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. 2019 Mar 6;20(1):161.
doi: 10.1186/s13063-019-3248-0.

Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT)

Nancy J Butcher  1 , Andrea Monsour  2 , Emma J Mew  2 , Peter Szatmari  3   4   5 , Agostino Pierro  6 , Lauren E Kelly  7 , Mufiza Farid-Kapadia  2 , Alyssandra Chee-A-Tow  2 , Leena Saeed  2 , Suneeta Monga  3 , Wendy Ungar  2   8 , Caroline B Terwee  9 , Sunita Vohra  10 , Dean Fergusson  11   12 , Lisa M Askie  13 , Paula R Williamson  14 , An-Wen Chan  8   15 , David Moher  16 , Martin Offringa  2
Affiliations

Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT)

Nancy J Butcher et al. Trials. .

Abstract

Background: Inadequate and poor quality outcome reporting in clinical trials is a well-documented problem that impedes the ability of researchers to evaluate, replicate, synthesize, and build upon study findings and impacts evidence-based decision-making by patients, clinicians, and policy-makers. To facilitate harmonized and transparent reporting of outcomes in trial protocols and published reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is being developed. The final product will provide unique InsPECT extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines.

Methods: The InsPECT SPIRIT and CONSORT extensions will be developed in accordance with the methodological framework created by the EQUATOR (Enhancing the Quality and Transparency of Health Research Quality) Network for reporting guideline development. Development will consist of (1) the creation of an initial list of candidate outcome reporting items synthesized from expert consultations and a scoping review of existing guidance for reporting outcomes in trial protocols and reports; (2) a three-round international Delphi study to identify additional candidate items and assess candidate item importance on a 9-point Likert scale, completed by stakeholders such as trial report and protocol authors, systematic review authors, biostatisticians and epidemiologists, reporting guideline developers, clinicians, journal editors, and research ethics board representatives; and (3) an in-person expert consensus meeting to finalize the set of essential outcome reporting items for trial protocols and reports, respectively. The consensus meeting discussions will be independently facilitated and informed by the empirical evidence identified in the primary literature and through the opinions (aggregate rankings and comments) collected via the Delphi study. An integrated knowledge translation approach will be used throughout InsPECT development to facilitate implementation and dissemination, in addition to standard post-development activities.

Discussion: InsPECT will provide evidence-informed and consensus-based standards focused on outcome reporting in clinical trials that can be applied across diverse disease areas, study populations, and outcomes. InsPECT will support the standardization of trial outcome reporting, which will maximize trial usability, reduce bias, foster trial replication, improve trial design and execution, and ultimately reduce research waste and help improve patient outcomes.

Keywords: CONSORT; Endpoint; Outcome; Reporting guideline; SPIRIT; Trial; Trial protocol.

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Conflict of interest statement

Ethics approval and consent to participate

Ethics approval is not required for this study, as per the Research Ethics Committee at the Hospital for Sick Children.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Outline of the InsPECT (Instrument for reporting Planned Endpoints in Clinical Trials) development process
See this image and copyright information in PMC

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