Purpose To establish a pilot clinical quality registry (CQR) to monitor the quality of care and device performance for breast device surgery in Australia.
Participants All patients having breast device surgery from contributing hospitals in Australia. A literature review was performed which identified quality indicators for breast device surgery.
Findings to date 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.
Future plans 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.
- breast implant registry
- clinical quality registry
- breast implant surgery
- breast reconstruction
- breast cancer
- anaplastic large cell lymphoma
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RDC and SME contributed equally.
Contributors SME, RDC and JJM contributed to the concept and design of the study. SME, RDC, EE, CCMM, CMM, RLB, MP and IH contributed to the acquisition, analysis and interpretation of the data. SME and RDC wrote the first draft of the protocol. SME, RDC, JJM, EE and CCMM revised the protocol for important intellectual content. All authors have read and approved the final version of the manuscript to be published.
Funding This pilot study was funded by the Australasian Foundation for Plastic Surgery.
Competing interests None declared.
Ethics approval Ethics approval for this project was obtained from the Human Research Ethics Committees of the Alfred Hospital, Melbourne, to operate the BDR. Ethics approval was also required from each pilot site.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The minimum data set is available to share through the International Collaboration of Breast Registry Activities (ICOBRA)
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