Cluster-randomized trials: A closer look

Clinical Trials

Volumn 13, Issue 3, 2016, Pages 294-300

  McRae, Andrew D ^a,b   Taljaard, Monica ^b,c,d   Weijer, Charles ^b,e  

^a UNIVERSITY OF CALGARY   (Canada)

^b WESTERN UNIVERSITY   (Canada)

^c OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^d UNIVERSITY OF OTTAWA   (Canada)

^e UNIVERSITY OF WESTERN ONTARIO   (Canada)

Author keywords

Cluster randomized trials; harm benefit analysis; informed consent; the Ottawa Statement

Indexed keywords

WARFARIN; ANTICOAGULANT AGENT;

ALGORITHM; ARTICLE; CLINICAL RESEARCH; CLUSTER ANALYSIS; CLUSTER RANDOMIZED TRIAL; CONTROLLED STUDY; DIAGNOSTIC TEST; FAMILY PLANNING; HEALTH SERVICE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; INFORMED CONSENT; MALARIA; MEDICAL ETHICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RAPID DIAGNOSTIC TEST; RESEARCH SUBJECT; RISK BENEFIT ANALYSIS; DISEASE MANAGEMENT; ETHICS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; METHODOLOGY; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; RESEARCH ETHICS; RISK ASSESSMENT;

ANTICOAGULANTS; DISEASE MANAGEMENT; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; FAMILY PLANNING SERVICES; GUIDELINES AS TOPIC; HEALTH SERVICES; HIV INFECTIONS; HUMANS; INFORMED CONSENT; MALARIA; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; RESEARCH DESIGN; RISK ASSESSMENT; WARFARIN;

EID: 84966593809     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774516629405     Document Type: Article

References (23)

1. Klar N, Donner A,. Ethical challenges posed by cluster randomization. In: D'Agostino EB, Sullivan LM, Massaro J, (eds) Wiley encyclopedia of clinical trials. Hoboken, NJ: John Wiley & Sons, 2007, pp. 1-5.
2. Edwards SJL, Braunholtz DA, Lilford RJ, et al. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999; 318: 1407-1409.
3. Hayes RJ, Moulton LH,. Cluster randomised trials. Boca Raton, FL: CRC Press, 2009.
4. Taljaard M, Weijer C, Grimshaw JM, et al. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. Trials 2009; 10: 61.
5. Weijer C, Grimshaw JM, Taljaard M, et al. Ethical issues posed by cluster randomized trials in health research. Trials 2011; 12: 100.
6. McRae A, Bennett C, Weijer C, et al. Researchers' perceptions of ethical challenges in cluster randomized trials: a qualitative analysis. Trials 2013; 14: 1.
7. Taljaard M, McRae A, Weijer C, et al. Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of a representative sample of published trials. BMJ 2011; 342: d2496.
8. Chaudhry SH, Brehaut JC, Grimshaw JM, et al. Challenges in the research ethics review of cluster randomized trials: international survey of investigators. Clin Trials 2013; 10: 257-268.
9. McRae AD, Weijer C, Binik A, et al. Who is the research subject in cluster randomized trials in health research? Trials 2011; 12: 183.
10. McRae AD, Weijer C, Binik A, et al. When is informed consent required in cluster randomized trials in health research? Trials 2011; 12: 202.
11. Binik A, Weijer C, McRae AD, et al. Does clinical equipoise apply to cluster randomized trials in health research? Trials 2011; 12: 118.
12. Gallo A, Weijer C, White A, et al. What is the role and authority of gatekeepers in cluster randomized trials in health research? Trials 2012; 13: 116.
13. Weijer C, Grimshaw JM, Eccles MP, et al.; Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa statement on the ethical design and conduct of cluster randomized trials. PLoS Med 2012; 9: e1001346.
14. Macklin R,. Cluster randomized trials: another look. Hastings Cent Rep 2014; 44: 37-43.
15. ClinicalTrials.gov. Randomized comparison of warfarin dosing quality between the Hamilton nomogram and a commercial computer system., https://ClinicalTrials.gov/ct2/show/NCT01024452?term=NCT01024452&rank=1 (. accessed 17 June 2015).
16. Nieuwlaat R, Eikelboom JW, Schulman S, et al. Cluster randomized controlled trial of a simple warfarin maintenance dosing algorithm versus usual care among primary care practices. J Thromb Thrombolysis 2014; 37: 435-442.
17. Nieuwlaat R, Eikelboom JR, Schulman S, et al. Cluster randomized trial to assess a simple dosing algorithm on the quality of INR control among Canadian family practices. Unpublished Study Protocol.
18. ClinicalTrials.gov. Cluster randomised trial of malaria RDTs used by CHWs in Afghanistan., https://ClinicalTrials.gov/ct2/show/NCT01403350?term=nCT01403350&rank=1 (. accessed 17 June 2015).
19. ClinicalTrials.gov. Integrating family planning services into HIV care and treatment in Nyanza Province, Kenya., https://ClinicalTrials.gov/ct2/show/NCT01001507?term=NCT01001507&rank=1 (. accessed 17 June 2015).
20. Grossman D, Onono M, Newmann SJ, et al. Integration of family planning services into HIV care and treatment in Kenya: a cluster-randomized trial. AIDS 2013; 27 (Suppl. 1): S77-S85.
21. Department of Health and Human Services. Rules and regulations: protection of human subjects. Title 45, Code of Federal Regulations, Part 46, 2009.
22. Baily MA, Bottrell M, Lynn J, et al. The ethics of using QI methods to improve health care quality and safety. Hastings Cent Rep 2006; 36: S1-S40.
23. Beauchamp TL, Childress JF,. Principles of biomedical ethics. Oxford: Oxford University Press, 2001.