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Nevin Manimala Statistics

Community-Based Surgery and Postoperative Survival Among Veterans Affairs Enrollees

JAMA Netw Open. 2026 Aug 3;9(8):e2628167. doi: 10.1001/jamanetworkopen.2026.28167.

ABSTRACT

IMPORTANCE: The Veterans Affairs Maintaining Internal Systems and Strengthening Integrated Outside Networks (VA MISSION) Act of 2018 greatly expanded Veterans Affairs (VA) enrollees’ access to non-VA (community care) services. Since then, community-based utilization has increased substantially, but the quality of noncardiac surgical procedures has not been compared in VA and community care facilities.

OBJECTIVE: To compare surgical outcomes among veterans at VA vs community care facilities.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used adjusted restricted mean survival time (RMST) to compare survival at 30, 90, and 365 days after carotid endarterectomy (CEA), cholecystectomy (CCY), primary total hip arthroplasty (THA), and primary total knee arthroplasty (TKA) among VA enrollees at VA and community care facilities between October 1, 2019, and July 31, 2024. Follow-up was completed July 31, 2025.

EXPOSURE: CEA, CCY, THA, and TKA performed at VA vs community care settings.

MAIN OUTCOMES AND MEASURES: Adjusted RMST at 30, 90, and 365 days.

RESULTS: A total of 215 542 unique surgical procedures-87 653 in VA-based and 127 889 in community-based facilities-were observed. The mean (SD) age of patients was 65.6 (11.7) years; 191 958 procedures (89.1%) were performed in male patients, and 94 105 (43.7%) were performed in patients who lived in rural or highly rural areas. Actuarial mortality rates were meaningfully higher for community-based CEA (30 days, 1.6% vs 0.9%; 90 days, 3.0% vs 2.0%; and 365 days, 8.5% vs 6.3%) and CCY (30 days, 1.4% vs 0.5%; 90 days, 2.6% vs 1.0%; and 365 days, 5.7% vs 2.8%) but similar for TKA (30 days, 0.1% vs 0.2%; 90 days, 0.4% vs 0.3%; and 365 days, 1.3% vs 1.2%) and THA (30 days, 0.3% vs 0.2%; 90 days, 0.7% vs 0.5%; and 365 days, 2.0% vs 1.7%). After CEA in a VA setting, adjusted survival times at 30 days increased by 0.12 (95% CI, 0.04-0.21) days; at 90 days, by 0.82 (95% CI, 0.45-1.19) days; and at 365 days, by 7.11 (95% CI, 4.71-9.51) days. After CCY in a VA setting, adjusted survival times at 30 days increased by 0.14 (95% CI, 0.11-0.18) days; at 90 days, by 0.82 (95% CI, 0.67-0.96) days; and at 365 days, by 6.20 (95% CI, 5.33-7.06) days. After THA in a VA setting, adjusted survival at 30 days increased by 0.002 (95% CI, -0.02 to 0.02) days; at 90 days, by 0.07 (95% CI, -0.02 to 0.16) days; and at 365 days, by 0.44 (95% CI, -0.17 to 1.05) days. After TKA in a VA setting, adjusted survival at 30 days increased by 0.004 (95% CI, -0.01 to 0.01) days; at 90 days, by 0.01 (95% CI, -0.04 to 0.04) days; and at 365 days, by 0.31 (95% CI, -0.03 to 0.65) days.

CONCLUSIONS AND RELEVANCE: In this cohort study, veterans who underwent surgery at community care vs VA facilities had significantly decreased survival times at 30, 90, and 365 days after CEA and CCY and similar survival times after THA and TKA. The reasons for these survival differences deserve further study.

PMID:42574014 | DOI:10.1001/jamanetworkopen.2026.28167

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Nevin Manimala Statistics

Physical Fitness and All-Cause Mortality in Older Adults

JAMA Netw Open. 2026 Aug 3;9(8):e2628227. doi: 10.1001/jamanetworkopen.2026.28227.

ABSTRACT

IMPORTANCE: Regular physical activity promotes healthy aging, yet clinical risk stratification in older adults relies largely on comorbidity burden, often overlooking functional capacity. Objective fitness assessment may serve as a clinically relevant indicator of physiological reserve, but evidence from large cohorts evaluating multiple fitness domains remains limited.

OBJECTIVE: To evaluate associations between objectively measured physical fitness across multiple domains and all-cause mortality in older adults.

DESIGN, SETTING, AND PARTICIPANTS: This nationwide cohort study included community-dwelling adults aged 65 years or older who completed standardized fitness assessments in Taiwan between January 11, 2015, and November 25, 2016. Participant data were linked to National Health Insurance records, with follow-up through December 31, 2022. Statistical analyses were conducted between July 1, 2025, and May 30, 2026.

EXPOSURES: Physical fitness was assessed across 4 domains: cardiorespiratory fitness (2-minute step test), muscular strength (30-second arm curl and chair stand tests), flexibility (back scratch and chair sit-and-reach tests), and balance and agility (1-leg stance and 8-foot up-and-go tests). A composite fitness index was constructed by summing sex-specific percentile ranks across all 7 assessments.

MAIN OUTCOME AND MEASURES: The main outcome was all-cause mortality, ascertained through linkage with the National Health Insurance death registry. Multivariable Cox proportional hazards models estimated adjusted hazard ratios (AHRs), adjusting for sociodemographic factors, comorbidities, and self-reported physical activity.

RESULTS: Of 13 423 participants (mean [SD] age, 72.9 [6.1] years; 8394 female [62.5%]), 1631 (12.2%) died during a median (IQR) follow-up of 7.0 (6.7-7.1) years. Compared with the lowest performance quintile, participants in the highest performance quintile had lower all-cause mortality across 4 physical fitness assessments: 8-foot up-and-go (AHR, 0.41 [95% CI, 0.33-0.51]), 1-leg stance (AHR, 0.50 [95% CI, 0.42-0.59]), 30-second chair stand (AHR, 0.55 [95% CI, 0.46-0.65]), and 2-minute step test (AHR, 0.58 [95% CI, 0.49-0.68]). The composite fitness index showed the lowest risk of all-cause mortality (AHR, 0.39 [95% CI, 0.32-0.48]).

CONCLUSIONS AND RELEVANCE: In this cohort study of older adults, objectively measured physical fitness-particularly balance and agility, lower-body strength, and cardiorespiratory fitness-was associated with lower all-cause mortality in a graded manner. These findings suggest that integrating objective fitness assessments into routine practice may refine risk stratification and guide function-oriented interventions in older adults.

PMID:42574013 | DOI:10.1001/jamanetworkopen.2026.28227

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Nevin Manimala Statistics

Timing Prompts for Advance Care Planning Discussions and Advance Directive Completion

JAMA Netw Open. 2026 Aug 3;9(8):e2628366. doi: 10.1001/jamanetworkopen.2026.28366.

ABSTRACT

IMPORTANCE: Advance care planning (ACP) is recommended to ensure that medical care for patients with serious illness aligns with their goals; however, effective pragmatic strategies have been elusive.

OBJECTIVE: To compare the association of an appointment-based ACP behavioral intervention delivered with the patient just before a primary care visit vs a non-appointment-based intervention.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of patients from a cluster randomized trial of ACP interventions conducted October 2019 to June 2022 (data analysis June to November 2025). This included 50 primary care clinics across 3 academic health systems. Participants were primary care patients with serious illness 18 years and older without an advance directive (AD) or Physician Order for Life Sustaining Treatment (POLST) in the electronic health record (EHR).

EXPOSURE: Three different appointment-based automated ACP interventions delivered to patients 7 to 21 days before a primary care visit. Eligible patients who did not receive an appointment-based intervention received a non-appointment-based intervention after 6 months.

MAIN OUTCOMES AND MEASURES: Posthoc analysis of AD or POLST in the EHR at 12 and 24 months and documented patient-clinician ACP discussions by 24 months. Generalized estimating equation logistic regression models were used to compute adjusted differences.

RESULTS: Among the original study sample of 8707 patients, there were 5810 patients with no AD or POLST in the EHR at baseline (mean age 71 [15] years; 3017 [51.9%] male). Of these, 5435 (93.5%) received an ACP intervention by 24 months: 2842 patients (52.3%) received at least 1 appointment-based intervention, and 2593 (47.7%) received only non-appointment-based interventions. After 24 months, 475 patients (16.7%) receiving any appointment-based intervention had an AD or POLST in the EHR compared with 254 (9.8%) receiving only non-appointment-based interventions (adjusted difference, 6.5 percentage points [pp]; 95% CI, 4.9-8.2%. Among patients receiving appointment-based interventions, 1143 (40.2%) had ACP discussion documentation in the EHR compared with 714 (27.5%) of patients receiving only non-appointment-based interventions (adjusted difference, 12.2 pp; 95% CI, 8.7-15.6). Appointment-based interventions were associated with more AD or POLST and documented ACP discussions than non-appointment-based interventions across all 3 ACP intervention groups.

CONCLUSIONS AND RELEVANCE: In this cohort of primary care patients with serious illness, an ACP intervention designed to engage patients and promote ACP discussions was associated with greater uptake if delivered before an office visit.

PMID:42574012 | DOI:10.1001/jamanetworkopen.2026.28366

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Nevin Manimala Statistics

Cancer Screening and Citizenship Status in the US

JAMA Netw Open. 2026 Aug 3;9(8):e2628371. doi: 10.1001/jamanetworkopen.2026.28371.

ABSTRACT

IMPORTANCE: Immigrants without US citizenship, or noncitizens, disproportionately endure poverty, labor exclusions, and inadequate health care access-structural drivers of adverse cancer outcomes. While screening is critical for preventing cancer deaths, and cancer is the leading cause of death among noncitizens, little is known about citizenship status and its potential influence on cancer screening.

OBJECTIVES: To examine cancer screening inequities associated with citizenship status, evaluate whether these inequities vary across states, and determine whether structural factors mediate these inequities.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used nationally representative data from the National Health Interview Survey (2010-2023). Eligibility for cancer screening and the timing and types of tests considered appropriate were determined using US Preventive Services Task Force guidelines. Data were analyzed from May to August 2025.

EXPOSURE: Citizenship status: noncitizen (regardless of documentation), naturalized, or US-born.

MAIN OUTCOMES AND MEASURES: Outcomes included colorectal, cervical, or breast cancer screening. Potential mediators included socioeconomic and health care factors (eg, poverty-to-income ratio and insurance), whereas clinical factors (eg, cancer history) were considered confounders. Mediation analysis using nonlinear multiple additive regression tree models was performed to evaluate associations between citizenship status and cancer screening and to identify mediators.

RESULTS: The sample included 131 501 participants eligible for colorectal (3687 [5.1%] noncitizen, median [IQR] age, 61.1 [55.0 to 67.0] years, 39 040 [47.8%] male), cervical (6812 [10.2%] noncitizen, median [IQR] age 41.1 [30.0-52.0]), or breast (1815 [5.1%] noncitizen, median [IQR] age 60.8 [55.0-66.0]) cancer screening. In 2023, noncitizens had significantly lower colorectal (43.6%; 95% CI, 38.7%-48.4% vs 75.5%; 95% CI, 74.6%-76.5%), cervical (57.1%; 95% CI, 53.1%-61.0% vs 71.6%; 95% CI, 70.3%-72.8%), and breast (73.0%; 95% CI, 66.4%-78.7% vs 80.1%; 95% CI, 78.8%-81.3%) cancer screening rates than US-born citizens. These citizenship-based disparities were observed throughout the study period and were present in many states. Noncitizens had significantly lower odds of receiving colorectal (OR, 0.35; 95% CI, 0.32-0.38), cervical (OR, 0.41; 95% CI, 0.38-0.44), and breast (OR, 0.57; 95% CI, 0.52-0.62) cancer screenings than US-born citizens, with socioeconomic and health care factors jointly mediating these inequities (proportion mediated, colorectal cancer: 56.6%; 95% CI, 49.1%-64.2%; cervical cancer: 39.6%; 95% CI, 32.3%-47.0%; breast cancer: 97.1%; 95% CI, 87.1%-107.1%).

CONCLUSIONS AND RELEVANCE: In this nationally representative study, noncitizens had lower rates of cancer screenings, an inequity largely explained by socioeconomic barriers and inadequate health care access. Efforts to increase cancer screening and reduce preventable cancer mortality among noncitizens should focus on improving their health care access.

PMID:42574011 | DOI:10.1001/jamanetworkopen.2026.28371

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Nevin Manimala Statistics

Remote Multicomponent Rehabilitation and Cost-Effectiveness in Survivors of Critical Illness

JAMA Netw Open. 2026 Aug 3;9(8):e2628380. doi: 10.1001/jamanetworkopen.2026.28380.

ABSTRACT

IMPORTANCE: The cost-effectiveness of remote rehabilitation for survivors following critical illness after intensive care unit (ICU) care is unknown.

OBJECTIVE: To evaluate the cost-effectiveness of remote multicomponent rehabilitation compared with standard care following discharge from hospital after an ICU admission.

DESIGN, SETTING, AND PARTICIPANTS: This economic evaluation was conducted within a pragmatic, multicenter, assessor-blinded trial comparing remote rehabilitation delivered online with standard care after discharge from ICU from both National Health Service (NHS) and Personal Social Services (PSS) and societal perspectives over a 6-month time horizon. The trial was conducted from December 2022 to November 2025. The setting was 52 NHS hospitals in the United Kingdom. Participants were adults (aged ≥18 years) within 12 weeks of discharge from hospital that included an ICU admission for critical illness, requiring mechanical ventilation for 48 hours or longer.

INTERVENTIONS: A remotely delivered rehabilitation program or standard care.

MAIN OUTCOMES AND MEASURES: Costs including using questionnaires and microcosting approach (in 2024 UK pounds sterling) and quality-adjusted life-years (QALYs), derived directly from trial data, were calculated per group and reported in terms of incremental cost per QALY gained.

RESULTS: A total of 429 participants (245 men [57%]; mean [SD] age, 55.4 [13.9] years) were enrolled, including 231 (54%) in the intervention group and 198 (46%) in the standard group. From a UK NHS-PSS perspective, the rehabilitation intervention was associated with increased mean costs (£1250; 95% CI, £562-£1938) and QALYs (0.023; 95% CI, 0.007-0.040) per participant, compared with the standard care group. Incremental cost-effectiveness ratio (ICER) was £54 034 per QALY. The probability of rehabilitation intervention being cost-effective was 3% and 11% at UK willingness-to-pay thresholds of £20 000 and £30 000 per QALY, respectively. The intervention was cost-effective for patients with mechanical ventilation for 7 days or less (ICER, £21 476 per QALY) or if a societal perspective was adopted (ICER, £6341 per QALY).

CONCLUSIONS AND RELEVANCE: In this economic analysis, among ICU survivors overall, a remotely delivered multicomponent rehabilitation program was not cost-effective from a UK NHS-PSS perspective. Cost-effectiveness was more favorable from a societal perspective and for patients receiving mechanical ventilation for 7 days or less. For rehabilitation interventions to be both clinically and cost-effective a precision medicine approach to medical and psychosocial health care interventions is needed once patients are home from hospital.

PMID:42574010 | DOI:10.1001/jamanetworkopen.2026.28380

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Nevin Manimala Statistics

Efficient estimation for deep generalized accelerated hazards models with interval-censored data

Biometrics. 2026 Jul 1;82(3):ujag140. doi: 10.1093/biomtc/ujag140.

ABSTRACT

For the analysis of interval-censored data, we propose a deep generalized accelerated hazards model. This model is designed to facilitate a detailed exploration of the relationship between various risk factors and the hazard associated with failure time. We develop a sieve maximum likelihood estimation procedure that combines deep neural networks and monotonic splines. By employing deep neural networks, we can effectively capture nonparametric effects, enabling a flexible and adaptive modeling approach for complex relationships. Under certain regularity conditions, we derive a nonasymptotic error bound for the resulting estimator and show that the finite-dimensional estimator is asymptotically normal and achieves the semiparametric efficiency. We conduct simulation studies to evaluate the finite-sample performance of the proposed approach. Furthermore, the proposed method is applied to the Atherosclerosis Risk in Communities study for practical illustration.

PMID:42574000 | DOI:10.1093/biomtc/ujag140

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Nevin Manimala Statistics

Shift-adjusted Neyman-Pearson classifiers via single index modeling (SACSIM)

Biometrics. 2026 Jul 1;82(3):ujag138. doi: 10.1093/biomtc/ujag138.

ABSTRACT

Neyman-Pearson (NP) classifiers, which aim to maximize the clinical benefit while adhering to risk constraints, are crucial in many practical fields, including early cancer detection. However, applying these classifiers can be challenging due to discrepancies between the data distributions of the source and target populations. The potential impact can be disproportionately severe for under-represented groups. We propose a semi-parametric model-based approach for adapting NP classifier decision rules to different populations while equitably controlling classification errors specific to clinical applications. Our method involves a shift-adjustment strategy that leverages a small unlabeled sample from the target population, along with minimal auxiliary information and the labeled source data. This approach enhances the applicability of the learned decision rules and ensures they are consistently tailored for the target population. We demonstrate the performance through theoretical studies and simulations and illustrate the approach with an example of a prostate cancer study.

PMID:42573999 | DOI:10.1093/biomtc/ujag138

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Nevin Manimala Statistics

Medicare Advantage and Type 2 Diabetes Outcomes

JAMA Intern Med. 2026 Aug 10. doi: 10.1001/jamainternmed.2026.3332. Online ahead of print.

ABSTRACT

IMPORTANCE: Medicare Advantage (MA) costs 22% more than original Medicare (OM) for a given individual ($83 billion in annual excess public costs). However, MA may improve type 2 diabetes (T2D) outcomes compared with OM by providing financial protections (eg, annual out-of-pocket spending caps) and supplemental benefits (eg, healthy food assistance) that OM cannot.

OBJECTIVE: To determine whether MA coverage is associated with better T2D outcomes than OM.

DESIGN, SETTING, AND PARTICIPANTS: A longitudinal cohort study using target trial emulation principles for design and analysis in adults aged 18 years or older receiving OM or MA with T2D, followed up before and after Medicare coverage in community-based health centers (January 2021 to June 2024) across 44 states. Analyses were conducted from September 2025 to May 2026.

EXPOSURES: MA or OM coverage.

MAIN OUTCOMES AND MEASURES: Hemoglobin A1c (HbA1c) (primary outcome), systolic blood pressure (SBP) and diastolic blood pressure (DBP), low-density lipoprotein (LDL) cholesterol, food insecurity, housing instability, and transportation barriers at 12 months after Medicare coverage (primary time point) and at 6, 18, and 24 months. Statistical analysis accounted for pre-Medicare coverage factors that may influence selection of MA vs OM using targeted minimum loss estimation. Covariates were age, sex, race and ethnicity, comorbidities, income, Social Vulnerability Index, pre-Medicare insurance, Medicaid coverage, and pre-Medicare coverage values for HbA1c, SBP, DBP, LDL cholesterol, body mass index, food insecurity, housing instability, and transportation barriers.

RESULTS: In this study in 34 648 adults (19 054 in OM, 15 594 in MA) with T2D, followed up before and after Medicare coverage, the mean (SD) age was 65.24 (9.73) years and 53.42% were women. Twelve months after Medicare coverage, MA was not associated with better HbA1c (mean difference, 0.01; 95% CI, -0.04 to 0.05, P = .74), SBP (-0.15; 95% CI, -0.54 to 0.24; P = .44), DBP (0.06; 95% CI, -0.15 to 0.27; P = .58), or LDL cholesterol (-0.41; 95% CI, -1.24 to 0.42; P = .33), with similar results at other time points. MA was also not associated with a lower risk of food insecurity (relative risk [RR], 1.00; 95% CI, 0.94-1.05), housing instability (RR, 1.00; 95% CI, 0.91-1.09), or transportation barriers (RR, 1.00; 95% CI, 0.93-1.07) at 12 months or any other time point.

CONCLUSIONS AND RELEVANCE: In this study, when accounting for factors that may drive MA selection, MA was not associated with better T2D outcomes or fewer health-related social needs than OM. Given substantially higher spending for MA, it is important to ensure this spending is being used effectively to improve health.

PMID:42573997 | DOI:10.1001/jamainternmed.2026.3332

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Nevin Manimala Statistics

Alcohol-Related Liver Disease After Metabolic Bariatric Surgery: Reassessing the Hidden Risk-A Meta-Analysis

Obes Surg. 2026 Aug 10. doi: 10.1007/s11695-026-08895-9. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate whether metabolic bariatric surgery (MBS) influences the risk of alcohol-related liver disease (ARLD), particularly alcoholic cirrhosis, and assess its long-term hepatic implications.

METHODS: This study followed PRISMA guidelines and was prospectively registered in PROSPERO. PubMed, Embase, Web of Science, Scopus, Cochrane Library, and ClinicalTrials.gov were systematically searched from inception to 26 December 2025 for observational cohort studies comparing the incidence of alcoholic cirrhosis between MBS patients and matched non-surgical controls. Data extraction and quality assessment were independently performed, and pooled effect sizes were calculated using random-effects models. Subgroup, sensitivity, and publication bias analyses were conducted. Statistical analyses were performed using Stata 17.0.

RESULTS: Five studies were included. The overall association between MBS and alcohol-related cirrhosis was not statistically significant (OR 1.18, 95% CI 0.91-1.53; p = 0.214), with substantial heterogeneity (I² = 97.5%). However, significantly increased odds were observed in studies with sample sizes ≥ 1,000,000 and in those with follow-up durations ≥ 10 years. Leave-one-out analysis showed that no single study substantially altered the pooled estimate, and Begg’s and Egger’s tests detected no significant publication bias.

CONCLUSIONS: Current evidence does not show a significant overall association between MBS and alcohol-related cirrhosis. However, substantial heterogeneity and increased odds in large-sample and long-term studies preclude firm conclusions regarding long-term hepatic safety.

PMID:42573970 | DOI:10.1007/s11695-026-08895-9

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Nevin Manimala Statistics

Adherence to CAL/BDP PAD-Cream Influences Treatment Effectiveness and Preference in Scalp Psoriasis Under Real-Life Conditions: Results from the Prospective, Multicenter, Observational PRO-SCALP Study

Dermatol Ther (Heidelb). 2026 Aug 10. doi: 10.1007/s13555-026-01884-x. Online ahead of print.

ABSTRACT

INTRODUCTION: Scalp psoriasis is often associated with poor adherence to topical therapy. A novel formulation of calcipotriol and betamethasone dipropionate based on polyaphron dispersion (CAL/BDP PAD-cream) showed improved outcomes and satisfaction in the PRO-SCALP study, particularly in patients with high adherence. We evaluated how adherence to CAL/BDP PAD-cream influences patients- and clinicians-reported outcomes and treatment preferences in mild-to-moderate scalp psoriasis under real-life conditions in Europe.

METHODS: PRO-SCALP patients reported their adherence level using a visual analogue scale (VAS). Outcomes were compared between low- and high-adherence subgroups.

RESULTS: Among 252 patients, 59.9% reported high adherence (VAS 80-100). Older patients and those with moderate disease reported high adherence (both p < 0.05). High-adherent patients reported higher scores in the Treatment Satisfaction Questionnaire for Medication Version 9, for Convenience of use (p = 0.0019) and Global Satisfaction (p = 0.0166) domains, and in the Psychosocial Effects of Scalp Psoriasis Questionnaire (p = 0.0004) at week 8. Both adherence subgroups showed significant reductions in the scalp Worst Itch Numeric Rating Scale (WI-NRS), scalp-modified Psoriasis Area and Severity Index (S-mPASI), and Scalpdex scores (all p < 0.0001 vs. baseline), although high-adherent patients achieved greater improvements in WI-NRS (p < 0.0001), S-mPASI (p = 0.0153), and the Scalpdex Symptoms domain (p = 0.001) than low-adherent. Each 10% increase in adherence corresponded to a 0.10- and 0.35-point reduction in S-mPASI and WI-NRS (both p < 0.05) at week 8. Scalp-Physician Global Assessment success rates were comparable in low- vs. high-adherence subgroups (65.0% vs. 70.5%; p = 0.3633). Sleep quality improved significantly in both subgroups (p < 0.0001). High adherence was associated with higher Patient Preference Questionnaire scores (p = 0.0012), better Cream Usability Scalp Psoriasis Questionnaire ratings (p = 0.0455) and greater product consumption (p < 0.0001), despite similar once-a-day usage.

CONCLUSION: High adherence to CAL/BDP PAD-cream was associated with greater effectiveness, satisfaction, preference, and QoL. While patients with low adherence still benefited, maximizing adherence is key for optimal real-world outcomes in scalp psoriasis.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT05811234.

PMID:42573965 | DOI:10.1007/s13555-026-01884-x