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
Informed consent is both an ethical and a legal requirement for trial participation. This study prospectively assessed the deliberation stage of the informed consent decision-making process of potential trial participants from across different clinical areas, highlighting some important considerations for those designing trials.
Decreased activity in children is linked to an average weight increase. This article describes the ABC intervention, which aims to evaluate the efficacy of increased activity levels in daycare and home settings, in particular moderate to vigorous physical activity, in children between the ages of three and five.
Automated real-time text messaging as a means for rapidly identifying acute stroke patients for clinical trials
The urgency for diagnosis and treatment of stroke patients makes recruitment to clinical trials challenging. The use of an automated real-time text messaging system in an emergency setting could enable a dedicated trial physician to readily identify patients suitable for inclusion in acute stroke trials.
Preclinical studies suggest baclofen could be used in treating persistent hiccups in stroke patients. Here, the results of this randomised controlled trial provide evidential support for this, though the authors highlight the need for larger studies.
Sample size requirements to estimate key design parameters from external pilot randomised controlled trials
Little consensus exists on how large a pilot study needs to be to aid the design of definite RCTs. This simulation study investigated the effect of sample size on precision and power under three realist scenarios, resulting in recommendations for external pilot study sizes for continuous outcomes and rare events.
Latest from the ISRCTN Register
- 01 August 2014
- ISRCTN65353263 - The operating room (OR) utility
- 31 July 2014
- ISRCTN35178384 - MRSA POC trial
- 31 July 2014
- ISRCTN35210084 - Comparison between two chlorhexidine gels for treatment of chronic periodontitis
Trials 2014, 15:302
Trials supports the AllTrials initiative, campaigning for the registration of all trials past and present, and the reporting of full methods and the results of all trials.
Restoring invisible and abandoned trials: a call for people to publish the findings published in the BMJ in June 2013, calling for wider publication of stopped and unfinished trials.
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).