Preventing Obesity in Midlife Women: A Systematic Review for the Women's Preventive Services Initiative

Background: Despite high prevalence rates of obesity in the United States, no clinical guidelines exist for obesity prevention in midlife women who commonly experience weight gain. Purpose: To evaluate evidence on the effectiveness and harms of behavioral interventions to reduce weight gain and improve health outcomes for women aged 40 to 60 years without obesity. Data Sources: English-language searches of Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews (inception to 26 October 2021); ClinicalTrials.gov (October 2021); and reference lists of studies and reviews. Study Selection: Randomized controlled trials (RCTs) enrolling predominantly midlife women comparing behavioral interventions to prevent weight gain with control groups and reporting health outcomes and potential harms. Data Extraction: Dual extraction and quality assessment of individual studies. Data Synthesis: Seven RCTs in 12 publications (n = 51 638) were included. Four RCTs showed statistically significant favorable differences in weight change for counseling interventions versus control groups (mean difference of weight change, −0.87 to −2.5 kg), whereas 1 trial of counseling and 2 trials of exercise showed no differences; 1 of 2 RCTs reported improved quality-of-life measures. Interventions did not increase measures of depression or stress in 1 trial; self-reported falls (37% vs. 29%; P < 0.001) and injuries (19% vs. 14%; P = 0.03) were higher with exercise counseling in 1 trial. Limitation: Trials were generally small, heterogeneous, and lacked data on harms, long-term health outcomes, and specific patient populations. Conclusion: Counseling interventions to prevent weight gain in women during midlife may result in modest differences in weight change without causing important harms. More research is needed to determine optimal content, frequency, length, and number of sessions required and should include additional patient populations. Primary Funding Source: Health Resources and Services Administration.

Shifting Focus to Evidence-Based Management of Substance Use Disorders

Now Is the Time to Make Screening for Lung Cancer Reportable

Effect of Social Needs Case Management on Hospital Use Among Adult Medicaid Beneficiaries: A Randomized Study: Annals of Internal Medicine: Vol 175, No 8

Background: Case management programs assisting patients with social needs may improve health and avoid unnecessary health care use, but little is known about their effectiveness. Objective: This large-scale study assessed the population-level impact of a case management program designed to address patients' social needs. Design: Single-site randomized encouragement design with administrative enrollment from an eligible population and intention-to-treat analysis. Study participants were enrolled between August 2017 and December 2018 and followed for 1 year. (ClinicalTrials.gov: NCT04000074) Setting: Contra Costa County, an economically and culturally diverse community in the San Francisco Bay Area. Participants: 57 972 randomized enrollments of adult Medicaid patients at elevated risk for health care use (top 15%) to the intervention or control group. Intervention: Enrollees were offered 12 months of social needs case management, which provided more intensive services to patients with higher demonstrated needs. Measurements: Medical use was measured via emergency department (ED) visits and inpatient admissions, some of which were classified as avoidable. Results: Participants in the intervention group visited the ED at ratios of 0.96 (95% CI, 0.91 to 1.00) for all visits and 0.97 (CI, 0.92 to 1.03) for avoidable visits relative to the control group. The intervention group was hospitalized at ratios of 0.89 (CI, 0.81 to 0.98) for all admissions and 0.72 (CI, 0.55 to 0.88) for avoidable admissions. Limitations: Only 40% of the intervention group engaged with the program. The program was in continual development during the trial period. Conclusion: Although social needs case management programs may reduce health care use, these savings may not cover full program costs. More work is needed to identify ways to increase patient uptake and define characteristics of successful programs. Primary Funding Source: Contra Costa Health Services via the Medicaid waiver program.

Tea Consumption and All-Cause and Cause-Specific Mortality in the UK Biobank: A Prospective Cohort Study: Annals of Internal Medicine: Vol 175, No 9

Background: Tea is frequently consumed worldwide, but the association of tea drinking with mortality risk remains inconclusive in populations where black tea is the main type consumed. Objective: To evaluate the associations of tea consumption with all-cause and cause-specific mortality and potential effect modification by genetic variation in caffeine metabolism. Design: Prospective cohort study. Setting: The UK Biobank. Participants: 498 043 men and women aged 40 to 69 years who completed the baseline touchscreen questionnaire from 2006 to 2010. Measurements: Self-reported tea intake and mortality from all causes and leading causes of death, including cancer, all cardiovascular disease (CVD), ischemic heart disease, stroke, and respiratory disease. Results: During a median follow-up of 11.2 years, higher tea intake was modestly associated with lower all-cause mortality risk among those who drank 2 or more cups per day. Relative to no tea drinking, the hazard ratios (95% CIs) for participants drinking 1 or fewer, 2 to 3, 4 to 5, 6 to 7, 8 to 9, and 10 or more cups per day were 0.95 (95% CI, 0.91 to 1.00), 0.87 (CI, 0.84 to 0.91), 0.88 (CI, 0.84 to 0.91), 0.88 (CI, 0.84 to 0.92), 0.91 (CI, 0.86 to 0.97), and 0.89 (CI, 0.84 to 0.95), respectively. The association was most consistent for those who drank tea without added sugar or added milk to their tea. Inverse associations were seen for mortality from all CVD, ischemic heart disease, and stroke. Findings were similar regardless of whether participants also drank coffee or not or of genetic score for caffeine metabolism. Limitation: Potentially important aspects of tea intake (for example, portion size and tea strength) were not assessed. Conclusion: Higher tea intake was associated with lower mortality risk among those drinking 2 or more cups per day, regardless of genetic variation in caffeine metabolism. These findings suggest that tea, even at higher levels of intake, can be part of a healthy diet. Primary Funding Source: National Cancer Institute Intramural Research Program.

Early Rhythm Control Therapy for Atrial Fibrillation in Low-Risk Patients: A Nationwide Propensity Score–Weighted Study: Annals of Internal Medicine: Vol 175, No 10

Background: Rhythm control is associated with lower risk for adverse cardiovascular outcomes compared with usual care among patients recently diagnosed with atrial fibrillation (AF) with a CHA2DS2-VASc score of approximately 2 or greater in EAST-AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial). Objective: To investigate whether the results can be generalized to patients with low stroke risk. Design: Population-based cohort study. Setting: Nationwide claims database of the Korean National Health Insurance Service. Participants: 54 216 patients with AF having early rhythm control (antiarrhythmic drugs or ablation) or rate control therapy that was initiated within 1 year of the AF diagnosis. Measurements: The effect of early rhythm control on the primary composite outcome of cardiovascular death, ischemic stroke, hospitalization for heart failure, or myocardial infarction was compared between eligible and ineligible patients for EAST-AFNET 4 (CHA2DS2-VASc score, approximately 0 to 1) using propensity overlap weighting. Results: In total, 37 557 study participants (69.3%) were eligible for the trial (median age, 70 years; median CHA2DS2-VASc score, 4), among whom early rhythm control was associated with lower risk for the primary composite outcome than rate control (hazard ratio, 0.86 [95% CI, 0.81 to 0.92]). Among the 16 659 low-risk patients (30.7%) who did not meet the inclusion criteria (median age, 54 years; median CHA2DS2-VASc score, 1), early rhythm control was consistently associated with lower risk for the primary outcome (hazard ratio, 0.81 [CI, 0.66 to 0.98]). No significant differences in safety outcomes were found between the rhythm and rate control strategies regardless of trial eligibility. Limitation: Residual confounding. Conclusion: In routine clinical practice, the beneficial association between early rhythm control and cardiovascular complications was consistent among low-risk patients regardless of trial eligibility. Primary Funding Source: The Ministry of Health and Welfare and the Ministry of Food and Drug Safety, Republic of Korea.

Testosterone and Cardiovascular Disease in Men

Efficacy and Safety of Dapagliflozin According to Frailty in Heart Failure With Reduced Ejection Fraction: A Post Hoc Analysis of the DAPA-HF Trial: Annals of Internal Medicine: Vol 175, No 6

Background: Frailty may modify the risk−benefit profile of certain treatments, and frail patients may have reduced tolerance to treatments. Objective: To investigate the efficacy of dapagliflozin according to frailty status, using the Rockwood cumulative deficit approach, in DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure). Design: Post hoc analysis of a phase 3 randomized clinical trial. (ClinicalTrials.gov: NCT03036124) Setting: 410 sites in 20 countries. Patients: Patients with symptomatic heart failure (HF) with a left ventricular ejection fraction of 40% or less and elevated natriuretic peptide. Intervention: Addition of once-daily 10 mg of dapagliflozin or placebo to guideline-recommended therapy. Measurements: The primary outcome was worsening HF or cardiovascular death. Results: Of the 4744 patients randomly assigned in DAPA-HF, a frailty index (FI) was calculable in 4742. In total, 2392 patients (50.4%) were in FI class 1 (FI ≤0.210; not frail), 1606 (33.9%) in FI class 2 (FI 0.211 to 0.310; more frail), and 744 (15.7%) in FI class 3 (FI ≥0.311; most frail). The median follow-up time was 18.2 months. Dapagliflozin reduced the risk for worsening HF or cardiovascular death, regardless of FI class. The differences in event rate per 100 person-years for dapagliflozin versus placebo from lowest to highest FI class were −3.5 (95% CI, −5.7 to −1.2), −3.6 (CI, −6.6 to −0.5), and −7.9 (CI, −13.9 to −1.9). Consistent benefits were observed for other clinical events and health status, but the absolute reductions were generally larger in the most frail patients. Study drug discontinuation and serious adverse events were not more frequent with dapagliflozin than placebo, regardless of FI class. Limitation: Enrollment criteria precluded the inclusion of very high-risk patients. Conclusion: Dapagliflozin improved all outcomes examined, regardless of frailty status. However, the absolute reductions were larger in more frail patients. Primary Funding Source: AstraZeneca.

Characteristics of High-Need, High-Cost Patients: A “Best-Fit” Framework Synthesis: Annals of Internal Medicine: Vol 175, No 12

Background: Accurately identifying high-need, high-cost (HNHC) patients to reduce their preventable or modifiable health care use for their chronic conditions is a priority and a challenge for U.S. policymakers, health care delivery systems, and payers. Purpose: To identify characteristics and criteria to distinguish HNHC patients. Data Sources: Searches of multiple databases and gray literature from 1 January 2000 to 22 January 2022. Study Selection: English-language studies of characteristics and criteria to identify HNHC adult patients, defined as those with high use (emergency department, inpatient, or total services) or high cost. Data Extraction: Independent, dual-review extraction and quality assessment. Data Synthesis: The review included 64 studies comprising multivariate exposure studies (n = 47), cluster analyses (n = 11), and qualitative studies (n = 6). A National Academy of Medicine (NAM) taxonomy was an initial “best-fit” framework for organizing the synthesis of the findings. Patient characteristics associated with being HNHC included number and severity of comorbid conditions and having chronic clinical conditions, particularly heart disease, chronic kidney disease, chronic lung disease, diabetes, cancer, and hypertension. Patients' risk for being HNHC was often amplified by behavioral health conditions and social risk factors. The reviewers revised the NAM taxonomy to create a final framework, adding chronic pain and prior patterns of high health care use as characteristics associated with an increased risk for being HNHC. Limitation: Little evidence distinguished potentially preventable or modifiable health care use from overall use. Conclusion: A combination of characteristics can be useful for identifying HNHC patients. Because of the complexity of their conditions and circumstances, improving their quality of care will likely also require an individualized assessment of care needs and availability of support services. Primary Funding Source: Agency for Healthcare Research and Quality. (PROSPERO: CRD42020161179)

Cardiometabolic Morbidity of Mild Cortisol Excess