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Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a
Ahmed A Al-Jaishi1,2,3, Kelly Carroll4, Cory E Goldstein5
1Lawson Health Research Institute, London, ON, Canada. Ahmed.AlJaishi@lhsc.on.ca.
Insights
Cluster randomized trials (CRTs) in hemodialysis present design and ethical challenges. This review found significant opportunities to improve the reporting of methodological and ethical considerations in these complex studies.
Area of Science:
- Nephrology
- Clinical Trials Methodology
- Public Health Research
Background:
- The hemodialysis setting is amenable to cluster randomized trials (CRTs), but these designs present unique methodological and ethical complexities.
- CRTs involve randomizing intact groups, which requires careful consideration in design, analysis, and reporting.
- Ethical challenges, particularly regarding patient consent, are prominent in CRTs.
Purpose of the Study:
- To systematically review cluster randomized trials (CRTs) conducted in the hemodialysis setting.
- To assess the reporting of key methodological and ethical issues within these CRTs.
- To identify areas for improvement in the conduct and reporting of future hemodialysis CRTs.
Main Methods:
- A systematic review of CRTs published in English between 2000 and 2019, indexed in MEDLINE or Embase.
- Data extraction by two independent reviewers.
- Descriptive statistics were used to summarize study findings.
Main Results:
- 26 completed CRTs and 5 study protocols were identified, primarily randomizing hemodialysis centers (55%) and shifts (39%).
- Reporting of methods accounting for clustering was inconsistent: 45% in sample size calculations and 71% in analyses.
- Ethical reporting was varied: 84% reported ethics approval, but only 32% detailed the patient consent process, with 16% providing unclear or no information.
Conclusions:
- There is a notable gap in the reporting of methodological and ethical considerations in hemodialysis CRTs.
- Improvements are needed in justifying clustered designs, accounting for clustering in sample size and analysis, and transparently reporting patient consent procedures.
- Addressing these issues will enhance the quality and ethical integrity of future CRTs in hemodialysis research.
Background:
The hemodialysis setting is suitable for trials that use cluster randomization, where intact groups of individuals are randomized. However, cluster randomized trials (CRTs) are complicated in their design, analysis, and reporting and can pose ethical challenges. We reviewed CRTs in the hemodialysis setting with respect to reporting of key methodological and ethical issues.
Methods:
We conducted a systematic review of CRTs in the hemodialysis setting, published in English, between 2000 and 2019, and indexed in MEDLINE or Embase. Two reviewers extracted data, and study results were summarized using descriptive statistics.
Results:
We identified 26 completed CRTs and five study protocols of CRTs. These studies randomized hemodialysis centers (n = 17, 55%), hemodialysis shifts (n = 12, 39%), healthcare providers (n = 1, 3%), and nephrology units (n = 1, 3%). Trials included a median of 28 clusters with a median cluster size of 20 patients. Justification for using a clustered design was provided by 15 trials (48%). Methods that accounted for clustering were used during sample size calculation in 14 (45%), during analyses in 22 (71%), and during both sample size calculation and analyses in 13 trials (42%). Among all CRTs, 26 (84%) reported receiving research ethics committee approval; patient consent was reported in 22 trials: 10 (32%) reported the method of consent for trial participation and 12 (39%) reported no details about how consent was obtained or its purpose. Four trials (13%) reported receiving waivers of consent, and the remaining 5 (16%) provided no or unclear information about the consent process.
Conclusion:
There is an opportunity to improve the conduct and reporting of essential methodological and ethical issues in future CRTs in hemodialysis.
Review Registration:
We conducted this systematic review using a pre-specified protocol that was not registered.
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