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The Effect of 4:3 Intermittent Fasting on Weight Loss at 12 Months: A Randomized Clinical Trial: Annals of Internal Medicine: Vol 178, No 5

Background: Long-term (≥12 months) randomized trials evaluating the efficacy of intermittent fasting (IMF) as a dietary weight loss strategy are limited. Furthermore, no studies have compared IMF versus daily caloric restriction (DCR) when both interventions are provided in the context of a guidelines-based behavioral weight loss program. Objective: To compare the effects of 4:3 IMF versus DCR on changes in weight at 12 months, with comprehensive behavioral support provided to both groups. Design: Randomized clinical trial. (ClinicalTrials.gov: NCT03411356) Setting: Denver, Colorado, and surrounding metropolitan area. Participants: Adults aged 18 to 60 years with body mass index (BMI) of 27 to 46 kg/m2. Intervention: The IMF group was instructed to restrict energy intake by 80% on 3 nonconsecutive days per week, with ad libitum intake (no restriction) the other 4 days (4:3 IMF). The DCR group was instructed to reduce daily energy intake by 34% to match the weekly energy deficit of 4:3 IMF. Both groups received a high-intensity comprehensive behavioral weight loss program that included group-based behavioral support and a recommendation to increase moderate-intensity physical activity to 300 minutes per week. Measurements: The primary outcome was change in body weight (in kilograms) at 12 months. Results: Of the 165 (4:3 IMF, n = 84; DCR, n = 81) randomly assigned participants (mean age, 42 years [SD, 9]; mean BMI, 34.1 kg/m2 [SD, 4.4]; 73.9% female), 125 completed the trial. In an intention-to-treat analysis, 4:3 IMF showed greater reductions in weight than DCR at 12 months (mean difference, 2.89 kg [95% CI, 5.65 to 0.14 kg]; P = 0.040). Limitation: Limited generalizability. Conclusion: Compared with DCR, 4:3 IMF resulted in modestly greater weight loss among adults with overweight or obesity enrolled in a 12-month, high-intensity, comprehensive behavioral weight loss program. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases.

Attention Among Health Care Professionals: A Scoping Review: Annals of Internal Medicine: Vol 177, No 7

Background: The concept of attention can provide insight into the needs of clinicians and how health systems design can impact patient care quality and medical errors. Purpose: To conduct a scoping review to 1) identify and characterize literature relevant to clinician attention; 2) compile metrics used to measure attention; and 3) create a framework of key concepts. Data Sources: Cumulated Index to Nursing and Allied Health Literature (CINAHL), Medline (PubMed), and Embase (Ovid) from 2001 to 26 February 2024. Study Selection: English-language studies addressing health care worker attention in patient care. At least dual review and data abstraction. Data Extraction: Article information, health care professional studied, practice environment, study design and intent, factor type related to attention, and metrics of attention used. Data Synthesis: Of 6448 screened articles, 585 met inclusion criteria. Most studies were descriptive (n = 469) versus investigational (n = 116). More studies focused on barriers to attention (n = 387; 342 descriptive and 45 investigational) versus facilitators to improving attention (n = 198; 112 descriptive and 86 investigational). We developed a framework, grouping studies into 6 categories: 1) definitions of attention, 2) the clinical environment and its effect on attention, 3) personal factors affecting attention, 4) relationships between interventions or factors that affect attention and patient outcomes, 5) the effect of clinical alarms and alarm fatigue on attention, and 6) health information technology’s effect on attention. Eighty-two metrics were used to measure attention. Limitations: Does not synthesize answers to specific questions. Quality of studies was not assessed. Conclusion: This overview may be a resource for researchers, quality improvement experts, and health system leaders to improve clinical environments. Future systematic reviews may synthesize evidence on metrics to measure attention and on the effectiveness of barriers or facilitators related to attention. Primary Funding Source: None.

Long-Term Effect of Salt Substitution for Cardiovascular Outcomes: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 177, No 5

Background: Salt substitution is a simple yet increasingly promising strategy to improve cardiovascular outcomes. Purpose: To evaluate the long-term effects of salt substitution on cardiovascular outcomes. Data Sources: PubMed, EMBASE, Cochrane CENTRAL, and CINAHL searched from inception to 23 August 2023. Trial registries, citation analysis, and hand-search were also done. Study Selection: Randomized controlled trials (RCTs) comparing provision of or advice to use a salt substitute with no intervention or use of regular salt among adults for 6 months or longer in total study duration. Data Extraction: Two authors independently screened articles, extracted data, and assessed risk of bias. Primary outcomes include mortality, major cardiovascular events (MACE), and adverse events at 6 months or greater. Secondary and post hoc outcomes include blood pressure, cause-specific mortality, and urinary excretion at 6 months or greater. Random-effects meta-analyses were done and certainty of effect estimates were assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation). Data Synthesis: Of the 16 included RCTs, 8 reported on primary outcomes. Most (n = 7 of 8) were done in China or Taiwan, 3 were done in residential facilities, and 7 included populations of older age (average 62 years) and/or with higher-than-average cardiovascular risk. In this population, salt substitute may reduce risk for all-cause mortality (6 RCTs; 27 710 participants; rate ratio [RR], 0.88 [95% CI, 0.82 to 0.93]; low certainty) and cardiovascular mortality (4 RCTs; 25 050 participants; RR, 0.83 [CI, 0.73 to 0.95]; low certainty). Salt substitute may result in a slight reduction in MACE (3 RCTs; 23 215 participants; RR, 0.85 [CI, 0.71 to 1.00]; very low certainty), with very low-certainty evidence of serious adverse events (6 RCTs; 27 995 participants; risk ratio, 1.04 [CI, 0.87 to 1.25]) Limitations: The evidence base is dominated by a single, large RCT. Most RCTs were from China or Taiwan and involved participants with higher-than-average cardiovascular risk; therefore, generalizability to other populations is very limited. Conclusion: Salt substitution may reduce all-cause or cardiovascular mortality, but the evidence for reducing cardiovascular events and for not increasing serious adverse events is uncertain, particularly for a Western population. The certainty of evidence is higher among populations at higher cardiovascular risk and/or following a Chinese diet. Primary Funding Source: National Health and Medical Research Council. (PROSPERO: CRD42022327566)

Association of Medicare Advantage Enrollment With Financial Burden of Care: A Retrospective Cohort Study: Annals of Internal Medicine: Vol 177, No 7

Background: Compared with traditional Medicare (TM), Medicare Advantage (MA) plans typically offer supplemental benefits and lower copayments for in-network services and must include an out-of-pocket spending limit. Objective: To examine whether the financial burden of care decreased for persons switching from TM to MA (TM-to-MA switchers) relative to those remaining in TM (TM stayers). Design: Retrospective longitudinal cohort study comparing changes in financial outcomes between TM-to-MA switchers and TM stayers. Setting: Population-based. Participants: 7054 TM stayers and 1544 TM-to-MA switchers from the Medical Expenditure Panel Survey, 2014 to 2021. Measurements: Individual health care costs (out-of-pocket spending and cost sharing), financial burden (high and catastrophic), and subjective financial hardship (difficulty paying medical bills, paying medical bills over time, and inability to pay medical bills). Results: Compared with TM stayers, TM-to-MA switchers had small differences in out-of-pocket spending ($168 [95% CI, −$133 to $469]) and proportions of total health expenses paid out of pocket (cost sharing) (0.2 percentage point [CI, −1.3 to 1.7 percentage points]), families with out-of-pocket spending greater than 20% of their income (high financial burden) (0.3 percentage point [CI, −2.5 to 3.0 percentage points]), families reporting out-of-pocket spending greater than 40% of their income (catastrophic financial burden) (0.7 percentage point [CI, −0.1 to 1.6 percentage points]), families reporting paying medical bills over time (−0.2 percentage point [CI, −1.7 to 1.4 percentage points]), families having problems paying medical bills (−0.4 percentage point [CI, −2.7 to 1.8 percentage points]), and families reporting being unable to pay medical bills (0.4 percentage point [CI, −1.3 to 2.0 percentage points]). Limitation: Inability to account for all medical care and cost needs and variations across MA plans, small baseline differences in out-of-pocket spending, and potential residual confounding. Conclusion: Differences in financial outcomes between beneficiaries who switched from TM to MA and those who stayed with TM were small. Differences in financial burden ranged across outcomes and did not have a consistent pattern. Primary Funding Source: The National Research Foundation of Korea.

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.

Health Care Contact Days Among Older Adults in Traditional Medicare: A Cross-Sectional Study: Annals of Internal Medicine: Vol 177, No 2

Background: Days spent obtaining health care outside the home can represent not only access to needed care but also substantial time, effort, and cost, especially for older adults and their care partners. Yet, these “health care contact days” have not been characterized. Objective: To assess composition of, variation and patterns in, and factors associated with contact days among older adults. Design: Cross-sectional study. Setting: Nationally representative 2019 Medicare Current Beneficiary Survey data linked to claims. Participants: Community-dwelling adults aged 65 years and older in traditional Medicare. Measurements: Ambulatory contact days (days with a primary care or specialty care office visit, test, imaging, procedure, or treatment) and total contact days (ambulatory days plus institutional days in a hospital, emergency department, skilled-nursing facility, or hospice facility); multivariable mixed-effects Poisson regression to identify patient factors associated with contact days. Results: In weighted results, 6619 older adults (weighted: 29 694 084) had means of 17.3 ambulatory contact days (SD, 22.1) and 20.7 total contact days (SD, 27.5) in the year; 11.1% had 50 or more total contact days. Older adults spent most contact days on ambulatory care, including primary care visits (mean [SD], 3.5 [5.0]), specialty care visits (5.7 [9.6]), tests (5.3 [7.2]), imaging (2.6 [3.9]), procedures (2.5 [6.4]), and treatments (5.7 [13.3]). Half of the test and imaging days were not on the same days as office visits (48.6% and 50.1%, respectively). Factors associated with more ambulatory contact days included younger age, female sex, White race, non-Hispanic ethnicity, higher income, higher educational attainment, urban residence, more chronic conditions, and care-seeking behaviors (for example, “go to the doctor…as soon as (I)…feel bad”). Limitation: Study population limited to those in traditional Medicare. Conclusion: On average, older adults spent 3 weeks in the year getting care outside the home. These contact days were mostly ambulatory and varied widely not only by number of chronic conditions but also by sociodemographic factors, geography, and care-seeking behaviors. These results show factors beyond clinical need that may drive overuse and underuse of contact days and opportunities to optimize this person-centered measure to reduce patient burdens, for example, via care coordination. Primary Funding Source: National Institute on Aging.

Disparities in Guideline-Recommended Statin Use for Prevention of Atherosclerotic Cardiovascular Disease by Race, Ethnicity, and Gender: A Nationally Representative Cross-Sectional Analysis of Adults in the United States: Annals of Internal Medicine: Vol 176, No 8

Background: Although statins are a class I recommendation for prevention of atherosclerotic cardiovascular disease and its complications, their use is suboptimal. Differential underuse may mediate disparities in cardiovascular health for systematically marginalized persons. Objective: To estimate disparities in statin use by race–ethnicity–gender and to determine whether these potential disparities are explained by medical appropriateness of therapy and structural factors. Design: Cross-sectional analysis. Setting: National Health and Nutrition Examination Survey from 2015 to 2020. Participants: Persons eligible for statin therapy based on 2013 and 2018 American College of Cardiology/American Heart Association blood cholesterol guidelines. Measurements: The independent variable was race–ethnicity–gender. The outcome of interest was use of a statin. Using the Institute of Medicine framework for examining unequal treatment, we calculated adjusted prevalence ratios (aPRs) to estimate disparities in statin use adjusted for age, disease severity, access to health care, and socioeconomic status relative to non-Hispanic White men. Results: For primary prevention, we identified a lower prevalence of statin use that was not explained by measurable differences in disease severity or structural factors among non-Hispanic Black men (aPR, 0.73 [95% CI, 0.59 to 0.88]) and non-Mexican Hispanic women (aPR, 0.74 [CI, 0.53 to 0.95]). For secondary prevention, we identified a lower prevalence of statin use that was not explained by measurable differences in disease severity or structural factors for non-Hispanic Black men (aPR, 0.81 [CI, 0.64 to 0.97]), other/multiracial men (aPR, 0.58 [CI, 0.20 to 0.97]), Mexican American women (aPR, 0.36 [CI, 0.10 to 0.61]), non-Mexican Hispanic women (aPR, 0.57 [CI, 0.33 to 0.82), non-Hispanic White women (aPR, 0.69 [CI, 0.56 to 0.83]), and non-Hispanic Black women (aPR, 0.75 [CI, 0.57 to 0.92]). Limitation: Cross-sectional data; lack of geographic, language, or statin-dose data. Conclusion: Statin use disparities for several race–ethnicity–gender groups are not explained by measurable differences in medical appropriateness of therapy, access to health care, and socioeconomic status. These residual disparities may be partially mediated by unobserved processes that contribute to health inequity, including bias, stereotyping, and mistrust. Primary Funding Source: National Institutes of Health.

Blood Pressure Level in Late Adolescence and Risk for Cardiovascular Events: A Cohort Study: Annals of Internal Medicine: Vol 176, No 10

Background: Not enough is known about the association between blood pressure (BP) in adolescence and future cardiovascular events. Objective: To measure this association using the 2017 American College of Cardiology/American Heart Association guidelines for classifying BP elevation. Design: Cohort study. Setting: Sweden. Participants: Males in late adolescence who were conscripted into the military from 1969 to 1997. Measurements: Baseline BP was measured at conscription. The primary outcome was a composite of cardiovascular death or first hospitalization for myocardial infarction, heart failure, ischemic stroke, or intracerebral hemorrhage. Results: The study included 1 366 519 males with a mean age of 18.3 years. The baseline BP was classified as elevated (120 to 129/<80 mm Hg) for 28.8% of participants and hypertensive (≥130/80 mm Hg) for 53.7%. During a median follow-up of 35.9 years, 79 644 had a primary outcome. The adjusted hazard ratio was 1.10 for elevated BP (95% CI, 1.07 to 1.13), 1.15 for stage 1 isolated systolic hypertension (ISH) (CI, 1.11 to 1.18), 1.23 for stage 1 isolated diastolic hypertension (IDH) (CI, 1.18 to 1.28), 1.32 for stage 1 systolic–diastolic hypertension (SDH) (CI, 1.27 to 1.37), 1.31 for stage 2 ISH (CI, 1.28 to 1.35), 1.55 for stage 2 IDH (CI, 1.42 to 1.69), and 1.71 for stage 2 SDH (CI, 1.58 to 1.84). The cumulative risk for cardiovascular events also increased gradually across BP stages, ranging from 14.7% for normal BP to 24.3% for stage 2 SDH at age 68 years. Limitation: This was an observational study of Swedish men. Conclusion: Increasing BP levels in late adolescence are associated with gradually increasing risks for major cardiovascular events, beginning at a BP level of 120/80 mm Hg. Primary Funding Source: Västerbotten County Council, Swedish Society for Medical Research, and Heart Foundation of Northern Sweden.

How Would You Manage This Patient With Chronic Insomnia?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 175, No 12

Insomnia, which is characterized by persistent sleep difficulties in association with daytime dysfunction, is a common concern in clinical practice. Chronic insomnia disorder is defined as symptoms that occur at least 3 times per week and persist for at least 3 months. The American Academy of Sleep Medicine (AASM) published recent guidelines on behavioral and psychological treatment as well as pharmacologic therapy for chronic insomnia disorder. Regarding behavioral and psychological approaches, the only intervention strongly recommended was multicomponent cognitive behavioral therapy for insomnia. Regarding pharmacologic treatment, the AASM, based on weak evidence, suggested a limited number of medications that might be useful and others that probably are not. Here, 2 clinicians with expertise in sleep disorders—one a clinical psychologist and the other a physician—debate the management of a patient with chronic insomnia who has been treated with medications. They discuss the role of behavioral and psychological interventions and pharmacologic therapy for chronic insomnia and how the primary care practitioner should approach such a patient.

Effects of Cognitive Behavioral Therapy and Cash Transfers on Older Persons Living Alone in India: A Randomized Trial: Annals of Internal Medicine: Vol 176, No 5

Background: A growing number of older persons in developing countries live entirely alone and are physically, mentally, and financially vulnerable. Objective: To determine whether phone-based cognitive behavioral therapy (CBT) or a cash transfer reduce functional impairment, depression, or food insecurity in this population. Design: Randomized controlled trial. (ClinicalTrials.gov: NCT04225845; American Economic Association RCT Registry: AEARCTR-0007582). Setting: Tamil Nadu, India, 2021. Participants: 1120 people aged 55 years and older and living alone. Interventions: A 6-week, phone-based CBT and a 1-time cash transfer of 1000 rupees (U.S. $12 at market exchange rates) were evaluated in a factorial design. Measurements: The World Health Organization Disability Assessment Schedule (WHODAS), the Geriatric Depression Scale, and food security, all measured 3 weeks after CBT for 977 people and 3 months after for 932. Surveyors were blind to treatment assignment. Results: The WHODAS score (scale 0 to 48, greater values representing more impairment) decreased between baseline and the 3-week follow-up by 2.92 more (95% CI, −5.60 to −0.23) in the group assigned cash only than in the control group, and the depression score (ranging from 0 to 15, higher score indicating more depressive symptoms) decreased by 1.01 more (CI, −2.07 to 0.06). These effects did not persist to the 3-month follow-up, and CBT alone and the 2 together had no significant effects. There were no effects on food security. Limitations: The study cannot say whether more sustained or in-person therapy would have been effective, how results would translate outside of the COVID-19 period, or whether results in the consented sample differ from those in a larger population. Primary outcomes were self-reported. Conclusion: Among older people living alone, a small cash transfer was effective in alleviating short-term (3 weeks) functional impairment, produced a small but not clinically or statistically significant reduction in depression, and had no effect on food security. There were no short-term effects from CBT or the 2 interventions together. None of the interventions showed any effect at 3 months. Primary Funding Source: National Institute on Aging (NIA).

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