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Prior proton-pump inhibitor use ups migraine risk
Key clinical point: Prior use of proton pump inhibitors (PPI) increased the risk for incident migraine with or without aura irrespective of the history and duration of use.
Major finding: Compared with non-use, past and current use of PPI increased the odds of migraine by 2.56-fold (P < .001) and 4.66-fold (P < .001), respectively, with the risk being persistent for migraine with or without aura (P < .001) and higher with PPI use for ≥30 (adjusted odds ratio [aOR] 4.41; P < .001) vs <30 (aOR 2.49; P < .001) days.
Study details: This retrospective, nested case-control study included 28,159 patients with incident migraine with or without aura and 112,636 propensity score-matched control participants.
Disclosures: This study was funded by the National Research Foundation of Korea from the Korean Ministry of Science and ICT. The authors declared no conflicts of interest.
Source: Kang HS et al. Association between migraines and prior proton pump inhibitor use: A nested case-control study using a national health screening cohort. Pharmaceuticals (Basel). 2022;15(11):1385 (Nov 10). Doi: 10.3390/ph15111385
Key clinical point: Prior use of proton pump inhibitors (PPI) increased the risk for incident migraine with or without aura irrespective of the history and duration of use.
Major finding: Compared with non-use, past and current use of PPI increased the odds of migraine by 2.56-fold (P < .001) and 4.66-fold (P < .001), respectively, with the risk being persistent for migraine with or without aura (P < .001) and higher with PPI use for ≥30 (adjusted odds ratio [aOR] 4.41; P < .001) vs <30 (aOR 2.49; P < .001) days.
Study details: This retrospective, nested case-control study included 28,159 patients with incident migraine with or without aura and 112,636 propensity score-matched control participants.
Disclosures: This study was funded by the National Research Foundation of Korea from the Korean Ministry of Science and ICT. The authors declared no conflicts of interest.
Source: Kang HS et al. Association between migraines and prior proton pump inhibitor use: A nested case-control study using a national health screening cohort. Pharmaceuticals (Basel). 2022;15(11):1385 (Nov 10). Doi: 10.3390/ph15111385
Key clinical point: Prior use of proton pump inhibitors (PPI) increased the risk for incident migraine with or without aura irrespective of the history and duration of use.
Major finding: Compared with non-use, past and current use of PPI increased the odds of migraine by 2.56-fold (P < .001) and 4.66-fold (P < .001), respectively, with the risk being persistent for migraine with or without aura (P < .001) and higher with PPI use for ≥30 (adjusted odds ratio [aOR] 4.41; P < .001) vs <30 (aOR 2.49; P < .001) days.
Study details: This retrospective, nested case-control study included 28,159 patients with incident migraine with or without aura and 112,636 propensity score-matched control participants.
Disclosures: This study was funded by the National Research Foundation of Korea from the Korean Ministry of Science and ICT. The authors declared no conflicts of interest.
Source: Kang HS et al. Association between migraines and prior proton pump inhibitor use: A nested case-control study using a national health screening cohort. Pharmaceuticals (Basel). 2022;15(11):1385 (Nov 10). Doi: 10.3390/ph15111385
Alcohol as a trigger for migraine: What is the link?
Key clinical point: Alcohol intake slightly reduced the likelihood of migraine attacks 48 hours after consumption in an English-speaking cohort of patients with episodic migraine who identified themselves as mostly low-dose alcohol consumers.
Major finding: The probability of migraine attack 48 hours after consuming alcohol was 25% lower than that after no alcohol consumption (adjusted odds ratio 0.75; 95% CI 0.68-0.82); however, alcohol consumption had no significant effect on migraine probability 24 hours after consumption.
Study details: This observational prospective cohort study included 487 patients with episodic migraine who reported 5913 migraine attacks and were alcohol consumers.
Disclosures: The study was partially funded by Curelator, Inc. M Vives-Mestres and A Casanova declared receiving consulting fees and holding stock options in Curelator, Inc. N Rosen reported ties with a headache society, journals, and various other sources.
Source: Vives-Mestres M et al. Alcohol as a trigger of migraine attacks in people with migraine. Results from a large prospective cohort study in English-speaking countries. Headache. 2022;62:1329-1338. (Nov 27). Doi: 10.1111/head.14428
Key clinical point: Alcohol intake slightly reduced the likelihood of migraine attacks 48 hours after consumption in an English-speaking cohort of patients with episodic migraine who identified themselves as mostly low-dose alcohol consumers.
Major finding: The probability of migraine attack 48 hours after consuming alcohol was 25% lower than that after no alcohol consumption (adjusted odds ratio 0.75; 95% CI 0.68-0.82); however, alcohol consumption had no significant effect on migraine probability 24 hours after consumption.
Study details: This observational prospective cohort study included 487 patients with episodic migraine who reported 5913 migraine attacks and were alcohol consumers.
Disclosures: The study was partially funded by Curelator, Inc. M Vives-Mestres and A Casanova declared receiving consulting fees and holding stock options in Curelator, Inc. N Rosen reported ties with a headache society, journals, and various other sources.
Source: Vives-Mestres M et al. Alcohol as a trigger of migraine attacks in people with migraine. Results from a large prospective cohort study in English-speaking countries. Headache. 2022;62:1329-1338. (Nov 27). Doi: 10.1111/head.14428
Key clinical point: Alcohol intake slightly reduced the likelihood of migraine attacks 48 hours after consumption in an English-speaking cohort of patients with episodic migraine who identified themselves as mostly low-dose alcohol consumers.
Major finding: The probability of migraine attack 48 hours after consuming alcohol was 25% lower than that after no alcohol consumption (adjusted odds ratio 0.75; 95% CI 0.68-0.82); however, alcohol consumption had no significant effect on migraine probability 24 hours after consumption.
Study details: This observational prospective cohort study included 487 patients with episodic migraine who reported 5913 migraine attacks and were alcohol consumers.
Disclosures: The study was partially funded by Curelator, Inc. M Vives-Mestres and A Casanova declared receiving consulting fees and holding stock options in Curelator, Inc. N Rosen reported ties with a headache society, journals, and various other sources.
Source: Vives-Mestres M et al. Alcohol as a trigger of migraine attacks in people with migraine. Results from a large prospective cohort study in English-speaking countries. Headache. 2022;62:1329-1338. (Nov 27). Doi: 10.1111/head.14428
Evidence supporting atogepant as a promising treatment for migraine prevention
Key clinical point: Once-daily atogepant at doses of 30 and 60 mg significantly improved the performance of social, work-related, and daily activities compared with placebo in patients with episodic migraine.
Major finding: At week 12, atogepant (30 and 60 mg) vs placebo significantly improved Migraine-Specific Quality of Life Questionnaire version 2.1 Role Function-Restrictive (least-squares mean difference [LSMD] 10.08 and 10.8, respectively; both P < .0001). Atogepant at doses of 30 and 60 mg significantly improved monthly Activity Impairment in Migraine-Diary Performance of Daily Activities (P = .0003 and P < .0001, respectively) and Physical Impairment (P = .001 and P < .0001, respectively) scores across the 12-week treatment.
Study details: Findings are from the phase 3, ADVANCE trial including 873 patients with episodic migraine who were randomly assigned to receive once-daily atogepant (10, 30, or 60 mg) or placebo.
Disclosures: This study was sponsored by AbbVie/Allergan. Four authors declared being current or former employees of or holding stocks in AbbVie. The lead author and several other authors reported ties with various sources, including AbbVie.
Source: Lipton RB et al. Effect of atogepant for preventive migraine treatment on patient-reported outcomes in the randomized, double-blind, phase 3 ADVANCE trial. Neurology. 2022 (Nov 17). Doi: 10.1212/WNL.0000000000201568
Key clinical point: Once-daily atogepant at doses of 30 and 60 mg significantly improved the performance of social, work-related, and daily activities compared with placebo in patients with episodic migraine.
Major finding: At week 12, atogepant (30 and 60 mg) vs placebo significantly improved Migraine-Specific Quality of Life Questionnaire version 2.1 Role Function-Restrictive (least-squares mean difference [LSMD] 10.08 and 10.8, respectively; both P < .0001). Atogepant at doses of 30 and 60 mg significantly improved monthly Activity Impairment in Migraine-Diary Performance of Daily Activities (P = .0003 and P < .0001, respectively) and Physical Impairment (P = .001 and P < .0001, respectively) scores across the 12-week treatment.
Study details: Findings are from the phase 3, ADVANCE trial including 873 patients with episodic migraine who were randomly assigned to receive once-daily atogepant (10, 30, or 60 mg) or placebo.
Disclosures: This study was sponsored by AbbVie/Allergan. Four authors declared being current or former employees of or holding stocks in AbbVie. The lead author and several other authors reported ties with various sources, including AbbVie.
Source: Lipton RB et al. Effect of atogepant for preventive migraine treatment on patient-reported outcomes in the randomized, double-blind, phase 3 ADVANCE trial. Neurology. 2022 (Nov 17). Doi: 10.1212/WNL.0000000000201568
Key clinical point: Once-daily atogepant at doses of 30 and 60 mg significantly improved the performance of social, work-related, and daily activities compared with placebo in patients with episodic migraine.
Major finding: At week 12, atogepant (30 and 60 mg) vs placebo significantly improved Migraine-Specific Quality of Life Questionnaire version 2.1 Role Function-Restrictive (least-squares mean difference [LSMD] 10.08 and 10.8, respectively; both P < .0001). Atogepant at doses of 30 and 60 mg significantly improved monthly Activity Impairment in Migraine-Diary Performance of Daily Activities (P = .0003 and P < .0001, respectively) and Physical Impairment (P = .001 and P < .0001, respectively) scores across the 12-week treatment.
Study details: Findings are from the phase 3, ADVANCE trial including 873 patients with episodic migraine who were randomly assigned to receive once-daily atogepant (10, 30, or 60 mg) or placebo.
Disclosures: This study was sponsored by AbbVie/Allergan. Four authors declared being current or former employees of or holding stocks in AbbVie. The lead author and several other authors reported ties with various sources, including AbbVie.
Source: Lipton RB et al. Effect of atogepant for preventive migraine treatment on patient-reported outcomes in the randomized, double-blind, phase 3 ADVANCE trial. Neurology. 2022 (Nov 17). Doi: 10.1212/WNL.0000000000201568
A Transdisciplinary Program for Care of Veterans With Neurocognitive Disorders
Dementia is a devastating condition resulting in major functional, emotional, and financial impact on patients, their caregivers, and families. Approximately 6.5 million Americans are living with Alzheimer disease (AD), the most common of many causes of dementia.1 The prevalence of AD could increase to 12.7 million Americans by 2050 as the population ages.1 Studies suggest that dementia, also known as major neurocognitive disorder, is common and underdiagnosed among US veterans, a population with a mean age of 65 years.2 During cognitive screening, memory impairment is present in approximately 20% of veterans aged ≥ 75 years who have not been diagnosed with a neurocognitive disorder.3 In addition, veterans might be particularly vulnerable to dementia at an earlier age than the general population because of vascular risk factors and traumatic brain injuries.4 These concerns highlight the need for effective dementia care programs at US Department of Veterans Affairs (VA) facilities.
The US health care system often does not adequately address the needs of patients with dementia and their caregivers.5 Dementia care requires specialized medical care among collaborating professionals and caregiver and psychosocial interventions and services. However, the US health care system is fragmented with different clinicians and services siloed into separate practices and most dementia care occurring in primary care settings.6 Primary care professionals (PCPs) often are uncomfortable diagnosing and managing dementia because of time constraints, lack of expertise and training, and inability to deal with the range of care needs.7 PCPs do not identify approximately 42% of their patients with dementia and, when recognized, do not adhere to dementia care guidelines and address caregiver needs.8-10 Research indicates that caregiver support improves dementia care by teaching behavioral management skills and caregiver coping strategies, allowing patients to stay at home and delay institutionalization.6,11,12 Clinicians underuse available resources and do not incorporate them in their patient care.10 These community services benefit patients and caregivers and significantly improve the overall quality of care.6
Memory clinics have emerged to address these deficiencies when managing dementia.13 The most effective memory clinics maximize the use of specialists with different expertise in dementia care, particularly integrated programs where disciplines function together rather than independently.1,5,14 Systematic reviews and meta-analyses have documented the effectiveness of collaborative care management programs.11,12,15 Integration of dementia care management is associated with earlier diagnosis and interventions, decreased functional and cognitive symptom severity, decreased or delayed institutionalization, improved quality of life for patients and caregivers, enhanced overall quality of care and cost-effectiveness, and better integration of community services.11,12,14-19 In these programs, designating a dementia care manager (DCM) as the patient’s advocate facilitates the integrated structure, increases the quality of care, helps caregivers, facilitates adherence to dementia practice guidelines, and prevents behavioral and psychological symptoms of dementia (BPSD).1,6,11,12,20,21
The best interprofessional model for dementia care might be the transdisciplinary model that includes a DCM. To meet the specific demands of dementia care, there must be a high level of interprofessional collaboration rather than multiple health care professionals (HCPs) delivering care in isolation—an approach that is time consuming and often difficult to implement.22 Whereas multidisciplinary care refers to delivery of parallel services and interdisciplinary care implies a joint formulation, transdisciplinary care aims to maximize integration of HCPs and their specific expertise and contributions through interactions and discussions that deliver focused input to the lead physician. The transdisciplinary model addresses needs that often are missed and can minimize disparities in the quality of dementia care.23 A DCM is an integral part of our program, facilitating understanding and implementation of the final care plan and providing long-term follow-up and care. We outline a conference-centered transdisciplinary dementia care model with a social worker as DCM (SW-DCM) at our VA medical center.
Program Description
In 2020, the VA Greater Los Angeles Healthcare System (VAGLAHS) in California established a multispecialty clinic dedicated to evaluation and treatment of veterans with memory and neurocognitive disorders and to provide support for their caregivers and families. With the agreement of leadership in mental health, neurology, and geriatrics services on the importance of collaboration for dementia care, the psychiatry and neurology services created a joint Memory and Neurobehavior Clinic, which completed its first 2 years of operation as a full-day program. In recent months, the clinic has scheduled 24 veterans per day, approximately 50% new evaluations and 50% follow-up patients, with wait times of < 2 months. There is a mean of 12 intake or lead physicians who could attend sessions in the morning, afternoon, or both. The general clinic flow consists of a 2-hour intake evaluation of new referrals by the lead physician followed by a clinic conference with transdisciplinary discussion. The DCM then follows up with the veteran/caregiver presenting a final care plan individualized to the veterans, caregivers, and families.
The Memory and Neurobehavior team includes behavioral neurologists, geriatric psychiatrists, neuropsychologists, geriatric fellows, advanced clinical nurses, and social workers who function as the DCM (Table 1).
Procedures
Before the office visit, the coordinating geriatric psychiatrist triages veterans to neurology, psychiatry, or geriatric physicians based on the clinical presentation, history of neurologic signs or symptoms, BPSD or psychiatric history, functional decline, or comorbid medical illnesses. Although veterans often have overlapping concerns, the triage process aims to coordinate the intake evaluations with the most indicated and available specialist with the intention to notify the other specialists during the transdisciplinary conference.
Referrals to the program occur from many sources, notably from primary care (70.8%), mental health (16.7%), and specialty clinics (12.5%). The clinic also receives referrals from the affiliated Veterans Cognitive Assessment and Management Program, which provides dementia evaluation and support via telehealth screening. This VAGLAHS program services a diverse population of veterans: 87% male; 43% aged > 65 years (75% in our clinic); 51% non-Hispanic White; 19% non-Hispanic African American; 16% Hispanic; 4% Asian; and 1% Native American. This population receives care at regional VA medical centers and community-based outpatient clinics over a wide geographic service area.
The initial standardized assessments by intake or lead physicians includes mental status screening with the Montreal Cognitive Assessment (with certified clinicians), the Neurobehavioral Status Examination for a more detailed assessment of cognitive domains, the Columbia-Suicide Severity Rating Scale, the Patient Health Questionnaire for depression screening, and assessment for impairments in instrumental or basic activities of daily living. This initial evaluation aims to apply clinical guidelines and diagnostic criteria for the differential diagnosis of neurocognitive disorders, determine eligibility for cognitive-enhancing medications and techniques, assess for BPSD and the need for nonpharmacologic or pharmacologic interventions, determine functional status, and evaluate the need for supervision, safety concerns, and evidence of neglect or abuse.
As part of its mission, the clinic is charged with implementing the VA Dementia System of Care (DSOC). The stated goals of the DSOC are to provide individualized person-centered dementia care to help veterans experiencing dementia and their caregivers maintain a positive and optimal quality of life and create an environment where VA medical center staff understand the health care needs of veterans with dementia and their caregivers’ role. As part of this initiative, the clinic includes (1) coordination of care through a SW-DCM; (2)
Transdisciplinary Conference
Clinic conferences are held after the veterans are seen. Staff gather to discuss the patient and review management. All team members are present, as well as the head of the clinical clerical staff who can facilitate appointments, make lobby and wait times more bearable for our patients and caregivers, and help manage emergencies. Although this is an in-person conference, the COVID-19 pandemic has allowed us to include staff who screen at remote sites via videoconferencing, similar to other VA programs.24 The Memory and Neurobehavior Clinic has two ≤ 90-minute conferences daily. The lead physicians and their senior attendings present the new intake evaluations (4-6 at each conference session) with a preliminary formulation and questions for discussion. The moderator solicits contributions from the different disciplines, going from one to the next and recording their responses for each veteran. Further specialists are available for consultation through the conference mechanism if necessary. The final assessment is reviewed, a diagnosis is established, and a tailored, individualized care plan for adjusting or optimizing the veteran’s care is presented to the lead physician who makes the final determination. At the close of the conference, the team’s discussion is recorded along with the lead physician’s original detailed intake evaluation. Currently, the records go into the Computerized Patient Record System, but we are making plans to transition to Cerner as it is implemented.
During the discussion, team members review several areas of consideration. If there is neuroimaging, neurologists review the images projected on a large computer screen. Team members also will assess for the need to obtain biomarker studies, such as blood, cerebrospinal fluid, or positron emission tomography. Psychiatrists could review management of BPSD and use of psychotropic agents, and neuropsychologists might consider the need for more precise cognitive testing and whether a capacity assessment is indicated. Social work might bring up the need for a durable power of attorney as well as applicable caregiver and community resources. Geriatric medicine and nursing could provide input into medical management and care and the ability of veterans and caregivers to follow the prescribed regimen. Further areas of discussion include driving safety and restrictions on driving (as required in California) and the presence of guns in the home. Finally, brief education is provided in short 10-to-15-minute lectures covering pertinent topics so staff remain up-to-date in this changing field.
Postconference Continuity
After the conference, the SW-DCM continues to provide support throughout the disease course, helping veterans and their caregivers understand and follow through on the team’s recommendations. The SW-DCM, who is experienced and trained in case management, forms an ongoing relationship with the veterans and their caregivers and remains an advocate for their care. The SW-DCM communicates the final plan by phone and, when necessary, requests the lead physician to call to clarify any poorly understood or technical aspects of the care plan. About 50% of our veterans—primarily those who do not have a neurocognitive disorder or have mild cognitive impairment—return to their PCPs with our care plan consultation; about 25% are already enrolled in geriatric and other programs with long-term follow-up. The assigned SW-DCM follows up with the remaining veterans and caregivers regularly by phone, facilitates communication with other team members, and endeavors to assure postvisit continuity of care and support during advancing stages of the disease. In addition, the SW-DCM can provide supportive counseling and psychotherapy for stressed caregivers, refer to support groups and cognitive rehabilitation programs, and help develop long-term goals and consideration for supervised living environments. The nurse specialist participates with follow-up calls regarding medications and scheduled tests and appointments, clearing up confusion about instructions, avoiding medication errors, and providing education in dementia care. Both social worker and nurse are present throughout the week, reachable by phone, and, in turn, able to contact the clinic physicians for veterans’ needs.
Discussion
Because of the heterogenous medical and psychosocial needs of veterans with dementia and their caregivers, a transdisciplinary team with a dedicated DCM might offer the most effective and efficient model for dementia care. We present a transdisciplinary program that incorporates dementia specialists in a single evaluation by maximizing their time through a conference-centered program. Our program involves neurologists, psychiatrists, geriatricians, psychologists, nurses, and social workers collaborating and communicating to enact effective dementia care. It further meets the goals of the VA-DSOC in implementing individualized patient and caregiver care.
This transdisciplinary model addresses a number of issues, starting with the differential diagnosis of underlying neurologic conditions. Within the transdisciplinary team, the neurologist can provide specific insights into any neurologic findings and illnesses, such as Alzheimer disease and other neurodegenerative dementias, vascular dementia syndromes, normal pressure hydrocephalus, Creutzfeldt-Jakob disease, neurosyphilis, and others. Most veterans with dementia experience BPSD at some point during of their illness. The psychiatrists on the transdisciplinary team can maximize management of BPSD with nonpharmacologic interventions and the fewest and least aversive psychoactive medications. Our program also addresses the need for more precise cognitive evaluation. Neuropsychologists are present and available for administrating neuropsychologic tests and interpreting cognitive performance and any earlier neuropsychologic testing. This model also cares for the caregivers and assesses their needs. The social worker—as well as other members of the team—can provide caregivers with strategies for coping with disruptive and other behaviors related to dementia, counsel them on how to manage the veteran’s functional decline, and aid in establishing a safe living space. Because the social worker serves as a DCM, these coping and adjustment questions occupy significant clinical attention between appointments. This transdisciplinary model places the patient’s illness in the context of their functional status, diagnoses, and medications. The team geriatrician and the nurse specialist are indispensable resources. The clinic conference provides a teaching venue for staff and trainees and a mechanism to discuss new developments in dementia care, such as the increasing need to assess individuals with mild cognitive impairment.25 This model depends on the DCM’s invaluable role in ensuring implementation of the dementia care plan and continuity of care.
Conclusions
We describe effective dementia care with a transdisciplinary team in a conference setting and with the participation of a dedicated DCM.5 To date, this program appears to be an efficient, sustainable application of the limited resources allocated to dementia care. Nevertheless, we are collecting data to compare with performance measures, track use, and assess the programs effects on continuity of care. We look forward to presenting metrics from our program that show improvement in the health care for veterans experiencing a devastating and increasingly common disorder.
1. 2022 Alzheimer’s disease facts and figures. Alzheimers Dement. 2022;18(4):700-789. doi:10.1002/alz.12638
2. National Center for Veterans Analysis and Statistics. Profile of veterans: 2016. Accessed October 12, 2022. https://www.va.gov/vetdata/docs/SpecialReports/Profile_of_Veterans_2016.pdf
3. Chodosh J, Sultzer DL, Lee ML, et al. Memory impairment among primary care veterans. Aging Ment Health. 2007;11(4):444-450. doi:10.1080/13607860601086272
4. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. Brain Inj. 2022;36(5):620-627. doi:10.1080/02699052.2022.20338465. Heintz H, Monette P, Epstein-Lubow G, Smith L, Rowlett S, Forester BP. Emerging collaborative care models for dementia care in the primary care setting: a narrative review. Am J Geriatr Psychiatry. 2020;28(3):320-330. doi:10.1016/j.jagp.2019.07.015
6. Reuben DB, Evertson LC, Wenger NS, et al. The University of California at Los Angeles Alzheimer’s and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. J Am Geriatr Soc. 2013;61(12):2214-2218. doi:10.1111/jgs.12562
7. Apesoa-Varano EC, Barker JC, Hinton L. Curing and caring: the work of primary care physicians with dementia patients. Qual Health Res. 2011;21(11):1469-1483. doi:10.1177/1049732311412788
8. Creavin ST, Noel-Storr AH, Langdon RJ, et al. Clinical judgement by primary care physicians for the diagnosis of all-cause dementia or cognitive impairment in symptomatic people. Cochrane Database Syst Rev. 2022;6:CD012558. doi:10.1002/14651858.CD012558.pub2
9. Sivananthan SN, Puyat JH, McGrail KM. Variations in self-reported practice of physicians providing clinical care to individuals with dementia: a systematic review. J Am Geriatr Soc. 2013;61(8):1277-1285. doi:10.1111/jgs.12368
10. Rosen CS, Chow HC, Greenbaum MA, et al. How well are clinicians following dementia practice guidelines? Alzheimer Dis Assoc Disord. 2002;16(1):15-23. doi:10.1097/00002093-200201000-00003
11. Reilly S, Miranda-Castillo C, Malouf R, et al. Case management approaches to home support for people with dementia. Cochrane Database Syst Rev. 2015;1:CD008345. doi:10.1002/14651858.CD008345.pub2
12. Tam-Tham H, Cepoiu-Martin M, Ronksley PE, Maxwell CJ, Hemmelgarn BR. Dementia case management and risk of long-term care placement: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2013;28(9):889-902. doi:10.1002/gps.3906
13. Jolley D, Benbow SM, Grizzell M. Memory clinics. Postgrad Med J. 2006;82(965):199-206. doi:10.1136/pgmj.2005.040592
14. Muhlichen F, Michalowsky B, Radke A, et al. Tasks and activities of an effective collaborative dementia care management program in German primary care. J Alzheimers Dis. 2022;87(4):1615-1625. doi:10.3233/JAD-215656
15. Somme D, Trouve H, Drame M, Gagnon D, Couturier Y, Saint-Jean O. Analysis of case management programs for patients with dementia: a systematic review. Alzheimers Dement. 2012;8(5):426-436. doi:10.1016/j.jalz.2011.06.004
16. Ramakers IH, Verhey FR. Development of memory clinics in the Netherlands: 1998 to 2009. Aging Ment Health. 2011;15(1):34-39. doi:10.1080/13607863.2010.519321
17. LaMantia MA, Alder CA, Callahan CM, et al. The aging brain care medical home: preliminary data. J Am Geriatr Soc. 2015;63(6):1209-1213. doi:10.1111/jgs.13447
18. Rubinsztein JS, van Rensburg MJ, Al-Salihy Z, et al. A memory clinic v. traditional community mental health team service: comparison of costs and quality. BJPsych Bull. 2015;39(1):6-11. doi:10.1192/pb.bp.113.044263
19. Lee L, Hillier LM, Harvey D. Integrating community services into primary care: improving the quality of dementia care. Neurodegener Dis Manag. 2014;4(1):11-21. doi:10.2217/nmt.13.72
20. Bass DM, Judge KS, Snow AL, et al. Caregiver outcomes of partners in dementia care: effect of a care coordination program for veterans with dementia and their family members and friends. J Am Geriatr Soc. 2013;61(8):1377-1386. doi:10.1111/jgs.12362
21. Callahan CM, Boustani MA, Unverzagt FW, et al. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006;295(18):2148-2157. doi:10.1001/jama.295.18.2148
22. Leggett A, Connell C, Dubin L, et al. Dementia care across a tertiary care health system: what exists now and what needs to change. J Am Med Dir Assoc. 2019;20(10):1307-12 e1. doi:10.1016/j.jamda.2019.04.006
23. Brown AF, Vassar SD, Connor KI, Vickrey BG. Collaborative care management reduces disparities in dementia care quality for caregivers with less education. J Am Geriatr Soc. 2013;61(2):243-251. doi:10.1111/jgs.12079
24. Powers BB, Homer MC, Morone N, Edmonds N, Rossi MI. Creation of an interprofessional teledementia clinic for rural veterans: preliminary data. J Am Geriatr Soc. 2017;65(5):1092-1099. doi:10.1111/jgs.14839
25. Galvin JE, Aisen P, Langbaum JB, et al. Early stages of Alzheimer’s Disease: evolving the care team for optimal patient management. Front Neurol. 2020;11:592302. doi:10.3389/fneur.2020.592302
Dementia is a devastating condition resulting in major functional, emotional, and financial impact on patients, their caregivers, and families. Approximately 6.5 million Americans are living with Alzheimer disease (AD), the most common of many causes of dementia.1 The prevalence of AD could increase to 12.7 million Americans by 2050 as the population ages.1 Studies suggest that dementia, also known as major neurocognitive disorder, is common and underdiagnosed among US veterans, a population with a mean age of 65 years.2 During cognitive screening, memory impairment is present in approximately 20% of veterans aged ≥ 75 years who have not been diagnosed with a neurocognitive disorder.3 In addition, veterans might be particularly vulnerable to dementia at an earlier age than the general population because of vascular risk factors and traumatic brain injuries.4 These concerns highlight the need for effective dementia care programs at US Department of Veterans Affairs (VA) facilities.
The US health care system often does not adequately address the needs of patients with dementia and their caregivers.5 Dementia care requires specialized medical care among collaborating professionals and caregiver and psychosocial interventions and services. However, the US health care system is fragmented with different clinicians and services siloed into separate practices and most dementia care occurring in primary care settings.6 Primary care professionals (PCPs) often are uncomfortable diagnosing and managing dementia because of time constraints, lack of expertise and training, and inability to deal with the range of care needs.7 PCPs do not identify approximately 42% of their patients with dementia and, when recognized, do not adhere to dementia care guidelines and address caregiver needs.8-10 Research indicates that caregiver support improves dementia care by teaching behavioral management skills and caregiver coping strategies, allowing patients to stay at home and delay institutionalization.6,11,12 Clinicians underuse available resources and do not incorporate them in their patient care.10 These community services benefit patients and caregivers and significantly improve the overall quality of care.6
Memory clinics have emerged to address these deficiencies when managing dementia.13 The most effective memory clinics maximize the use of specialists with different expertise in dementia care, particularly integrated programs where disciplines function together rather than independently.1,5,14 Systematic reviews and meta-analyses have documented the effectiveness of collaborative care management programs.11,12,15 Integration of dementia care management is associated with earlier diagnosis and interventions, decreased functional and cognitive symptom severity, decreased or delayed institutionalization, improved quality of life for patients and caregivers, enhanced overall quality of care and cost-effectiveness, and better integration of community services.11,12,14-19 In these programs, designating a dementia care manager (DCM) as the patient’s advocate facilitates the integrated structure, increases the quality of care, helps caregivers, facilitates adherence to dementia practice guidelines, and prevents behavioral and psychological symptoms of dementia (BPSD).1,6,11,12,20,21
The best interprofessional model for dementia care might be the transdisciplinary model that includes a DCM. To meet the specific demands of dementia care, there must be a high level of interprofessional collaboration rather than multiple health care professionals (HCPs) delivering care in isolation—an approach that is time consuming and often difficult to implement.22 Whereas multidisciplinary care refers to delivery of parallel services and interdisciplinary care implies a joint formulation, transdisciplinary care aims to maximize integration of HCPs and their specific expertise and contributions through interactions and discussions that deliver focused input to the lead physician. The transdisciplinary model addresses needs that often are missed and can minimize disparities in the quality of dementia care.23 A DCM is an integral part of our program, facilitating understanding and implementation of the final care plan and providing long-term follow-up and care. We outline a conference-centered transdisciplinary dementia care model with a social worker as DCM (SW-DCM) at our VA medical center.
Program Description
In 2020, the VA Greater Los Angeles Healthcare System (VAGLAHS) in California established a multispecialty clinic dedicated to evaluation and treatment of veterans with memory and neurocognitive disorders and to provide support for their caregivers and families. With the agreement of leadership in mental health, neurology, and geriatrics services on the importance of collaboration for dementia care, the psychiatry and neurology services created a joint Memory and Neurobehavior Clinic, which completed its first 2 years of operation as a full-day program. In recent months, the clinic has scheduled 24 veterans per day, approximately 50% new evaluations and 50% follow-up patients, with wait times of < 2 months. There is a mean of 12 intake or lead physicians who could attend sessions in the morning, afternoon, or both. The general clinic flow consists of a 2-hour intake evaluation of new referrals by the lead physician followed by a clinic conference with transdisciplinary discussion. The DCM then follows up with the veteran/caregiver presenting a final care plan individualized to the veterans, caregivers, and families.
The Memory and Neurobehavior team includes behavioral neurologists, geriatric psychiatrists, neuropsychologists, geriatric fellows, advanced clinical nurses, and social workers who function as the DCM (Table 1).
Procedures
Before the office visit, the coordinating geriatric psychiatrist triages veterans to neurology, psychiatry, or geriatric physicians based on the clinical presentation, history of neurologic signs or symptoms, BPSD or psychiatric history, functional decline, or comorbid medical illnesses. Although veterans often have overlapping concerns, the triage process aims to coordinate the intake evaluations with the most indicated and available specialist with the intention to notify the other specialists during the transdisciplinary conference.
Referrals to the program occur from many sources, notably from primary care (70.8%), mental health (16.7%), and specialty clinics (12.5%). The clinic also receives referrals from the affiliated Veterans Cognitive Assessment and Management Program, which provides dementia evaluation and support via telehealth screening. This VAGLAHS program services a diverse population of veterans: 87% male; 43% aged > 65 years (75% in our clinic); 51% non-Hispanic White; 19% non-Hispanic African American; 16% Hispanic; 4% Asian; and 1% Native American. This population receives care at regional VA medical centers and community-based outpatient clinics over a wide geographic service area.
The initial standardized assessments by intake or lead physicians includes mental status screening with the Montreal Cognitive Assessment (with certified clinicians), the Neurobehavioral Status Examination for a more detailed assessment of cognitive domains, the Columbia-Suicide Severity Rating Scale, the Patient Health Questionnaire for depression screening, and assessment for impairments in instrumental or basic activities of daily living. This initial evaluation aims to apply clinical guidelines and diagnostic criteria for the differential diagnosis of neurocognitive disorders, determine eligibility for cognitive-enhancing medications and techniques, assess for BPSD and the need for nonpharmacologic or pharmacologic interventions, determine functional status, and evaluate the need for supervision, safety concerns, and evidence of neglect or abuse.
As part of its mission, the clinic is charged with implementing the VA Dementia System of Care (DSOC). The stated goals of the DSOC are to provide individualized person-centered dementia care to help veterans experiencing dementia and their caregivers maintain a positive and optimal quality of life and create an environment where VA medical center staff understand the health care needs of veterans with dementia and their caregivers’ role. As part of this initiative, the clinic includes (1) coordination of care through a SW-DCM; (2)
Transdisciplinary Conference
Clinic conferences are held after the veterans are seen. Staff gather to discuss the patient and review management. All team members are present, as well as the head of the clinical clerical staff who can facilitate appointments, make lobby and wait times more bearable for our patients and caregivers, and help manage emergencies. Although this is an in-person conference, the COVID-19 pandemic has allowed us to include staff who screen at remote sites via videoconferencing, similar to other VA programs.24 The Memory and Neurobehavior Clinic has two ≤ 90-minute conferences daily. The lead physicians and their senior attendings present the new intake evaluations (4-6 at each conference session) with a preliminary formulation and questions for discussion. The moderator solicits contributions from the different disciplines, going from one to the next and recording their responses for each veteran. Further specialists are available for consultation through the conference mechanism if necessary. The final assessment is reviewed, a diagnosis is established, and a tailored, individualized care plan for adjusting or optimizing the veteran’s care is presented to the lead physician who makes the final determination. At the close of the conference, the team’s discussion is recorded along with the lead physician’s original detailed intake evaluation. Currently, the records go into the Computerized Patient Record System, but we are making plans to transition to Cerner as it is implemented.
During the discussion, team members review several areas of consideration. If there is neuroimaging, neurologists review the images projected on a large computer screen. Team members also will assess for the need to obtain biomarker studies, such as blood, cerebrospinal fluid, or positron emission tomography. Psychiatrists could review management of BPSD and use of psychotropic agents, and neuropsychologists might consider the need for more precise cognitive testing and whether a capacity assessment is indicated. Social work might bring up the need for a durable power of attorney as well as applicable caregiver and community resources. Geriatric medicine and nursing could provide input into medical management and care and the ability of veterans and caregivers to follow the prescribed regimen. Further areas of discussion include driving safety and restrictions on driving (as required in California) and the presence of guns in the home. Finally, brief education is provided in short 10-to-15-minute lectures covering pertinent topics so staff remain up-to-date in this changing field.
Postconference Continuity
After the conference, the SW-DCM continues to provide support throughout the disease course, helping veterans and their caregivers understand and follow through on the team’s recommendations. The SW-DCM, who is experienced and trained in case management, forms an ongoing relationship with the veterans and their caregivers and remains an advocate for their care. The SW-DCM communicates the final plan by phone and, when necessary, requests the lead physician to call to clarify any poorly understood or technical aspects of the care plan. About 50% of our veterans—primarily those who do not have a neurocognitive disorder or have mild cognitive impairment—return to their PCPs with our care plan consultation; about 25% are already enrolled in geriatric and other programs with long-term follow-up. The assigned SW-DCM follows up with the remaining veterans and caregivers regularly by phone, facilitates communication with other team members, and endeavors to assure postvisit continuity of care and support during advancing stages of the disease. In addition, the SW-DCM can provide supportive counseling and psychotherapy for stressed caregivers, refer to support groups and cognitive rehabilitation programs, and help develop long-term goals and consideration for supervised living environments. The nurse specialist participates with follow-up calls regarding medications and scheduled tests and appointments, clearing up confusion about instructions, avoiding medication errors, and providing education in dementia care. Both social worker and nurse are present throughout the week, reachable by phone, and, in turn, able to contact the clinic physicians for veterans’ needs.
Discussion
Because of the heterogenous medical and psychosocial needs of veterans with dementia and their caregivers, a transdisciplinary team with a dedicated DCM might offer the most effective and efficient model for dementia care. We present a transdisciplinary program that incorporates dementia specialists in a single evaluation by maximizing their time through a conference-centered program. Our program involves neurologists, psychiatrists, geriatricians, psychologists, nurses, and social workers collaborating and communicating to enact effective dementia care. It further meets the goals of the VA-DSOC in implementing individualized patient and caregiver care.
This transdisciplinary model addresses a number of issues, starting with the differential diagnosis of underlying neurologic conditions. Within the transdisciplinary team, the neurologist can provide specific insights into any neurologic findings and illnesses, such as Alzheimer disease and other neurodegenerative dementias, vascular dementia syndromes, normal pressure hydrocephalus, Creutzfeldt-Jakob disease, neurosyphilis, and others. Most veterans with dementia experience BPSD at some point during of their illness. The psychiatrists on the transdisciplinary team can maximize management of BPSD with nonpharmacologic interventions and the fewest and least aversive psychoactive medications. Our program also addresses the need for more precise cognitive evaluation. Neuropsychologists are present and available for administrating neuropsychologic tests and interpreting cognitive performance and any earlier neuropsychologic testing. This model also cares for the caregivers and assesses their needs. The social worker—as well as other members of the team—can provide caregivers with strategies for coping with disruptive and other behaviors related to dementia, counsel them on how to manage the veteran’s functional decline, and aid in establishing a safe living space. Because the social worker serves as a DCM, these coping and adjustment questions occupy significant clinical attention between appointments. This transdisciplinary model places the patient’s illness in the context of their functional status, diagnoses, and medications. The team geriatrician and the nurse specialist are indispensable resources. The clinic conference provides a teaching venue for staff and trainees and a mechanism to discuss new developments in dementia care, such as the increasing need to assess individuals with mild cognitive impairment.25 This model depends on the DCM’s invaluable role in ensuring implementation of the dementia care plan and continuity of care.
Conclusions
We describe effective dementia care with a transdisciplinary team in a conference setting and with the participation of a dedicated DCM.5 To date, this program appears to be an efficient, sustainable application of the limited resources allocated to dementia care. Nevertheless, we are collecting data to compare with performance measures, track use, and assess the programs effects on continuity of care. We look forward to presenting metrics from our program that show improvement in the health care for veterans experiencing a devastating and increasingly common disorder.
Dementia is a devastating condition resulting in major functional, emotional, and financial impact on patients, their caregivers, and families. Approximately 6.5 million Americans are living with Alzheimer disease (AD), the most common of many causes of dementia.1 The prevalence of AD could increase to 12.7 million Americans by 2050 as the population ages.1 Studies suggest that dementia, also known as major neurocognitive disorder, is common and underdiagnosed among US veterans, a population with a mean age of 65 years.2 During cognitive screening, memory impairment is present in approximately 20% of veterans aged ≥ 75 years who have not been diagnosed with a neurocognitive disorder.3 In addition, veterans might be particularly vulnerable to dementia at an earlier age than the general population because of vascular risk factors and traumatic brain injuries.4 These concerns highlight the need for effective dementia care programs at US Department of Veterans Affairs (VA) facilities.
The US health care system often does not adequately address the needs of patients with dementia and their caregivers.5 Dementia care requires specialized medical care among collaborating professionals and caregiver and psychosocial interventions and services. However, the US health care system is fragmented with different clinicians and services siloed into separate practices and most dementia care occurring in primary care settings.6 Primary care professionals (PCPs) often are uncomfortable diagnosing and managing dementia because of time constraints, lack of expertise and training, and inability to deal with the range of care needs.7 PCPs do not identify approximately 42% of their patients with dementia and, when recognized, do not adhere to dementia care guidelines and address caregiver needs.8-10 Research indicates that caregiver support improves dementia care by teaching behavioral management skills and caregiver coping strategies, allowing patients to stay at home and delay institutionalization.6,11,12 Clinicians underuse available resources and do not incorporate them in their patient care.10 These community services benefit patients and caregivers and significantly improve the overall quality of care.6
Memory clinics have emerged to address these deficiencies when managing dementia.13 The most effective memory clinics maximize the use of specialists with different expertise in dementia care, particularly integrated programs where disciplines function together rather than independently.1,5,14 Systematic reviews and meta-analyses have documented the effectiveness of collaborative care management programs.11,12,15 Integration of dementia care management is associated with earlier diagnosis and interventions, decreased functional and cognitive symptom severity, decreased or delayed institutionalization, improved quality of life for patients and caregivers, enhanced overall quality of care and cost-effectiveness, and better integration of community services.11,12,14-19 In these programs, designating a dementia care manager (DCM) as the patient’s advocate facilitates the integrated structure, increases the quality of care, helps caregivers, facilitates adherence to dementia practice guidelines, and prevents behavioral and psychological symptoms of dementia (BPSD).1,6,11,12,20,21
The best interprofessional model for dementia care might be the transdisciplinary model that includes a DCM. To meet the specific demands of dementia care, there must be a high level of interprofessional collaboration rather than multiple health care professionals (HCPs) delivering care in isolation—an approach that is time consuming and often difficult to implement.22 Whereas multidisciplinary care refers to delivery of parallel services and interdisciplinary care implies a joint formulation, transdisciplinary care aims to maximize integration of HCPs and their specific expertise and contributions through interactions and discussions that deliver focused input to the lead physician. The transdisciplinary model addresses needs that often are missed and can minimize disparities in the quality of dementia care.23 A DCM is an integral part of our program, facilitating understanding and implementation of the final care plan and providing long-term follow-up and care. We outline a conference-centered transdisciplinary dementia care model with a social worker as DCM (SW-DCM) at our VA medical center.
Program Description
In 2020, the VA Greater Los Angeles Healthcare System (VAGLAHS) in California established a multispecialty clinic dedicated to evaluation and treatment of veterans with memory and neurocognitive disorders and to provide support for their caregivers and families. With the agreement of leadership in mental health, neurology, and geriatrics services on the importance of collaboration for dementia care, the psychiatry and neurology services created a joint Memory and Neurobehavior Clinic, which completed its first 2 years of operation as a full-day program. In recent months, the clinic has scheduled 24 veterans per day, approximately 50% new evaluations and 50% follow-up patients, with wait times of < 2 months. There is a mean of 12 intake or lead physicians who could attend sessions in the morning, afternoon, or both. The general clinic flow consists of a 2-hour intake evaluation of new referrals by the lead physician followed by a clinic conference with transdisciplinary discussion. The DCM then follows up with the veteran/caregiver presenting a final care plan individualized to the veterans, caregivers, and families.
The Memory and Neurobehavior team includes behavioral neurologists, geriatric psychiatrists, neuropsychologists, geriatric fellows, advanced clinical nurses, and social workers who function as the DCM (Table 1).
Procedures
Before the office visit, the coordinating geriatric psychiatrist triages veterans to neurology, psychiatry, or geriatric physicians based on the clinical presentation, history of neurologic signs or symptoms, BPSD or psychiatric history, functional decline, or comorbid medical illnesses. Although veterans often have overlapping concerns, the triage process aims to coordinate the intake evaluations with the most indicated and available specialist with the intention to notify the other specialists during the transdisciplinary conference.
Referrals to the program occur from many sources, notably from primary care (70.8%), mental health (16.7%), and specialty clinics (12.5%). The clinic also receives referrals from the affiliated Veterans Cognitive Assessment and Management Program, which provides dementia evaluation and support via telehealth screening. This VAGLAHS program services a diverse population of veterans: 87% male; 43% aged > 65 years (75% in our clinic); 51% non-Hispanic White; 19% non-Hispanic African American; 16% Hispanic; 4% Asian; and 1% Native American. This population receives care at regional VA medical centers and community-based outpatient clinics over a wide geographic service area.
The initial standardized assessments by intake or lead physicians includes mental status screening with the Montreal Cognitive Assessment (with certified clinicians), the Neurobehavioral Status Examination for a more detailed assessment of cognitive domains, the Columbia-Suicide Severity Rating Scale, the Patient Health Questionnaire for depression screening, and assessment for impairments in instrumental or basic activities of daily living. This initial evaluation aims to apply clinical guidelines and diagnostic criteria for the differential diagnosis of neurocognitive disorders, determine eligibility for cognitive-enhancing medications and techniques, assess for BPSD and the need for nonpharmacologic or pharmacologic interventions, determine functional status, and evaluate the need for supervision, safety concerns, and evidence of neglect or abuse.
As part of its mission, the clinic is charged with implementing the VA Dementia System of Care (DSOC). The stated goals of the DSOC are to provide individualized person-centered dementia care to help veterans experiencing dementia and their caregivers maintain a positive and optimal quality of life and create an environment where VA medical center staff understand the health care needs of veterans with dementia and their caregivers’ role. As part of this initiative, the clinic includes (1) coordination of care through a SW-DCM; (2)
Transdisciplinary Conference
Clinic conferences are held after the veterans are seen. Staff gather to discuss the patient and review management. All team members are present, as well as the head of the clinical clerical staff who can facilitate appointments, make lobby and wait times more bearable for our patients and caregivers, and help manage emergencies. Although this is an in-person conference, the COVID-19 pandemic has allowed us to include staff who screen at remote sites via videoconferencing, similar to other VA programs.24 The Memory and Neurobehavior Clinic has two ≤ 90-minute conferences daily. The lead physicians and their senior attendings present the new intake evaluations (4-6 at each conference session) with a preliminary formulation and questions for discussion. The moderator solicits contributions from the different disciplines, going from one to the next and recording their responses for each veteran. Further specialists are available for consultation through the conference mechanism if necessary. The final assessment is reviewed, a diagnosis is established, and a tailored, individualized care plan for adjusting or optimizing the veteran’s care is presented to the lead physician who makes the final determination. At the close of the conference, the team’s discussion is recorded along with the lead physician’s original detailed intake evaluation. Currently, the records go into the Computerized Patient Record System, but we are making plans to transition to Cerner as it is implemented.
During the discussion, team members review several areas of consideration. If there is neuroimaging, neurologists review the images projected on a large computer screen. Team members also will assess for the need to obtain biomarker studies, such as blood, cerebrospinal fluid, or positron emission tomography. Psychiatrists could review management of BPSD and use of psychotropic agents, and neuropsychologists might consider the need for more precise cognitive testing and whether a capacity assessment is indicated. Social work might bring up the need for a durable power of attorney as well as applicable caregiver and community resources. Geriatric medicine and nursing could provide input into medical management and care and the ability of veterans and caregivers to follow the prescribed regimen. Further areas of discussion include driving safety and restrictions on driving (as required in California) and the presence of guns in the home. Finally, brief education is provided in short 10-to-15-minute lectures covering pertinent topics so staff remain up-to-date in this changing field.
Postconference Continuity
After the conference, the SW-DCM continues to provide support throughout the disease course, helping veterans and their caregivers understand and follow through on the team’s recommendations. The SW-DCM, who is experienced and trained in case management, forms an ongoing relationship with the veterans and their caregivers and remains an advocate for their care. The SW-DCM communicates the final plan by phone and, when necessary, requests the lead physician to call to clarify any poorly understood or technical aspects of the care plan. About 50% of our veterans—primarily those who do not have a neurocognitive disorder or have mild cognitive impairment—return to their PCPs with our care plan consultation; about 25% are already enrolled in geriatric and other programs with long-term follow-up. The assigned SW-DCM follows up with the remaining veterans and caregivers regularly by phone, facilitates communication with other team members, and endeavors to assure postvisit continuity of care and support during advancing stages of the disease. In addition, the SW-DCM can provide supportive counseling and psychotherapy for stressed caregivers, refer to support groups and cognitive rehabilitation programs, and help develop long-term goals and consideration for supervised living environments. The nurse specialist participates with follow-up calls regarding medications and scheduled tests and appointments, clearing up confusion about instructions, avoiding medication errors, and providing education in dementia care. Both social worker and nurse are present throughout the week, reachable by phone, and, in turn, able to contact the clinic physicians for veterans’ needs.
Discussion
Because of the heterogenous medical and psychosocial needs of veterans with dementia and their caregivers, a transdisciplinary team with a dedicated DCM might offer the most effective and efficient model for dementia care. We present a transdisciplinary program that incorporates dementia specialists in a single evaluation by maximizing their time through a conference-centered program. Our program involves neurologists, psychiatrists, geriatricians, psychologists, nurses, and social workers collaborating and communicating to enact effective dementia care. It further meets the goals of the VA-DSOC in implementing individualized patient and caregiver care.
This transdisciplinary model addresses a number of issues, starting with the differential diagnosis of underlying neurologic conditions. Within the transdisciplinary team, the neurologist can provide specific insights into any neurologic findings and illnesses, such as Alzheimer disease and other neurodegenerative dementias, vascular dementia syndromes, normal pressure hydrocephalus, Creutzfeldt-Jakob disease, neurosyphilis, and others. Most veterans with dementia experience BPSD at some point during of their illness. The psychiatrists on the transdisciplinary team can maximize management of BPSD with nonpharmacologic interventions and the fewest and least aversive psychoactive medications. Our program also addresses the need for more precise cognitive evaluation. Neuropsychologists are present and available for administrating neuropsychologic tests and interpreting cognitive performance and any earlier neuropsychologic testing. This model also cares for the caregivers and assesses their needs. The social worker—as well as other members of the team—can provide caregivers with strategies for coping with disruptive and other behaviors related to dementia, counsel them on how to manage the veteran’s functional decline, and aid in establishing a safe living space. Because the social worker serves as a DCM, these coping and adjustment questions occupy significant clinical attention between appointments. This transdisciplinary model places the patient’s illness in the context of their functional status, diagnoses, and medications. The team geriatrician and the nurse specialist are indispensable resources. The clinic conference provides a teaching venue for staff and trainees and a mechanism to discuss new developments in dementia care, such as the increasing need to assess individuals with mild cognitive impairment.25 This model depends on the DCM’s invaluable role in ensuring implementation of the dementia care plan and continuity of care.
Conclusions
We describe effective dementia care with a transdisciplinary team in a conference setting and with the participation of a dedicated DCM.5 To date, this program appears to be an efficient, sustainable application of the limited resources allocated to dementia care. Nevertheless, we are collecting data to compare with performance measures, track use, and assess the programs effects on continuity of care. We look forward to presenting metrics from our program that show improvement in the health care for veterans experiencing a devastating and increasingly common disorder.
1. 2022 Alzheimer’s disease facts and figures. Alzheimers Dement. 2022;18(4):700-789. doi:10.1002/alz.12638
2. National Center for Veterans Analysis and Statistics. Profile of veterans: 2016. Accessed October 12, 2022. https://www.va.gov/vetdata/docs/SpecialReports/Profile_of_Veterans_2016.pdf
3. Chodosh J, Sultzer DL, Lee ML, et al. Memory impairment among primary care veterans. Aging Ment Health. 2007;11(4):444-450. doi:10.1080/13607860601086272
4. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. Brain Inj. 2022;36(5):620-627. doi:10.1080/02699052.2022.20338465. Heintz H, Monette P, Epstein-Lubow G, Smith L, Rowlett S, Forester BP. Emerging collaborative care models for dementia care in the primary care setting: a narrative review. Am J Geriatr Psychiatry. 2020;28(3):320-330. doi:10.1016/j.jagp.2019.07.015
6. Reuben DB, Evertson LC, Wenger NS, et al. The University of California at Los Angeles Alzheimer’s and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. J Am Geriatr Soc. 2013;61(12):2214-2218. doi:10.1111/jgs.12562
7. Apesoa-Varano EC, Barker JC, Hinton L. Curing and caring: the work of primary care physicians with dementia patients. Qual Health Res. 2011;21(11):1469-1483. doi:10.1177/1049732311412788
8. Creavin ST, Noel-Storr AH, Langdon RJ, et al. Clinical judgement by primary care physicians for the diagnosis of all-cause dementia or cognitive impairment in symptomatic people. Cochrane Database Syst Rev. 2022;6:CD012558. doi:10.1002/14651858.CD012558.pub2
9. Sivananthan SN, Puyat JH, McGrail KM. Variations in self-reported practice of physicians providing clinical care to individuals with dementia: a systematic review. J Am Geriatr Soc. 2013;61(8):1277-1285. doi:10.1111/jgs.12368
10. Rosen CS, Chow HC, Greenbaum MA, et al. How well are clinicians following dementia practice guidelines? Alzheimer Dis Assoc Disord. 2002;16(1):15-23. doi:10.1097/00002093-200201000-00003
11. Reilly S, Miranda-Castillo C, Malouf R, et al. Case management approaches to home support for people with dementia. Cochrane Database Syst Rev. 2015;1:CD008345. doi:10.1002/14651858.CD008345.pub2
12. Tam-Tham H, Cepoiu-Martin M, Ronksley PE, Maxwell CJ, Hemmelgarn BR. Dementia case management and risk of long-term care placement: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2013;28(9):889-902. doi:10.1002/gps.3906
13. Jolley D, Benbow SM, Grizzell M. Memory clinics. Postgrad Med J. 2006;82(965):199-206. doi:10.1136/pgmj.2005.040592
14. Muhlichen F, Michalowsky B, Radke A, et al. Tasks and activities of an effective collaborative dementia care management program in German primary care. J Alzheimers Dis. 2022;87(4):1615-1625. doi:10.3233/JAD-215656
15. Somme D, Trouve H, Drame M, Gagnon D, Couturier Y, Saint-Jean O. Analysis of case management programs for patients with dementia: a systematic review. Alzheimers Dement. 2012;8(5):426-436. doi:10.1016/j.jalz.2011.06.004
16. Ramakers IH, Verhey FR. Development of memory clinics in the Netherlands: 1998 to 2009. Aging Ment Health. 2011;15(1):34-39. doi:10.1080/13607863.2010.519321
17. LaMantia MA, Alder CA, Callahan CM, et al. The aging brain care medical home: preliminary data. J Am Geriatr Soc. 2015;63(6):1209-1213. doi:10.1111/jgs.13447
18. Rubinsztein JS, van Rensburg MJ, Al-Salihy Z, et al. A memory clinic v. traditional community mental health team service: comparison of costs and quality. BJPsych Bull. 2015;39(1):6-11. doi:10.1192/pb.bp.113.044263
19. Lee L, Hillier LM, Harvey D. Integrating community services into primary care: improving the quality of dementia care. Neurodegener Dis Manag. 2014;4(1):11-21. doi:10.2217/nmt.13.72
20. Bass DM, Judge KS, Snow AL, et al. Caregiver outcomes of partners in dementia care: effect of a care coordination program for veterans with dementia and their family members and friends. J Am Geriatr Soc. 2013;61(8):1377-1386. doi:10.1111/jgs.12362
21. Callahan CM, Boustani MA, Unverzagt FW, et al. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006;295(18):2148-2157. doi:10.1001/jama.295.18.2148
22. Leggett A, Connell C, Dubin L, et al. Dementia care across a tertiary care health system: what exists now and what needs to change. J Am Med Dir Assoc. 2019;20(10):1307-12 e1. doi:10.1016/j.jamda.2019.04.006
23. Brown AF, Vassar SD, Connor KI, Vickrey BG. Collaborative care management reduces disparities in dementia care quality for caregivers with less education. J Am Geriatr Soc. 2013;61(2):243-251. doi:10.1111/jgs.12079
24. Powers BB, Homer MC, Morone N, Edmonds N, Rossi MI. Creation of an interprofessional teledementia clinic for rural veterans: preliminary data. J Am Geriatr Soc. 2017;65(5):1092-1099. doi:10.1111/jgs.14839
25. Galvin JE, Aisen P, Langbaum JB, et al. Early stages of Alzheimer’s Disease: evolving the care team for optimal patient management. Front Neurol. 2020;11:592302. doi:10.3389/fneur.2020.592302
1. 2022 Alzheimer’s disease facts and figures. Alzheimers Dement. 2022;18(4):700-789. doi:10.1002/alz.12638
2. National Center for Veterans Analysis and Statistics. Profile of veterans: 2016. Accessed October 12, 2022. https://www.va.gov/vetdata/docs/SpecialReports/Profile_of_Veterans_2016.pdf
3. Chodosh J, Sultzer DL, Lee ML, et al. Memory impairment among primary care veterans. Aging Ment Health. 2007;11(4):444-450. doi:10.1080/13607860601086272
4. Kennedy E, Panahi S, Stewart IJ, et al. Traumatic brain injury and early onset dementia in post 9-11 veterans. Brain Inj. 2022;36(5):620-627. doi:10.1080/02699052.2022.20338465. Heintz H, Monette P, Epstein-Lubow G, Smith L, Rowlett S, Forester BP. Emerging collaborative care models for dementia care in the primary care setting: a narrative review. Am J Geriatr Psychiatry. 2020;28(3):320-330. doi:10.1016/j.jagp.2019.07.015
6. Reuben DB, Evertson LC, Wenger NS, et al. The University of California at Los Angeles Alzheimer’s and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. J Am Geriatr Soc. 2013;61(12):2214-2218. doi:10.1111/jgs.12562
7. Apesoa-Varano EC, Barker JC, Hinton L. Curing and caring: the work of primary care physicians with dementia patients. Qual Health Res. 2011;21(11):1469-1483. doi:10.1177/1049732311412788
8. Creavin ST, Noel-Storr AH, Langdon RJ, et al. Clinical judgement by primary care physicians for the diagnosis of all-cause dementia or cognitive impairment in symptomatic people. Cochrane Database Syst Rev. 2022;6:CD012558. doi:10.1002/14651858.CD012558.pub2
9. Sivananthan SN, Puyat JH, McGrail KM. Variations in self-reported practice of physicians providing clinical care to individuals with dementia: a systematic review. J Am Geriatr Soc. 2013;61(8):1277-1285. doi:10.1111/jgs.12368
10. Rosen CS, Chow HC, Greenbaum MA, et al. How well are clinicians following dementia practice guidelines? Alzheimer Dis Assoc Disord. 2002;16(1):15-23. doi:10.1097/00002093-200201000-00003
11. Reilly S, Miranda-Castillo C, Malouf R, et al. Case management approaches to home support for people with dementia. Cochrane Database Syst Rev. 2015;1:CD008345. doi:10.1002/14651858.CD008345.pub2
12. Tam-Tham H, Cepoiu-Martin M, Ronksley PE, Maxwell CJ, Hemmelgarn BR. Dementia case management and risk of long-term care placement: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2013;28(9):889-902. doi:10.1002/gps.3906
13. Jolley D, Benbow SM, Grizzell M. Memory clinics. Postgrad Med J. 2006;82(965):199-206. doi:10.1136/pgmj.2005.040592
14. Muhlichen F, Michalowsky B, Radke A, et al. Tasks and activities of an effective collaborative dementia care management program in German primary care. J Alzheimers Dis. 2022;87(4):1615-1625. doi:10.3233/JAD-215656
15. Somme D, Trouve H, Drame M, Gagnon D, Couturier Y, Saint-Jean O. Analysis of case management programs for patients with dementia: a systematic review. Alzheimers Dement. 2012;8(5):426-436. doi:10.1016/j.jalz.2011.06.004
16. Ramakers IH, Verhey FR. Development of memory clinics in the Netherlands: 1998 to 2009. Aging Ment Health. 2011;15(1):34-39. doi:10.1080/13607863.2010.519321
17. LaMantia MA, Alder CA, Callahan CM, et al. The aging brain care medical home: preliminary data. J Am Geriatr Soc. 2015;63(6):1209-1213. doi:10.1111/jgs.13447
18. Rubinsztein JS, van Rensburg MJ, Al-Salihy Z, et al. A memory clinic v. traditional community mental health team service: comparison of costs and quality. BJPsych Bull. 2015;39(1):6-11. doi:10.1192/pb.bp.113.044263
19. Lee L, Hillier LM, Harvey D. Integrating community services into primary care: improving the quality of dementia care. Neurodegener Dis Manag. 2014;4(1):11-21. doi:10.2217/nmt.13.72
20. Bass DM, Judge KS, Snow AL, et al. Caregiver outcomes of partners in dementia care: effect of a care coordination program for veterans with dementia and their family members and friends. J Am Geriatr Soc. 2013;61(8):1377-1386. doi:10.1111/jgs.12362
21. Callahan CM, Boustani MA, Unverzagt FW, et al. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006;295(18):2148-2157. doi:10.1001/jama.295.18.2148
22. Leggett A, Connell C, Dubin L, et al. Dementia care across a tertiary care health system: what exists now and what needs to change. J Am Med Dir Assoc. 2019;20(10):1307-12 e1. doi:10.1016/j.jamda.2019.04.006
23. Brown AF, Vassar SD, Connor KI, Vickrey BG. Collaborative care management reduces disparities in dementia care quality for caregivers with less education. J Am Geriatr Soc. 2013;61(2):243-251. doi:10.1111/jgs.12079
24. Powers BB, Homer MC, Morone N, Edmonds N, Rossi MI. Creation of an interprofessional teledementia clinic for rural veterans: preliminary data. J Am Geriatr Soc. 2017;65(5):1092-1099. doi:10.1111/jgs.14839
25. Galvin JE, Aisen P, Langbaum JB, et al. Early stages of Alzheimer’s Disease: evolving the care team for optimal patient management. Front Neurol. 2020;11:592302. doi:10.3389/fneur.2020.592302
A Novel Text Message Protocol to Improve Bowel Preparation for Outpatient Colonoscopies in Veterans
Colorectal cancer is the third leading cause of cancer-related death in both men and women.1 Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.2 Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.3
Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.3-5 Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.6-10
In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.11 We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.
Methods
We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group.
The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed.
On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures.
We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.12 Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.12 Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.13 Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.3-5 We note that immobility was defined by International Classification of Diseases (ICD)-9 and ICD-10 codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).
Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually.
Statistical Analysis
We used both Pearson χ2 test and 2-sample t test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent t tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages.
RESULTS
During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.
The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1).
Patient Feedback
We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place.
Patient satisfaction with the Annie text messaging service was high.
DISCUSSION
To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures.
The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.
We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.
Limitations
Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages.
Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.14 This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.15-17 Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains.
Conclusions
There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond.
1. Centers for Disease Control and Prevention. Colorectal cancer statistics. Updated June 6, 2022. Accessed September 8, 2022. https://www.cdc.gov/cancer/colorectal/statistics
2. Lieberman D, Ladabaum U, Cruz-Correa M, et al. Screening for colorectal cancer and evolving issues for physicians and patients: a review. JAMA. 2016;316(20):2135-2145. doi:10.1001/jama.2016.17418
3. Nguyen DL, Wieland M. Risk factors predictive of poor quality preparation during average risk colonoscopy screening: the importance of health literacy. J Gastrointestin Liver Dis. 2010;19(4):369-372.
4. Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018;30(8):819-826. doi:10.1097/MEG.0000000000001175
5. Harrington KM, Nguyen XT, Song RJ, et al. Gender differences in demographic and health characteristics of the Million Veteran Program cohort. Womens Health Issues. 2019;29(suppl 1):S56-S66. doi:10.1016/j.whi.2019.04.012
6. Zhang QX, Li J, Zhang Q, et al. Effect of education by messaging software on the quality of bowel preparation for colonoscopy. Chin Med J (Engl). 2018;131(14):1750-1752. doi:10.4103/0366-6999.235881
7. Walter B, Klare P, Strehle K, et al. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019;89(3):506-513.e4. doi:10.1016/j.gie.2018.08.014
8. Nadim MM, Doshi S, Coniglio M, et al. Automated text message navigation to improve preparation quality and show rate for colonoscopy. Am J Gastroenterol. 2018;113:S64-S66.
9. Walter B, Frank R, Ludwig L, et al. Smartphone application to reinforce education increases high-quality preparation for colorectal cancer screening colonoscopies in a randomized trial. Clin Gastroenterol Hepatol. 2021;19(2):331-338.e5. doi:10.1016/j.cgh.2020.03.051
10. Guo B, Zuo X, Li Z, et al. Improving the quality of bowel preparation through an app for inpatients undergoing colonoscopy: a randomized controlled trial. J Adv Nurs. 2020;76(4):1037-1045. doi:10.1111/jan.14295
11. Yakovchenko V, Hogan TP, Houston TK, et al. Automated text messaging with patients in department of veterans affairs specialty clinics: cluster randomized trial. J Med Internet Res. 2019;21(8):e14750. doi:10.2196/14750
12. Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009;69(3 Pt 2):620-625. doi:10.1016/j.gie.2008.05.057
13. Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010;72(4):686-692. doi:10.1016/j.gie.2010.06.068
14. Duan-Porter W, Van Houtven CH, Mahanna EP, et al. Internet use and technology-related attitudes of veterans and informal caregivers of veterans. Telemed J E Health. 2018;24(7):471-480. doi:10.1089/tmj.2017.0015
15. Boston University School of Public Health. how mobile technology can increase veteran healthcare and wellbeing. November 10, 2021. Accessed November 1, 2022. https://www.ideahub.org/research-data/how-mobile-technology-increases-veteran-healthcare-and-wellbeing/
16. Klee A, Stacy M, Rosenheck R, Harkness L, Tsai J. Interest in technology-based therapies hampered by access: A survey of veterans with serious mental illnesses. Psychiatr Rehabil J. 2016;39(2):173-179. doi:10.1037/prj0000180
17. Berrouiguet S, Baca-García E, Brandt S, Walter M, Courtet P. Fundamentals for future mobile-health (mHealth): a systematic review of mobile phone and web-based text messaging in mental health. J Med Internet Res. 2016;18(6):e135. Published 2016 Jun 10. doi:10.2196/jmir.5066
Colorectal cancer is the third leading cause of cancer-related death in both men and women.1 Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.2 Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.3
Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.3-5 Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.6-10
In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.11 We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.
Methods
We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group.
The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed.
On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures.
We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.12 Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.12 Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.13 Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.3-5 We note that immobility was defined by International Classification of Diseases (ICD)-9 and ICD-10 codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).
Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually.
Statistical Analysis
We used both Pearson χ2 test and 2-sample t test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent t tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages.
RESULTS
During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.
The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1).
Patient Feedback
We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place.
Patient satisfaction with the Annie text messaging service was high.
DISCUSSION
To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures.
The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.
We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.
Limitations
Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages.
Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.14 This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.15-17 Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains.
Conclusions
There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond.
Colorectal cancer is the third leading cause of cancer-related death in both men and women.1 Colonoscopy is the current gold standard for screening due to the ability to remove precancerous lesions but remains highly dependent on the quality of bowel preparation.2 Poor bowel preparation has been associated with impaired adenoma detection as well as increased health care utilization due to the need for a repeat colonoscopy.3
Multiple patient factors are associated with increased risk of poor bowel preparation, including age > 60 years, male sex, diabetes mellitus, and presence of a mental health diagnosis, factors that are prevalent among the veteran population.3-5 Text messages have been shown to improve the quality of bowel preparation by increasing patients' understanding and adherence with the preparation process. Improved adherence with bowel preparation directions is associated with a cleaner colon prior to colonoscopy, leading to a thorough examination. Studies using text messaging instructions prior to colonoscopies have also shown measurable improvement in adenoma detection rate, patient preparation-associated discomfort, and completion of colonoscopy.6-10
In 2016, the Veterans Health Administration (VHA) introduced Annie, one of the first automated text messaging services, named after Army Lieutenant Annie Fox, the first woman to receive the Purple Heart for combat. The Annie platform allows for notifications, instructions, and simple data collection. The development of this platform allows VHA practitioners to engage and educate veterans in a similar way to other health care systems using text messaging protocols. Annie text messages have been piloted for the use of hepatitis C treatment, demonstrating promise of improved medication adherence and patient satisfaction.11 We aimed to develop and pilot the Annie bowel preparation protocol to improve the quality of colonoscopy bowel preparation for outpatients at the Minneapolis Veterans Affairs Medical Center (MVAMC) in Minnesota. A secondary goal included measuring patient satisfaction with the text messaging instructions for outpatient colonoscopy preparation.
Methods
We conducted a single center, prospective, endoscopist-blinded, study with two 3-month long Plan-Do-Study-Act (PDSA) cycles to improve the text messaging bowel preparation protocol at MVAMC between January 2019 and April 2020. The MVAMC Institutional Review Board determined the quality improvement project was exempt. Veterans who had outpatient colonoscopies scheduled were included. Veterans undergoing inpatient colonoscopies or outpatients who could not be reached to obtain informed consent, lacked text message capability, declined participation, or required extended colonoscopy preparation were excluded. Per MVAMC procedures, extended colonoscopy preparation was provided to patients receiving general or monitored anesthesia care, with a history of poor bowel preparation, or with risk factors for poor preparation as determined by the ordering health care professional (HCP). Standard bowel preparation involves ingestion of 4 L of polyethylene glycol 3350 with electrolytes; extended bowel preparation requires ingestion of an additional 2 L to total 6 L and uses a different set of instructions. Additionally, the patient population requiring extended bowel preparation also includes patients with spinal cord injuries, who often are admitted for assistance with extended preparation. Patients who consented to receiving text messages were placed in the Annie intervention group, and all others were placed in the control group.
The control group received standardized patient education, including a mailed copy of bowel preparation instructions and a phone call from a gastroenterology service nurse about 1 to 2 weeks before the procedure. Current MVAMC standard of care involves a phone call from a nurse to confirm that patients have received the polyethylene glycol preparation solution, the mailed instructions, have an escort and transportation, and to answer any questions. Both the usual care and intervention group received the phone call. During this call, the Annie text messaging bowel preparation protocol was introduced; if the veteran chose to participate, consent and enrollment were completed.
On the day of the colonoscopy, veterans in the intervention group were surveyed in the waiting room about their experience receiving the text messages and soliciting feedback for improvement or surveyed via telephone call within 3 days of their procedure. Patient satisfaction was quantified with a scale from 1 (low) to 10 (high), including questions about how helpful the texts were in relation to total number, timing, and content of messages as well as whether veterans would like to receive the text messages again for future procedures.
We reviewed individual charts and collected Boston Bowel Preparation Scale (BBPS) scores to determine adequate preparation. BBPS assigns a score of 0 to 3 for the right, transverse, and left colon applied upon withdrawal after flushing and suctioning have been completed.12 Adequate preparation is considered a total score of ≥ 6 with no segment scoring < 2. This method of preparation assessment is preferred due to its ability to account for difference in preparation quality among colonic segments, well-defined scoring characteristics, and several studies validating its use showing inter- and intraobserver reliability.12 Follow-up studies have shown validity of the BBPS when compared with relevant outcomes such as polyp detection rate and recommended timing for repeat procedure.13 Variables associated with poor bowel preparation (ie, gender, prior abdominal surgery, impaired mobility, high body mass index, diabetes mellitus, stroke, dementia, any neurologic diagnosis, cirrhosis, smoking, polypharmacy [> 8 active medications], and narcotic or tricyclic antidepressant medication use) were also collected through chart review.3-5 We note that immobility was defined by International Classification of Diseases (ICD)-9 and ICD-10 codes and prescriptions for assistive devices (ie, canes, wheelchairs, 4-wheeled walkers).
Veterans assent to be enrolled in Annie. After enrollment, veterans must text back a specific word response to an initial text message to receive the protocolized messages from the Annie program. A contact phone number to the gastrointestinal nurse line was provided for questions during business hours. The start date for the text message protocol is 6 days prior to the procedure date. If a patient rescheduled their colonoscopy, the Annie database was updated manually.
Statistical Analysis
We used both Pearson χ2 test and 2-sample t test analyses to compare demographic information and patient satisfaction scores between the control and intervention groups. We compared continuous BBPS scores between Annie intervention vs control group using parametric and nonparametric independent t tests using the Mann-Whitney U test. We repeated this analysis controlling for both mental health diagnoses and age using linear regression. We were unable to survey 61 of the 187 veterans who received Annie text messages.
RESULTS
During PDSA cycles 1 and 2, 640 veterans were scheduled for outpatient colonoscopy: 453 veterans were in the control group; 187 veterans were in the intervention group, of which 126 were surveyed. A significant percentage of veterans declined participation because they felt like they did not need reinforced education; others were not eligible for Annie due to requirement for extended bowel preparation, cancelled colonoscopy, inability to physically read text messages, or lack of cell phone.
The mean (SD) age was 65 (8) years; 184 (28.8%) had a diabetes mellitus diagnosis, and the mean (SD) body mass index was 31.6 (6.4). The Annie group was slightly more likely to have mental health diagnoses and lower age compared with the control group (Table 1).
Patient Feedback
We collected feedback from veterans after each PDSA cycle to identify areas for improvement by both in-person and telephone surveys. Based on feedback from PDSA cycle 1, we decreased the total number of text messages to create a more succinct set of instructions. The most frequently requested change involved timing the text messages to align with the exact morning a specific instruction should take place.
Patient satisfaction with the Annie text messaging service was high.
DISCUSSION
To our knowledge, this is the first report of using Annie at a VAMC for colonoscopy bowel preparation improvement. We found a statistically significant improvement in the average BBPS in those receiving Annie text messages compared with the routine care control group. We also found high levels of patient satisfaction with most patients requesting to receive them again for future procedures.
The clinical significance of a BBPS of 7.8 vs 8.2 is unclear, although any score > 6 is considered to be adequate. However, subjectively speaking, the higher the BBPS the cleaner the colon, and theoretically the easier it is to see small or flat polyps. Future steps could include calculating adenoma detection rates for those enrolled in the Annie program vs the control group.
We have received inquiries regarding potential program implementation at other facilities. Success and sustainability of the program will require long-term commitment and ideally protected time for staff. It is helpful to remember that for each person who chooses to enroll in the intervention, the program currently requires that a brief consent note is placed in the patient’s chart. Thus, depending on the facilities’ resources, it is ideal for one staff member to be the designated lead to help oversee, troubleshoot, and train additional personnel. Surveys can be intermittently used to obtain feedback for improvement but are not required for sustainability. Automated text messaging is a promising addition to medicine for clinical education and communication. Future studies should examine the clinical significance (ie, adenoma detection rates) of text messaging bowel preparation protocols.
Limitations
Our study has several limitations. First, this was a single center study, thus generalizability is limited. MVAMC represents a predominantly White, male, and rural population. Second, data are likely an underestimation of the true impact of intervention, because results do not account for patients who were turned away on day of procedure (typically still reporting brown stools at time of check-in for procedure) due to poor preparation or aborted procedures secondary to poor preparation. Only about one-third of the 640 veterans opted to receive Annie text messages.
Studies have shown veterans are willing to use technology for health care; however, access to technology and lack of training remain barriers to use.14 This has been most robustly studied at the VA in veterans experiencing mental illness and homelessness. Targeted strategies to improve veteran adoption of technology within their health care include supplying veterans with cell phones and paid data plans and providing training on specific technology-based resources.15-17 Future improvement for the Annie platform should include improved integration with CPRS. Integration will facilitate automatic import of key information such as mobile phone number or colonoscopy procedure date. Unfortunately, this is not currently an automated process, and the manual workload of staff limits sustainability. Since our study ended, the Annie database now allows an “event date” to be programmed in to center the text message series around. This will be entered at the time of Annie enrollment and eliminate manual activation of the protocol. The issue of updating information for rescheduled procedures remains.
Conclusions
There is increasing evidence that automated text messaging is a promising addition to medicine for clinical education and communication. It continues to gain traction as a readily available and acceptable option, and many patients are willing to incorporate the technology platform into their care plan. We found high patient satisfaction with our protocol, and Annie patients had cleaner bowel preparations compared with control patients. Our study supports the use of text message reminders as an effective intervention for improving patient adherence with bowel preparation instructions. We suspect that creation of a text messaging protocol designed for patients requiring outpatient extended bowel preparation will yield great benefit. As technology continues to improve, future implementation of Annie text messaging will become increasingly seamless within the field of gastroenterology and beyond.
1. Centers for Disease Control and Prevention. Colorectal cancer statistics. Updated June 6, 2022. Accessed September 8, 2022. https://www.cdc.gov/cancer/colorectal/statistics
2. Lieberman D, Ladabaum U, Cruz-Correa M, et al. Screening for colorectal cancer and evolving issues for physicians and patients: a review. JAMA. 2016;316(20):2135-2145. doi:10.1001/jama.2016.17418
3. Nguyen DL, Wieland M. Risk factors predictive of poor quality preparation during average risk colonoscopy screening: the importance of health literacy. J Gastrointestin Liver Dis. 2010;19(4):369-372.
4. Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018;30(8):819-826. doi:10.1097/MEG.0000000000001175
5. Harrington KM, Nguyen XT, Song RJ, et al. Gender differences in demographic and health characteristics of the Million Veteran Program cohort. Womens Health Issues. 2019;29(suppl 1):S56-S66. doi:10.1016/j.whi.2019.04.012
6. Zhang QX, Li J, Zhang Q, et al. Effect of education by messaging software on the quality of bowel preparation for colonoscopy. Chin Med J (Engl). 2018;131(14):1750-1752. doi:10.4103/0366-6999.235881
7. Walter B, Klare P, Strehle K, et al. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019;89(3):506-513.e4. doi:10.1016/j.gie.2018.08.014
8. Nadim MM, Doshi S, Coniglio M, et al. Automated text message navigation to improve preparation quality and show rate for colonoscopy. Am J Gastroenterol. 2018;113:S64-S66.
9. Walter B, Frank R, Ludwig L, et al. Smartphone application to reinforce education increases high-quality preparation for colorectal cancer screening colonoscopies in a randomized trial. Clin Gastroenterol Hepatol. 2021;19(2):331-338.e5. doi:10.1016/j.cgh.2020.03.051
10. Guo B, Zuo X, Li Z, et al. Improving the quality of bowel preparation through an app for inpatients undergoing colonoscopy: a randomized controlled trial. J Adv Nurs. 2020;76(4):1037-1045. doi:10.1111/jan.14295
11. Yakovchenko V, Hogan TP, Houston TK, et al. Automated text messaging with patients in department of veterans affairs specialty clinics: cluster randomized trial. J Med Internet Res. 2019;21(8):e14750. doi:10.2196/14750
12. Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009;69(3 Pt 2):620-625. doi:10.1016/j.gie.2008.05.057
13. Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010;72(4):686-692. doi:10.1016/j.gie.2010.06.068
14. Duan-Porter W, Van Houtven CH, Mahanna EP, et al. Internet use and technology-related attitudes of veterans and informal caregivers of veterans. Telemed J E Health. 2018;24(7):471-480. doi:10.1089/tmj.2017.0015
15. Boston University School of Public Health. how mobile technology can increase veteran healthcare and wellbeing. November 10, 2021. Accessed November 1, 2022. https://www.ideahub.org/research-data/how-mobile-technology-increases-veteran-healthcare-and-wellbeing/
16. Klee A, Stacy M, Rosenheck R, Harkness L, Tsai J. Interest in technology-based therapies hampered by access: A survey of veterans with serious mental illnesses. Psychiatr Rehabil J. 2016;39(2):173-179. doi:10.1037/prj0000180
17. Berrouiguet S, Baca-García E, Brandt S, Walter M, Courtet P. Fundamentals for future mobile-health (mHealth): a systematic review of mobile phone and web-based text messaging in mental health. J Med Internet Res. 2016;18(6):e135. Published 2016 Jun 10. doi:10.2196/jmir.5066
1. Centers for Disease Control and Prevention. Colorectal cancer statistics. Updated June 6, 2022. Accessed September 8, 2022. https://www.cdc.gov/cancer/colorectal/statistics
2. Lieberman D, Ladabaum U, Cruz-Correa M, et al. Screening for colorectal cancer and evolving issues for physicians and patients: a review. JAMA. 2016;316(20):2135-2145. doi:10.1001/jama.2016.17418
3. Nguyen DL, Wieland M. Risk factors predictive of poor quality preparation during average risk colonoscopy screening: the importance of health literacy. J Gastrointestin Liver Dis. 2010;19(4):369-372.
4. Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018;30(8):819-826. doi:10.1097/MEG.0000000000001175
5. Harrington KM, Nguyen XT, Song RJ, et al. Gender differences in demographic and health characteristics of the Million Veteran Program cohort. Womens Health Issues. 2019;29(suppl 1):S56-S66. doi:10.1016/j.whi.2019.04.012
6. Zhang QX, Li J, Zhang Q, et al. Effect of education by messaging software on the quality of bowel preparation for colonoscopy. Chin Med J (Engl). 2018;131(14):1750-1752. doi:10.4103/0366-6999.235881
7. Walter B, Klare P, Strehle K, et al. Improving the quality and acceptance of colonoscopy preparation by reinforced patient education with short message service: results from a randomized, multicenter study (PERICLES-II). Gastrointest Endosc. 2019;89(3):506-513.e4. doi:10.1016/j.gie.2018.08.014
8. Nadim MM, Doshi S, Coniglio M, et al. Automated text message navigation to improve preparation quality and show rate for colonoscopy. Am J Gastroenterol. 2018;113:S64-S66.
9. Walter B, Frank R, Ludwig L, et al. Smartphone application to reinforce education increases high-quality preparation for colorectal cancer screening colonoscopies in a randomized trial. Clin Gastroenterol Hepatol. 2021;19(2):331-338.e5. doi:10.1016/j.cgh.2020.03.051
10. Guo B, Zuo X, Li Z, et al. Improving the quality of bowel preparation through an app for inpatients undergoing colonoscopy: a randomized controlled trial. J Adv Nurs. 2020;76(4):1037-1045. doi:10.1111/jan.14295
11. Yakovchenko V, Hogan TP, Houston TK, et al. Automated text messaging with patients in department of veterans affairs specialty clinics: cluster randomized trial. J Med Internet Res. 2019;21(8):e14750. doi:10.2196/14750
12. Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009;69(3 Pt 2):620-625. doi:10.1016/j.gie.2008.05.057
13. Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010;72(4):686-692. doi:10.1016/j.gie.2010.06.068
14. Duan-Porter W, Van Houtven CH, Mahanna EP, et al. Internet use and technology-related attitudes of veterans and informal caregivers of veterans. Telemed J E Health. 2018;24(7):471-480. doi:10.1089/tmj.2017.0015
15. Boston University School of Public Health. how mobile technology can increase veteran healthcare and wellbeing. November 10, 2021. Accessed November 1, 2022. https://www.ideahub.org/research-data/how-mobile-technology-increases-veteran-healthcare-and-wellbeing/
16. Klee A, Stacy M, Rosenheck R, Harkness L, Tsai J. Interest in technology-based therapies hampered by access: A survey of veterans with serious mental illnesses. Psychiatr Rehabil J. 2016;39(2):173-179. doi:10.1037/prj0000180
17. Berrouiguet S, Baca-García E, Brandt S, Walter M, Courtet P. Fundamentals for future mobile-health (mHealth): a systematic review of mobile phone and web-based text messaging in mental health. J Med Internet Res. 2016;18(6):e135. Published 2016 Jun 10. doi:10.2196/jmir.5066
Contralateral Constrictor Dose Predicts Swallowing Function After Radiation for Head and Neck Cancer
Radiation therapy can cause long-term dysphagia that seriously affects quality of life for survivors of head and neck (H&N) cancer.1-3 Numerous studies have linked pharyngeal constrictor dose to long-term dysphagia, but conclusions about the dose distribution that can be safely tolerated have been inconsistent. For example, a group from the Netherlands found that the mean dose to the superior pharyngeal constrictor muscle and the supraglottic larynx were each predictive of dysphagia.4 A subsequent Vanderbilt study refuted these findings, reporting that these structures were not predictive but that dose to the inferior pharyngeal constrictor muscle was.5 Other studies have connected late dysphagia with dose to the middle pharyngeal constrictor muscle, total larynx, oral cavity, contralateral submandibular gland, contralateral parotid gland, or a combination of these structures.6-14 NRG Oncology trials commonly evaluate dose to the “uninvolved pharynx,” which is the total pharyngeal constrictor muscle volume minus the planning target volume for the lowest dose target volume. NRG H&N trials 3, 4, 5, 6, 8, and 9 all use uninvolved pharynx mean dose ≤ 45 Gy as a constraint to judge radiation plan quality.
Differences in methodology or patient population may explain the inconsistency of prior studies on dosimetric predictors of dysphagia, but it is possible that these studies did not evaluate the optimal metric for dysphagia. This study evaluates a novel organ at risk, the contralateral pharyngeal constrictor muscle, to determine whether dose to this structure is predictive of late swallowing function. The study also compares a constraint based on this structure to the NRG uninvolved pharynx constraint mentioned earlier.
Methods
This study is a retrospective review of patients treated at the Richard L. Roudebush Veterans Affairs (VA) Medical Center in Indianapolis, Indiana. Patients were identified by searching the VA Cancer Registry for patients treated for H&N squamous cell carcinoma between September 1, 2016, and August 30, 2019. Eligible sites included cancers of the nasopharynx, oropharynx, hypopharynx, larynx and oral cavity, as well as H&N cancer of an unknown primary site. Only patients treated with primary radiation with concurrent systemic therapy were included. Patients were excluded if they had prior surgery or radiation to the H&N.
The pharyngeal constrictor muscles were contoured per the techniques described by Bhide and colleagues.11 The contralateral constrictor was defined as the half of the constrictor volume contralateral to the primary site. For midline tumors, the side of the neck with a lower volume of lymph node metastases was judged to be the contralateral side.
One-year dysphagia was defined as having a gastronomy tube (G-tube) in place or an abnormal modified barium swallow (MBS) ≥ 12 months after the completion of radiation. At the study institution, MBS is not routinely done after therapy but is ordered if a patient or clinician has concerns about swallowing function. MBS was considered abnormal if there was laryngeal penetration that reached the level of the glottis or was not ejected from the larynx.
Results
The VA Cancer Registry identified 113 patients treated for H&N cancer during the study period. Of these, 55 patients met the inclusion criteria. No patients were lost to follow-up. The median follow-up was 29 months. The median age was 67 years (range, 41-83) (Table 1).
All patients were treated with intensity-modulated radiotherapy (IMRT). Patients treated with a sequential boost had an initial dose of 54 Gy and/or 50 Gy, followed by a boost to a total of 70 Gy at 2 Gy per fraction. Patients treated with a simultaneous integrated boost (SIB) technique received 69.96 Gy in 33 fractions, with elective volumes treated to 54.45 Gy in 33 fractions. Both patients with nasopharyngeal cancer were treated with SIB plans and had an intermediate dose volume of 59.4 Gy.
Systemic therapy was weekly cisplatin in 41 patients (75%) and cetuximab in 14 (25%). Twenty percent of patients receiving cisplatin switched to an alternative agent during treatment, most commonly carboplatin.
Forty-nine patients (89%) had a G-tube placed before starting radiation. G-tubes were in place for an interval of 0 to 47 months (mean, 8.6); 12 (22%) had a G-tube > 12 months. After completion of radiation, 18 patients (33%) had an abnormal MBS. These were done 1 to 50 months (mean, 14.8) after completion of radiation. Abnormal MBS occurred ≥ 12 months after radiation in 9 patients, 5 of whom had their G-tube in place for less than a year.
Forty-six patients (84%) survived more than 1 year and could be evaluated for late swallowing function. One-year dysphagia was seen in 17 (37%) of these patients. Recurrence was seen in 20 patients (36%), with locoregional recurrence in 12 (60%) of these cases. Recurrence occurred at a range of 0 to 15 months (mean, 5.6). Neither recurrence (P = .69) nor locoregional recurrence (P = .11) was associated with increased 1-year dysphagia.
In patients who could be evaluated for long-term swallowing function, contralateral constrictor V60 ranged from 0% to 100% (median, 51%). V60 was < 40% in 18 patients (39%). With V60 < 40%, there was a 6% rate of 1-year dysphagia compared with 57% for V60 ≥ 40% (P < .001).
Patients with contralateral constrictor V60 < 40 and V60 ≥ 40 both had a mean age of 65 years. χ2 analysis did not show a difference in T stage or systemic treatment but did show that patients with V60 < 40% were more likely to have N1 disease (P = .01), and less likely to have N2 disease (P = .01) compared with patients with V60 ≥ 40%. The difference in 1-year dysphagia between N0 to N1 patients (27%) and N2 to N3 patients (46%) was not statistically significant (P = .19).
In patients who could be evaluated for long-term swallowing function, the uninvolved pharynx volume median of the total constrictor volume was 32% (range, < 1%-62%). The uninvolved pharynx mean dose ranged from 28 to 68 Gy (median, 45). When the uninvolved pharynx mean dose was < 45 Gy, 1-year dysphagia was 22% compared with 52% with a dose ≥ 45 Gy (P = .03).
Air cavity editing was performed in 27 patients (49%). One-year survival was 93% with air cavity editing, and 75% without, which was not statistically significant. Locoregional recurrence occurred in 3 patients (11%) with air cavity editing, and 9 (32%) without, which was not statistically significant. In patients surviving at least 1 year, contralateral constrictor V60 averaged 33% with editing and 62% without editing (P < .001). One-year dysphagia was 12% with air cavity editing and 67% without editing (P < .001).
An SIB technique was done in 26 patients (47%). One-year survival was 85% (n = 22) with SIB and 83% (n = 24) with sequential boost, which was not statistically significant. Locoregional recurrence occurred in 19% with SIB, and 32% with sequential boost, which was not statistically significant. For SIB patients alive at 1 year, the median contralateral V60 was 28%, compared with 66% for patients treated with sequential technique. Seventeen patients (77%) with SIB had V60 < 40%. Nineteen (86%) of SIB plans also had air cavity editing. One patient (5%) with SIB had dysphagia at 1 year, compared with 16 (67%) sequential patients (P < .001).
Discussion
This is the first study to link contralateral constrictor dose to long-term dysphagia in patients treated with radiation for H&N cancer. Editing the boost volume off air cavities was associated with lower contralateral constrictor V60 and with less long-term dysphagia. This may indicate that optimizing plans to meet a contralateral constrictor constraint can reduce rates of long-term dysphagia.
The most useful clinical predictors are those that identify a patient at low risk for toxicity. These constraints are useful because they reassure physicians that treatments will have a favorable risk/benefit ratio while identifying plans that may need modification before starting treatment.
The contralateral constrictor outperformed the uninvolved pharynx in identifying patients at low risk for long-term dysphagia. This difference could not be overcome by decreasing the threshold of the pharynx constraint, as 17% of patients with dysphagia had a mean dose of < 40 Gy to the uninvolved pharynx, which was not statistically significant.
An advantage of contralateral constrictor is that it is independent of planning target volume (PTV) size. The uninvolved pharynx structure depends on the PTV contour, so it may obscure a connection between PTV size and dysphagia.
In the context of a clinical trial, only measuring dose to the uninvolved pharynx may allow more plans to meet constraints, but even in NRG trials, physicians have some control over target volumes. For example, NRG HN009, a national trial for patients with H&N cancer, recommends editing the CTV_7000 (clinical target volume treated to 70 Gy) off air cavities but does not define how much the volume should be cropped or specify protocol violations if the volume is not cropped.15 Furthermore, constraints used in clinical trials are often adopted for use outside the trial, where physicians have extensive control over target volumes.
The broad range of uninvolved pharynx volume relative to total constrictor volume confounds predictions using this variable. For example, according to the NRG constraint, a patient with an uninvolved pharynx mean dose of 44 Gy will have a low risk of dysphagia even if this structure is only 1% of the total constrictor. The contralateral constrictor is always about 50% of the total constrictor volume, which means that predictions using this structure will not be confounded by the same variation in volume size.
Figure 2 shows a representative patient who met the NRG uninvolved pharynx constraint but developed long-term dysphagia.
Pharyngoesophageal stricture is a common cause of dysphagia after IMRT for H&N cancer.16 Radiation has been shown to decrease pharyngeal function in patients with H&N cancer.17 Sparing one side of the pharynx may allow for better pharyngeal compliance throughout the length of the pharynx, possibly decreasing the rate of pharyngoesophageal stricture. Additionally, constraining the contralateral constrictor may preserve strength on this side, allowing it to compensate for weakness on the side of the primary cancer. An exercise sometimes used for dysphagia involves head rotation toward the affected side during swallowing. This technique has been shown to cause food to move to the unaffected side.18 Sparing the contralateral constrictor may help such techniques work better in patients with H&N cancer.
Few studies have commented specifically on dose to swallowing structures contralateral to the primary tumor. Two studies have proposed contralateral submandibular gland constraints for dysphagia (not xerostomia), but neither measured the dose to the contralateral constrictor muscle.9,10 Although the contralateral submandibular dose may correlate with dose to the constrictor on that side, the submandibular gland may have a less direct impact on swallowing than the constrictor muscle, and its limited dimensions may make constraints based on the gland less robust for cancers outside the oropharynx.
Another study reported improved quality of life in patients who were not treated with elective contralateral retropharyngeal radiation.19 Although it is likely that doses to the contralateral constrictor were lower in patients who did not receive elective radiation to this area, this study did not measure or constrain doses to the contralateral constrictors.
Limitations
This study is limited by its single institution, retrospective design, small sample size, and by all patients being male. The high correlation between air cavity editing and the use of SIB makes it impossible to assess the impact of each technique individually. Patients with contralateral constrictor V60 < 40% were less likely to have N2 disease, but N2 to N3 disease did not predict higher 1-year dysphagia, so the difference in N-category cannot fully explain the difference in 1-year dysphagia. It is possible that unreported factors, such as CTV, may contribute significantly to swallowing function. Nevertheless, within the study population, contralateral constrictor dose was able to identify a group with a low rate of long-term dysphagia.
Conclusions
Contralateral constrictor dose is a promising predictor of late dysphagia for patients with H&N cancer treated with radiation with concurrent systemic therapy. Contralateral constrictor V60 < 40% was able to identify a group of patients with a low rate of 1-year dysphagia in this single-center retrospective study. The correlation between air cavity editing and contralateral constrictor V60 suggests that contralateral constrictor dose may depend partly on technique. Further studies are needed to see if the contralateral constrictor dose can be used to predict long-term dysphagia prospectively and in other patient populations.
1. Langendijk JA, Doornaert P, Verdonck-de Leeuw IM, et al. Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy. J Clin Oncol. 2008;26(22):3770-3776. doi:10.1200/JCO.2007.14.6647
2. Nguyen NP, Frank C, Moltz CC, et al. Impact of dysphagia on quality of life after treatment of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2005;61(3):772-778. doi:10.1016/j.ijrobp.2004.06.017
3. Ramaekers BLT, Joore MA, Grutters JPC, et al. The impact of late treatment-toxicity on generic health-related quality of life in head and neck cancer patients after radiotherapy. Oral Oncol. 2011;47(8):768-774. doi:10.1016/j.oraloncology.2011.05.012
4. Christianen MEMC, Schilstra C, Beetz I, et al. Predictive modelling for swallowing dysfunction after primary (chemo)radiation: results of a prospective observational study. Radiother Oncol. 2012;105(1):107-114. doi:10.1016/j.radonc.2011.08.009
5. Vlachich G, Spratt DE, Diaz R, et al. Dose to inferior pharyngeal conctrictor predicts prolonged gastrostomy tube dependence with concurrent intensity-modulated radiation therapy and chemotherapy for locally-advanced head and neck cancer. Radiother Oncol. 2014;110(3):435-440. doi:10.1016/j.radonc.2013.12.007
6. Mogadas S, Busch CJ, Pflug Cet al. Influence of radiation dose to pharyngeal constrictor muscles on late dysphagia and quality of life in patients with locally advanced oropharyngeal carcinoma. Strahlenther Onkol. 2020;196(6):522-529. doi:10.1007/s00066-019-01572-0
7. Caglar HB, Tishler RB, Othus M, et al. Dose to larynx predicts of swallowing complications after intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2008;72(4):1110-1118. doi:10.1016/j.ijrobp.2008.02.048
8. Schwartz DL, Hutcheson K, Barringer D, et al. Candidate dosimetric predictors of long-term swallowing dysfunction after oropharyngeal intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2010;78(5):1356-1365. doi:10.1016/j.ijrobp.2009.10.002
9. Gensheimer MF, Nyflot M, Laramore GE, Laio JL, Parvathaneni U. Contribution of submandibular gland and swallowing structure sparing to post-radiation therapy peg dependence in oropharynx cancer patients treated with split-neck IMRT technique. Radiat Oncol. 2015;11(1):1-7. doi:10.1186/s13014-016-0726-3
10. Hedström J, Tuomi L, Finizia C, Olsson C. Identifying organs at risk for radiation-induced late dysphagia in head and neck cancer patients. Clin Transl Radiat Oncol. 2019;19:87-95. doi:10.1016/j.ctro.2019.08.005
11. Bhide SA, Gulliford S, Kazi R, et al. Correlation between dose to the pharyngeal constrictors and patient quality of life and late dysphagia following chemo-IMRT for head and neck cancer. Radiother Oncol. 2009;93(3):539-544. doi:10.1016/j.radonc.2009.09.017
12. Caudell JJ, Schaner PE, Desmond RA, Meredith RF, Spencer SA, Bonner JA. Dosimetric factors associated with long-term dysphagia after definitive radiotherapy for squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2010;76(2):403-409. doi:10.1016/j.ijrobp.2009.02.017
13. Levendag PC, Teguh DN, Voet P, et al. Dysphagia disorders in patients with cancer of the oropharynx are significantly affected by the radiation therapy dose to the superior and middle constrictor muscle: a dose-effect relationship. Radiother Oncol. 2007;85(1):64-73. doi:10.1016/j.radonc.2007.07.009
14. Eisbruch A, Schwartz M, Rasch C, et al. Dysphagia and aspiration after chemoradiotherapy for head-and-neck cancer: which anatomic structures are affected and can they be spared by IMRT? Int J Radiat Oncol Biol Phys. 2004;60(5):1425-1439. doi:10.1016/j.ijrobp.2004.05.050
15. Harari PM; NRG Oncology. Comparing high-dose cisplatin every three weeks to low-dose cisplatin weekly when combined with radiation for patients with advanced head and neck cancer. ClinicalTrials.gov identifier: NCT05050162. Updated November 25, 2022. Accessed December 7, 2022. https://clinicaltrials.gov/ct2/show/NCT05050162
16. Wang JJ, Goldsmith TA, Holman AS, Cianchetti M, Chan AW. Pharyngoesophageal stricture after treatment for head and neck cancer. Head Neck. 2011;34(7):967-973. doi:10.1002/hed.21842
17. Kendall KA, McKenzie SW, Leonard RJ, Jones CU. Timing of swallowing events after single-modality treatment of head and neck carcinoma with radiotherapy. Ann Otol Rhinol Laryngol. 2000;109(8, pt 1):767-775. doi:10.1177/000348940010900812
18. Ohmae Y, Ogura M, Kitahara S. Effects of head rotation on pharyngeal function during normal swallow. Ann Otol Rhinol Laryngol. 1998;107(4):344-348. doi:10.1177/000348949810700414
19. Spencer CR, Gay HA, Haughey BH, et al. Eliminating radiotherapy to the contralateral retropharyngeal and high level II lymph nodes in head and neck squamous cell carcinoma is safe and improves quality of life. Cancer. 2014;120(24):3994-4002. doi:10.1002/cncr.28938
Radiation therapy can cause long-term dysphagia that seriously affects quality of life for survivors of head and neck (H&N) cancer.1-3 Numerous studies have linked pharyngeal constrictor dose to long-term dysphagia, but conclusions about the dose distribution that can be safely tolerated have been inconsistent. For example, a group from the Netherlands found that the mean dose to the superior pharyngeal constrictor muscle and the supraglottic larynx were each predictive of dysphagia.4 A subsequent Vanderbilt study refuted these findings, reporting that these structures were not predictive but that dose to the inferior pharyngeal constrictor muscle was.5 Other studies have connected late dysphagia with dose to the middle pharyngeal constrictor muscle, total larynx, oral cavity, contralateral submandibular gland, contralateral parotid gland, or a combination of these structures.6-14 NRG Oncology trials commonly evaluate dose to the “uninvolved pharynx,” which is the total pharyngeal constrictor muscle volume minus the planning target volume for the lowest dose target volume. NRG H&N trials 3, 4, 5, 6, 8, and 9 all use uninvolved pharynx mean dose ≤ 45 Gy as a constraint to judge radiation plan quality.
Differences in methodology or patient population may explain the inconsistency of prior studies on dosimetric predictors of dysphagia, but it is possible that these studies did not evaluate the optimal metric for dysphagia. This study evaluates a novel organ at risk, the contralateral pharyngeal constrictor muscle, to determine whether dose to this structure is predictive of late swallowing function. The study also compares a constraint based on this structure to the NRG uninvolved pharynx constraint mentioned earlier.
Methods
This study is a retrospective review of patients treated at the Richard L. Roudebush Veterans Affairs (VA) Medical Center in Indianapolis, Indiana. Patients were identified by searching the VA Cancer Registry for patients treated for H&N squamous cell carcinoma between September 1, 2016, and August 30, 2019. Eligible sites included cancers of the nasopharynx, oropharynx, hypopharynx, larynx and oral cavity, as well as H&N cancer of an unknown primary site. Only patients treated with primary radiation with concurrent systemic therapy were included. Patients were excluded if they had prior surgery or radiation to the H&N.
The pharyngeal constrictor muscles were contoured per the techniques described by Bhide and colleagues.11 The contralateral constrictor was defined as the half of the constrictor volume contralateral to the primary site. For midline tumors, the side of the neck with a lower volume of lymph node metastases was judged to be the contralateral side.
One-year dysphagia was defined as having a gastronomy tube (G-tube) in place or an abnormal modified barium swallow (MBS) ≥ 12 months after the completion of radiation. At the study institution, MBS is not routinely done after therapy but is ordered if a patient or clinician has concerns about swallowing function. MBS was considered abnormal if there was laryngeal penetration that reached the level of the glottis or was not ejected from the larynx.
Results
The VA Cancer Registry identified 113 patients treated for H&N cancer during the study period. Of these, 55 patients met the inclusion criteria. No patients were lost to follow-up. The median follow-up was 29 months. The median age was 67 years (range, 41-83) (Table 1).
All patients were treated with intensity-modulated radiotherapy (IMRT). Patients treated with a sequential boost had an initial dose of 54 Gy and/or 50 Gy, followed by a boost to a total of 70 Gy at 2 Gy per fraction. Patients treated with a simultaneous integrated boost (SIB) technique received 69.96 Gy in 33 fractions, with elective volumes treated to 54.45 Gy in 33 fractions. Both patients with nasopharyngeal cancer were treated with SIB plans and had an intermediate dose volume of 59.4 Gy.
Systemic therapy was weekly cisplatin in 41 patients (75%) and cetuximab in 14 (25%). Twenty percent of patients receiving cisplatin switched to an alternative agent during treatment, most commonly carboplatin.
Forty-nine patients (89%) had a G-tube placed before starting radiation. G-tubes were in place for an interval of 0 to 47 months (mean, 8.6); 12 (22%) had a G-tube > 12 months. After completion of radiation, 18 patients (33%) had an abnormal MBS. These were done 1 to 50 months (mean, 14.8) after completion of radiation. Abnormal MBS occurred ≥ 12 months after radiation in 9 patients, 5 of whom had their G-tube in place for less than a year.
Forty-six patients (84%) survived more than 1 year and could be evaluated for late swallowing function. One-year dysphagia was seen in 17 (37%) of these patients. Recurrence was seen in 20 patients (36%), with locoregional recurrence in 12 (60%) of these cases. Recurrence occurred at a range of 0 to 15 months (mean, 5.6). Neither recurrence (P = .69) nor locoregional recurrence (P = .11) was associated with increased 1-year dysphagia.
In patients who could be evaluated for long-term swallowing function, contralateral constrictor V60 ranged from 0% to 100% (median, 51%). V60 was < 40% in 18 patients (39%). With V60 < 40%, there was a 6% rate of 1-year dysphagia compared with 57% for V60 ≥ 40% (P < .001).
Patients with contralateral constrictor V60 < 40 and V60 ≥ 40 both had a mean age of 65 years. χ2 analysis did not show a difference in T stage or systemic treatment but did show that patients with V60 < 40% were more likely to have N1 disease (P = .01), and less likely to have N2 disease (P = .01) compared with patients with V60 ≥ 40%. The difference in 1-year dysphagia between N0 to N1 patients (27%) and N2 to N3 patients (46%) was not statistically significant (P = .19).
In patients who could be evaluated for long-term swallowing function, the uninvolved pharynx volume median of the total constrictor volume was 32% (range, < 1%-62%). The uninvolved pharynx mean dose ranged from 28 to 68 Gy (median, 45). When the uninvolved pharynx mean dose was < 45 Gy, 1-year dysphagia was 22% compared with 52% with a dose ≥ 45 Gy (P = .03).
Air cavity editing was performed in 27 patients (49%). One-year survival was 93% with air cavity editing, and 75% without, which was not statistically significant. Locoregional recurrence occurred in 3 patients (11%) with air cavity editing, and 9 (32%) without, which was not statistically significant. In patients surviving at least 1 year, contralateral constrictor V60 averaged 33% with editing and 62% without editing (P < .001). One-year dysphagia was 12% with air cavity editing and 67% without editing (P < .001).
An SIB technique was done in 26 patients (47%). One-year survival was 85% (n = 22) with SIB and 83% (n = 24) with sequential boost, which was not statistically significant. Locoregional recurrence occurred in 19% with SIB, and 32% with sequential boost, which was not statistically significant. For SIB patients alive at 1 year, the median contralateral V60 was 28%, compared with 66% for patients treated with sequential technique. Seventeen patients (77%) with SIB had V60 < 40%. Nineteen (86%) of SIB plans also had air cavity editing. One patient (5%) with SIB had dysphagia at 1 year, compared with 16 (67%) sequential patients (P < .001).
Discussion
This is the first study to link contralateral constrictor dose to long-term dysphagia in patients treated with radiation for H&N cancer. Editing the boost volume off air cavities was associated with lower contralateral constrictor V60 and with less long-term dysphagia. This may indicate that optimizing plans to meet a contralateral constrictor constraint can reduce rates of long-term dysphagia.
The most useful clinical predictors are those that identify a patient at low risk for toxicity. These constraints are useful because they reassure physicians that treatments will have a favorable risk/benefit ratio while identifying plans that may need modification before starting treatment.
The contralateral constrictor outperformed the uninvolved pharynx in identifying patients at low risk for long-term dysphagia. This difference could not be overcome by decreasing the threshold of the pharynx constraint, as 17% of patients with dysphagia had a mean dose of < 40 Gy to the uninvolved pharynx, which was not statistically significant.
An advantage of contralateral constrictor is that it is independent of planning target volume (PTV) size. The uninvolved pharynx structure depends on the PTV contour, so it may obscure a connection between PTV size and dysphagia.
In the context of a clinical trial, only measuring dose to the uninvolved pharynx may allow more plans to meet constraints, but even in NRG trials, physicians have some control over target volumes. For example, NRG HN009, a national trial for patients with H&N cancer, recommends editing the CTV_7000 (clinical target volume treated to 70 Gy) off air cavities but does not define how much the volume should be cropped or specify protocol violations if the volume is not cropped.15 Furthermore, constraints used in clinical trials are often adopted for use outside the trial, where physicians have extensive control over target volumes.
The broad range of uninvolved pharynx volume relative to total constrictor volume confounds predictions using this variable. For example, according to the NRG constraint, a patient with an uninvolved pharynx mean dose of 44 Gy will have a low risk of dysphagia even if this structure is only 1% of the total constrictor. The contralateral constrictor is always about 50% of the total constrictor volume, which means that predictions using this structure will not be confounded by the same variation in volume size.
Figure 2 shows a representative patient who met the NRG uninvolved pharynx constraint but developed long-term dysphagia.
Pharyngoesophageal stricture is a common cause of dysphagia after IMRT for H&N cancer.16 Radiation has been shown to decrease pharyngeal function in patients with H&N cancer.17 Sparing one side of the pharynx may allow for better pharyngeal compliance throughout the length of the pharynx, possibly decreasing the rate of pharyngoesophageal stricture. Additionally, constraining the contralateral constrictor may preserve strength on this side, allowing it to compensate for weakness on the side of the primary cancer. An exercise sometimes used for dysphagia involves head rotation toward the affected side during swallowing. This technique has been shown to cause food to move to the unaffected side.18 Sparing the contralateral constrictor may help such techniques work better in patients with H&N cancer.
Few studies have commented specifically on dose to swallowing structures contralateral to the primary tumor. Two studies have proposed contralateral submandibular gland constraints for dysphagia (not xerostomia), but neither measured the dose to the contralateral constrictor muscle.9,10 Although the contralateral submandibular dose may correlate with dose to the constrictor on that side, the submandibular gland may have a less direct impact on swallowing than the constrictor muscle, and its limited dimensions may make constraints based on the gland less robust for cancers outside the oropharynx.
Another study reported improved quality of life in patients who were not treated with elective contralateral retropharyngeal radiation.19 Although it is likely that doses to the contralateral constrictor were lower in patients who did not receive elective radiation to this area, this study did not measure or constrain doses to the contralateral constrictors.
Limitations
This study is limited by its single institution, retrospective design, small sample size, and by all patients being male. The high correlation between air cavity editing and the use of SIB makes it impossible to assess the impact of each technique individually. Patients with contralateral constrictor V60 < 40% were less likely to have N2 disease, but N2 to N3 disease did not predict higher 1-year dysphagia, so the difference in N-category cannot fully explain the difference in 1-year dysphagia. It is possible that unreported factors, such as CTV, may contribute significantly to swallowing function. Nevertheless, within the study population, contralateral constrictor dose was able to identify a group with a low rate of long-term dysphagia.
Conclusions
Contralateral constrictor dose is a promising predictor of late dysphagia for patients with H&N cancer treated with radiation with concurrent systemic therapy. Contralateral constrictor V60 < 40% was able to identify a group of patients with a low rate of 1-year dysphagia in this single-center retrospective study. The correlation between air cavity editing and contralateral constrictor V60 suggests that contralateral constrictor dose may depend partly on technique. Further studies are needed to see if the contralateral constrictor dose can be used to predict long-term dysphagia prospectively and in other patient populations.
Radiation therapy can cause long-term dysphagia that seriously affects quality of life for survivors of head and neck (H&N) cancer.1-3 Numerous studies have linked pharyngeal constrictor dose to long-term dysphagia, but conclusions about the dose distribution that can be safely tolerated have been inconsistent. For example, a group from the Netherlands found that the mean dose to the superior pharyngeal constrictor muscle and the supraglottic larynx were each predictive of dysphagia.4 A subsequent Vanderbilt study refuted these findings, reporting that these structures were not predictive but that dose to the inferior pharyngeal constrictor muscle was.5 Other studies have connected late dysphagia with dose to the middle pharyngeal constrictor muscle, total larynx, oral cavity, contralateral submandibular gland, contralateral parotid gland, or a combination of these structures.6-14 NRG Oncology trials commonly evaluate dose to the “uninvolved pharynx,” which is the total pharyngeal constrictor muscle volume minus the planning target volume for the lowest dose target volume. NRG H&N trials 3, 4, 5, 6, 8, and 9 all use uninvolved pharynx mean dose ≤ 45 Gy as a constraint to judge radiation plan quality.
Differences in methodology or patient population may explain the inconsistency of prior studies on dosimetric predictors of dysphagia, but it is possible that these studies did not evaluate the optimal metric for dysphagia. This study evaluates a novel organ at risk, the contralateral pharyngeal constrictor muscle, to determine whether dose to this structure is predictive of late swallowing function. The study also compares a constraint based on this structure to the NRG uninvolved pharynx constraint mentioned earlier.
Methods
This study is a retrospective review of patients treated at the Richard L. Roudebush Veterans Affairs (VA) Medical Center in Indianapolis, Indiana. Patients were identified by searching the VA Cancer Registry for patients treated for H&N squamous cell carcinoma between September 1, 2016, and August 30, 2019. Eligible sites included cancers of the nasopharynx, oropharynx, hypopharynx, larynx and oral cavity, as well as H&N cancer of an unknown primary site. Only patients treated with primary radiation with concurrent systemic therapy were included. Patients were excluded if they had prior surgery or radiation to the H&N.
The pharyngeal constrictor muscles were contoured per the techniques described by Bhide and colleagues.11 The contralateral constrictor was defined as the half of the constrictor volume contralateral to the primary site. For midline tumors, the side of the neck with a lower volume of lymph node metastases was judged to be the contralateral side.
One-year dysphagia was defined as having a gastronomy tube (G-tube) in place or an abnormal modified barium swallow (MBS) ≥ 12 months after the completion of radiation. At the study institution, MBS is not routinely done after therapy but is ordered if a patient or clinician has concerns about swallowing function. MBS was considered abnormal if there was laryngeal penetration that reached the level of the glottis or was not ejected from the larynx.
Results
The VA Cancer Registry identified 113 patients treated for H&N cancer during the study period. Of these, 55 patients met the inclusion criteria. No patients were lost to follow-up. The median follow-up was 29 months. The median age was 67 years (range, 41-83) (Table 1).
All patients were treated with intensity-modulated radiotherapy (IMRT). Patients treated with a sequential boost had an initial dose of 54 Gy and/or 50 Gy, followed by a boost to a total of 70 Gy at 2 Gy per fraction. Patients treated with a simultaneous integrated boost (SIB) technique received 69.96 Gy in 33 fractions, with elective volumes treated to 54.45 Gy in 33 fractions. Both patients with nasopharyngeal cancer were treated with SIB plans and had an intermediate dose volume of 59.4 Gy.
Systemic therapy was weekly cisplatin in 41 patients (75%) and cetuximab in 14 (25%). Twenty percent of patients receiving cisplatin switched to an alternative agent during treatment, most commonly carboplatin.
Forty-nine patients (89%) had a G-tube placed before starting radiation. G-tubes were in place for an interval of 0 to 47 months (mean, 8.6); 12 (22%) had a G-tube > 12 months. After completion of radiation, 18 patients (33%) had an abnormal MBS. These were done 1 to 50 months (mean, 14.8) after completion of radiation. Abnormal MBS occurred ≥ 12 months after radiation in 9 patients, 5 of whom had their G-tube in place for less than a year.
Forty-six patients (84%) survived more than 1 year and could be evaluated for late swallowing function. One-year dysphagia was seen in 17 (37%) of these patients. Recurrence was seen in 20 patients (36%), with locoregional recurrence in 12 (60%) of these cases. Recurrence occurred at a range of 0 to 15 months (mean, 5.6). Neither recurrence (P = .69) nor locoregional recurrence (P = .11) was associated with increased 1-year dysphagia.
In patients who could be evaluated for long-term swallowing function, contralateral constrictor V60 ranged from 0% to 100% (median, 51%). V60 was < 40% in 18 patients (39%). With V60 < 40%, there was a 6% rate of 1-year dysphagia compared with 57% for V60 ≥ 40% (P < .001).
Patients with contralateral constrictor V60 < 40 and V60 ≥ 40 both had a mean age of 65 years. χ2 analysis did not show a difference in T stage or systemic treatment but did show that patients with V60 < 40% were more likely to have N1 disease (P = .01), and less likely to have N2 disease (P = .01) compared with patients with V60 ≥ 40%. The difference in 1-year dysphagia between N0 to N1 patients (27%) and N2 to N3 patients (46%) was not statistically significant (P = .19).
In patients who could be evaluated for long-term swallowing function, the uninvolved pharynx volume median of the total constrictor volume was 32% (range, < 1%-62%). The uninvolved pharynx mean dose ranged from 28 to 68 Gy (median, 45). When the uninvolved pharynx mean dose was < 45 Gy, 1-year dysphagia was 22% compared with 52% with a dose ≥ 45 Gy (P = .03).
Air cavity editing was performed in 27 patients (49%). One-year survival was 93% with air cavity editing, and 75% without, which was not statistically significant. Locoregional recurrence occurred in 3 patients (11%) with air cavity editing, and 9 (32%) without, which was not statistically significant. In patients surviving at least 1 year, contralateral constrictor V60 averaged 33% with editing and 62% without editing (P < .001). One-year dysphagia was 12% with air cavity editing and 67% without editing (P < .001).
An SIB technique was done in 26 patients (47%). One-year survival was 85% (n = 22) with SIB and 83% (n = 24) with sequential boost, which was not statistically significant. Locoregional recurrence occurred in 19% with SIB, and 32% with sequential boost, which was not statistically significant. For SIB patients alive at 1 year, the median contralateral V60 was 28%, compared with 66% for patients treated with sequential technique. Seventeen patients (77%) with SIB had V60 < 40%. Nineteen (86%) of SIB plans also had air cavity editing. One patient (5%) with SIB had dysphagia at 1 year, compared with 16 (67%) sequential patients (P < .001).
Discussion
This is the first study to link contralateral constrictor dose to long-term dysphagia in patients treated with radiation for H&N cancer. Editing the boost volume off air cavities was associated with lower contralateral constrictor V60 and with less long-term dysphagia. This may indicate that optimizing plans to meet a contralateral constrictor constraint can reduce rates of long-term dysphagia.
The most useful clinical predictors are those that identify a patient at low risk for toxicity. These constraints are useful because they reassure physicians that treatments will have a favorable risk/benefit ratio while identifying plans that may need modification before starting treatment.
The contralateral constrictor outperformed the uninvolved pharynx in identifying patients at low risk for long-term dysphagia. This difference could not be overcome by decreasing the threshold of the pharynx constraint, as 17% of patients with dysphagia had a mean dose of < 40 Gy to the uninvolved pharynx, which was not statistically significant.
An advantage of contralateral constrictor is that it is independent of planning target volume (PTV) size. The uninvolved pharynx structure depends on the PTV contour, so it may obscure a connection between PTV size and dysphagia.
In the context of a clinical trial, only measuring dose to the uninvolved pharynx may allow more plans to meet constraints, but even in NRG trials, physicians have some control over target volumes. For example, NRG HN009, a national trial for patients with H&N cancer, recommends editing the CTV_7000 (clinical target volume treated to 70 Gy) off air cavities but does not define how much the volume should be cropped or specify protocol violations if the volume is not cropped.15 Furthermore, constraints used in clinical trials are often adopted for use outside the trial, where physicians have extensive control over target volumes.
The broad range of uninvolved pharynx volume relative to total constrictor volume confounds predictions using this variable. For example, according to the NRG constraint, a patient with an uninvolved pharynx mean dose of 44 Gy will have a low risk of dysphagia even if this structure is only 1% of the total constrictor. The contralateral constrictor is always about 50% of the total constrictor volume, which means that predictions using this structure will not be confounded by the same variation in volume size.
Figure 2 shows a representative patient who met the NRG uninvolved pharynx constraint but developed long-term dysphagia.
Pharyngoesophageal stricture is a common cause of dysphagia after IMRT for H&N cancer.16 Radiation has been shown to decrease pharyngeal function in patients with H&N cancer.17 Sparing one side of the pharynx may allow for better pharyngeal compliance throughout the length of the pharynx, possibly decreasing the rate of pharyngoesophageal stricture. Additionally, constraining the contralateral constrictor may preserve strength on this side, allowing it to compensate for weakness on the side of the primary cancer. An exercise sometimes used for dysphagia involves head rotation toward the affected side during swallowing. This technique has been shown to cause food to move to the unaffected side.18 Sparing the contralateral constrictor may help such techniques work better in patients with H&N cancer.
Few studies have commented specifically on dose to swallowing structures contralateral to the primary tumor. Two studies have proposed contralateral submandibular gland constraints for dysphagia (not xerostomia), but neither measured the dose to the contralateral constrictor muscle.9,10 Although the contralateral submandibular dose may correlate with dose to the constrictor on that side, the submandibular gland may have a less direct impact on swallowing than the constrictor muscle, and its limited dimensions may make constraints based on the gland less robust for cancers outside the oropharynx.
Another study reported improved quality of life in patients who were not treated with elective contralateral retropharyngeal radiation.19 Although it is likely that doses to the contralateral constrictor were lower in patients who did not receive elective radiation to this area, this study did not measure or constrain doses to the contralateral constrictors.
Limitations
This study is limited by its single institution, retrospective design, small sample size, and by all patients being male. The high correlation between air cavity editing and the use of SIB makes it impossible to assess the impact of each technique individually. Patients with contralateral constrictor V60 < 40% were less likely to have N2 disease, but N2 to N3 disease did not predict higher 1-year dysphagia, so the difference in N-category cannot fully explain the difference in 1-year dysphagia. It is possible that unreported factors, such as CTV, may contribute significantly to swallowing function. Nevertheless, within the study population, contralateral constrictor dose was able to identify a group with a low rate of long-term dysphagia.
Conclusions
Contralateral constrictor dose is a promising predictor of late dysphagia for patients with H&N cancer treated with radiation with concurrent systemic therapy. Contralateral constrictor V60 < 40% was able to identify a group of patients with a low rate of 1-year dysphagia in this single-center retrospective study. The correlation between air cavity editing and contralateral constrictor V60 suggests that contralateral constrictor dose may depend partly on technique. Further studies are needed to see if the contralateral constrictor dose can be used to predict long-term dysphagia prospectively and in other patient populations.
1. Langendijk JA, Doornaert P, Verdonck-de Leeuw IM, et al. Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy. J Clin Oncol. 2008;26(22):3770-3776. doi:10.1200/JCO.2007.14.6647
2. Nguyen NP, Frank C, Moltz CC, et al. Impact of dysphagia on quality of life after treatment of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2005;61(3):772-778. doi:10.1016/j.ijrobp.2004.06.017
3. Ramaekers BLT, Joore MA, Grutters JPC, et al. The impact of late treatment-toxicity on generic health-related quality of life in head and neck cancer patients after radiotherapy. Oral Oncol. 2011;47(8):768-774. doi:10.1016/j.oraloncology.2011.05.012
4. Christianen MEMC, Schilstra C, Beetz I, et al. Predictive modelling for swallowing dysfunction after primary (chemo)radiation: results of a prospective observational study. Radiother Oncol. 2012;105(1):107-114. doi:10.1016/j.radonc.2011.08.009
5. Vlachich G, Spratt DE, Diaz R, et al. Dose to inferior pharyngeal conctrictor predicts prolonged gastrostomy tube dependence with concurrent intensity-modulated radiation therapy and chemotherapy for locally-advanced head and neck cancer. Radiother Oncol. 2014;110(3):435-440. doi:10.1016/j.radonc.2013.12.007
6. Mogadas S, Busch CJ, Pflug Cet al. Influence of radiation dose to pharyngeal constrictor muscles on late dysphagia and quality of life in patients with locally advanced oropharyngeal carcinoma. Strahlenther Onkol. 2020;196(6):522-529. doi:10.1007/s00066-019-01572-0
7. Caglar HB, Tishler RB, Othus M, et al. Dose to larynx predicts of swallowing complications after intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2008;72(4):1110-1118. doi:10.1016/j.ijrobp.2008.02.048
8. Schwartz DL, Hutcheson K, Barringer D, et al. Candidate dosimetric predictors of long-term swallowing dysfunction after oropharyngeal intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2010;78(5):1356-1365. doi:10.1016/j.ijrobp.2009.10.002
9. Gensheimer MF, Nyflot M, Laramore GE, Laio JL, Parvathaneni U. Contribution of submandibular gland and swallowing structure sparing to post-radiation therapy peg dependence in oropharynx cancer patients treated with split-neck IMRT technique. Radiat Oncol. 2015;11(1):1-7. doi:10.1186/s13014-016-0726-3
10. Hedström J, Tuomi L, Finizia C, Olsson C. Identifying organs at risk for radiation-induced late dysphagia in head and neck cancer patients. Clin Transl Radiat Oncol. 2019;19:87-95. doi:10.1016/j.ctro.2019.08.005
11. Bhide SA, Gulliford S, Kazi R, et al. Correlation between dose to the pharyngeal constrictors and patient quality of life and late dysphagia following chemo-IMRT for head and neck cancer. Radiother Oncol. 2009;93(3):539-544. doi:10.1016/j.radonc.2009.09.017
12. Caudell JJ, Schaner PE, Desmond RA, Meredith RF, Spencer SA, Bonner JA. Dosimetric factors associated with long-term dysphagia after definitive radiotherapy for squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2010;76(2):403-409. doi:10.1016/j.ijrobp.2009.02.017
13. Levendag PC, Teguh DN, Voet P, et al. Dysphagia disorders in patients with cancer of the oropharynx are significantly affected by the radiation therapy dose to the superior and middle constrictor muscle: a dose-effect relationship. Radiother Oncol. 2007;85(1):64-73. doi:10.1016/j.radonc.2007.07.009
14. Eisbruch A, Schwartz M, Rasch C, et al. Dysphagia and aspiration after chemoradiotherapy for head-and-neck cancer: which anatomic structures are affected and can they be spared by IMRT? Int J Radiat Oncol Biol Phys. 2004;60(5):1425-1439. doi:10.1016/j.ijrobp.2004.05.050
15. Harari PM; NRG Oncology. Comparing high-dose cisplatin every three weeks to low-dose cisplatin weekly when combined with radiation for patients with advanced head and neck cancer. ClinicalTrials.gov identifier: NCT05050162. Updated November 25, 2022. Accessed December 7, 2022. https://clinicaltrials.gov/ct2/show/NCT05050162
16. Wang JJ, Goldsmith TA, Holman AS, Cianchetti M, Chan AW. Pharyngoesophageal stricture after treatment for head and neck cancer. Head Neck. 2011;34(7):967-973. doi:10.1002/hed.21842
17. Kendall KA, McKenzie SW, Leonard RJ, Jones CU. Timing of swallowing events after single-modality treatment of head and neck carcinoma with radiotherapy. Ann Otol Rhinol Laryngol. 2000;109(8, pt 1):767-775. doi:10.1177/000348940010900812
18. Ohmae Y, Ogura M, Kitahara S. Effects of head rotation on pharyngeal function during normal swallow. Ann Otol Rhinol Laryngol. 1998;107(4):344-348. doi:10.1177/000348949810700414
19. Spencer CR, Gay HA, Haughey BH, et al. Eliminating radiotherapy to the contralateral retropharyngeal and high level II lymph nodes in head and neck squamous cell carcinoma is safe and improves quality of life. Cancer. 2014;120(24):3994-4002. doi:10.1002/cncr.28938
1. Langendijk JA, Doornaert P, Verdonck-de Leeuw IM, et al. Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy. J Clin Oncol. 2008;26(22):3770-3776. doi:10.1200/JCO.2007.14.6647
2. Nguyen NP, Frank C, Moltz CC, et al. Impact of dysphagia on quality of life after treatment of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2005;61(3):772-778. doi:10.1016/j.ijrobp.2004.06.017
3. Ramaekers BLT, Joore MA, Grutters JPC, et al. The impact of late treatment-toxicity on generic health-related quality of life in head and neck cancer patients after radiotherapy. Oral Oncol. 2011;47(8):768-774. doi:10.1016/j.oraloncology.2011.05.012
4. Christianen MEMC, Schilstra C, Beetz I, et al. Predictive modelling for swallowing dysfunction after primary (chemo)radiation: results of a prospective observational study. Radiother Oncol. 2012;105(1):107-114. doi:10.1016/j.radonc.2011.08.009
5. Vlachich G, Spratt DE, Diaz R, et al. Dose to inferior pharyngeal conctrictor predicts prolonged gastrostomy tube dependence with concurrent intensity-modulated radiation therapy and chemotherapy for locally-advanced head and neck cancer. Radiother Oncol. 2014;110(3):435-440. doi:10.1016/j.radonc.2013.12.007
6. Mogadas S, Busch CJ, Pflug Cet al. Influence of radiation dose to pharyngeal constrictor muscles on late dysphagia and quality of life in patients with locally advanced oropharyngeal carcinoma. Strahlenther Onkol. 2020;196(6):522-529. doi:10.1007/s00066-019-01572-0
7. Caglar HB, Tishler RB, Othus M, et al. Dose to larynx predicts of swallowing complications after intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2008;72(4):1110-1118. doi:10.1016/j.ijrobp.2008.02.048
8. Schwartz DL, Hutcheson K, Barringer D, et al. Candidate dosimetric predictors of long-term swallowing dysfunction after oropharyngeal intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2010;78(5):1356-1365. doi:10.1016/j.ijrobp.2009.10.002
9. Gensheimer MF, Nyflot M, Laramore GE, Laio JL, Parvathaneni U. Contribution of submandibular gland and swallowing structure sparing to post-radiation therapy peg dependence in oropharynx cancer patients treated with split-neck IMRT technique. Radiat Oncol. 2015;11(1):1-7. doi:10.1186/s13014-016-0726-3
10. Hedström J, Tuomi L, Finizia C, Olsson C. Identifying organs at risk for radiation-induced late dysphagia in head and neck cancer patients. Clin Transl Radiat Oncol. 2019;19:87-95. doi:10.1016/j.ctro.2019.08.005
11. Bhide SA, Gulliford S, Kazi R, et al. Correlation between dose to the pharyngeal constrictors and patient quality of life and late dysphagia following chemo-IMRT for head and neck cancer. Radiother Oncol. 2009;93(3):539-544. doi:10.1016/j.radonc.2009.09.017
12. Caudell JJ, Schaner PE, Desmond RA, Meredith RF, Spencer SA, Bonner JA. Dosimetric factors associated with long-term dysphagia after definitive radiotherapy for squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2010;76(2):403-409. doi:10.1016/j.ijrobp.2009.02.017
13. Levendag PC, Teguh DN, Voet P, et al. Dysphagia disorders in patients with cancer of the oropharynx are significantly affected by the radiation therapy dose to the superior and middle constrictor muscle: a dose-effect relationship. Radiother Oncol. 2007;85(1):64-73. doi:10.1016/j.radonc.2007.07.009
14. Eisbruch A, Schwartz M, Rasch C, et al. Dysphagia and aspiration after chemoradiotherapy for head-and-neck cancer: which anatomic structures are affected and can they be spared by IMRT? Int J Radiat Oncol Biol Phys. 2004;60(5):1425-1439. doi:10.1016/j.ijrobp.2004.05.050
15. Harari PM; NRG Oncology. Comparing high-dose cisplatin every three weeks to low-dose cisplatin weekly when combined with radiation for patients with advanced head and neck cancer. ClinicalTrials.gov identifier: NCT05050162. Updated November 25, 2022. Accessed December 7, 2022. https://clinicaltrials.gov/ct2/show/NCT05050162
16. Wang JJ, Goldsmith TA, Holman AS, Cianchetti M, Chan AW. Pharyngoesophageal stricture after treatment for head and neck cancer. Head Neck. 2011;34(7):967-973. doi:10.1002/hed.21842
17. Kendall KA, McKenzie SW, Leonard RJ, Jones CU. Timing of swallowing events after single-modality treatment of head and neck carcinoma with radiotherapy. Ann Otol Rhinol Laryngol. 2000;109(8, pt 1):767-775. doi:10.1177/000348940010900812
18. Ohmae Y, Ogura M, Kitahara S. Effects of head rotation on pharyngeal function during normal swallow. Ann Otol Rhinol Laryngol. 1998;107(4):344-348. doi:10.1177/000348949810700414
19. Spencer CR, Gay HA, Haughey BH, et al. Eliminating radiotherapy to the contralateral retropharyngeal and high level II lymph nodes in head and neck squamous cell carcinoma is safe and improves quality of life. Cancer. 2014;120(24):3994-4002. doi:10.1002/cncr.28938
Doctors of Virtue and Vice: The Best and Worst of Federal Practice in 2023
Regular readers of Federal Practitioner may recall that I have had a tradition of dedicating the last column of the year to an ethics rendition of the popular trope of the annual best and worst. This year we will examine the stories of 2 military physicians through the lens of virtue ethics. Aristotle (384-322
Virtue ethics is among the oldest of ethical theories, and Aristotle articulates this school of thought in his work Nicomachean Ethics.2 It is a good fit for Federal Practitioner as it has been constructively applied to the moral development of both military3 and medical professionals.4
Here is a Reader’s Digest version of virtue theory with apologizes to all the real philosophers out there. There are different ways to categorize ethical theories. One approach is to distinguish them based on the aspects of primary interest. Consequentialist ethics theories are concerned with the outcomes of actions. Deontologic theories emphasize the intention of the moral agent. In contrast, virtue ethics theories focus on the character of a person. The virtuous individual is one who has practiced the habits of moral excellence and embodies the good life. They are honored as heroes and revered as saints; they are the exemplars we imitate in our aspirations.3
The epigraph sums up one of Aristotle’s central philosophical doctrines: the close relationship of ethics and politics.1 Personal virtue is intelligible only in the context of community and aim, and the goal of virtue is to contribute to human happiness.5 War, whether in ancient Greece or modern Europe, is among the forces most inimical to human flourishing. The current war in Ukraine that has united much of the Western world in opposition to tyranny has divided the 2 physicians in our story along the normative lines of virtue ethics.
The doctor of virtue: Michael Siclari, MD. A 71-year-old US Department of Veterans Affairs physician, Siclari had previously served in the military as a National Guard physician during Operation Enduring Freedom (2001-2014) in Afghanistan. He decided to serve again in Ukraine. Siclari expressed his reasons for going to Ukraine in the language of what Aristotle thought was among the highest virtues: justice. “In retrospect, as I think about why I wanted to go to Ukraine, I think it’s more of a sense that I thought an injustice was happening.”7
Echoing the great Rabbi Hillel, Siclari saw the Russian invasion of Ukraine as a personal call to use his experience and training as a trauma and emergency medicine physician to help the Ukrainian people. “If not me, then who?” Siclari demonstrated another virtue: generosity in taking 10 days of personal leave in August 2022 to make the trip to Ukraine, hoping to work in a combat zone tending to wounded soldiers as he had in Afghanistan. When due to logistics he instead was assigned to care for refugees and assist with evacuations from the battlefield, he humbly and compassionately cared for those in his charge. Even now, back home, he speaks to audiences of health care professionals encouraging them to consider similar acts of altruism.5
Virtue for Aristotle is technically defined as the mean between 2 extremes of disposition or temperament. The virtue of courage is found in the moral middle ground between the deficiency of bravery that is cowardice and the vice of excess of reckless abandon. The former person fears too much and the latter too little and both thus exhibit vicious behavior.
The doctor of vice: James Lee Henry. Henry is a major and internal medicine physician in the United States Army stationed at Fort Bragg, headquarters of the US Army Special Operations Command. Along with his wife Anna Gabrielian, a civilian anesthesiologist, he was charged in September with conspiring to divulge the protected health information of American military and government employees to the Russian government.8 According to the Grand Jury indictment, Henry delivered into the hands of an undercover Federal Bureau of Investigation (FBI) agent, the medical records of a US Army officer, Department of Defense employee, and the spouses of 3 Army veterans, 2 of whom were deceased.9 In a gross twisting of virtue language, Gabrielian explained her motivation for the couple’s espionage in terms of sacrifice and loyalty. In an antipode of Siclari’s service, Henry purportedly wanted to join the Russian army but did not have the requisite combat experience. For his part, Henry’s abysmal defense of his betrayal of his country and his oath speaks for itself, if the United States were to declare war on Russia, Henry told the FBI agent, “at that point, I’ll have some ethical issues I have to work through.”8
We become virtuous people through imitating the example of those who have perfected the habits of moral excellence. During 2022, 2 federal practitioners responded to the challenge of war: one displayed the zenith of virtue, the other exhibited the nadir of vice. Seldom does a single year present us with such clear choices of who and how we want to be in 2023. American culture has so trivialized New Year’s resolutions that they are no longer substantive enough for the weight of the profound question of what constitutes the good life. Rather let us make a commitment in keeping with such morally serious matters. All of us live as mixed creatures, drawn to virtue and prone to vice. May we all strive this coming year to help each other meet the high bar another great man of virtue Abraham Lincoln set in his first inaugural address, to be the “better angels of our natures.”10
1. Aristotle. Politics. Book I, 1253.a31.
2. The Ethics of Aristotle. Aristotle. The Nicomachean Ethics. Thompson JAK, trans. Penguin Books; 1953.
3. Schonfeld TL, Hester DM. Brief introduction to ethics and ethical theory. In: Schonfeld TL, Hester DM, eds. Guidance for Healthcare Ethics Committees. 2nd ed. Cambridge University Press; 2022:11-19.
4. Olsthoorn P. Military Ethics and Virtues: An Interdisciplinary Approach for the 21st Century. Routledge; 2010.
5. Pellegrino ED, Thomasma DC. The Virtues in Medical Practice. Oxford University Press; 1993.
6. Edward Clayton. Aristotle Politics. In: Internet Encyclopedia of Philosophy. Accessed November 28, 2022. https://iep.utm.edu/aristotle-politics
7. Tippets R. A VA doctor’s calling to help in Ukraine. VA News. October 23, 2022. Accessed November 28, 2022. https://news.va.gov/109957/a-va-doctors-calling-to-help-in-ukraine
8. Lybrand H. US Army doctor and anesthesiologist charged with conspiring to US military records to the Russian government. CNN Politics, September 29, 2022. Accessed November 28, 2022 https://www.cnn.com/2022/09/29/politics/us-army-doctor-anesthesiologist-russian-government-medical-records
9. United States v Anna Gabrielian and James Lee Henry, (SD Md 2022). Accessed November 28, 2022. https://www.documentcloud.org/documents/23106067-gabrielian-and-henry-indictment
10. Lincoln A. First Inaugural Address of Abraham Lincoln. Accessed November 28, 2022. https://avalon.law.yale.edu/19th_century/lincoln1.asp
Regular readers of Federal Practitioner may recall that I have had a tradition of dedicating the last column of the year to an ethics rendition of the popular trope of the annual best and worst. This year we will examine the stories of 2 military physicians through the lens of virtue ethics. Aristotle (384-322
Virtue ethics is among the oldest of ethical theories, and Aristotle articulates this school of thought in his work Nicomachean Ethics.2 It is a good fit for Federal Practitioner as it has been constructively applied to the moral development of both military3 and medical professionals.4
Here is a Reader’s Digest version of virtue theory with apologizes to all the real philosophers out there. There are different ways to categorize ethical theories. One approach is to distinguish them based on the aspects of primary interest. Consequentialist ethics theories are concerned with the outcomes of actions. Deontologic theories emphasize the intention of the moral agent. In contrast, virtue ethics theories focus on the character of a person. The virtuous individual is one who has practiced the habits of moral excellence and embodies the good life. They are honored as heroes and revered as saints; they are the exemplars we imitate in our aspirations.3
The epigraph sums up one of Aristotle’s central philosophical doctrines: the close relationship of ethics and politics.1 Personal virtue is intelligible only in the context of community and aim, and the goal of virtue is to contribute to human happiness.5 War, whether in ancient Greece or modern Europe, is among the forces most inimical to human flourishing. The current war in Ukraine that has united much of the Western world in opposition to tyranny has divided the 2 physicians in our story along the normative lines of virtue ethics.
The doctor of virtue: Michael Siclari, MD. A 71-year-old US Department of Veterans Affairs physician, Siclari had previously served in the military as a National Guard physician during Operation Enduring Freedom (2001-2014) in Afghanistan. He decided to serve again in Ukraine. Siclari expressed his reasons for going to Ukraine in the language of what Aristotle thought was among the highest virtues: justice. “In retrospect, as I think about why I wanted to go to Ukraine, I think it’s more of a sense that I thought an injustice was happening.”7
Echoing the great Rabbi Hillel, Siclari saw the Russian invasion of Ukraine as a personal call to use his experience and training as a trauma and emergency medicine physician to help the Ukrainian people. “If not me, then who?” Siclari demonstrated another virtue: generosity in taking 10 days of personal leave in August 2022 to make the trip to Ukraine, hoping to work in a combat zone tending to wounded soldiers as he had in Afghanistan. When due to logistics he instead was assigned to care for refugees and assist with evacuations from the battlefield, he humbly and compassionately cared for those in his charge. Even now, back home, he speaks to audiences of health care professionals encouraging them to consider similar acts of altruism.5
Virtue for Aristotle is technically defined as the mean between 2 extremes of disposition or temperament. The virtue of courage is found in the moral middle ground between the deficiency of bravery that is cowardice and the vice of excess of reckless abandon. The former person fears too much and the latter too little and both thus exhibit vicious behavior.
The doctor of vice: James Lee Henry. Henry is a major and internal medicine physician in the United States Army stationed at Fort Bragg, headquarters of the US Army Special Operations Command. Along with his wife Anna Gabrielian, a civilian anesthesiologist, he was charged in September with conspiring to divulge the protected health information of American military and government employees to the Russian government.8 According to the Grand Jury indictment, Henry delivered into the hands of an undercover Federal Bureau of Investigation (FBI) agent, the medical records of a US Army officer, Department of Defense employee, and the spouses of 3 Army veterans, 2 of whom were deceased.9 In a gross twisting of virtue language, Gabrielian explained her motivation for the couple’s espionage in terms of sacrifice and loyalty. In an antipode of Siclari’s service, Henry purportedly wanted to join the Russian army but did not have the requisite combat experience. For his part, Henry’s abysmal defense of his betrayal of his country and his oath speaks for itself, if the United States were to declare war on Russia, Henry told the FBI agent, “at that point, I’ll have some ethical issues I have to work through.”8
We become virtuous people through imitating the example of those who have perfected the habits of moral excellence. During 2022, 2 federal practitioners responded to the challenge of war: one displayed the zenith of virtue, the other exhibited the nadir of vice. Seldom does a single year present us with such clear choices of who and how we want to be in 2023. American culture has so trivialized New Year’s resolutions that they are no longer substantive enough for the weight of the profound question of what constitutes the good life. Rather let us make a commitment in keeping with such morally serious matters. All of us live as mixed creatures, drawn to virtue and prone to vice. May we all strive this coming year to help each other meet the high bar another great man of virtue Abraham Lincoln set in his first inaugural address, to be the “better angels of our natures.”10
Regular readers of Federal Practitioner may recall that I have had a tradition of dedicating the last column of the year to an ethics rendition of the popular trope of the annual best and worst. This year we will examine the stories of 2 military physicians through the lens of virtue ethics. Aristotle (384-322
Virtue ethics is among the oldest of ethical theories, and Aristotle articulates this school of thought in his work Nicomachean Ethics.2 It is a good fit for Federal Practitioner as it has been constructively applied to the moral development of both military3 and medical professionals.4
Here is a Reader’s Digest version of virtue theory with apologizes to all the real philosophers out there. There are different ways to categorize ethical theories. One approach is to distinguish them based on the aspects of primary interest. Consequentialist ethics theories are concerned with the outcomes of actions. Deontologic theories emphasize the intention of the moral agent. In contrast, virtue ethics theories focus on the character of a person. The virtuous individual is one who has practiced the habits of moral excellence and embodies the good life. They are honored as heroes and revered as saints; they are the exemplars we imitate in our aspirations.3
The epigraph sums up one of Aristotle’s central philosophical doctrines: the close relationship of ethics and politics.1 Personal virtue is intelligible only in the context of community and aim, and the goal of virtue is to contribute to human happiness.5 War, whether in ancient Greece or modern Europe, is among the forces most inimical to human flourishing. The current war in Ukraine that has united much of the Western world in opposition to tyranny has divided the 2 physicians in our story along the normative lines of virtue ethics.
The doctor of virtue: Michael Siclari, MD. A 71-year-old US Department of Veterans Affairs physician, Siclari had previously served in the military as a National Guard physician during Operation Enduring Freedom (2001-2014) in Afghanistan. He decided to serve again in Ukraine. Siclari expressed his reasons for going to Ukraine in the language of what Aristotle thought was among the highest virtues: justice. “In retrospect, as I think about why I wanted to go to Ukraine, I think it’s more of a sense that I thought an injustice was happening.”7
Echoing the great Rabbi Hillel, Siclari saw the Russian invasion of Ukraine as a personal call to use his experience and training as a trauma and emergency medicine physician to help the Ukrainian people. “If not me, then who?” Siclari demonstrated another virtue: generosity in taking 10 days of personal leave in August 2022 to make the trip to Ukraine, hoping to work in a combat zone tending to wounded soldiers as he had in Afghanistan. When due to logistics he instead was assigned to care for refugees and assist with evacuations from the battlefield, he humbly and compassionately cared for those in his charge. Even now, back home, he speaks to audiences of health care professionals encouraging them to consider similar acts of altruism.5
Virtue for Aristotle is technically defined as the mean between 2 extremes of disposition or temperament. The virtue of courage is found in the moral middle ground between the deficiency of bravery that is cowardice and the vice of excess of reckless abandon. The former person fears too much and the latter too little and both thus exhibit vicious behavior.
The doctor of vice: James Lee Henry. Henry is a major and internal medicine physician in the United States Army stationed at Fort Bragg, headquarters of the US Army Special Operations Command. Along with his wife Anna Gabrielian, a civilian anesthesiologist, he was charged in September with conspiring to divulge the protected health information of American military and government employees to the Russian government.8 According to the Grand Jury indictment, Henry delivered into the hands of an undercover Federal Bureau of Investigation (FBI) agent, the medical records of a US Army officer, Department of Defense employee, and the spouses of 3 Army veterans, 2 of whom were deceased.9 In a gross twisting of virtue language, Gabrielian explained her motivation for the couple’s espionage in terms of sacrifice and loyalty. In an antipode of Siclari’s service, Henry purportedly wanted to join the Russian army but did not have the requisite combat experience. For his part, Henry’s abysmal defense of his betrayal of his country and his oath speaks for itself, if the United States were to declare war on Russia, Henry told the FBI agent, “at that point, I’ll have some ethical issues I have to work through.”8
We become virtuous people through imitating the example of those who have perfected the habits of moral excellence. During 2022, 2 federal practitioners responded to the challenge of war: one displayed the zenith of virtue, the other exhibited the nadir of vice. Seldom does a single year present us with such clear choices of who and how we want to be in 2023. American culture has so trivialized New Year’s resolutions that they are no longer substantive enough for the weight of the profound question of what constitutes the good life. Rather let us make a commitment in keeping with such morally serious matters. All of us live as mixed creatures, drawn to virtue and prone to vice. May we all strive this coming year to help each other meet the high bar another great man of virtue Abraham Lincoln set in his first inaugural address, to be the “better angels of our natures.”10
1. Aristotle. Politics. Book I, 1253.a31.
2. The Ethics of Aristotle. Aristotle. The Nicomachean Ethics. Thompson JAK, trans. Penguin Books; 1953.
3. Schonfeld TL, Hester DM. Brief introduction to ethics and ethical theory. In: Schonfeld TL, Hester DM, eds. Guidance for Healthcare Ethics Committees. 2nd ed. Cambridge University Press; 2022:11-19.
4. Olsthoorn P. Military Ethics and Virtues: An Interdisciplinary Approach for the 21st Century. Routledge; 2010.
5. Pellegrino ED, Thomasma DC. The Virtues in Medical Practice. Oxford University Press; 1993.
6. Edward Clayton. Aristotle Politics. In: Internet Encyclopedia of Philosophy. Accessed November 28, 2022. https://iep.utm.edu/aristotle-politics
7. Tippets R. A VA doctor’s calling to help in Ukraine. VA News. October 23, 2022. Accessed November 28, 2022. https://news.va.gov/109957/a-va-doctors-calling-to-help-in-ukraine
8. Lybrand H. US Army doctor and anesthesiologist charged with conspiring to US military records to the Russian government. CNN Politics, September 29, 2022. Accessed November 28, 2022 https://www.cnn.com/2022/09/29/politics/us-army-doctor-anesthesiologist-russian-government-medical-records
9. United States v Anna Gabrielian and James Lee Henry, (SD Md 2022). Accessed November 28, 2022. https://www.documentcloud.org/documents/23106067-gabrielian-and-henry-indictment
10. Lincoln A. First Inaugural Address of Abraham Lincoln. Accessed November 28, 2022. https://avalon.law.yale.edu/19th_century/lincoln1.asp
1. Aristotle. Politics. Book I, 1253.a31.
2. The Ethics of Aristotle. Aristotle. The Nicomachean Ethics. Thompson JAK, trans. Penguin Books; 1953.
3. Schonfeld TL, Hester DM. Brief introduction to ethics and ethical theory. In: Schonfeld TL, Hester DM, eds. Guidance for Healthcare Ethics Committees. 2nd ed. Cambridge University Press; 2022:11-19.
4. Olsthoorn P. Military Ethics and Virtues: An Interdisciplinary Approach for the 21st Century. Routledge; 2010.
5. Pellegrino ED, Thomasma DC. The Virtues in Medical Practice. Oxford University Press; 1993.
6. Edward Clayton. Aristotle Politics. In: Internet Encyclopedia of Philosophy. Accessed November 28, 2022. https://iep.utm.edu/aristotle-politics
7. Tippets R. A VA doctor’s calling to help in Ukraine. VA News. October 23, 2022. Accessed November 28, 2022. https://news.va.gov/109957/a-va-doctors-calling-to-help-in-ukraine
8. Lybrand H. US Army doctor and anesthesiologist charged with conspiring to US military records to the Russian government. CNN Politics, September 29, 2022. Accessed November 28, 2022 https://www.cnn.com/2022/09/29/politics/us-army-doctor-anesthesiologist-russian-government-medical-records
9. United States v Anna Gabrielian and James Lee Henry, (SD Md 2022). Accessed November 28, 2022. https://www.documentcloud.org/documents/23106067-gabrielian-and-henry-indictment
10. Lincoln A. First Inaugural Address of Abraham Lincoln. Accessed November 28, 2022. https://avalon.law.yale.edu/19th_century/lincoln1.asp
Improving Patient Access to the My HealtheVet Electronic Patient Portal for Veterans
Patient portals are secure online website tools that provide patient access to personal health information (PHI). Access to online PHI improves health equity and satisfies the meaningful use objectives of the Medicare electronic health record (EHR) incentive program.1,2 Through patient portals, individuals can access PHI records and current diagnoses, request and reschedule appointments, locate test results, track trends for vital signs and laboratory values, refill medications, and communicate directly with the health care team through secure messaging. This alternative method of communication with the team is associated with increased patient satisfaction.3 Patients reported improved patient engagement in health care self-management and decision making, as well as strengthened relationships with their health care team.4
Background
One well-documented strategy to improve portal use includes the development of a nurse champion to facilitate enrollment during the clinic visit.5 Patient perceptions of portal value increased after education by a health care professional (HCP) and assistance in enrollment to familiarize patients with the platform for ongoing use.5 Use of patient portals has been associated with favorable outcomes in chronic disease management. Patients with diabetes mellitus who regularly use patient portals for prescription refills and secure messaging have demonstrated improved glycemic control, medication adherence, and associated health parameters compared with nonusers.5-7 In patients with congestive heart failure, meaningful patient portal use results in fewer emergency department visits, fewer hospital admissions, lower readmission rates, and reduced unscheduled and no-show visits.8-11
Patient portal access is a quality improvement (QI) measure that meets Medicare and Medicaid meaningful use requirements that is designed to improve collaboration between HCPs and patients through EHRs. Despite legislation, uptake of patient portal access has been slow, especially among older adults.10,12,13 Barriers to patient portal registration and use include patient lack of awareness, perceived or actual digital illiteracy, mistrust in privacy precautions, lack of user-friendly interfaces, lack of internet or technology, HCP bias and workload, and misperceptions of usefulness.9,10,12,14 The HCPs most likely to facilitate the use of patient portals, typically include nurse practitioners (NPs), nurses, and medical residents.10,15 Patient portal platforms promote the partnership of these disciplines with the veteran to help the patient better manage their health. Despite the benefits and widespread integration of patient portals in health care systems, socioeconomic inequalities and HCP attitudes contribute to persistent disparities in its adoption by underserved populations. The veteran population is often faced with additional barriers to health care access with regard to geographic location, advanced age, trauma, disabilities, mental health challenges, and homelessness.10,16 These barriers require unique approaches to maximize the use of technologic advances.17 Advanced age contributes to low rates of patient portal enrollment and lack of digital platform use, thus creating a digital divide.11,12
The digital divide is described as the gap between those persons who use technology including computers and internet, and those persons who do not because of social and geographic barriers.16 It contributes to a growing health disparity in both access to care and quality of care especially for rural veterans. About 25% of the US population lacks fixed broadband at home; these individuals are more likely to be racial minorities, older, widowed, or to have lower levels of education.18,19 Veterans are disproportionately represented in these demographic categories.20 According to the US Department of Veterans Affairs (VA) Office of Rural Health, the percentage of rural veterans enrolled in the VA health care system (58%) is significantly higher than enrollment of urban veterans (38%); additionally, 27% of rural veterans do not access the internet at home.21
My HealtheVet
The VA plays an integral part in increasing virtual access to care, from the introduction of My Healthevet (MHV) in 2003 to the distribution of iPad tablets to vulnerable veterans during the COVID-19 pandemic.22,23 Due to COVID-19, the need for VA patient access to the internet and VA Video-Connect (VVC) telehealth services increased significantly.22 Access to internet and hardware supporting use of VVC and MHV has been facilitated by the Digital Divide Consult, a VA program launched in 2020 to increase access to telehealth services.24 The VA has distributed > 26,000 cellular-enabled tablets and provided > 50,000 veterans with connectivity in collaboration with various private sector companies.22 Patients report that MHV facilitates engagement in health care through improved access to EHRs and expedited communication with the health care team.4
MHV is a secure online tool that provides patients access to PHI. MHV aims to empower veterans to take charge of their health by improving communication with HCPs, setting patient goals, and offering health and well-being resources.25,26 In a study of outpatients at a large urban multisite health care system, < 35% of patients on 16 medical resident panels were enrolled in a patient portal.15 MHV internal national metrics show increasing registration and active users of the patient portal, yet locally, disparities in the use of the portal by rural and older veterans exist.
The Local Problem
A review of the registration process at a rural VA clinic revealed barriers to facilitating the veteran registration process at the point of care. Clinical reminders exist within the EHR to prompt clinicians at the point of care to improve quality of care. At the New England Healthcare System (Veterans Integrated Service Network [VISN] 1), a patient portal clinical reminder prompts staff to encourage veterans to register. Anecdotal data obtained from primary care staff interviews at a rural VA primary care clinic in Vermont revealed low clinician confidence in completing the clinical reminder, a lack of knowledge of MHV, and lack of time to educate veterans about the benefits of MHV.
Despite availability of a registration process at the point of care and clinical staff assigned to provide registration information to the veteran, access to the patient portal among veterans at this clinic remained low. This QI project aimed to increase patient portal enrollment of veterans in MHV in a single NP patient panel of 100 patients from a baseline of 33% by 10% in a 3-month time frame.
Implementation
Before implementing the first Plan-Do-Study-Act (PDSA) cycle, we established the baseline data for 1 patient panel to be 33%. A retrospective review of the NP resident’s panel of 100 revealed 33 veterans were enrolled in MHV, providing a setting for process improvement. Evaluation of potential enrollment data for the panel population revealed unenrolled veterans were primarily aged ≥ 65 years. A rapid cycle QI (RCQI) strategy using the PDSA method was used to identify, implement, and measure changes over a 3-month time frame in 1 NP patient panel.14
The RCQI process included establishing baseline data and 3 PDSA cycles that evaluated the current state of patient access to the electronic patient portal, elucidated patient barriers to registration, assessed the processes for point-of-care enrollment, and developed strategies to improve the process and increase veteran enrollment. The QI project team included an NP resident as the project manager and MHV champion, a clinical faculty mentor at the site, a telehealth coordinator, an MHV coordinator, clinic registered nurse (RN), and clinic licensed nursing assistant (LNA). The RN and LNA additionally served as MHV champions as the project progressed.
PDSA Cycles
The objective for PDSA cycle 1 was to evaluate the process of patient registration and assess the impact on NP workload and clinic workflow over a 4-week period to improve veteran enrollment. Data were collected in a spreadsheet to track the number of veterans enrolled, time frame to enroll, and field notes that the NP resident recorded about the experience. The NP resident was trained in registration methods by the MHV coordinator. Several barriers to the registration process were identified: The process resulted in a change of the clinic visit closure focus, the clinic room was blocked for use by another patient, veterans had difficulty generating a unique username and password, veterans were unfamiliar with basic tablet accessibility and use, and additional time was required if incorrect information was entered. The veterans displayed low confidence in using tablet technology and were unaware of the patient portal or its usefulness. After discussion of the process with the project team, recommendations were made to address challenges, including an RN-led registration process. The first PDSA cycle increased the total patient panel enrollment by 4 veterans to 37%.
In PDSA cycle 2 after the NP visit, patients who agreed to register for the MHV portal were introduced to the tablet. The registration process was completed by the patient with the RN prior to the patient checkout. Once patient registration was completed, the veteran met the MHV coordinator and upgraded to a premium account, which provided full access to portal features. Electronic messaging was tested by the MHV coordinator and veteran to validate patient understanding. Although preloading demographic information improved accessibility issues, time was still required for the RN to orient the veteran to the tablet, provide additional directions, and answer questions.
The registration process reduced NP time commitment but added to the RN time burden and disrupted workflow; and clinic room access continued to be an issue. The wait time for the veteran to register in the clinic remained dependent on the availability of the RN. The decision was to move the registration process to the initial patient rooming assignment in the clinic and was transitioned from RN to LNA, prior to the NP-veteran encounter. Four additional veterans registered in the second PDSA cycle, and total enrollment increased to 41%, an overall 8% increase from baseline.
In the third PDSA cycle the patient enrollment process was managed by the clinic LNA using scripted information about MHV prior to the veteran encounter. A partially preloaded tablet was offered to the veteran to register with MHV during the rooming process, and written and oral instruction were provided to the veteran. The time required for each veteran to register for MHV averaged 10 minutes, and the veteran was able to register while waiting for the NP to enter the room. Typical LNA tasks included greeting patients, updating health records, completing clinical reminders with the veteran, obtaining vital signs, and addressing questions. The LNA introduced the veteran to MHV using scripted information and supported them in registering for MHV prior to the NP-veteran encounter. Registration at point of care during the rooming process was well received by both the LNA and veterans. The LNA reported the process was efficient and did not add excessive time to the LNA workflow. The LNA reported verbal patient satisfaction and registration was facilitated for 6 veterans during the 4-week period.
Registration during point of care was reported as feasible and sustainable by the LNA. Upgrading the patient to a premium MHV account was transitioned to the MHV coordinator. All veterans seen during the 4-week period were approached about registration; if the veteran declined, written at-home step-by-step instructions were provided. A replacement electronic clinical reminder was proposed to the VISN clinical reminders team for review and was pilot tested by the primary care clinical team. The third PDSA cycle increased the total patient panel enrollment to 47%, an overall 14% increase from baseline. Six new veteran users were added during PDSA cycle 3.
Discussion
The project team successfully used a RCQI method with a PDSA strategy to improve patient access to the MHV portal and increased veteran enrollment by 14% on 1 NP resident patient panel. The project evaluated clinic workflow regarding veteran patient portal registration, uncovered inefficiencies, and developed improved processes to increase veteran access to the patient portal. Results were positively impacted through the recognition of inefficiencies and initiation of new processes to engage veterans in the portal registration process. Familiarizing the entire clinical team with the clinical reminder and registration process raised the awareness of a digital divide consult and the utility of the portal in patient care. The project provided an opportunity to evaluate veterans’ digital literacy, digital access to send and receive messages, and to provide coaching as needed. Sequential PDSA cycles employed audit and feedback, information preloading, multimodal teaching strategies (verbal, print, hands-on tablet learning), scripting, staff interviews, time studies, and workflow evaluation to improve processes. An MHV champion led the team, monitored the progress, set deadlines, and effectively communicated project performance.
Limitations
Project limitations included the single-site location, its small sample size, and the short 3-month implementation time frame. The patient panel was representative of other NP resident patient panels at the facility but may not be representative of other VA facilities.
Ethical Considerations
Patient confidentiality was maintained throughout the registration and data collection process. The project team (NP, RN, LNA) received training and written instructions on protection of patient confidentiality by the MHV coordinator prior to assisting veterans with the registration process. Privacy was maintained, no patient identifiers were collected or viewed, and no assistance was provided for username, password, or security questions. The tablet was password protected and secured, used only by the project team when veteran was interested in point-of-care portal registration.
Sustainability
QI projects require ongoing systemic efforts to enhance sustainability.26,27 The project team used the PDSA methodology to stimulate the design of new workflow processes to engage staff and veterans in portal registration. Several actions were taken to promote sustainability for veteran portal registration and improve access to health care for rural and underserved veterans. First, printed instructions and website link are available in the clinic intake and examination rooms. Staff are equipped with patient education discussion points about the portal. A tablet is available in the clinic to encourage veterans to sign up. A clinical reminder is in place to encourage portal registration. A designated super-user is available to help new patient portal users register and navigate the system. Outcomes of the QI project were presented at 2 separate VISN 1 nursing grand rounds and reported to the MHV coordinator and telehealth coordinator to promote dialogue among staff and raise awareness of challenges to veteran MHV access.
Conclusions
Reviewing patient portal registration processes at the local level is essential to improve veteran access. This QI project proposed a realistic and scalable solution to implementing and improving patient enrollment to MHV in primary care clinics. Integrating measurement of patient registration into the daily routine of the clinic empowers the entire clinical team to improve the quality of access to patient portal.
The project team worked together to accomplish a shared goal, using errors as opportunities to improve the process, while using available staff without compromising significant time or resources. Engaging the entire team to audit processes and designating one member of the team as an MHV champion to provide feedback is critical to the sustainability of point-of-care registration in the MHV patient portal. Multifaceted approaches to maximizing the use of technology lessens the digital divide for veterans who are faced with geographical and social barriers to health care access.
Acknowledgments
We thank the Office of Academic Affiliations and the US Department of Veterans Affairs Nursing Academic Partnerships in Graduate Education Nurse Practitioner residency program and clinical faculty and the affiliated University of Vermont faculty mentor/quality improvement coach for the support of the project.
1. Centers for Medicare and Medicaid Services. Promoting interoperability programs. Updated October 6, 2022. Accessed November 3, 2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms
2. American Hospital Association. Goals of the Medicare and Medicaid electronic health records programs. Accessed November 3, 2022. https://www.aha.org/websites/2009-12-11-goals-medicare-and-medicaid-electronic-health-records-programs
3. Rozenblum R, Donzé J, Hockey PM, et al. The impact of medical informatics on patient satisfaction: a USA-based literature review. Int J Med Inform. 2013;82(3):141-158. doi:10.1016/j.ijmedinf.2012.12.008
4. Stewart MT, Hogan TP, Nicklas J, et al. The promise of patient portals for individuals living with chronic illness: qualitative study identifying pathways of patient engagement. J Med Internet Res. 2020;22(7):e17744. Published 2020 Jul 17. doi:10.2196/17744
5. Harris LT, Haneuse SJ, Martin DP, Ralston JD. Diabetes quality of care and outpatient utilization associated with electronic patient-provider messaging: a cross-sectional analysis. Diabetes Care. 2009;32(7):1182-1187. doi:10.2337/dc08-1771
6. Robinson SA, Zocchi MS, Netherton D, et al. Secure messaging, diabetes self-management, and the importance of patient autonomy: a mixed methods study. J Gen Intern Med. 2020;35(10):2955-2962. doi:10.1007/s11606-020-05834-x
7. Zocchi MS, Robinson SA, Ash AS, et al. Patient portal engagement and diabetes management among new portal users in the Veterans Health Administration. J Am Med Inform Assoc. 2021;28(10):2176-2183. doi:10.1093/jamia/ocab115
8. Bao C, Bardhan IR, Singh H, Meyer BA, Kirksey K. Patient-provider engagement and its impact on health outcomes: a longitudinal study of patient portal use. MIS Quarterly. 2020;44(2):699-723. doi:10.25300/MISQ/2020/14180
9. Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Informs Assoc. 2019;26(8-9):855-870. doi:10.1093/jamia/ocz023
10. Zhao JY, Song B, Anand E, et al. Barriers, facilitators, and solutions to optimal patient portal and personal health record use: a systematic review of the literature. AMIA Annu Symp Proc. 2018;2017:1913-1922. Published 2018 Apr 16.
11. Zhong X, Park J, Liang M, et al. Characteristics of patients using different patient portal functions and the impact on primary care service utilization and appointment adherence: retrospective observational study. J Med Internet Res. 2020;22(2):e14410. Published 2020 Feb 25. doi:10.2196/14410
12. Krishnaswami A, Beavers C, Dorsch MP, et al. Gerotechnology for older adults with cardiovascular diseases. J Am Coll Cardiol. 2020;76(22):2650-2670. doi:10.1016/j.jacc.2020.09.606
13. Fix GM, Hogan TP, Amante DJ, McInnes DK, Nazi KM, Simon SR. Encouraging patient portal use in the patient-centered medical home: three stakeholder perspectives. J Med Internet Res. 2016;18(11):e308. Published 2016 Nov 22. doi:10.2196/jmir.6488
14. Ancker JS, Nosal S, Hauser D, Way C, Calman N. Access policy and the digital divide in patient access to medical records. Health Policy Technol. 2016;6(3-11). doi:10.1016/j.hlpt.2016.11.004
15. Rhudy C, Broxterman J, Stewart S, et al. Improving patient portal enrolment in an academic resident continuity clinic: quality improvement made simple. BMJ Open Qual. 2019;8(2):e000430. Published 2019 Apr 25. doi:10.1136/bmjoq-2018-000430
16. Kontos E, Blake KD, Chou WY, Prestin A. Predictors of eHealth usage: insights on the digital divide from the Health Information National Trends Survey 2012. J Med Internet Res. 2014;16(7):e172. Published 2014 Jul 16. doi:10.2196/jmir.3117
17. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice. The state of health disparities in the United States. In: Baciu A, Negussie Y, Geller A, et al, eds. Communities in Action: Pathways to Health Equity. National Academies Press (US); January 11, 2017. Accessed November 3, 2022. https://www.ncbi.nlm.nih.gov/books/NBK425848/
18. Pew Research Center. Internet/broadband fact sheet. Updated April 7, 2021. Accessed November 3, 2022. https://www.pewresearch.org/internet/fact-sheet/internet-broadband
19. Roberts ET, Mehrotra A. Assessment of disparities in digital access among Medicare beneficiaries and implications for telemedicine. JAMA Intern Med. 2020;180(10):1386-1389. doi:10.1001/jamainternmed.2020.2666
20. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Veteran population. Updated September 7, 2022. Accessed November 3, 2022. https://www.va.gov/vetdata/veteran_population.asp
21. US Department of Veterans Affairs, Office of Rural Health. Rural veterans health care challenges. Updated March 31, 2022. Accessed November 3, 2022. https://www.ruralhealth.va.gov/aboutus/ruralvets.asp
22. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA expands veteran access to telehealth with iPad services. Press release. September 15, 2020. Accessed November 3, 2022. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5521
23. Zulman DM, Wong EP, Slightam C, et al. Making connections: National implementation of video telehealth tablets to address access barriers in veterans. JAMIA Open. 2019;2(3):323-329. doi:10.1093/jamiaopen/ooz024
24. Malone NC, Williams MM, Smith Fawzi MC, et al. Mobile health clinics in the United States. Int J Equity Health. 2020;19(1):40. doi:10.1186/s12939-020-1135-7
25. US Department of Veterans Affairs. How to use My HealtheVet. Accessed November 3, 2022. https://www.myhealth.va.gov/mhv-portal-web/how-to-use-mhv
26. US Department of Veterans Affairs, Veterans Health Administration, Office of Patient Centered Care and Cultural Transformation. Whole health for life. 2017. Accessed November 3, 2022. https://www.va.gov/wholehealth/docs/2017-AR-Vet-Facing_FNL-W508.pdf27. Mortimer F, Isherwood J, Wilkinson A, Vaux E. Sustainability in quality improvement: redefining value. Future Healthc J. 2018;5(2):88-93. doi:10.7861/futurehosp.5-2-88
Patient portals are secure online website tools that provide patient access to personal health information (PHI). Access to online PHI improves health equity and satisfies the meaningful use objectives of the Medicare electronic health record (EHR) incentive program.1,2 Through patient portals, individuals can access PHI records and current diagnoses, request and reschedule appointments, locate test results, track trends for vital signs and laboratory values, refill medications, and communicate directly with the health care team through secure messaging. This alternative method of communication with the team is associated with increased patient satisfaction.3 Patients reported improved patient engagement in health care self-management and decision making, as well as strengthened relationships with their health care team.4
Background
One well-documented strategy to improve portal use includes the development of a nurse champion to facilitate enrollment during the clinic visit.5 Patient perceptions of portal value increased after education by a health care professional (HCP) and assistance in enrollment to familiarize patients with the platform for ongoing use.5 Use of patient portals has been associated with favorable outcomes in chronic disease management. Patients with diabetes mellitus who regularly use patient portals for prescription refills and secure messaging have demonstrated improved glycemic control, medication adherence, and associated health parameters compared with nonusers.5-7 In patients with congestive heart failure, meaningful patient portal use results in fewer emergency department visits, fewer hospital admissions, lower readmission rates, and reduced unscheduled and no-show visits.8-11
Patient portal access is a quality improvement (QI) measure that meets Medicare and Medicaid meaningful use requirements that is designed to improve collaboration between HCPs and patients through EHRs. Despite legislation, uptake of patient portal access has been slow, especially among older adults.10,12,13 Barriers to patient portal registration and use include patient lack of awareness, perceived or actual digital illiteracy, mistrust in privacy precautions, lack of user-friendly interfaces, lack of internet or technology, HCP bias and workload, and misperceptions of usefulness.9,10,12,14 The HCPs most likely to facilitate the use of patient portals, typically include nurse practitioners (NPs), nurses, and medical residents.10,15 Patient portal platforms promote the partnership of these disciplines with the veteran to help the patient better manage their health. Despite the benefits and widespread integration of patient portals in health care systems, socioeconomic inequalities and HCP attitudes contribute to persistent disparities in its adoption by underserved populations. The veteran population is often faced with additional barriers to health care access with regard to geographic location, advanced age, trauma, disabilities, mental health challenges, and homelessness.10,16 These barriers require unique approaches to maximize the use of technologic advances.17 Advanced age contributes to low rates of patient portal enrollment and lack of digital platform use, thus creating a digital divide.11,12
The digital divide is described as the gap between those persons who use technology including computers and internet, and those persons who do not because of social and geographic barriers.16 It contributes to a growing health disparity in both access to care and quality of care especially for rural veterans. About 25% of the US population lacks fixed broadband at home; these individuals are more likely to be racial minorities, older, widowed, or to have lower levels of education.18,19 Veterans are disproportionately represented in these demographic categories.20 According to the US Department of Veterans Affairs (VA) Office of Rural Health, the percentage of rural veterans enrolled in the VA health care system (58%) is significantly higher than enrollment of urban veterans (38%); additionally, 27% of rural veterans do not access the internet at home.21
My HealtheVet
The VA plays an integral part in increasing virtual access to care, from the introduction of My Healthevet (MHV) in 2003 to the distribution of iPad tablets to vulnerable veterans during the COVID-19 pandemic.22,23 Due to COVID-19, the need for VA patient access to the internet and VA Video-Connect (VVC) telehealth services increased significantly.22 Access to internet and hardware supporting use of VVC and MHV has been facilitated by the Digital Divide Consult, a VA program launched in 2020 to increase access to telehealth services.24 The VA has distributed > 26,000 cellular-enabled tablets and provided > 50,000 veterans with connectivity in collaboration with various private sector companies.22 Patients report that MHV facilitates engagement in health care through improved access to EHRs and expedited communication with the health care team.4
MHV is a secure online tool that provides patients access to PHI. MHV aims to empower veterans to take charge of their health by improving communication with HCPs, setting patient goals, and offering health and well-being resources.25,26 In a study of outpatients at a large urban multisite health care system, < 35% of patients on 16 medical resident panels were enrolled in a patient portal.15 MHV internal national metrics show increasing registration and active users of the patient portal, yet locally, disparities in the use of the portal by rural and older veterans exist.
The Local Problem
A review of the registration process at a rural VA clinic revealed barriers to facilitating the veteran registration process at the point of care. Clinical reminders exist within the EHR to prompt clinicians at the point of care to improve quality of care. At the New England Healthcare System (Veterans Integrated Service Network [VISN] 1), a patient portal clinical reminder prompts staff to encourage veterans to register. Anecdotal data obtained from primary care staff interviews at a rural VA primary care clinic in Vermont revealed low clinician confidence in completing the clinical reminder, a lack of knowledge of MHV, and lack of time to educate veterans about the benefits of MHV.
Despite availability of a registration process at the point of care and clinical staff assigned to provide registration information to the veteran, access to the patient portal among veterans at this clinic remained low. This QI project aimed to increase patient portal enrollment of veterans in MHV in a single NP patient panel of 100 patients from a baseline of 33% by 10% in a 3-month time frame.
Implementation
Before implementing the first Plan-Do-Study-Act (PDSA) cycle, we established the baseline data for 1 patient panel to be 33%. A retrospective review of the NP resident’s panel of 100 revealed 33 veterans were enrolled in MHV, providing a setting for process improvement. Evaluation of potential enrollment data for the panel population revealed unenrolled veterans were primarily aged ≥ 65 years. A rapid cycle QI (RCQI) strategy using the PDSA method was used to identify, implement, and measure changes over a 3-month time frame in 1 NP patient panel.14
The RCQI process included establishing baseline data and 3 PDSA cycles that evaluated the current state of patient access to the electronic patient portal, elucidated patient barriers to registration, assessed the processes for point-of-care enrollment, and developed strategies to improve the process and increase veteran enrollment. The QI project team included an NP resident as the project manager and MHV champion, a clinical faculty mentor at the site, a telehealth coordinator, an MHV coordinator, clinic registered nurse (RN), and clinic licensed nursing assistant (LNA). The RN and LNA additionally served as MHV champions as the project progressed.
PDSA Cycles
The objective for PDSA cycle 1 was to evaluate the process of patient registration and assess the impact on NP workload and clinic workflow over a 4-week period to improve veteran enrollment. Data were collected in a spreadsheet to track the number of veterans enrolled, time frame to enroll, and field notes that the NP resident recorded about the experience. The NP resident was trained in registration methods by the MHV coordinator. Several barriers to the registration process were identified: The process resulted in a change of the clinic visit closure focus, the clinic room was blocked for use by another patient, veterans had difficulty generating a unique username and password, veterans were unfamiliar with basic tablet accessibility and use, and additional time was required if incorrect information was entered. The veterans displayed low confidence in using tablet technology and were unaware of the patient portal or its usefulness. After discussion of the process with the project team, recommendations were made to address challenges, including an RN-led registration process. The first PDSA cycle increased the total patient panel enrollment by 4 veterans to 37%.
In PDSA cycle 2 after the NP visit, patients who agreed to register for the MHV portal were introduced to the tablet. The registration process was completed by the patient with the RN prior to the patient checkout. Once patient registration was completed, the veteran met the MHV coordinator and upgraded to a premium account, which provided full access to portal features. Electronic messaging was tested by the MHV coordinator and veteran to validate patient understanding. Although preloading demographic information improved accessibility issues, time was still required for the RN to orient the veteran to the tablet, provide additional directions, and answer questions.
The registration process reduced NP time commitment but added to the RN time burden and disrupted workflow; and clinic room access continued to be an issue. The wait time for the veteran to register in the clinic remained dependent on the availability of the RN. The decision was to move the registration process to the initial patient rooming assignment in the clinic and was transitioned from RN to LNA, prior to the NP-veteran encounter. Four additional veterans registered in the second PDSA cycle, and total enrollment increased to 41%, an overall 8% increase from baseline.
In the third PDSA cycle the patient enrollment process was managed by the clinic LNA using scripted information about MHV prior to the veteran encounter. A partially preloaded tablet was offered to the veteran to register with MHV during the rooming process, and written and oral instruction were provided to the veteran. The time required for each veteran to register for MHV averaged 10 minutes, and the veteran was able to register while waiting for the NP to enter the room. Typical LNA tasks included greeting patients, updating health records, completing clinical reminders with the veteran, obtaining vital signs, and addressing questions. The LNA introduced the veteran to MHV using scripted information and supported them in registering for MHV prior to the NP-veteran encounter. Registration at point of care during the rooming process was well received by both the LNA and veterans. The LNA reported the process was efficient and did not add excessive time to the LNA workflow. The LNA reported verbal patient satisfaction and registration was facilitated for 6 veterans during the 4-week period.
Registration during point of care was reported as feasible and sustainable by the LNA. Upgrading the patient to a premium MHV account was transitioned to the MHV coordinator. All veterans seen during the 4-week period were approached about registration; if the veteran declined, written at-home step-by-step instructions were provided. A replacement electronic clinical reminder was proposed to the VISN clinical reminders team for review and was pilot tested by the primary care clinical team. The third PDSA cycle increased the total patient panel enrollment to 47%, an overall 14% increase from baseline. Six new veteran users were added during PDSA cycle 3.
Discussion
The project team successfully used a RCQI method with a PDSA strategy to improve patient access to the MHV portal and increased veteran enrollment by 14% on 1 NP resident patient panel. The project evaluated clinic workflow regarding veteran patient portal registration, uncovered inefficiencies, and developed improved processes to increase veteran access to the patient portal. Results were positively impacted through the recognition of inefficiencies and initiation of new processes to engage veterans in the portal registration process. Familiarizing the entire clinical team with the clinical reminder and registration process raised the awareness of a digital divide consult and the utility of the portal in patient care. The project provided an opportunity to evaluate veterans’ digital literacy, digital access to send and receive messages, and to provide coaching as needed. Sequential PDSA cycles employed audit and feedback, information preloading, multimodal teaching strategies (verbal, print, hands-on tablet learning), scripting, staff interviews, time studies, and workflow evaluation to improve processes. An MHV champion led the team, monitored the progress, set deadlines, and effectively communicated project performance.
Limitations
Project limitations included the single-site location, its small sample size, and the short 3-month implementation time frame. The patient panel was representative of other NP resident patient panels at the facility but may not be representative of other VA facilities.
Ethical Considerations
Patient confidentiality was maintained throughout the registration and data collection process. The project team (NP, RN, LNA) received training and written instructions on protection of patient confidentiality by the MHV coordinator prior to assisting veterans with the registration process. Privacy was maintained, no patient identifiers were collected or viewed, and no assistance was provided for username, password, or security questions. The tablet was password protected and secured, used only by the project team when veteran was interested in point-of-care portal registration.
Sustainability
QI projects require ongoing systemic efforts to enhance sustainability.26,27 The project team used the PDSA methodology to stimulate the design of new workflow processes to engage staff and veterans in portal registration. Several actions were taken to promote sustainability for veteran portal registration and improve access to health care for rural and underserved veterans. First, printed instructions and website link are available in the clinic intake and examination rooms. Staff are equipped with patient education discussion points about the portal. A tablet is available in the clinic to encourage veterans to sign up. A clinical reminder is in place to encourage portal registration. A designated super-user is available to help new patient portal users register and navigate the system. Outcomes of the QI project were presented at 2 separate VISN 1 nursing grand rounds and reported to the MHV coordinator and telehealth coordinator to promote dialogue among staff and raise awareness of challenges to veteran MHV access.
Conclusions
Reviewing patient portal registration processes at the local level is essential to improve veteran access. This QI project proposed a realistic and scalable solution to implementing and improving patient enrollment to MHV in primary care clinics. Integrating measurement of patient registration into the daily routine of the clinic empowers the entire clinical team to improve the quality of access to patient portal.
The project team worked together to accomplish a shared goal, using errors as opportunities to improve the process, while using available staff without compromising significant time or resources. Engaging the entire team to audit processes and designating one member of the team as an MHV champion to provide feedback is critical to the sustainability of point-of-care registration in the MHV patient portal. Multifaceted approaches to maximizing the use of technology lessens the digital divide for veterans who are faced with geographical and social barriers to health care access.
Acknowledgments
We thank the Office of Academic Affiliations and the US Department of Veterans Affairs Nursing Academic Partnerships in Graduate Education Nurse Practitioner residency program and clinical faculty and the affiliated University of Vermont faculty mentor/quality improvement coach for the support of the project.
Patient portals are secure online website tools that provide patient access to personal health information (PHI). Access to online PHI improves health equity and satisfies the meaningful use objectives of the Medicare electronic health record (EHR) incentive program.1,2 Through patient portals, individuals can access PHI records and current diagnoses, request and reschedule appointments, locate test results, track trends for vital signs and laboratory values, refill medications, and communicate directly with the health care team through secure messaging. This alternative method of communication with the team is associated with increased patient satisfaction.3 Patients reported improved patient engagement in health care self-management and decision making, as well as strengthened relationships with their health care team.4
Background
One well-documented strategy to improve portal use includes the development of a nurse champion to facilitate enrollment during the clinic visit.5 Patient perceptions of portal value increased after education by a health care professional (HCP) and assistance in enrollment to familiarize patients with the platform for ongoing use.5 Use of patient portals has been associated with favorable outcomes in chronic disease management. Patients with diabetes mellitus who regularly use patient portals for prescription refills and secure messaging have demonstrated improved glycemic control, medication adherence, and associated health parameters compared with nonusers.5-7 In patients with congestive heart failure, meaningful patient portal use results in fewer emergency department visits, fewer hospital admissions, lower readmission rates, and reduced unscheduled and no-show visits.8-11
Patient portal access is a quality improvement (QI) measure that meets Medicare and Medicaid meaningful use requirements that is designed to improve collaboration between HCPs and patients through EHRs. Despite legislation, uptake of patient portal access has been slow, especially among older adults.10,12,13 Barriers to patient portal registration and use include patient lack of awareness, perceived or actual digital illiteracy, mistrust in privacy precautions, lack of user-friendly interfaces, lack of internet or technology, HCP bias and workload, and misperceptions of usefulness.9,10,12,14 The HCPs most likely to facilitate the use of patient portals, typically include nurse practitioners (NPs), nurses, and medical residents.10,15 Patient portal platforms promote the partnership of these disciplines with the veteran to help the patient better manage their health. Despite the benefits and widespread integration of patient portals in health care systems, socioeconomic inequalities and HCP attitudes contribute to persistent disparities in its adoption by underserved populations. The veteran population is often faced with additional barriers to health care access with regard to geographic location, advanced age, trauma, disabilities, mental health challenges, and homelessness.10,16 These barriers require unique approaches to maximize the use of technologic advances.17 Advanced age contributes to low rates of patient portal enrollment and lack of digital platform use, thus creating a digital divide.11,12
The digital divide is described as the gap between those persons who use technology including computers and internet, and those persons who do not because of social and geographic barriers.16 It contributes to a growing health disparity in both access to care and quality of care especially for rural veterans. About 25% of the US population lacks fixed broadband at home; these individuals are more likely to be racial minorities, older, widowed, or to have lower levels of education.18,19 Veterans are disproportionately represented in these demographic categories.20 According to the US Department of Veterans Affairs (VA) Office of Rural Health, the percentage of rural veterans enrolled in the VA health care system (58%) is significantly higher than enrollment of urban veterans (38%); additionally, 27% of rural veterans do not access the internet at home.21
My HealtheVet
The VA plays an integral part in increasing virtual access to care, from the introduction of My Healthevet (MHV) in 2003 to the distribution of iPad tablets to vulnerable veterans during the COVID-19 pandemic.22,23 Due to COVID-19, the need for VA patient access to the internet and VA Video-Connect (VVC) telehealth services increased significantly.22 Access to internet and hardware supporting use of VVC and MHV has been facilitated by the Digital Divide Consult, a VA program launched in 2020 to increase access to telehealth services.24 The VA has distributed > 26,000 cellular-enabled tablets and provided > 50,000 veterans with connectivity in collaboration with various private sector companies.22 Patients report that MHV facilitates engagement in health care through improved access to EHRs and expedited communication with the health care team.4
MHV is a secure online tool that provides patients access to PHI. MHV aims to empower veterans to take charge of their health by improving communication with HCPs, setting patient goals, and offering health and well-being resources.25,26 In a study of outpatients at a large urban multisite health care system, < 35% of patients on 16 medical resident panels were enrolled in a patient portal.15 MHV internal national metrics show increasing registration and active users of the patient portal, yet locally, disparities in the use of the portal by rural and older veterans exist.
The Local Problem
A review of the registration process at a rural VA clinic revealed barriers to facilitating the veteran registration process at the point of care. Clinical reminders exist within the EHR to prompt clinicians at the point of care to improve quality of care. At the New England Healthcare System (Veterans Integrated Service Network [VISN] 1), a patient portal clinical reminder prompts staff to encourage veterans to register. Anecdotal data obtained from primary care staff interviews at a rural VA primary care clinic in Vermont revealed low clinician confidence in completing the clinical reminder, a lack of knowledge of MHV, and lack of time to educate veterans about the benefits of MHV.
Despite availability of a registration process at the point of care and clinical staff assigned to provide registration information to the veteran, access to the patient portal among veterans at this clinic remained low. This QI project aimed to increase patient portal enrollment of veterans in MHV in a single NP patient panel of 100 patients from a baseline of 33% by 10% in a 3-month time frame.
Implementation
Before implementing the first Plan-Do-Study-Act (PDSA) cycle, we established the baseline data for 1 patient panel to be 33%. A retrospective review of the NP resident’s panel of 100 revealed 33 veterans were enrolled in MHV, providing a setting for process improvement. Evaluation of potential enrollment data for the panel population revealed unenrolled veterans were primarily aged ≥ 65 years. A rapid cycle QI (RCQI) strategy using the PDSA method was used to identify, implement, and measure changes over a 3-month time frame in 1 NP patient panel.14
The RCQI process included establishing baseline data and 3 PDSA cycles that evaluated the current state of patient access to the electronic patient portal, elucidated patient barriers to registration, assessed the processes for point-of-care enrollment, and developed strategies to improve the process and increase veteran enrollment. The QI project team included an NP resident as the project manager and MHV champion, a clinical faculty mentor at the site, a telehealth coordinator, an MHV coordinator, clinic registered nurse (RN), and clinic licensed nursing assistant (LNA). The RN and LNA additionally served as MHV champions as the project progressed.
PDSA Cycles
The objective for PDSA cycle 1 was to evaluate the process of patient registration and assess the impact on NP workload and clinic workflow over a 4-week period to improve veteran enrollment. Data were collected in a spreadsheet to track the number of veterans enrolled, time frame to enroll, and field notes that the NP resident recorded about the experience. The NP resident was trained in registration methods by the MHV coordinator. Several barriers to the registration process were identified: The process resulted in a change of the clinic visit closure focus, the clinic room was blocked for use by another patient, veterans had difficulty generating a unique username and password, veterans were unfamiliar with basic tablet accessibility and use, and additional time was required if incorrect information was entered. The veterans displayed low confidence in using tablet technology and were unaware of the patient portal or its usefulness. After discussion of the process with the project team, recommendations were made to address challenges, including an RN-led registration process. The first PDSA cycle increased the total patient panel enrollment by 4 veterans to 37%.
In PDSA cycle 2 after the NP visit, patients who agreed to register for the MHV portal were introduced to the tablet. The registration process was completed by the patient with the RN prior to the patient checkout. Once patient registration was completed, the veteran met the MHV coordinator and upgraded to a premium account, which provided full access to portal features. Electronic messaging was tested by the MHV coordinator and veteran to validate patient understanding. Although preloading demographic information improved accessibility issues, time was still required for the RN to orient the veteran to the tablet, provide additional directions, and answer questions.
The registration process reduced NP time commitment but added to the RN time burden and disrupted workflow; and clinic room access continued to be an issue. The wait time for the veteran to register in the clinic remained dependent on the availability of the RN. The decision was to move the registration process to the initial patient rooming assignment in the clinic and was transitioned from RN to LNA, prior to the NP-veteran encounter. Four additional veterans registered in the second PDSA cycle, and total enrollment increased to 41%, an overall 8% increase from baseline.
In the third PDSA cycle the patient enrollment process was managed by the clinic LNA using scripted information about MHV prior to the veteran encounter. A partially preloaded tablet was offered to the veteran to register with MHV during the rooming process, and written and oral instruction were provided to the veteran. The time required for each veteran to register for MHV averaged 10 minutes, and the veteran was able to register while waiting for the NP to enter the room. Typical LNA tasks included greeting patients, updating health records, completing clinical reminders with the veteran, obtaining vital signs, and addressing questions. The LNA introduced the veteran to MHV using scripted information and supported them in registering for MHV prior to the NP-veteran encounter. Registration at point of care during the rooming process was well received by both the LNA and veterans. The LNA reported the process was efficient and did not add excessive time to the LNA workflow. The LNA reported verbal patient satisfaction and registration was facilitated for 6 veterans during the 4-week period.
Registration during point of care was reported as feasible and sustainable by the LNA. Upgrading the patient to a premium MHV account was transitioned to the MHV coordinator. All veterans seen during the 4-week period were approached about registration; if the veteran declined, written at-home step-by-step instructions were provided. A replacement electronic clinical reminder was proposed to the VISN clinical reminders team for review and was pilot tested by the primary care clinical team. The third PDSA cycle increased the total patient panel enrollment to 47%, an overall 14% increase from baseline. Six new veteran users were added during PDSA cycle 3.
Discussion
The project team successfully used a RCQI method with a PDSA strategy to improve patient access to the MHV portal and increased veteran enrollment by 14% on 1 NP resident patient panel. The project evaluated clinic workflow regarding veteran patient portal registration, uncovered inefficiencies, and developed improved processes to increase veteran access to the patient portal. Results were positively impacted through the recognition of inefficiencies and initiation of new processes to engage veterans in the portal registration process. Familiarizing the entire clinical team with the clinical reminder and registration process raised the awareness of a digital divide consult and the utility of the portal in patient care. The project provided an opportunity to evaluate veterans’ digital literacy, digital access to send and receive messages, and to provide coaching as needed. Sequential PDSA cycles employed audit and feedback, information preloading, multimodal teaching strategies (verbal, print, hands-on tablet learning), scripting, staff interviews, time studies, and workflow evaluation to improve processes. An MHV champion led the team, monitored the progress, set deadlines, and effectively communicated project performance.
Limitations
Project limitations included the single-site location, its small sample size, and the short 3-month implementation time frame. The patient panel was representative of other NP resident patient panels at the facility but may not be representative of other VA facilities.
Ethical Considerations
Patient confidentiality was maintained throughout the registration and data collection process. The project team (NP, RN, LNA) received training and written instructions on protection of patient confidentiality by the MHV coordinator prior to assisting veterans with the registration process. Privacy was maintained, no patient identifiers were collected or viewed, and no assistance was provided for username, password, or security questions. The tablet was password protected and secured, used only by the project team when veteran was interested in point-of-care portal registration.
Sustainability
QI projects require ongoing systemic efforts to enhance sustainability.26,27 The project team used the PDSA methodology to stimulate the design of new workflow processes to engage staff and veterans in portal registration. Several actions were taken to promote sustainability for veteran portal registration and improve access to health care for rural and underserved veterans. First, printed instructions and website link are available in the clinic intake and examination rooms. Staff are equipped with patient education discussion points about the portal. A tablet is available in the clinic to encourage veterans to sign up. A clinical reminder is in place to encourage portal registration. A designated super-user is available to help new patient portal users register and navigate the system. Outcomes of the QI project were presented at 2 separate VISN 1 nursing grand rounds and reported to the MHV coordinator and telehealth coordinator to promote dialogue among staff and raise awareness of challenges to veteran MHV access.
Conclusions
Reviewing patient portal registration processes at the local level is essential to improve veteran access. This QI project proposed a realistic and scalable solution to implementing and improving patient enrollment to MHV in primary care clinics. Integrating measurement of patient registration into the daily routine of the clinic empowers the entire clinical team to improve the quality of access to patient portal.
The project team worked together to accomplish a shared goal, using errors as opportunities to improve the process, while using available staff without compromising significant time or resources. Engaging the entire team to audit processes and designating one member of the team as an MHV champion to provide feedback is critical to the sustainability of point-of-care registration in the MHV patient portal. Multifaceted approaches to maximizing the use of technology lessens the digital divide for veterans who are faced with geographical and social barriers to health care access.
Acknowledgments
We thank the Office of Academic Affiliations and the US Department of Veterans Affairs Nursing Academic Partnerships in Graduate Education Nurse Practitioner residency program and clinical faculty and the affiliated University of Vermont faculty mentor/quality improvement coach for the support of the project.
1. Centers for Medicare and Medicaid Services. Promoting interoperability programs. Updated October 6, 2022. Accessed November 3, 2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms
2. American Hospital Association. Goals of the Medicare and Medicaid electronic health records programs. Accessed November 3, 2022. https://www.aha.org/websites/2009-12-11-goals-medicare-and-medicaid-electronic-health-records-programs
3. Rozenblum R, Donzé J, Hockey PM, et al. The impact of medical informatics on patient satisfaction: a USA-based literature review. Int J Med Inform. 2013;82(3):141-158. doi:10.1016/j.ijmedinf.2012.12.008
4. Stewart MT, Hogan TP, Nicklas J, et al. The promise of patient portals for individuals living with chronic illness: qualitative study identifying pathways of patient engagement. J Med Internet Res. 2020;22(7):e17744. Published 2020 Jul 17. doi:10.2196/17744
5. Harris LT, Haneuse SJ, Martin DP, Ralston JD. Diabetes quality of care and outpatient utilization associated with electronic patient-provider messaging: a cross-sectional analysis. Diabetes Care. 2009;32(7):1182-1187. doi:10.2337/dc08-1771
6. Robinson SA, Zocchi MS, Netherton D, et al. Secure messaging, diabetes self-management, and the importance of patient autonomy: a mixed methods study. J Gen Intern Med. 2020;35(10):2955-2962. doi:10.1007/s11606-020-05834-x
7. Zocchi MS, Robinson SA, Ash AS, et al. Patient portal engagement and diabetes management among new portal users in the Veterans Health Administration. J Am Med Inform Assoc. 2021;28(10):2176-2183. doi:10.1093/jamia/ocab115
8. Bao C, Bardhan IR, Singh H, Meyer BA, Kirksey K. Patient-provider engagement and its impact on health outcomes: a longitudinal study of patient portal use. MIS Quarterly. 2020;44(2):699-723. doi:10.25300/MISQ/2020/14180
9. Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Informs Assoc. 2019;26(8-9):855-870. doi:10.1093/jamia/ocz023
10. Zhao JY, Song B, Anand E, et al. Barriers, facilitators, and solutions to optimal patient portal and personal health record use: a systematic review of the literature. AMIA Annu Symp Proc. 2018;2017:1913-1922. Published 2018 Apr 16.
11. Zhong X, Park J, Liang M, et al. Characteristics of patients using different patient portal functions and the impact on primary care service utilization and appointment adherence: retrospective observational study. J Med Internet Res. 2020;22(2):e14410. Published 2020 Feb 25. doi:10.2196/14410
12. Krishnaswami A, Beavers C, Dorsch MP, et al. Gerotechnology for older adults with cardiovascular diseases. J Am Coll Cardiol. 2020;76(22):2650-2670. doi:10.1016/j.jacc.2020.09.606
13. Fix GM, Hogan TP, Amante DJ, McInnes DK, Nazi KM, Simon SR. Encouraging patient portal use in the patient-centered medical home: three stakeholder perspectives. J Med Internet Res. 2016;18(11):e308. Published 2016 Nov 22. doi:10.2196/jmir.6488
14. Ancker JS, Nosal S, Hauser D, Way C, Calman N. Access policy and the digital divide in patient access to medical records. Health Policy Technol. 2016;6(3-11). doi:10.1016/j.hlpt.2016.11.004
15. Rhudy C, Broxterman J, Stewart S, et al. Improving patient portal enrolment in an academic resident continuity clinic: quality improvement made simple. BMJ Open Qual. 2019;8(2):e000430. Published 2019 Apr 25. doi:10.1136/bmjoq-2018-000430
16. Kontos E, Blake KD, Chou WY, Prestin A. Predictors of eHealth usage: insights on the digital divide from the Health Information National Trends Survey 2012. J Med Internet Res. 2014;16(7):e172. Published 2014 Jul 16. doi:10.2196/jmir.3117
17. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice. The state of health disparities in the United States. In: Baciu A, Negussie Y, Geller A, et al, eds. Communities in Action: Pathways to Health Equity. National Academies Press (US); January 11, 2017. Accessed November 3, 2022. https://www.ncbi.nlm.nih.gov/books/NBK425848/
18. Pew Research Center. Internet/broadband fact sheet. Updated April 7, 2021. Accessed November 3, 2022. https://www.pewresearch.org/internet/fact-sheet/internet-broadband
19. Roberts ET, Mehrotra A. Assessment of disparities in digital access among Medicare beneficiaries and implications for telemedicine. JAMA Intern Med. 2020;180(10):1386-1389. doi:10.1001/jamainternmed.2020.2666
20. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Veteran population. Updated September 7, 2022. Accessed November 3, 2022. https://www.va.gov/vetdata/veteran_population.asp
21. US Department of Veterans Affairs, Office of Rural Health. Rural veterans health care challenges. Updated March 31, 2022. Accessed November 3, 2022. https://www.ruralhealth.va.gov/aboutus/ruralvets.asp
22. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA expands veteran access to telehealth with iPad services. Press release. September 15, 2020. Accessed November 3, 2022. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5521
23. Zulman DM, Wong EP, Slightam C, et al. Making connections: National implementation of video telehealth tablets to address access barriers in veterans. JAMIA Open. 2019;2(3):323-329. doi:10.1093/jamiaopen/ooz024
24. Malone NC, Williams MM, Smith Fawzi MC, et al. Mobile health clinics in the United States. Int J Equity Health. 2020;19(1):40. doi:10.1186/s12939-020-1135-7
25. US Department of Veterans Affairs. How to use My HealtheVet. Accessed November 3, 2022. https://www.myhealth.va.gov/mhv-portal-web/how-to-use-mhv
26. US Department of Veterans Affairs, Veterans Health Administration, Office of Patient Centered Care and Cultural Transformation. Whole health for life. 2017. Accessed November 3, 2022. https://www.va.gov/wholehealth/docs/2017-AR-Vet-Facing_FNL-W508.pdf27. Mortimer F, Isherwood J, Wilkinson A, Vaux E. Sustainability in quality improvement: redefining value. Future Healthc J. 2018;5(2):88-93. doi:10.7861/futurehosp.5-2-88
1. Centers for Medicare and Medicaid Services. Promoting interoperability programs. Updated October 6, 2022. Accessed November 3, 2022. https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms
2. American Hospital Association. Goals of the Medicare and Medicaid electronic health records programs. Accessed November 3, 2022. https://www.aha.org/websites/2009-12-11-goals-medicare-and-medicaid-electronic-health-records-programs
3. Rozenblum R, Donzé J, Hockey PM, et al. The impact of medical informatics on patient satisfaction: a USA-based literature review. Int J Med Inform. 2013;82(3):141-158. doi:10.1016/j.ijmedinf.2012.12.008
4. Stewart MT, Hogan TP, Nicklas J, et al. The promise of patient portals for individuals living with chronic illness: qualitative study identifying pathways of patient engagement. J Med Internet Res. 2020;22(7):e17744. Published 2020 Jul 17. doi:10.2196/17744
5. Harris LT, Haneuse SJ, Martin DP, Ralston JD. Diabetes quality of care and outpatient utilization associated with electronic patient-provider messaging: a cross-sectional analysis. Diabetes Care. 2009;32(7):1182-1187. doi:10.2337/dc08-1771
6. Robinson SA, Zocchi MS, Netherton D, et al. Secure messaging, diabetes self-management, and the importance of patient autonomy: a mixed methods study. J Gen Intern Med. 2020;35(10):2955-2962. doi:10.1007/s11606-020-05834-x
7. Zocchi MS, Robinson SA, Ash AS, et al. Patient portal engagement and diabetes management among new portal users in the Veterans Health Administration. J Am Med Inform Assoc. 2021;28(10):2176-2183. doi:10.1093/jamia/ocab115
8. Bao C, Bardhan IR, Singh H, Meyer BA, Kirksey K. Patient-provider engagement and its impact on health outcomes: a longitudinal study of patient portal use. MIS Quarterly. 2020;44(2):699-723. doi:10.25300/MISQ/2020/14180
9. Grossman LV, Masterson Creber RM, Benda NC, Wright D, Vawdrey DK, Ancker JS. Interventions to increase patient portal use in vulnerable populations: a systematic review. J Am Med Informs Assoc. 2019;26(8-9):855-870. doi:10.1093/jamia/ocz023
10. Zhao JY, Song B, Anand E, et al. Barriers, facilitators, and solutions to optimal patient portal and personal health record use: a systematic review of the literature. AMIA Annu Symp Proc. 2018;2017:1913-1922. Published 2018 Apr 16.
11. Zhong X, Park J, Liang M, et al. Characteristics of patients using different patient portal functions and the impact on primary care service utilization and appointment adherence: retrospective observational study. J Med Internet Res. 2020;22(2):e14410. Published 2020 Feb 25. doi:10.2196/14410
12. Krishnaswami A, Beavers C, Dorsch MP, et al. Gerotechnology for older adults with cardiovascular diseases. J Am Coll Cardiol. 2020;76(22):2650-2670. doi:10.1016/j.jacc.2020.09.606
13. Fix GM, Hogan TP, Amante DJ, McInnes DK, Nazi KM, Simon SR. Encouraging patient portal use in the patient-centered medical home: three stakeholder perspectives. J Med Internet Res. 2016;18(11):e308. Published 2016 Nov 22. doi:10.2196/jmir.6488
14. Ancker JS, Nosal S, Hauser D, Way C, Calman N. Access policy and the digital divide in patient access to medical records. Health Policy Technol. 2016;6(3-11). doi:10.1016/j.hlpt.2016.11.004
15. Rhudy C, Broxterman J, Stewart S, et al. Improving patient portal enrolment in an academic resident continuity clinic: quality improvement made simple. BMJ Open Qual. 2019;8(2):e000430. Published 2019 Apr 25. doi:10.1136/bmjoq-2018-000430
16. Kontos E, Blake KD, Chou WY, Prestin A. Predictors of eHealth usage: insights on the digital divide from the Health Information National Trends Survey 2012. J Med Internet Res. 2014;16(7):e172. Published 2014 Jul 16. doi:10.2196/jmir.3117
17. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice. The state of health disparities in the United States. In: Baciu A, Negussie Y, Geller A, et al, eds. Communities in Action: Pathways to Health Equity. National Academies Press (US); January 11, 2017. Accessed November 3, 2022. https://www.ncbi.nlm.nih.gov/books/NBK425848/
18. Pew Research Center. Internet/broadband fact sheet. Updated April 7, 2021. Accessed November 3, 2022. https://www.pewresearch.org/internet/fact-sheet/internet-broadband
19. Roberts ET, Mehrotra A. Assessment of disparities in digital access among Medicare beneficiaries and implications for telemedicine. JAMA Intern Med. 2020;180(10):1386-1389. doi:10.1001/jamainternmed.2020.2666
20. US Department of Veterans Affairs, National Center for Veterans Analysis and Statistics. Veteran population. Updated September 7, 2022. Accessed November 3, 2022. https://www.va.gov/vetdata/veteran_population.asp
21. US Department of Veterans Affairs, Office of Rural Health. Rural veterans health care challenges. Updated March 31, 2022. Accessed November 3, 2022. https://www.ruralhealth.va.gov/aboutus/ruralvets.asp
22. US Department of Veterans Affairs, Office of Public and Intergovernmental Affairs. VA expands veteran access to telehealth with iPad services. Press release. September 15, 2020. Accessed November 3, 2022. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5521
23. Zulman DM, Wong EP, Slightam C, et al. Making connections: National implementation of video telehealth tablets to address access barriers in veterans. JAMIA Open. 2019;2(3):323-329. doi:10.1093/jamiaopen/ooz024
24. Malone NC, Williams MM, Smith Fawzi MC, et al. Mobile health clinics in the United States. Int J Equity Health. 2020;19(1):40. doi:10.1186/s12939-020-1135-7
25. US Department of Veterans Affairs. How to use My HealtheVet. Accessed November 3, 2022. https://www.myhealth.va.gov/mhv-portal-web/how-to-use-mhv
26. US Department of Veterans Affairs, Veterans Health Administration, Office of Patient Centered Care and Cultural Transformation. Whole health for life. 2017. Accessed November 3, 2022. https://www.va.gov/wholehealth/docs/2017-AR-Vet-Facing_FNL-W508.pdf27. Mortimer F, Isherwood J, Wilkinson A, Vaux E. Sustainability in quality improvement: redefining value. Future Healthc J. 2018;5(2):88-93. doi:10.7861/futurehosp.5-2-88
How to advocate in a post-Roe world, no matter your zip code
For many, the recent Supreme Court decision in the Dobbs v Jackson case that removed the constitutional right to an abortion has introduced outrage, fear, and confusion throughout the country. While the American College of Obstetricians and Gynecologists (ACOG) clearly has established that abortion is essential health care and has published resources regarding the issue (www.acog.org/advocacy/abortion-is-essential), and many providers know what to do medically, they do not know what they can do legally. In a country where 45% of pregnancies are unplanned and 25% of women will access abortion services in their lifetime, this decision will completely change the landscape of providing and receiving abortion care. This decision will affect every provider and their patients and will affect them differently in each state. The country likely will be divided into 24 destination states that will protect the right to abortion and another 26 states that have or will soon ban abortion or severely restrict access to it.
Regardless of the state you practice in, it is clear that our voices, actions, and advocacy are essential during these challenging times. It can feel difficult to find ways to advocate, especially if you are in a state or have an employer that supports anti-abortion legislation or has been silent after the Dobbs decision was released. We have created a guide to help and encourage all ObGyn providers to find ways to advocate, no matter their zip code.
1. Donate
Many of our patients will need to travel out of state to seek abortion care. The cost of abortion care can be expensive, and travel, child care, and time off of work add to the costs of the procedure itself, making access to abortion care financially out of reach for some. There are many well-established abortion funds throughout the country; consider donating to one of them or organizing a fundraiser in your community. Go to abortionfunds.org/funds to find an abortion fund that will support patients in your community, or donate generally to support them all.
2. Save your stories
We already are hearing the devastating impact abortion bans have on patient care around the country. If you had to deny or delay care because of the new legal landscape surrounding abortion, write down or record the experience. Your stories can be critical in discussing the impact of legislation. If you choose to share on social media, ask the involved patients if they are comfortable with their story being shared online (as long as their identity is protected).
3. Talk about it
Talking about abortion is a critical step in destigmatizing it and supporting our patients as well as our field. These conversations can be challenging, but ACOG has provided an important guide that includes key phrases and statements to help shape the conversation and avoid polarizing language (https://www.acog.org/advocacy/abortion-is-essential/come-prepared). This guide also can be helpful to keep in mind when talking to members of the media.
Continue to: 4. Write about it...
4. Write about it
There are many opportunities to write about the impact of the Dobbs decision, especially locally. As a clinician and trusted member of the community, you can uniquely share your and your patients’ experiences. Your article does not have to appear in a major publication; you can still have an important impact in your local paper. See resources on how to write an op-ed and letter to the editor (https://www.acog.org/advocacy/abortion-is-essential/connect-in-your-community/legislative-rx-op-eds-and-letters-to-the-editor).
5. Teach about it
These legislative changes uniquely impact our ObGyn residents; 44% of residents likely will be in a training program in a state that will ban or severely restrict abortion access. Abortion is health care, and a vast majority of our residents could graduate without important skills to save lives. As we strategize to ensure all ObGyn residents are able to receive this important training, work on incorporating an advocacy curriculum into your residents’ educational experience. Teaching about how to advocate is an important skill for supporting our patients and ensuring critical health policy. ACOG has published guides focused on education and training (www.acog.org/advocacy/abortion-is-essential/education-and-training). We also have included our own medical center’s advocacy curriculum (https://docs.google.com/document/d/1STxLzE0j55mlDEbF0_wZbo9O QryAcs6RpfZ47Mwfs4I/edit).
6. Get involved and seek out allies
It’s important that ObGyns be at the table for all discussions surrounding abortion care and reproductive health. Join hospital committees and help influence policy within your own institution. Refer back to those abortion talking points—this will help in some of these challenging conversations.
7. Get on social media
Using social media can be a powerful tool for advocacy. You can help elevate issues and encourage others to get active as well. Using a common hashtag, such as #AbortionisHealthcare, on different platforms can help connect you to other advocates. Share simple and important graphics provided by ACOG on important topics in our field (https://www.acog.org/advocacy/abortion-is-essential/advocate-in-your-state/social-media) and review ACOG’s recommendation for professionalism in social media (https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/10/professional-use-of-digital-and-social-media).
8. Get active locally
We have seen the introduction of hundreds of bills in states around the country not only on abortion but also on other legislation that directly impacts the care we provide. It is critical that we get involved in advocating for important reproductive health legislation and against bills that cause harm and interfere with the doctor-patient relationship. Stay up to date on legislative issues with your local ACOG and medical chapters (https://www.acog.org/advocacy/abortion-is-essential/advocate-in-your-state). Consider testifying at your State house, providing written or oral testimony. Connect with ACOG or your state medical chapter to help with talking points!
9. Read up
There have been many new policies at the federal level that could impact the care you provide. Take some time to read up on these new changes. Patients also may ask you about self-managed abortion. There are guides and resources (https://www.acog.org/advocacy/abortion-is-essential/practice-management) for patients that may seek medication online, and we want to ensure that patients have the resources to make informed decisions.
10. Hit the Capitol
Consider making time to come to the annual Congressional Leadership Conference in Washington, DC (https://www.acog.org/education-and-events/meetings/acog-congressional-leadership-conference), or other advocacy events offered through the American Medical Association or other subspecialty organizations. When we all come together as an organization, a field, and a community, it sends a powerful message that we are standing up together for our patients and our colleagues.
Make a difference
There is no advocacy too big or too small. It is critical that we continue to use our voices and our platforms to stand up for health care and access to critical services, including abortion care. ●
For many, the recent Supreme Court decision in the Dobbs v Jackson case that removed the constitutional right to an abortion has introduced outrage, fear, and confusion throughout the country. While the American College of Obstetricians and Gynecologists (ACOG) clearly has established that abortion is essential health care and has published resources regarding the issue (www.acog.org/advocacy/abortion-is-essential), and many providers know what to do medically, they do not know what they can do legally. In a country where 45% of pregnancies are unplanned and 25% of women will access abortion services in their lifetime, this decision will completely change the landscape of providing and receiving abortion care. This decision will affect every provider and their patients and will affect them differently in each state. The country likely will be divided into 24 destination states that will protect the right to abortion and another 26 states that have or will soon ban abortion or severely restrict access to it.
Regardless of the state you practice in, it is clear that our voices, actions, and advocacy are essential during these challenging times. It can feel difficult to find ways to advocate, especially if you are in a state or have an employer that supports anti-abortion legislation or has been silent after the Dobbs decision was released. We have created a guide to help and encourage all ObGyn providers to find ways to advocate, no matter their zip code.
1. Donate
Many of our patients will need to travel out of state to seek abortion care. The cost of abortion care can be expensive, and travel, child care, and time off of work add to the costs of the procedure itself, making access to abortion care financially out of reach for some. There are many well-established abortion funds throughout the country; consider donating to one of them or organizing a fundraiser in your community. Go to abortionfunds.org/funds to find an abortion fund that will support patients in your community, or donate generally to support them all.
2. Save your stories
We already are hearing the devastating impact abortion bans have on patient care around the country. If you had to deny or delay care because of the new legal landscape surrounding abortion, write down or record the experience. Your stories can be critical in discussing the impact of legislation. If you choose to share on social media, ask the involved patients if they are comfortable with their story being shared online (as long as their identity is protected).
3. Talk about it
Talking about abortion is a critical step in destigmatizing it and supporting our patients as well as our field. These conversations can be challenging, but ACOG has provided an important guide that includes key phrases and statements to help shape the conversation and avoid polarizing language (https://www.acog.org/advocacy/abortion-is-essential/come-prepared). This guide also can be helpful to keep in mind when talking to members of the media.
Continue to: 4. Write about it...
4. Write about it
There are many opportunities to write about the impact of the Dobbs decision, especially locally. As a clinician and trusted member of the community, you can uniquely share your and your patients’ experiences. Your article does not have to appear in a major publication; you can still have an important impact in your local paper. See resources on how to write an op-ed and letter to the editor (https://www.acog.org/advocacy/abortion-is-essential/connect-in-your-community/legislative-rx-op-eds-and-letters-to-the-editor).
5. Teach about it
These legislative changes uniquely impact our ObGyn residents; 44% of residents likely will be in a training program in a state that will ban or severely restrict abortion access. Abortion is health care, and a vast majority of our residents could graduate without important skills to save lives. As we strategize to ensure all ObGyn residents are able to receive this important training, work on incorporating an advocacy curriculum into your residents’ educational experience. Teaching about how to advocate is an important skill for supporting our patients and ensuring critical health policy. ACOG has published guides focused on education and training (www.acog.org/advocacy/abortion-is-essential/education-and-training). We also have included our own medical center’s advocacy curriculum (https://docs.google.com/document/d/1STxLzE0j55mlDEbF0_wZbo9O QryAcs6RpfZ47Mwfs4I/edit).
6. Get involved and seek out allies
It’s important that ObGyns be at the table for all discussions surrounding abortion care and reproductive health. Join hospital committees and help influence policy within your own institution. Refer back to those abortion talking points—this will help in some of these challenging conversations.
7. Get on social media
Using social media can be a powerful tool for advocacy. You can help elevate issues and encourage others to get active as well. Using a common hashtag, such as #AbortionisHealthcare, on different platforms can help connect you to other advocates. Share simple and important graphics provided by ACOG on important topics in our field (https://www.acog.org/advocacy/abortion-is-essential/advocate-in-your-state/social-media) and review ACOG’s recommendation for professionalism in social media (https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/10/professional-use-of-digital-and-social-media).
8. Get active locally
We have seen the introduction of hundreds of bills in states around the country not only on abortion but also on other legislation that directly impacts the care we provide. It is critical that we get involved in advocating for important reproductive health legislation and against bills that cause harm and interfere with the doctor-patient relationship. Stay up to date on legislative issues with your local ACOG and medical chapters (https://www.acog.org/advocacy/abortion-is-essential/advocate-in-your-state). Consider testifying at your State house, providing written or oral testimony. Connect with ACOG or your state medical chapter to help with talking points!
9. Read up
There have been many new policies at the federal level that could impact the care you provide. Take some time to read up on these new changes. Patients also may ask you about self-managed abortion. There are guides and resources (https://www.acog.org/advocacy/abortion-is-essential/practice-management) for patients that may seek medication online, and we want to ensure that patients have the resources to make informed decisions.
10. Hit the Capitol
Consider making time to come to the annual Congressional Leadership Conference in Washington, DC (https://www.acog.org/education-and-events/meetings/acog-congressional-leadership-conference), or other advocacy events offered through the American Medical Association or other subspecialty organizations. When we all come together as an organization, a field, and a community, it sends a powerful message that we are standing up together for our patients and our colleagues.
Make a difference
There is no advocacy too big or too small. It is critical that we continue to use our voices and our platforms to stand up for health care and access to critical services, including abortion care. ●
For many, the recent Supreme Court decision in the Dobbs v Jackson case that removed the constitutional right to an abortion has introduced outrage, fear, and confusion throughout the country. While the American College of Obstetricians and Gynecologists (ACOG) clearly has established that abortion is essential health care and has published resources regarding the issue (www.acog.org/advocacy/abortion-is-essential), and many providers know what to do medically, they do not know what they can do legally. In a country where 45% of pregnancies are unplanned and 25% of women will access abortion services in their lifetime, this decision will completely change the landscape of providing and receiving abortion care. This decision will affect every provider and their patients and will affect them differently in each state. The country likely will be divided into 24 destination states that will protect the right to abortion and another 26 states that have or will soon ban abortion or severely restrict access to it.
Regardless of the state you practice in, it is clear that our voices, actions, and advocacy are essential during these challenging times. It can feel difficult to find ways to advocate, especially if you are in a state or have an employer that supports anti-abortion legislation or has been silent after the Dobbs decision was released. We have created a guide to help and encourage all ObGyn providers to find ways to advocate, no matter their zip code.
1. Donate
Many of our patients will need to travel out of state to seek abortion care. The cost of abortion care can be expensive, and travel, child care, and time off of work add to the costs of the procedure itself, making access to abortion care financially out of reach for some. There are many well-established abortion funds throughout the country; consider donating to one of them or organizing a fundraiser in your community. Go to abortionfunds.org/funds to find an abortion fund that will support patients in your community, or donate generally to support them all.
2. Save your stories
We already are hearing the devastating impact abortion bans have on patient care around the country. If you had to deny or delay care because of the new legal landscape surrounding abortion, write down or record the experience. Your stories can be critical in discussing the impact of legislation. If you choose to share on social media, ask the involved patients if they are comfortable with their story being shared online (as long as their identity is protected).
3. Talk about it
Talking about abortion is a critical step in destigmatizing it and supporting our patients as well as our field. These conversations can be challenging, but ACOG has provided an important guide that includes key phrases and statements to help shape the conversation and avoid polarizing language (https://www.acog.org/advocacy/abortion-is-essential/come-prepared). This guide also can be helpful to keep in mind when talking to members of the media.
Continue to: 4. Write about it...
4. Write about it
There are many opportunities to write about the impact of the Dobbs decision, especially locally. As a clinician and trusted member of the community, you can uniquely share your and your patients’ experiences. Your article does not have to appear in a major publication; you can still have an important impact in your local paper. See resources on how to write an op-ed and letter to the editor (https://www.acog.org/advocacy/abortion-is-essential/connect-in-your-community/legislative-rx-op-eds-and-letters-to-the-editor).
5. Teach about it
These legislative changes uniquely impact our ObGyn residents; 44% of residents likely will be in a training program in a state that will ban or severely restrict abortion access. Abortion is health care, and a vast majority of our residents could graduate without important skills to save lives. As we strategize to ensure all ObGyn residents are able to receive this important training, work on incorporating an advocacy curriculum into your residents’ educational experience. Teaching about how to advocate is an important skill for supporting our patients and ensuring critical health policy. ACOG has published guides focused on education and training (www.acog.org/advocacy/abortion-is-essential/education-and-training). We also have included our own medical center’s advocacy curriculum (https://docs.google.com/document/d/1STxLzE0j55mlDEbF0_wZbo9O QryAcs6RpfZ47Mwfs4I/edit).
6. Get involved and seek out allies
It’s important that ObGyns be at the table for all discussions surrounding abortion care and reproductive health. Join hospital committees and help influence policy within your own institution. Refer back to those abortion talking points—this will help in some of these challenging conversations.
7. Get on social media
Using social media can be a powerful tool for advocacy. You can help elevate issues and encourage others to get active as well. Using a common hashtag, such as #AbortionisHealthcare, on different platforms can help connect you to other advocates. Share simple and important graphics provided by ACOG on important topics in our field (https://www.acog.org/advocacy/abortion-is-essential/advocate-in-your-state/social-media) and review ACOG’s recommendation for professionalism in social media (https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/10/professional-use-of-digital-and-social-media).
8. Get active locally
We have seen the introduction of hundreds of bills in states around the country not only on abortion but also on other legislation that directly impacts the care we provide. It is critical that we get involved in advocating for important reproductive health legislation and against bills that cause harm and interfere with the doctor-patient relationship. Stay up to date on legislative issues with your local ACOG and medical chapters (https://www.acog.org/advocacy/abortion-is-essential/advocate-in-your-state). Consider testifying at your State house, providing written or oral testimony. Connect with ACOG or your state medical chapter to help with talking points!
9. Read up
There have been many new policies at the federal level that could impact the care you provide. Take some time to read up on these new changes. Patients also may ask you about self-managed abortion. There are guides and resources (https://www.acog.org/advocacy/abortion-is-essential/practice-management) for patients that may seek medication online, and we want to ensure that patients have the resources to make informed decisions.
10. Hit the Capitol
Consider making time to come to the annual Congressional Leadership Conference in Washington, DC (https://www.acog.org/education-and-events/meetings/acog-congressional-leadership-conference), or other advocacy events offered through the American Medical Association or other subspecialty organizations. When we all come together as an organization, a field, and a community, it sends a powerful message that we are standing up together for our patients and our colleagues.
Make a difference
There is no advocacy too big or too small. It is critical that we continue to use our voices and our platforms to stand up for health care and access to critical services, including abortion care. ●
Simplify your approach to the diagnosis and treatment of PCOS
PCOS is a common problem, with a prevalence of 6% to 10% among women of reproductive age.1 Patients with PCOS often present with hirsutism, acne, female androgenetic alopecia, oligomenorrhea (also known as infrequent menstrual bleeding), amenorrhea, infertility, overweight, or obesity. In addition, many patients with PCOS have insulin resistance, dyslipidemia, metabolic syndrome, and an increased risk for developing type 2 diabetes mellitus (DM).2 A simplified approach to the diagnosis of PCOS will save health care resources by reducing the use of low-value diagnostic tests. A simplified approach to the treatment of PCOS will support patient medication adherence and improve health outcomes.
Simplify the diagnosis of PCOS
Simplify PCOS diagnosis by focusing on the core criteria of hyperandrogenism and oligo-ovulation. There are 3 major approaches to diagnosis:
- the 1990 National Institutes of Health (NIH) criteria3
- the 2003 Rotterdam criteria4,5
- the 2008 Androgen Excess and PCOS Society (AES) criteria.6
Using the 1990 NIH approach, the diagnosis of PCOS is made by the presence of 2 core criteria: hyperandrogenism and oligo-ovulation, typically manifested as oligomenorrhea. In addition, other causes of hyperandrogenism should be excluded, including nonclassical adrenal hyperplasia (NCAH) due to 21-hydroxylase deficiency.3 Using the 1990 NIH criteria, PCOS can be diagnosed based on history (oligomenorrhea) and physical examination (assessment of the severity of hirsutism), but laboratory tests including total testosterone are often ordered.7
The Rotterdam approach to the diagnosis added a third criteria, the detection by ultrasonography of a multifollicular ovary and/or increased ovarian volume.4,5 Using the Rotterdam approach, PCOS is diagnosed in the presence of any 2 of the following 3 criteria: hyperandrogenism, oligo-ovulation, or ultrasound imaging showing the presence of a multifollicular ovary, identified by ≥ 12 antral follicles (2 to 9 mm in diameter) in each ovary or increased ovarian volume (> 10 mL).4,5
The Rotterdam approach using ovarian ultrasound as a criterion to diagnose PCOS is rife with serious problems, including:
- The number of small antral follicles in the normal ovary is age dependent, and many ovulatory and nonhirsute patients have ≥ 12 small antral follicles in each ovary.8,9
- There is no consensus on the number of small antral follicles needed to diagnose a multifollicular ovary, with recommendations to use thresholds of 124,5 or 20 follicles10 as the diagnostic cut-off.
- Accurate counting of the number of small ovarian follicles requires transvaginal ultrasound, which is not appropriate for many young adolescent patients.
- The process of counting ovarian follicles is operator-dependent.
- The high cost of ultrasound assessment of ovarian follicles (≥ $500 per examination).
The Rotterdam approach supports the diagnosis of PCOS in a patient with oligo-ovulation plus an ultrasound showing a multifollicular ovary in the absence of any clinical or laboratory evidence of hyperandrogenism.3,4,5 This approach to the diagnosis of PCOS is rejected by both the 1990 NIH3 and AES6 recommendations, which require the presence of hyperandrogenism as the sine qua non in the diagnosis of PCOS. I recommend against diagnosing PCOS in a non-hyperandrogenic patient with oligo-ovulation and a multifollicular ovary because other diagnoses are also possible, such as functional hypothalamic oligo-ovulation, especially in young patients. The Rotterdam approach also supports the diagnosis of PCOS in a patient with hyperandrogenism, an ultrasound showing a multifollicular ovary, and normal ovulation and menses.3,4 For most patients with normal, regular ovulation and menses, the testosterone concentration is normal and the only evidence of hyperandrogenism is hirsutism. Patients with normal, regular ovulation and menses plus hirsutism usually have idiopathic hirsutism. Idiopathic hirsutism is a problem caused by excessive 5-alpha-reductase activity in the hair pilosebaceous unit, which catalyzes the conversion of weak androgens into dihydrotestosterone, a potent intracellular androgen that stimulates terminal hair growth.11 In my opinion, the Rotterdam approach to diagnosing PCOS has created unnecessary confusion and complexity for both clinicians and patients. I believe we should simplify the diagnosis of PCOS and return to the 1990 NIH criteria.3
On occasion, a patient presents for a consultation and has already had an ovarian ultrasound to assess for a multifollicular ovary. I carefully read the report and, if a multifollicular ovary has been identified, I consider it as a secondary supporting finding of PCOS in my clinical assessment. But I do not base my diagnosis on the ultrasound finding. Patients often present with other laboratory tests that are secondary supporting findings of PCOS, which I carefully consider but do not use to make a diagnosis of PCOS. Secondary supporting laboratory findings consistent with PCOS include: 1) a markedly elevated anti-müllerian hormone (AMH) level,12 2) an elevated fasting insulin level,2,13 and 3) an elevated luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio.13,14 But it is not necessary to measure AMH, fasting insulin, LH, and FSH levels. To conserve health care resources, I recommend against measuring those analytes to diagnose PCOS.
Continue to: Simplify the core laboratory tests...
Simplify the core laboratory tests
Simplify the testing used to support the diagnosis of PCOS by measuring total testosterone, sex-hormone binding globulin (SHBG) and early morning 17-hydroxyprogesterone (17-OH Prog).
The core criteria for diagnosis of PCOS are hyperandrogenism and oligo-ovulation, typically manifested as oligomenorrhea or amenorrhea. Hyperandrogenism can be clinically diagnosed by assessing for the presence of hirsutism.7 Elevated levels of total testosterone, free testosterone, androstenedione, and/or dehydroepiandrosterone sulfate (DHEAS) suggest the presence of hyperandrogenism. In clinical practice, the laboratory approach to the diagnosis of hyperandrogenism can be simplified to the measurement of total testosterone, SHBG, and 17-OH Prog. By measuring total testosterone and SHBG, an estimate of free testosterone can be made. If the total testosterone is elevated, it is highly likely that the free testosterone is elevated. If the SHBG is abnormally low and the total testosterone level is in the upper limit of the normal range, the free testosterone is likely to be elevated.15 Using this approach, either an elevated total testosterone or an abnormally low SHBG indicate elevated free testosterone. For patients with hyperandrogenism and oligo-ovulation, an early morning (8 to 9 AM) 17-OH Prog level ≤ 2 ng/mL rules out the presence of NCAH due to a 21-hydroxylase deficiency.16 In my practice, the core laboratory tests I order when considering the diagnosis of PCOS are a total testosterone, SHBG, and 17-OH Prog.
Additional laboratory tests may be warranted to assess the patient diagnosed with PCOS. For example, if the patient has amenorrhea due to anovulation, tests for prolactin, FSH, and thyroid-stimulating hormone levels are warranted to assess for the presence of a prolactinoma, primary ovarian insufficiency, or thyroid disease, respectively. If the patient has a body mass index (BMI) ≥ 25 kg/m2, a hemoglobin A1c concentration is warranted to assess for the presence of prediabetes or DM.2 Many patients with PCOS have dyslipidemia, manifested through low high-density lipoprotein cholesterol levels and elevated low-density lipoprotein cholesterol levels, and a lipid panel assessment may be indicated. Among patients with PCOS, the most common lipid abnormality is a low high-density lipoprotein cholesterol level.17
Simplify the treatment of PCOS
Simplify treatment by counseling about lifestyle changes and prescribing an estrogen-progestin contraceptive, spironolactone, and metformin.
Most patients with PCOS have dysfunction in reproductive, metabolic, and dermatologic systems. For patients who are overweight or obese, lifestyle changes, including diet and exercise, that result in a 5% to 10% decrease in weight can improve metabolic balance, reduce circulating androgens, and increase menstrual frequency.18 For patients with PCOS and weight issues, referral to nutrition counseling or a full-service weight loss program can be very beneficial. In addition to lifestyle changes, patients with PCOS benefit from treatment with estrogen-progestin medications, spironolactone, and metformin.
Combination estrogen-progestin medications will lower LH secretion, decrease ovarian androgen production, increase SHBG production, decrease free testosterone levels and, if given cyclically, cause regular withdrawal bleeding.19 Spironolactone is an antiandrogen, which blocks the intracellular action of dihydrotestosterone and improves hirsutism and acne. Spironolactone also modestly decreases circulating levels of testosterone and DHEAS.20 For patients with metabolic problems, including insulin resistance and obesity, weight loss and/or treatment with metformin can help improve metabolic balance, which may result in restoration of ovulatory menses.21,22 Metformin can be effective in restoring ovulatory menses in both obese and lean patients with PCOS.22 The most common dermatologic problem caused by PCOS are hirsutism and acne. Both combination estrogen-progestin medications and spironolactone are effective treatments for hirsutism and acne.23
Estrogen-progestin hormones, spironolactone, and metformin are low-cost medications for the treatment of PCOS. Additional high-cost options for treatment of PCOS in obese patients include bariatric surgery and glucagon-like peptide (GLP-1) agonist medications (liraglutide and exenatide). For patients with PCOS and a body mass index (BMI) ≥ 35 kg/m2, bariatric surgery often results in sufficient weight loss to resolve the patient’s hyperandrogenism and oligo-ovulation, restoring spontaneous ovulatory cycles.24 In a study of more than 1,000 patients with: PCOS; mean BMI, 44 kg/m2; mean age, 31 years who were followed post-bariatric surgery for 5 years, > 90% of patients reported reductions in hirsutism and resumption of regular menses.25 For patients with PCOS seeking fertility, bariatric surgery often results in spontaneous pregnancy and live birth.26 GLP-1 agonists, including liraglutide or exenatide with or without metformin are effective in reducing weight, decreasing androgen levels, and restoring ovulatory menses.27,28
In my practice, I often prescribe 2 or 3 core medications for a patient with PCOS: 1) combination estrogen-progestin used cyclically or continuously, 2) spironolactone, and 3) metformin.19 Any estrogen-progestin contraceptive will suppress LH and ovarian androgen production; however, in the treatment of patients with PCOS, I prefer to use an estrogen-progestin combination that does not contain the androgenic progestin levonorgestrel.29 For the treatment of PCOS, I prefer to use an estrogen-progestin contraceptive with a non-androgenic progestin such as drospirenone, desogestrel, or gestodene. I routinely prescribe spironolactone at a dose of 100 mg, once daily, a dose near the top of the dose-response curve. A daily dose ≤ 50 mg of spironolactone is subtherapeutic for the treatment of hirsutism. A daily dose of 200 mg of spironolactone may cause bothersome breakthrough bleeding. When prescribing metformin, I usually recommend the extended-release formulation, at a dose of 750 mg with dinner. If well tolerated, I will increase the dose to 1,500 mg with dinner. Most of my patients with PCOS are taking a combination of 2 medications, either an estrogen-progestin contraceptive plus spironolactone or an estrogen-progestin contraceptive plus metformin.19 Some of my patients are taking all 3 medications. All 3 medications are very low cost.
For patients with PCOS and anovulatory infertility, letrozole treatment often results in ovulatory cycles and pregnancy with live birth. In obese PCOS patients, compared with clomiphene, letrozole results in superior live birth rates.30 Unlike clomiphene, letrozole is not approved by the US Food and Drug Administration for the treatment of anovulatory infertility.
The diagnosis of PCOS is often delayed due to confusion about how to make the diagnosis.31 To simplify the diagnosis of PCOS and improve patient encounters for PCOS, I focus on 2 core criteria: hyperandrogenism and oligo-ovulation. I recommend against ordering ultrasound imaging to assess for the presence of a multifollicular ovary. To simplify the treatment of PCOS I frequently prescribe an estrogen-progestin contraceptive, spironolactone, and metformin. By simplifying the diagnosis and treatment of PCOS, ObGyns will reduce patient confusion, improve outcomes, and save health care resources. ●
PCOS and adolescent patients
It is difficult to diagnose polycystic ovary syndrome (PCOS) in adolescents because oligo-ovulation is a common physiological feature of adolescence. Based on consensus among experts, PCOS should not be diagnosed within the first 2 years following menarche because the prevalence of oligo-ovulation is common at this stage of pubertal development. Two years after menarche, if an adolescent has a cycle length that is routinely > 45 days, it is likely that the pattern will persist, suggesting the presence of oligo-ovulation. Hyperandrogenism can be diagnosed based on the presence of moderate to severe hirsutism and/or an elevated testosterone or abnormally low sex-hormone binding globulin (SHBG) concentration. Two years after menarche the presence of oligo-ovulation and hyperandrogenism establishes the diagnosis of PCOS.1
PCOS and thrombophilia or migraine with aura
For patients with PCOS and a Factor V Leiden allele, where an estrogen-progestin contraceptive is contraindicated because of an increased risk of a venous thrombus, I prescribe spironolactone plus a levonorgestrel-intrauterine device. A low-dose oral progestin also may be considered because it will modestly suppress LH and ovarian androgen production. Similarly for patients with migraine with aura, where an estrogen-progestin contraceptive is contraindicated because of an increased of stroke, spironolactone plus a levonorgesterel intrauterine device may be effective in the treatment of hirsutism.
Androgen secreting tumors
Occasionally during the evaluation of a patient with hyperandrogenism and oligo-ovulation, measurement of total testosterone levels will reveal a value > 1.5 ng/mL. Most patients with PCOS have a total testosterone level ≤ 1.5 ng/mL. A total testosterone concentration > 1.5 ng/mL may be caused by ovarian stromal hyperthecosis or an androgen-producing tumor.2
Strongly-held patient perspectives on PCOS
At the first consultation visit, some patients are fearful and not receptive to a diagnosis of PCOS. If a clinician senses that the patient is not prepared to hear that they have PCOS, the clinician can be supportive of the patient’s perspective and focus on the patient’s chief health concerns, which may include abnormal cycle length, hirsutism, and/or overweight or obesity. During follow-up visits, as the patient builds trust with the clinician, the patient will be better prepared to discuss the diagnosis of PCOS. At the first consultation visit, some patients present with a strong belief that they have PCOS but have seen clinicians who conclude that they do not have PCOS. The diagnosis of PCOS is confusing because of competing diagnostic frameworks (NIH, Rotterdam, and AES). I avoid engaging in an argument with a patient who strongly believes that they have PCOS. In these situations, I focus on identifying the patient’s chief health concerns and discussing interventions to support their health goals.
References
1. Rosenfield RL. Perspectives on the international recommendations for the diagnosis and treatment of polycystic ovary syndrome in adolescence. J Pediatr Adolesc Gynecol. 2020;33:445-447.
2. Meczekalski B, Szeliga A, Maciejewska-Jeske M, et al. Hyperthecosis: an underestimated nontumorous cause of hyperandrogenism. Gynecol Endocrinol. 2021;37:677-682.
- Bozdag G, Mumusoglu S, Zengin D, et al. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016;31:2841-2855.
- Livadas S, Anagnostis P, Bosdou JK, et al. Polycystic ovary syndrome and type 2 diabetes mellitus: a state-of-the-art review. World J Diabetes. 2022;13:5-26.
- Zawadski JK, Dunaif A. Diagnostic criteria for polycystic ovary syndrome: towards a rational approach. In: Polycystic Ovary Syndrome. Current Issues in Endocrinology and Metabolism. Dunaif A, Givens JR, Haseltine FP, Merriam GE (eds.). Blackwell Scientific Inc. Boston, Massachusetts; 1992:377.
- Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Human Reprod. 2004;19:41-47.
- Legro RS, Arslanian SA, Ehrmann DA, et al. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013;98:4565-4592.
- Azziz R, Carmina E, Dewailly D, et al. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009;91:456-488.
- Hatch R, Rosenfield RS, Kim MH, et al. Hirsutism: implications, etiology, and management. Am J Obstet Gynecol. 1981;140:815-830.
- Johnstone EB, Rosen MP, Neril R, et al. The polycystic ovary post-Rotterdam: a common age-dependent finding in ovulatory women without metabolic significance. J Clin Endocrinol Metab. 2010;95:4965-4972.
- Alsamarai S, Adams JM, Murphy MK, et al. Criteria for polycystic ovarian morphology in polycystic ovary syndrome as a function of age. J Clin Endocrinol Metab. 2009;94:4961-4970.
- Teede HJ, Misso ML, Costello MF, et al. International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril. 2018;110:364-379.
- Serafini P, Lobo RA. Increased 5 alpha-reductase activity in idiopathic hirsutism. Fertil Steril. 1985;43:74-78.
- Pigny P, Jonard S, Robert Y, et al. Serum anti-Müllerian hormone as a surrogate for antral follicle count for definition of the polycystic ovary syndrome. J Clin Endocrinol Metab. 2006;91:941-945.
- Randeva HS, Tan BK, Weickert MO, et al. Cardiometabolic aspects of the polycystic ovary syndrome. Endocr Rev. 2012;33:812-841.
- Kumar N, Agarwal H. Early clinical, biochemical and radiologic features in obese and non-obese young women with polycystic ovarian syndrome: a comparative study. Horm Metab Res. 2022;54:620-624.
- Lim SS, Norman RJ, Davies MJ, et al. The effect of obesity on polycystic ovary syndrome: a systematic review and meta-analysis. Obes Rev. 2013;14:95-109.
- Nordenstrom A, Falhammar H. Management of endocrine disease: diagnosis and management of the patient with non-classic CAH due to 21-hydroxylase deficiency. Eur J Endocrinol. 2019;180:R127-145.
- Guo F, Gong Z, Fernando T, et al. The lipid profiles in different characteristics of women with PCOS and the interaction between dyslipidemia and metabolic disorder states: a retrospective study in Chinese population. Front Endocrinol. 2022;13:892125.
- Dietz de Loos ALP, Jiskoot G, Timman R, et al. Improvements in PCOS characteristics and phenotype severity during a randomized controlled lifestyle intervention. Reprod Biomed Online. 2021;43:298-309.
- Ezeh U, Huang A, Landay M, et al. Long-term response of hirsutism and other hyperandrogenic symptoms to combination therapy in polycystic ovary syndrome. J Women’s Health. 2018;27:892-902.
- Ashraf Ganie M, Khurana ML, Eunice M, et al. Comparison of efficacy of spironolactone with metformin in the management of polycystic ovary syndrome: an open-labeled study. J Clin Endocrinol Metab. 2004;89:2756-2762.
- Pasquali R, Gambineri A, Cavazza C, et al. Heterogeneity in the responsiveness to long-term lifestyle intervention and predictability in obese women with polycystic ovary syndrome. Eur J Endocrinol. 2011;164:53-60.
- Yang PK, Hsu CY, Chen MJ, et al. The efficacy of 24-month metformin for improving menses, hormones and metabolic profiles in polycystic ovary syndrome. J Clin Endocrinol Metab. 2018;103:890-899.
- Garg V, Choi J, James WD, et al. Long-term use of spironolactone for acne in women: a case series of 403 patients. J Am Acad Dermatol. 2021;84:1348-1355.
- Hu L, Ma L, Ying T, et al. Efficacy of bariatric surgery in the treatment of women with obesity and polycystic ovary syndrome. J Clin Endocrinol Metab. 2022;107:e3217-3229.
- Bhandari M, Kosta S, Bhandari M, et al. Effects of bariatric surgery on people with obesity and polycystic ovary syndrome: a large single center study from India. Obes Surg. 2022;32:3305-3312.
- Benito E, Gomez-Martin JM, Vega-Pinero B, et al. Fertility and pregnancy outcomes in women with polycystic ovary syndrome following bariatric surgery. J Clin Endocrinol Metab. 2020;105:e3384-3391.
- Xing C, Li C, He B. Insulin sensitizers for improving the endocrine and metabolic profile in overweight women with PCOS. J Clin Endocrinol Metab. 2020;105:2950-2963.
- Elkind-Hirsch KE, Chappell N, Shaler D, et al. Liraglutide 3 mg on weight, body composition and hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome: a randomized placebo-controlled-phase 3 study. Fertil Steril. 2022;118:371-381.
- Amiri M, Nahidi F, Bidhendi-Yarandi R, et al. A comparison of the effects of oral contraceptives on the clinical and biochemical manifestations of polycystic ovary syndrome: a crossover randomized controlled trial. Hum Reprod. 2020;35:175-186.
- Legro RS, Brzyski RG, Diamond NP, et al. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med. 2014;371:119-129.
- Gibson-Helm M, Teede H, Dunaif A, et al. Delayed diagnosis and lack of information associated with dissatisfaction in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2017;102:604-612.
PCOS is a common problem, with a prevalence of 6% to 10% among women of reproductive age.1 Patients with PCOS often present with hirsutism, acne, female androgenetic alopecia, oligomenorrhea (also known as infrequent menstrual bleeding), amenorrhea, infertility, overweight, or obesity. In addition, many patients with PCOS have insulin resistance, dyslipidemia, metabolic syndrome, and an increased risk for developing type 2 diabetes mellitus (DM).2 A simplified approach to the diagnosis of PCOS will save health care resources by reducing the use of low-value diagnostic tests. A simplified approach to the treatment of PCOS will support patient medication adherence and improve health outcomes.
Simplify the diagnosis of PCOS
Simplify PCOS diagnosis by focusing on the core criteria of hyperandrogenism and oligo-ovulation. There are 3 major approaches to diagnosis:
- the 1990 National Institutes of Health (NIH) criteria3
- the 2003 Rotterdam criteria4,5
- the 2008 Androgen Excess and PCOS Society (AES) criteria.6
Using the 1990 NIH approach, the diagnosis of PCOS is made by the presence of 2 core criteria: hyperandrogenism and oligo-ovulation, typically manifested as oligomenorrhea. In addition, other causes of hyperandrogenism should be excluded, including nonclassical adrenal hyperplasia (NCAH) due to 21-hydroxylase deficiency.3 Using the 1990 NIH criteria, PCOS can be diagnosed based on history (oligomenorrhea) and physical examination (assessment of the severity of hirsutism), but laboratory tests including total testosterone are often ordered.7
The Rotterdam approach to the diagnosis added a third criteria, the detection by ultrasonography of a multifollicular ovary and/or increased ovarian volume.4,5 Using the Rotterdam approach, PCOS is diagnosed in the presence of any 2 of the following 3 criteria: hyperandrogenism, oligo-ovulation, or ultrasound imaging showing the presence of a multifollicular ovary, identified by ≥ 12 antral follicles (2 to 9 mm in diameter) in each ovary or increased ovarian volume (> 10 mL).4,5
The Rotterdam approach using ovarian ultrasound as a criterion to diagnose PCOS is rife with serious problems, including:
- The number of small antral follicles in the normal ovary is age dependent, and many ovulatory and nonhirsute patients have ≥ 12 small antral follicles in each ovary.8,9
- There is no consensus on the number of small antral follicles needed to diagnose a multifollicular ovary, with recommendations to use thresholds of 124,5 or 20 follicles10 as the diagnostic cut-off.
- Accurate counting of the number of small ovarian follicles requires transvaginal ultrasound, which is not appropriate for many young adolescent patients.
- The process of counting ovarian follicles is operator-dependent.
- The high cost of ultrasound assessment of ovarian follicles (≥ $500 per examination).
The Rotterdam approach supports the diagnosis of PCOS in a patient with oligo-ovulation plus an ultrasound showing a multifollicular ovary in the absence of any clinical or laboratory evidence of hyperandrogenism.3,4,5 This approach to the diagnosis of PCOS is rejected by both the 1990 NIH3 and AES6 recommendations, which require the presence of hyperandrogenism as the sine qua non in the diagnosis of PCOS. I recommend against diagnosing PCOS in a non-hyperandrogenic patient with oligo-ovulation and a multifollicular ovary because other diagnoses are also possible, such as functional hypothalamic oligo-ovulation, especially in young patients. The Rotterdam approach also supports the diagnosis of PCOS in a patient with hyperandrogenism, an ultrasound showing a multifollicular ovary, and normal ovulation and menses.3,4 For most patients with normal, regular ovulation and menses, the testosterone concentration is normal and the only evidence of hyperandrogenism is hirsutism. Patients with normal, regular ovulation and menses plus hirsutism usually have idiopathic hirsutism. Idiopathic hirsutism is a problem caused by excessive 5-alpha-reductase activity in the hair pilosebaceous unit, which catalyzes the conversion of weak androgens into dihydrotestosterone, a potent intracellular androgen that stimulates terminal hair growth.11 In my opinion, the Rotterdam approach to diagnosing PCOS has created unnecessary confusion and complexity for both clinicians and patients. I believe we should simplify the diagnosis of PCOS and return to the 1990 NIH criteria.3
On occasion, a patient presents for a consultation and has already had an ovarian ultrasound to assess for a multifollicular ovary. I carefully read the report and, if a multifollicular ovary has been identified, I consider it as a secondary supporting finding of PCOS in my clinical assessment. But I do not base my diagnosis on the ultrasound finding. Patients often present with other laboratory tests that are secondary supporting findings of PCOS, which I carefully consider but do not use to make a diagnosis of PCOS. Secondary supporting laboratory findings consistent with PCOS include: 1) a markedly elevated anti-müllerian hormone (AMH) level,12 2) an elevated fasting insulin level,2,13 and 3) an elevated luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio.13,14 But it is not necessary to measure AMH, fasting insulin, LH, and FSH levels. To conserve health care resources, I recommend against measuring those analytes to diagnose PCOS.
Continue to: Simplify the core laboratory tests...
Simplify the core laboratory tests
Simplify the testing used to support the diagnosis of PCOS by measuring total testosterone, sex-hormone binding globulin (SHBG) and early morning 17-hydroxyprogesterone (17-OH Prog).
The core criteria for diagnosis of PCOS are hyperandrogenism and oligo-ovulation, typically manifested as oligomenorrhea or amenorrhea. Hyperandrogenism can be clinically diagnosed by assessing for the presence of hirsutism.7 Elevated levels of total testosterone, free testosterone, androstenedione, and/or dehydroepiandrosterone sulfate (DHEAS) suggest the presence of hyperandrogenism. In clinical practice, the laboratory approach to the diagnosis of hyperandrogenism can be simplified to the measurement of total testosterone, SHBG, and 17-OH Prog. By measuring total testosterone and SHBG, an estimate of free testosterone can be made. If the total testosterone is elevated, it is highly likely that the free testosterone is elevated. If the SHBG is abnormally low and the total testosterone level is in the upper limit of the normal range, the free testosterone is likely to be elevated.15 Using this approach, either an elevated total testosterone or an abnormally low SHBG indicate elevated free testosterone. For patients with hyperandrogenism and oligo-ovulation, an early morning (8 to 9 AM) 17-OH Prog level ≤ 2 ng/mL rules out the presence of NCAH due to a 21-hydroxylase deficiency.16 In my practice, the core laboratory tests I order when considering the diagnosis of PCOS are a total testosterone, SHBG, and 17-OH Prog.
Additional laboratory tests may be warranted to assess the patient diagnosed with PCOS. For example, if the patient has amenorrhea due to anovulation, tests for prolactin, FSH, and thyroid-stimulating hormone levels are warranted to assess for the presence of a prolactinoma, primary ovarian insufficiency, or thyroid disease, respectively. If the patient has a body mass index (BMI) ≥ 25 kg/m2, a hemoglobin A1c concentration is warranted to assess for the presence of prediabetes or DM.2 Many patients with PCOS have dyslipidemia, manifested through low high-density lipoprotein cholesterol levels and elevated low-density lipoprotein cholesterol levels, and a lipid panel assessment may be indicated. Among patients with PCOS, the most common lipid abnormality is a low high-density lipoprotein cholesterol level.17
Simplify the treatment of PCOS
Simplify treatment by counseling about lifestyle changes and prescribing an estrogen-progestin contraceptive, spironolactone, and metformin.
Most patients with PCOS have dysfunction in reproductive, metabolic, and dermatologic systems. For patients who are overweight or obese, lifestyle changes, including diet and exercise, that result in a 5% to 10% decrease in weight can improve metabolic balance, reduce circulating androgens, and increase menstrual frequency.18 For patients with PCOS and weight issues, referral to nutrition counseling or a full-service weight loss program can be very beneficial. In addition to lifestyle changes, patients with PCOS benefit from treatment with estrogen-progestin medications, spironolactone, and metformin.
Combination estrogen-progestin medications will lower LH secretion, decrease ovarian androgen production, increase SHBG production, decrease free testosterone levels and, if given cyclically, cause regular withdrawal bleeding.19 Spironolactone is an antiandrogen, which blocks the intracellular action of dihydrotestosterone and improves hirsutism and acne. Spironolactone also modestly decreases circulating levels of testosterone and DHEAS.20 For patients with metabolic problems, including insulin resistance and obesity, weight loss and/or treatment with metformin can help improve metabolic balance, which may result in restoration of ovulatory menses.21,22 Metformin can be effective in restoring ovulatory menses in both obese and lean patients with PCOS.22 The most common dermatologic problem caused by PCOS are hirsutism and acne. Both combination estrogen-progestin medications and spironolactone are effective treatments for hirsutism and acne.23
Estrogen-progestin hormones, spironolactone, and metformin are low-cost medications for the treatment of PCOS. Additional high-cost options for treatment of PCOS in obese patients include bariatric surgery and glucagon-like peptide (GLP-1) agonist medications (liraglutide and exenatide). For patients with PCOS and a body mass index (BMI) ≥ 35 kg/m2, bariatric surgery often results in sufficient weight loss to resolve the patient’s hyperandrogenism and oligo-ovulation, restoring spontaneous ovulatory cycles.24 In a study of more than 1,000 patients with: PCOS; mean BMI, 44 kg/m2; mean age, 31 years who were followed post-bariatric surgery for 5 years, > 90% of patients reported reductions in hirsutism and resumption of regular menses.25 For patients with PCOS seeking fertility, bariatric surgery often results in spontaneous pregnancy and live birth.26 GLP-1 agonists, including liraglutide or exenatide with or without metformin are effective in reducing weight, decreasing androgen levels, and restoring ovulatory menses.27,28
In my practice, I often prescribe 2 or 3 core medications for a patient with PCOS: 1) combination estrogen-progestin used cyclically or continuously, 2) spironolactone, and 3) metformin.19 Any estrogen-progestin contraceptive will suppress LH and ovarian androgen production; however, in the treatment of patients with PCOS, I prefer to use an estrogen-progestin combination that does not contain the androgenic progestin levonorgestrel.29 For the treatment of PCOS, I prefer to use an estrogen-progestin contraceptive with a non-androgenic progestin such as drospirenone, desogestrel, or gestodene. I routinely prescribe spironolactone at a dose of 100 mg, once daily, a dose near the top of the dose-response curve. A daily dose ≤ 50 mg of spironolactone is subtherapeutic for the treatment of hirsutism. A daily dose of 200 mg of spironolactone may cause bothersome breakthrough bleeding. When prescribing metformin, I usually recommend the extended-release formulation, at a dose of 750 mg with dinner. If well tolerated, I will increase the dose to 1,500 mg with dinner. Most of my patients with PCOS are taking a combination of 2 medications, either an estrogen-progestin contraceptive plus spironolactone or an estrogen-progestin contraceptive plus metformin.19 Some of my patients are taking all 3 medications. All 3 medications are very low cost.
For patients with PCOS and anovulatory infertility, letrozole treatment often results in ovulatory cycles and pregnancy with live birth. In obese PCOS patients, compared with clomiphene, letrozole results in superior live birth rates.30 Unlike clomiphene, letrozole is not approved by the US Food and Drug Administration for the treatment of anovulatory infertility.
The diagnosis of PCOS is often delayed due to confusion about how to make the diagnosis.31 To simplify the diagnosis of PCOS and improve patient encounters for PCOS, I focus on 2 core criteria: hyperandrogenism and oligo-ovulation. I recommend against ordering ultrasound imaging to assess for the presence of a multifollicular ovary. To simplify the treatment of PCOS I frequently prescribe an estrogen-progestin contraceptive, spironolactone, and metformin. By simplifying the diagnosis and treatment of PCOS, ObGyns will reduce patient confusion, improve outcomes, and save health care resources. ●
PCOS and adolescent patients
It is difficult to diagnose polycystic ovary syndrome (PCOS) in adolescents because oligo-ovulation is a common physiological feature of adolescence. Based on consensus among experts, PCOS should not be diagnosed within the first 2 years following menarche because the prevalence of oligo-ovulation is common at this stage of pubertal development. Two years after menarche, if an adolescent has a cycle length that is routinely > 45 days, it is likely that the pattern will persist, suggesting the presence of oligo-ovulation. Hyperandrogenism can be diagnosed based on the presence of moderate to severe hirsutism and/or an elevated testosterone or abnormally low sex-hormone binding globulin (SHBG) concentration. Two years after menarche the presence of oligo-ovulation and hyperandrogenism establishes the diagnosis of PCOS.1
PCOS and thrombophilia or migraine with aura
For patients with PCOS and a Factor V Leiden allele, where an estrogen-progestin contraceptive is contraindicated because of an increased risk of a venous thrombus, I prescribe spironolactone plus a levonorgestrel-intrauterine device. A low-dose oral progestin also may be considered because it will modestly suppress LH and ovarian androgen production. Similarly for patients with migraine with aura, where an estrogen-progestin contraceptive is contraindicated because of an increased of stroke, spironolactone plus a levonorgesterel intrauterine device may be effective in the treatment of hirsutism.
Androgen secreting tumors
Occasionally during the evaluation of a patient with hyperandrogenism and oligo-ovulation, measurement of total testosterone levels will reveal a value > 1.5 ng/mL. Most patients with PCOS have a total testosterone level ≤ 1.5 ng/mL. A total testosterone concentration > 1.5 ng/mL may be caused by ovarian stromal hyperthecosis or an androgen-producing tumor.2
Strongly-held patient perspectives on PCOS
At the first consultation visit, some patients are fearful and not receptive to a diagnosis of PCOS. If a clinician senses that the patient is not prepared to hear that they have PCOS, the clinician can be supportive of the patient’s perspective and focus on the patient’s chief health concerns, which may include abnormal cycle length, hirsutism, and/or overweight or obesity. During follow-up visits, as the patient builds trust with the clinician, the patient will be better prepared to discuss the diagnosis of PCOS. At the first consultation visit, some patients present with a strong belief that they have PCOS but have seen clinicians who conclude that they do not have PCOS. The diagnosis of PCOS is confusing because of competing diagnostic frameworks (NIH, Rotterdam, and AES). I avoid engaging in an argument with a patient who strongly believes that they have PCOS. In these situations, I focus on identifying the patient’s chief health concerns and discussing interventions to support their health goals.
References
1. Rosenfield RL. Perspectives on the international recommendations for the diagnosis and treatment of polycystic ovary syndrome in adolescence. J Pediatr Adolesc Gynecol. 2020;33:445-447.
2. Meczekalski B, Szeliga A, Maciejewska-Jeske M, et al. Hyperthecosis: an underestimated nontumorous cause of hyperandrogenism. Gynecol Endocrinol. 2021;37:677-682.
PCOS is a common problem, with a prevalence of 6% to 10% among women of reproductive age.1 Patients with PCOS often present with hirsutism, acne, female androgenetic alopecia, oligomenorrhea (also known as infrequent menstrual bleeding), amenorrhea, infertility, overweight, or obesity. In addition, many patients with PCOS have insulin resistance, dyslipidemia, metabolic syndrome, and an increased risk for developing type 2 diabetes mellitus (DM).2 A simplified approach to the diagnosis of PCOS will save health care resources by reducing the use of low-value diagnostic tests. A simplified approach to the treatment of PCOS will support patient medication adherence and improve health outcomes.
Simplify the diagnosis of PCOS
Simplify PCOS diagnosis by focusing on the core criteria of hyperandrogenism and oligo-ovulation. There are 3 major approaches to diagnosis:
- the 1990 National Institutes of Health (NIH) criteria3
- the 2003 Rotterdam criteria4,5
- the 2008 Androgen Excess and PCOS Society (AES) criteria.6
Using the 1990 NIH approach, the diagnosis of PCOS is made by the presence of 2 core criteria: hyperandrogenism and oligo-ovulation, typically manifested as oligomenorrhea. In addition, other causes of hyperandrogenism should be excluded, including nonclassical adrenal hyperplasia (NCAH) due to 21-hydroxylase deficiency.3 Using the 1990 NIH criteria, PCOS can be diagnosed based on history (oligomenorrhea) and physical examination (assessment of the severity of hirsutism), but laboratory tests including total testosterone are often ordered.7
The Rotterdam approach to the diagnosis added a third criteria, the detection by ultrasonography of a multifollicular ovary and/or increased ovarian volume.4,5 Using the Rotterdam approach, PCOS is diagnosed in the presence of any 2 of the following 3 criteria: hyperandrogenism, oligo-ovulation, or ultrasound imaging showing the presence of a multifollicular ovary, identified by ≥ 12 antral follicles (2 to 9 mm in diameter) in each ovary or increased ovarian volume (> 10 mL).4,5
The Rotterdam approach using ovarian ultrasound as a criterion to diagnose PCOS is rife with serious problems, including:
- The number of small antral follicles in the normal ovary is age dependent, and many ovulatory and nonhirsute patients have ≥ 12 small antral follicles in each ovary.8,9
- There is no consensus on the number of small antral follicles needed to diagnose a multifollicular ovary, with recommendations to use thresholds of 124,5 or 20 follicles10 as the diagnostic cut-off.
- Accurate counting of the number of small ovarian follicles requires transvaginal ultrasound, which is not appropriate for many young adolescent patients.
- The process of counting ovarian follicles is operator-dependent.
- The high cost of ultrasound assessment of ovarian follicles (≥ $500 per examination).
The Rotterdam approach supports the diagnosis of PCOS in a patient with oligo-ovulation plus an ultrasound showing a multifollicular ovary in the absence of any clinical or laboratory evidence of hyperandrogenism.3,4,5 This approach to the diagnosis of PCOS is rejected by both the 1990 NIH3 and AES6 recommendations, which require the presence of hyperandrogenism as the sine qua non in the diagnosis of PCOS. I recommend against diagnosing PCOS in a non-hyperandrogenic patient with oligo-ovulation and a multifollicular ovary because other diagnoses are also possible, such as functional hypothalamic oligo-ovulation, especially in young patients. The Rotterdam approach also supports the diagnosis of PCOS in a patient with hyperandrogenism, an ultrasound showing a multifollicular ovary, and normal ovulation and menses.3,4 For most patients with normal, regular ovulation and menses, the testosterone concentration is normal and the only evidence of hyperandrogenism is hirsutism. Patients with normal, regular ovulation and menses plus hirsutism usually have idiopathic hirsutism. Idiopathic hirsutism is a problem caused by excessive 5-alpha-reductase activity in the hair pilosebaceous unit, which catalyzes the conversion of weak androgens into dihydrotestosterone, a potent intracellular androgen that stimulates terminal hair growth.11 In my opinion, the Rotterdam approach to diagnosing PCOS has created unnecessary confusion and complexity for both clinicians and patients. I believe we should simplify the diagnosis of PCOS and return to the 1990 NIH criteria.3
On occasion, a patient presents for a consultation and has already had an ovarian ultrasound to assess for a multifollicular ovary. I carefully read the report and, if a multifollicular ovary has been identified, I consider it as a secondary supporting finding of PCOS in my clinical assessment. But I do not base my diagnosis on the ultrasound finding. Patients often present with other laboratory tests that are secondary supporting findings of PCOS, which I carefully consider but do not use to make a diagnosis of PCOS. Secondary supporting laboratory findings consistent with PCOS include: 1) a markedly elevated anti-müllerian hormone (AMH) level,12 2) an elevated fasting insulin level,2,13 and 3) an elevated luteinizing hormone (LH) to follicle-stimulating hormone (FSH) ratio.13,14 But it is not necessary to measure AMH, fasting insulin, LH, and FSH levels. To conserve health care resources, I recommend against measuring those analytes to diagnose PCOS.
Continue to: Simplify the core laboratory tests...
Simplify the core laboratory tests
Simplify the testing used to support the diagnosis of PCOS by measuring total testosterone, sex-hormone binding globulin (SHBG) and early morning 17-hydroxyprogesterone (17-OH Prog).
The core criteria for diagnosis of PCOS are hyperandrogenism and oligo-ovulation, typically manifested as oligomenorrhea or amenorrhea. Hyperandrogenism can be clinically diagnosed by assessing for the presence of hirsutism.7 Elevated levels of total testosterone, free testosterone, androstenedione, and/or dehydroepiandrosterone sulfate (DHEAS) suggest the presence of hyperandrogenism. In clinical practice, the laboratory approach to the diagnosis of hyperandrogenism can be simplified to the measurement of total testosterone, SHBG, and 17-OH Prog. By measuring total testosterone and SHBG, an estimate of free testosterone can be made. If the total testosterone is elevated, it is highly likely that the free testosterone is elevated. If the SHBG is abnormally low and the total testosterone level is in the upper limit of the normal range, the free testosterone is likely to be elevated.15 Using this approach, either an elevated total testosterone or an abnormally low SHBG indicate elevated free testosterone. For patients with hyperandrogenism and oligo-ovulation, an early morning (8 to 9 AM) 17-OH Prog level ≤ 2 ng/mL rules out the presence of NCAH due to a 21-hydroxylase deficiency.16 In my practice, the core laboratory tests I order when considering the diagnosis of PCOS are a total testosterone, SHBG, and 17-OH Prog.
Additional laboratory tests may be warranted to assess the patient diagnosed with PCOS. For example, if the patient has amenorrhea due to anovulation, tests for prolactin, FSH, and thyroid-stimulating hormone levels are warranted to assess for the presence of a prolactinoma, primary ovarian insufficiency, or thyroid disease, respectively. If the patient has a body mass index (BMI) ≥ 25 kg/m2, a hemoglobin A1c concentration is warranted to assess for the presence of prediabetes or DM.2 Many patients with PCOS have dyslipidemia, manifested through low high-density lipoprotein cholesterol levels and elevated low-density lipoprotein cholesterol levels, and a lipid panel assessment may be indicated. Among patients with PCOS, the most common lipid abnormality is a low high-density lipoprotein cholesterol level.17
Simplify the treatment of PCOS
Simplify treatment by counseling about lifestyle changes and prescribing an estrogen-progestin contraceptive, spironolactone, and metformin.
Most patients with PCOS have dysfunction in reproductive, metabolic, and dermatologic systems. For patients who are overweight or obese, lifestyle changes, including diet and exercise, that result in a 5% to 10% decrease in weight can improve metabolic balance, reduce circulating androgens, and increase menstrual frequency.18 For patients with PCOS and weight issues, referral to nutrition counseling or a full-service weight loss program can be very beneficial. In addition to lifestyle changes, patients with PCOS benefit from treatment with estrogen-progestin medications, spironolactone, and metformin.
Combination estrogen-progestin medications will lower LH secretion, decrease ovarian androgen production, increase SHBG production, decrease free testosterone levels and, if given cyclically, cause regular withdrawal bleeding.19 Spironolactone is an antiandrogen, which blocks the intracellular action of dihydrotestosterone and improves hirsutism and acne. Spironolactone also modestly decreases circulating levels of testosterone and DHEAS.20 For patients with metabolic problems, including insulin resistance and obesity, weight loss and/or treatment with metformin can help improve metabolic balance, which may result in restoration of ovulatory menses.21,22 Metformin can be effective in restoring ovulatory menses in both obese and lean patients with PCOS.22 The most common dermatologic problem caused by PCOS are hirsutism and acne. Both combination estrogen-progestin medications and spironolactone are effective treatments for hirsutism and acne.23
Estrogen-progestin hormones, spironolactone, and metformin are low-cost medications for the treatment of PCOS. Additional high-cost options for treatment of PCOS in obese patients include bariatric surgery and glucagon-like peptide (GLP-1) agonist medications (liraglutide and exenatide). For patients with PCOS and a body mass index (BMI) ≥ 35 kg/m2, bariatric surgery often results in sufficient weight loss to resolve the patient’s hyperandrogenism and oligo-ovulation, restoring spontaneous ovulatory cycles.24 In a study of more than 1,000 patients with: PCOS; mean BMI, 44 kg/m2; mean age, 31 years who were followed post-bariatric surgery for 5 years, > 90% of patients reported reductions in hirsutism and resumption of regular menses.25 For patients with PCOS seeking fertility, bariatric surgery often results in spontaneous pregnancy and live birth.26 GLP-1 agonists, including liraglutide or exenatide with or without metformin are effective in reducing weight, decreasing androgen levels, and restoring ovulatory menses.27,28
In my practice, I often prescribe 2 or 3 core medications for a patient with PCOS: 1) combination estrogen-progestin used cyclically or continuously, 2) spironolactone, and 3) metformin.19 Any estrogen-progestin contraceptive will suppress LH and ovarian androgen production; however, in the treatment of patients with PCOS, I prefer to use an estrogen-progestin combination that does not contain the androgenic progestin levonorgestrel.29 For the treatment of PCOS, I prefer to use an estrogen-progestin contraceptive with a non-androgenic progestin such as drospirenone, desogestrel, or gestodene. I routinely prescribe spironolactone at a dose of 100 mg, once daily, a dose near the top of the dose-response curve. A daily dose ≤ 50 mg of spironolactone is subtherapeutic for the treatment of hirsutism. A daily dose of 200 mg of spironolactone may cause bothersome breakthrough bleeding. When prescribing metformin, I usually recommend the extended-release formulation, at a dose of 750 mg with dinner. If well tolerated, I will increase the dose to 1,500 mg with dinner. Most of my patients with PCOS are taking a combination of 2 medications, either an estrogen-progestin contraceptive plus spironolactone or an estrogen-progestin contraceptive plus metformin.19 Some of my patients are taking all 3 medications. All 3 medications are very low cost.
For patients with PCOS and anovulatory infertility, letrozole treatment often results in ovulatory cycles and pregnancy with live birth. In obese PCOS patients, compared with clomiphene, letrozole results in superior live birth rates.30 Unlike clomiphene, letrozole is not approved by the US Food and Drug Administration for the treatment of anovulatory infertility.
The diagnosis of PCOS is often delayed due to confusion about how to make the diagnosis.31 To simplify the diagnosis of PCOS and improve patient encounters for PCOS, I focus on 2 core criteria: hyperandrogenism and oligo-ovulation. I recommend against ordering ultrasound imaging to assess for the presence of a multifollicular ovary. To simplify the treatment of PCOS I frequently prescribe an estrogen-progestin contraceptive, spironolactone, and metformin. By simplifying the diagnosis and treatment of PCOS, ObGyns will reduce patient confusion, improve outcomes, and save health care resources. ●
PCOS and adolescent patients
It is difficult to diagnose polycystic ovary syndrome (PCOS) in adolescents because oligo-ovulation is a common physiological feature of adolescence. Based on consensus among experts, PCOS should not be diagnosed within the first 2 years following menarche because the prevalence of oligo-ovulation is common at this stage of pubertal development. Two years after menarche, if an adolescent has a cycle length that is routinely > 45 days, it is likely that the pattern will persist, suggesting the presence of oligo-ovulation. Hyperandrogenism can be diagnosed based on the presence of moderate to severe hirsutism and/or an elevated testosterone or abnormally low sex-hormone binding globulin (SHBG) concentration. Two years after menarche the presence of oligo-ovulation and hyperandrogenism establishes the diagnosis of PCOS.1
PCOS and thrombophilia or migraine with aura
For patients with PCOS and a Factor V Leiden allele, where an estrogen-progestin contraceptive is contraindicated because of an increased risk of a venous thrombus, I prescribe spironolactone plus a levonorgestrel-intrauterine device. A low-dose oral progestin also may be considered because it will modestly suppress LH and ovarian androgen production. Similarly for patients with migraine with aura, where an estrogen-progestin contraceptive is contraindicated because of an increased of stroke, spironolactone plus a levonorgesterel intrauterine device may be effective in the treatment of hirsutism.
Androgen secreting tumors
Occasionally during the evaluation of a patient with hyperandrogenism and oligo-ovulation, measurement of total testosterone levels will reveal a value > 1.5 ng/mL. Most patients with PCOS have a total testosterone level ≤ 1.5 ng/mL. A total testosterone concentration > 1.5 ng/mL may be caused by ovarian stromal hyperthecosis or an androgen-producing tumor.2
Strongly-held patient perspectives on PCOS
At the first consultation visit, some patients are fearful and not receptive to a diagnosis of PCOS. If a clinician senses that the patient is not prepared to hear that they have PCOS, the clinician can be supportive of the patient’s perspective and focus on the patient’s chief health concerns, which may include abnormal cycle length, hirsutism, and/or overweight or obesity. During follow-up visits, as the patient builds trust with the clinician, the patient will be better prepared to discuss the diagnosis of PCOS. At the first consultation visit, some patients present with a strong belief that they have PCOS but have seen clinicians who conclude that they do not have PCOS. The diagnosis of PCOS is confusing because of competing diagnostic frameworks (NIH, Rotterdam, and AES). I avoid engaging in an argument with a patient who strongly believes that they have PCOS. In these situations, I focus on identifying the patient’s chief health concerns and discussing interventions to support their health goals.
References
1. Rosenfield RL. Perspectives on the international recommendations for the diagnosis and treatment of polycystic ovary syndrome in adolescence. J Pediatr Adolesc Gynecol. 2020;33:445-447.
2. Meczekalski B, Szeliga A, Maciejewska-Jeske M, et al. Hyperthecosis: an underestimated nontumorous cause of hyperandrogenism. Gynecol Endocrinol. 2021;37:677-682.
- Bozdag G, Mumusoglu S, Zengin D, et al. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016;31:2841-2855.
- Livadas S, Anagnostis P, Bosdou JK, et al. Polycystic ovary syndrome and type 2 diabetes mellitus: a state-of-the-art review. World J Diabetes. 2022;13:5-26.
- Zawadski JK, Dunaif A. Diagnostic criteria for polycystic ovary syndrome: towards a rational approach. In: Polycystic Ovary Syndrome. Current Issues in Endocrinology and Metabolism. Dunaif A, Givens JR, Haseltine FP, Merriam GE (eds.). Blackwell Scientific Inc. Boston, Massachusetts; 1992:377.
- Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Human Reprod. 2004;19:41-47.
- Legro RS, Arslanian SA, Ehrmann DA, et al. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013;98:4565-4592.
- Azziz R, Carmina E, Dewailly D, et al. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009;91:456-488.
- Hatch R, Rosenfield RS, Kim MH, et al. Hirsutism: implications, etiology, and management. Am J Obstet Gynecol. 1981;140:815-830.
- Johnstone EB, Rosen MP, Neril R, et al. The polycystic ovary post-Rotterdam: a common age-dependent finding in ovulatory women without metabolic significance. J Clin Endocrinol Metab. 2010;95:4965-4972.
- Alsamarai S, Adams JM, Murphy MK, et al. Criteria for polycystic ovarian morphology in polycystic ovary syndrome as a function of age. J Clin Endocrinol Metab. 2009;94:4961-4970.
- Teede HJ, Misso ML, Costello MF, et al. International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril. 2018;110:364-379.
- Serafini P, Lobo RA. Increased 5 alpha-reductase activity in idiopathic hirsutism. Fertil Steril. 1985;43:74-78.
- Pigny P, Jonard S, Robert Y, et al. Serum anti-Müllerian hormone as a surrogate for antral follicle count for definition of the polycystic ovary syndrome. J Clin Endocrinol Metab. 2006;91:941-945.
- Randeva HS, Tan BK, Weickert MO, et al. Cardiometabolic aspects of the polycystic ovary syndrome. Endocr Rev. 2012;33:812-841.
- Kumar N, Agarwal H. Early clinical, biochemical and radiologic features in obese and non-obese young women with polycystic ovarian syndrome: a comparative study. Horm Metab Res. 2022;54:620-624.
- Lim SS, Norman RJ, Davies MJ, et al. The effect of obesity on polycystic ovary syndrome: a systematic review and meta-analysis. Obes Rev. 2013;14:95-109.
- Nordenstrom A, Falhammar H. Management of endocrine disease: diagnosis and management of the patient with non-classic CAH due to 21-hydroxylase deficiency. Eur J Endocrinol. 2019;180:R127-145.
- Guo F, Gong Z, Fernando T, et al. The lipid profiles in different characteristics of women with PCOS and the interaction between dyslipidemia and metabolic disorder states: a retrospective study in Chinese population. Front Endocrinol. 2022;13:892125.
- Dietz de Loos ALP, Jiskoot G, Timman R, et al. Improvements in PCOS characteristics and phenotype severity during a randomized controlled lifestyle intervention. Reprod Biomed Online. 2021;43:298-309.
- Ezeh U, Huang A, Landay M, et al. Long-term response of hirsutism and other hyperandrogenic symptoms to combination therapy in polycystic ovary syndrome. J Women’s Health. 2018;27:892-902.
- Ashraf Ganie M, Khurana ML, Eunice M, et al. Comparison of efficacy of spironolactone with metformin in the management of polycystic ovary syndrome: an open-labeled study. J Clin Endocrinol Metab. 2004;89:2756-2762.
- Pasquali R, Gambineri A, Cavazza C, et al. Heterogeneity in the responsiveness to long-term lifestyle intervention and predictability in obese women with polycystic ovary syndrome. Eur J Endocrinol. 2011;164:53-60.
- Yang PK, Hsu CY, Chen MJ, et al. The efficacy of 24-month metformin for improving menses, hormones and metabolic profiles in polycystic ovary syndrome. J Clin Endocrinol Metab. 2018;103:890-899.
- Garg V, Choi J, James WD, et al. Long-term use of spironolactone for acne in women: a case series of 403 patients. J Am Acad Dermatol. 2021;84:1348-1355.
- Hu L, Ma L, Ying T, et al. Efficacy of bariatric surgery in the treatment of women with obesity and polycystic ovary syndrome. J Clin Endocrinol Metab. 2022;107:e3217-3229.
- Bhandari M, Kosta S, Bhandari M, et al. Effects of bariatric surgery on people with obesity and polycystic ovary syndrome: a large single center study from India. Obes Surg. 2022;32:3305-3312.
- Benito E, Gomez-Martin JM, Vega-Pinero B, et al. Fertility and pregnancy outcomes in women with polycystic ovary syndrome following bariatric surgery. J Clin Endocrinol Metab. 2020;105:e3384-3391.
- Xing C, Li C, He B. Insulin sensitizers for improving the endocrine and metabolic profile in overweight women with PCOS. J Clin Endocrinol Metab. 2020;105:2950-2963.
- Elkind-Hirsch KE, Chappell N, Shaler D, et al. Liraglutide 3 mg on weight, body composition and hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome: a randomized placebo-controlled-phase 3 study. Fertil Steril. 2022;118:371-381.
- Amiri M, Nahidi F, Bidhendi-Yarandi R, et al. A comparison of the effects of oral contraceptives on the clinical and biochemical manifestations of polycystic ovary syndrome: a crossover randomized controlled trial. Hum Reprod. 2020;35:175-186.
- Legro RS, Brzyski RG, Diamond NP, et al. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med. 2014;371:119-129.
- Gibson-Helm M, Teede H, Dunaif A, et al. Delayed diagnosis and lack of information associated with dissatisfaction in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2017;102:604-612.
- Bozdag G, Mumusoglu S, Zengin D, et al. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016;31:2841-2855.
- Livadas S, Anagnostis P, Bosdou JK, et al. Polycystic ovary syndrome and type 2 diabetes mellitus: a state-of-the-art review. World J Diabetes. 2022;13:5-26.
- Zawadski JK, Dunaif A. Diagnostic criteria for polycystic ovary syndrome: towards a rational approach. In: Polycystic Ovary Syndrome. Current Issues in Endocrinology and Metabolism. Dunaif A, Givens JR, Haseltine FP, Merriam GE (eds.). Blackwell Scientific Inc. Boston, Massachusetts; 1992:377.
- Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Human Reprod. 2004;19:41-47.
- Legro RS, Arslanian SA, Ehrmann DA, et al. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013;98:4565-4592.
- Azziz R, Carmina E, Dewailly D, et al. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009;91:456-488.
- Hatch R, Rosenfield RS, Kim MH, et al. Hirsutism: implications, etiology, and management. Am J Obstet Gynecol. 1981;140:815-830.
- Johnstone EB, Rosen MP, Neril R, et al. The polycystic ovary post-Rotterdam: a common age-dependent finding in ovulatory women without metabolic significance. J Clin Endocrinol Metab. 2010;95:4965-4972.
- Alsamarai S, Adams JM, Murphy MK, et al. Criteria for polycystic ovarian morphology in polycystic ovary syndrome as a function of age. J Clin Endocrinol Metab. 2009;94:4961-4970.
- Teede HJ, Misso ML, Costello MF, et al. International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril. 2018;110:364-379.
- Serafini P, Lobo RA. Increased 5 alpha-reductase activity in idiopathic hirsutism. Fertil Steril. 1985;43:74-78.
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