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Guidance for Reporting Outcomes in Clinical Trials: Scoping Review Protocol

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Guidance for Reporting Outcomes in Clinical Trials: Scoping Review Protocol Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2018-023001 on 5 February 2019. Downloaded from Guidance for reporting outcomes in clinical trials: scoping review protocol Nancy J Butcher,1 Emma J Mew,1 Leena Saeed,1 Andrea Monsour,1 Alyssandra Chee-a-tow,1 An-Wen Chan,2 David Moher,3 Martin Offringa1 To cite: Butcher NJ, Mew EJ, ABSTRACT Strengths and limitations of this study Saeed L, et al. Guidance Introduction Patients, families and clinicians rely on for reporting outcomes published research to help inform treatment decisions. ► We will employ a comprehensive search strategy to in clinical trials: scoping Without complete reporting of the outcomes studied, review protocol. BMJ Open identify guidance on trial outcome reporting includ- evidence-based clinical and policy decisions are limited 2019;9:e023001. doi:10.1136/ ing electronic databases, grey literature sources, and researchers cannot synthesise, replicate or build bmjopen-2018-023001 expert colleagues and reference list screening pub- on existing research findings. To facilitate harmonised lished in the last 10 years. ► Prepublication history and reporting of outcomes in published trial protocols and ► Our methods are based on the methodologically rig- additional material for this reports, the Instrument for reporting Planned Endpoints in orous Joanna Briggs Institute scoping review meth- paper are available online. To Clinical Trials (InsPECT) is under development. As one of view these files, please visit ods manual. the initial steps in the development of InsPECT, a scoping the journal online (http:// dx. doi. ► To increase feasibility, two trained reviewers will review will identify and synthesise existing guidance on org/ 10. 1136/ bmjopen- 2018- perform screening and data charting, following the reporting of trial outcomes. 023001). training procedures and reliability assessments. Methods and analysis We will apply methods based ► As this is a scoping review of trial reporting guid- Received 16 March 2018 on the Joanna Briggs Institute scoping review methods ance, quality of the evidence and risk of bias will not Revised 11 October 2018 manual. Documents that provide explicit guidance on be systematically assessed. Accepted 19 December 2018 trial outcome reporting will be searched for using: (1) an electronic bibliographic database search; (2) a grey literature search; and (3) solicitation of colleagues for the quality of research reporting and reduce guidance documents using a snowballing approach. Reference list screening will be performed for included research waste, reporting guidelines have been developed to guide the preparation documents. Search results will be divided between two 4 trained reviewers who will complete title and abstract and publication of research studies. These screening, full-text screening and data charting. Captured include reporting guidelines for clinical trial http://bmjopen.bmj.com/ trial outcome reporting guidance will be compared reports (Consolidated Standards of Reporting with candidate InsPECT items to support, refute or Trials (CONSORT))5 and protocols (Stan- refine InsPECT content and to assess the need for the dard Protocol Items: Recommendations for development of additional items. Data analysis will explore Interventional Trials (SPIRIT)).6 common features of guidance and use quantitative Although CONSORT and SPIRIT measures (eg, frequencies) to characterise guidance and provide general guidance on how to report its sources. © Author(s) (or their outcomes,5 6 more detail is needed to employer(s)) 2019. Re-use Ethics and dissemination A paper describing the review 7–9 on September 30, 2021 by guest. Protected copyright. permitted under CC BY-NC. No findings will be published in a peer-reviewed journal. The adequately describe trial outcomes. Key commercial re-use. See rights results will be used to inform the InsPECT development information about how trial outcomes were and permissions. Published by process, helping to ensure that InsPECT provides an selected, defined, measured and analysed BMJ. is often missing or poorly reported.2 3 7 10–14 1 evidence-based tool for standardising trial outcome Child Health Evaluative reporting. Poor outcome reporting has been docu- Sciences, The Hospital for Sick mented across a diversity of disciplines and Children Research Institute, 10–12 Toronto, Ontario, Canada populations. Notably, 40%-60% of trials 2Department of Medicine, INTRODUCTIon have been found to have at least one primary Women's College Research Inadequate reporting remains a major chal- outcome that was changed, introduced or Institute, Women's College lenge in biomedical research.1 The quality omitted between protocol and publication.7 Hospital, University of Toronto, Toronto, Ontario, Canada of published research affects the ability of Without clear and complete reporting of trial 3Centre for Journalology, Clinical researchers and stakeholders to evaluate, outcomes, researchers cannot adequately Epidemiology Program, Ottawa replicate and build on study findings, which appraise, consolidate or replicate findings, Hospital Research Institute, in turn impacts evidence-based clinical and hindering the translation of evidence into Toronto, Ontario, Canada policy decision making. Poor reporting of clinical practice and policy. Correspondence to clinical trials, which provide the gold stan- Despite recommendations that a change Dr Nancy J Butcher; dard of evidence in research, has been in the reporting of trial outcomes is nancy. butcher@ sickkids. ca well documented.2 3 In an effort to improve needed,10 15–17 there is currently no dedicated Butcher NJ, et al. BMJ Open 2019;9:e023001. doi:10.1136/bmjopen-2018-023001 1 Open access BMJ Open: first published as 10.1136/bmjopen-2018-023001 on 5 February 2019. Downloaded from guidance that authors can follow when describing trial Eligibility criteria outcomes in published protocols and reports. To address The inclusion criteria are based on the Population, this issue, an international group of experts and knowl- Concept and Context framework, as recommended by edge users are developing the Instrument for reporting The Joanna Briggs Institute for scoping reviews as a less of Planned Endpoints in Clinical Trials (InsPECT)18 to restrictive alternative to the Population, Intervention, standardise and harmonise trial outcome reporting. Comparator, Outcome framework. To date, this team has developed an initial list of candi- date InsPECT items through an environmental scan of Population academic and regulatory publications16 and through Eligible documents will include those with content rele- consultations with methodologists and knowledge users vant to clinical trials performed in any human popula- (including clinicians, guideline developers and trial- tion, including any age, sex or health condition. ists). The candidate InsPECT items can be found on Concept the Open Science Framework at https://osf. io/ arwy8/. Eligible documents will include those that provide guid- Draft versions will be iteratively updated as the project ance (advice or formal recommendation) and/or a progresses. The final product will be unique InsPECT checklist describing outcome-specific information that extensions for the SPIRIT and CONSORT reporting should be included in clinical trial reports or protocols. guidelines. Reporting guidance relevant to any type of outcome (eg, No review of current guidance on how to adequately primary or secondary outcomes; biomarker/surrogate report outcomes in clinical trial protocols and final trial outcomes or clinical outcomes such as clinician-reported reports exists. The purpose of this scoping review is to outcomes; harms) will be eligible. As there is consider- identify and synthesise existing guidance for outcome able heterogeneity in the terms used in the published reporting in clinical trials and protocols to inform 10 literature to describe outcomes, guidance that uses InsPECT development. The results of this scoping review synonyms for outcomes will also be included, as appro- will be presented during the InsPECT Delphi process and priate (eg, endpoint, outcome measure, efficacy vari- consensus meeting. The specific research questions are: able). To increase study feasibility and reliability, this 1. What published guidance exists on the reporting of review will only include explicit guidance ("stated clearly outcomes for clinical trial protocols and reports? and in detail, leaving no room for confusion or doubt"26; 2. Does the identified guidance support or refute each such that the guidance must specifically state that the candidate InsPECT item as a reporting item for clini- information should be included in a clinical trial protocol cal trial protocols and/or reports? or report).27 An example of a statement of included 3. Does any identified guidance support the creation of guidance follows from the CONSORT patient-reported additional candidate InsPECT items or the refinement outcomes (PRO) extension: "Evidence of patient-re- http://bmjopen.bmj.com/ of existing items? ported outcome instrument validity and reliability should be provided or cited, if available".27 METHODS AND ANALYSIS Study design Context A scoping review was considered to be the most suitable Sources from any country or setting will be considered. Dates will be restricted to the last 10 years; as InsPECT will approach for addressing the broad aim of this study. A 5 scoping review is a type of knowledge synthesis approach form extensions to CONSORT (published in 2010)
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