title: [Is there a rationale for pluralistic evaluation models? Limitations of randomized clinical trials].
abstract: Randomized clinical trials (RCTs) are believed to deliver the highest level of clinical evidence, and other types of evidence are rarely integrated in therapy assessments. Under ideal circumstances, RCTs are perfect tools of therapy evaluation; however, in clinical reality they suffer from a variety of limitations. Their prioritization can distort public health regulation because of commercial bias, career bias, bias of large numbers, mediocrity bias, and bias of therapy preferences; also, they can lead to discrepancies between clinical research and routine medical practice, to ethical problems, and to divergent and asymmetrical results. Moreover, the seemingly simple therapy assessment based on RCT results bears the danger of their endorsement and misuse by non-medical personnel, especially bureaucrats. To meet the demands of the complex reality of medical care, the physician's judgment should be methodologically professionalized and re-integrated into the process of generating medical knowledge; fixed hierarchies of medical evidence should be de-emphasized in favor of information syntheses from different types of (quality assessed) evidence.
authors.affiliation: Institut für angewandte Erkenntnistheorie und medizinische Methodologie, Bad Krozingen. gunver.kienle@ifaemm.de
authors.forename: Gunver S
authors.initials: GS
authors.lastname: Kienle
mesh_terms: D015510:Clinical Medicine / Q000379:methods / Q000592:standards; D018864:Cultural Diversity; D019317:Evidence-Based Medicine; D006801:Humans; D015588:Observer Variation; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*