Interpretation of ambiguous TP53 test results: Mosaicism, clonal hematopoiesis, and variants of uncertain significance.

The increased use of next-generation sequencing has led to the detection of pathogenic TP53 variants in the germline setting in patients without a personal or family history consistent with Li-Fraumeni syndrome (LFS). These variants can represent low-penetrance LFS, mosaic LFS, or clonal hematopoiesis of indeterminate potential. Additionally, TP53 variants of uncertain significance can be detected in patients with a history suspicious for LFS. The interpretation of the significance of these variants can be challenging but is crucial for an accurate diagnosis and appropriate medical management. This retrospective case review provides illustrative examples of the interpretation of challenging TP53 results through multidisciplinary expertise and use of a flowchart. The authors describe eight patients with TP53 variants associated with ambiguous diagnoses and, for each case, describe how the results were interpreted and the medical care that was implemented. This report presents illustrative cases to help guide clinicians to reach definitive diagnoses for patients when confronted with TP53 variants that are inconsistent with the clinical picture and to add to the body of literature regarding interpretation and medical management of TP53 variants discovered on germline testing.

Examining disparities in large-scale patient-reported data capture using digital tools among cancer patients at clinical intake.

BACKGROUND: Patient-reported data can improve quality of healthcare delivery and patient outcomes. Moffitt Cancer Center ("Moffitt") administers the Electronic Patient Questionnaire (EPQ) to collect data on demographics, including sexual orientation and gender identity (SOGI), medical history, cancer risk factors, and quality of life. Here we investigated differences in EPQ completion by demographic and cancer characteristics. METHODS: An analysis including 146,142 new adult patients at Moffitt in 2009-2020 was conducted using scheduling, EPQ and cancer registry data. EPQ completion was described by calendar year and demographics. Logistic regression was used to estimate associations between demographic/cancer characteristics and EPQ completion. More recently collected information on SOGI were described. RESULTS: Patient portal usage (81%) and EPQ completion rates (79%) were consistently high since 2014. Among patients in the cancer registry, females were more likely to complete the EPQ than males (odds ratio [OR] = 1.17, 95% confidence interval [CI] = 1.14-1.20). Patients ages 18-64 years were more likely to complete the EPQ than patients aged ≥65. Lower EPQ completion rates were observed among Black or African American patients (OR = 0.59, 95% CI = 0.56-0.63) as compared to Whites and among patients whose preferred language was Spanish (OR = 0.40, 95% CI = 0.36-0.44) or another language as compared to English. Furthermore, patients with localized (OR = 1.16, 95% CI = 1.12-1.19) or regional (OR = 1.16, 95% CI = 1.12-1.20) cancer were more likely to complete the EPQ compared to those with metastatic disease. Less than 3% of patients self-identified as being lesbian, gay, or bisexual and <0.1% self-identified as transgender, genderqueer, or other. CONCLUSIONS: EPQ completion rates differed across demographics highlighting opportunities for targeted process improvement. Healthcare organizations should evaluate data acquisition methods to identify potential disparities in data completeness that can impact quality of clinical care and generalizability of self-reported data.

Implementing Digital Scribes to Reduce Electronic Health Record Documentation Burden Among Cancer Care Clinicians: A Mixed-Methods Pilot Study.

PURPOSE: To address shortcomings of human scribes (eg, turnover), clinicians are considering digital scribes (DSs). To our knowledge, to date, no study has assessed DS implementation or clinician user experience in cancer centers. We assessed the DS's feasibility, acceptability, appropriateness, usability and its preliminary association on clinician well-being in a cancer center. We also identified implementation facilitators and barriers to DS use. METHODS: Using a mixed-methods longitudinal pilot study design, we implemented a DS at a cancer center. Data collection included surveys at baseline and 1 month after DS use and a semistructured interview with clinicians. The survey assessed demographics, Mini Z (workplace stress and burnout), sleep quality, and implementation outcomes (feasibility, acceptability, appropriateness, and usability). The interview assessed how the DS was used and its impacts on workflows and recommendations for future implementations of the DS. We used paired t tests to assess differences in Mini Z and sleep quality measures over time. RESULTS: Across nine survey responses and eight interviews, we found that although feasibility scores were slightly lower than our cutoff point (15.2 v 16.0), clinicians rated the DS as marginally acceptable (16.0) and appropriate (16.3). Usability was considered marginally usable (68.6 v 68.0). Although the DS did not significantly improve burnout (3.6 v 3.9, P = .081), it improved perceptions of having sufficient documentation time (2.1 v 3.6, P = .005). Clinicians identified suggestions for future implementations, including training needs and usability improvements. CONCLUSION: Our preliminary findings suggest that DS implementation is marginally acceptable, appropriate, and usable among cancer care clinicians. Individualized training and on-site support may improve implementation.

Are we there yet? Management baselines and biodiversity indicators for the protection and restoration of subtidal bivalve shellfish habitats.

Biodiversity loss and degradation of natural habitats is increasing at an unprecedented rate. Of all marine habitats, biogenic reefs created by once-widespread shellfish, are now one of the most imperilled, and globally scarce. Conservation managers seek to protect and restore these habitats, but suitable baselines and indicators are required, and detailed scientific accounts are rare and inconsistent. In the present study the biodiversity of a model subtidal habitat, formed by the keystone horse mussel Modiolus modiolus (L.), was analysed across its Northeast Atlantic biogeographical range. Consistent samples of 'clumped' mussels were collected at 16 locations, covering a wide range of environmental conditions. Analysis of the associated macroscopic biota showed high biodiversity across all sites, cumulatively hosting 924 marine macroinvertebrate and algal taxa. There was a rapid increase in macroinvertebrate biodiversity (H') and community evenness (J) between 2 and 10 mussels per clump, reaching an asymptote at mussel densities of 10 per clump. Diversity declined at more northern latitudes, with depth and in coarser substrata with the fastest tidal flows. Diversity metrics corrected for species abundance were generally high across the habitats sampled, with significant latitudinal variability caused by current, depth and substrate type. Faunal community composition varied significantly between most sites and was difficult to assign to a 'typical' M. modiolus assemblage, being significantly influenced by regional environmental conditions, including the presence of algal turfs. Within the context of the rapid global increase in protection and restoration of bivalve shellfish habitats, site and density-specific values of diversity are probably the best targets for conservation management and upon which to base monitoring programmes.

Oncology Providers' and Professionals' Experiences With Suicide Risk Screening Among Patients With Head and Neck Cancer: A Qualitative Study.

PURPOSE: There has been limited study of the implementation of suicide risk screening for patients with head and neck cancer (HNC) as a part of routine care. To address this gap, this study assessed oncology providers' and professionals' perspectives about barriers and facilitators of implementing a suicide risk screening among patients with HNC. MATERIALS AND METHODS: All patients with HNC with an in-person visit completed a suicide risk screening on an electronic tablet. Patients reporting passive death wish were then screened for active suicidal ideation and referred for appropriate intervention. Interviews were conducted with 25 oncology providers and professionals who played a key role in implementation including nurses, medical assistants, patient access representatives, advanced practice providers, physicians, social workers, and informatics staff. The interview guide was based on the Consolidated Framework for Implementation Research. Interviews were transcribed and analyzed for themes. RESULTS: Participants identified multilevel implementation barriers, such as intervention level (eg, patient difficulty with using a tablet), process level (eg, limited nursing engagement), organizational level (eg, limited clinic Wi-Fi connectivity), and individual level (eg, low clinician self-efficacy for interpreting and acting upon patient-reported outcome scores). Participants noted facilitators, such as effective care coordination across nursing and social work staff and the opportunity for patients to be screened multiple times. Participants recommended strengthening patient and clinician education and providing patients with other modalities for data entry (eg, desktop computer in the waiting room). CONCLUSION: Participants identified important intervention modifications that may be needed to optimize suicide risk screening in cancer care settings.

Benign goiters requiring thyroidectomy as the signal for PTEN hamartoma tumor syndrome diagnosis.

PTEN hamartoma tumor syndrome (PHTS) is a rare genetic cancer and tumor predisposition syndrome. Due to the wide spectrum of clinical manifestations and variable age at onset, the pathways leading to a PHTS diagnosis are difficult and highly variable. Many patients were found to have PHTS after a cancer diagnosis, missing the opportunity of prevention or enhanced cancer screening. This retrospective study evaluated a PHTS cohort followed in a high-risk surveillance clinic in a comprehensive cancer institution. A significant portion of the patients (60.9%, 14/23) had at least one cancer diagnosis (average age 34.6 years at diagnosis). A significant portion (78.3%, 18/23) were affected with clinically significant goiters (age 27.9 years), and many (60.9%, 14/23) had partial or total thyroidectomy (age 27.1 years). The average age at goiter diagnosis or thyroidectomy is younger than a cancer diagnosis. In 12 individuals who were affected with clinically significant goiter and cancer, all cancers were diagnosed after the thyroid disease (6.3 years). As clinically significant thyroid nodules in childhood or early young adulthood are common in PHTS, but uncommon for general population, these early onset thyroid nodules may alert the clinician to initiate PHTS-targeted evaluation and genetic testing.

GeneHome - a Novel Model to Deliver Care to Individuals with Genetic Predisposition to Cancer.

Genetic testing for hereditary cancer predisposition is more widely available, resulting in more patients being identified as carriers of pathogenic variants (PV) of cancer susceptibility genes. PV carriers may be at high risk for multiple cancers of different organ systems. Traditional high-risk cancer screening is often organ specific and conducted separately by specialists. However, with many genes associated with 3 or more types of cancer risks, coordination of such cancer screening can be overwhelming for patients and providers. At Moffitt Cancer Center (MCC), GeneHome clinic functions as a "home" to conduct and coordinate prevention, screening, counseling, and education for individuals carrying germline genetic PVs across the entire spectrum of cancer genes. The screening includes, but is not limited to, history review, physical examination, image studies, blood tests, urine tests, and endoscopy. GeneHome is a novel model for genetic high-risk cancer surveillance and has grown in 4 years since establishment. We sought to study various characteristics of the patient population it serves, common themes in referral patterns and evolution of the clinic since its inception. A total of 821 patients were seen over 42 months, encompassing PV carriers of 46 genes. Patients were 84.9% female and 13.3% male. Most PVs were of BRCA1 and BRCA2. Most patients had private insurance, and most were from Florida. Annual increase in patient visits was over 74.7% over the last year. Overall, GeneHome has been well accepted by providers and patients and is a valuable service for patients with a genetic predisposition to cancer.

Identification of Predictive Factors for Patient-Reported Outcomes in the Prospective Australian Breast Device Registry.

BACKGROUND: Patient-reported outcome measures (PROMs) are an important tool for evaluating outcomes following breast device procedures and are used by breast device registries. PROMs can assist with device monitoring through benchmarked outcomes but need to account for demographic and clinical factors that may affect PROM responses. OBJECTIVES: This study aimed to develop appropriate risk-adjustment models for the benchmarking of PROM data to accurately track device outcomes and identify outliers in an equitable manner. METHODS: Data for this study were obtained from the Australian Breast Device Registry, which consists of a large prospective cohort of patients with primary breast implants. The 5-question BREAST-Q implant surveillance module was used to assess PROMs at 1 year following implant insertion. Logistic regression models were used to evaluate associations between demographic and clinical characteristics and PROMs separately by implant indication. Final multivariate risk-adjustment models were built sequentially, assessing the independent significant association of these variables. RESULTS: In total, 2221 reconstructive and 12,045 aesthetic primary breast implants with complete 1-year follow-up PROMs were included in the study. Indication for operation (post-cancer, risk reduction, or developmental deformity) was included in the final model for all reconstructive implant PROMs. Site type (private or public hospital) was included in the final breast reconstruction model for look, rippling, and tightness. Age at operation was included in the reconstruction models for rippling and tightness and in the aesthetic models for look, rippling, pain, and tightness. CONCLUSIONS: These multivariate models will be useful for equitable benchmarking of breast devices by PROMs to help track device performance.

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.

Grouping Hypotheses and an Integrated Approach to Testing and Assessment of Nanomaterials Following Oral Ingestion.

The risk assessment of ingested nanomaterials (NMs) is an important issue. Here we present nine integrated approaches to testing and assessment (IATAs) to group ingested NMs following predefined hypotheses. The IATAs are structured as decision trees and tiered testing strategies for each decision node to support a grouping decision. Implications (e.g., regulatory or precautionary) per group are indicated. IATAs integrate information on durability and biopersistence (dissolution kinetics) to specific hazard endpoints, e.g., inflammation and genotoxicity, which are possibly indicative of toxicity. Based on IATAs, groups of similar nanoforms (NFs) of a NM can be formed, such as very slow dissolving, highly biopersistent and systemically toxic NFs. Reference NMs (ZnO, SiO2 and TiO2) along with related NFs are applied as case studies to testing the oral IATAs. Results based on the Tier 1 level suggest a hierarchy of biodurability and biopersistence of TiO2 > SiO2 > ZnO, and are confirmed by in vivo data (Tier 3 level). Interestingly, our analysis suggests that TiO2 and SiO2 NFs are able to induce both local and systemic toxicity along with microbiota dysbiosis and can be grouped according to the tested fate and hazard descriptors. This supports that the decision nodes of the oral IATAs are suitable for classification and assessment of the toxicity of NFs.

Using Log Data to Measure Provider EHR Activity at a Cancer Center during Rapid Telemedicine Deployment.

OBJECTIVES: Accurate metrics of provider activity within the electronic health record (EHR) are critical to understand workflow efficiency and target optimization initiatives. We utilized newly described, log-based core metrics at a tertiary cancer center during rapid escalation of telemedicine secondary to initial coronavirus disease-2019 (COVID-19) peak onset of social distancing restrictions at our medical center (COVID-19 peak). These metrics evaluate the impact on total EHR time, work outside of work, time on documentation, time on prescriptions, inbox time, teamwork for orders, and undivided attention patients receive during an encounter. Our study aims were to evaluate feasibility of implementing these metrics as an efficient tool to optimize provider workflow and to track impact on workflow to various provider groups, including physicians, advanced practice providers (APPs), and different medical divisions, during times of significant policy change in the treatment landscape. METHODS: Data compilation and analysis was retrospectively performed in Tableau utilizing user and schedule data obtained from Cerner Millennium PowerChart and our internal scheduling software. We analyzed three distinct time periods: the 3 months prior to the initial COVID-19 peak, the 3 months during peak, and 3 months immediately post-peak. RESULTS: Application of early COVID-19 restrictions led to a significant increase of telemedicine encounters from baseline <1% up to 29.2% of all patient encounters. During initial peak period, there was a significant increase in total EHR time, work outside of work, time on documentation, and inbox time for providers. Overall APPs spent significantly more time in the EHR compared with physicians. All of the metrics returned to near baseline after the initial COVID-19 peak in our area. CONCLUSION: Our analysis showed that implementation of these core metrics is both feasible and can provide an accurate representation of provider EHR workflow adjustments during periods of change, while providing a basis for cross-vendor and cross-institutional analysis.

Nanomedicines and microneedles: a guide to their analysis and application.

The fast-advancing progress in the research of nanomedicine and microneedle applications in the past two decades has suggested that the combination of the two concepts could help to overcome some of the challenges we are facing in healthcare. They include poor patient compliance with medication and the lack of appropriate administration forms that enable the optimal dose to reach the target site. Nanoparticles as drug vesicles can protect their cargo and deliver it to the target site, while evading the body's defence mechanisms. Unfortunately, despite intense research on nanomedicine in the past 20 years, we still haven't answered some crucial questions, e.g. about their colloidal stability in solution and their optimal formulation, which makes the translation of this exciting technology from the lab bench to a viable product difficult. Dissolvable microneedles could be an effective way to maintain and stabilise nano-sized formulations, whilst enhancing the ability of nanoparticles to penetrate the stratum corneum barrier. Both concepts have been individually investigated fairly well and many analytical techniques for tracking the fate of nanomaterials with their precious cargo, both in vitro and in vivo, have been established. Yet, to the best of our knowledge, a comprehensive overview of the analytical tools encompassing the concepts of microneedles and nanoparticles with specific and successful examples is missing. In this review, we have attempted to briefly analyse the challenges associated with nanomedicine itself, but crucially we provide an easy-to-navigate scheme of methods, suitable for characterisation and imaging the physico-chemical properties of the material matrix.

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.

The right place at the right time: Improving the odds of biogenic reef restoration.

Habitat restoration is an international priority. With this demand there is a need for ecological knowledge to underpin restoration projects to ensure their success and cost-effective delivery. This study is the first temperate marine restoration project to examine the role seasonality and location may have on restoration projects. The study found that the settlement of Serpula vermicularis, a rare biogenic reef forming species of conservation importance, was up to three times higher on materials deployed during July than other months. The results also found similar differences in settlement between restoration sites. These results suggest that the timing and location of a restoration effort could affect its overall success in the medium to long term. For the restoration of marine biogenic species of conservation importance, targeted spatial and temporal pre-restoration experiments can greatly increase a project's chance of success as well as making large-scale restoration programs more cost efficient.

Fiber type composition of contiguous palmaris longus and abductor pollicis brevis muscles: Morphological evidence of a functional synergy.

The palmaris longus (PL) tendon is used in surgical opponensplasty to restore functional hand movements in thenar paralysis. Although successful PL autologous tendon transfer has been attributed to an established synergistic relationship between the PL and abductor pollicis brevis (APB) muscles in vivo, this functional relationship may be dependent on the quality of their spatial relationship and properties of their constituent muscle fibers. The purpose was to compare the proportion of type I and type II muscle fibers in the APB based on its contiguous morphological relationship with the PL tendon for indirect insight into their functional synergy, contractile capacity, and digastric arrangement. Twenty-four contiguous PL and APB specimens were harvested from the upper limbs (12 right and 12 left) of twelve formalin-embalmed cadavers (mean age: 74 ± 10 years). The fiber type composition of these muscles was determined by labeling serial cross sections with myosin heavy chain (MyHC) type I and type II monoclonal antibodies. The PL consisted of a relatively heterogeneous fiber type composition irrespective of the presence of a discrete (type I: 41 ± 11%; type II: 55 ± 12%; hybrid: 4 ± 3%) or rudimentary (type I: 49 ± 10%; type II: 45 ± 9%; hybrid: 6 ± 4%) tendinous connection with the APB. The APB fascicles arranged contiguously with the PL through a discrete tendon had significantly greater proportions of type II fibers (41 ± 19%) compared to those with rudimentary PL connections (type II: 15 ± 8%). Therefore, the APB fascicles arranged in a digastric relationship with the PL may have the capacity to produce more powerful contractions than those with rudimentary PL tendons based on the known contractile properties of type II muscle fibers. Knowledge of the spatial relationship between the PL and thenar musculature prior to PL autologous tendon transfer may be a useful indicator of the quality of established synergy in vivo.

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.

TRIM28 congenital predisposition to Wilms' tumor: novel mutations and presentation in a sibling pair.

Wilms' tumor is the most common renal malignancy in children. In addition to staging, molecular risk stratification, such as loss of heterozygosity (LOH) in Chromosomes 1 and 16, is being increasingly used. Although genetic predisposition syndromes have been well-characterized in some Wilms' tumors, recent sequencing and biology efforts are expanding the classification of this malignancy. Here we present a case of siblings with remarkably similar presentations of bilateral Wilms' tumor at ∼12 mo of age. Thorough exam after the younger sibling was diagnosed did not reveal any signs to suggest one of the known Wilms' predisposition syndromes. Both were treated with standard therapies with good response and long-term sustained complete remission of 53 and 97 mo, respectively. Whole-exome sequencing was performed on a tumor sample from each patient and matched blood from one, revealing a shared truncation mutation of TRIM28 in all three samples with heterozygosity in the germline sample. TRIM28 loss has been recently implicated in early-stage Wilms' tumors with epithelioid morphology. These siblings expand the phenotype for presentation with multifocal disease with retained excellent response to standard therapy.

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.

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.