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

J. Bleidorn, C. Költzsch, E. Hummers-Pradier, I. Gágyor, G. Theile
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引用次数: 2

Abstract

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.
家庭医生作为临床试验调查员?-双盲临床试验对医师经验的定性研究
背景:临床(药物)试验被认为是提供治疗证据的“金标准”,但很少在德国家庭实践中进行。试点研究HWI-01“抗生素与布洛芬治疗非复杂性尿路感染”是一项非商业性双盲临床试验,评估布洛芬对症治疗与抗生素治疗非复杂性尿路感染(UTI)的临床等效性,并于2007/08年根据德国家庭实践的现行良好临床实践指南进行。由于广泛的监管要求,临床药物试验对参与的医生和他们的团队来说是一个巨大的挑战。为了优化家庭医学环境下进一步随机对照药物试验的计划和实施,本研究在定性访谈中探讨了参与家庭医生的观点和经验。方法:在HWI-01研究结束后,对作为试验调查员的FPs进行半结构化访谈。访谈指南包括参与的一般动机、患者招募的经验以及实践中的研究程序。采访被数字记录下来,并逐字抄写。通过内容分析进行评价。结果/结论:对德国下萨克森州20名家庭医生进行了访谈。可以从医生参与动机、患者招募和试验实施的实际方面进行阐述。为了在家庭医学中成功实施进一步的临床试验,人们应该考虑a)相关的研究主题促进研究参与,b)“满候诊室”总是优先考虑,c)程序应尽可能简单,d)应考虑患者的期望。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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