Wiegand RE, Payne AB, Mak J
… +35 more, Chickery S, Reese SE, Klein NP, Grannis SJ, Ong TC, Rowley EAK, DeSilva M, Dascomb K, Irving SA, Zerbo O, Hansen JR, Block L, Jacobson KB, Dixon BE, Rogerson CM, Duszynski TJ, Fadel WF, Barron MA, Mayer D, Chavez C, Yang DH, Ball SW, McEvoy CE, Akinsete OO, Sheffield T, Bride D, Arndorfer J, Van Otterloo J, Naleway AL, Natarajan K, Najdowski M, Ciesla AA, Kautz A, DeCuir J, Link-Gelles R
JAMA Intern Med
· 2026 Jun · PMID 42295789
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IMPORTANCE: Vaccine effectiveness (VE) estimates are needed to monitor the effect of updated COVID-19 vaccinations. OBJECTIVE: To assess the effectiveness of 2024-2025 COVID-19 vaccines against medically attended COVID-1...IMPORTANCE: Vaccine effectiveness (VE) estimates are needed to monitor the effect of updated COVID-19 vaccinations. OBJECTIVE: To assess the effectiveness of 2024-2025 COVID-19 vaccines against medically attended COVID-19 among adults 18 years and older in the US. DESIGN, SETTING, AND PARTICIPANTS: This case-control study with a test-negative design included patient encounters with a COVID-19-like illness discharge diagnosis code and a molecular or antigen SARS-CoV-2 test within 10 days before to 3 days after the encounter date, from September 5, 2024, to September 2, 2025. Encounters were captured in VISION (Virtual SARS-CoV-2, Influenza, and Other Respiratory Viruses Network), a multisite, electronic medical record-based network of health care systems, including 381 emergency department/urgent care (ED/UC) departments and 246 hospitals in 6 states. EXPOSURE: Vaccination with a 2024-2025 COVID-19 vaccine formulation (approved by the US Food and Drug Administration in August 2024) in the previous 7 to 299 days. MAIN OUTCOMES AND MEASURES: Outcomes were COVID-19-associated ED/UC encounters, COVID-19-associated hospitalization, and COVID-19-associated critical illness (hospitalization with an intensive care unit admission or in-hospital death). Encounters with a positive molecular or antigen SARS-CoV-2 test result were classified as cases, and encounters with a negative molecular SARS-CoV-2 test result were classified as controls. The odds of 2024-2025 COVID-19 vaccination were compared among cases and controls, adjusting for confounders, with estimated VE calculated as (1 - adjusted odds ratio) × 100%. RESULTS: In 333 262 eligible ED/UC encounters (median [IQR] age of patients, 54 [35-72] years; 60% female) and 97 663 eligible hospitalizations among immunocompetent adults 18 years and older (median [IQR] age of patients, 72 [59-81] years; 53% female), estimated VE was 26% (95% CI, 23%-29%) against COVID-19-associated ED/UC encounters, 35% (95% CI, 30%-40%) against COVID-19-associated hospitalization, and 41% (95% CI, 28%-51%) against COVID-19-associated critical illness 7 to 299 days after vaccination. Among immunocompetent adults 65 years and older (122 663 ED/UC encounters and 63 958 hospitalizations), estimated VE was 26% (95% CI, 22%-30%) against COVID-19-associated ED/UC encounters, 35% (95% CI, 29%-40%) against COVID-19-associated hospitalization, and 41% (95% CI, 28%-52%) against COVID-19-associated critical illness 7 to 299 days after vaccination. Among 32 629 hospitalizations in immunocompromised adults 18 years and older, estimated VE against COVID-19-associated hospitalization was 24% (95% CI, 13%-34%). VE estimates waned with more time since vaccination. CONCLUSIONS AND RELEVANCE: In this test-negative case-control study, 2024-2025 COVID-19 vaccination was associated with reduced likelihood of medically attended COVID-19-associated outcomes among immunocompetent and immunocompromised adults, highlighting the importance of adults receiving recommended COVID-19 vaccinations.
Vaughan EM, Yu X, Amspoker AB
… +8 more, Naik AD, Balasubramanyam A, Johnston CA, Ballantyne CM, Virani SS, Brown HS, Mena K, Porterfield LR
JAMA Intern Med
· 2026 Jun · PMID 42258200
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IMPORTANCE: Community health workers (CHWs) improve chronic disease management in underserved populations, but scalable integration strategies are limited. OBJECTIVE: To evaluate whether a multidimensional intervention i...IMPORTANCE: Community health workers (CHWs) improve chronic disease management in underserved populations, but scalable integration strategies are limited. OBJECTIVE: To evaluate whether a multidimensional intervention incorporating telementored CHWs and a structured participant-CHW-clinician feedback loop can improve diabetes outcomes. DESIGN, SETTING, AND PARTICIPANTS: This 12-month randomized clinical trial was conducted at 3 institutionally and geographically diverse community clinics in Texas between September 1, 2023, and April 30, 2025, and included low-income, uninsured White Hispanic adults with type 2 diabetes identified through clinic databases. Data were analyzed between May 1 and July 31, 2025. INTERVENTION: Individuals were randomized 1:1 to the intervention or control. For the intervention, CHWs delivered (1) group diabetes education, (2) individualized telehealth-based coaching, and (3) a novel participant-CHW-clinician feedback loop to facilitate communication, address participant concerns, and improve care coordination. The control was usual care (quarterly clinician visits and access to multidisciplinary and social services). MAIN OUTCOMES AND MEASURES: The primary outcome was baseline to 12-month change in hemoglobin A1c (HbA1c) level. Secondary outcomes included changes in cholesterol levels, American Diabetes Association (ADA) guideline adherence, participant recruitment, intervention fidelity, and feedback loop issue resolution. RESULTS: Of 257 participants included in the intention-to-treat analysis (mean [SD] age 54 [11] years; 166 [64.6%] female), 129 were in the intervention group and 128 were in the control group. The intervention reduced HbA1c (net difference, -1.0 [95% CI, -1.5 to -0.4] percentage points [pp]; P = .001), total cholesterol (net difference, -35.4 mg/dL; 95% CI, -54.6 to -17.2 mg/dL; P = .02), and low-density lipoprotein cholesterol (net difference, -29.7 mg/dL; 95% CI, -44.5 to -14.9 mg/dL; P < .001) levels compared with control. ADA guideline adherence improved for foot examinations (absolute risk [AR], 19.2 [95% CI, 7.4-30.9] pp; relative risk [RR], 1.65 [95% CI, 1.19-2.27]; P = .03) and urine microalbumin screening (AR, 15.8 [95% CI, 5.3-26.3] pp; RR, 1.24 [95% CI, 1.07-1.43]; P = .048). CHWs addressed 490 participant concerns (87.2%) via the feedback loop, including medication refills, glucose management, and access to care. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the CHW intervention significantly improved diabetes outcomes in low-income settings, potentially by reducing fragmentation through structured feedback. Findings also highlight limitations in usual care, underscoring the need for scalable strategies to strengthen chronic disease management in low-income populations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04835493.
Hshieh TT, Kunicki ZJ, Fong TG
… +5 more, Marcantonio ER, Schmitt EM, Xu G, Jones RN, Inouye SK
JAMA Intern Med
· 2026 Jun · PMID 42258189
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IMPORTANCE: Postoperative delirium is associated with long-term cognitive decline in older adults. This might be caused by the delirium itself or because delirium is more common in persons who are ill and frail, and thes...IMPORTANCE: Postoperative delirium is associated with long-term cognitive decline in older adults. This might be caused by the delirium itself or because delirium is more common in persons who are ill and frail, and these conditions are also associated with cognitive decline. OBJECTIVE: To determine whether cognitive decline associated with postoperative delirium is mediated by illness and frailty, as measured by recurrent hospitalizations. DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study included community-dwelling older adults (age ≥70 years), enrolled from June 2010 to August 2013 with 5 years of follow-up data in the ongoing Successful Aging after Elective Surgery longitudinal study. Data were analyzed from November 2022 to May 2026. EXPOSURES: Incident delirium following major elective surgery, with and without rehospitalizations, combined and by type (rehospitalization alone, rehospitalization with intensive care unit stay, rehospitalization with postacute care stay). MAIN OUTCOMES AND MEASURES: The main outcome was long-term cognitive decline, measured as change in General Cognitive Performance (GCP) score, a composite measure of 11 neuropsychological tests, between preoperative baseline and 10 repeated assessments over 5 years. RESULTS: In the cohort of 560 older adults (mean [SD] age, 76.7 [5.2] years; 326 female [58%]), the mean (SD) GCP score at baseline was 57.6 (7.3). Each rehospitalization was associated with a decline of -0.19 (95% CI, -0.31 to -0.09) GCP units per year. Delirium was associated with more marked cognitive decline of -0.33 (95% CI, -0.67 to -0.06) GCP units per year. Rehospitalizations were more common among patients who developed delirium (adjusted incidence rate ratio, 1.42 [95% CI, 1.17 to 1.72]). However, adjustment for combined rehospitalizations and for each type of rehospitalization resulted in only a minimal percentage change that was not statistically significant (-6% to -9%) in the association of delirium with cognitive decline. CONCLUSIONS AND RELEVANCE: In this cohort study, contrary to expectations, rehospitalization did not mediate the association between delirium and long-term cognitive decline. Future work will be needed to elucidate the pathways by which delirium is associated with long-term cognitive decline.
JAMA Intern Med
· 2026 Jun · PMID 42223964
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IMPORTANCE: Quality metrics with financial incentives are widely used, but their impact on clinical care and patient health remains challenging to isolate. OBJECTIVE: To evaluate the association of a physician-facing qua...IMPORTANCE: Quality metrics with financial incentives are widely used, but their impact on clinical care and patient health remains challenging to isolate. OBJECTIVE: To evaluate the association of a physician-facing quality metric and financial incentive for hypertension control (blood pressure <140/90 mm Hg) with clinical decisions and health outcomes. DESIGN, SETTING, AND PARTICIPANTS: This quasi-experimental difference-in-differences study in a large US health system compared changes in outcomes at practices that did vs those that did not adopt the financial incentive before (2021) vs after (2022-2023) adoption. Participants included patients with previously diagnosed hypertension, aged 18 to 85 years, with encounters at eligible primary care practices. Data were analyzed from January 2024 to September 2025. EXPOSURES: Patient exposure to the financial incentive was determined by which practice delivered their care. MAIN OUTCOMES AND MEASURES: Initial and final systolic blood pressure at the primary care encounter and number of measurements, antihypertensive prescriptions and dose adjustments, and hospitalizations for incident stroke or acute coronary syndrome (ACS). RESULTS: The study included 334 364 patients with hypertension (mean [SD] age, 64.9 [12.6] years; 53.3% female) and their 770 907 encounters at 103 primary care practices. In January 2022, the hypertension control financial incentive was introduced in physician contracts for 63 of these practices. In the overall population of patients with hypertension, the financial incentive was associated with an increased probability of blood pressure remeasurement (by 1.9 [95% CI, 0.7-3.1] percentage points [pp]; P = .002) with no statistically significant change in hypertension control, medication outcomes, or cardiovascular hospitalizations. For the subgroup of patients with marginally high blood pressure (defined as initial systolic blood pressure of 140-145 mm Hg), the financial incentive was associated with an increased probability (by 4.1 [95% CI, 2.1-6.0] pp; P < .001) that blood pressure was documented as controlled, subsequent to an increased probability of blood pressure remeasurement (by 5.6 [95% CI, 2.9-8.3] pp; P < .001). The probability of an existing antihypertensive medication dose being increased was reduced (-1.1 [95% CI, -2.0 to -3.0] pp; P = .01), and the 3-month risk of hospitalization for stroke or ACS increased (by 0.25 [95% CI, 0.07-0.44] pp; P = .005), with excess risk growing to 0.52 pp (95% CI, 0.17-0.87 pp; P = .008) pp at 1 year. CONCLUSIONS AND RELEVANCE: This study's findings suggest that the addition a quality metric and financial incentive to physicians' contracts in a large health system had little impact on measured outcomes in the overall population of patients with hypertension. For patients with marginally high blood pressure, the incentive was associated with increased documented hypertension control because of selective remeasurement of blood pressure, decreased medication adjustments, and increased cardiovascular hospitalizations.
Bronfort G, Meier EN, Leininger B
… +17 more, Schneider M, Evans R, Greco C, Hanson L, McFarland C, Chou R, Connett J, Delitto A, George SZ, Glick RM, Keefe F, Licciardone J, Schulz C, Turk D, Comstock BA, Vasconcelos AG, Heagerty PJ
JAMA Intern Med
· 2026 Jun · PMID 42223934
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IMPORTANCE: Acute and subacute low back pain (LBP) often progresses to a chronic impactful back problem in patients with elevated risk. The most effective way to prevent this progression is unknown. OBJECTIVE: To determi...IMPORTANCE: Acute and subacute low back pain (LBP) often progresses to a chronic impactful back problem in patients with elevated risk. The most effective way to prevent this progression is unknown. OBJECTIVE: To determine the effectiveness of spinal manipulation and clinician-supported biopsychosocial self-management vs medical care for preventing chronic impactful LBP. DESIGN, SETTING, AND PARTICIPANTS: This 2 × 2 factorial randomized clinical trial was conducted in research clinics at the University of Minnesota and the University of Pittsburgh, Pennsylvania, from November 2018 to May 2023, with follow-up concluding in June 2024. Adults with acute or subacute LBP with a moderate to high risk of chronicity were included. INTERVENTIONS: Four interventions were applied for 8 weeks: spinal manipulation therapy; supported self-management; combined spinal manipulation therapy and supported self-management; and guideline-based medical care. Spinal manipulation and supported self-management were provided by physical therapists and chiropractors. MAIN OUTCOMES AND MEASURES: Mean LBP impact score per the US National Institutes of Health Task Force on Chronic LBP scale (8 [best] to 50 [worst]) during 10 to 12 months, responder analyses of group differences in the proportion of participants with at least 50% reductions. A reduction of 30% was considered the minimal clinically important within-patient difference. Secondary outcomes included measures of chronicity and LBP burden (ie, health care and medication use, productivity), important patient-reported outcomes (eg, improvement, satisfaction), biopsychosocial measures (eg, Patient-Reported Outcomes Measurement Information System), and potential mediating psychosocial measures (eg, self-efficacy, kinesiophobia, pain catastrophizing). RESULTS: Of the 1000 participants (mean [SD] age, 47 [16] years; 577 females [58%]) randomized, 928 (93%) completed the trial. An omnibus test of the primary outcome was statistically significant (P = .006). Group differences in mean LBP impact scores were small but statistically significant: supported self-management vs medical care, -1.7 (95% CI, -2.7 to -0.6); combined self-management and spinal manipulation vs medical care, -1.3 (95% CI, -2.5 to 0). Spinal manipulation therapy and medical care did not differ: -0.3 (95% CI, -1.5 to 1.0). Adding spinal manipulation to supported self-management did not provide additional benefit. The supported self-management group had a significantly higher proportion with at least 50% reduction in LBP impact vs medical care (64% vs 55%). Supported self-management also performed better on most secondary outcomes compared to medical care, including 12% fewer reporting chronic pain that frequently interfered with regular activities. Mediation analyses showed changes in psychosocial factors at 6 months and explained 76% of supported self-management effects at 1 year. CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that for patients with acute or subacute LBP at increased risk of chronic impactful LBP, clinician-supported biopsychosocial self-management resulted in a lower mean LBP impact score at 10 to 12 months vs medical care; spinal manipulation and medical care did not differ. While the LBP impact difference was small, the consistent results of the responder analyses and most secondary outcomes suggest differences between clinician-supported self-management and medical care are clinically relevant. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03581123.