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. 2019 Feb 19;9(2):e023001.
doi: 10.1136/bmjopen-2018-023001.

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 Offringa  1
Affiliations

Guidance for reporting outcomes in clinical trials: scoping review protocol

Nancy J Butcher et al. BMJ Open. .

Abstract

Introduction: Patients, families and clinicians rely on published research to help inform treatment decisions. Without complete reporting of the outcomes studied, evidence-based clinical and policy decisions are limited and researchers cannot synthesise, replicate or build on existing research findings. To facilitate harmonised reporting of outcomes in published trial protocols and reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is under development. As one of the initial steps in the development of InsPECT, a scoping review will identify and synthesise existing guidance on the reporting of trial outcomes.

Methods and analysis: We will apply methods based on the Joanna Briggs Institute scoping review methods manual. Documents that provide explicit guidance on 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 guidance documents using a snowballing approach. Reference list screening will be performed for included documents. Search results will be divided between two trained reviewers who will complete title and abstract screening, full-text screening and data charting. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute or refine InsPECT content and to assess the need for the development of additional items. Data analysis will explore common features of guidance and use quantitative measures (eg, frequencies) to characterise guidance and its sources.

Ethics and dissemination: A paper describing the review findings will be published in a peer-reviewed journal. The results will be used to inform the InsPECT development process, helping to ensure that InsPECT provides an evidence-based tool for standardising trial outcome reporting.

Keywords: Consort Reporting Guideline; Endpoint; Outcome; Spirit Reporting Guideline; Trial; Trial Protocols.

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Conflict of interest statement

Competing interests: None declared.

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