For persons with obesity who lost a substantial amount of weight on a low-calorie diet, the combination of exercise and medication significantly improved weight-loss maintenance, and more so than either strategy alone, according to results of a randomized, head-to-head trial.

A year after starting moderate to vigorous exercise coupled with liraglutide treatment, study participants had a weight loss 9.5 kg more than those who received placebo and usual activity, study results show.

Reductions in both weight and fat loss seen with exercise and liraglutide was roughly twice as much as what was achieved at 1 year with the strategies of liraglutide or exercise alone, according to authors of the study, which appears in the New England Journal of Medicine .

Although the findings may not apply to those who can’t or won’t perform moderate to vigorous exercise, the intervention in this study was nevertheless feasible in this group of persons with obesity who had a very low level of fitness, according to the authors.
 

Hope for healthy weight loss maintenance

Investigator Signe S. Torekov, PhD, said in an interview that these results provide hope that more-intensive exercise regimens, with or without medication, can be useful and well accepted among individuals struggling with obesity.

“When we started our study, we were told, ‘you are never going to have people with obesity exercising that much, and for that long’ – but people were actually very happy about the exercise,” said Dr. Torekov, a professor in the department of biomedical sciences at the University of Copenhagen.

“If you actually set up a program where people are monitored and you have a feedback system, then exercise is an excellent component in obesity treatment that should be much more actively used – not only for its weight-lowering component, but also for improving health and quality of life,” she said in an interview.

Weight-management specialist John D. Clark, MD, PhD, said results of this study can be used to help inform patients about how successful different strategies incorporating exercise and medication may be following initial weight loss.

“When patients plateau on a consistent, calorie-restricted dietary plan, we can educate them and manage expectations about what options may be available to them after their initial weight loss,” said Dr. Clark, of the University of Texas, Dallas.

“If the patient’s goal specifically is weight loss at all costs, then I may suggest, ‘let’s consider liraglutide or liraglutide in combination with exercise,’ ” he said in an interview. “Exercise improves body composition, even if it may not on its own be as successful in the next phase of their weight-loss journey, as shown in this study.”
 

Obesity and weight-loss challenges

Although it’s not uncommon for obese patients to lose a large amount of weight, keeping the weight off is frequently a challenge unless the patient follows a structured weight maintenance program, according to Dr. Torekov and coauthors.

The rapid weight regain seen in many obese patients could be a result of reductions in total energy expenditure or increased appetite. Exercise is one strategy to sustain weight loss, though according to the authors, very few studies have looked at exercise in isolation to quantify its contribution to maintenance.

Accordingly, the present study sought to determine whether exercise, medication, or the combination thereof works best to keep weight off.

The study incorporated liraglutide, a GLP-1 receptor agonist indicated for chronic weight management, along with a reduced-calorie diet and increased physical activity, in adults with elevated body mass index and at least one weight-related comorbidity.

The investigator-initiated phase 3 trial included 215 adults with a body mass index of 32-43. Individuals with type 2 diabetes were excluded. All participants followed an 8-week, low-calorie diet comprising 800 calories per day.

Participants who lost 5% or more of their body weight were then randomized to 1 year of exercise plus liraglutide, exercise plus placebo, usual activity plus liraglutide, or usual activity plus placebo.

The exercise program – which was structured but flexible, according to investigators – included group exercise sessions that incorporated 30 minutes of indoor cycling and 15 minutes of circuit training 2 days each week. Participants wore heart rate monitors during exercise to make sure they reached targets for moderate to vigorous intensity.

Instructors trained in exercise physiology planned and monitored individualized exercise programs for each participant in the exercise-medication or exercise-only arms of the study.

Participants in all groups attended 12 one-on-one consultations where body weight was measured and dietetic support was provided.
 

Weight loss with exercise and medication

Out of 215 individuals enrolled in the study, 195 lost at least 5% of body weight and continued on to the randomized portion, the investigators reported. During the diet phase, they lost a mean of 13.1 kg, translating into a 12% mean reduction in body weight.

The mean frequency of exercise was 2.4 times per week in the exercise-plus-medication group and 2.5 times per week in the exercise-only group. About one-third of the exercise took place in the group sessions, and there was no difference in relative intensity between group and individual exercise regimens, the investigators said.

Individuals in the exercise plus medication group continued to lose more weight, such that, at the end of 1 year, the weight loss decreased even further, by a mean of –3.4 kg. By contrast, weight increased by a mean of 6.1 kg for the placebo group, adding up to a treatment difference of –9.5 kg (95% confidence interval, –13.1 to –5.9; P < .001), according to the report.

That treatment effect was also seen, but more muted, in the exercise- and liraglutide-only groups, at –4.1 kg and –6.8 kg, respectively.

A significant treatment effect was observed for exercise plus liraglutide, compared with exercise alone, at –5.4 kg (P = .004), while the treatment effect for the combination versus liraglutide alone was not significant at –2.7 kg (P = .13), the data show.

Body-fat reduction at 52 weeks was –3.9 percentage points for exercise plus liraglutide as compared with placebo, or roughly twice the reductions seen in the exercise- and liraglutide-alone groups, the investigators said, adding that the combination preserved lean mass.

Reductions in hemoglobin A1c, which are generally thought to reduce diabetes risk, were reduced in both the liraglutide and liraglutide-exercise combination group, according to their report.

The research was supported in part by grants from the Novo Nordisk Foundation.

For persons with obesity who lost a substantial amount of weight on a low-calorie diet, the combination of exercise and medication significantly improved weight-loss maintenance, and more so than either strategy alone, according to results of a randomized, head-to-head trial.

A year after starting moderate to vigorous exercise coupled with liraglutide treatment, study participants had a weight loss 9.5 kg more than those who received placebo and usual activity, study results show.

Reductions in both weight and fat loss seen with exercise and liraglutide was roughly twice as much as what was achieved at 1 year with the strategies of liraglutide or exercise alone, according to authors of the study, which appears in the New England Journal of Medicine .

Although the findings may not apply to those who can’t or won’t perform moderate to vigorous exercise, the intervention in this study was nevertheless feasible in this group of persons with obesity who had a very low level of fitness, according to the authors.
 

Hope for healthy weight loss maintenance

Investigator Signe S. Torekov, PhD, said in an interview that these results provide hope that more-intensive exercise regimens, with or without medication, can be useful and well accepted among individuals struggling with obesity.

“When we started our study, we were told, ‘you are never going to have people with obesity exercising that much, and for that long’ – but people were actually very happy about the exercise,” said Dr. Torekov, a professor in the department of biomedical sciences at the University of Copenhagen.

“If you actually set up a program where people are monitored and you have a feedback system, then exercise is an excellent component in obesity treatment that should be much more actively used – not only for its weight-lowering component, but also for improving health and quality of life,” she said in an interview.

Weight-management specialist John D. Clark, MD, PhD, said results of this study can be used to help inform patients about how successful different strategies incorporating exercise and medication may be following initial weight loss.

“When patients plateau on a consistent, calorie-restricted dietary plan, we can educate them and manage expectations about what options may be available to them after their initial weight loss,” said Dr. Clark, of the University of Texas, Dallas.

“If the patient’s goal specifically is weight loss at all costs, then I may suggest, ‘let’s consider liraglutide or liraglutide in combination with exercise,’ ” he said in an interview. “Exercise improves body composition, even if it may not on its own be as successful in the next phase of their weight-loss journey, as shown in this study.”
 

Obesity and weight-loss challenges

Although it’s not uncommon for obese patients to lose a large amount of weight, keeping the weight off is frequently a challenge unless the patient follows a structured weight maintenance program, according to Dr. Torekov and coauthors.

The rapid weight regain seen in many obese patients could be a result of reductions in total energy expenditure or increased appetite. Exercise is one strategy to sustain weight loss, though according to the authors, very few studies have looked at exercise in isolation to quantify its contribution to maintenance.

Accordingly, the present study sought to determine whether exercise, medication, or the combination thereof works best to keep weight off.

The study incorporated liraglutide, a GLP-1 receptor agonist indicated for chronic weight management, along with a reduced-calorie diet and increased physical activity, in adults with elevated body mass index and at least one weight-related comorbidity.

The investigator-initiated phase 3 trial included 215 adults with a body mass index of 32-43. Individuals with type 2 diabetes were excluded. All participants followed an 8-week, low-calorie diet comprising 800 calories per day.

Participants who lost 5% or more of their body weight were then randomized to 1 year of exercise plus liraglutide, exercise plus placebo, usual activity plus liraglutide, or usual activity plus placebo.

The exercise program – which was structured but flexible, according to investigators – included group exercise sessions that incorporated 30 minutes of indoor cycling and 15 minutes of circuit training 2 days each week. Participants wore heart rate monitors during exercise to make sure they reached targets for moderate to vigorous intensity.

Instructors trained in exercise physiology planned and monitored individualized exercise programs for each participant in the exercise-medication or exercise-only arms of the study.

Participants in all groups attended 12 one-on-one consultations where body weight was measured and dietetic support was provided.
 

Weight loss with exercise and medication

Out of 215 individuals enrolled in the study, 195 lost at least 5% of body weight and continued on to the randomized portion, the investigators reported. During the diet phase, they lost a mean of 13.1 kg, translating into a 12% mean reduction in body weight.

The mean frequency of exercise was 2.4 times per week in the exercise-plus-medication group and 2.5 times per week in the exercise-only group. About one-third of the exercise took place in the group sessions, and there was no difference in relative intensity between group and individual exercise regimens, the investigators said.

Individuals in the exercise plus medication group continued to lose more weight, such that, at the end of 1 year, the weight loss decreased even further, by a mean of –3.4 kg. By contrast, weight increased by a mean of 6.1 kg for the placebo group, adding up to a treatment difference of –9.5 kg (95% confidence interval, –13.1 to –5.9; P < .001), according to the report.

That treatment effect was also seen, but more muted, in the exercise- and liraglutide-only groups, at –4.1 kg and –6.8 kg, respectively.

A significant treatment effect was observed for exercise plus liraglutide, compared with exercise alone, at –5.4 kg (P = .004), while the treatment effect for the combination versus liraglutide alone was not significant at –2.7 kg (P = .13), the data show.

Body-fat reduction at 52 weeks was –3.9 percentage points for exercise plus liraglutide as compared with placebo, or roughly twice the reductions seen in the exercise- and liraglutide-alone groups, the investigators said, adding that the combination preserved lean mass.

Reductions in hemoglobin A1c, which are generally thought to reduce diabetes risk, were reduced in both the liraglutide and liraglutide-exercise combination group, according to their report.

The research was supported in part by grants from the Novo Nordisk Foundation.

For persons with obesity who lost a substantial amount of weight on a low-calorie diet, the combination of exercise and medication significantly improved weight-loss maintenance, and more so than either strategy alone, according to results of a randomized, head-to-head trial.

A year after starting moderate to vigorous exercise coupled with liraglutide treatment, study participants had a weight loss 9.5 kg more than those who received placebo and usual activity, study results show.

Reductions in both weight and fat loss seen with exercise and liraglutide was roughly twice as much as what was achieved at 1 year with the strategies of liraglutide or exercise alone, according to authors of the study, which appears in the New England Journal of Medicine .

Although the findings may not apply to those who can’t or won’t perform moderate to vigorous exercise, the intervention in this study was nevertheless feasible in this group of persons with obesity who had a very low level of fitness, according to the authors.
 

Hope for healthy weight loss maintenance

Investigator Signe S. Torekov, PhD, said in an interview that these results provide hope that more-intensive exercise regimens, with or without medication, can be useful and well accepted among individuals struggling with obesity.

“When we started our study, we were told, ‘you are never going to have people with obesity exercising that much, and for that long’ – but people were actually very happy about the exercise,” said Dr. Torekov, a professor in the department of biomedical sciences at the University of Copenhagen.

“If you actually set up a program where people are monitored and you have a feedback system, then exercise is an excellent component in obesity treatment that should be much more actively used – not only for its weight-lowering component, but also for improving health and quality of life,” she said in an interview.

Weight-management specialist John D. Clark, MD, PhD, said results of this study can be used to help inform patients about how successful different strategies incorporating exercise and medication may be following initial weight loss.

“When patients plateau on a consistent, calorie-restricted dietary plan, we can educate them and manage expectations about what options may be available to them after their initial weight loss,” said Dr. Clark, of the University of Texas, Dallas.

“If the patient’s goal specifically is weight loss at all costs, then I may suggest, ‘let’s consider liraglutide or liraglutide in combination with exercise,’ ” he said in an interview. “Exercise improves body composition, even if it may not on its own be as successful in the next phase of their weight-loss journey, as shown in this study.”
 

Obesity and weight-loss challenges

Although it’s not uncommon for obese patients to lose a large amount of weight, keeping the weight off is frequently a challenge unless the patient follows a structured weight maintenance program, according to Dr. Torekov and coauthors.

The rapid weight regain seen in many obese patients could be a result of reductions in total energy expenditure or increased appetite. Exercise is one strategy to sustain weight loss, though according to the authors, very few studies have looked at exercise in isolation to quantify its contribution to maintenance.

Accordingly, the present study sought to determine whether exercise, medication, or the combination thereof works best to keep weight off.

The study incorporated liraglutide, a GLP-1 receptor agonist indicated for chronic weight management, along with a reduced-calorie diet and increased physical activity, in adults with elevated body mass index and at least one weight-related comorbidity.

The investigator-initiated phase 3 trial included 215 adults with a body mass index of 32-43. Individuals with type 2 diabetes were excluded. All participants followed an 8-week, low-calorie diet comprising 800 calories per day.

Participants who lost 5% or more of their body weight were then randomized to 1 year of exercise plus liraglutide, exercise plus placebo, usual activity plus liraglutide, or usual activity plus placebo.

The exercise program – which was structured but flexible, according to investigators – included group exercise sessions that incorporated 30 minutes of indoor cycling and 15 minutes of circuit training 2 days each week. Participants wore heart rate monitors during exercise to make sure they reached targets for moderate to vigorous intensity.

Instructors trained in exercise physiology planned and monitored individualized exercise programs for each participant in the exercise-medication or exercise-only arms of the study.

Participants in all groups attended 12 one-on-one consultations where body weight was measured and dietetic support was provided.
 

Weight loss with exercise and medication

Out of 215 individuals enrolled in the study, 195 lost at least 5% of body weight and continued on to the randomized portion, the investigators reported. During the diet phase, they lost a mean of 13.1 kg, translating into a 12% mean reduction in body weight.

The mean frequency of exercise was 2.4 times per week in the exercise-plus-medication group and 2.5 times per week in the exercise-only group. About one-third of the exercise took place in the group sessions, and there was no difference in relative intensity between group and individual exercise regimens, the investigators said.

Individuals in the exercise plus medication group continued to lose more weight, such that, at the end of 1 year, the weight loss decreased even further, by a mean of –3.4 kg. By contrast, weight increased by a mean of 6.1 kg for the placebo group, adding up to a treatment difference of –9.5 kg (95% confidence interval, –13.1 to –5.9; P < .001), according to the report.

That treatment effect was also seen, but more muted, in the exercise- and liraglutide-only groups, at –4.1 kg and –6.8 kg, respectively.

A significant treatment effect was observed for exercise plus liraglutide, compared with exercise alone, at –5.4 kg (P = .004), while the treatment effect for the combination versus liraglutide alone was not significant at –2.7 kg (P = .13), the data show.

Body-fat reduction at 52 weeks was –3.9 percentage points for exercise plus liraglutide as compared with placebo, or roughly twice the reductions seen in the exercise- and liraglutide-alone groups, the investigators said, adding that the combination preserved lean mass.

Reductions in hemoglobin A1c, which are generally thought to reduce diabetes risk, were reduced in both the liraglutide and liraglutide-exercise combination group, according to their report.

The research was supported in part by grants from the Novo Nordisk Foundation.

In 2017-2018, only one in three U.S. adults with diabetes received five basic elements of care recommended by the American Diabetes Association, new research indicates.

BakiBG

The proportions of patients who visited a physician for diabetes care and received hemoglobin A1c testing, foot and eye exams, and cholesterol testing increased from 2005 to 2018. However, this increase was primarily among those aged 65 years and older, and therefore eligible for Medicare.

“Our study suggests that providing affordable health care coverage can help ensure people with diabetes get recommended care. We also found that patients who were not receiving recommended care were more likely to be younger, newly diagnosed with diabetes, and not on diabetes medication. Clinicians can pay more attention to these patient populations to improve recommended care delivery and prevent diabetes-related complications,” lead author Jung-Im Shin, MD, said in an interview.

The data predate the COVID-19 pandemic, which has also had major effects on delivery of diabetes care, added Dr. Shin of Johns Hopkins University, Baltimore.

“Routine visits to the doctor and important screenings for retinopathy or foot examination have been postponed. People with diabetes have had to reschedule or cancel nonurgent visits, some have lost ... insurance following unemployment, and many have avoided health care facilities out of fear. We are only just beginning to understand the consequences of the pandemic on the health of people with diabetes,” Dr. Shin noted.
 

Overall improvements seen only in those aged 65 and older

The data, from 4,069 adults aged 20 years and older from the 2005-2018 National Health and Nutrition and Examination Survey (NHANES), were published online April 16, 2021, in Diabetes Care.

Dr. Shin and colleagues defined receipt of diabetes care as meeting all of the following five criteria in the past 12 months, based on the ADA Standards of Care and NHANES data availability: seeing a primary doctor for diabetes care, receiving A1c testing, receiving a foot examination, receiving an eye examination, and receiving cholesterol testing.

Over the entire 13-year period, 29.2% of respondents reported having received all five components.

That proportion increased significantly over time, from 25.0% in 2005-2006 to 34.1% in 2017-2018 (P = .004). However, among the individual components, only receiving A1c testing increased significantly over time, from 64.4% to 85.3%, in all age groups (P < .001).

Moreover, when stratified by age, receipt of all five components only increased significantly among participants aged 65 and older, from 29.3% in 2005-2006 to 44.2% in 2017-2018 (P = .001).

The proportion remained unchanged among those aged 40-64 (25.2% to 25.8%; P =  .457) and showed a nonsignificant increase in those aged 20-39 (9.9% to 26.0%; P = .401).

In adjusted analyses, older age, higher income and education, health insurance, longer duration of diabetes, use of diabetes medications, and hypercholesterolemia were significantly associated with receipt of ADA guideline–recommended diabetes care.

Factors not found to be associated with care receipt included sex, race/ethnicity, body mass index, smoking status, A1c, hypertension, cardiovascular disease, chronic kidney disease, and depressive symptoms.

Participants who received ADA guideline–recommended care were significantly more likely to achieve A1c below 7.5% (adjusted odds ratio, 1.52), blood pressure less than 140/90 mm Hg (aOR, 1.47), and LDL cholesterol below 100 mg/dL (aOR, 1.47), and to receive cholesterol-lowering medication (aOR, 1.79).

Dr. Shin said that it will be “important to study the impact of COVID-19 on diabetes care when new data are available.”

The project was supported by a research grant from Merck to Johns Hopkins University. Shin has reported receiving a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Two coauthors are Merck employees.

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

In 2017-2018, only one in three U.S. adults with diabetes received five basic elements of care recommended by the American Diabetes Association, new research indicates.

BakiBG

The proportions of patients who visited a physician for diabetes care and received hemoglobin A1c testing, foot and eye exams, and cholesterol testing increased from 2005 to 2018. However, this increase was primarily among those aged 65 years and older, and therefore eligible for Medicare.

“Our study suggests that providing affordable health care coverage can help ensure people with diabetes get recommended care. We also found that patients who were not receiving recommended care were more likely to be younger, newly diagnosed with diabetes, and not on diabetes medication. Clinicians can pay more attention to these patient populations to improve recommended care delivery and prevent diabetes-related complications,” lead author Jung-Im Shin, MD, said in an interview.

The data predate the COVID-19 pandemic, which has also had major effects on delivery of diabetes care, added Dr. Shin of Johns Hopkins University, Baltimore.

“Routine visits to the doctor and important screenings for retinopathy or foot examination have been postponed. People with diabetes have had to reschedule or cancel nonurgent visits, some have lost ... insurance following unemployment, and many have avoided health care facilities out of fear. We are only just beginning to understand the consequences of the pandemic on the health of people with diabetes,” Dr. Shin noted.
 

Overall improvements seen only in those aged 65 and older

The data, from 4,069 adults aged 20 years and older from the 2005-2018 National Health and Nutrition and Examination Survey (NHANES), were published online April 16, 2021, in Diabetes Care.

Dr. Shin and colleagues defined receipt of diabetes care as meeting all of the following five criteria in the past 12 months, based on the ADA Standards of Care and NHANES data availability: seeing a primary doctor for diabetes care, receiving A1c testing, receiving a foot examination, receiving an eye examination, and receiving cholesterol testing.

Over the entire 13-year period, 29.2% of respondents reported having received all five components.

That proportion increased significantly over time, from 25.0% in 2005-2006 to 34.1% in 2017-2018 (P = .004). However, among the individual components, only receiving A1c testing increased significantly over time, from 64.4% to 85.3%, in all age groups (P < .001).

Moreover, when stratified by age, receipt of all five components only increased significantly among participants aged 65 and older, from 29.3% in 2005-2006 to 44.2% in 2017-2018 (P = .001).

The proportion remained unchanged among those aged 40-64 (25.2% to 25.8%; P =  .457) and showed a nonsignificant increase in those aged 20-39 (9.9% to 26.0%; P = .401).

In adjusted analyses, older age, higher income and education, health insurance, longer duration of diabetes, use of diabetes medications, and hypercholesterolemia were significantly associated with receipt of ADA guideline–recommended diabetes care.

Factors not found to be associated with care receipt included sex, race/ethnicity, body mass index, smoking status, A1c, hypertension, cardiovascular disease, chronic kidney disease, and depressive symptoms.

Participants who received ADA guideline–recommended care were significantly more likely to achieve A1c below 7.5% (adjusted odds ratio, 1.52), blood pressure less than 140/90 mm Hg (aOR, 1.47), and LDL cholesterol below 100 mg/dL (aOR, 1.47), and to receive cholesterol-lowering medication (aOR, 1.79).

Dr. Shin said that it will be “important to study the impact of COVID-19 on diabetes care when new data are available.”

The project was supported by a research grant from Merck to Johns Hopkins University. Shin has reported receiving a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Two coauthors are Merck employees.

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

In 2017-2018, only one in three U.S. adults with diabetes received five basic elements of care recommended by the American Diabetes Association, new research indicates.

BakiBG

The proportions of patients who visited a physician for diabetes care and received hemoglobin A1c testing, foot and eye exams, and cholesterol testing increased from 2005 to 2018. However, this increase was primarily among those aged 65 years and older, and therefore eligible for Medicare.

“Our study suggests that providing affordable health care coverage can help ensure people with diabetes get recommended care. We also found that patients who were not receiving recommended care were more likely to be younger, newly diagnosed with diabetes, and not on diabetes medication. Clinicians can pay more attention to these patient populations to improve recommended care delivery and prevent diabetes-related complications,” lead author Jung-Im Shin, MD, said in an interview.

The data predate the COVID-19 pandemic, which has also had major effects on delivery of diabetes care, added Dr. Shin of Johns Hopkins University, Baltimore.

“Routine visits to the doctor and important screenings for retinopathy or foot examination have been postponed. People with diabetes have had to reschedule or cancel nonurgent visits, some have lost ... insurance following unemployment, and many have avoided health care facilities out of fear. We are only just beginning to understand the consequences of the pandemic on the health of people with diabetes,” Dr. Shin noted.
 

Overall improvements seen only in those aged 65 and older

The data, from 4,069 adults aged 20 years and older from the 2005-2018 National Health and Nutrition and Examination Survey (NHANES), were published online April 16, 2021, in Diabetes Care.

Dr. Shin and colleagues defined receipt of diabetes care as meeting all of the following five criteria in the past 12 months, based on the ADA Standards of Care and NHANES data availability: seeing a primary doctor for diabetes care, receiving A1c testing, receiving a foot examination, receiving an eye examination, and receiving cholesterol testing.

Over the entire 13-year period, 29.2% of respondents reported having received all five components.

That proportion increased significantly over time, from 25.0% in 2005-2006 to 34.1% in 2017-2018 (P = .004). However, among the individual components, only receiving A1c testing increased significantly over time, from 64.4% to 85.3%, in all age groups (P < .001).

Moreover, when stratified by age, receipt of all five components only increased significantly among participants aged 65 and older, from 29.3% in 2005-2006 to 44.2% in 2017-2018 (P = .001).

The proportion remained unchanged among those aged 40-64 (25.2% to 25.8%; P =  .457) and showed a nonsignificant increase in those aged 20-39 (9.9% to 26.0%; P = .401).

In adjusted analyses, older age, higher income and education, health insurance, longer duration of diabetes, use of diabetes medications, and hypercholesterolemia were significantly associated with receipt of ADA guideline–recommended diabetes care.

Factors not found to be associated with care receipt included sex, race/ethnicity, body mass index, smoking status, A1c, hypertension, cardiovascular disease, chronic kidney disease, and depressive symptoms.

Participants who received ADA guideline–recommended care were significantly more likely to achieve A1c below 7.5% (adjusted odds ratio, 1.52), blood pressure less than 140/90 mm Hg (aOR, 1.47), and LDL cholesterol below 100 mg/dL (aOR, 1.47), and to receive cholesterol-lowering medication (aOR, 1.79).

Dr. Shin said that it will be “important to study the impact of COVID-19 on diabetes care when new data are available.”

The project was supported by a research grant from Merck to Johns Hopkins University. Shin has reported receiving a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Two coauthors are Merck employees.

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

For patients with postural tachycardia syndrome (POTS), dietary sodium intake can be increased more confidently, suggests the first study to yield solid evidence to support this treatment strategy.

The results showed that high dietary sodium intake can lower plasma norepinephrine levels and ameliorate standing and orthostatic tachycardia for patients with POTS.

“These results suggest that increasing dietary salt is a good rationale for treatment of this condition, and this study gives reassurance we are doing the right thing for POTS patients by increasing their sodium intake,” senior author Satish R. Raj, MD, said in an interview.

The study, with lead author Emily M. Garland, PhD, was published online April 26, 2021, in the Journal of the American College of Cardiology.

Dr. Raj, who is professor of cardiac science at the University of Calgary (Alta.), explained that POTS includes a spectrum of disorders that affect the automatic nervous system, which regulates heart rate and blood pressure.

“It is a disorder of orthostatic intolerance – patients feel better when they lie down. It differs from orthostatic hypotension in that, when a POTS patient stands up, the blood pressure does not necessarily drop, but the heart rate increases excessively.”

Although it is normal for the heart rate to increase somewhat on standing, among patients with POTS, the heart rate increases excessively. The condition is defined as an orthostatic heart rate increase of at least 30 beats/min (or 40 beats/min among individuals aged 12-19 years ) in the absence of orthostatic hypotension.

The disorder is characterized by a range of symptoms, including lightheadedness, shortness of breath, palpitations, and exertional intolerance, that are worse when in an upright position. Patients also experience chronic fatigue and perceived cognitive impairment, Dr. Raj noted.

The typical demographic for POTS is young women; the condition often starts during the teenage years.

Patients often have low blood volume, so one approach to treatment is to increase the intake of salt and water so as to increase blood volume.

“This is one of the mainstays of treatment, but it has never really been properly studied,” Dr. Raj commented. Increasing salt intake “is an unusual message from a cardiologist, and there have been concerns that we are making recommendations against traditional advice, so we urgently need evidence to support this recommendation.”

The current crossover study enrolled 14 patients with POTS and 13 healthy control persons who, over a period of 6 days, underwent treatment with a low-sodium diet (10 mEq sodium per day) or a high-sodium diet (300 mEq sodium per day).

Supine and standing heart rate, blood pressure, serum aldosterone level, plasma renin activity, blood volume, and plasma norepinephrine and epinephrine levels were measured.

Results showed that, among the POTS patients, the high-sodium diet reduced upright heart rate and the change in heart rate on standing, compared with the low-sodium diet.

Heart rate increased by 46 beats/min with the high-sodium diet versus 60 beats/min with the low-sodium diet.

Total blood volume and plasma volume increased, and standing norepinephrine levels decreased with the high-sodium diet, compared with the low-sodium diet.

However, upright heart rate, change in heart rate, and upright norepinephrine levels remained higher among POTS patients than among control persons receiving the high-sodium diet.

There was a nonsignificant trend for a lower symptom burden score among the POTS patients who received the high-sodium diet in comparison with those taking the low-sodium diet. Scores for mental confusion, palpitations, lightheadedness, and headache trending downward on the high-sodium diet.

“We found that high levels of dietary salt did what we hoped, with increased blood volume and reduced norepinephrine levels on standing and reduced excessive increase in heart rate. While it didn’t completely normalize heart rate, this was reduced significantly,” Dr. Raj said.

Another observation from the study was that the increased salt intake seemed to be beneficial across the whole spectrum of patients.

“There are some patients who have very high levels of sympathetic activation, and there have been anecdotal reports that increasing salt may not work so well in this group,” he said. “In this study, we didn’t differentiate, but average norepinephrine levels were very high, and many patients would be considered to be hyperadrenergic. Our results suggest this treatment will help these patients too.”

He noted that sodium intake was increased in this study just through diet. “We had a special metabolic kitchen. In clinical practice, we advise patients to add regular table salt to their food, and we only use salt tablets when they cannot tolerate so much salt in their diet.”

Recognizing that there may be concerns about hypertension with long-term use of such a treatment, Dr. Raj said there were no signs of an increase in blood pressure in this study. “But this should be considered a short-term therapy for the time being, and patients need to be reassessed every few years as their physiology changes.”

The authors estimated that POTS affects up to 1% of the population. Because there is no diagnostic code for the condition at present, all incidence data are estimates.

Dr. Raj pointed out that potentially a lot of people are affected, but there is little recognition of the condition among patients and physicians.

“Many family doctors are unaware of POTS,” he noted. “Patients often have to research their symptoms themselves and inform their doctor of the condition. Many patients wait years and often see many different doctors before getting a correct diagnosis.”

He explained that patients with POTS are often diagnosed as having a psychiatric illness. “They are mainly young women with palpitations, heart pounding, shakiness, which is often labeled as anxiety.”

Dr. Raj urged clinicians to consider POTS if patients have symptoms that are worse when standing up. The diagnosis is confirmed if their blood pressure doesn’t fall when standing up but their heart rate increases by at least 30 beats/min.

He noted that not enough specialists treat this condition, so family doctors need to be able to diagnose and initiate treatment. If more aggressive treatment is required, patients can be referred to a specialist.

“One of the problems is that this condition pans across different medical specialties. No one field owns it, so it tends to get ignored. But there are clinicians who are interested in POTS, and the key is finding one of these,” he said.

“We have finally established that this high-sodium diet works as treatment for POTS,” he concluded. “We have been using it for some time, but now we have evidence for its use across the whole spectrum of patients.”

In an accompanying editorial (J Am Coll Cardiol. 2021 May 4;77[17]:2185-2186), Blair P. Grubb, MD, University of Toledo (Ohio) Medical Center, wrote that this “superb study by Garland et al. helps better establish our understanding of the pathophysiologic process taking place in POTS while at the same time providing good evidence for the augmentation of dietary sodium as one of the cornerstones of treatment.”

He added that the field needs more such studies “in our quest to better understand POTS and to elaborate therapeutic modalities to help those suffering from this debilitating illness.”

The study was supported in part by the National Heart, Lung, and Blood Institute; the National Center for Advancing Translational Sciences; and the Vanderbilt Hormone and Analytical Services Core. Dr. Raj has served as a consultant for Lundbeck NA and Theravance; has served as chair of the data safety and monitoring board for Arena Pharmaceuticals and as Cardiac Arrhythmia Network of Canada network investigator; and has served on the medical advisory board of Dysautonomia International and PoTS UK, both without financial compensation.

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

For patients with postural tachycardia syndrome (POTS), dietary sodium intake can be increased more confidently, suggests the first study to yield solid evidence to support this treatment strategy.

The results showed that high dietary sodium intake can lower plasma norepinephrine levels and ameliorate standing and orthostatic tachycardia for patients with POTS.

“These results suggest that increasing dietary salt is a good rationale for treatment of this condition, and this study gives reassurance we are doing the right thing for POTS patients by increasing their sodium intake,” senior author Satish R. Raj, MD, said in an interview.

The study, with lead author Emily M. Garland, PhD, was published online April 26, 2021, in the Journal of the American College of Cardiology.

Dr. Raj, who is professor of cardiac science at the University of Calgary (Alta.), explained that POTS includes a spectrum of disorders that affect the automatic nervous system, which regulates heart rate and blood pressure.

“It is a disorder of orthostatic intolerance – patients feel better when they lie down. It differs from orthostatic hypotension in that, when a POTS patient stands up, the blood pressure does not necessarily drop, but the heart rate increases excessively.”

Although it is normal for the heart rate to increase somewhat on standing, among patients with POTS, the heart rate increases excessively. The condition is defined as an orthostatic heart rate increase of at least 30 beats/min (or 40 beats/min among individuals aged 12-19 years ) in the absence of orthostatic hypotension.

The disorder is characterized by a range of symptoms, including lightheadedness, shortness of breath, palpitations, and exertional intolerance, that are worse when in an upright position. Patients also experience chronic fatigue and perceived cognitive impairment, Dr. Raj noted.

The typical demographic for POTS is young women; the condition often starts during the teenage years.

Patients often have low blood volume, so one approach to treatment is to increase the intake of salt and water so as to increase blood volume.

“This is one of the mainstays of treatment, but it has never really been properly studied,” Dr. Raj commented. Increasing salt intake “is an unusual message from a cardiologist, and there have been concerns that we are making recommendations against traditional advice, so we urgently need evidence to support this recommendation.”

The current crossover study enrolled 14 patients with POTS and 13 healthy control persons who, over a period of 6 days, underwent treatment with a low-sodium diet (10 mEq sodium per day) or a high-sodium diet (300 mEq sodium per day).

Supine and standing heart rate, blood pressure, serum aldosterone level, plasma renin activity, blood volume, and plasma norepinephrine and epinephrine levels were measured.

Results showed that, among the POTS patients, the high-sodium diet reduced upright heart rate and the change in heart rate on standing, compared with the low-sodium diet.

Heart rate increased by 46 beats/min with the high-sodium diet versus 60 beats/min with the low-sodium diet.

Total blood volume and plasma volume increased, and standing norepinephrine levels decreased with the high-sodium diet, compared with the low-sodium diet.

However, upright heart rate, change in heart rate, and upright norepinephrine levels remained higher among POTS patients than among control persons receiving the high-sodium diet.

There was a nonsignificant trend for a lower symptom burden score among the POTS patients who received the high-sodium diet in comparison with those taking the low-sodium diet. Scores for mental confusion, palpitations, lightheadedness, and headache trending downward on the high-sodium diet.

“We found that high levels of dietary salt did what we hoped, with increased blood volume and reduced norepinephrine levels on standing and reduced excessive increase in heart rate. While it didn’t completely normalize heart rate, this was reduced significantly,” Dr. Raj said.

Another observation from the study was that the increased salt intake seemed to be beneficial across the whole spectrum of patients.

“There are some patients who have very high levels of sympathetic activation, and there have been anecdotal reports that increasing salt may not work so well in this group,” he said. “In this study, we didn’t differentiate, but average norepinephrine levels were very high, and many patients would be considered to be hyperadrenergic. Our results suggest this treatment will help these patients too.”

He noted that sodium intake was increased in this study just through diet. “We had a special metabolic kitchen. In clinical practice, we advise patients to add regular table salt to their food, and we only use salt tablets when they cannot tolerate so much salt in their diet.”

Recognizing that there may be concerns about hypertension with long-term use of such a treatment, Dr. Raj said there were no signs of an increase in blood pressure in this study. “But this should be considered a short-term therapy for the time being, and patients need to be reassessed every few years as their physiology changes.”

The authors estimated that POTS affects up to 1% of the population. Because there is no diagnostic code for the condition at present, all incidence data are estimates.

Dr. Raj pointed out that potentially a lot of people are affected, but there is little recognition of the condition among patients and physicians.

“Many family doctors are unaware of POTS,” he noted. “Patients often have to research their symptoms themselves and inform their doctor of the condition. Many patients wait years and often see many different doctors before getting a correct diagnosis.”

He explained that patients with POTS are often diagnosed as having a psychiatric illness. “They are mainly young women with palpitations, heart pounding, shakiness, which is often labeled as anxiety.”

Dr. Raj urged clinicians to consider POTS if patients have symptoms that are worse when standing up. The diagnosis is confirmed if their blood pressure doesn’t fall when standing up but their heart rate increases by at least 30 beats/min.

He noted that not enough specialists treat this condition, so family doctors need to be able to diagnose and initiate treatment. If more aggressive treatment is required, patients can be referred to a specialist.

“One of the problems is that this condition pans across different medical specialties. No one field owns it, so it tends to get ignored. But there are clinicians who are interested in POTS, and the key is finding one of these,” he said.

“We have finally established that this high-sodium diet works as treatment for POTS,” he concluded. “We have been using it for some time, but now we have evidence for its use across the whole spectrum of patients.”

In an accompanying editorial (J Am Coll Cardiol. 2021 May 4;77[17]:2185-2186), Blair P. Grubb, MD, University of Toledo (Ohio) Medical Center, wrote that this “superb study by Garland et al. helps better establish our understanding of the pathophysiologic process taking place in POTS while at the same time providing good evidence for the augmentation of dietary sodium as one of the cornerstones of treatment.”

He added that the field needs more such studies “in our quest to better understand POTS and to elaborate therapeutic modalities to help those suffering from this debilitating illness.”

The study was supported in part by the National Heart, Lung, and Blood Institute; the National Center for Advancing Translational Sciences; and the Vanderbilt Hormone and Analytical Services Core. Dr. Raj has served as a consultant for Lundbeck NA and Theravance; has served as chair of the data safety and monitoring board for Arena Pharmaceuticals and as Cardiac Arrhythmia Network of Canada network investigator; and has served on the medical advisory board of Dysautonomia International and PoTS UK, both without financial compensation.

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

For patients with postural tachycardia syndrome (POTS), dietary sodium intake can be increased more confidently, suggests the first study to yield solid evidence to support this treatment strategy.

The results showed that high dietary sodium intake can lower plasma norepinephrine levels and ameliorate standing and orthostatic tachycardia for patients with POTS.

“These results suggest that increasing dietary salt is a good rationale for treatment of this condition, and this study gives reassurance we are doing the right thing for POTS patients by increasing their sodium intake,” senior author Satish R. Raj, MD, said in an interview.

The study, with lead author Emily M. Garland, PhD, was published online April 26, 2021, in the Journal of the American College of Cardiology.

Dr. Raj, who is professor of cardiac science at the University of Calgary (Alta.), explained that POTS includes a spectrum of disorders that affect the automatic nervous system, which regulates heart rate and blood pressure.

“It is a disorder of orthostatic intolerance – patients feel better when they lie down. It differs from orthostatic hypotension in that, when a POTS patient stands up, the blood pressure does not necessarily drop, but the heart rate increases excessively.”

Although it is normal for the heart rate to increase somewhat on standing, among patients with POTS, the heart rate increases excessively. The condition is defined as an orthostatic heart rate increase of at least 30 beats/min (or 40 beats/min among individuals aged 12-19 years ) in the absence of orthostatic hypotension.

The disorder is characterized by a range of symptoms, including lightheadedness, shortness of breath, palpitations, and exertional intolerance, that are worse when in an upright position. Patients also experience chronic fatigue and perceived cognitive impairment, Dr. Raj noted.

The typical demographic for POTS is young women; the condition often starts during the teenage years.

Patients often have low blood volume, so one approach to treatment is to increase the intake of salt and water so as to increase blood volume.

“This is one of the mainstays of treatment, but it has never really been properly studied,” Dr. Raj commented. Increasing salt intake “is an unusual message from a cardiologist, and there have been concerns that we are making recommendations against traditional advice, so we urgently need evidence to support this recommendation.”

The current crossover study enrolled 14 patients with POTS and 13 healthy control persons who, over a period of 6 days, underwent treatment with a low-sodium diet (10 mEq sodium per day) or a high-sodium diet (300 mEq sodium per day).

Supine and standing heart rate, blood pressure, serum aldosterone level, plasma renin activity, blood volume, and plasma norepinephrine and epinephrine levels were measured.

Results showed that, among the POTS patients, the high-sodium diet reduced upright heart rate and the change in heart rate on standing, compared with the low-sodium diet.

Heart rate increased by 46 beats/min with the high-sodium diet versus 60 beats/min with the low-sodium diet.

Total blood volume and plasma volume increased, and standing norepinephrine levels decreased with the high-sodium diet, compared with the low-sodium diet.

However, upright heart rate, change in heart rate, and upright norepinephrine levels remained higher among POTS patients than among control persons receiving the high-sodium diet.

There was a nonsignificant trend for a lower symptom burden score among the POTS patients who received the high-sodium diet in comparison with those taking the low-sodium diet. Scores for mental confusion, palpitations, lightheadedness, and headache trending downward on the high-sodium diet.

“We found that high levels of dietary salt did what we hoped, with increased blood volume and reduced norepinephrine levels on standing and reduced excessive increase in heart rate. While it didn’t completely normalize heart rate, this was reduced significantly,” Dr. Raj said.

Another observation from the study was that the increased salt intake seemed to be beneficial across the whole spectrum of patients.

“There are some patients who have very high levels of sympathetic activation, and there have been anecdotal reports that increasing salt may not work so well in this group,” he said. “In this study, we didn’t differentiate, but average norepinephrine levels were very high, and many patients would be considered to be hyperadrenergic. Our results suggest this treatment will help these patients too.”

He noted that sodium intake was increased in this study just through diet. “We had a special metabolic kitchen. In clinical practice, we advise patients to add regular table salt to their food, and we only use salt tablets when they cannot tolerate so much salt in their diet.”

Recognizing that there may be concerns about hypertension with long-term use of such a treatment, Dr. Raj said there were no signs of an increase in blood pressure in this study. “But this should be considered a short-term therapy for the time being, and patients need to be reassessed every few years as their physiology changes.”

The authors estimated that POTS affects up to 1% of the population. Because there is no diagnostic code for the condition at present, all incidence data are estimates.

Dr. Raj pointed out that potentially a lot of people are affected, but there is little recognition of the condition among patients and physicians.

“Many family doctors are unaware of POTS,” he noted. “Patients often have to research their symptoms themselves and inform their doctor of the condition. Many patients wait years and often see many different doctors before getting a correct diagnosis.”

He explained that patients with POTS are often diagnosed as having a psychiatric illness. “They are mainly young women with palpitations, heart pounding, shakiness, which is often labeled as anxiety.”

Dr. Raj urged clinicians to consider POTS if patients have symptoms that are worse when standing up. The diagnosis is confirmed if their blood pressure doesn’t fall when standing up but their heart rate increases by at least 30 beats/min.

He noted that not enough specialists treat this condition, so family doctors need to be able to diagnose and initiate treatment. If more aggressive treatment is required, patients can be referred to a specialist.

“One of the problems is that this condition pans across different medical specialties. No one field owns it, so it tends to get ignored. But there are clinicians who are interested in POTS, and the key is finding one of these,” he said.

“We have finally established that this high-sodium diet works as treatment for POTS,” he concluded. “We have been using it for some time, but now we have evidence for its use across the whole spectrum of patients.”

In an accompanying editorial (J Am Coll Cardiol. 2021 May 4;77[17]:2185-2186), Blair P. Grubb, MD, University of Toledo (Ohio) Medical Center, wrote that this “superb study by Garland et al. helps better establish our understanding of the pathophysiologic process taking place in POTS while at the same time providing good evidence for the augmentation of dietary sodium as one of the cornerstones of treatment.”

He added that the field needs more such studies “in our quest to better understand POTS and to elaborate therapeutic modalities to help those suffering from this debilitating illness.”

The study was supported in part by the National Heart, Lung, and Blood Institute; the National Center for Advancing Translational Sciences; and the Vanderbilt Hormone and Analytical Services Core. Dr. Raj has served as a consultant for Lundbeck NA and Theravance; has served as chair of the data safety and monitoring board for Arena Pharmaceuticals and as Cardiac Arrhythmia Network of Canada network investigator; and has served on the medical advisory board of Dysautonomia International and PoTS UK, both without financial compensation.

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

Due to its size, 2 shave biopsies targeting the most concerning portions of the lesion were performed; the results were consistent with a lichenoid keratosis (LK), also known as lichen planus-like keratosis.

LK is a benign solitary lesion that mimics basal cell carcinoma, squamous cell carcinoma, and superficial spreading or amelanotic melanoma.¹ One theory suggests that LK is a solar lentigo or actinic keratosis undergoing attack from the immune system. Lesions most often manifest as a pink, gray, or brown macule to thin papule on the trunk or extremities. Itching or mild pain may be present. Dermoscopy can help distinguish an LK from malignancy but overlapping features of fine dark regression structures (called peppering, as seen in this case) should prompt further evaluation.

LKs are great mimics and biopsy is key to distinguishing them from cancer. In this case, shave biopsies were performed in the thickest and most characteristic portions of the lesion. Punch or incisional biopsies also would have been appropriate, but any result would have been a partial result. If the result had come back as an atypical melanocytic lesion, a complete excision would have been necessary to make sure the pathology reflected the entirety of the lesion.

Armed with the knowledge that the LK was benign, the patient in this case was scheduled for a follow-up visit for cryotherapy to remove the residual lesion.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

Due to its size, 2 shave biopsies targeting the most concerning portions of the lesion were performed; the results were consistent with a lichenoid keratosis (LK), also known as lichen planus-like keratosis.

LK is a benign solitary lesion that mimics basal cell carcinoma, squamous cell carcinoma, and superficial spreading or amelanotic melanoma.¹ One theory suggests that LK is a solar lentigo or actinic keratosis undergoing attack from the immune system. Lesions most often manifest as a pink, gray, or brown macule to thin papule on the trunk or extremities. Itching or mild pain may be present. Dermoscopy can help distinguish an LK from malignancy but overlapping features of fine dark regression structures (called peppering, as seen in this case) should prompt further evaluation.

LKs are great mimics and biopsy is key to distinguishing them from cancer. In this case, shave biopsies were performed in the thickest and most characteristic portions of the lesion. Punch or incisional biopsies also would have been appropriate, but any result would have been a partial result. If the result had come back as an atypical melanocytic lesion, a complete excision would have been necessary to make sure the pathology reflected the entirety of the lesion.

Armed with the knowledge that the LK was benign, the patient in this case was scheduled for a follow-up visit for cryotherapy to remove the residual lesion.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

Due to its size, 2 shave biopsies targeting the most concerning portions of the lesion were performed; the results were consistent with a lichenoid keratosis (LK), also known as lichen planus-like keratosis.

LK is a benign solitary lesion that mimics basal cell carcinoma, squamous cell carcinoma, and superficial spreading or amelanotic melanoma.¹ One theory suggests that LK is a solar lentigo or actinic keratosis undergoing attack from the immune system. Lesions most often manifest as a pink, gray, or brown macule to thin papule on the trunk or extremities. Itching or mild pain may be present. Dermoscopy can help distinguish an LK from malignancy but overlapping features of fine dark regression structures (called peppering, as seen in this case) should prompt further evaluation.

LKs are great mimics and biopsy is key to distinguishing them from cancer. In this case, shave biopsies were performed in the thickest and most characteristic portions of the lesion. Punch or incisional biopsies also would have been appropriate, but any result would have been a partial result. If the result had come back as an atypical melanocytic lesion, a complete excision would have been necessary to make sure the pathology reflected the entirety of the lesion.

Armed with the knowledge that the LK was benign, the patient in this case was scheduled for a follow-up visit for cryotherapy to remove the residual lesion.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

When caring for older adults with multiple chronic conditions, prioritizing patient goals is more effective and efficient than trying to address each condition in isolation, said Mary Tinetti, MD, Gladys Phillips Crofoot Professor of Medicine and Public Health and chief of geriatrics at Yale University, New Haven, Conn.

During a virtual presentation at the American College of Physicians annual Internal Medicine meeting, the gerontologist noted that primary care providers face a number of challenges when managing elderly patients with multimorbidity. These challenges include a lack of representative data in clinical trials, conflicting guideline recommendations, patient nonadherence, and decreased benefit from therapies due to competing conditions, she said.

“Trying to follow multiple guidelines can result in unintentional harms to these people with multiple conditions,” Dr. Tinetti said. She gave examples of the wide-ranging goals patients can have.

“Some [patients] will maximize the focus on function, regardless of how long they are likely to live,” Dr. Tinetti said. “Others will say symptom burden management is most important to them. And others will say they want to live as long as possible, and survival is most important, even if that means a reduction in their function. These individuals also vary in the care they are willing and able to receive to achieve the outcomes that matter most to them.”

For these reasons, Dr. Tinetti recommended patient priorities care, which she and her colleagues have been developing and implementing over the past 5-6 years.

“If the benefits and harms of addressing each condition in isolation is of uncertain benefit and potentially burdensome to both clinician and patient, and we know that patients vary in their health priorities ... then what else would you want to focus on in your 20-minute visit ... except each patient’s priorities?” Dr. Tinetti asked. “This is one solution to the challenge.”


 

What is patient priorities care?

Patient priorities care is a multidisciplinary, cyclical approach to clinical decision-making composed of three steps, Dr. Tinetti explained. First, a clinician identifies the patient’s health priorities. Second, this information is transmitted to comanaging providers, who decide which of their respective treatments are consistent with the patient’s priorities. And third, those decisions are disseminated to everyone involved in the patient’s care, both within and outside of the health care system, allowing all care providers to align with the patient’s priorities, she noted.

“Each person does that from their own expertise,” Dr. Tinetti said. “The social worker will do something different than the cardiologist, the physical therapist, the endocrinologist – but everybody is aiming at the same outcome – the patient’s priorities.”

In 2019, Dr. Tinetti led a nonrandomized clinical trial to test the feasibility of patient priorities care. The study involved 366 older adults with multimorbidity, among whom 203 received usual care, while 163 received this type of care. Patients in the latter group were twice as likely to have medications stopped, and significantly less likely to have self-management tasks added and diagnostic tests ordered.
 

How electronic health records can help

In an interview, Dr. Tinetti suggested that comanaging physicians communicate through electronic health records (EHRs), first to ensure that all care providers understand a patient’s goals, then to determine if recommended therapies align with those goals.

“It would be a little bit of a culture change to do that,” Dr. Tinetti said, “but the technology is there and it isn’t too terribly time consuming.”

She went on to suggest that primary care providers are typically best suited to coordinate this process; however, if a patient receives the majority of their care from a particular specialist, then that clinician may be the most suitable coordinator.
 

Systemic obstacles and solutions

According to Cynthia Boyd, MD, interim director of the division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore, clinicians may encounter obstacles when implementing patient priorities care.

When caring for older adults with multiple chronic conditions, prioritizing patient goals is more effective and efficient than trying to address each condition in isolation, said Mary Tinetti, MD, Gladys Phillips Crofoot Professor of Medicine and Public Health and chief of geriatrics at Yale University, New Haven, Conn.

During a virtual presentation at the American College of Physicians annual Internal Medicine meeting, the gerontologist noted that primary care providers face a number of challenges when managing elderly patients with multimorbidity. These challenges include a lack of representative data in clinical trials, conflicting guideline recommendations, patient nonadherence, and decreased benefit from therapies due to competing conditions, she said.

“Trying to follow multiple guidelines can result in unintentional harms to these people with multiple conditions,” Dr. Tinetti said. She gave examples of the wide-ranging goals patients can have.

“Some [patients] will maximize the focus on function, regardless of how long they are likely to live,” Dr. Tinetti said. “Others will say symptom burden management is most important to them. And others will say they want to live as long as possible, and survival is most important, even if that means a reduction in their function. These individuals also vary in the care they are willing and able to receive to achieve the outcomes that matter most to them.”

For these reasons, Dr. Tinetti recommended patient priorities care, which she and her colleagues have been developing and implementing over the past 5-6 years.

“If the benefits and harms of addressing each condition in isolation is of uncertain benefit and potentially burdensome to both clinician and patient, and we know that patients vary in their health priorities ... then what else would you want to focus on in your 20-minute visit ... except each patient’s priorities?” Dr. Tinetti asked. “This is one solution to the challenge.”


 

What is patient priorities care?

Patient priorities care is a multidisciplinary, cyclical approach to clinical decision-making composed of three steps, Dr. Tinetti explained. First, a clinician identifies the patient’s health priorities. Second, this information is transmitted to comanaging providers, who decide which of their respective treatments are consistent with the patient’s priorities. And third, those decisions are disseminated to everyone involved in the patient’s care, both within and outside of the health care system, allowing all care providers to align with the patient’s priorities, she noted.

“Each person does that from their own expertise,” Dr. Tinetti said. “The social worker will do something different than the cardiologist, the physical therapist, the endocrinologist – but everybody is aiming at the same outcome – the patient’s priorities.”

In 2019, Dr. Tinetti led a nonrandomized clinical trial to test the feasibility of patient priorities care. The study involved 366 older adults with multimorbidity, among whom 203 received usual care, while 163 received this type of care. Patients in the latter group were twice as likely to have medications stopped, and significantly less likely to have self-management tasks added and diagnostic tests ordered.
 

How electronic health records can help

In an interview, Dr. Tinetti suggested that comanaging physicians communicate through electronic health records (EHRs), first to ensure that all care providers understand a patient’s goals, then to determine if recommended therapies align with those goals.

“It would be a little bit of a culture change to do that,” Dr. Tinetti said, “but the technology is there and it isn’t too terribly time consuming.”

She went on to suggest that primary care providers are typically best suited to coordinate this process; however, if a patient receives the majority of their care from a particular specialist, then that clinician may be the most suitable coordinator.
 

Systemic obstacles and solutions

According to Cynthia Boyd, MD, interim director of the division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore, clinicians may encounter obstacles when implementing patient priorities care.

When caring for older adults with multiple chronic conditions, prioritizing patient goals is more effective and efficient than trying to address each condition in isolation, said Mary Tinetti, MD, Gladys Phillips Crofoot Professor of Medicine and Public Health and chief of geriatrics at Yale University, New Haven, Conn.

During a virtual presentation at the American College of Physicians annual Internal Medicine meeting, the gerontologist noted that primary care providers face a number of challenges when managing elderly patients with multimorbidity. These challenges include a lack of representative data in clinical trials, conflicting guideline recommendations, patient nonadherence, and decreased benefit from therapies due to competing conditions, she said.

“Trying to follow multiple guidelines can result in unintentional harms to these people with multiple conditions,” Dr. Tinetti said. She gave examples of the wide-ranging goals patients can have.

“Some [patients] will maximize the focus on function, regardless of how long they are likely to live,” Dr. Tinetti said. “Others will say symptom burden management is most important to them. And others will say they want to live as long as possible, and survival is most important, even if that means a reduction in their function. These individuals also vary in the care they are willing and able to receive to achieve the outcomes that matter most to them.”

For these reasons, Dr. Tinetti recommended patient priorities care, which she and her colleagues have been developing and implementing over the past 5-6 years.

“If the benefits and harms of addressing each condition in isolation is of uncertain benefit and potentially burdensome to both clinician and patient, and we know that patients vary in their health priorities ... then what else would you want to focus on in your 20-minute visit ... except each patient’s priorities?” Dr. Tinetti asked. “This is one solution to the challenge.”


 

What is patient priorities care?

Patient priorities care is a multidisciplinary, cyclical approach to clinical decision-making composed of three steps, Dr. Tinetti explained. First, a clinician identifies the patient’s health priorities. Second, this information is transmitted to comanaging providers, who decide which of their respective treatments are consistent with the patient’s priorities. And third, those decisions are disseminated to everyone involved in the patient’s care, both within and outside of the health care system, allowing all care providers to align with the patient’s priorities, she noted.

“Each person does that from their own expertise,” Dr. Tinetti said. “The social worker will do something different than the cardiologist, the physical therapist, the endocrinologist – but everybody is aiming at the same outcome – the patient’s priorities.”

In 2019, Dr. Tinetti led a nonrandomized clinical trial to test the feasibility of patient priorities care. The study involved 366 older adults with multimorbidity, among whom 203 received usual care, while 163 received this type of care. Patients in the latter group were twice as likely to have medications stopped, and significantly less likely to have self-management tasks added and diagnostic tests ordered.
 

How electronic health records can help

In an interview, Dr. Tinetti suggested that comanaging physicians communicate through electronic health records (EHRs), first to ensure that all care providers understand a patient’s goals, then to determine if recommended therapies align with those goals.

“It would be a little bit of a culture change to do that,” Dr. Tinetti said, “but the technology is there and it isn’t too terribly time consuming.”

She went on to suggest that primary care providers are typically best suited to coordinate this process; however, if a patient receives the majority of their care from a particular specialist, then that clinician may be the most suitable coordinator.
 

Systemic obstacles and solutions

According to Cynthia Boyd, MD, interim director of the division of geriatric medicine and gerontology, Johns Hopkins University, Baltimore, clinicians may encounter obstacles when implementing patient priorities care.

Click here for the Thursday issue of the SHM Converge Daily News newsletter.

Click here for the Thursday issue of the SHM Converge Daily News newsletter.

Click here for the Thursday issue of the SHM Converge Daily News newsletter.

To the Editor:

Melanocytic nevi are ubiquitous, and although they are benign, patients often desire to have them removed. We report a patient who presented to our clinic after attempting home removal of a concerning mole on the back with frankincense, a remedy that she found online.

A 43-year-old woman presented with a worrisome mole on the back. She had no personal history of skin cancer, but her father had a history of melanoma in situ in his 60s. The patient reported that she had the mole for years, but approximately 1 month prior to her visit she noticed that it began to bleed and crust, causing concern for melanoma. She read online that the lesion could be removed with topical application of the essential oil frankincense; she applied it directly to the lesion on the back. Within hours she developed a burn where it was applied with associated blistering.

Clinically, the lesion appeared as a darkly pigmented, well-circumscribed papule with hemorrhagic crust overlying a well-demarcated pink plaque (Figure 1). Dermatoscopically, the lesion lacked a pigment network and demonstrated 2 distinct pink papules with peripheral telangiectasia and a pink background with white streaks (Figure 2). A shave biopsy of the lesion demonstrated a nodular basal cell carcinoma extending to the base and margin.

Approximately 6 million individuals in the United States search the internet for health information daily, and as many as 41% of those do so to learn about alternative medicine.^5,6 Although information gleaned from search engines can be useful, it is unregulated and often can be inaccurate. Clinicians generally are unaware of the erroneous material presented online and, therefore, cannot appropriately combat patient misinformation. Our case demonstrates the need to maintain an awareness of common online fallacies to better answer patient questions and guide them to more accurate sources of dermatologic information and appropriate treatment.

To the Editor:

Melanocytic nevi are ubiquitous, and although they are benign, patients often desire to have them removed. We report a patient who presented to our clinic after attempting home removal of a concerning mole on the back with frankincense, a remedy that she found online.

A 43-year-old woman presented with a worrisome mole on the back. She had no personal history of skin cancer, but her father had a history of melanoma in situ in his 60s. The patient reported that she had the mole for years, but approximately 1 month prior to her visit she noticed that it began to bleed and crust, causing concern for melanoma. She read online that the lesion could be removed with topical application of the essential oil frankincense; she applied it directly to the lesion on the back. Within hours she developed a burn where it was applied with associated blistering.

Clinically, the lesion appeared as a darkly pigmented, well-circumscribed papule with hemorrhagic crust overlying a well-demarcated pink plaque (Figure 1). Dermatoscopically, the lesion lacked a pigment network and demonstrated 2 distinct pink papules with peripheral telangiectasia and a pink background with white streaks (Figure 2). A shave biopsy of the lesion demonstrated a nodular basal cell carcinoma extending to the base and margin.

Approximately 6 million individuals in the United States search the internet for health information daily, and as many as 41% of those do so to learn about alternative medicine.^5,6 Although information gleaned from search engines can be useful, it is unregulated and often can be inaccurate. Clinicians generally are unaware of the erroneous material presented online and, therefore, cannot appropriately combat patient misinformation. Our case demonstrates the need to maintain an awareness of common online fallacies to better answer patient questions and guide them to more accurate sources of dermatologic information and appropriate treatment.

To the Editor:

Melanocytic nevi are ubiquitous, and although they are benign, patients often desire to have them removed. We report a patient who presented to our clinic after attempting home removal of a concerning mole on the back with frankincense, a remedy that she found online.

A 43-year-old woman presented with a worrisome mole on the back. She had no personal history of skin cancer, but her father had a history of melanoma in situ in his 60s. The patient reported that she had the mole for years, but approximately 1 month prior to her visit she noticed that it began to bleed and crust, causing concern for melanoma. She read online that the lesion could be removed with topical application of the essential oil frankincense; she applied it directly to the lesion on the back. Within hours she developed a burn where it was applied with associated blistering.

Clinically, the lesion appeared as a darkly pigmented, well-circumscribed papule with hemorrhagic crust overlying a well-demarcated pink plaque (Figure 1). Dermatoscopically, the lesion lacked a pigment network and demonstrated 2 distinct pink papules with peripheral telangiectasia and a pink background with white streaks (Figure 2). A shave biopsy of the lesion demonstrated a nodular basal cell carcinoma extending to the base and margin.

Approximately 6 million individuals in the United States search the internet for health information daily, and as many as 41% of those do so to learn about alternative medicine.^5,6 Although information gleaned from search engines can be useful, it is unregulated and often can be inaccurate. Clinicians generally are unaware of the erroneous material presented online and, therefore, cannot appropriately combat patient misinformation. Our case demonstrates the need to maintain an awareness of common online fallacies to better answer patient questions and guide them to more accurate sources of dermatologic information and appropriate treatment.

Reduced access to medical care, increased mental health issues, poor lifestyle habits, and concern over future care are just some of the patient-reported problems associated with the early phases of the COVID-19 pandemic, according to the results of multiple studies.

Data from the Europe-based REUMAVID study, which surveyed more 1,800 patients between April and July last year, have revealed that 58% of patients with rheumatic and musculoskeletal diseases (RMDs) had their appointments with their rheumatologists canceled, 42% could not get in touch with their primary care physicians, and 52% experienced interrupted visits to mental health specialists.

Not surprisingly, this took a toll on patients’ self-perceived health, with nearly two-thirds stating that they had fair to very poor health, and 47% reporting that their health had worsened. Furthermore, 57% of respondents reported high levels of anxiety, almost 46% were at risk for depression, and 49% reported having poor well-being overall.

“The COVID-19 pandemic has had tremendous impact,” Marco Garrido-Cumbrera, PhD, of the University of Seville, Spain, said at the British Society for Rheumatology annual conference.

Dr. Garrido-Cumbrera, who is key player in the REUMAVID initiative, explained that the project was conceived to respond to concerns raised by the president of the Spanish Federation of Spondyloarthritis Associations (CEADE) about providing the right information to their members.

“First in Italy and then in Spain, it was really difficult to deal with the pandemic and there was a lot of uncertainty from a patient perspective,” Dr. Garrido-Cumbrera said.

Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid, who was not involved in the study, observed: “I think this reflects how important collaboration between patient organizations is in order to gather relevant data, and to do it in record time.”

The REUMAVID project was the result of initial collaboration between the Health and Territory Research Group at the University of Seville and CEADE but also involved patient organizations from six other European countries: the National Axial Spondyloarthritis Society, National Rheumatoid Arthritis Society, and Arthritis Action in the United Kingdom; the French Association for the Fight against Rheumatism (AFLAR; L’Association Française de Lutte Anti-Rhumatismale); the National Association of People with Rheumatological and Rare Diseases (APMARR; Associazione Nazionale Persone con Malattie Reumatologiche e Rare) in Italy; Portuguese League Against Rheumatic Diseases (LPCDR; Liga Portuguesa contra as Doenças Reumáticas) in Portugal; the Hellenic League Against Rheumatism (ELEANA) in Greece; and the Cyprus League Against Rheumatism.
 

Pandemic presented ‘perfect storm’

“We’ve never been so well-communicated as we are now,” said Helena Marzo-Ortega, MD, PhD, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust in England who participated the REUMAVID project. The beginning of the pandemic was “the perfect storm” in that everybody jumped in to try to do something. This resulted in a myriad of research publications, surveys, and attempts to try to understand and make sense of what was happening.

“Research is being conducted in a more structured manner, and it’s given us a lot of very insightful information,” Dr. Marzo-Ortega added. Obviously, patients are important stakeholders to consult when conducting research into how the pandemic has affected them, she added, as they are the ones who had their lives turned upside down.

“A pandemic knows no boundaries, has no limits, everybody can be affected equally. But patients with rheumatic conditions were at particular risk because of the treatments,” she said. “You can remember how worried we all were initially, and thinking about the potential impact of immunosuppressants and many other aspects of these conditions.”

One of the many positives to come out of the pandemic is the “possibility of doing collaborative research at a worldwide level, not just European,” Dr. Marzo-Ortega said, referring to how the EULAR COVID-19 registries are part of the COVID-19 Global Rheumatology Alliance.

Furthermore, Dr. Marzo-Ortega believes the rheumatology community is now better prepared for any upsurges in COVID-19 or any new potentially pandemic-causing viruses.

“What we know now is that we have to be alert, and we know how to respond. We also know how to communicate effectively in order to be able to improve outcomes, not only for the health of the whole population, but also to protect patients such as ours,” she said.
 

Rheumatology practice changed practically overnight

The REUMAVID study is not alone in looking at the impact that the COVID-19 pandemic has had on RMD patients’ health and well-being, particularly during periods of lockdown or where patients were advised to “shield.”

There were “near overnight changes to rheumatology practice,” said Chris Wincup, MBBS, a clinical research fellow at University College London (UCL), who presented the findings of another large-scale survey that looked at the early effects of the pandemic nationally in the United Kingdom.

“The recovery of those services has taken time and, speaking with patients, this varies between different locations,” Dr. Wincup noted. “Unfortunately, access to care does remain a major area of unmet need [and] is something that we’re going to need to think about when planning services in the future,” he added.

Between September and October last year, Dr. Wincup and fellow UCL researchers conducted an online survey among 2,054 patients attending U.K. rheumatology clinics. As in the REUMAVID study, accessing care was difficult or very difficult for a substantial proportion of patients. However, getting medication and monitoring “were generally well maintained” despite lockdown measures.

Many patients (57%) had “extremely high levels of worry about their future care being negatively impacted as a result of the pandemic,” Dr. Wincup said, with 44% saying that their current care was worse than before the pandemic and 41% being dissatisfied with the services they were able to access.

While 48% of patients welcomed a more hybrid approach to their care, 69% thought face-to-face appointments with their rheumatologists were important and 49% wanted only face-to-face appointments. “A possible more hybrid approach, compared with pure face-to-face, is going to be something that may be required,” he said.
 

Different approach taken in CONTAIN Study

A different approach to assessing the impact of the COVID pandemic was taken by researchers at the University of Aberdeen in Scotland, observed Gary Macfarlane, MBChB, PhD.

In the COVID-19 and Musculoskeletal Heath During Lockdown (CONTAIN) study, three well-defined populations of patients from existing cohort studies were looked at prospectively. This included patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) participating in two separate British Society for Rheumatology registries, and patients at high risk for developing chronic widespread pain who had been part of the MAmMOTH (Maintaining Musculoskeletal Health) study.

“Our aim was to quantify the changes from the previous prepandemic assessment, focusing on quality of life, changes in lifestyle, and recording what has happened to their musculoskeletal health, including symptoms and disease-specific measures,” Dr. Macfarlane said.

Patients had been invited to participate in June 2020 and were reminded in October 2020 and could respond online or via a postal questionnaire. Some patients were invited to participate in in-depth interviews.

Although the participation rate was low, at 29%, this was typical of studies being conducted at this time due to “survey fatigue,” Dr. Macfarlane said. The CONTAIN study population still included a good number of patients, however, with 596 having AS, 162 PsA, and 296 at risk for chronic widespread pain.

According to Dr. Macfarlane, the CONTAIN study results were “generally reassuring.” Although there was a significant decrease in quality of life as measured by the five-level EQ-5D instrument overall, and in every subgroup population studied, “the magnitude of the decrease was small.” There was no change in disease-specific quality of life in patients with AS, for example.

Levels of pain, anxiety, or depression did increase somewhat, he reported, but the factors that influenced quality of life remained the same before and during the pandemic, such as high levels of deprivation, living in an urban location, low levels of physical activity, and sleep problems.

“Rather surprisingly, sleep problems significantly decreased overall,” Dr. Macfarlane reported. Again, it was only a small change, but “the benefit in terms of the improvement in sleep strengthened with later periods in the follow-up.”

There was also some evidence of increased low-level and high-level physical activity in patients with psoriatic arthritis.

“Mental health is a key issue not just in maintaining musculoskeletal health but also, in terms of the likelihood responding to therapy,” Dr. Macfarlane acknowledged. “Focusing on addressing anxiety is important,” he added.

“Providing enhanced support for self-management, including in relation to pain, is likely to be a priority in the absence of normal health care being available,” he suggested. Importantly, regardless of circumstances, “all patients can be affected.”

The REUMAVID study is conducted by the Health & Territory Research of the University of Seville, with the support of Novartis Pharma AG. The CONTAIN study is supported by the British Society for Rheumatology and Versus Arthritis.

No other relevant conflicts of interested were declared.
 

Reduced access to medical care, increased mental health issues, poor lifestyle habits, and concern over future care are just some of the patient-reported problems associated with the early phases of the COVID-19 pandemic, according to the results of multiple studies.

Data from the Europe-based REUMAVID study, which surveyed more 1,800 patients between April and July last year, have revealed that 58% of patients with rheumatic and musculoskeletal diseases (RMDs) had their appointments with their rheumatologists canceled, 42% could not get in touch with their primary care physicians, and 52% experienced interrupted visits to mental health specialists.

Not surprisingly, this took a toll on patients’ self-perceived health, with nearly two-thirds stating that they had fair to very poor health, and 47% reporting that their health had worsened. Furthermore, 57% of respondents reported high levels of anxiety, almost 46% were at risk for depression, and 49% reported having poor well-being overall.

“The COVID-19 pandemic has had tremendous impact,” Marco Garrido-Cumbrera, PhD, of the University of Seville, Spain, said at the British Society for Rheumatology annual conference.

Dr. Garrido-Cumbrera, who is key player in the REUMAVID initiative, explained that the project was conceived to respond to concerns raised by the president of the Spanish Federation of Spondyloarthritis Associations (CEADE) about providing the right information to their members.

“First in Italy and then in Spain, it was really difficult to deal with the pandemic and there was a lot of uncertainty from a patient perspective,” Dr. Garrido-Cumbrera said.

Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid, who was not involved in the study, observed: “I think this reflects how important collaboration between patient organizations is in order to gather relevant data, and to do it in record time.”

The REUMAVID project was the result of initial collaboration between the Health and Territory Research Group at the University of Seville and CEADE but also involved patient organizations from six other European countries: the National Axial Spondyloarthritis Society, National Rheumatoid Arthritis Society, and Arthritis Action in the United Kingdom; the French Association for the Fight against Rheumatism (AFLAR; L’Association Française de Lutte Anti-Rhumatismale); the National Association of People with Rheumatological and Rare Diseases (APMARR; Associazione Nazionale Persone con Malattie Reumatologiche e Rare) in Italy; Portuguese League Against Rheumatic Diseases (LPCDR; Liga Portuguesa contra as Doenças Reumáticas) in Portugal; the Hellenic League Against Rheumatism (ELEANA) in Greece; and the Cyprus League Against Rheumatism.
 

Pandemic presented ‘perfect storm’

“We’ve never been so well-communicated as we are now,” said Helena Marzo-Ortega, MD, PhD, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust in England who participated the REUMAVID project. The beginning of the pandemic was “the perfect storm” in that everybody jumped in to try to do something. This resulted in a myriad of research publications, surveys, and attempts to try to understand and make sense of what was happening.

“Research is being conducted in a more structured manner, and it’s given us a lot of very insightful information,” Dr. Marzo-Ortega added. Obviously, patients are important stakeholders to consult when conducting research into how the pandemic has affected them, she added, as they are the ones who had their lives turned upside down.

“A pandemic knows no boundaries, has no limits, everybody can be affected equally. But patients with rheumatic conditions were at particular risk because of the treatments,” she said. “You can remember how worried we all were initially, and thinking about the potential impact of immunosuppressants and many other aspects of these conditions.”

One of the many positives to come out of the pandemic is the “possibility of doing collaborative research at a worldwide level, not just European,” Dr. Marzo-Ortega said, referring to how the EULAR COVID-19 registries are part of the COVID-19 Global Rheumatology Alliance.

Furthermore, Dr. Marzo-Ortega believes the rheumatology community is now better prepared for any upsurges in COVID-19 or any new potentially pandemic-causing viruses.

“What we know now is that we have to be alert, and we know how to respond. We also know how to communicate effectively in order to be able to improve outcomes, not only for the health of the whole population, but also to protect patients such as ours,” she said.
 

Rheumatology practice changed practically overnight

The REUMAVID study is not alone in looking at the impact that the COVID-19 pandemic has had on RMD patients’ health and well-being, particularly during periods of lockdown or where patients were advised to “shield.”

There were “near overnight changes to rheumatology practice,” said Chris Wincup, MBBS, a clinical research fellow at University College London (UCL), who presented the findings of another large-scale survey that looked at the early effects of the pandemic nationally in the United Kingdom.

“The recovery of those services has taken time and, speaking with patients, this varies between different locations,” Dr. Wincup noted. “Unfortunately, access to care does remain a major area of unmet need [and] is something that we’re going to need to think about when planning services in the future,” he added.

Between September and October last year, Dr. Wincup and fellow UCL researchers conducted an online survey among 2,054 patients attending U.K. rheumatology clinics. As in the REUMAVID study, accessing care was difficult or very difficult for a substantial proportion of patients. However, getting medication and monitoring “were generally well maintained” despite lockdown measures.

Many patients (57%) had “extremely high levels of worry about their future care being negatively impacted as a result of the pandemic,” Dr. Wincup said, with 44% saying that their current care was worse than before the pandemic and 41% being dissatisfied with the services they were able to access.

While 48% of patients welcomed a more hybrid approach to their care, 69% thought face-to-face appointments with their rheumatologists were important and 49% wanted only face-to-face appointments. “A possible more hybrid approach, compared with pure face-to-face, is going to be something that may be required,” he said.
 

Different approach taken in CONTAIN Study

A different approach to assessing the impact of the COVID pandemic was taken by researchers at the University of Aberdeen in Scotland, observed Gary Macfarlane, MBChB, PhD.

In the COVID-19 and Musculoskeletal Heath During Lockdown (CONTAIN) study, three well-defined populations of patients from existing cohort studies were looked at prospectively. This included patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) participating in two separate British Society for Rheumatology registries, and patients at high risk for developing chronic widespread pain who had been part of the MAmMOTH (Maintaining Musculoskeletal Health) study.

“Our aim was to quantify the changes from the previous prepandemic assessment, focusing on quality of life, changes in lifestyle, and recording what has happened to their musculoskeletal health, including symptoms and disease-specific measures,” Dr. Macfarlane said.

Patients had been invited to participate in June 2020 and were reminded in October 2020 and could respond online or via a postal questionnaire. Some patients were invited to participate in in-depth interviews.

Although the participation rate was low, at 29%, this was typical of studies being conducted at this time due to “survey fatigue,” Dr. Macfarlane said. The CONTAIN study population still included a good number of patients, however, with 596 having AS, 162 PsA, and 296 at risk for chronic widespread pain.

According to Dr. Macfarlane, the CONTAIN study results were “generally reassuring.” Although there was a significant decrease in quality of life as measured by the five-level EQ-5D instrument overall, and in every subgroup population studied, “the magnitude of the decrease was small.” There was no change in disease-specific quality of life in patients with AS, for example.

Levels of pain, anxiety, or depression did increase somewhat, he reported, but the factors that influenced quality of life remained the same before and during the pandemic, such as high levels of deprivation, living in an urban location, low levels of physical activity, and sleep problems.

“Rather surprisingly, sleep problems significantly decreased overall,” Dr. Macfarlane reported. Again, it was only a small change, but “the benefit in terms of the improvement in sleep strengthened with later periods in the follow-up.”

There was also some evidence of increased low-level and high-level physical activity in patients with psoriatic arthritis.

“Mental health is a key issue not just in maintaining musculoskeletal health but also, in terms of the likelihood responding to therapy,” Dr. Macfarlane acknowledged. “Focusing on addressing anxiety is important,” he added.

“Providing enhanced support for self-management, including in relation to pain, is likely to be a priority in the absence of normal health care being available,” he suggested. Importantly, regardless of circumstances, “all patients can be affected.”

The REUMAVID study is conducted by the Health & Territory Research of the University of Seville, with the support of Novartis Pharma AG. The CONTAIN study is supported by the British Society for Rheumatology and Versus Arthritis.

No other relevant conflicts of interested were declared.
 

Reduced access to medical care, increased mental health issues, poor lifestyle habits, and concern over future care are just some of the patient-reported problems associated with the early phases of the COVID-19 pandemic, according to the results of multiple studies.

Data from the Europe-based REUMAVID study, which surveyed more 1,800 patients between April and July last year, have revealed that 58% of patients with rheumatic and musculoskeletal diseases (RMDs) had their appointments with their rheumatologists canceled, 42% could not get in touch with their primary care physicians, and 52% experienced interrupted visits to mental health specialists.

Not surprisingly, this took a toll on patients’ self-perceived health, with nearly two-thirds stating that they had fair to very poor health, and 47% reporting that their health had worsened. Furthermore, 57% of respondents reported high levels of anxiety, almost 46% were at risk for depression, and 49% reported having poor well-being overall.

“The COVID-19 pandemic has had tremendous impact,” Marco Garrido-Cumbrera, PhD, of the University of Seville, Spain, said at the British Society for Rheumatology annual conference.

Dr. Garrido-Cumbrera, who is key player in the REUMAVID initiative, explained that the project was conceived to respond to concerns raised by the president of the Spanish Federation of Spondyloarthritis Associations (CEADE) about providing the right information to their members.

“First in Italy and then in Spain, it was really difficult to deal with the pandemic and there was a lot of uncertainty from a patient perspective,” Dr. Garrido-Cumbrera said.

Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid, who was not involved in the study, observed: “I think this reflects how important collaboration between patient organizations is in order to gather relevant data, and to do it in record time.”

The REUMAVID project was the result of initial collaboration between the Health and Territory Research Group at the University of Seville and CEADE but also involved patient organizations from six other European countries: the National Axial Spondyloarthritis Society, National Rheumatoid Arthritis Society, and Arthritis Action in the United Kingdom; the French Association for the Fight against Rheumatism (AFLAR; L’Association Française de Lutte Anti-Rhumatismale); the National Association of People with Rheumatological and Rare Diseases (APMARR; Associazione Nazionale Persone con Malattie Reumatologiche e Rare) in Italy; Portuguese League Against Rheumatic Diseases (LPCDR; Liga Portuguesa contra as Doenças Reumáticas) in Portugal; the Hellenic League Against Rheumatism (ELEANA) in Greece; and the Cyprus League Against Rheumatism.
 

Pandemic presented ‘perfect storm’

“We’ve never been so well-communicated as we are now,” said Helena Marzo-Ortega, MD, PhD, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust in England who participated the REUMAVID project. The beginning of the pandemic was “the perfect storm” in that everybody jumped in to try to do something. This resulted in a myriad of research publications, surveys, and attempts to try to understand and make sense of what was happening.

“Research is being conducted in a more structured manner, and it’s given us a lot of very insightful information,” Dr. Marzo-Ortega added. Obviously, patients are important stakeholders to consult when conducting research into how the pandemic has affected them, she added, as they are the ones who had their lives turned upside down.

“A pandemic knows no boundaries, has no limits, everybody can be affected equally. But patients with rheumatic conditions were at particular risk because of the treatments,” she said. “You can remember how worried we all were initially, and thinking about the potential impact of immunosuppressants and many other aspects of these conditions.”

One of the many positives to come out of the pandemic is the “possibility of doing collaborative research at a worldwide level, not just European,” Dr. Marzo-Ortega said, referring to how the EULAR COVID-19 registries are part of the COVID-19 Global Rheumatology Alliance.

Furthermore, Dr. Marzo-Ortega believes the rheumatology community is now better prepared for any upsurges in COVID-19 or any new potentially pandemic-causing viruses.

“What we know now is that we have to be alert, and we know how to respond. We also know how to communicate effectively in order to be able to improve outcomes, not only for the health of the whole population, but also to protect patients such as ours,” she said.
 

Rheumatology practice changed practically overnight

The REUMAVID study is not alone in looking at the impact that the COVID-19 pandemic has had on RMD patients’ health and well-being, particularly during periods of lockdown or where patients were advised to “shield.”

There were “near overnight changes to rheumatology practice,” said Chris Wincup, MBBS, a clinical research fellow at University College London (UCL), who presented the findings of another large-scale survey that looked at the early effects of the pandemic nationally in the United Kingdom.

“The recovery of those services has taken time and, speaking with patients, this varies between different locations,” Dr. Wincup noted. “Unfortunately, access to care does remain a major area of unmet need [and] is something that we’re going to need to think about when planning services in the future,” he added.

Between September and October last year, Dr. Wincup and fellow UCL researchers conducted an online survey among 2,054 patients attending U.K. rheumatology clinics. As in the REUMAVID study, accessing care was difficult or very difficult for a substantial proportion of patients. However, getting medication and monitoring “were generally well maintained” despite lockdown measures.

Many patients (57%) had “extremely high levels of worry about their future care being negatively impacted as a result of the pandemic,” Dr. Wincup said, with 44% saying that their current care was worse than before the pandemic and 41% being dissatisfied with the services they were able to access.

While 48% of patients welcomed a more hybrid approach to their care, 69% thought face-to-face appointments with their rheumatologists were important and 49% wanted only face-to-face appointments. “A possible more hybrid approach, compared with pure face-to-face, is going to be something that may be required,” he said.
 

Different approach taken in CONTAIN Study

A different approach to assessing the impact of the COVID pandemic was taken by researchers at the University of Aberdeen in Scotland, observed Gary Macfarlane, MBChB, PhD.

In the COVID-19 and Musculoskeletal Heath During Lockdown (CONTAIN) study, three well-defined populations of patients from existing cohort studies were looked at prospectively. This included patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) participating in two separate British Society for Rheumatology registries, and patients at high risk for developing chronic widespread pain who had been part of the MAmMOTH (Maintaining Musculoskeletal Health) study.

“Our aim was to quantify the changes from the previous prepandemic assessment, focusing on quality of life, changes in lifestyle, and recording what has happened to their musculoskeletal health, including symptoms and disease-specific measures,” Dr. Macfarlane said.

Patients had been invited to participate in June 2020 and were reminded in October 2020 and could respond online or via a postal questionnaire. Some patients were invited to participate in in-depth interviews.

Although the participation rate was low, at 29%, this was typical of studies being conducted at this time due to “survey fatigue,” Dr. Macfarlane said. The CONTAIN study population still included a good number of patients, however, with 596 having AS, 162 PsA, and 296 at risk for chronic widespread pain.

According to Dr. Macfarlane, the CONTAIN study results were “generally reassuring.” Although there was a significant decrease in quality of life as measured by the five-level EQ-5D instrument overall, and in every subgroup population studied, “the magnitude of the decrease was small.” There was no change in disease-specific quality of life in patients with AS, for example.

Levels of pain, anxiety, or depression did increase somewhat, he reported, but the factors that influenced quality of life remained the same before and during the pandemic, such as high levels of deprivation, living in an urban location, low levels of physical activity, and sleep problems.

“Rather surprisingly, sleep problems significantly decreased overall,” Dr. Macfarlane reported. Again, it was only a small change, but “the benefit in terms of the improvement in sleep strengthened with later periods in the follow-up.”

There was also some evidence of increased low-level and high-level physical activity in patients with psoriatic arthritis.

“Mental health is a key issue not just in maintaining musculoskeletal health but also, in terms of the likelihood responding to therapy,” Dr. Macfarlane acknowledged. “Focusing on addressing anxiety is important,” he added.

“Providing enhanced support for self-management, including in relation to pain, is likely to be a priority in the absence of normal health care being available,” he suggested. Importantly, regardless of circumstances, “all patients can be affected.”

The REUMAVID study is conducted by the Health & Territory Research of the University of Seville, with the support of Novartis Pharma AG. The CONTAIN study is supported by the British Society for Rheumatology and Versus Arthritis.

No other relevant conflicts of interested were declared.
 

Converge 2021 session

Fall Down Seven Get Up Eight: Making Your Setbacks Count: Strategic Risk Taking, Maintaining Resilience, and Finding Success

Presenters

Marisha Burden, MD, and Flora Kisuule, MD, MPH, SFHM

Session summary

The speakers at this Converge session, in the “Wellness and Resilience” track, covered four major topics: strategic risk-taking, wrestling with failure, embracing constraints, and embracing institutional chaos. First, they began by relating a personal story about failure and discussed how reframing failure could help you learn how to “fail forward.” They outlined how building upon failures can lead to many benefits, such as gaining personal strength, gaining perspective, and seeing new possibilities. They also introduced three roadblocks to failing forward: Personalization, Pervasiveness, and Permanence.

Next, the speakers lead the attendees through an exercise called The Nine Dot Problem, the purpose of which was to illustrate how thinking outside the box can help you find solutions that you cannot otherwise see. They also discussed how thinking inside the box could have its own advantages in that it teaches us to embrace our limitations, which can open up our creativity. They expounded upon this by showing a TED talk about finding liberation in constraints. The speakers wrapped up the session relating the tale of David and Goliath, and explained how David used his own unique advantages to gain power over a seemingly insurmountable problem.
 

Key takeaways

• Failing forward helps you continue to push ahead and grow, and perspective can help you fail forward.
• When failing, beware the Three Ps.
• Reframe constraints and be sure to think both inside and outside of the box – embrace limitations as a way to inspire new thinking.
• When facing something bigger than you, play to your own advantages in order to succeed.

Ms. Panek is hospital medicine division administrator at the Johns Hopkins Bayview Medical Center, Baltimore.

Converge 2021 session

Fall Down Seven Get Up Eight: Making Your Setbacks Count: Strategic Risk Taking, Maintaining Resilience, and Finding Success

Presenters

Marisha Burden, MD, and Flora Kisuule, MD, MPH, SFHM

Session summary

The speakers at this Converge session, in the “Wellness and Resilience” track, covered four major topics: strategic risk-taking, wrestling with failure, embracing constraints, and embracing institutional chaos. First, they began by relating a personal story about failure and discussed how reframing failure could help you learn how to “fail forward.” They outlined how building upon failures can lead to many benefits, such as gaining personal strength, gaining perspective, and seeing new possibilities. They also introduced three roadblocks to failing forward: Personalization, Pervasiveness, and Permanence.

Next, the speakers lead the attendees through an exercise called The Nine Dot Problem, the purpose of which was to illustrate how thinking outside the box can help you find solutions that you cannot otherwise see. They also discussed how thinking inside the box could have its own advantages in that it teaches us to embrace our limitations, which can open up our creativity. They expounded upon this by showing a TED talk about finding liberation in constraints. The speakers wrapped up the session relating the tale of David and Goliath, and explained how David used his own unique advantages to gain power over a seemingly insurmountable problem.
 

Key takeaways

• Failing forward helps you continue to push ahead and grow, and perspective can help you fail forward.
• When failing, beware the Three Ps.
• Reframe constraints and be sure to think both inside and outside of the box – embrace limitations as a way to inspire new thinking.
• When facing something bigger than you, play to your own advantages in order to succeed.

Ms. Panek is hospital medicine division administrator at the Johns Hopkins Bayview Medical Center, Baltimore.

Converge 2021 session

Fall Down Seven Get Up Eight: Making Your Setbacks Count: Strategic Risk Taking, Maintaining Resilience, and Finding Success

Presenters

Marisha Burden, MD, and Flora Kisuule, MD, MPH, SFHM

Session summary

The speakers at this Converge session, in the “Wellness and Resilience” track, covered four major topics: strategic risk-taking, wrestling with failure, embracing constraints, and embracing institutional chaos. First, they began by relating a personal story about failure and discussed how reframing failure could help you learn how to “fail forward.” They outlined how building upon failures can lead to many benefits, such as gaining personal strength, gaining perspective, and seeing new possibilities. They also introduced three roadblocks to failing forward: Personalization, Pervasiveness, and Permanence.

Next, the speakers lead the attendees through an exercise called The Nine Dot Problem, the purpose of which was to illustrate how thinking outside the box can help you find solutions that you cannot otherwise see. They also discussed how thinking inside the box could have its own advantages in that it teaches us to embrace our limitations, which can open up our creativity. They expounded upon this by showing a TED talk about finding liberation in constraints. The speakers wrapped up the session relating the tale of David and Goliath, and explained how David used his own unique advantages to gain power over a seemingly insurmountable problem.
 

Key takeaways

• Failing forward helps you continue to push ahead and grow, and perspective can help you fail forward.
• When failing, beware the Three Ps.
• Reframe constraints and be sure to think both inside and outside of the box – embrace limitations as a way to inspire new thinking.
• When facing something bigger than you, play to your own advantages in order to succeed.

Ms. Panek is hospital medicine division administrator at the Johns Hopkins Bayview Medical Center, Baltimore.

Nonalcoholic fatty liver disease (NAFLD) was present in approximately two-thirds of patients who did not undergo a liver biopsy. These patients were more likely to be non-White and older, as well as have normal ALT levels, which shows potential gaps in knowledge about this population.

Shidlovski/Getty Images

Data from studies of patients diagnosed with NAFLD that require biopsy among their inclusion criteria may be subject to selection and detection bias, wrote A. Sidney Barritt, MD, of the University of North Carolina at Chapel Hill, and colleagues. The researchers sought to compare characteristics of patients with NAFLD who were diagnosed using clinical criteria and those diagnosed via liver biopsy.

In a study published in Hepatology Communications, the researchers reviewed data from TARGET-NASH, a longitudinal, observational cohort study designed to follow patients with NAFLD in clinical practice to provide data on the effectiveness of treatments.

“TARGET-NASH represents a large cohort of NAFLD patients from multiple sites and can provide us with real world information on progression of disease in patients with NAFLD and particular risk factors that may be clinically relevant,” Zachary Henry, MD, MS, of the division of gastroenterology & hepatology at the University of Virginia Health System in Charlottesville, said in an interview. “This is one of the first studies from this database, and as time goes on, we will see more large-population data like this to answer specific questions for NAFLD patient.”
 

Surprising findings

The researchers included 3,474 patients aged 18 years and older who were enrolled in the TARGET-NASH study between Aug. 1, 2016, and March 4, 2019. The study participants were classified according to severity of liver disease: nonalcoholic fatty liver (30%), nonalcoholic steatohepatitis (37%), and NAFLD cirrhosis (33%).

A total of 766 patients were diagnosed with NASH based on clinical criteria without biopsy, and all met the criteria for abnormal ALT and steatosis based on imaging. In addition, these patients had at least one secondary diagnostic criteria: body mass index greater than 30 kg/m2 (74%), type 2 diabetes (42%), and dyslipidemia (54%). Significant independent predictors of liver biopsy included younger age, White race, female gender, diabetes, and elevated levels of ALT.

Elevated ALT increased the odds of liver biopsy by 14% per 10-point rise, according to the study. A machine learning model showed that non-White patients with ALT less than 69 IU/mL had a 6% chance of liver biopsy. By comparison, White patients had a 21% chance of biopsy with ALT between 29 IU/mL and 69 IU/mL that dropped to 10% if the ALT was less than 29 IU/mL.

However, ALT remains a “suboptimal surrogate” for disease severity, the researchers noted. “How a normal ALT is defined and how a normal ALT range may vary across different laboratories may play a role in its utility as a diagnostic tool as well.”

Dr. Henry was surprised by this finding: “With the advent of noninvasive measures of fibrosis, such as the NAFLD fibrosis score, Fibrosis-4, and transient elastography, I thought these would have a more significant role in that decision as opposed to ALT levels.”

Notably, mental health diagnoses accounted for nearly half (49%) of comorbid conditions, followed by cardiovascular disease (19%), and osteoarthritis (10%). The prevalence of these conditions emphasizes the challenges of managing patients with NAFLD with diet and exercise alone because mental and physical problems may impede progress, the researchers wrote.

The study findings were limited by several factors including the inability to determine health care provider intent, as well as undocumented factors related to patients and providers that might influence a biopsy decision, such as assessment of disease severity, the researchers noted. In addition, they noted that the mostly White study population treated in specialty settings might not generalize to other populations or primary care.

However, the findings are strengthened by the large study population and real-world setting, the researchers emphasized. “These data provide context for the selection bias that may be present in many registries and randomized, controlled trials of therapies for NAFLD, where biopsy is required for inclusion,” and show potential knowledge gaps about the patient population less likely to undergo biopsy.
 

Knowledge gaps and implications

The study is important because of the need to identify patient factors that predict histologic versus clinical diagnosis of NAFLD as the number of patient registries and clinical trials for NAFLD increase, Bubu Banini, MD, of Yale University, New Haven, Conn., said in an interview. “This information helps to elucidate selection and ascertainment bias and place findings from NAFLD registries and clinical trials into context.”

Dr. Banini said that some of the findings were to be expected, while others were not.

“Historically, males and non-Whites are less likely to participate in registries and clinical trials, compared to females and Whites. However, I was surprised to find that these discrepancies further paralleled the likelihood of undergoing liver biopsy even among those who chose to participate. In addition, while mental health disorders (such as anxiety and depression) are a fairly prevalent comorbidity in patients with NAFLD, I was surprised to find that NAFLD patients with mental health disorders were more likely to undergo liver biopsy compared to those without these disorders. I would have expected the reverse,” he noted.

“These findings highlight the gaps in knowledge regarding the impact of demographic and psychosocial factors on choice and assess to care among patients with NAFLD, and the need for further studies to address these gaps,” she emphasized.

“A number of [studies] such as TARGET-NASH are doing away with the requirement for liver biopsy for participation; hence, it is less likely that selection bias related to liver biopsy would be a problem in these [studies] if clinical diagnosis is considered as a surrogate for histological diagnosis,” Dr. Banini added.

“On the contrary, many NAFLD clinical trials require liver biopsy for inclusion.” As nicely demonstrated in the current study, “this inclusion criterion may introduce selection bias,” she said. “Awareness of potential biases would hopefully inform the design and recruitment strategy for registries and clinical trials in order to overcome these issues.”

“I think the results of this study may actually point to a larger issue within medicine in general, which is a difference in care provided to minority communities,” Dr. Henry said. “Whether this is intentional, related to unconscious bias on the part of providers, or related to a significant mistrust between minority communities and their health care providers is unclear but certainly needs to be addressed.”

He noted that the purpose of TARGET-NASH is to enroll all patients with NAFLD regardless of biopsy. “Over time, as we have more data on these patients, we will have a better understanding of both diagnostic and therapeutic decisions in patients with NAFLD.”

The study was supported by Target RWE, sponsor of the TARGET-NASH study. TARGET-NASH is a collaboration of academic and community investigators and the pharmaceutical industry. Lead author Dr. Barritt had no financial conflicts to disclose, but many study coauthors disclosed relationships with multiple pharmaceutical companies, including those involved in the TARGET-NASH study. Dr. Banini currently serves on the NASH advisory board for Boehringer Ingelheim. Dr. Henry reported no disclosures, although his institution is one of the enrollment sites for TARGET-NASH.

Nonalcoholic fatty liver disease (NAFLD) was present in approximately two-thirds of patients who did not undergo a liver biopsy. These patients were more likely to be non-White and older, as well as have normal ALT levels, which shows potential gaps in knowledge about this population.

Shidlovski/Getty Images

Data from studies of patients diagnosed with NAFLD that require biopsy among their inclusion criteria may be subject to selection and detection bias, wrote A. Sidney Barritt, MD, of the University of North Carolina at Chapel Hill, and colleagues. The researchers sought to compare characteristics of patients with NAFLD who were diagnosed using clinical criteria and those diagnosed via liver biopsy.

In a study published in Hepatology Communications, the researchers reviewed data from TARGET-NASH, a longitudinal, observational cohort study designed to follow patients with NAFLD in clinical practice to provide data on the effectiveness of treatments.

“TARGET-NASH represents a large cohort of NAFLD patients from multiple sites and can provide us with real world information on progression of disease in patients with NAFLD and particular risk factors that may be clinically relevant,” Zachary Henry, MD, MS, of the division of gastroenterology & hepatology at the University of Virginia Health System in Charlottesville, said in an interview. “This is one of the first studies from this database, and as time goes on, we will see more large-population data like this to answer specific questions for NAFLD patient.”
 

Surprising findings

The researchers included 3,474 patients aged 18 years and older who were enrolled in the TARGET-NASH study between Aug. 1, 2016, and March 4, 2019. The study participants were classified according to severity of liver disease: nonalcoholic fatty liver (30%), nonalcoholic steatohepatitis (37%), and NAFLD cirrhosis (33%).

A total of 766 patients were diagnosed with NASH based on clinical criteria without biopsy, and all met the criteria for abnormal ALT and steatosis based on imaging. In addition, these patients had at least one secondary diagnostic criteria: body mass index greater than 30 kg/m2 (74%), type 2 diabetes (42%), and dyslipidemia (54%). Significant independent predictors of liver biopsy included younger age, White race, female gender, diabetes, and elevated levels of ALT.

Elevated ALT increased the odds of liver biopsy by 14% per 10-point rise, according to the study. A machine learning model showed that non-White patients with ALT less than 69 IU/mL had a 6% chance of liver biopsy. By comparison, White patients had a 21% chance of biopsy with ALT between 29 IU/mL and 69 IU/mL that dropped to 10% if the ALT was less than 29 IU/mL.

However, ALT remains a “suboptimal surrogate” for disease severity, the researchers noted. “How a normal ALT is defined and how a normal ALT range may vary across different laboratories may play a role in its utility as a diagnostic tool as well.”

Dr. Henry was surprised by this finding: “With the advent of noninvasive measures of fibrosis, such as the NAFLD fibrosis score, Fibrosis-4, and transient elastography, I thought these would have a more significant role in that decision as opposed to ALT levels.”

Notably, mental health diagnoses accounted for nearly half (49%) of comorbid conditions, followed by cardiovascular disease (19%), and osteoarthritis (10%). The prevalence of these conditions emphasizes the challenges of managing patients with NAFLD with diet and exercise alone because mental and physical problems may impede progress, the researchers wrote.

The study findings were limited by several factors including the inability to determine health care provider intent, as well as undocumented factors related to patients and providers that might influence a biopsy decision, such as assessment of disease severity, the researchers noted. In addition, they noted that the mostly White study population treated in specialty settings might not generalize to other populations or primary care.

However, the findings are strengthened by the large study population and real-world setting, the researchers emphasized. “These data provide context for the selection bias that may be present in many registries and randomized, controlled trials of therapies for NAFLD, where biopsy is required for inclusion,” and show potential knowledge gaps about the patient population less likely to undergo biopsy.
 

Knowledge gaps and implications

The study is important because of the need to identify patient factors that predict histologic versus clinical diagnosis of NAFLD as the number of patient registries and clinical trials for NAFLD increase, Bubu Banini, MD, of Yale University, New Haven, Conn., said in an interview. “This information helps to elucidate selection and ascertainment bias and place findings from NAFLD registries and clinical trials into context.”

Dr. Banini said that some of the findings were to be expected, while others were not.

“Historically, males and non-Whites are less likely to participate in registries and clinical trials, compared to females and Whites. However, I was surprised to find that these discrepancies further paralleled the likelihood of undergoing liver biopsy even among those who chose to participate. In addition, while mental health disorders (such as anxiety and depression) are a fairly prevalent comorbidity in patients with NAFLD, I was surprised to find that NAFLD patients with mental health disorders were more likely to undergo liver biopsy compared to those without these disorders. I would have expected the reverse,” he noted.

“These findings highlight the gaps in knowledge regarding the impact of demographic and psychosocial factors on choice and assess to care among patients with NAFLD, and the need for further studies to address these gaps,” she emphasized.

“A number of [studies] such as TARGET-NASH are doing away with the requirement for liver biopsy for participation; hence, it is less likely that selection bias related to liver biopsy would be a problem in these [studies] if clinical diagnosis is considered as a surrogate for histological diagnosis,” Dr. Banini added.

“On the contrary, many NAFLD clinical trials require liver biopsy for inclusion.” As nicely demonstrated in the current study, “this inclusion criterion may introduce selection bias,” she said. “Awareness of potential biases would hopefully inform the design and recruitment strategy for registries and clinical trials in order to overcome these issues.”

“I think the results of this study may actually point to a larger issue within medicine in general, which is a difference in care provided to minority communities,” Dr. Henry said. “Whether this is intentional, related to unconscious bias on the part of providers, or related to a significant mistrust between minority communities and their health care providers is unclear but certainly needs to be addressed.”

He noted that the purpose of TARGET-NASH is to enroll all patients with NAFLD regardless of biopsy. “Over time, as we have more data on these patients, we will have a better understanding of both diagnostic and therapeutic decisions in patients with NAFLD.”

The study was supported by Target RWE, sponsor of the TARGET-NASH study. TARGET-NASH is a collaboration of academic and community investigators and the pharmaceutical industry. Lead author Dr. Barritt had no financial conflicts to disclose, but many study coauthors disclosed relationships with multiple pharmaceutical companies, including those involved in the TARGET-NASH study. Dr. Banini currently serves on the NASH advisory board for Boehringer Ingelheim. Dr. Henry reported no disclosures, although his institution is one of the enrollment sites for TARGET-NASH.

Nonalcoholic fatty liver disease (NAFLD) was present in approximately two-thirds of patients who did not undergo a liver biopsy. These patients were more likely to be non-White and older, as well as have normal ALT levels, which shows potential gaps in knowledge about this population.

Shidlovski/Getty Images

Data from studies of patients diagnosed with NAFLD that require biopsy among their inclusion criteria may be subject to selection and detection bias, wrote A. Sidney Barritt, MD, of the University of North Carolina at Chapel Hill, and colleagues. The researchers sought to compare characteristics of patients with NAFLD who were diagnosed using clinical criteria and those diagnosed via liver biopsy.

In a study published in Hepatology Communications, the researchers reviewed data from TARGET-NASH, a longitudinal, observational cohort study designed to follow patients with NAFLD in clinical practice to provide data on the effectiveness of treatments.

“TARGET-NASH represents a large cohort of NAFLD patients from multiple sites and can provide us with real world information on progression of disease in patients with NAFLD and particular risk factors that may be clinically relevant,” Zachary Henry, MD, MS, of the division of gastroenterology & hepatology at the University of Virginia Health System in Charlottesville, said in an interview. “This is one of the first studies from this database, and as time goes on, we will see more large-population data like this to answer specific questions for NAFLD patient.”
 

Surprising findings

The researchers included 3,474 patients aged 18 years and older who were enrolled in the TARGET-NASH study between Aug. 1, 2016, and March 4, 2019. The study participants were classified according to severity of liver disease: nonalcoholic fatty liver (30%), nonalcoholic steatohepatitis (37%), and NAFLD cirrhosis (33%).

A total of 766 patients were diagnosed with NASH based on clinical criteria without biopsy, and all met the criteria for abnormal ALT and steatosis based on imaging. In addition, these patients had at least one secondary diagnostic criteria: body mass index greater than 30 kg/m2 (74%), type 2 diabetes (42%), and dyslipidemia (54%). Significant independent predictors of liver biopsy included younger age, White race, female gender, diabetes, and elevated levels of ALT.

Elevated ALT increased the odds of liver biopsy by 14% per 10-point rise, according to the study. A machine learning model showed that non-White patients with ALT less than 69 IU/mL had a 6% chance of liver biopsy. By comparison, White patients had a 21% chance of biopsy with ALT between 29 IU/mL and 69 IU/mL that dropped to 10% if the ALT was less than 29 IU/mL.

However, ALT remains a “suboptimal surrogate” for disease severity, the researchers noted. “How a normal ALT is defined and how a normal ALT range may vary across different laboratories may play a role in its utility as a diagnostic tool as well.”

Dr. Henry was surprised by this finding: “With the advent of noninvasive measures of fibrosis, such as the NAFLD fibrosis score, Fibrosis-4, and transient elastography, I thought these would have a more significant role in that decision as opposed to ALT levels.”

Notably, mental health diagnoses accounted for nearly half (49%) of comorbid conditions, followed by cardiovascular disease (19%), and osteoarthritis (10%). The prevalence of these conditions emphasizes the challenges of managing patients with NAFLD with diet and exercise alone because mental and physical problems may impede progress, the researchers wrote.

The study findings were limited by several factors including the inability to determine health care provider intent, as well as undocumented factors related to patients and providers that might influence a biopsy decision, such as assessment of disease severity, the researchers noted. In addition, they noted that the mostly White study population treated in specialty settings might not generalize to other populations or primary care.

However, the findings are strengthened by the large study population and real-world setting, the researchers emphasized. “These data provide context for the selection bias that may be present in many registries and randomized, controlled trials of therapies for NAFLD, where biopsy is required for inclusion,” and show potential knowledge gaps about the patient population less likely to undergo biopsy.
 

Knowledge gaps and implications

The study is important because of the need to identify patient factors that predict histologic versus clinical diagnosis of NAFLD as the number of patient registries and clinical trials for NAFLD increase, Bubu Banini, MD, of Yale University, New Haven, Conn., said in an interview. “This information helps to elucidate selection and ascertainment bias and place findings from NAFLD registries and clinical trials into context.”

Dr. Banini said that some of the findings were to be expected, while others were not.

“Historically, males and non-Whites are less likely to participate in registries and clinical trials, compared to females and Whites. However, I was surprised to find that these discrepancies further paralleled the likelihood of undergoing liver biopsy even among those who chose to participate. In addition, while mental health disorders (such as anxiety and depression) are a fairly prevalent comorbidity in patients with NAFLD, I was surprised to find that NAFLD patients with mental health disorders were more likely to undergo liver biopsy compared to those without these disorders. I would have expected the reverse,” he noted.

“These findings highlight the gaps in knowledge regarding the impact of demographic and psychosocial factors on choice and assess to care among patients with NAFLD, and the need for further studies to address these gaps,” she emphasized.

“A number of [studies] such as TARGET-NASH are doing away with the requirement for liver biopsy for participation; hence, it is less likely that selection bias related to liver biopsy would be a problem in these [studies] if clinical diagnosis is considered as a surrogate for histological diagnosis,” Dr. Banini added.

“On the contrary, many NAFLD clinical trials require liver biopsy for inclusion.” As nicely demonstrated in the current study, “this inclusion criterion may introduce selection bias,” she said. “Awareness of potential biases would hopefully inform the design and recruitment strategy for registries and clinical trials in order to overcome these issues.”

“I think the results of this study may actually point to a larger issue within medicine in general, which is a difference in care provided to minority communities,” Dr. Henry said. “Whether this is intentional, related to unconscious bias on the part of providers, or related to a significant mistrust between minority communities and their health care providers is unclear but certainly needs to be addressed.”

He noted that the purpose of TARGET-NASH is to enroll all patients with NAFLD regardless of biopsy. “Over time, as we have more data on these patients, we will have a better understanding of both diagnostic and therapeutic decisions in patients with NAFLD.”

The study was supported by Target RWE, sponsor of the TARGET-NASH study. TARGET-NASH is a collaboration of academic and community investigators and the pharmaceutical industry. Lead author Dr. Barritt had no financial conflicts to disclose, but many study coauthors disclosed relationships with multiple pharmaceutical companies, including those involved in the TARGET-NASH study. Dr. Banini currently serves on the NASH advisory board for Boehringer Ingelheim. Dr. Henry reported no disclosures, although his institution is one of the enrollment sites for TARGET-NASH.