc; 2008.

6. Iskandrian AE, Bateman TM, Belardinelli L, et al. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007;14(5):645-658. doi:10.1016/j.nuclcard.2007.06.114

7. Hajar R. Risk factors for coronary artery disease: historical perspectives. Heart Views. 2017;18(3):109-114. doi:10.4103/HEARTVIEWS.HEARTVIEWS_106_17

8. Benowitz NL, Burbank AD. Cardiovascular toxicity of nicotine: implications for electronic cigarette use. Trends Cardiovasc Med. 2016;26(6):515-523. doi:10.1016/j.tcm.2016.03.001

9. Czernin J, Sun K, Brunken R, Böttcher M, Phelps M, Schelbert H. Effect of acute and long-term smoking on myocardial blood flow and flow reserve. Circulation. 1995;91:2891-2897. doi:10.1161/01.CIR.91.12.2891

10. Winniford MD, Wheelan KR, Kremers MS, et al. Smoking-induced coronary vasoconstriction in patients with atherosclerotic coronary artery disease: evidence for adrenergically mediated alterations in coronary artery tone. Circulation. 1986;73(4):662-667. doi:10.1161/01.cir.73.4.662

11. Klein LW, Ambrose J, Pichard A, Holt J, Gorlin R, Teichholz LE. Acute coronary hemodynamic response to cigarette smoking in patients with coronary artery disease. J Am Coll Cardiol. 1984;3(4):879-886. doi:10.1016/s0735-1097(84)80344-7

12. Quillen JE, Rossen JD, Oskarsson HJ, Minor RL Jr, Lopez AG, Winniford MD. Acute effect of cigarette smoking on the coronary circulation: constriction of epicardial and resistance vessels. J Am Coll Cardiol. 1993;22(3):642-647. doi:10.1016/0735-1097(93)90170-6

13. Dacosta A, Guy JM, Tardy B, et al. Myocardial infarction and nicotine patch: a contributing or causative factor?. Eur Heart J. 1993;14(12):1709-1711. doi:10.1093/eurheartj/14.12.1709

14. Ottervanger JP, Festen JM, de Vries AG, Stricker BH. Acute myocardial infarction while using the nicotine patch. Chest. 1995;107(6):1765-1766. doi:10.1378/chest.107.6.1765

15. Dollerup J, Vestbo J, Murray-Thomas T, et al. Cardiovascular risks in smokers treated with nicotine replacement therapy: a historical cohort study. Clin Epidemiol. 2017;9:231-243. Published 2017 Apr 26. doi:10.2147/CLEP.S127775

16. Mills EJ, Wu P, Lockhart I, Wilson K, Ebbert JO. Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals. Tob Induc Dis. 2010;8(1):8. Published 2010 Jul 13. doi:10.1186/1617-9625-8-8

17. Mills EJ, Thorlund K, Eapen S, Wu P, Prochaska JJ. Cardiovascular events associated with smoking cessation pharmacotherapies: a network meta-analysis. Circulation. 2014;129(1):28-41. doi:10.1161/CIRCULATIONAHA.113.003961

18. Tzivoni D, Keren A, Meyler S, Khoury Z, Lerer T, Brunel P. Cardiovascular safety of transdermal nicotine patches in patients with coronary artery disease who try to quit smoking. Cardiovasc Drugs Ther. 1998;12(3):239-244. doi:10.1023/a:1007757530765

19. Lucini D, Bertocchi F, Malliani A, Pagani M. Autonomic effects of nicotine patch administration in habitual cigarette smokers: a double-blind, placebo-controlled study using spectral analysis of RR interval and systolic arterial pressure variabilities. J Cardiovasc Pharmacol. 1998;31(5):714-720. doi:10.1097/00005344-199805000-00010

20. Kaijser L, Berglund B. Effect of nicotine on coronary blood-flow in man. Clin Physiol. 1985;5(6):541-552. doi:10.1111/j.1475-097x.1985.tb00767.x

21. Nitenberg A, Antony I. Effects of nicotine gum on coronary vasomotor responses during sympathetic stimulation in patients with coronary artery stenosis. J Cardiovasc Pharmacol. 1999;34(5):694-699. doi:10.1097/00005344-199911000-00011

22. Keeley EC, Pirwitz MJ, Landau C, et al. Intranasal nicotine spray does not augment the adverse effects of cigarette smoking on myocardial oxygen demand or coronary arterial dimensions. Am J Med. 1996;101(4):357-363. doi:10.1016/s0002-9343(96)00237-9

23. Benowitz NL, Gourlay SG. Cardiovascular toxicity of nicotine: implications for nicotine replacement therapy. J Am Coll Cardiol. 1997;29(7):1422-1431. doi:10.1016/s0735-1097(97)00079-x

24. Flowers L. Nicotine replacement therapy. Amer J Psych. 2017;11(6):4-7.

25. Adenosine; Package insert. Astellas Pharma US Inc; 1989.

26. Dipyridamole; Package insert. Boehringer Ingelheim Pharmaceuticals Inc; 2019.

27. Dobutamine; Package insert. Baxter Healthcare Corporation; 2012.

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A 1-Year Review of a Nationally Led Intervention to Improve Suicide Prevention Screening at a Large Homeless Veterans Clinic

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Suicide is a national public health concern that affects thousands of US individuals and families, with repercussions that reverberate through entire communities. In 2019, there were 47,500 US deaths by suicide, which accounted for about 1 death every 11 minutes.1 Suicide remains the tenth leading cause of death in the United States and has been part of the top 12 leading causes of death since 1975.2 Unfortunately, this trend has worsened; suicide rates have increased by 35% from 1999 to 2018.3 One particularly vulnerable population is US veterans who accounted for 13.8% of all suicide deaths in 2018.4 Among veterans, the suicide death average increased from 16.6 per day in 2005 to 17.6 in 2018.4 Furthermore, veterans experiencing homelessness are 5 times more likely to attempt suicide and 2.5 times more likely to have suicidal ideation compared with veterans without a history of homelessness.4 Suicide is a significant issue among veterans experiencing homelessness: Veterans account for about 11% of the overall US homeless population.5

Recent data suggest opportunities for suicide risk assessment in the primary care setting. A study from the Veterans Health Administration (VHA) Office for Suicide Prevention found that in 2014 an average of 20 veterans died by suicide every day and 6 of the 20 (30%) on average used VHA services within the prior year.6 Similarly, a review of 40 studies on suicide found that 45% of suicide victims had contact with their primary care practitioner (PCP) within 1 month of suicide, and 75% of victims had contact within the year of suicide.7 An analysis of depression screening in 2008/2009 using Patient Health Questionnaire-2 (PHQ-2) or Patient Health Questionnaire-9 (PHQ-9) at 3 large western US Department of Veterans Affairs (VA) medical centers found that 55% were screened for depression.8 The VA has made suicide prevention a top priority and supports the established US goal of reducing annual suicide deaths by 20% by 2025.9 Given key opportunities for suicide risk assessment in the primary care setting, the VHA Office of Mental Health and Suicide Prevention implemented a national, standardized process for suicide risk assessment on October 1, 2018.10,11

The VA approach to suicide screening, evaluation, and documentation has evolved over time. Between October 2018 and December 2020, the process was augmented to include 3 stages embedded into the electronic health record (EHR): a primary screen (PHQ-2 with Item 9 from the PHQ-9 [PHQ-2+I9]), a secondary screen (Columbia-Suicide Severity Rating Scale [C-SSRS]), and a tertiary screen (Comprehensive Suicide Risk Evaluation [CSRE]). The primary screen consisted of the depression screening using the PHQ-2 with the addition of I9 asking about suicidal ideation. The secondary screening, or C-SSRS, included 8 questions to elaborate on suicidal ideation, intent, plan, and any history of suicidal attempts or preparatory behaviors. The tertiary screen consisted of the CSRE, a questionnaire developed internally by the VA in 2018 to further evaluate the veteran’s suicidal thoughts, attempts, warning signs, risk factors, protective factors, and reasons for living. The goal of the screenings was to identify veterans at risk of suicide, assess risk severity, and to individually tailor risk mitigation strategies for safe disposition. These risk categories were developed by the regional Mental Illness Research, Education and Clinical Center, which suggested treatment strategies, such as hospitalization or close outpatient follow-up.12,13

The Homeless Patient Aligned Care Team (HPACT) clinic at the West Los Angeles VA Medical Center (WLAVAMC) in California, one of the largest VA homeless clinics in the country and 1 of 7 national VA Office of Academic Affiliation Centers of Excellence in Primary Care Education training programs implemented the standardized tools for suicide risk screening and quality improvement (QI). The HPACT clinic is an interprofessional team, including primary care, mental health, social work, pharmacy, and peer support, that is adjacent to the WLAVAMC general primary care clinics. The team collaboratively addresses both medical and psychosocial needs of veterans with a focus on the Housing First Model, an approach that prioritizes ending homelessness while addressing all factors associated with veterans' health and well-being. After 1 year of stable housing, veterans graduate to the WLAVAMC general primary care clinics.

Given the vulnerability of veterans experiencing homelessness, the clinic leadership identified suicide risk screening as a high priority initiative and created a taskforce to oversee effective implementation of clinic screening efforts. An interprofessional team of nurse practitioners (NPs), pharmacists, physicians, psychologists, social workers (SWs), and trainees formed to improve screening efforts and use the QI principles to guide analysis and intervention. The team wrote the following SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) Aim statements: (1) ensure > 90% of eligible patients receive a primary screen; (2) ensure > 90% of positive primary I9 screens receive subsequent screenings within 24 hours; and (3) increase staff comfort and familiarity using the screening tools. This article examines the results of the screening initiative 1-year postimplementation, describes difficulties faced, and suggests strategies that might be used to overcome those challenges.

Methods

This QI analysis was exempt from institutional review board review. Prior to the standardized national suicide risk assessment rollout of October 1, 2018, the QI team met to review and understand the workflow to be implemented into the HPACT clinic. To describe the initial screening process, the new suicide risk assessment consisted of primary, secondary, and tertiary screens that would warrant subsequent intervention by clinicians if positive (Figure 1). The primary screen included the PHQ-2+I9 questionnaire (PHQ-2 for depression and I9 for suicidal ideation). If either were positive, follow-up questionnaires were required. Of note, patients with a prior depression diagnosis, cognitive impairment defined at a severity of moderate or greater based on clinician evaluation and judgement, or life expectancy < 6 months were exempt from screening because, by definition, they had theoretically already been screened and classified as under surveillance.

A positive I9 response prompted a secondary screen using C-SSRS. A positive secondary screen prompted a tertiary screen using CSRE. If the PHQ-2 screening was positive but I9 was negative, the standard follow-up depression clinical reminder was used. Any clinical staff member could perform the primary screen, including licensed vocational nurses (LVNs), registered nurses (RNs), and SWs in any setting (eg, emergency department, primary care, inpatient services). The secondary and tertiary screens required completion by a licensed clinician. RNs were able to perform the secondary screen but not the tertiary screen.

The HPACT clinic serves approximately 3000 patients by 50 staff and trainees divided into 2 teams. LVNs and RNs were tasked to conduct the primary screen as part of their initial clinic check-in. If the primary screen was positive for scheduled patients, LVNs notified a PCP to complete the secondary screen. For unscheduled patients, RNs conducted a primary screen and, if positive, a secondary screen. If the secondary screen was positive, a tertiary screen was performed by mental health practitioners or SWs, or PCPs if the former were unavailable. SWs, mental health practitioners, and PCPs were colocated in the clinic, which allowed for safe and convenient warm handoffs between clinicians.

 

 



During this process, the interprofessional team overseeing the suicide screening implementation efforts in the HPACT clinic met in-person biweekly beginning 1 month prior to the October 1, 2018 implementation. QI tools, including flowcharts and root cause analyses, were used to analyze feedback on efficient workflow and optimize staff responsibilities. A survey assessed staff comfort and familiarity using the suicide screening tools. Informal interviews were conducted with a representative from each stage of patient care to facilitate interprofessional participation and to troubleshoot any issues. Process flowcharts that clearly delineated staff roles based on current clinic workflow and the recommendations set forth by the new process were distributed at an initial staff meeting. The process flowchart was updated after staff feedback and distributed again along with a review of the C-SSRS and CSRE at an all-staff meeting in February 2019. The QI team continued to meet to formally evaluate their SMART Aims and to identify factors driving the success and failure of the implementation.

The VA Informatics and Computing Infrastructure (VINCI) provided project data after a formal request was submitted for this analysis. At the direction of the local QI team, the VINCI team provided aggregate patient counts derived from individual patient data in the VA Corporate Data Warehouse. The data analyzed are frequencies and proportions; no bivariate or multivariate statistics were performed.

Results

During the project year, the HPACT clinic had 2932 unique patients assigned to primary care. Of those veterans, 533 (18%) were exempt from screening by protocol. Of the remainder, staff screened 1876 (64%) of eligible veterans for suicide risk (Figure 2), which did not meet the SMART Aim of screening > 90% of eligible veterans. For the follow-up screens, using a QI dashboard designed for reviewing I9 and C-SSRS results, the QI team reviewed a convenience sample of 5 provider panels and identified 34 positive I9 screens. Twenty of those 34 patients (59%) received a C-SSRS within 24 hours of the positive I9, which did not meet the SMART Aim of ensuring > 90% of primary I9 screens had subsequent C-SSRS screening within 24 hours.

Suicide Risk Screening of HPACT Empaneled Veterans

Of the veterans screened, 1,271 (43%) had their screening performed outside of the HPACT primary care team assigned, while 605 (21%) patients had their screening performed by an HPACT member. Most of the screening that occurred outside of the assigned primary care team occurred in other physical settings, including other VA facilities.

Of the 523 (18%) patients who were not screened, 331 (11%) patients had no visit to the HPACT clinic and 132 (5%) empaneled patients did not visit any VA site within the 1-year period. There were 192 (7%) patients who were not screened that had a visit to HPACT while 19 (1%) of those patients declined screening. A total of 184 (6%) patients were not screened and thus were considered true missed opportunities. This group of patients were eligible for screening but did not undergo screening in the HPACT clinic or any other VA setting despite visiting the VA.

Fishbone Diagram Demonstrating Initial Barriers to Implementation


The QI team created a fishbone diagram to identify opportunities to improve screening rates and patient care (Figure 3). Using the fishbone tool, the QI team identified 5 main categories limiting complete uptake of suicide risk assessment at the HPACT clinic: health record factors, communication, clinician buy-in, system factors, and patient factors. Among the most salient barriers to use of the screening tool, the EHR system needed to be refreshed after a positive screen to be reminded of the next step, requiring close communication during patient handoffs. Handoff was confusing as there was no dedicated process to communicate positive screen information. Clinicians were concerned that completing the process, especially the tertiary screen, would be time consuming and burdensome in an already busy clinic; some clinicians were uncomfortable discussing the topic of suicide as they did not feel they had the expertise to address a positive screen. In addition, some patients were reluctant to answer the screen honestly due to past hospitalizations or concerns about stigma.

Discussion

Though the QI project failed to meet the SMART Aim of ensuring > 90% of eligible patients received a primary screen for suicide risk and > 90% of positive primary I9 screens received subsequent screenings within 24 hours, the results highlight effective practices and barriers for implementation of wide-scale EHR-based interventions for suicide assessment. Most missed screening opportunities were due to patients being lost to follow-up over the duration of the project, which is a challenge faced in this patient population. A recent analysis of the national rollout of this screening program found that 95% of eligible veterans with a visit to the VA in the first year of the program received screening.14 In a post hoc analysis using the same eligibility criteria, the rate of screening for this project was 83%. Reflecting on the data from this national cohort compared with the HPACT clinic, this brings to light potential circumstances that may be unique to veterans experiencing homelessness compared with the general veteran population, for instance, the level of engagement may be lower among veterans experiencing homelessness, though this is beyond the scope of this article. Nonetheless, promoting interprofessional collaboration, visualizing effective process flows, establishing clear lines of communication and roles for involved staff, and opening avenues for continuous feedback and troubleshooting are all potentially effective interventions to improve suicide screening rates within the veteran population.

This HPACT clinic initiative aimed to determine how a new screening process would be implemented while identifying potential areas for improvement. Surprisingly, 43% of patients who were screened had their screening performed outside of the HPACT clinic, most often in the inpatient setting at other WLAVAMC clinics or other VA systems. It is possible that due to the nature of the patient population that the HPACT clinic serves with intensive service needs, these patients have wider geographic and clinical location use than most clinic populations due to the transient nature of patients with housing insecurity. What is encouraging, however, is that through this systemwide initiative, there is an impetus to screen veterans, regardless of who performs the screening. This is particularly meaningful given that rates of depression screening may be as low as 4% among PCPs.15 During implementation, the QI team learned that nearly 18% of the empaneled HPACT patients were exempt from screening. The exempt patients do not have an active clinical reminder for depression screens. Instead, these patients are receiving mental health surveillance and specialty treatment, during which continuous monitoring and assessment for suicidal ideation and risk of suicide are performed. Additionally, an EHR-based factor that also may limit appropriate follow-up and contribute to missed opportunities is that secondary and tertiary screens do not populate until the EHR was refreshed after positive primary screens, which introduces human error in a process that could be automated. Both RNs and PCPs may occasionally miss secondary and tertiary screens due to this issue, which continues to be a barrier. Given the high risk HPACT clinic population, the QI team encouraged staff members to frequently screen patients for suicidal ideation regardless of clinical reminders. A consideration for the future would be to identify optimal frequency for screening and to continue to validate assessment methods.

 

 



Finally, while the percentage of patients who were considered missed opportunities (visited the HPACT clinic but were not screened) was relatively small at 6% of the total panel of patients, this number theoretically should be zero. Though this project was not designed to identify the specific causes for missed opportunities, future QI efforts may consider evaluating for other potential reasons. These may include differing process flows for various encounters (same-day care visits, scheduled primary care visit, RN-only visit), screening not activating at time of visit, time constraints, or other unseen reasons. Another important population is the 11% of patients who were otherwise eligible for screening but did not visit the HPACT clinic, and in some cases, no other VA location. There are a few explanatory reasons centered on the mobility of this population between health systems. However, this patient population also may be among the most vulnerable and at risk: 62% of veteran suicides in 2017 had not had a VA encounter that year.13 While there is no requirement that the veteran visit the HPACT clinic annually, future efforts may focus on increasing engagement through other means of outreach, including site visits and community care involvement, knowing the nature of the sporadic follow-up patterns in this patient population. Future work may also involve examining suicide rates by primary care clinic and triage patterns between interprofessional staff.

Limitations

Due to the limited sample size, findings cannot be generalized to all VA sites. The QI team used retrospective, administrative data. Additionally, since this is a primary care clinic focused on a specialized population, this result may not be generalizable to all primary care settings, other primary care populations, or even other homeless primary care clinics, though it may establish a benchmark when other clinics internally examine their data and processes.

Conclusions

Improving screening protocols can lead to identification of at-risk individuals who would not have otherwise been identified.16,17 As the US continues to grapple with mental health and suicide, efforts toward addressing this important issue among veterans remains a top priority.

Acknowledgments

Thank you to the VAGLAHS Center of Excellence in Primary Care Education faculty and trainees, the HPACT staff, and the VA Informatics and Computing Infrastructure (VINCI) for data support.

References

1. Centers for Disease Control and Prevention. Facts about suicide. Reviewed August 30, 2021. Accessed December 13, 2021. https://www.cdc.gov/suicide/facts/index.html

2. Centers for Disease Control and Prevention. Preventing suicide: a technical package of policies, programs, and practices. Published 2017. Accessed December 13, 2021. https://www.cdc.gov/violenceprevention/pdf/suicideTechnicalPackage.pdf

3. Centers for Disease Control and Prevention. Increase in suicide mortality in the United States, 1999-2018. April 8, 2020. Accessed December 13, 2021. https://www.cdc.gov/nchs/products/databriefs/db362.htm

4. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. 2020 National Veteran Suicide Prevention Annual Report. Published November 2020. Accessed December 13, 2021. https://www.mentalhealth.va.gov/docs/data-sheets/2020/2020-National-Veteran-Suicide-Prevention-Annual-Report-11-2020-508.pdf

5. Culhane D, Szymkowiak D, Schinka, JA. Suicidality and the onset of homelessness: evidence for a temporal association from VHA treatment records. Psychiatr Serv. 2019;70(11):1049-1052. doi:10.1176/appi.ps.201800415

6. US Department of Housing and Urban Development. The 2015 annual homeless assessment report (AHAR) to Congress. Published November 2015. Accessed December 13, 2021. https://www.hudexchange.info/resources/documents/2015-AHAR-Part-1.pdf

7. US Department of Veterans Affairs, Office of Suicide Prevention. Suicide among veterans and other Americans 2001-2014. Published August 3, 2016. Updated August 2017. Accessed December 13, 2021. https://www.mentalhealth.va.gov/docs/2016suicidedatareport.pdf

8. Dobscha SK, Corson K, Helmer DA, et al. Brief assessment for suicidal ideation in OEF/OIF veterans with positive depression screens. Gen Hosp Psychiatry. 2013;35(3):272-278. doi:10.1016/j.genhosppsych.2012.12.001

9. Luoma JB, Martin CE, Pearson JL. Contact with mental health and primary care providers before suicide: a review of the evidence. Am J Psychiatry. 2002;159(6):909-916. doi:10.1176/appi.ajp.159.6.909

10. US Department of Veterans Affairs. National strategy for preventing veteran suicide 2018-2028. Accessed December 13, 2021. https://sprc.org/sites/default/files/resource-program/VA_National-Strategy-for-Preventing-Veterans-Suicide2018.pdf

11. US Department of Veterans Affairs. VA suicide prevention efforts. Published July 2019. Accessed December 15, 2021. https://www.mentalhealth.va.gov/suicide_prevention/docs/VA_Suicide_Prevention_Program_Fact_Sheet_508.pdf

12. Wortzel H, Matarazzo B, Homaifer B. A model for therapeutic risk management of the suicidal patient. J Psychiatr Pract. 2013;19(4):323-326. doi:10.1097/01.pra.0000432603.99211.e8

13. US Department of Veterans Affairs. VA/DoD clinical practice guidelines for the assessment and management of patients at risk for suicide. Provider summary version 2.0. Published 2019. Accessed on December 3, 2020. https://www.healthquality.va.gov/guidelines/MH/srb/VADoDSuicideRiskFullCPGFinal5088919.pdf

14. Bahraini N, Brenner LA, Barry C, et al. Assessment of rates of suicide risk screening and prevalence of positive screening results among US veterans after implementation of the Veterans Affairs suicide risk identification strategy. JAMA Netw Open. 2020;3(10):e2022531. doi:10.1001/jamanetworkopen.2020.22531

15. Akincigil A, Matthews EB. National rates and patterns of depression screening in primary care: results from 2012 and 2013. Psychiatr Serv. 2017;68(7):660-666. doi:10.1176/appi.ps.201600096

16. Posner K, Brent D, Lucas C, et al. Columbia-suicide severity rating scale (C-SSRS). Columbia University Medical Center, New York, NY. 2008. Accessed December 3, 2020. https://cssrs.columbia.edu/wp-content/uploads/C-SSRS-Screening_AU5.1_eng-USori.pdf

17. Boudreaux ED, Camargo CA Jr, Arias SA, et al. Improving suicide risk screening and detection in the emergency department. Am J Prev Med. 2016;50(4):445-453. doi:10.1016/j/amepre.2015.09.029

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Correspondence:
Eileen Kay Ramos Temblique ([email protected])

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The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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This analysis was exempt from institutional review board review as it was conducted as part of a quality improvement initiative of the Veterans Affairs Greater Los Angeles Healthcare System in California, West Los Angeles Homeless Patient Aligned Care Team.

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Eileen Kay Ramos Temblique, MSN, AGPCNP-BCa; Kayla Foster, MSN, FNP-Ca; Jeffrey Fujimoto, MD, MBAb; Kristin Kopelson, MS, FNP-BC, ACNP-BCa; Katharine Maile Borthwick, MDa,b; and Peter Capone-Newton, MD, MPH, PhDa,b
Correspondence:
Eileen Kay Ramos Temblique ([email protected])

Author affiliations
aVeterans Affairs Greater Los Angeles Healthcare System
bUniversity of California, Los Angeles David Geffen School of Medicine

Author disclosures
The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics
This analysis was exempt from institutional review board review as it was conducted as part of a quality improvement initiative of the Veterans Affairs Greater Los Angeles Healthcare System in California, West Los Angeles Homeless Patient Aligned Care Team.

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Related Articles

Suicide is a national public health concern that affects thousands of US individuals and families, with repercussions that reverberate through entire communities. In 2019, there were 47,500 US deaths by suicide, which accounted for about 1 death every 11 minutes.1 Suicide remains the tenth leading cause of death in the United States and has been part of the top 12 leading causes of death since 1975.2 Unfortunately, this trend has worsened; suicide rates have increased by 35% from 1999 to 2018.3 One particularly vulnerable population is US veterans who accounted for 13.8% of all suicide deaths in 2018.4 Among veterans, the suicide death average increased from 16.6 per day in 2005 to 17.6 in 2018.4 Furthermore, veterans experiencing homelessness are 5 times more likely to attempt suicide and 2.5 times more likely to have suicidal ideation compared with veterans without a history of homelessness.4 Suicide is a significant issue among veterans experiencing homelessness: Veterans account for about 11% of the overall US homeless population.5

Recent data suggest opportunities for suicide risk assessment in the primary care setting. A study from the Veterans Health Administration (VHA) Office for Suicide Prevention found that in 2014 an average of 20 veterans died by suicide every day and 6 of the 20 (30%) on average used VHA services within the prior year.6 Similarly, a review of 40 studies on suicide found that 45% of suicide victims had contact with their primary care practitioner (PCP) within 1 month of suicide, and 75% of victims had contact within the year of suicide.7 An analysis of depression screening in 2008/2009 using Patient Health Questionnaire-2 (PHQ-2) or Patient Health Questionnaire-9 (PHQ-9) at 3 large western US Department of Veterans Affairs (VA) medical centers found that 55% were screened for depression.8 The VA has made suicide prevention a top priority and supports the established US goal of reducing annual suicide deaths by 20% by 2025.9 Given key opportunities for suicide risk assessment in the primary care setting, the VHA Office of Mental Health and Suicide Prevention implemented a national, standardized process for suicide risk assessment on October 1, 2018.10,11

The VA approach to suicide screening, evaluation, and documentation has evolved over time. Between October 2018 and December 2020, the process was augmented to include 3 stages embedded into the electronic health record (EHR): a primary screen (PHQ-2 with Item 9 from the PHQ-9 [PHQ-2+I9]), a secondary screen (Columbia-Suicide Severity Rating Scale [C-SSRS]), and a tertiary screen (Comprehensive Suicide Risk Evaluation [CSRE]). The primary screen consisted of the depression screening using the PHQ-2 with the addition of I9 asking about suicidal ideation. The secondary screening, or C-SSRS, included 8 questions to elaborate on suicidal ideation, intent, plan, and any history of suicidal attempts or preparatory behaviors. The tertiary screen consisted of the CSRE, a questionnaire developed internally by the VA in 2018 to further evaluate the veteran’s suicidal thoughts, attempts, warning signs, risk factors, protective factors, and reasons for living. The goal of the screenings was to identify veterans at risk of suicide, assess risk severity, and to individually tailor risk mitigation strategies for safe disposition. These risk categories were developed by the regional Mental Illness Research, Education and Clinical Center, which suggested treatment strategies, such as hospitalization or close outpatient follow-up.12,13

The Homeless Patient Aligned Care Team (HPACT) clinic at the West Los Angeles VA Medical Center (WLAVAMC) in California, one of the largest VA homeless clinics in the country and 1 of 7 national VA Office of Academic Affiliation Centers of Excellence in Primary Care Education training programs implemented the standardized tools for suicide risk screening and quality improvement (QI). The HPACT clinic is an interprofessional team, including primary care, mental health, social work, pharmacy, and peer support, that is adjacent to the WLAVAMC general primary care clinics. The team collaboratively addresses both medical and psychosocial needs of veterans with a focus on the Housing First Model, an approach that prioritizes ending homelessness while addressing all factors associated with veterans' health and well-being. After 1 year of stable housing, veterans graduate to the WLAVAMC general primary care clinics.

Given the vulnerability of veterans experiencing homelessness, the clinic leadership identified suicide risk screening as a high priority initiative and created a taskforce to oversee effective implementation of clinic screening efforts. An interprofessional team of nurse practitioners (NPs), pharmacists, physicians, psychologists, social workers (SWs), and trainees formed to improve screening efforts and use the QI principles to guide analysis and intervention. The team wrote the following SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) Aim statements: (1) ensure > 90% of eligible patients receive a primary screen; (2) ensure > 90% of positive primary I9 screens receive subsequent screenings within 24 hours; and (3) increase staff comfort and familiarity using the screening tools. This article examines the results of the screening initiative 1-year postimplementation, describes difficulties faced, and suggests strategies that might be used to overcome those challenges.

Methods

This QI analysis was exempt from institutional review board review. Prior to the standardized national suicide risk assessment rollout of October 1, 2018, the QI team met to review and understand the workflow to be implemented into the HPACT clinic. To describe the initial screening process, the new suicide risk assessment consisted of primary, secondary, and tertiary screens that would warrant subsequent intervention by clinicians if positive (Figure 1). The primary screen included the PHQ-2+I9 questionnaire (PHQ-2 for depression and I9 for suicidal ideation). If either were positive, follow-up questionnaires were required. Of note, patients with a prior depression diagnosis, cognitive impairment defined at a severity of moderate or greater based on clinician evaluation and judgement, or life expectancy < 6 months were exempt from screening because, by definition, they had theoretically already been screened and classified as under surveillance.

A positive I9 response prompted a secondary screen using C-SSRS. A positive secondary screen prompted a tertiary screen using CSRE. If the PHQ-2 screening was positive but I9 was negative, the standard follow-up depression clinical reminder was used. Any clinical staff member could perform the primary screen, including licensed vocational nurses (LVNs), registered nurses (RNs), and SWs in any setting (eg, emergency department, primary care, inpatient services). The secondary and tertiary screens required completion by a licensed clinician. RNs were able to perform the secondary screen but not the tertiary screen.

The HPACT clinic serves approximately 3000 patients by 50 staff and trainees divided into 2 teams. LVNs and RNs were tasked to conduct the primary screen as part of their initial clinic check-in. If the primary screen was positive for scheduled patients, LVNs notified a PCP to complete the secondary screen. For unscheduled patients, RNs conducted a primary screen and, if positive, a secondary screen. If the secondary screen was positive, a tertiary screen was performed by mental health practitioners or SWs, or PCPs if the former were unavailable. SWs, mental health practitioners, and PCPs were colocated in the clinic, which allowed for safe and convenient warm handoffs between clinicians.

 

 



During this process, the interprofessional team overseeing the suicide screening implementation efforts in the HPACT clinic met in-person biweekly beginning 1 month prior to the October 1, 2018 implementation. QI tools, including flowcharts and root cause analyses, were used to analyze feedback on efficient workflow and optimize staff responsibilities. A survey assessed staff comfort and familiarity using the suicide screening tools. Informal interviews were conducted with a representative from each stage of patient care to facilitate interprofessional participation and to troubleshoot any issues. Process flowcharts that clearly delineated staff roles based on current clinic workflow and the recommendations set forth by the new process were distributed at an initial staff meeting. The process flowchart was updated after staff feedback and distributed again along with a review of the C-SSRS and CSRE at an all-staff meeting in February 2019. The QI team continued to meet to formally evaluate their SMART Aims and to identify factors driving the success and failure of the implementation.

The VA Informatics and Computing Infrastructure (VINCI) provided project data after a formal request was submitted for this analysis. At the direction of the local QI team, the VINCI team provided aggregate patient counts derived from individual patient data in the VA Corporate Data Warehouse. The data analyzed are frequencies and proportions; no bivariate or multivariate statistics were performed.

Results

During the project year, the HPACT clinic had 2932 unique patients assigned to primary care. Of those veterans, 533 (18%) were exempt from screening by protocol. Of the remainder, staff screened 1876 (64%) of eligible veterans for suicide risk (Figure 2), which did not meet the SMART Aim of screening > 90% of eligible veterans. For the follow-up screens, using a QI dashboard designed for reviewing I9 and C-SSRS results, the QI team reviewed a convenience sample of 5 provider panels and identified 34 positive I9 screens. Twenty of those 34 patients (59%) received a C-SSRS within 24 hours of the positive I9, which did not meet the SMART Aim of ensuring > 90% of primary I9 screens had subsequent C-SSRS screening within 24 hours.

Suicide Risk Screening of HPACT Empaneled Veterans

Of the veterans screened, 1,271 (43%) had their screening performed outside of the HPACT primary care team assigned, while 605 (21%) patients had their screening performed by an HPACT member. Most of the screening that occurred outside of the assigned primary care team occurred in other physical settings, including other VA facilities.

Of the 523 (18%) patients who were not screened, 331 (11%) patients had no visit to the HPACT clinic and 132 (5%) empaneled patients did not visit any VA site within the 1-year period. There were 192 (7%) patients who were not screened that had a visit to HPACT while 19 (1%) of those patients declined screening. A total of 184 (6%) patients were not screened and thus were considered true missed opportunities. This group of patients were eligible for screening but did not undergo screening in the HPACT clinic or any other VA setting despite visiting the VA.

Fishbone Diagram Demonstrating Initial Barriers to Implementation


The QI team created a fishbone diagram to identify opportunities to improve screening rates and patient care (Figure 3). Using the fishbone tool, the QI team identified 5 main categories limiting complete uptake of suicide risk assessment at the HPACT clinic: health record factors, communication, clinician buy-in, system factors, and patient factors. Among the most salient barriers to use of the screening tool, the EHR system needed to be refreshed after a positive screen to be reminded of the next step, requiring close communication during patient handoffs. Handoff was confusing as there was no dedicated process to communicate positive screen information. Clinicians were concerned that completing the process, especially the tertiary screen, would be time consuming and burdensome in an already busy clinic; some clinicians were uncomfortable discussing the topic of suicide as they did not feel they had the expertise to address a positive screen. In addition, some patients were reluctant to answer the screen honestly due to past hospitalizations or concerns about stigma.

Discussion

Though the QI project failed to meet the SMART Aim of ensuring > 90% of eligible patients received a primary screen for suicide risk and > 90% of positive primary I9 screens received subsequent screenings within 24 hours, the results highlight effective practices and barriers for implementation of wide-scale EHR-based interventions for suicide assessment. Most missed screening opportunities were due to patients being lost to follow-up over the duration of the project, which is a challenge faced in this patient population. A recent analysis of the national rollout of this screening program found that 95% of eligible veterans with a visit to the VA in the first year of the program received screening.14 In a post hoc analysis using the same eligibility criteria, the rate of screening for this project was 83%. Reflecting on the data from this national cohort compared with the HPACT clinic, this brings to light potential circumstances that may be unique to veterans experiencing homelessness compared with the general veteran population, for instance, the level of engagement may be lower among veterans experiencing homelessness, though this is beyond the scope of this article. Nonetheless, promoting interprofessional collaboration, visualizing effective process flows, establishing clear lines of communication and roles for involved staff, and opening avenues for continuous feedback and troubleshooting are all potentially effective interventions to improve suicide screening rates within the veteran population.

This HPACT clinic initiative aimed to determine how a new screening process would be implemented while identifying potential areas for improvement. Surprisingly, 43% of patients who were screened had their screening performed outside of the HPACT clinic, most often in the inpatient setting at other WLAVAMC clinics or other VA systems. It is possible that due to the nature of the patient population that the HPACT clinic serves with intensive service needs, these patients have wider geographic and clinical location use than most clinic populations due to the transient nature of patients with housing insecurity. What is encouraging, however, is that through this systemwide initiative, there is an impetus to screen veterans, regardless of who performs the screening. This is particularly meaningful given that rates of depression screening may be as low as 4% among PCPs.15 During implementation, the QI team learned that nearly 18% of the empaneled HPACT patients were exempt from screening. The exempt patients do not have an active clinical reminder for depression screens. Instead, these patients are receiving mental health surveillance and specialty treatment, during which continuous monitoring and assessment for suicidal ideation and risk of suicide are performed. Additionally, an EHR-based factor that also may limit appropriate follow-up and contribute to missed opportunities is that secondary and tertiary screens do not populate until the EHR was refreshed after positive primary screens, which introduces human error in a process that could be automated. Both RNs and PCPs may occasionally miss secondary and tertiary screens due to this issue, which continues to be a barrier. Given the high risk HPACT clinic population, the QI team encouraged staff members to frequently screen patients for suicidal ideation regardless of clinical reminders. A consideration for the future would be to identify optimal frequency for screening and to continue to validate assessment methods.

 

 



Finally, while the percentage of patients who were considered missed opportunities (visited the HPACT clinic but were not screened) was relatively small at 6% of the total panel of patients, this number theoretically should be zero. Though this project was not designed to identify the specific causes for missed opportunities, future QI efforts may consider evaluating for other potential reasons. These may include differing process flows for various encounters (same-day care visits, scheduled primary care visit, RN-only visit), screening not activating at time of visit, time constraints, or other unseen reasons. Another important population is the 11% of patients who were otherwise eligible for screening but did not visit the HPACT clinic, and in some cases, no other VA location. There are a few explanatory reasons centered on the mobility of this population between health systems. However, this patient population also may be among the most vulnerable and at risk: 62% of veteran suicides in 2017 had not had a VA encounter that year.13 While there is no requirement that the veteran visit the HPACT clinic annually, future efforts may focus on increasing engagement through other means of outreach, including site visits and community care involvement, knowing the nature of the sporadic follow-up patterns in this patient population. Future work may also involve examining suicide rates by primary care clinic and triage patterns between interprofessional staff.

Limitations

Due to the limited sample size, findings cannot be generalized to all VA sites. The QI team used retrospective, administrative data. Additionally, since this is a primary care clinic focused on a specialized population, this result may not be generalizable to all primary care settings, other primary care populations, or even other homeless primary care clinics, though it may establish a benchmark when other clinics internally examine their data and processes.

Conclusions

Improving screening protocols can lead to identification of at-risk individuals who would not have otherwise been identified.16,17 As the US continues to grapple with mental health and suicide, efforts toward addressing this important issue among veterans remains a top priority.

Acknowledgments

Thank you to the VAGLAHS Center of Excellence in Primary Care Education faculty and trainees, the HPACT staff, and the VA Informatics and Computing Infrastructure (VINCI) for data support.

Suicide is a national public health concern that affects thousands of US individuals and families, with repercussions that reverberate through entire communities. In 2019, there were 47,500 US deaths by suicide, which accounted for about 1 death every 11 minutes.1 Suicide remains the tenth leading cause of death in the United States and has been part of the top 12 leading causes of death since 1975.2 Unfortunately, this trend has worsened; suicide rates have increased by 35% from 1999 to 2018.3 One particularly vulnerable population is US veterans who accounted for 13.8% of all suicide deaths in 2018.4 Among veterans, the suicide death average increased from 16.6 per day in 2005 to 17.6 in 2018.4 Furthermore, veterans experiencing homelessness are 5 times more likely to attempt suicide and 2.5 times more likely to have suicidal ideation compared with veterans without a history of homelessness.4 Suicide is a significant issue among veterans experiencing homelessness: Veterans account for about 11% of the overall US homeless population.5

Recent data suggest opportunities for suicide risk assessment in the primary care setting. A study from the Veterans Health Administration (VHA) Office for Suicide Prevention found that in 2014 an average of 20 veterans died by suicide every day and 6 of the 20 (30%) on average used VHA services within the prior year.6 Similarly, a review of 40 studies on suicide found that 45% of suicide victims had contact with their primary care practitioner (PCP) within 1 month of suicide, and 75% of victims had contact within the year of suicide.7 An analysis of depression screening in 2008/2009 using Patient Health Questionnaire-2 (PHQ-2) or Patient Health Questionnaire-9 (PHQ-9) at 3 large western US Department of Veterans Affairs (VA) medical centers found that 55% were screened for depression.8 The VA has made suicide prevention a top priority and supports the established US goal of reducing annual suicide deaths by 20% by 2025.9 Given key opportunities for suicide risk assessment in the primary care setting, the VHA Office of Mental Health and Suicide Prevention implemented a national, standardized process for suicide risk assessment on October 1, 2018.10,11

The VA approach to suicide screening, evaluation, and documentation has evolved over time. Between October 2018 and December 2020, the process was augmented to include 3 stages embedded into the electronic health record (EHR): a primary screen (PHQ-2 with Item 9 from the PHQ-9 [PHQ-2+I9]), a secondary screen (Columbia-Suicide Severity Rating Scale [C-SSRS]), and a tertiary screen (Comprehensive Suicide Risk Evaluation [CSRE]). The primary screen consisted of the depression screening using the PHQ-2 with the addition of I9 asking about suicidal ideation. The secondary screening, or C-SSRS, included 8 questions to elaborate on suicidal ideation, intent, plan, and any history of suicidal attempts or preparatory behaviors. The tertiary screen consisted of the CSRE, a questionnaire developed internally by the VA in 2018 to further evaluate the veteran’s suicidal thoughts, attempts, warning signs, risk factors, protective factors, and reasons for living. The goal of the screenings was to identify veterans at risk of suicide, assess risk severity, and to individually tailor risk mitigation strategies for safe disposition. These risk categories were developed by the regional Mental Illness Research, Education and Clinical Center, which suggested treatment strategies, such as hospitalization or close outpatient follow-up.12,13

The Homeless Patient Aligned Care Team (HPACT) clinic at the West Los Angeles VA Medical Center (WLAVAMC) in California, one of the largest VA homeless clinics in the country and 1 of 7 national VA Office of Academic Affiliation Centers of Excellence in Primary Care Education training programs implemented the standardized tools for suicide risk screening and quality improvement (QI). The HPACT clinic is an interprofessional team, including primary care, mental health, social work, pharmacy, and peer support, that is adjacent to the WLAVAMC general primary care clinics. The team collaboratively addresses both medical and psychosocial needs of veterans with a focus on the Housing First Model, an approach that prioritizes ending homelessness while addressing all factors associated with veterans' health and well-being. After 1 year of stable housing, veterans graduate to the WLAVAMC general primary care clinics.

Given the vulnerability of veterans experiencing homelessness, the clinic leadership identified suicide risk screening as a high priority initiative and created a taskforce to oversee effective implementation of clinic screening efforts. An interprofessional team of nurse practitioners (NPs), pharmacists, physicians, psychologists, social workers (SWs), and trainees formed to improve screening efforts and use the QI principles to guide analysis and intervention. The team wrote the following SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) Aim statements: (1) ensure > 90% of eligible patients receive a primary screen; (2) ensure > 90% of positive primary I9 screens receive subsequent screenings within 24 hours; and (3) increase staff comfort and familiarity using the screening tools. This article examines the results of the screening initiative 1-year postimplementation, describes difficulties faced, and suggests strategies that might be used to overcome those challenges.

Methods

This QI analysis was exempt from institutional review board review. Prior to the standardized national suicide risk assessment rollout of October 1, 2018, the QI team met to review and understand the workflow to be implemented into the HPACT clinic. To describe the initial screening process, the new suicide risk assessment consisted of primary, secondary, and tertiary screens that would warrant subsequent intervention by clinicians if positive (Figure 1). The primary screen included the PHQ-2+I9 questionnaire (PHQ-2 for depression and I9 for suicidal ideation). If either were positive, follow-up questionnaires were required. Of note, patients with a prior depression diagnosis, cognitive impairment defined at a severity of moderate or greater based on clinician evaluation and judgement, or life expectancy < 6 months were exempt from screening because, by definition, they had theoretically already been screened and classified as under surveillance.

A positive I9 response prompted a secondary screen using C-SSRS. A positive secondary screen prompted a tertiary screen using CSRE. If the PHQ-2 screening was positive but I9 was negative, the standard follow-up depression clinical reminder was used. Any clinical staff member could perform the primary screen, including licensed vocational nurses (LVNs), registered nurses (RNs), and SWs in any setting (eg, emergency department, primary care, inpatient services). The secondary and tertiary screens required completion by a licensed clinician. RNs were able to perform the secondary screen but not the tertiary screen.

The HPACT clinic serves approximately 3000 patients by 50 staff and trainees divided into 2 teams. LVNs and RNs were tasked to conduct the primary screen as part of their initial clinic check-in. If the primary screen was positive for scheduled patients, LVNs notified a PCP to complete the secondary screen. For unscheduled patients, RNs conducted a primary screen and, if positive, a secondary screen. If the secondary screen was positive, a tertiary screen was performed by mental health practitioners or SWs, or PCPs if the former were unavailable. SWs, mental health practitioners, and PCPs were colocated in the clinic, which allowed for safe and convenient warm handoffs between clinicians.

 

 



During this process, the interprofessional team overseeing the suicide screening implementation efforts in the HPACT clinic met in-person biweekly beginning 1 month prior to the October 1, 2018 implementation. QI tools, including flowcharts and root cause analyses, were used to analyze feedback on efficient workflow and optimize staff responsibilities. A survey assessed staff comfort and familiarity using the suicide screening tools. Informal interviews were conducted with a representative from each stage of patient care to facilitate interprofessional participation and to troubleshoot any issues. Process flowcharts that clearly delineated staff roles based on current clinic workflow and the recommendations set forth by the new process were distributed at an initial staff meeting. The process flowchart was updated after staff feedback and distributed again along with a review of the C-SSRS and CSRE at an all-staff meeting in February 2019. The QI team continued to meet to formally evaluate their SMART Aims and to identify factors driving the success and failure of the implementation.

The VA Informatics and Computing Infrastructure (VINCI) provided project data after a formal request was submitted for this analysis. At the direction of the local QI team, the VINCI team provided aggregate patient counts derived from individual patient data in the VA Corporate Data Warehouse. The data analyzed are frequencies and proportions; no bivariate or multivariate statistics were performed.

Results

During the project year, the HPACT clinic had 2932 unique patients assigned to primary care. Of those veterans, 533 (18%) were exempt from screening by protocol. Of the remainder, staff screened 1876 (64%) of eligible veterans for suicide risk (Figure 2), which did not meet the SMART Aim of screening > 90% of eligible veterans. For the follow-up screens, using a QI dashboard designed for reviewing I9 and C-SSRS results, the QI team reviewed a convenience sample of 5 provider panels and identified 34 positive I9 screens. Twenty of those 34 patients (59%) received a C-SSRS within 24 hours of the positive I9, which did not meet the SMART Aim of ensuring > 90% of primary I9 screens had subsequent C-SSRS screening within 24 hours.

Suicide Risk Screening of HPACT Empaneled Veterans

Of the veterans screened, 1,271 (43%) had their screening performed outside of the HPACT primary care team assigned, while 605 (21%) patients had their screening performed by an HPACT member. Most of the screening that occurred outside of the assigned primary care team occurred in other physical settings, including other VA facilities.

Of the 523 (18%) patients who were not screened, 331 (11%) patients had no visit to the HPACT clinic and 132 (5%) empaneled patients did not visit any VA site within the 1-year period. There were 192 (7%) patients who were not screened that had a visit to HPACT while 19 (1%) of those patients declined screening. A total of 184 (6%) patients were not screened and thus were considered true missed opportunities. This group of patients were eligible for screening but did not undergo screening in the HPACT clinic or any other VA setting despite visiting the VA.

Fishbone Diagram Demonstrating Initial Barriers to Implementation


The QI team created a fishbone diagram to identify opportunities to improve screening rates and patient care (Figure 3). Using the fishbone tool, the QI team identified 5 main categories limiting complete uptake of suicide risk assessment at the HPACT clinic: health record factors, communication, clinician buy-in, system factors, and patient factors. Among the most salient barriers to use of the screening tool, the EHR system needed to be refreshed after a positive screen to be reminded of the next step, requiring close communication during patient handoffs. Handoff was confusing as there was no dedicated process to communicate positive screen information. Clinicians were concerned that completing the process, especially the tertiary screen, would be time consuming and burdensome in an already busy clinic; some clinicians were uncomfortable discussing the topic of suicide as they did not feel they had the expertise to address a positive screen. In addition, some patients were reluctant to answer the screen honestly due to past hospitalizations or concerns about stigma.

Discussion

Though the QI project failed to meet the SMART Aim of ensuring > 90% of eligible patients received a primary screen for suicide risk and > 90% of positive primary I9 screens received subsequent screenings within 24 hours, the results highlight effective practices and barriers for implementation of wide-scale EHR-based interventions for suicide assessment. Most missed screening opportunities were due to patients being lost to follow-up over the duration of the project, which is a challenge faced in this patient population. A recent analysis of the national rollout of this screening program found that 95% of eligible veterans with a visit to the VA in the first year of the program received screening.14 In a post hoc analysis using the same eligibility criteria, the rate of screening for this project was 83%. Reflecting on the data from this national cohort compared with the HPACT clinic, this brings to light potential circumstances that may be unique to veterans experiencing homelessness compared with the general veteran population, for instance, the level of engagement may be lower among veterans experiencing homelessness, though this is beyond the scope of this article. Nonetheless, promoting interprofessional collaboration, visualizing effective process flows, establishing clear lines of communication and roles for involved staff, and opening avenues for continuous feedback and troubleshooting are all potentially effective interventions to improve suicide screening rates within the veteran population.

This HPACT clinic initiative aimed to determine how a new screening process would be implemented while identifying potential areas for improvement. Surprisingly, 43% of patients who were screened had their screening performed outside of the HPACT clinic, most often in the inpatient setting at other WLAVAMC clinics or other VA systems. It is possible that due to the nature of the patient population that the HPACT clinic serves with intensive service needs, these patients have wider geographic and clinical location use than most clinic populations due to the transient nature of patients with housing insecurity. What is encouraging, however, is that through this systemwide initiative, there is an impetus to screen veterans, regardless of who performs the screening. This is particularly meaningful given that rates of depression screening may be as low as 4% among PCPs.15 During implementation, the QI team learned that nearly 18% of the empaneled HPACT patients were exempt from screening. The exempt patients do not have an active clinical reminder for depression screens. Instead, these patients are receiving mental health surveillance and specialty treatment, during which continuous monitoring and assessment for suicidal ideation and risk of suicide are performed. Additionally, an EHR-based factor that also may limit appropriate follow-up and contribute to missed opportunities is that secondary and tertiary screens do not populate until the EHR was refreshed after positive primary screens, which introduces human error in a process that could be automated. Both RNs and PCPs may occasionally miss secondary and tertiary screens due to this issue, which continues to be a barrier. Given the high risk HPACT clinic population, the QI team encouraged staff members to frequently screen patients for suicidal ideation regardless of clinical reminders. A consideration for the future would be to identify optimal frequency for screening and to continue to validate assessment methods.

 

 



Finally, while the percentage of patients who were considered missed opportunities (visited the HPACT clinic but were not screened) was relatively small at 6% of the total panel of patients, this number theoretically should be zero. Though this project was not designed to identify the specific causes for missed opportunities, future QI efforts may consider evaluating for other potential reasons. These may include differing process flows for various encounters (same-day care visits, scheduled primary care visit, RN-only visit), screening not activating at time of visit, time constraints, or other unseen reasons. Another important population is the 11% of patients who were otherwise eligible for screening but did not visit the HPACT clinic, and in some cases, no other VA location. There are a few explanatory reasons centered on the mobility of this population between health systems. However, this patient population also may be among the most vulnerable and at risk: 62% of veteran suicides in 2017 had not had a VA encounter that year.13 While there is no requirement that the veteran visit the HPACT clinic annually, future efforts may focus on increasing engagement through other means of outreach, including site visits and community care involvement, knowing the nature of the sporadic follow-up patterns in this patient population. Future work may also involve examining suicide rates by primary care clinic and triage patterns between interprofessional staff.

Limitations

Due to the limited sample size, findings cannot be generalized to all VA sites. The QI team used retrospective, administrative data. Additionally, since this is a primary care clinic focused on a specialized population, this result may not be generalizable to all primary care settings, other primary care populations, or even other homeless primary care clinics, though it may establish a benchmark when other clinics internally examine their data and processes.

Conclusions

Improving screening protocols can lead to identification of at-risk individuals who would not have otherwise been identified.16,17 As the US continues to grapple with mental health and suicide, efforts toward addressing this important issue among veterans remains a top priority.

Acknowledgments

Thank you to the VAGLAHS Center of Excellence in Primary Care Education faculty and trainees, the HPACT staff, and the VA Informatics and Computing Infrastructure (VINCI) for data support.

References

1. Centers for Disease Control and Prevention. Facts about suicide. Reviewed August 30, 2021. Accessed December 13, 2021. https://www.cdc.gov/suicide/facts/index.html

2. Centers for Disease Control and Prevention. Preventing suicide: a technical package of policies, programs, and practices. Published 2017. Accessed December 13, 2021. https://www.cdc.gov/violenceprevention/pdf/suicideTechnicalPackage.pdf

3. Centers for Disease Control and Prevention. Increase in suicide mortality in the United States, 1999-2018. April 8, 2020. Accessed December 13, 2021. https://www.cdc.gov/nchs/products/databriefs/db362.htm

4. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. 2020 National Veteran Suicide Prevention Annual Report. Published November 2020. Accessed December 13, 2021. https://www.mentalhealth.va.gov/docs/data-sheets/2020/2020-National-Veteran-Suicide-Prevention-Annual-Report-11-2020-508.pdf

5. Culhane D, Szymkowiak D, Schinka, JA. Suicidality and the onset of homelessness: evidence for a temporal association from VHA treatment records. Psychiatr Serv. 2019;70(11):1049-1052. doi:10.1176/appi.ps.201800415

6. US Department of Housing and Urban Development. The 2015 annual homeless assessment report (AHAR) to Congress. Published November 2015. Accessed December 13, 2021. https://www.hudexchange.info/resources/documents/2015-AHAR-Part-1.pdf

7. US Department of Veterans Affairs, Office of Suicide Prevention. Suicide among veterans and other Americans 2001-2014. Published August 3, 2016. Updated August 2017. Accessed December 13, 2021. https://www.mentalhealth.va.gov/docs/2016suicidedatareport.pdf

8. Dobscha SK, Corson K, Helmer DA, et al. Brief assessment for suicidal ideation in OEF/OIF veterans with positive depression screens. Gen Hosp Psychiatry. 2013;35(3):272-278. doi:10.1016/j.genhosppsych.2012.12.001

9. Luoma JB, Martin CE, Pearson JL. Contact with mental health and primary care providers before suicide: a review of the evidence. Am J Psychiatry. 2002;159(6):909-916. doi:10.1176/appi.ajp.159.6.909

10. US Department of Veterans Affairs. National strategy for preventing veteran suicide 2018-2028. Accessed December 13, 2021. https://sprc.org/sites/default/files/resource-program/VA_National-Strategy-for-Preventing-Veterans-Suicide2018.pdf

11. US Department of Veterans Affairs. VA suicide prevention efforts. Published July 2019. Accessed December 15, 2021. https://www.mentalhealth.va.gov/suicide_prevention/docs/VA_Suicide_Prevention_Program_Fact_Sheet_508.pdf

12. Wortzel H, Matarazzo B, Homaifer B. A model for therapeutic risk management of the suicidal patient. J Psychiatr Pract. 2013;19(4):323-326. doi:10.1097/01.pra.0000432603.99211.e8

13. US Department of Veterans Affairs. VA/DoD clinical practice guidelines for the assessment and management of patients at risk for suicide. Provider summary version 2.0. Published 2019. Accessed on December 3, 2020. https://www.healthquality.va.gov/guidelines/MH/srb/VADoDSuicideRiskFullCPGFinal5088919.pdf

14. Bahraini N, Brenner LA, Barry C, et al. Assessment of rates of suicide risk screening and prevalence of positive screening results among US veterans after implementation of the Veterans Affairs suicide risk identification strategy. JAMA Netw Open. 2020;3(10):e2022531. doi:10.1001/jamanetworkopen.2020.22531

15. Akincigil A, Matthews EB. National rates and patterns of depression screening in primary care: results from 2012 and 2013. Psychiatr Serv. 2017;68(7):660-666. doi:10.1176/appi.ps.201600096

16. Posner K, Brent D, Lucas C, et al. Columbia-suicide severity rating scale (C-SSRS). Columbia University Medical Center, New York, NY. 2008. Accessed December 3, 2020. https://cssrs.columbia.edu/wp-content/uploads/C-SSRS-Screening_AU5.1_eng-USori.pdf

17. Boudreaux ED, Camargo CA Jr, Arias SA, et al. Improving suicide risk screening and detection in the emergency department. Am J Prev Med. 2016;50(4):445-453. doi:10.1016/j/amepre.2015.09.029

References

1. Centers for Disease Control and Prevention. Facts about suicide. Reviewed August 30, 2021. Accessed December 13, 2021. https://www.cdc.gov/suicide/facts/index.html

2. Centers for Disease Control and Prevention. Preventing suicide: a technical package of policies, programs, and practices. Published 2017. Accessed December 13, 2021. https://www.cdc.gov/violenceprevention/pdf/suicideTechnicalPackage.pdf

3. Centers for Disease Control and Prevention. Increase in suicide mortality in the United States, 1999-2018. April 8, 2020. Accessed December 13, 2021. https://www.cdc.gov/nchs/products/databriefs/db362.htm

4. US Department of Veterans Affairs, Office of Mental Health and Suicide Prevention. 2020 National Veteran Suicide Prevention Annual Report. Published November 2020. Accessed December 13, 2021. https://www.mentalhealth.va.gov/docs/data-sheets/2020/2020-National-Veteran-Suicide-Prevention-Annual-Report-11-2020-508.pdf

5. Culhane D, Szymkowiak D, Schinka, JA. Suicidality and the onset of homelessness: evidence for a temporal association from VHA treatment records. Psychiatr Serv. 2019;70(11):1049-1052. doi:10.1176/appi.ps.201800415

6. US Department of Housing and Urban Development. The 2015 annual homeless assessment report (AHAR) to Congress. Published November 2015. Accessed December 13, 2021. https://www.hudexchange.info/resources/documents/2015-AHAR-Part-1.pdf

7. US Department of Veterans Affairs, Office of Suicide Prevention. Suicide among veterans and other Americans 2001-2014. Published August 3, 2016. Updated August 2017. Accessed December 13, 2021. https://www.mentalhealth.va.gov/docs/2016suicidedatareport.pdf

8. Dobscha SK, Corson K, Helmer DA, et al. Brief assessment for suicidal ideation in OEF/OIF veterans with positive depression screens. Gen Hosp Psychiatry. 2013;35(3):272-278. doi:10.1016/j.genhosppsych.2012.12.001

9. Luoma JB, Martin CE, Pearson JL. Contact with mental health and primary care providers before suicide: a review of the evidence. Am J Psychiatry. 2002;159(6):909-916. doi:10.1176/appi.ajp.159.6.909

10. US Department of Veterans Affairs. National strategy for preventing veteran suicide 2018-2028. Accessed December 13, 2021. https://sprc.org/sites/default/files/resource-program/VA_National-Strategy-for-Preventing-Veterans-Suicide2018.pdf

11. US Department of Veterans Affairs. VA suicide prevention efforts. Published July 2019. Accessed December 15, 2021. https://www.mentalhealth.va.gov/suicide_prevention/docs/VA_Suicide_Prevention_Program_Fact_Sheet_508.pdf

12. Wortzel H, Matarazzo B, Homaifer B. A model for therapeutic risk management of the suicidal patient. J Psychiatr Pract. 2013;19(4):323-326. doi:10.1097/01.pra.0000432603.99211.e8

13. US Department of Veterans Affairs. VA/DoD clinical practice guidelines for the assessment and management of patients at risk for suicide. Provider summary version 2.0. Published 2019. Accessed on December 3, 2020. https://www.healthquality.va.gov/guidelines/MH/srb/VADoDSuicideRiskFullCPGFinal5088919.pdf

14. Bahraini N, Brenner LA, Barry C, et al. Assessment of rates of suicide risk screening and prevalence of positive screening results among US veterans after implementation of the Veterans Affairs suicide risk identification strategy. JAMA Netw Open. 2020;3(10):e2022531. doi:10.1001/jamanetworkopen.2020.22531

15. Akincigil A, Matthews EB. National rates and patterns of depression screening in primary care: results from 2012 and 2013. Psychiatr Serv. 2017;68(7):660-666. doi:10.1176/appi.ps.201600096

16. Posner K, Brent D, Lucas C, et al. Columbia-suicide severity rating scale (C-SSRS). Columbia University Medical Center, New York, NY. 2008. Accessed December 3, 2020. https://cssrs.columbia.edu/wp-content/uploads/C-SSRS-Screening_AU5.1_eng-USori.pdf

17. Boudreaux ED, Camargo CA Jr, Arias SA, et al. Improving suicide risk screening and detection in the emergency department. Am J Prev Med. 2016;50(4):445-453. doi:10.1016/j/amepre.2015.09.029

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Understanding the Intersection of Homelessness and Justice Involvement: Enhancing Veteran Suicide Prevention Through VA Programming

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Despite the success of several US Department of Veterans Affairs (VA) initiatives in facilitating psychosocial functioning, rehabilitation, and re-entry among veterans experiencing homelessness and/or interactions with the criminal justice system (ie, justice-involved veterans), suicide risk among these veterans remains a significant public health concern. Rates of suicide among veterans experiencing homelessness are more than double that of veterans with no history of homelessness.1 Similarly, justice-involved veterans experience myriad mental health concerns, including elevated rates of psychiatric symptoms, suicidal thoughts, and self-directed violence relative to those with no history of criminal justice involvement.2

In addition, a bidirectional relationship between criminal justice involvement and homelessness, often called the “institutional circuit,” is well established. Criminal justice involvement can directly result in difficulty finding housing.3 For example, veterans may have their lease agreement denied based solely on their history of criminogenic behavior. Moreover, criminal justice involvement can indirectly impact a veteran’s ability to maintain housing. Indeed, justice-involved veterans can experience difficulty attaining and sustaining employment, which in turn can result in financial difficulties, including inability to afford rental or mortgage payments.

Similarly, those at risk for or experiencing housing instability may resort to criminogenic behavior to survive in the context of limited psychosocial resources.4-6 For instance, a veteran experiencing homelessness may seek refuge from inclement weather in a heated apartment stairwell and subsequently be charged with trespassing. Similarly, these veterans also may resort to theft to eat or pay bills. To this end, homelessness and justice involvement are likely a deleterious cycle that is difficult for the veteran to escape.

Unfortunately, the concurrent impact of housing insecurity and criminal justice involvement often serves to further exacerbate mental health sequelae, including suicide risk (Figure).7 In addition to precipitating frustration and helplessness among veterans who are navigating these stressors, these social determinants of health can engender a perception that the veteran is a burden to those in their support system. For example, these veterans may depend on friends or family to procure housing or transportation assistance for a job, medical appointments, and court hearings.

Understanding the Institutional Circuit and Suicide Risk


Furthermore, homelessness and justice involvement can impact veterans’ interpersonal relationships. For instance, veterans with a history of criminal justice involvement may feel stigmatized and ostracized from their social support system. Justice-involved veterans sometimes endorse being labeled an offender, which can result in perceptions that one is poorly perceived by others and generally seen as a bad person.8 In addition, the conditions of a justice-involved veteran’s probation or parole may further exacerbate social relationships. For example, veterans with histories of engaging in intimate partner violence may lose visitation rights with their children, further reinforcing negative views of self and impacting the veterans’ family network.

As such, these homeless and justice-involved veterans may lack a meaningful social support system when navigating psychosocial stressors. Because hopelessness, burdensomeness, and perceptions that one lacks a social support network are potential drivers of suicidal self-directed violence among these populations, facilitating access to and engagement in health (eg, psychotherapy, medication management) and social (eg, case management, transitional housing) services is necessary to enhance veteran suicide prevention efforts.9

Several VA homeless and justice-related programs have been developed to meet the needs of these veterans (Table). Such programs offer direct access to health and social services capable of addressing mental health symptoms and suicide risk. Moreover, these programs support veterans at various intercepts, or points at which there is an opportunity to identify those at elevated risk and provide access to evidence-based care. For instance, VA homeless programs exist tailored toward those currently, or at risk for, experiencing homelessness. Additionally, VA justice-related programs can target intercepts prior to jail or prison, such as working with crisis intervention teams or diversion courts as well as intercepts following release, such as providing services to facilitate postincarceration reentry. Even VA programs that do not directly administer mental health intervention (eg, Grant and Per Diem, Veterans Justice Outreach) serve as critical points of contact that can connect these veterans to evidence-based suicide prevention treatments (eg, Cognitive Behavioral Therapy for Suicide Prevention; pharmacotherapy) in the VA or the community.

VA Programs Targeting the Needs of Homeless and Justice-Involved Veterans


Within these programs, several suicide prevention efforts also are currently underway. In particular, the VA has mandated routine screening for suicide risk. This includes screening for the presence of elevations in acute risk (eg, suicidal intent, recent suicide attempt) and, within the context of acute risk, conducting a comprehensive risk evaluation that captures veterans’ risk and protective factors as well as access to lethal means. These clinical data are used to determine the veteran’s severity of acute and chronic risk and match them to an appropriate intervention.

 

 


Despite these ongoing efforts, several gaps in understanding exist, such as for example, elucidating the potential role of traditional VA homeless and justice-related programming in reducing risk for suicide.10 Additional research specific to suicide prevention programming among these populations also remains important.11 In particular, no examination to date has evaluated national rates of suicide risk assessment within these settings or elucidated if specific subsets of homeless and justice-involved veterans may be less likely to receive suicide risk screening. For instance, understanding whether homeless veterans accessing mental health services are more likely to be screened for suicide risk relative to homeless veterans accessing care in other VA settings (eg, emergency services). Moreover, the effectiveness of existing suicide-focused evidence-based treatments among homeless and justice-involved veterans remains unknown. Such research may reveal a need to adapt existing interventions, such as safety planning, to the idiographic needs of homeless or justice-involved veterans in order to improve effectiveness.10 Finally, social determinants of health, such as race, ethnicity, gender, and rurality may confer additional risk coupled with difficulties accessing and engaging in care within these populations.11 As such, research specific to these veteran populations and their inherent suicide prevention needs may further inform suicide prevention efforts.

Despite these gaps, it is important to acknowledge ongoing research and programmatic efforts focused on enhancing mental health and suicide prevention practices within VA settings. For example, efforts led by Temblique and colleagues acknowledge not only challenges to the execution of suicide prevention efforts in VA homeless programs, but also potential methods of enhancing care, including additional training in suicide risk screening and evaluation due to provider discomfort.12 Such quality improvement projects are paramount in their potential to identify gaps in health service delivery and thus potentially save veteran lives.

The VA currently has several programs focused on enhancing care for homeless and justice-involved veterans, and many incorporate suicide prevention initiatives. Further understanding of factors that may impact health service delivery of suicide risk assessment and intervention among these populations may be beneficial in order to enhance veteran suicide prevention efforts.
References

1. McCarthy JF, Bossarte RM, Katz IR, et al. Predictive modeling and concentration of the risk of suicide: implications for preventive interventions in the US Department of Veterans Affairs. Am J Public Health. 2015;105(9):1935-1942. doi:10.2105/AJPH.2015.302737

2. Holliday R, Hoffmire CA, Martin WB, Hoff RA, Monteith LL. Associations between justice involvement and PTSD and depressive symptoms, suicidal ideation, and suicide attempt among post-9/11 veterans. Psychol Trauma. 2021;13(7):730-739. doi:10.1037/tra0001038

3. Tsai J, Rosenheck RA. Risk factors for homelessness among US veterans. Epidemiol Rev. 2015;37:177-195. doi:10.1093/epirev/mxu004

4. Fischer PJ. Criminal activity among the homeless: a study of arrests in Baltimore. Hosp Community Psychiatry. 1988;39(1):46-51. doi:10.1176/ps.39.1.46

5. McCarthy B, Hagan J. Homelessness: a criminogenic situation? Br J Criminol. 1991;31(4):393–410.doi:10.1093/oxfordjournals.bjc.a048137

6. Solomon P, Draine J. Issues in serving the forensic client. Soc Work. 1995;40(1):25-33.

7. Holliday R, Forster JE, Desai A, et al. Association of lifetime homelessness and justice involvement with psychiatric symptoms, suicidal ideation, and suicide attempt among post-9/11 veterans. J Psychiatr Res. 2021;144:455-461. doi:10.1016/j.jpsychires.2021.11.007

8. Desai A, Holliday R, Borges LM, et al. Facilitating successful reentry among justice-involved veterans: the role of veteran and offender identity. J Psychiatr Pract. 2021;27(1):52-60. Published 2021 Jan 21. doi:10.1097/PRA.0000000000000520

9. Holliday R, Martin WB, Monteith LL, Clark SC, LePage JP. Suicide among justice-involved veterans: a brief overview of extant research, theoretical conceptualization, and recommendations for future research. J Soc Distress Homeless. 2021;30(1):41-49. doi: 10.1080/10530789.2019.1711306

10. Hoffberg AS, Spitzer E, Mackelprang JL, Farro SA, Brenner LA. Suicidal self-directed violence among homeless US veterans: a systematic review. Suicide Life Threat Behav. 2018;48(4):481-498. doi:10.1111/sltb.12369

11. Holliday R, Liu S, Brenner LA, et al. Preventing suicide among homeless veterans: a consensus statement by the Veterans Affairs Suicide Prevention Among Veterans Experiencing Homelessness Workgroup. Med Care. 2021;59(suppl 2):S103-S105. doi:10.1097/MLR.0000000000001399.

12. Temblique EKR, Foster K, Fujimoto J, Kopelson K, Borthick KM, et al. Addressing the mental health crisis: a one year review of a nationally-led intervention to improve suicide prevention screening at a large homeless veterans clinic. Fed Pract. 2022;39(1):12-18. doi:10.12788/fp.0215

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Ryan Holliday, PhDa,e; Alisha Desai, PhDb; Georgia Gerard, MSWa; Shawn Liu, MSWc; and Matthew Stimmel, PhDd
aRocky Mountain Mental Illness Research, Education and Clinical Center for Suicide Prevention, Aurora, Colorado
bVeterans Affairs (VA) Eastern Colorado Health Care System, Aurora, Colorado
cVeterans Health Administration Homeless Programs Office, Washington, DC
dUS Department of Veterans Affairs Veterans Justice Programs
eDepartment of Psychiatry, University of Colorado Anschutz Medical Campus

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The authors report no actual or potential conflicts of interest with regard to this article. This material is the result of work supported in part by the VA and the Rocky Mountain Mental Illness Research, Education and Clinical Center (MIRECC) for Suicide Prevention.

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aRocky Mountain Mental Illness Research, Education and Clinical Center for Suicide Prevention, Aurora, Colorado
bVeterans Affairs (VA) Eastern Colorado Health Care System, Aurora, Colorado
cVeterans Health Administration Homeless Programs Office, Washington, DC
dUS Department of Veterans Affairs Veterans Justice Programs
eDepartment of Psychiatry, University of Colorado Anschutz Medical Campus

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article. This material is the result of work supported in part by the VA and the Rocky Mountain Mental Illness Research, Education and Clinical Center (MIRECC) for Suicide Prevention.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Ryan Holliday, PhDa,e; Alisha Desai, PhDb; Georgia Gerard, MSWa; Shawn Liu, MSWc; and Matthew Stimmel, PhDd
aRocky Mountain Mental Illness Research, Education and Clinical Center for Suicide Prevention, Aurora, Colorado
bVeterans Affairs (VA) Eastern Colorado Health Care System, Aurora, Colorado
cVeterans Health Administration Homeless Programs Office, Washington, DC
dUS Department of Veterans Affairs Veterans Justice Programs
eDepartment of Psychiatry, University of Colorado Anschutz Medical Campus

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article. This material is the result of work supported in part by the VA and the Rocky Mountain Mental Illness Research, Education and Clinical Center (MIRECC) for Suicide Prevention.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Related Articles

Despite the success of several US Department of Veterans Affairs (VA) initiatives in facilitating psychosocial functioning, rehabilitation, and re-entry among veterans experiencing homelessness and/or interactions with the criminal justice system (ie, justice-involved veterans), suicide risk among these veterans remains a significant public health concern. Rates of suicide among veterans experiencing homelessness are more than double that of veterans with no history of homelessness.1 Similarly, justice-involved veterans experience myriad mental health concerns, including elevated rates of psychiatric symptoms, suicidal thoughts, and self-directed violence relative to those with no history of criminal justice involvement.2

In addition, a bidirectional relationship between criminal justice involvement and homelessness, often called the “institutional circuit,” is well established. Criminal justice involvement can directly result in difficulty finding housing.3 For example, veterans may have their lease agreement denied based solely on their history of criminogenic behavior. Moreover, criminal justice involvement can indirectly impact a veteran’s ability to maintain housing. Indeed, justice-involved veterans can experience difficulty attaining and sustaining employment, which in turn can result in financial difficulties, including inability to afford rental or mortgage payments.

Similarly, those at risk for or experiencing housing instability may resort to criminogenic behavior to survive in the context of limited psychosocial resources.4-6 For instance, a veteran experiencing homelessness may seek refuge from inclement weather in a heated apartment stairwell and subsequently be charged with trespassing. Similarly, these veterans also may resort to theft to eat or pay bills. To this end, homelessness and justice involvement are likely a deleterious cycle that is difficult for the veteran to escape.

Unfortunately, the concurrent impact of housing insecurity and criminal justice involvement often serves to further exacerbate mental health sequelae, including suicide risk (Figure).7 In addition to precipitating frustration and helplessness among veterans who are navigating these stressors, these social determinants of health can engender a perception that the veteran is a burden to those in their support system. For example, these veterans may depend on friends or family to procure housing or transportation assistance for a job, medical appointments, and court hearings.

Understanding the Institutional Circuit and Suicide Risk


Furthermore, homelessness and justice involvement can impact veterans’ interpersonal relationships. For instance, veterans with a history of criminal justice involvement may feel stigmatized and ostracized from their social support system. Justice-involved veterans sometimes endorse being labeled an offender, which can result in perceptions that one is poorly perceived by others and generally seen as a bad person.8 In addition, the conditions of a justice-involved veteran’s probation or parole may further exacerbate social relationships. For example, veterans with histories of engaging in intimate partner violence may lose visitation rights with their children, further reinforcing negative views of self and impacting the veterans’ family network.

As such, these homeless and justice-involved veterans may lack a meaningful social support system when navigating psychosocial stressors. Because hopelessness, burdensomeness, and perceptions that one lacks a social support network are potential drivers of suicidal self-directed violence among these populations, facilitating access to and engagement in health (eg, psychotherapy, medication management) and social (eg, case management, transitional housing) services is necessary to enhance veteran suicide prevention efforts.9

Several VA homeless and justice-related programs have been developed to meet the needs of these veterans (Table). Such programs offer direct access to health and social services capable of addressing mental health symptoms and suicide risk. Moreover, these programs support veterans at various intercepts, or points at which there is an opportunity to identify those at elevated risk and provide access to evidence-based care. For instance, VA homeless programs exist tailored toward those currently, or at risk for, experiencing homelessness. Additionally, VA justice-related programs can target intercepts prior to jail or prison, such as working with crisis intervention teams or diversion courts as well as intercepts following release, such as providing services to facilitate postincarceration reentry. Even VA programs that do not directly administer mental health intervention (eg, Grant and Per Diem, Veterans Justice Outreach) serve as critical points of contact that can connect these veterans to evidence-based suicide prevention treatments (eg, Cognitive Behavioral Therapy for Suicide Prevention; pharmacotherapy) in the VA or the community.

VA Programs Targeting the Needs of Homeless and Justice-Involved Veterans


Within these programs, several suicide prevention efforts also are currently underway. In particular, the VA has mandated routine screening for suicide risk. This includes screening for the presence of elevations in acute risk (eg, suicidal intent, recent suicide attempt) and, within the context of acute risk, conducting a comprehensive risk evaluation that captures veterans’ risk and protective factors as well as access to lethal means. These clinical data are used to determine the veteran’s severity of acute and chronic risk and match them to an appropriate intervention.

 

 


Despite these ongoing efforts, several gaps in understanding exist, such as for example, elucidating the potential role of traditional VA homeless and justice-related programming in reducing risk for suicide.10 Additional research specific to suicide prevention programming among these populations also remains important.11 In particular, no examination to date has evaluated national rates of suicide risk assessment within these settings or elucidated if specific subsets of homeless and justice-involved veterans may be less likely to receive suicide risk screening. For instance, understanding whether homeless veterans accessing mental health services are more likely to be screened for suicide risk relative to homeless veterans accessing care in other VA settings (eg, emergency services). Moreover, the effectiveness of existing suicide-focused evidence-based treatments among homeless and justice-involved veterans remains unknown. Such research may reveal a need to adapt existing interventions, such as safety planning, to the idiographic needs of homeless or justice-involved veterans in order to improve effectiveness.10 Finally, social determinants of health, such as race, ethnicity, gender, and rurality may confer additional risk coupled with difficulties accessing and engaging in care within these populations.11 As such, research specific to these veteran populations and their inherent suicide prevention needs may further inform suicide prevention efforts.

Despite these gaps, it is important to acknowledge ongoing research and programmatic efforts focused on enhancing mental health and suicide prevention practices within VA settings. For example, efforts led by Temblique and colleagues acknowledge not only challenges to the execution of suicide prevention efforts in VA homeless programs, but also potential methods of enhancing care, including additional training in suicide risk screening and evaluation due to provider discomfort.12 Such quality improvement projects are paramount in their potential to identify gaps in health service delivery and thus potentially save veteran lives.

The VA currently has several programs focused on enhancing care for homeless and justice-involved veterans, and many incorporate suicide prevention initiatives. Further understanding of factors that may impact health service delivery of suicide risk assessment and intervention among these populations may be beneficial in order to enhance veteran suicide prevention efforts.

Despite the success of several US Department of Veterans Affairs (VA) initiatives in facilitating psychosocial functioning, rehabilitation, and re-entry among veterans experiencing homelessness and/or interactions with the criminal justice system (ie, justice-involved veterans), suicide risk among these veterans remains a significant public health concern. Rates of suicide among veterans experiencing homelessness are more than double that of veterans with no history of homelessness.1 Similarly, justice-involved veterans experience myriad mental health concerns, including elevated rates of psychiatric symptoms, suicidal thoughts, and self-directed violence relative to those with no history of criminal justice involvement.2

In addition, a bidirectional relationship between criminal justice involvement and homelessness, often called the “institutional circuit,” is well established. Criminal justice involvement can directly result in difficulty finding housing.3 For example, veterans may have their lease agreement denied based solely on their history of criminogenic behavior. Moreover, criminal justice involvement can indirectly impact a veteran’s ability to maintain housing. Indeed, justice-involved veterans can experience difficulty attaining and sustaining employment, which in turn can result in financial difficulties, including inability to afford rental or mortgage payments.

Similarly, those at risk for or experiencing housing instability may resort to criminogenic behavior to survive in the context of limited psychosocial resources.4-6 For instance, a veteran experiencing homelessness may seek refuge from inclement weather in a heated apartment stairwell and subsequently be charged with trespassing. Similarly, these veterans also may resort to theft to eat or pay bills. To this end, homelessness and justice involvement are likely a deleterious cycle that is difficult for the veteran to escape.

Unfortunately, the concurrent impact of housing insecurity and criminal justice involvement often serves to further exacerbate mental health sequelae, including suicide risk (Figure).7 In addition to precipitating frustration and helplessness among veterans who are navigating these stressors, these social determinants of health can engender a perception that the veteran is a burden to those in their support system. For example, these veterans may depend on friends or family to procure housing or transportation assistance for a job, medical appointments, and court hearings.

Understanding the Institutional Circuit and Suicide Risk


Furthermore, homelessness and justice involvement can impact veterans’ interpersonal relationships. For instance, veterans with a history of criminal justice involvement may feel stigmatized and ostracized from their social support system. Justice-involved veterans sometimes endorse being labeled an offender, which can result in perceptions that one is poorly perceived by others and generally seen as a bad person.8 In addition, the conditions of a justice-involved veteran’s probation or parole may further exacerbate social relationships. For example, veterans with histories of engaging in intimate partner violence may lose visitation rights with their children, further reinforcing negative views of self and impacting the veterans’ family network.

As such, these homeless and justice-involved veterans may lack a meaningful social support system when navigating psychosocial stressors. Because hopelessness, burdensomeness, and perceptions that one lacks a social support network are potential drivers of suicidal self-directed violence among these populations, facilitating access to and engagement in health (eg, psychotherapy, medication management) and social (eg, case management, transitional housing) services is necessary to enhance veteran suicide prevention efforts.9

Several VA homeless and justice-related programs have been developed to meet the needs of these veterans (Table). Such programs offer direct access to health and social services capable of addressing mental health symptoms and suicide risk. Moreover, these programs support veterans at various intercepts, or points at which there is an opportunity to identify those at elevated risk and provide access to evidence-based care. For instance, VA homeless programs exist tailored toward those currently, or at risk for, experiencing homelessness. Additionally, VA justice-related programs can target intercepts prior to jail or prison, such as working with crisis intervention teams or diversion courts as well as intercepts following release, such as providing services to facilitate postincarceration reentry. Even VA programs that do not directly administer mental health intervention (eg, Grant and Per Diem, Veterans Justice Outreach) serve as critical points of contact that can connect these veterans to evidence-based suicide prevention treatments (eg, Cognitive Behavioral Therapy for Suicide Prevention; pharmacotherapy) in the VA or the community.

VA Programs Targeting the Needs of Homeless and Justice-Involved Veterans


Within these programs, several suicide prevention efforts also are currently underway. In particular, the VA has mandated routine screening for suicide risk. This includes screening for the presence of elevations in acute risk (eg, suicidal intent, recent suicide attempt) and, within the context of acute risk, conducting a comprehensive risk evaluation that captures veterans’ risk and protective factors as well as access to lethal means. These clinical data are used to determine the veteran’s severity of acute and chronic risk and match them to an appropriate intervention.

 

 


Despite these ongoing efforts, several gaps in understanding exist, such as for example, elucidating the potential role of traditional VA homeless and justice-related programming in reducing risk for suicide.10 Additional research specific to suicide prevention programming among these populations also remains important.11 In particular, no examination to date has evaluated national rates of suicide risk assessment within these settings or elucidated if specific subsets of homeless and justice-involved veterans may be less likely to receive suicide risk screening. For instance, understanding whether homeless veterans accessing mental health services are more likely to be screened for suicide risk relative to homeless veterans accessing care in other VA settings (eg, emergency services). Moreover, the effectiveness of existing suicide-focused evidence-based treatments among homeless and justice-involved veterans remains unknown. Such research may reveal a need to adapt existing interventions, such as safety planning, to the idiographic needs of homeless or justice-involved veterans in order to improve effectiveness.10 Finally, social determinants of health, such as race, ethnicity, gender, and rurality may confer additional risk coupled with difficulties accessing and engaging in care within these populations.11 As such, research specific to these veteran populations and their inherent suicide prevention needs may further inform suicide prevention efforts.

Despite these gaps, it is important to acknowledge ongoing research and programmatic efforts focused on enhancing mental health and suicide prevention practices within VA settings. For example, efforts led by Temblique and colleagues acknowledge not only challenges to the execution of suicide prevention efforts in VA homeless programs, but also potential methods of enhancing care, including additional training in suicide risk screening and evaluation due to provider discomfort.12 Such quality improvement projects are paramount in their potential to identify gaps in health service delivery and thus potentially save veteran lives.

The VA currently has several programs focused on enhancing care for homeless and justice-involved veterans, and many incorporate suicide prevention initiatives. Further understanding of factors that may impact health service delivery of suicide risk assessment and intervention among these populations may be beneficial in order to enhance veteran suicide prevention efforts.
References

1. McCarthy JF, Bossarte RM, Katz IR, et al. Predictive modeling and concentration of the risk of suicide: implications for preventive interventions in the US Department of Veterans Affairs. Am J Public Health. 2015;105(9):1935-1942. doi:10.2105/AJPH.2015.302737

2. Holliday R, Hoffmire CA, Martin WB, Hoff RA, Monteith LL. Associations between justice involvement and PTSD and depressive symptoms, suicidal ideation, and suicide attempt among post-9/11 veterans. Psychol Trauma. 2021;13(7):730-739. doi:10.1037/tra0001038

3. Tsai J, Rosenheck RA. Risk factors for homelessness among US veterans. Epidemiol Rev. 2015;37:177-195. doi:10.1093/epirev/mxu004

4. Fischer PJ. Criminal activity among the homeless: a study of arrests in Baltimore. Hosp Community Psychiatry. 1988;39(1):46-51. doi:10.1176/ps.39.1.46

5. McCarthy B, Hagan J. Homelessness: a criminogenic situation? Br J Criminol. 1991;31(4):393–410.doi:10.1093/oxfordjournals.bjc.a048137

6. Solomon P, Draine J. Issues in serving the forensic client. Soc Work. 1995;40(1):25-33.

7. Holliday R, Forster JE, Desai A, et al. Association of lifetime homelessness and justice involvement with psychiatric symptoms, suicidal ideation, and suicide attempt among post-9/11 veterans. J Psychiatr Res. 2021;144:455-461. doi:10.1016/j.jpsychires.2021.11.007

8. Desai A, Holliday R, Borges LM, et al. Facilitating successful reentry among justice-involved veterans: the role of veteran and offender identity. J Psychiatr Pract. 2021;27(1):52-60. Published 2021 Jan 21. doi:10.1097/PRA.0000000000000520

9. Holliday R, Martin WB, Monteith LL, Clark SC, LePage JP. Suicide among justice-involved veterans: a brief overview of extant research, theoretical conceptualization, and recommendations for future research. J Soc Distress Homeless. 2021;30(1):41-49. doi: 10.1080/10530789.2019.1711306

10. Hoffberg AS, Spitzer E, Mackelprang JL, Farro SA, Brenner LA. Suicidal self-directed violence among homeless US veterans: a systematic review. Suicide Life Threat Behav. 2018;48(4):481-498. doi:10.1111/sltb.12369

11. Holliday R, Liu S, Brenner LA, et al. Preventing suicide among homeless veterans: a consensus statement by the Veterans Affairs Suicide Prevention Among Veterans Experiencing Homelessness Workgroup. Med Care. 2021;59(suppl 2):S103-S105. doi:10.1097/MLR.0000000000001399.

12. Temblique EKR, Foster K, Fujimoto J, Kopelson K, Borthick KM, et al. Addressing the mental health crisis: a one year review of a nationally-led intervention to improve suicide prevention screening at a large homeless veterans clinic. Fed Pract. 2022;39(1):12-18. doi:10.12788/fp.0215

References

1. McCarthy JF, Bossarte RM, Katz IR, et al. Predictive modeling and concentration of the risk of suicide: implications for preventive interventions in the US Department of Veterans Affairs. Am J Public Health. 2015;105(9):1935-1942. doi:10.2105/AJPH.2015.302737

2. Holliday R, Hoffmire CA, Martin WB, Hoff RA, Monteith LL. Associations between justice involvement and PTSD and depressive symptoms, suicidal ideation, and suicide attempt among post-9/11 veterans. Psychol Trauma. 2021;13(7):730-739. doi:10.1037/tra0001038

3. Tsai J, Rosenheck RA. Risk factors for homelessness among US veterans. Epidemiol Rev. 2015;37:177-195. doi:10.1093/epirev/mxu004

4. Fischer PJ. Criminal activity among the homeless: a study of arrests in Baltimore. Hosp Community Psychiatry. 1988;39(1):46-51. doi:10.1176/ps.39.1.46

5. McCarthy B, Hagan J. Homelessness: a criminogenic situation? Br J Criminol. 1991;31(4):393–410.doi:10.1093/oxfordjournals.bjc.a048137

6. Solomon P, Draine J. Issues in serving the forensic client. Soc Work. 1995;40(1):25-33.

7. Holliday R, Forster JE, Desai A, et al. Association of lifetime homelessness and justice involvement with psychiatric symptoms, suicidal ideation, and suicide attempt among post-9/11 veterans. J Psychiatr Res. 2021;144:455-461. doi:10.1016/j.jpsychires.2021.11.007

8. Desai A, Holliday R, Borges LM, et al. Facilitating successful reentry among justice-involved veterans: the role of veteran and offender identity. J Psychiatr Pract. 2021;27(1):52-60. Published 2021 Jan 21. doi:10.1097/PRA.0000000000000520

9. Holliday R, Martin WB, Monteith LL, Clark SC, LePage JP. Suicide among justice-involved veterans: a brief overview of extant research, theoretical conceptualization, and recommendations for future research. J Soc Distress Homeless. 2021;30(1):41-49. doi: 10.1080/10530789.2019.1711306

10. Hoffberg AS, Spitzer E, Mackelprang JL, Farro SA, Brenner LA. Suicidal self-directed violence among homeless US veterans: a systematic review. Suicide Life Threat Behav. 2018;48(4):481-498. doi:10.1111/sltb.12369

11. Holliday R, Liu S, Brenner LA, et al. Preventing suicide among homeless veterans: a consensus statement by the Veterans Affairs Suicide Prevention Among Veterans Experiencing Homelessness Workgroup. Med Care. 2021;59(suppl 2):S103-S105. doi:10.1097/MLR.0000000000001399.

12. Temblique EKR, Foster K, Fujimoto J, Kopelson K, Borthick KM, et al. Addressing the mental health crisis: a one year review of a nationally-led intervention to improve suicide prevention screening at a large homeless veterans clinic. Fed Pract. 2022;39(1):12-18. doi:10.12788/fp.0215

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Common Ground: Primary Care and Specialty Clinicians’ Perceptions of E-Consults in the Veterans Health Administration

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Electronic consultation (e-consult) is designed to increase access to specialty care by facilitating communication between primary care and specialty clinicians without the need for outpatient face-to-face encounters.1–4 In 2011, the US Department of Veterans Affairs (VA) implemented an e-consult program as a component of its overall strategy to increase access to specialty services, reduce costs of care, and reduce appointment travel burden on patients.

E-consult has substantially increased within the VA since its implementation.5,6 Consistent with limited evaluations from other health care systems, evaluations of the VA e-consult program demonstrated reduced costs, reduced travel time for patients, and improved access to specialty care.2,5–11 However, there is wide variation in e-consult use across VA specialties, facilities, and regions.5,6,12,13 For example, hematology, preoperative evaluation, neurosurgery, endocrinology, and infectious diseases use e-consults more frequently when compared with in-person consults in the VA.6 Reasons for this variation or specific barriers and facilitators of using e-consults have not been described.

Prior qualitative studies report that primary care practitioners (PCPs) describe e-consults as convenient, educational, beneficial for patient care, and useful for improving patient access to specialty care.8,14,15 One study identified limited PCP knowledge of e-consults as a barrier to use.16 Specialists have reported that e-consult improves clinical communication, but increases their workload.1,14,17,18 These studies did not assess perspectives from both clinicians who initiate e-consults and those who respond to them. This is the first qualitative study to assess e-consult perceptions from perspectives of both PCPs and specialists among a large, national sample of VA clinicians who use e-consults. The objective of this study was to understand perspectives of e-consults between PCPs and specialists that may be relevant to increasing adoption in the VA.

 

Methods

The team (CL, ML, PG, 2 analysts under the guidance of GS and JS and support from RRK, and a biostatistician) conducted semistructured interviews with PCPs, specialists, and specialty division leaders who were employed by VA in 2016 and 2017. Specialties of interest were identified by the VA Office of Specialty Care and included cardiology, endocrinology, gastroenterology, and hematology.

E-Consult Procedures

Within the VA, the specific procedures used to initiate, triage and manage e-consults are coordinated at VA medical centers (VAMCs) and at the Veterans Integrated Service Network (VISN) regional level. E-consult can be requested by any clinician. Generally, e-consults are initiated by PCPs through standardized, specialty-specific templates. Recipients, typically specialists, respond by answering questions, suggesting additional testing and evaluation, or requesting an in-person visit. Communication is documented in the patient’s electronic health record (EHR). Specialists receive different levels of workload credit for responding to e-consults similar to a relative value unit reimbursement model. Training in the use of e-consults is available to practitioners but may vary at local and regional levels.

Recruitment

Our sample included PCPs, specialists, and specialty care division leaders. We first quantified e-consult rates (e-consults per 100 patient visits) between July 2016 and June 2017 at VA facilities within primary care and the 4 priority specialties and identified the 30 sites with the highest e-consult rates and 30 sites with the lowest e-consult rates. Sites with < 500 total visits, < 3 specialties, or without any e-consult visit during the study period were excluded. E-consult rates at community-based outpatient clinics were included with associated VAMCs. We then stratified PCPs by whether they were high or low users of e-consults (determined by the top and bottom users within each site) and credentials (MD vs nurse practitioner [NP] or physician assistant [PA]). Specialists were sampled based on their rate of use relative to colleagues within their site and the use rate of their division. We sampled division chiefs and individuals who had > 300 total visits and 1 e-consult during the study period. To recruit participants, the primary investigator sent an initial email and 2 reminder emails. The team followed up with respondents to schedule an interview.

Interview guides were designed to elicit rich descriptions of barriers and facilitators to e-consult use (eAppendix available at doi:10.12788/fp.0214). The team used the Practical Robust Implementation and Sustainability Model (PRISM), which considers factors along 6 domains for intervention planning, implementation, and sustainment.19 Telephone interviews lasted about 20 minutes and were conducted between September 2017 and March 2018. Interviews were recorded and transcribed verbatim.

Analysis

The team used an iterative, team-based, inductive/deductive approach to conventional content analysis.20,21 Initial code categories were created so that we could identify e-consult best practices—facilitators of e-consult that were recommended by both PCPs and specialists. Inductive codes or labels applied to identify meaningful quotations, phrases, or key terms were used to identify emergent ideas and were added throughout coding after discussion among team members. Consensus was reached using a team-based approach.21 Four analysts independently coded the same 3 transcripts and met to discuss points of divergence and convergence. Analyses continued with emergent themes, categories, and conclusions. Atlas.ti. v.7 was used for coding and data management.22

 

 

Results

We conducted 34 interviews with clinicians (Table 1) from 13 VISNs. Four best-practice themes emerged among both PCPs and specialists, including that e-consults (1) are best suited for certain clinical questions and patients; (2) require relevant background information from requesting clinicians and clear recommendations from responding clinicians; (3) are a novel opportunity to provide efficient, transparent care; and (4) may not be fully adopted due to low awareness. Supporting quotations for the following findings are provided in Table 2.

Supporting Quotations

Description of Participants

Specific Clinical Questions and Patients

PCPs described specific patients and questions for which they most frequently used e-consults, such as for medication changes (Q1), determining treatment steps (Q2,3), and or clarifying laboratory or imaging findings. PCPs frequently used e-consults for patients who did not require a physical examination or when specialists could make recommendations without seeing patients face-to-face (Q3). An important use of e-consults described by PCPs was for treating conditions they could manage within primary care if additional guidance were available (Q4). Several PCPs and specialists also noted that e-consults were particularly useful for patients who were unable to travel or did not want face-to-face appointments (Q5). Notably, PCPs and specialists mentioned situations for which e-consults were inappropriate, including when a detailed history or physical examination was needed, or if a complex condition was suspected (Q6).

Background Data and Clear Recommendations

Participants described necessary data that should be included in high-quality e-consults. Specialists voiced frustration in time-consuming chart reviews that were often necessary when these data were not provided by the requestor. In some cases, specialists were unable to access necessary EHR data, which delayed responses (Q7). PCPs noted that the most useful responses carefully considered the question, used current patient information to determine treatments, provided clear recommendations, and defined who was responsible for next steps (Q8). PCPs and specialists stated that e-consult templates that required relevant information facilitated high-quality e-consults. Neither wanted to waste the other clinician's time (Q8).

A Novel Opportunity

Many PCPs felt that e-consults improved communication (eg, efficiency, response time), established new communication between clinicians, and reduced patients’ appointment burden (Q10, Q11). Many specialists felt that e-consults improved documentation of communication between clinicians and increased transparency of clinical decisions (Q12). Additionally, many specialists mentioned that e-consults capture previously informal curbside consults, enabling them to receive workload credit (Q13).

Lack of Awareness

Some noted that the biggest barrier to e-consults was not being aware of them generally, or which specialties offer e-consults (Q14). One PCP described e-consults as the best kept secret and found value in sharing the utility of e-consults with colleagues (Q15). All participants, including those who did not frequently use e-consults, felt that e-consults improved the quality of care by providing more timely care or better answers to clinical questions (Q16). Several practitioners also felt that e-consults increased access to specialty care. For example, specialists reported that e-consults enabled them to better manage patient load by using e-consults to answer relatively simple questions, reserving face-to-face consults for more complex patients (Q17).

Discussion

The objective of this study was to identify potential best practices for e-consults that may help increase their quality and use within the VA. We built on prior studies that offered insights on PCP and specialists’ overall satisfaction with e-consult by identifying several themes relevant to the further adoption of e-consults in the VA and elsewhere without a face-to-face visit.8,13,14,16–18 Future work may be beneficial in identifying whether the study themes identified can explain variation in e-consult use or whether addressing these factors might lead to increased or higher quality e-consult use. We are unaware of any qualitative study of comparable scale in a different health care system. Further, this is the first study to assess perspectives on e-consults among those who initiate and respond to them within the same health care system. Perhaps the most important finding from this study is that e-consults are generally viewed favorably, which is a necessary leverage point to increase their adoption within the system.

 

 

Clinicians reported several benefits to e-consults, including timely responses to clinical questions, efficient communication, allow for documentation of specialist recommendations, and help capture workload. These benefits are consistent with prior literature that indicates both PCPs and specialists in the VA and other health care systems feel that e-consults improves communication, decreases unnecessary visits, and improves quality of care.1,14,17,18 In particular, clinicians reported that e-consults improve their practice efficiency and efficacy. This is of critical importance given the pressures of providing timely access to primary and specialty care within the VA. Interestingly, many VA practitioners were unaware which specialties offered e-consults within their facilities, reflecting previous work showing that PCPs are often unaware of e-consult options.16 This may partially explain variation in e-consult use. Increasing awareness and educating clinicians on the benefits of e-consults may help promote use among non- and low users.

A common theme reported by both groups was the importance of providing necessary information within e-consult questions and responses. Specialists felt there was a need to ensure that PCPs provide relevant and patient-specific information that would enable them to efficiently and accurately answer questions without the need for extensive EHR review. This reflects previous work showing that specialists are often unable to respond to e-consult requests because they do not contain sufficient information.22 PCPs described a need to ensure that specialists’ responses included information that was detailed enough to make clinical decisions without the need for a reconsult. This highlights a common challenge to medical consultation, in that necessary or relevant information may not be apparent to all clinicians. To address this, there may be a role in developing enhanced, flexible templating that elicits necessary patient-specific information. Such a template may automatically pull relevant data from the EHR and prompt clinicians to provide important information. We did not assess how perspectives of templates varied, and further work could help define precisely what constitutes an effective template, including how it should capture appropriate patient data and how this impacts acceptability or use of e-consults generally. Collaboratively developed service agreements and e-consult templates could help guide PCPs and specialists to engage in efficient communication.

Another theme among both groups was that e-consult is most appropriate within specific clinical scenarios. Examples included review of laboratory results, questions about medication changes, or for patients who were reluctant to travel to appointments. Identifying and promoting specific opportunities for e-consults may help increase their use and align e-consult practices with scenarios that are likely to provide the most benefit to patients. For example, it could be helpful to understand the distance patients must travel for specialty care. Providing that information during clinical encounters could trigger clinicians to consider e-consults as an option. Future work might aim to identify clinical scenarios that clinicians feel are not well suited for e-consults and determine how to adapt them for those scenarios.

Limitations

Generalizability of these findings is limited given the qualitative study design. Participants’ descriptions of experiences with e-consults reflect the experiences of clinicians in the VA and may not reflect clinicians in other settings. We also interviewed a sample of clinicians who were already using e-consults. Important information could be learned from future work with those who have not yet adopted e-consult procedures or adopted and abandoned them.

Conclusions

E-consult is perceived as beneficial by VA PCPs and specialists. Participants suggested using e-consults for appropriate questions or patients and including necessary information and next steps in both the initial e-consult and response. Finding ways to facilitate e-consults with these suggestions in mind may increase delivery of high-quality e-consults. Future work could compare the findings of this work to similar work assessing clinicians perceptions of e-consults outside of the VA.

Files
References

1. Battaglia C, Lambert-Kerzner A, Aron DC, et al. Evaluation of e-consults in the VHA: provider perspectives. Fed Pract. 2015;32(7):42-48.

2. Haverhals LM, Sayre G, Helfrich CD, et al. E-consult implementation: lessons learned using consolidated framework for implementation research. Am J Manag Care. 2015;21(12):e640-e647. Published 2015 Dec 1.

3. Sewell JL, Telischak KS, Day LW, Kirschner N, Weissman A. Preconsultation exchange in the United States: use, awareness, and attitudes. Am J Manag Care. 2014;20(12):e556-e564. Published 2014 Dec 1.

4. Horner K, Wagner E, Tufano J. Electronic consultations between primary and specialty care clinicians: early insights. Issue Brief (Commonw Fund). 2011;23:1-14.

5. Kirsh S, Carey E, Aron DC, et al. Impact of a national specialty e-consultation implementation project on access. Am J Manag Care. 2015;21(12):e648-654. Published 2015 Dec 1.

6. Saxon DR, Kaboli PJ, Haraldsson B, Wilson C, Ohl M, Augustine MR. Growth of electronic consultations in the Veterans Health Administration. Am J Manag Care. 2021;27(1):12-19. doi:10.37765/ajmc.2021.88572

7. Olayiwola JN, Anderson D, Jepeal N, et al. Electronic consultations to improve the primary care-specialty care interface for cardiology in the medically underserved: a cluster-randomized controlled trial. Ann Fam Med. 2016;14(2):133-140. doi:10.1370/afm.1869

8. Schettini P, Shah KP, O’Leary CP, et al. Keeping care connected: e-Consultation program improves access to nephrology care. J Telemed Telecare. 2019;25(3):142-150. doi:10.1177/1357633X17748350

9. Whittington MD, Ho PM, Kirsh SR, et al. Cost savings associated with electronic specialty consultations. Am J Manag Care. 2021;27(1):e16-e23. Published 2021 Jan 1. doi:10.37765/ajmc.2021.88579

10. Shipherd JC, Kauth MR, Matza A. Nationwide interdisciplinary e-consultation on transgender care in the Veterans Health Administration. Telemed J E Health. 2016;22(12):1008-1012. doi:10.1089/tmj.2016.0013

11. Strymish J, Gupte G, Afable MK, et al. Electronic consultations (E-consults): advancing infectious disease care in a large Veterans Affairs Healthcare System. Clin Infect Dis. 2017;64(8):1123-1125. doi:10.1093/cid/cix058

12. Williams KM, Kirsh S, Aron D, et al. Evaluation of the Veterans Health Administration’s Specialty Care Transformational Initiatives to promote patient-centered delivery of specialty care: a mixed-methods approach. Telemed J E-Health. 2017;23(7):577-589. doi:10.1089/tmj.2016.0166

13. US Department of Veterans Affairs, Veterans Health Administration, Specialty Care Transformational Initiative Evaluation Center. Evaluation of specialty care initiatives. Published 2013.

14. Vimalananda VG, Gupte G, Seraj SM, et al. Electronic consultations (e-consults) to improve access to specialty care: a systematic review and narrative synthesis. J Telemed Telecare. 2015;21(6):323-330. doi:10.1177/1357633X15582108

15. Lee M, Leonard C, Greene P, et al. Perspectives of VA primary care clinicians toward electronic consultation-related workload burden. JAMA Netw Open. 2020;3(10):e2018104. Published 2020 Oct 1. doi:10.1001/jamanetworkopen.2020.18104

16. Deeds SA, Dowdell KJ, Chew LD, Ackerman SL. Implementing an opt-in eConsult program at seven academic medical centers: a qualitative analysis of primary care provider experiences. J Gen Intern Med. 2019;34(8):1427-1433. doi:10.1007/s11606-019-05067-7

17. Rodriguez KL, Burkitt KH, Bayliss NK, et al. Veteran, primary care provider, and specialist satisfaction with electronic consultation. JMIR Med Inform. 2015;3(1):e5. Published 2015 Jan 14. doi:10.2196/medinform.3725

18. Gupte G, Vimalananda V, Simon SR, DeVito K, Clark J, Orlander JD. Disruptive innovation: implementation of electronic consultations in a Veterans Affairs Health Care System. JMIR Med Inform. 2016;4(1):e6. Published 2016 Feb 12. doi:10.2196/medinform.4801

19. Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008;34(4):228-243. doi:10.1016/s1553-7250(08)34030-6

20. Patton MQ. Qualitative Research and Evaluation Methods. 3rd ed. Sage Publications; 2002.

21. Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007;42(4):1758-1772. doi:10.1111/j.1475-6773.2006.00684.x

22. Kim EJ, Orlander JD, Afable M, et al. Cardiology electronic consultation (e-consult) use by primary care providers at VA medical centres in New England. J Telemed Telecare. 2019;25(6):370-377. doi:10.1177/1357633X18774468

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Author and Disclosure Information

Chelsea Leonard, PhDa; Rachael R. Kenney, MAa; Marcie Lee, MA, MPHa; Preston Greene, PhDb; Melanie Whittington, PhDa,c; Susan Kirsh, MD, MPAd; P. Michael Ho, MD, PhDa; George Sayre, PsyDb; and Joseph Simonetti, MD, MPHe
Correspondence: Chelsea.Leonard ([email protected])

Author affiliations

aDenver/Seattle Center of Innovation for Veteran-Centered and Value-Driven Care, Aurora, Colorado
bDenver/Seattle Center of Innovation for Veteran-Centered and Value-Driven Care, Seattle, Washington
cDepartment of Clinical Pharmacy at the University of Colorado Anschutz Medical Campus, Aurora
dCase Western Reserve University School of Medicine, Cleveland, Ohio; Veteran Affairs Central Office, Washington, DC
eDivision of Hospital Medicine, University of Colorado School of Medicine, Aurora

Author disclosures

Dr. Ho is supported by research grants from NHLBI, VA HSR&D, and University of Colorado School of Medicine. He has a research agreement with Bristol-Myers Squibb administered by the University of Colorado. The authors report no other actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The activities were undertaken in support of a Veterans Health Administration (VHA) operational project and did not constitute research, in whole or in part, in compliance with VHA Handbook 1058.05. Therefore, institutional review board approval was not required.

Funding

This work was funded by the VHA Office of Rural Health and sponsored by the VHA Office of Veterans Access to Care, Department of Veterans Affairs, Washington, DC through a MyVA Access Improvement Project Grant: “VISN 19 VA Denver Developing best practices for subspecialty e‐consultation procedures.”

 

 

 

 

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Chelsea Leonard, PhDa; Rachael R. Kenney, MAa; Marcie Lee, MA, MPHa; Preston Greene, PhDb; Melanie Whittington, PhDa,c; Susan Kirsh, MD, MPAd; P. Michael Ho, MD, PhDa; George Sayre, PsyDb; and Joseph Simonetti, MD, MPHe
Correspondence: Chelsea.Leonard ([email protected])

Author affiliations

aDenver/Seattle Center of Innovation for Veteran-Centered and Value-Driven Care, Aurora, Colorado
bDenver/Seattle Center of Innovation for Veteran-Centered and Value-Driven Care, Seattle, Washington
cDepartment of Clinical Pharmacy at the University of Colorado Anschutz Medical Campus, Aurora
dCase Western Reserve University School of Medicine, Cleveland, Ohio; Veteran Affairs Central Office, Washington, DC
eDivision of Hospital Medicine, University of Colorado School of Medicine, Aurora

Author disclosures

Dr. Ho is supported by research grants from NHLBI, VA HSR&D, and University of Colorado School of Medicine. He has a research agreement with Bristol-Myers Squibb administered by the University of Colorado. The authors report no other actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The activities were undertaken in support of a Veterans Health Administration (VHA) operational project and did not constitute research, in whole or in part, in compliance with VHA Handbook 1058.05. Therefore, institutional review board approval was not required.

Funding

This work was funded by the VHA Office of Rural Health and sponsored by the VHA Office of Veterans Access to Care, Department of Veterans Affairs, Washington, DC through a MyVA Access Improvement Project Grant: “VISN 19 VA Denver Developing best practices for subspecialty e‐consultation procedures.”

 

 

 

 

Author and Disclosure Information

Chelsea Leonard, PhDa; Rachael R. Kenney, MAa; Marcie Lee, MA, MPHa; Preston Greene, PhDb; Melanie Whittington, PhDa,c; Susan Kirsh, MD, MPAd; P. Michael Ho, MD, PhDa; George Sayre, PsyDb; and Joseph Simonetti, MD, MPHe
Correspondence: Chelsea.Leonard ([email protected])

Author affiliations

aDenver/Seattle Center of Innovation for Veteran-Centered and Value-Driven Care, Aurora, Colorado
bDenver/Seattle Center of Innovation for Veteran-Centered and Value-Driven Care, Seattle, Washington
cDepartment of Clinical Pharmacy at the University of Colorado Anschutz Medical Campus, Aurora
dCase Western Reserve University School of Medicine, Cleveland, Ohio; Veteran Affairs Central Office, Washington, DC
eDivision of Hospital Medicine, University of Colorado School of Medicine, Aurora

Author disclosures

Dr. Ho is supported by research grants from NHLBI, VA HSR&D, and University of Colorado School of Medicine. He has a research agreement with Bristol-Myers Squibb administered by the University of Colorado. The authors report no other actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The activities were undertaken in support of a Veterans Health Administration (VHA) operational project and did not constitute research, in whole or in part, in compliance with VHA Handbook 1058.05. Therefore, institutional review board approval was not required.

Funding

This work was funded by the VHA Office of Rural Health and sponsored by the VHA Office of Veterans Access to Care, Department of Veterans Affairs, Washington, DC through a MyVA Access Improvement Project Grant: “VISN 19 VA Denver Developing best practices for subspecialty e‐consultation procedures.”

 

 

 

 

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Related Articles

Electronic consultation (e-consult) is designed to increase access to specialty care by facilitating communication between primary care and specialty clinicians without the need for outpatient face-to-face encounters.1–4 In 2011, the US Department of Veterans Affairs (VA) implemented an e-consult program as a component of its overall strategy to increase access to specialty services, reduce costs of care, and reduce appointment travel burden on patients.

E-consult has substantially increased within the VA since its implementation.5,6 Consistent with limited evaluations from other health care systems, evaluations of the VA e-consult program demonstrated reduced costs, reduced travel time for patients, and improved access to specialty care.2,5–11 However, there is wide variation in e-consult use across VA specialties, facilities, and regions.5,6,12,13 For example, hematology, preoperative evaluation, neurosurgery, endocrinology, and infectious diseases use e-consults more frequently when compared with in-person consults in the VA.6 Reasons for this variation or specific barriers and facilitators of using e-consults have not been described.

Prior qualitative studies report that primary care practitioners (PCPs) describe e-consults as convenient, educational, beneficial for patient care, and useful for improving patient access to specialty care.8,14,15 One study identified limited PCP knowledge of e-consults as a barrier to use.16 Specialists have reported that e-consult improves clinical communication, but increases their workload.1,14,17,18 These studies did not assess perspectives from both clinicians who initiate e-consults and those who respond to them. This is the first qualitative study to assess e-consult perceptions from perspectives of both PCPs and specialists among a large, national sample of VA clinicians who use e-consults. The objective of this study was to understand perspectives of e-consults between PCPs and specialists that may be relevant to increasing adoption in the VA.

 

Methods

The team (CL, ML, PG, 2 analysts under the guidance of GS and JS and support from RRK, and a biostatistician) conducted semistructured interviews with PCPs, specialists, and specialty division leaders who were employed by VA in 2016 and 2017. Specialties of interest were identified by the VA Office of Specialty Care and included cardiology, endocrinology, gastroenterology, and hematology.

E-Consult Procedures

Within the VA, the specific procedures used to initiate, triage and manage e-consults are coordinated at VA medical centers (VAMCs) and at the Veterans Integrated Service Network (VISN) regional level. E-consult can be requested by any clinician. Generally, e-consults are initiated by PCPs through standardized, specialty-specific templates. Recipients, typically specialists, respond by answering questions, suggesting additional testing and evaluation, or requesting an in-person visit. Communication is documented in the patient’s electronic health record (EHR). Specialists receive different levels of workload credit for responding to e-consults similar to a relative value unit reimbursement model. Training in the use of e-consults is available to practitioners but may vary at local and regional levels.

Recruitment

Our sample included PCPs, specialists, and specialty care division leaders. We first quantified e-consult rates (e-consults per 100 patient visits) between July 2016 and June 2017 at VA facilities within primary care and the 4 priority specialties and identified the 30 sites with the highest e-consult rates and 30 sites with the lowest e-consult rates. Sites with < 500 total visits, < 3 specialties, or without any e-consult visit during the study period were excluded. E-consult rates at community-based outpatient clinics were included with associated VAMCs. We then stratified PCPs by whether they were high or low users of e-consults (determined by the top and bottom users within each site) and credentials (MD vs nurse practitioner [NP] or physician assistant [PA]). Specialists were sampled based on their rate of use relative to colleagues within their site and the use rate of their division. We sampled division chiefs and individuals who had > 300 total visits and 1 e-consult during the study period. To recruit participants, the primary investigator sent an initial email and 2 reminder emails. The team followed up with respondents to schedule an interview.

Interview guides were designed to elicit rich descriptions of barriers and facilitators to e-consult use (eAppendix available at doi:10.12788/fp.0214). The team used the Practical Robust Implementation and Sustainability Model (PRISM), which considers factors along 6 domains for intervention planning, implementation, and sustainment.19 Telephone interviews lasted about 20 minutes and were conducted between September 2017 and March 2018. Interviews were recorded and transcribed verbatim.

Analysis

The team used an iterative, team-based, inductive/deductive approach to conventional content analysis.20,21 Initial code categories were created so that we could identify e-consult best practices—facilitators of e-consult that were recommended by both PCPs and specialists. Inductive codes or labels applied to identify meaningful quotations, phrases, or key terms were used to identify emergent ideas and were added throughout coding after discussion among team members. Consensus was reached using a team-based approach.21 Four analysts independently coded the same 3 transcripts and met to discuss points of divergence and convergence. Analyses continued with emergent themes, categories, and conclusions. Atlas.ti. v.7 was used for coding and data management.22

 

 

Results

We conducted 34 interviews with clinicians (Table 1) from 13 VISNs. Four best-practice themes emerged among both PCPs and specialists, including that e-consults (1) are best suited for certain clinical questions and patients; (2) require relevant background information from requesting clinicians and clear recommendations from responding clinicians; (3) are a novel opportunity to provide efficient, transparent care; and (4) may not be fully adopted due to low awareness. Supporting quotations for the following findings are provided in Table 2.

Supporting Quotations

Description of Participants

Specific Clinical Questions and Patients

PCPs described specific patients and questions for which they most frequently used e-consults, such as for medication changes (Q1), determining treatment steps (Q2,3), and or clarifying laboratory or imaging findings. PCPs frequently used e-consults for patients who did not require a physical examination or when specialists could make recommendations without seeing patients face-to-face (Q3). An important use of e-consults described by PCPs was for treating conditions they could manage within primary care if additional guidance were available (Q4). Several PCPs and specialists also noted that e-consults were particularly useful for patients who were unable to travel or did not want face-to-face appointments (Q5). Notably, PCPs and specialists mentioned situations for which e-consults were inappropriate, including when a detailed history or physical examination was needed, or if a complex condition was suspected (Q6).

Background Data and Clear Recommendations

Participants described necessary data that should be included in high-quality e-consults. Specialists voiced frustration in time-consuming chart reviews that were often necessary when these data were not provided by the requestor. In some cases, specialists were unable to access necessary EHR data, which delayed responses (Q7). PCPs noted that the most useful responses carefully considered the question, used current patient information to determine treatments, provided clear recommendations, and defined who was responsible for next steps (Q8). PCPs and specialists stated that e-consult templates that required relevant information facilitated high-quality e-consults. Neither wanted to waste the other clinician's time (Q8).

A Novel Opportunity

Many PCPs felt that e-consults improved communication (eg, efficiency, response time), established new communication between clinicians, and reduced patients’ appointment burden (Q10, Q11). Many specialists felt that e-consults improved documentation of communication between clinicians and increased transparency of clinical decisions (Q12). Additionally, many specialists mentioned that e-consults capture previously informal curbside consults, enabling them to receive workload credit (Q13).

Lack of Awareness

Some noted that the biggest barrier to e-consults was not being aware of them generally, or which specialties offer e-consults (Q14). One PCP described e-consults as the best kept secret and found value in sharing the utility of e-consults with colleagues (Q15). All participants, including those who did not frequently use e-consults, felt that e-consults improved the quality of care by providing more timely care or better answers to clinical questions (Q16). Several practitioners also felt that e-consults increased access to specialty care. For example, specialists reported that e-consults enabled them to better manage patient load by using e-consults to answer relatively simple questions, reserving face-to-face consults for more complex patients (Q17).

Discussion

The objective of this study was to identify potential best practices for e-consults that may help increase their quality and use within the VA. We built on prior studies that offered insights on PCP and specialists’ overall satisfaction with e-consult by identifying several themes relevant to the further adoption of e-consults in the VA and elsewhere without a face-to-face visit.8,13,14,16–18 Future work may be beneficial in identifying whether the study themes identified can explain variation in e-consult use or whether addressing these factors might lead to increased or higher quality e-consult use. We are unaware of any qualitative study of comparable scale in a different health care system. Further, this is the first study to assess perspectives on e-consults among those who initiate and respond to them within the same health care system. Perhaps the most important finding from this study is that e-consults are generally viewed favorably, which is a necessary leverage point to increase their adoption within the system.

 

 

Clinicians reported several benefits to e-consults, including timely responses to clinical questions, efficient communication, allow for documentation of specialist recommendations, and help capture workload. These benefits are consistent with prior literature that indicates both PCPs and specialists in the VA and other health care systems feel that e-consults improves communication, decreases unnecessary visits, and improves quality of care.1,14,17,18 In particular, clinicians reported that e-consults improve their practice efficiency and efficacy. This is of critical importance given the pressures of providing timely access to primary and specialty care within the VA. Interestingly, many VA practitioners were unaware which specialties offered e-consults within their facilities, reflecting previous work showing that PCPs are often unaware of e-consult options.16 This may partially explain variation in e-consult use. Increasing awareness and educating clinicians on the benefits of e-consults may help promote use among non- and low users.

A common theme reported by both groups was the importance of providing necessary information within e-consult questions and responses. Specialists felt there was a need to ensure that PCPs provide relevant and patient-specific information that would enable them to efficiently and accurately answer questions without the need for extensive EHR review. This reflects previous work showing that specialists are often unable to respond to e-consult requests because they do not contain sufficient information.22 PCPs described a need to ensure that specialists’ responses included information that was detailed enough to make clinical decisions without the need for a reconsult. This highlights a common challenge to medical consultation, in that necessary or relevant information may not be apparent to all clinicians. To address this, there may be a role in developing enhanced, flexible templating that elicits necessary patient-specific information. Such a template may automatically pull relevant data from the EHR and prompt clinicians to provide important information. We did not assess how perspectives of templates varied, and further work could help define precisely what constitutes an effective template, including how it should capture appropriate patient data and how this impacts acceptability or use of e-consults generally. Collaboratively developed service agreements and e-consult templates could help guide PCPs and specialists to engage in efficient communication.

Another theme among both groups was that e-consult is most appropriate within specific clinical scenarios. Examples included review of laboratory results, questions about medication changes, or for patients who were reluctant to travel to appointments. Identifying and promoting specific opportunities for e-consults may help increase their use and align e-consult practices with scenarios that are likely to provide the most benefit to patients. For example, it could be helpful to understand the distance patients must travel for specialty care. Providing that information during clinical encounters could trigger clinicians to consider e-consults as an option. Future work might aim to identify clinical scenarios that clinicians feel are not well suited for e-consults and determine how to adapt them for those scenarios.

Limitations

Generalizability of these findings is limited given the qualitative study design. Participants’ descriptions of experiences with e-consults reflect the experiences of clinicians in the VA and may not reflect clinicians in other settings. We also interviewed a sample of clinicians who were already using e-consults. Important information could be learned from future work with those who have not yet adopted e-consult procedures or adopted and abandoned them.

Conclusions

E-consult is perceived as beneficial by VA PCPs and specialists. Participants suggested using e-consults for appropriate questions or patients and including necessary information and next steps in both the initial e-consult and response. Finding ways to facilitate e-consults with these suggestions in mind may increase delivery of high-quality e-consults. Future work could compare the findings of this work to similar work assessing clinicians perceptions of e-consults outside of the VA.

Electronic consultation (e-consult) is designed to increase access to specialty care by facilitating communication between primary care and specialty clinicians without the need for outpatient face-to-face encounters.1–4 In 2011, the US Department of Veterans Affairs (VA) implemented an e-consult program as a component of its overall strategy to increase access to specialty services, reduce costs of care, and reduce appointment travel burden on patients.

E-consult has substantially increased within the VA since its implementation.5,6 Consistent with limited evaluations from other health care systems, evaluations of the VA e-consult program demonstrated reduced costs, reduced travel time for patients, and improved access to specialty care.2,5–11 However, there is wide variation in e-consult use across VA specialties, facilities, and regions.5,6,12,13 For example, hematology, preoperative evaluation, neurosurgery, endocrinology, and infectious diseases use e-consults more frequently when compared with in-person consults in the VA.6 Reasons for this variation or specific barriers and facilitators of using e-consults have not been described.

Prior qualitative studies report that primary care practitioners (PCPs) describe e-consults as convenient, educational, beneficial for patient care, and useful for improving patient access to specialty care.8,14,15 One study identified limited PCP knowledge of e-consults as a barrier to use.16 Specialists have reported that e-consult improves clinical communication, but increases their workload.1,14,17,18 These studies did not assess perspectives from both clinicians who initiate e-consults and those who respond to them. This is the first qualitative study to assess e-consult perceptions from perspectives of both PCPs and specialists among a large, national sample of VA clinicians who use e-consults. The objective of this study was to understand perspectives of e-consults between PCPs and specialists that may be relevant to increasing adoption in the VA.

 

Methods

The team (CL, ML, PG, 2 analysts under the guidance of GS and JS and support from RRK, and a biostatistician) conducted semistructured interviews with PCPs, specialists, and specialty division leaders who were employed by VA in 2016 and 2017. Specialties of interest were identified by the VA Office of Specialty Care and included cardiology, endocrinology, gastroenterology, and hematology.

E-Consult Procedures

Within the VA, the specific procedures used to initiate, triage and manage e-consults are coordinated at VA medical centers (VAMCs) and at the Veterans Integrated Service Network (VISN) regional level. E-consult can be requested by any clinician. Generally, e-consults are initiated by PCPs through standardized, specialty-specific templates. Recipients, typically specialists, respond by answering questions, suggesting additional testing and evaluation, or requesting an in-person visit. Communication is documented in the patient’s electronic health record (EHR). Specialists receive different levels of workload credit for responding to e-consults similar to a relative value unit reimbursement model. Training in the use of e-consults is available to practitioners but may vary at local and regional levels.

Recruitment

Our sample included PCPs, specialists, and specialty care division leaders. We first quantified e-consult rates (e-consults per 100 patient visits) between July 2016 and June 2017 at VA facilities within primary care and the 4 priority specialties and identified the 30 sites with the highest e-consult rates and 30 sites with the lowest e-consult rates. Sites with < 500 total visits, < 3 specialties, or without any e-consult visit during the study period were excluded. E-consult rates at community-based outpatient clinics were included with associated VAMCs. We then stratified PCPs by whether they were high or low users of e-consults (determined by the top and bottom users within each site) and credentials (MD vs nurse practitioner [NP] or physician assistant [PA]). Specialists were sampled based on their rate of use relative to colleagues within their site and the use rate of their division. We sampled division chiefs and individuals who had > 300 total visits and 1 e-consult during the study period. To recruit participants, the primary investigator sent an initial email and 2 reminder emails. The team followed up with respondents to schedule an interview.

Interview guides were designed to elicit rich descriptions of barriers and facilitators to e-consult use (eAppendix available at doi:10.12788/fp.0214). The team used the Practical Robust Implementation and Sustainability Model (PRISM), which considers factors along 6 domains for intervention planning, implementation, and sustainment.19 Telephone interviews lasted about 20 minutes and were conducted between September 2017 and March 2018. Interviews were recorded and transcribed verbatim.

Analysis

The team used an iterative, team-based, inductive/deductive approach to conventional content analysis.20,21 Initial code categories were created so that we could identify e-consult best practices—facilitators of e-consult that were recommended by both PCPs and specialists. Inductive codes or labels applied to identify meaningful quotations, phrases, or key terms were used to identify emergent ideas and were added throughout coding after discussion among team members. Consensus was reached using a team-based approach.21 Four analysts independently coded the same 3 transcripts and met to discuss points of divergence and convergence. Analyses continued with emergent themes, categories, and conclusions. Atlas.ti. v.7 was used for coding and data management.22

 

 

Results

We conducted 34 interviews with clinicians (Table 1) from 13 VISNs. Four best-practice themes emerged among both PCPs and specialists, including that e-consults (1) are best suited for certain clinical questions and patients; (2) require relevant background information from requesting clinicians and clear recommendations from responding clinicians; (3) are a novel opportunity to provide efficient, transparent care; and (4) may not be fully adopted due to low awareness. Supporting quotations for the following findings are provided in Table 2.

Supporting Quotations

Description of Participants

Specific Clinical Questions and Patients

PCPs described specific patients and questions for which they most frequently used e-consults, such as for medication changes (Q1), determining treatment steps (Q2,3), and or clarifying laboratory or imaging findings. PCPs frequently used e-consults for patients who did not require a physical examination or when specialists could make recommendations without seeing patients face-to-face (Q3). An important use of e-consults described by PCPs was for treating conditions they could manage within primary care if additional guidance were available (Q4). Several PCPs and specialists also noted that e-consults were particularly useful for patients who were unable to travel or did not want face-to-face appointments (Q5). Notably, PCPs and specialists mentioned situations for which e-consults were inappropriate, including when a detailed history or physical examination was needed, or if a complex condition was suspected (Q6).

Background Data and Clear Recommendations

Participants described necessary data that should be included in high-quality e-consults. Specialists voiced frustration in time-consuming chart reviews that were often necessary when these data were not provided by the requestor. In some cases, specialists were unable to access necessary EHR data, which delayed responses (Q7). PCPs noted that the most useful responses carefully considered the question, used current patient information to determine treatments, provided clear recommendations, and defined who was responsible for next steps (Q8). PCPs and specialists stated that e-consult templates that required relevant information facilitated high-quality e-consults. Neither wanted to waste the other clinician's time (Q8).

A Novel Opportunity

Many PCPs felt that e-consults improved communication (eg, efficiency, response time), established new communication between clinicians, and reduced patients’ appointment burden (Q10, Q11). Many specialists felt that e-consults improved documentation of communication between clinicians and increased transparency of clinical decisions (Q12). Additionally, many specialists mentioned that e-consults capture previously informal curbside consults, enabling them to receive workload credit (Q13).

Lack of Awareness

Some noted that the biggest barrier to e-consults was not being aware of them generally, or which specialties offer e-consults (Q14). One PCP described e-consults as the best kept secret and found value in sharing the utility of e-consults with colleagues (Q15). All participants, including those who did not frequently use e-consults, felt that e-consults improved the quality of care by providing more timely care or better answers to clinical questions (Q16). Several practitioners also felt that e-consults increased access to specialty care. For example, specialists reported that e-consults enabled them to better manage patient load by using e-consults to answer relatively simple questions, reserving face-to-face consults for more complex patients (Q17).

Discussion

The objective of this study was to identify potential best practices for e-consults that may help increase their quality and use within the VA. We built on prior studies that offered insights on PCP and specialists’ overall satisfaction with e-consult by identifying several themes relevant to the further adoption of e-consults in the VA and elsewhere without a face-to-face visit.8,13,14,16–18 Future work may be beneficial in identifying whether the study themes identified can explain variation in e-consult use or whether addressing these factors might lead to increased or higher quality e-consult use. We are unaware of any qualitative study of comparable scale in a different health care system. Further, this is the first study to assess perspectives on e-consults among those who initiate and respond to them within the same health care system. Perhaps the most important finding from this study is that e-consults are generally viewed favorably, which is a necessary leverage point to increase their adoption within the system.

 

 

Clinicians reported several benefits to e-consults, including timely responses to clinical questions, efficient communication, allow for documentation of specialist recommendations, and help capture workload. These benefits are consistent with prior literature that indicates both PCPs and specialists in the VA and other health care systems feel that e-consults improves communication, decreases unnecessary visits, and improves quality of care.1,14,17,18 In particular, clinicians reported that e-consults improve their practice efficiency and efficacy. This is of critical importance given the pressures of providing timely access to primary and specialty care within the VA. Interestingly, many VA practitioners were unaware which specialties offered e-consults within their facilities, reflecting previous work showing that PCPs are often unaware of e-consult options.16 This may partially explain variation in e-consult use. Increasing awareness and educating clinicians on the benefits of e-consults may help promote use among non- and low users.

A common theme reported by both groups was the importance of providing necessary information within e-consult questions and responses. Specialists felt there was a need to ensure that PCPs provide relevant and patient-specific information that would enable them to efficiently and accurately answer questions without the need for extensive EHR review. This reflects previous work showing that specialists are often unable to respond to e-consult requests because they do not contain sufficient information.22 PCPs described a need to ensure that specialists’ responses included information that was detailed enough to make clinical decisions without the need for a reconsult. This highlights a common challenge to medical consultation, in that necessary or relevant information may not be apparent to all clinicians. To address this, there may be a role in developing enhanced, flexible templating that elicits necessary patient-specific information. Such a template may automatically pull relevant data from the EHR and prompt clinicians to provide important information. We did not assess how perspectives of templates varied, and further work could help define precisely what constitutes an effective template, including how it should capture appropriate patient data and how this impacts acceptability or use of e-consults generally. Collaboratively developed service agreements and e-consult templates could help guide PCPs and specialists to engage in efficient communication.

Another theme among both groups was that e-consult is most appropriate within specific clinical scenarios. Examples included review of laboratory results, questions about medication changes, or for patients who were reluctant to travel to appointments. Identifying and promoting specific opportunities for e-consults may help increase their use and align e-consult practices with scenarios that are likely to provide the most benefit to patients. For example, it could be helpful to understand the distance patients must travel for specialty care. Providing that information during clinical encounters could trigger clinicians to consider e-consults as an option. Future work might aim to identify clinical scenarios that clinicians feel are not well suited for e-consults and determine how to adapt them for those scenarios.

Limitations

Generalizability of these findings is limited given the qualitative study design. Participants’ descriptions of experiences with e-consults reflect the experiences of clinicians in the VA and may not reflect clinicians in other settings. We also interviewed a sample of clinicians who were already using e-consults. Important information could be learned from future work with those who have not yet adopted e-consult procedures or adopted and abandoned them.

Conclusions

E-consult is perceived as beneficial by VA PCPs and specialists. Participants suggested using e-consults for appropriate questions or patients and including necessary information and next steps in both the initial e-consult and response. Finding ways to facilitate e-consults with these suggestions in mind may increase delivery of high-quality e-consults. Future work could compare the findings of this work to similar work assessing clinicians perceptions of e-consults outside of the VA.

References

1. Battaglia C, Lambert-Kerzner A, Aron DC, et al. Evaluation of e-consults in the VHA: provider perspectives. Fed Pract. 2015;32(7):42-48.

2. Haverhals LM, Sayre G, Helfrich CD, et al. E-consult implementation: lessons learned using consolidated framework for implementation research. Am J Manag Care. 2015;21(12):e640-e647. Published 2015 Dec 1.

3. Sewell JL, Telischak KS, Day LW, Kirschner N, Weissman A. Preconsultation exchange in the United States: use, awareness, and attitudes. Am J Manag Care. 2014;20(12):e556-e564. Published 2014 Dec 1.

4. Horner K, Wagner E, Tufano J. Electronic consultations between primary and specialty care clinicians: early insights. Issue Brief (Commonw Fund). 2011;23:1-14.

5. Kirsh S, Carey E, Aron DC, et al. Impact of a national specialty e-consultation implementation project on access. Am J Manag Care. 2015;21(12):e648-654. Published 2015 Dec 1.

6. Saxon DR, Kaboli PJ, Haraldsson B, Wilson C, Ohl M, Augustine MR. Growth of electronic consultations in the Veterans Health Administration. Am J Manag Care. 2021;27(1):12-19. doi:10.37765/ajmc.2021.88572

7. Olayiwola JN, Anderson D, Jepeal N, et al. Electronic consultations to improve the primary care-specialty care interface for cardiology in the medically underserved: a cluster-randomized controlled trial. Ann Fam Med. 2016;14(2):133-140. doi:10.1370/afm.1869

8. Schettini P, Shah KP, O’Leary CP, et al. Keeping care connected: e-Consultation program improves access to nephrology care. J Telemed Telecare. 2019;25(3):142-150. doi:10.1177/1357633X17748350

9. Whittington MD, Ho PM, Kirsh SR, et al. Cost savings associated with electronic specialty consultations. Am J Manag Care. 2021;27(1):e16-e23. Published 2021 Jan 1. doi:10.37765/ajmc.2021.88579

10. Shipherd JC, Kauth MR, Matza A. Nationwide interdisciplinary e-consultation on transgender care in the Veterans Health Administration. Telemed J E Health. 2016;22(12):1008-1012. doi:10.1089/tmj.2016.0013

11. Strymish J, Gupte G, Afable MK, et al. Electronic consultations (E-consults): advancing infectious disease care in a large Veterans Affairs Healthcare System. Clin Infect Dis. 2017;64(8):1123-1125. doi:10.1093/cid/cix058

12. Williams KM, Kirsh S, Aron D, et al. Evaluation of the Veterans Health Administration’s Specialty Care Transformational Initiatives to promote patient-centered delivery of specialty care: a mixed-methods approach. Telemed J E-Health. 2017;23(7):577-589. doi:10.1089/tmj.2016.0166

13. US Department of Veterans Affairs, Veterans Health Administration, Specialty Care Transformational Initiative Evaluation Center. Evaluation of specialty care initiatives. Published 2013.

14. Vimalananda VG, Gupte G, Seraj SM, et al. Electronic consultations (e-consults) to improve access to specialty care: a systematic review and narrative synthesis. J Telemed Telecare. 2015;21(6):323-330. doi:10.1177/1357633X15582108

15. Lee M, Leonard C, Greene P, et al. Perspectives of VA primary care clinicians toward electronic consultation-related workload burden. JAMA Netw Open. 2020;3(10):e2018104. Published 2020 Oct 1. doi:10.1001/jamanetworkopen.2020.18104

16. Deeds SA, Dowdell KJ, Chew LD, Ackerman SL. Implementing an opt-in eConsult program at seven academic medical centers: a qualitative analysis of primary care provider experiences. J Gen Intern Med. 2019;34(8):1427-1433. doi:10.1007/s11606-019-05067-7

17. Rodriguez KL, Burkitt KH, Bayliss NK, et al. Veteran, primary care provider, and specialist satisfaction with electronic consultation. JMIR Med Inform. 2015;3(1):e5. Published 2015 Jan 14. doi:10.2196/medinform.3725

18. Gupte G, Vimalananda V, Simon SR, DeVito K, Clark J, Orlander JD. Disruptive innovation: implementation of electronic consultations in a Veterans Affairs Health Care System. JMIR Med Inform. 2016;4(1):e6. Published 2016 Feb 12. doi:10.2196/medinform.4801

19. Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008;34(4):228-243. doi:10.1016/s1553-7250(08)34030-6

20. Patton MQ. Qualitative Research and Evaluation Methods. 3rd ed. Sage Publications; 2002.

21. Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007;42(4):1758-1772. doi:10.1111/j.1475-6773.2006.00684.x

22. Kim EJ, Orlander JD, Afable M, et al. Cardiology electronic consultation (e-consult) use by primary care providers at VA medical centres in New England. J Telemed Telecare. 2019;25(6):370-377. doi:10.1177/1357633X18774468

References

1. Battaglia C, Lambert-Kerzner A, Aron DC, et al. Evaluation of e-consults in the VHA: provider perspectives. Fed Pract. 2015;32(7):42-48.

2. Haverhals LM, Sayre G, Helfrich CD, et al. E-consult implementation: lessons learned using consolidated framework for implementation research. Am J Manag Care. 2015;21(12):e640-e647. Published 2015 Dec 1.

3. Sewell JL, Telischak KS, Day LW, Kirschner N, Weissman A. Preconsultation exchange in the United States: use, awareness, and attitudes. Am J Manag Care. 2014;20(12):e556-e564. Published 2014 Dec 1.

4. Horner K, Wagner E, Tufano J. Electronic consultations between primary and specialty care clinicians: early insights. Issue Brief (Commonw Fund). 2011;23:1-14.

5. Kirsh S, Carey E, Aron DC, et al. Impact of a national specialty e-consultation implementation project on access. Am J Manag Care. 2015;21(12):e648-654. Published 2015 Dec 1.

6. Saxon DR, Kaboli PJ, Haraldsson B, Wilson C, Ohl M, Augustine MR. Growth of electronic consultations in the Veterans Health Administration. Am J Manag Care. 2021;27(1):12-19. doi:10.37765/ajmc.2021.88572

7. Olayiwola JN, Anderson D, Jepeal N, et al. Electronic consultations to improve the primary care-specialty care interface for cardiology in the medically underserved: a cluster-randomized controlled trial. Ann Fam Med. 2016;14(2):133-140. doi:10.1370/afm.1869

8. Schettini P, Shah KP, O’Leary CP, et al. Keeping care connected: e-Consultation program improves access to nephrology care. J Telemed Telecare. 2019;25(3):142-150. doi:10.1177/1357633X17748350

9. Whittington MD, Ho PM, Kirsh SR, et al. Cost savings associated with electronic specialty consultations. Am J Manag Care. 2021;27(1):e16-e23. Published 2021 Jan 1. doi:10.37765/ajmc.2021.88579

10. Shipherd JC, Kauth MR, Matza A. Nationwide interdisciplinary e-consultation on transgender care in the Veterans Health Administration. Telemed J E Health. 2016;22(12):1008-1012. doi:10.1089/tmj.2016.0013

11. Strymish J, Gupte G, Afable MK, et al. Electronic consultations (E-consults): advancing infectious disease care in a large Veterans Affairs Healthcare System. Clin Infect Dis. 2017;64(8):1123-1125. doi:10.1093/cid/cix058

12. Williams KM, Kirsh S, Aron D, et al. Evaluation of the Veterans Health Administration’s Specialty Care Transformational Initiatives to promote patient-centered delivery of specialty care: a mixed-methods approach. Telemed J E-Health. 2017;23(7):577-589. doi:10.1089/tmj.2016.0166

13. US Department of Veterans Affairs, Veterans Health Administration, Specialty Care Transformational Initiative Evaluation Center. Evaluation of specialty care initiatives. Published 2013.

14. Vimalananda VG, Gupte G, Seraj SM, et al. Electronic consultations (e-consults) to improve access to specialty care: a systematic review and narrative synthesis. J Telemed Telecare. 2015;21(6):323-330. doi:10.1177/1357633X15582108

15. Lee M, Leonard C, Greene P, et al. Perspectives of VA primary care clinicians toward electronic consultation-related workload burden. JAMA Netw Open. 2020;3(10):e2018104. Published 2020 Oct 1. doi:10.1001/jamanetworkopen.2020.18104

16. Deeds SA, Dowdell KJ, Chew LD, Ackerman SL. Implementing an opt-in eConsult program at seven academic medical centers: a qualitative analysis of primary care provider experiences. J Gen Intern Med. 2019;34(8):1427-1433. doi:10.1007/s11606-019-05067-7

17. Rodriguez KL, Burkitt KH, Bayliss NK, et al. Veteran, primary care provider, and specialist satisfaction with electronic consultation. JMIR Med Inform. 2015;3(1):e5. Published 2015 Jan 14. doi:10.2196/medinform.3725

18. Gupte G, Vimalananda V, Simon SR, DeVito K, Clark J, Orlander JD. Disruptive innovation: implementation of electronic consultations in a Veterans Affairs Health Care System. JMIR Med Inform. 2016;4(1):e6. Published 2016 Feb 12. doi:10.2196/medinform.4801

19. Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008;34(4):228-243. doi:10.1016/s1553-7250(08)34030-6

20. Patton MQ. Qualitative Research and Evaluation Methods. 3rd ed. Sage Publications; 2002.

21. Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007;42(4):1758-1772. doi:10.1111/j.1475-6773.2006.00684.x

22. Kim EJ, Orlander JD, Afable M, et al. Cardiology electronic consultation (e-consult) use by primary care providers at VA medical centres in New England. J Telemed Telecare. 2019;25(6):370-377. doi:10.1177/1357633X18774468

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Therapeutic aquatic exercise superior to physical therapy for back pain in study

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Mon, 01/10/2022 - 10:28

 

Patients with chronic low back pain who participated in therapeutic aquatic exercise had superior improvement in function, pain, quality of life, sleep quality, and mental state, compared with those who received physical therapy, in a new study.

“This is the first study to compare the efficacy of therapeutic aquatic exercise and physical therapy modalities in the treatment of chronic low back pain,” senior coauthors Pei-Jie Chen, PhD and Xue-Qiang Wang, PhD, both of the department of sport rehabilitation, Shanghai (China) University of Sport, wrote in JAMA Network Open. “Therapeutic aquatic exercise is a safe treatment for chronic low back pain and most participants who received it were willing to recommend it to other patients with chronic low back pain.”

As compared with individuals in the physical therapy modalities arm, the therapeutic aquatic exercise experienced greater relief of disability at all time points assessed: after the 3-month intervention, at the 6-month follow-up, and at the 12-month follow-up.

Commenting on the study, Linda Girgis, MD, FAAFP, a family physician in private practice in South River, N.J., agreed that aquatic therapy is a great tool for many chronic low back patients. “It helps them get active for one and do things that may exacerbate their symptoms doing the same exercises on land,” noted Dr. Girgis, who also is a clinical assistant professor at Robert Wood Johnson Medical School, New Brunswick.

She pointed out that access to a pool can be a problem. “But I have found a few physical therapy places in my area that do have access to a pool, and I refer appropriate patients there,” added Dr. Girgis, who was not involved with the study. “I have also found it works well for other types of pain, such as knee and hip pain. It is not for everyone but I have seen some patients get great benefit from it when they didn’t get any with traditional physical therapy.”
 

Aquatic therapy was more beneficial

Low back pain is a common condition, and clinical practice guidelines currently recommend therapeutic exercise and physical therapy modalities. Among the modalities that are available, therapeutic aquatic exercise is often prescribed for chronic low back pain, and it is becoming increasingly popular for treatment of chronic low back pain, the authors stated in their paper. The authors noted that water is an ideal environment for conducting an exercise program given its various properties, including buoyancy pressure, density, thermal capacity, and conductivity.

Two previously published systematic reviews have suggested that therapeutic aquatic exercise may be able to reduce the intensity of back pain and improve function in this population. But to date, evidence regarding long-term benefits in patients with chronic low back pain is very limited and there haven’t been any studies comparing the efficacy of therapeutic aquatic exercise and physical therapy modalities for chronic low back pain, according to the authors.

In this study, 113 individuals with chronic low back pain were randomized to either therapeutic aquatic exercise or to physical therapy, with an endpoint of efficacy regarding disability. This was measured using the Roland-Morris Disability Questionnaire.

Scores ranged from 0 to 24, with higher scores indicating more severe disability. Secondary endpoints included pain intensity, quality of life, sleep quality, and recommendation of intervention, and these were rated using various standardized tools.

Those randomized to the therapeutic aquatic exercise group had about an hour of therapy, beginning with a 10-minute active warm-up session to enhance neuromuscular activation, then an exercise session for 40 minutes followed by a 10-minute cooldown.

The physical therapy group received transcutaneous electrical nerve stimulation and infrared ray thermal therapy, also for 60 minutes. Both groups received these interventions twice a week for 3 months.

The overall mean age of the cohort was 31.0 years, and they were almost evenly divided by gender; 54 were men (47.8%), and 59 were women (52.2%).

As compared with the physical therapy group, individuals participating in therapeutic aquatic exercise group showed improvement in disability by an additional −1.77 points (95% confidence interval, −3.02 to −0.51) at the end of the 3-month intervention; at 6 months it was −2.42 points (95% CI, −4.13 to −0.70) and −3.61 points (95% CI, −5.63 to −1.58) at the 12-month follow-up (P < .001 for overall group x time interaction).

Functional improvement did not appear to be significantly affected by confounders that included age, sex, body mass index, low back pain duration, educational level, or pain level.

For secondary outcomes, those in the therapeutic aquatic exercise group demonstrated improvement in the most severe pain by an additional −0.79 points (95% CI, −1.31 to −0.27) after the 3-month intervention, −1.34 points (95% CI, −2.06 to −0.62) at 6 months, and −2.04 points (95% CI, −2.75 to −1.34) at the 12-month follow-up (P < .001 for overall group x time interaction), as compared with the physical therapy group. All pain scores differed significantly between the two groups at every time point.

In addition, individuals in the therapeutic aquatic exercise group showed more improvements on the 36-item Short-form Health Survey (overall group x time interaction, P = .003), Pittsburgh Sleep Quality Index (overall group x time interaction, P = .02), Tampa Scale for Kinesiophobia (overall group x time interaction, P < .001), and Fear-Avoidance Beliefs Questionnaire (physical activity subscale overall group x time interaction, P = .04), as compared with the physical therapy group. These improvements were also not influenced by confounders.

Finally, at the 12-month follow-up point, those in the aquatic therapy group had significantly greater improvements in the number of participants who met the minimal clinically important difference in pain (at least a 2-point improvement on the numeric rating scale).
 

More outside experts’ takes

“The current research evidence does suggest indeed that aquatic exercise therapy is suitable and often better than land exercise, passive relaxation, or other treatments for many people with low back pain,” commented Stelios Psycharakis PhD, senior lecturer in biomechanics, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh.

He also noted that since low back pain is an issue affecting about 80% of all people at some stage of their life, it is “improbable that one could identify a single type of treatment or exercise therapy that would be suitable for every person with this problem.”

Dr. Psycharakis pointed out that there are also some contraindications for aquatic therapy, such as incontinence and skin conditions. “Other than that though, clinicians should definitely consider aquatic exercise therapy when advising people with chronic low back pain,” he said.

Justin M. Lantz, DPT, agreed that the study showed therapeutic aquatic exercise appears to be safe and beneficial in some patients with chronic low back pain, but he also shared limitations of the new research.

“The study has notable limitations as it did not include patients above 65 years old, pain levels were generally low for the subjects involved, and it did not include a treatment group with land therapeutic exercise – so it is difficult to determine if the beneficial effects reported were due to active exercise or because the exercises were performed in water,” said Dr. Lantz, director of the spine physical therapy fellowship program at the University of Southern California, Los Angeles, and an assistant professor of clinical physical therapy.

He also pointed out that, since active exercise has been shown to be beneficial and is advocated in multiple clinical practice guidelines for chronic low back pain, “it would be helpful to determine if the true effects on pain and disability were due to the water environment or the effect of active exercise itself.”

“Due to the significant positive long-term effects and limited adverse events reported, I believe this study supports the use of therapeutic aquatic exercise in select patient populations with chronic low back pain and should be considered as a part of a rehabilitation treatment plan if accessibility is feasible,” Dr. Lantz said.

The authors of the paper, Dr. Girgis, and Dr. Psycharakis had no conflicts of interest. Justin Lantz is a physical therapy consultant to SI-Bone.

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Patients with chronic low back pain who participated in therapeutic aquatic exercise had superior improvement in function, pain, quality of life, sleep quality, and mental state, compared with those who received physical therapy, in a new study.

“This is the first study to compare the efficacy of therapeutic aquatic exercise and physical therapy modalities in the treatment of chronic low back pain,” senior coauthors Pei-Jie Chen, PhD and Xue-Qiang Wang, PhD, both of the department of sport rehabilitation, Shanghai (China) University of Sport, wrote in JAMA Network Open. “Therapeutic aquatic exercise is a safe treatment for chronic low back pain and most participants who received it were willing to recommend it to other patients with chronic low back pain.”

As compared with individuals in the physical therapy modalities arm, the therapeutic aquatic exercise experienced greater relief of disability at all time points assessed: after the 3-month intervention, at the 6-month follow-up, and at the 12-month follow-up.

Commenting on the study, Linda Girgis, MD, FAAFP, a family physician in private practice in South River, N.J., agreed that aquatic therapy is a great tool for many chronic low back patients. “It helps them get active for one and do things that may exacerbate their symptoms doing the same exercises on land,” noted Dr. Girgis, who also is a clinical assistant professor at Robert Wood Johnson Medical School, New Brunswick.

She pointed out that access to a pool can be a problem. “But I have found a few physical therapy places in my area that do have access to a pool, and I refer appropriate patients there,” added Dr. Girgis, who was not involved with the study. “I have also found it works well for other types of pain, such as knee and hip pain. It is not for everyone but I have seen some patients get great benefit from it when they didn’t get any with traditional physical therapy.”
 

Aquatic therapy was more beneficial

Low back pain is a common condition, and clinical practice guidelines currently recommend therapeutic exercise and physical therapy modalities. Among the modalities that are available, therapeutic aquatic exercise is often prescribed for chronic low back pain, and it is becoming increasingly popular for treatment of chronic low back pain, the authors stated in their paper. The authors noted that water is an ideal environment for conducting an exercise program given its various properties, including buoyancy pressure, density, thermal capacity, and conductivity.

Two previously published systematic reviews have suggested that therapeutic aquatic exercise may be able to reduce the intensity of back pain and improve function in this population. But to date, evidence regarding long-term benefits in patients with chronic low back pain is very limited and there haven’t been any studies comparing the efficacy of therapeutic aquatic exercise and physical therapy modalities for chronic low back pain, according to the authors.

In this study, 113 individuals with chronic low back pain were randomized to either therapeutic aquatic exercise or to physical therapy, with an endpoint of efficacy regarding disability. This was measured using the Roland-Morris Disability Questionnaire.

Scores ranged from 0 to 24, with higher scores indicating more severe disability. Secondary endpoints included pain intensity, quality of life, sleep quality, and recommendation of intervention, and these were rated using various standardized tools.

Those randomized to the therapeutic aquatic exercise group had about an hour of therapy, beginning with a 10-minute active warm-up session to enhance neuromuscular activation, then an exercise session for 40 minutes followed by a 10-minute cooldown.

The physical therapy group received transcutaneous electrical nerve stimulation and infrared ray thermal therapy, also for 60 minutes. Both groups received these interventions twice a week for 3 months.

The overall mean age of the cohort was 31.0 years, and they were almost evenly divided by gender; 54 were men (47.8%), and 59 were women (52.2%).

As compared with the physical therapy group, individuals participating in therapeutic aquatic exercise group showed improvement in disability by an additional −1.77 points (95% confidence interval, −3.02 to −0.51) at the end of the 3-month intervention; at 6 months it was −2.42 points (95% CI, −4.13 to −0.70) and −3.61 points (95% CI, −5.63 to −1.58) at the 12-month follow-up (P < .001 for overall group x time interaction).

Functional improvement did not appear to be significantly affected by confounders that included age, sex, body mass index, low back pain duration, educational level, or pain level.

For secondary outcomes, those in the therapeutic aquatic exercise group demonstrated improvement in the most severe pain by an additional −0.79 points (95% CI, −1.31 to −0.27) after the 3-month intervention, −1.34 points (95% CI, −2.06 to −0.62) at 6 months, and −2.04 points (95% CI, −2.75 to −1.34) at the 12-month follow-up (P < .001 for overall group x time interaction), as compared with the physical therapy group. All pain scores differed significantly between the two groups at every time point.

In addition, individuals in the therapeutic aquatic exercise group showed more improvements on the 36-item Short-form Health Survey (overall group x time interaction, P = .003), Pittsburgh Sleep Quality Index (overall group x time interaction, P = .02), Tampa Scale for Kinesiophobia (overall group x time interaction, P < .001), and Fear-Avoidance Beliefs Questionnaire (physical activity subscale overall group x time interaction, P = .04), as compared with the physical therapy group. These improvements were also not influenced by confounders.

Finally, at the 12-month follow-up point, those in the aquatic therapy group had significantly greater improvements in the number of participants who met the minimal clinically important difference in pain (at least a 2-point improvement on the numeric rating scale).
 

More outside experts’ takes

“The current research evidence does suggest indeed that aquatic exercise therapy is suitable and often better than land exercise, passive relaxation, or other treatments for many people with low back pain,” commented Stelios Psycharakis PhD, senior lecturer in biomechanics, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh.

He also noted that since low back pain is an issue affecting about 80% of all people at some stage of their life, it is “improbable that one could identify a single type of treatment or exercise therapy that would be suitable for every person with this problem.”

Dr. Psycharakis pointed out that there are also some contraindications for aquatic therapy, such as incontinence and skin conditions. “Other than that though, clinicians should definitely consider aquatic exercise therapy when advising people with chronic low back pain,” he said.

Justin M. Lantz, DPT, agreed that the study showed therapeutic aquatic exercise appears to be safe and beneficial in some patients with chronic low back pain, but he also shared limitations of the new research.

“The study has notable limitations as it did not include patients above 65 years old, pain levels were generally low for the subjects involved, and it did not include a treatment group with land therapeutic exercise – so it is difficult to determine if the beneficial effects reported were due to active exercise or because the exercises were performed in water,” said Dr. Lantz, director of the spine physical therapy fellowship program at the University of Southern California, Los Angeles, and an assistant professor of clinical physical therapy.

He also pointed out that, since active exercise has been shown to be beneficial and is advocated in multiple clinical practice guidelines for chronic low back pain, “it would be helpful to determine if the true effects on pain and disability were due to the water environment or the effect of active exercise itself.”

“Due to the significant positive long-term effects and limited adverse events reported, I believe this study supports the use of therapeutic aquatic exercise in select patient populations with chronic low back pain and should be considered as a part of a rehabilitation treatment plan if accessibility is feasible,” Dr. Lantz said.

The authors of the paper, Dr. Girgis, and Dr. Psycharakis had no conflicts of interest. Justin Lantz is a physical therapy consultant to SI-Bone.

 

Patients with chronic low back pain who participated in therapeutic aquatic exercise had superior improvement in function, pain, quality of life, sleep quality, and mental state, compared with those who received physical therapy, in a new study.

“This is the first study to compare the efficacy of therapeutic aquatic exercise and physical therapy modalities in the treatment of chronic low back pain,” senior coauthors Pei-Jie Chen, PhD and Xue-Qiang Wang, PhD, both of the department of sport rehabilitation, Shanghai (China) University of Sport, wrote in JAMA Network Open. “Therapeutic aquatic exercise is a safe treatment for chronic low back pain and most participants who received it were willing to recommend it to other patients with chronic low back pain.”

As compared with individuals in the physical therapy modalities arm, the therapeutic aquatic exercise experienced greater relief of disability at all time points assessed: after the 3-month intervention, at the 6-month follow-up, and at the 12-month follow-up.

Commenting on the study, Linda Girgis, MD, FAAFP, a family physician in private practice in South River, N.J., agreed that aquatic therapy is a great tool for many chronic low back patients. “It helps them get active for one and do things that may exacerbate their symptoms doing the same exercises on land,” noted Dr. Girgis, who also is a clinical assistant professor at Robert Wood Johnson Medical School, New Brunswick.

She pointed out that access to a pool can be a problem. “But I have found a few physical therapy places in my area that do have access to a pool, and I refer appropriate patients there,” added Dr. Girgis, who was not involved with the study. “I have also found it works well for other types of pain, such as knee and hip pain. It is not for everyone but I have seen some patients get great benefit from it when they didn’t get any with traditional physical therapy.”
 

Aquatic therapy was more beneficial

Low back pain is a common condition, and clinical practice guidelines currently recommend therapeutic exercise and physical therapy modalities. Among the modalities that are available, therapeutic aquatic exercise is often prescribed for chronic low back pain, and it is becoming increasingly popular for treatment of chronic low back pain, the authors stated in their paper. The authors noted that water is an ideal environment for conducting an exercise program given its various properties, including buoyancy pressure, density, thermal capacity, and conductivity.

Two previously published systematic reviews have suggested that therapeutic aquatic exercise may be able to reduce the intensity of back pain and improve function in this population. But to date, evidence regarding long-term benefits in patients with chronic low back pain is very limited and there haven’t been any studies comparing the efficacy of therapeutic aquatic exercise and physical therapy modalities for chronic low back pain, according to the authors.

In this study, 113 individuals with chronic low back pain were randomized to either therapeutic aquatic exercise or to physical therapy, with an endpoint of efficacy regarding disability. This was measured using the Roland-Morris Disability Questionnaire.

Scores ranged from 0 to 24, with higher scores indicating more severe disability. Secondary endpoints included pain intensity, quality of life, sleep quality, and recommendation of intervention, and these were rated using various standardized tools.

Those randomized to the therapeutic aquatic exercise group had about an hour of therapy, beginning with a 10-minute active warm-up session to enhance neuromuscular activation, then an exercise session for 40 minutes followed by a 10-minute cooldown.

The physical therapy group received transcutaneous electrical nerve stimulation and infrared ray thermal therapy, also for 60 minutes. Both groups received these interventions twice a week for 3 months.

The overall mean age of the cohort was 31.0 years, and they were almost evenly divided by gender; 54 were men (47.8%), and 59 were women (52.2%).

As compared with the physical therapy group, individuals participating in therapeutic aquatic exercise group showed improvement in disability by an additional −1.77 points (95% confidence interval, −3.02 to −0.51) at the end of the 3-month intervention; at 6 months it was −2.42 points (95% CI, −4.13 to −0.70) and −3.61 points (95% CI, −5.63 to −1.58) at the 12-month follow-up (P < .001 for overall group x time interaction).

Functional improvement did not appear to be significantly affected by confounders that included age, sex, body mass index, low back pain duration, educational level, or pain level.

For secondary outcomes, those in the therapeutic aquatic exercise group demonstrated improvement in the most severe pain by an additional −0.79 points (95% CI, −1.31 to −0.27) after the 3-month intervention, −1.34 points (95% CI, −2.06 to −0.62) at 6 months, and −2.04 points (95% CI, −2.75 to −1.34) at the 12-month follow-up (P < .001 for overall group x time interaction), as compared with the physical therapy group. All pain scores differed significantly between the two groups at every time point.

In addition, individuals in the therapeutic aquatic exercise group showed more improvements on the 36-item Short-form Health Survey (overall group x time interaction, P = .003), Pittsburgh Sleep Quality Index (overall group x time interaction, P = .02), Tampa Scale for Kinesiophobia (overall group x time interaction, P < .001), and Fear-Avoidance Beliefs Questionnaire (physical activity subscale overall group x time interaction, P = .04), as compared with the physical therapy group. These improvements were also not influenced by confounders.

Finally, at the 12-month follow-up point, those in the aquatic therapy group had significantly greater improvements in the number of participants who met the minimal clinically important difference in pain (at least a 2-point improvement on the numeric rating scale).
 

More outside experts’ takes

“The current research evidence does suggest indeed that aquatic exercise therapy is suitable and often better than land exercise, passive relaxation, or other treatments for many people with low back pain,” commented Stelios Psycharakis PhD, senior lecturer in biomechanics, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh.

He also noted that since low back pain is an issue affecting about 80% of all people at some stage of their life, it is “improbable that one could identify a single type of treatment or exercise therapy that would be suitable for every person with this problem.”

Dr. Psycharakis pointed out that there are also some contraindications for aquatic therapy, such as incontinence and skin conditions. “Other than that though, clinicians should definitely consider aquatic exercise therapy when advising people with chronic low back pain,” he said.

Justin M. Lantz, DPT, agreed that the study showed therapeutic aquatic exercise appears to be safe and beneficial in some patients with chronic low back pain, but he also shared limitations of the new research.

“The study has notable limitations as it did not include patients above 65 years old, pain levels were generally low for the subjects involved, and it did not include a treatment group with land therapeutic exercise – so it is difficult to determine if the beneficial effects reported were due to active exercise or because the exercises were performed in water,” said Dr. Lantz, director of the spine physical therapy fellowship program at the University of Southern California, Los Angeles, and an assistant professor of clinical physical therapy.

He also pointed out that, since active exercise has been shown to be beneficial and is advocated in multiple clinical practice guidelines for chronic low back pain, “it would be helpful to determine if the true effects on pain and disability were due to the water environment or the effect of active exercise itself.”

“Due to the significant positive long-term effects and limited adverse events reported, I believe this study supports the use of therapeutic aquatic exercise in select patient populations with chronic low back pain and should be considered as a part of a rehabilitation treatment plan if accessibility is feasible,” Dr. Lantz said.

The authors of the paper, Dr. Girgis, and Dr. Psycharakis had no conflicts of interest. Justin Lantz is a physical therapy consultant to SI-Bone.

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A Simple Message

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I do not usually have difficulty writing editorials. However, this month was different. I kept coming up with grand ideas that flopped. First, I thought I would write a column entitled, “For What Should We Hope For?” When I started exploring the concept of hope, I quickly learned that there was extensive literature from multiple disciplines and even several centers and research projects dedicated to studying it.1 It seemed unlikely that I would have anything worthwhile to add to that literature. Then I thought I would discuss new year’s resolutions for federal practitioners. There was not much written about that topic, yet it seemed to be overly self-indulgent and superficial to discuss eating less and exercising more amid a pandemic and a climate change crisis. Finally, I wanted to opine on the futility of telling people to be resilient when we are all exhausted and demoralized, and yet that seemed too ponderous and paradoxical for our beleaguered state. With the third strike, I finally realized I was trying too hard. And perhaps that was exactly what I needed to say, at least to myself, and maybe some readers would benefit from reading that simple message as well.

I was surprised—though I probably should not have been given the explosion of media—to find that Americans were surveyed about what months they hate most. A 2021 poll of more than 15,000 adults found that January was the most disliked month.2 It’s not hard to figure out why. Characterized by a postholiday let down, these months in the middle of winter marked by either too much precipitation or if you live in the West not enough; short days and gray nights that are dark and cold. It is a long time to wait before spring with few holidays to break up the quotidian routine of work and school. January is a hard enough month in a good or even ordinary year. And 2022 is shaping up to be neither. We are entering the third year of a prolonged pandemic. Every time we have hope we are coming to the end of this long ordeal or at least things are moving toward normality, a new variant emerges, and we are back to living in fear and uncertainty.

COVID-19 is only the most relentless and deadly of our current disasters: There are rumors of wars, tornadoes, droughts, floods, shootings in schools and churches, political turmoil, and police violence. American society and the very planet seem to be in a perilous situation more than ever. No wonder then, that in the last month, several people have asked me, “Do you think this is the end of the world?” I suppose they think I am so old that I have become wise. And though I should cite a brilliant philosopher or renowned theologian: I am going to revert to my youth as a rock musician and quote R.E.M.: “It is the end of the world as we know it.” And “most of us do not feel fine!”

The world of 2022 is far more constricted and confined than it was before we heard the word COVID-19. We have less freedom of movement and fewer opportunities for companionship and gathering, for advancement and enjoyment. To thrive, and even to survive, in this cramped existence of limited possibilities, we need different values and attitudes than those that made us happy and successful in the open, hurried world before 2019. No generation since World War II has confronted such shortages of automobiles, paper goods, food, and even medicines as we have.

That is the first of the important simple messages I want to convey. Find something to be grateful for: your loved ones, your companion animals, your friends. Cherish the rainy or sunny day depending on how your climate has changed. Treasure the most basic and enduring pleasures, homemade cookies, favorite music, talking to a good friend even virtually, reading an actual book on a Sunday afternoon. These are things even the pandemic cannot take away from us unless we let our own inability to accept the conditions of our time ruin even what the meager, harsh Master of History has spared us.

The second of these simple messages is even more essential to finding any peace or joy in our current tense and somber existence: to show compassion for others and kindness to yourself. The most consistent report I have heard from people all over the country is that their fellow citizens are angry and selfish. We all understand, and even in some measure empathize with this the frustration and impatience with all the extraordinary pressure of having to function under these challenging conditions. Though we can take it out on the stranger at the grocery store or the family of the patient who has different views of masks and vaccines; it likely will not make the line shorter, the family any less demanding or seemingly unreasonable and probably will waste the little energy we have left to get home with the groceries or take care of the patient.

You never know what burden the person annoying you is carrying; it may perhaps be heavier than yours. And how we react to each other makes the weight of world weariness we all bear either easier or harder to shoulder. It sounds trite and trivial to say, yet tell people you care, and value, and love them. Although no less than Pope Francis in a Christmas present to marriages under strain from the stress of the pandemic that the 3 key words to remember are please, sorry, and thank you.3 I am applying that sage advice liberally to all relationships and interactions in the daily grind of work and home. The cost is little, the reward priceless.

It is good and right to have high hopes. We all need to take care of ourselves, whether we make resolutions to do so or not. Though more than anything else what we need is to be kind to ourselves. It is presumptuous of me to tell you what wellness means for your individual struggle, as it is inhuman of me to deign to tell you to be resilient when many of you face intolerable working conditions.4 As Jackson Browne sang in “Rock Me on the Water”, “Everyone must have some thought that’s going to pull them through somehow. Find your own thought, the reason you keep getting up and going to care for patients who increasingly respond with the rage of denial and resentment. Amid what morally distressed public health professionals have called so many unnecessary deaths,choose what gives you reason to keep serving that other side of this life full of healing.5 And if like so many of my fellow health care professionals, you are so spent and bent, that you feel that you can no longer practice without becoming someone you do not want to be, then let go with grace, get the help you deserve and perhaps one day when rested and mended, find another way to give.6

I rarely self-disclose but I want to end this column with a personal story that exemplifies more than all these words living this simple message. My spouse is a health care practitioner at a Veterans Affairs medical center. Like all of you on the front lines they work far too long hours in difficult conditions, with challenging patients and not enough staff to care for them. My partner had not an hour to get any gifts for me or our furry children. On Christmas Eve, before a long shift, they went to a packed Walgreens to buy our huskies each a toy and me a pair of fuzzy slippers. We sat by the tree and opened the hastily wrapped packages, and nothing could have been more memorable or meaningful. All of us at Federal Practitioner wish you, our readers, find in 2022 many such moments to sustain you.

References

1. The Center for the Advanced Study and Practice of Hope. T Denny Sanford School of Social and Family Dynamics, Arizona State University. Accessed January 3, 2022. https://thesanfordschool.asu.edu/research/centers-initiatives/hope-center

2. Ballard J. What is America’s favorite (and least favorite) month?” Published March 1, 2021. Accessed January 3, 2022. https://today.yougov.com/topics/lifestyle/articles-reports/2021/03/01/favorite-least-favorite-month-poll

3. Winlfield N. Pope’s 3 key words for a marriage: ‘please, thanks sorry.’ Associated Press. December 26, 2021. Accessed January 3, 2022. https://apnews.com/article/pope-francis-lifestyle-religion-relationships-couples-23c81169982e50c35d1c1fc7bfef8cbc

4. Dineen K. Why resilience isn’t always the answer to coping with challenging times. Published September 29, 2020. Accessed January 3, 2022. https://theconversation.com/why-resilience-isnt-always-the-answer-to-coping-with-challenging-times-145796

5. Caldwell T. ‘Everyone of those deaths is unnecessary,’ expert says of rising COVID-19 U.S. death toll as tens of millions remain unvaccinated. Published October 3, 2021. Accessed December 29, 2021. https://www.cnn.com/2021/10/03/health/us-coronavirus-sunday/index.html 6. Yong E. Why healthcare professionals are quitting in droves. The Atlantic. November 16, 2021. Accessed December 29, 2021. https://www.theatlantic.com/health/archive/2021/11/the-mass-exodus-of-americas-health-care-workers/620713/

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I do not usually have difficulty writing editorials. However, this month was different. I kept coming up with grand ideas that flopped. First, I thought I would write a column entitled, “For What Should We Hope For?” When I started exploring the concept of hope, I quickly learned that there was extensive literature from multiple disciplines and even several centers and research projects dedicated to studying it.1 It seemed unlikely that I would have anything worthwhile to add to that literature. Then I thought I would discuss new year’s resolutions for federal practitioners. There was not much written about that topic, yet it seemed to be overly self-indulgent and superficial to discuss eating less and exercising more amid a pandemic and a climate change crisis. Finally, I wanted to opine on the futility of telling people to be resilient when we are all exhausted and demoralized, and yet that seemed too ponderous and paradoxical for our beleaguered state. With the third strike, I finally realized I was trying too hard. And perhaps that was exactly what I needed to say, at least to myself, and maybe some readers would benefit from reading that simple message as well.

I was surprised—though I probably should not have been given the explosion of media—to find that Americans were surveyed about what months they hate most. A 2021 poll of more than 15,000 adults found that January was the most disliked month.2 It’s not hard to figure out why. Characterized by a postholiday let down, these months in the middle of winter marked by either too much precipitation or if you live in the West not enough; short days and gray nights that are dark and cold. It is a long time to wait before spring with few holidays to break up the quotidian routine of work and school. January is a hard enough month in a good or even ordinary year. And 2022 is shaping up to be neither. We are entering the third year of a prolonged pandemic. Every time we have hope we are coming to the end of this long ordeal or at least things are moving toward normality, a new variant emerges, and we are back to living in fear and uncertainty.

COVID-19 is only the most relentless and deadly of our current disasters: There are rumors of wars, tornadoes, droughts, floods, shootings in schools and churches, political turmoil, and police violence. American society and the very planet seem to be in a perilous situation more than ever. No wonder then, that in the last month, several people have asked me, “Do you think this is the end of the world?” I suppose they think I am so old that I have become wise. And though I should cite a brilliant philosopher or renowned theologian: I am going to revert to my youth as a rock musician and quote R.E.M.: “It is the end of the world as we know it.” And “most of us do not feel fine!”

The world of 2022 is far more constricted and confined than it was before we heard the word COVID-19. We have less freedom of movement and fewer opportunities for companionship and gathering, for advancement and enjoyment. To thrive, and even to survive, in this cramped existence of limited possibilities, we need different values and attitudes than those that made us happy and successful in the open, hurried world before 2019. No generation since World War II has confronted such shortages of automobiles, paper goods, food, and even medicines as we have.

That is the first of the important simple messages I want to convey. Find something to be grateful for: your loved ones, your companion animals, your friends. Cherish the rainy or sunny day depending on how your climate has changed. Treasure the most basic and enduring pleasures, homemade cookies, favorite music, talking to a good friend even virtually, reading an actual book on a Sunday afternoon. These are things even the pandemic cannot take away from us unless we let our own inability to accept the conditions of our time ruin even what the meager, harsh Master of History has spared us.

The second of these simple messages is even more essential to finding any peace or joy in our current tense and somber existence: to show compassion for others and kindness to yourself. The most consistent report I have heard from people all over the country is that their fellow citizens are angry and selfish. We all understand, and even in some measure empathize with this the frustration and impatience with all the extraordinary pressure of having to function under these challenging conditions. Though we can take it out on the stranger at the grocery store or the family of the patient who has different views of masks and vaccines; it likely will not make the line shorter, the family any less demanding or seemingly unreasonable and probably will waste the little energy we have left to get home with the groceries or take care of the patient.

You never know what burden the person annoying you is carrying; it may perhaps be heavier than yours. And how we react to each other makes the weight of world weariness we all bear either easier or harder to shoulder. It sounds trite and trivial to say, yet tell people you care, and value, and love them. Although no less than Pope Francis in a Christmas present to marriages under strain from the stress of the pandemic that the 3 key words to remember are please, sorry, and thank you.3 I am applying that sage advice liberally to all relationships and interactions in the daily grind of work and home. The cost is little, the reward priceless.

It is good and right to have high hopes. We all need to take care of ourselves, whether we make resolutions to do so or not. Though more than anything else what we need is to be kind to ourselves. It is presumptuous of me to tell you what wellness means for your individual struggle, as it is inhuman of me to deign to tell you to be resilient when many of you face intolerable working conditions.4 As Jackson Browne sang in “Rock Me on the Water”, “Everyone must have some thought that’s going to pull them through somehow. Find your own thought, the reason you keep getting up and going to care for patients who increasingly respond with the rage of denial and resentment. Amid what morally distressed public health professionals have called so many unnecessary deaths,choose what gives you reason to keep serving that other side of this life full of healing.5 And if like so many of my fellow health care professionals, you are so spent and bent, that you feel that you can no longer practice without becoming someone you do not want to be, then let go with grace, get the help you deserve and perhaps one day when rested and mended, find another way to give.6

I rarely self-disclose but I want to end this column with a personal story that exemplifies more than all these words living this simple message. My spouse is a health care practitioner at a Veterans Affairs medical center. Like all of you on the front lines they work far too long hours in difficult conditions, with challenging patients and not enough staff to care for them. My partner had not an hour to get any gifts for me or our furry children. On Christmas Eve, before a long shift, they went to a packed Walgreens to buy our huskies each a toy and me a pair of fuzzy slippers. We sat by the tree and opened the hastily wrapped packages, and nothing could have been more memorable or meaningful. All of us at Federal Practitioner wish you, our readers, find in 2022 many such moments to sustain you.

I do not usually have difficulty writing editorials. However, this month was different. I kept coming up with grand ideas that flopped. First, I thought I would write a column entitled, “For What Should We Hope For?” When I started exploring the concept of hope, I quickly learned that there was extensive literature from multiple disciplines and even several centers and research projects dedicated to studying it.1 It seemed unlikely that I would have anything worthwhile to add to that literature. Then I thought I would discuss new year’s resolutions for federal practitioners. There was not much written about that topic, yet it seemed to be overly self-indulgent and superficial to discuss eating less and exercising more amid a pandemic and a climate change crisis. Finally, I wanted to opine on the futility of telling people to be resilient when we are all exhausted and demoralized, and yet that seemed too ponderous and paradoxical for our beleaguered state. With the third strike, I finally realized I was trying too hard. And perhaps that was exactly what I needed to say, at least to myself, and maybe some readers would benefit from reading that simple message as well.

I was surprised—though I probably should not have been given the explosion of media—to find that Americans were surveyed about what months they hate most. A 2021 poll of more than 15,000 adults found that January was the most disliked month.2 It’s not hard to figure out why. Characterized by a postholiday let down, these months in the middle of winter marked by either too much precipitation or if you live in the West not enough; short days and gray nights that are dark and cold. It is a long time to wait before spring with few holidays to break up the quotidian routine of work and school. January is a hard enough month in a good or even ordinary year. And 2022 is shaping up to be neither. We are entering the third year of a prolonged pandemic. Every time we have hope we are coming to the end of this long ordeal or at least things are moving toward normality, a new variant emerges, and we are back to living in fear and uncertainty.

COVID-19 is only the most relentless and deadly of our current disasters: There are rumors of wars, tornadoes, droughts, floods, shootings in schools and churches, political turmoil, and police violence. American society and the very planet seem to be in a perilous situation more than ever. No wonder then, that in the last month, several people have asked me, “Do you think this is the end of the world?” I suppose they think I am so old that I have become wise. And though I should cite a brilliant philosopher or renowned theologian: I am going to revert to my youth as a rock musician and quote R.E.M.: “It is the end of the world as we know it.” And “most of us do not feel fine!”

The world of 2022 is far more constricted and confined than it was before we heard the word COVID-19. We have less freedom of movement and fewer opportunities for companionship and gathering, for advancement and enjoyment. To thrive, and even to survive, in this cramped existence of limited possibilities, we need different values and attitudes than those that made us happy and successful in the open, hurried world before 2019. No generation since World War II has confronted such shortages of automobiles, paper goods, food, and even medicines as we have.

That is the first of the important simple messages I want to convey. Find something to be grateful for: your loved ones, your companion animals, your friends. Cherish the rainy or sunny day depending on how your climate has changed. Treasure the most basic and enduring pleasures, homemade cookies, favorite music, talking to a good friend even virtually, reading an actual book on a Sunday afternoon. These are things even the pandemic cannot take away from us unless we let our own inability to accept the conditions of our time ruin even what the meager, harsh Master of History has spared us.

The second of these simple messages is even more essential to finding any peace or joy in our current tense and somber existence: to show compassion for others and kindness to yourself. The most consistent report I have heard from people all over the country is that their fellow citizens are angry and selfish. We all understand, and even in some measure empathize with this the frustration and impatience with all the extraordinary pressure of having to function under these challenging conditions. Though we can take it out on the stranger at the grocery store or the family of the patient who has different views of masks and vaccines; it likely will not make the line shorter, the family any less demanding or seemingly unreasonable and probably will waste the little energy we have left to get home with the groceries or take care of the patient.

You never know what burden the person annoying you is carrying; it may perhaps be heavier than yours. And how we react to each other makes the weight of world weariness we all bear either easier or harder to shoulder. It sounds trite and trivial to say, yet tell people you care, and value, and love them. Although no less than Pope Francis in a Christmas present to marriages under strain from the stress of the pandemic that the 3 key words to remember are please, sorry, and thank you.3 I am applying that sage advice liberally to all relationships and interactions in the daily grind of work and home. The cost is little, the reward priceless.

It is good and right to have high hopes. We all need to take care of ourselves, whether we make resolutions to do so or not. Though more than anything else what we need is to be kind to ourselves. It is presumptuous of me to tell you what wellness means for your individual struggle, as it is inhuman of me to deign to tell you to be resilient when many of you face intolerable working conditions.4 As Jackson Browne sang in “Rock Me on the Water”, “Everyone must have some thought that’s going to pull them through somehow. Find your own thought, the reason you keep getting up and going to care for patients who increasingly respond with the rage of denial and resentment. Amid what morally distressed public health professionals have called so many unnecessary deaths,choose what gives you reason to keep serving that other side of this life full of healing.5 And if like so many of my fellow health care professionals, you are so spent and bent, that you feel that you can no longer practice without becoming someone you do not want to be, then let go with grace, get the help you deserve and perhaps one day when rested and mended, find another way to give.6

I rarely self-disclose but I want to end this column with a personal story that exemplifies more than all these words living this simple message. My spouse is a health care practitioner at a Veterans Affairs medical center. Like all of you on the front lines they work far too long hours in difficult conditions, with challenging patients and not enough staff to care for them. My partner had not an hour to get any gifts for me or our furry children. On Christmas Eve, before a long shift, they went to a packed Walgreens to buy our huskies each a toy and me a pair of fuzzy slippers. We sat by the tree and opened the hastily wrapped packages, and nothing could have been more memorable or meaningful. All of us at Federal Practitioner wish you, our readers, find in 2022 many such moments to sustain you.

References

1. The Center for the Advanced Study and Practice of Hope. T Denny Sanford School of Social and Family Dynamics, Arizona State University. Accessed January 3, 2022. https://thesanfordschool.asu.edu/research/centers-initiatives/hope-center

2. Ballard J. What is America’s favorite (and least favorite) month?” Published March 1, 2021. Accessed January 3, 2022. https://today.yougov.com/topics/lifestyle/articles-reports/2021/03/01/favorite-least-favorite-month-poll

3. Winlfield N. Pope’s 3 key words for a marriage: ‘please, thanks sorry.’ Associated Press. December 26, 2021. Accessed January 3, 2022. https://apnews.com/article/pope-francis-lifestyle-religion-relationships-couples-23c81169982e50c35d1c1fc7bfef8cbc

4. Dineen K. Why resilience isn’t always the answer to coping with challenging times. Published September 29, 2020. Accessed January 3, 2022. https://theconversation.com/why-resilience-isnt-always-the-answer-to-coping-with-challenging-times-145796

5. Caldwell T. ‘Everyone of those deaths is unnecessary,’ expert says of rising COVID-19 U.S. death toll as tens of millions remain unvaccinated. Published October 3, 2021. Accessed December 29, 2021. https://www.cnn.com/2021/10/03/health/us-coronavirus-sunday/index.html 6. Yong E. Why healthcare professionals are quitting in droves. The Atlantic. November 16, 2021. Accessed December 29, 2021. https://www.theatlantic.com/health/archive/2021/11/the-mass-exodus-of-americas-health-care-workers/620713/

References

1. The Center for the Advanced Study and Practice of Hope. T Denny Sanford School of Social and Family Dynamics, Arizona State University. Accessed January 3, 2022. https://thesanfordschool.asu.edu/research/centers-initiatives/hope-center

2. Ballard J. What is America’s favorite (and least favorite) month?” Published March 1, 2021. Accessed January 3, 2022. https://today.yougov.com/topics/lifestyle/articles-reports/2021/03/01/favorite-least-favorite-month-poll

3. Winlfield N. Pope’s 3 key words for a marriage: ‘please, thanks sorry.’ Associated Press. December 26, 2021. Accessed January 3, 2022. https://apnews.com/article/pope-francis-lifestyle-religion-relationships-couples-23c81169982e50c35d1c1fc7bfef8cbc

4. Dineen K. Why resilience isn’t always the answer to coping with challenging times. Published September 29, 2020. Accessed January 3, 2022. https://theconversation.com/why-resilience-isnt-always-the-answer-to-coping-with-challenging-times-145796

5. Caldwell T. ‘Everyone of those deaths is unnecessary,’ expert says of rising COVID-19 U.S. death toll as tens of millions remain unvaccinated. Published October 3, 2021. Accessed December 29, 2021. https://www.cnn.com/2021/10/03/health/us-coronavirus-sunday/index.html 6. Yong E. Why healthcare professionals are quitting in droves. The Atlantic. November 16, 2021. Accessed December 29, 2021. https://www.theatlantic.com/health/archive/2021/11/the-mass-exodus-of-americas-health-care-workers/620713/

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Surgical groups push back against new revascularization guidelines

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Mon, 01/10/2022 - 10:29

 

The new 2021 coronary revascularization guidelines are spurring controversy, as surgical associations raise concerns about the interpretation of the evidence behind key recommendations and the makeup of the writing committee.

The guideline was published in December by the American College of Cardiology, American Heart Association, and Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI), and replaces the 2011 coronary artery bypass surgery (CABG) and the 2011 and 2015 percutaneous coronary intervention (PCI) guidelines.

Dr. Joseph Sabik III

The American Association for Thoracic Surgery (AATS) and Society of Thoracic Surgeons (STS) were part of the development of the document but have withdrawn their support, citing three areas of concern in a recent editorial in Annals of Thoracic Surgery.

“I do have to emphasize this is not just the AATS and STS – the European societies, Latin American societies, Asian societies, and even cardiologists are all coming out against these guidelines,” Joseph F. Sabik III, MD, University Hospitals Cleveland Medical Center, lead author of the editorial, said in an interview. “So, I think that tells us that something didn’t go right here.”

The main objection is the downgrading of CABG surgery from a class 1 to weak 2b recommendation to improve survival in patients with three-vessel coronary artery disease (CAD) and normal left ventricular function.

The ISCHEMIA trial was used to support this two-level downgrade and a class 1 to 2a downgrade for CABG in three-vessel CAD with mild to moderate left ventricular dysfunction. But the trial wasn’t powered for survival, only 20% of patients underwent CABG as the initial invasive strategy, and patients were followed for less than 5 years, the editorialists observed.

At the same time, there’s plenty of observational and randomized studies such as SYNTAX, EXCEL, and FAME 3 showing a clear survival benefit of CABG over PCI, Dr. Sabik said. “The criticism is that these are old studies and aren’t applicable today, but we don’t understand downgrading without any evidence suggesting it [CABG] isn’t effective anymore.”
 

CABG and PCI treated as equal

AATS and STS also object to the new guidelines treating PCI and CABG as equivalent revascularization strategies in decreasing ischemic events. Both were given a 2b recommendation for survival with triple-vessel disease, but randomized trials have demonstrated not only lower mortality with surgery but fewer reinterventions and myocardial infarctions.

“None of that gets acknowledged in the guidelines; they are treated equally,” Dr. Sabik said. “So if you’re going to say that CABG isn’t any better than medical therapy, in our mind, you have to say that PCI is worse than medical therapy. And we don’t believe that, I want you to know. We just think that the logic doesn’t make any sense. The committee used what it wanted to but didn’t use many things that committees have used in the past to give CABG a level 1 recommendation.”

The downgrade is also at odds with the 2018 European Society of Cardiology (ESC)/ European Association for Cardio-Thoracic Surgery (EACTS) guidelines, which give CABG a class 1 recommendation in three-vessel CAD as well as one- or two-vessel CAD with proximal left atrial descending artery stenosis.

In a Dec. 14 letter to the ACC/AHA Joint Committee, the Latin American Association of Cardiac and Endovascular Surgery (LACES) also called out the guideline committee for the 2b class of recommendation (COR) for PCI and CABG, saying it contradicts the text, which “clearly considers” the need to give a weaker endorsement for PCI than for CABG in patients with multivessel CAD.

“Considering that this section has the most significant impact due to the prevalence of stable ischemic heart disease in patients with multivessel CAD, such a contradiction may affect the lives and survival of millions of patients worldwide and have a major socioeconomic impact,” the letter states.

“Therefore, LACES respectfully but vehemently believes the Task Force should seriously reconsider the wording and recommendations in this specific large group of patients.”
 

 

 

Class I for radial conduit

AATS and STS also express concern about the new class 1 recommendation for the radial artery as a conduit in CABG. They note this is higher than bilateral internal mammary artery grafting and based on a meta-analysis of six relatively small studies with very strict inclusion criteria favorable for radial artery usage and patency.

“There’s a lot of studies that showed if you use the radial artery incorrectly, you have worse outcomes, and that’s what scares us a bit,” Dr. Sabik said. “If they’re giving it a class 1 recommendation, does that mean that becomes standard of care and could that cause patient harm? We think that level 1 is too high and that a [class] 2a with qualifications would be appropriate.”
 

Unequal footing

In a Dec. 23 letter, EACTS said it is “extremely concerned” about downgrading the COR for CABG without new randomized controlled trials to support the decision or to reject previously held evidence.

“The downgrading of CABG, and placing PCI at the same COR, does not meet our interpretation of the evidence, and may lead to avoidable loss of life,” EACTS officials said. “These guidelines also have implications on patient care: A COR IIb entails that CABG may not be reimbursable in some countries.”

EACTS called on AHA, ACC, and SCAI to review the evidence and called out the makeup of the guideline writing committee. “It is astonishing that no surgical association was involved, coauthored, or endorsed these guidelines.”

The AATS and STS each had a single representative on the guidelines’ writing committee but note that the six remaining surgeons were chosen by the ACC and AHA. Surgeons were also in the minority and only a majority was needed to approve the guidelines, highlighting the need to revisit the guideline development process to ensure equal representation by multidisciplinary experts across specialties.

“I hope the cardiology and surgical societies can come together and figure out how we do this better in the future, and we take a look again at these guidelines and come up with what we think is appropriate, especially since this is not just AATS and STS,” Dr. Sabik said.

In an emailed statement, the ACC/AHA said the AATS and STS representatives “actively participated throughout the writing process the past 3 years” and that the AATS and STS were involved in the “extensive peer review process” for the document with a reviewer from each organization. Nevertheless, AATS and STS both elected not to endorse the guidelines when at the organizational approval stage.

“Consequently, the AATS representative chose to stay with the committee and be recognized as having been appointed on behalf of the ACC and the AHA,” according to the statement. “The STS representative chose to withdraw from the committee and is not listed as a writing committee member on the final guideline. The final guideline reflects the latest evidence-based recommendations for coronary artery revascularization, as agreed by the ACC, AHA, SCAI, and the full writing committee.”

Despite pleas from the surgical groups to reconsider the evidence, “there is no further review process for the revascularization guideline,” the ACC/AHA spokesperson noted.

Jennifer S. Lawton, MD, chief of cardiac surgery at Johns Hopkins University, Baltimore, and guideline writing committee chair, did not respond to numerous requests for comment.

A version of this article first appeared on Medscape.com.

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The new 2021 coronary revascularization guidelines are spurring controversy, as surgical associations raise concerns about the interpretation of the evidence behind key recommendations and the makeup of the writing committee.

The guideline was published in December by the American College of Cardiology, American Heart Association, and Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI), and replaces the 2011 coronary artery bypass surgery (CABG) and the 2011 and 2015 percutaneous coronary intervention (PCI) guidelines.

Dr. Joseph Sabik III

The American Association for Thoracic Surgery (AATS) and Society of Thoracic Surgeons (STS) were part of the development of the document but have withdrawn their support, citing three areas of concern in a recent editorial in Annals of Thoracic Surgery.

“I do have to emphasize this is not just the AATS and STS – the European societies, Latin American societies, Asian societies, and even cardiologists are all coming out against these guidelines,” Joseph F. Sabik III, MD, University Hospitals Cleveland Medical Center, lead author of the editorial, said in an interview. “So, I think that tells us that something didn’t go right here.”

The main objection is the downgrading of CABG surgery from a class 1 to weak 2b recommendation to improve survival in patients with three-vessel coronary artery disease (CAD) and normal left ventricular function.

The ISCHEMIA trial was used to support this two-level downgrade and a class 1 to 2a downgrade for CABG in three-vessel CAD with mild to moderate left ventricular dysfunction. But the trial wasn’t powered for survival, only 20% of patients underwent CABG as the initial invasive strategy, and patients were followed for less than 5 years, the editorialists observed.

At the same time, there’s plenty of observational and randomized studies such as SYNTAX, EXCEL, and FAME 3 showing a clear survival benefit of CABG over PCI, Dr. Sabik said. “The criticism is that these are old studies and aren’t applicable today, but we don’t understand downgrading without any evidence suggesting it [CABG] isn’t effective anymore.”
 

CABG and PCI treated as equal

AATS and STS also object to the new guidelines treating PCI and CABG as equivalent revascularization strategies in decreasing ischemic events. Both were given a 2b recommendation for survival with triple-vessel disease, but randomized trials have demonstrated not only lower mortality with surgery but fewer reinterventions and myocardial infarctions.

“None of that gets acknowledged in the guidelines; they are treated equally,” Dr. Sabik said. “So if you’re going to say that CABG isn’t any better than medical therapy, in our mind, you have to say that PCI is worse than medical therapy. And we don’t believe that, I want you to know. We just think that the logic doesn’t make any sense. The committee used what it wanted to but didn’t use many things that committees have used in the past to give CABG a level 1 recommendation.”

The downgrade is also at odds with the 2018 European Society of Cardiology (ESC)/ European Association for Cardio-Thoracic Surgery (EACTS) guidelines, which give CABG a class 1 recommendation in three-vessel CAD as well as one- or two-vessel CAD with proximal left atrial descending artery stenosis.

In a Dec. 14 letter to the ACC/AHA Joint Committee, the Latin American Association of Cardiac and Endovascular Surgery (LACES) also called out the guideline committee for the 2b class of recommendation (COR) for PCI and CABG, saying it contradicts the text, which “clearly considers” the need to give a weaker endorsement for PCI than for CABG in patients with multivessel CAD.

“Considering that this section has the most significant impact due to the prevalence of stable ischemic heart disease in patients with multivessel CAD, such a contradiction may affect the lives and survival of millions of patients worldwide and have a major socioeconomic impact,” the letter states.

“Therefore, LACES respectfully but vehemently believes the Task Force should seriously reconsider the wording and recommendations in this specific large group of patients.”
 

 

 

Class I for radial conduit

AATS and STS also express concern about the new class 1 recommendation for the radial artery as a conduit in CABG. They note this is higher than bilateral internal mammary artery grafting and based on a meta-analysis of six relatively small studies with very strict inclusion criteria favorable for radial artery usage and patency.

“There’s a lot of studies that showed if you use the radial artery incorrectly, you have worse outcomes, and that’s what scares us a bit,” Dr. Sabik said. “If they’re giving it a class 1 recommendation, does that mean that becomes standard of care and could that cause patient harm? We think that level 1 is too high and that a [class] 2a with qualifications would be appropriate.”
 

Unequal footing

In a Dec. 23 letter, EACTS said it is “extremely concerned” about downgrading the COR for CABG without new randomized controlled trials to support the decision or to reject previously held evidence.

“The downgrading of CABG, and placing PCI at the same COR, does not meet our interpretation of the evidence, and may lead to avoidable loss of life,” EACTS officials said. “These guidelines also have implications on patient care: A COR IIb entails that CABG may not be reimbursable in some countries.”

EACTS called on AHA, ACC, and SCAI to review the evidence and called out the makeup of the guideline writing committee. “It is astonishing that no surgical association was involved, coauthored, or endorsed these guidelines.”

The AATS and STS each had a single representative on the guidelines’ writing committee but note that the six remaining surgeons were chosen by the ACC and AHA. Surgeons were also in the minority and only a majority was needed to approve the guidelines, highlighting the need to revisit the guideline development process to ensure equal representation by multidisciplinary experts across specialties.

“I hope the cardiology and surgical societies can come together and figure out how we do this better in the future, and we take a look again at these guidelines and come up with what we think is appropriate, especially since this is not just AATS and STS,” Dr. Sabik said.

In an emailed statement, the ACC/AHA said the AATS and STS representatives “actively participated throughout the writing process the past 3 years” and that the AATS and STS were involved in the “extensive peer review process” for the document with a reviewer from each organization. Nevertheless, AATS and STS both elected not to endorse the guidelines when at the organizational approval stage.

“Consequently, the AATS representative chose to stay with the committee and be recognized as having been appointed on behalf of the ACC and the AHA,” according to the statement. “The STS representative chose to withdraw from the committee and is not listed as a writing committee member on the final guideline. The final guideline reflects the latest evidence-based recommendations for coronary artery revascularization, as agreed by the ACC, AHA, SCAI, and the full writing committee.”

Despite pleas from the surgical groups to reconsider the evidence, “there is no further review process for the revascularization guideline,” the ACC/AHA spokesperson noted.

Jennifer S. Lawton, MD, chief of cardiac surgery at Johns Hopkins University, Baltimore, and guideline writing committee chair, did not respond to numerous requests for comment.

A version of this article first appeared on Medscape.com.

 

The new 2021 coronary revascularization guidelines are spurring controversy, as surgical associations raise concerns about the interpretation of the evidence behind key recommendations and the makeup of the writing committee.

The guideline was published in December by the American College of Cardiology, American Heart Association, and Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI), and replaces the 2011 coronary artery bypass surgery (CABG) and the 2011 and 2015 percutaneous coronary intervention (PCI) guidelines.

Dr. Joseph Sabik III

The American Association for Thoracic Surgery (AATS) and Society of Thoracic Surgeons (STS) were part of the development of the document but have withdrawn their support, citing three areas of concern in a recent editorial in Annals of Thoracic Surgery.

“I do have to emphasize this is not just the AATS and STS – the European societies, Latin American societies, Asian societies, and even cardiologists are all coming out against these guidelines,” Joseph F. Sabik III, MD, University Hospitals Cleveland Medical Center, lead author of the editorial, said in an interview. “So, I think that tells us that something didn’t go right here.”

The main objection is the downgrading of CABG surgery from a class 1 to weak 2b recommendation to improve survival in patients with three-vessel coronary artery disease (CAD) and normal left ventricular function.

The ISCHEMIA trial was used to support this two-level downgrade and a class 1 to 2a downgrade for CABG in three-vessel CAD with mild to moderate left ventricular dysfunction. But the trial wasn’t powered for survival, only 20% of patients underwent CABG as the initial invasive strategy, and patients were followed for less than 5 years, the editorialists observed.

At the same time, there’s plenty of observational and randomized studies such as SYNTAX, EXCEL, and FAME 3 showing a clear survival benefit of CABG over PCI, Dr. Sabik said. “The criticism is that these are old studies and aren’t applicable today, but we don’t understand downgrading without any evidence suggesting it [CABG] isn’t effective anymore.”
 

CABG and PCI treated as equal

AATS and STS also object to the new guidelines treating PCI and CABG as equivalent revascularization strategies in decreasing ischemic events. Both were given a 2b recommendation for survival with triple-vessel disease, but randomized trials have demonstrated not only lower mortality with surgery but fewer reinterventions and myocardial infarctions.

“None of that gets acknowledged in the guidelines; they are treated equally,” Dr. Sabik said. “So if you’re going to say that CABG isn’t any better than medical therapy, in our mind, you have to say that PCI is worse than medical therapy. And we don’t believe that, I want you to know. We just think that the logic doesn’t make any sense. The committee used what it wanted to but didn’t use many things that committees have used in the past to give CABG a level 1 recommendation.”

The downgrade is also at odds with the 2018 European Society of Cardiology (ESC)/ European Association for Cardio-Thoracic Surgery (EACTS) guidelines, which give CABG a class 1 recommendation in three-vessel CAD as well as one- or two-vessel CAD with proximal left atrial descending artery stenosis.

In a Dec. 14 letter to the ACC/AHA Joint Committee, the Latin American Association of Cardiac and Endovascular Surgery (LACES) also called out the guideline committee for the 2b class of recommendation (COR) for PCI and CABG, saying it contradicts the text, which “clearly considers” the need to give a weaker endorsement for PCI than for CABG in patients with multivessel CAD.

“Considering that this section has the most significant impact due to the prevalence of stable ischemic heart disease in patients with multivessel CAD, such a contradiction may affect the lives and survival of millions of patients worldwide and have a major socioeconomic impact,” the letter states.

“Therefore, LACES respectfully but vehemently believes the Task Force should seriously reconsider the wording and recommendations in this specific large group of patients.”
 

 

 

Class I for radial conduit

AATS and STS also express concern about the new class 1 recommendation for the radial artery as a conduit in CABG. They note this is higher than bilateral internal mammary artery grafting and based on a meta-analysis of six relatively small studies with very strict inclusion criteria favorable for radial artery usage and patency.

“There’s a lot of studies that showed if you use the radial artery incorrectly, you have worse outcomes, and that’s what scares us a bit,” Dr. Sabik said. “If they’re giving it a class 1 recommendation, does that mean that becomes standard of care and could that cause patient harm? We think that level 1 is too high and that a [class] 2a with qualifications would be appropriate.”
 

Unequal footing

In a Dec. 23 letter, EACTS said it is “extremely concerned” about downgrading the COR for CABG without new randomized controlled trials to support the decision or to reject previously held evidence.

“The downgrading of CABG, and placing PCI at the same COR, does not meet our interpretation of the evidence, and may lead to avoidable loss of life,” EACTS officials said. “These guidelines also have implications on patient care: A COR IIb entails that CABG may not be reimbursable in some countries.”

EACTS called on AHA, ACC, and SCAI to review the evidence and called out the makeup of the guideline writing committee. “It is astonishing that no surgical association was involved, coauthored, or endorsed these guidelines.”

The AATS and STS each had a single representative on the guidelines’ writing committee but note that the six remaining surgeons were chosen by the ACC and AHA. Surgeons were also in the minority and only a majority was needed to approve the guidelines, highlighting the need to revisit the guideline development process to ensure equal representation by multidisciplinary experts across specialties.

“I hope the cardiology and surgical societies can come together and figure out how we do this better in the future, and we take a look again at these guidelines and come up with what we think is appropriate, especially since this is not just AATS and STS,” Dr. Sabik said.

In an emailed statement, the ACC/AHA said the AATS and STS representatives “actively participated throughout the writing process the past 3 years” and that the AATS and STS were involved in the “extensive peer review process” for the document with a reviewer from each organization. Nevertheless, AATS and STS both elected not to endorse the guidelines when at the organizational approval stage.

“Consequently, the AATS representative chose to stay with the committee and be recognized as having been appointed on behalf of the ACC and the AHA,” according to the statement. “The STS representative chose to withdraw from the committee and is not listed as a writing committee member on the final guideline. The final guideline reflects the latest evidence-based recommendations for coronary artery revascularization, as agreed by the ACC, AHA, SCAI, and the full writing committee.”

Despite pleas from the surgical groups to reconsider the evidence, “there is no further review process for the revascularization guideline,” the ACC/AHA spokesperson noted.

Jennifer S. Lawton, MD, chief of cardiac surgery at Johns Hopkins University, Baltimore, and guideline writing committee chair, did not respond to numerous requests for comment.

A version of this article first appeared on Medscape.com.

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Midlife cardiovascular conditions tied to greater cognitive decline in women

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Fri, 01/07/2022 - 14:51

Even though men in midlife have more cardiovascular (CV) conditions and risk factors than women of the same age, women are more affected by these conditions in terms of cognitive decline, new research suggests.

Analyses of almost 1,400 participants in the population-based Mayo Clinic Study of Aging showed that diabetes, dyslipidemia, and coronary heart disease (CHD) all had stronger associations with global cognitive decline in women than in men.

“All men and women should be treated for cardiovascular risk factors and conditions, but this study really highlights the importance of very early and perhaps more aggressive treatment in women with these conditions,” co-investigator Michelle M. Mielke, PhD, professor of epidemiology and neurology, Mayo Clinic, Rochester, Minn., told this news organization.

The findings were published online Jan. 5 in Neurology.
 

Assessing sex differences

Most previous studies in this area have focused on CV risk factors in midlife in relation to late-life dementia (after age 75) or on late-life vascular risk factors and late-life dementia, Dr. Mielke noted.

However, a few recent studies have suggested vascular risk factors can affect cognition even in midlife. The current investigators sought to determine whether there are sex differences in these associations.

They assessed 1,857 nondemented participants aged 50 to 69 years from the Mayo Clinic Study on Aging. The mean education level was 14.9 years, and the mean body mass index (BMI) was 29.7.

Among the participants, 78.9% had at least one CV condition or risk factor, and the proportion was higher in men than women (83.4% vs. 74.5%; P < .0001).

Frequency of each individual CV condition or risk factor was also higher in men than women, and they had more years of education and higher BMI but took fewer medications.

Every 15 months, participants had an in-person interview and physical examination that included a neurologic assessment and short test of memory.

The neuropsychological battery included nine tests across four domains: memory, language, executive function, and visuospatial skills. Researchers calculated z-scores for these domains and for global cognition.
 

Multiple cognitive domains

Whereas this study evaluated multiple cognitive domains, most previous research has focused on global cognitive decline and/or decline in only one or two cognitive domains, the investigators note.

They collected information from medical records on CV conditions such as CHD, arrhythmias, congestive heart failure, peripheral vascular disease (PVD), and stroke; and CV risk factors such as hypertension, diabetes, dyslipidemia, smoking status, and BMI.

Because of the small number of patients with stroke and PVD, these were classified as “other cardiovascular conditions” in the statistical analysis.

Researchers adjusted for sex, age, years of education, depressive symptoms, comorbidities, medications, and apolipoprotein E (APOE) genotyping. The mean follow-up was 3 years and did not differ by sex.

As some participants didn’t have a follow-up visit, the current analysis included 1,394 individuals. Those without follow-up visits were younger, had less education and more comorbidities, and took more medications compared with those with a follow-up.

Results showed most CV conditions were more strongly associated with cognitive function among women than men. For example, CHD was associated with global decline only in women (P < .05).

CHD, diabetes, and dyslipidemia were associated with language decline in women only (all, P < .05), but congestive heart failure was significantly associated with language decline in men only.

Dr. Mielke cautioned about reading too much into the language results for women.

“It’s an intriguing finding and definitely we need to follow up on it,” she said. However, “more studies are needed to examine sex differences before we start saying it only has an effect on language.”
 

 

 

‘Treat aggressively and right away’

The researchers were somewhat surprised by the study findings. Because there is a higher prevalence of CV conditions and risk factors in men, they presumed men would be more affected by these conditions, said Dr. Mielke.

“But that’s not what we saw; we saw the reverse. It was actually the women who were affected more by these cardiovascular risk factors and conditions,” she said.

As midlife is when women enter menopause, fluctuating estrogen levels may help explain the differential impact on cognition among women. But Dr. Mielke said she wants to “move beyond” just looking at hormones.

She pointed out there are a variety of psychosocial factors that may also contribute to an imbalance in the cognitive impact of CV conditions on women.

“Midlife is when many women are still taking care of their children at home, are also taking care of their adult parents, and may be undergoing more stress while continuing to do a job,” Dr. Miekle said.

Structural brain development and genetics may also contribute to the greater effect on cognition in women, the investigators note.

Dr. Mielke stressed that the current study only identifies associations. “The next steps are to understand what some of the underlying mechanisms for this are,” she said.

In the meantime, these new results suggest middle-aged women with high blood pressure, cholesterol, or glucose measures “should be treated aggressively and right away” said Dr. Mielke.

“For example, for women who are just starting to become hypertensive, clinicians should treat them right away and not watch and wait.”

Study limitations cited include that its sample was limited to Olmsted County, Minnesota – so results may not be generalized to other populations. Also, as researchers combined PVD and stroke into one group, larger sample sizes are needed, especially for stroke. Another limitation was the study did not have information on duration of all CV conditions or risk factors.
 

Helpful for tailoring interventions?

Commenting on the study, Glen R. Finney, MD, director, Memory and Cognition Program, Geisinger Health Clinic, Wilkes-Barre, Pennsylvania, said the results are important.

“The more we understand about risk factors for the development of Alzheimer’s disease and related dementias, the better we understand how we can reduce the risks,” said Dr. Finney, who was not involved with the research.

Awareness that CV conditions are major risk factors in midlife has been “definitely rising,” said Dr. Finney. “Many studies originally were looking at late life and are now looking more at earlier in the disease process, and I think that’s important.”

Understanding how sex, ethnicity, and other demographic variables affect risks can help to “tailor interventions” for individual patients, he said.

The study was supported by the National Institutes of Health, the GHR Foundation, and the Rochester Epidemiology Project. Dr. Mielke is a consultant for Biogen and Brain Protection Company and is on the editorial boards of Neurology and Alzheimer’s and Dementia. Dr. Finney has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Even though men in midlife have more cardiovascular (CV) conditions and risk factors than women of the same age, women are more affected by these conditions in terms of cognitive decline, new research suggests.

Analyses of almost 1,400 participants in the population-based Mayo Clinic Study of Aging showed that diabetes, dyslipidemia, and coronary heart disease (CHD) all had stronger associations with global cognitive decline in women than in men.

“All men and women should be treated for cardiovascular risk factors and conditions, but this study really highlights the importance of very early and perhaps more aggressive treatment in women with these conditions,” co-investigator Michelle M. Mielke, PhD, professor of epidemiology and neurology, Mayo Clinic, Rochester, Minn., told this news organization.

The findings were published online Jan. 5 in Neurology.
 

Assessing sex differences

Most previous studies in this area have focused on CV risk factors in midlife in relation to late-life dementia (after age 75) or on late-life vascular risk factors and late-life dementia, Dr. Mielke noted.

However, a few recent studies have suggested vascular risk factors can affect cognition even in midlife. The current investigators sought to determine whether there are sex differences in these associations.

They assessed 1,857 nondemented participants aged 50 to 69 years from the Mayo Clinic Study on Aging. The mean education level was 14.9 years, and the mean body mass index (BMI) was 29.7.

Among the participants, 78.9% had at least one CV condition or risk factor, and the proportion was higher in men than women (83.4% vs. 74.5%; P < .0001).

Frequency of each individual CV condition or risk factor was also higher in men than women, and they had more years of education and higher BMI but took fewer medications.

Every 15 months, participants had an in-person interview and physical examination that included a neurologic assessment and short test of memory.

The neuropsychological battery included nine tests across four domains: memory, language, executive function, and visuospatial skills. Researchers calculated z-scores for these domains and for global cognition.
 

Multiple cognitive domains

Whereas this study evaluated multiple cognitive domains, most previous research has focused on global cognitive decline and/or decline in only one or two cognitive domains, the investigators note.

They collected information from medical records on CV conditions such as CHD, arrhythmias, congestive heart failure, peripheral vascular disease (PVD), and stroke; and CV risk factors such as hypertension, diabetes, dyslipidemia, smoking status, and BMI.

Because of the small number of patients with stroke and PVD, these were classified as “other cardiovascular conditions” in the statistical analysis.

Researchers adjusted for sex, age, years of education, depressive symptoms, comorbidities, medications, and apolipoprotein E (APOE) genotyping. The mean follow-up was 3 years and did not differ by sex.

As some participants didn’t have a follow-up visit, the current analysis included 1,394 individuals. Those without follow-up visits were younger, had less education and more comorbidities, and took more medications compared with those with a follow-up.

Results showed most CV conditions were more strongly associated with cognitive function among women than men. For example, CHD was associated with global decline only in women (P < .05).

CHD, diabetes, and dyslipidemia were associated with language decline in women only (all, P < .05), but congestive heart failure was significantly associated with language decline in men only.

Dr. Mielke cautioned about reading too much into the language results for women.

“It’s an intriguing finding and definitely we need to follow up on it,” she said. However, “more studies are needed to examine sex differences before we start saying it only has an effect on language.”
 

 

 

‘Treat aggressively and right away’

The researchers were somewhat surprised by the study findings. Because there is a higher prevalence of CV conditions and risk factors in men, they presumed men would be more affected by these conditions, said Dr. Mielke.

“But that’s not what we saw; we saw the reverse. It was actually the women who were affected more by these cardiovascular risk factors and conditions,” she said.

As midlife is when women enter menopause, fluctuating estrogen levels may help explain the differential impact on cognition among women. But Dr. Mielke said she wants to “move beyond” just looking at hormones.

She pointed out there are a variety of psychosocial factors that may also contribute to an imbalance in the cognitive impact of CV conditions on women.

“Midlife is when many women are still taking care of their children at home, are also taking care of their adult parents, and may be undergoing more stress while continuing to do a job,” Dr. Miekle said.

Structural brain development and genetics may also contribute to the greater effect on cognition in women, the investigators note.

Dr. Mielke stressed that the current study only identifies associations. “The next steps are to understand what some of the underlying mechanisms for this are,” she said.

In the meantime, these new results suggest middle-aged women with high blood pressure, cholesterol, or glucose measures “should be treated aggressively and right away” said Dr. Mielke.

“For example, for women who are just starting to become hypertensive, clinicians should treat them right away and not watch and wait.”

Study limitations cited include that its sample was limited to Olmsted County, Minnesota – so results may not be generalized to other populations. Also, as researchers combined PVD and stroke into one group, larger sample sizes are needed, especially for stroke. Another limitation was the study did not have information on duration of all CV conditions or risk factors.
 

Helpful for tailoring interventions?

Commenting on the study, Glen R. Finney, MD, director, Memory and Cognition Program, Geisinger Health Clinic, Wilkes-Barre, Pennsylvania, said the results are important.

“The more we understand about risk factors for the development of Alzheimer’s disease and related dementias, the better we understand how we can reduce the risks,” said Dr. Finney, who was not involved with the research.

Awareness that CV conditions are major risk factors in midlife has been “definitely rising,” said Dr. Finney. “Many studies originally were looking at late life and are now looking more at earlier in the disease process, and I think that’s important.”

Understanding how sex, ethnicity, and other demographic variables affect risks can help to “tailor interventions” for individual patients, he said.

The study was supported by the National Institutes of Health, the GHR Foundation, and the Rochester Epidemiology Project. Dr. Mielke is a consultant for Biogen and Brain Protection Company and is on the editorial boards of Neurology and Alzheimer’s and Dementia. Dr. Finney has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Even though men in midlife have more cardiovascular (CV) conditions and risk factors than women of the same age, women are more affected by these conditions in terms of cognitive decline, new research suggests.

Analyses of almost 1,400 participants in the population-based Mayo Clinic Study of Aging showed that diabetes, dyslipidemia, and coronary heart disease (CHD) all had stronger associations with global cognitive decline in women than in men.

“All men and women should be treated for cardiovascular risk factors and conditions, but this study really highlights the importance of very early and perhaps more aggressive treatment in women with these conditions,” co-investigator Michelle M. Mielke, PhD, professor of epidemiology and neurology, Mayo Clinic, Rochester, Minn., told this news organization.

The findings were published online Jan. 5 in Neurology.
 

Assessing sex differences

Most previous studies in this area have focused on CV risk factors in midlife in relation to late-life dementia (after age 75) or on late-life vascular risk factors and late-life dementia, Dr. Mielke noted.

However, a few recent studies have suggested vascular risk factors can affect cognition even in midlife. The current investigators sought to determine whether there are sex differences in these associations.

They assessed 1,857 nondemented participants aged 50 to 69 years from the Mayo Clinic Study on Aging. The mean education level was 14.9 years, and the mean body mass index (BMI) was 29.7.

Among the participants, 78.9% had at least one CV condition or risk factor, and the proportion was higher in men than women (83.4% vs. 74.5%; P < .0001).

Frequency of each individual CV condition or risk factor was also higher in men than women, and they had more years of education and higher BMI but took fewer medications.

Every 15 months, participants had an in-person interview and physical examination that included a neurologic assessment and short test of memory.

The neuropsychological battery included nine tests across four domains: memory, language, executive function, and visuospatial skills. Researchers calculated z-scores for these domains and for global cognition.
 

Multiple cognitive domains

Whereas this study evaluated multiple cognitive domains, most previous research has focused on global cognitive decline and/or decline in only one or two cognitive domains, the investigators note.

They collected information from medical records on CV conditions such as CHD, arrhythmias, congestive heart failure, peripheral vascular disease (PVD), and stroke; and CV risk factors such as hypertension, diabetes, dyslipidemia, smoking status, and BMI.

Because of the small number of patients with stroke and PVD, these were classified as “other cardiovascular conditions” in the statistical analysis.

Researchers adjusted for sex, age, years of education, depressive symptoms, comorbidities, medications, and apolipoprotein E (APOE) genotyping. The mean follow-up was 3 years and did not differ by sex.

As some participants didn’t have a follow-up visit, the current analysis included 1,394 individuals. Those without follow-up visits were younger, had less education and more comorbidities, and took more medications compared with those with a follow-up.

Results showed most CV conditions were more strongly associated with cognitive function among women than men. For example, CHD was associated with global decline only in women (P < .05).

CHD, diabetes, and dyslipidemia were associated with language decline in women only (all, P < .05), but congestive heart failure was significantly associated with language decline in men only.

Dr. Mielke cautioned about reading too much into the language results for women.

“It’s an intriguing finding and definitely we need to follow up on it,” she said. However, “more studies are needed to examine sex differences before we start saying it only has an effect on language.”
 

 

 

‘Treat aggressively and right away’

The researchers were somewhat surprised by the study findings. Because there is a higher prevalence of CV conditions and risk factors in men, they presumed men would be more affected by these conditions, said Dr. Mielke.

“But that’s not what we saw; we saw the reverse. It was actually the women who were affected more by these cardiovascular risk factors and conditions,” she said.

As midlife is when women enter menopause, fluctuating estrogen levels may help explain the differential impact on cognition among women. But Dr. Mielke said she wants to “move beyond” just looking at hormones.

She pointed out there are a variety of psychosocial factors that may also contribute to an imbalance in the cognitive impact of CV conditions on women.

“Midlife is when many women are still taking care of their children at home, are also taking care of their adult parents, and may be undergoing more stress while continuing to do a job,” Dr. Miekle said.

Structural brain development and genetics may also contribute to the greater effect on cognition in women, the investigators note.

Dr. Mielke stressed that the current study only identifies associations. “The next steps are to understand what some of the underlying mechanisms for this are,” she said.

In the meantime, these new results suggest middle-aged women with high blood pressure, cholesterol, or glucose measures “should be treated aggressively and right away” said Dr. Mielke.

“For example, for women who are just starting to become hypertensive, clinicians should treat them right away and not watch and wait.”

Study limitations cited include that its sample was limited to Olmsted County, Minnesota – so results may not be generalized to other populations. Also, as researchers combined PVD and stroke into one group, larger sample sizes are needed, especially for stroke. Another limitation was the study did not have information on duration of all CV conditions or risk factors.
 

Helpful for tailoring interventions?

Commenting on the study, Glen R. Finney, MD, director, Memory and Cognition Program, Geisinger Health Clinic, Wilkes-Barre, Pennsylvania, said the results are important.

“The more we understand about risk factors for the development of Alzheimer’s disease and related dementias, the better we understand how we can reduce the risks,” said Dr. Finney, who was not involved with the research.

Awareness that CV conditions are major risk factors in midlife has been “definitely rising,” said Dr. Finney. “Many studies originally were looking at late life and are now looking more at earlier in the disease process, and I think that’s important.”

Understanding how sex, ethnicity, and other demographic variables affect risks can help to “tailor interventions” for individual patients, he said.

The study was supported by the National Institutes of Health, the GHR Foundation, and the Rochester Epidemiology Project. Dr. Mielke is a consultant for Biogen and Brain Protection Company and is on the editorial boards of Neurology and Alzheimer’s and Dementia. Dr. Finney has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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