家庭医学と医療科学の研究
オープンアクセス

概要

Family Physicians as Clinical Trial Investigators? - A Qualitative Study of Physicians’ Experiences with a Double-Blind Clinical Trial

Bleidorn J, Költzsch C, Hummers-Pradier E, Gágyor I and Theile G

Background: Clinical (drug) trials are known as "gold standard" to provide evidence on therapy, but have rarely been undertaken in German family practices. The pilot study HWI-01 "Antibiotic vs Ibuprofen for uncomplicated urinary tract infection" was a noncommercial, double-blind clinical trial, assessing the clinical equivalence of a symptomatic treatment with ibuprofen compared to antibiotic treatment for uncomplicated urinary tract infection (UTI), and was conducted in 2007/08 according to current good clinical practice-guidelines in German family practices. Due to extensive regulatory requirements, a clinical drug trial is a great challenge for participating physicians and their teams. To optimize the planning and implementation of further randomized- controlled drug trials in a family medicine setting, views and experiences of participating family practitioners (FP) were explored subsequently in this qualitative interview study.

Methods: After close- out of the HWI-01 study, semi-structured interviews were conducted with the FPs who acted as trial investigators. The interview guideline included the areas of general motivation for participation, experience with patient recruitment as well as with study procedures in the practice. Interviews were digitally recorded and transcribed verbatim. The evaluation was carried out by content analysis.

Results/ Conclusions: Interviews were conducted with 20 family physicians in Lower Saxony, Germany. Aspects concerning physicians´ motivation to participate, patient recruitment and practical aspects of trial implementation could be elucidated. For successful implementation of further clinical trials in family medicine one should consider that a) relevant study themes facilitate research participation, b) a "full waiting room" always has priority, c) procedures should be as simple as possible and d) patients expectations should be minded.