Table 2.
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.