Avent Minyon L, Hansen Malene Plejdrup, Gilks Charles, Del Mar Chris, Halton Kate, Sidjabat Hanna, Hall Lisa, Dobson Annette, Paterson David L, van Driel Mieke L
The University of Queensland, School of Public Health, Herston, QLD, 4006, Australia.
The University of Queensland, UQ Centre for Clinical Research, Herston, QLD, 4006, Australia.
BMC Fam Pract. 2016 Apr 21;17:48. doi: 10.1186/s12875-016-0446-7.
There is a strong link between antibiotic consumption and the rate of antibiotic resistance. In Australia, the vast majority of antibiotics are prescribed by general practitioners, and the most common indication is for acute respiratory infections. The aim of this study is to assess if implementing a package of integrated, multifaceted interventions reduces antibiotic prescribing for acute respiratory infections in general practice.
METHODS/DESIGN: This is a cluster randomised trial comparing two parallel groups of general practitioners in 28 urban general practices in Queensland, Australia: 14 intervention and 14 control practices. The protocol was peer-reviewed by content experts who were nominated by the funding organization. This study evaluates an integrated, multifaceted evidence-based package of interventions implemented over a six month period. The included interventions, which have previously been demonstrated to be effective at reducing antibiotic prescribing for acute respiratory infections, are: delayed prescribing; patient decision aids; communication training; commitment to a practice prescribing policy for antibiotics; patient information leaflet; and near patient testing with C-reactive protein. In addition, two sub-studies are nested in the main study: (1) point prevalence estimation carriage of bacterial upper respiratory pathogens in practice staff and asymptomatic patients; (2) feasibility of direct measures of antibiotic resistance by nose/throat swabbing. The main outcome data are from Australia's national health insurance scheme, Medicare, which will be accessed after the completion of the intervention phase. They include the number of antibiotic prescriptions and the number of patient visits per general practitioner for periods before and during the intervention. The incidence of antibiotic prescriptions will be modelled using the numbers of patients as the denominator and seasonal and other factors as explanatory variables. Results will compare the change in prescription rates before and during the intervention in the two groups of practices. Semi-structured interviews will be conducted with the general practitioners and practice staff (practice nurse and/or practice manager) from the intervention practices on conclusion of the intervention phase to assess the feasibility and uptake of the interventions. An economic evaluation will be conducted to estimate the costs of implementing the package, and its cost-effectiveness in terms of cost per unit reduction in prescribing.
The results on the effectiveness, cost-effectiveness, acceptability and feasibility of this package of interventions will inform the policy for any national implementation.
The GAPS trial is registered under the Australian New Zealand Clinical Trials Register, reference number: ACTRN12615001128583 (registered 26/10/2015).
抗生素使用与抗生素耐药率之间存在紧密联系。在澳大利亚，绝大多数抗生素由全科医生开具，最常见的适应症是急性呼吸道感染。本研究的目的是评估实施一套综合、多方面的干预措施是否能减少全科医疗中急性呼吸道感染的抗生素处方。
方法/设计：这是一项整群随机试验，比较澳大利亚昆士兰州28家城市全科诊所中两组平行的全科医生：14家干预诊所和14家对照诊所。该方案由资助机构提名的内容专家进行同行评审。本研究评估在六个月期间实施的一套综合、多方面的循证干预措施。所纳入的干预措施此前已被证明能有效减少急性呼吸道感染的抗生素处方，包括：延迟处方；患者决策辅助工具；沟通培训；对诊所抗生素处方政策的承诺；患者信息手册；以及使用C反应蛋白进行即时检测。此外，两项子研究嵌套在主要研究中：（1）对诊所工作人员和无症状患者中细菌上呼吸道病原体携带情况的现患率估计；（2）通过鼻/咽拭子直接检测抗生素耐药性的可行性。主要结局数据来自澳大利亚国家医疗保险计划“医疗保险”，将在干预阶段结束后获取。这些数据包括干预前和干预期间每位全科医生的抗生素处方数量和患者就诊数量。抗生素处方发生率将以患者数量为分母，季节和其他因素为解释变量进行建模。结果将比较两组诊所在干预前和干预期间处方率的变化。在干预阶段结束时，将对干预诊所的全科医生和诊所工作人员（执业护士和/或诊所经理）进行半结构式访谈，以评估干预措施的可行性和接受程度。将进行经济评估，以估计实施该方案的成本及其在每减少一个单位处方量的成本效益。
这套干预措施在有效性、成本效益、可接受性和可行性方面的结果将为任何全国性实施的政策提供参考。
GAPS试验已在澳大利亚新西兰临床试验注册中心注册，注册号：ACTRN12615001128583（2015年10月26日注册）。
