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Full-Text Articles in Arts and Humanities
Reporting Of Patient Consent In Healthcare Cluster Randomised Trials Is Associated With The Type Of Study Interventions And Publication Characteristics, Andrew Mcrae, Monica Taljaard, Charles Weijer, Carol Bennett, Zoe Skea, Robert Boruch, Jamie Brehaut, Martin Eccles, Jeremy Grimshaw, Allan Donner
Reporting Of Patient Consent In Healthcare Cluster Randomised Trials Is Associated With The Type Of Study Interventions And Publication Characteristics, Andrew Mcrae, Monica Taljaard, Charles Weijer, Carol Bennett, Zoe Skea, Robert Boruch, Jamie Brehaut, Martin Eccles, Jeremy Grimshaw, Allan Donner
Charles Weijer
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 …
Researchers’ Perceptions Of Ethical Challenges In Cluster Randomized Trials: A Qualitative Analysis, Andrew Mcrae, Carol Bennett, Judith Belle Brown, Charles Weijer, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Allan Donner, Martin Eccles, Jeremy Grimshaw, Merrick Zwarenstein, Monica Taljaard
Researchers’ Perceptions Of Ethical Challenges In Cluster Randomized Trials: A Qualitative Analysis, Andrew Mcrae, Carol Bennett, Judith Belle Brown, Charles Weijer, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Allan Donner, Martin Eccles, Jeremy Grimshaw, Merrick Zwarenstein, Monica Taljaard
Charles Weijer
Background
Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.
Methods
Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.
Results
Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to …