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. 2019 Jul 30;9(7):e026866. doi: 10.1136/bmjopen-2018-026866

Table 2.

Stages in the development of CONSORT-Equity 2017 update terms

Stage 1: establish guiding features Example
 1. Find common ground. A process to initiate and develop a collaborative work plan that for CONSORT-Equity 2017 was an iterative three-step process to prepare a research team.
 2. Form an advisory board. Defined advisory board roles, accessed networks to recruit advisory board members; terms of reference to structure relationships within and between the advisory board-research team members (‘the team’) (table 1). Set an agreed-upon agenda that eventually resulted in a published protocol.7
Consensus-building processes promoted engagement in active debate and co-development of knowledge that resulted in, for example, defining and validating when a randomised trial is health equity-relevant.18
 3. Commit to ethical guidance. The team agreed on study conduct to adhere to ethical guidelines (in Canada, the Tri-Council Policy Statement V.2)45 and that could include other research ethics protocols or requirements considered relevant by team members, such as the example of research conduct with Indigenous people.46 47
 4. Clarify theoretical perspective. CONSORT-Equity 2017 is premised on understandings of key concepts, their definitions and usage by the team: understandings of health equity and agreements among team members about underpinning assumptions: the role of social determinants of health theory, a definition of ‘health equity’, defining a health equity-relevant randomised trial and when there is a health disadvantage, and that are reflected in publications.7 18
Stage 2: research actions that supported the co-development of the reporting guideline.
Reporting guideline development process steps.
The five reporting guideline development steps of stage 2 are bound by the guiding features of stage 1.
 1. Define. Establish guideline need with the team: team members were engaged in a process to determine whether and how they might collaborate to develop an extension of CONSORT for equity. Following funding, further work among the team members resulted in a published protocol7 and a tool that determines when a randomised trial is health equity-relevant18 and so should use a reporting guideline for health equity.
 2. Assess. Determine the state of the literature7 28 32: consultation with experts on health equity and this included the use of key informant interviews with interdisciplinary knowledge users.17
 3. Develop/Adapt. Propose and debate adaptation of the reporting guideline: identification of potential guideline knowledge users from high-income, middle-income and lower-income countries that include, for example, patients and methodologists, and who were invited to participate in an online Delphi study to identify items for the reporting guideline.28 Then, a consensus meeting (the 2016 Boston Equity Symposium which included guideline knowledge users) was held to discuss and debate evidence for inclusion in CONSORT-Equity 2017.28
 4. Disseminate. Develop and execute plan for uptake of the reporting guideline.
Outcomes are reflected in the success of an invitational study meeting (the 2016 Boston Equity Symposium) and co-authored publications,17 18 28 32 33 and the CONSORT-Equity 2017 checklist elaboration and explanation.28 48
 5. Apply. A process of road-testing the reporting guideline: work is under way to further disseminate and promote the application of the CONSORT-Equity 2017 guideline.

CONSORT-Equity 2017, CONsolidated Standards Of Reporting Trials extension for equity.