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Oct 2, 2024 | bmcmedresmethodol.biomedcentral.com | F. Shiely |A. Willis |C. Cooper |K. Biggs |Ja. Lane |C. Dix | +5 more

It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusion of particular under-served groups when designing a trial, but there is a lack of practical guidance on how to implement these frameworks. This paper describes the ACCESS project, the findings from each phase of the project and the guidance we developed (STEP UP) on how to design more inclusive trials. Development of the STEP UP guidance had five phases: (1) Scoping literature review, (2) ‘roundtable’ discussion meetings, (3) redesign of trials, (4) interviews and (5) guidance document development, with input from public contributors and the ACCESS team. Over 40 experts contributed to the ACCESS project—patients and the public, clinicians, NHS research staff, trialists and other academics. The scoping review identified several strategies being used to improve inclusion, mostly around recruitment settings, but there was little evaluation of these strategies. The ‘roundtable’ discussions identified additional strategies being used across the UK and Ireland to improve inclusion, which were grouped into: Communication, Community engagement, Recruitment sites, Patient information, Flexibility, Recruitment settings, Consent process, Monitoring, Training for researchers and Incentives. These strategies were used to redesign three existing trials by applying one of the three INCLUDE frameworks (ethnicity, socioeconomic disadvantage, impaired capacity to consent) to one trial each, to produce the key recommendations for the guidance. Issues around implementation were explored in stakeholder interviews and key facilitators were identified: funders requesting information on inclusion, having the time and funding to implement strategies, dedicated staff, flexibility in trial protocols, and considering inclusion of under-served groups at the design stages. The STEP UP guidance is freely available at http://step-up-clinical-trials.co.uk . Researchers should consider inclusivity to shape initial trial design decisions. Trial teams and funders need to ensure that trials are given both the resources and time needed to implement the STEP UP guidance and increase the opportunities to recruit a diverse population. Randomised clinical trials compare one or more treatments to another to see which ones work best. Trials don’t always include people or groups who might benefit from the results: those excluded are sometimes called ‘under- served groups’. Recent work has shone a light on this and now researchers are being asked by the public, trial funders and others to design their research so that under-served groups are more able to take part. We worked on a project to find out how to make sure everyone can be part of clinical trials. We looked at published work and held five online meetings with researchers, doctors, and patients to see what was being done already, and to think of other things that could help under-served groups take part in trials. Three groups of people, including scientists, patients, doctors and other NHS workers then  used this information to redesign three older trials using some existing inclusivity frameworks to think through the barriers for under-served groups in these trials. The three groups then talked through these trials at a 2-hour meeting, suggesting changes to the original trial plan, and discussed whether the suggestions were practical and useful. From this we came up with recommendations for how to design trials so that they have fewer barriers for under-served groups. We interviewed people to find out the best way to put these things into practice and talk through any practical issues. Using all of this information: the recommendations and what came out of the interviews, the study team created some guidance – ‘STEP UP (Strategies for Trialists to promote Equal Participation in clinical trials for Under-served Populations)’ – for people working in trials.

Aug 9, 2024 | bmcmedresmethodol.biomedcentral.com | Helmholtz Zentrum München

ReferencesBauer GR. Sex and gender multidimensionality in Epidemiologic Research. Am J Epidemiol. 2023. https://doi.org/10.1093/aje/kwac173. Article  PubMed  Google Scholar  Bolte G, Jacke K, Groth K, Kraus U, Dandolo L, Fiedel L, et al. Integrating Sex/Gender into Environmental Health Research: development of a conceptual Framework. Int J Environ Res Public Health. 2021. https://doi.org/10.3390/ijerph182212118.

Apr 22, 2024 | bmcmedresmethodol.biomedcentral.com | Clara Locher |Florian Naudet |Hervé Léna |Constant Vinatier |Loïc Fin |Anne Sophie Alix-Doucet | +1 more

The dissemination of clinical trial results is an important scientific and ethical endeavour. This survey of completed interventional studies in a French academic center describes their reporting status. We explored all interventional studies sponsored by Rennes University Hospital identified on the French Open Science Monitor which tracks trials registered on EUCTR or clinicaltrials.gov, and provides an automatic assessment of the reporting of results. For each study, we ascertained the actual reporting of results using systematic searches on the hospital internal database, bibliographic databases (Google Scholar, PubMed), and by contacting all principal investigators (PIs). We describe several features (including total budget and numbers of trial participants) of the studies that did not report any results. The French Open Science Monitor identified 93 interventional studies, among which 10 (11%) reported results. In contrast, our survey identified 36 studies (39%) reporting primary analysis results and an additional 18 (19%) reporting results for secondary analyses (without results for their primary analysis). The overall budget for studies that did not report any results was estimated to be €5,051,253 for a total of 6,735 trial participants. The most frequent reasons for the absence of results reported by PIs were lack of time for 18 (42%), and logistic difficulties (e.g. delay in obtaining results or another blocking factor) for 12 (28%). An association was found between non-publication and negative results (adjusted Odds Ratio = 4.70, 95% Confidence Interval [1.67;14.11]). Even allowing for the fact that automatic searches underestimate the number of studies with published results, the level of reporting was disappointingly low. This amounts to a waste of trial participants' implication and money. Corrective actions are needed. https://osf.io/q5hcs

Sep 14, 2023 | bmcmedresmethodol.biomedcentral.com | Box Hill

The initial data base for the calendar year 2016 consisted of 94,361 adult patients from 125 ICUs with median annual patient number of 524 (25th percentile 328, 75th percentile 1028, minimum 152 and maximum 2887). Patient demographics are displayed in Table 1.

Jun 16, 2020 | bmcmedresmethodol.biomedcentral.com | Herman Van Oyen