ILLUSTRATIVE CASE

A 54-year-old White woman presents to your office with new-onset hypertension. As you are discussing options for treatment, she mentions she would prefer once-daily dosing to help her remember to take her medication. She also wants to know what the best time of day is to take her medication to reduce her risk of cardiovascular disease (CVD). What do you advise?

The burden of hypertension is significant and growing in the United States. The 2017 American College of Cardiology/American Heart Association (ACC/AHA) guidelines reported that more than 108 million people were affected in 2015-2016—up from 87 million in 1999-2000.² Yet control of hypertension is improving among those receiving antihypertension pharmacotherapy. As reported in the ACC/AHA guidelines, data from the 2016 National Health and Nutrition Examination Survey (NHANES) indicate an increase of controlled hypertension among those receiving treatment from 25.6% (1999-2000) to 43.5% (2015-2016).²

Chronotherapy involves the administration of medication in coordination with the body’s circadian rhythms to maximize therapeutic effectiveness and/or minimize adverse effects. It is not a new concept as it applies to hypertension. Circadian rhythm–­dependent mechanisms influence the natural rise and fall of blood pressure (BP).¹ The ­renin-­angiotensin-aldosterone system, known to be most active at night, is a target mechanism for BP control.¹ Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are more effective (alone or in combination with other agents) at reducing BP during sleep and wakefulness when they are taken at night.^3,4 Additional prospective clinical trials and systematic reviews have documented improved BP during sleep and on 24-hour ambulatory monitoring when antihypertensives are taken at bedtime.^3-5

However, there have been few long-term studies assessing the effects of bedtime administration of antihypertensive medication on CVD risk reduction with patient-oriented outcomes.^6,7 Additionally, no studies have evaluated morning vs bedtime administration of antihypertensive medication for CVD risk reduction in a primary care setting. The 2019 ACC/AHA guideline on the primary prevention of CVD offers no recommendation regarding when to take antihypertensive medication.⁸ Timing of medication administration also is not addressed in the NHANES study of hypertension awareness, treatment, and control in US adults.⁹

This study sought to determine in a primary care setting whether taking antihypertensives at bedtime, as opposed to upon waking, more effectively reduces CVD risk.

STUDY SUMMARY

PM vs AM antihypertensive dosing reduces CV events

This prospective, randomized, open-label, blinded endpoint trial of antihypertensive medication administration timing was part of a large, multicenter Spanish study investigating ambulatory BP monitoring (ABPM) as a routine diagnostic tool.

A simple change in administration time has the potential to significantly improve the lives of our patients by reducing the risk for cardiovascular events and their medication burden.

Study participants were randomly assigned in a 1:1 ratio to 2 treatment arms; participants either took all of their BP medications in the morning upon waking (n = 9532) or right before bedtime (n = 9552). The study was conducted in a primary care clinical setting. It included adult participants (age ≥ 18 years) with hypertension (defined as having at least 1 of the following benchmarks: awake systolic BP [SBP] mean ≥ 135 mm Hg, awake diastolic BP (DBP) mean ≥ 85 mm Hg, asleep SBP mean ≥ 120 mm Hg, asleep DBP mean ≥ 70 mm Hg as corroborated by 48-hour ABPM) who were taking at least 1 antihypertensive medication.

Continue to: Any antihypertension medication...

Any antihypertension medication included in the Spanish national formulary was allowed (exact agents were not delineated, but the following classes were included: ARB, ACE inhibitor, calcium channel blocker [CCB], beta-blocker, and/or diuretic). All BP medications had to be dosed once daily for inclusion. Exclusion criteria included pregnancy, night or rotating-shift work, alcohol or other substance dependence, acquired immunodeficiency syndrome, preexisting CVD (unstable angina, heart failure, arrhythmia, kidney failure, and retinopathy), inability to tolerate ABPM, and inability to comply with required 1-year follow-up.

Upon enrollment and at every subsequent clinic visit (scheduled at least annually), participants underwent 48-hour ABPM. Those with uncontrolled BP or elevated CVD risk had scheduled follow-up and ABPM more frequently. The primary outcome was a composite of CVD events including new-onset myocardial infarction, coronary revascularization, heart failure, ischemic stroke, hemorrhagic stroke, and CVD death. Secondary endpoints were individually analyzed primary outcomes of CVD events. The typical patient at baseline was 60.5 years of age with a body mass index of 29.7, an almost 9-year duration of hypertension, and a baseline office BP of 149/86 mm Hg. The patient break-out by antihypertensive class (awakening vs bedtime groups) was as follows: ARB (53% vs 53%), ACE inhibitor (25% vs 23%), CCB (33% vs 37%), beta-blocker (22% vs 18%), and diuretic (47% vs 40%).

See “It’s time to change when BP meds are taken” for more on the controversy that surrounded the initial release of this study.

During the median 6.3-year patient follow-up period, 1752 participants experienced a total of 2454 CVD events. Patients in the bedtime administration group, compared with those in the morning group, showed significantly lower risk for a CVD event (hazard ratio [HR] = 0.55; 95% confidence interval [CI], 0.50-0.61; P < .001). Also, there was a lower risk for individual CVD events in the bedtime administration group: CVD death (HR = 0.44; 95% CI, 0.34-0.56), myocardial infarction (HR = 0.66; 95% CI, 0.52-0.84), coronary revascularization (HR = 0.60; 95% CI, 0.47-0.75), heart failure (HR = 0.58; 95% CI, 0.49-0.70), and stroke (HR = 0.51; 95% CI, 0.41-0.63). This difference remained after correction for multiple potential confounders. There were no differences in adverse events, such as sleep-time hypotension, between groups.

WHAT’S NEW

First RCT in primary care to show dosing time change reduces CV risk

This is the first randomized controlled trial (RCT) performed in a primary care setting to compare before-bedtime to upon-waking administration of antihypertensive medications using clinically significant endpoints. The study demonstrates that a simple change in administration time has the potential to significantly improve the lives of our patients by reducing the risk for cardiovascular events and their medication burden.

CAVEATS

Homogenous population and exclusions limit generalizability

Because the study population consisted of white Spanish men and women, the results may not be generalizable beyond that ethnic group. In addition, the study exclusions limit interpretation in night/rotating-shift employees, patients with secondary hypertension, and those with CVD, chronic kidney disease, or severe retinopathy looking to reduce their risk.

Continue to: CHALLENGES TO IMPLEMENTATION

Nighttime urination could lead to nonadherence

Taking diuretics at bedtime may result in unwanted nighttime awakenings for visits to the bathroom, which could lead to nonadherence in some patients.

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 54-year-old White woman presents to your office with new-onset hypertension. As you are discussing options for treatment, she mentions she would prefer once-daily dosing to help her remember to take her medication. She also wants to know what the best time of day is to take her medication to reduce her risk of cardiovascular disease (CVD). What do you advise?

The burden of hypertension is significant and growing in the United States. The 2017 American College of Cardiology/American Heart Association (ACC/AHA) guidelines reported that more than 108 million people were affected in 2015-2016—up from 87 million in 1999-2000.² Yet control of hypertension is improving among those receiving antihypertension pharmacotherapy. As reported in the ACC/AHA guidelines, data from the 2016 National Health and Nutrition Examination Survey (NHANES) indicate an increase of controlled hypertension among those receiving treatment from 25.6% (1999-2000) to 43.5% (2015-2016).²

Chronotherapy involves the administration of medication in coordination with the body’s circadian rhythms to maximize therapeutic effectiveness and/or minimize adverse effects. It is not a new concept as it applies to hypertension. Circadian rhythm–­dependent mechanisms influence the natural rise and fall of blood pressure (BP).¹ The ­renin-­angiotensin-aldosterone system, known to be most active at night, is a target mechanism for BP control.¹ Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are more effective (alone or in combination with other agents) at reducing BP during sleep and wakefulness when they are taken at night.^3,4 Additional prospective clinical trials and systematic reviews have documented improved BP during sleep and on 24-hour ambulatory monitoring when antihypertensives are taken at bedtime.^3-5

However, there have been few long-term studies assessing the effects of bedtime administration of antihypertensive medication on CVD risk reduction with patient-oriented outcomes.^6,7 Additionally, no studies have evaluated morning vs bedtime administration of antihypertensive medication for CVD risk reduction in a primary care setting. The 2019 ACC/AHA guideline on the primary prevention of CVD offers no recommendation regarding when to take antihypertensive medication.⁸ Timing of medication administration also is not addressed in the NHANES study of hypertension awareness, treatment, and control in US adults.⁹

This study sought to determine in a primary care setting whether taking antihypertensives at bedtime, as opposed to upon waking, more effectively reduces CVD risk.

STUDY SUMMARY

PM vs AM antihypertensive dosing reduces CV events

This prospective, randomized, open-label, blinded endpoint trial of antihypertensive medication administration timing was part of a large, multicenter Spanish study investigating ambulatory BP monitoring (ABPM) as a routine diagnostic tool.

A simple change in administration time has the potential to significantly improve the lives of our patients by reducing the risk for cardiovascular events and their medication burden.

Study participants were randomly assigned in a 1:1 ratio to 2 treatment arms; participants either took all of their BP medications in the morning upon waking (n = 9532) or right before bedtime (n = 9552). The study was conducted in a primary care clinical setting. It included adult participants (age ≥ 18 years) with hypertension (defined as having at least 1 of the following benchmarks: awake systolic BP [SBP] mean ≥ 135 mm Hg, awake diastolic BP (DBP) mean ≥ 85 mm Hg, asleep SBP mean ≥ 120 mm Hg, asleep DBP mean ≥ 70 mm Hg as corroborated by 48-hour ABPM) who were taking at least 1 antihypertensive medication.

Continue to: Any antihypertension medication...

Any antihypertension medication included in the Spanish national formulary was allowed (exact agents were not delineated, but the following classes were included: ARB, ACE inhibitor, calcium channel blocker [CCB], beta-blocker, and/or diuretic). All BP medications had to be dosed once daily for inclusion. Exclusion criteria included pregnancy, night or rotating-shift work, alcohol or other substance dependence, acquired immunodeficiency syndrome, preexisting CVD (unstable angina, heart failure, arrhythmia, kidney failure, and retinopathy), inability to tolerate ABPM, and inability to comply with required 1-year follow-up.

Upon enrollment and at every subsequent clinic visit (scheduled at least annually), participants underwent 48-hour ABPM. Those with uncontrolled BP or elevated CVD risk had scheduled follow-up and ABPM more frequently. The primary outcome was a composite of CVD events including new-onset myocardial infarction, coronary revascularization, heart failure, ischemic stroke, hemorrhagic stroke, and CVD death. Secondary endpoints were individually analyzed primary outcomes of CVD events. The typical patient at baseline was 60.5 years of age with a body mass index of 29.7, an almost 9-year duration of hypertension, and a baseline office BP of 149/86 mm Hg. The patient break-out by antihypertensive class (awakening vs bedtime groups) was as follows: ARB (53% vs 53%), ACE inhibitor (25% vs 23%), CCB (33% vs 37%), beta-blocker (22% vs 18%), and diuretic (47% vs 40%).

See “It’s time to change when BP meds are taken” for more on the controversy that surrounded the initial release of this study.

During the median 6.3-year patient follow-up period, 1752 participants experienced a total of 2454 CVD events. Patients in the bedtime administration group, compared with those in the morning group, showed significantly lower risk for a CVD event (hazard ratio [HR] = 0.55; 95% confidence interval [CI], 0.50-0.61; P < .001). Also, there was a lower risk for individual CVD events in the bedtime administration group: CVD death (HR = 0.44; 95% CI, 0.34-0.56), myocardial infarction (HR = 0.66; 95% CI, 0.52-0.84), coronary revascularization (HR = 0.60; 95% CI, 0.47-0.75), heart failure (HR = 0.58; 95% CI, 0.49-0.70), and stroke (HR = 0.51; 95% CI, 0.41-0.63). This difference remained after correction for multiple potential confounders. There were no differences in adverse events, such as sleep-time hypotension, between groups.

WHAT’S NEW

First RCT in primary care to show dosing time change reduces CV risk

This is the first randomized controlled trial (RCT) performed in a primary care setting to compare before-bedtime to upon-waking administration of antihypertensive medications using clinically significant endpoints. The study demonstrates that a simple change in administration time has the potential to significantly improve the lives of our patients by reducing the risk for cardiovascular events and their medication burden.

CAVEATS

Homogenous population and exclusions limit generalizability

Because the study population consisted of white Spanish men and women, the results may not be generalizable beyond that ethnic group. In addition, the study exclusions limit interpretation in night/rotating-shift employees, patients with secondary hypertension, and those with CVD, chronic kidney disease, or severe retinopathy looking to reduce their risk.

Continue to: CHALLENGES TO IMPLEMENTATION

Nighttime urination could lead to nonadherence

Taking diuretics at bedtime may result in unwanted nighttime awakenings for visits to the bathroom, which could lead to nonadherence in some patients.

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

ILLUSTRATIVE CASE

A 54-year-old White woman presents to your office with new-onset hypertension. As you are discussing options for treatment, she mentions she would prefer once-daily dosing to help her remember to take her medication. She also wants to know what the best time of day is to take her medication to reduce her risk of cardiovascular disease (CVD). What do you advise?

The burden of hypertension is significant and growing in the United States. The 2017 American College of Cardiology/American Heart Association (ACC/AHA) guidelines reported that more than 108 million people were affected in 2015-2016—up from 87 million in 1999-2000.² Yet control of hypertension is improving among those receiving antihypertension pharmacotherapy. As reported in the ACC/AHA guidelines, data from the 2016 National Health and Nutrition Examination Survey (NHANES) indicate an increase of controlled hypertension among those receiving treatment from 25.6% (1999-2000) to 43.5% (2015-2016).²

Chronotherapy involves the administration of medication in coordination with the body’s circadian rhythms to maximize therapeutic effectiveness and/or minimize adverse effects. It is not a new concept as it applies to hypertension. Circadian rhythm–­dependent mechanisms influence the natural rise and fall of blood pressure (BP).¹ The ­renin-­angiotensin-aldosterone system, known to be most active at night, is a target mechanism for BP control.¹ Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are more effective (alone or in combination with other agents) at reducing BP during sleep and wakefulness when they are taken at night.^3,4 Additional prospective clinical trials and systematic reviews have documented improved BP during sleep and on 24-hour ambulatory monitoring when antihypertensives are taken at bedtime.^3-5

However, there have been few long-term studies assessing the effects of bedtime administration of antihypertensive medication on CVD risk reduction with patient-oriented outcomes.^6,7 Additionally, no studies have evaluated morning vs bedtime administration of antihypertensive medication for CVD risk reduction in a primary care setting. The 2019 ACC/AHA guideline on the primary prevention of CVD offers no recommendation regarding when to take antihypertensive medication.⁸ Timing of medication administration also is not addressed in the NHANES study of hypertension awareness, treatment, and control in US adults.⁹

This study sought to determine in a primary care setting whether taking antihypertensives at bedtime, as opposed to upon waking, more effectively reduces CVD risk.

STUDY SUMMARY

PM vs AM antihypertensive dosing reduces CV events

This prospective, randomized, open-label, blinded endpoint trial of antihypertensive medication administration timing was part of a large, multicenter Spanish study investigating ambulatory BP monitoring (ABPM) as a routine diagnostic tool.

A simple change in administration time has the potential to significantly improve the lives of our patients by reducing the risk for cardiovascular events and their medication burden.

Study participants were randomly assigned in a 1:1 ratio to 2 treatment arms; participants either took all of their BP medications in the morning upon waking (n = 9532) or right before bedtime (n = 9552). The study was conducted in a primary care clinical setting. It included adult participants (age ≥ 18 years) with hypertension (defined as having at least 1 of the following benchmarks: awake systolic BP [SBP] mean ≥ 135 mm Hg, awake diastolic BP (DBP) mean ≥ 85 mm Hg, asleep SBP mean ≥ 120 mm Hg, asleep DBP mean ≥ 70 mm Hg as corroborated by 48-hour ABPM) who were taking at least 1 antihypertensive medication.

Continue to: Any antihypertension medication...

Any antihypertension medication included in the Spanish national formulary was allowed (exact agents were not delineated, but the following classes were included: ARB, ACE inhibitor, calcium channel blocker [CCB], beta-blocker, and/or diuretic). All BP medications had to be dosed once daily for inclusion. Exclusion criteria included pregnancy, night or rotating-shift work, alcohol or other substance dependence, acquired immunodeficiency syndrome, preexisting CVD (unstable angina, heart failure, arrhythmia, kidney failure, and retinopathy), inability to tolerate ABPM, and inability to comply with required 1-year follow-up.

Upon enrollment and at every subsequent clinic visit (scheduled at least annually), participants underwent 48-hour ABPM. Those with uncontrolled BP or elevated CVD risk had scheduled follow-up and ABPM more frequently. The primary outcome was a composite of CVD events including new-onset myocardial infarction, coronary revascularization, heart failure, ischemic stroke, hemorrhagic stroke, and CVD death. Secondary endpoints were individually analyzed primary outcomes of CVD events. The typical patient at baseline was 60.5 years of age with a body mass index of 29.7, an almost 9-year duration of hypertension, and a baseline office BP of 149/86 mm Hg. The patient break-out by antihypertensive class (awakening vs bedtime groups) was as follows: ARB (53% vs 53%), ACE inhibitor (25% vs 23%), CCB (33% vs 37%), beta-blocker (22% vs 18%), and diuretic (47% vs 40%).

See “It’s time to change when BP meds are taken” for more on the controversy that surrounded the initial release of this study.

During the median 6.3-year patient follow-up period, 1752 participants experienced a total of 2454 CVD events. Patients in the bedtime administration group, compared with those in the morning group, showed significantly lower risk for a CVD event (hazard ratio [HR] = 0.55; 95% confidence interval [CI], 0.50-0.61; P < .001). Also, there was a lower risk for individual CVD events in the bedtime administration group: CVD death (HR = 0.44; 95% CI, 0.34-0.56), myocardial infarction (HR = 0.66; 95% CI, 0.52-0.84), coronary revascularization (HR = 0.60; 95% CI, 0.47-0.75), heart failure (HR = 0.58; 95% CI, 0.49-0.70), and stroke (HR = 0.51; 95% CI, 0.41-0.63). This difference remained after correction for multiple potential confounders. There were no differences in adverse events, such as sleep-time hypotension, between groups.

WHAT’S NEW

First RCT in primary care to show dosing time change reduces CV risk

This is the first randomized controlled trial (RCT) performed in a primary care setting to compare before-bedtime to upon-waking administration of antihypertensive medications using clinically significant endpoints. The study demonstrates that a simple change in administration time has the potential to significantly improve the lives of our patients by reducing the risk for cardiovascular events and their medication burden.

CAVEATS

Homogenous population and exclusions limit generalizability

Because the study population consisted of white Spanish men and women, the results may not be generalizable beyond that ethnic group. In addition, the study exclusions limit interpretation in night/rotating-shift employees, patients with secondary hypertension, and those with CVD, chronic kidney disease, or severe retinopathy looking to reduce their risk.

Continue to: CHALLENGES TO IMPLEMENTATION

Nighttime urination could lead to nonadherence

Taking diuretics at bedtime may result in unwanted nighttime awakenings for visits to the bathroom, which could lead to nonadherence in some patients.

ACKNOWLEDGMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Click here to access August 2020 Advances in Precision Oncology

Table of Contents

• Foreword
• Introduction: Precision Oncology Changes the Game for VA Health Care
• VA National Precision Oncology Program
• Prostate Cancer Foundation-Department of Veterans Affairs Partnership: A Model to Advance Treatment and Care of Invasive Cancers
• The Precision Oncology Program for Cancer of the Prostate Network: A VA-Prostate Cancer Foundation Alliance
• Leveraging Veterans Health Administration Clinical and Research Resources to Accelerate Discovery and Testing in Precision Oncology
• Strategic Initiatives for Veterans With Lung Cancer
• Integrating Germline Genetics Into Precision Oncology Practice in the Veterans Health Administration: Challenges and Opportunities

Click here to access August 2020 Advances in Precision Oncology

Table of Contents

• Foreword
• Introduction: Precision Oncology Changes the Game for VA Health Care
• VA National Precision Oncology Program
• Prostate Cancer Foundation-Department of Veterans Affairs Partnership: A Model to Advance Treatment and Care of Invasive Cancers
• The Precision Oncology Program for Cancer of the Prostate Network: A VA-Prostate Cancer Foundation Alliance
• Leveraging Veterans Health Administration Clinical and Research Resources to Accelerate Discovery and Testing in Precision Oncology
• Strategic Initiatives for Veterans With Lung Cancer
• Integrating Germline Genetics Into Precision Oncology Practice in the Veterans Health Administration: Challenges and Opportunities

Click here to access August 2020 Advances in Precision Oncology

Table of Contents

• Foreword
• Introduction: Precision Oncology Changes the Game for VA Health Care
• VA National Precision Oncology Program
• Prostate Cancer Foundation-Department of Veterans Affairs Partnership: A Model to Advance Treatment and Care of Invasive Cancers
• The Precision Oncology Program for Cancer of the Prostate Network: A VA-Prostate Cancer Foundation Alliance
• Leveraging Veterans Health Administration Clinical and Research Resources to Accelerate Discovery and Testing in Precision Oncology
• Strategic Initiatives for Veterans With Lung Cancer
• Integrating Germline Genetics Into Precision Oncology Practice in the Veterans Health Administration: Challenges and Opportunities

One high school student out of every seven ever has either misused a prescription pain medicine or taken one without a prescription, according to an analysis from the Centers for Disease Control and Prevention.

That type of opioid use/misuse, reported by 14.3% of respondents to the 2019 Youth Risk Behavior Survey, was more common among females (16.1%) than males (12.4%) and even more prevalent among nonheterosexuals and those who are unsure about their sexual identity, Christopher M. Jones, PharmD, DrPH, and associates at the CDC said in the Morbidity and Mortality Weekly Report.

The YRBS data show that 18.5% of gay or lesbian students had, at some point in their lives, used a prescription opioid differently than a physician had told them to or taken one without a prescription. That figure was slightly higher (19.1%) for those unsure of their sexual identity, considerably higher (25.4%) for bisexuals, and lower for heterosexuals (12.7%), they reported.

The pattern for current use/misuse of opioids, defined as use one or more times in the 30 days before the survey, was similar to ever use but somewhat less pronounced in 2019. Prevalence was 7.2% for all students in grades 9-12, 8.3% for females, and 6.1% for males. By sexual identity, prevalence was 6.4% for heterosexuals, 7.6% for gays or lesbians, 11.5% for those unsure about their sexual identity, and 13.1% for bisexuals, based on the YRBS data.

This increased misuse of opioids among sexual minority youths, “even after controlling for other demographic and substance use characteristics ... emphasizes the importance of identifying tailored prevention strategies to address disparities among this vulnerable population,” the CDC researchers wrote.

[email protected]

SOURCE: Jones CM et al. MMWR Suppl. 2020 Aug 21;69(1):38-46.

One high school student out of every seven ever has either misused a prescription pain medicine or taken one without a prescription, according to an analysis from the Centers for Disease Control and Prevention.

That type of opioid use/misuse, reported by 14.3% of respondents to the 2019 Youth Risk Behavior Survey, was more common among females (16.1%) than males (12.4%) and even more prevalent among nonheterosexuals and those who are unsure about their sexual identity, Christopher M. Jones, PharmD, DrPH, and associates at the CDC said in the Morbidity and Mortality Weekly Report.

The YRBS data show that 18.5% of gay or lesbian students had, at some point in their lives, used a prescription opioid differently than a physician had told them to or taken one without a prescription. That figure was slightly higher (19.1%) for those unsure of their sexual identity, considerably higher (25.4%) for bisexuals, and lower for heterosexuals (12.7%), they reported.

The pattern for current use/misuse of opioids, defined as use one or more times in the 30 days before the survey, was similar to ever use but somewhat less pronounced in 2019. Prevalence was 7.2% for all students in grades 9-12, 8.3% for females, and 6.1% for males. By sexual identity, prevalence was 6.4% for heterosexuals, 7.6% for gays or lesbians, 11.5% for those unsure about their sexual identity, and 13.1% for bisexuals, based on the YRBS data.

This increased misuse of opioids among sexual minority youths, “even after controlling for other demographic and substance use characteristics ... emphasizes the importance of identifying tailored prevention strategies to address disparities among this vulnerable population,” the CDC researchers wrote.

[email protected]

SOURCE: Jones CM et al. MMWR Suppl. 2020 Aug 21;69(1):38-46.

One high school student out of every seven ever has either misused a prescription pain medicine or taken one without a prescription, according to an analysis from the Centers for Disease Control and Prevention.

That type of opioid use/misuse, reported by 14.3% of respondents to the 2019 Youth Risk Behavior Survey, was more common among females (16.1%) than males (12.4%) and even more prevalent among nonheterosexuals and those who are unsure about their sexual identity, Christopher M. Jones, PharmD, DrPH, and associates at the CDC said in the Morbidity and Mortality Weekly Report.

The YRBS data show that 18.5% of gay or lesbian students had, at some point in their lives, used a prescription opioid differently than a physician had told them to or taken one without a prescription. That figure was slightly higher (19.1%) for those unsure of their sexual identity, considerably higher (25.4%) for bisexuals, and lower for heterosexuals (12.7%), they reported.

The pattern for current use/misuse of opioids, defined as use one or more times in the 30 days before the survey, was similar to ever use but somewhat less pronounced in 2019. Prevalence was 7.2% for all students in grades 9-12, 8.3% for females, and 6.1% for males. By sexual identity, prevalence was 6.4% for heterosexuals, 7.6% for gays or lesbians, 11.5% for those unsure about their sexual identity, and 13.1% for bisexuals, based on the YRBS data.

This increased misuse of opioids among sexual minority youths, “even after controlling for other demographic and substance use characteristics ... emphasizes the importance of identifying tailored prevention strategies to address disparities among this vulnerable population,” the CDC researchers wrote.

[email protected]

SOURCE: Jones CM et al. MMWR Suppl. 2020 Aug 21;69(1):38-46.

The emergence of the coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) in December 2019, has resulted in a global pandemic that has challenged the medical community and will continue to represent a public health emergency for the next several months.¹ It has rapidly spread globally, infecting many individuals in an unprecedented rate of infection and worldwide reach. On March 11, 2020, the World Health Organization designated COVID-19 as a pandemic. While the majority of infected individuals are asymptomatic or develop only mild symptoms, some have an unfortunate clinical course resulting in multi-organ failure and death.²

It is accepted that the virus mainly spreads during close contact and via respiratory droplets.³ The average time from infection to onset of symptoms ranges from 2 to 14 days, with an average of 5 days.⁴ Recommended measures to prevent the spread of the infection include social distancing (at least 6 feet from others), meticulous hand hygiene, and wearing a mask covering the mouth and nose when in public.⁵ Aiming to mitigate the risk of viral dissemination for patients and health care providers, and to preserve hospital resources, all nonessential medical interventions were initially suspended. Recently, the American College of Surgeons in a joint statement with 9 women’s health care societies have provided recommendations on how to resume clinical activities as we recover from the pandemic.⁶

As we reinitiate clinical activities, gynecologists have been alerted of the potential risk of viral dissemination during gynecologic minimally invasive surgical procedures due to the presence of the virus in blood, stool, and the potential risk of aerosolization of the virus, especially when using smoke-generating devices.^7,8 This risk is not limited to intubation and extubation of the airway during anesthesia; the risk also presents itself during other aerosol-generating procedures, such as laparoscopy or robotic surgery.^9,10

Hysteroscopy is considered the gold standard procedure for the diagnosis and management of intrauterine pathologies.¹¹ It is frequently performed in an office setting without the use of anesthesia.^11,12 It is usually well tolerated, with only a few patients reporting discomfort.¹² It allows for immediate treatment (using the “see and treat” approach) while avoiding not only the risk of anesthesia, as stated, but also the need for intubation—which has a high risk of droplet contamination in COVID-19–infected individuals.¹³

Is there risk of viral dissemination during hysteroscopic procedures?

The novel and rapidly changing nature of the COVID-19 pandemic present many challenges to the gynecologist. Significant concerns have been raised regarding potential risk of viral dissemination during laparoscopic surgery due to aerosolization of viral particles and the presence of the virus in blood and the gastrointestinal tract of infected patients.⁷ Diagnostic, and some simple, hysteroscopic procedures are commonly performed in an outpatient setting, with the patient awake. Complex hysteroscopic interventions, however, are generally performed in the operating room, typically with the use of general anesthesia. Hysteroscopy has the theoretical risks of viral dissemination when performed in COVID-19–positive patients. Two important questions must be addressed to better understand the potential risk of COVID-19 viral dissemination during hysteroscopic procedures.

Continue to: 1. Is the virus present in the vaginal fluid of women infected with COVID-19?...

1. Is the virus present in the vaginal fluid of women infected with COVID-19?

Recent studies have confirmed the presence of viral particles in urine, feces, blood, and tears in addition to the respiratory tract in patients infected with COVID-19.^3,14,15 The presence of the SARS-CoV-2 virus in the female genital system is currently unknown. Previous studies, of other epidemic viral infections, have demonstrated the presence of the virus in the female genital tract in affected patients of Zika virus and Ebola.^16,17 However, 2 recent studies have failed to demonstrate the presence of the SARS-CoV-2 virus in the vaginal fluid of pregnant¹⁴ and not pregnant¹⁸ women with severe COVID-19 infection.

2. Is there risk of viral dissemination during hysteroscopy if using electrosurgery?

There are significant concerns with possible risk of COVID-19 transmission to health care providers in direct contact with infected patients during minimally invasive gynecologic procedures due to direct contamination and aerosolization of the virus.^10,19 Current data on COVID-19 transmission during surgery are limited. However, it is important to recognize that viral aerosolization has been documented with other viral diseases, such as human papillomavirus and hepatitis B.²⁰ A recent report called for awareness in the surgical community about the potential risks of COVID-19 viral dissemination during laparoscopic surgery. Among other recommendations, international experts advised minimizing the use of electrosurgery to reduce the creation of surgical plume, decreasing the pneumoperitoneum pressure to minimum levels, and using suction devices in a closed system.²¹ Although these preventive measures apply to laparoscopic surgery, it is important to consider that hysteroscopy is performed in a unique environment.

During hysteroscopy the uterine cavity is distended with a liquid medium (normal saline or electrolyte-free solutions); this is opposed to gynecologic laparoscopy, in which the peritoneal cavity is distended with carbon dioxide.²² The smoke produced with the use of hysteroscopic electrosurgical instruments generates bubbles that are immediately cooled down to the temperature of the distention media and subsequently dissolve into it. Therefore, there are no bubbles generated during hysteroscopic surgery that are subsequently released into the air. This results in a low risk for viral dissemination during hysteroscopic procedures. Nevertheless, the necessary precautions to minimize the risk of COVID-19 transmission during hysteroscopic intervention are extremely important.

Recommendations for hysteroscopic procedures during the COVID-19 pandemic

We provide our overall recommendations for hysteroscopy, as well as those specific to the office and hospital setting.

Recommendations: General

Limit hysteroscopic procedures to COVID-19–negative patients and to those patients in whom delaying the procedure could result in adverse clinical outcomes.²³

Universally screen for potential COVID-19 infection. When possible, a phone interview to triage patients based on their symptoms and infection exposure status should take place before the patient arrives to the health care center. Patients with suspected or confirmed COVID-19 infection who require immediate evaluation should be directed to COVID-19–designated emergency areas.

Universally test for SARS-CoV-2 before procedures performed in the operating room (OR). Using nasopharyngeal swabs for the detection of viral RNA, employing molecular methods such as polymerase chain reaction (PCR), within 48 to 72 hours prior to all OR hysteroscopic procedures is strongly recommended. Adopting this testing strategy will aid to identify asymptomatic SARS-CoV-2‒infected patients, allowing to defer the procedure, if possible, among patients testing positive. If tests are limited, testing only patients scheduled for hysteroscopic procedures in which general or regional anesthesia will be required is acceptable.

Universal SARS-CoV-2 testing of patients undergoing in-office hysteroscopic diagnostic or minor operative procedures without the use of anesthesia is not required.

Limit the presence of a companion. It is understood that visitor policies may vary at the discretion of each institution’s guidelines. Children and individuals over the age of 60 years should not be granted access to the center. Companions will be subjected to the same screening criteria as patients.

Provide for social distancing and other precautionary measures. If more than one patient is scheduled to be at the facility at the same time, ensure that the facility provides adequate space to allow the appropriate social distancing recommendations between patients. Hand sanitizers and facemasks should be available for patients and companions.

Provide PPE for clinicians. All health care providers in close contact with the patient must wear personal protective equipment (PPE), which includes an apron and gown, a surgical mask, eye protection, and gloves. Health care providers should wear PPE deemed appropriate by their regulatory institutions following their local and national guidelines during clinical patient interactions.

Restrict surgical attendees to vital personnel. The participation of learners by physical presence in the office or operating room should be restricted.

Continue to: Recommendations: Office setting...

Preprocedural recommendations

• Advise patients to come to the office alone. If the patient requires a companion, a maximum of one adult companion under the age of 60 should be accepted.
• Limit the number of health care team members present in the procedure room.

Intraprocedural recommendations

• Choose the appropriate device(s) that will allow for an effective and fast procedure.
• Use the recommended PPE for all clinicians.
• Limit the movement of staff members in and out of the procedure room.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same procedure room, allow enough time in between cases to grant a thorough OR decontamination.
• Allow for patients to recover from the procedure in the same room as the procedure took place in order to avoid potential contamination of multiple rooms.
• Expedite patient discharge.
• Follow up after the procedure by phone or telemedicine.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Continue to: Recommendations: Operating room setting...

Preprocedural recommendations

• Perform adequate patient screening for potential COVID-19 infection. (Screening should be independent of symptoms and not be limited to those with clinical symptoms.)
• Limit the number of health care team members in the operating procedure room.
• To minimize unnecessary staff exposure, have surgeons and staff not needed for intubation remain outside the OR until intubation is completed and leave the OR before extubation.

Intraprocedure recommendations

• Limit personnel in the OR to a minimum.
• Staff should not enter or leave the room during the procedure.
• When possible, use conscious sedation or regional anesthesia to avoid the risk of viral dissemination at the time of intubation/extubation.
• Choose the device that will allow an effective and fast procedure.
• Favor non–smoke-generating devices, such as hysteroscopic scissors, graspers, and tissue retrieval systems.
• Connect active suction to the outflow, especially when using smoke-generating instruments, to facilitate the extraction of surgical smoke.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same room, allow enough time in between cases to grant a thorough OR decontamination.
• Expedite postprocedure recovery and patient discharge.
• After completion of the procedure, staff should remove scrubs and change into clean clothing.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Conclusions

The COVID-19 pandemic has caused a global health emergency. Our knowledge of this devastating virus is constantly evolving as we continue to fight this overwhelming disease. Theoretical risk of “viral” dissemination is considered extremely low, or negligible, during hysterosocopy. Hysteroscopic procedures in COVID-19–positive patients with life-threatening conditions or in patients in whom delaying the procedure could worsen outcomes should be performed taking appropriate measures. Patients who test negative for COVID-19 (confirmed by PCR) and require hysteroscopic procedures, should be treated using universal precautions. ●

The emergence of the coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) in December 2019, has resulted in a global pandemic that has challenged the medical community and will continue to represent a public health emergency for the next several months.¹ It has rapidly spread globally, infecting many individuals in an unprecedented rate of infection and worldwide reach. On March 11, 2020, the World Health Organization designated COVID-19 as a pandemic. While the majority of infected individuals are asymptomatic or develop only mild symptoms, some have an unfortunate clinical course resulting in multi-organ failure and death.²

It is accepted that the virus mainly spreads during close contact and via respiratory droplets.³ The average time from infection to onset of symptoms ranges from 2 to 14 days, with an average of 5 days.⁴ Recommended measures to prevent the spread of the infection include social distancing (at least 6 feet from others), meticulous hand hygiene, and wearing a mask covering the mouth and nose when in public.⁵ Aiming to mitigate the risk of viral dissemination for patients and health care providers, and to preserve hospital resources, all nonessential medical interventions were initially suspended. Recently, the American College of Surgeons in a joint statement with 9 women’s health care societies have provided recommendations on how to resume clinical activities as we recover from the pandemic.⁶

As we reinitiate clinical activities, gynecologists have been alerted of the potential risk of viral dissemination during gynecologic minimally invasive surgical procedures due to the presence of the virus in blood, stool, and the potential risk of aerosolization of the virus, especially when using smoke-generating devices.^7,8 This risk is not limited to intubation and extubation of the airway during anesthesia; the risk also presents itself during other aerosol-generating procedures, such as laparoscopy or robotic surgery.^9,10

Hysteroscopy is considered the gold standard procedure for the diagnosis and management of intrauterine pathologies.¹¹ It is frequently performed in an office setting without the use of anesthesia.^11,12 It is usually well tolerated, with only a few patients reporting discomfort.¹² It allows for immediate treatment (using the “see and treat” approach) while avoiding not only the risk of anesthesia, as stated, but also the need for intubation—which has a high risk of droplet contamination in COVID-19–infected individuals.¹³

Is there risk of viral dissemination during hysteroscopic procedures?

The novel and rapidly changing nature of the COVID-19 pandemic present many challenges to the gynecologist. Significant concerns have been raised regarding potential risk of viral dissemination during laparoscopic surgery due to aerosolization of viral particles and the presence of the virus in blood and the gastrointestinal tract of infected patients.⁷ Diagnostic, and some simple, hysteroscopic procedures are commonly performed in an outpatient setting, with the patient awake. Complex hysteroscopic interventions, however, are generally performed in the operating room, typically with the use of general anesthesia. Hysteroscopy has the theoretical risks of viral dissemination when performed in COVID-19–positive patients. Two important questions must be addressed to better understand the potential risk of COVID-19 viral dissemination during hysteroscopic procedures.

Continue to: 1. Is the virus present in the vaginal fluid of women infected with COVID-19?...

1. Is the virus present in the vaginal fluid of women infected with COVID-19?

Recent studies have confirmed the presence of viral particles in urine, feces, blood, and tears in addition to the respiratory tract in patients infected with COVID-19.^3,14,15 The presence of the SARS-CoV-2 virus in the female genital system is currently unknown. Previous studies, of other epidemic viral infections, have demonstrated the presence of the virus in the female genital tract in affected patients of Zika virus and Ebola.^16,17 However, 2 recent studies have failed to demonstrate the presence of the SARS-CoV-2 virus in the vaginal fluid of pregnant¹⁴ and not pregnant¹⁸ women with severe COVID-19 infection.

2. Is there risk of viral dissemination during hysteroscopy if using electrosurgery?

There are significant concerns with possible risk of COVID-19 transmission to health care providers in direct contact with infected patients during minimally invasive gynecologic procedures due to direct contamination and aerosolization of the virus.^10,19 Current data on COVID-19 transmission during surgery are limited. However, it is important to recognize that viral aerosolization has been documented with other viral diseases, such as human papillomavirus and hepatitis B.²⁰ A recent report called for awareness in the surgical community about the potential risks of COVID-19 viral dissemination during laparoscopic surgery. Among other recommendations, international experts advised minimizing the use of electrosurgery to reduce the creation of surgical plume, decreasing the pneumoperitoneum pressure to minimum levels, and using suction devices in a closed system.²¹ Although these preventive measures apply to laparoscopic surgery, it is important to consider that hysteroscopy is performed in a unique environment.

During hysteroscopy the uterine cavity is distended with a liquid medium (normal saline or electrolyte-free solutions); this is opposed to gynecologic laparoscopy, in which the peritoneal cavity is distended with carbon dioxide.²² The smoke produced with the use of hysteroscopic electrosurgical instruments generates bubbles that are immediately cooled down to the temperature of the distention media and subsequently dissolve into it. Therefore, there are no bubbles generated during hysteroscopic surgery that are subsequently released into the air. This results in a low risk for viral dissemination during hysteroscopic procedures. Nevertheless, the necessary precautions to minimize the risk of COVID-19 transmission during hysteroscopic intervention are extremely important.

Recommendations for hysteroscopic procedures during the COVID-19 pandemic

We provide our overall recommendations for hysteroscopy, as well as those specific to the office and hospital setting.

Recommendations: General

Limit hysteroscopic procedures to COVID-19–negative patients and to those patients in whom delaying the procedure could result in adverse clinical outcomes.²³

Universally screen for potential COVID-19 infection. When possible, a phone interview to triage patients based on their symptoms and infection exposure status should take place before the patient arrives to the health care center. Patients with suspected or confirmed COVID-19 infection who require immediate evaluation should be directed to COVID-19–designated emergency areas.

Universally test for SARS-CoV-2 before procedures performed in the operating room (OR). Using nasopharyngeal swabs for the detection of viral RNA, employing molecular methods such as polymerase chain reaction (PCR), within 48 to 72 hours prior to all OR hysteroscopic procedures is strongly recommended. Adopting this testing strategy will aid to identify asymptomatic SARS-CoV-2‒infected patients, allowing to defer the procedure, if possible, among patients testing positive. If tests are limited, testing only patients scheduled for hysteroscopic procedures in which general or regional anesthesia will be required is acceptable.

Universal SARS-CoV-2 testing of patients undergoing in-office hysteroscopic diagnostic or minor operative procedures without the use of anesthesia is not required.

Limit the presence of a companion. It is understood that visitor policies may vary at the discretion of each institution’s guidelines. Children and individuals over the age of 60 years should not be granted access to the center. Companions will be subjected to the same screening criteria as patients.

Provide for social distancing and other precautionary measures. If more than one patient is scheduled to be at the facility at the same time, ensure that the facility provides adequate space to allow the appropriate social distancing recommendations between patients. Hand sanitizers and facemasks should be available for patients and companions.

Provide PPE for clinicians. All health care providers in close contact with the patient must wear personal protective equipment (PPE), which includes an apron and gown, a surgical mask, eye protection, and gloves. Health care providers should wear PPE deemed appropriate by their regulatory institutions following their local and national guidelines during clinical patient interactions.

Restrict surgical attendees to vital personnel. The participation of learners by physical presence in the office or operating room should be restricted.

Continue to: Recommendations: Office setting...

Preprocedural recommendations

• Advise patients to come to the office alone. If the patient requires a companion, a maximum of one adult companion under the age of 60 should be accepted.
• Limit the number of health care team members present in the procedure room.

Intraprocedural recommendations

• Choose the appropriate device(s) that will allow for an effective and fast procedure.
• Use the recommended PPE for all clinicians.
• Limit the movement of staff members in and out of the procedure room.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same procedure room, allow enough time in between cases to grant a thorough OR decontamination.
• Allow for patients to recover from the procedure in the same room as the procedure took place in order to avoid potential contamination of multiple rooms.
• Expedite patient discharge.
• Follow up after the procedure by phone or telemedicine.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Continue to: Recommendations: Operating room setting...

Preprocedural recommendations

• Perform adequate patient screening for potential COVID-19 infection. (Screening should be independent of symptoms and not be limited to those with clinical symptoms.)
• Limit the number of health care team members in the operating procedure room.
• To minimize unnecessary staff exposure, have surgeons and staff not needed for intubation remain outside the OR until intubation is completed and leave the OR before extubation.

Intraprocedure recommendations

• Limit personnel in the OR to a minimum.
• Staff should not enter or leave the room during the procedure.
• When possible, use conscious sedation or regional anesthesia to avoid the risk of viral dissemination at the time of intubation/extubation.
• Choose the device that will allow an effective and fast procedure.
• Favor non–smoke-generating devices, such as hysteroscopic scissors, graspers, and tissue retrieval systems.
• Connect active suction to the outflow, especially when using smoke-generating instruments, to facilitate the extraction of surgical smoke.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same room, allow enough time in between cases to grant a thorough OR decontamination.
• Expedite postprocedure recovery and patient discharge.
• After completion of the procedure, staff should remove scrubs and change into clean clothing.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Conclusions

The COVID-19 pandemic has caused a global health emergency. Our knowledge of this devastating virus is constantly evolving as we continue to fight this overwhelming disease. Theoretical risk of “viral” dissemination is considered extremely low, or negligible, during hysterosocopy. Hysteroscopic procedures in COVID-19–positive patients with life-threatening conditions or in patients in whom delaying the procedure could worsen outcomes should be performed taking appropriate measures. Patients who test negative for COVID-19 (confirmed by PCR) and require hysteroscopic procedures, should be treated using universal precautions. ●

The emergence of the coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) in December 2019, has resulted in a global pandemic that has challenged the medical community and will continue to represent a public health emergency for the next several months.¹ It has rapidly spread globally, infecting many individuals in an unprecedented rate of infection and worldwide reach. On March 11, 2020, the World Health Organization designated COVID-19 as a pandemic. While the majority of infected individuals are asymptomatic or develop only mild symptoms, some have an unfortunate clinical course resulting in multi-organ failure and death.²

It is accepted that the virus mainly spreads during close contact and via respiratory droplets.³ The average time from infection to onset of symptoms ranges from 2 to 14 days, with an average of 5 days.⁴ Recommended measures to prevent the spread of the infection include social distancing (at least 6 feet from others), meticulous hand hygiene, and wearing a mask covering the mouth and nose when in public.⁵ Aiming to mitigate the risk of viral dissemination for patients and health care providers, and to preserve hospital resources, all nonessential medical interventions were initially suspended. Recently, the American College of Surgeons in a joint statement with 9 women’s health care societies have provided recommendations on how to resume clinical activities as we recover from the pandemic.⁶

As we reinitiate clinical activities, gynecologists have been alerted of the potential risk of viral dissemination during gynecologic minimally invasive surgical procedures due to the presence of the virus in blood, stool, and the potential risk of aerosolization of the virus, especially when using smoke-generating devices.^7,8 This risk is not limited to intubation and extubation of the airway during anesthesia; the risk also presents itself during other aerosol-generating procedures, such as laparoscopy or robotic surgery.^9,10

Hysteroscopy is considered the gold standard procedure for the diagnosis and management of intrauterine pathologies.¹¹ It is frequently performed in an office setting without the use of anesthesia.^11,12 It is usually well tolerated, with only a few patients reporting discomfort.¹² It allows for immediate treatment (using the “see and treat” approach) while avoiding not only the risk of anesthesia, as stated, but also the need for intubation—which has a high risk of droplet contamination in COVID-19–infected individuals.¹³

Is there risk of viral dissemination during hysteroscopic procedures?

The novel and rapidly changing nature of the COVID-19 pandemic present many challenges to the gynecologist. Significant concerns have been raised regarding potential risk of viral dissemination during laparoscopic surgery due to aerosolization of viral particles and the presence of the virus in blood and the gastrointestinal tract of infected patients.⁷ Diagnostic, and some simple, hysteroscopic procedures are commonly performed in an outpatient setting, with the patient awake. Complex hysteroscopic interventions, however, are generally performed in the operating room, typically with the use of general anesthesia. Hysteroscopy has the theoretical risks of viral dissemination when performed in COVID-19–positive patients. Two important questions must be addressed to better understand the potential risk of COVID-19 viral dissemination during hysteroscopic procedures.

Continue to: 1. Is the virus present in the vaginal fluid of women infected with COVID-19?...

1. Is the virus present in the vaginal fluid of women infected with COVID-19?

Recent studies have confirmed the presence of viral particles in urine, feces, blood, and tears in addition to the respiratory tract in patients infected with COVID-19.^3,14,15 The presence of the SARS-CoV-2 virus in the female genital system is currently unknown. Previous studies, of other epidemic viral infections, have demonstrated the presence of the virus in the female genital tract in affected patients of Zika virus and Ebola.^16,17 However, 2 recent studies have failed to demonstrate the presence of the SARS-CoV-2 virus in the vaginal fluid of pregnant¹⁴ and not pregnant¹⁸ women with severe COVID-19 infection.

2. Is there risk of viral dissemination during hysteroscopy if using electrosurgery?

There are significant concerns with possible risk of COVID-19 transmission to health care providers in direct contact with infected patients during minimally invasive gynecologic procedures due to direct contamination and aerosolization of the virus.^10,19 Current data on COVID-19 transmission during surgery are limited. However, it is important to recognize that viral aerosolization has been documented with other viral diseases, such as human papillomavirus and hepatitis B.²⁰ A recent report called for awareness in the surgical community about the potential risks of COVID-19 viral dissemination during laparoscopic surgery. Among other recommendations, international experts advised minimizing the use of electrosurgery to reduce the creation of surgical plume, decreasing the pneumoperitoneum pressure to minimum levels, and using suction devices in a closed system.²¹ Although these preventive measures apply to laparoscopic surgery, it is important to consider that hysteroscopy is performed in a unique environment.

During hysteroscopy the uterine cavity is distended with a liquid medium (normal saline or electrolyte-free solutions); this is opposed to gynecologic laparoscopy, in which the peritoneal cavity is distended with carbon dioxide.²² The smoke produced with the use of hysteroscopic electrosurgical instruments generates bubbles that are immediately cooled down to the temperature of the distention media and subsequently dissolve into it. Therefore, there are no bubbles generated during hysteroscopic surgery that are subsequently released into the air. This results in a low risk for viral dissemination during hysteroscopic procedures. Nevertheless, the necessary precautions to minimize the risk of COVID-19 transmission during hysteroscopic intervention are extremely important.

Recommendations for hysteroscopic procedures during the COVID-19 pandemic

We provide our overall recommendations for hysteroscopy, as well as those specific to the office and hospital setting.

Recommendations: General

Limit hysteroscopic procedures to COVID-19–negative patients and to those patients in whom delaying the procedure could result in adverse clinical outcomes.²³

Universally screen for potential COVID-19 infection. When possible, a phone interview to triage patients based on their symptoms and infection exposure status should take place before the patient arrives to the health care center. Patients with suspected or confirmed COVID-19 infection who require immediate evaluation should be directed to COVID-19–designated emergency areas.

Universally test for SARS-CoV-2 before procedures performed in the operating room (OR). Using nasopharyngeal swabs for the detection of viral RNA, employing molecular methods such as polymerase chain reaction (PCR), within 48 to 72 hours prior to all OR hysteroscopic procedures is strongly recommended. Adopting this testing strategy will aid to identify asymptomatic SARS-CoV-2‒infected patients, allowing to defer the procedure, if possible, among patients testing positive. If tests are limited, testing only patients scheduled for hysteroscopic procedures in which general or regional anesthesia will be required is acceptable.

Universal SARS-CoV-2 testing of patients undergoing in-office hysteroscopic diagnostic or minor operative procedures without the use of anesthesia is not required.

Limit the presence of a companion. It is understood that visitor policies may vary at the discretion of each institution’s guidelines. Children and individuals over the age of 60 years should not be granted access to the center. Companions will be subjected to the same screening criteria as patients.

Provide for social distancing and other precautionary measures. If more than one patient is scheduled to be at the facility at the same time, ensure that the facility provides adequate space to allow the appropriate social distancing recommendations between patients. Hand sanitizers and facemasks should be available for patients and companions.

Provide PPE for clinicians. All health care providers in close contact with the patient must wear personal protective equipment (PPE), which includes an apron and gown, a surgical mask, eye protection, and gloves. Health care providers should wear PPE deemed appropriate by their regulatory institutions following their local and national guidelines during clinical patient interactions.

Restrict surgical attendees to vital personnel. The participation of learners by physical presence in the office or operating room should be restricted.

Continue to: Recommendations: Office setting...

Preprocedural recommendations

• Advise patients to come to the office alone. If the patient requires a companion, a maximum of one adult companion under the age of 60 should be accepted.
• Limit the number of health care team members present in the procedure room.

Intraprocedural recommendations

• Choose the appropriate device(s) that will allow for an effective and fast procedure.
• Use the recommended PPE for all clinicians.
• Limit the movement of staff members in and out of the procedure room.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same procedure room, allow enough time in between cases to grant a thorough OR decontamination.
• Allow for patients to recover from the procedure in the same room as the procedure took place in order to avoid potential contamination of multiple rooms.
• Expedite patient discharge.
• Follow up after the procedure by phone or telemedicine.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Continue to: Recommendations: Operating room setting...

Preprocedural recommendations

• Perform adequate patient screening for potential COVID-19 infection. (Screening should be independent of symptoms and not be limited to those with clinical symptoms.)
• Limit the number of health care team members in the operating procedure room.
• To minimize unnecessary staff exposure, have surgeons and staff not needed for intubation remain outside the OR until intubation is completed and leave the OR before extubation.

Intraprocedure recommendations

• Limit personnel in the OR to a minimum.
• Staff should not enter or leave the room during the procedure.
• When possible, use conscious sedation or regional anesthesia to avoid the risk of viral dissemination at the time of intubation/extubation.
• Choose the device that will allow an effective and fast procedure.
• Favor non–smoke-generating devices, such as hysteroscopic scissors, graspers, and tissue retrieval systems.
• Connect active suction to the outflow, especially when using smoke-generating instruments, to facilitate the extraction of surgical smoke.

Postprocedure recommendations

• When more than one case is scheduled to be performed in the same room, allow enough time in between cases to grant a thorough OR decontamination.
• Expedite postprocedure recovery and patient discharge.
• After completion of the procedure, staff should remove scrubs and change into clean clothing.
• Use standard endoscope disinfection procedures, as they are effective and should not be modified.

Conclusions

The COVID-19 pandemic has caused a global health emergency. Our knowledge of this devastating virus is constantly evolving as we continue to fight this overwhelming disease. Theoretical risk of “viral” dissemination is considered extremely low, or negligible, during hysterosocopy. Hysteroscopic procedures in COVID-19–positive patients with life-threatening conditions or in patients in whom delaying the procedure could worsen outcomes should be performed taking appropriate measures. Patients who test negative for COVID-19 (confirmed by PCR) and require hysteroscopic procedures, should be treated using universal precautions. ●

A novel biomarker could help identify progression in Parkinson’s disease, distinguish it from other neurodegenerative disorders, and monitor response to treatments. Although the biomarker, neurofilament light chain (NfL), is not especially specific, it is the first blood-based biomarker for Parkinson’s disease.

Neurofilaments are components of the neural cytoskeleton, where they maintain structure along with other functions. Following axonal damage, NfL gets released into extracellular fluids. Previously, NfL has been detected in cerebrospinal fluid (CSF) in patients with multiple sclerosis and neurodegenerative dementias. NfL in the CSF can distinguish Parkinson’s disease (PD) from multiple system atrophy and progressive supranuclear palsy.

That’s useful, but a serum marker would open new doors. “An easily accessible biomarker that will serve as an indicator of diagnosis, disease state, and progression, as well as a marker of response to therapeutic intervention is needed. A biomarker will strengthen the ability to select patients for inclusion or stratification within clinical trials,” commented Okeanis Vaou, MD, director of the movement disorders program at St. Elizabeth’s Medical Center in Brighton, Mass. Dr. Vaou was not involved in the study, which was published Aug. 15 in Movement Disorders.
 

A potential biomarker?

To determine if serum NfL levels would correlate with CSF values and had potential as a biomarker, a large, multi-institutional team of researchers led by Brit Mollenhauer, MD, of the University Medical Center Goettingen (Germany), and Danielle Graham, MD, of Biogen, drew data from a prospective, longitudinal, single-center project called the De Novo Parkinson’s disease (DeNoPa) cohort.

The researchers analyzed data from 176 subjects, including drug-naive patients with newly diagnosed PD; age, sex, and education matched healthy controls; and patients who were initially diagnosed with Parkinson’s disease but had their diagnoses changed to a cognate or neurodegenerative disorder (OND). The researchers also drew 514 serum samples from the prospective longitudinal, observational, international multicenter study Parkinson’s Progression Marker Initiative (PPMI) cohort.

In the DeNoPa cohort, OND patients had the highest median CSF NfL levels at baseline (839 pg/mL) followed by PD patients (562 pg/mL) and healthy controls (494 pg/mL; P = .01). There was a strong correlation between CSF and serum NfL levels in a cross-sectional exploratory study with the PPMI cohort.

Age and sex covariates in the PPMI cohort explained 51% of NfL variability. After adjustment for age and sex, baseline median blood NfL levels were highest in the OND group (16.23 pg/mL), followed by the genetic PD group (13.36 pg/mL), prodromal participants (12.20 pg/mL), PD patients (11.73 pg/mL), unaffected mutation carriers (11.63 pg/mL), and healthy controls (11.05 pg/mL; F test P < .0001). Median serum NfL increased by 3.35% per year of age (P < .0001), and median serum NfL was 6.79% higher in women (P = .0002).

Doubling of adjusted serum NfL levels were associated with a median increase in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale total score of 3.45 points (false-discovery rate–adjusted P = .0115), a median decrease in Symbol Digit Modality Test total score of 1.39 (FDR P = .026), a median decrease in Hopkins Verbal Learning Tests with discrimination recognition score of 0.3 (FDR P = .03), and a median decrease in Hopkins Verbal Learning Tests with retention score of 0.029 (FDR P = .04).
 

More specific markers needed

The findings are intriguing, said Dr Vaou, but “we need to acknowledge that increased NfL levels are not specific enough to Parkinson’s disease and reflect neuronal and axonal damage. Therefore, there is a need for more specific markers to support diagnostic accuracy, rate of progression, and ultimate prognosis. A serum NfL assay may be useful to clinicians evaluating patients with PD or OND diagnosis and mitigate the misdiagnosis of atypical PD. NfL may be particularly useful in differentiating PD from cognate disorders such as multiple system atrophy, progressive supranuclear palsy, and dementia with Lewy bodies.”

The current success is the result of large patient databases containing phenotypic data, imaging, and tests of tissue, blood, and cerebrospinal fluid, along with collaborations between advocacy groups, academia, and industry, according to Dr. Vaou. As that work continues, it could uncover more specific biomarkers “that will allow us not only to help with diagnosis and treatment but with disease progression, inclusion, recruitment and stratification in clinical studies, as well as (be an) indicator of response to therapeutic intervention of an investigational drug.”

The study was funded by the Michael J. Fox Foundation for Parkinson’s Research. Dr. Vaou had no relevant financial disclosures.

SOURCE: Mollenhauer B et al. Mov Disord. 2020 Aug 15. doi: 10.1002/mds.28206.

A novel biomarker could help identify progression in Parkinson’s disease, distinguish it from other neurodegenerative disorders, and monitor response to treatments. Although the biomarker, neurofilament light chain (NfL), is not especially specific, it is the first blood-based biomarker for Parkinson’s disease.

Neurofilaments are components of the neural cytoskeleton, where they maintain structure along with other functions. Following axonal damage, NfL gets released into extracellular fluids. Previously, NfL has been detected in cerebrospinal fluid (CSF) in patients with multiple sclerosis and neurodegenerative dementias. NfL in the CSF can distinguish Parkinson’s disease (PD) from multiple system atrophy and progressive supranuclear palsy.

That’s useful, but a serum marker would open new doors. “An easily accessible biomarker that will serve as an indicator of diagnosis, disease state, and progression, as well as a marker of response to therapeutic intervention is needed. A biomarker will strengthen the ability to select patients for inclusion or stratification within clinical trials,” commented Okeanis Vaou, MD, director of the movement disorders program at St. Elizabeth’s Medical Center in Brighton, Mass. Dr. Vaou was not involved in the study, which was published Aug. 15 in Movement Disorders.
 

A potential biomarker?

To determine if serum NfL levels would correlate with CSF values and had potential as a biomarker, a large, multi-institutional team of researchers led by Brit Mollenhauer, MD, of the University Medical Center Goettingen (Germany), and Danielle Graham, MD, of Biogen, drew data from a prospective, longitudinal, single-center project called the De Novo Parkinson’s disease (DeNoPa) cohort.

The researchers analyzed data from 176 subjects, including drug-naive patients with newly diagnosed PD; age, sex, and education matched healthy controls; and patients who were initially diagnosed with Parkinson’s disease but had their diagnoses changed to a cognate or neurodegenerative disorder (OND). The researchers also drew 514 serum samples from the prospective longitudinal, observational, international multicenter study Parkinson’s Progression Marker Initiative (PPMI) cohort.

In the DeNoPa cohort, OND patients had the highest median CSF NfL levels at baseline (839 pg/mL) followed by PD patients (562 pg/mL) and healthy controls (494 pg/mL; P = .01). There was a strong correlation between CSF and serum NfL levels in a cross-sectional exploratory study with the PPMI cohort.

Age and sex covariates in the PPMI cohort explained 51% of NfL variability. After adjustment for age and sex, baseline median blood NfL levels were highest in the OND group (16.23 pg/mL), followed by the genetic PD group (13.36 pg/mL), prodromal participants (12.20 pg/mL), PD patients (11.73 pg/mL), unaffected mutation carriers (11.63 pg/mL), and healthy controls (11.05 pg/mL; F test P < .0001). Median serum NfL increased by 3.35% per year of age (P < .0001), and median serum NfL was 6.79% higher in women (P = .0002).

Doubling of adjusted serum NfL levels were associated with a median increase in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale total score of 3.45 points (false-discovery rate–adjusted P = .0115), a median decrease in Symbol Digit Modality Test total score of 1.39 (FDR P = .026), a median decrease in Hopkins Verbal Learning Tests with discrimination recognition score of 0.3 (FDR P = .03), and a median decrease in Hopkins Verbal Learning Tests with retention score of 0.029 (FDR P = .04).
 

More specific markers needed

The findings are intriguing, said Dr Vaou, but “we need to acknowledge that increased NfL levels are not specific enough to Parkinson’s disease and reflect neuronal and axonal damage. Therefore, there is a need for more specific markers to support diagnostic accuracy, rate of progression, and ultimate prognosis. A serum NfL assay may be useful to clinicians evaluating patients with PD or OND diagnosis and mitigate the misdiagnosis of atypical PD. NfL may be particularly useful in differentiating PD from cognate disorders such as multiple system atrophy, progressive supranuclear palsy, and dementia with Lewy bodies.”

The current success is the result of large patient databases containing phenotypic data, imaging, and tests of tissue, blood, and cerebrospinal fluid, along with collaborations between advocacy groups, academia, and industry, according to Dr. Vaou. As that work continues, it could uncover more specific biomarkers “that will allow us not only to help with diagnosis and treatment but with disease progression, inclusion, recruitment and stratification in clinical studies, as well as (be an) indicator of response to therapeutic intervention of an investigational drug.”

The study was funded by the Michael J. Fox Foundation for Parkinson’s Research. Dr. Vaou had no relevant financial disclosures.

SOURCE: Mollenhauer B et al. Mov Disord. 2020 Aug 15. doi: 10.1002/mds.28206.

A novel biomarker could help identify progression in Parkinson’s disease, distinguish it from other neurodegenerative disorders, and monitor response to treatments. Although the biomarker, neurofilament light chain (NfL), is not especially specific, it is the first blood-based biomarker for Parkinson’s disease.

Neurofilaments are components of the neural cytoskeleton, where they maintain structure along with other functions. Following axonal damage, NfL gets released into extracellular fluids. Previously, NfL has been detected in cerebrospinal fluid (CSF) in patients with multiple sclerosis and neurodegenerative dementias. NfL in the CSF can distinguish Parkinson’s disease (PD) from multiple system atrophy and progressive supranuclear palsy.

That’s useful, but a serum marker would open new doors. “An easily accessible biomarker that will serve as an indicator of diagnosis, disease state, and progression, as well as a marker of response to therapeutic intervention is needed. A biomarker will strengthen the ability to select patients for inclusion or stratification within clinical trials,” commented Okeanis Vaou, MD, director of the movement disorders program at St. Elizabeth’s Medical Center in Brighton, Mass. Dr. Vaou was not involved in the study, which was published Aug. 15 in Movement Disorders.
 

A potential biomarker?

To determine if serum NfL levels would correlate with CSF values and had potential as a biomarker, a large, multi-institutional team of researchers led by Brit Mollenhauer, MD, of the University Medical Center Goettingen (Germany), and Danielle Graham, MD, of Biogen, drew data from a prospective, longitudinal, single-center project called the De Novo Parkinson’s disease (DeNoPa) cohort.

The researchers analyzed data from 176 subjects, including drug-naive patients with newly diagnosed PD; age, sex, and education matched healthy controls; and patients who were initially diagnosed with Parkinson’s disease but had their diagnoses changed to a cognate or neurodegenerative disorder (OND). The researchers also drew 514 serum samples from the prospective longitudinal, observational, international multicenter study Parkinson’s Progression Marker Initiative (PPMI) cohort.

In the DeNoPa cohort, OND patients had the highest median CSF NfL levels at baseline (839 pg/mL) followed by PD patients (562 pg/mL) and healthy controls (494 pg/mL; P = .01). There was a strong correlation between CSF and serum NfL levels in a cross-sectional exploratory study with the PPMI cohort.

Age and sex covariates in the PPMI cohort explained 51% of NfL variability. After adjustment for age and sex, baseline median blood NfL levels were highest in the OND group (16.23 pg/mL), followed by the genetic PD group (13.36 pg/mL), prodromal participants (12.20 pg/mL), PD patients (11.73 pg/mL), unaffected mutation carriers (11.63 pg/mL), and healthy controls (11.05 pg/mL; F test P < .0001). Median serum NfL increased by 3.35% per year of age (P < .0001), and median serum NfL was 6.79% higher in women (P = .0002).

Doubling of adjusted serum NfL levels were associated with a median increase in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale total score of 3.45 points (false-discovery rate–adjusted P = .0115), a median decrease in Symbol Digit Modality Test total score of 1.39 (FDR P = .026), a median decrease in Hopkins Verbal Learning Tests with discrimination recognition score of 0.3 (FDR P = .03), and a median decrease in Hopkins Verbal Learning Tests with retention score of 0.029 (FDR P = .04).
 

More specific markers needed

The findings are intriguing, said Dr Vaou, but “we need to acknowledge that increased NfL levels are not specific enough to Parkinson’s disease and reflect neuronal and axonal damage. Therefore, there is a need for more specific markers to support diagnostic accuracy, rate of progression, and ultimate prognosis. A serum NfL assay may be useful to clinicians evaluating patients with PD or OND diagnosis and mitigate the misdiagnosis of atypical PD. NfL may be particularly useful in differentiating PD from cognate disorders such as multiple system atrophy, progressive supranuclear palsy, and dementia with Lewy bodies.”

The current success is the result of large patient databases containing phenotypic data, imaging, and tests of tissue, blood, and cerebrospinal fluid, along with collaborations between advocacy groups, academia, and industry, according to Dr. Vaou. As that work continues, it could uncover more specific biomarkers “that will allow us not only to help with diagnosis and treatment but with disease progression, inclusion, recruitment and stratification in clinical studies, as well as (be an) indicator of response to therapeutic intervention of an investigational drug.”

The study was funded by the Michael J. Fox Foundation for Parkinson’s Research. Dr. Vaou had no relevant financial disclosures.

SOURCE: Mollenhauer B et al. Mov Disord. 2020 Aug 15. doi: 10.1002/mds.28206.

THE CASE

Sandra H,* a 24-year-old single woman with a history of asthma, presented to our family medicine clinic as a new patient. Ms. H said she lived at home with her mother. She completed high school but never attended college due to anxiety. She had held several jobs since high school and recently decided to apply to a local college, which prompted a desire to gain control over the anxiety that had been present since middle school. She reported feeling anxious, having difficulty breathing, shaking all over, having difficulty concentrating, and experiencing numbness and tingling in her fingers. She was often irritable at home, which she attributed partly to anxiety but mostly to disrupted sleep. We administered the 7-question Generalized Anxiety Disorder (GAD-7) questionnaire and she scored 15 (of a possible 21) points, indicative of severe anxiety.

● How would you proceed with this patient?

* The patient’s name has been changed to protect her identity.

Approximately 1 in 5 patients presenting to primary care clinics have at least 1 anxiety disorder and 7.6% have generalized anxiety disorder (GAD).¹ Yet many go untreated. The lifetime prevalence of GAD is 3.7% worldwide and 7.8% in the United States.² Only 5% of cases emerge by age 13,² but incidence increases through adolescence and young adulthood, with a quarter of all cases occurring by age 25.² GAD occurs about twice as often in women as it does in men. It is typically recurrent, and many patients require ongoing treatment.²

GAD diagnostic criteria and differential considerations

Diagnosis of GAD requires at least 6 months of excessive worry or anxiety about a variety of circumstances, occurring on most days and for more than half the day.³ The worry or anxiety in GAD is difficult to control, disrupts meaningful areas of life, and surrounds everyday concerns, such as finances, health, or family-related issues. Among adolescents with GAD, worries typically include school performance and may often present as perfectionism.⁴ At least 3 of the following 6 symptoms result from chronic anxiety: restlessness, fatigue, poor concentration, irritability, muscle tension, and sleep disturbance.²

Rule out other conditions. Make sure symptoms of GAD are not better explained by another medical problem, including other mental disorders or substance use disorders.³ Complaints of anxiety in the context of mania, hypomania, or withdrawal from alcohol or a sedative hypnotic suggest a different underlying cause, thereby requiring a complete history with symptom chronology and collateral information. The pattern of anxiety seen in GAD also differs from the focused sources of anxiety found in disorders such as social anxiety disorder (SAD) and post-traumatic stress disorder. For example, SAD might center on embarrassment in a social setting rather than reflect a pattern of general worry.⁵

Consider comorbidities. Further complicating diagnosis and treatment, GAD has been linked to higher rates of comorbidity and higher health care utilization. About 90% of GAD patients experience psychiatric comorbidity, with major depressive disorder co-­occurring about 60% of the time.⁶ Substance use disorders co-occur with GAD more than 20% of the time.² Despite comorbidities, it is the somatic complaints in GAD that often drive patient requests for medical care.^7,8 GAD itself is an independent predictor of heart disease⁹ and is linked to increased risk of chronic or severe headaches¹⁰ and suicide.^11,12

Continue to: Work with patients and family toward a diagnosis

Work with patients and family toward a diagnosis

Despite the potential benefits of early identification and treatment of GAD,¹³ the average elapsed time from symptom onset to initial medication treatment is 7 years.¹⁴ Multiple factors likely account for this delay. Clinical presentations can be highly variable,⁶ with 1 patient presenting primarily with sleep complaints and another with gastrointestinal symptoms. Some medical conditions (TABLE 1)¹⁵ and substances (TABLE 2)^16-18 can cause secondary anxiety symptoms, and their presence should prompt a thorough ­evaluation.

Address the mind-body connection. Because uncertainty and ambiguity surrounding a diagnosis often drive worry,¹⁹ anxious patients or their family members commonly seek additional medical visits and tests in search of answers. In such instances, it helps to explain the physiologic connection between somatic complaints and anxiety.⁸ Describe how areas of the brain that manage fear and stress can also cause muscle tension, gastrointestinal complaints, hyperarousal, or sleep disturbance.

Despite the potential benefits of early identification and treatment of generalized anxiety disorder, the average elapsed time from symptom onset to initial medication treatment is 7 years.

Empathy and early psychoeducation on the reason anxiety is being considered can decrease stigma and enable appropriate follow-up and treatment. You might introduce the connection between health complaints and GAD specifically by exploring the amount of worry surrounding the presenting symptoms, followed by a question such as, “Sometimes your worry will fit the situation and sometimes it’ll be too much. Has anyone ever told you that you worry too much?” The patient’s response to such a question could signal a need to use the GAD-7 screening tool¹ as an aid to diagnosis and as a baseline measure for monitoring subsequent treatment progress.

Psycho- and pharmacotherapy aspects of management

Helping someone understand a GAD diagnosis and treatment options can test a clinician’s communication skills. Avoid trying to reason patients out of their worries or fears (TABLE 3). Instead, rely on psychoeducation about the mind-body connection and on focused counseling (TABLE 4) to help patients and their family members understand effective next steps.^8,20 At a minimum, ensure that everyone involved understands how anxiety is influenced by unhealthy lifestyle choices such as poor sleep hygiene and caffeine misuse.

Let patients choose from among various coping strategies. Be prepared to offer patients user-friendly handouts, reading material, or links to educational Web sites. Many patients are interested in using smartphone applications to learn and practice coping strategies. Although these apps can encourage the regular practice of coping skills, caution teens and parents about privacy issues and the lack of evidence supporting this approach as stand-alone therapy.²¹ Offering several choices (TABLE 4) can increase the sense of ownership an individual experiences when choosing the next step.

Continue to: For patients who remain focused...

For patients who remain focused on somatic complaints and resist adopting coping skills or treatment, pushing certain recommendations can actually increase resistance to proper treatment.²² Instead, explore their ambivalence, offer facts, express concern about the current course of the illness, and emphasize the need to revisit the discussion at a future appointment. Offer follow-up monitoring to assess the course of the illness and readiness for GAD treatment.

Initiate treatment in a stepwise manner¹³ for the patient who is ready for GAD treatment. This approach includes education and monitoring; low-intensity interventions (eg, treatment workbooks or group sessions); medication and/or referral for psychotherapy; referral for outpatient psychiatric care; and hospitalization for patients who pose a danger to self or others.¹³ Studies suggest that patients receiving both psychotherapy and pharmacotherapy benefit from the complementary targeting of symptoms, exhibit increased adherence, and report fewer adverse effects.²³

Patients are most likely to benefit from therapy when they have the capacity for introspection and forming friendships (ie, can form a therapeutic alliance). With such patients who have mild or moderate symptoms of GAD, offer cognitive behavioral therapy (CBT) or applied relaxation training. Consider a trial of medication when symptoms are severe, when psychotherapy is not a good option, or when response to psychotherapy is inadequate.¹³ Medications work by targeting primitive parts of the brain such as the amygdala (bottom up), while psychotherapy targets the cortex or more evolved part of the brain, teaching it to modulate the lower or more primitive structures (top down).²⁴

Medication considerations. Selective serotonin reuptake inhibitors (SSRIs) are considered first-line pharmacotherapy for adult and adolescent patients with GAD.²⁰ However, in adolescents, no SSRIs are approved by the US Food and Drug Administration (FDA) to treat anxiety disorders unassociated with obsessive-compulsive disorder. Use caution if prescribing an SSRI for off-label treatment in an adolescent; talk with the patient and family about the FDA’s black-box warning regarding the potential for suicidality in adolescents.

Say to the patient: “Sometimes your worry will fit the situation and sometimes it’ll be too much. Has anyone ever told you that you worry too much?”

For adults, selective norepinephrine reuptake inhibitors (SNRIs) are also considered a first-line treatment option.²³ SSRIs and SNRIs are well-studied, effective, safe, and better tolerated than earlier antidepressants. However, be aware that both SSRIs and SNRIs are often associated with headache, nausea, and sexual dysfunction. They are dosed once daily and have not been shown to cause dependence. Inform patients that onset of action is often delayed 4 to 8 weeks²³ and that there is a risk for anxiety-producing effects early in treatment. To minimize these effects, consider starting treatment at a lower dose and titrate upward more gradually than when treating depression.

Continue to: Continue treatment for 12 months...

Continue treatment for 12 months to reduce the risk of recurrence.²³ If response to treatment is insufficient after 2 adequate trials of an SSRI or SNRI, consider second-line agents such as azapirones or benzodiazepines for adults, keeping in mind the risk for dependence with benzodiazepines.¹³

Evidence supports GABAergic drugs such as gabapentin and pregabalin as off-label treatments for GAD in refractory adult cases.²⁵ In the European Union, pregabalin is approved for use in GAD. Caution is recommended with both drugs due to abuse potential. Next steps for an inadequate response should include referral to Psychiatry or for inpatient care when risk of harm to self or others is high.

CASE

Considering Ms. H’s ability to work and complete daily activities, we talked to her about CBT as a first step and referred her to a therapist in the community. One month after her initial visit with us, Ms. H returned for a follow-up visit and scored a 17 on her GAD-7, still in the severe range. After one CBT session, she had cancelled her second and third appointments due to work conflicts. She had missed some work from oversleeping after worried sleepless nights. Her worries concerned friendships, paying bills, physical appearance, not being able to exercise and therefore gaining weight, and troubles at work and with her mother. She also described several episodes of nightmares after breaking up with a boyfriend.

To minimize the anxiety-producing effects of SSRIs and SNRIs, consider starting treatment at a lower dose and titrate upward more gradually than when treating depression.

She agreed to try an SSRI, and we started her on fluoxetine 10 mg/d. We counseled her on SSRI risks and benefits, including the potential for increased suicidal ideation and how to respond if such thoughts developed. Three weeks after starting fluoxetine, Ms. H reported improvement with no adverse effects from the medication, except for decreased appetite and some weight loss, which she welcomed. She had registered for college courses, and her third score on the GAD-7 was an 8.

We increased her fluoxetine dose to 20 mg/d for maintenance. We encouraged her to return to her therapist for CBT and she scheduled that appointment. Therapy records noted a GAD-7 score of 5 at follow-up 8 weeks later. Ms. H reported improved sleep, reduced irritability at home, and better relationships with her mother and friends. She had begun college classes and was writing about her thoughts and worries as part of her CBT homework. She continued follow-up appointments with both her family physician and her therapist.

CORRESPONDENCE
Christopher A. Ebberwein, PhD, Wesley Family Medicine Residency, 850 North Hillside, Wichita, KS 67214; chris. [email protected].

THE CASE

Sandra H,* a 24-year-old single woman with a history of asthma, presented to our family medicine clinic as a new patient. Ms. H said she lived at home with her mother. She completed high school but never attended college due to anxiety. She had held several jobs since high school and recently decided to apply to a local college, which prompted a desire to gain control over the anxiety that had been present since middle school. She reported feeling anxious, having difficulty breathing, shaking all over, having difficulty concentrating, and experiencing numbness and tingling in her fingers. She was often irritable at home, which she attributed partly to anxiety but mostly to disrupted sleep. We administered the 7-question Generalized Anxiety Disorder (GAD-7) questionnaire and she scored 15 (of a possible 21) points, indicative of severe anxiety.

● How would you proceed with this patient?

* The patient’s name has been changed to protect her identity.

Approximately 1 in 5 patients presenting to primary care clinics have at least 1 anxiety disorder and 7.6% have generalized anxiety disorder (GAD).¹ Yet many go untreated. The lifetime prevalence of GAD is 3.7% worldwide and 7.8% in the United States.² Only 5% of cases emerge by age 13,² but incidence increases through adolescence and young adulthood, with a quarter of all cases occurring by age 25.² GAD occurs about twice as often in women as it does in men. It is typically recurrent, and many patients require ongoing treatment.²

GAD diagnostic criteria and differential considerations

Diagnosis of GAD requires at least 6 months of excessive worry or anxiety about a variety of circumstances, occurring on most days and for more than half the day.³ The worry or anxiety in GAD is difficult to control, disrupts meaningful areas of life, and surrounds everyday concerns, such as finances, health, or family-related issues. Among adolescents with GAD, worries typically include school performance and may often present as perfectionism.⁴ At least 3 of the following 6 symptoms result from chronic anxiety: restlessness, fatigue, poor concentration, irritability, muscle tension, and sleep disturbance.²

Rule out other conditions. Make sure symptoms of GAD are not better explained by another medical problem, including other mental disorders or substance use disorders.³ Complaints of anxiety in the context of mania, hypomania, or withdrawal from alcohol or a sedative hypnotic suggest a different underlying cause, thereby requiring a complete history with symptom chronology and collateral information. The pattern of anxiety seen in GAD also differs from the focused sources of anxiety found in disorders such as social anxiety disorder (SAD) and post-traumatic stress disorder. For example, SAD might center on embarrassment in a social setting rather than reflect a pattern of general worry.⁵

Consider comorbidities. Further complicating diagnosis and treatment, GAD has been linked to higher rates of comorbidity and higher health care utilization. About 90% of GAD patients experience psychiatric comorbidity, with major depressive disorder co-­occurring about 60% of the time.⁶ Substance use disorders co-occur with GAD more than 20% of the time.² Despite comorbidities, it is the somatic complaints in GAD that often drive patient requests for medical care.^7,8 GAD itself is an independent predictor of heart disease⁹ and is linked to increased risk of chronic or severe headaches¹⁰ and suicide.^11,12

Continue to: Work with patients and family toward a diagnosis

Work with patients and family toward a diagnosis

Despite the potential benefits of early identification and treatment of GAD,¹³ the average elapsed time from symptom onset to initial medication treatment is 7 years.¹⁴ Multiple factors likely account for this delay. Clinical presentations can be highly variable,⁶ with 1 patient presenting primarily with sleep complaints and another with gastrointestinal symptoms. Some medical conditions (TABLE 1)¹⁵ and substances (TABLE 2)^16-18 can cause secondary anxiety symptoms, and their presence should prompt a thorough ­evaluation.

Address the mind-body connection. Because uncertainty and ambiguity surrounding a diagnosis often drive worry,¹⁹ anxious patients or their family members commonly seek additional medical visits and tests in search of answers. In such instances, it helps to explain the physiologic connection between somatic complaints and anxiety.⁸ Describe how areas of the brain that manage fear and stress can also cause muscle tension, gastrointestinal complaints, hyperarousal, or sleep disturbance.

Despite the potential benefits of early identification and treatment of generalized anxiety disorder, the average elapsed time from symptom onset to initial medication treatment is 7 years.

Empathy and early psychoeducation on the reason anxiety is being considered can decrease stigma and enable appropriate follow-up and treatment. You might introduce the connection between health complaints and GAD specifically by exploring the amount of worry surrounding the presenting symptoms, followed by a question such as, “Sometimes your worry will fit the situation and sometimes it’ll be too much. Has anyone ever told you that you worry too much?” The patient’s response to such a question could signal a need to use the GAD-7 screening tool¹ as an aid to diagnosis and as a baseline measure for monitoring subsequent treatment progress.

Psycho- and pharmacotherapy aspects of management

Helping someone understand a GAD diagnosis and treatment options can test a clinician’s communication skills. Avoid trying to reason patients out of their worries or fears (TABLE 3). Instead, rely on psychoeducation about the mind-body connection and on focused counseling (TABLE 4) to help patients and their family members understand effective next steps.^8,20 At a minimum, ensure that everyone involved understands how anxiety is influenced by unhealthy lifestyle choices such as poor sleep hygiene and caffeine misuse.

Let patients choose from among various coping strategies. Be prepared to offer patients user-friendly handouts, reading material, or links to educational Web sites. Many patients are interested in using smartphone applications to learn and practice coping strategies. Although these apps can encourage the regular practice of coping skills, caution teens and parents about privacy issues and the lack of evidence supporting this approach as stand-alone therapy.²¹ Offering several choices (TABLE 4) can increase the sense of ownership an individual experiences when choosing the next step.

Continue to: For patients who remain focused...

For patients who remain focused on somatic complaints and resist adopting coping skills or treatment, pushing certain recommendations can actually increase resistance to proper treatment.²² Instead, explore their ambivalence, offer facts, express concern about the current course of the illness, and emphasize the need to revisit the discussion at a future appointment. Offer follow-up monitoring to assess the course of the illness and readiness for GAD treatment.

Initiate treatment in a stepwise manner¹³ for the patient who is ready for GAD treatment. This approach includes education and monitoring; low-intensity interventions (eg, treatment workbooks or group sessions); medication and/or referral for psychotherapy; referral for outpatient psychiatric care; and hospitalization for patients who pose a danger to self or others.¹³ Studies suggest that patients receiving both psychotherapy and pharmacotherapy benefit from the complementary targeting of symptoms, exhibit increased adherence, and report fewer adverse effects.²³

Patients are most likely to benefit from therapy when they have the capacity for introspection and forming friendships (ie, can form a therapeutic alliance). With such patients who have mild or moderate symptoms of GAD, offer cognitive behavioral therapy (CBT) or applied relaxation training. Consider a trial of medication when symptoms are severe, when psychotherapy is not a good option, or when response to psychotherapy is inadequate.¹³ Medications work by targeting primitive parts of the brain such as the amygdala (bottom up), while psychotherapy targets the cortex or more evolved part of the brain, teaching it to modulate the lower or more primitive structures (top down).²⁴

Medication considerations. Selective serotonin reuptake inhibitors (SSRIs) are considered first-line pharmacotherapy for adult and adolescent patients with GAD.²⁰ However, in adolescents, no SSRIs are approved by the US Food and Drug Administration (FDA) to treat anxiety disorders unassociated with obsessive-compulsive disorder. Use caution if prescribing an SSRI for off-label treatment in an adolescent; talk with the patient and family about the FDA’s black-box warning regarding the potential for suicidality in adolescents.

Say to the patient: “Sometimes your worry will fit the situation and sometimes it’ll be too much. Has anyone ever told you that you worry too much?”

For adults, selective norepinephrine reuptake inhibitors (SNRIs) are also considered a first-line treatment option.²³ SSRIs and SNRIs are well-studied, effective, safe, and better tolerated than earlier antidepressants. However, be aware that both SSRIs and SNRIs are often associated with headache, nausea, and sexual dysfunction. They are dosed once daily and have not been shown to cause dependence. Inform patients that onset of action is often delayed 4 to 8 weeks²³ and that there is a risk for anxiety-producing effects early in treatment. To minimize these effects, consider starting treatment at a lower dose and titrate upward more gradually than when treating depression.

Continue to: Continue treatment for 12 months...

Continue treatment for 12 months to reduce the risk of recurrence.²³ If response to treatment is insufficient after 2 adequate trials of an SSRI or SNRI, consider second-line agents such as azapirones or benzodiazepines for adults, keeping in mind the risk for dependence with benzodiazepines.¹³

Evidence supports GABAergic drugs such as gabapentin and pregabalin as off-label treatments for GAD in refractory adult cases.²⁵ In the European Union, pregabalin is approved for use in GAD. Caution is recommended with both drugs due to abuse potential. Next steps for an inadequate response should include referral to Psychiatry or for inpatient care when risk of harm to self or others is high.

CASE

Considering Ms. H’s ability to work and complete daily activities, we talked to her about CBT as a first step and referred her to a therapist in the community. One month after her initial visit with us, Ms. H returned for a follow-up visit and scored a 17 on her GAD-7, still in the severe range. After one CBT session, she had cancelled her second and third appointments due to work conflicts. She had missed some work from oversleeping after worried sleepless nights. Her worries concerned friendships, paying bills, physical appearance, not being able to exercise and therefore gaining weight, and troubles at work and with her mother. She also described several episodes of nightmares after breaking up with a boyfriend.

To minimize the anxiety-producing effects of SSRIs and SNRIs, consider starting treatment at a lower dose and titrate upward more gradually than when treating depression.

She agreed to try an SSRI, and we started her on fluoxetine 10 mg/d. We counseled her on SSRI risks and benefits, including the potential for increased suicidal ideation and how to respond if such thoughts developed. Three weeks after starting fluoxetine, Ms. H reported improvement with no adverse effects from the medication, except for decreased appetite and some weight loss, which she welcomed. She had registered for college courses, and her third score on the GAD-7 was an 8.

We increased her fluoxetine dose to 20 mg/d for maintenance. We encouraged her to return to her therapist for CBT and she scheduled that appointment. Therapy records noted a GAD-7 score of 5 at follow-up 8 weeks later. Ms. H reported improved sleep, reduced irritability at home, and better relationships with her mother and friends. She had begun college classes and was writing about her thoughts and worries as part of her CBT homework. She continued follow-up appointments with both her family physician and her therapist.

CORRESPONDENCE
Christopher A. Ebberwein, PhD, Wesley Family Medicine Residency, 850 North Hillside, Wichita, KS 67214; chris. [email protected].

THE CASE

Sandra H,* a 24-year-old single woman with a history of asthma, presented to our family medicine clinic as a new patient. Ms. H said she lived at home with her mother. She completed high school but never attended college due to anxiety. She had held several jobs since high school and recently decided to apply to a local college, which prompted a desire to gain control over the anxiety that had been present since middle school. She reported feeling anxious, having difficulty breathing, shaking all over, having difficulty concentrating, and experiencing numbness and tingling in her fingers. She was often irritable at home, which she attributed partly to anxiety but mostly to disrupted sleep. We administered the 7-question Generalized Anxiety Disorder (GAD-7) questionnaire and she scored 15 (of a possible 21) points, indicative of severe anxiety.

● How would you proceed with this patient?

* The patient’s name has been changed to protect her identity.

Approximately 1 in 5 patients presenting to primary care clinics have at least 1 anxiety disorder and 7.6% have generalized anxiety disorder (GAD).¹ Yet many go untreated. The lifetime prevalence of GAD is 3.7% worldwide and 7.8% in the United States.² Only 5% of cases emerge by age 13,² but incidence increases through adolescence and young adulthood, with a quarter of all cases occurring by age 25.² GAD occurs about twice as often in women as it does in men. It is typically recurrent, and many patients require ongoing treatment.²

GAD diagnostic criteria and differential considerations

Diagnosis of GAD requires at least 6 months of excessive worry or anxiety about a variety of circumstances, occurring on most days and for more than half the day.³ The worry or anxiety in GAD is difficult to control, disrupts meaningful areas of life, and surrounds everyday concerns, such as finances, health, or family-related issues. Among adolescents with GAD, worries typically include school performance and may often present as perfectionism.⁴ At least 3 of the following 6 symptoms result from chronic anxiety: restlessness, fatigue, poor concentration, irritability, muscle tension, and sleep disturbance.²

Rule out other conditions. Make sure symptoms of GAD are not better explained by another medical problem, including other mental disorders or substance use disorders.³ Complaints of anxiety in the context of mania, hypomania, or withdrawal from alcohol or a sedative hypnotic suggest a different underlying cause, thereby requiring a complete history with symptom chronology and collateral information. The pattern of anxiety seen in GAD also differs from the focused sources of anxiety found in disorders such as social anxiety disorder (SAD) and post-traumatic stress disorder. For example, SAD might center on embarrassment in a social setting rather than reflect a pattern of general worry.⁵

Consider comorbidities. Further complicating diagnosis and treatment, GAD has been linked to higher rates of comorbidity and higher health care utilization. About 90% of GAD patients experience psychiatric comorbidity, with major depressive disorder co-­occurring about 60% of the time.⁶ Substance use disorders co-occur with GAD more than 20% of the time.² Despite comorbidities, it is the somatic complaints in GAD that often drive patient requests for medical care.^7,8 GAD itself is an independent predictor of heart disease⁹ and is linked to increased risk of chronic or severe headaches¹⁰ and suicide.^11,12

Continue to: Work with patients and family toward a diagnosis

Work with patients and family toward a diagnosis

Despite the potential benefits of early identification and treatment of GAD,¹³ the average elapsed time from symptom onset to initial medication treatment is 7 years.¹⁴ Multiple factors likely account for this delay. Clinical presentations can be highly variable,⁶ with 1 patient presenting primarily with sleep complaints and another with gastrointestinal symptoms. Some medical conditions (TABLE 1)¹⁵ and substances (TABLE 2)^16-18 can cause secondary anxiety symptoms, and their presence should prompt a thorough ­evaluation.

Address the mind-body connection. Because uncertainty and ambiguity surrounding a diagnosis often drive worry,¹⁹ anxious patients or their family members commonly seek additional medical visits and tests in search of answers. In such instances, it helps to explain the physiologic connection between somatic complaints and anxiety.⁸ Describe how areas of the brain that manage fear and stress can also cause muscle tension, gastrointestinal complaints, hyperarousal, or sleep disturbance.

Despite the potential benefits of early identification and treatment of generalized anxiety disorder, the average elapsed time from symptom onset to initial medication treatment is 7 years.

Empathy and early psychoeducation on the reason anxiety is being considered can decrease stigma and enable appropriate follow-up and treatment. You might introduce the connection between health complaints and GAD specifically by exploring the amount of worry surrounding the presenting symptoms, followed by a question such as, “Sometimes your worry will fit the situation and sometimes it’ll be too much. Has anyone ever told you that you worry too much?” The patient’s response to such a question could signal a need to use the GAD-7 screening tool¹ as an aid to diagnosis and as a baseline measure for monitoring subsequent treatment progress.

Psycho- and pharmacotherapy aspects of management

Helping someone understand a GAD diagnosis and treatment options can test a clinician’s communication skills. Avoid trying to reason patients out of their worries or fears (TABLE 3). Instead, rely on psychoeducation about the mind-body connection and on focused counseling (TABLE 4) to help patients and their family members understand effective next steps.^8,20 At a minimum, ensure that everyone involved understands how anxiety is influenced by unhealthy lifestyle choices such as poor sleep hygiene and caffeine misuse.

Let patients choose from among various coping strategies. Be prepared to offer patients user-friendly handouts, reading material, or links to educational Web sites. Many patients are interested in using smartphone applications to learn and practice coping strategies. Although these apps can encourage the regular practice of coping skills, caution teens and parents about privacy issues and the lack of evidence supporting this approach as stand-alone therapy.²¹ Offering several choices (TABLE 4) can increase the sense of ownership an individual experiences when choosing the next step.

Continue to: For patients who remain focused...

For patients who remain focused on somatic complaints and resist adopting coping skills or treatment, pushing certain recommendations can actually increase resistance to proper treatment.²² Instead, explore their ambivalence, offer facts, express concern about the current course of the illness, and emphasize the need to revisit the discussion at a future appointment. Offer follow-up monitoring to assess the course of the illness and readiness for GAD treatment.

Initiate treatment in a stepwise manner¹³ for the patient who is ready for GAD treatment. This approach includes education and monitoring; low-intensity interventions (eg, treatment workbooks or group sessions); medication and/or referral for psychotherapy; referral for outpatient psychiatric care; and hospitalization for patients who pose a danger to self or others.¹³ Studies suggest that patients receiving both psychotherapy and pharmacotherapy benefit from the complementary targeting of symptoms, exhibit increased adherence, and report fewer adverse effects.²³

Patients are most likely to benefit from therapy when they have the capacity for introspection and forming friendships (ie, can form a therapeutic alliance). With such patients who have mild or moderate symptoms of GAD, offer cognitive behavioral therapy (CBT) or applied relaxation training. Consider a trial of medication when symptoms are severe, when psychotherapy is not a good option, or when response to psychotherapy is inadequate.¹³ Medications work by targeting primitive parts of the brain such as the amygdala (bottom up), while psychotherapy targets the cortex or more evolved part of the brain, teaching it to modulate the lower or more primitive structures (top down).²⁴

Medication considerations. Selective serotonin reuptake inhibitors (SSRIs) are considered first-line pharmacotherapy for adult and adolescent patients with GAD.²⁰ However, in adolescents, no SSRIs are approved by the US Food and Drug Administration (FDA) to treat anxiety disorders unassociated with obsessive-compulsive disorder. Use caution if prescribing an SSRI for off-label treatment in an adolescent; talk with the patient and family about the FDA’s black-box warning regarding the potential for suicidality in adolescents.

Say to the patient: “Sometimes your worry will fit the situation and sometimes it’ll be too much. Has anyone ever told you that you worry too much?”

For adults, selective norepinephrine reuptake inhibitors (SNRIs) are also considered a first-line treatment option.²³ SSRIs and SNRIs are well-studied, effective, safe, and better tolerated than earlier antidepressants. However, be aware that both SSRIs and SNRIs are often associated with headache, nausea, and sexual dysfunction. They are dosed once daily and have not been shown to cause dependence. Inform patients that onset of action is often delayed 4 to 8 weeks²³ and that there is a risk for anxiety-producing effects early in treatment. To minimize these effects, consider starting treatment at a lower dose and titrate upward more gradually than when treating depression.

Continue to: Continue treatment for 12 months...

Continue treatment for 12 months to reduce the risk of recurrence.²³ If response to treatment is insufficient after 2 adequate trials of an SSRI or SNRI, consider second-line agents such as azapirones or benzodiazepines for adults, keeping in mind the risk for dependence with benzodiazepines.¹³

Evidence supports GABAergic drugs such as gabapentin and pregabalin as off-label treatments for GAD in refractory adult cases.²⁵ In the European Union, pregabalin is approved for use in GAD. Caution is recommended with both drugs due to abuse potential. Next steps for an inadequate response should include referral to Psychiatry or for inpatient care when risk of harm to self or others is high.

CASE

Considering Ms. H’s ability to work and complete daily activities, we talked to her about CBT as a first step and referred her to a therapist in the community. One month after her initial visit with us, Ms. H returned for a follow-up visit and scored a 17 on her GAD-7, still in the severe range. After one CBT session, she had cancelled her second and third appointments due to work conflicts. She had missed some work from oversleeping after worried sleepless nights. Her worries concerned friendships, paying bills, physical appearance, not being able to exercise and therefore gaining weight, and troubles at work and with her mother. She also described several episodes of nightmares after breaking up with a boyfriend.

To minimize the anxiety-producing effects of SSRIs and SNRIs, consider starting treatment at a lower dose and titrate upward more gradually than when treating depression.

She agreed to try an SSRI, and we started her on fluoxetine 10 mg/d. We counseled her on SSRI risks and benefits, including the potential for increased suicidal ideation and how to respond if such thoughts developed. Three weeks after starting fluoxetine, Ms. H reported improvement with no adverse effects from the medication, except for decreased appetite and some weight loss, which she welcomed. She had registered for college courses, and her third score on the GAD-7 was an 8.

We increased her fluoxetine dose to 20 mg/d for maintenance. We encouraged her to return to her therapist for CBT and she scheduled that appointment. Therapy records noted a GAD-7 score of 5 at follow-up 8 weeks later. Ms. H reported improved sleep, reduced irritability at home, and better relationships with her mother and friends. She had begun college classes and was writing about her thoughts and worries as part of her CBT homework. She continued follow-up appointments with both her family physician and her therapist.

CORRESPONDENCE
Christopher A. Ebberwein, PhD, Wesley Family Medicine Residency, 850 North Hillside, Wichita, KS 67214; chris. [email protected].

Postoperative voiding dysfunction refers to the acute inability to spontaneously and adequately empty the bladder after surgery. Postoperative voiding dysfunction occurs in 21% to 42% of pelvic reconstructive surgeries, as well as 7% to 21% of benign gynecologic surgeries.^1-4 While much of its peril lies in patient discomfort or dissatisfaction with temporary bladder drainage, serious consequences of the disorder include bladder overdistension injury with inadequate drainage and urinary tract infection (UTI) associated with prolonged catheterization.^4-6

Although transient postoperative voiding dysfunction is associated with anti-incontinence surgery, tricyclic antidepressant use, diabetes, preoperative voiding dysfunction, and postoperative narcotic use, it also may occur in patients without risk factors.^4,7,8 Thus, all gynecologic surgeons should be prepared to assess and manage the patient with postoperative voiding dysfunction.

Diagnosis of postoperative voiding dysfunction can be approached in myriad ways, including spontaneous (or natural) bladder filling or bladder backfill followed by spontaneous void. When compared with spontaneous void trials, backfill-assisted void trial is associated with improved accuracy in predicting voiding dysfunction in patients who undergo urogynecologic surgery, leading to widespread adoption of the procedure following pelvic reconstructive surgeries.^9,10

Criteria for “passing” a void trial may include the patient’s subjective feeling of having emptied her bladder; having a near-baseline force of stream; or commonly by objective parameters of voided volume and postvoid residual (PVR), assessed via catheterization or bladder scan.^3,6,10 Completing a postoperative void trial typically requires significant nursing effort because of the technical demands of backfilling the bladder, obtaining the voided volume and PVR, or assessing subjective emptying.

Management of postoperative voiding dysfunction typically consists of continuous drainage with a transurethral catheter or clean intermittent self-catheterization (CISC). Patients discharged home with a bladder drainage method also may be prescribed various medications, such as antibiotics, anticholinergics, and bladder analgesics, which often depends on provider practice.

Given the minimal universal guidance available for gynecologic surgeons on postoperative voiding dysfunction, we review several articles that contribute new evidence on the assessment and management of this condition.

Continue to: How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

Chao L, Mansuria S. Postoperative bladder filling after outpatient laparoscopic hysterectomy and time to discharge: a randomized controlled trial. Obstet Gynecol. 2019;133:879-887. 

Despite efforts to implement and promote enhanced recovery after surgery pathways, waiting for spontaneous void can be a barrier to efficient same-day discharge. Chao and Mansuria conducted a randomized controlled trial (RCT) to determine whether backfilling the bladder intraoperatively, compared with spontaneous (physiologic) filling, would reduce time to discharge in patients undergoing total laparoscopic hysterectomy (TLH) or supracervical hysterectomy (SCH). 

Study details 

Women undergoing TLH or laparoscopic SCH for benign indications were randomly assigned to undergo either a backfill-assisted void trial in the operating room with 200 mL of sterile normal saline (n = 75) or Foley catheter removal with spontaneous fill in the postanesthesia care unit (PACU) (n = 78). 

For both groups, the maximum time allowed for spontaneous void was 5 hours. A successful void trial was defined as a voided volume of at least 200 mL. If a patient was unable to void at least 200 mL, a bladder scan was performed, and the patient was considered to have failed the void trial if a PVR of 200 mL or greater was noted. If the PVR was less than 200 mL, the patient was given an additional 1 hour to spontaneously void 200 mL by 6 hours after the surgery. Patients who failed the void trial were discharged home with a transurethral catheter. 

The primary outcome was time to discharge, and the sample size (153 participants included in the analysis) allowed 80% power to detect a 30-minute difference in time to discharge. Participant baseline characteristics, concomitant procedures, and indication for hysterectomy were similar for both groups. 

Results. The mean time to discharge was 273.4 minutes for the backfill-assisted void trial group and 283.2 minutes for the spontaneous fill group, a difference of 9.8 minutes that was not statistically significant (P = .45). 

Although it was not a primary outcome, time to spontaneous void was 24.9 minutes shorter in the backfill group (P = .04). Rates of postoperative voiding dysfunction did not differ between the 2 groups (6.7% for the backfill group and 12.8% for the spontaneous fill group; P = .2). There were no significant differences in emergency department visits, UTI rates, or readmissions. 

Bladder backfill is safe, simple, and may reduce time to spontaneous void 

Strengths of the study included its prospective randomized design, blinded outcome assessors, and diversity in benign gynecologic surgeries performed. Although this study found a reduced time to spontaneous void in the backfill group, it was not powered to assess this difference, limiting ability to draw conclusions from those data. Data on postoperative nausea and pain scores also were not collected, which likely influenced the overall time to discharge. 

Void trial completion is one of many criteria to fulfill prior to patient discharge, and a reduced time to first void may not decrease the overall length of PACU stay if other factors, such as nausea or pain, are not controlled. Nonetheless, backfilling the bladder intraoperatively is a safe alternative that may decrease the time to first spontaneous void, and it is a relatively simple alteration in the surgical workflow that could significantly lessen PACU nursing demands.

Continue to: Algorithm assesses need for PVR, although further study required...

Algorithm assesses need for PVR, although further study required 

Meekins AR, Siddiqui N, Amundsen CL, et al. Improving postoperative efficiency: an algorithm for expedited void trials after urogynecologic surgery. South Med J. 2017;110:785-790. 

To determine ways to further maximize postoperative efficiency, Meekins and colleagues sought to determine whether certain voided volumes during backfill-assisted void trials could obviate the need for PVR assessment. 

Void trial results calculated to develop algorithm 

The study was a secondary analysis of a previously conducted RCT that assessed antibiotics for the prevention of UTI after urogynecologic surgery. Void trials from the parent RCT were performed via the backfill-assisted method in which the bladder was backfilled in the PACU with 300 mL of normal saline or until the patient reported urgency to void, after which the catheter was removed and the patient was prompted to void immediately. 

Postvoid residual levels were assessed via ultrasonography or catheterization. A void trial was considered to be passed when a PVR was less than 100 mL or less than 50% of the total bladder volume, with a minimum voided volume of 200 mL. 

In the follow-up study, the authors analyzed the void trial results of 255 women of the original 264 in the parent RCT. A total of 69% of patients passed their void trial. The authors assessed the optimal positive predictive value (PPV) and negative predictive value (NPV) combinations, which were then used to create lower and upper voided volume thresholds that would best predict a failed or passed trial, thus obviating PVR measurement. 

Results. When patients voided less than 100 mL, the NPV was 96.7% (meaning that they had a 96.7% chance of failing the void trial). When patients voided 200 mL or more, the PPV was 97% (meaning that they had a 97% chance of passing the void trial). Receiver operating characteristic analysis confirmed that voided volume alone was an excellent predictor of final void trial results, with area under the curve of 0.97. The authors estimated that applying this algorithm to their study population would have eliminated the need for assessing PVR in 85% of patients. Ultimately, they proposed the algorithm shown in TABLE 1. 

A potential alternative for assessing PVR 

This study's strengths include the use of prospectively and systematically collected void trial data in a large patient population undergoing various urogynecologic procedures. By contrast, the generalizability of the results is limited regarding other void trial methods, such as spontaneous filling and void, as well as populations outside of the studied institution. 

With the algorithm, the authors estimated that the majority of postoperative patients would no longer require a PVR assessment in the PACU. This could have beneficial downstream implications, including decreasing the nursing workload, reducing total time in the PACU, and minimizing patient discomfort with PVR assessment. 

While further studies are needed to validate the proposed algorithm in larger populations, this study provides evidence of an efficient alternative to the traditional approach to PVR assessment in the PACU.

Continue to: An alternative to Foley use if a patient does not know CISC...

An alternative to Foley use if a patient does not know CISC 

Boyd SS, O'Sullivan DM, Tunitsky-Bitton E. A comparison of two methods of catheter management after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:1037-1045. 

The traditional indwelling catheter as a postoperative bladder drainage method has a number of drawbacks, including an increased rate of UTI, patient discomfort, and potential limitations in mobility due to the presence of a drainage bag.⁵ 

Boyd and colleagues reported on a variation of traditional transurethral catheterization that hypothetically allows for improved mobility. With this method, the transurethral catheter is occluded with a plastic plug that is intermittently plugged and unplugged (plug-unplug method) for bladder drainage. To test whether activity levels are improved with the plug-unplug method versus the continuous drainage approach, the authors conducted an RCT in women undergoing pelvic reconstructive surgery to compare the plug-unplug method with transurethral catheterization (with a continuous drainage bag) and a reference group of freely voiding women. 

Study particulars and outcomes 

The trial's primary outcome was the patients' activity score as measured by the Activity Assessment Scale (AAS) at 5 to 7 days postoperatively. Because of the theoretically increased risk of a UTI with opening and closing a closed drainage system, secondary outcomes included the UTI rate, the time to pass an outpatient void trial, postoperative pain, patient satisfaction, and catheter effect. To detect an effect size of 0.33 in the primary outcome between the 3 groups, 90 participants were needed along with a difference in proportions of 0.3 between the catheterized and noncatheterized groups. 

The participants were randomly assigned 1:1 preoperatively to the continuous drainage or plug-unplug method. All patients underwent a backfill-assisted void trial prior to hospital discharge; the first 30 randomly assigned patients to pass their void trial comprised the reference group. Patients in the plug-unplug arm were instructed to uncap the plastic plug to drain their bladder when they felt the urge to void or at least every 4 hours. All catheterized patients were provided with a large drainage bag for gravity-based drainage for overnight use. 

Participants who were discharged home with a catheter underwent an outpatient void trial between postoperative days 5 and 7. A urinalysis was performed at that time and a urine culture was done if a patient reported UTI symptoms. All patients underwent routine follow-up until they passed the office void trial. 

Results. Ninety-three women were included in the primary analysis. There were no differences in baseline characteristics between groups. No difference was detected in activity by AAS scores between all 3 groups (scores: plug-unplug, 70.3; continuous drainage, 67.7; reference arm, 79.4; P = .09). The 2 treatment arms had no overall difference in culture-positive UTI (plug-unplug, 68.8%; continuous drainage, 48.4%; P = .625). No significant difference was found in the percentage of patients who passed their initial outpatient void trial (plug-unplug, 71.9%, vs continuous drainage, 58.1%; P = .25) (TABLE 2).

Catheter impact on postoperative activity considered 

Strengths of the study include the prospective randomized design, the inclusion of a noncatheterized reference arm, and use of a validated questionnaire to assess activity. The study was limited, however, by the inability to blind patients to treatment and the lack of power to assess other important outcomes, such as UTI rates. 

Although the authors did not find a difference in activity scores between the 2 catheterization methods, no significant difference was found between the catheterized and noncatheterized groups, which suggests that catheters in general may not significantly impact postoperative activity. The theoretical concern that opening and closing a transurethral drainage system would increase UTI rates was not substantiated, although the study was not powered specifically for this outcome. 

Ultimately, the plug-unplug method may be a safe alternative for patients who desire to avoid attachment to a drainage bag postoperatively. 

Continue to: Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Lavelle ES, Alam P, Meister M, et al. Antibiotic prophylaxis during catheter-managed postoperative urinary retention after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:727-735. 

Limited high-quality evidence supports the use of prophylactic antibiotics during catheterization following prolapse or incontinence surgery, and the Infectious Disease Society of America cautions against routine antibiotic prophylaxis for those requiring catheterization.¹¹ 

Lavelle and colleagues conducted a multicenter RCT to determine whether nitrofurantoin is more effective than placebo in decreasing UTIs among patients with postoperative voiding dysfunction following surgery for prolapse or incontinence. 

Focus of the study 

The investigators conducted a double-blind RCT at 5 academic sites that included women with postoperative voiding dysfunction who required catheter management (transurethral indwelling catheter or CISC). Voiding dysfunction was diagnosed by backfill or spontaneous fill void trial and was defined as a PVR of greater than 100 mL. Women were randomly assigned 1:1 to nitrofurantoin 100 mg or placebo taken daily during catheter use. Catheter use was discontinued once an outpatient void trial confirmed efficient voiding. 

The primary outcome was symptomatic culture-confirmed UTI within 6 weeks of surgery. Secondary outcomes included frequency of urine cultures with nitrofurantoin-resistant or intermediate-sensitivity isolates and adverse symptoms possibly related to nitrofurantoin. The authors calculated that 154 participants would provide 80% power to detect a decrease in UTI incidence from 33% to 13%, allowing for 10% dropout. 

A total of 151 women were randomly assigned and included in the intention-to-treat analysis. There were no differences in baseline characteristics. The median duration of catheter use was 4 days (interquartile range, 3-7). 

Results. Overall, 13 women in the nitrofurantoin group and 13 in the placebo group experienced the primary outcome of UTI within 6 weeks postoperatively (17.3% nitrofurantoin vs 17.1% placebo; P = .97; relative risk [RR], 1.01; 95% confidence interval [CI], 0.50-2.04). The number needed to treat with nitrofurantoin to prevent 1 UTI was 500. A subanalysis found no difference in UTI incidence stratified by CISC versus indwelling catheter. 

Urine cultures were obtained for 94.5% of all patients reporting UTI symptoms. Four isolates of the 13 cultures in the nitrofurantoin group (30.8%) and 3 in the placebo group (21.4%) showed nitrofurantoin resistance (P = .58). The rate of endorsing at least 1 adverse symptom attributable to nitrofurantoin was similar between groups (68.0% vs 60.5%, respectively; P = .34). 

Study strong points and limitations 

This study's randomized, placebo-controlled design and multicenter recruitment increase the generalizability of the results. An additional strength is that the authors chose a clinically relevant definition of UTI. The study was likely underpowered, however, to detect differences in secondary outcomes, such as nitrofurantoin resistance. We cannot conclude on the role of antibiotics for patients who require more prolonged catheterization. 

Notably, a similar RCT by Dieter and colleagues of 159 patients undergoing daily nitrofurantoin versus placebo during CISC or transurethral catheterization failed to detect a difference in the rate of UTI treatment up to 3 weeks postoperatively with nitrofurantoin prophylaxis.¹² 

Ultimately, the study by Lavelle and colleagues contributes to a growing body of evidence that supports the avoidance of antibiotic prophylaxis during short-term postoperative catheterization.

Postoperative voiding dysfunction refers to the acute inability to spontaneously and adequately empty the bladder after surgery. Postoperative voiding dysfunction occurs in 21% to 42% of pelvic reconstructive surgeries, as well as 7% to 21% of benign gynecologic surgeries.^1-4 While much of its peril lies in patient discomfort or dissatisfaction with temporary bladder drainage, serious consequences of the disorder include bladder overdistension injury with inadequate drainage and urinary tract infection (UTI) associated with prolonged catheterization.^4-6

Although transient postoperative voiding dysfunction is associated with anti-incontinence surgery, tricyclic antidepressant use, diabetes, preoperative voiding dysfunction, and postoperative narcotic use, it also may occur in patients without risk factors.^4,7,8 Thus, all gynecologic surgeons should be prepared to assess and manage the patient with postoperative voiding dysfunction.

Diagnosis of postoperative voiding dysfunction can be approached in myriad ways, including spontaneous (or natural) bladder filling or bladder backfill followed by spontaneous void. When compared with spontaneous void trials, backfill-assisted void trial is associated with improved accuracy in predicting voiding dysfunction in patients who undergo urogynecologic surgery, leading to widespread adoption of the procedure following pelvic reconstructive surgeries.^9,10

Criteria for “passing” a void trial may include the patient’s subjective feeling of having emptied her bladder; having a near-baseline force of stream; or commonly by objective parameters of voided volume and postvoid residual (PVR), assessed via catheterization or bladder scan.^3,6,10 Completing a postoperative void trial typically requires significant nursing effort because of the technical demands of backfilling the bladder, obtaining the voided volume and PVR, or assessing subjective emptying.

Management of postoperative voiding dysfunction typically consists of continuous drainage with a transurethral catheter or clean intermittent self-catheterization (CISC). Patients discharged home with a bladder drainage method also may be prescribed various medications, such as antibiotics, anticholinergics, and bladder analgesics, which often depends on provider practice.

Given the minimal universal guidance available for gynecologic surgeons on postoperative voiding dysfunction, we review several articles that contribute new evidence on the assessment and management of this condition.

Continue to: How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

Chao L, Mansuria S. Postoperative bladder filling after outpatient laparoscopic hysterectomy and time to discharge: a randomized controlled trial. Obstet Gynecol. 2019;133:879-887. 

Despite efforts to implement and promote enhanced recovery after surgery pathways, waiting for spontaneous void can be a barrier to efficient same-day discharge. Chao and Mansuria conducted a randomized controlled trial (RCT) to determine whether backfilling the bladder intraoperatively, compared with spontaneous (physiologic) filling, would reduce time to discharge in patients undergoing total laparoscopic hysterectomy (TLH) or supracervical hysterectomy (SCH). 

Study details 

Women undergoing TLH or laparoscopic SCH for benign indications were randomly assigned to undergo either a backfill-assisted void trial in the operating room with 200 mL of sterile normal saline (n = 75) or Foley catheter removal with spontaneous fill in the postanesthesia care unit (PACU) (n = 78). 

For both groups, the maximum time allowed for spontaneous void was 5 hours. A successful void trial was defined as a voided volume of at least 200 mL. If a patient was unable to void at least 200 mL, a bladder scan was performed, and the patient was considered to have failed the void trial if a PVR of 200 mL or greater was noted. If the PVR was less than 200 mL, the patient was given an additional 1 hour to spontaneously void 200 mL by 6 hours after the surgery. Patients who failed the void trial were discharged home with a transurethral catheter. 

The primary outcome was time to discharge, and the sample size (153 participants included in the analysis) allowed 80% power to detect a 30-minute difference in time to discharge. Participant baseline characteristics, concomitant procedures, and indication for hysterectomy were similar for both groups. 

Results. The mean time to discharge was 273.4 minutes for the backfill-assisted void trial group and 283.2 minutes for the spontaneous fill group, a difference of 9.8 minutes that was not statistically significant (P = .45). 

Although it was not a primary outcome, time to spontaneous void was 24.9 minutes shorter in the backfill group (P = .04). Rates of postoperative voiding dysfunction did not differ between the 2 groups (6.7% for the backfill group and 12.8% for the spontaneous fill group; P = .2). There were no significant differences in emergency department visits, UTI rates, or readmissions. 

Bladder backfill is safe, simple, and may reduce time to spontaneous void 

Strengths of the study included its prospective randomized design, blinded outcome assessors, and diversity in benign gynecologic surgeries performed. Although this study found a reduced time to spontaneous void in the backfill group, it was not powered to assess this difference, limiting ability to draw conclusions from those data. Data on postoperative nausea and pain scores also were not collected, which likely influenced the overall time to discharge. 

Void trial completion is one of many criteria to fulfill prior to patient discharge, and a reduced time to first void may not decrease the overall length of PACU stay if other factors, such as nausea or pain, are not controlled. Nonetheless, backfilling the bladder intraoperatively is a safe alternative that may decrease the time to first spontaneous void, and it is a relatively simple alteration in the surgical workflow that could significantly lessen PACU nursing demands.

Continue to: Algorithm assesses need for PVR, although further study required...

Algorithm assesses need for PVR, although further study required 

Meekins AR, Siddiqui N, Amundsen CL, et al. Improving postoperative efficiency: an algorithm for expedited void trials after urogynecologic surgery. South Med J. 2017;110:785-790. 

To determine ways to further maximize postoperative efficiency, Meekins and colleagues sought to determine whether certain voided volumes during backfill-assisted void trials could obviate the need for PVR assessment. 

Void trial results calculated to develop algorithm 

The study was a secondary analysis of a previously conducted RCT that assessed antibiotics for the prevention of UTI after urogynecologic surgery. Void trials from the parent RCT were performed via the backfill-assisted method in which the bladder was backfilled in the PACU with 300 mL of normal saline or until the patient reported urgency to void, after which the catheter was removed and the patient was prompted to void immediately. 

Postvoid residual levels were assessed via ultrasonography or catheterization. A void trial was considered to be passed when a PVR was less than 100 mL or less than 50% of the total bladder volume, with a minimum voided volume of 200 mL. 

In the follow-up study, the authors analyzed the void trial results of 255 women of the original 264 in the parent RCT. A total of 69% of patients passed their void trial. The authors assessed the optimal positive predictive value (PPV) and negative predictive value (NPV) combinations, which were then used to create lower and upper voided volume thresholds that would best predict a failed or passed trial, thus obviating PVR measurement. 

Results. When patients voided less than 100 mL, the NPV was 96.7% (meaning that they had a 96.7% chance of failing the void trial). When patients voided 200 mL or more, the PPV was 97% (meaning that they had a 97% chance of passing the void trial). Receiver operating characteristic analysis confirmed that voided volume alone was an excellent predictor of final void trial results, with area under the curve of 0.97. The authors estimated that applying this algorithm to their study population would have eliminated the need for assessing PVR in 85% of patients. Ultimately, they proposed the algorithm shown in TABLE 1. 

A potential alternative for assessing PVR 

This study's strengths include the use of prospectively and systematically collected void trial data in a large patient population undergoing various urogynecologic procedures. By contrast, the generalizability of the results is limited regarding other void trial methods, such as spontaneous filling and void, as well as populations outside of the studied institution. 

With the algorithm, the authors estimated that the majority of postoperative patients would no longer require a PVR assessment in the PACU. This could have beneficial downstream implications, including decreasing the nursing workload, reducing total time in the PACU, and minimizing patient discomfort with PVR assessment. 

While further studies are needed to validate the proposed algorithm in larger populations, this study provides evidence of an efficient alternative to the traditional approach to PVR assessment in the PACU.

Continue to: An alternative to Foley use if a patient does not know CISC...

An alternative to Foley use if a patient does not know CISC 

Boyd SS, O'Sullivan DM, Tunitsky-Bitton E. A comparison of two methods of catheter management after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:1037-1045. 

The traditional indwelling catheter as a postoperative bladder drainage method has a number of drawbacks, including an increased rate of UTI, patient discomfort, and potential limitations in mobility due to the presence of a drainage bag.⁵ 

Boyd and colleagues reported on a variation of traditional transurethral catheterization that hypothetically allows for improved mobility. With this method, the transurethral catheter is occluded with a plastic plug that is intermittently plugged and unplugged (plug-unplug method) for bladder drainage. To test whether activity levels are improved with the plug-unplug method versus the continuous drainage approach, the authors conducted an RCT in women undergoing pelvic reconstructive surgery to compare the plug-unplug method with transurethral catheterization (with a continuous drainage bag) and a reference group of freely voiding women. 

Study particulars and outcomes 

The trial's primary outcome was the patients' activity score as measured by the Activity Assessment Scale (AAS) at 5 to 7 days postoperatively. Because of the theoretically increased risk of a UTI with opening and closing a closed drainage system, secondary outcomes included the UTI rate, the time to pass an outpatient void trial, postoperative pain, patient satisfaction, and catheter effect. To detect an effect size of 0.33 in the primary outcome between the 3 groups, 90 participants were needed along with a difference in proportions of 0.3 between the catheterized and noncatheterized groups. 

The participants were randomly assigned 1:1 preoperatively to the continuous drainage or plug-unplug method. All patients underwent a backfill-assisted void trial prior to hospital discharge; the first 30 randomly assigned patients to pass their void trial comprised the reference group. Patients in the plug-unplug arm were instructed to uncap the plastic plug to drain their bladder when they felt the urge to void or at least every 4 hours. All catheterized patients were provided with a large drainage bag for gravity-based drainage for overnight use. 

Participants who were discharged home with a catheter underwent an outpatient void trial between postoperative days 5 and 7. A urinalysis was performed at that time and a urine culture was done if a patient reported UTI symptoms. All patients underwent routine follow-up until they passed the office void trial. 

Results. Ninety-three women were included in the primary analysis. There were no differences in baseline characteristics between groups. No difference was detected in activity by AAS scores between all 3 groups (scores: plug-unplug, 70.3; continuous drainage, 67.7; reference arm, 79.4; P = .09). The 2 treatment arms had no overall difference in culture-positive UTI (plug-unplug, 68.8%; continuous drainage, 48.4%; P = .625). No significant difference was found in the percentage of patients who passed their initial outpatient void trial (plug-unplug, 71.9%, vs continuous drainage, 58.1%; P = .25) (TABLE 2).

Catheter impact on postoperative activity considered 

Strengths of the study include the prospective randomized design, the inclusion of a noncatheterized reference arm, and use of a validated questionnaire to assess activity. The study was limited, however, by the inability to blind patients to treatment and the lack of power to assess other important outcomes, such as UTI rates. 

Although the authors did not find a difference in activity scores between the 2 catheterization methods, no significant difference was found between the catheterized and noncatheterized groups, which suggests that catheters in general may not significantly impact postoperative activity. The theoretical concern that opening and closing a transurethral drainage system would increase UTI rates was not substantiated, although the study was not powered specifically for this outcome. 

Ultimately, the plug-unplug method may be a safe alternative for patients who desire to avoid attachment to a drainage bag postoperatively. 

Continue to: Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Lavelle ES, Alam P, Meister M, et al. Antibiotic prophylaxis during catheter-managed postoperative urinary retention after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:727-735. 

Limited high-quality evidence supports the use of prophylactic antibiotics during catheterization following prolapse or incontinence surgery, and the Infectious Disease Society of America cautions against routine antibiotic prophylaxis for those requiring catheterization.¹¹ 

Lavelle and colleagues conducted a multicenter RCT to determine whether nitrofurantoin is more effective than placebo in decreasing UTIs among patients with postoperative voiding dysfunction following surgery for prolapse or incontinence. 

Focus of the study 

The investigators conducted a double-blind RCT at 5 academic sites that included women with postoperative voiding dysfunction who required catheter management (transurethral indwelling catheter or CISC). Voiding dysfunction was diagnosed by backfill or spontaneous fill void trial and was defined as a PVR of greater than 100 mL. Women were randomly assigned 1:1 to nitrofurantoin 100 mg or placebo taken daily during catheter use. Catheter use was discontinued once an outpatient void trial confirmed efficient voiding. 

The primary outcome was symptomatic culture-confirmed UTI within 6 weeks of surgery. Secondary outcomes included frequency of urine cultures with nitrofurantoin-resistant or intermediate-sensitivity isolates and adverse symptoms possibly related to nitrofurantoin. The authors calculated that 154 participants would provide 80% power to detect a decrease in UTI incidence from 33% to 13%, allowing for 10% dropout. 

A total of 151 women were randomly assigned and included in the intention-to-treat analysis. There were no differences in baseline characteristics. The median duration of catheter use was 4 days (interquartile range, 3-7). 

Results. Overall, 13 women in the nitrofurantoin group and 13 in the placebo group experienced the primary outcome of UTI within 6 weeks postoperatively (17.3% nitrofurantoin vs 17.1% placebo; P = .97; relative risk [RR], 1.01; 95% confidence interval [CI], 0.50-2.04). The number needed to treat with nitrofurantoin to prevent 1 UTI was 500. A subanalysis found no difference in UTI incidence stratified by CISC versus indwelling catheter. 

Urine cultures were obtained for 94.5% of all patients reporting UTI symptoms. Four isolates of the 13 cultures in the nitrofurantoin group (30.8%) and 3 in the placebo group (21.4%) showed nitrofurantoin resistance (P = .58). The rate of endorsing at least 1 adverse symptom attributable to nitrofurantoin was similar between groups (68.0% vs 60.5%, respectively; P = .34). 

Study strong points and limitations 

This study's randomized, placebo-controlled design and multicenter recruitment increase the generalizability of the results. An additional strength is that the authors chose a clinically relevant definition of UTI. The study was likely underpowered, however, to detect differences in secondary outcomes, such as nitrofurantoin resistance. We cannot conclude on the role of antibiotics for patients who require more prolonged catheterization. 

Notably, a similar RCT by Dieter and colleagues of 159 patients undergoing daily nitrofurantoin versus placebo during CISC or transurethral catheterization failed to detect a difference in the rate of UTI treatment up to 3 weeks postoperatively with nitrofurantoin prophylaxis.¹² 

Ultimately, the study by Lavelle and colleagues contributes to a growing body of evidence that supports the avoidance of antibiotic prophylaxis during short-term postoperative catheterization.

Postoperative voiding dysfunction refers to the acute inability to spontaneously and adequately empty the bladder after surgery. Postoperative voiding dysfunction occurs in 21% to 42% of pelvic reconstructive surgeries, as well as 7% to 21% of benign gynecologic surgeries.^1-4 While much of its peril lies in patient discomfort or dissatisfaction with temporary bladder drainage, serious consequences of the disorder include bladder overdistension injury with inadequate drainage and urinary tract infection (UTI) associated with prolonged catheterization.^4-6

Although transient postoperative voiding dysfunction is associated with anti-incontinence surgery, tricyclic antidepressant use, diabetes, preoperative voiding dysfunction, and postoperative narcotic use, it also may occur in patients without risk factors.^4,7,8 Thus, all gynecologic surgeons should be prepared to assess and manage the patient with postoperative voiding dysfunction.

Diagnosis of postoperative voiding dysfunction can be approached in myriad ways, including spontaneous (or natural) bladder filling or bladder backfill followed by spontaneous void. When compared with spontaneous void trials, backfill-assisted void trial is associated with improved accuracy in predicting voiding dysfunction in patients who undergo urogynecologic surgery, leading to widespread adoption of the procedure following pelvic reconstructive surgeries.^9,10

Criteria for “passing” a void trial may include the patient’s subjective feeling of having emptied her bladder; having a near-baseline force of stream; or commonly by objective parameters of voided volume and postvoid residual (PVR), assessed via catheterization or bladder scan.^3,6,10 Completing a postoperative void trial typically requires significant nursing effort because of the technical demands of backfilling the bladder, obtaining the voided volume and PVR, or assessing subjective emptying.

Management of postoperative voiding dysfunction typically consists of continuous drainage with a transurethral catheter or clean intermittent self-catheterization (CISC). Patients discharged home with a bladder drainage method also may be prescribed various medications, such as antibiotics, anticholinergics, and bladder analgesics, which often depends on provider practice.

Given the minimal universal guidance available for gynecologic surgeons on postoperative voiding dysfunction, we review several articles that contribute new evidence on the assessment and management of this condition.

Continue to: How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

How can we efficiently approach the postoperative void trial for pelvic floor surgery? 

Chao L, Mansuria S. Postoperative bladder filling after outpatient laparoscopic hysterectomy and time to discharge: a randomized controlled trial. Obstet Gynecol. 2019;133:879-887. 

Despite efforts to implement and promote enhanced recovery after surgery pathways, waiting for spontaneous void can be a barrier to efficient same-day discharge. Chao and Mansuria conducted a randomized controlled trial (RCT) to determine whether backfilling the bladder intraoperatively, compared with spontaneous (physiologic) filling, would reduce time to discharge in patients undergoing total laparoscopic hysterectomy (TLH) or supracervical hysterectomy (SCH). 

Study details 

Women undergoing TLH or laparoscopic SCH for benign indications were randomly assigned to undergo either a backfill-assisted void trial in the operating room with 200 mL of sterile normal saline (n = 75) or Foley catheter removal with spontaneous fill in the postanesthesia care unit (PACU) (n = 78). 

For both groups, the maximum time allowed for spontaneous void was 5 hours. A successful void trial was defined as a voided volume of at least 200 mL. If a patient was unable to void at least 200 mL, a bladder scan was performed, and the patient was considered to have failed the void trial if a PVR of 200 mL or greater was noted. If the PVR was less than 200 mL, the patient was given an additional 1 hour to spontaneously void 200 mL by 6 hours after the surgery. Patients who failed the void trial were discharged home with a transurethral catheter. 

The primary outcome was time to discharge, and the sample size (153 participants included in the analysis) allowed 80% power to detect a 30-minute difference in time to discharge. Participant baseline characteristics, concomitant procedures, and indication for hysterectomy were similar for both groups. 

Results. The mean time to discharge was 273.4 minutes for the backfill-assisted void trial group and 283.2 minutes for the spontaneous fill group, a difference of 9.8 minutes that was not statistically significant (P = .45). 

Although it was not a primary outcome, time to spontaneous void was 24.9 minutes shorter in the backfill group (P = .04). Rates of postoperative voiding dysfunction did not differ between the 2 groups (6.7% for the backfill group and 12.8% for the spontaneous fill group; P = .2). There were no significant differences in emergency department visits, UTI rates, or readmissions. 

Bladder backfill is safe, simple, and may reduce time to spontaneous void 

Strengths of the study included its prospective randomized design, blinded outcome assessors, and diversity in benign gynecologic surgeries performed. Although this study found a reduced time to spontaneous void in the backfill group, it was not powered to assess this difference, limiting ability to draw conclusions from those data. Data on postoperative nausea and pain scores also were not collected, which likely influenced the overall time to discharge. 

Void trial completion is one of many criteria to fulfill prior to patient discharge, and a reduced time to first void may not decrease the overall length of PACU stay if other factors, such as nausea or pain, are not controlled. Nonetheless, backfilling the bladder intraoperatively is a safe alternative that may decrease the time to first spontaneous void, and it is a relatively simple alteration in the surgical workflow that could significantly lessen PACU nursing demands.

Continue to: Algorithm assesses need for PVR, although further study required...

Algorithm assesses need for PVR, although further study required 

Meekins AR, Siddiqui N, Amundsen CL, et al. Improving postoperative efficiency: an algorithm for expedited void trials after urogynecologic surgery. South Med J. 2017;110:785-790. 

To determine ways to further maximize postoperative efficiency, Meekins and colleagues sought to determine whether certain voided volumes during backfill-assisted void trials could obviate the need for PVR assessment. 

Void trial results calculated to develop algorithm 

The study was a secondary analysis of a previously conducted RCT that assessed antibiotics for the prevention of UTI after urogynecologic surgery. Void trials from the parent RCT were performed via the backfill-assisted method in which the bladder was backfilled in the PACU with 300 mL of normal saline or until the patient reported urgency to void, after which the catheter was removed and the patient was prompted to void immediately. 

Postvoid residual levels were assessed via ultrasonography or catheterization. A void trial was considered to be passed when a PVR was less than 100 mL or less than 50% of the total bladder volume, with a minimum voided volume of 200 mL. 

In the follow-up study, the authors analyzed the void trial results of 255 women of the original 264 in the parent RCT. A total of 69% of patients passed their void trial. The authors assessed the optimal positive predictive value (PPV) and negative predictive value (NPV) combinations, which were then used to create lower and upper voided volume thresholds that would best predict a failed or passed trial, thus obviating PVR measurement. 

Results. When patients voided less than 100 mL, the NPV was 96.7% (meaning that they had a 96.7% chance of failing the void trial). When patients voided 200 mL or more, the PPV was 97% (meaning that they had a 97% chance of passing the void trial). Receiver operating characteristic analysis confirmed that voided volume alone was an excellent predictor of final void trial results, with area under the curve of 0.97. The authors estimated that applying this algorithm to their study population would have eliminated the need for assessing PVR in 85% of patients. Ultimately, they proposed the algorithm shown in TABLE 1. 

A potential alternative for assessing PVR 

This study's strengths include the use of prospectively and systematically collected void trial data in a large patient population undergoing various urogynecologic procedures. By contrast, the generalizability of the results is limited regarding other void trial methods, such as spontaneous filling and void, as well as populations outside of the studied institution. 

With the algorithm, the authors estimated that the majority of postoperative patients would no longer require a PVR assessment in the PACU. This could have beneficial downstream implications, including decreasing the nursing workload, reducing total time in the PACU, and minimizing patient discomfort with PVR assessment. 

While further studies are needed to validate the proposed algorithm in larger populations, this study provides evidence of an efficient alternative to the traditional approach to PVR assessment in the PACU.

Continue to: An alternative to Foley use if a patient does not know CISC...

An alternative to Foley use if a patient does not know CISC 

Boyd SS, O'Sullivan DM, Tunitsky-Bitton E. A comparison of two methods of catheter management after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:1037-1045. 

The traditional indwelling catheter as a postoperative bladder drainage method has a number of drawbacks, including an increased rate of UTI, patient discomfort, and potential limitations in mobility due to the presence of a drainage bag.⁵ 

Boyd and colleagues reported on a variation of traditional transurethral catheterization that hypothetically allows for improved mobility. With this method, the transurethral catheter is occluded with a plastic plug that is intermittently plugged and unplugged (plug-unplug method) for bladder drainage. To test whether activity levels are improved with the plug-unplug method versus the continuous drainage approach, the authors conducted an RCT in women undergoing pelvic reconstructive surgery to compare the plug-unplug method with transurethral catheterization (with a continuous drainage bag) and a reference group of freely voiding women. 

Study particulars and outcomes 

The trial's primary outcome was the patients' activity score as measured by the Activity Assessment Scale (AAS) at 5 to 7 days postoperatively. Because of the theoretically increased risk of a UTI with opening and closing a closed drainage system, secondary outcomes included the UTI rate, the time to pass an outpatient void trial, postoperative pain, patient satisfaction, and catheter effect. To detect an effect size of 0.33 in the primary outcome between the 3 groups, 90 participants were needed along with a difference in proportions of 0.3 between the catheterized and noncatheterized groups. 

The participants were randomly assigned 1:1 preoperatively to the continuous drainage or plug-unplug method. All patients underwent a backfill-assisted void trial prior to hospital discharge; the first 30 randomly assigned patients to pass their void trial comprised the reference group. Patients in the plug-unplug arm were instructed to uncap the plastic plug to drain their bladder when they felt the urge to void or at least every 4 hours. All catheterized patients were provided with a large drainage bag for gravity-based drainage for overnight use. 

Participants who were discharged home with a catheter underwent an outpatient void trial between postoperative days 5 and 7. A urinalysis was performed at that time and a urine culture was done if a patient reported UTI symptoms. All patients underwent routine follow-up until they passed the office void trial. 

Results. Ninety-three women were included in the primary analysis. There were no differences in baseline characteristics between groups. No difference was detected in activity by AAS scores between all 3 groups (scores: plug-unplug, 70.3; continuous drainage, 67.7; reference arm, 79.4; P = .09). The 2 treatment arms had no overall difference in culture-positive UTI (plug-unplug, 68.8%; continuous drainage, 48.4%; P = .625). No significant difference was found in the percentage of patients who passed their initial outpatient void trial (plug-unplug, 71.9%, vs continuous drainage, 58.1%; P = .25) (TABLE 2).

Catheter impact on postoperative activity considered 

Strengths of the study include the prospective randomized design, the inclusion of a noncatheterized reference arm, and use of a validated questionnaire to assess activity. The study was limited, however, by the inability to blind patients to treatment and the lack of power to assess other important outcomes, such as UTI rates. 

Although the authors did not find a difference in activity scores between the 2 catheterization methods, no significant difference was found between the catheterized and noncatheterized groups, which suggests that catheters in general may not significantly impact postoperative activity. The theoretical concern that opening and closing a transurethral drainage system would increase UTI rates was not substantiated, although the study was not powered specifically for this outcome. 

Ultimately, the plug-unplug method may be a safe alternative for patients who desire to avoid attachment to a drainage bag postoperatively. 

Continue to: Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Does antibiotic prophylaxis reduce UTI for patients catheter-managed postoperatively? 

Lavelle ES, Alam P, Meister M, et al. Antibiotic prophylaxis during catheter-managed postoperative urinary retention after pelvic reconstructive surgery: a randomized controlled trial. Obstet Gynecol. 2019;134:727-735. 

Limited high-quality evidence supports the use of prophylactic antibiotics during catheterization following prolapse or incontinence surgery, and the Infectious Disease Society of America cautions against routine antibiotic prophylaxis for those requiring catheterization.¹¹ 

Lavelle and colleagues conducted a multicenter RCT to determine whether nitrofurantoin is more effective than placebo in decreasing UTIs among patients with postoperative voiding dysfunction following surgery for prolapse or incontinence. 

Focus of the study 

The investigators conducted a double-blind RCT at 5 academic sites that included women with postoperative voiding dysfunction who required catheter management (transurethral indwelling catheter or CISC). Voiding dysfunction was diagnosed by backfill or spontaneous fill void trial and was defined as a PVR of greater than 100 mL. Women were randomly assigned 1:1 to nitrofurantoin 100 mg or placebo taken daily during catheter use. Catheter use was discontinued once an outpatient void trial confirmed efficient voiding. 

The primary outcome was symptomatic culture-confirmed UTI within 6 weeks of surgery. Secondary outcomes included frequency of urine cultures with nitrofurantoin-resistant or intermediate-sensitivity isolates and adverse symptoms possibly related to nitrofurantoin. The authors calculated that 154 participants would provide 80% power to detect a decrease in UTI incidence from 33% to 13%, allowing for 10% dropout. 

A total of 151 women were randomly assigned and included in the intention-to-treat analysis. There were no differences in baseline characteristics. The median duration of catheter use was 4 days (interquartile range, 3-7). 

Results. Overall, 13 women in the nitrofurantoin group and 13 in the placebo group experienced the primary outcome of UTI within 6 weeks postoperatively (17.3% nitrofurantoin vs 17.1% placebo; P = .97; relative risk [RR], 1.01; 95% confidence interval [CI], 0.50-2.04). The number needed to treat with nitrofurantoin to prevent 1 UTI was 500. A subanalysis found no difference in UTI incidence stratified by CISC versus indwelling catheter. 

Urine cultures were obtained for 94.5% of all patients reporting UTI symptoms. Four isolates of the 13 cultures in the nitrofurantoin group (30.8%) and 3 in the placebo group (21.4%) showed nitrofurantoin resistance (P = .58). The rate of endorsing at least 1 adverse symptom attributable to nitrofurantoin was similar between groups (68.0% vs 60.5%, respectively; P = .34). 

Study strong points and limitations 

This study's randomized, placebo-controlled design and multicenter recruitment increase the generalizability of the results. An additional strength is that the authors chose a clinically relevant definition of UTI. The study was likely underpowered, however, to detect differences in secondary outcomes, such as nitrofurantoin resistance. We cannot conclude on the role of antibiotics for patients who require more prolonged catheterization. 

Notably, a similar RCT by Dieter and colleagues of 159 patients undergoing daily nitrofurantoin versus placebo during CISC or transurethral catheterization failed to detect a difference in the rate of UTI treatment up to 3 weeks postoperatively with nitrofurantoin prophylaxis.¹² 

Ultimately, the study by Lavelle and colleagues contributes to a growing body of evidence that supports the avoidance of antibiotic prophylaxis during short-term postoperative catheterization.

Every 2 years the Society of Hospital Medicine’s Practice Analysis Committee (PAC) surveys hospitalist groups nationwide on such key practice parameters as compensation, services provided, hours of work, and participation in leadership roles. Combined with compensation and productivity data on adult and pediatric hospitalists collected by the Medical Group Management Association, licensed to SHM for inclusion in this report, the State of Hospital Medicine (SoHM) report is the most authoritative and comprehensive source of information regarding contemporary hospitalist practice.

This year’s biannual report is based on survey responses submitted between Jan. 6 and Feb. 28, 2020, by 502 hospitalist group practices. That’s slightly fewer groups reporting data than for past surveys, but these groups were larger, on average, resulting in more full-time equivalents (FTEs) incorporated into the results, said PAC member Leslie Flores, MHA, SFHM, of Nelson Flores Hospital Medicine Consultants. A total of 19.7% of the reporting groups provided pediatric hospital medicine data only, a much larger proportion than in past years.

The report is slated for publication in September, and SHM members can purchase it at a discount in print or electronic versions. “Our sense is that a lot of the fundamental information in the report will not have changed that much from 2018,” Ms. Flores said. “But these results convey the state of the field prior to the world-altering impact of the COVID-19 pandemic on hospitals of all sizes and settings.” How the hospital business and the practice of hospitalist groups have been and will be impacted by the pandemic, obviously, aren’t reflected in the data.

“We are finalizing a supplemental survey to go out to members at the end of the summer, specifically asking how COVID has impacted their hospitalist groups,” Ms. Flores said. These COVID-19 supplemental results will be released after the main report, sometime around the end of September. But results from the main survey, showing consistency in a number of key parameters, indicate that hospitalists continue to have a large and essential role in the U.S. health care system.

The leadership offered by hospitalists in the U.S. health care system’s response to surges of COVID-19 patients in many hospitals only underscores their importance, Ms. Flores added. “Hospitalists have definitely proven their worth. Imagine what the pandemic would have been like for hospitals if our specialty hadn’t been well-positioned to respond.” Hospitalists also showed an ability to adapt quickly to crises on the ground. But financial pressures imposed by the pandemic, combined with other trends previously in play, suggest that demands to cut costs and do more with less will be relentless as the field – and the world – tries to pull out of the pandemic crisis.
 

Compensation trends

One of the most eagerly anticipated findings in the SoHM is compensation. The median compensation for all adult hospitalists at the beginning of 2020 was $307,633 (with an average of $317,640), higher in the Midwest and lower in the East. The average base rate share of hospitalist compensation was 81.3%, with 11.6% based on productivity and 7.1% for performance – scored on such measures as patient satisfaction; accuracy and/or timeliness of documentation, billing, and coding; clinical processes; early morning discharge orders and times; and readmissions rates. A total of 46.6% of responding groups said they anticipated an increase in budgeted FTEs in the next year, while 51.2% expected to stay the same.

Subsidies or financial support for hospitalist practices break down in different ways, but in 2020 the median figure for financial support provided per adult hospitalist FTE was $198,750 (average, $201,760). This suggests that hospitals continue to see hospitalists as valued partners in health care, with useful knowledge of how the various components of the health care system work, said Tresa McNeal, MD, a hospitalist at Baylor Scott & White Medical Center, Temple, Tex., and a member of the PAC.
 

Scope of practice

Scope of practice for the hospitalist model continues to evolve, with increased demand for comanagement roles as other medical specialties are less inclined to visit patients in the hospital. Surgical comanagement accounted for much of that growth, but there were significant rates of comanagement for neurology, gastrointestinal and liver medicine, cardiology, and palliative care.

“Comanagement is a broad term without a single clear definition,” Ms. Flores said. “But when I talk about it, I refer to a broader array of hospitalists interacting with specialists.” The hospitalist‘s role could be as a consultant, or taking responsibility for admitting and attending.

Other identified roles played by hospitalists in adult-only groups included providing care for patients in the ICU (59.6% of reporting groups); primary responsibility for observation/short stay units, rapid response teams or code blue/cardiac arrest teams; cross-coverage for patients admitted without a hospitalist; and performing procedures such as vascular access, lumbar puncture, paracentesis, and thoracentesis. The hospitalist role’s in the ICU likely increased in many hospitals confronting COVID surges, Ms. Flores said.

The median number of shifts performed per year by a full-time hospitalist physician was 182.0 (average, 182.3), with 12 hours as the most common average duration for a shift in a daytime schedule. The 7-days-on/7-days-off model remained the most popular way to schedule adult hospitalists, at the same rate as in 2018. Backup coverage is another important issue for hospitalist groups, with 52.6% reporting no formal backup system. For those with a backup system, the highest proportion paid no additional compensation to the physician for being on the on-call schedule, but additional compensation was paid if called into the hospital.

Presence of nocturnists was reported by 71.9% of responding groups, slightly down from 2018, but increasing with the size of the group. “We continue to see a trend for dedicated nocturnists,” said Dr. McNeal. Hospitals see the benefits from the presence of a nocturnist, reflected in pay differentials or requiring fewer full-time shifts from nocturnists. It’s more consistent, higher quality of care delivered by people who are dedicated to that role.

In other findings from the survey, turnover in adult hospitalist groups is 10.9%t, which is up from 2018 but down from 2016. Unit-based assignment, also known as geographical rounding, was utilized by 42.7% of responding adult groups, with likelihood increasing with the size of the group. Unfilled positions were reported by 73.5% of groups, with an average of 11.2% of positions unfilled at the time of the survey.

The use of telemedicine in the hospital setting is evolving, likely considerably accelerated of necessity by the pandemic. “Many of us are using telemedicine with COVID patients in order to decrease clinicians’ time in the room, and to find a way to use a work force that has to be on leave,” Dr. McNeal said.
 

Nurse practitioners and physician assistants

The role for nurse practitioners and physician assistants in adult hospital medicine groups continues to increase, with 83.3% of groups reporting the presence of PAs and NPs, up from 77% in 2018. NPs/PAs are more likely in multistate hospitalist groups or integrated delivery system practices in hospitals/health systems.

The most common billing model for their professional services is a combination of independent billing by the PA/NP where allowed and shared services billing under a supervisory physician’s provider number – although 8.1% of groups report that their NPs/PAs didn’t generally provide billable services or submit bills for payment.

NPs and PAs spend one-fifth of their time, on average, on nonbillable, value-added work, including dedicated cross-coverage shifts, scheduling, patient assignments, nonbillable clinical work such as glycemic control, and quality improvement and performance improvement activities. “This is one example of the changing skill mix for the hospitalist group, helping the practice become more efficient,” Ms. Flores said.

NPs and PAs provide valuable services, Dr. McNeal added. “But it also takes some investment in time and training for them to be able to practice at the top of their license. My own hospitalist group has a training program for newly hired NPs/PAs. Everyone goes through this orientation for around 6-10 weeks, largely in a shadowing role starting out, until they gradually adjust to more clinical autonomy.”

This onboarding includes real-time evaluations and self-evaluations, and opportunities for conversations with experienced clinicians, working from a list of 30 “bread-and-butter” topics in hospital medicine, she noted.
 

Pediatric hospital medicine

The 2020 SoHM report includes a greater representation for pediatric hospital medicine, with a 200% increase in the proportion of reporting hospitalist groups that only take care of children. Thus, the pediatric data are more robust – and helpful – than in prior year surveys, said Sandra Gage, MD, SFHM, a pediatric hospitalist at Phoenix Children’s Hospital. Dr. Gage headed up the PAC’s expanded pediatric data initiative, with targeted outreach to pediatric groups to encourage their participation. She also convened a task force to come up with pediatric-specific questions that were more pertinent and user friendly.

One of the important questions for pediatric hospitalists involves scheduling – including variations in length of shifts – which can vary dramatically in pediatric HM groups. “This year we reported by number of hours expected for a clinical FTE, which should be more useful for group leaders,” Dr. Gage said. The median number of hours required per FTE from pediatric hospitalists was fairly consistent at 1,800 per year, with minor variations based on region and academic status.

“I don’t know that there’s anything too surprising in most of the data,” she said, but noted that SHM will now have a better pediatric baseline going forward. The survey also asked how many pediatric hospitalists were board certified in the new subspecialty of pediatric hospital medicine under the program launched last year by the American Board of Pediatrics. Its first qualifying exam was in November 2019. The average was 26%, but the variation between academic and nonacademic programs was unexpected, Dr. Gage said.

Pediatric hospitalists come from a variety of professional specialties besides pediatrics. Nearly half of all programs had at least one med/peds provider, while a smaller number of programs had providers from family medicine, internal medicine, emergency medicine, or palliative care, she noted. Half of pediatric hospitalists reported joining their practice directly out of residency. About 26% of pediatric hospital medicine (PHM) physicians were described as part time, and 34.3% of pediatric groups had the presence of an NP or PA.

“I think PHM evolved a little later than for adult hospitalists, but it has clearly come into its own as a field,” Dr. Gage said. In the COVID-19 crisis, some pediatric hospitalists have been asked to care for adult patients, which necessitated a flurry of activity to refresh their medical knowledge. Where pediatric units existed within the walls of adult hospitals and were temporarily closed for COVID, it’s not clear how many will reopen – perhaps ever.
 

Long-term impacts of the crisis

Some of the hospitalist group leaders Ms. Flores has spoken with in recent months point out that, while New York and some other early COVID-19 hot spots experienced a tremendous surge of patients and hospital crowding in March and April 2020, other hospitals didn’t see anywhere near the impact.

“For some, there was nothing going on with COVID where they were,” she said. Elective surgeries were widely canceled, but with no corresponding increase of COVID admissions; and with fewer patients showing up in EDs, some physicians found themselves idled.

What will be the longer-term impact of COVID-19? How will it change hospital medicine? “I definitely think things are going to change,” Ms. Flores said, speculating that licensing boards could find a way to make it easier for physicians to practice across state lines in response to crises like the pandemic. “Do we need to think at the national level about what we can do to create more surge capacity, to move people when and where they need to go in a crisis? Are there things SHM could do to help?”

Ms. Flores expects more hospital closures than followed the 2008-2009 economic recession, which likely will further drive the trend toward mergers and acquisitions – both of hospitalist groups and of hospitals.

“From the point of view of hospitals, financial pressures will only get worse, pressing us to reinvent how hospitalists work and how that could be made more efficient,” she said. “I hear hospitals saying: ‘We can’t sustain current trends.’ Meanwhile, specialists are saying they need more help from hospitalists, and frontline hospitalists are saying they’re already working too hard. What will we do about burnout?”

These competing trends were all headed toward a perfect storm even before the epidemic hit, Ms. Flores said. “The response will require some innovations we haven’t yet conceived of. Incremental change won’t get us where we need to be. But the hospitalist’s role will be more essential than ever.”

The 2020 data show that a lot of things have been fairly steady for hospitalists, said Thomas Frederickson, MD, a member of SHM’s PAC and a specialist in hospital medicine at CHI Health in Omaha, Neb. But one concern about this stability is that, while hospitalist compensation continues to go up, workload and by extension productivity remain relatively flat. “That has been a trend over the past decade, and some of us find it hard to make sense of that.”

Dr. Frederickson, too, sees a need for disruptive innovation. “I just wish I knew what that will be.” Perhaps, just as hospitalists played a large role in the quality revolution in hospitals over the past decade, maybe in the next decade they will come to play a large role in the right-sizing of hospital care in health systems, he said.

One other important finding: the number of hospitalists per group who play roles as physician leaders has also increased, with an average of 3.2 physicians per group in a formal leadership role (median of 2). But currently, 73% of the highest-ranking leaders in hospitalist groups are male, and they are disproportionally white. As reported in Medscape in 2019, 40% of working hospitalists are women and only 36% of hospitalists overall self-identified as White.¹

“When you think of the demographics of actual working hospitalists, we could say the field of hospital medicine could and should do better in creating opportunities for diversity in leadership roles,” Ms. Flores said.
 

Reference

1. Martin KL. Hospitalist Compensation Report for 2019. Medscape. 2019 Jun 5. https://www.medscape.com/slideshow/2019-compensation-hospitalist-6011429#3.

Every 2 years the Society of Hospital Medicine’s Practice Analysis Committee (PAC) surveys hospitalist groups nationwide on such key practice parameters as compensation, services provided, hours of work, and participation in leadership roles. Combined with compensation and productivity data on adult and pediatric hospitalists collected by the Medical Group Management Association, licensed to SHM for inclusion in this report, the State of Hospital Medicine (SoHM) report is the most authoritative and comprehensive source of information regarding contemporary hospitalist practice.

This year’s biannual report is based on survey responses submitted between Jan. 6 and Feb. 28, 2020, by 502 hospitalist group practices. That’s slightly fewer groups reporting data than for past surveys, but these groups were larger, on average, resulting in more full-time equivalents (FTEs) incorporated into the results, said PAC member Leslie Flores, MHA, SFHM, of Nelson Flores Hospital Medicine Consultants. A total of 19.7% of the reporting groups provided pediatric hospital medicine data only, a much larger proportion than in past years.

The report is slated for publication in September, and SHM members can purchase it at a discount in print or electronic versions. “Our sense is that a lot of the fundamental information in the report will not have changed that much from 2018,” Ms. Flores said. “But these results convey the state of the field prior to the world-altering impact of the COVID-19 pandemic on hospitals of all sizes and settings.” How the hospital business and the practice of hospitalist groups have been and will be impacted by the pandemic, obviously, aren’t reflected in the data.

“We are finalizing a supplemental survey to go out to members at the end of the summer, specifically asking how COVID has impacted their hospitalist groups,” Ms. Flores said. These COVID-19 supplemental results will be released after the main report, sometime around the end of September. But results from the main survey, showing consistency in a number of key parameters, indicate that hospitalists continue to have a large and essential role in the U.S. health care system.

The leadership offered by hospitalists in the U.S. health care system’s response to surges of COVID-19 patients in many hospitals only underscores their importance, Ms. Flores added. “Hospitalists have definitely proven their worth. Imagine what the pandemic would have been like for hospitals if our specialty hadn’t been well-positioned to respond.” Hospitalists also showed an ability to adapt quickly to crises on the ground. But financial pressures imposed by the pandemic, combined with other trends previously in play, suggest that demands to cut costs and do more with less will be relentless as the field – and the world – tries to pull out of the pandemic crisis.
 

Compensation trends

One of the most eagerly anticipated findings in the SoHM is compensation. The median compensation for all adult hospitalists at the beginning of 2020 was $307,633 (with an average of $317,640), higher in the Midwest and lower in the East. The average base rate share of hospitalist compensation was 81.3%, with 11.6% based on productivity and 7.1% for performance – scored on such measures as patient satisfaction; accuracy and/or timeliness of documentation, billing, and coding; clinical processes; early morning discharge orders and times; and readmissions rates. A total of 46.6% of responding groups said they anticipated an increase in budgeted FTEs in the next year, while 51.2% expected to stay the same.

Subsidies or financial support for hospitalist practices break down in different ways, but in 2020 the median figure for financial support provided per adult hospitalist FTE was $198,750 (average, $201,760). This suggests that hospitals continue to see hospitalists as valued partners in health care, with useful knowledge of how the various components of the health care system work, said Tresa McNeal, MD, a hospitalist at Baylor Scott & White Medical Center, Temple, Tex., and a member of the PAC.
 

Scope of practice

Scope of practice for the hospitalist model continues to evolve, with increased demand for comanagement roles as other medical specialties are less inclined to visit patients in the hospital. Surgical comanagement accounted for much of that growth, but there were significant rates of comanagement for neurology, gastrointestinal and liver medicine, cardiology, and palliative care.

“Comanagement is a broad term without a single clear definition,” Ms. Flores said. “But when I talk about it, I refer to a broader array of hospitalists interacting with specialists.” The hospitalist‘s role could be as a consultant, or taking responsibility for admitting and attending.

Other identified roles played by hospitalists in adult-only groups included providing care for patients in the ICU (59.6% of reporting groups); primary responsibility for observation/short stay units, rapid response teams or code blue/cardiac arrest teams; cross-coverage for patients admitted without a hospitalist; and performing procedures such as vascular access, lumbar puncture, paracentesis, and thoracentesis. The hospitalist role’s in the ICU likely increased in many hospitals confronting COVID surges, Ms. Flores said.

The median number of shifts performed per year by a full-time hospitalist physician was 182.0 (average, 182.3), with 12 hours as the most common average duration for a shift in a daytime schedule. The 7-days-on/7-days-off model remained the most popular way to schedule adult hospitalists, at the same rate as in 2018. Backup coverage is another important issue for hospitalist groups, with 52.6% reporting no formal backup system. For those with a backup system, the highest proportion paid no additional compensation to the physician for being on the on-call schedule, but additional compensation was paid if called into the hospital.

Presence of nocturnists was reported by 71.9% of responding groups, slightly down from 2018, but increasing with the size of the group. “We continue to see a trend for dedicated nocturnists,” said Dr. McNeal. Hospitals see the benefits from the presence of a nocturnist, reflected in pay differentials or requiring fewer full-time shifts from nocturnists. It’s more consistent, higher quality of care delivered by people who are dedicated to that role.

In other findings from the survey, turnover in adult hospitalist groups is 10.9%t, which is up from 2018 but down from 2016. Unit-based assignment, also known as geographical rounding, was utilized by 42.7% of responding adult groups, with likelihood increasing with the size of the group. Unfilled positions were reported by 73.5% of groups, with an average of 11.2% of positions unfilled at the time of the survey.

The use of telemedicine in the hospital setting is evolving, likely considerably accelerated of necessity by the pandemic. “Many of us are using telemedicine with COVID patients in order to decrease clinicians’ time in the room, and to find a way to use a work force that has to be on leave,” Dr. McNeal said.
 

Nurse practitioners and physician assistants

The role for nurse practitioners and physician assistants in adult hospital medicine groups continues to increase, with 83.3% of groups reporting the presence of PAs and NPs, up from 77% in 2018. NPs/PAs are more likely in multistate hospitalist groups or integrated delivery system practices in hospitals/health systems.

The most common billing model for their professional services is a combination of independent billing by the PA/NP where allowed and shared services billing under a supervisory physician’s provider number – although 8.1% of groups report that their NPs/PAs didn’t generally provide billable services or submit bills for payment.

NPs and PAs spend one-fifth of their time, on average, on nonbillable, value-added work, including dedicated cross-coverage shifts, scheduling, patient assignments, nonbillable clinical work such as glycemic control, and quality improvement and performance improvement activities. “This is one example of the changing skill mix for the hospitalist group, helping the practice become more efficient,” Ms. Flores said.

NPs and PAs provide valuable services, Dr. McNeal added. “But it also takes some investment in time and training for them to be able to practice at the top of their license. My own hospitalist group has a training program for newly hired NPs/PAs. Everyone goes through this orientation for around 6-10 weeks, largely in a shadowing role starting out, until they gradually adjust to more clinical autonomy.”

This onboarding includes real-time evaluations and self-evaluations, and opportunities for conversations with experienced clinicians, working from a list of 30 “bread-and-butter” topics in hospital medicine, she noted.
 

Pediatric hospital medicine

The 2020 SoHM report includes a greater representation for pediatric hospital medicine, with a 200% increase in the proportion of reporting hospitalist groups that only take care of children. Thus, the pediatric data are more robust – and helpful – than in prior year surveys, said Sandra Gage, MD, SFHM, a pediatric hospitalist at Phoenix Children’s Hospital. Dr. Gage headed up the PAC’s expanded pediatric data initiative, with targeted outreach to pediatric groups to encourage their participation. She also convened a task force to come up with pediatric-specific questions that were more pertinent and user friendly.

One of the important questions for pediatric hospitalists involves scheduling – including variations in length of shifts – which can vary dramatically in pediatric HM groups. “This year we reported by number of hours expected for a clinical FTE, which should be more useful for group leaders,” Dr. Gage said. The median number of hours required per FTE from pediatric hospitalists was fairly consistent at 1,800 per year, with minor variations based on region and academic status.

“I don’t know that there’s anything too surprising in most of the data,” she said, but noted that SHM will now have a better pediatric baseline going forward. The survey also asked how many pediatric hospitalists were board certified in the new subspecialty of pediatric hospital medicine under the program launched last year by the American Board of Pediatrics. Its first qualifying exam was in November 2019. The average was 26%, but the variation between academic and nonacademic programs was unexpected, Dr. Gage said.

Pediatric hospitalists come from a variety of professional specialties besides pediatrics. Nearly half of all programs had at least one med/peds provider, while a smaller number of programs had providers from family medicine, internal medicine, emergency medicine, or palliative care, she noted. Half of pediatric hospitalists reported joining their practice directly out of residency. About 26% of pediatric hospital medicine (PHM) physicians were described as part time, and 34.3% of pediatric groups had the presence of an NP or PA.

“I think PHM evolved a little later than for adult hospitalists, but it has clearly come into its own as a field,” Dr. Gage said. In the COVID-19 crisis, some pediatric hospitalists have been asked to care for adult patients, which necessitated a flurry of activity to refresh their medical knowledge. Where pediatric units existed within the walls of adult hospitals and were temporarily closed for COVID, it’s not clear how many will reopen – perhaps ever.
 

Long-term impacts of the crisis

Some of the hospitalist group leaders Ms. Flores has spoken with in recent months point out that, while New York and some other early COVID-19 hot spots experienced a tremendous surge of patients and hospital crowding in March and April 2020, other hospitals didn’t see anywhere near the impact.

“For some, there was nothing going on with COVID where they were,” she said. Elective surgeries were widely canceled, but with no corresponding increase of COVID admissions; and with fewer patients showing up in EDs, some physicians found themselves idled.

What will be the longer-term impact of COVID-19? How will it change hospital medicine? “I definitely think things are going to change,” Ms. Flores said, speculating that licensing boards could find a way to make it easier for physicians to practice across state lines in response to crises like the pandemic. “Do we need to think at the national level about what we can do to create more surge capacity, to move people when and where they need to go in a crisis? Are there things SHM could do to help?”

Ms. Flores expects more hospital closures than followed the 2008-2009 economic recession, which likely will further drive the trend toward mergers and acquisitions – both of hospitalist groups and of hospitals.

“From the point of view of hospitals, financial pressures will only get worse, pressing us to reinvent how hospitalists work and how that could be made more efficient,” she said. “I hear hospitals saying: ‘We can’t sustain current trends.’ Meanwhile, specialists are saying they need more help from hospitalists, and frontline hospitalists are saying they’re already working too hard. What will we do about burnout?”

These competing trends were all headed toward a perfect storm even before the epidemic hit, Ms. Flores said. “The response will require some innovations we haven’t yet conceived of. Incremental change won’t get us where we need to be. But the hospitalist’s role will be more essential than ever.”

The 2020 data show that a lot of things have been fairly steady for hospitalists, said Thomas Frederickson, MD, a member of SHM’s PAC and a specialist in hospital medicine at CHI Health in Omaha, Neb. But one concern about this stability is that, while hospitalist compensation continues to go up, workload and by extension productivity remain relatively flat. “That has been a trend over the past decade, and some of us find it hard to make sense of that.”

Dr. Frederickson, too, sees a need for disruptive innovation. “I just wish I knew what that will be.” Perhaps, just as hospitalists played a large role in the quality revolution in hospitals over the past decade, maybe in the next decade they will come to play a large role in the right-sizing of hospital care in health systems, he said.

One other important finding: the number of hospitalists per group who play roles as physician leaders has also increased, with an average of 3.2 physicians per group in a formal leadership role (median of 2). But currently, 73% of the highest-ranking leaders in hospitalist groups are male, and they are disproportionally white. As reported in Medscape in 2019, 40% of working hospitalists are women and only 36% of hospitalists overall self-identified as White.¹

“When you think of the demographics of actual working hospitalists, we could say the field of hospital medicine could and should do better in creating opportunities for diversity in leadership roles,” Ms. Flores said.
 

Reference

1. Martin KL. Hospitalist Compensation Report for 2019. Medscape. 2019 Jun 5. https://www.medscape.com/slideshow/2019-compensation-hospitalist-6011429#3.

Every 2 years the Society of Hospital Medicine’s Practice Analysis Committee (PAC) surveys hospitalist groups nationwide on such key practice parameters as compensation, services provided, hours of work, and participation in leadership roles. Combined with compensation and productivity data on adult and pediatric hospitalists collected by the Medical Group Management Association, licensed to SHM for inclusion in this report, the State of Hospital Medicine (SoHM) report is the most authoritative and comprehensive source of information regarding contemporary hospitalist practice.

This year’s biannual report is based on survey responses submitted between Jan. 6 and Feb. 28, 2020, by 502 hospitalist group practices. That’s slightly fewer groups reporting data than for past surveys, but these groups were larger, on average, resulting in more full-time equivalents (FTEs) incorporated into the results, said PAC member Leslie Flores, MHA, SFHM, of Nelson Flores Hospital Medicine Consultants. A total of 19.7% of the reporting groups provided pediatric hospital medicine data only, a much larger proportion than in past years.

The report is slated for publication in September, and SHM members can purchase it at a discount in print or electronic versions. “Our sense is that a lot of the fundamental information in the report will not have changed that much from 2018,” Ms. Flores said. “But these results convey the state of the field prior to the world-altering impact of the COVID-19 pandemic on hospitals of all sizes and settings.” How the hospital business and the practice of hospitalist groups have been and will be impacted by the pandemic, obviously, aren’t reflected in the data.

“We are finalizing a supplemental survey to go out to members at the end of the summer, specifically asking how COVID has impacted their hospitalist groups,” Ms. Flores said. These COVID-19 supplemental results will be released after the main report, sometime around the end of September. But results from the main survey, showing consistency in a number of key parameters, indicate that hospitalists continue to have a large and essential role in the U.S. health care system.

The leadership offered by hospitalists in the U.S. health care system’s response to surges of COVID-19 patients in many hospitals only underscores their importance, Ms. Flores added. “Hospitalists have definitely proven their worth. Imagine what the pandemic would have been like for hospitals if our specialty hadn’t been well-positioned to respond.” Hospitalists also showed an ability to adapt quickly to crises on the ground. But financial pressures imposed by the pandemic, combined with other trends previously in play, suggest that demands to cut costs and do more with less will be relentless as the field – and the world – tries to pull out of the pandemic crisis.
 

Compensation trends

One of the most eagerly anticipated findings in the SoHM is compensation. The median compensation for all adult hospitalists at the beginning of 2020 was $307,633 (with an average of $317,640), higher in the Midwest and lower in the East. The average base rate share of hospitalist compensation was 81.3%, with 11.6% based on productivity and 7.1% for performance – scored on such measures as patient satisfaction; accuracy and/or timeliness of documentation, billing, and coding; clinical processes; early morning discharge orders and times; and readmissions rates. A total of 46.6% of responding groups said they anticipated an increase in budgeted FTEs in the next year, while 51.2% expected to stay the same.

Subsidies or financial support for hospitalist practices break down in different ways, but in 2020 the median figure for financial support provided per adult hospitalist FTE was $198,750 (average, $201,760). This suggests that hospitals continue to see hospitalists as valued partners in health care, with useful knowledge of how the various components of the health care system work, said Tresa McNeal, MD, a hospitalist at Baylor Scott & White Medical Center, Temple, Tex., and a member of the PAC.
 

Scope of practice

Scope of practice for the hospitalist model continues to evolve, with increased demand for comanagement roles as other medical specialties are less inclined to visit patients in the hospital. Surgical comanagement accounted for much of that growth, but there were significant rates of comanagement for neurology, gastrointestinal and liver medicine, cardiology, and palliative care.

“Comanagement is a broad term without a single clear definition,” Ms. Flores said. “But when I talk about it, I refer to a broader array of hospitalists interacting with specialists.” The hospitalist‘s role could be as a consultant, or taking responsibility for admitting and attending.

Other identified roles played by hospitalists in adult-only groups included providing care for patients in the ICU (59.6% of reporting groups); primary responsibility for observation/short stay units, rapid response teams or code blue/cardiac arrest teams; cross-coverage for patients admitted without a hospitalist; and performing procedures such as vascular access, lumbar puncture, paracentesis, and thoracentesis. The hospitalist role’s in the ICU likely increased in many hospitals confronting COVID surges, Ms. Flores said.

The median number of shifts performed per year by a full-time hospitalist physician was 182.0 (average, 182.3), with 12 hours as the most common average duration for a shift in a daytime schedule. The 7-days-on/7-days-off model remained the most popular way to schedule adult hospitalists, at the same rate as in 2018. Backup coverage is another important issue for hospitalist groups, with 52.6% reporting no formal backup system. For those with a backup system, the highest proportion paid no additional compensation to the physician for being on the on-call schedule, but additional compensation was paid if called into the hospital.

Presence of nocturnists was reported by 71.9% of responding groups, slightly down from 2018, but increasing with the size of the group. “We continue to see a trend for dedicated nocturnists,” said Dr. McNeal. Hospitals see the benefits from the presence of a nocturnist, reflected in pay differentials or requiring fewer full-time shifts from nocturnists. It’s more consistent, higher quality of care delivered by people who are dedicated to that role.

In other findings from the survey, turnover in adult hospitalist groups is 10.9%t, which is up from 2018 but down from 2016. Unit-based assignment, also known as geographical rounding, was utilized by 42.7% of responding adult groups, with likelihood increasing with the size of the group. Unfilled positions were reported by 73.5% of groups, with an average of 11.2% of positions unfilled at the time of the survey.

The use of telemedicine in the hospital setting is evolving, likely considerably accelerated of necessity by the pandemic. “Many of us are using telemedicine with COVID patients in order to decrease clinicians’ time in the room, and to find a way to use a work force that has to be on leave,” Dr. McNeal said.
 

Nurse practitioners and physician assistants

The role for nurse practitioners and physician assistants in adult hospital medicine groups continues to increase, with 83.3% of groups reporting the presence of PAs and NPs, up from 77% in 2018. NPs/PAs are more likely in multistate hospitalist groups or integrated delivery system practices in hospitals/health systems.

The most common billing model for their professional services is a combination of independent billing by the PA/NP where allowed and shared services billing under a supervisory physician’s provider number – although 8.1% of groups report that their NPs/PAs didn’t generally provide billable services or submit bills for payment.

NPs and PAs spend one-fifth of their time, on average, on nonbillable, value-added work, including dedicated cross-coverage shifts, scheduling, patient assignments, nonbillable clinical work such as glycemic control, and quality improvement and performance improvement activities. “This is one example of the changing skill mix for the hospitalist group, helping the practice become more efficient,” Ms. Flores said.

NPs and PAs provide valuable services, Dr. McNeal added. “But it also takes some investment in time and training for them to be able to practice at the top of their license. My own hospitalist group has a training program for newly hired NPs/PAs. Everyone goes through this orientation for around 6-10 weeks, largely in a shadowing role starting out, until they gradually adjust to more clinical autonomy.”

This onboarding includes real-time evaluations and self-evaluations, and opportunities for conversations with experienced clinicians, working from a list of 30 “bread-and-butter” topics in hospital medicine, she noted.
 

Pediatric hospital medicine

The 2020 SoHM report includes a greater representation for pediatric hospital medicine, with a 200% increase in the proportion of reporting hospitalist groups that only take care of children. Thus, the pediatric data are more robust – and helpful – than in prior year surveys, said Sandra Gage, MD, SFHM, a pediatric hospitalist at Phoenix Children’s Hospital. Dr. Gage headed up the PAC’s expanded pediatric data initiative, with targeted outreach to pediatric groups to encourage their participation. She also convened a task force to come up with pediatric-specific questions that were more pertinent and user friendly.

One of the important questions for pediatric hospitalists involves scheduling – including variations in length of shifts – which can vary dramatically in pediatric HM groups. “This year we reported by number of hours expected for a clinical FTE, which should be more useful for group leaders,” Dr. Gage said. The median number of hours required per FTE from pediatric hospitalists was fairly consistent at 1,800 per year, with minor variations based on region and academic status.

“I don’t know that there’s anything too surprising in most of the data,” she said, but noted that SHM will now have a better pediatric baseline going forward. The survey also asked how many pediatric hospitalists were board certified in the new subspecialty of pediatric hospital medicine under the program launched last year by the American Board of Pediatrics. Its first qualifying exam was in November 2019. The average was 26%, but the variation between academic and nonacademic programs was unexpected, Dr. Gage said.

Pediatric hospitalists come from a variety of professional specialties besides pediatrics. Nearly half of all programs had at least one med/peds provider, while a smaller number of programs had providers from family medicine, internal medicine, emergency medicine, or palliative care, she noted. Half of pediatric hospitalists reported joining their practice directly out of residency. About 26% of pediatric hospital medicine (PHM) physicians were described as part time, and 34.3% of pediatric groups had the presence of an NP or PA.

“I think PHM evolved a little later than for adult hospitalists, but it has clearly come into its own as a field,” Dr. Gage said. In the COVID-19 crisis, some pediatric hospitalists have been asked to care for adult patients, which necessitated a flurry of activity to refresh their medical knowledge. Where pediatric units existed within the walls of adult hospitals and were temporarily closed for COVID, it’s not clear how many will reopen – perhaps ever.
 

Long-term impacts of the crisis

Some of the hospitalist group leaders Ms. Flores has spoken with in recent months point out that, while New York and some other early COVID-19 hot spots experienced a tremendous surge of patients and hospital crowding in March and April 2020, other hospitals didn’t see anywhere near the impact.

“For some, there was nothing going on with COVID where they were,” she said. Elective surgeries were widely canceled, but with no corresponding increase of COVID admissions; and with fewer patients showing up in EDs, some physicians found themselves idled.

What will be the longer-term impact of COVID-19? How will it change hospital medicine? “I definitely think things are going to change,” Ms. Flores said, speculating that licensing boards could find a way to make it easier for physicians to practice across state lines in response to crises like the pandemic. “Do we need to think at the national level about what we can do to create more surge capacity, to move people when and where they need to go in a crisis? Are there things SHM could do to help?”

Ms. Flores expects more hospital closures than followed the 2008-2009 economic recession, which likely will further drive the trend toward mergers and acquisitions – both of hospitalist groups and of hospitals.

“From the point of view of hospitals, financial pressures will only get worse, pressing us to reinvent how hospitalists work and how that could be made more efficient,” she said. “I hear hospitals saying: ‘We can’t sustain current trends.’ Meanwhile, specialists are saying they need more help from hospitalists, and frontline hospitalists are saying they’re already working too hard. What will we do about burnout?”

These competing trends were all headed toward a perfect storm even before the epidemic hit, Ms. Flores said. “The response will require some innovations we haven’t yet conceived of. Incremental change won’t get us where we need to be. But the hospitalist’s role will be more essential than ever.”

The 2020 data show that a lot of things have been fairly steady for hospitalists, said Thomas Frederickson, MD, a member of SHM’s PAC and a specialist in hospital medicine at CHI Health in Omaha, Neb. But one concern about this stability is that, while hospitalist compensation continues to go up, workload and by extension productivity remain relatively flat. “That has been a trend over the past decade, and some of us find it hard to make sense of that.”

Dr. Frederickson, too, sees a need for disruptive innovation. “I just wish I knew what that will be.” Perhaps, just as hospitalists played a large role in the quality revolution in hospitals over the past decade, maybe in the next decade they will come to play a large role in the right-sizing of hospital care in health systems, he said.

One other important finding: the number of hospitalists per group who play roles as physician leaders has also increased, with an average of 3.2 physicians per group in a formal leadership role (median of 2). But currently, 73% of the highest-ranking leaders in hospitalist groups are male, and they are disproportionally white. As reported in Medscape in 2019, 40% of working hospitalists are women and only 36% of hospitalists overall self-identified as White.¹

“When you think of the demographics of actual working hospitalists, we could say the field of hospital medicine could and should do better in creating opportunities for diversity in leadership roles,” Ms. Flores said.
 

Reference

1. Martin KL. Hospitalist Compensation Report for 2019. Medscape. 2019 Jun 5. https://www.medscape.com/slideshow/2019-compensation-hospitalist-6011429#3.

Statin use was associated with an overall reduction of the risk of death in multiple myeloma (MM) patients, according to a report published in Clinical Lymphoma, Myeloma & Leukemia.

Statins maintained their benefit in patients with multiple myeloma treated with modern-day chemotherapy regimens based on novel agents, but the benefit is less pronounced, reported Amber Afzal, MD, Washington University, St Louis, and colleagues.

Dr. Afzal and colleagues assessed results from 5,922 patients who were diagnosed with multiple myeloma within the study period between 2007 and 2013. The association of statins with mortality in patients with MM was determined using multivariate Cox proportional hazards regression analysis, and a subanalysis was also performed to investigate the effect of statins on mortality in those patients treated with novel agents.
 

Mortality reduction seen

The study found that the use of statins was associated with a 21% reduction in risk of death (adjusted hazard ratio,] 0.79; 95% confidence interval, 0.74-0.84) among all patients with MM. Among the patents treated with novel agents (n = 3,603), statins reduced mortality by 10% (aHR, 0.90; 95% CI, 0.83-0.98).

“Our current study is the first one to support the survival benefit of statins in patients with myeloma treated with modern-day regimens based on novel agents, although it appears the benefit may not be as pronounced. Therefore, as myeloma regimens become more effective, the benefits of statins may diminish,” the researchers concluded.

The authors reported that they had no relevant disclosures.

[email protected]

SOURCE: Afzal A et al. Clin Lymphoma Myeloma Leuk. 2020 Jul 16. doi: 10.1016/j.clml.2020.07.003.

Statin use was associated with an overall reduction of the risk of death in multiple myeloma (MM) patients, according to a report published in Clinical Lymphoma, Myeloma & Leukemia.

Statins maintained their benefit in patients with multiple myeloma treated with modern-day chemotherapy regimens based on novel agents, but the benefit is less pronounced, reported Amber Afzal, MD, Washington University, St Louis, and colleagues.

Dr. Afzal and colleagues assessed results from 5,922 patients who were diagnosed with multiple myeloma within the study period between 2007 and 2013. The association of statins with mortality in patients with MM was determined using multivariate Cox proportional hazards regression analysis, and a subanalysis was also performed to investigate the effect of statins on mortality in those patients treated with novel agents.
 

Mortality reduction seen

The study found that the use of statins was associated with a 21% reduction in risk of death (adjusted hazard ratio,] 0.79; 95% confidence interval, 0.74-0.84) among all patients with MM. Among the patents treated with novel agents (n = 3,603), statins reduced mortality by 10% (aHR, 0.90; 95% CI, 0.83-0.98).

“Our current study is the first one to support the survival benefit of statins in patients with myeloma treated with modern-day regimens based on novel agents, although it appears the benefit may not be as pronounced. Therefore, as myeloma regimens become more effective, the benefits of statins may diminish,” the researchers concluded.

The authors reported that they had no relevant disclosures.

[email protected]

SOURCE: Afzal A et al. Clin Lymphoma Myeloma Leuk. 2020 Jul 16. doi: 10.1016/j.clml.2020.07.003.

Statin use was associated with an overall reduction of the risk of death in multiple myeloma (MM) patients, according to a report published in Clinical Lymphoma, Myeloma & Leukemia.

Statins maintained their benefit in patients with multiple myeloma treated with modern-day chemotherapy regimens based on novel agents, but the benefit is less pronounced, reported Amber Afzal, MD, Washington University, St Louis, and colleagues.

Dr. Afzal and colleagues assessed results from 5,922 patients who were diagnosed with multiple myeloma within the study period between 2007 and 2013. The association of statins with mortality in patients with MM was determined using multivariate Cox proportional hazards regression analysis, and a subanalysis was also performed to investigate the effect of statins on mortality in those patients treated with novel agents.
 

Mortality reduction seen

The study found that the use of statins was associated with a 21% reduction in risk of death (adjusted hazard ratio,] 0.79; 95% confidence interval, 0.74-0.84) among all patients with MM. Among the patents treated with novel agents (n = 3,603), statins reduced mortality by 10% (aHR, 0.90; 95% CI, 0.83-0.98).

“Our current study is the first one to support the survival benefit of statins in patients with myeloma treated with modern-day regimens based on novel agents, although it appears the benefit may not be as pronounced. Therefore, as myeloma regimens become more effective, the benefits of statins may diminish,” the researchers concluded.

The authors reported that they had no relevant disclosures.

[email protected]

SOURCE: Afzal A et al. Clin Lymphoma Myeloma Leuk. 2020 Jul 16. doi: 10.1016/j.clml.2020.07.003.

An elevated Health Assessment Questionnaire Disability Index (HAQ) score at 1 year significantly increased all-cause mortality in patients with early RA over the course of up to 10 years of follow-up, according to an analysis of patients enrolled in the Canadian Early Arthritis Cohort (CATCH).

Higher Disease Activity Score in 28 joints (DAS28) at follow-up was also associated with higher all-cause mortality among the patients, who all took at least one conventional synthetic or biologic disease-modifying antirheumatic drug during the first year. Higher DAS28 scores in previous studies has been associated with increased disability as measured by the HAQ, Safoora Fatima, MD, of the University of Western Ontario, London, and colleagues wrote in Arthritis & Rheumatology.

“Combining our study findings with this association suggests that poorer disease control (high DAS28) within the first treatment year for RA may lead to increased disability (high HAQ scores) which in turn may contribute to higher mortality. This may indicate that RA patients who do not have a deep response in the first year to treatment have higher subsequent mortality,” the researchers wrote.

In addition to higher HAQ scores, all-cause mortality was independently associated with age, male sex, lower education, smoking, more comorbidities, higher baseline disease activity, and glucocorticoid use. “This is helpful in a clinical setting as it can guide physician-patient discussions in terms of risk factors associated with prognosis, prescribing glucocorticoids, counseling on smoking cessation, monitoring treatment responses, and focusing on patient education,” the authors wrote.

While the impact of increased disease activity and damage likely plays a role in the association between high HAQ score and increased mortality, the authors noted that “comorbidities could be causing deaths and those with comorbidities in [early RA] have less chance of remission and more functional impairment at 1 year versus those without any comorbidities, as has been shown [before] in the CATCH [early RA] cohort.”

Dr. Fatima and associates studied 1,724 patients with RA who had a symptom duration of less than 1 year at the time of enrollment in CATCH during 2007-2017. These patients had a mean age of 55 years, and 72% were women. Over the 10-year follow up period, 62 patients (2.4%) died. HAQ scores proved to be significantly higher at both baseline and 1 year for those who died, going from 1.2 to 0.9, compared with scores moving from 1.0 to 0.5 among patients who did not die. (The HAQ has eight categories that are each scored 0-3, with 0 meaning no self-reported functional impairment and 3 meaning severe functional impairment.) Similarly, DAS28 scores were significantly higher at both time points for patients who died versus those who lived, declining from 5.4 to 3.6 for deceased and from 4.9 to 2.8 for nondeceased patients in a year.

Whereas HAQ at baseline was not significantly associated with all-cause mortality in a multivariate, discrete-time survival model that adjusted for age, gender, comorbidities, disease activity, smoking, education, seropositivity, symptom duration, and glucocorticoid use, the association between HAQ at 1 year and death remained statistically significant with a hazard ratio of 1.87.

The authors noted that potential confounders may not have been adjusted for in the comparisons, such as “variable access to advanced therapies, other comorbidities not in the standardized comorbidity questionnaire, [and] severity of comorbidities.”

CATCH has been funded over many years by multiple companies including Amgen and Pfizer Canada, AbbVie, Medexus, Eli Lilly Canada, Merck Canada, Sandoz, Hoffman–La Roche, Janssen, UCB Canada, Bristol-Myers Squibb Canada, and Sanofi Genzyme. The authors had no disclosures.

SOURCE: Fatima S et al. Arthritis Rheumatol. 2020 Sep 6. doi: 10.1002/art.41513.

An elevated Health Assessment Questionnaire Disability Index (HAQ) score at 1 year significantly increased all-cause mortality in patients with early RA over the course of up to 10 years of follow-up, according to an analysis of patients enrolled in the Canadian Early Arthritis Cohort (CATCH).

Higher Disease Activity Score in 28 joints (DAS28) at follow-up was also associated with higher all-cause mortality among the patients, who all took at least one conventional synthetic or biologic disease-modifying antirheumatic drug during the first year. Higher DAS28 scores in previous studies has been associated with increased disability as measured by the HAQ, Safoora Fatima, MD, of the University of Western Ontario, London, and colleagues wrote in Arthritis & Rheumatology.

“Combining our study findings with this association suggests that poorer disease control (high DAS28) within the first treatment year for RA may lead to increased disability (high HAQ scores) which in turn may contribute to higher mortality. This may indicate that RA patients who do not have a deep response in the first year to treatment have higher subsequent mortality,” the researchers wrote.

In addition to higher HAQ scores, all-cause mortality was independently associated with age, male sex, lower education, smoking, more comorbidities, higher baseline disease activity, and glucocorticoid use. “This is helpful in a clinical setting as it can guide physician-patient discussions in terms of risk factors associated with prognosis, prescribing glucocorticoids, counseling on smoking cessation, monitoring treatment responses, and focusing on patient education,” the authors wrote.

While the impact of increased disease activity and damage likely plays a role in the association between high HAQ score and increased mortality, the authors noted that “comorbidities could be causing deaths and those with comorbidities in [early RA] have less chance of remission and more functional impairment at 1 year versus those without any comorbidities, as has been shown [before] in the CATCH [early RA] cohort.”

Dr. Fatima and associates studied 1,724 patients with RA who had a symptom duration of less than 1 year at the time of enrollment in CATCH during 2007-2017. These patients had a mean age of 55 years, and 72% were women. Over the 10-year follow up period, 62 patients (2.4%) died. HAQ scores proved to be significantly higher at both baseline and 1 year for those who died, going from 1.2 to 0.9, compared with scores moving from 1.0 to 0.5 among patients who did not die. (The HAQ has eight categories that are each scored 0-3, with 0 meaning no self-reported functional impairment and 3 meaning severe functional impairment.) Similarly, DAS28 scores were significantly higher at both time points for patients who died versus those who lived, declining from 5.4 to 3.6 for deceased and from 4.9 to 2.8 for nondeceased patients in a year.

Whereas HAQ at baseline was not significantly associated with all-cause mortality in a multivariate, discrete-time survival model that adjusted for age, gender, comorbidities, disease activity, smoking, education, seropositivity, symptom duration, and glucocorticoid use, the association between HAQ at 1 year and death remained statistically significant with a hazard ratio of 1.87.

The authors noted that potential confounders may not have been adjusted for in the comparisons, such as “variable access to advanced therapies, other comorbidities not in the standardized comorbidity questionnaire, [and] severity of comorbidities.”

CATCH has been funded over many years by multiple companies including Amgen and Pfizer Canada, AbbVie, Medexus, Eli Lilly Canada, Merck Canada, Sandoz, Hoffman–La Roche, Janssen, UCB Canada, Bristol-Myers Squibb Canada, and Sanofi Genzyme. The authors had no disclosures.

SOURCE: Fatima S et al. Arthritis Rheumatol. 2020 Sep 6. doi: 10.1002/art.41513.

An elevated Health Assessment Questionnaire Disability Index (HAQ) score at 1 year significantly increased all-cause mortality in patients with early RA over the course of up to 10 years of follow-up, according to an analysis of patients enrolled in the Canadian Early Arthritis Cohort (CATCH).

Higher Disease Activity Score in 28 joints (DAS28) at follow-up was also associated with higher all-cause mortality among the patients, who all took at least one conventional synthetic or biologic disease-modifying antirheumatic drug during the first year. Higher DAS28 scores in previous studies has been associated with increased disability as measured by the HAQ, Safoora Fatima, MD, of the University of Western Ontario, London, and colleagues wrote in Arthritis & Rheumatology.

“Combining our study findings with this association suggests that poorer disease control (high DAS28) within the first treatment year for RA may lead to increased disability (high HAQ scores) which in turn may contribute to higher mortality. This may indicate that RA patients who do not have a deep response in the first year to treatment have higher subsequent mortality,” the researchers wrote.

In addition to higher HAQ scores, all-cause mortality was independently associated with age, male sex, lower education, smoking, more comorbidities, higher baseline disease activity, and glucocorticoid use. “This is helpful in a clinical setting as it can guide physician-patient discussions in terms of risk factors associated with prognosis, prescribing glucocorticoids, counseling on smoking cessation, monitoring treatment responses, and focusing on patient education,” the authors wrote.

While the impact of increased disease activity and damage likely plays a role in the association between high HAQ score and increased mortality, the authors noted that “comorbidities could be causing deaths and those with comorbidities in [early RA] have less chance of remission and more functional impairment at 1 year versus those without any comorbidities, as has been shown [before] in the CATCH [early RA] cohort.”

Dr. Fatima and associates studied 1,724 patients with RA who had a symptom duration of less than 1 year at the time of enrollment in CATCH during 2007-2017. These patients had a mean age of 55 years, and 72% were women. Over the 10-year follow up period, 62 patients (2.4%) died. HAQ scores proved to be significantly higher at both baseline and 1 year for those who died, going from 1.2 to 0.9, compared with scores moving from 1.0 to 0.5 among patients who did not die. (The HAQ has eight categories that are each scored 0-3, with 0 meaning no self-reported functional impairment and 3 meaning severe functional impairment.) Similarly, DAS28 scores were significantly higher at both time points for patients who died versus those who lived, declining from 5.4 to 3.6 for deceased and from 4.9 to 2.8 for nondeceased patients in a year.

Whereas HAQ at baseline was not significantly associated with all-cause mortality in a multivariate, discrete-time survival model that adjusted for age, gender, comorbidities, disease activity, smoking, education, seropositivity, symptom duration, and glucocorticoid use, the association between HAQ at 1 year and death remained statistically significant with a hazard ratio of 1.87.

The authors noted that potential confounders may not have been adjusted for in the comparisons, such as “variable access to advanced therapies, other comorbidities not in the standardized comorbidity questionnaire, [and] severity of comorbidities.”

CATCH has been funded over many years by multiple companies including Amgen and Pfizer Canada, AbbVie, Medexus, Eli Lilly Canada, Merck Canada, Sandoz, Hoffman–La Roche, Janssen, UCB Canada, Bristol-Myers Squibb Canada, and Sanofi Genzyme. The authors had no disclosures.

SOURCE: Fatima S et al. Arthritis Rheumatol. 2020 Sep 6. doi: 10.1002/art.41513.