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.

Niket Sonpal, MD, thought he’d heard most of the myths about wearing masks during the pandemic, but the recent claim from a patient was a new one for the New York City gastroenterologist.

iStock/Getty Images Plus/skynesher

The patient refused to wear a mask because she heard inhaling bad breath through a mask could be toxic. The woman said the rumor was circulating on Facebook. Sonpal calmly explained that breathing your own breath is not going to cause health problems, he said.

“There’s a lot of controversy on masks,” he said. “Unfortunately, it’s really just a lack of education and buy-in. Social media is the primary source of all this misinformation. These kinds of over-the-top hyperbole has basically led to a disbelief that masks are effective. The disbelief is hard to break up.”

As mask requirements have tightened amid the ongoing pandemic, debates about face coverings have emerged front and center, with a growing number of people opposing mask usage. So-called antimaskers dispute the benefits of wearing masks and many contend that face coverings decrease oxygen flow and can lead to illness. Sentiment against masks have led to protests nationwide, ignited public conflicts in some areas, and even generated lawsuits over mask mandates.

The issue presents an ongoing challenge for physicians as they strive to educate patients about the significance of masking against the flood of antimask messages on social media and beyond. Opposition to masks is particularly frustrating for health professionals who have witnessed patients, family, or friends become ill or die from the virus. Refusing to mask and failing to social distance have been linked to the rapid spread of the coronavirus and subsequent deaths.

“I have had colleagues pass away, and it’s extremely disheartening and frustrating to see science so easily disregarded,” Sonpal said. “Masks save lives and protect people and not wearing them is simply a lack of respect, not just for your fellow colleagues, but for a member of your species.”

Michael Rebresh, who helped create the antimask group Million Unmasked Patriots, says his group’s objections to masks are rational and reasonable. The group, which has more than 8,000 members, formed in response to guidance by Illinois state officials that children would only be allowed to return to school wearing a mask.

“Our objections are to the fact that masks on children in school have a greater propensity to make children sick from breathing in bacteria that forms on the inner layer of a mask worn for hours on end,” Rebresh said. “We have an objection to the increase of CO₂ intake and a decrease in oxygen flow for kids who need all the oxygen they can get during a learning environment. We recognized the masking of ourselves and kids for what it is: A political move to separate the two parties in our November election and define and create division between the two.”

Million Unmasked Patriots is one of dozens of antimask groups on social media platforms such as Facebook, Instagram, and TikTok. In July, Facebook suspended one such group, Unmasking America, which boasts 9,600 members, for posting repeated claims that face masks obstruct oxygen flow and have negative mental health effects.

Experts say the antiscience rhetoric is far from new. The antimask movement in many ways, shares similarities with that of the anti-vaccine movement, says Todd Wolynn, MD, a Pittsburgh pediatrician and cofounder of Shots Heard Round the World, an organization that defends vaccine advocates against coordinated online attacks by antivaxxers. Those espousing antimask views often relay similar or the same disinformation pushed by those with antivaccine views, Wolynn said.

“A lot of it is conspiracy-laden,” said Wolynn of the disinformation. “That Dr. [Anthony] Fauci somehow helped construct the pandemic and that it’s not real. That Bill Gates is funding the vaccine so he can inject people with microchips. All sorts of really out-there, ungrounded conspiracy theories. If you had Venn diagram of antimask and antivaxx, I would say there’s clearly overlap.”
 

Parallels between antimaskers, antivaxxers

Opponents to masks fall on a spectrum, explains Vineet Arora, MD, a hospitalist and associate chief medical officer–clinical learning environment at University of Chicago Medicine. People who believe conspiracy theories and push misinformation are on one end, she said. There are also those who generally don’t believe the seriousness of the pandemic, feel their risk is minimal, or doubt the benefits of masks.

The two trains of thought resemble the distinction among parents who are antivaccine and those who are simply “vaccine hesitant,” says Arora, who co-authored a recent article about masking and misinformation that addresses antivaccine attitudes.

“While the antimask sentiment gets a lot of attention, I think it’s important to highlight there’s a lot of vocal anti-mask sentiment since most people are supportive of masks,” she said. “There might be people sitting on the fence who are just unsure about wearing a mask. That’s understandable because the science and the communication has evolved. There was a lot of early mixed messages about masking. Anytime you have confusion about the science or the science is evolving, it’s easy to have misinformation and then have that take off as myth.”

Just as antivaxxers work to swing the opinion of the vaccine hesitant, antimaskers are vying with public health advocates for the support of the mask hesitant, she said. Creating doubt in public health authorities is one way they are gaining followers. Anti-maskers often question and scrutinize past messaging about masks by public health officials, claiming that because guidance on masks has changed over time, the science behind masks and current guidance can’t be trusted, Wolynn said. Similarly, antivaxxers frequently question past actions by public health officials, such as the Tuskegee Experiment (which began in 1932), to try to poke holes in the credibility of public health officials and their advice.

Both the antimask and antivaccine movements also tend to base their resistance on a personal liberties argument, adds Jacqueline Winfield Fincher, MD, president for the American College of Physicians and an internist based in Thomson, Georgia. Antimaskers contend they should be free to decide whether to wear face coverings and that rules requiring masks infringe upon their civil liberties. Similarly, antivaxxers argue they should be free to decide whether to vaccinate their children and contend vaccine mandates violate their personal liberties.

Taking a deeper look, fear and control are two likely drivers of antimasking and antivaccine attitudes, Fincher said. Those refusing to wear masks may feel they have no control over the pandemic or its impacts, but they can control how they respond to mask-wearing requirements, she said.

Antivaccine parents often want more control over their children’s healthcare and falsely believe that vaccines are injecting something harmful into their children or may lead to harmful reactions.

“It’s a control issue and a defense mechanism,” she said. “Some people may feel helpless to deal with the pandemic or believe since it is not affecting them or their family, that it is not real. ‘If I just deny it and I don’t acknowledge facts, I don’t have to worry about it or do anything about it, and therefore I will have more control over my day-to-day life.’”
 

Groups fueling each other

In some cases, antimask and antivaxx groups are joining forces or adopting dual causes.

In California for instance, longtime opponents to vaccines are now objecting to mask policies as similar infringement to their bodily autonomy. Demonstrations in Texas, Idaho, and Michigan against mask mandates and other COVID-19 requirements have drawn support from anti-vaccine activists and incorporated antivaccine propaganda.

In Illinois, Million Unmasked Patriots, formally the Million Unmasked March, has received widespread attention for protesting both masks for returning schoolchildren and a future COVID-19 vaccine requirement.

A July protest planned by the antimask group triggered a letter by Arora and 500 other healthcare professionals to Illinois lawmakers decrying the group’s views and urging the state to move forward with universal masking in schools.

“What’s happening is those who are distrustful of government and public health and science are joining together,” said Arora, who coauthored a piece about the problem on KevinMD.com. “It’s important to address both movements together because they can quickly feed off each other and build in momentum. At the heart of both is really this deep skepticism of science.”

Rebresh of Million Unmasked Patriots said most of his members are not opposed to all vaccines, but rather they are opposed to “untested vaccines.” The primary concern is the inability to research long-term effects of a COVID-19 vaccine before its approval, he said.

Rebresh disagrees with the antimask movement being compared with the antivaccine movement. The two groups are “motivated by different things and a different set of circumstances drive their opinions,” he said. However, Rebresh believes that potential harm resulting from “mass vaccinations” is a valid concern. For this reason, he and his wife chose for their children to receive their vaccinations individually over a series of weeks, rather than the “kiddie cocktail of vaccines,” at a single visit, he said.

Vaccine scientist Peter Hotez, MD, PhD, said the antivaccine movement appears to have grown stronger from the pandemic fueled by fresh conspiracies and new alliances. Antivaccine sentiment has been gaining steam over the last several years and collecting more allies from the far-right, said Hotez, dean for the National School of Tropical Medicine and codirector for the Texas Children’s Hospital Center for Vaccine Development.

“Now what you’re seeing is yet another expansion this year, with antivaccine groups, under the banner of ‘health freedom,’ campaigning against social distancing and wearing masks and contact tracing,” he said. “What was an antivaccine movement has now become a full-blown antiscience movement and an anti-public health movement. It’s causing a lot of damage and I believe costing a lot of American lives.”

Neil F. Johnson, PhD, who has studied the antivaccine movement and its social media proliferation during the pandemic, said online comments by antivaxxers frequently condemn mask usage and showcase memes making fun of masks.

“In those same narratives about opposing vaccines for COVID, we see a lot of discussion against masks,” said Johnson, a physics professor at George Washington University in Washington, D.C. “If you don’t believe in the official picture of COVID, you don’t believe the policies or the advice that’s given about COVID.”

An analysis by Johnson that examined 1,300 Facebook pages found that, while antivaxxers have fewer followers than provaccine pages, antivaccine pages are more numerous, faster growing, and are more often connected to unrelated, undecided pages. Conversely, pages that advocate the benefits of vaccinations and explain the science behind immunizations are largely disconnected from such undecided communities, according to the study, published May 13 in Nature.

The study suggests the antivaccine movement is making influential strides during the pandemic and connecting with people who are undecided, while public health advocates are not building the same bridges, Johnson said.

“I think it’s hugely dangerous, because I don’t know any other moment in science or in public health when there was so much uncertainty in something affecting everybody,” he said. “Every policy that will be coming, everything depends on people buying into the official message. Once you have the seeds of doubt, that’s a very difficult thing to overcome. It’s an unprecedented challenge.”
 

How physicians and clinicians can help

A more aggressive approach is necessary when it comes to taking down antiscience content on social media, says Hotez. Too often, misinformation and antiscience rhetoric is allowed to linger on popular sites such as Facebook and Amazon.

Wolynn agrees. On personal or business platforms, it’s crucial to ban, hide, and delete such comments as quickly as possible, he said. On public sites, purposeful disinformation should be immediately reported to the platform.

At the same time, Wolynn said it’s essential to support those who make sound, science-based comments in social media forums.

“If you see someone who is pushing accurate, evidence-based information, and they come under attack, they should be supported and defended and empowered,” Wolynn said. “Shots Heard Round the World is doing all of those things, including galvanizing and recruiting more people to help get their voices out there.”

Expanded visibility by physicians and scientists would greatly help counter the spread of antiscience sentiment, adds Hotez.

“Too often, antiscience movements are able to flourish because scientists and physicians are invisible,” he said. “They’re too focused on either clinical practices or in the case of physician scientists, on grants and papers and not enough attention to public engagement. We’re going to have to change that around. We need to hear more from scientists directly.”

To that end, Wolynn said health care professionals, including medical students and residents, need to have formal training in communications, media, and social media as part of their education – and more support from employers to engage through social media.

“That’s where the fight is,” Wolynn said. “You can be the best diagnostician, the best clinician. You can make the right diagnosis and prescribe the right medication, but if families don’t hear what you’re saying, you’re not going to be effective. If you can’t be on the platform where they’re being influenced, we’re losing the battle.”
 

Speaking to your mask-hesitant patients

Concentrating on those who are uncertain about masks is particularly key for physicians and public health advocates as the pandemic continues, says Arora.

“It’s important for us to focus on the mask-hesitant who often don’t get the attention they need,” she said.

She suggests bringing up the subject of masks with patients during visits, asking about mask usage, discussing rumors they’ve heard, and emphasizing why masks are important. Be a role model by wearing a mask in your community and on social media, she added.

Some patients have real concerns about not being able to breathe through masks or anxiety disorders that can be aggravated even by the thought of wearing a mask, noted Susan R. Bailey, MD, president for the American Medical Association. Bailey, an immunologist, recently counseled a patient with a deviated nasal septum in addition to a panic disorder who was worried about wearing a mask, she said. Bailey listened to the patient’s concerns, discussed his health conditions, and proposed an alternative face covering that might make him more comfortable.

“Every patient is different,” Bailey said. “It’s important for us to remember that each person who is reluctant to wear a mask has their own reasons. It’s important for us to express some empathy – to agree with them, yes, masks are hot and inconvenient – and help understand their questions, which you may be able to answer to their satisfaction. There are patients that have legitimate questions and a physician caring about how they feel, can make all the difference.”

Physicians can also get involved with the AMA’s #MaskUp campaign, an effort to normalize mask wearing and debunk myths associated with masks. The campaign includes social media materials, slogans doctors can tweet, and profile pictures they can use on social media. The campaign’s toolkit includes images, videos, and information that physicians can share with patients and the public.

Enforcing strong mask policies at your practice and ensuring all staff are modeling appropriate mask behavior is also important, adds Fincher of the ACP. The college recently issued a policy supporting mask usage in community settings.

If a patient conveys an antimask belief, Fincher suggests not directly challenging the person’s views, but listening to them and offering objective data, discussing the science behind masks, and directing them to credible sources.

“Doctors are used to this. We recommend a lot of things to patients that they don’t want to do,” Fincher said. “If a patient feels attacked, they act defensively. But if you base your explanation in more objective terms with data, numbers, and personalize the risks and benefits of a vaccine, a healthy change in behavior, or a medication, then patients are more likely to hear your concerns and do the right thing. Having a long-term relationship with a trusted physician makes all of these issues much easier to discuss and to implement the best plan for the individual patient.”

This article first appeared on Medscape.com.

Niket Sonpal, MD, thought he’d heard most of the myths about wearing masks during the pandemic, but the recent claim from a patient was a new one for the New York City gastroenterologist.

iStock/Getty Images Plus/skynesher

The patient refused to wear a mask because she heard inhaling bad breath through a mask could be toxic. The woman said the rumor was circulating on Facebook. Sonpal calmly explained that breathing your own breath is not going to cause health problems, he said.

“There’s a lot of controversy on masks,” he said. “Unfortunately, it’s really just a lack of education and buy-in. Social media is the primary source of all this misinformation. These kinds of over-the-top hyperbole has basically led to a disbelief that masks are effective. The disbelief is hard to break up.”

As mask requirements have tightened amid the ongoing pandemic, debates about face coverings have emerged front and center, with a growing number of people opposing mask usage. So-called antimaskers dispute the benefits of wearing masks and many contend that face coverings decrease oxygen flow and can lead to illness. Sentiment against masks have led to protests nationwide, ignited public conflicts in some areas, and even generated lawsuits over mask mandates.

The issue presents an ongoing challenge for physicians as they strive to educate patients about the significance of masking against the flood of antimask messages on social media and beyond. Opposition to masks is particularly frustrating for health professionals who have witnessed patients, family, or friends become ill or die from the virus. Refusing to mask and failing to social distance have been linked to the rapid spread of the coronavirus and subsequent deaths.

“I have had colleagues pass away, and it’s extremely disheartening and frustrating to see science so easily disregarded,” Sonpal said. “Masks save lives and protect people and not wearing them is simply a lack of respect, not just for your fellow colleagues, but for a member of your species.”

Michael Rebresh, who helped create the antimask group Million Unmasked Patriots, says his group’s objections to masks are rational and reasonable. The group, which has more than 8,000 members, formed in response to guidance by Illinois state officials that children would only be allowed to return to school wearing a mask.

“Our objections are to the fact that masks on children in school have a greater propensity to make children sick from breathing in bacteria that forms on the inner layer of a mask worn for hours on end,” Rebresh said. “We have an objection to the increase of CO₂ intake and a decrease in oxygen flow for kids who need all the oxygen they can get during a learning environment. We recognized the masking of ourselves and kids for what it is: A political move to separate the two parties in our November election and define and create division between the two.”

Million Unmasked Patriots is one of dozens of antimask groups on social media platforms such as Facebook, Instagram, and TikTok. In July, Facebook suspended one such group, Unmasking America, which boasts 9,600 members, for posting repeated claims that face masks obstruct oxygen flow and have negative mental health effects.

Experts say the antiscience rhetoric is far from new. The antimask movement in many ways, shares similarities with that of the anti-vaccine movement, says Todd Wolynn, MD, a Pittsburgh pediatrician and cofounder of Shots Heard Round the World, an organization that defends vaccine advocates against coordinated online attacks by antivaxxers. Those espousing antimask views often relay similar or the same disinformation pushed by those with antivaccine views, Wolynn said.

“A lot of it is conspiracy-laden,” said Wolynn of the disinformation. “That Dr. [Anthony] Fauci somehow helped construct the pandemic and that it’s not real. That Bill Gates is funding the vaccine so he can inject people with microchips. All sorts of really out-there, ungrounded conspiracy theories. If you had Venn diagram of antimask and antivaxx, I would say there’s clearly overlap.”
 

Parallels between antimaskers, antivaxxers

Opponents to masks fall on a spectrum, explains Vineet Arora, MD, a hospitalist and associate chief medical officer–clinical learning environment at University of Chicago Medicine. People who believe conspiracy theories and push misinformation are on one end, she said. There are also those who generally don’t believe the seriousness of the pandemic, feel their risk is minimal, or doubt the benefits of masks.

The two trains of thought resemble the distinction among parents who are antivaccine and those who are simply “vaccine hesitant,” says Arora, who co-authored a recent article about masking and misinformation that addresses antivaccine attitudes.

“While the antimask sentiment gets a lot of attention, I think it’s important to highlight there’s a lot of vocal anti-mask sentiment since most people are supportive of masks,” she said. “There might be people sitting on the fence who are just unsure about wearing a mask. That’s understandable because the science and the communication has evolved. There was a lot of early mixed messages about masking. Anytime you have confusion about the science or the science is evolving, it’s easy to have misinformation and then have that take off as myth.”

Just as antivaxxers work to swing the opinion of the vaccine hesitant, antimaskers are vying with public health advocates for the support of the mask hesitant, she said. Creating doubt in public health authorities is one way they are gaining followers. Anti-maskers often question and scrutinize past messaging about masks by public health officials, claiming that because guidance on masks has changed over time, the science behind masks and current guidance can’t be trusted, Wolynn said. Similarly, antivaxxers frequently question past actions by public health officials, such as the Tuskegee Experiment (which began in 1932), to try to poke holes in the credibility of public health officials and their advice.

Both the antimask and antivaccine movements also tend to base their resistance on a personal liberties argument, adds Jacqueline Winfield Fincher, MD, president for the American College of Physicians and an internist based in Thomson, Georgia. Antimaskers contend they should be free to decide whether to wear face coverings and that rules requiring masks infringe upon their civil liberties. Similarly, antivaxxers argue they should be free to decide whether to vaccinate their children and contend vaccine mandates violate their personal liberties.

Taking a deeper look, fear and control are two likely drivers of antimasking and antivaccine attitudes, Fincher said. Those refusing to wear masks may feel they have no control over the pandemic or its impacts, but they can control how they respond to mask-wearing requirements, she said.

Antivaccine parents often want more control over their children’s healthcare and falsely believe that vaccines are injecting something harmful into their children or may lead to harmful reactions.

“It’s a control issue and a defense mechanism,” she said. “Some people may feel helpless to deal with the pandemic or believe since it is not affecting them or their family, that it is not real. ‘If I just deny it and I don’t acknowledge facts, I don’t have to worry about it or do anything about it, and therefore I will have more control over my day-to-day life.’”
 

Groups fueling each other

In some cases, antimask and antivaxx groups are joining forces or adopting dual causes.

In California for instance, longtime opponents to vaccines are now objecting to mask policies as similar infringement to their bodily autonomy. Demonstrations in Texas, Idaho, and Michigan against mask mandates and other COVID-19 requirements have drawn support from anti-vaccine activists and incorporated antivaccine propaganda.

In Illinois, Million Unmasked Patriots, formally the Million Unmasked March, has received widespread attention for protesting both masks for returning schoolchildren and a future COVID-19 vaccine requirement.

A July protest planned by the antimask group triggered a letter by Arora and 500 other healthcare professionals to Illinois lawmakers decrying the group’s views and urging the state to move forward with universal masking in schools.

“What’s happening is those who are distrustful of government and public health and science are joining together,” said Arora, who coauthored a piece about the problem on KevinMD.com. “It’s important to address both movements together because they can quickly feed off each other and build in momentum. At the heart of both is really this deep skepticism of science.”

Rebresh of Million Unmasked Patriots said most of his members are not opposed to all vaccines, but rather they are opposed to “untested vaccines.” The primary concern is the inability to research long-term effects of a COVID-19 vaccine before its approval, he said.

Rebresh disagrees with the antimask movement being compared with the antivaccine movement. The two groups are “motivated by different things and a different set of circumstances drive their opinions,” he said. However, Rebresh believes that potential harm resulting from “mass vaccinations” is a valid concern. For this reason, he and his wife chose for their children to receive their vaccinations individually over a series of weeks, rather than the “kiddie cocktail of vaccines,” at a single visit, he said.

Vaccine scientist Peter Hotez, MD, PhD, said the antivaccine movement appears to have grown stronger from the pandemic fueled by fresh conspiracies and new alliances. Antivaccine sentiment has been gaining steam over the last several years and collecting more allies from the far-right, said Hotez, dean for the National School of Tropical Medicine and codirector for the Texas Children’s Hospital Center for Vaccine Development.

“Now what you’re seeing is yet another expansion this year, with antivaccine groups, under the banner of ‘health freedom,’ campaigning against social distancing and wearing masks and contact tracing,” he said. “What was an antivaccine movement has now become a full-blown antiscience movement and an anti-public health movement. It’s causing a lot of damage and I believe costing a lot of American lives.”

Neil F. Johnson, PhD, who has studied the antivaccine movement and its social media proliferation during the pandemic, said online comments by antivaxxers frequently condemn mask usage and showcase memes making fun of masks.

“In those same narratives about opposing vaccines for COVID, we see a lot of discussion against masks,” said Johnson, a physics professor at George Washington University in Washington, D.C. “If you don’t believe in the official picture of COVID, you don’t believe the policies or the advice that’s given about COVID.”

An analysis by Johnson that examined 1,300 Facebook pages found that, while antivaxxers have fewer followers than provaccine pages, antivaccine pages are more numerous, faster growing, and are more often connected to unrelated, undecided pages. Conversely, pages that advocate the benefits of vaccinations and explain the science behind immunizations are largely disconnected from such undecided communities, according to the study, published May 13 in Nature.

The study suggests the antivaccine movement is making influential strides during the pandemic and connecting with people who are undecided, while public health advocates are not building the same bridges, Johnson said.

“I think it’s hugely dangerous, because I don’t know any other moment in science or in public health when there was so much uncertainty in something affecting everybody,” he said. “Every policy that will be coming, everything depends on people buying into the official message. Once you have the seeds of doubt, that’s a very difficult thing to overcome. It’s an unprecedented challenge.”
 

How physicians and clinicians can help

A more aggressive approach is necessary when it comes to taking down antiscience content on social media, says Hotez. Too often, misinformation and antiscience rhetoric is allowed to linger on popular sites such as Facebook and Amazon.

Wolynn agrees. On personal or business platforms, it’s crucial to ban, hide, and delete such comments as quickly as possible, he said. On public sites, purposeful disinformation should be immediately reported to the platform.

At the same time, Wolynn said it’s essential to support those who make sound, science-based comments in social media forums.

“If you see someone who is pushing accurate, evidence-based information, and they come under attack, they should be supported and defended and empowered,” Wolynn said. “Shots Heard Round the World is doing all of those things, including galvanizing and recruiting more people to help get their voices out there.”

Expanded visibility by physicians and scientists would greatly help counter the spread of antiscience sentiment, adds Hotez.

“Too often, antiscience movements are able to flourish because scientists and physicians are invisible,” he said. “They’re too focused on either clinical practices or in the case of physician scientists, on grants and papers and not enough attention to public engagement. We’re going to have to change that around. We need to hear more from scientists directly.”

To that end, Wolynn said health care professionals, including medical students and residents, need to have formal training in communications, media, and social media as part of their education – and more support from employers to engage through social media.

“That’s where the fight is,” Wolynn said. “You can be the best diagnostician, the best clinician. You can make the right diagnosis and prescribe the right medication, but if families don’t hear what you’re saying, you’re not going to be effective. If you can’t be on the platform where they’re being influenced, we’re losing the battle.”
 

Speaking to your mask-hesitant patients

Concentrating on those who are uncertain about masks is particularly key for physicians and public health advocates as the pandemic continues, says Arora.

“It’s important for us to focus on the mask-hesitant who often don’t get the attention they need,” she said.

She suggests bringing up the subject of masks with patients during visits, asking about mask usage, discussing rumors they’ve heard, and emphasizing why masks are important. Be a role model by wearing a mask in your community and on social media, she added.

Some patients have real concerns about not being able to breathe through masks or anxiety disorders that can be aggravated even by the thought of wearing a mask, noted Susan R. Bailey, MD, president for the American Medical Association. Bailey, an immunologist, recently counseled a patient with a deviated nasal septum in addition to a panic disorder who was worried about wearing a mask, she said. Bailey listened to the patient’s concerns, discussed his health conditions, and proposed an alternative face covering that might make him more comfortable.

“Every patient is different,” Bailey said. “It’s important for us to remember that each person who is reluctant to wear a mask has their own reasons. It’s important for us to express some empathy – to agree with them, yes, masks are hot and inconvenient – and help understand their questions, which you may be able to answer to their satisfaction. There are patients that have legitimate questions and a physician caring about how they feel, can make all the difference.”

Physicians can also get involved with the AMA’s #MaskUp campaign, an effort to normalize mask wearing and debunk myths associated with masks. The campaign includes social media materials, slogans doctors can tweet, and profile pictures they can use on social media. The campaign’s toolkit includes images, videos, and information that physicians can share with patients and the public.

Enforcing strong mask policies at your practice and ensuring all staff are modeling appropriate mask behavior is also important, adds Fincher of the ACP. The college recently issued a policy supporting mask usage in community settings.

If a patient conveys an antimask belief, Fincher suggests not directly challenging the person’s views, but listening to them and offering objective data, discussing the science behind masks, and directing them to credible sources.

“Doctors are used to this. We recommend a lot of things to patients that they don’t want to do,” Fincher said. “If a patient feels attacked, they act defensively. But if you base your explanation in more objective terms with data, numbers, and personalize the risks and benefits of a vaccine, a healthy change in behavior, or a medication, then patients are more likely to hear your concerns and do the right thing. Having a long-term relationship with a trusted physician makes all of these issues much easier to discuss and to implement the best plan for the individual patient.”

This article first appeared on Medscape.com.

Niket Sonpal, MD, thought he’d heard most of the myths about wearing masks during the pandemic, but the recent claim from a patient was a new one for the New York City gastroenterologist.

iStock/Getty Images Plus/skynesher

The patient refused to wear a mask because she heard inhaling bad breath through a mask could be toxic. The woman said the rumor was circulating on Facebook. Sonpal calmly explained that breathing your own breath is not going to cause health problems, he said.

“There’s a lot of controversy on masks,” he said. “Unfortunately, it’s really just a lack of education and buy-in. Social media is the primary source of all this misinformation. These kinds of over-the-top hyperbole has basically led to a disbelief that masks are effective. The disbelief is hard to break up.”

As mask requirements have tightened amid the ongoing pandemic, debates about face coverings have emerged front and center, with a growing number of people opposing mask usage. So-called antimaskers dispute the benefits of wearing masks and many contend that face coverings decrease oxygen flow and can lead to illness. Sentiment against masks have led to protests nationwide, ignited public conflicts in some areas, and even generated lawsuits over mask mandates.

The issue presents an ongoing challenge for physicians as they strive to educate patients about the significance of masking against the flood of antimask messages on social media and beyond. Opposition to masks is particularly frustrating for health professionals who have witnessed patients, family, or friends become ill or die from the virus. Refusing to mask and failing to social distance have been linked to the rapid spread of the coronavirus and subsequent deaths.

“I have had colleagues pass away, and it’s extremely disheartening and frustrating to see science so easily disregarded,” Sonpal said. “Masks save lives and protect people and not wearing them is simply a lack of respect, not just for your fellow colleagues, but for a member of your species.”

Michael Rebresh, who helped create the antimask group Million Unmasked Patriots, says his group’s objections to masks are rational and reasonable. The group, which has more than 8,000 members, formed in response to guidance by Illinois state officials that children would only be allowed to return to school wearing a mask.

“Our objections are to the fact that masks on children in school have a greater propensity to make children sick from breathing in bacteria that forms on the inner layer of a mask worn for hours on end,” Rebresh said. “We have an objection to the increase of CO₂ intake and a decrease in oxygen flow for kids who need all the oxygen they can get during a learning environment. We recognized the masking of ourselves and kids for what it is: A political move to separate the two parties in our November election and define and create division between the two.”

Million Unmasked Patriots is one of dozens of antimask groups on social media platforms such as Facebook, Instagram, and TikTok. In July, Facebook suspended one such group, Unmasking America, which boasts 9,600 members, for posting repeated claims that face masks obstruct oxygen flow and have negative mental health effects.

Experts say the antiscience rhetoric is far from new. The antimask movement in many ways, shares similarities with that of the anti-vaccine movement, says Todd Wolynn, MD, a Pittsburgh pediatrician and cofounder of Shots Heard Round the World, an organization that defends vaccine advocates against coordinated online attacks by antivaxxers. Those espousing antimask views often relay similar or the same disinformation pushed by those with antivaccine views, Wolynn said.

“A lot of it is conspiracy-laden,” said Wolynn of the disinformation. “That Dr. [Anthony] Fauci somehow helped construct the pandemic and that it’s not real. That Bill Gates is funding the vaccine so he can inject people with microchips. All sorts of really out-there, ungrounded conspiracy theories. If you had Venn diagram of antimask and antivaxx, I would say there’s clearly overlap.”
 

Parallels between antimaskers, antivaxxers

Opponents to masks fall on a spectrum, explains Vineet Arora, MD, a hospitalist and associate chief medical officer–clinical learning environment at University of Chicago Medicine. People who believe conspiracy theories and push misinformation are on one end, she said. There are also those who generally don’t believe the seriousness of the pandemic, feel their risk is minimal, or doubt the benefits of masks.

The two trains of thought resemble the distinction among parents who are antivaccine and those who are simply “vaccine hesitant,” says Arora, who co-authored a recent article about masking and misinformation that addresses antivaccine attitudes.

“While the antimask sentiment gets a lot of attention, I think it’s important to highlight there’s a lot of vocal anti-mask sentiment since most people are supportive of masks,” she said. “There might be people sitting on the fence who are just unsure about wearing a mask. That’s understandable because the science and the communication has evolved. There was a lot of early mixed messages about masking. Anytime you have confusion about the science or the science is evolving, it’s easy to have misinformation and then have that take off as myth.”

Just as antivaxxers work to swing the opinion of the vaccine hesitant, antimaskers are vying with public health advocates for the support of the mask hesitant, she said. Creating doubt in public health authorities is one way they are gaining followers. Anti-maskers often question and scrutinize past messaging about masks by public health officials, claiming that because guidance on masks has changed over time, the science behind masks and current guidance can’t be trusted, Wolynn said. Similarly, antivaxxers frequently question past actions by public health officials, such as the Tuskegee Experiment (which began in 1932), to try to poke holes in the credibility of public health officials and their advice.

Both the antimask and antivaccine movements also tend to base their resistance on a personal liberties argument, adds Jacqueline Winfield Fincher, MD, president for the American College of Physicians and an internist based in Thomson, Georgia. Antimaskers contend they should be free to decide whether to wear face coverings and that rules requiring masks infringe upon their civil liberties. Similarly, antivaxxers argue they should be free to decide whether to vaccinate their children and contend vaccine mandates violate their personal liberties.

Taking a deeper look, fear and control are two likely drivers of antimasking and antivaccine attitudes, Fincher said. Those refusing to wear masks may feel they have no control over the pandemic or its impacts, but they can control how they respond to mask-wearing requirements, she said.

Antivaccine parents often want more control over their children’s healthcare and falsely believe that vaccines are injecting something harmful into their children or may lead to harmful reactions.

“It’s a control issue and a defense mechanism,” she said. “Some people may feel helpless to deal with the pandemic or believe since it is not affecting them or their family, that it is not real. ‘If I just deny it and I don’t acknowledge facts, I don’t have to worry about it or do anything about it, and therefore I will have more control over my day-to-day life.’”
 

Groups fueling each other

In some cases, antimask and antivaxx groups are joining forces or adopting dual causes.

In California for instance, longtime opponents to vaccines are now objecting to mask policies as similar infringement to their bodily autonomy. Demonstrations in Texas, Idaho, and Michigan against mask mandates and other COVID-19 requirements have drawn support from anti-vaccine activists and incorporated antivaccine propaganda.

In Illinois, Million Unmasked Patriots, formally the Million Unmasked March, has received widespread attention for protesting both masks for returning schoolchildren and a future COVID-19 vaccine requirement.

A July protest planned by the antimask group triggered a letter by Arora and 500 other healthcare professionals to Illinois lawmakers decrying the group’s views and urging the state to move forward with universal masking in schools.

“What’s happening is those who are distrustful of government and public health and science are joining together,” said Arora, who coauthored a piece about the problem on KevinMD.com. “It’s important to address both movements together because they can quickly feed off each other and build in momentum. At the heart of both is really this deep skepticism of science.”

Rebresh of Million Unmasked Patriots said most of his members are not opposed to all vaccines, but rather they are opposed to “untested vaccines.” The primary concern is the inability to research long-term effects of a COVID-19 vaccine before its approval, he said.

Rebresh disagrees with the antimask movement being compared with the antivaccine movement. The two groups are “motivated by different things and a different set of circumstances drive their opinions,” he said. However, Rebresh believes that potential harm resulting from “mass vaccinations” is a valid concern. For this reason, he and his wife chose for their children to receive their vaccinations individually over a series of weeks, rather than the “kiddie cocktail of vaccines,” at a single visit, he said.

Vaccine scientist Peter Hotez, MD, PhD, said the antivaccine movement appears to have grown stronger from the pandemic fueled by fresh conspiracies and new alliances. Antivaccine sentiment has been gaining steam over the last several years and collecting more allies from the far-right, said Hotez, dean for the National School of Tropical Medicine and codirector for the Texas Children’s Hospital Center for Vaccine Development.

“Now what you’re seeing is yet another expansion this year, with antivaccine groups, under the banner of ‘health freedom,’ campaigning against social distancing and wearing masks and contact tracing,” he said. “What was an antivaccine movement has now become a full-blown antiscience movement and an anti-public health movement. It’s causing a lot of damage and I believe costing a lot of American lives.”

Neil F. Johnson, PhD, who has studied the antivaccine movement and its social media proliferation during the pandemic, said online comments by antivaxxers frequently condemn mask usage and showcase memes making fun of masks.

“In those same narratives about opposing vaccines for COVID, we see a lot of discussion against masks,” said Johnson, a physics professor at George Washington University in Washington, D.C. “If you don’t believe in the official picture of COVID, you don’t believe the policies or the advice that’s given about COVID.”

An analysis by Johnson that examined 1,300 Facebook pages found that, while antivaxxers have fewer followers than provaccine pages, antivaccine pages are more numerous, faster growing, and are more often connected to unrelated, undecided pages. Conversely, pages that advocate the benefits of vaccinations and explain the science behind immunizations are largely disconnected from such undecided communities, according to the study, published May 13 in Nature.

The study suggests the antivaccine movement is making influential strides during the pandemic and connecting with people who are undecided, while public health advocates are not building the same bridges, Johnson said.

“I think it’s hugely dangerous, because I don’t know any other moment in science or in public health when there was so much uncertainty in something affecting everybody,” he said. “Every policy that will be coming, everything depends on people buying into the official message. Once you have the seeds of doubt, that’s a very difficult thing to overcome. It’s an unprecedented challenge.”
 

How physicians and clinicians can help

A more aggressive approach is necessary when it comes to taking down antiscience content on social media, says Hotez. Too often, misinformation and antiscience rhetoric is allowed to linger on popular sites such as Facebook and Amazon.

Wolynn agrees. On personal or business platforms, it’s crucial to ban, hide, and delete such comments as quickly as possible, he said. On public sites, purposeful disinformation should be immediately reported to the platform.

At the same time, Wolynn said it’s essential to support those who make sound, science-based comments in social media forums.

“If you see someone who is pushing accurate, evidence-based information, and they come under attack, they should be supported and defended and empowered,” Wolynn said. “Shots Heard Round the World is doing all of those things, including galvanizing and recruiting more people to help get their voices out there.”

Expanded visibility by physicians and scientists would greatly help counter the spread of antiscience sentiment, adds Hotez.

“Too often, antiscience movements are able to flourish because scientists and physicians are invisible,” he said. “They’re too focused on either clinical practices or in the case of physician scientists, on grants and papers and not enough attention to public engagement. We’re going to have to change that around. We need to hear more from scientists directly.”

To that end, Wolynn said health care professionals, including medical students and residents, need to have formal training in communications, media, and social media as part of their education – and more support from employers to engage through social media.

“That’s where the fight is,” Wolynn said. “You can be the best diagnostician, the best clinician. You can make the right diagnosis and prescribe the right medication, but if families don’t hear what you’re saying, you’re not going to be effective. If you can’t be on the platform where they’re being influenced, we’re losing the battle.”
 

Speaking to your mask-hesitant patients

Concentrating on those who are uncertain about masks is particularly key for physicians and public health advocates as the pandemic continues, says Arora.

“It’s important for us to focus on the mask-hesitant who often don’t get the attention they need,” she said.

She suggests bringing up the subject of masks with patients during visits, asking about mask usage, discussing rumors they’ve heard, and emphasizing why masks are important. Be a role model by wearing a mask in your community and on social media, she added.

Some patients have real concerns about not being able to breathe through masks or anxiety disorders that can be aggravated even by the thought of wearing a mask, noted Susan R. Bailey, MD, president for the American Medical Association. Bailey, an immunologist, recently counseled a patient with a deviated nasal septum in addition to a panic disorder who was worried about wearing a mask, she said. Bailey listened to the patient’s concerns, discussed his health conditions, and proposed an alternative face covering that might make him more comfortable.

“Every patient is different,” Bailey said. “It’s important for us to remember that each person who is reluctant to wear a mask has their own reasons. It’s important for us to express some empathy – to agree with them, yes, masks are hot and inconvenient – and help understand their questions, which you may be able to answer to their satisfaction. There are patients that have legitimate questions and a physician caring about how they feel, can make all the difference.”

Physicians can also get involved with the AMA’s #MaskUp campaign, an effort to normalize mask wearing and debunk myths associated with masks. The campaign includes social media materials, slogans doctors can tweet, and profile pictures they can use on social media. The campaign’s toolkit includes images, videos, and information that physicians can share with patients and the public.

Enforcing strong mask policies at your practice and ensuring all staff are modeling appropriate mask behavior is also important, adds Fincher of the ACP. The college recently issued a policy supporting mask usage in community settings.

If a patient conveys an antimask belief, Fincher suggests not directly challenging the person’s views, but listening to them and offering objective data, discussing the science behind masks, and directing them to credible sources.

“Doctors are used to this. We recommend a lot of things to patients that they don’t want to do,” Fincher said. “If a patient feels attacked, they act defensively. But if you base your explanation in more objective terms with data, numbers, and personalize the risks and benefits of a vaccine, a healthy change in behavior, or a medication, then patients are more likely to hear your concerns and do the right thing. Having a long-term relationship with a trusted physician makes all of these issues much easier to discuss and to implement the best plan for the individual patient.”

This article first appeared on Medscape.com.

Click here to get access to Abstracts Presented at the 2020 AVAHO Annual Meeting

Click here to get access to Abstracts Presented at the 2020 AVAHO Annual Meeting

Click here to get access to Abstracts Presented at the 2020 AVAHO Annual Meeting

CASE A 73-year-old woman presents to your clinic with 1 year of gradual-onset left knee pain. The pain is worse at the medial knee and at the beginning and end of the day, with some mild improvement after activity in the morning. The patient has already tried oral acetaminophen, an over-the-counter menthol cream, and a soft elastic knee brace, but these interventions have helped only minimally.

On physical exam, there is no obvious deformity of the knee. There is a bit of small joint effusion without redness or warmth. There is mild tenderness to palpation of the medial joint line. Radiographic findings include osteophytes of the medial and lateral tibial plateaus and medial and lateral femoral condyles with mild joint-space narrowing of the medial compartment, consistent with mild osteoarthritis.

How would you manage this patient’s care?

The knee is the most common joint to be affected by osteoarthritis (OA) and accounts for the majority of the disease’s total burden.¹ More than 19% of American adults ages ≥ 45 years have knee OA,^1,2 and more than half of the people with symptomatic knee OA in the United States are younger than 65 years of age.³ Longer lifespan and increasing rates of obesity are thought to be driving the increasing prevalence of knee OA, although this remains debated.¹ Risk factors for knee OA are outlined in TABLE.^1,4-8

Diagnosis: Radiographs are helpful, not essential

The diagnosis of knee OA is relatively straightforward. Gradual onset of knee joint pain is present most days, with pain worse after activity and better with rest. Patients are usually middle-aged or older and/or have a distant history of knee joint injury. Other signs, symptoms, and physical exam findings associated with knee OA include: morning stiffness < 30 minutes, crepitus, instability, range-of-motion deficit, varus or valgus deformity, bony exostosis, joint-line tenderness, joint swelling/effusion, and the absence of erythema/warmth.^1,9,10

Although radiographs are not necessary to diagnose knee OA, they can be helpful in confirming the diagnosis by assessing the degree and location of OA and ruling out other pathology. Standing, weight-bearing radiographs are particularly helpful for assessing the degree of joint-space narrowing. In addition to joint-space narrowing, radiographic findings indicative of knee OA include marginal osteophytes, subchondral sclerosis, and subchondral cysts. (See FIGURE 1.)

Keep in mind that radiographs are less sensitive for early OA, that the degree of OA seen on radiographs does not correlate well with symptoms, and that radiographic evidence of OA is a common incidental finding—especially in elderly individuals.¹¹ Although not routinely utilized for knee OA diagnosis, magnetic resonance imaging (MRI) can be used to assess for earlier stages of the disease and to rule out pathology associated with the soft tissue and cartilage that is not directly associated with OA.

Continue to: Management

Because there is no cure for OA, the primary goals of treatment are to decrease pain, improve function of the joint, and slow progression of the disease. As a result, a multifaceted treatment approach is usually undertaken that includes weight reduction and exercise therapy and may include pharmacotherapy, depending on the degree of symptoms. ­FIGURE 2 contains a summary of the stepwise management of knee OA.

Weight management can slow progression of the disease

Obesity is a causative factor in knee OA.^12,13 Patients with knee OA who achieve and maintain an appropriate body weight can potentially slow progression of the disease.^13,14 One pound of weight loss can lead to a 4-fold reduction in the load exerted on the knee per step.¹⁵

Specific methods of weight reduction are beyond the scope of this article; however, one randomized controlled trial (RCT) involving 399 overweight and obese adults with knee OA found that individuals who participated in a dietary intervention or a combined diet and exercise intervention achieved more weight loss than those who undertook exercise alone.¹⁶ Additionally, the diet group had greater reductions in knee compression forces compared to the exercise group, and the combined diet and exercise group had less pain and better function than both the diet group and the exercise group.¹⁶ This would suggest that both diet and exercise interventions should be employed in the treatment of knee OA, not only for weight management, but also for knee joint health.

What kind of exercise? Evidence exists to support the utilization of various forms of exercise. In general, land-based therapeutic exercise improves knee pain, physical function, and quality of life, but these benefits often last less than 1 year because people often fail to maintain exercise programs for the long term.¹⁷

Specific therapies such as yoga, Tai Chi, balance training, and aquatic exercise have shown some minor improvement in symptoms related to knee OA.^18-22 Weight-bearing strength training, non–weight-­bearing strength training, and aerobic exercise have all been shown to be effective for short-term pain relief in knee OA, with non–weight-bearing strength training being the most effective.²³

Continue to: Strengthening of the upper leg muscles...

Strengthening of the upper leg muscles is thought to be one of the factors involved in reducing pain associated with knee OA.²⁴ Strength training, Tai Chi, and aerobic exercise have also been shown to decrease fall risk in the elderly with knee OA.²⁵ In general, lower impact activities (eg, walking, swimming, biking, yoga) are preferred over higher impact activities (eg, running, jumping) in order to lessen pain with exercise.^26-28

Knee orthoses: Many forms and mixed findings

Knee braces come in many forms, including soft braces (eg, elastic sleeves, simple hinged braces) and unloading braces. Many of these braces have been purported to help with knee OA although the evidence remains mixed, with a lack of high-quality trials. A systematic review of RCTs comparing various knee braces, foot orthotics, and conservative treatment for the management of medial compartment OA concluded that the optimal choice for orthosis remains unclear, and long-term evidence is lacking.²⁹

The medial unloading (valgus) knee brace is often used to treat medial compartment OA and varus malalignment of the knee by applying a valgus force, thereby reducing the load on the medial compartment. One recent systematic review concluded that medial unloading braces improve pain from medial compartment OA, but whether they improve function and stiffness is unclear.³⁰ Another study showed that compared to conservative treatment alone, valgus knee bracing has some benefit in decreasing pain and improving knee function.³¹ Additionally, an 8-year prospective study found that the valgus unloading brace can delay the time before patients need to undergo knee arthroplasty.³² However, another prospective study examining the efficacy of valgus bracing at 2.7 years and 11.2 years showed short-term but not long-term benefit.³³

Soft knee braces include a variety of elastic sleeves and simple hinged knee braces. These braces are available commercially at most pharmacies and athletic retail stores. Soft braces are thought to improve pain by a thermal and compressive effect, and to provide stability to the knee joint. One systematic review concluded that soft knee braces have a moderate effect on pain and a small-to-moderate effect on self-reported physical function.³⁴ A small trial showed that soft knee braces reduced pain and dynamic instability in individuals with knee OA.³⁵

One pound of weight loss can lead to a 4-fold reduction in the load exerted on the knee per step.

In summary, many types of soft knee braces exist, but the evidence for recommending them individually or collectively is limited, as high-quality trials are lacking. However, the available evidence does suggest some mild benefit with regard to pain and function with no concern for adverse effects.

Continue to: Pharmacotherapy

Pharmacotherapy: Oral agents

Acetaminophen. Although people commonly use this over-the-counter analgesic for knee OA pain, recent meta-analyses have shown that acetaminophen provides little to no benefit.^36,37 Furthermore, although many believe acetaminophen causes fewer adverse effects than oral nonsteroidal anti-inflammatory drugs (NSAIDs), liver, gastrointestinal, and renal complications are not uncommon with long-term acetaminophen use. Nevertheless, a trial of acetaminophen may be beneficial in patients with cardiovascular disease or who are taking oral anticoagulants.

Oral NSAIDs. Many studies have concluded that NSAIDs are more effective at controlling pain from knee OA than acetaminophen.^37,38 They are among the most commonly prescribed treatments for knee OA, but patients and their physicians should be cautious about long-term use because of potential cardiac, renal, gastrointestinal, and other adverse effects. Although evidence regarding optimal frequency of use is scarce, oral NSAIDs should be used intermittently and at the minimal effective dose in order to decrease the risk of adverse events.

One recent meta-analysis of RCTs concluded that diclofenac at a dose of 150 mg/d is the most effective NSAID for improving pain and function associated with knee OA.³⁷ Another recent systematic review and meta-analysis analyzing multiple pharmacologic treatments found an association between celecoxib and decreased pain from knee OA.³⁹ However, this study also concluded that uncertainty surrounded all of the estimates of effect size for change in pain compared to placebo for all of the pharmacologic treatments included in the study.³⁹

A meta-analysis of RCTs comparing celecoxib to no treatment, placebo, naproxen, and diclofenac concluded that celecoxib is slightly better than placebo and the aforementioned NSAIDs in reducing pain and improving function in general OA. However, the authors had reservations regarding pharmaceutical industry involvement in the studies and overall limited data.⁴⁰

With all of that said, the American Academy of Orthopaedic Surgeons (AAOS) recommends strongly for the use of oral NSAIDs in the management of knee OA.⁴¹

Continue to: Glucosamine and chondroitin

Glucosamine and chondroitin. Glucosamine and chondroitin are supplements that have gained popularity in the treatment of knee OA. These constituents are found naturally in articular cartilage, which explains the rationale for their use. Glucosamine and chondroitin (or a combination of the 2) are associated with few adverse effects, but the evidence to support their use in knee OA management is mixed.

One large double-blind RCT (the Glucosamine/Chondroitin Arthritis Intervention Trial [GAIT]) concluded that glucosamine, chondroitin, or the combination of the 2 did not have a significant effect on reducing pain from knee OA compared to placebo and did not slow structural joint disease.⁴² However, this same study found that in a subset of patients with moderate-to-severe knee OA, the combination of glucosamine and chondroitin was mildly effective in reducing pain.⁴²

Multiple studies have shown either no benefit, inconsistent results, or limited benefit of glucosamine and chondroitin in the treatment of knee OA, with the patented crystalline form of glucosamine showing the most efficacy.^43-47 The AAOS and the American College of Rheumatology (ACR) do not recommend glucosamine and chondroitin for knee OA management.^10,41

In summary, the evidence for glucosamine, chondroitin, or a combination of the 2 for knee OA is mixed with likely limited benefit, but because they are associated with few adverse effects, patients may be offered a 3- to 6-month trial of these supplements if other effective options are exhausted.

Injections

Limited-quality evidence suggests that oral NSAIDs and intra-articular (IA) hyaluronic acid (HA) injections are equally efficacious for knee OA pain.^38,48 There is insufficient evidence directly comparing oral NSAIDs with IA corticosteroid (CS) injections.

Continue to: HA is found naturally...

HA is found naturally in articular cartilage, which explains the rationale behind its use. A network meta-analysis performed by the American Medical Society for Sports Medicine concluded that knee OA is more likely to respond to IAHA than to IACS or IA placebo, leading the society to recommend the use of IAHA in knee OA management, especially for patients > 60 years with mild-to-moderate knee OA.⁹ Conversely, the AAOS does not recommend the use of IAHA, and the ACR does not recommend for or against the use of IAHA.^10,41

Platelet-rich plasma therapy is expensive and generally is not covered by insurance companies, which precludes its use for many people.

IACSs are commonly used to provide pain relief in those with moderate-to-severe knee OA. There is evidence that a single IACS injection provides mild pain relief for up to 6 weeks.⁴⁹ However, there is some concern that repetitive IACS injections may speed cartilage loss. A 2-year randomized double-blind placebo-controlled trial comparing the effectiveness of repetitive IA triamcinolone vs saline in knee OA found no difference in pain severity and concluded that there was greater cartilage volume loss in the triamcinolone group.⁵⁰

AAOS does not recommend for or against the use of IACSs, whereas the ACR does recommend for the use of IACSs.^10,41 Given the available evidence, conservative use of IACS injections remains an option for patients with refractory moderate-to-severe knee OA.

Topicals

Topical analgesics are often utilized for knee OA because of their efficacy, tolerability, low risk of adverse effects, and ease of use. They are generally recommended over oral NSAIDs in the elderly and in individuals at risk for cardiac, renal, and gastrointestinal complications from oral NSAIDs.

Extendedrelease IA triamcinolone acetonide (Zilretta) has shown some superiority to standard IA triamcinolone acetonide in both degree and duration of pain relief for knee OA.

One review found that topical diclofenac and topical ketoprofen were comparable to the oral forms of these medications.⁵¹ One RCT concluded that topical and oral diclofenac were equally efficacious in treating knee OA symptoms, although topical diclofenac was associated with significantly fewer gastrointestinal adverse effects.⁵² In multiple randomized trials, topical diclofenac has shown efficacy compared to placebo.^53-55 A recent systematic review and meta-analysis of RCTs concluded that topical NSAIDs were safe and effective for treating general OA compared to placebo, with diclofenac patches most effective for pain relief and piroxicam most effective for functional improvement.⁵⁶

Continue to: Topical capsaicin has shown...

Topical capsaicin has shown some efficacy in treating pain associated with knee OA.⁵⁷ One meta-analysis of RCTs concluded that topical NSAIDs and capsaicin may be equally efficacious for OA-associated pain relief, although none of the RCTs directly compared the two.⁵⁸ The major limitation of capsaicin is a patient-reported mild-to-moderate burning sensation with application that may decrease compliance.

Emerging treatments: IA PRP & extended-release IA triamcinolone acetonide

IA platelet-rich plasma (PRP) has been investigated for efficacy in treating knee OA. PRP is thought to decrease inflammation in the joint, although its exact mechanism remains unknown.⁵⁹ Multiple studies have shown some benefit of PRP in reducing pain and improving function in individuals with knee OA, but nearly all of these studies have failed to show a clear benefit of PRP over HA injections.^59-63 Additionally, the authors of most of these studies mention a high risk of bias. PRP therapy is expensive and generally is not covered by insurance companies, which precludes its use for many people.

Extended-release (ER) IA triamcinolone acetonide (Zilretta) has shown some superiority to standard IA triamcinolone acetonide in both degree and duration of pain relief for knee OA.^64-66 The ER version tolerability did not differ from placebo and also showed prolonged synovial presence, lower systemic absorption, and lower blood glucose elevations compared with standard triamcinolone.^64-66

Surgical intervention: A last resort

Select patients with severe pain and disability from knee OA that is refractory to conservative management options should be referred for consideration of knee arthroplasty. Age, weight, OA location, and degree of OA are all considered with respect to knee arthroplasty timing and technique.

There is good evidence that arthroscopy with debridement, on the other hand, is no more effective than conservative management.⁶⁷

Continue to: Unicompartmental or "partial"...

Unicompartmental or “partial” knee replacements are reserved for select cases when 1 knee compartment has a significantly higher degree of degenerative change.

CASE After reviewing the therapeutic options with your patient, you agree that she will undergo a course of physical therapy and try using topical diclofenac along with a hinged knee brace. Because of the patient’s age and co-morbidities of cardiovascular disease and mild chronic kidney disease, oral NSAIDs are avoided at this time.

Unicompartmental or “partial” knee replacements are reserved for select cases when 1 knee compartment has a significantly higher degree of degenerative change.

The patient returns to the office in 2 months reporting mild improvement in her pain. To provide additional pain relief, an ­ultrasound-guided IA steroid injection is attempted. The patient also continues home physical therapy, activity modification, topical diclofenac, and use of a hinged knee brace.

She returns to the office 2 months later, reporting continued improvement in her pain. No further intervention is undertaken at this time.

CORRESPONDENCE
Ryan A. Sprouse, MD, CAQSM, West Virginia University School of Medicine–Eastern Campus, WVU Medicine Orthopaedics and Sports Medicine, 912 Somerset Boulevard, Charles Town, WV 25414; [email protected].

CASE A 73-year-old woman presents to your clinic with 1 year of gradual-onset left knee pain. The pain is worse at the medial knee and at the beginning and end of the day, with some mild improvement after activity in the morning. The patient has already tried oral acetaminophen, an over-the-counter menthol cream, and a soft elastic knee brace, but these interventions have helped only minimally.

On physical exam, there is no obvious deformity of the knee. There is a bit of small joint effusion without redness or warmth. There is mild tenderness to palpation of the medial joint line. Radiographic findings include osteophytes of the medial and lateral tibial plateaus and medial and lateral femoral condyles with mild joint-space narrowing of the medial compartment, consistent with mild osteoarthritis.

How would you manage this patient’s care?

The knee is the most common joint to be affected by osteoarthritis (OA) and accounts for the majority of the disease’s total burden.¹ More than 19% of American adults ages ≥ 45 years have knee OA,^1,2 and more than half of the people with symptomatic knee OA in the United States are younger than 65 years of age.³ Longer lifespan and increasing rates of obesity are thought to be driving the increasing prevalence of knee OA, although this remains debated.¹ Risk factors for knee OA are outlined in TABLE.^1,4-8

Diagnosis: Radiographs are helpful, not essential

The diagnosis of knee OA is relatively straightforward. Gradual onset of knee joint pain is present most days, with pain worse after activity and better with rest. Patients are usually middle-aged or older and/or have a distant history of knee joint injury. Other signs, symptoms, and physical exam findings associated with knee OA include: morning stiffness < 30 minutes, crepitus, instability, range-of-motion deficit, varus or valgus deformity, bony exostosis, joint-line tenderness, joint swelling/effusion, and the absence of erythema/warmth.^1,9,10

Although radiographs are not necessary to diagnose knee OA, they can be helpful in confirming the diagnosis by assessing the degree and location of OA and ruling out other pathology. Standing, weight-bearing radiographs are particularly helpful for assessing the degree of joint-space narrowing. In addition to joint-space narrowing, radiographic findings indicative of knee OA include marginal osteophytes, subchondral sclerosis, and subchondral cysts. (See FIGURE 1.)

Keep in mind that radiographs are less sensitive for early OA, that the degree of OA seen on radiographs does not correlate well with symptoms, and that radiographic evidence of OA is a common incidental finding—especially in elderly individuals.¹¹ Although not routinely utilized for knee OA diagnosis, magnetic resonance imaging (MRI) can be used to assess for earlier stages of the disease and to rule out pathology associated with the soft tissue and cartilage that is not directly associated with OA.

Continue to: Management

Because there is no cure for OA, the primary goals of treatment are to decrease pain, improve function of the joint, and slow progression of the disease. As a result, a multifaceted treatment approach is usually undertaken that includes weight reduction and exercise therapy and may include pharmacotherapy, depending on the degree of symptoms. ­FIGURE 2 contains a summary of the stepwise management of knee OA.

Weight management can slow progression of the disease

Obesity is a causative factor in knee OA.^12,13 Patients with knee OA who achieve and maintain an appropriate body weight can potentially slow progression of the disease.^13,14 One pound of weight loss can lead to a 4-fold reduction in the load exerted on the knee per step.¹⁵

Specific methods of weight reduction are beyond the scope of this article; however, one randomized controlled trial (RCT) involving 399 overweight and obese adults with knee OA found that individuals who participated in a dietary intervention or a combined diet and exercise intervention achieved more weight loss than those who undertook exercise alone.¹⁶ Additionally, the diet group had greater reductions in knee compression forces compared to the exercise group, and the combined diet and exercise group had less pain and better function than both the diet group and the exercise group.¹⁶ This would suggest that both diet and exercise interventions should be employed in the treatment of knee OA, not only for weight management, but also for knee joint health.

What kind of exercise? Evidence exists to support the utilization of various forms of exercise. In general, land-based therapeutic exercise improves knee pain, physical function, and quality of life, but these benefits often last less than 1 year because people often fail to maintain exercise programs for the long term.¹⁷

Specific therapies such as yoga, Tai Chi, balance training, and aquatic exercise have shown some minor improvement in symptoms related to knee OA.^18-22 Weight-bearing strength training, non–weight-­bearing strength training, and aerobic exercise have all been shown to be effective for short-term pain relief in knee OA, with non–weight-bearing strength training being the most effective.²³

Continue to: Strengthening of the upper leg muscles...

Strengthening of the upper leg muscles is thought to be one of the factors involved in reducing pain associated with knee OA.²⁴ Strength training, Tai Chi, and aerobic exercise have also been shown to decrease fall risk in the elderly with knee OA.²⁵ In general, lower impact activities (eg, walking, swimming, biking, yoga) are preferred over higher impact activities (eg, running, jumping) in order to lessen pain with exercise.^26-28

Knee orthoses: Many forms and mixed findings

Knee braces come in many forms, including soft braces (eg, elastic sleeves, simple hinged braces) and unloading braces. Many of these braces have been purported to help with knee OA although the evidence remains mixed, with a lack of high-quality trials. A systematic review of RCTs comparing various knee braces, foot orthotics, and conservative treatment for the management of medial compartment OA concluded that the optimal choice for orthosis remains unclear, and long-term evidence is lacking.²⁹

The medial unloading (valgus) knee brace is often used to treat medial compartment OA and varus malalignment of the knee by applying a valgus force, thereby reducing the load on the medial compartment. One recent systematic review concluded that medial unloading braces improve pain from medial compartment OA, but whether they improve function and stiffness is unclear.³⁰ Another study showed that compared to conservative treatment alone, valgus knee bracing has some benefit in decreasing pain and improving knee function.³¹ Additionally, an 8-year prospective study found that the valgus unloading brace can delay the time before patients need to undergo knee arthroplasty.³² However, another prospective study examining the efficacy of valgus bracing at 2.7 years and 11.2 years showed short-term but not long-term benefit.³³

Soft knee braces include a variety of elastic sleeves and simple hinged knee braces. These braces are available commercially at most pharmacies and athletic retail stores. Soft braces are thought to improve pain by a thermal and compressive effect, and to provide stability to the knee joint. One systematic review concluded that soft knee braces have a moderate effect on pain and a small-to-moderate effect on self-reported physical function.³⁴ A small trial showed that soft knee braces reduced pain and dynamic instability in individuals with knee OA.³⁵

One pound of weight loss can lead to a 4-fold reduction in the load exerted on the knee per step.

In summary, many types of soft knee braces exist, but the evidence for recommending them individually or collectively is limited, as high-quality trials are lacking. However, the available evidence does suggest some mild benefit with regard to pain and function with no concern for adverse effects.

Continue to: Pharmacotherapy

Pharmacotherapy: Oral agents

Acetaminophen. Although people commonly use this over-the-counter analgesic for knee OA pain, recent meta-analyses have shown that acetaminophen provides little to no benefit.^36,37 Furthermore, although many believe acetaminophen causes fewer adverse effects than oral nonsteroidal anti-inflammatory drugs (NSAIDs), liver, gastrointestinal, and renal complications are not uncommon with long-term acetaminophen use. Nevertheless, a trial of acetaminophen may be beneficial in patients with cardiovascular disease or who are taking oral anticoagulants.

Oral NSAIDs. Many studies have concluded that NSAIDs are more effective at controlling pain from knee OA than acetaminophen.^37,38 They are among the most commonly prescribed treatments for knee OA, but patients and their physicians should be cautious about long-term use because of potential cardiac, renal, gastrointestinal, and other adverse effects. Although evidence regarding optimal frequency of use is scarce, oral NSAIDs should be used intermittently and at the minimal effective dose in order to decrease the risk of adverse events.

One recent meta-analysis of RCTs concluded that diclofenac at a dose of 150 mg/d is the most effective NSAID for improving pain and function associated with knee OA.³⁷ Another recent systematic review and meta-analysis analyzing multiple pharmacologic treatments found an association between celecoxib and decreased pain from knee OA.³⁹ However, this study also concluded that uncertainty surrounded all of the estimates of effect size for change in pain compared to placebo for all of the pharmacologic treatments included in the study.³⁹

A meta-analysis of RCTs comparing celecoxib to no treatment, placebo, naproxen, and diclofenac concluded that celecoxib is slightly better than placebo and the aforementioned NSAIDs in reducing pain and improving function in general OA. However, the authors had reservations regarding pharmaceutical industry involvement in the studies and overall limited data.⁴⁰

With all of that said, the American Academy of Orthopaedic Surgeons (AAOS) recommends strongly for the use of oral NSAIDs in the management of knee OA.⁴¹

Continue to: Glucosamine and chondroitin

Glucosamine and chondroitin. Glucosamine and chondroitin are supplements that have gained popularity in the treatment of knee OA. These constituents are found naturally in articular cartilage, which explains the rationale for their use. Glucosamine and chondroitin (or a combination of the 2) are associated with few adverse effects, but the evidence to support their use in knee OA management is mixed.

One large double-blind RCT (the Glucosamine/Chondroitin Arthritis Intervention Trial [GAIT]) concluded that glucosamine, chondroitin, or the combination of the 2 did not have a significant effect on reducing pain from knee OA compared to placebo and did not slow structural joint disease.⁴² However, this same study found that in a subset of patients with moderate-to-severe knee OA, the combination of glucosamine and chondroitin was mildly effective in reducing pain.⁴²

Multiple studies have shown either no benefit, inconsistent results, or limited benefit of glucosamine and chondroitin in the treatment of knee OA, with the patented crystalline form of glucosamine showing the most efficacy.^43-47 The AAOS and the American College of Rheumatology (ACR) do not recommend glucosamine and chondroitin for knee OA management.^10,41

In summary, the evidence for glucosamine, chondroitin, or a combination of the 2 for knee OA is mixed with likely limited benefit, but because they are associated with few adverse effects, patients may be offered a 3- to 6-month trial of these supplements if other effective options are exhausted.

Injections

Limited-quality evidence suggests that oral NSAIDs and intra-articular (IA) hyaluronic acid (HA) injections are equally efficacious for knee OA pain.^38,48 There is insufficient evidence directly comparing oral NSAIDs with IA corticosteroid (CS) injections.

Continue to: HA is found naturally...

HA is found naturally in articular cartilage, which explains the rationale behind its use. A network meta-analysis performed by the American Medical Society for Sports Medicine concluded that knee OA is more likely to respond to IAHA than to IACS or IA placebo, leading the society to recommend the use of IAHA in knee OA management, especially for patients > 60 years with mild-to-moderate knee OA.⁹ Conversely, the AAOS does not recommend the use of IAHA, and the ACR does not recommend for or against the use of IAHA.^10,41

Platelet-rich plasma therapy is expensive and generally is not covered by insurance companies, which precludes its use for many people.

IACSs are commonly used to provide pain relief in those with moderate-to-severe knee OA. There is evidence that a single IACS injection provides mild pain relief for up to 6 weeks.⁴⁹ However, there is some concern that repetitive IACS injections may speed cartilage loss. A 2-year randomized double-blind placebo-controlled trial comparing the effectiveness of repetitive IA triamcinolone vs saline in knee OA found no difference in pain severity and concluded that there was greater cartilage volume loss in the triamcinolone group.⁵⁰

AAOS does not recommend for or against the use of IACSs, whereas the ACR does recommend for the use of IACSs.^10,41 Given the available evidence, conservative use of IACS injections remains an option for patients with refractory moderate-to-severe knee OA.

Topicals

Topical analgesics are often utilized for knee OA because of their efficacy, tolerability, low risk of adverse effects, and ease of use. They are generally recommended over oral NSAIDs in the elderly and in individuals at risk for cardiac, renal, and gastrointestinal complications from oral NSAIDs.

Extendedrelease IA triamcinolone acetonide (Zilretta) has shown some superiority to standard IA triamcinolone acetonide in both degree and duration of pain relief for knee OA.

One review found that topical diclofenac and topical ketoprofen were comparable to the oral forms of these medications.⁵¹ One RCT concluded that topical and oral diclofenac were equally efficacious in treating knee OA symptoms, although topical diclofenac was associated with significantly fewer gastrointestinal adverse effects.⁵² In multiple randomized trials, topical diclofenac has shown efficacy compared to placebo.^53-55 A recent systematic review and meta-analysis of RCTs concluded that topical NSAIDs were safe and effective for treating general OA compared to placebo, with diclofenac patches most effective for pain relief and piroxicam most effective for functional improvement.⁵⁶

Continue to: Topical capsaicin has shown...

Topical capsaicin has shown some efficacy in treating pain associated with knee OA.⁵⁷ One meta-analysis of RCTs concluded that topical NSAIDs and capsaicin may be equally efficacious for OA-associated pain relief, although none of the RCTs directly compared the two.⁵⁸ The major limitation of capsaicin is a patient-reported mild-to-moderate burning sensation with application that may decrease compliance.

Emerging treatments: IA PRP & extended-release IA triamcinolone acetonide

IA platelet-rich plasma (PRP) has been investigated for efficacy in treating knee OA. PRP is thought to decrease inflammation in the joint, although its exact mechanism remains unknown.⁵⁹ Multiple studies have shown some benefit of PRP in reducing pain and improving function in individuals with knee OA, but nearly all of these studies have failed to show a clear benefit of PRP over HA injections.^59-63 Additionally, the authors of most of these studies mention a high risk of bias. PRP therapy is expensive and generally is not covered by insurance companies, which precludes its use for many people.

Extended-release (ER) IA triamcinolone acetonide (Zilretta) has shown some superiority to standard IA triamcinolone acetonide in both degree and duration of pain relief for knee OA.^64-66 The ER version tolerability did not differ from placebo and also showed prolonged synovial presence, lower systemic absorption, and lower blood glucose elevations compared with standard triamcinolone.^64-66

Surgical intervention: A last resort

Select patients with severe pain and disability from knee OA that is refractory to conservative management options should be referred for consideration of knee arthroplasty. Age, weight, OA location, and degree of OA are all considered with respect to knee arthroplasty timing and technique.

There is good evidence that arthroscopy with debridement, on the other hand, is no more effective than conservative management.⁶⁷

Continue to: Unicompartmental or "partial"...

Unicompartmental or “partial” knee replacements are reserved for select cases when 1 knee compartment has a significantly higher degree of degenerative change.

CASE After reviewing the therapeutic options with your patient, you agree that she will undergo a course of physical therapy and try using topical diclofenac along with a hinged knee brace. Because of the patient’s age and co-morbidities of cardiovascular disease and mild chronic kidney disease, oral NSAIDs are avoided at this time.

Unicompartmental or “partial” knee replacements are reserved for select cases when 1 knee compartment has a significantly higher degree of degenerative change.

The patient returns to the office in 2 months reporting mild improvement in her pain. To provide additional pain relief, an ­ultrasound-guided IA steroid injection is attempted. The patient also continues home physical therapy, activity modification, topical diclofenac, and use of a hinged knee brace.

She returns to the office 2 months later, reporting continued improvement in her pain. No further intervention is undertaken at this time.

CORRESPONDENCE
Ryan A. Sprouse, MD, CAQSM, West Virginia University School of Medicine–Eastern Campus, WVU Medicine Orthopaedics and Sports Medicine, 912 Somerset Boulevard, Charles Town, WV 25414; [email protected].

CASE A 73-year-old woman presents to your clinic with 1 year of gradual-onset left knee pain. The pain is worse at the medial knee and at the beginning and end of the day, with some mild improvement after activity in the morning. The patient has already tried oral acetaminophen, an over-the-counter menthol cream, and a soft elastic knee brace, but these interventions have helped only minimally.

On physical exam, there is no obvious deformity of the knee. There is a bit of small joint effusion without redness or warmth. There is mild tenderness to palpation of the medial joint line. Radiographic findings include osteophytes of the medial and lateral tibial plateaus and medial and lateral femoral condyles with mild joint-space narrowing of the medial compartment, consistent with mild osteoarthritis.

How would you manage this patient’s care?

The knee is the most common joint to be affected by osteoarthritis (OA) and accounts for the majority of the disease’s total burden.¹ More than 19% of American adults ages ≥ 45 years have knee OA,^1,2 and more than half of the people with symptomatic knee OA in the United States are younger than 65 years of age.³ Longer lifespan and increasing rates of obesity are thought to be driving the increasing prevalence of knee OA, although this remains debated.¹ Risk factors for knee OA are outlined in TABLE.^1,4-8

Diagnosis: Radiographs are helpful, not essential

The diagnosis of knee OA is relatively straightforward. Gradual onset of knee joint pain is present most days, with pain worse after activity and better with rest. Patients are usually middle-aged or older and/or have a distant history of knee joint injury. Other signs, symptoms, and physical exam findings associated with knee OA include: morning stiffness < 30 minutes, crepitus, instability, range-of-motion deficit, varus or valgus deformity, bony exostosis, joint-line tenderness, joint swelling/effusion, and the absence of erythema/warmth.^1,9,10

Although radiographs are not necessary to diagnose knee OA, they can be helpful in confirming the diagnosis by assessing the degree and location of OA and ruling out other pathology. Standing, weight-bearing radiographs are particularly helpful for assessing the degree of joint-space narrowing. In addition to joint-space narrowing, radiographic findings indicative of knee OA include marginal osteophytes, subchondral sclerosis, and subchondral cysts. (See FIGURE 1.)

Keep in mind that radiographs are less sensitive for early OA, that the degree of OA seen on radiographs does not correlate well with symptoms, and that radiographic evidence of OA is a common incidental finding—especially in elderly individuals.¹¹ Although not routinely utilized for knee OA diagnosis, magnetic resonance imaging (MRI) can be used to assess for earlier stages of the disease and to rule out pathology associated with the soft tissue and cartilage that is not directly associated with OA.

Continue to: Management

Because there is no cure for OA, the primary goals of treatment are to decrease pain, improve function of the joint, and slow progression of the disease. As a result, a multifaceted treatment approach is usually undertaken that includes weight reduction and exercise therapy and may include pharmacotherapy, depending on the degree of symptoms. ­FIGURE 2 contains a summary of the stepwise management of knee OA.

Weight management can slow progression of the disease

Obesity is a causative factor in knee OA.^12,13 Patients with knee OA who achieve and maintain an appropriate body weight can potentially slow progression of the disease.^13,14 One pound of weight loss can lead to a 4-fold reduction in the load exerted on the knee per step.¹⁵

Specific methods of weight reduction are beyond the scope of this article; however, one randomized controlled trial (RCT) involving 399 overweight and obese adults with knee OA found that individuals who participated in a dietary intervention or a combined diet and exercise intervention achieved more weight loss than those who undertook exercise alone.¹⁶ Additionally, the diet group had greater reductions in knee compression forces compared to the exercise group, and the combined diet and exercise group had less pain and better function than both the diet group and the exercise group.¹⁶ This would suggest that both diet and exercise interventions should be employed in the treatment of knee OA, not only for weight management, but also for knee joint health.

What kind of exercise? Evidence exists to support the utilization of various forms of exercise. In general, land-based therapeutic exercise improves knee pain, physical function, and quality of life, but these benefits often last less than 1 year because people often fail to maintain exercise programs for the long term.¹⁷

Specific therapies such as yoga, Tai Chi, balance training, and aquatic exercise have shown some minor improvement in symptoms related to knee OA.^18-22 Weight-bearing strength training, non–weight-­bearing strength training, and aerobic exercise have all been shown to be effective for short-term pain relief in knee OA, with non–weight-bearing strength training being the most effective.²³

Continue to: Strengthening of the upper leg muscles...

Strengthening of the upper leg muscles is thought to be one of the factors involved in reducing pain associated with knee OA.²⁴ Strength training, Tai Chi, and aerobic exercise have also been shown to decrease fall risk in the elderly with knee OA.²⁵ In general, lower impact activities (eg, walking, swimming, biking, yoga) are preferred over higher impact activities (eg, running, jumping) in order to lessen pain with exercise.^26-28

Knee orthoses: Many forms and mixed findings

Knee braces come in many forms, including soft braces (eg, elastic sleeves, simple hinged braces) and unloading braces. Many of these braces have been purported to help with knee OA although the evidence remains mixed, with a lack of high-quality trials. A systematic review of RCTs comparing various knee braces, foot orthotics, and conservative treatment for the management of medial compartment OA concluded that the optimal choice for orthosis remains unclear, and long-term evidence is lacking.²⁹

The medial unloading (valgus) knee brace is often used to treat medial compartment OA and varus malalignment of the knee by applying a valgus force, thereby reducing the load on the medial compartment. One recent systematic review concluded that medial unloading braces improve pain from medial compartment OA, but whether they improve function and stiffness is unclear.³⁰ Another study showed that compared to conservative treatment alone, valgus knee bracing has some benefit in decreasing pain and improving knee function.³¹ Additionally, an 8-year prospective study found that the valgus unloading brace can delay the time before patients need to undergo knee arthroplasty.³² However, another prospective study examining the efficacy of valgus bracing at 2.7 years and 11.2 years showed short-term but not long-term benefit.³³

Soft knee braces include a variety of elastic sleeves and simple hinged knee braces. These braces are available commercially at most pharmacies and athletic retail stores. Soft braces are thought to improve pain by a thermal and compressive effect, and to provide stability to the knee joint. One systematic review concluded that soft knee braces have a moderate effect on pain and a small-to-moderate effect on self-reported physical function.³⁴ A small trial showed that soft knee braces reduced pain and dynamic instability in individuals with knee OA.³⁵

One pound of weight loss can lead to a 4-fold reduction in the load exerted on the knee per step.

In summary, many types of soft knee braces exist, but the evidence for recommending them individually or collectively is limited, as high-quality trials are lacking. However, the available evidence does suggest some mild benefit with regard to pain and function with no concern for adverse effects.

Continue to: Pharmacotherapy

Pharmacotherapy: Oral agents

Acetaminophen. Although people commonly use this over-the-counter analgesic for knee OA pain, recent meta-analyses have shown that acetaminophen provides little to no benefit.^36,37 Furthermore, although many believe acetaminophen causes fewer adverse effects than oral nonsteroidal anti-inflammatory drugs (NSAIDs), liver, gastrointestinal, and renal complications are not uncommon with long-term acetaminophen use. Nevertheless, a trial of acetaminophen may be beneficial in patients with cardiovascular disease or who are taking oral anticoagulants.

Oral NSAIDs. Many studies have concluded that NSAIDs are more effective at controlling pain from knee OA than acetaminophen.^37,38 They are among the most commonly prescribed treatments for knee OA, but patients and their physicians should be cautious about long-term use because of potential cardiac, renal, gastrointestinal, and other adverse effects. Although evidence regarding optimal frequency of use is scarce, oral NSAIDs should be used intermittently and at the minimal effective dose in order to decrease the risk of adverse events.

One recent meta-analysis of RCTs concluded that diclofenac at a dose of 150 mg/d is the most effective NSAID for improving pain and function associated with knee OA.³⁷ Another recent systematic review and meta-analysis analyzing multiple pharmacologic treatments found an association between celecoxib and decreased pain from knee OA.³⁹ However, this study also concluded that uncertainty surrounded all of the estimates of effect size for change in pain compared to placebo for all of the pharmacologic treatments included in the study.³⁹

A meta-analysis of RCTs comparing celecoxib to no treatment, placebo, naproxen, and diclofenac concluded that celecoxib is slightly better than placebo and the aforementioned NSAIDs in reducing pain and improving function in general OA. However, the authors had reservations regarding pharmaceutical industry involvement in the studies and overall limited data.⁴⁰

With all of that said, the American Academy of Orthopaedic Surgeons (AAOS) recommends strongly for the use of oral NSAIDs in the management of knee OA.⁴¹

Continue to: Glucosamine and chondroitin

Glucosamine and chondroitin. Glucosamine and chondroitin are supplements that have gained popularity in the treatment of knee OA. These constituents are found naturally in articular cartilage, which explains the rationale for their use. Glucosamine and chondroitin (or a combination of the 2) are associated with few adverse effects, but the evidence to support their use in knee OA management is mixed.

One large double-blind RCT (the Glucosamine/Chondroitin Arthritis Intervention Trial [GAIT]) concluded that glucosamine, chondroitin, or the combination of the 2 did not have a significant effect on reducing pain from knee OA compared to placebo and did not slow structural joint disease.⁴² However, this same study found that in a subset of patients with moderate-to-severe knee OA, the combination of glucosamine and chondroitin was mildly effective in reducing pain.⁴²

Multiple studies have shown either no benefit, inconsistent results, or limited benefit of glucosamine and chondroitin in the treatment of knee OA, with the patented crystalline form of glucosamine showing the most efficacy.^43-47 The AAOS and the American College of Rheumatology (ACR) do not recommend glucosamine and chondroitin for knee OA management.^10,41

In summary, the evidence for glucosamine, chondroitin, or a combination of the 2 for knee OA is mixed with likely limited benefit, but because they are associated with few adverse effects, patients may be offered a 3- to 6-month trial of these supplements if other effective options are exhausted.

Injections

Limited-quality evidence suggests that oral NSAIDs and intra-articular (IA) hyaluronic acid (HA) injections are equally efficacious for knee OA pain.^38,48 There is insufficient evidence directly comparing oral NSAIDs with IA corticosteroid (CS) injections.

Continue to: HA is found naturally...

HA is found naturally in articular cartilage, which explains the rationale behind its use. A network meta-analysis performed by the American Medical Society for Sports Medicine concluded that knee OA is more likely to respond to IAHA than to IACS or IA placebo, leading the society to recommend the use of IAHA in knee OA management, especially for patients > 60 years with mild-to-moderate knee OA.⁹ Conversely, the AAOS does not recommend the use of IAHA, and the ACR does not recommend for or against the use of IAHA.^10,41

Platelet-rich plasma therapy is expensive and generally is not covered by insurance companies, which precludes its use for many people.

IACSs are commonly used to provide pain relief in those with moderate-to-severe knee OA. There is evidence that a single IACS injection provides mild pain relief for up to 6 weeks.⁴⁹ However, there is some concern that repetitive IACS injections may speed cartilage loss. A 2-year randomized double-blind placebo-controlled trial comparing the effectiveness of repetitive IA triamcinolone vs saline in knee OA found no difference in pain severity and concluded that there was greater cartilage volume loss in the triamcinolone group.⁵⁰

AAOS does not recommend for or against the use of IACSs, whereas the ACR does recommend for the use of IACSs.^10,41 Given the available evidence, conservative use of IACS injections remains an option for patients with refractory moderate-to-severe knee OA.

Topicals

Topical analgesics are often utilized for knee OA because of their efficacy, tolerability, low risk of adverse effects, and ease of use. They are generally recommended over oral NSAIDs in the elderly and in individuals at risk for cardiac, renal, and gastrointestinal complications from oral NSAIDs.

Extendedrelease IA triamcinolone acetonide (Zilretta) has shown some superiority to standard IA triamcinolone acetonide in both degree and duration of pain relief for knee OA.

One review found that topical diclofenac and topical ketoprofen were comparable to the oral forms of these medications.⁵¹ One RCT concluded that topical and oral diclofenac were equally efficacious in treating knee OA symptoms, although topical diclofenac was associated with significantly fewer gastrointestinal adverse effects.⁵² In multiple randomized trials, topical diclofenac has shown efficacy compared to placebo.^53-55 A recent systematic review and meta-analysis of RCTs concluded that topical NSAIDs were safe and effective for treating general OA compared to placebo, with diclofenac patches most effective for pain relief and piroxicam most effective for functional improvement.⁵⁶

Continue to: Topical capsaicin has shown...

Topical capsaicin has shown some efficacy in treating pain associated with knee OA.⁵⁷ One meta-analysis of RCTs concluded that topical NSAIDs and capsaicin may be equally efficacious for OA-associated pain relief, although none of the RCTs directly compared the two.⁵⁸ The major limitation of capsaicin is a patient-reported mild-to-moderate burning sensation with application that may decrease compliance.

Emerging treatments: IA PRP & extended-release IA triamcinolone acetonide

IA platelet-rich plasma (PRP) has been investigated for efficacy in treating knee OA. PRP is thought to decrease inflammation in the joint, although its exact mechanism remains unknown.⁵⁹ Multiple studies have shown some benefit of PRP in reducing pain and improving function in individuals with knee OA, but nearly all of these studies have failed to show a clear benefit of PRP over HA injections.^59-63 Additionally, the authors of most of these studies mention a high risk of bias. PRP therapy is expensive and generally is not covered by insurance companies, which precludes its use for many people.

Extended-release (ER) IA triamcinolone acetonide (Zilretta) has shown some superiority to standard IA triamcinolone acetonide in both degree and duration of pain relief for knee OA.^64-66 The ER version tolerability did not differ from placebo and also showed prolonged synovial presence, lower systemic absorption, and lower blood glucose elevations compared with standard triamcinolone.^64-66

Surgical intervention: A last resort

Select patients with severe pain and disability from knee OA that is refractory to conservative management options should be referred for consideration of knee arthroplasty. Age, weight, OA location, and degree of OA are all considered with respect to knee arthroplasty timing and technique.

There is good evidence that arthroscopy with debridement, on the other hand, is no more effective than conservative management.⁶⁷

Continue to: Unicompartmental or "partial"...

Unicompartmental or “partial” knee replacements are reserved for select cases when 1 knee compartment has a significantly higher degree of degenerative change.

CASE After reviewing the therapeutic options with your patient, you agree that she will undergo a course of physical therapy and try using topical diclofenac along with a hinged knee brace. Because of the patient’s age and co-morbidities of cardiovascular disease and mild chronic kidney disease, oral NSAIDs are avoided at this time.

Unicompartmental or “partial” knee replacements are reserved for select cases when 1 knee compartment has a significantly higher degree of degenerative change.

The patient returns to the office in 2 months reporting mild improvement in her pain. To provide additional pain relief, an ­ultrasound-guided IA steroid injection is attempted. The patient also continues home physical therapy, activity modification, topical diclofenac, and use of a hinged knee brace.

She returns to the office 2 months later, reporting continued improvement in her pain. No further intervention is undertaken at this time.

CORRESPONDENCE
Ryan A. Sprouse, MD, CAQSM, West Virginia University School of Medicine–Eastern Campus, WVU Medicine Orthopaedics and Sports Medicine, 912 Somerset Boulevard, Charles Town, WV 25414; [email protected].

Mounting data support acute pancreatitis as one possible GI manifestation of COVID-19, according to investigators.

While previous case reports suggested that infection with SARS-CoV2 may lead to pancreatitis, this retrospective analysis, which is the largest to date, is the first to offer substantial evidence for this claim, reported lead author Sumant Inamdar, MBBS, of the University of Arkansas, Little Rock, and colleagues.

“It has become increasingly clear that COVID-19 has systemic effects that also includes the gastrointestinal and pancreaticobiliary systems,” the investigators wrote in Gastroenterology. “As islet cells of the pancreas contain ACE2 receptor proteins, SARS-CoV2 can bind to these receptors and cause pancreatic injury.”

For the present analysis, Dr. Inamdar and colleagues reviewed charts from 48,012 patients who were hospitalized in New York between March and June of this year. While pancreatitis is usually diagnosed based on two out of three criteria, disease classification in the study required all three: characteristic upper abdominal pain upon admission, lipase greater than three times the upper limit of normal, and evidence of pancreatitis on cross-sectional imaging.

“[B]y including all three criteria for pancreatitis in our definition, we may be underestimating the rate of pancreatitis,” the investigators wrote. “However, we felt including diagnostic lipase levels and imaging was important for the accuracy of the diagnosis.”

Primary outcomes included mechanical ventilation, length of stay, development of pancreatic necrosis, and mortality. Outcomes were compared between patients with and without COVID-19.

Out of 48,012 hospitalized patients, 11,883 (24.75%) tested positive for SARS-CoV2. Across the entire population, 189 patients had pancreatitis (0.39%), and of these, 32 (17%) also had COVID-19. This translates to a point prevalence for pancreatitis of 0.27% for patients hospitalized with COVID-19.

Among patients with pancreatitis who did not have COVID-19, the most common etiologies for pancreatitis were gallstones (34%) and alcohol (37%), compared with just 16% and 6% of SARS-CoV2-positive cases of pancreatitis, respectively. Idiopathic pancreatitis was significantly more common among patients with COVID-19 than those without (69% vs 21%; P less than .0001).

Black or Hispanic patients with pancreatitis were 4-5 times more likely to have COVID-19 than patients with pancreatitis who were white. Across all races/ethnicities, patients with pancreatitis and COVID-19 more often required mechanical ventilation (odds ratio [OR], 5.65) and longer hospital stays (OR, 3.22), compared with those who had pancreatitis alone. While rates of mortality and pancreatic necrosis showed similar trends, associations with COVID-19 were not statistically significant.

“These findings support the notion that pancreatitis should be included in the list of GI manifestations of COVID-19,” the investigators wrote.

When caring for patients with COVID-19, Dr. Inamdar and colleagues recommended that clinicians pay close attention to any history of abdominal pain, and consider testing serum lipase levels.

“Further large studies are needed to confirm our findings,” they concluded.

Avinash Ketwaroo, MD, of Baylor College of Medicine in Houston, agreed that more work is needed; in the meantime, he suggested that evidence is now strong enough for clinicians to take notice.

SOURCE: Inamdar S et al. Gastroenterology. 2020 Aug 26. doi: 10.1053/j.gastro.2020.08.044.

Share AGA GI Patient Center content to help your patients understand the symptoms and complications of pancreatitis at http://ow.ly/j1AN30r8ZDa.

This story was updated on 9/14/2020.

Mounting data support acute pancreatitis as one possible GI manifestation of COVID-19, according to investigators.

While previous case reports suggested that infection with SARS-CoV2 may lead to pancreatitis, this retrospective analysis, which is the largest to date, is the first to offer substantial evidence for this claim, reported lead author Sumant Inamdar, MBBS, of the University of Arkansas, Little Rock, and colleagues.

“It has become increasingly clear that COVID-19 has systemic effects that also includes the gastrointestinal and pancreaticobiliary systems,” the investigators wrote in Gastroenterology. “As islet cells of the pancreas contain ACE2 receptor proteins, SARS-CoV2 can bind to these receptors and cause pancreatic injury.”

For the present analysis, Dr. Inamdar and colleagues reviewed charts from 48,012 patients who were hospitalized in New York between March and June of this year. While pancreatitis is usually diagnosed based on two out of three criteria, disease classification in the study required all three: characteristic upper abdominal pain upon admission, lipase greater than three times the upper limit of normal, and evidence of pancreatitis on cross-sectional imaging.

“[B]y including all three criteria for pancreatitis in our definition, we may be underestimating the rate of pancreatitis,” the investigators wrote. “However, we felt including diagnostic lipase levels and imaging was important for the accuracy of the diagnosis.”

Primary outcomes included mechanical ventilation, length of stay, development of pancreatic necrosis, and mortality. Outcomes were compared between patients with and without COVID-19.

Out of 48,012 hospitalized patients, 11,883 (24.75%) tested positive for SARS-CoV2. Across the entire population, 189 patients had pancreatitis (0.39%), and of these, 32 (17%) also had COVID-19. This translates to a point prevalence for pancreatitis of 0.27% for patients hospitalized with COVID-19.

Among patients with pancreatitis who did not have COVID-19, the most common etiologies for pancreatitis were gallstones (34%) and alcohol (37%), compared with just 16% and 6% of SARS-CoV2-positive cases of pancreatitis, respectively. Idiopathic pancreatitis was significantly more common among patients with COVID-19 than those without (69% vs 21%; P less than .0001).

Black or Hispanic patients with pancreatitis were 4-5 times more likely to have COVID-19 than patients with pancreatitis who were white. Across all races/ethnicities, patients with pancreatitis and COVID-19 more often required mechanical ventilation (odds ratio [OR], 5.65) and longer hospital stays (OR, 3.22), compared with those who had pancreatitis alone. While rates of mortality and pancreatic necrosis showed similar trends, associations with COVID-19 were not statistically significant.

“These findings support the notion that pancreatitis should be included in the list of GI manifestations of COVID-19,” the investigators wrote.

When caring for patients with COVID-19, Dr. Inamdar and colleagues recommended that clinicians pay close attention to any history of abdominal pain, and consider testing serum lipase levels.

“Further large studies are needed to confirm our findings,” they concluded.

Avinash Ketwaroo, MD, of Baylor College of Medicine in Houston, agreed that more work is needed; in the meantime, he suggested that evidence is now strong enough for clinicians to take notice.

SOURCE: Inamdar S et al. Gastroenterology. 2020 Aug 26. doi: 10.1053/j.gastro.2020.08.044.

Share AGA GI Patient Center content to help your patients understand the symptoms and complications of pancreatitis at http://ow.ly/j1AN30r8ZDa.

This story was updated on 9/14/2020.

Mounting data support acute pancreatitis as one possible GI manifestation of COVID-19, according to investigators.

While previous case reports suggested that infection with SARS-CoV2 may lead to pancreatitis, this retrospective analysis, which is the largest to date, is the first to offer substantial evidence for this claim, reported lead author Sumant Inamdar, MBBS, of the University of Arkansas, Little Rock, and colleagues.

“It has become increasingly clear that COVID-19 has systemic effects that also includes the gastrointestinal and pancreaticobiliary systems,” the investigators wrote in Gastroenterology. “As islet cells of the pancreas contain ACE2 receptor proteins, SARS-CoV2 can bind to these receptors and cause pancreatic injury.”

For the present analysis, Dr. Inamdar and colleagues reviewed charts from 48,012 patients who were hospitalized in New York between March and June of this year. While pancreatitis is usually diagnosed based on two out of three criteria, disease classification in the study required all three: characteristic upper abdominal pain upon admission, lipase greater than three times the upper limit of normal, and evidence of pancreatitis on cross-sectional imaging.

“[B]y including all three criteria for pancreatitis in our definition, we may be underestimating the rate of pancreatitis,” the investigators wrote. “However, we felt including diagnostic lipase levels and imaging was important for the accuracy of the diagnosis.”

Primary outcomes included mechanical ventilation, length of stay, development of pancreatic necrosis, and mortality. Outcomes were compared between patients with and without COVID-19.

Out of 48,012 hospitalized patients, 11,883 (24.75%) tested positive for SARS-CoV2. Across the entire population, 189 patients had pancreatitis (0.39%), and of these, 32 (17%) also had COVID-19. This translates to a point prevalence for pancreatitis of 0.27% for patients hospitalized with COVID-19.

Among patients with pancreatitis who did not have COVID-19, the most common etiologies for pancreatitis were gallstones (34%) and alcohol (37%), compared with just 16% and 6% of SARS-CoV2-positive cases of pancreatitis, respectively. Idiopathic pancreatitis was significantly more common among patients with COVID-19 than those without (69% vs 21%; P less than .0001).

Black or Hispanic patients with pancreatitis were 4-5 times more likely to have COVID-19 than patients with pancreatitis who were white. Across all races/ethnicities, patients with pancreatitis and COVID-19 more often required mechanical ventilation (odds ratio [OR], 5.65) and longer hospital stays (OR, 3.22), compared with those who had pancreatitis alone. While rates of mortality and pancreatic necrosis showed similar trends, associations with COVID-19 were not statistically significant.

“These findings support the notion that pancreatitis should be included in the list of GI manifestations of COVID-19,” the investigators wrote.

When caring for patients with COVID-19, Dr. Inamdar and colleagues recommended that clinicians pay close attention to any history of abdominal pain, and consider testing serum lipase levels.

“Further large studies are needed to confirm our findings,” they concluded.

Avinash Ketwaroo, MD, of Baylor College of Medicine in Houston, agreed that more work is needed; in the meantime, he suggested that evidence is now strong enough for clinicians to take notice.

SOURCE: Inamdar S et al. Gastroenterology. 2020 Aug 26. doi: 10.1053/j.gastro.2020.08.044.

Share AGA GI Patient Center content to help your patients understand the symptoms and complications of pancreatitis at http://ow.ly/j1AN30r8ZDa.

This story was updated on 9/14/2020.