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对家庭医生进行共同决策培训是否能促进急性呼吸道感染抗生素的合理使用?一项试点整群随机对照试验的研究方案。

Does training family physicians in shared decision making promote optimal use of antibiotics for acute respiratory infections? Study protocol of a pilot clustered randomised controlled trial.

作者信息

Légaré France, Labrecque Michel, Leblanc Annie, Thivierge Robert, Godin Gaston, Laurier Claudine, Côté Luc, O'Connor Annette M, Allain-Boulé Nadine, Rousseau Jean, Tapp Sylvie

机构信息

Research Centre of the Centre Hospitalier Universitaire de Québec, Québec, Canada.

出版信息

BMC Fam Pract. 2007 Nov 29;8:65. doi: 10.1186/1471-2296-8-65.

Abstract

BACKGROUND

In North America, although it varies according to the specific type of acute respiratory infections (ARI), use of antibiotics is estimated to be well above the expected prevalence of bacterial infections. The objective of this pilot clustered randomized controlled trial (RCT) is to assess the feasibility of a larger clustered RCT aiming at evaluating the impact of DECISION+, a continuing professional development (CPD) program in shared decision making, on the optimal use of antibiotics in the context of ARI.

METHODS/DESIGN: This pilot study is a cluster RCT conducted with family physicians from Family Medicine Groups (FMG) in the Quebec City area, Canada. Participating FMG are randomised to an immediate DECISION+ group, a CPD program in shared decision making, (experimental group), or a delayed DECISION+ group (control group). Data collection involves recruiting five patients consulting for ARI per physician from both study groups before (Phase 1) and after (Phase 2) exposure of the experimental group to the DECISION+ program, and after exposure of the control group to the DECISION+ program (Phase 3). The primary outcome measures to assess the feasibility of a larger RCT include: 1) proportion of contacted FMG that agree to participate; 2) proportion of recruited physicians who participate in the DECISION+ program; 3) level of satisfaction of physicians regarding DECISION+; and 4) proportion of missing data in each data collection phase. Levels of agreement of the patient-physician dyad on the Decisional Conflict Scale and physicians' prescription profile for ARI are performed as secondary outcome measures.

DISCUSSION

This study protocol is informative for researchers and clinicians interested in designing and/or conducting clustered RCT with FMG regarding training of physicians in shared decision making.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT00354315.

摘要

背景

在北美,尽管抗生素的使用因急性呼吸道感染(ARI)的具体类型而异,但据估计其使用量远高于细菌感染的预期患病率。这项初步整群随机对照试验(RCT)的目的是评估一项更大规模整群RCT的可行性,该RCT旨在评估DECISION+(一项关于共同决策的持续专业发展[CPD]计划)对ARI背景下抗生素的合理使用的影响。

方法/设计:这项初步研究是一项整群RCT,研究对象为加拿大魁北克市地区家庭医学组(FMG)的家庭医生。参与的FMG被随机分为立即接受DECISION+组(共同决策方面的CPD计划,即实验组)或延迟接受DECISION+组(对照组)。数据收集包括在实验组接触DECISION+计划之前(第1阶段)和之后(第2阶段),以及对照组接触DECISION+计划之后(第3阶段),从两个研究组的每位医生那里招募5名因ARI前来咨询的患者。评估更大规模RCT可行性的主要结局指标包括:1)同意参与的被联系FMG的比例;2)参与DECISION+计划的招募医生的比例;3)医生对DECISION+的满意度;4)每个数据收集阶段的缺失数据比例。患者-医生二元组在决策冲突量表上的一致程度以及医生针对ARI的处方情况作为次要结局指标。

讨论

本研究方案对于有兴趣就共同决策方面的医生培训设计和/或开展FMG整群RCT的研究人员和临床医生具有参考价值。

试验注册

ClinicalTrials.gov标识符:NCT00354315。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3083/2234396/56c16e7eeaff/1471-2296-8-65-1.jpg

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