Trials is an open access, peer-reviewed, online journal that encompasses all aspects of the performance and findings of randomized controlled trials in health. We publish articles on general trial methodology as well as protocols, commentaries and traditional results papers - regardless of outcome or significance of findings.
- Doug Altman, University of Oxford
- Curt Furberg, Wake Forest University of Medicine
- Jeremy Grimshaw, Ottawa Health Research Institute
A review of published trials assessed the methods used for reducing the risk of selection bias in unblinded RCTs; poor reporting of most trials meant the risk could not be ascertained and those with details were at risk of selection bias due to poorly selected methods.
There are practical issues that undermine the impact of RCTs within evidence-based medicine and therefore decision making. Four main ways in which the evidence from randomized trials is limited or partial is highlighted and the social aspects of these problems are discussed.
Using a stepped wedge trial design in RCTs adds a level of complexity in regards to statistical design and analysis. A framework for handling the sample size and power calculations in stepped wedge RCTs is outlined and the authors propose simulation-based methods may be most effective.
Stepped wedge cluster RCT designs are becoming increasingly popular. A systematic review of studies published between 2010 and 2014 concluded they are predominantly conducted in developed countries and that there is a need for further reporting and analysis guidance.
With the increasing popularity of stepped wedge RCTs, there are five questions researchers need to carefully consider before conducting their stepped wedge trial; from why are you using this trial design to how will you report your trial.
Trials advocates the complete and transparent reporting of research. Authors are required to adhere to the CONSORT Statement for any submitted clinical trials, and encouraged to follow the SPIRIT Statement for study protocols. The Editors also encourage authors to follow any relevant extensions to the CONSORT Statement, available from the EQUATOR Network.
Call for papers: Qualitative Methods thematic series
Trials is inviting submissions to its new cross-journal thematic series, 'Qualitative Methods, Trials and Systematic Reviews'. For more information, please see here.
Professor Doug Altman graduated in statistics from the University of Bath and has worked for the Medical Research Council as a statistical consultant in a wide variety of medical areas. In 1988 he became head of the newly formed Medical Statistics Laboratory (now Medical Statistics Group) at ICRF (now Cancer Research UK), and in 1995 also became founding director of the Centre for Statistics in Medicine (CSM) in Oxford. In 1997, Professor Altman received the Bradford Hill Medal for his contributions to medical statistics and a DSc from the University of London and, in 1998 was made Professor of Statistics in Medicine by the University of Oxford. His varied research interests include the use and abuse of statistics in medical research, studies of prognosis, regression modelling, systematic reviews and meta-analysis, randomised trials, and studies of medical measurement.
Curt D. Furberg
Professor Curt D. Furberg is a co-Editor-in-Chief of Trials. He is a Professor of Public Health at Wake Forest University Health Sciences, where he has been since 1986. Professor Furberg earned his MD in Sweden in 1963 and has worked at the Minneapolis LRC Clinic as the Chief of the Clinical Trials Branch and the Clinical Trials Research Branch of the National Heart, Lung, and Blood Institute - where he was the Associate Director for the Clinical Applications and Prevention Program. In addition, Professor Furberg is a nationally and internationally recognized expert on the design, conduct, analysis and monitoring of clinical trials. He has worked closely with investigators at the NIH and several pharmaceutical companies and is also a world-renowned cardiovascular epidemiologist with special expertise in lipid-lowering and blood pressure-lowering therapies. He is a strong proponent for evidence-based medicine, and his public health background provides a strong foundation for his views on drug evaluation and patient safety.
Professor Jeremy Grimshaw is the Director of the Clinical Epidemiology Program at the Ottawa Health Research Institute and the Director of the Center for Best Practice at the University of Ottawa. He holds a Tier 1 Canadian Research Chair in health knowledge transfer and uptake and was made a Professor of Medicine by the University of Ottawa. Prior to this, he held a Personal Chair in health services research at the University of Aberdeen and was the Program Director of the Effective Professional Program within health services research, one of the largest implementation research programs within the UK. Professor Grimshaw’s research interests are in knowledge translation,quality improvement,complex interventions. systematic reviews, cluster randomized trials, quasi experimental studies and behavioural theories (and their application to professional behaviour).
Volume 16 Suppl 1 (29 May 2015)
Abstracts of the 4th Meeting of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative
Rome, Italy. 19-20 November 2014