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BACKGROUND

 

Survey for the Extension of the CONSORT Statement for Equity – Proposed additional items or extensions of existing items for equity relevant trials.


What is the motivation for the extension of CONSORT for Equity? The Consolidated Standards for Reporting Trials (“CONSORT”) Statement is an evidence-based guideline consisting of 25 items, intended to encourage completeness and transparency of reporting RCTs. CONSORT extension statements have been developed for specific issues: reporting of cluster RCTs, harms, pragmatic trials, non-pharmacologic therapy and social and psychological interventions. None of the existing or planned CONSORT extensions address reporting characteristics needed to assess the effects of an intervention on health equity

Health equity is defined as the absence of avoidable and unfair differences in health within and between populations. Randomized controlled trials (RCTs) are a powerful research design for ascertaining the impact of an intervention and for informing health decisions. We use the term ‘disadvantaged’ to describe populations who are denied opportunities that others have to benefit from social and environmental conditions that lead to better health.  Commitment to health equity is about improving health outcomes for people who experience socially-structured disadvantage and as a result are not able to achieve their optimal health status. We use the acronym PROGRESS Plus.

  • Place of residence (rural/urban/inner city, low- or middle-income country)
  • Race/ethnicity/culture
  • Occupation
  • Gender/sex
  • Religion
  • Education (literacy)
  • Socioeconomic status
  • Social capital
  • “Plus” refers to other categories across which discrimination may exist such as sexual orientation, age, disability, or disease status. Other lists of factors or criteria may be also used.
What is the purpose of the extension of CONSORT for equity? The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs. The equity extension supplements the original core CONSORT. Extensions of the CONSORT Statement have been developed to give additional guidance for RCTs with specific designs, data and interventions, and which in this case are focused on equity.

What is the name of the CONSORT extension for Equity? The name of the extended version of CONSORT for equity is "CONSORT Statement for Equity".

How were the candidate checklist items developed? The candidate items presented in this survey were developed from key informant interviews with people who work with and/or are members of groups who conduct, participate in, or use, randomized trials, as well as through discussion with experts on the CONSORT Equity Executive and Advisory Board.  Both international groups and membership are listed here.

Who will use the CONSORT extension for Equity?  For the same reason that people use CONSORT, people who have conducted trials that build evidence that is relevant to equity, or "equity-relevant trials" will use the extension, as well as those wanting to see how the trials are reported. In addition, this extension of CONSORT for Equity can be used with other CONSORT extensions (for example, with CONSORT for Cluster Randomized Trials). The CONSORT Equity extension will be made publicly available on the equity methods group website [http://methods.cochrane.org/equity/consort-equity].

For more information, please refer to the study protocol: Protocol for the development of a CONSORT equity guideline to improve reporting of health equity in randomized trials.

The survey will remain open until September 5th, 2016.

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