德国初级保健中呼吸道感染抗生素处方习惯的转变-群组随机对照 CHANGE-2 试验。
Converting habits of antibiotic prescribing for respiratory tract infections in German primary care--the cluster-randomized controlled CHANGE-2 trial.
机构信息
Institute of General Practice, Rostock University Medical Center, Rostock, Germany.
出版信息
BMC Fam Pract. 2012 Dec 20;13:124. doi: 10.1186/1471-2296-13-124.
BACKGROUND
With an average prescription rate of 50%, in German primary care antibiotics are still too frequently prescribed for respiratory tract infections. The over-prescription of antibiotics is often explained by perceived patient pressure and fears of a complicated disease progression. The CHANGE-2 trial will test the effectiveness of two interventions to reduce the rate of inappropriate antibiotic prescriptions for adults and children suffering from respiratory tract infections in German primary care.
METHODS/DESIGN: The study is a three-arm cluster-randomized controlled trial that measures antibiotic prescription rates over three successive winter periods and reverts to administrative data of the German statutory health insurance company AOK. More than 30,000 patients in two regions of Germany, who visit their general practitioner or pediatrician for respiratory tract infections will be included. Interventions are: A) communication training for general practitioners and pediatricians and B) intervention A plus point-of-care testing. Both interventions are tested against usual care. Outcome measure is the physicians' antibiotic prescription rate for respiratory tract infections derived from data of the health insurance company AOK. Secondary outcomes include reconsultation rate, complications, and hospital admissions.
DISCUSSION
Major aim of the study is to improve the process of decision-making and to ensure that patients who are likely to benefit from antibiotics are treated accordingly. Our approach is simple to implement and might be used rapidly among general practitioners and pediatricians. We expect the results of this trial to have major impact on antibiotic prescription strategies and practices in Germany, both among general practitioners and pediatricians.
TRIAL REGISTRATION
The study is registered at the Current Controlled Trials Ltd (ISRCTN01559032).
背景
在德国初级保健中，抗生素的平均处方率为 50%，但仍过于频繁地用于治疗呼吸道感染。抗生素的过度处方通常归因于患者的压力和对疾病进展复杂化的担忧。CHANGE-2 试验将测试两种干预措施的有效性，以降低德国初级保健中患有呼吸道感染的成人和儿童的不合理抗生素处方率。
方法/设计：该研究是一项三臂聚类随机对照试验，在三个连续的冬季期间测量抗生素处方率，并恢复德国法定健康保险公司 AOK 的行政数据。德国两个地区的 30,000 多名患者因呼吸道感染就诊于全科医生或儿科医生，将被纳入研究。干预措施是：A）全科医生和儿科医生的沟通培训和 B）干预 A 加即时检测。两种干预措施均与常规护理进行比较。主要结局是医生从 AOK 健康保险公司数据中得出的呼吸道感染抗生素处方率。次要结局包括再就诊率、并发症和住院治疗。
讨论
该研究的主要目的是改善决策过程，确保可能受益于抗生素的患者得到相应治疗。我们的方法简单易行，可在全科医生和儿科医生中迅速实施。我们预计该试验的结果将对德国的抗生素处方策略和实践产生重大影响，包括全科医生和儿科医生。
试验注册
该研究在 Current Controlled Trials Ltd（ISRCTN01559032）注册。
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