[How large is the loss of effectiveness of a treatment procedure between "theory" and "practice"? Evaluating health economics basic data within the scope of a trial model of ambulatory synchronous balenophototherapy of atopic eczema]

Abstract

Background and objective: Before introducing new treatment modalities, efficacy has to be proven in clinical trials. Furthermore, it is of special interest to what extent results of clinical trials can be transferred to daily routine.

Patients/methods: In the framework of a trial on out-patient synchronous balneophototherapy, a possible loss in treatment efficacy from "clinical trial" to "daily routine" was examined. Therefore all patients without protocol deviations (representing treatment success available in a "clinical trial") and all patients with at least one treatment session regardless of protocol deviations (model for "daily routine") were analyzed.

Results: 257 "daily routine" and 1281 "clinical trial" patients with atopic dermatitis were analyzed. Relative SCORAD-improvements provided a clear loss in treatment efficacy in the "daily routine" group of 14.2%: 55% of patients received less than the planned 3 treatments per week and 48% left the study early because of noncompliance, good improvement, lack of time or lack of efficacy.

Conclusions: For the first time a loss of efficacy of a treatment modality between "theory" and "practice" can be demonstrated in a representative number of patients suffering from atopic dermatitis. For the optimal use of rare financial resources, the comparison of different treatment modalities under "daily routine" conditions is also necessary in future.