Trials is an open access, peer-reviewed, online journal that encompasses all aspects of the performance and findings of randomized controlled trials in biomedicine. 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
The process of developing and implementing a telephone-based peer support program for postpartum depression
Postpartum depression has detrimental health consequences for the mother, child and other members of the family. This paper describes how a peer support program was developed and implemented in high risk women, and further outlines the process of maintaining and evaluating this program for postpartum depression prevention.
A Remote Monitoring and Telephone Nurse Coaching Intervention to Reduce Readmissions among Patients with Heart Failure
Heart failure is a prevalent and costly condition, and reported to be highly associated with hospital readmissions. This article describes the protocol to evaluate the effectiveness of a care transition intervention that includes heart failure education prior to patient discharge, along with telephone nurse coaching following discharge.
Computer-assisted surgery is becoming an increasingly important option for surgeons. Thus, the authors conducted a prospective study to evaluate the benefits of computer-assisted mandibular reconstruction with iliac crest bone grafts, which resulted in reduced defect reconstruction and transplant ischemic times, along with reducing possible risks of postoperative complications.
The use of predictive biomarkers to select subjects for RCTs has the potential to improve the efficiency of clinical trials. Here, simulations were used to compare trial designs where participant recruitment was dependent on either a baseline biomarker level or early improvement in biomarker levels following a short active run-in phase.
Diet modulates the effect of the APOA5 -1131C variant on triglyceride and apolipoprotein A-V concentrations
The APOA5 – 1131T>C polymorphism is associated with hypertriglyceridemia in individuals with type 2 diabetes. This study investigated the substitution of refined rice with whole grains and legumes in impaired fasting glucose and diabetic individuals with the APOA5 – 1131C variant, and concluded this dietary change may help prevent diabetic hypertriglyceridemia.
Latest from the ISRCTN Register
- 17 April 2014
- ISRCTN10858225 - A first in human study to investigate the safety, tolerability and pharmacokinetics of single and multiple doses of SMT19969 in male healthy subjects
- 17 April 2014
- ISRCTN11725083 - A phase III/IV open-label study of the immunogenicity and safety of a single dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for each of three successive years in children naïve to, or in previous receipt of the AS03B adjuvanted H1N1 (2009)
- 17 April 2014
- ISRCTN38578686 - A randomised, placebo controlled trial of extra-oesophageal reflux treatment in the management of upper respiratory symptoms. [TOPPITS: Trial of Proton Pump Inhibitors in Throat Symptoms]
- 17 April 2014
- ISRCTN48152791 - A randomised controlled trial of the effectiveness of PDSAFE to prevent falls among people with ParkinsonÂs disease
- 17 April 2014
- ISRCTN26184967 - Sub-study 5 Randomised Controlled Trial Comparing Virtually Observed Therapy (VOT) versus Directly Observed Therapy (DOT)
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).
Reviewer acknowledgements 2013
Published: 26 February 2014
Last updated: 31 March 2014
Study protocols of trials in the Tailored Implementation for Chronic Diseases (TICD) project
Published: 5 December 2013
Last updated: 4 April 2014
Volume 14 Suppl 1 (29 November 2013)
Edinburgh, UK. 18-19 November 2013