Category 1: “Differentiate the type of trial”|
This category contributed to thinking and discussion during the Delphi and consensus meeting about the extension of CONSORT Statement items to report if equity is a major focus in the title (Item 1a) and in the abstract section to consider reporting any research question(s) related to health equity, as well as the results of all planned health equity analyses and the extent and limits of applicability across population characteristics (Items 1b).
Category 2: “Prompts for health equity”|
This category contributed to thinking and discussion about how to extend the CONSORT Statement background section so that reporting on the rationale to focus on health equity could be explicit, and also provided the opportunity to state whether or how the objectives of the trial relate to health equity (Items 2a, 2b).
For this reason, in the survey and discussions that followed the key informant interviews, concerns about whether and how to extend the CONSORT Statement for equity were considered so that they would be most likely “usable”. Findings helped to guide the broad inclusion of membership in the Delphi survey and invitations to attend the face-to-face consensus meeting. Care was taken to define health equity in trials and examples of “health-equity relevant trials” sought and tested and agreed upon by the CONSORT Equity core team and advisory board.
Category 3: “Ethics matter”|
As there are no items related to ethics in the original CONSORT Statement, participant suggestions led to the proposal in the Delphi survey for the addition of a new item (to report details of ethical concern and patient/community engagement) and consideration for extensions of existing items to bring equity considerations forward within the randomized trials (for example, item 6a to report whether items were identified as relevant and important to populations and how it was done). These extension items were affirmed during the Delphi study and then further discussed (and approved) during the consensus meeting.
Category 4: “Opportunity to describe unique research strategies”|
During the interviews, most key informants raised concerns about innovative approaches to research that facilitate inclusive randomized trials. For this reason, the extension of the item about randomized trial design to describe aspects of the study design that were chosen to answer equity questions was specifically proposed and then voted upon in the Delphi study. The inclusion of an item to describe unique research strategies was then discussed during the consensus meeting and agreed upon with changes made to ensure there were opportunities to describe/explain unique strategies with description of trial design (item #3a).
Category 5: “Details are important”|
This category contributed to thinking and discussion during the Delphi and consensus meeting about the extension of CONSORT Statement items to consider reporting on research methods and the reporting of details on participants and the settings and locations where the data were collected (items 4a, 4b). As well, this contributed to the background information for CONSORT Equity and the explicit use of the PROGRESS Plus framework to guide the thinking about how to describe details on the study as they relate to health equity (item 15).
Category 6: “Guidance for statistics”|
Many participants emphasized the benefits of consultation with a biostatistician to help with general barriers to sample size calculations and the lack of evidence about equity-relevant trials and statistical analysis. For this reason, care was taken to include biostatisticians in the Delphi survey and as part of the group membership at the consensus meeting. During the Delphi survey and the consensus meeting there was broad discussion about sample size and the importance of reporting and that focused to be about whether analyses are powered to detect differences (item 7a) as well as about any additional analyses focused on health equity (item 12b) and ancillary analysis (item 18).
Category 7: “Think beyond the immediate trial”|
During the Delphi study additional detail for items about harms and the study discussion section were proposed. These were carried forward to the consensus meeting and discussion focused on the need for reporting about whether intervention generated inequities (that is, unintended effects) were assessed, any limitations related to assessing effects on health equity, and reporting of applicability related to the population of interest (Items 19, 20, 21). For, as one participant stated “identifying inequity is the first step but it does not get us further in promoting equitable health if we don’t move past and say “now what?””.