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• W2073553093 abstract "We greatly commend Charles Young and Richard Horton's Comment1Young C Horton R Putting clinical trials into context.Lancet. 2005; 366: 107-108Summary Full Text Full Text PDF PubMed Scopus (148) Google Scholar and the paper by Fergusson and colleagues2Fergusson D Glass K Hutton B Shapiro S Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?.Clin Trials. 2005; 2: 218-232Crossref PubMed Scopus (125) Google Scholar which stimulated it. We wholly applaud the initiative announced by The Lancet. However, our experience identifying, appraising, and doing systematic reviews relevant to transfusion medicine3National Blood Service Systematic Reviews Initiative.http://www.transfusionguidelines.org/index.asp?Publication=SRIGoogle Scholar compels us to offer some observations. The first of these is that multiplicity of systematic reviews is becoming as great a problem as multiplicity of randomised controlled trials (RCTs) and is one of the rationales for our initiative. Secondary researchers as much as primary researchers must explicitly relate their findings to previous systematic reviews, and this too should be insisted on by The Lancet. We have identified six systematic reviews addressing the effectiveness of aprotinin. None was limited to current research (ie, that done in the past 3 years) and all assessed multiple interventions. Our brief summary of each of these, based on detailed appraisals by a clinician and methodologist, is shown in the table (expanded version available from the authors). We found, as did Fergusson and colleagues,2Fergusson D Glass K Hutton B Shapiro S Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?.Clin Trials. 2005; 2: 218-232Crossref PubMed Scopus (125) Google Scholar that systematic reviews had established the effectiveness of aprotinin, judged by perioperative transfusion, in the 1990s. Why then did the review authors not disseminate their results sufficiently to ensure further RCTs were not undertaken? Our experience suggests that results as clear-cut as the aprotinin example are rare; therefore when they occur there is an ethical imperative to pursue dissemination beyond the usual endpoint of publication in a journal.TableAppraisal of six systematic reviews addressing effectiveness of aprotininAprotinin RCTs includedImplications for practiceImplications for researchFremes 199416Continued use of intervention, but with concern about costFurther primary research recommendedLaupacis 199745Continued use of intervention, but with concern about costNo further research requiredLaupacis 199845..Update recommended to incorporate PRP, fibrin sealant, and newer trials in this areaWhether targeted primary research is required that needs addressingMunoz 1999Unknown*Review included 52 RCTs in total, but number on aprotinin was not specified...Any trials involving aprotinin need to measure costsLevi 199945Continued use of intervention, but with concern about costAny further research needs to measure mortality and compare active interventionsHenry 199961Continued use of intervention, but with concern about costFurther research recommended for aprotinin in non-cardiac surgery.Further research needs to evaluate costs, mortality, and adverse events, and should consider comparing active interventions—eg, aprotinin vs TXATXA=tranexamic acid. PRP=platelet-rich plasmapheresis.* Review included 52 RCTs in total, but number on aprotinin was not specified. Open table in a new tab TXA=tranexamic acid. PRP=platelet-rich plasmapheresis. Our appraisals also highlight a growing need for assessment of cost-effectiveness. For aprotinin there is substantial debate about whether the demonstrated effects are worth the cost, but calls for assessments of cost and cost-effectiveness do not seem to have been heard. A further difficult question is whether it is ethical to pursue further RCTs just to improve estimates of the exact size of a beneficial effect. For governments to make decisions sanctioning widespread use, provision of more precise estimates of the ratio of costs to quality-adjusted life-years (QALYs) might be essential. A related dilemma arises if the effect on one important outcome—say, survival—is established, but the effect on quality of life is unknown. Would an RCT which sought to establish the effect on quality of life be deemed unnecessary if a small benefit in survival had been established? Finally, although identification of the point at which RCTs become unnecessary is easy retrospectively, identifying this point prospectively is much more difficult. Many factors beyond precision can contribute to sufficient uncertainty to be less conclusive than the 95% CI might superficially indicate in a review. Such factors include study quality, publication bias, missing data, population type, and insufficient coverage of other outcomes. Authoritative investigation of the influence of this multitude of factors is feasible when a large RCT dataset has accumulated (albeit partly unnecessarily), but may be impossible to disentangle with small numbers of RCTs. None of the above undermines the need for RCTs to better report preceding RCTs, and explain how they contribute to the evidence base. However, any tendency to quick judgment needs to be tempered by the practical difficulties about gauging exactly when too much research has been done. We declare that we have no conflict of interest." @default.
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• W2073553093 title "Putting clinical trials into context" @default.
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• W2073553093 doi "https://doi.org/10.1016/s0140-6736(05)67370-9" @default.
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