Lessons Learned in Implementing Patient-Reported Outcome Measures (PROMs) in the Australian Breast Device Registry (ABDR).

BACKGROUND: 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. OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Patient-Reported Outcome Measures for Breast Implant Surgery: A Pilot Study.

BACKGROUND: The Breast-Q Implant Surveillance module (BREAST-Q IS) is a patient-reported outcome measure (PROM) that asks 5 questions on satisfaction (shape, feel, and rippling) and symptoms (pain and tightness) derived from the BREAST-Q. OBJECTIVES: We aimed to pilot BREAST-Q IS on patients within the Australian Breast Device Registry (ABDR), an opt-out clinical quality device registry, and explored Short Message Service (SMS) communication as a follow-up method. METHODS: Patients with a breast device surgery in the previous 10 to 15 months, age ≥18 years, with a mobile phone number, were invited to complete the 5-question PROM via SMS initially, followed by 3 phone call attempts if no response, an e-mail, and then a letter by post as a final engagement strategy. RESULTS: The study included 197 participants [breast augmentation (BA) = 118; breast reconstruction (BR) = 79]. Mean ± SD age was 40 ± 12 years (BA) and 44 ± 11 years (BR). Mean ± SD time since surgery was 414 ± 36 days (BA) and 413 ± 51 days (BR). The total response rate, including opt-outs, was 76%. Responses indicated that >90% of BA and >79% of BR were very or somewhat satisfied with shape, feel, and wrinkling; >70% of BA and >46% of BR reported no pain or tightness. Completion of survey via SMS was 51% (BA) and 55% (BR). Further responses were received by phone (25%, 26%), post (21%, 16%), and e-mail (3%, 3%). CONCLUSIONS: This pilot demonstrated high levels of satisfaction and low levels of pain and tightness in patients with breast augmentation and breast reconstruction 1 year postoperatively. It also showed the effectiveness of our engagement strategy, which achieved a 76% response rate. Over 50% of respondents used SMS to reply to a 5-question PROM assessing long-term surgical outcomes. This engagement strategy will be used as BREAST-Q IS is rolled out nationally.

Developing an International Framework for Informed Consent in Plastic Surgery: A Focus on Cosmetic Breast Augmentation.

Background: Informed consent is a fundamental pillar of patient rights and is an essential part of good clinical practice. In 2019, the International Confederation of Plastic Surgery Societies launched a survey to collect feedback on informed consent practices, with an aim to develop an international guideline for cosmetic surgery. Methods: A 15-question survey was sent to delegates of the International Confederation of Plastic Surgery Societies for dissemination to their national society members. The survey comprised a range of quantitative and qualitative questions. Descriptive and thematic analysis was performed. Results: There were 364 respondents. Over half of the respondents reported no local informed consent policy, whereas others noted national society, specialist college, or government policies. The majority of respondents believed that the performing surgeon should be responsible for obtaining informed consent with at least two face-to-face consultations. Most respondents agreed with a cooling-off period (duration based on procedure type and use of high-risk devices). Regarding cosmetic breast augmentation, the majority of respondents felt that the performing surgeon should be responsible for postoperative management, including cases that occur as part of surgical tourism. Some respondents incorporate financial consent as part of their informed consent practice. Most supported the development of an international informed consent guideline. Conclusions: Informed consent should result from face-to-face consultations with the performing surgeon. There should be a minimum cooling-off period. Postoperative surveillance should be available in all settings. The findings of this survey will help inform an international standardized informed consent guideline for cosmetic surgery.

Comparing 200,000 Breast Implants and 85,000 Patients over Four National Breast Implant Registries.

BACKGROUND: Growing awareness about breast implant-related adverse events has stimulated the demand for large, independent data resources. For this, data from breast implant registries could be combined. However, that has never been achieved yet. METHODS: Real-world data from four currently active national breast implant registries were used. All permanent breast implants from the Australian, Dutch, Swedish, and American registries were included. A subpopulation present across all registries between 2015 and 2018 was subsequently selected, including only permanent breast implants inserted during primary surgery for breast reconstruction or augmentation in patients without previous breast device surgery. Nationwide coverage, patient and implant characteristics, infection control measures, and revision incidences were analyzed. RESULTS: A total of 207,189 breast implants were registered. Nationwide coverage varied between 3% and 98%. The subpopulation included 111,590 implants (7% reconstruction, 93% augmentation). Across the registries, mean patient age varied between 41 and 49 years ( P < 0.001) for reconstruction and 31 and 36 years ( P < 0.001) for augmentation. Variation was observed in implant preferences across the countries and over the years. Infection control measures were most frequently registered in Australia. Cumulative revision incidence at 2 years ranged from 6% to 16% after reconstruction and from 1% to 4% after augmentation. CONCLUSIONS: For the first time, independent, national, registry-based data from four breast implant registries were combined. This is a powerful step forward in optimizing international breast implant monitoring, evidence-based decision-making, and patient safety.

Breast Device Surgery in Australia: Early Results from the Australian Breast Device Registry.

BACKGROUND: The Australian Breast Device Registry (ABDR) is a clinical quality registry designed to monitor the performance of breast devices; and the quality and safety of breast device surgery. OBJECTIVE: To report on breast device surgery characteristics across Australia. METHODS: Participants were registered patients in the ABDR from 2012 to 2018. Results are described using percentages, mean and median. Revision rates were calculated using survival analysis methods. RESULTS: A total of 37,603 patients were registered and had undergone reconstruction (post-cancer 15.1%, risk-reducing mastectomy 3.4% and developmental deformity 2.4%) or cosmetic augmentation (74.7%) procedures. The majority of breast implant devices were silicone filled with textured surface (reconstruction 74.0% and augmentation 64.0%). Sub-pectoral plane was the most common for both reconstruction (60.1%) and augmentation (76.6%) procedures. For reconstruction surgery, the most common surgical incision was previous mastectomy scar (44.0%) and inframammary (31.8%), and for augmentation, it was inframammary (83.4%). Intraoperative/postoperative antibiotic usage for reconstruction was 85.8% and augmentation was 89.4%. Revision incidence due to complication at 12 months post-cancer reconstruction was 5.1%, risk-reducing reconstruction 5.7% and developmental deformity implants 4.5%. Revision incidence due to complication at 12 months after augmentation procedure was 1.1%. Patient-reported outcome measures (PROMs) indicate high levels of satisfaction at 1 year for augmentation and reconstruction procedures. CONCLUSION: We report on early data from the ABDR and reflect on the uptake of the registry by surgeons and patients. The registry also benefits from international collaborative approaches to addressing challenges and is committed to facilitate international post-market surveillance.

Brief reports: paravertebral block for anesthesia: a systematic review.

BACKGROUND: The objective of this review was to assess the safety and efficacy of thoracic and lumbar paravertebral blocks (PVBs) for surgical anesthesia through a systematic review of the peer-reviewed literature. PVBs for surgical anesthesia were compared with general anesthesia (GA) or other regional anesthetic techniques. METHODS: We searched literature databases including MEDLINE, EMBASE, and The Cochrane Library up to May 2008. Included studies were limited to eligible randomized controlled trials. Eight randomized controlled trials were included in this review, 6 of which used PVBs for anesthesia during breast surgery, and 2 trials used PVB for anesthesia during herniorrhaphy. RESULTS: The ability to obtain firm conclusions was limited by the diversity of outcomes and how they were measured, which varied across studies. The PVB failure rate was not >13%, and patients were more satisfied with PVB than with GA. There was some indication that PVB could achieve shorter hospital stays than GA. PVB for anesthesia substantially reduces nausea and vomiting in comparison with GA (relative risk: 0.25, 95% CI: 0.13-0.50; P < 0.05), although it does carry a risk of pleural puncture and epidural spread of local anesthetic. CONCLUSIONS: In conclusion, based on the current evidence, PVBs for surgical anesthesia at the level of the thoracic and lumbar vertebrae are associated with less pain during the immediate postoperative period, as well as less postoperative nausea and vomiting, and greater patient satisfaction compared with GA.

Toward International Harmonization of Breast Implant Registries: International Collaboration of Breast Registry Activities Global Common Data Set.

BACKGROUND: The Poly Implant Prothèse incident and breast implant-associated anaplastic large cell lymphoma have pointed to the need for uniform registries for breast implants as key features to monitoring the outcomes of breast implant surgeries internationally. The purpose of this study was to identify and harmonize common data elements collected by breast implant registries across the International Collaboration of Breast Registry Activities (ICOBRA) global consortium. METHODS: The authors convened an international group of surgeons, consumers, nurses, registry experts, and regulators to review the data points. A modified Delphi approach was applied, to rate the importance of each point on a six-point Likert scale. RESULTS: Data points from six national breast implant registries were divided into categories: clinical, implant-related, patient-reported findings; operation details and implanting technique details; patient characteristics; unique device identifiers; unique patient identifiers; and clinical demographics. A total of 52 data points collected by over 33 percent of national registries were identified. After five rounds, 34 data points formed the final set with agreed definitions. The group recognized the critical importance of additional elements that are currently not uniformly collected (e.g., patient-reported outcomes and long-term data) and set out the process for the dynamic global set updates driven by evidence gaps. CONCLUSIONS: The authors defined internationally agreed on common data elements and definitions used in breast implant registries. This collaboration will allow data sets to be combined, enabling an effective global early warning system of implant-related problems and further work on data sets.

Establishing the acceptability of a brief patient reported outcome measure and feasibility of implementing it in a breast device registry - a qualitative study.

BACKGROUND: To examine the acceptability of a Patient Reported Outcome Measure (PROM) that assesses perceptions and experiences of implants for breast reconstruction or augmentation, and the feasibility of implementing it in the Australian Breast Device Registry (ABDR). METHODS: The BREAST-Q Implant Surveillance (BREAST-Q IS) is a 5-question PROM derived from the BREAST-Q questionnaire. It assesses perceptions of breast appearance and sensation, and experiences of pain. Breast implant recipients (recruited via community networks, social media and notices in surgeons' rooms) and surgeons contributing to the ABDR were invited to review the BREAST-Q-IS. Participation was by individual semi-structured interviews by telephone or email, or by completion of a paper questionnaire. Transcripts of audio recordings and emailed text were analysed thematically. RESULTS: Twenty one breast implant recipients (10 after reconstruction and 11 augmentation), 8 surgeons (five plastic, three breast) and 2 medical professionals performing cosmetic surgeries were interviewed. Six themes were identified: Overall impression, Emotional response to the BREAST-Q IS, Method of follow-up, Suggested improvements, Group variation, and Potential Clinical utility. Overall, breast implant recipients and surgeons found the BREAST-Q IS to be acceptable and unlikely to provoke strong emotional reactions. Email was the preferred mode of contact. Most suggested improvements were to add questions. Surgeons expressed concern that subjective responses to the PROM might not accurately reflect experiences and that the PROM would predict need for revision rather than device failure. CONCLUSION: This study supports the acceptability and feasibility of BREAST-Q IS as a PROM for recipients of breast implants. Further validation of the Breast-Q IS is required.

Defining Quality Indicators for Breast Device Surgery: Using Registries for Global Benchmarking.

Breast device registries monitor devices encompassing breast implants, tissue expanders and dermal matrices, and the quality of care and patient outcomes for breast device surgery. Defining a standard set of quality indicators and risk adjustment factors will enable consistency and adjustment for case-mix in benchmarking quality of care across breast implant registries. This study aimed to develop a set of quality indicators to enable assessment and reporting of quality of care for breast device surgery which can be applied globally. METHODS: A scoping literature review was undertaken, and potential quality indicators were identified. Consensus on the final list of quality indicators was obtained using a modified Delphi approach. This process involved a series of online surveys, and teleconferences over 6 months. The Delphi panel included participants from various countries and representation from surgical specialty groups including breast and general surgeons, plastic and reconstructive surgeons, cosmetic surgeons, a breast-care nurse, a consumer, a devices regulator (Therapeutic Goods Administration), and a biostatistician. A total of 12 candidate indicators were proposed: Intraoperative antibiotic wash, intraoperative antiseptic wash, preoperative antibiotics, nipple shields, surgical plane, volume of implant, funnels, immediate versus delayed reconstruction, time to revision, reoperation due to complications, patient satisfaction, and volume of activity. RESULTS: Three of the 12 proposed indicators were endorsed by the panel: preoperative intravenous antibiotics, reoperation due to complication, and patient reported outcome measures. CONCLUSION: The 3 endorsed quality indicator measures will enable breast device registries to standardize benchmarking of care internationally for patients undergoing breast device surgery.

Bilateral thoracic paravertebral block for abdominoplasty.

Thoracic bilateral paravertebral block is a technique commonly used in the ambulatory setting for numerous plastic surgery procedures. Paravertebral block has not been reported with abdominoplasty surgery. This case series explores this anesthetic technique in the inpatient and day patient setting.

Establishing Priorities for the International Confederation of Plastic Surgery Societies.

BACKGROUND: The mission of the International Confederation of Plastic Surgery Societies (ICOPLAST) is to improve patient outcomes through collaboratively structured processes in education, advocacy and communication. This article explains how we approached the task of establishing priorities for this nascent confederation in an equitable and achievable manner. METHODS: In late 2016, an online survey was sent to the inaugural 62 ICOPLAST member national societies for dissemination to their respective plastic surgeon members. Functional domains and proposed initiatives were ranked according to their level of importance by individual plastic surgeons. RESULTS: The survey was completed by 572 plastic surgeons. As a functional domain, education was highly ranked by 75.3% of respondents, followed by patient safety (67.4%), communication (59.3%), humanitarian (46.6%), regulation (41.2%), and advocacy (41.1%). Respondents also ranked individual initiatives within each domain to produce a compilation list of the top 13 initiatives of importance. CONCLUSION: This study has identified priorities of importance to ICOPLAST members, which will aid in building a strategic framework and enhancing outcomes for patients, plastic surgeons, and the field of plastic surgery more broadly.

High risk device registries: Global value, costs, and sustainable funding.

BACKGROUND: Well-designed implant registries have been shown to be a worthwhile investment, from both a health and economic perspective. However, many registries do not attain desirable capture rates or lack sufficient funding, potentially leading to premature termination. This study aims to provide information about rarely discussed, yet pivotal topics regarding the long-term survival of implant registries, focusing on costs, funding models, and the role of stakeholders. METHODS: Worldwide, relatively recently developed breast device (BD) registries were compared to long-standing, orthopaedic (OD) and cardiovascular device (CD) registries. A standardised questionnaire was sent to the registries' designated representatives with key positions, discussing start-up costs, costs of maintenance, value of investment, governance, stakeholders, funding, and sustainability. RESULTS: Thirteen registries were included, originating from nine countries (seven BD registries, five OD registries, one CD registry). In general, start-up costs were comparable, and younger registries were more expensive to maintain. Numerous stakeholders showed interest in registry outcomes. However, only 50% of the registries reported a sustainable funding structure. CONCLUSION: This study provides a global perspective on implantable device registries. All registries provided important information, serving three unique purposes by evaluating the quality of healthcare provided, the quality of all registered devices, and processing recall information. Yet, only half of the registries were certain of sustainable funding, and thus their future existence. It is of utmost importance to bring this to the attention of all parties involved.