Search

Introduction Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. Methods and analysis The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. Ethics and dissemination The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from

Background: There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions. Objective: To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials. Methods: Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group. Results: Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome. Limitations: English-speaking patients and professionals rated outcomes extracted from English language studies. Conclusion: A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.

BACKGROUND: Problems continue to exist with the reporting quality and risk of bias in search methods and strategies in systematic reviews and related review types. Peer reviewers who are not familiar with what is required to transparently and fully report a search may not be prepared to review the search components of systematic reviews, nor may they know what is likely to introduce bias into a search. Librarians and information specialists, who have expertise in searching, may offer specialized knowledge that would help improve systematic review search reporting and lessen risk of bias, but they are underutilized as methodological peer reviewers.METHODS: This study will evaluate the effect of adding librarians and information specialists as methodological peer reviewers on the quality of search reporting and risk of bias in systematic review searches. The study will be a pragmatic randomized controlled trial using 150 systematic review manuscripts submitted to BMJ and BMJ Open as the unit of randomization. Manuscripts that report on completed systematic reviews and related review types and have been sent for peer review are eligible. For each manuscript randomized to the intervention, a librarian/information specialist will be invited as an additional peer reviewer using standard practices for each journal. First revision manuscripts will be assessed in duplicate for reporting quality and risk of bias, using adherence to 4 items from PRISMA-S and assessors' judgements on 4 signaling questions from ROBIS Domain 2, respectively. Identifying information from the manuscripts will be removed prior to assessment.DISCUSSION: The primary outcomes for this study are quality of reporting as indicated by differences in the proportion of adequately reported searches in first revision manuscripts between intervention and control groups and risk of bias as indicated by differences in the proportions of first revision manuscripts with high, low, and unclear bias.

Cotutela Universitat Politècnica de Catalunya i Université Paris V-Descartes, The lack of transparency and accuracy of research reports has been pointed out as one of the main factors causing research waste. Reporting guidelines (RGs) are sets of recommendations for authors on how to report research methods and findings in a way that no relevant information is missing. Nowadays, there exist more than 400 RGs for different study types, data, and clinical areas. However, biomedical authors’ adherence to RGs has been shown to be poor. For this reason, it is warranted to explore what strategies to improve adherence to RGs can be implemented at different points in the research process. This thesis has three objectives: (i) to identify, classify, and analyse interventions to improve adherence to RGs that have been described in the biomedical literature, and to determine the existing gaps in research on the evaluation of interventions, (ii) to explore biomedical editors’ perceptions of different interventions that have been or can be implemented at various points in the editorial process (iii) to evaluate in a real editorial context the impact of an intervention designed based on the studies that address objectives (i) and (ii). For the first objective, we performed a scoping review of interventions to improve adherence to RGs and identified 31 interventions (11 evaluated, 20 non-evaluated). These were grouped into five categories: training on the use of RGs; improving understanding; encouraging adherence; checking adherence and providing feedback; and involvement of experts. Research gaps identified included the evaluation of interventions (i) on training on the use of RGs and improving understanding of these, (ii) at early stages of research (education, grant writing or protocol writing), and (iii) after the final acceptance of the manuscript (copyediting or post-publication peer review). Furthermore, we showed that one of the most widespread editorial interventions, the requirement for authors to submit a completed RG checklist together with thei, La falta de transparencia y precisión de los informes de investigación es uno de los principales factores asociados al derroche de recursos financieros invertidos en investigación. Las guías de publicación (¿Reporting Guidelines¿, RGs) especifican cómo los investigadores han de informar de los métodos y resultados de sus estudios, de tal forma que los manuscritos contengan toda la información esencial para los lectores. Hoy en día, existen más de 400 RGs para distintos tipos de estudios, datos y áreas clínicas. Sin embargo, el nivel de adherencia a las RGs es deficiente. Por tanto, es necesario explorar qué estrategias para mejorar la adherencia a las RGs se pueden implementar en distintos momentos del proceso de investigación. Esta tesis tiene tres objetivos: (i) identificar, clasificar y analizar qué intervenciones para mejorar la adherencia a las RGs han sido descritas en la literatura biomédica, y determinar qué lagunas existen en la evaluación de intervenciones, (ii) explorar las percepciones de los editores biomédicos expertos sobre distintas intervenciones que afectan a los procesos editoriales, y (iii) evaluar el impacto de una intervención diseñada a partir de los estudios relativos a los objetivos (i) y (ii). Para alcanzar el primer objetivo, realizamos una revisión exploratoria. Esta revisión nos permitió identificar 31 intervenciones que agrupamos en cinco categorías: formación en el uso de RGs; mejora de la comprensión de las RGs; verificación de la adherencia a las RGs y propuestas de mejora para los autores; y colaboración de expertos. Además, identificamos algunas lagunas en las evaluaciones de intervenciones (i) relativas a la formación y mejora de la comprensión de las RGs, (ii) en fases iniciales del proceso de investigación (educación, solicitud de financiación o elaboración de protocolos), y (iii) después de la aceptación para publicación del manuscrito de investigación (durante el proceso de edición, o la revisión post-publicación del artículo), La manca de transparència y precisió dels informes d’investigació és un dels principals factors associats al malbaratament de recursos financers invertits en investigació. Les guies de publicació ("Reporting Guidelines", RGs) especifiquen com els investigadors han d'informar dels mètodes i resultats dels seus estudis, de manera que els manuscrits continguin tota la informació essencial per als lectors. Avui dia, n’hi ha més de 400 RGs per a diferents tipus d'estudis, dades i àrees clíniques. Tanmateix, el nivell d’adherència a les RGs és deficient. Per tant, és necessari explorar quines estratègies per millorar l'adherència a les RGs es poden implementar en diferents moments del procés d'investigació. Aquesta tesi té tres objectius: (i) identificar, classificar i analitzar quines intervencions han estat descrites per millorar l'adherència a les RGs en la literatura biomèdica, i determinar quines mancances existeixen en l'avaluació d'intervencions, (ii) explorar les percepcions dels editors biomèdics experts sobre diferents intervencions que afecten als processos editorials, i (iii) avaluar, en un context editorial real, l'impacte d'una intervenció dissenyada a partir dels estudis relatius als objectius (i) i (ii). Per assolir el primer objectiu, vam realitzar una revisió exploratòria. Aquesta revisió ens va permetre identificar 31 intervencions que vam agrupar en cinc categories: formació en l'ús de RGs; millora de la comprensió de les RGs; verificació de l'adherència a les RGs i propostes de millora per als autors; i col·laboració d'experts. Encara més, vam detectar mancances en l’avaluació d'intervencions (i) relatives a la formació i millora de la comprensió de les RGs, (ii) en fases inicials del procés de recerca (formació, sol·licitud de finançament o elaboració de protocols), i (iii) després de l'acceptació per a publicació dels manuscrits de recerca (durant el procés d'edició, o la revisió post-publicació de l’article). D’altra banda, vam demostrar que una de, Postprint (published version)

Background: Improving the completeness of reporting of biomedical research is essential for improving its usability. For this reason, hundreds of reporting guidelines have been created in the last few decades but adherence to these remains suboptimal. This survey aims to inform future evaluations of interventions to improve adherence to reporting guidelines. In particular, it gathers editors’ perceptions of a range of interventions at various stages in the editorial process. Methods: We surveyed biomedical journal editors that were knowledgeable about this topic. The questionnaire included open and closed questions that explored (i) the current practice of their journals, (ii) their perceptions of the ease of implementation and the potential effectiveness of different interventions, (iii) the barriers and facilitators associated with these interventions, and (iv) suggestions for future interventions and incentives. Results: Of the 99 editors invited, 24 (24%) completed the survey. Involving trained editors or administrative staff was deemed the potentially most effective intervention but, at the same time, it was considered moderately difficult to implement due to logistic and resource issues. Participants believed that checking adherence to guidelines goes beyond the role of peer reviewers and could decrease the overall quality of reviews. Journals incentivising adherence, and publishers and medical institutions encouraging journals to adopt strategies to boost adherence were two recurrent themes, Postprint (author's final draft)