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These Annals of Internal Medicine results only contain recent articles.

A Framework for Considering the Value of Race and Ethnicity in Estimating Disease Risk

Background: Accounting for race and ethnicity in estimating disease risk may improve the accuracy of predictions but may also encourage a racialized view of medicine. Objective: To present a decision analytic framework for considering the potential benefits of race-aware over race-unaware risk predictions, using cardiovascular disease, breast cancer, and lung cancer as case studies. Design: Cross-sectional study. Setting: NHANES (National Health and Nutrition Examination Survey), 2011 to 2018, and NLST (National Lung Screening Trial), 2002 to 2004. Patients: U.S. adults. Measurements: Starting with risk predictions from clinically recommended race-aware models, the researchers generated race-unaware predictions via statistical marginalization. They then estimated the utility gains of the race-aware over the race-unaware models, based on a simple utility function that assumes constant costs of screening and constant benefits of disease detection. Results: The race-unaware predictions were substantially miscalibrated across racial and ethnic groups compared with the race-aware predictions as the benchmark. However, the clinical net benefit at the population level of race-aware predictions over race-unaware predictions was smaller than expected. This result stems from 2 empirical patterns: First, across all 3 diseases, 95% or more of individuals would receive the same decision regardless of whether race and ethnicity are included in risk models; second, for those who receive different decisions, the net benefit of screening or treatment is relatively small because these patients have disease risks close to the decision threshold (that is, the theoretical “point of indifference”). When used to inform rationing, race-aware models may have a more substantial net benefit. Limitations: For illustrative purposes, the race-aware models were assumed to yield accurate estimates of risk given the input variables. The researchers used a simplified approach to generate race-unaware risk predictions from the race-aware models and a simple utility function to compare models. Conclusion: The analysis highlights the importance of foregrounding changes in decisions and utility when evaluating the potential benefit of using race and ethnicity to estimate disease risk. Primary Funding Source: The Greenwall Foundation.

How Would You Prevent Subsequent Strokes in This Patient? Grand Rounds Discussion From Beth Israel Deaconess Medical Center

Stroke is a major cause of morbidity, mortality, and disability. The American Heart Association/American Stroke Association recently published updated guidelines on secondary stroke prevention. In these rounds, 2 vascular neurologists use the case of Mr. S, a 75-year-old man with a history of 2 strokes, to discuss and debate questions in the guideline concerning intensity of atrial fibrillation monitoring in embolic stroke of undetermined source, diagnosis and management of moderate symptomatic carotid stenosis, and therapeutic strategies for recurrent embolic stroke of undetermined source in the setting of guideline-concordant therapy.

Efficacy of a Therapeutic Pelvic Yoga Program Versus a Physical Conditioning Program on Urinary Incontinence in Women: A Randomized Trial: Annals of Internal Medicine: Vol 177, No 10

Background: Pelvic floor yoga has been recommended as a complementary treatment strategy for urinary incontinence (UI) in women, but evidence of its efficacy is lacking. Objective: To evaluate the effects of a therapeutic pelvic floor yoga program versus a nonspecific physical conditioning program on UI in women. Design: Randomized trial. (ClinicalTrials.gov: NCT03672461) Setting: Three study sites in California, United States. Participants: Ambulatory women aged 45 years or older reporting daily urgency-, stress-, or mixed-type UI. Intervention: Twelve-week program of twice-weekly group instruction and once-weekly self-directed practice of pelvic floor–specific Hatha yoga techniques (pelvic yoga) versus equivalent-time instruction and practice of general skeletal muscle stretching and strengthening exercises (physical conditioning). Measurements: Total and type-specific UI frequency assessed by 3-day voiding diaries. Results: Among the 240 randomly assigned women (age range, 45 to 90 years), mean baseline UI frequency was 3.4 episodes per day (SD, 2.2), including 1.9 urgency-type episodes per day (SD, 1.9) and 1.4 stress-type episodes per day (SD, 1.7). Over a 12-week time period, total UI frequency (primary outcome) decreased by an average of 2.3 episodes per day with pelvic yoga and 1.9 episodes per day with physical conditioning (between-group difference of −0.3 episodes per day [95% CI, −0.7 to 0.0]). Urgency-type UI frequency decreased by 1.2 episodes per day in the pelvic yoga group and 1.0 episode per day in the physical conditioning group (between-group difference of −0.3 episodes per day [CI, −0.5 to 0.0]). Reductions in stress-type UI frequency did not differ between groups (−0.1 episodes per day [CI, −0.3 to 0.3]). Limitation: No comparison to no treatment or other clinical UI treatments; conversion to videoconference-based intervention instruction during the COVID-19 pandemic. Conclusion: A 12-week pelvic yoga program was not superior to a general muscle stretching and strengthening program in reducing clinically important UI in midlife and older women with daily UI. Primary Funding Source: National Institutes of Health.

Trends in Psychological Distress and Outpatient Mental Health Care of Adults During the COVID-19 Era

Background: In addition to the physical disease burden of the COVID-19 pandemic, concern exists over its adverse mental health effects. Objective: To characterize trends in psychological distress and outpatient mental health care among U.S. adults from 2018 to 2021 and to describe patterns of in-person, telephone, and video outpatient mental health care. Design: Cross-sectional nationally representative survey of noninstitutionalized adults. Setting: United States. Participants: Adults included in the Medical Expenditure Panel Survey Household Component, 2018 to 2021 (n = 86 658). Measurements: Psychological distress was measured with the Kessler-6 scale (range of 0 to 24, with higher scores indicating more severe distress), with a score of 13 or higher defined as serious psychological distress, 1 to 12 as less serious distress, and 0 as no distress. Outpatient mental health care use was measured via computer-assisted personal interviews. Results: Between 2018 and 2021, the rate of serious psychological distress among adults increased from 3.5% to 4.2%. Although the rate of outpatient mental health care increased from 11.2% to 12.4% overall, the rate decreased from 46.5% to 40.4% among adults with serious psychological distress. When age, sex, and distress were controlled for, a significant increase in outpatient mental health care was observed for young adults (aged 18 to 44 years) but not middle-aged (aged 45 to 64 years) and older (aged >65 years) adults and for employed adults but not unemployed adults. In 2021, 33.4% of mental health outpatients received at least 1 video visit, including a disproportionate percentage of young, college-educated, higher-income, employed, and urban adults. Limitation: Information about outpatient mental health service modality (in-person, video, telephone) was first fully available in the 2021 survey. Conclusion: These trends and patterns underscore the persistent challenges of connecting older adults, unemployed persons, and seriously distressed adults to outpatient mental health care and the difficulties faced by older, less educated, lower-income, unemployed, and rural patients in accessing outpatient mental health care via video. Primary Funding Source: None.

Association of Semaglutide With Tobacco Use Disorder in Patients With Type 2 Diabetes: Target Trial Emulation Using Real-World Data: Annals of Internal Medicine: Vol 177, No 8

Background: Reports of reduced desire to smoke in patients treated with semaglutide, a glucagon-like peptide receptor agonist (GLP-1RA) medication for type 2 diabetes mellitus (T2DM) and obesity, have raised interest about its potential benefit for tobacco use disorders (TUDs). Objective: To examine the association of semaglutide with TUD-related health care measures in patients with comorbid T2DM and TUD. Design: Emulation target trial based on a nationwide population-based database of patient electronic health records. Setting: United States, 1 December 2017 to 31 March 2023. Participants: Seven target trials were emulated among eligible patients with comorbid T2DM and TUD by comparing the new use of semaglutide versus 7 other antidiabetes medications (insulins, metformin, dipeptidyl-peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors, sulfonylureas, thiazolidinediones, and other GLP-1RAs). Measurements: The TUD-related health care measures (medical encounter for diagnosis of TUD, smoking cessation medication prescriptions, and smoking cessation counseling) that occurred within a 12-month follow-up were examined using Cox proportional hazards and Kaplan–Meier survival analyses. Results: The study compared 222 942 new users of antidiabetes medications including 5967 of semaglutide. Semaglutide was associated with a significantly lower risk for medical encounters for TUD diagnosis compared with other antidiabetes medications, and was strongest compared with insulins (hazard ratio [HR], 0.68 [95% CI, 0.63 to 0.74]) and weakest but statistically significant compared with other GLP-1RAs (HR, 0.88 [CI, 0.81 to 0.96]). Semaglutide was associated with reduced smoking cessation medication prescriptions and counseling. Similar findings were observed in patients with and without a diagnosis of obesity. For most of the group comparisons, the differences occurred within 30 days of prescription initiation. Limitation: Documentation bias, residual confounding, missing data on current smoking behavior, body mass index, and medication adherence. Conclusion: Semaglutide was associated with lower risks for TUD-related health care measures in patients with comorbid T2DM and TUD compared with other antidiabetes medications including other GLP-1Ras, primarily within 30 days of prescription. These findings suggest the need for clinical trials to evaluate semaglutide’s potential for TUD treatment. Primary Funding Source: National Institutes of Health.

How Would You Manage This Patient With Heart Failure With Preserved Ejection Fraction?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 176, No 12

The proportion of patients with new-onset heart failure who have preserved rather than reduced left ventricular ejection fraction (HFpEF and HFrEF) has been increasing over recent decades. In fact, HFpEF now outweighs HFrEF as the predominant heart failure subtype and likely remains underdiagnosed in the community. This is due in part to an aging population and a rise in other risk factors for HFpEF, including obesity and associated cardiometabolic disease. Whereas the diagnosis of HFrEF is relatively straightforward, the diagnosis of HFpEF is often more challenging because there can be other causes for symptoms, including dyspnea and fatigue, and cardinal physical examination findings of elevated jugular venous pressure or pulmonary congestion may not be evident at rest. In 2022, the American College of Cardiology, the American Heart Association, and the Heart Failure Society of America published a comprehensive guideline on heart failure that included recommendations for the management of HFpEF. The use of diuretics for the management of congestion remained the only class 1 (strong) recommendation. New recommendations included broader use of sodium–glucose cotransporter-2 inhibitors (SGLT2i, class 2a), and angiotensin receptor–neprilysin inhibitors (class 2b). In 2023, the American College of Cardiology published an expert consensus decision pathway for the management of HFpEF that suggests treatment strategies based on sex assigned at birth, ejection fraction, clinical evidence of congestion, and candidacy for SGLT2i therapy. Here, 2 experts, a cardiologist and a geriatrician, discuss their approach to the diagnosis and management of HFpEF and how they would apply guidelines to an individual patient.

Reducing Care Overuse in Older Patients Using Professional Norms and Accountability: A Cluster Randomized Controlled Trial: Annals of Internal Medicine: Vol 177, No 3

Background: Effective strategies are needed to curtail overuse that may lead to harm. Objective: To evaluate the effects of clinician decision support redirecting attention to harms and engaging social and reputational concerns on overuse in older primary care patients. Design: 18-month, single-blind, pragmatic, cluster randomized trial, constrained randomization. (ClinicalTrials.gov: NCT04289753) Setting: 60 primary care internal medicine, family medicine and geriatrics practices within a health system from 1 September 2020 to 28 February 2022. Participants: 371 primary care clinicians and their older adult patients from participating practices. Intervention: Behavioral science–informed, point-of-care, clinical decision support tools plus brief case-based education addressing the 3 primary clinical outcomes (187 clinicians from 30 clinics) were compared with brief case-based education alone (187 clinicians from 30 clinics). Decision support was designed to increase salience of potential harms, convey social norms, and promote accountability. Measurements: Prostate-specific antigen (PSA) testing in men aged 76 years and older without previous prostate cancer, urine testing for nonspecific reasons in women aged 65 years and older, and overtreatment of diabetes with hypoglycemic agents in patients aged 75 years and older and hemoglobin A1c (HbA1c) less than 7%. Results: At randomization, mean clinic annual PSA testing, unspecified urine testing, and diabetes overtreatment rates were 24.9, 23.9, and 16.8 per 100 patients, respectively. After 18 months of intervention, the intervention group had lower adjusted difference-in-differences in annual rates of PSA testing (−8.7 [95% CI, −10.2 to −7.1]), unspecified urine testing (−5.5 [CI, −7.0 to −3.6]), and diabetes overtreatment (−1.4 [CI, −2.9 to −0.03]) compared with education only. Safety measures did not show increased emergency care related to urinary tract infections or hyperglycemia. An HbA1c greater than 9.0% was more common with the intervention among previously overtreated diabetes patients (adjusted difference-in-differences, 0.47 per 100 patients [95% CI, 0.04 to 1.20]). Limitation: A single health system limits generalizability; electronic health data limit ability to differentiate between overtesting and underdocumentation. Conclusion: Decision support designed to increase clinicians’ attention to possible harms, social norms, and reputational concerns reduced unspecified testing compared with offering traditional case-based education alone. Small decreases in diabetes overtreatment may also result in higher rates of uncontrolled diabetes. Primary Funding Source: National Institute on Aging.

The Effect of Practitioner Empathy on Patient Satisfaction: A Systematic Review of Randomized Trials: Annals of Internal Medicine: Vol 177, No 2

Background: Practitioners who deliver enhanced empathy may improve patient satisfaction with care. Patient satisfaction is associated with positive patient outcomes ranging from medication adherence to survival. Purpose: To evaluate the effect of health care practitioner empathy on patient satisfaction, using a systematic review of randomized trials. Data Sources: Ovid MEDLINE, CINAHL, PsycInfo, Cochrane Central Register of Controlled Trials, and Scopus to 23 October 2023. Study Selection: Randomized trials published in any language that evaluated the effect of empathy on improving patient satisfaction as measured on a validated patient satisfaction scale. Data Extraction: Data extraction, risk-of-bias assessments, and strength-of-evidence assessments were done by 2 independent reviewers. Disagreements were resolved through consensus. Data Synthesis: Fourteen eligible randomized trials (80 practitioners; 1986 patients) were included in the analysis. Five studies had high risk of bias, and 9 had some concerns about bias. The trials were heterogeneous in terms of geographic locations (North America, Europe, Asia, and Africa), settings (hospital and primary care), practitioner types (family and hospital physicians, anesthesiologists, nurses, psychologists, and caregivers), and type of randomization (individual patient or clustered by practitioner). Although all trials suggested a positive change in patient satisfaction, inadequate reporting hindered the ability to draw definitive conclusions about the overall effect size. Limitations: Heterogeneity in the way that empathy was delivered and patient satisfaction was measured and incomplete reporting leading to concerns about the certainty of the underpinning evidence. Conclusion: Various empathy interventions have been studied to improve patient satisfaction. Development, testing, and reporting of high-quality studies within well-defined contexts is needed to optimize empathy interventions that increase patient satisfaction. Primary Funding Source: Stoneygate Trust. (PROSPERO: CRD42023412981)

The Safety of Outpatient Health Care: Review of Electronic Health Records: Annals of Internal Medicine: Vol 177, No 6

Background: Despite considerable emphasis on delivering safe care, substantial patient harm occurs. Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited. Objective: To measure AEs in the outpatient setting. Design: Retrospective review of the electronic health record (EHR). Setting: 11 outpatient sites in Massachusetts in 2018. Patients: 3103 patients who received outpatient care. Measurements: Using a trigger method, nurse reviewers identified possible AEs and physicians adjudicated them, ranked severity, and assessed preventability. Generalized estimating equations were used to assess the association of having at least 1 AE with age, sex, race, and primary insurance. Variation in AE rates was analyzed across sites. Results: The 3103 patients (mean age, 52 years) were more often female (59.8%), White (75.1%), English speakers (90.8%), and privately insured (70.4%) and had a mean of 4 outpatient encounters in 2018. Overall, 7.0% (95% CI, 4.6% to 9.3%) of patients had at least 1 AE (8.6 events per 100 patients annually). Adverse drug events were the most common AE (63.8%), followed by health care–associated infections (14.8%) and surgical or procedural events (14.2%). Severity was serious in 17.4% of AEs, life-threatening in 2.1%, and never fatal. Overall, 23.2% of AEs were preventable. Having at least 1 AE was less often associated with ages 18 to 44 years than with ages 65 to 84 years (standardized risk difference, −0.05 [CI, −0.09 to −0.02]) and more often associated with Black race than with Asian race (standardized risk difference, 0.09 [CI, 0.01 to 0.17]). Across study sites, 1.8% to 23.6% of patients had at least 1 AE and clinical category of AEs varied substantially. Limitation: Retrospective EHR review may miss AEs. Conclusion: Outpatient harm was relatively common and often serious. Adverse drug events were most frequent. Rates were higher among older adults. Interventions to curtail outpatient harm are urgently needed. Primary Funding Source: Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.