Arts and Humanities Commons^™

Impact Of Consort Extension For Cluster Randomised Trials On Quality Of Reporting And Study Methodology: Review Of Random Sample Of 300 Trials, 2000-8, N. Ivers, M. Taljaard, Stephanie Dixon, C. Bennett, A. Mcrae, J. Taleban, Z. Skea, J. Brehaut, R. Boruch, M. Eccles, J. Grimshaw, Charles Weijer, M. Zwarenstein, A. Donner

Charles Weijer

OBJECTIVE: To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials.

DESIGN: Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting.

DATA SOURCES: A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, …

Minimal Risk Remains An Open Question, Ariella Binik, Charles Weijer, Mark Sheehan

Charles Weijer

No abstract provided.

Inadequate Reporting Of Research Ethics Review And Informed Consent In Cluster Randomised Trials: Review Of Random Sample Of Published Trials, Monica Taljaard, Andrew Mcrae, Charles Weijer, Carol Bennett, Stephanie Dixon, Julia Taleban, Zoe Skea, Martin P Eccles, Jamie Brehaut, Allan Donner, Raphael Saginur, Robert Boruch, Jeremy Grimshaw

Charles Weijer

OBJECTIVES: To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association's Declaration of Helsinki and the International Committee of Medical Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices.

DESIGN: Review of a random sample of published cluster randomised trials from an electronic search in Medline.

SETTING: Cluster randomised trials in health research published in English language journals …

Does Clinical Equipoise Apply To Cluster Randomized Trials In Health Research?, Ariella Binik, Charles Weijer, Andrew Mcrae, Jeremy Grimshaw, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Raphael Saginur, Monica Taljaard, Merrick Zwarenstein

Charles Weijer

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have …

Ethical Issues Posed By Cluster Randomized Trials In Health Research, Charles Weijer, Jeremy Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein

Charles Weijer

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. …