Patient-Based Medicine – A Novel Framework to Restore Focus on the Patient

Abstract

The reorientation of clinical research towards the questions of treatment benefit (beyond the question of treatment efficacy) and of whether clinical trials represent actual practice (external validity) is the timely path to clinical research questions of real interest and importance. Postmodern anything goes makes it possible to also consider hitherto dismissed effects, such as placebo, as valuable. However, that would require a precise documentation of the external validity of such effects. Not disease as such, but the disease context, not therapy as such, but the therapeutic context, not the patient as such, but the patient context, not a test as such, but the test situation has become an important focus of clinical research. In respect to test results, current medicine can and should recognize its preoccupation with allegedly objective and hard data. The patient context can determine whether an efficacious therapy is beneficial or harmful. It is thus the proper definition of the patient context which makes medicine documentable, no matter how objective or subjective the effect of therapy is. The consideration of the therapeutic context leads to the important distinction between efficacy and effectiveness (or benefit), and this makes it clear that the randomized controlled trial in its traditional design as the placebo controlled double-blind trial (DBRCT) is limited to the evaluation of drug theory. The evaluation of treatment effectiveness requires more pragmatic trials which study treatment operations and not isolated components and which may also compare entire treatment strategies. Pragmatic clinical trials, in future, will not only allow the study of pathogenesis blockers, but also the study of salutogenic interventions working with the host constitution. The following illustration gives a good picture of this way of thinking and its importance for individuals receiving treatment. It is clear we have paid too little attention to the importance of environment and host resiliency in our modern paradigms that have been more or less ubiquitous in our research. The illustration below provides a graphic of this way of thinking, and the importance of taking the patient and the environment into account in the patient encounter. The illustration provides a backdrop for the development of a holistic approach to the patient which is key to the development of patient-based medicine.