Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
Harvard Medical School, Boston, MA, USA.
Aesthet Surg J. 2022 Jan 1;42(1):31-37. doi: 10.1093/asj/sjaa376.
The Australian Breast Device Registry (ABDR) is a clinical quality registry which utilizes both surgical data and patient-reported outcome measures (PROMs) to understand device performance. The ABDR is the first national breast device registry utilizing the BREAST-Q Implant Surveillance module to conduct PROMs via text messaging as the primary method of contact for most patients. ABDR PROMs are structured upon a successful acceptability and feasibility study and a pilot study.
This aim of this paper was to examine the challenges we faced and consider how lessons learned in implementing PROMs might inform future registry studies and interventions.
We tracked the number of completed follow-ups and documented feedback between October 2017 and December 2018 from various stakeholders, including sites, surgeons, and patients.
In total, 10,617 patients were contacted: 59% of breast augmentation and 77% breast reconstruction patients responded to our PROMs survey. We encountered challenges and developed solutions to overcome several key issues, including database setup; follow-up contact methods; ethics; education of surgeons and patients; associated costs; and ongoing evaluation and modification. The strategies we devised to address these challenges included drawing on experiences from previous studies, greater communication with sites and surgeons, and having the flexibility to improve and modify our PROMs.
The ABDR PROMs experience and lessons learned can inform a growing number of registries seeking to conduct PROMs. We describe our approach, obstacles encountered, and strategies to increase patient participation. As more breast device registries worldwide adopt PROMs, data harmonization is crucial to better understand patient outcomes and device performance.
澳大利亚乳房器械注册处（ABDR）是一个临床质量注册处，利用手术数据和患者报告的结果测量（PROMs）来了解器械性能。ABDR 是第一个利用 BREAST-Q 植入物监测模块进行 PROMs 的全国性乳房器械注册处，通过短信作为大多数患者的主要联系方式。ABDR 的 PROMs 是在成功的可接受性和可行性研究以及试点研究的基础上构建的。
本文旨在探讨我们所面临的挑战，并考虑在实施 PROMs 方面吸取的经验教训如何为未来的注册研究和干预措施提供信息。
我们跟踪了从 2017 年 10 月至 2018 年 12 月期间各个利益相关者（包括站点、外科医生和患者）的完成随访次数和记录的反馈。
共联系了 10617 名患者：59%的乳房隆乳和 77%的乳房重建患者对我们的 PROMs 调查做出了回应。我们遇到了挑战，并制定了解决方案来克服几个关键问题，包括数据库设置；后续联系方法；伦理；外科医生和患者的教育；相关成本；以及持续的评估和修改。我们为解决这些问题而设计的策略包括借鉴以前研究的经验、加强与站点和外科医生的沟通，以及具有改进和修改 PROMs 的灵活性。
ABDR 的 PROMs 经验和吸取的教训可以为越来越多寻求进行 PROMs 的注册处提供信息。我们描述了我们的方法、遇到的障碍和增加患者参与的策略。随着全球越来越多的乳房器械注册处采用 PROMs，数据协调对于更好地了解患者结局和器械性能至关重要。
