Knowledge Transfer and Evaluation of Health Technologies and Interventions Unit, Research Centre of the Centre Hospitalier Universitaire de Québec, Québec, Canada.
Implement Sci. 2011 Jan 18;6:5. doi: 10.1186/1748-5908-6-5.
The misuse and limited effectiveness of antibiotics for acute respiratory infections (ARIs) are well documented, and current approaches targeting physicians or patients to improve appropriate use have had limited effect. Shared decision-making could be a promising strategy to improve appropriate antibiotic use for ARIs, but very little is known about its implementation processes and outcomes in clinical settings. In this matter, pilot studies have played a key role in health science research over the past years in providing information for the planning, justification, and/or refinement of larger studies. The objective of our study was to assess the feasibility and acceptability of the study design, procedures, and intervention of the DECISION+ program, a continuing medical education program in shared decision-making among family physicians and their patients on the optimal use of antibiotics for treating ARIs in primary care.
A pilot clustered randomised trial was conducted. Family medicine groups (FMGs) were randomly assigned, to either the DECISION+ program, which included three 3-hour workshops over a four- to six-month period, or a control group that had a delayed exposure to the program.
Among 21 FMGs contacted, 5 (24%) agreed to participate in the pilot study. A total of 39 family physicians (18 in the two experimental and 21 in the three control FMGs) and their 544 patients consulting for an ARI were recruited. The proportion of recruited family physicians who participated in all three workshops was 46% (50% for the experimental group and 43% for the control group), and the overall mean level of satisfaction regarding the workshops was 94%.
This trial, while aiming to demonstrate the feasibility and acceptability of conducting a larger study, has identified important opportunities for improving the design of a definitive trial. This pilot trial is informative for researchers and clinicians interested in designing and/or conducting studies with FMGs regarding training of physicians in shared decision-making.
Clinicaltrials.Gov NCT00354315.
抗生素被滥用于急性呼吸道感染(ARI),且疗效有限,针对医生或患者以改善合理使用抗生素的现行方法效果有限。共决可能是改善 ARI 抗生素合理使用的一种有前途的策略,但在临床环境中,对于其实施过程和结果知之甚少。在这方面,试点研究在过去几年的健康科学研究中发挥了关键作用,为规划、证明和/或改进更大规模的研究提供了信息。我们的研究目的是评估 DECISION+ 项目的研究设计、程序和干预措施的可行性和可接受性,该项目是一个针对家庭医生及其患者的继续教育项目,旨在就初级保健中抗生素治疗 ARI 的最佳使用进行共决。
开展了一项试点性聚类随机试验。家庭医学组(FMG)被随机分配到 DECISION+ 项目组或对照组。DECISION+ 项目包括在四到六个月期间进行三次为期 3 小时的研讨会,而对照组则延迟接触该项目。
在联系的 21 个 FMG 中,有 5 个(24%)同意参加试点研究。共招募了 39 名家庭医生(实验组 18 名,对照组 21 名)及其 544 名因 ARI 就诊的患者。参加全部三次研讨会的招募家庭医生比例为 46%(实验组为 50%,对照组为 43%),对研讨会的总体满意度平均为 94%。
虽然本试验旨在证明开展更大规模研究的可行性和可接受性,但也确定了改进确证性试验设计的重要机会。该试点试验为对 FMG 进行医生共决培训的研究人员和临床医生提供了有用的信息。
Clinicaltrials.Gov NCT00354315。