Article type
Year
Abstract
Background:
Clinicians, patients, and policy makers rely on published results from clinical trials to help inform evidence-based decision-making. Readers require complete and transparent information with respect to what was planned, what was done, and what was found. Inadequate reporting of trials is well-documented in the medical literature, including for study outcomes. Key information about the selection process, definition, measurement, and analysis of outcomes is often missing or poorly reported in trial protocols and subsequent published reports, impairing reproducibility of results, knowledge synthesis efforts, and prevention of outcome switching and other reporting biases.
Objectives:
This international project developed the SPIRIT- and CONSORT-Outcomes 2020 reporting guidelines to provide harmonized guidance for describing outcomes in trial protocols and reports, respectively.
Methods:
We developed the SPIRIT- and CONSORT-Outcomes reporting guidelines using the EQUATOR framework for health research reporting guidelines. This included the generation and evaluation of candidate outcome reporting items via expert consultations, a scoping review, a three-round international Delphi survey, and a two-day in-person expert Consensus Meeting. A diverse group of stakeholders was involved throughout the process including those with experience in the design, conduct, oversight, publication, and interpretation of clinical trials (trialists, biostatisticians, health economists, trial registries, research ethics board members, epidemiologists) and stakeholders who use the results of clinical trial reports (journal editors, clinicians, systematic review authors, health technology assessors). Patient and public representatives and research funders, contributed during the Consensus Meeting.
Results:
We identified 133 outcome reporting items from the scoping review and expert consultations, the majority of which are not currently included in CONSORT or SPIRIT reporting guidelines. Items were consolidated into 67 candidate items for Delphi voting, which was completed by 124 participants from 22 countries. After the Delphi survey, 19 items met criteria for further evaluation at the Consensus Meeting for inclusion in CONSORT-Outcomes and 30 for inclusion in SPIRIT-Outcomes. The Consensus Meeting and post-Consensus Meeting finalization process ultimately yielded 8 SPIRIT-Outcomes and 16 CONSORT-Outcomes extension items, focused on outcome definition, rationale of outcome selection, composite outcomes components, minimal important difference and change, measurement properties of study instruments, outcome assessors, and planned adjustments for multiplicity.
Conclusions:
SPIRIT-Outcomes and CONSORT-Outcomes provide new frameworks aimed to enhance trial transparency in areas known to be associated with outcome reporting bias.
Patient or healthcare consumer involvement:
The patient member, public member, research funder, and industry representatives attended the consensus meeting, helped finalize item wording, and advised on implementation strategies.
Clinicians, patients, and policy makers rely on published results from clinical trials to help inform evidence-based decision-making. Readers require complete and transparent information with respect to what was planned, what was done, and what was found. Inadequate reporting of trials is well-documented in the medical literature, including for study outcomes. Key information about the selection process, definition, measurement, and analysis of outcomes is often missing or poorly reported in trial protocols and subsequent published reports, impairing reproducibility of results, knowledge synthesis efforts, and prevention of outcome switching and other reporting biases.
Objectives:
This international project developed the SPIRIT- and CONSORT-Outcomes 2020 reporting guidelines to provide harmonized guidance for describing outcomes in trial protocols and reports, respectively.
Methods:
We developed the SPIRIT- and CONSORT-Outcomes reporting guidelines using the EQUATOR framework for health research reporting guidelines. This included the generation and evaluation of candidate outcome reporting items via expert consultations, a scoping review, a three-round international Delphi survey, and a two-day in-person expert Consensus Meeting. A diverse group of stakeholders was involved throughout the process including those with experience in the design, conduct, oversight, publication, and interpretation of clinical trials (trialists, biostatisticians, health economists, trial registries, research ethics board members, epidemiologists) and stakeholders who use the results of clinical trial reports (journal editors, clinicians, systematic review authors, health technology assessors). Patient and public representatives and research funders, contributed during the Consensus Meeting.
Results:
We identified 133 outcome reporting items from the scoping review and expert consultations, the majority of which are not currently included in CONSORT or SPIRIT reporting guidelines. Items were consolidated into 67 candidate items for Delphi voting, which was completed by 124 participants from 22 countries. After the Delphi survey, 19 items met criteria for further evaluation at the Consensus Meeting for inclusion in CONSORT-Outcomes and 30 for inclusion in SPIRIT-Outcomes. The Consensus Meeting and post-Consensus Meeting finalization process ultimately yielded 8 SPIRIT-Outcomes and 16 CONSORT-Outcomes extension items, focused on outcome definition, rationale of outcome selection, composite outcomes components, minimal important difference and change, measurement properties of study instruments, outcome assessors, and planned adjustments for multiplicity.
Conclusions:
SPIRIT-Outcomes and CONSORT-Outcomes provide new frameworks aimed to enhance trial transparency in areas known to be associated with outcome reporting bias.
Patient or healthcare consumer involvement:
The patient member, public member, research funder, and industry representatives attended the consensus meeting, helped finalize item wording, and advised on implementation strategies.