Pelvic floor procedures are associated with pain in some women, adversely affecting health-related quality of life (HRQoL). Current patient-reported outcome measures (PROMs) are inadequate for assessing pain following pelvic floor procedures. A new 16-item pain-specific PROM, the Pelvic Floor Procedure Pain Questionnaire (PPPQ), was developed to address this gap. This study aimed to undertake a psychometric assessment of the PPPQ through field testing and to understand its latent structure. The PPPQ was administered online to 103 adult women from pelvic mesh support groups who underwent pelvic floor surgery. Exploratory factor analysis (EFA) using principal axis factoring and Promax rotation was conducted to assess the PROM’s psychometric properties (i.e. structural validity, internal consistency), refine items, and explore the relationship between items. Most commonly, participants were aged 60–69 years (n = 46, 44.7

BACKGROUND:Medullary thyroid cancer (MTC) is a neuroendocrine tumor comprising approximately 1%-2% of all thyroid malignancies. The rarity and more aggressive biology of MTC requires robust sample sizes to enhance our understanding of this complex disease. Harmonization is the process of standardizing raw data from multiple sources, by resolving differences in format and terminology, to create a unified dataset that can be analyzed for a common purpose. The aim of this project was to assess the feasibility of collaboration, data mapping, and harmonization among clinical sites investigating MTC internationally. METHODS:The Maelstrom guidelines were used to perform retrospective data harmonization from three clinical networks in Australia and the Unites States for adult patients with MTC, between 2018 and 2021. Data received were categorized as an exact, close, or low match. Exact and close matches were combined to form a harmonized dataset. A logistic regression analysis was then performed to determine pre-operative factors associated with the presence of cervical lymph node metastases. RESULTS:Data were received from three separate clinical networks. This comprised 114 patients, 17 hospitals and 4674 data points. The completeness of data received ranged from 57.4% to 97.3%. Overall, 80.8% of data received were suitable for harmonization including basic demographics, basis of diagnosis, genetic testing (but not results), select clinical findings, pre-operative investigations, operative details, histopathology, and TNM staging. The prevalence of palpable lymph node involvement at presentation in the harmonized dataset was 15.8%. Younger patients (less than 55 years) and patients with abnormal nodes on ultrasound were strongly associated with cervical lymph node metastases. Conversely, patients with an incidental diagnosis of MTC had markedly lower odds of presenting with cervical lymph node metastases. CONCLUSION:Data mapping and harmonization across national and international sites is feasible and enables meaningful modeling that would not be possible with individual datasets. The Maelstrom guidelines provide a useful template regarding how to achieve this efficiently. This manuscript is a white paper for clinicians and researchers studying rare diseases, such as MTC, regarding how to share heterogeneous raw data and collaborate with other clinical sites.

Background Clinal Quality Registries (CQRs) often collect patient reported measures (PRMs) for the purpose of reporting these data to clinicians. By incorporating PRM data, CQRs and participating healthcare providers can gain a more comprehensive understanding of patient experiences and outcomes to inform both individual care and broader health service improvements. However, many CQRs do not routinely provide patient access to PRM data or report these data back to patients. Objectives To understand how PRMs captured in CQRs should be reported to patients, and to develop a guide for reporting registry-collected PRMs to this population. Methods First, a targeted literature review was undertaken, involving a structured search of the scientific literature to identify evidence on patient preferences regarding the reporting of PRMs. Data were extracted and managed using Microsoft Excel. Second, focus group discussions were conducted with 15 registry consumers to explore their PRM information needs, and preferences for how registry-collected PRM data should be reported. Results The literature review identified 23 studies and found that many patients preferred to receive their own PRM data. Access to these data helped them better understand their health, support discussions with clinicians, and feel more empowered in their care. Graphical displays and lay summaries were most preferred. Focus group participants also valued receiving aggregate reports and being informed about how their data were used and recommended clear terminology and accessible formats for diverse audiences. Conclusion Based on the findings from this study, we developed a guide with practical resources, examples, and guidance for CQRs on how to engage with patients in the PRMs’ reporting process. The goal of this document is to support transparency in PRMs reporting, patient engagement with CQRs, and the real-world use of this data for improving healthcare quality.

BACKGROUND:Breast implant surgery is a high-volume procedure, yet predicting device-related complications that require revision surgery remains challenging, with current registry-based methods lacking accuracy. We aimed to develop and validate machine learning (ML) models to predict revision owing to complications following primary breast implant surgery, using a large multi-centre data from the Australian Breast Device Registry (ABDR). METHODS:This cohort study analysed ABDR data from January 2012 to December 2023, including 106,413 cosmetic and 22,107 reconstructive primary implant procedures across 239 sites in Australia. Demographic, clinical, surgical, device-related and socioeconomic factors were evaluated. Separate ML models were developed for the cosmetic and reconstructive (further stratified by direct-to-implant and two-stage tissue expander-to-implant) cohorts. The primary outcome was revision surgery owing to any complications. Exploratory analyses were used to evaluate specific types of complications. Model performance was assessed using area under the receiver operating characteristic curve (AUC) and other metrics. RESULTS:In the cosmetic cohort, the random forest (RF) model achieved the highest performance (AUC = 0.92), with key predictors of complication revisions including implant manufacturer (Allergan), implant shell type (macrotextured) and older patient age. In the reconstructive cohort, the RF model similarly performed the best (AUC = 0.91), with implant manufacturer (Allergan), incision site, use of acellular dermal matrix, older age and concurrent mastectomy being significant predictors of complication revisions. Socioeconomic advantage was also positively associated with revision in both the groups. CONCLUSIONS:This large multi-centre study demonstrated that ML models can accurately predict revisions owing to complications following breast implant surgery, highlighting patient, surgical, device and contextual factors as key contributors. Integration of these models into registry workflows may help improve patient safety and regulatory oversight.

Background Despite widespread clinical use, the long-term performance of breast implants remains debated. Current evidence is limited by small sample sizes and inconsistent methodologies. National breast device registries provide valuable real-world data, yet their impact is constrained by heterogeneity in variable definitions, data structures, and analytical approaches. The International Collaboration of Breast Registry Activities (ICOBRA) initiative established a harmonized dataset utilized by several countries.Objectives Evaluate the implementation of the dataset of the ICOBRA across national registries, identify inconsistencies in data definitions and structures, and develop an updated international dataset supporting standardized, federated analyses.Methods Datasets from 5 national breast implant registries utilizing the harmonized dataset were systematically reviewed. Variations in data points and definitions were identified and discussed through a series of in-person and online consensus meetings. Structured voting was used to finalize revisions and establish the updated international core dataset.Results Key discrepancies were identified in the classification of surgical indications, inclusion of implant types, and variable definitions across registries. As a result, more than half of the original core variables required revision, reclassification, or removal to enable multinational analyses. A federated analysis model was proposed to accommodate privacy regulations and registry diversity while supporting standardized, risk-adjusted analyses.Conclusions The updated international breast implant registry dataset represents a crucial step toward integrated global surveillance. Together with standardized statistical methods within a federated data model, it enables robust pooled analyses without requiring uniform registry structures. Countries are encouraged to adopt the revised dataset and contribute to a collaborative framework that enhances patient safety through structured, large-scale data collection and analysis.Level of Evidence: 5 (Therapeutic) For image description, please refer to the figure legend and surrounding text.

Background Currently, no internationally recognised, evidence-based guiding document for implementing patient-reported measures (PRMs) in clinical registries (CRs) exists globally. Although preliminary recommendations exist for CRs in Australia, their applicability to international settings remains uncertain. This study aimed to understand current international practices, barriers and enablers to implementing PRMs in CRs and to obtain feedback on the Australian recommendations. Methodology : This study used an explanatory sequential mixed methods design. First, a list of international CRs was compiled from the academic literature, websites, annual reports, and collegial networks. A cross-sectional 34-question online survey was distributed to 66 registry contacts. Secondly, survey participants were invited to participate in semi-structured interviews. Quantitative and qualitative data were analysed using descriptive statistics and content analysis, respectively. Results Of the 66 registries surveyed, 36 (55%) responded, and personnel from 20 registries were interviewed. Based on the survey results, 21 (58.3%) registries were aware of existing guiding documents for PRMs implementation. Interviewees highlighted that digital, cost, funding, administrative, clinician participation, and legislative barriers were common impediments to PRMs implementation. However, sufficient resources, strategies for participation, and rewards were identified as enablers. Registries well received Australian recommendations; however, several amendments were proposed before their application in an international context. Conclusions A variation in approaches to PRMs implementation among CRs was identified. While registry-specific guiding documents are used, a generic guiding document for PRMs implementation in CRs is yet to be developed. Registries supported the need for an international guiding document, noting that a generic guide would substantially facilitate effective PRMs implementation in CRs globally.

To determine the incidence, timing, type, and indications for revisional surgery (defined as any operation performed after primary MBS up to 10 y). Understanding long-term reoperation rates is essential for patient counselling and service planning in metabolic bariatric surgery (MBS). While primary MBS is well established as the most effective treatment for severe obesity, revisional procedures are increasingly required due to weight regain, complications or intolerance of the index procedure. However, high-quality population-level data on revision risk after metabolic bariatric surgery is limited. We conducted a retrospective cohort study using prospectively collected data from the Australian and New Zealand Bariatric Surgery Registry. Patients undergoing primary MBS on or before December 31, 2023, were followed for up to 10 years. Kaplan-Meier analysis was conducted. 145,193 patients (median age 42 (IQR 33-50) years 78.7% female) underwent primary MBS. Over a median 5.6 y (IQR 2.9–8.1), 5,681 patients (4%) underwent a first revisional surgery (7.3 per 1,000 person-years; 95% CI, 7.1-7.4). The observed incidence was highest after AGB (28.7%; 46.7% reversals), followed by RYGB (4.8%; 94.8% corrective), OAGB (3.5%; 52.7% corrective) and SG (2.5%; 69.6% conversions). AGB revisions were mostly due to recurrent weight gain (13.3%) and port-related issues (12.7%); reflux was the most common reason after SG (29.1%) and OAGB (27.3%), while strictures were the most frequent indication following RYGB (23.4%). Incidence, type, and indication of revisional procedures differ from those of the primary procedure. These findings may guide patient decision-making and health system planning.

Objectives To identify existing guiding documents such as guidelines, frameworks, checklists and recommendations on implementing patient-reported outcome measures (PROMs) in clinical trials, clinical practice and clinical registries. Study design Scoping Review. Methods A literature search of five scientific databases was conducted from database inception to June 2024. Google Scholar and grey literature sites were searched to identify relevant guiding documents. Existing documentation, including guidelines, frameworks, checklists, and recommendations for implementing PROMs in clinical trials, practice, and clinical registries, was included. A narrative synthesis of selected publications was conducted. Results In total, 4905 records were identified and assessed for eligibility, and 177 publications underwent full-text screening, resulting in 38 guiding documents in this review. Of the 38, 18 (47 %) were guiding documents for PROMs use in clinical trials, 12 (32 %) in clinical practice, and eight (21 %) in clinical registries. Most guidelines and recommendations were on PROMs implementation in clinical trials and clinical practice, with only a few recommendations published for clinical registries. Conclusions This review mostly identified guiding documents for implementing PROMs in clinical trials and practice. There is a gap in the literature regarding guidelines for implementing PROMs in clinical registries. Given the growing recognition of clinical registries and PROMs data for healthcare quality improvement and patient-centred care, an evidence-based standard guideline to implement PROMs in clinical registries efficiently will be beneficial.

OBJECTIVE:To determine the incidence, timing, type, and indications for revisional surgery (defined as any operation performed after primary MBS up to 10 y). BACKGROUND:Understanding long-term reoperation rates is essential for patient counselling and service planning in metabolic bariatric surgery (MBS). While primary MBS is well established as the most effective treatment for severe obesity, revisional procedures are increasingly required due to weight regain, complications or intolerance of the index procedure. However, high-quality population-level data on revision risk after metabolic bariatric surgery is limited. METHODS:We conducted a retrospective cohort study using prospectively collected data from the Australian and New Zealand Bariatric Surgery Registry. Patients undergoing primary MBS on or before December 31, 2023, were followed for up to 10 years. Kaplan-Meier analysis was conducted. RESULTS:145,193 patients (median age 42 (IQR 33-50) years 78.7% female) underwent primary MBS. Over a median 5.6 y (IQR 2.9-8.1), 5,681 patients (4%) underwent a first revisional surgery (7.3 per 1,000 person-years; 95% CI, 7.1-7.4). The observed incidence was highest after AGB (28.7%; 46.7% reversals), followed by RYGB (4.8%; 94.8% corrective), OAGB (3.5%; 52.7% corrective) and SG (2.5%; 69.6% conversions). AGB revisions were mostly due to recurrent weight gain (13.3%) and port-related issues (12.7%); reflux was the most common reason after SG (29.1%) and OAGB (27.3%), while strictures were the most frequent indication following RYGB (23.4%). CONCLUSIONS:Incidence, type, and indication of revisional procedures differ from those of the primary procedure. These findings may guide patient decision-making and health system planning.

Background: There is increasing interest in the public reporting of health provider benchmarking within clinical registries to identify underperforming sites (also known as outliers). As such, research into the optimal methods and ideal conditions for outlier detection is important. Objective: The aim of this study was to assess the accuracy of benchmarking and outlier classification methods for different values of clinical registry sizes and case volume minimums. Method: Clinical registry datasets were parametrically simulated varying the following parameters: number of sites, clinicians, patients and outcome events, case volume minimum and outcome prevalence. Two benchmarking models (unadjusted and risk-adjusted with logistic regression) and two outlier classification techniques (confidence intervals and control limits) were applied to each simulated dataset. The accuracy of outlier flagging was assessed using the receiver operator characteristic area under the curve (ROCAUC). Results: Risk-adjusted benchmarking performed better than unadjusted benchmarking across the registry sizes evaluated, providing up to a 20% increase in ROCAUC. The number of sites and clinicians had little effect on performance, while higher accuracy with increasing number of patients per site and outcome prevalence was observed. A threshold of 100 to 150 outcome events per site was needed to reach >80% ROCAUC. Conclusion: The use of low prevalence outcomes for benchmarking hospitals to detect outliers may be inappropriate, especially for clinical registries with low patient volumes. Implications for health information management practice: Clinical registries should consider their patient volumes and outcome prevalence before commencing benchmarking analyses to determine if acceptable accuracy can be achieved for their setting.

Importance Despite the widespread use of breast implants, to date, no large-scale international studies on long-term revision incidence of different implant types have been conducted. Objective To determine whether international data could be combined using a harmonized dataset to increase power and investigate clinically relevant differences in complication-related revision incidence between breast implant types. Design, Setting, and Participants This multicenter, population-based cohort study used data from the Australian Breast Device Registry and the Dutch Breast Implant Registry from 2016 to 2021. Time-to-event analysis was performed using a frailty Cox proportional hazards regression model with pooled data. The study included all permanent breast implants that were inserted for primary postmastectomy or benign breast reconstruction or cosmetic augmentation. Data were analyzed from January 1, 2016, through December 31, 2021. Exposure Permanent breast implants grouped based on implant shape, shell, and fill. Main outcomes and measures Complication-related revision incidence between breast implant types. Results Data exchange between registries was successful. In total, 21 115 reconstructive and 129 854 cosmetic breast implants inserted in patients with a median (IQR) age of 47 (38-55) years and 31 (25-38) years, respectively, were included. Overall complication-related revision was 6.3% for reconstructive and 1.2% for cosmetic implants. For reconstructive implants, hazard ratios (HRs) for implant types showed no significant differences compared with anatomical textured-silicone implants. For cosmetic implants, anatomical polyurethane-silicone implants showed a lower risk of revision (HR, 0.38; 95% CI, 0.22-0.64) compared with anatomical-textured-silicone implants. At 5 years, no significant differences in cumulative revision incidence were observed between implant types for either reconstructive or cosmetic implants. Conclusions and relevance This study showed that international datasets can be pooled to assess real-world incidence of breast implant revision, which is anticipated to generate a foundation on which future breast implant studies can be based.

BACKGROUND:Although clinical quality registries have been established worldwide to monitor cardiothoracic surgery outcomes through benchmarking to detect underperforming hospitals (outliers) and improve quality of care, the accuracy of such analyses remains unclear. This study aimed to compare and evaluate methods of outlier classification when applied to real-world and simulated data. METHODS:Data relating to isolated coronary artery bypass graft procedures were obtained from the Australian and New Zealand Society of Cardiac and Thoracic Surgeons Cardiac Surgery Database registry. Unadjusted and risk-adjusted operative mortality and new renal insufficiency were the key outcomes evaluated for two timeframes: cumulative (2018-2021) and rolling (2022); additional data were parametrically generated to simulate these datasets. Agreement in outlier flagging was compared between variations of control limit and confidence interval methods when applied to the real data, and the expected accuracy of the methods evaluated using the simulated data. RESULTS:While outlier flagging was similar between techniques, agreement between different risk-adjustment, timeframes and significance levels were moderate to poor. The expected accuracy of outlier classification also differed between these considerations, with high performance only reached for risk-adjusted outcomes using cumulative data. Of the methods, outliers flagged using exact binomial 95 % control limits had the highest accuracy. CONCLUSIONS:Clinical registries should consider their data parameters before commencing benchmarking to detect underperforming sites. To optimise accuracy of outlier flagging, outcomes should be risk-adjusted, cumulative datasets should be used in the case of low patient volumes and, where possible, outcomes with higher prevalence should be evaluated.

Existing literature has identified inequalities in incidence and health outcomes between urban and rural populations with Alzheimer's disease (AD), however, potential disparities in the diagnostic process are poorly understood. We aimed to investigate differences in the diagnostic pathway – including the completion of key diagnostic investigations and diagnostic wait times – among individuals with all-cause mild cognitive impairment (MCI) or dementia due to AD residing in rural and urban Australia. We conducted a cross-sectional study using data from the Australia Dementia Network (ADNeT) Registry. Patients diagnosed with all-cause MCI or AD dementia between registry commencement (March 2020) and December 2023 were included. Participants were categorised into three geographic groups – Major Cities (urban), Inner Regional, Outer Regional (both rural) – based on patient postcode (or clinic postcode if unavailable). Logistic and quantile regression models were used to investigate associations between rural/urban residence and the clinical diagnostic pathway. We identified 3,648 patients, 1,455(39.88%) with all-cause MCI and 2,193(60.12%) with dementia due to AD. Participants in inner regional areas were more likely (odds ratio [OR]=1.55; 95% confidence interval [CI]=1.14,2.13; p  = 0.006) to have had more basic diagnostic investigations completed (including core blood tests, cognitive assessments, functional assessments, structural neuroimaging) compared to those in major cities. However, participants in both inner regional (OR=0.37; 95% CI=0.28,0.48; p  <0.001) and outer regional (OR=0.32; 95% CI=0.21,0.48; p  <0.001) areas were less likely to have functional neuroimaging completed. Median wait times for an initial appointment following referral to a memory clinic were up to 28 days longer for rural compared to urban participants (Inner regional: Beta (median)=12.92; 95% CI=5.15,20.69; p  = 0.001; Outer regional: Beta (median)=27.50; 95% CI=18.80,36.20; p  <0.001). However, median wait times from initial appointment to diagnosis were up to 47 days shorter in rural compared to urban residents (Inner regional: Beta (median)=-46.83; 95% CI=-52.35,-41.32; p  <0.001; Outer regional: Beta (median)=-44.42; 95% CI=-50.35,-38.49; p  <0.001). Findings suggest disparities in access to advanced diagnostic investigations and timely initial appointments across rural Australia. These inequalities may preclude access to timely post-diagnostic services and exacerbate existing barriers to access novel disease modifying therapies which often require advanced diagnostic investigations such as functional neuroimaging.

ABSTRACT Background The aim of this study was to develop a template for a synoptic operative report (SOR), for thyroid surgical data, and improve interdisciplinary communication and collaboration. Methods Twenty‐five expert endocrine surgeons, endocrinologists, surgical oncology, and ear‐nose‐and‐throat surgeons were invited to participate in a modified Delphi process. Initial domains for consideration were determined from literature review and were compatible with domains previously endorsed by the American Thyroid Association. Consensus for individual variables was predefined as mean > 70th percentile and a low disagreement index (< 1.0). An academic working party reviewed the indeterminate domains to reach a final consensus. Results Of 25 invited, 24 participated in the study. Two rounds of questionnaires were conducted. Consensus was reached for 39 data elements across five domains and were included in the final SOR template. A further eight data elements were shortlisted for inclusion in a secondary list of desirable but optional data elements. Conclusion We developed a consensus‐derived SOR for thyroid surgery. Future studies are required to review the uptake and utility of this template in a clinical setting. There is a literary void regarding the role of SOR for parathyroid and adrenal surgery and this could be approached with similar methodology.

BACKGROUND:Women undergoing pelvic floor procedures (PFPs) to treat their pelvic floor disorder (PFD) may experience pain, affecting their health-related quality of life. Current patient-reported outcome measures (PROMs) assess pain but are not specific to PFD post-surgery. This study was part of developing a new pain-specific PROM for women following PFP, aimed to (1) refine an existing conceptual framework to better understand post- post-PFP in women, (2) draft potential items, and (3) develop a consensus set of items for the new measure to ensure content validity. METHODS:A mixed-methods approach was used to address the aim in three phases: (1) refining an existing conceptual framework for post-PFP pain based on feedback from semi-structured interviews with 16 women, (2) drafting potential items based on the revised framework, and (3) conducting an online two-round Delphi survey with 17 experts ranked to rank, review items, then produce a consensus set. RESULTS:The interviews conducted identified key attributes of pain that need to be addressed in the new pain instrument for PFP. From the interviews, 114 items were drafted under eight framework domains, and then presented to a panel in the Delphi survey. After two Delphi rounds, 35 items were finalised, with 11 equally merged or deleted, resulting in a final set of 35 items. CONCLUSION:This is the first study to develop a set of items for the new pain measure based on the experiences and expertise of women and clinicians. Inclusion of the items can offer valuable insight into pain after PFP.

BACKGROUND:Patient Reported Outcome Measures (PROMs) are increasingly being introduced in clinical registries. The Australasian Pelvic Floor Procedure Registry (APFPR) is a clinical quality registry which records information about procedures for stress urinary incontinence and pelvic organ prolapse. This study aimed to determine the feasibility of capturing PROMs in women with pelvic floor disorders (PFDs) identified via the APFPR, using various modes and methods of administration. METHODS:We administered the Australian Pelvic Floor Questionnaire (APFQ) in women with PFDs prior to surgery (baseline) and 6 months post-surgery through a combination of email, postal mail, SMS and telephone. The study was carried out from July 2022 to May 2023. Results were reported descriptively, as number and proportion for PROMs response rates and data completeness, and as a mean and standard deviation (SD) for the APFQ scores. RESULTS:The APFQ was administered to 140 patients at baseline and to 112 post-surgery. The baseline PROMs response rates were high (75%), but decreased to 56% at follow up. The overall APFQ completeness was ~98%. The APFQ dysfunction scores revealed a significant improvement at 6 months (mean [SD] score at baseline = 14.5 [5.7], 6 months = 11.4 [6.5], p ≤ 0.001). Significant improvement in the bladder and prolapse domains (p ≤ 0.001) were particularly observed. CONCLUSION:The results showed an overall improvement in quality of life scores at follow up. The APFQ data completeness was high and response rates were satisfactory, suggesting that the APFQ was a suitable instrument for the APFPR.