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
Evidence suggests that thyroid hormones affect the cardiovascular system; a double-blinded RCT of levothyroxine versus placebo will assess its effect on left ventricular function in patients with acute myocardial infarction and subclinical hypothyroidism.
Sharing individual patient data from clinical trials is a key issue in the move towards greater transparency. The Medical Research Council Clinical Trials Unit at University College London discusses their approach and the rationale behind it.
A composite outcome score for a complex intervention in primary care research was developed and evaluated using simulation of the Community Health Workers intervention; potential benefits include increased statistical power and avoidance of over-emphasis on a single outcome from a complex intervention.
A cluster RCT indicates that incorporating modified early warning scoring to observation charts to aid nurses timely response to patients’ deterioration enhanced chart recording and nurses’ knowledge, but not response to patients’ deterioration.
Simple randomization of participants can introduce bias and limit statistical power if intervention acceptance differs between arms in a RCT. A simulation study evaluated a preference-adaptive randomization methodology, designed to overcome these and enhance the validity of results in comparative effectiveness studies.
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.
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).