Pain

Sleep specialists might want to take a closer look at the connections between obstructive sleep apnea, chronic pain, and reported pain intensity in younger patients. Young adults with a diagnosis of obstructive sleep apnea (OSA) are more likely to report moderate to severe pain intensity, compared with their peers who do not have the diagnosis, results from a large cross-sectional analysis of veterans showed.

“Because of the high burden of chronic pain conditions in younger adults, this study highlights the need to understand the impact of OSA diagnosis and treatment on pain intensity,” researchers led by Wardah Athar, a graduate student at Yale University, New Haven, Conn., and Lori A. Bastian, MD, MPH, a professor of internal medicine at Yale, wrote in an article published in the Annals of the American Thoracic Society. “This understanding would then help inform the development of interventions to promote screening for OSA among young adults with chronic pain and pain management among those with diagnosed OSA.”

In an effort to assess whether young adults with diagnosed OSA are more likely to report higher pain intensity, compared with those without OSA, the researchers drew from a sample of 858,226 veterans from Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn who had at least one visit to a VA clinic between 2001 and 2014. They used ICD-9 codes to identify OSA and assessed self-reported responses to pain measures on a 0-10 numeric scale which were recorded in each veteran’s EMR. Next, they averaged pain intensity responses over a 12-month period and categorized them as none (0), mild (1-3), and moderate/severe (4–10). Covariates included age, sex, education, race, mental health diagnoses, headache diagnoses, pain diagnoses, hypertension, diabetes, body mass index, and smoking status. The researchers used multivariate logistic regression models and multiple imputation to generate values for missing variables.

The mean age of the patients was 30 years, 64% were White, 17% were Black, 12% were Hispanic, and remainder were other/unknown race/ethnicity. Ninety percent were male, and 20% had greater than a high school education. Of the 858,226 patients, 91,244 (11%) had a diagnosis of OSA. Compared with patients who had no diagnosis of OSA, the unadjusted odds of reporting moderate/severe pain was 48% higher among those with OSA (odds ratio 1.48; P < .0001). After the researchers adjusted for all covariates in the model, the association between OSA and moderate/severe pain remained significant though attenuated, with an adjusted odds ratio of 1.09 (P < .0001).

Several characteristics were different between those who had a diagnosis of OSA and those who did not, including age (a mean of 36 vs. 26 years, respectively) and having the following diagnoses: pain (36% vs. 16%), headache (28% vs. 14%), diabetes (12% vs. 2%), hypertension (40% vs. 12%), and a body mass index of 30 kg/m² or greater (69% vs. 35%). Certain psychiatric disorders were also common among patients with OSA, including major depressive disorder (20% vs. 10%), posttraumatic stress disorder (50% vs. 30%), and substance use disorder (26% vs. 17%). Patients with OSA were also more likely to have been prescribed benzodiazepines or opioids within 90 days of their OSA diagnosis. Although men were more likely to have a diagnosis of OSA, no differences related to sex in the association of OSA and pain were observed in sex-based stratified analyses.

“Based on these results, we suggest more thorough and more frequent pain intensity screening in patients with OSA, particularly in those patients who are younger than 60 years old without significant comorbid illness,” the researchers concluded. “Furthermore, we also recommend increased OSA screening for patients with moderate/severe pain intensity and pain diagnoses.” One tool they recommend is the STOP-Bang (Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference, and Gender) questionnaire, which has been validated in multiple settings.

Commenting on the findings of this study, Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City, commended the study design. “One of the problems with sleep apnea studies is that there are always confounding effects, especially from BMI. This is a population that has a significant medical burden of disease, but I think this is a well-done study to look at the relationship between pain and OSA in a younger population. The authors tried to adjust for all these confounders and they still found a significant association. This indicates that sleep affects one’s pain threshold. And sleep apnea, by mechanisms still yet to be defined, also alters that pain threshold. It may also affect the expression of pain or management of pain, making treatment more problematic in this population,” he said in an interview.

A key limitation of the study, he continued, was the fact it evaluated only one aspect of sleep: OSA. “They didn’t look at duration of sleep, comorbid insomnia, or fragmentation of sleep from apnea or from other causes,” Dr. Sundar said. “We have multiple ways of treating sleep apnea. Clearly, we need studies of treating sleep apnea with [continuous positive airway pressure] and how that affects the occurrence of pain. The relevant practical aspect of this is that there are pain clinics all over the country that should screen for sleep apnea. Along the same lines, sleep practitioners should be aware that pain has an important association with sleep apnea.”

The study was supported by the Health Services Research & Development in the Department of Veterans Affairs of the Veterans Health Administration, the Yale School of Medicine Medical Student Fellowship, and the U.S. National Institutes of Health.

[email protected]

SOURCE: Athar W et al. Ann Am Thorac Soc. 2020;17(10):1273-48.

Correction, 10/28/20: An earlier version of this article misstated Wardah Athar's name in the photo caption.

Sleep specialists might want to take a closer look at the connections between obstructive sleep apnea, chronic pain, and reported pain intensity in younger patients. Young adults with a diagnosis of obstructive sleep apnea (OSA) are more likely to report moderate to severe pain intensity, compared with their peers who do not have the diagnosis, results from a large cross-sectional analysis of veterans showed.

“Because of the high burden of chronic pain conditions in younger adults, this study highlights the need to understand the impact of OSA diagnosis and treatment on pain intensity,” researchers led by Wardah Athar, a graduate student at Yale University, New Haven, Conn., and Lori A. Bastian, MD, MPH, a professor of internal medicine at Yale, wrote in an article published in the Annals of the American Thoracic Society. “This understanding would then help inform the development of interventions to promote screening for OSA among young adults with chronic pain and pain management among those with diagnosed OSA.”

In an effort to assess whether young adults with diagnosed OSA are more likely to report higher pain intensity, compared with those without OSA, the researchers drew from a sample of 858,226 veterans from Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn who had at least one visit to a VA clinic between 2001 and 2014. They used ICD-9 codes to identify OSA and assessed self-reported responses to pain measures on a 0-10 numeric scale which were recorded in each veteran’s EMR. Next, they averaged pain intensity responses over a 12-month period and categorized them as none (0), mild (1-3), and moderate/severe (4–10). Covariates included age, sex, education, race, mental health diagnoses, headache diagnoses, pain diagnoses, hypertension, diabetes, body mass index, and smoking status. The researchers used multivariate logistic regression models and multiple imputation to generate values for missing variables.

The mean age of the patients was 30 years, 64% were White, 17% were Black, 12% were Hispanic, and remainder were other/unknown race/ethnicity. Ninety percent were male, and 20% had greater than a high school education. Of the 858,226 patients, 91,244 (11%) had a diagnosis of OSA. Compared with patients who had no diagnosis of OSA, the unadjusted odds of reporting moderate/severe pain was 48% higher among those with OSA (odds ratio 1.48; P < .0001). After the researchers adjusted for all covariates in the model, the association between OSA and moderate/severe pain remained significant though attenuated, with an adjusted odds ratio of 1.09 (P < .0001).

Several characteristics were different between those who had a diagnosis of OSA and those who did not, including age (a mean of 36 vs. 26 years, respectively) and having the following diagnoses: pain (36% vs. 16%), headache (28% vs. 14%), diabetes (12% vs. 2%), hypertension (40% vs. 12%), and a body mass index of 30 kg/m² or greater (69% vs. 35%). Certain psychiatric disorders were also common among patients with OSA, including major depressive disorder (20% vs. 10%), posttraumatic stress disorder (50% vs. 30%), and substance use disorder (26% vs. 17%). Patients with OSA were also more likely to have been prescribed benzodiazepines or opioids within 90 days of their OSA diagnosis. Although men were more likely to have a diagnosis of OSA, no differences related to sex in the association of OSA and pain were observed in sex-based stratified analyses.

“Based on these results, we suggest more thorough and more frequent pain intensity screening in patients with OSA, particularly in those patients who are younger than 60 years old without significant comorbid illness,” the researchers concluded. “Furthermore, we also recommend increased OSA screening for patients with moderate/severe pain intensity and pain diagnoses.” One tool they recommend is the STOP-Bang (Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference, and Gender) questionnaire, which has been validated in multiple settings.

Commenting on the findings of this study, Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City, commended the study design. “One of the problems with sleep apnea studies is that there are always confounding effects, especially from BMI. This is a population that has a significant medical burden of disease, but I think this is a well-done study to look at the relationship between pain and OSA in a younger population. The authors tried to adjust for all these confounders and they still found a significant association. This indicates that sleep affects one’s pain threshold. And sleep apnea, by mechanisms still yet to be defined, also alters that pain threshold. It may also affect the expression of pain or management of pain, making treatment more problematic in this population,” he said in an interview.

A key limitation of the study, he continued, was the fact it evaluated only one aspect of sleep: OSA. “They didn’t look at duration of sleep, comorbid insomnia, or fragmentation of sleep from apnea or from other causes,” Dr. Sundar said. “We have multiple ways of treating sleep apnea. Clearly, we need studies of treating sleep apnea with [continuous positive airway pressure] and how that affects the occurrence of pain. The relevant practical aspect of this is that there are pain clinics all over the country that should screen for sleep apnea. Along the same lines, sleep practitioners should be aware that pain has an important association with sleep apnea.”

The study was supported by the Health Services Research & Development in the Department of Veterans Affairs of the Veterans Health Administration, the Yale School of Medicine Medical Student Fellowship, and the U.S. National Institutes of Health.

[email protected]

SOURCE: Athar W et al. Ann Am Thorac Soc. 2020;17(10):1273-48.

Correction, 10/28/20: An earlier version of this article misstated Wardah Athar's name in the photo caption.

Sleep specialists might want to take a closer look at the connections between obstructive sleep apnea, chronic pain, and reported pain intensity in younger patients. Young adults with a diagnosis of obstructive sleep apnea (OSA) are more likely to report moderate to severe pain intensity, compared with their peers who do not have the diagnosis, results from a large cross-sectional analysis of veterans showed.

“Because of the high burden of chronic pain conditions in younger adults, this study highlights the need to understand the impact of OSA diagnosis and treatment on pain intensity,” researchers led by Wardah Athar, a graduate student at Yale University, New Haven, Conn., and Lori A. Bastian, MD, MPH, a professor of internal medicine at Yale, wrote in an article published in the Annals of the American Thoracic Society. “This understanding would then help inform the development of interventions to promote screening for OSA among young adults with chronic pain and pain management among those with diagnosed OSA.”

In an effort to assess whether young adults with diagnosed OSA are more likely to report higher pain intensity, compared with those without OSA, the researchers drew from a sample of 858,226 veterans from Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn who had at least one visit to a VA clinic between 2001 and 2014. They used ICD-9 codes to identify OSA and assessed self-reported responses to pain measures on a 0-10 numeric scale which were recorded in each veteran’s EMR. Next, they averaged pain intensity responses over a 12-month period and categorized them as none (0), mild (1-3), and moderate/severe (4–10). Covariates included age, sex, education, race, mental health diagnoses, headache diagnoses, pain diagnoses, hypertension, diabetes, body mass index, and smoking status. The researchers used multivariate logistic regression models and multiple imputation to generate values for missing variables.

The mean age of the patients was 30 years, 64% were White, 17% were Black, 12% were Hispanic, and remainder were other/unknown race/ethnicity. Ninety percent were male, and 20% had greater than a high school education. Of the 858,226 patients, 91,244 (11%) had a diagnosis of OSA. Compared with patients who had no diagnosis of OSA, the unadjusted odds of reporting moderate/severe pain was 48% higher among those with OSA (odds ratio 1.48; P < .0001). After the researchers adjusted for all covariates in the model, the association between OSA and moderate/severe pain remained significant though attenuated, with an adjusted odds ratio of 1.09 (P < .0001).

Several characteristics were different between those who had a diagnosis of OSA and those who did not, including age (a mean of 36 vs. 26 years, respectively) and having the following diagnoses: pain (36% vs. 16%), headache (28% vs. 14%), diabetes (12% vs. 2%), hypertension (40% vs. 12%), and a body mass index of 30 kg/m² or greater (69% vs. 35%). Certain psychiatric disorders were also common among patients with OSA, including major depressive disorder (20% vs. 10%), posttraumatic stress disorder (50% vs. 30%), and substance use disorder (26% vs. 17%). Patients with OSA were also more likely to have been prescribed benzodiazepines or opioids within 90 days of their OSA diagnosis. Although men were more likely to have a diagnosis of OSA, no differences related to sex in the association of OSA and pain were observed in sex-based stratified analyses.

“Based on these results, we suggest more thorough and more frequent pain intensity screening in patients with OSA, particularly in those patients who are younger than 60 years old without significant comorbid illness,” the researchers concluded. “Furthermore, we also recommend increased OSA screening for patients with moderate/severe pain intensity and pain diagnoses.” One tool they recommend is the STOP-Bang (Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference, and Gender) questionnaire, which has been validated in multiple settings.

Commenting on the findings of this study, Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City, commended the study design. “One of the problems with sleep apnea studies is that there are always confounding effects, especially from BMI. This is a population that has a significant medical burden of disease, but I think this is a well-done study to look at the relationship between pain and OSA in a younger population. The authors tried to adjust for all these confounders and they still found a significant association. This indicates that sleep affects one’s pain threshold. And sleep apnea, by mechanisms still yet to be defined, also alters that pain threshold. It may also affect the expression of pain or management of pain, making treatment more problematic in this population,” he said in an interview.

A key limitation of the study, he continued, was the fact it evaluated only one aspect of sleep: OSA. “They didn’t look at duration of sleep, comorbid insomnia, or fragmentation of sleep from apnea or from other causes,” Dr. Sundar said. “We have multiple ways of treating sleep apnea. Clearly, we need studies of treating sleep apnea with [continuous positive airway pressure] and how that affects the occurrence of pain. The relevant practical aspect of this is that there are pain clinics all over the country that should screen for sleep apnea. Along the same lines, sleep practitioners should be aware that pain has an important association with sleep apnea.”

The study was supported by the Health Services Research & Development in the Department of Veterans Affairs of the Veterans Health Administration, the Yale School of Medicine Medical Student Fellowship, and the U.S. National Institutes of Health.

[email protected]

SOURCE: Athar W et al. Ann Am Thorac Soc. 2020;17(10):1273-48.

Correction, 10/28/20: An earlier version of this article misstated Wardah Athar's name in the photo caption.

Abnormal mitochondrial activity in pain-processing areas of the brain may explain why some persons with type 2 diabetes experience painful peripheral neuropathy while others do not, new U.K. study findings have suggested.

A greater ratio of adenosine triphosphate (ATP) – “the cellular energy currency of all life” – to phosphocreatine (PCr) was observed in the somatosensory cortex and right thalamus in those with painful diabetic peripheral neuropathy (DPN). Importantly, this correlated with neuropathic pain symptom intensity as measured by the Neuropathic Pain Symptom Inventory (NPSI) and the Doleur Neuroathique en 4 (DN4).

The findings suggest that altered cerebral phosphorus metabolite ratios may serve as a biomarker of DPN, said the study’s investigators.

“Normally the ATP:Cr ratio will be unaltered, but there’s stress to the brain that might change,” Gordon Sloan, a clinical research fellow within the Diabetes Research Unit at the Royal Hallamshire Hospital in Sheffield (England) said at the virtual annual meeting of the European Association for the Study of Diabetes.

DPN affects around a quarter of patients with type 2 diabetes but treatments are “inadequate”, and “unfortunately fewer than a third of individuals receive 50% or greater pain relief from current neuropathic pain treatments,” Mr. Sloan said. “Ultimately, this lack of understanding of the pathophysiology of the condition is therefore clear rationale to investigate the disease mechanisms further and to find novel targets for treatments,” he added.


 

Brain metabolites offer clues to neuropathic pain levels

The thalamus and primary somatosensory cortex are two key areas of the brain that are involved in the perception of painful stimuli, Mr. Sloan explained. “The thalamus receives most of the slowest sensory impulses from the peripheral nervous system modulating and processing them for relaying the signals to the rest of the pain matrix, including the somatosensory cortex where these sensations are interpreted and localized.”

Prior imaging work by Mr. Sloan’s group and others have shown that there are alterations in the functioning of both these brain areas in those with painful DPN versus healthy volunteers and those with type 2 diabetes but no DPN. So for their current study, Mr. Sloan and associates from Sheffield University and Sheffield Teaching Hospitals National Health Service Trust, used an advanced imaging method – phosphorus magnetic resonance spectroscopy (MRS) – to scan the thalamus and somatosensory cortex of 43 persons with type 2 diabetes and 12 healthy volunteers. Of those with diabetes, 11 had no DPN, 12 had DPN but were not currently in pain, and 20 had painful DPN.

From the scans, three phosphorus metabolite ratios were calculated, which gave an indication of mitochondrial activity: first, the ATP to PCr ratio, which gives a measure of cellular energy status; second, the ATP to inorganic phosphate (Pi) ratio, which measures oxidative phosphorylation; and third, the ratio of phosphomonoesters (PME) to phosphodiesters (PDE), which gives a measure of cell membrane turnover.

“We have measured the ratio of high-energy phosphate levels which are an indirect representation of the balance between energy generation, reserve and usage in the brain,” Mr. Sloan said.

The subjects studied were of a similar age, around 63 years on average, and well matched in terms of their sex and body mass index. Those with diabetes of course had higher blood glucose and glycated hemoglobin than did the healthy volunteers during the scans. Among those with diabetes, those with DPN were significantly more likely to have a longer duration of diabetes (12.5 years for painful DPN and 15.8 years for nonpainful DPN) than were those with no DPN (8.7 years).

Furthermore, those with DPN had higher scores on the Neuropathic Pain Symptom Inventory (NPSI) than did those without, although there was not much difference between those with painful or nonpainful DPN. On the other had, those with painful DPN were more likely to have higher scores when using the Doleur Neuroathique en 4 (DN4) to assess their pain level.

Results showed significant changes in cerebral cellular bioenergetics in the pain processing regions of the brain in those with painful DPN. The ATP:PCr at the thalamus and at the somatosensory cortex was significantly higher in those with painful DPN, compared with healthy volunteers. The other measures of phosphorus metabolite levels (ATP:Pi and PME:PDE) were unaltered.

“We hypothesize that the findings of the study are suggestive of increased energy demands in regions of pain perception due to increased neuronal activity” said Dr. Sloan.

The study’s results add further evidence for cerebral alterations playing a key role in the generation and maintenance of pain in painful DPN.

SOURCE: Sloan S et al. EASD 2020, oral presentation 181.




 

Abnormal mitochondrial activity in pain-processing areas of the brain may explain why some persons with type 2 diabetes experience painful peripheral neuropathy while others do not, new U.K. study findings have suggested.

A greater ratio of adenosine triphosphate (ATP) – “the cellular energy currency of all life” – to phosphocreatine (PCr) was observed in the somatosensory cortex and right thalamus in those with painful diabetic peripheral neuropathy (DPN). Importantly, this correlated with neuropathic pain symptom intensity as measured by the Neuropathic Pain Symptom Inventory (NPSI) and the Doleur Neuroathique en 4 (DN4).

The findings suggest that altered cerebral phosphorus metabolite ratios may serve as a biomarker of DPN, said the study’s investigators.

“Normally the ATP:Cr ratio will be unaltered, but there’s stress to the brain that might change,” Gordon Sloan, a clinical research fellow within the Diabetes Research Unit at the Royal Hallamshire Hospital in Sheffield (England) said at the virtual annual meeting of the European Association for the Study of Diabetes.

DPN affects around a quarter of patients with type 2 diabetes but treatments are “inadequate”, and “unfortunately fewer than a third of individuals receive 50% or greater pain relief from current neuropathic pain treatments,” Mr. Sloan said. “Ultimately, this lack of understanding of the pathophysiology of the condition is therefore clear rationale to investigate the disease mechanisms further and to find novel targets for treatments,” he added.


 

Brain metabolites offer clues to neuropathic pain levels

The thalamus and primary somatosensory cortex are two key areas of the brain that are involved in the perception of painful stimuli, Mr. Sloan explained. “The thalamus receives most of the slowest sensory impulses from the peripheral nervous system modulating and processing them for relaying the signals to the rest of the pain matrix, including the somatosensory cortex where these sensations are interpreted and localized.”

Prior imaging work by Mr. Sloan’s group and others have shown that there are alterations in the functioning of both these brain areas in those with painful DPN versus healthy volunteers and those with type 2 diabetes but no DPN. So for their current study, Mr. Sloan and associates from Sheffield University and Sheffield Teaching Hospitals National Health Service Trust, used an advanced imaging method – phosphorus magnetic resonance spectroscopy (MRS) – to scan the thalamus and somatosensory cortex of 43 persons with type 2 diabetes and 12 healthy volunteers. Of those with diabetes, 11 had no DPN, 12 had DPN but were not currently in pain, and 20 had painful DPN.

From the scans, three phosphorus metabolite ratios were calculated, which gave an indication of mitochondrial activity: first, the ATP to PCr ratio, which gives a measure of cellular energy status; second, the ATP to inorganic phosphate (Pi) ratio, which measures oxidative phosphorylation; and third, the ratio of phosphomonoesters (PME) to phosphodiesters (PDE), which gives a measure of cell membrane turnover.

“We have measured the ratio of high-energy phosphate levels which are an indirect representation of the balance between energy generation, reserve and usage in the brain,” Mr. Sloan said.

The subjects studied were of a similar age, around 63 years on average, and well matched in terms of their sex and body mass index. Those with diabetes of course had higher blood glucose and glycated hemoglobin than did the healthy volunteers during the scans. Among those with diabetes, those with DPN were significantly more likely to have a longer duration of diabetes (12.5 years for painful DPN and 15.8 years for nonpainful DPN) than were those with no DPN (8.7 years).

Furthermore, those with DPN had higher scores on the Neuropathic Pain Symptom Inventory (NPSI) than did those without, although there was not much difference between those with painful or nonpainful DPN. On the other had, those with painful DPN were more likely to have higher scores when using the Doleur Neuroathique en 4 (DN4) to assess their pain level.

Results showed significant changes in cerebral cellular bioenergetics in the pain processing regions of the brain in those with painful DPN. The ATP:PCr at the thalamus and at the somatosensory cortex was significantly higher in those with painful DPN, compared with healthy volunteers. The other measures of phosphorus metabolite levels (ATP:Pi and PME:PDE) were unaltered.

“We hypothesize that the findings of the study are suggestive of increased energy demands in regions of pain perception due to increased neuronal activity” said Dr. Sloan.

The study’s results add further evidence for cerebral alterations playing a key role in the generation and maintenance of pain in painful DPN.

SOURCE: Sloan S et al. EASD 2020, oral presentation 181.




 

Abnormal mitochondrial activity in pain-processing areas of the brain may explain why some persons with type 2 diabetes experience painful peripheral neuropathy while others do not, new U.K. study findings have suggested.

A greater ratio of adenosine triphosphate (ATP) – “the cellular energy currency of all life” – to phosphocreatine (PCr) was observed in the somatosensory cortex and right thalamus in those with painful diabetic peripheral neuropathy (DPN). Importantly, this correlated with neuropathic pain symptom intensity as measured by the Neuropathic Pain Symptom Inventory (NPSI) and the Doleur Neuroathique en 4 (DN4).

The findings suggest that altered cerebral phosphorus metabolite ratios may serve as a biomarker of DPN, said the study’s investigators.

“Normally the ATP:Cr ratio will be unaltered, but there’s stress to the brain that might change,” Gordon Sloan, a clinical research fellow within the Diabetes Research Unit at the Royal Hallamshire Hospital in Sheffield (England) said at the virtual annual meeting of the European Association for the Study of Diabetes.

DPN affects around a quarter of patients with type 2 diabetes but treatments are “inadequate”, and “unfortunately fewer than a third of individuals receive 50% or greater pain relief from current neuropathic pain treatments,” Mr. Sloan said. “Ultimately, this lack of understanding of the pathophysiology of the condition is therefore clear rationale to investigate the disease mechanisms further and to find novel targets for treatments,” he added.


 

Brain metabolites offer clues to neuropathic pain levels

The thalamus and primary somatosensory cortex are two key areas of the brain that are involved in the perception of painful stimuli, Mr. Sloan explained. “The thalamus receives most of the slowest sensory impulses from the peripheral nervous system modulating and processing them for relaying the signals to the rest of the pain matrix, including the somatosensory cortex where these sensations are interpreted and localized.”

Prior imaging work by Mr. Sloan’s group and others have shown that there are alterations in the functioning of both these brain areas in those with painful DPN versus healthy volunteers and those with type 2 diabetes but no DPN. So for their current study, Mr. Sloan and associates from Sheffield University and Sheffield Teaching Hospitals National Health Service Trust, used an advanced imaging method – phosphorus magnetic resonance spectroscopy (MRS) – to scan the thalamus and somatosensory cortex of 43 persons with type 2 diabetes and 12 healthy volunteers. Of those with diabetes, 11 had no DPN, 12 had DPN but were not currently in pain, and 20 had painful DPN.

From the scans, three phosphorus metabolite ratios were calculated, which gave an indication of mitochondrial activity: first, the ATP to PCr ratio, which gives a measure of cellular energy status; second, the ATP to inorganic phosphate (Pi) ratio, which measures oxidative phosphorylation; and third, the ratio of phosphomonoesters (PME) to phosphodiesters (PDE), which gives a measure of cell membrane turnover.

“We have measured the ratio of high-energy phosphate levels which are an indirect representation of the balance between energy generation, reserve and usage in the brain,” Mr. Sloan said.

The subjects studied were of a similar age, around 63 years on average, and well matched in terms of their sex and body mass index. Those with diabetes of course had higher blood glucose and glycated hemoglobin than did the healthy volunteers during the scans. Among those with diabetes, those with DPN were significantly more likely to have a longer duration of diabetes (12.5 years for painful DPN and 15.8 years for nonpainful DPN) than were those with no DPN (8.7 years).

Furthermore, those with DPN had higher scores on the Neuropathic Pain Symptom Inventory (NPSI) than did those without, although there was not much difference between those with painful or nonpainful DPN. On the other had, those with painful DPN were more likely to have higher scores when using the Doleur Neuroathique en 4 (DN4) to assess their pain level.

Results showed significant changes in cerebral cellular bioenergetics in the pain processing regions of the brain in those with painful DPN. The ATP:PCr at the thalamus and at the somatosensory cortex was significantly higher in those with painful DPN, compared with healthy volunteers. The other measures of phosphorus metabolite levels (ATP:Pi and PME:PDE) were unaltered.

“We hypothesize that the findings of the study are suggestive of increased energy demands in regions of pain perception due to increased neuronal activity” said Dr. Sloan.

The study’s results add further evidence for cerebral alterations playing a key role in the generation and maintenance of pain in painful DPN.

SOURCE: Sloan S et al. EASD 2020, oral presentation 181.




 

The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.

Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.

Low-dose (81-mg) aspirin is excluded from this warning.

“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.

As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.

A version of this article originally appeared on Medscape.com.

The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.

Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.

Low-dose (81-mg) aspirin is excluded from this warning.

“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.

As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.

A version of this article originally appeared on Medscape.com.

The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.

Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.

Low-dose (81-mg) aspirin is excluded from this warning.

“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.

As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.

A version of this article originally appeared on Medscape.com.

Low back pain in not uncommon in children and adolescents.^1-3 Although the prevalence of low back pain in children < 7 years is low, it increases with age, with studies reporting lifetime prevalence at age 12 years between 16% and 18% and rates as high as 66% by 16 years of age.^4,5 Although children and adolescents usually have pain that is transient and benign without a defined cause, structural causes of low back pain should be considered in school-aged children with pain that persists for > 3 to 6 weeks. ⁴ The most common structural causes of adolescent low back pain are reviewed here.

Etiology: A mixed bag

Back pain in school-aged children is most commonly due to muscular strain, overuse, or poor posture. The pain is often transient in nature and responds to rest and postural education.^4,6 A herniated disc is an uncommon finding in younger school-aged children, but incidence increases slightly among older adolescents, particularly those who are active in collision sports and/or weight-lifting.^7,8 Pain caused by a herniated disc often radiates along the distribution of the sciatic nerve and worsens during lumbar flexion.

Spondylolysis and spondylolisthesis are important causes of back pain in children. Spondylolysis is defined as a defect or abnormality of the pars interarticularis and surrounding lamina and pedicle. Spondylolisthesis, which is less common, is defined as the translation or “slippage” of one vertebral segment in relation to the next caudal segment. These conditions commonly occur as a result of repetitive stress.

In a prospective study of adolescents < 19 years with low back pain for > 2 weeks, the prevalence of spondylolysis was 39.7%.⁹ Adolescent athletes with symptomatic low back pain are more likely to have spondylolysis than nonathletes (32% vs 2%, respectively).^2,10 Pain is often made worse by extension of the spine. Spondylolysis and spondylolisthesis can be congenital or acquired, and both can be asymptomatic. Children and teens who are athletes are at higher risk for symptomatic spondylolysis and spondylolisthesis.^10-12 This is especially true for those involved in gymnastics, dance, football, and/or volleyball, where a repetitive load is placed onto an extended spine.

Idiopathic scoliosis is an abnormal lateral curvature of the spine that usually develops during adolescence and worsens with growth. Historically, painful scoliosis was considered rare, but more recently researchers determined that children with scoliosis have a higher rate of pain compared to their peers.^13,14 School-aged children with scoliosis were found to be at 2 times the risk of low back pain compared to those without scoliosis.¹³ It is important to identify scoliosis in adolescents so that progression can be monitored.

Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side.

Screening for scoliosis in primary care is somewhat controversial. The US Preventive Services Task Force (USPSTF) finds insufficient evidence for screening asymptomatic adolescents for scoliosis.¹⁵ This recommendation is based on the fact that there is little evidence on the effect of screening on long-term outcomes. Screening may also lead to unnecessary radiation. Conversely, a position statement released by the Scoliosis Research Society, the Pediatric Orthopedic Society of North America, the American Association of Orthopedic Surgeons, and the American Academy of Pediatrics recommends scoliosis screening during routine pediatric office visits.¹⁶ Screening for girls is recommended at ages 10 and 12 years, and for boys, once between ages 13 and 14 years. The statement highlights evidence showing that focused screening by appropriate personnel has value in detecting a clinically significant curve (> 20°).

Scheuermann disease is a rare cause of back pain in children that usually develops during adolescence and results in increasing thoracic kyphosis. An autosomal dominant mutation plays a role in this disease of the growth cartilage endplate; repetitive strain on the growth cartilage is also a contributing factor.^17,18 An atypical variant manifests with kyphosis in the thoracolumbar region.¹⁷

Continue to: Other causes of low back pain

Other causes of low back pain—including inflammatory arthritis, infection (eg, discitis), and tumor—are rare in children but must always be considered, especially in the setting of persistent symptoms.^4,19-21 More on the features of these conditions is listed in TABLE 1.^{1-7,13-15,17-30}

History: Focus on onset, timing, and duration of symptoms

As with adults, obtaining a history that includes the onset, timing, and duration of symptoms is key in the evaluation of low back pain in children, as is obtaining a history of the patient’s activities; sports that repetitively load the lumbar spine in an extended position increase the risk of injury.¹⁰

Specific risk factors for low back pain in children and adolescents are poorly understood.^4,9,31 Pain can be associated with trauma, or it can have a more progressive or insidious onset. Generally, pain that is present for up to 6 weeks and is intermittent or improving has a self-limited course. Pain that persists beyond 3 to 6 weeks or is worsening is more likely to have an anatomical cause that needs further evaluation.^2,3,10,21

Identifying exacerbating and alleviating factors can provide useful information. Pain that is worse with lumbar flexion is more likely to come from muscular strain or disc pathology. Pain with extension is more likely due to a structural cause such as spondylolysis/spondylolisthesis, scoliosis, or Scheuermann disease.^{2,4,10,17,18,21} See TABLE 2 for red flag symptoms that indicate the need for imaging and further work-up.

The physical exam: Visualize, assess range of motion, and reproduce pain

The physical examination of any patient with low back pain should include direct visualization and inspection of the back, spine, and pelvis; palpation of the spine and paraspinal regions; assessment of lumbar range of motion and of the lumbar nerve roots, including tests of sensation, strength, and deep tendon reflexes; and an evaluation of the patient’s posture, which can provide clues to underlying causes of pain.

Continue to: Increased thoracic kyphosis...

Increased thoracic kyphosis that is not reversible is concerning for Scheuermann disease.^9,17,18 A significant elevation in one shoulder or side of the pelvis can be indicative of scoliosis. Increased lumbar lordosis may predispose a patient to spondylolysis.

In patients with spondylolysis, lumbar extension will usually reproduce pain, which is often unilateral. Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side. The sensitivity of the Stork test for unilateral spondylolysis is approximately 50%.³² (For more information on the Stork test, see www.physio-pedia.com/Stork_test.)

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain. Lumbar flexion with concomitant radicular pain is associated with disc pathology.⁸ Pain with a straight-leg raise is also associated with disk pathology, especially if raising the contralateral leg increases pain.⁸

Using a scoliometer. Evaluate the flexed spine for the presence of asymmetry, which can indicate scoliosis.³³ If asymmetry is present, use a scoliometer to determine the degree of asymmetry. Zero to 5° is considered clinically insignificant; monitor and reevaluate these patients at subsequent visits.^34,35 Ten degrees or more of asymmetry with a scoliometer should prompt you to order radiographs.^35,36 A smartphone-based scoliometer for iPhones was evaluated in 1 study and was shown to have reasonable reliability and validity for clinical use.³⁷

Deformity of the lower extremities. Because low back pain may be caused by biomechanical or structural deformity of the lower extremities, examine the flexibility of the hip flexors, gluteal musculature, hamstrings, and the iliotibial band.³⁸ In addition, evaluate for leg-length discrepancy and lower-extremity malalignment, such as femoral anteversion, tibial torsion, or pes planus.

Continue to: Imaging

Imaging: Know when it’s needed

Although imaging of the lumbar spine is often unnecessary in the presence of acute low back pain in children, always consider imaging in the setting of bony tenderness, pain that wakes a patient from sleep, and in the setting of other red flag symptoms (see TABLE 2). Low back pain in children that is reproducible with lumbar extension is concerning for spondylolysis or spondylolisthesis. If the pain with extension persists beyond 3 to 6 weeks, order imaging starting with radiographs.^2,39

Traditionally, 4 views of the spine—­anteroposterior (AP), lateral, and oblique (one right and one left)—were obtained, but recent evidence indicates that 2 views (AP and lateral) have similar sensitivity and specificity to 4 views with significantly reduced radiation exposure.^2,39 Because the sensitivity of plain films is relatively low, consider more advanced imaging if spondylolysis or spondylolisthesis is strongly suspected. Recent studies indicate that magnetic resonance imaging (MRI) may be as effective as computed tomography (CT) or bone scan and has the advantage of lower radiation (FIGURE 1).^2,22

Similarly, order radiographs if there is > 10° of asymmetry noted on physical exam using a scoliometer.^15,23 Calculate the Cobb angle to determine the severity of scoliosis. Refer patients with angles ≥ 20° to a pediatric orthopedist for monitoring of progression and consideration of bracing (FIGURE 2).^23,34 For patients with curvatures between 10° and 19°, repeat imaging every 6 to 12 months. Because scoliosis is a risk factor for spondylolysis, evaluate radiographs in the setting of painful scoliosis for the presence of a spondylolysis.^34,35

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain.

If excessive kyphosis is noted on exam, order radiographs to evaluate for Scheuermann disease. Classic imaging findings include Schmorl nodes, vertebral endplate changes, and anterior wedging (FIGURE 3).^17,18

In the absence of the above concerns, defer imaging of the lumbar spine until after adequate rest and rehabilitation have been attempted.

Continue to: Treatment typically involves restor physical therapy

Most cases of low back pain in children and adolescents are benign and self-limited. Many children with low back pain can be treated with relative rest from the offending activity. For children with more persistent pain, physical therapy (PT) is often indicated. Similar to that for adults, there is little evidence for specific PT programs to help children with low back pain. Rehabilitation should be individualized based on the condition being treated.

Medications. There have been no high-quality studies on the benefit of medications to treat low back pain in children. Studies have shown nonsteroidal anti-inflammatory drugs (NSAIDs) have value in adults, and they are likely safe for use in children,⁴⁰ but the risk of opiate abuse is significantly increased in adolescents who have been prescribed opiate pain medication prior to 12th grade.⁴¹

Lumbar disc herniation. Although still relatively rare, lumbar disc herniation is more common in older children and adolescents than in younger children and is treated similarly to that in adults.⁸ Range-of-motion exercise to restore lumbar motion is often first-line treatment. Research has shown that exercises that strengthen the abdominal or “core” musculature help prevent the return of low back pain.^24,25

In the case of spondylolysis or spondylolisthesis, rest from activity is generally required for a minimum of 4 to 6 weeks. Rehabilitation in the form of range of motion, especially into the lumbar extension, and spinal stabilization exercises are effective for both reducing pain and restoring range-­of-motion and strength.⁴² Have patients avoid heavy backpacks, which can reproduce pain. Children often benefit from leaving a second set of schoolbooks at home. For most patients with spondylolysis, conservative treatment with rehabilitation is equal to or better than surgical intervention in returning the patient to his/her pre-injury activity level.^26,43,44 When returning athletes to their sport, aggressive PT, defined as rest for < 10 weeks prior to initiating PT, is superior to delaying PT beyond 10 weeks of rest.²⁷

Idiopathic scoliosis. Much of the literature on the treatment of scoliosis is focused on limiting progression of the scoliotic curvature. Researchers thought that more severe curves were associated with more severe pain, but a recent systematic review showed that back pain can occur in patients with even small curvatures.²⁸ Treatment for patients with smaller degrees of curvature is similar to that for mechanical low back pain. PT may have a role in the treatment of scoliosis, but there is little evidence in the literature of its effectiveness.

Continue to: A Cochrane review showed...

Always consider imaging in the setting of bony tenderness, pain that wakes the patient from sleep, and when there is > 10° of asymmetry on physical exam using a scoliometer.

A Cochrane review showed that PT and exercise-based treatments had no effect on back pain or disability in patients with scoliosis.²⁹ And outpatient PT alone, in the absence of bracing, does not arrest progression of the scoliotic curvature.³⁵ One trial did demonstrate that an intensive inpatient treatment program of 4 to 6 weeks for patients with curvature of at least 40° reduced progression of curvature compared to an untreated control group at 1 year.³⁴ The outcomes of functional mobility and pain were not measured. Follow-up data on curve progression beyond 1 year are not available. Unfortunately, intensive inpatient treatment is not readily available or cost-effective for most patients with scoliosis.

Scheuermann disease. The mainstay of treatment for mild Scheuermann disease is advising the patient to avoid repetitive loading of the spine. Patients should avoid sports such as competitive weight-lifting, gymnastics, and football. Lower impact athletics are encouraged. Refer patients with pain to PT to address posture and core stabilization. Patients with severe kyphosis may require surgery.^17,18

Bracing: Rarely helpful for low back pain

The use of lumbar braces or corsets is rarely helpful for low back pain in children. Bracing in the setting of spondylolysis is controversial.One study indicated that bracing in combination with activity restriction and lumbar extension exercise is superior to activity restriction and lumbar flexion exercises alone.⁴³ But a meta-analysis did not demonstrate a significant difference in recovery when bracing was added.⁴⁴ Bracing may help to reduce pain initially in patients with spondylolysis who have pain at rest. Bracing is not recommended for patients with pain that abates with activity modification.

Scoliosis and Scheuermann kyphosis. Treatment of adolescent idiopathic scoliosis usually consists of observation and periodic reevaluation. Bracing is a mainstay of the nonsurgical management of scoliosis and is appropriate for curves of 20° to 40°; studies have reported successful control of curve progression in > 70% of patients.³⁶ According to 1 study, the number of cases of scoliosis needed to treat with bracing to prevent 1 surgery is 3.³⁰ Surgery is often indicated for patients with curvatures > 40°, although this is also debated.³³

Bracing is used rarely for Scheuermann kyphosis but may be helpful in more severe or painful cases.¹⁷

CORRESPONDENCE
Shawn F. Phillips, MD, MSPT, 500 University Drive H154, Hershey, PA, 17033; [email protected].

Low back pain in not uncommon in children and adolescents.^1-3 Although the prevalence of low back pain in children < 7 years is low, it increases with age, with studies reporting lifetime prevalence at age 12 years between 16% and 18% and rates as high as 66% by 16 years of age.^4,5 Although children and adolescents usually have pain that is transient and benign without a defined cause, structural causes of low back pain should be considered in school-aged children with pain that persists for > 3 to 6 weeks. ⁴ The most common structural causes of adolescent low back pain are reviewed here.

Etiology: A mixed bag

Back pain in school-aged children is most commonly due to muscular strain, overuse, or poor posture. The pain is often transient in nature and responds to rest and postural education.^4,6 A herniated disc is an uncommon finding in younger school-aged children, but incidence increases slightly among older adolescents, particularly those who are active in collision sports and/or weight-lifting.^7,8 Pain caused by a herniated disc often radiates along the distribution of the sciatic nerve and worsens during lumbar flexion.

Spondylolysis and spondylolisthesis are important causes of back pain in children. Spondylolysis is defined as a defect or abnormality of the pars interarticularis and surrounding lamina and pedicle. Spondylolisthesis, which is less common, is defined as the translation or “slippage” of one vertebral segment in relation to the next caudal segment. These conditions commonly occur as a result of repetitive stress.

In a prospective study of adolescents < 19 years with low back pain for > 2 weeks, the prevalence of spondylolysis was 39.7%.⁹ Adolescent athletes with symptomatic low back pain are more likely to have spondylolysis than nonathletes (32% vs 2%, respectively).^2,10 Pain is often made worse by extension of the spine. Spondylolysis and spondylolisthesis can be congenital or acquired, and both can be asymptomatic. Children and teens who are athletes are at higher risk for symptomatic spondylolysis and spondylolisthesis.^10-12 This is especially true for those involved in gymnastics, dance, football, and/or volleyball, where a repetitive load is placed onto an extended spine.

Idiopathic scoliosis is an abnormal lateral curvature of the spine that usually develops during adolescence and worsens with growth. Historically, painful scoliosis was considered rare, but more recently researchers determined that children with scoliosis have a higher rate of pain compared to their peers.^13,14 School-aged children with scoliosis were found to be at 2 times the risk of low back pain compared to those without scoliosis.¹³ It is important to identify scoliosis in adolescents so that progression can be monitored.

Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side.

Screening for scoliosis in primary care is somewhat controversial. The US Preventive Services Task Force (USPSTF) finds insufficient evidence for screening asymptomatic adolescents for scoliosis.¹⁵ This recommendation is based on the fact that there is little evidence on the effect of screening on long-term outcomes. Screening may also lead to unnecessary radiation. Conversely, a position statement released by the Scoliosis Research Society, the Pediatric Orthopedic Society of North America, the American Association of Orthopedic Surgeons, and the American Academy of Pediatrics recommends scoliosis screening during routine pediatric office visits.¹⁶ Screening for girls is recommended at ages 10 and 12 years, and for boys, once between ages 13 and 14 years. The statement highlights evidence showing that focused screening by appropriate personnel has value in detecting a clinically significant curve (> 20°).

Scheuermann disease is a rare cause of back pain in children that usually develops during adolescence and results in increasing thoracic kyphosis. An autosomal dominant mutation plays a role in this disease of the growth cartilage endplate; repetitive strain on the growth cartilage is also a contributing factor.^17,18 An atypical variant manifests with kyphosis in the thoracolumbar region.¹⁷

Continue to: Other causes of low back pain

Other causes of low back pain—including inflammatory arthritis, infection (eg, discitis), and tumor—are rare in children but must always be considered, especially in the setting of persistent symptoms.^4,19-21 More on the features of these conditions is listed in TABLE 1.^{1-7,13-15,17-30}

History: Focus on onset, timing, and duration of symptoms

As with adults, obtaining a history that includes the onset, timing, and duration of symptoms is key in the evaluation of low back pain in children, as is obtaining a history of the patient’s activities; sports that repetitively load the lumbar spine in an extended position increase the risk of injury.¹⁰

Specific risk factors for low back pain in children and adolescents are poorly understood.^4,9,31 Pain can be associated with trauma, or it can have a more progressive or insidious onset. Generally, pain that is present for up to 6 weeks and is intermittent or improving has a self-limited course. Pain that persists beyond 3 to 6 weeks or is worsening is more likely to have an anatomical cause that needs further evaluation.^2,3,10,21

Identifying exacerbating and alleviating factors can provide useful information. Pain that is worse with lumbar flexion is more likely to come from muscular strain or disc pathology. Pain with extension is more likely due to a structural cause such as spondylolysis/spondylolisthesis, scoliosis, or Scheuermann disease.^{2,4,10,17,18,21} See TABLE 2 for red flag symptoms that indicate the need for imaging and further work-up.

The physical exam: Visualize, assess range of motion, and reproduce pain

The physical examination of any patient with low back pain should include direct visualization and inspection of the back, spine, and pelvis; palpation of the spine and paraspinal regions; assessment of lumbar range of motion and of the lumbar nerve roots, including tests of sensation, strength, and deep tendon reflexes; and an evaluation of the patient’s posture, which can provide clues to underlying causes of pain.

Continue to: Increased thoracic kyphosis...

Increased thoracic kyphosis that is not reversible is concerning for Scheuermann disease.^9,17,18 A significant elevation in one shoulder or side of the pelvis can be indicative of scoliosis. Increased lumbar lordosis may predispose a patient to spondylolysis.

In patients with spondylolysis, lumbar extension will usually reproduce pain, which is often unilateral. Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side. The sensitivity of the Stork test for unilateral spondylolysis is approximately 50%.³² (For more information on the Stork test, see www.physio-pedia.com/Stork_test.)

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain. Lumbar flexion with concomitant radicular pain is associated with disc pathology.⁸ Pain with a straight-leg raise is also associated with disk pathology, especially if raising the contralateral leg increases pain.⁸

Using a scoliometer. Evaluate the flexed spine for the presence of asymmetry, which can indicate scoliosis.³³ If asymmetry is present, use a scoliometer to determine the degree of asymmetry. Zero to 5° is considered clinically insignificant; monitor and reevaluate these patients at subsequent visits.^34,35 Ten degrees or more of asymmetry with a scoliometer should prompt you to order radiographs.^35,36 A smartphone-based scoliometer for iPhones was evaluated in 1 study and was shown to have reasonable reliability and validity for clinical use.³⁷

Deformity of the lower extremities. Because low back pain may be caused by biomechanical or structural deformity of the lower extremities, examine the flexibility of the hip flexors, gluteal musculature, hamstrings, and the iliotibial band.³⁸ In addition, evaluate for leg-length discrepancy and lower-extremity malalignment, such as femoral anteversion, tibial torsion, or pes planus.

Continue to: Imaging

Imaging: Know when it’s needed

Although imaging of the lumbar spine is often unnecessary in the presence of acute low back pain in children, always consider imaging in the setting of bony tenderness, pain that wakes a patient from sleep, and in the setting of other red flag symptoms (see TABLE 2). Low back pain in children that is reproducible with lumbar extension is concerning for spondylolysis or spondylolisthesis. If the pain with extension persists beyond 3 to 6 weeks, order imaging starting with radiographs.^2,39

Traditionally, 4 views of the spine—­anteroposterior (AP), lateral, and oblique (one right and one left)—were obtained, but recent evidence indicates that 2 views (AP and lateral) have similar sensitivity and specificity to 4 views with significantly reduced radiation exposure.^2,39 Because the sensitivity of plain films is relatively low, consider more advanced imaging if spondylolysis or spondylolisthesis is strongly suspected. Recent studies indicate that magnetic resonance imaging (MRI) may be as effective as computed tomography (CT) or bone scan and has the advantage of lower radiation (FIGURE 1).^2,22

Similarly, order radiographs if there is > 10° of asymmetry noted on physical exam using a scoliometer.^15,23 Calculate the Cobb angle to determine the severity of scoliosis. Refer patients with angles ≥ 20° to a pediatric orthopedist for monitoring of progression and consideration of bracing (FIGURE 2).^23,34 For patients with curvatures between 10° and 19°, repeat imaging every 6 to 12 months. Because scoliosis is a risk factor for spondylolysis, evaluate radiographs in the setting of painful scoliosis for the presence of a spondylolysis.^34,35

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain.

If excessive kyphosis is noted on exam, order radiographs to evaluate for Scheuermann disease. Classic imaging findings include Schmorl nodes, vertebral endplate changes, and anterior wedging (FIGURE 3).^17,18

In the absence of the above concerns, defer imaging of the lumbar spine until after adequate rest and rehabilitation have been attempted.

Continue to: Treatment typically involves restor physical therapy

Most cases of low back pain in children and adolescents are benign and self-limited. Many children with low back pain can be treated with relative rest from the offending activity. For children with more persistent pain, physical therapy (PT) is often indicated. Similar to that for adults, there is little evidence for specific PT programs to help children with low back pain. Rehabilitation should be individualized based on the condition being treated.

Medications. There have been no high-quality studies on the benefit of medications to treat low back pain in children. Studies have shown nonsteroidal anti-inflammatory drugs (NSAIDs) have value in adults, and they are likely safe for use in children,⁴⁰ but the risk of opiate abuse is significantly increased in adolescents who have been prescribed opiate pain medication prior to 12th grade.⁴¹

Lumbar disc herniation. Although still relatively rare, lumbar disc herniation is more common in older children and adolescents than in younger children and is treated similarly to that in adults.⁸ Range-of-motion exercise to restore lumbar motion is often first-line treatment. Research has shown that exercises that strengthen the abdominal or “core” musculature help prevent the return of low back pain.^24,25

In the case of spondylolysis or spondylolisthesis, rest from activity is generally required for a minimum of 4 to 6 weeks. Rehabilitation in the form of range of motion, especially into the lumbar extension, and spinal stabilization exercises are effective for both reducing pain and restoring range-­of-motion and strength.⁴² Have patients avoid heavy backpacks, which can reproduce pain. Children often benefit from leaving a second set of schoolbooks at home. For most patients with spondylolysis, conservative treatment with rehabilitation is equal to or better than surgical intervention in returning the patient to his/her pre-injury activity level.^26,43,44 When returning athletes to their sport, aggressive PT, defined as rest for < 10 weeks prior to initiating PT, is superior to delaying PT beyond 10 weeks of rest.²⁷

Idiopathic scoliosis. Much of the literature on the treatment of scoliosis is focused on limiting progression of the scoliotic curvature. Researchers thought that more severe curves were associated with more severe pain, but a recent systematic review showed that back pain can occur in patients with even small curvatures.²⁸ Treatment for patients with smaller degrees of curvature is similar to that for mechanical low back pain. PT may have a role in the treatment of scoliosis, but there is little evidence in the literature of its effectiveness.

Continue to: A Cochrane review showed...

Always consider imaging in the setting of bony tenderness, pain that wakes the patient from sleep, and when there is > 10° of asymmetry on physical exam using a scoliometer.

A Cochrane review showed that PT and exercise-based treatments had no effect on back pain or disability in patients with scoliosis.²⁹ And outpatient PT alone, in the absence of bracing, does not arrest progression of the scoliotic curvature.³⁵ One trial did demonstrate that an intensive inpatient treatment program of 4 to 6 weeks for patients with curvature of at least 40° reduced progression of curvature compared to an untreated control group at 1 year.³⁴ The outcomes of functional mobility and pain were not measured. Follow-up data on curve progression beyond 1 year are not available. Unfortunately, intensive inpatient treatment is not readily available or cost-effective for most patients with scoliosis.

Scheuermann disease. The mainstay of treatment for mild Scheuermann disease is advising the patient to avoid repetitive loading of the spine. Patients should avoid sports such as competitive weight-lifting, gymnastics, and football. Lower impact athletics are encouraged. Refer patients with pain to PT to address posture and core stabilization. Patients with severe kyphosis may require surgery.^17,18

Bracing: Rarely helpful for low back pain

The use of lumbar braces or corsets is rarely helpful for low back pain in children. Bracing in the setting of spondylolysis is controversial.One study indicated that bracing in combination with activity restriction and lumbar extension exercise is superior to activity restriction and lumbar flexion exercises alone.⁴³ But a meta-analysis did not demonstrate a significant difference in recovery when bracing was added.⁴⁴ Bracing may help to reduce pain initially in patients with spondylolysis who have pain at rest. Bracing is not recommended for patients with pain that abates with activity modification.

Scoliosis and Scheuermann kyphosis. Treatment of adolescent idiopathic scoliosis usually consists of observation and periodic reevaluation. Bracing is a mainstay of the nonsurgical management of scoliosis and is appropriate for curves of 20° to 40°; studies have reported successful control of curve progression in > 70% of patients.³⁶ According to 1 study, the number of cases of scoliosis needed to treat with bracing to prevent 1 surgery is 3.³⁰ Surgery is often indicated for patients with curvatures > 40°, although this is also debated.³³

Bracing is used rarely for Scheuermann kyphosis but may be helpful in more severe or painful cases.¹⁷

CORRESPONDENCE
Shawn F. Phillips, MD, MSPT, 500 University Drive H154, Hershey, PA, 17033; [email protected].

Low back pain in not uncommon in children and adolescents.^1-3 Although the prevalence of low back pain in children < 7 years is low, it increases with age, with studies reporting lifetime prevalence at age 12 years between 16% and 18% and rates as high as 66% by 16 years of age.^4,5 Although children and adolescents usually have pain that is transient and benign without a defined cause, structural causes of low back pain should be considered in school-aged children with pain that persists for > 3 to 6 weeks. ⁴ The most common structural causes of adolescent low back pain are reviewed here.

Etiology: A mixed bag

Back pain in school-aged children is most commonly due to muscular strain, overuse, or poor posture. The pain is often transient in nature and responds to rest and postural education.^4,6 A herniated disc is an uncommon finding in younger school-aged children, but incidence increases slightly among older adolescents, particularly those who are active in collision sports and/or weight-lifting.^7,8 Pain caused by a herniated disc often radiates along the distribution of the sciatic nerve and worsens during lumbar flexion.

Spondylolysis and spondylolisthesis are important causes of back pain in children. Spondylolysis is defined as a defect or abnormality of the pars interarticularis and surrounding lamina and pedicle. Spondylolisthesis, which is less common, is defined as the translation or “slippage” of one vertebral segment in relation to the next caudal segment. These conditions commonly occur as a result of repetitive stress.

In a prospective study of adolescents < 19 years with low back pain for > 2 weeks, the prevalence of spondylolysis was 39.7%.⁹ Adolescent athletes with symptomatic low back pain are more likely to have spondylolysis than nonathletes (32% vs 2%, respectively).^2,10 Pain is often made worse by extension of the spine. Spondylolysis and spondylolisthesis can be congenital or acquired, and both can be asymptomatic. Children and teens who are athletes are at higher risk for symptomatic spondylolysis and spondylolisthesis.^10-12 This is especially true for those involved in gymnastics, dance, football, and/or volleyball, where a repetitive load is placed onto an extended spine.

Idiopathic scoliosis is an abnormal lateral curvature of the spine that usually develops during adolescence and worsens with growth. Historically, painful scoliosis was considered rare, but more recently researchers determined that children with scoliosis have a higher rate of pain compared to their peers.^13,14 School-aged children with scoliosis were found to be at 2 times the risk of low back pain compared to those without scoliosis.¹³ It is important to identify scoliosis in adolescents so that progression can be monitored.

Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side.

Screening for scoliosis in primary care is somewhat controversial. The US Preventive Services Task Force (USPSTF) finds insufficient evidence for screening asymptomatic adolescents for scoliosis.¹⁵ This recommendation is based on the fact that there is little evidence on the effect of screening on long-term outcomes. Screening may also lead to unnecessary radiation. Conversely, a position statement released by the Scoliosis Research Society, the Pediatric Orthopedic Society of North America, the American Association of Orthopedic Surgeons, and the American Academy of Pediatrics recommends scoliosis screening during routine pediatric office visits.¹⁶ Screening for girls is recommended at ages 10 and 12 years, and for boys, once between ages 13 and 14 years. The statement highlights evidence showing that focused screening by appropriate personnel has value in detecting a clinically significant curve (> 20°).

Scheuermann disease is a rare cause of back pain in children that usually develops during adolescence and results in increasing thoracic kyphosis. An autosomal dominant mutation plays a role in this disease of the growth cartilage endplate; repetitive strain on the growth cartilage is also a contributing factor.^17,18 An atypical variant manifests with kyphosis in the thoracolumbar region.¹⁷

Continue to: Other causes of low back pain

Other causes of low back pain—including inflammatory arthritis, infection (eg, discitis), and tumor—are rare in children but must always be considered, especially in the setting of persistent symptoms.^4,19-21 More on the features of these conditions is listed in TABLE 1.^{1-7,13-15,17-30}

History: Focus on onset, timing, and duration of symptoms

As with adults, obtaining a history that includes the onset, timing, and duration of symptoms is key in the evaluation of low back pain in children, as is obtaining a history of the patient’s activities; sports that repetitively load the lumbar spine in an extended position increase the risk of injury.¹⁰

Specific risk factors for low back pain in children and adolescents are poorly understood.^4,9,31 Pain can be associated with trauma, or it can have a more progressive or insidious onset. Generally, pain that is present for up to 6 weeks and is intermittent or improving has a self-limited course. Pain that persists beyond 3 to 6 weeks or is worsening is more likely to have an anatomical cause that needs further evaluation.^2,3,10,21

Identifying exacerbating and alleviating factors can provide useful information. Pain that is worse with lumbar flexion is more likely to come from muscular strain or disc pathology. Pain with extension is more likely due to a structural cause such as spondylolysis/spondylolisthesis, scoliosis, or Scheuermann disease.^{2,4,10,17,18,21} See TABLE 2 for red flag symptoms that indicate the need for imaging and further work-up.

The physical exam: Visualize, assess range of motion, and reproduce pain

The physical examination of any patient with low back pain should include direct visualization and inspection of the back, spine, and pelvis; palpation of the spine and paraspinal regions; assessment of lumbar range of motion and of the lumbar nerve roots, including tests of sensation, strength, and deep tendon reflexes; and an evaluation of the patient’s posture, which can provide clues to underlying causes of pain.

Continue to: Increased thoracic kyphosis...

Increased thoracic kyphosis that is not reversible is concerning for Scheuermann disease.^9,17,18 A significant elevation in one shoulder or side of the pelvis can be indicative of scoliosis. Increased lumbar lordosis may predispose a patient to spondylolysis.

In patients with spondylolysis, lumbar extension will usually reproduce pain, which is often unilateral. Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side. The sensitivity of the Stork test for unilateral spondylolysis is approximately 50%.³² (For more information on the Stork test, see www.physio-pedia.com/Stork_test.)

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain. Lumbar flexion with concomitant radicular pain is associated with disc pathology.⁸ Pain with a straight-leg raise is also associated with disk pathology, especially if raising the contralateral leg increases pain.⁸

Using a scoliometer. Evaluate the flexed spine for the presence of asymmetry, which can indicate scoliosis.³³ If asymmetry is present, use a scoliometer to determine the degree of asymmetry. Zero to 5° is considered clinically insignificant; monitor and reevaluate these patients at subsequent visits.^34,35 Ten degrees or more of asymmetry with a scoliometer should prompt you to order radiographs.^35,36 A smartphone-based scoliometer for iPhones was evaluated in 1 study and was shown to have reasonable reliability and validity for clinical use.³⁷

Deformity of the lower extremities. Because low back pain may be caused by biomechanical or structural deformity of the lower extremities, examine the flexibility of the hip flexors, gluteal musculature, hamstrings, and the iliotibial band.³⁸ In addition, evaluate for leg-length discrepancy and lower-extremity malalignment, such as femoral anteversion, tibial torsion, or pes planus.

Continue to: Imaging

Imaging: Know when it’s needed

Although imaging of the lumbar spine is often unnecessary in the presence of acute low back pain in children, always consider imaging in the setting of bony tenderness, pain that wakes a patient from sleep, and in the setting of other red flag symptoms (see TABLE 2). Low back pain in children that is reproducible with lumbar extension is concerning for spondylolysis or spondylolisthesis. If the pain with extension persists beyond 3 to 6 weeks, order imaging starting with radiographs.^2,39

Traditionally, 4 views of the spine—­anteroposterior (AP), lateral, and oblique (one right and one left)—were obtained, but recent evidence indicates that 2 views (AP and lateral) have similar sensitivity and specificity to 4 views with significantly reduced radiation exposure.^2,39 Because the sensitivity of plain films is relatively low, consider more advanced imaging if spondylolysis or spondylolisthesis is strongly suspected. Recent studies indicate that magnetic resonance imaging (MRI) may be as effective as computed tomography (CT) or bone scan and has the advantage of lower radiation (FIGURE 1).^2,22

Similarly, order radiographs if there is > 10° of asymmetry noted on physical exam using a scoliometer.^15,23 Calculate the Cobb angle to determine the severity of scoliosis. Refer patients with angles ≥ 20° to a pediatric orthopedist for monitoring of progression and consideration of bracing (FIGURE 2).^23,34 For patients with curvatures between 10° and 19°, repeat imaging every 6 to 12 months. Because scoliosis is a risk factor for spondylolysis, evaluate radiographs in the setting of painful scoliosis for the presence of a spondylolysis.^34,35

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain.

If excessive kyphosis is noted on exam, order radiographs to evaluate for Scheuermann disease. Classic imaging findings include Schmorl nodes, vertebral endplate changes, and anterior wedging (FIGURE 3).^17,18

In the absence of the above concerns, defer imaging of the lumbar spine until after adequate rest and rehabilitation have been attempted.

Continue to: Treatment typically involves restor physical therapy

Most cases of low back pain in children and adolescents are benign and self-limited. Many children with low back pain can be treated with relative rest from the offending activity. For children with more persistent pain, physical therapy (PT) is often indicated. Similar to that for adults, there is little evidence for specific PT programs to help children with low back pain. Rehabilitation should be individualized based on the condition being treated.

Medications. There have been no high-quality studies on the benefit of medications to treat low back pain in children. Studies have shown nonsteroidal anti-inflammatory drugs (NSAIDs) have value in adults, and they are likely safe for use in children,⁴⁰ but the risk of opiate abuse is significantly increased in adolescents who have been prescribed opiate pain medication prior to 12th grade.⁴¹

Lumbar disc herniation. Although still relatively rare, lumbar disc herniation is more common in older children and adolescents than in younger children and is treated similarly to that in adults.⁸ Range-of-motion exercise to restore lumbar motion is often first-line treatment. Research has shown that exercises that strengthen the abdominal or “core” musculature help prevent the return of low back pain.^24,25

In the case of spondylolysis or spondylolisthesis, rest from activity is generally required for a minimum of 4 to 6 weeks. Rehabilitation in the form of range of motion, especially into the lumbar extension, and spinal stabilization exercises are effective for both reducing pain and restoring range-­of-motion and strength.⁴² Have patients avoid heavy backpacks, which can reproduce pain. Children often benefit from leaving a second set of schoolbooks at home. For most patients with spondylolysis, conservative treatment with rehabilitation is equal to or better than surgical intervention in returning the patient to his/her pre-injury activity level.^26,43,44 When returning athletes to their sport, aggressive PT, defined as rest for < 10 weeks prior to initiating PT, is superior to delaying PT beyond 10 weeks of rest.²⁷

Idiopathic scoliosis. Much of the literature on the treatment of scoliosis is focused on limiting progression of the scoliotic curvature. Researchers thought that more severe curves were associated with more severe pain, but a recent systematic review showed that back pain can occur in patients with even small curvatures.²⁸ Treatment for patients with smaller degrees of curvature is similar to that for mechanical low back pain. PT may have a role in the treatment of scoliosis, but there is little evidence in the literature of its effectiveness.

Continue to: A Cochrane review showed...

Always consider imaging in the setting of bony tenderness, pain that wakes the patient from sleep, and when there is > 10° of asymmetry on physical exam using a scoliometer.

A Cochrane review showed that PT and exercise-based treatments had no effect on back pain or disability in patients with scoliosis.²⁹ And outpatient PT alone, in the absence of bracing, does not arrest progression of the scoliotic curvature.³⁵ One trial did demonstrate that an intensive inpatient treatment program of 4 to 6 weeks for patients with curvature of at least 40° reduced progression of curvature compared to an untreated control group at 1 year.³⁴ The outcomes of functional mobility and pain were not measured. Follow-up data on curve progression beyond 1 year are not available. Unfortunately, intensive inpatient treatment is not readily available or cost-effective for most patients with scoliosis.

Scheuermann disease. The mainstay of treatment for mild Scheuermann disease is advising the patient to avoid repetitive loading of the spine. Patients should avoid sports such as competitive weight-lifting, gymnastics, and football. Lower impact athletics are encouraged. Refer patients with pain to PT to address posture and core stabilization. Patients with severe kyphosis may require surgery.^17,18

Bracing: Rarely helpful for low back pain

The use of lumbar braces or corsets is rarely helpful for low back pain in children. Bracing in the setting of spondylolysis is controversial.One study indicated that bracing in combination with activity restriction and lumbar extension exercise is superior to activity restriction and lumbar flexion exercises alone.⁴³ But a meta-analysis did not demonstrate a significant difference in recovery when bracing was added.⁴⁴ Bracing may help to reduce pain initially in patients with spondylolysis who have pain at rest. Bracing is not recommended for patients with pain that abates with activity modification.

Scoliosis and Scheuermann kyphosis. Treatment of adolescent idiopathic scoliosis usually consists of observation and periodic reevaluation. Bracing is a mainstay of the nonsurgical management of scoliosis and is appropriate for curves of 20° to 40°; studies have reported successful control of curve progression in > 70% of patients.³⁶ According to 1 study, the number of cases of scoliosis needed to treat with bracing to prevent 1 surgery is 3.³⁰ Surgery is often indicated for patients with curvatures > 40°, although this is also debated.³³

Bracing is used rarely for Scheuermann kyphosis but may be helpful in more severe or painful cases.¹⁷

CORRESPONDENCE
Shawn F. Phillips, MD, MSPT, 500 University Drive H154, Hershey, PA, 17033; [email protected].

Thanks to Dr. Linn et al for “Tips and tools for safe opioid prescribing” (J Fam Pract. 2020;69:280-292), which addressed an important topic: the risks of, and poor evidence for, chronic opioids in noncancer pain.

We should not be starting people on opioids for knee and back pain.

Pain management is challenging, and it is easy to prescribe opioids from a desire to help. However, we must translate the evidence of chronic opioids’ poor benefit and real harms into practice. No studies show a long-term benefit of opioids for chronic noncancer pain, but they do demonstrate abundant findings of harm. As a family medicine community, we should be practicing at the highest level of evidence and addressing legacy opioid prescribing for chronic noncancer pain.

Increasing opioid doses for pain only offers short-term benefits and can result in rapid tolerance and withdrawal. We should not be starting people on opioids for knee and back pain. We do not need more ways to initiate opioids or tables on how to dose long-acting opioids—drugs that increase mortality.¹ Let’s stop using poorly validated tools like DIRE to ignore the evidence against opioids (validated with 61 retrospective chart reviews; 81% sensitivity, 76% specificity for predicting efficacy of opioids).^2,3

A 2018 randomized controlled trial of 240 patients with back, knee, or hip osteoarthritis found opioids were not superior to nonopioid medication for pain-related function at 12 months and had more adverse effects.⁴ A 2015 systematic review concluded there was insufficient evidence of long-term benefits of opioids but a dose-dependent risk of serious harm.⁵ Just 1 year of taking low-dose opioids can increase the risk of opioid use disorder by 0.7%, compared with 0.004% with no opioids.⁵

Practical approaches exist. Excellent examples of modern pain care have been developed by the Department of Veterans Affairs/Department of Defense, the Department of Health and Human Services, and state-level initiatives such as the Oregon Pain Guidance.^6-8 All use a similar clinical algorithm (FIGURE). If pain is poorly controlled, a slow medically supervised tapering of opioids is indicated.

Start the pain management conversation by saying: “I’ve been thinking a lot about your chronic pain and how best to help you with it. I worry that opioids are causing more harm than good now.”

It can be challenging to raise the subject of opioid tapering with patients; I use Stanford’s BRAVO method to guide these conversations.^9,10 At my facility, we are tapering about 50 legacy opioid patients, and most are surprised to find that their pain is the same or better with reduced to no opioids, with fewer adverse effects. Many are happier on sublingual buprenorphine, a safer opioid analgesic.¹¹ The algorithm shown in the FIGURE and the BRAVO method should be more widely used within our specialty for a safe and patient-centered approach to chronic pain. 

Above all, let the patient know that you are with them on this journey to safe pain management. Start the conversation: “I’ve been thinking a lot about your chronic pain and how best to help you with it. Our understanding of what opioids do for pain has changed, and I worry they’re causing more harm than good now. This is a scary thing to talk about, but I’ll be with you every step of the way.”

Matt Perez, MD
Neighborcare Health
Seattle

Thanks to Dr. Linn et al for “Tips and tools for safe opioid prescribing” (J Fam Pract. 2020;69:280-292), which addressed an important topic: the risks of, and poor evidence for, chronic opioids in noncancer pain.

We should not be starting people on opioids for knee and back pain.

Pain management is challenging, and it is easy to prescribe opioids from a desire to help. However, we must translate the evidence of chronic opioids’ poor benefit and real harms into practice. No studies show a long-term benefit of opioids for chronic noncancer pain, but they do demonstrate abundant findings of harm. As a family medicine community, we should be practicing at the highest level of evidence and addressing legacy opioid prescribing for chronic noncancer pain.

Increasing opioid doses for pain only offers short-term benefits and can result in rapid tolerance and withdrawal. We should not be starting people on opioids for knee and back pain. We do not need more ways to initiate opioids or tables on how to dose long-acting opioids—drugs that increase mortality.¹ Let’s stop using poorly validated tools like DIRE to ignore the evidence against opioids (validated with 61 retrospective chart reviews; 81% sensitivity, 76% specificity for predicting efficacy of opioids).^2,3

A 2018 randomized controlled trial of 240 patients with back, knee, or hip osteoarthritis found opioids were not superior to nonopioid medication for pain-related function at 12 months and had more adverse effects.⁴ A 2015 systematic review concluded there was insufficient evidence of long-term benefits of opioids but a dose-dependent risk of serious harm.⁵ Just 1 year of taking low-dose opioids can increase the risk of opioid use disorder by 0.7%, compared with 0.004% with no opioids.⁵

Practical approaches exist. Excellent examples of modern pain care have been developed by the Department of Veterans Affairs/Department of Defense, the Department of Health and Human Services, and state-level initiatives such as the Oregon Pain Guidance.^6-8 All use a similar clinical algorithm (FIGURE). If pain is poorly controlled, a slow medically supervised tapering of opioids is indicated.

Start the pain management conversation by saying: “I’ve been thinking a lot about your chronic pain and how best to help you with it. I worry that opioids are causing more harm than good now.”

It can be challenging to raise the subject of opioid tapering with patients; I use Stanford’s BRAVO method to guide these conversations.^9,10 At my facility, we are tapering about 50 legacy opioid patients, and most are surprised to find that their pain is the same or better with reduced to no opioids, with fewer adverse effects. Many are happier on sublingual buprenorphine, a safer opioid analgesic.¹¹ The algorithm shown in the FIGURE and the BRAVO method should be more widely used within our specialty for a safe and patient-centered approach to chronic pain. 

Above all, let the patient know that you are with them on this journey to safe pain management. Start the conversation: “I’ve been thinking a lot about your chronic pain and how best to help you with it. Our understanding of what opioids do for pain has changed, and I worry they’re causing more harm than good now. This is a scary thing to talk about, but I’ll be with you every step of the way.”

Matt Perez, MD
Neighborcare Health
Seattle

Thanks to Dr. Linn et al for “Tips and tools for safe opioid prescribing” (J Fam Pract. 2020;69:280-292), which addressed an important topic: the risks of, and poor evidence for, chronic opioids in noncancer pain.

We should not be starting people on opioids for knee and back pain.

Pain management is challenging, and it is easy to prescribe opioids from a desire to help. However, we must translate the evidence of chronic opioids’ poor benefit and real harms into practice. No studies show a long-term benefit of opioids for chronic noncancer pain, but they do demonstrate abundant findings of harm. As a family medicine community, we should be practicing at the highest level of evidence and addressing legacy opioid prescribing for chronic noncancer pain.

Increasing opioid doses for pain only offers short-term benefits and can result in rapid tolerance and withdrawal. We should not be starting people on opioids for knee and back pain. We do not need more ways to initiate opioids or tables on how to dose long-acting opioids—drugs that increase mortality.¹ Let’s stop using poorly validated tools like DIRE to ignore the evidence against opioids (validated with 61 retrospective chart reviews; 81% sensitivity, 76% specificity for predicting efficacy of opioids).^2,3

A 2018 randomized controlled trial of 240 patients with back, knee, or hip osteoarthritis found opioids were not superior to nonopioid medication for pain-related function at 12 months and had more adverse effects.⁴ A 2015 systematic review concluded there was insufficient evidence of long-term benefits of opioids but a dose-dependent risk of serious harm.⁵ Just 1 year of taking low-dose opioids can increase the risk of opioid use disorder by 0.7%, compared with 0.004% with no opioids.⁵

Practical approaches exist. Excellent examples of modern pain care have been developed by the Department of Veterans Affairs/Department of Defense, the Department of Health and Human Services, and state-level initiatives such as the Oregon Pain Guidance.^6-8 All use a similar clinical algorithm (FIGURE). If pain is poorly controlled, a slow medically supervised tapering of opioids is indicated.

Start the pain management conversation by saying: “I’ve been thinking a lot about your chronic pain and how best to help you with it. I worry that opioids are causing more harm than good now.”

It can be challenging to raise the subject of opioid tapering with patients; I use Stanford’s BRAVO method to guide these conversations.^9,10 At my facility, we are tapering about 50 legacy opioid patients, and most are surprised to find that their pain is the same or better with reduced to no opioids, with fewer adverse effects. Many are happier on sublingual buprenorphine, a safer opioid analgesic.¹¹ The algorithm shown in the FIGURE and the BRAVO method should be more widely used within our specialty for a safe and patient-centered approach to chronic pain. 

Above all, let the patient know that you are with them on this journey to safe pain management. Start the conversation: “I’ve been thinking a lot about your chronic pain and how best to help you with it. Our understanding of what opioids do for pain has changed, and I worry they’re causing more harm than good now. This is a scary thing to talk about, but I’ll be with you every step of the way.”

Matt Perez, MD
Neighborcare Health
Seattle

When medical care is based on consistent, good-quality evidence, most physicians adopt it. However, not all care is well supported by the literature and may, in fact, be overused without offering benefit to patients. Choosing Wisely, at www.choosingwisely.org, is a health care initiative that highlights screening and testing recommendations from specialty societies in an effort to encourage patients and clinicians to talk about how to make high-value, effective health care decisions and avoid overuse. (See “Test and Tx overutilization: A bigger problem than you might think"^1-3).

Enabling physician and patient dialogue. The initiative began in 2010 when the American Board of Internal Medicine convened a panel of experts to identify low-value tests and therapies. Their list took the form of a “Top Five Things” that may not be high value in patient care, and it used language tailored to patients and physicians so that they could converse meaningfully. Physicians could use the evidence to make a clinical decision, and patients could feel empowered to ask informed questions about recommendations they received. The initiative has now expanded to include ways that health care systems can reduce low-value interventions.

Scope of participation. Since the first Choosing Wisely recommendations were published in 2013, more than 80 professional associations have contributed lists of their own. Professional societies participate voluntarily. The American Academy of Family Physicians (AAFP), Society of General Internal Medicine, and American Academy of Pediatrics (AAP) have contributed lists relevant to primary care. All Choosing Wisely recommendations can be searched or sorted by specialty organization. Recommendations are reviewed and revised regularly. If the evidence becomes conflicted or contradictory, recommendations are withdrawn.

Making meaningful improvements by Choosing Wisely

Several studies have shown that health care systems can implement Choosing Wisely recommendations to reduce overuse of unnecessary tests. A 2015 study examined the effect of applying a Choosing Wisely recommendation to reduce the use of continuous pulse oximetry in pediatric inpatients with asthma, wheezing, or bronchiolitis. The recommendation, from the Society of Hospital Medicine–Pediatric Hospital Medicine, advises against continuous pulse oximetry in children with acute respiratory illnesses unless the child is using supplemental oxygen.⁴ This study, done at the Cincinnati Children’s Hospital Medical Center, found that within 3 months of initiating a protocol on all general pediatrics floors, the average time on pulse oximetry after meeting clinical goals decreased from 10.7 hours to 3.1 hours. In addition, the percentage of patients who had their continuous pulse oximetry stopped within 2 hours of clinical stability (a goal time) increased from 25% to 46%.⁵

Patients are important drivers of health care utilization. A 2003 study showed that physicians are more likely to order referrals, tests, and prescriptions when patients ask for them, and that nearly 1 in 4 patients did so.⁶ A 2002 study found that physicians granted all but 3% of patient’s requests for orders or tests, and that fulfilling requests correlated with patient satisfaction in the specialty office studied (cardiology) but not in the primary care (internal medicine) office.⁷

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidencebased advice from a specialty society to its members and to patients about care that is often unnecessary.

From its inception, Choosing Wisely has considered patients as full partners in conversations about health care utilization. Choosing Wisely partners with Consumer Reports to create and disseminate plain-language summaries of recommendations. Community groups and physician organizations have also participated in implementation efforts. In 2018, Choosing Wisely secured a grant to expand outreach to diverse or underserved communities.

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidence-based advice from a specialty society to its members and to patients about care that is often unnecessary. The goal is to create a conversation and not to eliminate these services from ever being offered or used.

Continue to: Improve your practice with these 10 primary care recommendations

Improve your practice with these 10 primary care recommendations

 1 Avoid imaging studies in early acute low back pain without red flags.

Both the AAFP and the American Society of Anesthesiologists recommend against routine X-rays, magnetic resonance imaging, and computed tomography (CT) scans in the first 6 weeks of acute low back pain (LBP).^8,9 The American College of Emergency Physicians (ACEP) recommends against routine lumbar spine imaging for emergency department (ED) patients.¹⁰ In all cases, imaging is indicated if the patient has any signs or symptoms of neurologic deficits or other indications, such as signs of spinal infection or fracture. However, as ACEP notes, diagnostic imaging does not typically help identify the cause of acute LBP, and when it does, it does not reduce the time to symptom improvement.¹⁰

2 Prescribe oral contraceptives on the basis of a medical history and a blood pressure measurement. No routine pelvic exam or other physical exam is necessary.

This AAFP recommendation¹¹ is based on clinical practice guidelines from the American College of Obstetricians and Gynecologists (ACOG) and other research.¹² The ACOG practice guideline supports provision of hormonal contraception without a pelvic exam, cervical cancer (Pap) testing, urine pregnancy testing, or testing for sexually transmitted infections. ACOG guidelines also support over-the-counter provision of hormonal contraceptives, including combined oral contraceptives.¹²

3 Stop recommending daily self-glucose monitoring for patients with diabetes who are not using insulin.

Both the AAFP and the Society for General Internal Medicine recommend against daily blood sugar checks for people who do not use insulin.^13,14 A Cochrane review of 9 trials (3300 patients) found that after 6 months, hemoglobin A1C was reduced by 0.3% in people who checked their sugar daily compared with those who did not, but this difference was not significant after a year.¹⁵ Hypoglycemic episodes were more common in the “checking” group, and there were no differences in quality of life. A qualitative study found that blood sugar results had little impact on patients’ motivation to change behavior.¹⁶

4 Don’t screen for herpes simplex virus (HSV) infection in asymptomatic adults, even those who are pregnant.

This AAFP recommendation¹⁷ comes from a US Preventive Services Task Force (USPSTF) Grade D recommendation.18 Most people with positive HSV-2 serology have had an outbreak; even those who do not think they have had one will realize that they had the symptoms once they hear them described.18 With available tests, 1 in 2 positive results for HSV-2 among asymptomatic people will be a false-positive.¹⁸

A 2006 analysis of inpatient lab studies found that doctors ordered an average of 2.96 studies per patient per day, but only 29% of these tests contributed to management.

There is no known cure, intervention, or reduction in transmission for infected patients who do not have symptoms.¹⁸ Also, serologically detected HSV-2 does not reliably predict genital herpes; and HSV-1 has been found to cause an increasing percentage of genital infection cases.¹⁸

Continue to: 5 Don't screen for testicular cancer in asymptomatic individuals

5 Don’t screen for testicular cancer in asymptomatic individuals.

This AAFP recommendation¹⁹ also comes from a USPSTF Grade D recommendation.²⁰ A 2010 systematic review found no evidence to support screening of asymptomatic people with a physical exam or ultrasound. All available studies involved symptomatic patients.²⁰

 6 Stop recommending cough and cold medicines for children younger than 4 years.

The AAP recommends that clinicians discourage the use of any cough or cold medicine for children in this age-group.²¹ A 2008 study found that more than 7000 children annually presented to EDs for adverse events from cough and cold medicines.²² Previous studies found no benefit in reducing symptoms.²³ In children older than 12 months, a Cochrane review found that honey has a modest benefit for cough in single-night trials.²⁴

7 Avoid performing serum allergy panels.

The American Academy of Allergy, Asthma, and Immunology discourages the use of serum panel testing when patients present with allergy symptoms.²⁵ A patient can have a strong positive immunoglobulin E (IgE) serum result to an allergen and have no clinical allergic symptoms or can have a weak positive serum result and a strong clinical reaction. Targeted skin or serum IgE testing—for example, testing for cashew allergy in a patient known to have had a reaction after eating one—is reasonable.²⁶

8 Avoid routine electroencephalography (EEG), head CT, and carotid ultrasound as initial work-up for simple syncope in adults.

These recommendations, from the American Epilepsy Society,²⁷ ACEP,²⁸ American College of Physicians,²⁹ and American Academy of Neurology (AAN),³⁰ emphasize the low yield of routine work-ups for patients with simple syncope. The AAN notes that 40% of people will experience syncope during adulthood and most will not have carotid disease, which generally manifests with stroke-like symptoms rather than syncope. One study found that approximately 1 in 8 patients referred to an epilepsy clinic had neurocardiogenic syncope rather than epilepsy.³¹

EEGs have high false-negative and false-positive rates, and history-taking is a better tool with which to make a diagnosis. CT scans performed in the ED were found to contribute to the diagnosis of simple syncope in fewer than 2% of cases of syncope, compared with orthostatic blood pressure (25% of cases).³²

Continue to: 9 Wait to refer children with umbilical hernias to pediatric surgery until they are 4 to 5 years of age

The AAP Section on Surgery offers evidence that the risk-benefit analysis strongly favors waiting on intervention.³³ About 1 in 4 children will have an umbilical hernia, and about 85% of cases will resolve by age 5. The strangulation rate with umbilical hernias is very low, and although the risk of infection with surgery is likewise low, the risk of recurrence following surgery before the age of 4 is as high as 2.4%.³⁴ The AAP Section on Surgery recommends against strapping or restraining the hernia, as well.

10 Avoid using appetite stimulants, such as megesterol, and high-calorie nutritional supplements to treat anorexia and cachexia in older adults.

Instead, the American Geriatrics Society recommends that physicians encourage caregivers to serve appealing food, provide support with eating, and remove barriers to appetite and nutrition.³⁵ A Cochrane review showed that high-calorie supplements, such as Boost or Ensure, are associated with very modest weight gain—about 2% of weight—but are not associated with an increased life expectancy or improved quality of life.³⁶

Both the AAFP and the American Society of Anesthesiologists recommend against routine x-rays, MRIs, and CT scans during the first 6 weeks of acute low back pain.

Prescription appetite stimulants are associated with adverse effects and yield inconsistent benefits in older adults. Megesterol, for example, was associated with headache, gastrointestinal adverse effects, insomnia, weakness, and fatigue. Mirtazapine is associated with sedation and fatigue.³⁷

CORRESPONDENCE
Kathleen Rowland, MD, MS, Rush Copley Family Medicine Residency, Rush Medical College, 600 South Paulina, Kidston House Room 605, Chicago IL 60612; [email protected].

When medical care is based on consistent, good-quality evidence, most physicians adopt it. However, not all care is well supported by the literature and may, in fact, be overused without offering benefit to patients. Choosing Wisely, at www.choosingwisely.org, is a health care initiative that highlights screening and testing recommendations from specialty societies in an effort to encourage patients and clinicians to talk about how to make high-value, effective health care decisions and avoid overuse. (See “Test and Tx overutilization: A bigger problem than you might think"^1-3).

Enabling physician and patient dialogue. The initiative began in 2010 when the American Board of Internal Medicine convened a panel of experts to identify low-value tests and therapies. Their list took the form of a “Top Five Things” that may not be high value in patient care, and it used language tailored to patients and physicians so that they could converse meaningfully. Physicians could use the evidence to make a clinical decision, and patients could feel empowered to ask informed questions about recommendations they received. The initiative has now expanded to include ways that health care systems can reduce low-value interventions.

Scope of participation. Since the first Choosing Wisely recommendations were published in 2013, more than 80 professional associations have contributed lists of their own. Professional societies participate voluntarily. The American Academy of Family Physicians (AAFP), Society of General Internal Medicine, and American Academy of Pediatrics (AAP) have contributed lists relevant to primary care. All Choosing Wisely recommendations can be searched or sorted by specialty organization. Recommendations are reviewed and revised regularly. If the evidence becomes conflicted or contradictory, recommendations are withdrawn.

Making meaningful improvements by Choosing Wisely

Several studies have shown that health care systems can implement Choosing Wisely recommendations to reduce overuse of unnecessary tests. A 2015 study examined the effect of applying a Choosing Wisely recommendation to reduce the use of continuous pulse oximetry in pediatric inpatients with asthma, wheezing, or bronchiolitis. The recommendation, from the Society of Hospital Medicine–Pediatric Hospital Medicine, advises against continuous pulse oximetry in children with acute respiratory illnesses unless the child is using supplemental oxygen.⁴ This study, done at the Cincinnati Children’s Hospital Medical Center, found that within 3 months of initiating a protocol on all general pediatrics floors, the average time on pulse oximetry after meeting clinical goals decreased from 10.7 hours to 3.1 hours. In addition, the percentage of patients who had their continuous pulse oximetry stopped within 2 hours of clinical stability (a goal time) increased from 25% to 46%.⁵

Patients are important drivers of health care utilization. A 2003 study showed that physicians are more likely to order referrals, tests, and prescriptions when patients ask for them, and that nearly 1 in 4 patients did so.⁶ A 2002 study found that physicians granted all but 3% of patient’s requests for orders or tests, and that fulfilling requests correlated with patient satisfaction in the specialty office studied (cardiology) but not in the primary care (internal medicine) office.⁷

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidencebased advice from a specialty society to its members and to patients about care that is often unnecessary.

From its inception, Choosing Wisely has considered patients as full partners in conversations about health care utilization. Choosing Wisely partners with Consumer Reports to create and disseminate plain-language summaries of recommendations. Community groups and physician organizations have also participated in implementation efforts. In 2018, Choosing Wisely secured a grant to expand outreach to diverse or underserved communities.

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidence-based advice from a specialty society to its members and to patients about care that is often unnecessary. The goal is to create a conversation and not to eliminate these services from ever being offered or used.

Continue to: Improve your practice with these 10 primary care recommendations

Improve your practice with these 10 primary care recommendations

 1 Avoid imaging studies in early acute low back pain without red flags.

Both the AAFP and the American Society of Anesthesiologists recommend against routine X-rays, magnetic resonance imaging, and computed tomography (CT) scans in the first 6 weeks of acute low back pain (LBP).^8,9 The American College of Emergency Physicians (ACEP) recommends against routine lumbar spine imaging for emergency department (ED) patients.¹⁰ In all cases, imaging is indicated if the patient has any signs or symptoms of neurologic deficits or other indications, such as signs of spinal infection or fracture. However, as ACEP notes, diagnostic imaging does not typically help identify the cause of acute LBP, and when it does, it does not reduce the time to symptom improvement.¹⁰

2 Prescribe oral contraceptives on the basis of a medical history and a blood pressure measurement. No routine pelvic exam or other physical exam is necessary.

This AAFP recommendation¹¹ is based on clinical practice guidelines from the American College of Obstetricians and Gynecologists (ACOG) and other research.¹² The ACOG practice guideline supports provision of hormonal contraception without a pelvic exam, cervical cancer (Pap) testing, urine pregnancy testing, or testing for sexually transmitted infections. ACOG guidelines also support over-the-counter provision of hormonal contraceptives, including combined oral contraceptives.¹²

3 Stop recommending daily self-glucose monitoring for patients with diabetes who are not using insulin.

Both the AAFP and the Society for General Internal Medicine recommend against daily blood sugar checks for people who do not use insulin.^13,14 A Cochrane review of 9 trials (3300 patients) found that after 6 months, hemoglobin A1C was reduced by 0.3% in people who checked their sugar daily compared with those who did not, but this difference was not significant after a year.¹⁵ Hypoglycemic episodes were more common in the “checking” group, and there were no differences in quality of life. A qualitative study found that blood sugar results had little impact on patients’ motivation to change behavior.¹⁶

4 Don’t screen for herpes simplex virus (HSV) infection in asymptomatic adults, even those who are pregnant.

This AAFP recommendation¹⁷ comes from a US Preventive Services Task Force (USPSTF) Grade D recommendation.18 Most people with positive HSV-2 serology have had an outbreak; even those who do not think they have had one will realize that they had the symptoms once they hear them described.18 With available tests, 1 in 2 positive results for HSV-2 among asymptomatic people will be a false-positive.¹⁸

A 2006 analysis of inpatient lab studies found that doctors ordered an average of 2.96 studies per patient per day, but only 29% of these tests contributed to management.

There is no known cure, intervention, or reduction in transmission for infected patients who do not have symptoms.¹⁸ Also, serologically detected HSV-2 does not reliably predict genital herpes; and HSV-1 has been found to cause an increasing percentage of genital infection cases.¹⁸

Continue to: 5 Don't screen for testicular cancer in asymptomatic individuals

5 Don’t screen for testicular cancer in asymptomatic individuals.

This AAFP recommendation¹⁹ also comes from a USPSTF Grade D recommendation.²⁰ A 2010 systematic review found no evidence to support screening of asymptomatic people with a physical exam or ultrasound. All available studies involved symptomatic patients.²⁰

 6 Stop recommending cough and cold medicines for children younger than 4 years.

The AAP recommends that clinicians discourage the use of any cough or cold medicine for children in this age-group.²¹ A 2008 study found that more than 7000 children annually presented to EDs for adverse events from cough and cold medicines.²² Previous studies found no benefit in reducing symptoms.²³ In children older than 12 months, a Cochrane review found that honey has a modest benefit for cough in single-night trials.²⁴

7 Avoid performing serum allergy panels.

The American Academy of Allergy, Asthma, and Immunology discourages the use of serum panel testing when patients present with allergy symptoms.²⁵ A patient can have a strong positive immunoglobulin E (IgE) serum result to an allergen and have no clinical allergic symptoms or can have a weak positive serum result and a strong clinical reaction. Targeted skin or serum IgE testing—for example, testing for cashew allergy in a patient known to have had a reaction after eating one—is reasonable.²⁶

8 Avoid routine electroencephalography (EEG), head CT, and carotid ultrasound as initial work-up for simple syncope in adults.

These recommendations, from the American Epilepsy Society,²⁷ ACEP,²⁸ American College of Physicians,²⁹ and American Academy of Neurology (AAN),³⁰ emphasize the low yield of routine work-ups for patients with simple syncope. The AAN notes that 40% of people will experience syncope during adulthood and most will not have carotid disease, which generally manifests with stroke-like symptoms rather than syncope. One study found that approximately 1 in 8 patients referred to an epilepsy clinic had neurocardiogenic syncope rather than epilepsy.³¹

EEGs have high false-negative and false-positive rates, and history-taking is a better tool with which to make a diagnosis. CT scans performed in the ED were found to contribute to the diagnosis of simple syncope in fewer than 2% of cases of syncope, compared with orthostatic blood pressure (25% of cases).³²

Continue to: 9 Wait to refer children with umbilical hernias to pediatric surgery until they are 4 to 5 years of age

The AAP Section on Surgery offers evidence that the risk-benefit analysis strongly favors waiting on intervention.³³ About 1 in 4 children will have an umbilical hernia, and about 85% of cases will resolve by age 5. The strangulation rate with umbilical hernias is very low, and although the risk of infection with surgery is likewise low, the risk of recurrence following surgery before the age of 4 is as high as 2.4%.³⁴ The AAP Section on Surgery recommends against strapping or restraining the hernia, as well.

10 Avoid using appetite stimulants, such as megesterol, and high-calorie nutritional supplements to treat anorexia and cachexia in older adults.

Instead, the American Geriatrics Society recommends that physicians encourage caregivers to serve appealing food, provide support with eating, and remove barriers to appetite and nutrition.³⁵ A Cochrane review showed that high-calorie supplements, such as Boost or Ensure, are associated with very modest weight gain—about 2% of weight—but are not associated with an increased life expectancy or improved quality of life.³⁶

Both the AAFP and the American Society of Anesthesiologists recommend against routine x-rays, MRIs, and CT scans during the first 6 weeks of acute low back pain.

Prescription appetite stimulants are associated with adverse effects and yield inconsistent benefits in older adults. Megesterol, for example, was associated with headache, gastrointestinal adverse effects, insomnia, weakness, and fatigue. Mirtazapine is associated with sedation and fatigue.³⁷

CORRESPONDENCE
Kathleen Rowland, MD, MS, Rush Copley Family Medicine Residency, Rush Medical College, 600 South Paulina, Kidston House Room 605, Chicago IL 60612; [email protected].

When medical care is based on consistent, good-quality evidence, most physicians adopt it. However, not all care is well supported by the literature and may, in fact, be overused without offering benefit to patients. Choosing Wisely, at www.choosingwisely.org, is a health care initiative that highlights screening and testing recommendations from specialty societies in an effort to encourage patients and clinicians to talk about how to make high-value, effective health care decisions and avoid overuse. (See “Test and Tx overutilization: A bigger problem than you might think"^1-3).

Enabling physician and patient dialogue. The initiative began in 2010 when the American Board of Internal Medicine convened a panel of experts to identify low-value tests and therapies. Their list took the form of a “Top Five Things” that may not be high value in patient care, and it used language tailored to patients and physicians so that they could converse meaningfully. Physicians could use the evidence to make a clinical decision, and patients could feel empowered to ask informed questions about recommendations they received. The initiative has now expanded to include ways that health care systems can reduce low-value interventions.

Scope of participation. Since the first Choosing Wisely recommendations were published in 2013, more than 80 professional associations have contributed lists of their own. Professional societies participate voluntarily. The American Academy of Family Physicians (AAFP), Society of General Internal Medicine, and American Academy of Pediatrics (AAP) have contributed lists relevant to primary care. All Choosing Wisely recommendations can be searched or sorted by specialty organization. Recommendations are reviewed and revised regularly. If the evidence becomes conflicted or contradictory, recommendations are withdrawn.

Making meaningful improvements by Choosing Wisely

Several studies have shown that health care systems can implement Choosing Wisely recommendations to reduce overuse of unnecessary tests. A 2015 study examined the effect of applying a Choosing Wisely recommendation to reduce the use of continuous pulse oximetry in pediatric inpatients with asthma, wheezing, or bronchiolitis. The recommendation, from the Society of Hospital Medicine–Pediatric Hospital Medicine, advises against continuous pulse oximetry in children with acute respiratory illnesses unless the child is using supplemental oxygen.⁴ This study, done at the Cincinnati Children’s Hospital Medical Center, found that within 3 months of initiating a protocol on all general pediatrics floors, the average time on pulse oximetry after meeting clinical goals decreased from 10.7 hours to 3.1 hours. In addition, the percentage of patients who had their continuous pulse oximetry stopped within 2 hours of clinical stability (a goal time) increased from 25% to 46%.⁵

Patients are important drivers of health care utilization. A 2003 study showed that physicians are more likely to order referrals, tests, and prescriptions when patients ask for them, and that nearly 1 in 4 patients did so.⁶ A 2002 study found that physicians granted all but 3% of patient’s requests for orders or tests, and that fulfilling requests correlated with patient satisfaction in the specialty office studied (cardiology) but not in the primary care (internal medicine) office.⁷

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidencebased advice from a specialty society to its members and to patients about care that is often unnecessary.

From its inception, Choosing Wisely has considered patients as full partners in conversations about health care utilization. Choosing Wisely partners with Consumer Reports to create and disseminate plain-language summaries of recommendations. Community groups and physician organizations have also participated in implementation efforts. In 2018, Choosing Wisely secured a grant to expand outreach to diverse or underserved communities.

Choosing Wisely recommendations are not guidelines or mandates. They are intended to be evidence-based advice from a specialty society to its members and to patients about care that is often unnecessary. The goal is to create a conversation and not to eliminate these services from ever being offered or used.

Continue to: Improve your practice with these 10 primary care recommendations

Improve your practice with these 10 primary care recommendations

 1 Avoid imaging studies in early acute low back pain without red flags.

Both the AAFP and the American Society of Anesthesiologists recommend against routine X-rays, magnetic resonance imaging, and computed tomography (CT) scans in the first 6 weeks of acute low back pain (LBP).^8,9 The American College of Emergency Physicians (ACEP) recommends against routine lumbar spine imaging for emergency department (ED) patients.¹⁰ In all cases, imaging is indicated if the patient has any signs or symptoms of neurologic deficits or other indications, such as signs of spinal infection or fracture. However, as ACEP notes, diagnostic imaging does not typically help identify the cause of acute LBP, and when it does, it does not reduce the time to symptom improvement.¹⁰

2 Prescribe oral contraceptives on the basis of a medical history and a blood pressure measurement. No routine pelvic exam or other physical exam is necessary.

This AAFP recommendation¹¹ is based on clinical practice guidelines from the American College of Obstetricians and Gynecologists (ACOG) and other research.¹² The ACOG practice guideline supports provision of hormonal contraception without a pelvic exam, cervical cancer (Pap) testing, urine pregnancy testing, or testing for sexually transmitted infections. ACOG guidelines also support over-the-counter provision of hormonal contraceptives, including combined oral contraceptives.¹²

3 Stop recommending daily self-glucose monitoring for patients with diabetes who are not using insulin.

Both the AAFP and the Society for General Internal Medicine recommend against daily blood sugar checks for people who do not use insulin.^13,14 A Cochrane review of 9 trials (3300 patients) found that after 6 months, hemoglobin A1C was reduced by 0.3% in people who checked their sugar daily compared with those who did not, but this difference was not significant after a year.¹⁵ Hypoglycemic episodes were more common in the “checking” group, and there were no differences in quality of life. A qualitative study found that blood sugar results had little impact on patients’ motivation to change behavior.¹⁶

4 Don’t screen for herpes simplex virus (HSV) infection in asymptomatic adults, even those who are pregnant.

This AAFP recommendation¹⁷ comes from a US Preventive Services Task Force (USPSTF) Grade D recommendation.18 Most people with positive HSV-2 serology have had an outbreak; even those who do not think they have had one will realize that they had the symptoms once they hear them described.18 With available tests, 1 in 2 positive results for HSV-2 among asymptomatic people will be a false-positive.¹⁸

A 2006 analysis of inpatient lab studies found that doctors ordered an average of 2.96 studies per patient per day, but only 29% of these tests contributed to management.

There is no known cure, intervention, or reduction in transmission for infected patients who do not have symptoms.¹⁸ Also, serologically detected HSV-2 does not reliably predict genital herpes; and HSV-1 has been found to cause an increasing percentage of genital infection cases.¹⁸

Continue to: 5 Don't screen for testicular cancer in asymptomatic individuals

5 Don’t screen for testicular cancer in asymptomatic individuals.

This AAFP recommendation¹⁹ also comes from a USPSTF Grade D recommendation.²⁰ A 2010 systematic review found no evidence to support screening of asymptomatic people with a physical exam or ultrasound. All available studies involved symptomatic patients.²⁰

 6 Stop recommending cough and cold medicines for children younger than 4 years.

The AAP recommends that clinicians discourage the use of any cough or cold medicine for children in this age-group.²¹ A 2008 study found that more than 7000 children annually presented to EDs for adverse events from cough and cold medicines.²² Previous studies found no benefit in reducing symptoms.²³ In children older than 12 months, a Cochrane review found that honey has a modest benefit for cough in single-night trials.²⁴

7 Avoid performing serum allergy panels.

The American Academy of Allergy, Asthma, and Immunology discourages the use of serum panel testing when patients present with allergy symptoms.²⁵ A patient can have a strong positive immunoglobulin E (IgE) serum result to an allergen and have no clinical allergic symptoms or can have a weak positive serum result and a strong clinical reaction. Targeted skin or serum IgE testing—for example, testing for cashew allergy in a patient known to have had a reaction after eating one—is reasonable.²⁶

8 Avoid routine electroencephalography (EEG), head CT, and carotid ultrasound as initial work-up for simple syncope in adults.

These recommendations, from the American Epilepsy Society,²⁷ ACEP,²⁸ American College of Physicians,²⁹ and American Academy of Neurology (AAN),³⁰ emphasize the low yield of routine work-ups for patients with simple syncope. The AAN notes that 40% of people will experience syncope during adulthood and most will not have carotid disease, which generally manifests with stroke-like symptoms rather than syncope. One study found that approximately 1 in 8 patients referred to an epilepsy clinic had neurocardiogenic syncope rather than epilepsy.³¹

EEGs have high false-negative and false-positive rates, and history-taking is a better tool with which to make a diagnosis. CT scans performed in the ED were found to contribute to the diagnosis of simple syncope in fewer than 2% of cases of syncope, compared with orthostatic blood pressure (25% of cases).³²

Continue to: 9 Wait to refer children with umbilical hernias to pediatric surgery until they are 4 to 5 years of age

The AAP Section on Surgery offers evidence that the risk-benefit analysis strongly favors waiting on intervention.³³ About 1 in 4 children will have an umbilical hernia, and about 85% of cases will resolve by age 5. The strangulation rate with umbilical hernias is very low, and although the risk of infection with surgery is likewise low, the risk of recurrence following surgery before the age of 4 is as high as 2.4%.³⁴ The AAP Section on Surgery recommends against strapping or restraining the hernia, as well.

10 Avoid using appetite stimulants, such as megesterol, and high-calorie nutritional supplements to treat anorexia and cachexia in older adults.

Instead, the American Geriatrics Society recommends that physicians encourage caregivers to serve appealing food, provide support with eating, and remove barriers to appetite and nutrition.³⁵ A Cochrane review showed that high-calorie supplements, such as Boost or Ensure, are associated with very modest weight gain—about 2% of weight—but are not associated with an increased life expectancy or improved quality of life.³⁶

Both the AAFP and the American Society of Anesthesiologists recommend against routine x-rays, MRIs, and CT scans during the first 6 weeks of acute low back pain.

Prescription appetite stimulants are associated with adverse effects and yield inconsistent benefits in older adults. Megesterol, for example, was associated with headache, gastrointestinal adverse effects, insomnia, weakness, and fatigue. Mirtazapine is associated with sedation and fatigue.³⁷

CORRESPONDENCE
Kathleen Rowland, MD, MS, Rush Copley Family Medicine Residency, Rush Medical College, 600 South Paulina, Kidston House Room 605, Chicago IL 60612; [email protected].

Despite advancements in techniques, postsurgical pain continues to be a prominent part of the patient experience. Often this experience can lead to developing chronic postsurgical pain that interferes with quality of life after the expected time to recovery.^1-3 As many as 14% of patients who undergo surgery without any history of opioid use develop chronic opioid use that persists after recovery from their operation.^4-8 For patients with existing chronic opioid use or a history of substance use disorder (SUD), surgeons, primary care providers, or addiction providers often do not provide sufficient presurgical planning or postsurgical coordination of care. This lack of pain care coordination can increase the risk of inadequate pain control, opioid use escalation, or SUD relapse after surgery.

Convincing arguments have been made that a perioperative surgical home can improve significantly the quality of perioperative care.^9-14 This report describes our experience implementing a perioperative surgical home at the US Department of Veterans Affairs (VA) Salt Lake City VA Medical Center (SLCVAMC), focusing on pain management extending from the preoperative period until 6 months or more after surgery. This type of Transitional Pain Service (TPS) has been described previously.^15-17 Our service differs from those described previously by enrolling all patients before surgery rather than select postsurgical enrollment of only patients with a history of opioid use or SUD or patients who struggle with persistent postsurgical pain.

Methods

In January 2018, we developed and implemented a new TPS at the SLCVAMC. The transitional pain team consisted of an anesthesiologist with specialization in acute pain management, a nurse practitioner (NP) with experience in both acute and chronic pain management, 2 nurse care coordinators, and a psychologist (Figure 1). Before implementation, a needs assessment took place with these key stakeholders and others at SLCVAMC to identify the following specific goals of the TPS: (1) reduce pain through pharmacologic and nonpharmacologic interventions; (2) eliminate new chronic opioid use in previously nonopioid user (NOU) patients; (3) address chronic opioid use in previous chronic opioid users (COUs) by providing support for opioid taper and alternative analgesic therapies for their chronic pain conditions; and (4) improve continuity of care by close coordination with the surgical team, primary care providers (PCPs), and mental health or chronic pain providers as needed.

Once these TPS goals were defined, the Consolidated Framework for Implementation Research (CFIR) guided the implementation. CFIR is a theory-based implementation framework consisting of 5 domains: intervention characteristics, inner setting, outer setting, characteristics of individuals, and process. These domains were used to identify barriers and facilitators during the early implementation process and helped refine TPS as it was put into clinical practice.

Patient Selection

During the initial implementation of TPS, enrollment was limited to patients scheduled for elective primary or revision knee, hip, or shoulder replacement as well as rotator cuff repair surgery. But as the TPS workflow became established after iterative refinement, we expanded the program to enroll patients with established risk factors for OUD having other types of surgery (Table 1). The diagnosis of risk factors, such as history of SUD, chronic opioid use, or significant mental health disorders (ie, history of suicidal ideation or attempt, posttraumatic stress disorder, and inpatient psychiatric care) were confirmed through both in-person interviews and electronic health record (EHR) documentation. The overall goal was to identify all at-risk patients as soon as they were indicated for surgery, to allow time for evaluation, education, developing an individualized pain plan, and opioid taper prior to surgery if indicated.

Preoperative Procedures

Once identified, patients were contacted by a TPS team member and invited to attend a onetime 90-minute presurgical expectations class held at SLCVAMC. The education curriculum was developed by the whole team, and classes were taught primarily by the TPS psychologist. The class included education about expectations for postoperative pain, available analgesic therapies, opioid education, appropriate use of opioids, and the effect of psychological factors on pain. Pain coping strategies were introduced using a mindfulness-based intervention (MBI) and the Acceptance and Commitment Therapy (ACT) matrix. Classes were offered multiple times a week to help maximize convenience for patients and were separate from the anesthesia preoperative evaluation. Patients attended class only once. High-risk patients (patients with chronic opioid therapy, recent history of or current SUDs, significant comorbid mental health issues) were encouraged to attend this class one-on-one with the TPS psychologist rather than in the group setting, so individual attention to mental health and SUD issues could be addressed directly. For patients who were unable to or who chose not to attend the class, the basic education component of the class without the MBI and ACT matrix was provided by nurse care coordinators and/or the anesthesiologist/NP individually before surgery either during the anesthesia preoperative visit or in the same-day surgery unit on the day of surgery.

Baseline history, morphine equivalent daily dose (MEDD), and patient-reported outcomes using measures from the Patient-Reported Outcome Measurement System (PROMIS) for pain intensity (PROMIS 3a), pain interference (PROMIS 6b), and physical function (PROMIS 8b), and a pain-catastrophizing scale (PCS) score were obtained on all patients.¹⁸ PROMIS measures are validated questionnaires developed with the National Institutes of Health to standardize and quantify patient-reported outcomes in many domains.¹⁹ Patients with a history of SUD or COU met with the anesthesiologist and/or NP, and a personalized pain plan was developed that included preoperative opioid taper, buprenorphine use strategy, or opioid-free strategies.

Hospital Procedures

On the day of surgery, the TPS team met with the patient preoperatively and implemented an individualized pain plan that included multimodal analgesic techniques with nonsteroidal anti-inflammatory drugs, acetaminophen, gabapentinoids, and regional anesthesia, where appropriate (Table 2). Enhanced recovery after surgery protocols were developed in conjunction with the surgeons to include local infiltration analgesia by the surgeon, postoperative multimodal analgesic strategies, and intensive physical therapy starting the day of surgery for inpatient procedures.

After surgery, the TPS team followed up with patients daily and provided recommendations for analgesic therapies. Patients were offered daily sessions with the psychologist to reinforce and practice nonpharmacologic pain-coping strategies, such as meditation and relaxation. Prior to patient discharge, the TPS team provided recommendations for discharge medications and an opioid taper plan. For some patients taking buprenorphine before surgery who had stopped this therapy prior to or during their hospital stay, TPS providers transitioned them back to buprenorphine before discharge.

Postoperative Procedures

Patients were called by the nurse care coordinators at postdischarge days 2, 7, 10, 14, 21, 28, and then monthly for ≥ 6 months. For patients who had not stopped opioid use or returned to their preoperative baseline opioid dose, weekly calls were made until opioid taper goals were achieved. At each call, nurses collected PROMIS scores for the previous 24 hours, the most recent 24-hour MEDD, the date of last opioid use, and the number of remaining opioid tablets after opioid cessation. In addition, nurses provided active listening and supportive care and encouragement as well as care coordination for issues related to rehabilitation facilities, physical therapy, transportation, medication questions, and wound questions. Nurses notified the anesthesiologist or NP when patients were unable to taper opioid use or had poor pain control as indicated by their PROMIS scores, opioid use, or directly expressed by the patient.

The TPS team prescribed alternative analgesic therapies, opioid taper plans, and communicated with surgeons and primary care providers if limited continued opioid therapy was recommended. Individual sessions with the psychologist were available to patients after discharge with a focus on ACT-matrix therapy and consultation with long-term mental health and/or substance abuse providers as indicated. Frequent communication and care coordination were maintained with the surgical team, the PCP, and other providers on the mental health or chronic pain services. This care coordination often included postsurgical joint clinic appointments in which TPS providers and nurses would be present with the surgeon or the PCP.

For patients with inadequately treated chronic pain conditions or who required long-term opioid tapers, we developed a combined clinic with the TPS and Anesthesia Chronic Pain group. This clinic allows patients to be seen by both services in the same setting, allowing a warm handoff by TPS to the chronic pain team.

Heath and Decision Support Tools 

An electronic dashboard registry of surgical episodes managed by TPS was developed to achieve clinical, administrative, and quality improvement goals. The dashboard registry consists of surgical episode data, opioid doses, patient-reported outcomes, and clinical decision-making processes. Custom-built note templates capture pertinent data through embedded data labels, called health factors. Data are captured as part of routine clinical care, recorded in Computerized Patient Record System as health factors. They are available in the VA Corporate Data Warehouse as structured data. Workflows are executed daily to keep the dashboard registry current, clean, and able to process new data. Information displays direct daily clinical workflow and support point-of-care clinical decision making (Figures 2, 3, and 4). Data are aggregated across patient-care encounters and allow nurse care coordinators to concisely review pertinent patient data prior to delivering care. These data include surgical history, comorbidities, timeline of opioid use, and PROMIS scores during their course of recovery. This system allows TPS to optimize care delivery by providing longitudinal data across the surgical episode, thereby reducing the time needed to review records. Secondary purposes of captured data include measuring clinic performance and quality improvement to improve care delivery.

Results

The TPS intervention was implemented January 1, 2018. Two-hundred thirteen patients were enrolled between January and December 2018, which included 60 (28%) patients with a history of chronic opioid use and 153 (72%) patients who were considered opioid naïve. A total of 99% of patients had ≥ 1 successful follow-up within 14 days after discharge, 96% had ≥ 1 follow-up between 14 and 30 days after surgery, and 72% had completed personal follow-up 90 days after discharge (Table 3). For patients who TPS was unable to contact in person or by phone, 90-day MEDD was obtained using prescription and Controlled Substance Database reviews. The protocol for this retrospective analysis was approved by the University of Utah Institutional Review Board and the VA Research Review Committee.

By 90 days after surgery, 26 (43.3%) COUs were off opioids completely, 17 (28.3%) had decreased their opioid dose from their preoperative baseline MEDD (120 [SD, 108] vs 55 [SD, 45]), 14 (23.3%) returned to their baseline dose, and 3 (5%) increased from their baseline dose. Of the 153 patients who were NOUs before surgery, only 1 (0.7%) was taking opioids after 90 days. TPS continued to work closely with the patient and their PCP and that patient was finally able to stop opioid use 262 days after discharge. Ten patients had an additional surgery within 90 days of the initial surgery. Of these, 6 were COU, of whom 3 stopped all opioids by 90 days from their original surgery, 2 had no change in MEDD at 90 days, and 1 had a lower MEDD at 90 days. Of the 4 NOU who had additional surgery, all were off opioids by 90 days from the original surgery.

Discussion

With any new clinical service, there are obstacles and challenges. TPS requires a considerable investment in personnel, and currently no mechanism is in place for obtaining payment for many of the provided services. We were fortunate the VA Whole Health Initiative, the VA Office of Rural Health, and the VA Centers of Innovation provided support for the development, implementation, and pilot evaluation of TPS. After we presented our initial results to hospital leadership, we also received hospital support to expand TPS service to include a total of 4 nurse care coordinators and 2 psychologists. We are currently performing a cost analysis of the service but recognize that this model may be difficult to reproduce at other institutions without a change in reimbursement standards.

Developing a working relationship with the surgical and primary care services required a concerted effort from the TPS team and a number of months to become effective. As most veterans receive primary care, mental health care, and surgical care within the VA system, this model lends itself to close care coordination. Initially there was skepticism about TPS recommendations to reduce opioid use, especially from PCPs who had cared for complex patients over many years. But this uncertainty went away as we showed evidence of close patient follow-up and detailed communication. TPS soon became the designated service for both primary care and surgical providers who were otherwise uncomfortable with how to approach opioid tapers and nonopioid pain strategies. In fact, a substantial portion of our referrals now come directly from the PCP who is referring a high-risk patient for evaluation for surgery rather than from the surgeons, and joint visits with TPS and primary care have become commonplace.

Challenges abound when working with patients with substance abuse history, opioid use history, high anxiety, significant pain catastrophizing, and those who have had previous negative experiences with surgery. We have found that the most important facet of our service comes from the amount of time and effort team members, especially the nurses, spend helping patients. Much of the nurses' work focuses on nonpain-related issues, such as assisting patients with finding transportation, housing issues, questions about medications, help scheduling appointments, etc. Through this concerted effort, patients gain trust in TPS providers and are willing to listen to and experiment with our recommendations. Many patients who were initially extremely unreceptive to the presurgery education asked for our support weeks after surgery to help with postsurgery pain.

Another challenge we continue to experience comes from the success of the program. We receive many requests from PCPs to help with opioid tapers and pain management for nonsurgical patients. Although we are happy that they look to TPS for assistance, the pressure to expand threatens our ability to maintain the expected quality of work we are trying to provide for surgical patients.

Conclusions

The multidisciplinary TPS supports greater preoperative to postoperative longitudinal care for surgical patients. This endeavor has resulted in better patient preparation before surgery and improved care coordination after surgery, with specific improvements in appropriate use of opioid medications and smooth transitions of care for patients with ongoing and complex needs. Development of sophisticated note templates and customized health information technology allows for accurate follow-through and data gathering for quality improvement, facilitating data-driven improvements and proving value to the facility.

Given that TPS is a multidisciplinary program with multiple interventions, it is difficult to pinpoint which specific aspects of TPS are most effective in achieving success. For example, although we have little doubt that the work our psychologists do with our patients is beneficial and even essential for the success we have had with some of our most difficult patients, it is less clear whether it matters if they use mindfulness, ACT matrix, or cognitive behavioral therapy. We think that an important part of TPS is the frequent human interaction with a caring individual. Therefore, as TPS continues to grow, maintaining the ability to provide frequent personal interaction is a priority.

The role of opioids in acute pain deserves further scrutiny. In 2018, with TPS use of opioids after orthopedic surgery decreased by > 40% from the previous year. Despite this more restricted use of opioids, pain interference and physical function scores indicated that surgical patients do not seem to experience increased pain or reduced physical function. In addition, stopping opioid use for COUs did not seem to affect the quality of recovery, pain, or physical function. Future prospective controlled studies of TPS are needed to confirm these findings and identify which aspects of TPS are most effective in improving functional recovery of patients. Also, more evidence is needed to determine the appropriateness or need for opioids in acute postsurgical pain.

TPS has expanded to include all surgical specialties. Given the high burden and limited resources, we have chosen to focus on patients at higher risk for chronic postsurgical pain by type of surgery (eg, thoracotomy, open abdominal, limb amputation, major joint surgery) and/or history of substance abuse or chronic opioid use. To better direct scarce resources where it would be of most benefit, we are now enrolling only NOUs without other risk factors postoperatively if they request a refill of opioids or are otherwise struggling with pain control after surgery. Whether this approach affects the success we had in the first year in preventing new COUs after surgery remains to be seen.

It is unlikely that any single model of a perioperative surgical home will fit the needs of the many different types of medical systems that exist. The TPS model fits well in large hospital systems, like the VA, where patients receive most of their care within the same system. However, it seems to us that the optimal TPS program in any health system will provide education, support, and care coordination beginning preoperatively to prepare the patient for surgery and then to facilitate care coordination to transition patients back to their PCPs or on to specialized chronic care.

Acknowledgments

We would like to acknowledge the contributions of Candice Harmon, RN; David Merrill, RN; Amy Beckstead, RN, who have provided invaluable assistance with establishing the TPS program at the VA Salt Lake City and helping with the evaluation process.

Funding for the implementation and evaluation of the TPS was received from the VA Whole Health Initiative, the VA Center of Innovation, the VA Office of Rural Health, and National Institutes of Health Grant UL1TR002538.

Despite advancements in techniques, postsurgical pain continues to be a prominent part of the patient experience. Often this experience can lead to developing chronic postsurgical pain that interferes with quality of life after the expected time to recovery.^1-3 As many as 14% of patients who undergo surgery without any history of opioid use develop chronic opioid use that persists after recovery from their operation.^4-8 For patients with existing chronic opioid use or a history of substance use disorder (SUD), surgeons, primary care providers, or addiction providers often do not provide sufficient presurgical planning or postsurgical coordination of care. This lack of pain care coordination can increase the risk of inadequate pain control, opioid use escalation, or SUD relapse after surgery.

Convincing arguments have been made that a perioperative surgical home can improve significantly the quality of perioperative care.^9-14 This report describes our experience implementing a perioperative surgical home at the US Department of Veterans Affairs (VA) Salt Lake City VA Medical Center (SLCVAMC), focusing on pain management extending from the preoperative period until 6 months or more after surgery. This type of Transitional Pain Service (TPS) has been described previously.^15-17 Our service differs from those described previously by enrolling all patients before surgery rather than select postsurgical enrollment of only patients with a history of opioid use or SUD or patients who struggle with persistent postsurgical pain.

Methods

In January 2018, we developed and implemented a new TPS at the SLCVAMC. The transitional pain team consisted of an anesthesiologist with specialization in acute pain management, a nurse practitioner (NP) with experience in both acute and chronic pain management, 2 nurse care coordinators, and a psychologist (Figure 1). Before implementation, a needs assessment took place with these key stakeholders and others at SLCVAMC to identify the following specific goals of the TPS: (1) reduce pain through pharmacologic and nonpharmacologic interventions; (2) eliminate new chronic opioid use in previously nonopioid user (NOU) patients; (3) address chronic opioid use in previous chronic opioid users (COUs) by providing support for opioid taper and alternative analgesic therapies for their chronic pain conditions; and (4) improve continuity of care by close coordination with the surgical team, primary care providers (PCPs), and mental health or chronic pain providers as needed.

Once these TPS goals were defined, the Consolidated Framework for Implementation Research (CFIR) guided the implementation. CFIR is a theory-based implementation framework consisting of 5 domains: intervention characteristics, inner setting, outer setting, characteristics of individuals, and process. These domains were used to identify barriers and facilitators during the early implementation process and helped refine TPS as it was put into clinical practice.

Patient Selection

During the initial implementation of TPS, enrollment was limited to patients scheduled for elective primary or revision knee, hip, or shoulder replacement as well as rotator cuff repair surgery. But as the TPS workflow became established after iterative refinement, we expanded the program to enroll patients with established risk factors for OUD having other types of surgery (Table 1). The diagnosis of risk factors, such as history of SUD, chronic opioid use, or significant mental health disorders (ie, history of suicidal ideation or attempt, posttraumatic stress disorder, and inpatient psychiatric care) were confirmed through both in-person interviews and electronic health record (EHR) documentation. The overall goal was to identify all at-risk patients as soon as they were indicated for surgery, to allow time for evaluation, education, developing an individualized pain plan, and opioid taper prior to surgery if indicated.

Preoperative Procedures

Once identified, patients were contacted by a TPS team member and invited to attend a onetime 90-minute presurgical expectations class held at SLCVAMC. The education curriculum was developed by the whole team, and classes were taught primarily by the TPS psychologist. The class included education about expectations for postoperative pain, available analgesic therapies, opioid education, appropriate use of opioids, and the effect of psychological factors on pain. Pain coping strategies were introduced using a mindfulness-based intervention (MBI) and the Acceptance and Commitment Therapy (ACT) matrix. Classes were offered multiple times a week to help maximize convenience for patients and were separate from the anesthesia preoperative evaluation. Patients attended class only once. High-risk patients (patients with chronic opioid therapy, recent history of or current SUDs, significant comorbid mental health issues) were encouraged to attend this class one-on-one with the TPS psychologist rather than in the group setting, so individual attention to mental health and SUD issues could be addressed directly. For patients who were unable to or who chose not to attend the class, the basic education component of the class without the MBI and ACT matrix was provided by nurse care coordinators and/or the anesthesiologist/NP individually before surgery either during the anesthesia preoperative visit or in the same-day surgery unit on the day of surgery.

Baseline history, morphine equivalent daily dose (MEDD), and patient-reported outcomes using measures from the Patient-Reported Outcome Measurement System (PROMIS) for pain intensity (PROMIS 3a), pain interference (PROMIS 6b), and physical function (PROMIS 8b), and a pain-catastrophizing scale (PCS) score were obtained on all patients.¹⁸ PROMIS measures are validated questionnaires developed with the National Institutes of Health to standardize and quantify patient-reported outcomes in many domains.¹⁹ Patients with a history of SUD or COU met with the anesthesiologist and/or NP, and a personalized pain plan was developed that included preoperative opioid taper, buprenorphine use strategy, or opioid-free strategies.

Hospital Procedures

On the day of surgery, the TPS team met with the patient preoperatively and implemented an individualized pain plan that included multimodal analgesic techniques with nonsteroidal anti-inflammatory drugs, acetaminophen, gabapentinoids, and regional anesthesia, where appropriate (Table 2). Enhanced recovery after surgery protocols were developed in conjunction with the surgeons to include local infiltration analgesia by the surgeon, postoperative multimodal analgesic strategies, and intensive physical therapy starting the day of surgery for inpatient procedures.

After surgery, the TPS team followed up with patients daily and provided recommendations for analgesic therapies. Patients were offered daily sessions with the psychologist to reinforce and practice nonpharmacologic pain-coping strategies, such as meditation and relaxation. Prior to patient discharge, the TPS team provided recommendations for discharge medications and an opioid taper plan. For some patients taking buprenorphine before surgery who had stopped this therapy prior to or during their hospital stay, TPS providers transitioned them back to buprenorphine before discharge.

Postoperative Procedures

Patients were called by the nurse care coordinators at postdischarge days 2, 7, 10, 14, 21, 28, and then monthly for ≥ 6 months. For patients who had not stopped opioid use or returned to their preoperative baseline opioid dose, weekly calls were made until opioid taper goals were achieved. At each call, nurses collected PROMIS scores for the previous 24 hours, the most recent 24-hour MEDD, the date of last opioid use, and the number of remaining opioid tablets after opioid cessation. In addition, nurses provided active listening and supportive care and encouragement as well as care coordination for issues related to rehabilitation facilities, physical therapy, transportation, medication questions, and wound questions. Nurses notified the anesthesiologist or NP when patients were unable to taper opioid use or had poor pain control as indicated by their PROMIS scores, opioid use, or directly expressed by the patient.

The TPS team prescribed alternative analgesic therapies, opioid taper plans, and communicated with surgeons and primary care providers if limited continued opioid therapy was recommended. Individual sessions with the psychologist were available to patients after discharge with a focus on ACT-matrix therapy and consultation with long-term mental health and/or substance abuse providers as indicated. Frequent communication and care coordination were maintained with the surgical team, the PCP, and other providers on the mental health or chronic pain services. This care coordination often included postsurgical joint clinic appointments in which TPS providers and nurses would be present with the surgeon or the PCP.

For patients with inadequately treated chronic pain conditions or who required long-term opioid tapers, we developed a combined clinic with the TPS and Anesthesia Chronic Pain group. This clinic allows patients to be seen by both services in the same setting, allowing a warm handoff by TPS to the chronic pain team.

Heath and Decision Support Tools 

An electronic dashboard registry of surgical episodes managed by TPS was developed to achieve clinical, administrative, and quality improvement goals. The dashboard registry consists of surgical episode data, opioid doses, patient-reported outcomes, and clinical decision-making processes. Custom-built note templates capture pertinent data through embedded data labels, called health factors. Data are captured as part of routine clinical care, recorded in Computerized Patient Record System as health factors. They are available in the VA Corporate Data Warehouse as structured data. Workflows are executed daily to keep the dashboard registry current, clean, and able to process new data. Information displays direct daily clinical workflow and support point-of-care clinical decision making (Figures 2, 3, and 4). Data are aggregated across patient-care encounters and allow nurse care coordinators to concisely review pertinent patient data prior to delivering care. These data include surgical history, comorbidities, timeline of opioid use, and PROMIS scores during their course of recovery. This system allows TPS to optimize care delivery by providing longitudinal data across the surgical episode, thereby reducing the time needed to review records. Secondary purposes of captured data include measuring clinic performance and quality improvement to improve care delivery.

Results

The TPS intervention was implemented January 1, 2018. Two-hundred thirteen patients were enrolled between January and December 2018, which included 60 (28%) patients with a history of chronic opioid use and 153 (72%) patients who were considered opioid naïve. A total of 99% of patients had ≥ 1 successful follow-up within 14 days after discharge, 96% had ≥ 1 follow-up between 14 and 30 days after surgery, and 72% had completed personal follow-up 90 days after discharge (Table 3). For patients who TPS was unable to contact in person or by phone, 90-day MEDD was obtained using prescription and Controlled Substance Database reviews. The protocol for this retrospective analysis was approved by the University of Utah Institutional Review Board and the VA Research Review Committee.

By 90 days after surgery, 26 (43.3%) COUs were off opioids completely, 17 (28.3%) had decreased their opioid dose from their preoperative baseline MEDD (120 [SD, 108] vs 55 [SD, 45]), 14 (23.3%) returned to their baseline dose, and 3 (5%) increased from their baseline dose. Of the 153 patients who were NOUs before surgery, only 1 (0.7%) was taking opioids after 90 days. TPS continued to work closely with the patient and their PCP and that patient was finally able to stop opioid use 262 days after discharge. Ten patients had an additional surgery within 90 days of the initial surgery. Of these, 6 were COU, of whom 3 stopped all opioids by 90 days from their original surgery, 2 had no change in MEDD at 90 days, and 1 had a lower MEDD at 90 days. Of the 4 NOU who had additional surgery, all were off opioids by 90 days from the original surgery.

Discussion

With any new clinical service, there are obstacles and challenges. TPS requires a considerable investment in personnel, and currently no mechanism is in place for obtaining payment for many of the provided services. We were fortunate the VA Whole Health Initiative, the VA Office of Rural Health, and the VA Centers of Innovation provided support for the development, implementation, and pilot evaluation of TPS. After we presented our initial results to hospital leadership, we also received hospital support to expand TPS service to include a total of 4 nurse care coordinators and 2 psychologists. We are currently performing a cost analysis of the service but recognize that this model may be difficult to reproduce at other institutions without a change in reimbursement standards.

Developing a working relationship with the surgical and primary care services required a concerted effort from the TPS team and a number of months to become effective. As most veterans receive primary care, mental health care, and surgical care within the VA system, this model lends itself to close care coordination. Initially there was skepticism about TPS recommendations to reduce opioid use, especially from PCPs who had cared for complex patients over many years. But this uncertainty went away as we showed evidence of close patient follow-up and detailed communication. TPS soon became the designated service for both primary care and surgical providers who were otherwise uncomfortable with how to approach opioid tapers and nonopioid pain strategies. In fact, a substantial portion of our referrals now come directly from the PCP who is referring a high-risk patient for evaluation for surgery rather than from the surgeons, and joint visits with TPS and primary care have become commonplace.

Challenges abound when working with patients with substance abuse history, opioid use history, high anxiety, significant pain catastrophizing, and those who have had previous negative experiences with surgery. We have found that the most important facet of our service comes from the amount of time and effort team members, especially the nurses, spend helping patients. Much of the nurses' work focuses on nonpain-related issues, such as assisting patients with finding transportation, housing issues, questions about medications, help scheduling appointments, etc. Through this concerted effort, patients gain trust in TPS providers and are willing to listen to and experiment with our recommendations. Many patients who were initially extremely unreceptive to the presurgery education asked for our support weeks after surgery to help with postsurgery pain.

Another challenge we continue to experience comes from the success of the program. We receive many requests from PCPs to help with opioid tapers and pain management for nonsurgical patients. Although we are happy that they look to TPS for assistance, the pressure to expand threatens our ability to maintain the expected quality of work we are trying to provide for surgical patients.

Conclusions

The multidisciplinary TPS supports greater preoperative to postoperative longitudinal care for surgical patients. This endeavor has resulted in better patient preparation before surgery and improved care coordination after surgery, with specific improvements in appropriate use of opioid medications and smooth transitions of care for patients with ongoing and complex needs. Development of sophisticated note templates and customized health information technology allows for accurate follow-through and data gathering for quality improvement, facilitating data-driven improvements and proving value to the facility.

Given that TPS is a multidisciplinary program with multiple interventions, it is difficult to pinpoint which specific aspects of TPS are most effective in achieving success. For example, although we have little doubt that the work our psychologists do with our patients is beneficial and even essential for the success we have had with some of our most difficult patients, it is less clear whether it matters if they use mindfulness, ACT matrix, or cognitive behavioral therapy. We think that an important part of TPS is the frequent human interaction with a caring individual. Therefore, as TPS continues to grow, maintaining the ability to provide frequent personal interaction is a priority.

The role of opioids in acute pain deserves further scrutiny. In 2018, with TPS use of opioids after orthopedic surgery decreased by > 40% from the previous year. Despite this more restricted use of opioids, pain interference and physical function scores indicated that surgical patients do not seem to experience increased pain or reduced physical function. In addition, stopping opioid use for COUs did not seem to affect the quality of recovery, pain, or physical function. Future prospective controlled studies of TPS are needed to confirm these findings and identify which aspects of TPS are most effective in improving functional recovery of patients. Also, more evidence is needed to determine the appropriateness or need for opioids in acute postsurgical pain.

TPS has expanded to include all surgical specialties. Given the high burden and limited resources, we have chosen to focus on patients at higher risk for chronic postsurgical pain by type of surgery (eg, thoracotomy, open abdominal, limb amputation, major joint surgery) and/or history of substance abuse or chronic opioid use. To better direct scarce resources where it would be of most benefit, we are now enrolling only NOUs without other risk factors postoperatively if they request a refill of opioids or are otherwise struggling with pain control after surgery. Whether this approach affects the success we had in the first year in preventing new COUs after surgery remains to be seen.

It is unlikely that any single model of a perioperative surgical home will fit the needs of the many different types of medical systems that exist. The TPS model fits well in large hospital systems, like the VA, where patients receive most of their care within the same system. However, it seems to us that the optimal TPS program in any health system will provide education, support, and care coordination beginning preoperatively to prepare the patient for surgery and then to facilitate care coordination to transition patients back to their PCPs or on to specialized chronic care.

Acknowledgments

We would like to acknowledge the contributions of Candice Harmon, RN; David Merrill, RN; Amy Beckstead, RN, who have provided invaluable assistance with establishing the TPS program at the VA Salt Lake City and helping with the evaluation process.

Funding for the implementation and evaluation of the TPS was received from the VA Whole Health Initiative, the VA Center of Innovation, the VA Office of Rural Health, and National Institutes of Health Grant UL1TR002538.

Despite advancements in techniques, postsurgical pain continues to be a prominent part of the patient experience. Often this experience can lead to developing chronic postsurgical pain that interferes with quality of life after the expected time to recovery.^1-3 As many as 14% of patients who undergo surgery without any history of opioid use develop chronic opioid use that persists after recovery from their operation.^4-8 For patients with existing chronic opioid use or a history of substance use disorder (SUD), surgeons, primary care providers, or addiction providers often do not provide sufficient presurgical planning or postsurgical coordination of care. This lack of pain care coordination can increase the risk of inadequate pain control, opioid use escalation, or SUD relapse after surgery.

Convincing arguments have been made that a perioperative surgical home can improve significantly the quality of perioperative care.^9-14 This report describes our experience implementing a perioperative surgical home at the US Department of Veterans Affairs (VA) Salt Lake City VA Medical Center (SLCVAMC), focusing on pain management extending from the preoperative period until 6 months or more after surgery. This type of Transitional Pain Service (TPS) has been described previously.^15-17 Our service differs from those described previously by enrolling all patients before surgery rather than select postsurgical enrollment of only patients with a history of opioid use or SUD or patients who struggle with persistent postsurgical pain.

Methods

In January 2018, we developed and implemented a new TPS at the SLCVAMC. The transitional pain team consisted of an anesthesiologist with specialization in acute pain management, a nurse practitioner (NP) with experience in both acute and chronic pain management, 2 nurse care coordinators, and a psychologist (Figure 1). Before implementation, a needs assessment took place with these key stakeholders and others at SLCVAMC to identify the following specific goals of the TPS: (1) reduce pain through pharmacologic and nonpharmacologic interventions; (2) eliminate new chronic opioid use in previously nonopioid user (NOU) patients; (3) address chronic opioid use in previous chronic opioid users (COUs) by providing support for opioid taper and alternative analgesic therapies for their chronic pain conditions; and (4) improve continuity of care by close coordination with the surgical team, primary care providers (PCPs), and mental health or chronic pain providers as needed.

Once these TPS goals were defined, the Consolidated Framework for Implementation Research (CFIR) guided the implementation. CFIR is a theory-based implementation framework consisting of 5 domains: intervention characteristics, inner setting, outer setting, characteristics of individuals, and process. These domains were used to identify barriers and facilitators during the early implementation process and helped refine TPS as it was put into clinical practice.

Patient Selection

During the initial implementation of TPS, enrollment was limited to patients scheduled for elective primary or revision knee, hip, or shoulder replacement as well as rotator cuff repair surgery. But as the TPS workflow became established after iterative refinement, we expanded the program to enroll patients with established risk factors for OUD having other types of surgery (Table 1). The diagnosis of risk factors, such as history of SUD, chronic opioid use, or significant mental health disorders (ie, history of suicidal ideation or attempt, posttraumatic stress disorder, and inpatient psychiatric care) were confirmed through both in-person interviews and electronic health record (EHR) documentation. The overall goal was to identify all at-risk patients as soon as they were indicated for surgery, to allow time for evaluation, education, developing an individualized pain plan, and opioid taper prior to surgery if indicated.

Preoperative Procedures

Once identified, patients were contacted by a TPS team member and invited to attend a onetime 90-minute presurgical expectations class held at SLCVAMC. The education curriculum was developed by the whole team, and classes were taught primarily by the TPS psychologist. The class included education about expectations for postoperative pain, available analgesic therapies, opioid education, appropriate use of opioids, and the effect of psychological factors on pain. Pain coping strategies were introduced using a mindfulness-based intervention (MBI) and the Acceptance and Commitment Therapy (ACT) matrix. Classes were offered multiple times a week to help maximize convenience for patients and were separate from the anesthesia preoperative evaluation. Patients attended class only once. High-risk patients (patients with chronic opioid therapy, recent history of or current SUDs, significant comorbid mental health issues) were encouraged to attend this class one-on-one with the TPS psychologist rather than in the group setting, so individual attention to mental health and SUD issues could be addressed directly. For patients who were unable to or who chose not to attend the class, the basic education component of the class without the MBI and ACT matrix was provided by nurse care coordinators and/or the anesthesiologist/NP individually before surgery either during the anesthesia preoperative visit or in the same-day surgery unit on the day of surgery.

Baseline history, morphine equivalent daily dose (MEDD), and patient-reported outcomes using measures from the Patient-Reported Outcome Measurement System (PROMIS) for pain intensity (PROMIS 3a), pain interference (PROMIS 6b), and physical function (PROMIS 8b), and a pain-catastrophizing scale (PCS) score were obtained on all patients.¹⁸ PROMIS measures are validated questionnaires developed with the National Institutes of Health to standardize and quantify patient-reported outcomes in many domains.¹⁹ Patients with a history of SUD or COU met with the anesthesiologist and/or NP, and a personalized pain plan was developed that included preoperative opioid taper, buprenorphine use strategy, or opioid-free strategies.

Hospital Procedures

On the day of surgery, the TPS team met with the patient preoperatively and implemented an individualized pain plan that included multimodal analgesic techniques with nonsteroidal anti-inflammatory drugs, acetaminophen, gabapentinoids, and regional anesthesia, where appropriate (Table 2). Enhanced recovery after surgery protocols were developed in conjunction with the surgeons to include local infiltration analgesia by the surgeon, postoperative multimodal analgesic strategies, and intensive physical therapy starting the day of surgery for inpatient procedures.

After surgery, the TPS team followed up with patients daily and provided recommendations for analgesic therapies. Patients were offered daily sessions with the psychologist to reinforce and practice nonpharmacologic pain-coping strategies, such as meditation and relaxation. Prior to patient discharge, the TPS team provided recommendations for discharge medications and an opioid taper plan. For some patients taking buprenorphine before surgery who had stopped this therapy prior to or during their hospital stay, TPS providers transitioned them back to buprenorphine before discharge.

Postoperative Procedures

Patients were called by the nurse care coordinators at postdischarge days 2, 7, 10, 14, 21, 28, and then monthly for ≥ 6 months. For patients who had not stopped opioid use or returned to their preoperative baseline opioid dose, weekly calls were made until opioid taper goals were achieved. At each call, nurses collected PROMIS scores for the previous 24 hours, the most recent 24-hour MEDD, the date of last opioid use, and the number of remaining opioid tablets after opioid cessation. In addition, nurses provided active listening and supportive care and encouragement as well as care coordination for issues related to rehabilitation facilities, physical therapy, transportation, medication questions, and wound questions. Nurses notified the anesthesiologist or NP when patients were unable to taper opioid use or had poor pain control as indicated by their PROMIS scores, opioid use, or directly expressed by the patient.

The TPS team prescribed alternative analgesic therapies, opioid taper plans, and communicated with surgeons and primary care providers if limited continued opioid therapy was recommended. Individual sessions with the psychologist were available to patients after discharge with a focus on ACT-matrix therapy and consultation with long-term mental health and/or substance abuse providers as indicated. Frequent communication and care coordination were maintained with the surgical team, the PCP, and other providers on the mental health or chronic pain services. This care coordination often included postsurgical joint clinic appointments in which TPS providers and nurses would be present with the surgeon or the PCP.

For patients with inadequately treated chronic pain conditions or who required long-term opioid tapers, we developed a combined clinic with the TPS and Anesthesia Chronic Pain group. This clinic allows patients to be seen by both services in the same setting, allowing a warm handoff by TPS to the chronic pain team.

Heath and Decision Support Tools 

An electronic dashboard registry of surgical episodes managed by TPS was developed to achieve clinical, administrative, and quality improvement goals. The dashboard registry consists of surgical episode data, opioid doses, patient-reported outcomes, and clinical decision-making processes. Custom-built note templates capture pertinent data through embedded data labels, called health factors. Data are captured as part of routine clinical care, recorded in Computerized Patient Record System as health factors. They are available in the VA Corporate Data Warehouse as structured data. Workflows are executed daily to keep the dashboard registry current, clean, and able to process new data. Information displays direct daily clinical workflow and support point-of-care clinical decision making (Figures 2, 3, and 4). Data are aggregated across patient-care encounters and allow nurse care coordinators to concisely review pertinent patient data prior to delivering care. These data include surgical history, comorbidities, timeline of opioid use, and PROMIS scores during their course of recovery. This system allows TPS to optimize care delivery by providing longitudinal data across the surgical episode, thereby reducing the time needed to review records. Secondary purposes of captured data include measuring clinic performance and quality improvement to improve care delivery.

Results

The TPS intervention was implemented January 1, 2018. Two-hundred thirteen patients were enrolled between January and December 2018, which included 60 (28%) patients with a history of chronic opioid use and 153 (72%) patients who were considered opioid naïve. A total of 99% of patients had ≥ 1 successful follow-up within 14 days after discharge, 96% had ≥ 1 follow-up between 14 and 30 days after surgery, and 72% had completed personal follow-up 90 days after discharge (Table 3). For patients who TPS was unable to contact in person or by phone, 90-day MEDD was obtained using prescription and Controlled Substance Database reviews. The protocol for this retrospective analysis was approved by the University of Utah Institutional Review Board and the VA Research Review Committee.

By 90 days after surgery, 26 (43.3%) COUs were off opioids completely, 17 (28.3%) had decreased their opioid dose from their preoperative baseline MEDD (120 [SD, 108] vs 55 [SD, 45]), 14 (23.3%) returned to their baseline dose, and 3 (5%) increased from their baseline dose. Of the 153 patients who were NOUs before surgery, only 1 (0.7%) was taking opioids after 90 days. TPS continued to work closely with the patient and their PCP and that patient was finally able to stop opioid use 262 days after discharge. Ten patients had an additional surgery within 90 days of the initial surgery. Of these, 6 were COU, of whom 3 stopped all opioids by 90 days from their original surgery, 2 had no change in MEDD at 90 days, and 1 had a lower MEDD at 90 days. Of the 4 NOU who had additional surgery, all were off opioids by 90 days from the original surgery.

Discussion

With any new clinical service, there are obstacles and challenges. TPS requires a considerable investment in personnel, and currently no mechanism is in place for obtaining payment for many of the provided services. We were fortunate the VA Whole Health Initiative, the VA Office of Rural Health, and the VA Centers of Innovation provided support for the development, implementation, and pilot evaluation of TPS. After we presented our initial results to hospital leadership, we also received hospital support to expand TPS service to include a total of 4 nurse care coordinators and 2 psychologists. We are currently performing a cost analysis of the service but recognize that this model may be difficult to reproduce at other institutions without a change in reimbursement standards.

Developing a working relationship with the surgical and primary care services required a concerted effort from the TPS team and a number of months to become effective. As most veterans receive primary care, mental health care, and surgical care within the VA system, this model lends itself to close care coordination. Initially there was skepticism about TPS recommendations to reduce opioid use, especially from PCPs who had cared for complex patients over many years. But this uncertainty went away as we showed evidence of close patient follow-up and detailed communication. TPS soon became the designated service for both primary care and surgical providers who were otherwise uncomfortable with how to approach opioid tapers and nonopioid pain strategies. In fact, a substantial portion of our referrals now come directly from the PCP who is referring a high-risk patient for evaluation for surgery rather than from the surgeons, and joint visits with TPS and primary care have become commonplace.

Challenges abound when working with patients with substance abuse history, opioid use history, high anxiety, significant pain catastrophizing, and those who have had previous negative experiences with surgery. We have found that the most important facet of our service comes from the amount of time and effort team members, especially the nurses, spend helping patients. Much of the nurses' work focuses on nonpain-related issues, such as assisting patients with finding transportation, housing issues, questions about medications, help scheduling appointments, etc. Through this concerted effort, patients gain trust in TPS providers and are willing to listen to and experiment with our recommendations. Many patients who were initially extremely unreceptive to the presurgery education asked for our support weeks after surgery to help with postsurgery pain.

Another challenge we continue to experience comes from the success of the program. We receive many requests from PCPs to help with opioid tapers and pain management for nonsurgical patients. Although we are happy that they look to TPS for assistance, the pressure to expand threatens our ability to maintain the expected quality of work we are trying to provide for surgical patients.

Conclusions

The multidisciplinary TPS supports greater preoperative to postoperative longitudinal care for surgical patients. This endeavor has resulted in better patient preparation before surgery and improved care coordination after surgery, with specific improvements in appropriate use of opioid medications and smooth transitions of care for patients with ongoing and complex needs. Development of sophisticated note templates and customized health information technology allows for accurate follow-through and data gathering for quality improvement, facilitating data-driven improvements and proving value to the facility.

Given that TPS is a multidisciplinary program with multiple interventions, it is difficult to pinpoint which specific aspects of TPS are most effective in achieving success. For example, although we have little doubt that the work our psychologists do with our patients is beneficial and even essential for the success we have had with some of our most difficult patients, it is less clear whether it matters if they use mindfulness, ACT matrix, or cognitive behavioral therapy. We think that an important part of TPS is the frequent human interaction with a caring individual. Therefore, as TPS continues to grow, maintaining the ability to provide frequent personal interaction is a priority.

The role of opioids in acute pain deserves further scrutiny. In 2018, with TPS use of opioids after orthopedic surgery decreased by > 40% from the previous year. Despite this more restricted use of opioids, pain interference and physical function scores indicated that surgical patients do not seem to experience increased pain or reduced physical function. In addition, stopping opioid use for COUs did not seem to affect the quality of recovery, pain, or physical function. Future prospective controlled studies of TPS are needed to confirm these findings and identify which aspects of TPS are most effective in improving functional recovery of patients. Also, more evidence is needed to determine the appropriateness or need for opioids in acute postsurgical pain.

TPS has expanded to include all surgical specialties. Given the high burden and limited resources, we have chosen to focus on patients at higher risk for chronic postsurgical pain by type of surgery (eg, thoracotomy, open abdominal, limb amputation, major joint surgery) and/or history of substance abuse or chronic opioid use. To better direct scarce resources where it would be of most benefit, we are now enrolling only NOUs without other risk factors postoperatively if they request a refill of opioids or are otherwise struggling with pain control after surgery. Whether this approach affects the success we had in the first year in preventing new COUs after surgery remains to be seen.

It is unlikely that any single model of a perioperative surgical home will fit the needs of the many different types of medical systems that exist. The TPS model fits well in large hospital systems, like the VA, where patients receive most of their care within the same system. However, it seems to us that the optimal TPS program in any health system will provide education, support, and care coordination beginning preoperatively to prepare the patient for surgery and then to facilitate care coordination to transition patients back to their PCPs or on to specialized chronic care.

Acknowledgments

We would like to acknowledge the contributions of Candice Harmon, RN; David Merrill, RN; Amy Beckstead, RN, who have provided invaluable assistance with establishing the TPS program at the VA Salt Lake City and helping with the evaluation process.

Funding for the implementation and evaluation of the TPS was received from the VA Whole Health Initiative, the VA Center of Innovation, the VA Office of Rural Health, and National Institutes of Health Grant UL1TR002538.

Black children and children living in urban areas are less likely to have opioid-related poisoning or withdrawal but more likely to experience abuse or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.

Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.

In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.

Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.

Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.

The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.

And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.

“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.

[email protected]

SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.

Black children and children living in urban areas are less likely to have opioid-related poisoning or withdrawal but more likely to experience abuse or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.

Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.

In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.

Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.

Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.

The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.

And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.

“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.

[email protected]

SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.

Black children and children living in urban areas are less likely to have opioid-related poisoning or withdrawal but more likely to experience abuse or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.

Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.

In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.

Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.

Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.

The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.

And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.

“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.

[email protected]

SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.

Music listening and singing each showed early, promising evidence for producing cardiovascular benefits, part of a burgeoning area of research that is exploring and documenting ways to effectively use music to improve health.

A study run at four centers in Italy randomized 159 patients with heart failure, primarily New York Heart Association class I or II disease, to either a daily regimen of at least 30 minutes spent listening to music daily or to a control group that received usual care with no music prescription. After 3 months, the 82 patients in the daily music-listening group had a statistically significant improvement in their Minnesota Living with Heart Failure Questionnaire scores, compared with 77 controls for the study’s primary outcome measure. The results also showed significant benefits, compared with placebo, for other, secondary efficacy measures including improvements in anxiety, depression, sleep quality, and cognition.

Although the results are considered preliminary, they drew significant attention when published in July 2020 (J Card Fail. 2020 Jul 1;26[7]:541-9), where it was accompanied by two editorials in the same issue as well as an editor’s statement. All these commentators as well as other experts interested in music as medicine gathered to further discuss the topic during a panel session at the virtual annual meeting of the Heart Failure Society of America.

Music as a calming influence

The source of the primary benefits seen in this Italian study likely involved “emotional, psychological, and relaxation,” suggested Jerome L. Fleg, MD, program officer for clinical cardiovascular disease at the National Heart, Lung, and Blood Institute in Bethesda, Md. Researchers had used calming potential as a major criterion when selecting the 80 classical pieces that the heart failure patients in the intervention arm of the study could shuffle on their play lists.

“The tempo/rhythm was set up in a range between 60 and 80 beats per minute, because this range mirrors the human heart rate and facilitates relaxation,” the investigators said in their published report. Unfortunately, noted Dr. Fleg, the study lacked physiologic and biomarker measurements that could have provided objective evidence of effects from music. And the study failed to include a control arm of patients instructed to spend 30 minutes a day resting and relaxing without instruction to listen to music, he noted.

Dr. Fleg had authored one of the July editorials, where he said “It is hoped that findings from these studies and others can expand the scientific evidence for music-based interventions and bring these therapies into clinical practice. The current study from Burrai et al. is a positive step in this direction for patients with heart failure.” (J Card Fail. 2020 Jul 1;26[7]: 550-1). What’s needed now, he added during the virtual session, are “more objective data” to better and more comprehensively document the benefits from a music-based intervention in patients with heart failure.
 

An add-on to standard care

The findings in heart failure patients follows a growing literature that’s shown music can generate a restful state by doing things like activating autonomic parasympathetic outflow while dampening sympathetic outflow. This produces moderation in mood and emotion as well as depressed heart rate, lowered blood pressure, and slowed respiration, commented Emmeline Edwards, PhD director of the division of extramural research of the National Center for Complementary and Integrative Health in Bethesda, Md. Music also seems able to stimulate higher-order brain regions that can result in reduced psychological stress, anxiety, and depression.

“It’s a promising protective intervention to add to standard care for cardiac patients,” Dr. Edwards said during the virtual session. “Music is part of the toolbox for managing symptoms and improving health and well-being.”

“Music is not a substitute for standard therapy, but could add to it,” declared Dr. Fleg.

The already-established intervention known as music therapy has identified music’s ability to modulate breathing as an important mediator of music’s effect.

“Breathing is one of the few physiological processes that can be voluntarily controlled making it a viable target for intervention,” noted opera soprano Renée Fleming and Sheri L. Robb, PhD, in the second editorial that accompanied the Italian heart failure report (J Card Fail. 2020 Jul 1;26[7]:552-4). The music-listening intervention “may have had more effect if they had used compositional features [of the music] to teach patients how to structure their breathing,” said Dr. Robb, a music therapist at Indiana University–Purdue University Indianapolis, during the virtual session.

Another variable to consider is the type of music. “What is the emotional response to the music, and how does that affect heart rate,” wondered Dr. Robb, a professor at the Indiana University School of Nursing in Indianapolis.

Music as exercise

The division that Dr. Edwards directs recently funded a pilot study that assessed the feasibility of using music to stimulate activity and improve breathing another way, by repurposing singing as a novel form of rehabilitative exercise.

The pilot study enrolled patients with coronary disease into a randomized study that tested whether a 14-minute session of supervised singing could produce acute improvement in vascular function, “a biomarker for the risk of future cardiovascular disease events,” explained Jacqueline P. Kulinski, MD, a preventive cardiologist at the Medical College of Wisconsin in Milwaukee. Dr. Kulinski did not report details of her yet-unpublished study, but said that her initial findings held promise for developing musical activities such as singing as a novel way to stimulate therapeutic physical activity in patients with heart disease.

“It’s exciting to see this signal” of benefit. “I envision music therapy as a part of cardiac rehabilitation, or an alternative for patients who can’t participate in traditional rehab,” Dr. Kulinski said during the virtual session. “I think of singing as a physical activity, as exercise, and using this exercise as medicine.”

Harmonizing with the NIH

“Singing is like swimming: You need to hold your breath,” agreed Ms. Fleming, who participated on the virtual panel and has spearheaded a collaboration between the National Institutes of Health and the Kennedy Center for the Performing Arts, the Sound Health Initiative, that’s coordinating research into the connections between music and health. Ms. Fleming helped launch the Sound Health Initiative in 2017 by coauthoring a JAMA article with the NIH director that spelled out the rationale and goals of the project (JAMA. 2017 Jun 27;317[24]:2470-1), and by launching a lecture tour on the topic in a presentation she calls Music and the Mind.

Andrew Eccles

Ms. Fleming has given her talk in more than 30 locations worldwide, and she’s found that “audiences love” the combination of neuroscience and music that her talks cover, she said. Her lectures highlight that, in addition to cardiovascular disease, the potential for music therapy and related interventions has been shown in patients with disorders that include autism, psychosis, pain, Parkinson’s disease, Alzheimer’s disease, and epilepsy.

The research highlighted in the session “opens new doors to prevention and treatment strategies using music for patients with heart failure and cardiovascular disease,” summed up Biykem Bozkurt, MD, professor of medicine at the Baylor College of Medicine in Houston and president of the Heart Failure Society of America, who helped organize the virtual session.

Dr. Fleg, Dr. Edwards, Dr. Robb, Dr Kulinski, Ms. Fleming, and Dr. Bozkurt had no relevant financial disclosures.
 

[email protected]
 

Music listening and singing each showed early, promising evidence for producing cardiovascular benefits, part of a burgeoning area of research that is exploring and documenting ways to effectively use music to improve health.

A study run at four centers in Italy randomized 159 patients with heart failure, primarily New York Heart Association class I or II disease, to either a daily regimen of at least 30 minutes spent listening to music daily or to a control group that received usual care with no music prescription. After 3 months, the 82 patients in the daily music-listening group had a statistically significant improvement in their Minnesota Living with Heart Failure Questionnaire scores, compared with 77 controls for the study’s primary outcome measure. The results also showed significant benefits, compared with placebo, for other, secondary efficacy measures including improvements in anxiety, depression, sleep quality, and cognition.

Although the results are considered preliminary, they drew significant attention when published in July 2020 (J Card Fail. 2020 Jul 1;26[7]:541-9), where it was accompanied by two editorials in the same issue as well as an editor’s statement. All these commentators as well as other experts interested in music as medicine gathered to further discuss the topic during a panel session at the virtual annual meeting of the Heart Failure Society of America.

Music as a calming influence

The source of the primary benefits seen in this Italian study likely involved “emotional, psychological, and relaxation,” suggested Jerome L. Fleg, MD, program officer for clinical cardiovascular disease at the National Heart, Lung, and Blood Institute in Bethesda, Md. Researchers had used calming potential as a major criterion when selecting the 80 classical pieces that the heart failure patients in the intervention arm of the study could shuffle on their play lists.

“The tempo/rhythm was set up in a range between 60 and 80 beats per minute, because this range mirrors the human heart rate and facilitates relaxation,” the investigators said in their published report. Unfortunately, noted Dr. Fleg, the study lacked physiologic and biomarker measurements that could have provided objective evidence of effects from music. And the study failed to include a control arm of patients instructed to spend 30 minutes a day resting and relaxing without instruction to listen to music, he noted.

Dr. Fleg had authored one of the July editorials, where he said “It is hoped that findings from these studies and others can expand the scientific evidence for music-based interventions and bring these therapies into clinical practice. The current study from Burrai et al. is a positive step in this direction for patients with heart failure.” (J Card Fail. 2020 Jul 1;26[7]: 550-1). What’s needed now, he added during the virtual session, are “more objective data” to better and more comprehensively document the benefits from a music-based intervention in patients with heart failure.
 

An add-on to standard care

The findings in heart failure patients follows a growing literature that’s shown music can generate a restful state by doing things like activating autonomic parasympathetic outflow while dampening sympathetic outflow. This produces moderation in mood and emotion as well as depressed heart rate, lowered blood pressure, and slowed respiration, commented Emmeline Edwards, PhD director of the division of extramural research of the National Center for Complementary and Integrative Health in Bethesda, Md. Music also seems able to stimulate higher-order brain regions that can result in reduced psychological stress, anxiety, and depression.

“It’s a promising protective intervention to add to standard care for cardiac patients,” Dr. Edwards said during the virtual session. “Music is part of the toolbox for managing symptoms and improving health and well-being.”

“Music is not a substitute for standard therapy, but could add to it,” declared Dr. Fleg.

The already-established intervention known as music therapy has identified music’s ability to modulate breathing as an important mediator of music’s effect.

“Breathing is one of the few physiological processes that can be voluntarily controlled making it a viable target for intervention,” noted opera soprano Renée Fleming and Sheri L. Robb, PhD, in the second editorial that accompanied the Italian heart failure report (J Card Fail. 2020 Jul 1;26[7]:552-4). The music-listening intervention “may have had more effect if they had used compositional features [of the music] to teach patients how to structure their breathing,” said Dr. Robb, a music therapist at Indiana University–Purdue University Indianapolis, during the virtual session.

Another variable to consider is the type of music. “What is the emotional response to the music, and how does that affect heart rate,” wondered Dr. Robb, a professor at the Indiana University School of Nursing in Indianapolis.

Music as exercise

The division that Dr. Edwards directs recently funded a pilot study that assessed the feasibility of using music to stimulate activity and improve breathing another way, by repurposing singing as a novel form of rehabilitative exercise.

The pilot study enrolled patients with coronary disease into a randomized study that tested whether a 14-minute session of supervised singing could produce acute improvement in vascular function, “a biomarker for the risk of future cardiovascular disease events,” explained Jacqueline P. Kulinski, MD, a preventive cardiologist at the Medical College of Wisconsin in Milwaukee. Dr. Kulinski did not report details of her yet-unpublished study, but said that her initial findings held promise for developing musical activities such as singing as a novel way to stimulate therapeutic physical activity in patients with heart disease.

“It’s exciting to see this signal” of benefit. “I envision music therapy as a part of cardiac rehabilitation, or an alternative for patients who can’t participate in traditional rehab,” Dr. Kulinski said during the virtual session. “I think of singing as a physical activity, as exercise, and using this exercise as medicine.”

Harmonizing with the NIH

“Singing is like swimming: You need to hold your breath,” agreed Ms. Fleming, who participated on the virtual panel and has spearheaded a collaboration between the National Institutes of Health and the Kennedy Center for the Performing Arts, the Sound Health Initiative, that’s coordinating research into the connections between music and health. Ms. Fleming helped launch the Sound Health Initiative in 2017 by coauthoring a JAMA article with the NIH director that spelled out the rationale and goals of the project (JAMA. 2017 Jun 27;317[24]:2470-1), and by launching a lecture tour on the topic in a presentation she calls Music and the Mind.

Andrew Eccles

Ms. Fleming has given her talk in more than 30 locations worldwide, and she’s found that “audiences love” the combination of neuroscience and music that her talks cover, she said. Her lectures highlight that, in addition to cardiovascular disease, the potential for music therapy and related interventions has been shown in patients with disorders that include autism, psychosis, pain, Parkinson’s disease, Alzheimer’s disease, and epilepsy.

The research highlighted in the session “opens new doors to prevention and treatment strategies using music for patients with heart failure and cardiovascular disease,” summed up Biykem Bozkurt, MD, professor of medicine at the Baylor College of Medicine in Houston and president of the Heart Failure Society of America, who helped organize the virtual session.

Dr. Fleg, Dr. Edwards, Dr. Robb, Dr Kulinski, Ms. Fleming, and Dr. Bozkurt had no relevant financial disclosures.
 

[email protected]
 

Music listening and singing each showed early, promising evidence for producing cardiovascular benefits, part of a burgeoning area of research that is exploring and documenting ways to effectively use music to improve health.

A study run at four centers in Italy randomized 159 patients with heart failure, primarily New York Heart Association class I or II disease, to either a daily regimen of at least 30 minutes spent listening to music daily or to a control group that received usual care with no music prescription. After 3 months, the 82 patients in the daily music-listening group had a statistically significant improvement in their Minnesota Living with Heart Failure Questionnaire scores, compared with 77 controls for the study’s primary outcome measure. The results also showed significant benefits, compared with placebo, for other, secondary efficacy measures including improvements in anxiety, depression, sleep quality, and cognition.

Although the results are considered preliminary, they drew significant attention when published in July 2020 (J Card Fail. 2020 Jul 1;26[7]:541-9), where it was accompanied by two editorials in the same issue as well as an editor’s statement. All these commentators as well as other experts interested in music as medicine gathered to further discuss the topic during a panel session at the virtual annual meeting of the Heart Failure Society of America.

Music as a calming influence

The source of the primary benefits seen in this Italian study likely involved “emotional, psychological, and relaxation,” suggested Jerome L. Fleg, MD, program officer for clinical cardiovascular disease at the National Heart, Lung, and Blood Institute in Bethesda, Md. Researchers had used calming potential as a major criterion when selecting the 80 classical pieces that the heart failure patients in the intervention arm of the study could shuffle on their play lists.

“The tempo/rhythm was set up in a range between 60 and 80 beats per minute, because this range mirrors the human heart rate and facilitates relaxation,” the investigators said in their published report. Unfortunately, noted Dr. Fleg, the study lacked physiologic and biomarker measurements that could have provided objective evidence of effects from music. And the study failed to include a control arm of patients instructed to spend 30 minutes a day resting and relaxing without instruction to listen to music, he noted.

Dr. Fleg had authored one of the July editorials, where he said “It is hoped that findings from these studies and others can expand the scientific evidence for music-based interventions and bring these therapies into clinical practice. The current study from Burrai et al. is a positive step in this direction for patients with heart failure.” (J Card Fail. 2020 Jul 1;26[7]: 550-1). What’s needed now, he added during the virtual session, are “more objective data” to better and more comprehensively document the benefits from a music-based intervention in patients with heart failure.
 

An add-on to standard care

The findings in heart failure patients follows a growing literature that’s shown music can generate a restful state by doing things like activating autonomic parasympathetic outflow while dampening sympathetic outflow. This produces moderation in mood and emotion as well as depressed heart rate, lowered blood pressure, and slowed respiration, commented Emmeline Edwards, PhD director of the division of extramural research of the National Center for Complementary and Integrative Health in Bethesda, Md. Music also seems able to stimulate higher-order brain regions that can result in reduced psychological stress, anxiety, and depression.

“It’s a promising protective intervention to add to standard care for cardiac patients,” Dr. Edwards said during the virtual session. “Music is part of the toolbox for managing symptoms and improving health and well-being.”

“Music is not a substitute for standard therapy, but could add to it,” declared Dr. Fleg.

The already-established intervention known as music therapy has identified music’s ability to modulate breathing as an important mediator of music’s effect.

“Breathing is one of the few physiological processes that can be voluntarily controlled making it a viable target for intervention,” noted opera soprano Renée Fleming and Sheri L. Robb, PhD, in the second editorial that accompanied the Italian heart failure report (J Card Fail. 2020 Jul 1;26[7]:552-4). The music-listening intervention “may have had more effect if they had used compositional features [of the music] to teach patients how to structure their breathing,” said Dr. Robb, a music therapist at Indiana University–Purdue University Indianapolis, during the virtual session.

Another variable to consider is the type of music. “What is the emotional response to the music, and how does that affect heart rate,” wondered Dr. Robb, a professor at the Indiana University School of Nursing in Indianapolis.

Music as exercise

The division that Dr. Edwards directs recently funded a pilot study that assessed the feasibility of using music to stimulate activity and improve breathing another way, by repurposing singing as a novel form of rehabilitative exercise.

The pilot study enrolled patients with coronary disease into a randomized study that tested whether a 14-minute session of supervised singing could produce acute improvement in vascular function, “a biomarker for the risk of future cardiovascular disease events,” explained Jacqueline P. Kulinski, MD, a preventive cardiologist at the Medical College of Wisconsin in Milwaukee. Dr. Kulinski did not report details of her yet-unpublished study, but said that her initial findings held promise for developing musical activities such as singing as a novel way to stimulate therapeutic physical activity in patients with heart disease.

“It’s exciting to see this signal” of benefit. “I envision music therapy as a part of cardiac rehabilitation, or an alternative for patients who can’t participate in traditional rehab,” Dr. Kulinski said during the virtual session. “I think of singing as a physical activity, as exercise, and using this exercise as medicine.”

Harmonizing with the NIH

“Singing is like swimming: You need to hold your breath,” agreed Ms. Fleming, who participated on the virtual panel and has spearheaded a collaboration between the National Institutes of Health and the Kennedy Center for the Performing Arts, the Sound Health Initiative, that’s coordinating research into the connections between music and health. Ms. Fleming helped launch the Sound Health Initiative in 2017 by coauthoring a JAMA article with the NIH director that spelled out the rationale and goals of the project (JAMA. 2017 Jun 27;317[24]:2470-1), and by launching a lecture tour on the topic in a presentation she calls Music and the Mind.

Andrew Eccles

Ms. Fleming has given her talk in more than 30 locations worldwide, and she’s found that “audiences love” the combination of neuroscience and music that her talks cover, she said. Her lectures highlight that, in addition to cardiovascular disease, the potential for music therapy and related interventions has been shown in patients with disorders that include autism, psychosis, pain, Parkinson’s disease, Alzheimer’s disease, and epilepsy.

The research highlighted in the session “opens new doors to prevention and treatment strategies using music for patients with heart failure and cardiovascular disease,” summed up Biykem Bozkurt, MD, professor of medicine at the Baylor College of Medicine in Houston and president of the Heart Failure Society of America, who helped organize the virtual session.

Dr. Fleg, Dr. Edwards, Dr. Robb, Dr Kulinski, Ms. Fleming, and Dr. Bozkurt had no relevant financial disclosures.
 

[email protected]
 

Despite the ongoing epidemic of misuse, overuse, and diversion of opioids, the Food and Drug Administration has set a low bar for approval of these medications over the past 20 years, new research suggests.

Results of a cross-sectional study reveal that between 1997 and 2018, the majority of approvals of opioids for the treatment of chronic pain were based on pivotal trials that lacked critical safety and efficacy data.

The study results also show that the FDA did not require manufacturers to collect safety data on tolerance, withdrawal, overdose, misuse, and diversion in any rigorous fashion.

In addition, during the study period, 17 of the 39 new drug applications (NDAs) (only one was an innovator product, known as a new molecular entity) for chronic pain were approved with an “enriched enrollment randomized withdrawal” (EERW) trial design. Such a design, in this case, allowed manufacturers to exclude 32%-43% of the initially enrolled patients from the double-blind treatment phase.

“The question for regulators, policy makers, and others is: How did we get to a point where these approvals took place based on trials that were by design unlikely to yield some of the most important information about safety and efficacy that patients and clinicians would care about?” study investigator G. Caleb Alexander, MD, Johns Hopkins University, Baltimore, said in an interview.

The study was published online Sept. 29 in the Annals of Internal Medicine.
 

‘Cooking the books’

Little is known about the evidence required by the FDA for new approvals of opioid analgesics.

To characterize the quality of safety and efficacy data in NDAs for opioid analgesics approved by the FDA between 1997 and 2018, the investigators conducted the cross-sectional analysis using data from ClinicalTrials.gov, FDA reviews, and peer-reviewed publications regarding phase 3 pivotal trials.

The investigators examined the key characteristics of each NDA, including the number, size, and duration of pivotal trials, trial control groups, use of EERW, and systematically measured safety outcomes.

Results showed that most of the 48 NDAs evaluated were for new dosage forms (52.1%) or new formulations (18.8%). Only one (2.1%) was for a new molecular entity.

Of 39 NDAs approved for the treatment of chronic pain, only 21 products were supported by at least one pivotal trial. The mean duration of these 28 trials was 84 days, and they enrolled a median of 299 patients.

Results showed that, for 17 of the 39 opioids approved for chronic pain, pivotal trials had an EERW design. For the latest period – 2012-2018 – trials of all eight of the approved opioids used the EERW method.

This EERW design allows the manufacturer to assess efficacy “among a subset of patients most likely to respond and least likely to have adverse effects, reducing generalizability to real-world settings,” the investigators noted.

They called on the FDA to stop relying on this type of trial to assess opioid efficacy.

In an August 2020 article, Andrew Kolodny, MD, pointed out the pitfalls of the EERW approach. In such a study, all participants are made physiologically dependent on the opioid in a 4- to 6-week open-label phase. Only those who tolerate the drug and find it helpful are included in the randomized study. Dr. Kolodny is codirector of opioid policy research at Brandeis University, Waltham, Mass.

“Critics of EERW have correctly described this methodology as ‘cooking the books,’ ” Dr. Kolodny writes.

He noted that the agency’s decision to rely on EERW trials for opioids was “based on discussions at private meetings between FDA officials and pharmaceutical company executives hosted by an organization called Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials.” The 2013 meetings were reported in an article published in the Washington Post.

Little sign of change

Among NDAs for chronic pain, the investigators found that eight (20.5%) included pooled safety reviews that reported systematic assessment of diversion. Seven (17.9%) reported systematic measurement of nonmedical use, and 15 (38.5%) assessed incident tolerance.

The study revealed that eight of nine products that were approved for acute pain were supported by at least one pivotal trial. The median duration of these 19 trials was 1 day, and they enrolled a median of 329 patients.

The investigators noted that the findings “underscore the evidence gaps that have limited clinicians’ and patients’ understanding and appreciation of the inherent risks of prescription opioid analgesics.”

Dr. Alexander, who has been an FDA advisory committee chairman and currently serves as a consultant to plaintiffs who are suing opioid manufacturers in federal multidistrict litigation, said the study “is a story about missed opportunities to improve the safety and to improve the regulatory review of these products.”

Coinvestigator Peter Lurie, MD, who was an official at the FDA from 2009 to 2017, said that “there’s not a lot of signs that things are changing” at the agency.

The study shows that the FDA has “accepted what the companies have been presenting,” said Dr. Lurie, who is president of the Center for Science in the Public Interest.

The FDA “absolutely has the authority” to require manufacturers to undertake more rigorous trials, but agency culture keeps it from making such demands, especially if doing so means a new applicant might have to conduct trials that weren’t previously required, Dr. Lurie said in an interview.

“FDA is pretty rigorous about trying to establish a level playing field. That’s a virtuous thing, but it becomes problematic when that prevents change,” said Dr. Lurie.

The most recent FDA guidance to manufacturers, issued in 2019, does not provide advice on criteria for endpoints, study duration, or which populations are most likely to benefit from opioid treatment. The agency also does not require drug manufacturers to formally collect data on safety, tolerance, overdose symptoms, or constipation.

The guidance does suggest that the agency would likely take into account public health considerations when evaluating opioids, such as the risk to the overall population for overdose and diversion.
 

‘Overwhelming evidence’

Dr. Kolodny said that, as far as he is aware, “this is the first scientific publication in a peer-reviewed journal demonstrating clearly the problems with FDA’s opioid approval process.”

The article offers “overwhelming evidence that they are improperly approving the most dangerous medications – medications that killed more people than any other medication on the market,” added Dr. Kolodny, who is also president of Physicians for Responsible Opioid Prescribing.

Asked to respond to the study findings, FDA spokesperson Charles Kohler said the agency “does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

A version of this article originally appeared on Medscape.com.

Despite the ongoing epidemic of misuse, overuse, and diversion of opioids, the Food and Drug Administration has set a low bar for approval of these medications over the past 20 years, new research suggests.

Results of a cross-sectional study reveal that between 1997 and 2018, the majority of approvals of opioids for the treatment of chronic pain were based on pivotal trials that lacked critical safety and efficacy data.

The study results also show that the FDA did not require manufacturers to collect safety data on tolerance, withdrawal, overdose, misuse, and diversion in any rigorous fashion.

In addition, during the study period, 17 of the 39 new drug applications (NDAs) (only one was an innovator product, known as a new molecular entity) for chronic pain were approved with an “enriched enrollment randomized withdrawal” (EERW) trial design. Such a design, in this case, allowed manufacturers to exclude 32%-43% of the initially enrolled patients from the double-blind treatment phase.

“The question for regulators, policy makers, and others is: How did we get to a point where these approvals took place based on trials that were by design unlikely to yield some of the most important information about safety and efficacy that patients and clinicians would care about?” study investigator G. Caleb Alexander, MD, Johns Hopkins University, Baltimore, said in an interview.

The study was published online Sept. 29 in the Annals of Internal Medicine.
 

‘Cooking the books’

Little is known about the evidence required by the FDA for new approvals of opioid analgesics.

To characterize the quality of safety and efficacy data in NDAs for opioid analgesics approved by the FDA between 1997 and 2018, the investigators conducted the cross-sectional analysis using data from ClinicalTrials.gov, FDA reviews, and peer-reviewed publications regarding phase 3 pivotal trials.

The investigators examined the key characteristics of each NDA, including the number, size, and duration of pivotal trials, trial control groups, use of EERW, and systematically measured safety outcomes.

Results showed that most of the 48 NDAs evaluated were for new dosage forms (52.1%) or new formulations (18.8%). Only one (2.1%) was for a new molecular entity.

Of 39 NDAs approved for the treatment of chronic pain, only 21 products were supported by at least one pivotal trial. The mean duration of these 28 trials was 84 days, and they enrolled a median of 299 patients.

Results showed that, for 17 of the 39 opioids approved for chronic pain, pivotal trials had an EERW design. For the latest period – 2012-2018 – trials of all eight of the approved opioids used the EERW method.

This EERW design allows the manufacturer to assess efficacy “among a subset of patients most likely to respond and least likely to have adverse effects, reducing generalizability to real-world settings,” the investigators noted.

They called on the FDA to stop relying on this type of trial to assess opioid efficacy.

In an August 2020 article, Andrew Kolodny, MD, pointed out the pitfalls of the EERW approach. In such a study, all participants are made physiologically dependent on the opioid in a 4- to 6-week open-label phase. Only those who tolerate the drug and find it helpful are included in the randomized study. Dr. Kolodny is codirector of opioid policy research at Brandeis University, Waltham, Mass.

“Critics of EERW have correctly described this methodology as ‘cooking the books,’ ” Dr. Kolodny writes.

He noted that the agency’s decision to rely on EERW trials for opioids was “based on discussions at private meetings between FDA officials and pharmaceutical company executives hosted by an organization called Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials.” The 2013 meetings were reported in an article published in the Washington Post.

Little sign of change

Among NDAs for chronic pain, the investigators found that eight (20.5%) included pooled safety reviews that reported systematic assessment of diversion. Seven (17.9%) reported systematic measurement of nonmedical use, and 15 (38.5%) assessed incident tolerance.

The study revealed that eight of nine products that were approved for acute pain were supported by at least one pivotal trial. The median duration of these 19 trials was 1 day, and they enrolled a median of 329 patients.

The investigators noted that the findings “underscore the evidence gaps that have limited clinicians’ and patients’ understanding and appreciation of the inherent risks of prescription opioid analgesics.”

Dr. Alexander, who has been an FDA advisory committee chairman and currently serves as a consultant to plaintiffs who are suing opioid manufacturers in federal multidistrict litigation, said the study “is a story about missed opportunities to improve the safety and to improve the regulatory review of these products.”

Coinvestigator Peter Lurie, MD, who was an official at the FDA from 2009 to 2017, said that “there’s not a lot of signs that things are changing” at the agency.

The study shows that the FDA has “accepted what the companies have been presenting,” said Dr. Lurie, who is president of the Center for Science in the Public Interest.

The FDA “absolutely has the authority” to require manufacturers to undertake more rigorous trials, but agency culture keeps it from making such demands, especially if doing so means a new applicant might have to conduct trials that weren’t previously required, Dr. Lurie said in an interview.

“FDA is pretty rigorous about trying to establish a level playing field. That’s a virtuous thing, but it becomes problematic when that prevents change,” said Dr. Lurie.

The most recent FDA guidance to manufacturers, issued in 2019, does not provide advice on criteria for endpoints, study duration, or which populations are most likely to benefit from opioid treatment. The agency also does not require drug manufacturers to formally collect data on safety, tolerance, overdose symptoms, or constipation.

The guidance does suggest that the agency would likely take into account public health considerations when evaluating opioids, such as the risk to the overall population for overdose and diversion.
 

‘Overwhelming evidence’

Dr. Kolodny said that, as far as he is aware, “this is the first scientific publication in a peer-reviewed journal demonstrating clearly the problems with FDA’s opioid approval process.”

The article offers “overwhelming evidence that they are improperly approving the most dangerous medications – medications that killed more people than any other medication on the market,” added Dr. Kolodny, who is also president of Physicians for Responsible Opioid Prescribing.

Asked to respond to the study findings, FDA spokesperson Charles Kohler said the agency “does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

A version of this article originally appeared on Medscape.com.

Despite the ongoing epidemic of misuse, overuse, and diversion of opioids, the Food and Drug Administration has set a low bar for approval of these medications over the past 20 years, new research suggests.

Results of a cross-sectional study reveal that between 1997 and 2018, the majority of approvals of opioids for the treatment of chronic pain were based on pivotal trials that lacked critical safety and efficacy data.

The study results also show that the FDA did not require manufacturers to collect safety data on tolerance, withdrawal, overdose, misuse, and diversion in any rigorous fashion.

In addition, during the study period, 17 of the 39 new drug applications (NDAs) (only one was an innovator product, known as a new molecular entity) for chronic pain were approved with an “enriched enrollment randomized withdrawal” (EERW) trial design. Such a design, in this case, allowed manufacturers to exclude 32%-43% of the initially enrolled patients from the double-blind treatment phase.

“The question for regulators, policy makers, and others is: How did we get to a point where these approvals took place based on trials that were by design unlikely to yield some of the most important information about safety and efficacy that patients and clinicians would care about?” study investigator G. Caleb Alexander, MD, Johns Hopkins University, Baltimore, said in an interview.

The study was published online Sept. 29 in the Annals of Internal Medicine.
 

‘Cooking the books’

Little is known about the evidence required by the FDA for new approvals of opioid analgesics.

To characterize the quality of safety and efficacy data in NDAs for opioid analgesics approved by the FDA between 1997 and 2018, the investigators conducted the cross-sectional analysis using data from ClinicalTrials.gov, FDA reviews, and peer-reviewed publications regarding phase 3 pivotal trials.

The investigators examined the key characteristics of each NDA, including the number, size, and duration of pivotal trials, trial control groups, use of EERW, and systematically measured safety outcomes.

Results showed that most of the 48 NDAs evaluated were for new dosage forms (52.1%) or new formulations (18.8%). Only one (2.1%) was for a new molecular entity.

Of 39 NDAs approved for the treatment of chronic pain, only 21 products were supported by at least one pivotal trial. The mean duration of these 28 trials was 84 days, and they enrolled a median of 299 patients.

Results showed that, for 17 of the 39 opioids approved for chronic pain, pivotal trials had an EERW design. For the latest period – 2012-2018 – trials of all eight of the approved opioids used the EERW method.

This EERW design allows the manufacturer to assess efficacy “among a subset of patients most likely to respond and least likely to have adverse effects, reducing generalizability to real-world settings,” the investigators noted.

They called on the FDA to stop relying on this type of trial to assess opioid efficacy.

In an August 2020 article, Andrew Kolodny, MD, pointed out the pitfalls of the EERW approach. In such a study, all participants are made physiologically dependent on the opioid in a 4- to 6-week open-label phase. Only those who tolerate the drug and find it helpful are included in the randomized study. Dr. Kolodny is codirector of opioid policy research at Brandeis University, Waltham, Mass.

“Critics of EERW have correctly described this methodology as ‘cooking the books,’ ” Dr. Kolodny writes.

He noted that the agency’s decision to rely on EERW trials for opioids was “based on discussions at private meetings between FDA officials and pharmaceutical company executives hosted by an organization called Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials.” The 2013 meetings were reported in an article published in the Washington Post.

Little sign of change

Among NDAs for chronic pain, the investigators found that eight (20.5%) included pooled safety reviews that reported systematic assessment of diversion. Seven (17.9%) reported systematic measurement of nonmedical use, and 15 (38.5%) assessed incident tolerance.

The study revealed that eight of nine products that were approved for acute pain were supported by at least one pivotal trial. The median duration of these 19 trials was 1 day, and they enrolled a median of 329 patients.

The investigators noted that the findings “underscore the evidence gaps that have limited clinicians’ and patients’ understanding and appreciation of the inherent risks of prescription opioid analgesics.”

Dr. Alexander, who has been an FDA advisory committee chairman and currently serves as a consultant to plaintiffs who are suing opioid manufacturers in federal multidistrict litigation, said the study “is a story about missed opportunities to improve the safety and to improve the regulatory review of these products.”

Coinvestigator Peter Lurie, MD, who was an official at the FDA from 2009 to 2017, said that “there’s not a lot of signs that things are changing” at the agency.

The study shows that the FDA has “accepted what the companies have been presenting,” said Dr. Lurie, who is president of the Center for Science in the Public Interest.

The FDA “absolutely has the authority” to require manufacturers to undertake more rigorous trials, but agency culture keeps it from making such demands, especially if doing so means a new applicant might have to conduct trials that weren’t previously required, Dr. Lurie said in an interview.

“FDA is pretty rigorous about trying to establish a level playing field. That’s a virtuous thing, but it becomes problematic when that prevents change,” said Dr. Lurie.

The most recent FDA guidance to manufacturers, issued in 2019, does not provide advice on criteria for endpoints, study duration, or which populations are most likely to benefit from opioid treatment. The agency also does not require drug manufacturers to formally collect data on safety, tolerance, overdose symptoms, or constipation.

The guidance does suggest that the agency would likely take into account public health considerations when evaluating opioids, such as the risk to the overall population for overdose and diversion.
 

‘Overwhelming evidence’

Dr. Kolodny said that, as far as he is aware, “this is the first scientific publication in a peer-reviewed journal demonstrating clearly the problems with FDA’s opioid approval process.”

The article offers “overwhelming evidence that they are improperly approving the most dangerous medications – medications that killed more people than any other medication on the market,” added Dr. Kolodny, who is also president of Physicians for Responsible Opioid Prescribing.

Asked to respond to the study findings, FDA spokesperson Charles Kohler said the agency “does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

A version of this article originally appeared on Medscape.com.