Hopper Ingrid, Best Renee L, McNeil John J, Mulvany Catherine M, Moore Colin C M, Elder Elisabeth, Pase Marie, Cooter Rodney D, Evans Sue M
Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine (SPHPM), Monash University, Melbourne, Victoria, Australia.
Australian Centre for Cosmetic Surgery, Neutral Bay, New South Wales, Australia.
BMJ Open. 2017 Dec 28;7(12):e017778. doi: 10.1136/bmjopen-2017-017778.
To establish a pilot clinical quality registry (CQR) to monitor the quality of care and device performance for breast device surgery in Australia.
All patients having breast device surgery from contributing hospitals in Australia. A literature review was performed which identified quality indicators for breast device surgery.
A pilot CQR was established in 2011 to capture prospective data on breast device surgery. An interim Steering Committee and Management Committee were established to provide clinical governance, and guide quality indicator selection. The registry's minimum dataset was formulated in consultation with stakeholder groups; potential quality indicators were assessed in terms of (1) importance and relevance, (2) usability, (3) feasibility to collect and (4) scientific validity. Data collection was by a two-sided paper-based form with manual data entry. Seven sites were recruited, including one public hospital, four private hospitals and two day surgeries. Patients were recruited and opt-out consent used.
The pilot breast device registry provides high-quality population-based data. It provides a model for developing a national CQR for breast devices; its minimum dataset and quality indicators reflect the opinions of the broad range of stakeholders. It is easily scalable, and has formed the basis for other international surgical groups establishing similar registries.
建立一个试点临床质量登记系统（CQR），以监测澳大利亚乳房植入手术的护理质量和器械性能。
澳大利亚参与医院中所有接受乳房植入手术的患者。进行了文献综述，确定了乳房植入手术的质量指标。
2011年建立了一个试点CQR，以收集乳房植入手术的前瞻性数据。成立了一个临时指导委员会和管理委员会，以提供临床治理并指导质量指标的选择。登记系统的最小数据集是在与利益相关者团体协商后制定的；潜在的质量指标从以下方面进行评估：（1）重要性和相关性，（2）可用性，（3）收集的可行性以及（4）科学有效性。数据收集采用双面纸质表格并手动录入数据。招募了七个地点，包括一家公立医院、四家私立医院和两家日间手术中心。招募了患者并采用退出同意的方式。
试点乳房植入登记系统提供了高质量的基于人群的数据。它为建立全国性乳房植入CQR提供了一个模型；其最小数据集和质量指标反映了广泛利益相关者的意见。它易于扩展，并已成为其他国际外科团体建立类似登记系统的基础。
