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Guidance for reporting outcomes in clinical trials: scoping review protocol
  1. Nancy J Butcher1,
  2. Emma J Mew1,
  3. Leena Saeed1,
  4. Andrea Monsour1,
  5. Alyssandra Chee-a-tow1,
  6. An-Wen Chan2,
  7. David Moher3,
  8. Martin Offringa1
  1. 1 Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
  2. 2 Department of Medicine, Women’s College Research Institute, Women’s College Hospital, University of Toronto, Toronto, Ontario, Canada
  3. 3 Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Toronto, Ontario, Canada
  1. Correspondence to Dr Nancy J Butcher; nancy.butcher{at}sickkids.ca

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.

  • Trial
  • Trial Protocols
  • Outcome
  • Endpoint
  • Consort Reporting Guideline
  • Spirit Reporting Guideline

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Patient consent for publication Not required.

  • Twitter @NancyJButcher, @InsPECT2019

  • Contributors NJB was responsible for study conception. NJB, EJM, and MO were responsible for the initial study design. NJB and EJM drafted the manuscript. All authors critically reviewed and provided feedback on the study design and manuscript, contributed to the development of the candidate InsPECT items, and read and approved the protocol prior to its submission. MO obtained funding for the development of InsPECT. NJB is the guarantor of the review.

  • Funding This project received financial support from the Canadian Institutes of Health Research (Project #148953).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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