The Clinical Inadequacy of Evidence-Based Medicine and the Need for a Conceptual Framework Based on Clinical Judgment

Each therapeutic act may be seen as a result of multiple ingredients that may be specific or nonspecific [6] . Expectations, preferences, motivation, and patient-doctor interactions are examples of variables that may affect treatment outcome [6, 7] . The changed spectrum of medical disorders (shifted toward aging and chronicity) and the interindividual differences in health priorities make the focus on single diseases potentially misleading, whereas there is growing awareness that the aim of the treatment should refer to personal goals (from attainment of cure to prevention of recurrence, from removal of functional impairment to alleviation of symptoms) [8] . EBM does not do justice to the importance of these interactions and provides an oversimplified and reductionistic view of treatment. Finally, the presence of investigators with substantial financial conflicts of interest in panels concerned with clinical guidelines and the excessive reliance of metaanalyses on industry-funded studies constitute two major sources of bias in literature interpretation [1, 9] . Horwitz et al. [10] developed a method of clinical inquiry within RCT that can enhance the applicability of results to clinical decision making. Reanalyzing the BetaBlocker Heart Attack Trial, they found that propranolol reduced the risk of dying for the ‘average’ patient who survived an acute myocardial infarction, whereas it was harmful in a subgroup characterized by specific cotherapy histories. If we accept the possibility that a treatment The gap between clinical guidelines developed by evidence-based medicine (EBM) and the real world of clinicians and patients has been widely recognized. There is currently little evidence that EBM has actually improved patient care [1] . It is thus not surprising that most of the time clinicians rely more on their own experience and that of their colleagues (tacit knowledge or ‘mindlines’) than on explicit evidence from research [2] . Feinstein and Horwitz [3] were among the first to warn about excessive reliance on randomized controlled trials (RCT) and meta-analyses that were not intended to answer questions about the treatment of individual patients. The results of these types of trials may show comparative efficacy of treatments for the average randomized patient but not for those whose characteristics, such as severity of symptoms, comorbidity and other clinical features, depart from standard presentations [3] . In addition, meta-analyses often include highly heterogeneous studies and ascribe conflicting results to random variability, whereas different outcomes may reflect different patient populations, enrollment and protocol characteristics [4] . Even though personalized medicine, described as genomicsbased knowledge, has promised to approach each patient as the biological individual he/she is, the practical applications still have a long way to go and neglect of social and behavioral features may actually lead to ‘depersonalized’ medicine [5] . Other limitations have emerged over time. Received: July 11, 2014 Accepted after revision: July 21, 2014 Published online: December 24, 2014