Ethical issues in the design and conduct of stepped-wedge cluster randomized trials in low-resource settings

Abstract

BackgroundStepped-wedge cluster randomized trials (SW-CRTs) are increasingly popular in health-related research in both high- and low-resource settings. There may be specific ethical issues that researchers face when designing and conducting SW-CRTs in low-resource settings. Knowledge of these issues can help to improve the ethical conduct of SW-CRTs in a global health context.MethodsWe performed an ethical analysis of two studies using SW-CRT designs in low-resource settings: the Que Vivan Las Madres study conducted from 2014 to 2017 in Guatemala and the Atmiyata study conducted from 2017 to 2018 in rural parts of India. For both case studies, we identified and evaluated the classification of the study as research or nonresearch and the ethical issues regarding the justification of the design, including the delayed rollout of an intervention that had a promising effect.ResultsIn our case studies, some minor ethical issues surfaced about the registration and stakeholder pressure on the order of randomization, but both included good justification for the design and delayed rollout. Our analysis did, however, demonstrate that careful consideration of the role of randomization and registration of the trials is important.DiscussionSW-CRTs can provide an opportunity for rigorous evaluation of interventions destined to be rolled out on the basis of limited evidence. Furthermore, in SW-CRTs, the underlying objective is often to provide a robust evaluation of the effectiveness for generalized dissemination, and this makes the SW-CRT no less a research study than any other form of cluster randomized trial.ConclusionThe design and conduct of stepped-wedge cluster randomized trials raises at least two ethical issues that need special consideration in both high- and low-resource settings: the justification for using the design, specifically the delayed rollout of the intervention to the control group, and the classification of the study as research or nonresearch. In our case studies, these issues did not seem to raise special ethical scrutiny in low-resource settings. Further ethical evaluation will hopefully result in specific ethical guidelines for the use of SW-CRTs in both high- and low-resource settings to contribute to responsible functioning of these trials and adequate protection of participants.

Arts-Based Interventions for Professionals in Caring Roles During and After Crisis: A Systematic Review of the Literature

“…The research design would need to be sensitive to ethical considerations of providing interventions within care contexts. For example, a step-wedge cluster-randomized community-based trial (De Allegri et al, 2008 ; Joag et al, 2019 ) may be a good design to provide comparative data about individual and social change. Whilst researchers have identified the problems of context, culture and accessibility, intervention development and research methodologies have often remained individualized (for example, see Selamu et al, 2017 ; Joag et al, 2019 ).…”

“…For example, a step-wedge cluster-randomized community-based trial (De Allegri et al, 2008 ; Joag et al, 2019 ) may be a good design to provide comparative data about individual and social change. Whilst researchers have identified the problems of context, culture and accessibility, intervention development and research methodologies have often remained individualized (for example, see Selamu et al, 2017 ; Joag et al, 2019 ). We return to the definition of a crisis as one of disrupted social communication and interactions.…”

Expanding Clinical Trials Designs to Extend Equitable Hearing Care

“…clusters of participants, or groups of clusters to receive the intervention at varying time points (Joag et al 2019). Historically, this design has been referred to as a waitlist design.…”

“…Compared to a parallel design, cluster randomized trial, a stepped wedge RCT design randomizes research participants, clusters of participants, or groups of clusters to receive the intervention at varying time points ( Joag et al 2019 ). Historically, this design has been referred to as a waitlist design.…”

“…The stepped wedge RCT design offers several unique benefits in addition to many overlapping benefits with the cluster RCT. As opposed to simultaneously launching the intervention into a large number of clusters at once, the stepped implementation of the intervention in this design over the course of months or years may allow the research team to logistically plan and prepare for intervention launch in each of the clusters increasing the feasibility of the study ( Joag et al 2019 ). If the population within the clusters differs significantly (i.e., size of the community, racial/ethnic diversity, socioeconomic status), the stepped wedge design is superior to a cluster design since within-cluster analysis is possible.…”