Challenges in the research ethics review of cluster randomized trials: International survey of investigators

2013 ◽  
Vol 10 (2) ◽  
pp. 257-268 ◽  
Author(s):  
Shazia H Chaudhry ◽  
Jamie C Brehaut ◽  
Jeremy M Grimshaw ◽  
Charles Weijer ◽  
Robert Boruch ◽  
...  
Keyword(s):  
Research Ethics ◽  
Randomized Trials ◽  
International Survey ◽  
Cluster Randomized Trials ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Cluster Randomized

scholarly journals Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Monica Taljaard ◽  
Jamie C Brehaut ◽  
Charles Weijer ◽  
Robert Boruch ◽  
Allan Donner ◽  
...  
Keyword(s):  
Research Ethics ◽  
Randomized Trials ◽  
Cluster Randomized Trials ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Cluster Randomized

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review

2017 ◽  
Vol 14 (4) ◽  
pp. 333-341 ◽  
Author(s):  
Monica Taljaard ◽  
Karla Hemming ◽  
Lena Shah ◽  
Bruno Giraudeau ◽  
Jeremy M Grimshaw ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Randomized Trials ◽  
Cluster Randomized Trials ◽  
Stepped Wedge ◽  
Research Participants ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Stepped Wedge Trials ◽  
Cluster Randomized

Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants—yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28%) had no identifiable data collected from any research participants. Overall, only three trials (9%) indicated that a waiver of consent had been granted by a research ethics committee. When considering the combined requirement of research ethics review and informed consent (or a waiver), only one in three studies were compliant. Conclusion The ethical conduct and reporting of key ethical protections in stepped wedge trials, namely, research ethics review and informed consent, are inadequate. We recommend that stepped wedge trials be classified as research and reviewed and approved by a research ethics committee. We also recommend that researchers appropriately identify research participants (which may include health professionals), seek informed consent or appeal to an ethics committee for a waiver of consent, and include explicit details of research ethics approval and informed consent in the trial report.

Stepped-wedge trials should be classified as research for the purpose of ethical review

2019 ◽  
Vol 16 (6) ◽  
pp. 580-588 ◽  
Author(s):  
Karla Hemming ◽  
Monica Taljaard ◽  
Tom Marshall ◽  
Cory E Goldstein ◽  
Charles Weijer
Keyword(s):  
Research Ethics ◽  
Randomized Trials ◽  
Ethical Review ◽  
Cluster Randomized Trials ◽  
Stepped Wedge ◽  
Research Ethics Review ◽  
Stepped Wedge Trials ◽  
Human Participants ◽  
Cluster Randomized ◽  
Ethical Oversight

Background: All studies classified as research involving human participants require research ethics review. Most regulation and guidance on ethical oversight of research involving human participants was written for pharmacotherapy interventions. Interpretation of such guidance for cluster-randomized trials and stepped-wedge trials, which commonly evaluate complex non-therapeutic interventions such as knowledge translation, public health, or health service delivery interventions, can pose challenges to researchers and regulators. Current guidance: The Ottawa Statement on the Ethical Design and Conduct of Cluster-Randomized Trials provides guidance on the ethical oversight and consent procedures for cluster-randomized trials, and while not explicit, this includes stepped-wedge trials. Yet, stepped-wedge trials have unique characteristics that differentiate them from standard cluster-randomized trials. In particular, they can be used to evaluate knowledge translation interventions within the context of a routine health system rollout; they may have a non-randomized design; and the decision to implement the intervention is not always made by the researcher. Many stepped-wedge trials do not undergo ethical review and do not report trial registration. This suggests that those undertaking these studies and research ethics committees perceive them as non-research activities. Recommendations: Through an ethical analysis of two case studies, we argue that stepped-wedge trials, like parallel arm cluster trials, are systematic investigations designed to produce generalizable knowledge. We contend that stepped-wedge trials usually include human research participants, which may be patients, health care providers, or both. Stepped-wedge trials are therefore research involving human participants for the purpose of ethical review. Nevertheless, the use of a waiver or alteration of consent may be appropriate in many stepped-wedge trials due to the infeasibility of obtaining informed consent and the low-risk nature of the interventions. To ensure that traditional ethical principles such as respect for persons are upheld, these studies must undergo research ethics review.

scholarly journals Covariate-constrained Randomization Routine for Achieving Baseline Balance in Cluster-randomized Trials

2017 ◽  
Vol 17 (2) ◽  
pp. 503-510 ◽  
Author(s):  
Eva Lorenz ◽  
Sabine Gabrysch
Keyword(s):  
Randomized Trials ◽  
Theoretical Background ◽  
Cluster Randomized Trials ◽  
Cluster Randomized ◽  
Baseline Covariates

In cluster-randomized trials, groups or clusters of individuals, rather than individuals themselves, are randomly allocated to intervention or control. In this article, we describe a new command, ccrand, that implements a covariate-constrained randomization procedure for cluster-randomized trials. It can ensure balance of one or more baseline covariates between trial arms by restriction to allocations that meet specified balance criteria. We provide a brief overview of the theoretical background, describe ccrand and its options, and illustrate it using an example.

Relative efficiency and sample size for cluster randomized trials with variable cluster sizes

2010 ◽  
Vol 8 (1) ◽  
pp. 27-36 ◽  
Author(s):  
Zhiying You ◽  
O Dale Williams ◽  
Inmaculada Aban ◽  
Edmond Kato Kabagambe ◽  
Hemant K Tiwari ◽  
...  
Keyword(s):  
Sample Size ◽  
Relative Efficiency ◽  
Randomized Trials ◽  
Cluster Randomized Trials ◽  
Variable Cluster ◽  
Cluster Randomized

scholarly journals The problem of imbalance in cluster randomized trials and the benefits of covariate constrained randomization

2021 ◽  
Author(s):  
L Miriam Dickinson ◽  
Patrick Hosokawa ◽  
Jeanette A Waxmonsky ◽  
Bethany M Kwan
Keyword(s):  
Randomized Trials ◽  
Cluster Randomized Trials ◽  
Cluster Randomized

xtgeebcv: A command for bias-corrected sandwich variance estimation for GEE analyses of cluster randomized trials

2020 ◽  
Vol 20 (2) ◽  
pp. 363-381 ◽  
Author(s):  
John A. Gallis ◽  
Fan Li ◽  
Elizabeth L. Turner
Keyword(s):  
Randomized Trials ◽  
Variance Estimation ◽  
Public Health Education ◽  
Standard Errors ◽  
Future Research ◽  
Type I ◽  
Cluster Randomized Trials ◽  
Finite Sample ◽  
Individual Level ◽  
Cluster Randomized

Cluster randomized trials, where clusters (for example, schools or clinics) are randomized to comparison arms but measurements are taken on individuals, are commonly used to evaluate interventions in public health, education, and the social sciences. Analysis is often conducted on individual-level outcomes, and such analysis methods must consider that outcomes for members of the same cluster tend to be more similar than outcomes for members of other clusters. A popular individual-level analysis technique is generalized estimating equations (GEE). However, it is common to randomize a small number of clusters (for example, 30 or fewer), and in this case, the GEE standard errors obtained from the sandwich variance estimator will be biased, leading to inflated type I errors. Some bias-corrected standard errors have been proposed and studied to account for this finite-sample bias, but none has yet been implemented in Stata. In this article, we describe several popular bias corrections to the robust sandwich variance. We then introduce our newly created command, xtgeebcv, which will allow Stata users to easily apply finite-sample corrections to standard errors obtained from GEE models. We then provide examples to demonstrate the use of xtgeebcv. Finally, we discuss suggestions about which finite-sample corrections to use in which situations and consider areas of future research that may improve xtgeebcv.

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