Cluster-randomized trials: A closer look

Andrew D McRae, Monica Taljaard, Charles Weijer
Clinical Trials: Journal of the Society for Clinical Trials 2016, 13 (3): 294-300

BACKGROUND: The cluster-randomized trial is the methodology of choice for evaluating interventions administered at the group level such as public health and healthcare quality improvement interventions. Because of unique features of this design, it can be difficult to apply standard research ethics guidelines to cluster-randomized trials. The Ottawa Statement on the Ethical Design and Conduct of Cluster-Randomized Trials provides researchers and research ethics committees with comprehensive guidance on the ethical design, conduct and review of cluster-randomized trials. The Ottawa Statement supplements current national and international research ethics guidelines with guidance that is specific to cluster-randomized trials. In a recently published commentary, three examples drawn from the registry were used to illustrate challenges associated with the cluster-randomized trial design. The commentary argued that the Ottawa Statement fails to provide comprehensive ethical guidance. In this article, we illustrate the application of the Ottawa Statement to the three trials. We challenge the conclusions reached in the commentary by demonstrating that an ethical analysis requires complete information. We correct some misperceptions about the cluster-randomized trial design.

METHODS: We collected essential additional information by contacting the authors of trials and by referring to published trial articles. We used the Ottawa Statement to conduct an ethical analysis of each trial and to address a number of substantive concerns raised regarding the identification of study participants, informed consent and harm benefit analysis.

RESULTS: In the two cases in which we were able to obtain detailed study information, we were able to complete the ethical analysis prescribed by the Ottawa Statement.

CONCLUSION: The Ottawa Statement does provide a useful framework for the ethical design, review and conduct of cluster-randomized trials.

Full Text Links

Find Full Text Links for this Article


You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read

Save your favorite articles in one place with a free QxMD account.


Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"