Guidance for Reporting Outcomes in Clinical Trials: A Scoping Review Protocol_Version 1

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 synthesize, replicate, or build on existing research findings. To facilitate harmonized reporting of outcomes in published trial protocols and reports, a new reporting standard, the Instrument for reporting of 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 synthesize 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 and citation list screening will be performed for included documents. Two trained reviewers will complete title and abstract screening. One reviewer and one verifier will independently complete full-text screening and data charting. Discrepancies will be resolved through discussion with a third reviewer. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute, and 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 (e.g., frequencies) to characterize 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 standardizing trial outcome reporting. Registration details: This protocol was registered prospectively with the Open Science Framework (https://osf.io/ktg84/).