Reporting of patient consent in healthcare cluster randomised trials is associated with the type of study interventions and publication characteristics

Journal of Medical Ethics 39 (2):119-124 (2013)
  Copy   BIBTEX


Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as well as publication features such as date and journal of publication. Results 82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals. Conclusions Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs



    Upload a copy of this work     Papers currently archived: 89,621

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Continuous consent and dignity in dentistry.David Shaw - 2007 - British Dental Journal 203 (11):569-571.
Patient preferences for physician persuasion strategies.Dan O'Hair - 1986 - Theoretical Medicine and Bioethics 7 (2).
Informed consent: a primer for clinical practice.Deborah Bowman - 2012 - New York: Cambridge University Press. Edited by John Spicer & Rehana Iqbal.


Added to PP

30 (#453,109)

6 months
2 (#646,201)

Historical graph of downloads
How can I increase my downloads?