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Background Randomized controlled trials (RCTs) are foundational in advancing medical knowledge and patient care, offering high-quality evidence on the comparative effectiveness of healthcare interventions. However, a common challenge for RCTs is the recruitment of trial participants. To understand and overcome potential obstacles in recruitment for a clinical trial (the LightBAR trial, NCT06309238) comparing the effectiveness of bariatric surgery versus an intensive weight loss program, a qualitative study was conducted. Methods Nine patients from the public bariatric surgery waiting list participated in focus groups at a hospital in the Capital Region of Denmark. Vignette scenarios were utilized to prompt participants to reflect on barriers and facilitators for participation. Three patients participated in a follow-up interview. Data was analyzed using thematic analysis. Results Analysis revealed four main themes: (1) having waited long for surgery reduced participants’ willingness to be randomized; (2) the cost of weight loss medication was a major concern for participants; (3) participants were concerned about the extra work involved in program participation; and (4) participants weighed the efficacy and potential negative side effects of surgery against those of an intensive weight loss program based on personal beliefs and experiences. Conclusions Tailoring the recruitment strategy to patients’ circumstances and concerns, and providing clear, patient-centered communication about the nature and potential implications of participating in the trial may improve recruitment success. Trial registration The LightBAR trial (NCT06309238). Registered on ClinicalTrials.gov on May 2, 2024.

Social inequity in healthcare persists even in countries with universal healthcare. The Social Health Bridge-Building Programme aims to reduce healthcare inequities. This paper provides a detailed description of the programme. The Template for Intervention Description and Replication (TIDieR) was used to structure the description. The programme theory was outlined using elements from the British Medical Research Council’s framework, including identifying barriers to healthcare, synthesising evidence, describing the theoretical framework, creating a logic model, and engaging stakeholders. In the Social Health Bridge-Building Programme, student volunteers accompany individuals to healthcare appointments and provide social support before, during, and after the visit. The programme is rooted in a recovery-oriented approach, emphasising personal resources and hope. The programme finds support in constructs within the health literacy framework. Student volunteers serve as health literacy mediators, supporting individuals in navigating the healthcare system while gaining knowledge and skills. This equips students for their forthcoming roles as healthcare professionals, and potentially empowers them to develop and implement egalitarian initiatives within the healthcare system, including initiatives that promote organisational health literacy responsiveness. The Social Health Bridge-Building Programme is a promising initiative that aims to improve equity in healthcare by addressing individual, social, and systemic barriers to healthcare. The programme’s description will guide forthcoming evaluations of its impact.

Introduction Validated patient-reported outcome measures (PROMs) are crucial for assessing patients’ experiences in the healthcare system. Both clinically and theoretically, patient-centered consultations are essential in patient-care, and are often suggested as the optimal strategy in caring for patients with multimorbidity. Aim To either identify or develop and validate a patient-reported outcome measure (PROM) to assess patient-centredness in consultations for patients with multimorbidity in general practice. Methods We attempted to identify an existing PROM through a systematic literature review. If a suitable PROM was not identified, we planned to (1) construct a draft PROM based on items from existing PROMs, (2) conduct group and individual interviews among members of the target population to ensure comprehensibility, comprehensiveness and relevance, and (3) perform a psychometric validation in a broad sample of patients from primary care. Results We did not identify an eligible PROM in the literature review. The item extraction and face validity meetings resulted in a new PROM consisting of 47 items divided into five domains: biopsychosocial perspective; `patient-as-person’; sharing power and responsibility; therapeutic alliance; and coordinated care. The interviews resulted in a number of changes to the layout and phrasing as well as the deletion of items. The PROM used in the psychometric validation consisted of 28 items. Psychometric validation showed high internal consistency, overall high reliability, and moderate fit indices in the confirmatory factor analysis for all five domains. Few items demonstrated differential item functioning concerning variables such as age, sex, and education. Conclusions This study successfully developed and validated a PROM to measure patient-centredness in consultations for patients with multimorbidity. The five domains demonstrated high reliability and validity, making it a valuable tool for measuring patient-centredness of consultations in general practice. Trial registration Trial registration number (data for psychometric validation): https://clinicaltrials.gov : NCT05676541 Registration Date: 2022-12-16.

IntroductionPatients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.Methods and analysisIn this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.Ethics and disseminationThe trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.Trial registration numberNCT05676541.

IntroductionThis study aimed to either identify or develop and validate a patient-reported outcome measure (PROM) to assess treatment burden related to general practice for patients with multimorbidity, which can be used alongside the MultiMorbidity Questionnaire part 1 (MMQ1) without overwhelming the target population with redundant items.MethodsWe conducted a systematic literature review to identify all existing PROMs measuring treatment burden. If no suitable PROM was found, our plan was to: (1) develop a draft PROM using items from existing instruments, (2) carry out group and individual interviews with patients with multimorbidity to ensure the PROM’s understandability, clarity, completeness and relevance and (3) undertake psychometric validation with a diverse sample of primary care patients with chronic conditions.ResultsWe did not identify an eligible PROM in the literature review. The draft PROM consisted of 30 items divided into six domains; Information about treatment, Challenges with medication, Medical appointments, Self-monitoring, Health behaviour and Challenges in the contact to the health system. In the psychometric validation, neither these domains nor any other theoretical constellation of items had adequate psychometric properties. Individual items had good criterion validity and sensitivity to change.ConclusionsIn this study, we developed a 30-item PROM with high content validity where various individual items showed adequate criterion validity and sensitivity to change, making these items useful as a supplemental measure to the MMQ1.Trial registration number NCT05676541 Registration Date: 16 December 2022.