Category: Nevin Manimala

JAMA Intern Med. 2025 Nov 10. doi: 10.1001/jamainternmed.2025.5917. Online ahead of print.

ABSTRACT

IMPORTANCE: Although risk-based payment contracts to health care organizations can reduce health care utilization, there is limited evidence on how these contracts influence the value of health care services delivered, whether effects depend on contract design features, and what these contracts achieve in Medicare Advantage, the segment of US health insurance with the most adoption of risk-based contracts.

OBJECTIVE: To assess whether voluntary transition to risk-based contracts (either upside-only, with financial bonuses possible, or 2-sided with both bonuses and penalties possible) was associated with changes in either broad domains of health care utilization or use of low-value services.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study analyzed claims from January 1, 2015, through December 31, 2021, for beneficiaries enrolled in health maintenance organization plans from Humana, a large, national Medicare Advantage insurer. A difference-in-differences analysis measured changes in outcomes for health care organizations that newly transitioned to upside-only or 2-sided risk contracts compared with organizations with stable fee-for-service (FFS) or upside-only risk contracts, respectively. Statistical analysis was conducted between April 4 and June 23, 2025.

MAIN OUTCOMES AND MEASURES: Nine utilization measures in 3 domains (inpatient encounters, outpatient visits, testing) and 26 measures of low-value service use in 6 domains (cancer screening, diagnostic and preventive testing, preoperative testing, imaging, cardiovascular testing and procedures, and other surgeries).

RESULTS: The sample included 658 organizations transitioning from FFS to upside-only risk contracts (1 042 272 beneficiary-years), 114 organizations transitioning from upside-only to 2-sided risk contracts (706 303 beneficiary-years), and 3385 control organizations (2 491 985 beneficiary-years). In difference-in-differences analyses, transitioning to upside-only risk contracts was associated with differential reductions in 4 of 9 utilization outcomes (emergency department visits, primary care visits, advanced imaging, and cardiovascular stress testing); however, when analyses accounted for differential temporal trends in outcomes prior to contract transitions, differential reductions were only detected for emergency department visits (-8.4% of baseline use; 95% CI, -15.5% to -1.3%; P = .02) and cardiovascular stress testing (-12.1%; 95% CI -23.4% to -0.7% P = .04). Transitioning to 2-sided risk contracts was associated with differential reductions in specialty visits and advanced imaging; however, neither association was detected after accounting for pretransition outcome trends. Neither type of contract adoption was associated with differential changes in total use of low-value services or differential reductions in any domain of low-value service use.

CONCLUSIONS AND RELEVANCE: This study found that voluntary transition to upside-only or 2-sided risk payment contracts in Medicare Advantage was not associated with consistent changes in health care utilization or low-value service use. It is uncertain what factors account for the lack of apparent changes.

PMID:41212579 | DOI:10.1001/jamainternmed.2025.5917

JAMA Netw Open. 2025 Nov 3;8(11):e2542147. doi: 10.1001/jamanetworkopen.2025.42147.

ABSTRACT

IMPORTANCE: Colorectal cancer (CRC) survivors frequently report bowel-related symptoms, but longitudinal data are scarce and diet has not been extensively investigated in relation to bowel-related symptoms.

OBJECTIVE: To investigate the prevalence of bowel-related symptoms as well as their association with dietary fiber intake until 5 years after CRC diagnosis.

DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study using data from the Colorectal Cancer: Longitudinal, Observational Study on Nutritional and Lifestyle Factors (COLON) study included CRC survivors with stage I-IV disease recruited at diagnosis from 11 hospitals in the Netherlands between August 2010 and February 2020. CRC survivors were followed up until 5 years after diagnosis. Data were analyzed between April 2024 and March 2025.

EXPOSURES: Clinical data including CRC treatment strategy, retrieved from hospital records and national registries, and habitual dietary fiber intake, assessed by a food frequency questionnaire, at 6 months, 2 years, and 5 years after CRC diagnosis.

MAIN OUTCOMES AND MEASURES: Prevalence of self-reported diarrhea, constipation, flatulence or bloating, frequent stools, mucus in stools, or false urgency at 6 months, 2 years, and 5 years after diagnosis, obtained via a questionnaire. The validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was also used to evaluate prevalence of moderate-to-severe diarrhea or constipation and health-related quality of life (HRQOL) at these time points. Odds ratios (ORs) for associations between fiber intake and bowel-related symptoms (yes or no) were calculated using multivariable logistic regression.

RESULTS: Among 1751 CRC survivors who underwent surgery and were included in the analysis, median age at diagnosis was 66 years (IQR, 61-71 years), and 1115 (63.7%) were men. Bowel-related symptoms were reported by 817 of 1751 survivors (46.7%) at 6 months, 614 of 1511 (40.6%) at 2 years, and 290 of 812 (35.7%) at 5 years after diagnosis. At 6 months after diagnosis, symptoms were predominantly reported by survivors who had received chemotherapy (260 of 446 [58.3%]), whereas symptoms at 2 and 5 years occurred mostly in those who received radiotherapy (86 of 160 [53.8%] at 2 years and 47 of 92 [51.1%] at 5 years). Of the studied bowel-related symptoms, diarrhea was associated with the lowest HRQOL score (B, -9.6; 95% CI, -14.0 to -5.2) at 5 years after diagnosis. In multivariable logistic regression analyses, higher fiber intake (per 10-g/d increment) was associated with a significantly lower prevalence of moderate-to-severe diarrhea at 6 months (OR, 0.44; 95% CI, 0.28-0.70) and 2 years (OR, 0.53; 95% CI, 0.30-0.94) after diagnosis, but the association was not statistically significant at 5 years (OR, 0.43; 95% CI, 0.16-1.13).

CONCLUSIONS AND RELEVANCE: In this cohort study of CRC survivors, the prevalence of bowel-related symptoms was considerably high during the 5 years after diagnosis, highlighting a need for effective symptom management. Higher dietary fiber intake was associated with a lower prevalence of diarrhea, suggesting a potential role of diet in management of bowel-related symptoms in CRC survivors.

PMID:41212563 | DOI:10.1001/jamanetworkopen.2025.42147

JAMA Netw Open. 2025 Nov 3;8(11):e2542668. doi: 10.1001/jamanetworkopen.2025.42668.

ABSTRACT

IMPORTANCE: Gestational diabetes (GD) is a heterogeneous condition that predisposes both mother and offspring to metabolic disorders. GD subtypes defined by antepartum testing results have been associated with adverse perinatal outcomes, but little is known about their relationship to maternal metabolic outcomes soon after pregnancy.

OBJECTIVE: To evaluate early postpartum glucose tolerance reclassification of GD subtypes.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study examined women from the Study of Women, Infant Feeding, and Type 2 Diabetes Mellitus After GD Pregnancy (SWIFT), who were recruited within the Kaiser Permanente Northern California integrated health care system between 2008 and 2011. All women were diagnosed with GD using Carpenter and Coustan criteria with complete glucose measurements at all 4 time points of the diagnostic 3-hour 100-gram oral glucose tolerance test (OGTT). Data analyses were conducted from January to July 2025.

EXPOSURE: Three subtypes of GD based on the diagnostic OGTT: (1) postload glucose intolerance (GD-P), as having elevations only at 2 or more postload time points; (2) fasting hyperglycemia (GD-F), as having elevations at fasting and 1 postload time point; and (3) both (GD-M), as having elevations at fasting and 2 or more post-load time points.

MAIN OUTCOMES AND MEASURES: At 6 to 9 weeks after delivery, glucose tolerance classification was evaluated using 2-hour, 75-g OGTTs. Modified Poisson regression models were used to estimate adjusted prevalence ratios (PRs) of postpartum prediabetes associated with GD subtypes, without and with adjustments for age, race and ethnicity, prepregnancy body mass index, educational level, and gestational weight gain.

RESULTS: This study included 1005 women with GD (median [IQR] age, 33.2 [29.8-36.7] years; 368 [36.6%] Asian, 78 [7.8%] Black, 308 [30.6%] Hispanic, 16 [1.6%] multiracial, and 235 [23.4%] White). Prevalence of postpartum prediabetes was 34.5% (347 women), with wide variation across GD subtypes; 23.9% (147 of 616), 41.9% (52 of 124), and 55.8% (148 of 265) for GD-P, GD-F, and GD-M, respectively. Compared with women with GD-P, the adjusted PR for GD-F was 1.74 (95% CI, 1.36-2.24), and for GD-M, it was 2.23 (95% CI, 1.85-2.68) (both P < .001). Pairwise comparisons between GD-F and GD-M were also statistically significant (adjusted PR, 1.28; 95% CI, 1.01-1.61; P = .04).

CONCLUSIONS AND RELEVANCE: In this cohort study, GD subtypes had distinct postpartum prediabetes risks. Early action and intervention to address dysglycemia may be most beneficial for women with fasting or mixed defects.

PMID:41212558 | DOI:10.1001/jamanetworkopen.2025.42668

JAMA Netw Open. 2025 Nov 3;8(11):e2543156. doi: 10.1001/jamanetworkopen.2025.43156.

ABSTRACT

IMPORTANCE: In the US, 1 in 5 adult suicide decedents has spent at least 1 night in jail in the year prior to death.

OBJECTIVE: To evaluate the effectiveness of the Safety Planning Intervention (SPI) with telephone follow-up as an adjunct to enhanced standard care (ESC) compared with ESC alone for reducing suicide events in the 12 months following release from pretrial jail detention.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included individuals with past 30-day suicide risk (suicide ideation with intent and/or suicide attempt) in pretrial jail detention who were recruited from 2 jails from May 11, 2016, to November 13, 2018, with a 12-month follow-up after release. Data analysis was completed from April 2023 to May 2025.

INTERVENTIONS: All participants received ESC. The SPI included a safety planning session in jail followed by 4 to 8 telephone calls 6 months after jail release.

MAIN OUTCOMES AND MEASURES: The primary outcome was the number of suicide events (a composite of suicide attempts and behaviors, suicide-related hospitalizations, and suicide deaths). Secondary outcomes included the number of suicide attempts, weeks and severity of active suicidal ideation, time to first suicide event, psychiatric symptoms, functioning, and hypothesized mediators. Suicidal ideation and behaviors were assessed using the Columbia-Suicide Severity Rating Scale, the Longitudinal Interval Follow-Up Evaluation, and record reviews from area hospitals. Deaths were identified through hospital, state, and national death records. Hospitalizations were measured with the Treatment History Interview and hospital records.

RESULTS: Of 800 participants randomized in jail, 655 (mean [SD] age, 33.0 [10.4] years; 473 males [72%]) were released to the community and included in analyses. Of those, 593 (91%) completed at least 1 follow-up interview. Medical records were available for all 655 participants (100%). Per person-year of follow-up over 12 months, those in the SPI group compared with those in the ESC group had 42% fewer suicide events (mean [SE], 1.82 [0.18] vs 3.11 [0.32]; mean [SE] difference, -1.30 [0.37]; P < .001), 55% fewer suicide attempts (mean [SE], 1.06 [0.14] vs 2.35 [0.33]; mean [SE] difference, -1.33 [0.38]; P < .001). Differences in weeks of suicidal ideation were not statistically significant (mean [SE], 10.39 [0.78] vs 12.86 [1.02]; mean [SE] difference, -2.47 [1.28]; P = .06). There were no other observed differences in outcomes.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of the SPI compared with ESC, those in the SPI group experienced reduced suicide risk by 42% in the year after jail release. These results suggest that SPI is effective for reducing suicide risk during this high-risk period.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02759172.

PMID:41212557 | DOI:10.1001/jamanetworkopen.2025.43156

JAMA Intern Med. 2025 Nov 10. doi: 10.1001/jamainternmed.2025.5792. Online ahead of print.

NO ABSTRACT

PMID:41212549 | DOI:10.1001/jamainternmed.2025.5792

JAMA Neurol. 2025 Nov 10. doi: 10.1001/jamaneurol.2025.4347. Online ahead of print.

ABSTRACT

IMPORTANCE: Geographic variation in epilepsy incidence among older adults may reflect contextual risk factors and point to opportunities for targeted prevention. However, privacy constraints and sparse case counts have historically limited small-area analyses.

OBJECTIVE: To map incident epilepsy among older adults at the smallest geography permissible by privacy constraints and identify contextual social and environmental determinants associated with high-incidence areas.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study examined Medicare administrative claims from 2016 to 2019 for all counties in the contiguous United States. A random sample of 4 999 999 Medicare Fee-for-Service beneficiaries 65 years or older with non-Hispanic Black and Hispanic beneficiaries oversampled at rates of 1.50 and 1.75 times their representation in the study population. Beneficiaries with incident epilepsy were identified by claims criteria and codes from the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, in 2019 and had no epilepsy claims during the period 2016 to 2018. Data were analyzed from January to March 2025.

EXPOSURES: Area-level social and environmental determinants of health (SEDH), obtained from publicly available sources and linked to beneficiaries’ residences.

MAIN OUTCOMES AND MEASURES: The outcome was area-level epilepsy incidence rate in 2019. To comply with data privacy requirements, the Max-P regionalization method was used to aggregate 3108 counties into 692 “MaxCounties,” each containing at least 11 incident cases. Incidence rates per 100 000 persons were mapped. Associations between SEDH variables and epilepsy incidence were estimated using random forest and multivariable logistic regression.

RESULTS: Among 4 817 147 beneficiaries, 20 263 incident epilepsy cases were identified in 2019 (mean [SD] age, 78.7 [7.5] years; 54.6% women). Incidence rates across MaxCounties varied more than 10-fold (range, 141-1476 per 100 000). In random forest models, higher incidence was associated with insufficient sleep, heat index, physical inactivity, uninsured rate, proportion of non-Hispanic Black residents, and obesity prevalence. In multivariable regression, MaxCounties in the highest tertile for insufficient sleep had nearly double the odds of high epilepsy incidence compared to the lowest tertile (odds ratio [OR], 1.99; 95% CI, 1.10-3.60). Lack of household vehicle access was similarly associated with high incidence (OR, 1.93; 95% CI, 1.16-3.25).

CONCLUSIONS AND RELEVANCE: Our findings highlight the spatial heterogeneity of epilepsy burden in the US Medicare population and underscore the importance of contextual SEDH factors, such as sleep, mobility, and infrastructure, in shaping disease patterns. These insights may help guide targeted public health interventions and resource allocation.

PMID:41212547 | DOI:10.1001/jamaneurol.2025.4347

Eur J Pain. 2025 Nov;29(10):e70166. doi: 10.1002/ejp.70166.

ABSTRACT

BACKGROUND: Hypnosis (H) and virtual reality (VR) are effective behavioural interventions to influence acute pain perception. Hypnotic suggestions have also been shown to modulate the nociceptive flexion reflex (NFR), suggesting the activation of descending modulatory mechanisms affecting spinal nociceptive activity. The combination of these techniques, virtual reality hypnosis (VRH), may reduce pain, but research on their comparative efficacy and mechanisms requires further experimental investigation. This study compared the effects of relaxation hypnosis, VR and VRH on pain perception and nociceptive physiological responses.

METHODS: Twenty-four healthy participants were tested at baseline followed by three experimental conditions (relaxation hypnosis, VR, VRH) in a counterbalanced order. Pain intensity and unpleasantness, as well as NFR amplitude evoked by noxious transcutaneous electrical stimulation, were measured. Bayesian statistics assessed evidence for analgesic effects on each variable.

RESULTS: The strength of evidence in favour of our hypotheses was categorised as follow: BF = 1-3: anecdotal evidence; BF = 3-10: moderate evidence and BF > 10: strong evidence. For NFR values, Bayesian paired-sample T-tests provided anecdotal support for the efficacy of relaxation hypnosis (BF + 0 = 2.11) and stronger evidence for VR (BF + 0 = 10.94) and VRH (BF + 0 = 14). For pain intensity, moderate evidence supported reductions with relaxation hypnosis (BF + 0 = 9.18), while strong evidence was found for VR (BF + 0 = 27.99) and low to moderate for VRH (BF + 0 = 5.88). Similarly, unpleasantness showed anecdotal reduction with hypnosis (BF + 0 = 1.9), and moderate evidence supported VR (BF + 0 = 4.86) and VRH (BF + 0 = 7.18). Across all measures, no significant differences were found between hypnosis, VR and VRH.

CONCLUSION: These findings suggest that these techniques did not differentially affect NFR, pain intensity, or unpleasantness.

SIGNIFICANCE STATEMENT: The strength of this fundamental study is to directly compare hypnosis, VR, and VRH on both pain perception and physiological responses. It shows that VR alone is effective, while adding hypnosis does not always lead to better results and the combination could even create interference in some cases. This article helps to nuance the existing literature and common assumptions about the tool’s use. These findings help clarify how VRH works and to propose guidance for clinical practices and further VRH development.

PMID:41212540 | DOI:10.1002/ejp.70166

Gerontologist. 2025 Nov 10:gnaf243. doi: 10.1093/geront/gnaf243. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: To assess the efficacy of a local volunteer program, delirium optimization with volunteer engagement (DOVE), in preventing in-hospital delirium.

RESEARCH DESIGN AND METHODS: Between February 2023 and June 2024, volunteers provided structured interventions to patients at risk for delirium, as identified by the Delirium Risk Assessment (DRA) score. Interventions are humanities-based and included sensory aide assistance, completion of “get to know me” forms, and conversation. Data were retrospectively acquired from electronic health records and compared to a control cohort, from another medical unit. Delirium occurrence was captured when nursing confusion assessment method (CAM) documentation was positive, or clinician documented delirium diagnoses. Cohorts were matched 1:2 (DOVE vs Control) by age, gender, DRA score, month/year of admission, and length of hospital stay.

RESULTS: A total of 168 patients received interventions by DOVE volunteers, of which 139 of those were matched with 261 controls. In-hospital delirium occurrence was lower in the DOVE cohort compared to the control cohort (46.8% vs 56.7%; P = 0.015). Conditional logistic regressions demonstrated a lower Odds Ratio for delirium occurrence 0.55 (95% Confidence Interval [CI]; 0.34-0.89; P = 0.015) associated with DOVE intervention. Subgroup analyses of delirium occurrence among patients with DRA score of 3-4 demonstrated an OR of 0.56 (95% CI; 0.31-1.01; P = 0.053) between the DOVE and control cohorts.

DISCUSSION AND IMPLICATIONS: In-hospital delirium occurrence was ∼10% lower among DOVE cohort patients. This humanities-based intervention offers a feasible strategy, particularly during times of staffing shortages, and should be considered for broader implementation across healthcare institutions.

PMID:41212537 | DOI:10.1093/geront/gnaf243

Acta Neurol Belg. 2025 Nov 10. doi: 10.1007/s13760-025-02945-2. Online ahead of print.

ABSTRACT

BACKGROUND: Primary central nervous system lymphoma (PCNSL) is a rare and aggressive form of extranodal non-Hodgkin lymphoma, most often a diffuse large B-cell lymphoma. Rituximab, an anti-CD20 monoclonal antibody is widely used in PCNSL treatment but its efficacy remains uncertain. Therefore, we conducted a systematic review and meta-analysis to assess the efficacy of rituximab in newly diagnosed adult PCNSL patients.

METHODS: Medline/PubMed and Scopus were searched for studies comparing rituximab/rituximab-containing regimens with therapies not including rituximab in adult PCNSL patients. A random-effects meta-analysis was conducted, and risk ratios (RR) and hazard ratios (HR) were reported with 95% confidence interval (CI). Outcomes included 3- and 5-year overall survival (OS), OS independent of time, 3- and 5-year progression-free survival (PFS), and complete response (CR).

RESULTS: Sixteen studies (three RCTs, thirteen retrospective) with 2,325 patients (rituximab: 1010; control: 1315) were included. Rituximab-containing therapy was significantly associated with higher 3-year OS (RR: 1.37; 95% CI: 1.07-1.76), higher CR rate (RR: 1.37; 95% CI: 1.05-1.79) and reduced hazard of death (HR: 0.65; 95% CI: 0.43-0.98). 3-year PFS showed a non-significant trend favoring rituximab (RR: 1.29; 95% CI: 0.99-1.68) which reached statistical significance in sensitivity analysis after excluding one study (RR: 1.40; 95% CI: 1.12-1.77). No statistically significant differences were observed for 5-year OS (RR: 1.33; 95% CI: 0.99-1.78) or 5-year PFS (RR: 1.24; 95% CI: 0.79-1.94) between the two groups.

CONCLUSION: Our findings indicate that rituximab-containing therapy was associated with improved short-term outcomes in newly diagnosed adult PCNSL. However, long-term advantages remain uncertain. Therefore, there is a need for larger randomized trials with standardized outcome and toxicity reporting and extended follow-up to confirm long-term survival benefit.

PMID:41212511 | DOI:10.1007/s13760-025-02945-2

Clin Pharmacokinet. 2025 Nov 10. doi: 10.1007/s40262-025-01563-8. Online ahead of print.

ABSTRACT

BACKGROUND: Baricitinib is approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy and has received regulatory authorization in Europe for moderate-to-severe AD in patients 2 to <18 years.

OBJECTIVE: This study aims to optimize dosing for baricitinib in pediatric patients with atopic dermatitis using pharmacokinetic/pharmacodynamic modeling leveraging adult data.

METHODS: The phase III, randomized, double-blind, placebo-controlled study, BREEZE-AD-PEDS (NCT03952559, registration date: 2019-05-16), enrolled patients (aged 2 to <18 years) with moderate-to-severe AD. During a pharmacokinetic (PK) lead-in period, baricitinib concentration data from age-based dose cohorts (4 mg once daily [QD]: 10 to <18 years; 2 mg QD: 2 to <10 years) were compared with actual and simulated concentration values from adult patients receiving baricitinib 4 mg QD. A population PK model incorporating allometric scaling was developed to determine weight-based dosing in pediatric patients that matches adult exposures. The exposure-response (E-R) relationships were analyzed for the primary endpoint: a validated Investigator Global Assessment^® (vIGA-AD) score of 0 or 1 (clear to almost clear skin) with ≥2-point improvement from baseline at week 16. Baricitinib pharmacokinetics were characterized from 393 pediatric patients using a 2-compartment model with allometric scaling on clearance and volume of distribution.

RESULTS: The age-based and subsequent weight-based dosing (2 mg for patients 10 to <30 kg and 4 mg for patients ≥30 kg) was comparable to the 4-mg adult exposure. A clear E-R relationship was observed for the primary endpoint when sorted for age or weight groups.

CONCLUSION: The population PK model developed using baricitinib concentrations from adult patients, with allometric scaling for weight on clearance and volume, adequately predicted exposures in the pediatric population. The PK modeling, with E-R analysis, informed an appropriate weight-based dosing regimen.

PMID:41212510 | DOI:10.1007/s40262-025-01563-8