Article type
Abstract
Background: Health equity concerns the absence of differences in health that are avoidable by reasonable action. Randomised trials have the potential to assess effects on health equity by either: 1) evaluating an intervention focused on people experiencing social disadvantage, or 2) exploring the difference in the effect of the intervention between two groups or as a gradient across more than two groups experiencing different levels of social disadvantage. Randomised trials have been found to rarely report information that may be used to inform decisions about health equity. The CONSORT (Consolidated Standards of Reporting Trials) reporting guideline and its extensions do not address this gap.
Objectives: We aimed to develop an evidence and consensus-based reporting guideline to improve reporting of health equity in randomised trials.
Methods: The research team and advisory board were representative of potential users from low- and middle-income countries, including knowledge users and methodologists. Empirical evidence was collected using 4 methods: 1) Assessing CONSORT and its extensions; 2) Assessing 200 health equity relevant trials; 3) conducting key informant interviews; and, 4) reviewing other related guidance. An online survey was used to gather broad input from a range of users (n=168) and a consensus meeting of global opinion leaders representing potential users and methodologist communities (The Boston Equity Symposium consensus panel) was held to discuss in depth the importance of each CONSORT item until consensus was reached.
Results: We reached agreement on extensions for 16 of the standard CONSORT items and the inclusion of one new item on ethics. Examples of good reporting for each item were identified to provide an explanation for each item.
Conclusions: This CONSORT-Equity 2017 reporting guideline will benefit peer reviewers, researchers, journal editors and other stakeholders by providing standards for improving the reporting of health equity in randomised trial. Ultimately, uptake of CONSORT-Equity 2017 will make it easier for decision makers to find and use evidence from randomised trials to reduce unfair inequalities in health.
Objectives: We aimed to develop an evidence and consensus-based reporting guideline to improve reporting of health equity in randomised trials.
Methods: The research team and advisory board were representative of potential users from low- and middle-income countries, including knowledge users and methodologists. Empirical evidence was collected using 4 methods: 1) Assessing CONSORT and its extensions; 2) Assessing 200 health equity relevant trials; 3) conducting key informant interviews; and, 4) reviewing other related guidance. An online survey was used to gather broad input from a range of users (n=168) and a consensus meeting of global opinion leaders representing potential users and methodologist communities (The Boston Equity Symposium consensus panel) was held to discuss in depth the importance of each CONSORT item until consensus was reached.
Results: We reached agreement on extensions for 16 of the standard CONSORT items and the inclusion of one new item on ethics. Examples of good reporting for each item were identified to provide an explanation for each item.
Conclusions: This CONSORT-Equity 2017 reporting guideline will benefit peer reviewers, researchers, journal editors and other stakeholders by providing standards for improving the reporting of health equity in randomised trial. Ultimately, uptake of CONSORT-Equity 2017 will make it easier for decision makers to find and use evidence from randomised trials to reduce unfair inequalities in health.