Showing papers by "Alessandro Liberati published in 2010"

A Review of Online Evidence-based Practice Point-of-Care Information Summary Providers

Abstract: Background: Busy clinicians need easy access to evidence-based information to inform their clinical practice. Publishers and organizations have designed specific tools to meet doctors’ needs at the point of care. Objective: The aim of this study was to describe online point-of-care summaries and evaluate their breadth, content development, and editorial policy against their claims of being “evidence-based.” Methods: We searched Medline, Google, librarian association websites, and information conference proceedings from January to December 2008. We included English Web-based point-of-care summaries designed to deliver predigested, rapidly accessible, comprehensive, periodically updated, evidence-based information to clinicians. Two investigators independently extracted data on the general characteristics and content presentation of summaries. We assessed and ranked point-of-care products according to: (1) coverage (volume) of medical conditions, (2) editorial quality, and (3) evidence-based methodology. We explored how these factors were associated. Results: We retrieved 30 eligible summaries. Of these products, 18 met our inclusion criteria and were qualitatively described, and 16 provided sufficient data for quantitative evaluation. The median volume of medical conditions covered was 80.6% (interquartile range, 68.9% - 84.2%) and varied for the different products. Similarly, differences emerged for editorial policy (median 8.0, interquartile range 5.8 - 10.3) and evidence-based methodology scores (median 10.0, interquartile range 1.0 - 12.8) on a 15-point scale. None of these dimensions turned out to be significantly associated with the other dimensions (editorial quality and volume, Spearman rank correlation r = -0.001, P = .99; evidence-based methodology and volume, r = -0.19, P = .48; editorial and evidence-based methodology, r = 0.43, P =.09). Conclusions: Publishers are moving to develop point-of-care summary products. Some of these have better profiles than others, and there is room for improved reporting of the strengths and weaknesses of these products. [J Med Internet Res 2010;12(3):e26]

Review of Online Evidence-based Practice Point-of-Care Information Summary Providers: Authors’ Reply to the Response by the Publisher of DynaMed

Abstract: We are pleased that the publisher of DynaMed clarified his evidence-based methodology in response to our review. We stress again how good reporting is a prerequisite for transparency. This lesson comes from the reporting of research findings but its extension to the development of information sources should be considered. [J Med Internet Res 2010;12(3):e40]

Commentary: The debate on non-inferiority trials: ‘when meta-analysis alone is not helpful’

Abstract: In a typical clinical trial, two treatments are compared to determine which is better, or if both are the same. The design of the classic, parallel group randomized trial involves formulating a null hypothesis of no difference between interventions and identifying a clinically relevant difference ( ) that researchers do not wish to overlook on the primary end-point. These trials are refered as ‘superiority trials’ (STs) as investigators hope to reject the null hypothesis demonstrating a difference between interventions. In an ST, the type I error is falsely finding a treatment effect when there is none, and a type II error is failing to detect a treatment effect when truly one exists. In contrast, a non-inferiority trial (NIT) seeks to determine whether a new intervention is no worse than a reference intervention within a pre-specified non-inferiority margin (from – to 0)—that is, a clinically irrelevant difference—for the primary outcome. The null hypothesis under which an NIT is designed is that the experimental intervention is worse than the standard treatment and that the absence of a relevant difference can be demonstrated by rejecting it. In NITs, the null and alternative hypotheses are reversed compared with STs: a type I error is the erroneous acceptance of an inferior new treatment, whereas a type II error is the erroneous rejection of a truly non-inferior treatment. It is the very nature of the NIT design that makes it susceptible to bias and misuse unless (i) the research question has a strong rationale; (ii) the effectiveness of the standard treatment is solid and (iii) the end point(s) on which the has been chosen for assessing non-inferiority are appropriate. Recognizing that NIT may—under specified circumstances—be useful does not mean that difficulties in design, conduct, analysis and interpretation can be overlooked, especially as NITs can be (mis) used to study new marketable products with questionable, or no, innovation, producing results only to obtain regulatory authority approval. The a priori concern, together with empirical evidence of NITs’ inappropriate use, fuels the current debate between those supporting NIT and those detracting it on both pragmatic and ethical grounds. The paper by Soonowala et al. published in this issue of the Journal should be read against this background. The paper is stated to be an attempt to ‘to address the concerns by performing a meta-analysis of non inferiority trials to see whether the systematic use of too large non inferiority margins or systematic bias in designs, conduct or reporting skewed the overall results’. Authors searched relevant NITs across a variety of clinical questions and pooled data to see whether the suspicion of a systematic bias could, or could not, be confirmed. They conclude that ‘the experimental treatments that gain the verdict of non inferiority in published trials do not appear to be systematically less effective than the standard treatments’, and then go a step further stating that ‘the findings are reassuring considering the criticism that has been levelled at non-inferiority trials’. Do the data support these conclusions? Hardly so, and I will now briefly discuss why. The statistical methodologies used by the authors are appropriate and rigorous. However, the results of the paper, and even more its implications, are not easy to interpret and readers should consider whether (i) the study addressed the crucial questions about NTIs; (ii) the findings provide a better understanding of the issues and (iii) the results provide clear indications of where to go next. I believe that Soonowala et al.’s study has, in the above respects, important limitations that the authors largely acknowledge. Among the most important are (i) the search strategy was far from comprehensive; (ii) publication bias cannot be ruled out and may have led to the failure to identify some relevant NITs and (iii) the design of the NIT, in particular the clinical rationale for choice of the non-inferiority Published by Oxford University Press on behalf of the International Epidemiological Association

Treating prehypertension: Citizens' juries in health care

Abstract: Moynihan raises a crucial question: how can we set up independent and broadly representative panels that can deliberate matters away from the long shadow of the drug industry?1 After years of promoting citizens’ and patients’ participation in healthcare decisions,2 we propose including citizens in deciding healthcare issues of …