The Hard Data Creed in Current Clinical Practice - Its Spurious Validity and the Challenge to Define Meaningful Clinical Variables

Abstract: Until the technologic advances of the past century, the main information available to physicians was the 'soft' clinical data of symptoms and physical signs. During the 20th century, this information was augmented and usually replaced by the scientific and statistical appeal of 'hard data' from technologic 'para-clinical' tests. The paraclinical focus, however, has led to many adverse scientific, statistical, and humanistic problems. Scientifically, the 'clinical material' under study is not precisely or reproducibly identified with para-clinical data alone. Statistically, the results of randomized trials are pertinent for efficacy in average patients, but cannot be applied for decisions about pertinent clinical subgroups and outcomes. Humanistically, patients are distressed that their most urgent concerns (in symptoms, function, and quality of live) do not receive adequate attention. Solutions to these problems will require that soft data be identified with new instruments and with new taxonomic classifications in which patients and clinical care are the main focus of intellectual attention.

Keyword(s): Randomisierte kontrollierte Studien

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