The Trial Methods Research Partnership Cultural Competency Study commenced on 1st October 2020, led by the Alcohol, Tobacco and Other Drug Research Unit of the South African Medical Research Council in partnership with Dr Sally Hopewell of Oxford University. The Project aims to evaluate the applicability and utility of currently available tools to measure cultural competence in trial design and conduct. Cultural competency refers to consideration of the cultural and linguistic diversity of the populations targeted for inclusion into a trial. Failure to consider relevant cultural and diversity parameters during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, adherence, and retention, potentially reducing overall internal validity.
Lack of reporting of these parameters may further hamper the successful implementation of effective interventions post trial due to an inability to assess external validity (generalizability). A checklist to guide the cultural competency of a trial may be useful to investigators during protocol development and trial reporting. Current CONSORT guidance does not include reporting related to cultural competence . The 2007 Gibbs framework comprises nine criteria to evaluate the degree to which a trial meets cultural competency commencing at the community engagement stage through to analysis and dissemination . The 2017 GRIPP-2 is a checklist for guidance for reporting of patient and public involvement in research . As far as we are aware, neither tool has been applied to a trial in a low- or middle-income (LMIC) setting. Our study thus aims to evaluate the utility and comparability between the Gibbs and GRIPP-2 tools for a complex trial conducted in an African setting.
Our method includes retrospectively applying the 2007 Gibbs framework and the GRIPP-2 checklist to Project Mind, a three-arm cluster randomised controlled trial of 1,340 patients conducted in 24 primary care clinics in both urban and rural settings in South Africa. Project Mind compares two different systems approaches to integrating mental health counselling into chronic disease care with treatment as usual.
Our study commenced on 1st September 2020 and is due to be completed within a year. To date we have conducted a secondary data source analysis by 1) identifying and collating trial documentation including, but not limited to, the trial protocol, intervention development activities, community preparedness, and the interim trial report, 2) prepared a trial process diagram specific to Project Mind with the responsible investigator linked to each phase of the trial, 3) completed a 2007 Gibbs framework and GRIPP-2 checklist against each stage of the trial process by interrogating the secondary data where this exists. Where information is lacking in the documentation or uncertainty remains, the Project Mind responsible investigator identified a priori in the process diagram has been approached to participate in an interview to provide greater detail regarding whether cultural and/or diversity parameters were considered.
At a trial design stage, use of a tool purposively designed to measure the consideration of cultural and diversity parameters can potentially provide investigators with a useful checklist to guide each stage of the trial design process. This will ensure a greater level of sensitivity to the needs of the target population which may in turn result in higher recruitment and greater retention. During trial reporting, use of a checklist can ensure that cultural and diversity parameters are adequately described allowing readers to better evaluate the generalizability of the findings and the applicability to their own settings and patient populations. Dependent on the findings of utility and comparability between the Gibbs and GRIPP, we may identify which checklist is most relevant to the LMIC setting. There would be potential for future studies to further evaluate this either by retrospective application to competed trials or prospective application in planned and ongoing trials.
1. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37.
2. Gibbs L, Waters E, Renzaho A, et al. Moving towards increased cultural competency in public health research. In: A Williamson, R D, editors. Researching with communities: grounded perspectives on engaging communities in research. London: Muddy Creek Press; 2007. p. 339–55.
3. Staniszewska S, Brett J, Simera I, et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. BMJ. 2017 Aug 2;358:j3453.