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Standardising Outcomes in Paediatric Clinical Trials
Mike Clarke
PLOS Medicine , 2008, DOI: 10.1371/journal.pmed.0050102
Abstract:
Doing New Research? Don't Forget the Old
Mike Clarke
PLOS Medicine , 2004, DOI: 10.1371/journal.pmed.0010035
Abstract:
Can you believe what you read in the papers?
Mike Clarke
Trials , 2009, DOI: 10.1186/1745-6215-10-55
Abstract: There are ever increasing numbers of papers available in healthcare journals, and even more articles appearing in newer media such as the Internet. At first sight, the depth and breadth of this material might mean that people making decisions about their own care or that of others have never had it so good. Surely, they will be able to find research in the relevant topic area. They will. But the problem is: some of this research might not be reliable and the decision maker might not be able to find a sufficiently unbiased collection of the research to help her to make the right decision.For decisions about the effects of health care, randomised trials should boost the chances that comparisons are not confounded by factors other than the interventions being compared. They are, therefore, a more reliable guide for estimates of the differences between the actual interventions [1]. However, the problem of publication bias means that trials which have findings that do not favour the experimental intervention are less likely to be published quickly or at all [2,3], making the available literature a potentially biased and unreliable source of knowledge.It is possible that the recent growth in the number of trial reports being published is a sign that publication bias is being overcome. During this first decade of the twenty-first century, at least 25,000 reports of randomised or controlled trials have been published each year [4]. However, we will not know if this is a fair reflection of the volume of research being done until recent initiatives on widespread trial registration provide a means of tracking large cohorts of trials over time, and there may still be some way to go before all trials are registered prospectively. For example, the World Health Organisation's International Clinical Trials Registry Platform shows that nearly 20,000 trials were registered in the constituent registers in 2008, an increase of more than 4000 compared to 2007 [4]. However, it will only
Standardising outcomes for clinical trials and systematic reviews
Mike Clarke
Trials , 2007, DOI: 10.1186/1745-6215-8-39
Abstract: Every year, millions of journal articles are added to the tens of millions that already exist in the health literature, and tens of millions of web pages are added to the hundreds of millions currently available. Within these, there are many tens of thousands of research studies which might provide the evidence needed to make well-informed decisions about health care. The task of working through all this material is overwhelming enough, without then finding that the studies of relevance to the decision you wish to make all describe their findings in different ways, making it difficult if not impossible to draw out the relevant information. Of course, you might be able to find a systematic review, but even then there is no guarantee that the authors of that review will not have been faced with an insurmountable task of bringing together and making sense of a variety of studies that used a variety of outcomes and outcome measures.These difficulties are great enough but the problem gets even worse when one considers the potential for bias. If researchers have measured a particular outcome in a variety of ways, (for example using different pain instruments filled in by different people at different times) they might not report all of their findings from all of these measures. Studies have highlighted this problem in clinical trials, showing that this selectivity in reporting is usually driven by a desire to present the most positive or statistically significant results [3]. This will mean that, where the original researcher had a choice, the reader of the clinical trial report might be presented with an overly optimistic estimate of the effect of an intervention and therefore be led towards the wrong decision.In the 1990s, the potential scale of the problem of multiple outcome measures was highlighted in mental health by a comprehensive descriptive account of randomised trials in the treatment of people with schizophrenia. Thornley andAdams identified a total of 2000 su
Effects on patients of their healthcare practitioner's or institution's participation in clinical trials: a systematic review
Mike Clarke, Kirsty Loudon
Trials , 2011, DOI: 10.1186/1745-6215-12-16
Abstract: We searched the Cochrane Methodology Register and MEDLINE (most recently in January 2009) for studies in which patients were allocated to treatment in one or other setting, and cohort studies reporting the outcomes of patients from different settings. We independently assessed study quality, including the control of bias in the generation of the comparison groups, and extracted data.We retrieved and checked more than 15,000 records. Thirteen articles were eligible: five practitioner studies and eight institution studies. Meta-analyses were not possible because of heterogeneity. Two practitioner studies were judged to be 'controlled' or better. A Canadian study among nurses found that use of research evidence was higher for those who took part in research working groups and a Danish study on general practitioners found that trial doctors were more likely to prescribe in accordance with research evidence and guidelines. Five institution studies were 'controlled' but provided mixed results. A study of North American patients at hospitals that had taken part in trials for myocardial infarction found no statistically significant difference in treatment for patients in trial and non-trial hospitals. A Canadian study of myocardial infarction patients found that trial participants had better survival than patients in the same hospitals who were not in trials or those in non-trial hospitals. A study of general practices in Denmark did not detect differences in guideline adherence between trial and non-trial practices but found that trial practices were more likely to prescribe the trial sponsor's drugs. The other two 'controlled' studies of institutions found lower mortality in trial than non-trial hospitals.The available findings from existing research suggest that there might be a 'trial effect' of better outcomes, greater adherence to guidelines and more use of evidence by practitioners and institutions that take part in trials. However, the consequences for patient healt
Is Evidence-Based Medicine Relevant to the Developing World?
Paul Chinnock ,Nandi Siegfried,Mike Clarke
PLOS Medicine , 2005, DOI: 10.1371/journal.pmed.0020107
Abstract:
How the Cochrane Collaboration Is Responding to the Asian Tsunami
Prathap Tharyan ,Mike Clarke,Sally Green
PLOS Medicine , 2005, DOI: 10.1371/journal.pmed.0020169
Abstract:
Researching the acceptability of using Skype to provide Speech and Language Therapy
Rebecca Alison Matthews,Bencie Woll,Mike Clarke
International Journal of Integrated Care , 2012,
Abstract:
How the Cochrane collaboration is responding to the Asian tsunami.
Tharyan Prathap,Clarke Mike,Green Sally
PLOS Medicine , 2005,
Abstract:
Is Evidence-Based Medicine Relevant to the Developing World?
Paul Chinnock,Nandi Siegfried,Mike Clarke
Evidence-Based Complementary and Alternative Medicine , 2005, DOI: 10.1093/ecam/neh114
Abstract:
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