Abstract
Objective
Cluster randomized trials (CRTs) are used for evaluating health-related interventions in low- and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterize CRTs conducted exclusively in LMICs, considering types of clusters, settings, author affiliations, and primary clinical focus, and evaluate adherence to trial registration and ethics reporting requirements over time.
Design
A systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR).
Data Sources
We searched MEDLINE between 1 January 2017 and 17 August 2022.
Eligibility criteria for selecting studies
We included primary reports of CRTs evaluating health-related interventions, conducted exclusively in LMICs, and published in English between 2017–2022.
Data extraction and synthesis
Data were extracted by one reviewer; a second reviewer verified accuracy by extracting data from 10% of reports. Results were summarized overall and by country economic level or publication year.
Results
Among 800 identified CRTs, 400 (50·0%) randomized geographical areas and 373 (46·6%) were conducted in Africa. Thirty (3·7%) had no authors with an LMIC affiliation, and 246 (30·8%) had neither first nor last author with an LMIC affiliation. The relative frequency of first or last authors holding an LMIC affiliation increases with country economic level. Most CRTs focused on reducing maternal and neonatal disorders (106, 13·3%). Six hundred and seventy (83·8%) CRTs reported trial registration, 786 (98·2%) reported research ethics committee review, and 757 (94·6%) reported consent statements. Among the 757 CRTs, 46 (6·1%) reported a waiver or no consent and, among these, 10 (21·7%) did not provide a rationale. Gatekeepers were identified in 403 (50·4%) CRTs. No meaningful trends were observed in adherence to trial registration or ethics reporting requirements over time.
Conclusion
Our findings suggest existing inequity in authorship practices. There is high adherence to trial registration and ethics reporting requirements, although greater attention to reporting a justification for using a waiver of consent is needed.
Cluster randomized trials (CRTs) are used for evaluating health-related interventions in low- and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterize CRTs conducted exclusively in LMICs, considering types of clusters, settings, author affiliations, and primary clinical focus, and evaluate adherence to trial registration and ethics reporting requirements over time.
Design
A systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR).
Data Sources
We searched MEDLINE between 1 January 2017 and 17 August 2022.
Eligibility criteria for selecting studies
We included primary reports of CRTs evaluating health-related interventions, conducted exclusively in LMICs, and published in English between 2017–2022.
Data extraction and synthesis
Data were extracted by one reviewer; a second reviewer verified accuracy by extracting data from 10% of reports. Results were summarized overall and by country economic level or publication year.
Results
Among 800 identified CRTs, 400 (50·0%) randomized geographical areas and 373 (46·6%) were conducted in Africa. Thirty (3·7%) had no authors with an LMIC affiliation, and 246 (30·8%) had neither first nor last author with an LMIC affiliation. The relative frequency of first or last authors holding an LMIC affiliation increases with country economic level. Most CRTs focused on reducing maternal and neonatal disorders (106, 13·3%). Six hundred and seventy (83·8%) CRTs reported trial registration, 786 (98·2%) reported research ethics committee review, and 757 (94·6%) reported consent statements. Among the 757 CRTs, 46 (6·1%) reported a waiver or no consent and, among these, 10 (21·7%) did not provide a rationale. Gatekeepers were identified in 403 (50·4%) CRTs. No meaningful trends were observed in adherence to trial registration or ethics reporting requirements over time.
Conclusion
Our findings suggest existing inequity in authorship practices. There is high adherence to trial registration and ethics reporting requirements, although greater attention to reporting a justification for using a waiver of consent is needed.
| Original language | English |
|---|---|
| Article number | e087724 |
| Number of pages | 11 |
| Journal | BMJ Open |
| Volume | 14 |
| Issue number | 9 |
| Early online date | 17 Sept 2024 |
| DOIs | |
| Publication status | Published - Sept 2024 |
Bibliographical note
AcknowledgementsThe authors would also like to thank Laura Quinn for assisting with full text screening, and Spencer Phillip Hey for assisting with ClincalTrials.gov data extraction and linkage.
Data Availability Statement
Data are available on reasonable request.Funding
This work was supported by a Canadian Institutes of Health Research (CIHR) project grant (PJT479757). Dr. Cory E. Goldstein is supported by a CIHR Fellowship Award. These funding sources had no role in the study design, data collection, data analysis, data interpretation, writing of the report, or decision to publish.
Keywords
- Systematic Review
- medical ethics
- Randomized Controlled Trial