There are currently no colorectal cancer (CRC) screening recommendations specifically outlined for people with HIV (PWH). Screening measures used for people without HIV (PWoH) have been previously discussed as sufficient for use among PWH, despite observations of higher CRC prevalence and CRC reportedly appearing at earlier ages among PWH in comparison to PWoH. Machine learning (ML) methods are regarded as robust approaches that may enhance predictive performance, particularly in the context of complex or high-dimensional data. This study aims to develop an ensemble ML model to predict CRC risk in PWH using comprehensive nationwide datasets. The model’s predictive performance will be evaluated and compared with a baseline Cox proportional regression model. The better-performing method will be implemented to develop a CRC risk prediction model with the aim of personalising screening recommendations for PWH.

The study population will include all PWH and PWoH born between 1940 and 2008, aged 18 or older and living in Sweden sometime between 1983 and 2024. The study population will be linked to six nationwide demographic and healthcare registers. Follow-up will continue until the first incident of CRC, emigration or death. The outcome of interest is CRC. PWH will be matched to negative controls 1:10. A Cox regression analysis will be completed first, and the results will be used as a baseline comparison to the ensemble ML results. A range of ML methods will be used to develop the ensemble model using stacking.

This study has ethical approval from the Regional Ethical Committee in Sweden (Dnr: 2024-04185-02, 2024-06783-02, 2023-00191-01, 2022-02897-02, 2022-05624-01, 2018/11-31/2). Given that the study is retrospective and register-based, using only pseudonymised data, there are minimal physical, psychological or privacy risks to included individuals. All results will be presented at the population level with no possibility of identification. The results of this study will be submitted for publication in a peer-reviewed journal.

Psychosocial interventions are essential to support people living with dementia and their carers. A consensus on what is most important for research on psychosocial intervention in dementia and how intervention studies should best be conducted is currently lacking. This protocol describes the research plan aimed at achieving consensus on (i) the relevance of core elements (CEs) for the development, feasibility testing/piloting, evaluation and/or implementation phases of psychosocial interventions in dementia and (ii) methodologies (eg, design) and methods most suitable to address CEs per phase.

This study was co-designed with a multi-stakeholder advisory group and a multi-disciplinary INTERDEM (psychosocial INTERventions in DEMentia) Methodology Taskforce steering committee. It will involve a multi-phase modified Delphi design, including surveys and group discussions with stakeholders, namely people living with dementia, (informal/unpaid/family) carers, health and social care professionals, policy makers, representatives from insurance companies and psychosocial researchers. A series of iterative ‘rounds’ will be conducted. In round 1 (Phase 1: ‘identification’), stakeholders will be asked to complete an online survey rating the importance of CEs from the UK Medical Research Council (MRC) Framework, namely (i) consider context; (ii) develop, refine and (retest) programme theory; (iii) engage stakeholders; (iv) identify key uncertainties; (v) refine interventions and (vi) economic considerations per phase; propose relevant additional CEs and list methodologies/methods that most suitably address CEs. These ratings will be further explored through online discussion rounds (Phase 2: ‘elaboration’). In round 2 (Phase 3: ‘consensus’), participants will be asked to rate the importance of CEs again (ie, new CEs and where no consensus was reached in Phase 1) and the usefulness of methodologies/methods to address CEs. Outcomes will be discussed with the advisory group and steering committee (Phase 4: ‘validation’). This process (Phases 3 and 4) will be repeated until a consensus on CEs and methodologies/methods is achieved.

Ethical approval was received at Maastricht University (FHML-REC/2025/078) and the University of West London (UWL/REC/SBS-01195). Participants will sign informed consent prior to study participation. Results will be disseminated through a peer-reviewed publication, seminars, webinars, conferences, postgraduate dementia programmes, blogs, commissioner briefings and social media.

Open Science Framework (https://doi.org/10.17605/OSF.IO/DQRFA).

To identify and appraise methods used to analyse patient flow across multiple care settings, and to describe how these methods have been applied to address health service research questions.

We searched MEDLINE, EMBASE, Web of Science databases and Google Scholar search engine between 1 January 2013 and 10 June 2026 using a systematic search strategy to identify the relevant literature for this review. Descriptive statistics and narrative synthesis were used to characterise the included papers.

Twenty-four studies met the inclusion criteria. Seven distinct methods and five health service research topics were identified. Most studies employed descriptive statistics and group comparison tests to provide a general description of the system. Discrete event simulation was more frequently used to simulate patient movement between settings. Furthermore, patient transfer volume and outcome, as well as capacity planning, were the most commonly studied health service research topics. This review highlights effective approaches—statistical analysis, mathematical modelling and computer simulation—for studying patient flow across care settings.

Statistical analysis, mathematical modelling and computer simulation offer complementary approaches for analysing patient flow between care settings. Each method has distinct strengths and limitations. Applying more than one method may provide a richer understanding of patient flow. Future research may focus on comprehensive patient flow analysis, particularly in managing chronic conditions and non-communicable diseases in interconnected care settings and organisations.

Dose can meaningfully affect the comparative effectiveness of depression treatments, yet how network meta-analyses (NMAs) in this field handle dose is not well characterised. We conducted a meta-research study to examine how current depression NMAs incorporate dosing information and identify methodological gaps in current practice.

Meta-research study following guidance for meta-epidemiological research and incorporating relevant elements of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020.

We searched PubMed, Embase, the Cochrane Library, PsycINFO, Web of Science and Scopus for NMAs published between January 2020 and May 2025.

NMAs comparing interventions, or different doses of a single intervention, in the context of depression—where an antidepressant was evaluated for depression-related indications and/or depressive symptoms were the primary clinical focus—and in which dose variation was incorporated into the evidence synthesis.

We extracted data on dose-handling strategies, analysis methods, statistical frameworks and reporting quality, and synthesised these narratively to characterise methodological practice across studies.

Twenty studies met inclusion criteria, evaluating pharmacologic interventions (n=11), non-pharmacologic interventions (n=7) or both (n=2). Dose handling varied substantially: in primary analyses, 50% treated dosages as separate nodes (split approach), 32% lumped doses together and only 15% used model-based methods incorporating dose-response relationships. Nine studies employed the R package MBNMAdose to conduct a model-based NMA for secondary analyses, primarily examining exercise interventions with varied dose-response functions. Reporting of priors, consistency assessments and justifications for dose categorisation or operationalisation was inconsistent.

Current depression NMAs demonstrate broad variability in handling dose-related heterogeneity, with dose-response modelling often absent or inconsistently applied—particularly for behavioural interventions lacking standardised dose metrics. Greater methodological clarity, practical guidance and reporting standards are needed to integrate dose-response modelling into NMAs of depression treatments, where both pharmacologic and behavioural interventions pose distinct dosing challenges.

Existing frameworks on Commercial Determinants of Health (CDoH) largely focus on macro-level corporate practices and policy environments. Individual-level exposure—mediated through targeted marketing, pricing strategies, product availability and placement—remains underexplored, particularly in low- and middle-income countries. The absence of standardised tools to capture these exposures limits the ability to quantify commercial influences on health and weakens evidence-informed public health responses. There is a critical need for a robust, contextually grounded instrument to measure individual-level exposure to CDoH. Developing and validating an individual-level CDoH measurement tool is therefore essential to strengthen research, surveillance and policy action aimed at mitigating health-harming commercial influences. The availability of this tool will allow policymakers and public health practitioners to identify high-risk populations and monitor the effectiveness of regulatory actions addressing harmful commercial practices.

This study will follow standard guidelines for tool (questionnaire) development. The process will include four sequential phases: item generation, refinement, validity testing and construct validation. A literature review with a systematic search strategy and in-depth interviews with purposively sampled adults will inform domain identification and item generation. An e-Delphi process involving experts in CDoH and public health will refine and confirm items followed by content validity. This will be followed by assessment of face validity for clarity and relevance. Construct validity will be assessed through exploratory and confirmatory factor analyses, using fit indices such as Minimum ²/df, Goodness of Fit Index, Tucker-Lewis Index, Comparative Fit Index, Root Mean Square Error of Approximation and Standardised Root Mean Square Residual. Reliability will be estimated using Cronbach’s alpha, and convergent and discriminant validity will be examined through correlation analyses.

Ethical approval has been obtained from the Institutional Ethics Committee, Amrita Institute of Medical Sciences, Kochi (ECASM-AIMS-2025-267). Results will be disseminated through peer-reviewed publications, conferences and policy briefs, and the validated tool will be made accessible for research and public health applications.

It is crucial that the outcomes used in clinical effectiveness studies are relevant to patients. This relevance can be assured by patients participating with other key stakeholders in core outcome set (COS) studies, yet recruiting patients to such studies can be challenging.

As no guidance currently exists to help COS developers create good COS invitations for patients, which are usually the first documents patients see when invited to participate in COS studies, the Good Research Invitation Study aimed to produce such guidance.

Consensus meeting to agree on guidance for COS developers designing research invitations.

Informed by findings from our previous qualitative study of patient and public opinions on COS study invitations, our team, which included a patient research partner, produced an initial set of candidate recommendations. An online consensus meeting was organised in the UK with 13 participants including patient research partners with and without COS study experience, COS developers, a representative from an ethics committee and experts in diversity, marketing and science communication. Through a process of discussion and voting, the initial set of recommendations was refined.

From the initial 35 recommendations, consensus meeting participants agreed a final set of 22 recommendations. Some initial recommendations were removed as they were beyond the scope, while others were merged. The finalised recommendations focused on producing and user testing invitations, reaching the audience, engaging potential COS participants and considering what they might find appealing or off-putting, explaining and creating interest in the study, keeping the invitation simple and understandable, considering the amount of information to include and how to present it, alongside ensuring accessibility. Discussion during the meeting highlighted the importance of improving the accessibility of all participant-facing resources in COS studies, not just the invitations.

Through consensus, a set of recommendations has been agreed on for use by COS developers to enhance study invitations for patients. Further testing and refinement of the recommendations will improve their utility.

The use of core outcome sets (COSs) in health research is widely recommended. COSs are developed with input from key decision makers, patients being a vital group to ensure COS relevance. However, recruitment to COS studies can be challenging.

The study aimed to explore what patients and the public think of COS study invitations, which are usually the first document a patient reads about a COS study.

Qualitative study involving focus groups and interviews. Analysis of transcribed data drew on reflexive thematic analysis.

Focus groups and interviews were conducted with a diverse range of patients and the public (n=31) from community and patient groups in North West England, exploring their perceptions of a sample of COS study invitations. Participants were eligible if aged over 18 years, they could speak English and had never previously participated in a COS study.

Themes identified included understanding, engagement, safety and accessibility. Participants were concerned about excessive information in the invitations which made them confused. Fear of cybercrime caused numerous concerns and participants were reluctant to click on links or attachments. Trust in the people sending the invitations was key. Participants wanted to see messages that COS studies had a meaningful purpose to feel their contributions were valuable. They were keen to contribute to improving future ‘treatment’ but less motivated to improve ‘research’. Messages that evoked a feeling of connection with others who they could relate to were positively regarded. Participants also highlighted ways that invitations could be made more accessible.

COS invitations can present numerous challenges for potential participants, but our study indicates ways that COS developers can address these challenges and make their invitations more appealing to potential participants. As part of the wider Good Research Invitation Study the findings have been used to inform guidance on designing a good COS invitation

To conduct a Delphi study to develop a consensus-based definition of complex case management within the UK context.

This study was conducted with members of the British Association of Brain Injury and Complex Case Management (BABICM).

A methodological approach informed by a modified Delphi design was employed, incorporating expert focus groups and two rounds of questionnaires distributed to members of the BABICM.

Initial focus groups (n=2) with eight expert case managers generated themes which were used to create a draft definition. Five definitions—four existing and one newly developed definition—were reviewed and refined through two rounds of online questionnaires. The top two definitions in round 1 were retained for round 2 (with no refinement required based on qualitative responses). The final definition was agreed-on when consensus was reached ≥80% agreement.

In round 1, 130 (10.8% of the 1200-member population) BABICM members ranked five definitions and provided qualitative feedback. Based on round 1 rankings, two definitions were retained for round 2. Definition 4, developed through expert focus groups, was ranked as the most preferred in round 1 (60%) and round 2 (85%), thus meeting the consensus threshold. The final definition emphasised collaborative, tailored support across systems, advocacy and person-centred care for clients and their families.

This study provides a consensus-based definition of complex case management in the UK, reflecting the complexity and interdisciplinary nature of the role. The definition offers a foundation for standardising practice, informing training and guiding future research and policy development.

To compare the diagnostic accuracy of four available automated electronic medical record (EMR) retrieval methods, including a large language model (LLM)-assisted workflow, against manual chart adjudication for identifying cardiovascular events.

Retrospective diagnostic accuracy study.

Three sites within a single US tertiary health system.

Two adult cohorts with previously adjudicated cardiovascular outcomes were included. Cohort 1 included 2258 patients treated with immune checkpoint inhibitors, and Cohort 2 included 1426 patients who underwent transcatheter aortic valve replacement.

The reference standard was clinician manual chart adjudication. Outcomes included ischaemic stroke or transient ischaemic attack, myocardial infarction (MI), heart failure (HF) exacerbation or hospitalisation and a composite major adverse cardiovascular events (MACE) outcome. Automated retrieval methods included International Classification of Diseases (ICD) codes, primary diagnosis, problem list and a zero-shot LLM workflow. Area under the (receiver operating characteristic) curve (AUC), sensitivity, specificity and net reclassification improvement were assessed.

In Cohort 1, the LLM achieved the highest AUC for stroke (0.920; 95% CI 0.881 to 0.958), MI (0.938; 95% CI 0.905 to 0.971) and composite MACE (0.880; 95% CI 0.854 to 0.907), whereas ICD-based retrieval had a higher AUC for HF (0.882; 95% CI 0.845 to 0.918 vs 0.873; 95% CI 0.831 to 0.914). In Cohort 2, the LLM achieved the highest AUC for all evaluated outcomes: stroke (0.915; 95% CI 0.862 to 0.968), MI (0.928; 95% CI 0.839 to 1.000), HF (0.844; 95% CI 0.803 to 0.884) and composite MACE (0.862; 95% CI 0.829 to 0.895). In Cohort 1, differences in AUC between the LLM and ICD methods were not statistically significant across outcomes, whereas in Cohort 2 the LLM showed significantly higher AUC for stroke and composite MACE.

In this multisite retrospective validation study, the LLM-assisted workflow showed strong but context-dependent performance for identifying cardiovascular events from the EMR. Performance varied by outcome and cohort, and ICD-based retrieval remained competitive for some use cases. These findings support a complementary role for LLM-assisted extraction in retrospective cardiovascular outcomes research.

Healthcare contributes substantially to global greenhouse gas emissions; however, the environmental impact of clinical research activities remains poorly understood. Quantifying emissions is a necessary first step toward reducing the carbon footprint of research.

To map and synthesise literature measuring carbon emissions associated with clinical research activities, with a focus on research domains assessed, tools and methods used and units of measurement reported.

A scoping review was conducted following the Arksey and O’Malley methodology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews guidance. PubMed, Web of Science, CINAHL, Scopus, EconBiz, GreenFile and ProQuest were searched from database inception to June 2026. Eligible studies reported measurement of carbon emissions related to clinical research activities. Data were charted and synthesised narratively.

Twenty-five studies met the inclusion criteria, most published between 2019 and 2025 and primarily from Europe and the UK. Studies used a wide range of tools and resources, including life cycle assessment databases, online calculators, international standards, government emission factor datasets and healthcare-specific sustainability frameworks. A clear trade-off emerged between methodological rigour and accessibility: comprehensive life cycle assessment tools required expertise and licensing, while simpler calculators enabled rapid but less precise estimates. Carbon dioxide equivalent and global warming potential over a 100-year time horizon were the dominant reporting metrics, although variation in functional units limited comparability across studies.

The methodological landscape for measuring emissions in clinical research is fragmented and lacks standardisation. Development of consensus guidance and reporting standards is needed to support consistent measurement and reduction of research-related emissions.

Oral capsules for gastric submucosal delivery represent a fundamentally new route of administration for biologics, which are currently limited to injection. Involving patients and members of the public to understand their perspectives on this novel pharmaceutical form, distinct from both injections and traditional oral tablets, is essential for the clinical development, regulatory approval, adoption and acceptability. This study aims to identify perceived benefits, concerns and communication preferences regarding oral capsules for gastric submucosal delivery, using BIONDD as a case study, to initially document the elements of the perceived value proposition and potential reservations about the oral delivery system from the patient and public perspectives.

This two-country exploratory sequential mixed-methods study will be conducted in Denmark and the USA. First, focus group interviews with purposively sampled patients and members of the public will explore attitudes towards oral capsules for gastric submucosal delivery. Qualitative data will be analysed using thematic analysis, combining manual and artificial intelligence-assisted coding. Insights from the focus groups will inform the development of a structured questionnaire, which will subsequently be distributed to a broader sample in both countries. Survey data will be analysed descriptively, and where possible, exploratory comparisons between country samples will be made. Main outcomes will include perceived benefits, concerns, acceptability and preferred terminology for discussing this novel pharmaceutical form.

The study has been approved by the relevant ethics committees at the University of Copenhagen and Nova Southeastern University. All data will be managed confidentially in line with General Data Protection Regulation and local regulations. Informed consent will be obtained in accordance with site-specific ethical procedures, and withdrawal will be possible up to a defined stage of data processing, after which data cannot be linked to individual participants. Results will be disseminated in peer-reviewed journals, at conferences and on institutional websites, in accordance with established ethical research and authorship guidelines.

Upper-limb (UL) impairment following stroke significantly limits independence in activities of daily living (ADLs). Although tabletop functional task-oriented training (FTOT) is a cornerstone of neurorehabilitation, both conventional therapist-led and technology-supported FTOT face limitations in consistency, supervision, progression and continuity across settings. The objectives are to characterise current clinical practices in UL tabletop FTOT and identify stroke survivor–caregiver dyads’ needs, constraints and support requirements across clinical and home contexts to inform user-centred technology development.

A multi-phase mixed-methods design will be employed. Phase-A will be an explanatory sequential design including a quantitative online survey of rehabilitation therapists (target minimum n=100) to characterise UL tabletop training delivery (eg, task selection, dose, progression). Survey findings will inform subsequent data collection through virtual qualitative interviews with a purposive subsample of therapists (anticipated n10–20) to examine task orchestration, adaptation and clinical decision-making in depth. Phase-B will use a descriptive qualitative design involving semi-structured interviews of stroke survivor–caregiver dyads (target n=15 dyads) to explore FTOT experiences across clinical and non-clinical contexts. Quantitative data will be analysed descriptively, and qualitative data will be analysed using inductive content analysis. Mixed-methods integration, within Phase-A and between the two phases, will examine convergence, complementarity, expansion and divergence. Integration will be illustrated using joint displays, visual tools that present the findings from both strands side-by-side using a table or figure. Patient and public involvement activities (n=5) and a pilot dyadic interview (two dyads) were completed to refine study materials and procedures.

Ethical approval was obtained from the Institutional Review Board of Christian Medical College, Vellore (IRB Min No. 2511113). Electronic informed consent will be obtained from therapists for the survey and qualitative interviews. Written informed consent will be obtained from the dyadic participants before the interviews. All study procedures will adhere to ethical principles for human research. Study findings will be disseminated through conference presentations and publication in peer-reviewed journals, with stakeholder-oriented dissemination to support clinical and technology development.

The Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were developed to improve the completeness and transparency of reporting of reliability and agreement of health measurement instruments. However, since their publication in 2011 methodological standards, both for reporting guideline development and reliability, agreement and measurement error studies have advanced, highlighting the need for aligning and updating. In addition, related initiatives like COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) have emerged, offering opportunities to harmonise terminology and promote consistency across diverse types of measurement instruments. This method review aims to (1) systematically identify and synthesise commentaries on and evaluations of the original GRRAS and (2) map recent methodological developments in the planning, conduct and interpretation of reliability, agreement and measurement error studies in health science, psychology and education that should be reflected in the reporting, to inform the development of the GRRAS-COSMIN reporting guidelines.

Two complementary search strategies will be employed. First, forward direct citation tracking of the original GRRAS publications will be conducted in Web of Science. We will include sources providing critique, commentaries or suggestions related to the GRRAS. We will exclude publications that used GRRAS just for structuring their report, withdrawn or retracted articles, textbooks, peer reviews, supplements and conference materials without full-text publications. Included articles will be analysed using descriptive content analysis. Second, we will perform a systematic search in MEDLINE, PsycInfo, Embase, ERIC and CINAHL supplemented by key references identified by or known to the author team. We will include studies, reviews, commentaries, editorials, methodological papers, tutorials and guidance documents that discuss or critically reflect on methodological aspects of the measurement properties reliability and/or agreement/measurement error published between 1 January 2015 and 30 June 2026 in health sciences, psychology or education. Eligibility will be assessed by two independent reviewers and included sources will be analysed using ‘codebook’ thematic analysis. Findings will be presented narratively supplemented by visuals and tables if appropriate.

This study involves publicly available data. No ethical approval is needed. Results will be disseminated through an open-access journal publication following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review Extension and conference presentations.

To review how statistically non-significant indirect treatment comparison (ITC) results are interpreted within National Institute for Health and Care Excellence (NICE) cost-comparison evaluations (CCEs) and develop a framework to support interpretations of these results from Bayesian network meta-analyses (NMAs).

A systematic review of CCEs between 2017 (first introduced) and April 2025. A framework (point-and-density plots) was developed to better interpret statistically non-significant NMA results for CCEs.

CCEs were identified through NICE website searches, references of similar reviews and communications with NICE.

NICE technology appraisals (from 2017) that followed a CCE approach ab initio, had final guidance available and used non-statistically significant ITC results were included.

A single reviewer performed screening and data extraction with validation by a second reviewer. Narrative syntheses were performed separately for company, External Assessment Group (EAG) and committee perspectives. Point-and-density plots combine elements of forest plots and density plots alongside reporting the probability that a treatment is non-inferior relative to a comparator. These were applied to a recent CCE (TA1019) for crovalimab for patients with paroxysmal nocturnal haemoglobinuria.

Among 41 CCEs, EAGs raised concerns about statistically non-significant ITC results while companies relied heavily on them. Only ~32% of CCEs applied formal methods to explore ITC result uncertainty.

For the example framework analysis, comparisons of crovalimab to eculizumab (mean difference (MD): 0.018; 95% CIs –0.22 to 0.25) and ravulizumab (MD: 0.079; 95% CIs –0.25 to 0.41) were statistically non-significant, with non-inferiority not demonstrated. However, point-and-density plots indicated a 95.9% and 86.3% probability of non-inferiority of crovalimab versus eculizumab and ravulizumab.

Interpretations of statistically non-significant ITC results are inconsistent within individual CCEs and across appraisals. Implementation of the presented recommendations and framework would improve the consistency and robustness of CCEs.

CRD420251034143.

The study aims to demonstrate non-inferior clinical success (safety and efficacy) of the MOTUS Total Joint Replacement device relative to posterior or transforaminal lumbar interbody fusion with respect to a composite endpoint. The primary hypothesis for this study is that the probability of achieving 24-month composite clinical success (CCS) for subjects receiving the investigational device is not clinically inferior to the probability of achieving 24-month CCS for subjects receiving lumbar interbody fusion collected in a separate real-world evidence (RWE) study.

This study is an interventional, multicentre (20 sites), prospective, non-blinded investigation of the MOTUS Total Joint Replacement device. The data collected in this study will be compared with a lumbar interbody fusion control group collected in an RWE study. The study design includes concurrently enrolled, non-randomised, investigational and control arms and features several elements intended to ensure comparability of subjects in the two groups. Sites were selected that would enrol both groups and represent a geographical mixture of urban and rural, teaching versus non-teaching institutions, surgical site status (ambulatory surgical centre vs hospital) and implanting surgeon specialty (neurological vs orthopaedic). Both groups were enrolled in overlapping time periods, ensuring consistency in the practice of medicine. The same postoperative protocol was applied to both groups. Covariate balance is ensured through the use of propensity score methods. The primary endpoint requires individual subject success, which is met when each subject achieves all of the following criteria at 24 months: (1) improvement of at least 15 points in Oswestry Disability Index score (out of 100) at 24 months compared with baseline; (2) maintenance or improvement in neurological status at 24 months compared with baseline; (3) no subsequent surgical intervention including revision, reoperation, removal or supplemental fixation at the index level and (4) absence of serious device-related adverse events.

This clinical study is part of an Investigational Device Exemption (IDE) from an ongoing Premarket Approval (PMA) application to the US Food and Drug Administration (FDA). Both arms of the study have been reviewed and approved by an independent IRB (WCG IRB, tracking numbers 20222831 and 20211903). The study is being conducted in accordance with the Good Clinical Practice guidelines and other applicable regulatory requirements including but not limited to FDA Regulations (21 CFR 50, 54, 56 and 812), Department of Health and Human Services Regulations (45 CFR 46), ISO 14155 and the Declaration of Helsinki. Study results will be disseminated within the context of the PMA process and ClinicalTrials.gov, with the intent of publication in conferences and peer-reviewed literature.

NCT05438719; NCT04823858.

Older adults are increasingly recognised as valuable contributors in health and social care research, yet their involvement as active research partners remains inconsistent and under-theorised across contexts. The aim of this study is to investigate how older adults are involved as active research partners in health and social care research and to build consensus on strategies and enabling conditions that can support and strengthen such involvement.

This study uses a sequential exploratory mixed-methods design comprising three phases. In the preparatory phase, the study protocol was developed and the ethical approval application was prepared and submitted. In the exploratory phase, an umbrella review of international evidence, a mapping survey with older adults and researchers, qualitative interviews and a participatory concept-mapping workshop will be conducted to identify experiences, practices, barriers and strategies for involving older adults as research partners. The empirical components will primarily be conducted within a Swedish context to generate context-sensitive insights. Findings will be triangulated to develop a preliminary framework and candidate consensus statements. In the consensus-building phase, a modified Delphi study will be conducted with two expert panels of older adults and researchers, respectively. Across iterative rounds, participants will rate the importance and feasibility of each statement using 5-point Likert scales. Quantitative data will be analysed descriptively to assess consensus levels and qualitative comments will undergo content analysis. Results will be analysed overall and by panel to identify areas of agreement and divergence.

The study has received an advisory opinion from the Swedish Ethical Review Authority (reference number 2025–08878-01). The study will be conducted in accordance with Swedish ethical regulations and applicable data protection legislation, including the General Data Protection Regulation. Older adults have been involved in shaping the study and corresponding protocol and will contribute to the interpretation and dissemination of findings. Results of this study will be shared through peer-reviewed publications and conference presentations.

Health interventions should be designed to be appropriate for scaling from the outset, but the extent to which factors that are important for scalability are reported on in pilot randomised trials is unclear. This review assesses the extent to which pilot randomised trials report on 15 domains of intervention scalability.

Methodological review.

Four journals were searched: BMJ Open, BMC Pilot and Feasibility Studies, BMC Trials and PLoS One for articles published between January 2023 and October 2024.

We included pilot randomised trials of health interventions.

Data relevant to 15 scalability domains, derived from the Intervention Scalability Assessment Tool and wider implementation science literature, were extracted. Data were double-extracted for 20% of the included studies. Two authors scored all studies from 0 to 3 (0=Not at all; 1=Small extent; 2=Moderate extent; 3=Large extent) on the extent to which each of the 15 scalability domains was reported. For each scalability domain, we calculated the mean score and the frequency of each categorical score across the included studies.

Titles and abstracts screening (521 publications) resulted in 132 full-text publications for review. Of the 104 eligible studies, a random sample of 50 studies were selected for detailed review. Through snowballing, an additional 49 associated publications were identified (eg, protocols), resulting in 99 publications across 50 studies. Most studies reported the Problem (30/50, 60%; mean=2.4 ± 0.8) and the Intervention (37/50, 74%; mean=2.7 ± 0.4) to a large extent (ie, scored 3), with the Delivery Setting and Workforce domain most often receiving a score of 2 (28/50, 56%; mean=2.2 ± 0.7). For eight of the scalability domains, the majority of studies scored 0.

The extent of scalability domain reporting in pilot trials of health interventions is limited. Explicit consideration of scalability in pilot trials could improve the design of fully powered randomised controlled trials and enhance the potential for effective interventions to be translated into practice. Future research should consider if and how to incorporate scalability considerations into pilot trials, and whether pilot trial and intervention reporting guidelines should be expanded to include scalability considerations.

Traumatic brain injury commonly causes dizziness and balance problems. Benign paroxysmal positional vertigo (BPPV) is the most frequent cause of inner-ear related post-traumatic vestibular dysfunction. However, optimal assessment and treatment practices are poorly evidenced. Using a mixed methods approach, we aimed to explore the feasibility of managing post-traumatic BPPV.

A mixed-methods randomised feasibility study. In this paper, quantitative and qualitative data relating to key feasibility targets around recruitment, randomisation and assessment and treatment were selected and integrated to provide an in-depth understanding of BPPV management.

Three UK major trauma centres

Hospitalised adults with post-traumatic BPPV.

Patients were randomised to one of three interventions (repositioning manoeuvres, Brandt-Daroff exercises and advice).

Screening and recruitment varied between sites due to individual and site-specific factors. Randomisation to advice was experienced differently by healthcare professionals and patients, suggesting that changes to the study design of a future effectiveness trial may be required. Assessment and treatment were acceptable to participants, supporting advancement to an effectiveness trial.

Integration of qualitative and quantitative data revealed new findings relating to the primary outcomes of the feasibility study, while strengths and weaknesses of the trial design were also elucidated. Taken together, such data will influence and enhance the design of a future trial.

ISRCTN91943864.

‘Spin’ refers to reporting practices that distort the interpretation of results and mislead readers’ impression of the research findings so that the results are viewed in a more favourable light. This systematic review aims to assess the impact of spin on the impressions and/or interpretation of research findings among healthcare professionals and decision makers involved in health-related decision-making and to evaluate interventions/strategies designed to reduce the influence of spin.

This systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE (via Ovid), EMBASE, the Cochrane Library (CENTRAL) and the Education Resources Information Center (ERIC) will be searched from their inceptions to 27 January 2026. Randomised controlled trials evaluating the impact of spin on participants’ impressions and/or interpretation of research findings, as well as trials assessing the effect of interventions/strategies on the recognition and interpretation of spin, will be considered. Study selection, data extraction and risk of bias (RoB) assessment with the Cochrane RoB2 tool will be performed independently by multiple reviewers. Where sufficient data are available, meta-analyses will be conducted.

As this study is based on a review of publicly available literature, ethical approval is not required. The findings will be disseminated through publication in peer-reviewed journals, presentations at international conferences and press releases.

INPLASY202620006.

To explore the feasibility of the confidante methodology to measure past-year intimate partner violence (IPV) experiences in Burkina Faso and the Democratic Republic of the Congo (DRC) through (1) comparison of direct assessment with indirect estimation via the confidante method and (2) assessment of the performance of each confidante method assumption.

Cross-sectional study with nationally and subnationally representative data collected from December 2020 to March 2021 in Burkina Faso (national) and from December 2021 to April 2022 in Kinshasa and Kongo Central, DRC (subnational).

Burkina Faso; Kinshasa, DRC; Kongo Central, DRC.

Partnered women (married or cohabiting) aged 15–49 in Burkina Faso (N=3047), Kinshasa, DRC (N=702) and Kongo Central, DRC (N=688) and their partnered confidantes aged 15–49 (N=2064 in Burkina Faso, N=304 in Kinshasa, DRC, N=393 women in Kongo Central, DRC).

Past-year IPV (emotional, physical, sexual, any) comparing differences in prevalence between the direct respondent sample and the indirect confidante sample, adjusting for confidante method assumptions.

The confidante method produced comparable IPV estimates to respondents’ direct reports across sites (35.3% respondent vs 36.1% confidante in Kinshasa, DRC; 29.7% respondent vs 39.0% confidante in Kongo Central, DRC; 25.7% respondent vs 26.0% confidante in Burkina Faso, differences not statistically significant). Of note, there were differences in IPV estimates between respondents and confidantes by IPV subtype, with physical IPV consistently lower among respondents across sites and sexual IPV lower among confidantes in Kinshasa, DRC and Burkina Faso, though generally not statistically significant.

The confidante methodology did not afford advantages over standard, direct assessment for IPV. Overall, findings indicate the reliability of population-based surveys with direct IPV questions when implemented under recommended ethical guidelines, though direct reports are likely undercounts.