CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials

Abstract:

We outline CONSORT-Equity 2017 reporting standards, an extension to the CONSORT (Consolidated Standards of Reporting Trials) statement that aims to improve the reporting of intervention effects in randomised trials where health equity is relevant. Health inequities are unfair differences in health that can be avoided by reasonable action. We defined a randomised trial where health equity is relevant as one that assesses effects on health equity by evaluating an intervention focused on people experiencing social disadvantage or by 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, or both. We held a consensus meeting with diverse potential users from high, middle, and low income countries, including knowledge users such as patients and methodologists. We discussed evidence for each proposed extension item from empirical studies, reviews, key informant interviews, and an online survey, aiming to improve clarity of reporting without imposing undue burden on authors. The new guidance contains equity extensions to 16 items from CONSORT 2010 plus one new item on research ethics reporting, with examples of good practice and a brief explanation and elaboration for each. Widespread uptake of this guidance for the reporting of trials where health equity is relevant will make it easier for decision makers to find and use evidence from randomised trials to reduce unfair inequalities in health.

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