Studying Group Behaviour: Cluster Randomized Clinical Trials

Charles J. Kowalski; Adam J. Mrdjenovich

doi:doi:10.11648/j.ajcem.20130101.12

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Studying Group Behaviour: Cluster Randomized Clinical Trials

Charles J. Kowalski, Adam J. Mrdjenovich

Published in American Journal of Clinical and Experimental Medicine (Volume 1, Issue 1)

Received: 16 May 2013 Published: 10 June 2013

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Abstract

Cluster randomized trials (CRTs) are experiments in which clusters of persons, rather than the persons themselves, are randomized to receive one of the interventions being studied. The use of CRTs has been increasing in response to the attention being paid to pragmatic as opposed to explanatory clinical trials, comparative effectiveness research, and community health promotional activities. We describe and illustrate the use of CRTs in these and other applications. Special attention is paid to ethical challenges in the design of such studies, and to tools for facilitating the implementation of interventions found to be efficacious in the trial into everyday clinical practice or effective community-wide programs. We argue that while CRTs have many useful and valid applications, there can be times when their use should be precluded due to ethical constraints. Special vigilance is required in research carried out in developing countries, where villages often seem to be a natural choice for clusters, but considerations of ‘standard of care’ may lead to control villages receiving no care or services. Full-fledged randomized controlled trials are not required to show that people who are doing poorly because of living in squalid conditions without proper sanitation and health care will, in the absence of change, continue to do so.

Published in	American Journal of Clinical and Experimental Medicine (Volume 1, Issue 1)
DOI	10.11648/j.ajcem.20130101.12
Page(s)	5-15
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2013. Published by Science Publishing Group

Keywords

Clinical Trials, Pragmatic Trials, Comparative Effectiveness Research, Health Promotional Activities, International Research, Ethics, Implementation Science, Ecological Validity

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APA Style

Charles J. Kowalski, Adam J. Mrdjenovich. (2013). Studying Group Behaviour: Cluster Randomized Clinical Trials. American Journal of Clinical and Experimental Medicine, 1(1), 5-15. https://doi.org/10.11648/j.ajcem.20130101.12

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ACS Style

Charles J. Kowalski; Adam J. Mrdjenovich. Studying Group Behaviour: Cluster Randomized Clinical Trials. Am. J. Clin. Exp. Med. 2013, 1(1), 5-15. doi: 10.11648/j.ajcem.20130101.12

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AMA Style

Charles J. Kowalski, Adam J. Mrdjenovich. Studying Group Behaviour: Cluster Randomized Clinical Trials. Am J Clin Exp Med. 2013;1(1):5-15. doi: 10.11648/j.ajcem.20130101.12

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@article{10.11648/j.ajcem.20130101.12,
  author = {Charles J. Kowalski and Adam J. Mrdjenovich},
  title = {Studying Group Behaviour: Cluster Randomized Clinical Trials},
  journal = {American Journal of Clinical and Experimental Medicine},
  volume = {1},
  number = {1},
  pages = {5-15},
  doi = {10.11648/j.ajcem.20130101.12},
  url = {https://doi.org/10.11648/j.ajcem.20130101.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajcem.20130101.12},
  abstract = {Cluster randomized trials (CRTs) are experiments in which clusters of persons, rather than the persons themselves, are randomized to receive one of the interventions being studied. The use of CRTs has been increasing in response to the attention being paid to pragmatic as opposed to explanatory clinical trials, comparative effectiveness research, and community health promotional activities. We describe and illustrate the use of CRTs in these and other applications. Special attention is paid to ethical challenges in the design of such studies, and to tools for facilitating the implementation of interventions found to be efficacious in the trial into everyday clinical practice or effective community-wide programs. We argue that while CRTs have many useful and valid applications, there can be times when their use should be precluded due to ethical constraints. Special vigilance is required in research carried out in developing countries, where villages often seem to be a natural choice for clusters, but considerations of ‘standard of care’ may lead to control villages receiving no care or services. Full-fledged randomized controlled trials are not required to show that people who are doing poorly because of living in squalid conditions without proper sanitation and health care will, in the absence of change, continue to do so.},
 year = {2013}
}

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TY  - JOUR
T1  - Studying Group Behaviour: Cluster Randomized Clinical Trials
AU  - Charles J. Kowalski
AU  - Adam J. Mrdjenovich
Y1  - 2013/06/10
PY  - 2013
N1  - https://doi.org/10.11648/j.ajcem.20130101.12
DO  - 10.11648/j.ajcem.20130101.12
T2  - American Journal of Clinical and Experimental Medicine
JF  - American Journal of Clinical and Experimental Medicine
JO  - American Journal of Clinical and Experimental Medicine
SP  - 5
EP  - 15
PB  - Science Publishing Group
SN  - 2330-8133
UR  - https://doi.org/10.11648/j.ajcem.20130101.12
AB  - Cluster randomized trials (CRTs) are experiments in which clusters of persons, rather than the persons themselves, are randomized to receive one of the interventions being studied. The use of CRTs has been increasing in response to the attention being paid to pragmatic as opposed to explanatory clinical trials, comparative effectiveness research, and community health promotional activities. We describe and illustrate the use of CRTs in these and other applications. Special attention is paid to ethical challenges in the design of such studies, and to tools for facilitating the implementation of interventions found to be efficacious in the trial into everyday clinical practice or effective community-wide programs. We argue that while CRTs have many useful and valid applications, there can be times when their use should be precluded due to ethical constraints. Special vigilance is required in research carried out in developing countries, where villages often seem to be a natural choice for clusters, but considerations of ‘standard of care’ may lead to control villages receiving no care or services. Full-fledged randomized controlled trials are not required to show that people who are doing poorly because of living in squalid conditions without proper sanitation and health care will, in the absence of change, continue to do so.
VL  - 1
IS  - 1
ER  -

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Author Information

Charles J. Kowalski

Health and Behavioral Sciences IRB, Office of the Vice President for Research, University of Michigan, Ann Arbor, USA
Adam J. Mrdjenovich

Health and Behavioral Sciences IRB, Office of the Vice President for Research, University of Michigan, Ann Arbor, USA

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APA Style

Charles J. Kowalski, Adam J. Mrdjenovich. (2013). Studying Group Behaviour: Cluster Randomized Clinical Trials. American Journal of Clinical and Experimental Medicine, 1(1), 5-15. https://doi.org/10.11648/j.ajcem.20130101.12

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ACS Style

Charles J. Kowalski; Adam J. Mrdjenovich. Studying Group Behaviour: Cluster Randomized Clinical Trials. Am. J. Clin. Exp. Med. 2013, 1(1), 5-15. doi: 10.11648/j.ajcem.20130101.12

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AMA Style

Charles J. Kowalski, Adam J. Mrdjenovich. Studying Group Behaviour: Cluster Randomized Clinical Trials. Am J Clin Exp Med. 2013;1(1):5-15. doi: 10.11648/j.ajcem.20130101.12

Copy | Download

@article{10.11648/j.ajcem.20130101.12,
  author = {Charles J. Kowalski and Adam J. Mrdjenovich},
  title = {Studying Group Behaviour: Cluster Randomized Clinical Trials},
  journal = {American Journal of Clinical and Experimental Medicine},
  volume = {1},
  number = {1},
  pages = {5-15},
  doi = {10.11648/j.ajcem.20130101.12},
  url = {https://doi.org/10.11648/j.ajcem.20130101.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajcem.20130101.12},
  abstract = {Cluster randomized trials (CRTs) are experiments in which clusters of persons, rather than the persons themselves, are randomized to receive one of the interventions being studied. The use of CRTs has been increasing in response to the attention being paid to pragmatic as opposed to explanatory clinical trials, comparative effectiveness research, and community health promotional activities. We describe and illustrate the use of CRTs in these and other applications. Special attention is paid to ethical challenges in the design of such studies, and to tools for facilitating the implementation of interventions found to be efficacious in the trial into everyday clinical practice or effective community-wide programs. We argue that while CRTs have many useful and valid applications, there can be times when their use should be precluded due to ethical constraints. Special vigilance is required in research carried out in developing countries, where villages often seem to be a natural choice for clusters, but considerations of ‘standard of care’ may lead to control villages receiving no care or services. Full-fledged randomized controlled trials are not required to show that people who are doing poorly because of living in squalid conditions without proper sanitation and health care will, in the absence of change, continue to do so.},
 year = {2013}
}

Copy | Download

TY  - JOUR
T1  - Studying Group Behaviour: Cluster Randomized Clinical Trials
AU  - Charles J. Kowalski
AU  - Adam J. Mrdjenovich
Y1  - 2013/06/10
PY  - 2013
N1  - https://doi.org/10.11648/j.ajcem.20130101.12
DO  - 10.11648/j.ajcem.20130101.12
T2  - American Journal of Clinical and Experimental Medicine
JF  - American Journal of Clinical and Experimental Medicine
JO  - American Journal of Clinical and Experimental Medicine
SP  - 5
EP  - 15
PB  - Science Publishing Group
SN  - 2330-8133
UR  - https://doi.org/10.11648/j.ajcem.20130101.12
AB  - Cluster randomized trials (CRTs) are experiments in which clusters of persons, rather than the persons themselves, are randomized to receive one of the interventions being studied. The use of CRTs has been increasing in response to the attention being paid to pragmatic as opposed to explanatory clinical trials, comparative effectiveness research, and community health promotional activities. We describe and illustrate the use of CRTs in these and other applications. Special attention is paid to ethical challenges in the design of such studies, and to tools for facilitating the implementation of interventions found to be efficacious in the trial into everyday clinical practice or effective community-wide programs. We argue that while CRTs have many useful and valid applications, there can be times when their use should be precluded due to ethical constraints. Special vigilance is required in research carried out in developing countries, where villages often seem to be a natural choice for clusters, but considerations of ‘standard of care’ may lead to control villages receiving no care or services. Full-fledged randomized controlled trials are not required to show that people who are doing poorly because of living in squalid conditions without proper sanitation and health care will, in the absence of change, continue to do so.
VL  - 1
IS  - 1
ER  -

Copy | Download