Journal
JOURNAL OF EVALUATION IN CLINICAL PRACTICE
Volume 19, Issue 4, Pages 638-643Publisher
WILEY
DOI: 10.1111/j.1365-2753.2012.01888.x
Keywords
applicability; external validity; generalizability; guidelines; randomized controlled trials
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Rationale, aims and objectives Randomized controlled trials (RCTs) are the preferred source for evidence for the effect of treatment. However, patients participating in RCTs often manifest important differences from patients seen in practice. Therefore, guideline developers have to decide whether the results are generalizable to the target population not represented in RCTs. Method Asystematic review of the literature was undertaken to identify methods to decide whether to generalize the results from RCTs to patients who were not represented in these trials. Results One approach is to examine the in- and exclusion criteria of trials and infer from these whether the trial population was sufficiently representative. Other authors suggest, because of the inclusion of a broader range of patients, reliance on observational studies if no direct evidence for the target population is available. Another approach is to apply the relative effect of treatment found in trials to patients in practice unless there is a compelling reason to believe the results would differ substantially as a function of particular characteristics of those patients. Although there are exceptions, this approach is supported by empirical evidence that, in general, relative effect of treatment on benefit outcomes seldom differs to an important extent across subgroups of patients. Conclusion We propose this last approach: focusing on RCTs unless there is a compelling reason not to do so. Compelling reasons will most often be found with respect to issues of rare adverse effects, for which observational studies are likely to provide the best estimates.
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