Patient-Reported Outcome Measures in High-Risk Medical Device Registries: A Scoping Review.

Little is known about the methods and outcomes of patient-reported outcome measure (PROM) use among high-risk medical device registries. The objective of this scoping review was to assess the utility and predictive ability of PROMs in high-risk medical device registries. We searched Ovid Medline, Embase, APA PsychINFO, Cochrane Library, and Scopus databases for published literature. After searching, 4323 titles and abstracts were screened, and 262 full texts were assessed for their eligibility. Seventy-six papers from across orthopedic (n = 64), cardiac (n = 10), penile (n = 1), and hernia mesh (n = 1) device registries were identified. Studies predominantly used PROMs as an outcome measure when comparing cohorts or surgical approaches (n = 45) or to compare time points (n = 13) including pre- and postintervention. Fifteen papers considered the predictive ability of PROMs. Of these, 8 treated PROMs as an outcome, 5 treated PROMs as a risk factor through regression analysis, and 2 papers treated PROMs as both a risk factor and as an outcome. One paper described PROMs to study implant survival. To advance methods of PROM integration into clinical decision-making for medical devices, an understanding of their use in high-risk device registries is needed. This scoping review found that there is a paucity of studies using PROMs to predict long-term patient and clinical outcomes in high-risk medical device registries. Determination as to why PROMs are rarely used for predictive purposes in long-term data collection is needed if PROM data are to be considered suitable as real-world evidence for high-risk device regulatory purposes, as well as to support clinical decision-making.

National surveillance using a clinical quality indicator for prolonged antipsychotic use among older Australians with dementia who access aged care services.

OBJECTIVES: Dementia guidelines recommend antipsychotics are only used for behavioral and psychological symptoms when non-drug interventions fail, and to regularly review use. Population-level clinical quality indicators (CQIs) for dementia care in permanent residential aged care (PRAC) typically monitor prevalence of antipsychotic use but not prolonged use. This study aimed to develop a CQI for antipsychotic use >90 days and examine trends, associated factors, and variation in CQI incidence; and examine duration of the first episode of use among individuals with dementia accessing home care packages (HCPs) or PRAC. METHODS: Retrospective cohort study, including older individuals with dementia who accessed HCPs (n = 50,257) or PRAC (n = 250,196). Trends in annual CQI incidence (2011-12 to 2015-16) and associated factors were determined using Poisson regression. Funnel plots examined geographical and facility variation. Time to antipsychotic discontinuation was estimated among new antipsychotic users accessing HCP (n = 2367) and PRAC (n = 15,597) using the cumulative incidence function. RESULTS: Between 2011-12 and 2015-16, antipsychotic use for >90 days decreased in HCP recipients from 10.7% (95% CI 10.2-11.1) to 10.1% (95% CI 9.6-10.5, adjusted incidence rate ratio (aIRR) 0.97 (95% CI 0.95-0.98)), and in PRAC residents from 24.5% (95% CI 24.2-24.7) to 21.8% (95% CI 21.5-22.0, aIRR 0.97 (95% CI 0.96-0.98)). Prior antipsychotic use (both cohorts) and being male and greater socioeconomic disadvantage (PRAC cohort) were associated with higher CQI incidence. Little geographical/facility variation was observed. Median treatment duration in HCP and PRAC was 334 (interquartile range [IQR] 108-958) and 555 (IQR 197-1239) days, respectively. CONCLUSIONS: While small decreases in antipsychotic use >90 days were observed between 2011-12 and 2015-16, findings suggest antipsychotic use among aged care recipients with dementia can be further minimized.

Comparing Patient-Reported Outcome Measures for Pain in Women With Pelvic Floor Disorders: A Scoping Review.

Women with pelvic floor disorders (PFDs) typically undergo surgery involving transvaginal mesh implants; however, transvaginal mesh surgery is associated with many adverse events including post-surgical pain. Assessment of pain as a symptom is necessary using patient-reported outcome measures (PROMs). This scoping review aimed to describe and compare existing PROMs previously used to measure pain in women with PFDs. A scoping search of Ovid MEDLINE, EMBASE, CINAHL Plus, Ovid PsycInfo, and grey literature was conducted. Studies published in English describing the development, implementation, and application of PFD-associated pain PROMs among adult women before and after pelvic floor surgery were included. From each article, a descriptive summary organised by study first author, publication year, country, setting, aim, study characteristics, and results were extracted. From 2,604 articles identified, 54 studies were included, describing 44 PROMs. Most studies described at least 2 to 3 instruments. The Pelvic Floor Distress Inventory-20 was most commonly described by 12 studies followed by the Patient Global Impression of Improvement scale. Of the 44 PROMs, 27 were condition-specific, of which 9 included items on pain; 17 generic PROMs, 4 of which contained items on pain; and 6 pain-specific PROMs. PROMs identified in our review measured pain not related to PFDs or pelvic floor surgery and quantified the pain experienced. These PROMs did not measure all areas of pain including region, sensation, impact, and triggers. The findings of this review will assist with developing a new pain-specific PROM in this population. PERSPECTIVE: Women with pelvic floor disorders often undergo surgery involving transvaginal mesh, from which they experience debilitating pain. Pain is a major issue impacting women's lives. Patient-reported outcome measures can be used to assess the pain; however, it is unclear whether existing instruments are relevant.

Clinical Quality Indicators for Monitoring Hospitalizations Among Older People with Dementia Accessing Aged Care Services.

BACKGROUND: There is a need for clinical quality indicators (CQIs) that can be applied to dementia quality registries to monitor care outcomes for people with Alzheimer's disease and other forms of dementia. OBJECTIVE: To develop tertiary and primary care-based dementia CQIs for application to clinical registries for individuals with dementia accessing aged care services and determine 1) annual trends in CQI incidence between 2011-2012 and 2015-2016, 2) associated factors, and 3) geographic and facility variation in CQI incidence. METHODS: This retrospective repeated cross-sectional study included non-Indigenous individuals aged 65-105 years who lived with dementia between July 2008-June 2016, were assessed for government-funded aged care services, and resided in New South Wales or Victoria (n = 180,675). Poisson or negative binomial regression models estimated trends in annual CQI incidence and associated factors. Funnel plots examined CQI variation. RESULTS: Between 2011-2012 and 2015-2016, CQI incidence increased for falls (11.0% to 13.9%, adjusted incidence rate ratio (aIRR) 1.05 (95% CI 1.01-1.06)) and delirium (4.7% to 6.7%, aIRR 1.09 (95% CI 1.07-1.10)), decreased for unplanned hospitalizations (28.7% to 27.9%, aIRR 0.99 (95% CI 0.98-0.99)) and remained steady for fracture (6.2% to 6.5%, aIRR 1.01 (95% CI 0.99-1.01)) and pressure injuries (0.5% to 0.4%, aIRR 0.99 (95% CI 0.96-1.02)). Being male, older, having more comorbidities and living in a major city were associated with higher CQI incidence. Considerable geographical and facility variation was observed for unplanned hospitalizations and delirium CQIs. CONCLUSIONS: The CQI results highlighted considerable morbidity. The CQIs tested should be considered for application in clinical quality registries to monitor dementia care quality.

Informing a national rare disease registry strategy in Australia: a mixed methods study.

BACKGROUND: Rare disease registries (RDRs) facilitate monitoring of rare diseases by pooling small datasets to increase clinical and epidemiological knowledge of rare diseases and promote patient centred best practice. The aim of this study was to understand the current state of RDRs in Australia, data captured, impact on patient outcomes, funding models, and barriers and enablers regarding their establishment and maintenance. METHODS: An exploratory sequential mixed methods study design was adopted. First, a list of Australian RDRs, primary contacts and data custodians was generated through online and consumer group (Rare Voices Australia (RVA)) contacts. A cross-sectional, anonymous online survey was distributed to registry custodians, managers, or principal investigators of 74 identified Australian RDRs, 88 RVA Partners, 17 pharmaceutical organizations and 12 RVA Scientific and Medical Advisory Committee members. Next, managers and coordinators of RDRs and databases who participated in the survey were invited to participate in semi-structured interviews. Quantitative and qualitative data were analysed using basic descriptive statistics and content analysis, respectively. RESULTS: Forty RDRs responded to the survey; nine were national, five were based in Australia and New Zealand, and the remaining were global. Of the 40 survey respondents, eight were interviewed. Most of the RDRs captured similar information regarding patient characteristics, comorbidities and clinical features, diagnosis, family history, genetic testing, procedures or treatment types, response to treatments and complications of treatments. Better treatment outcomes, changes in process of care and changes in quality of care were the most frequently reported benefits of the RDRs. The main challenges proved to be cost/funding of data collection, data completeness, and patient consent. When asked, the participants identified opportunities and challenges regarding potential options to streamline RDRs in Australia in the future. CONCLUSION: Findings from this study highlighted significant dataset heterogeneity based on the individual disease, and current lack of interoperability and coordination between different existing RDRs in Australia. Nevertheless, a nationally coordinated approach to RDRs should be investigated given the particular benefits RDRs offer, such as access to research and the monitoring of new disease-modifying treatments.

Tackling Dementia Together via The Australian Dementia Network (ADNeT): A Summary of Initiatives, Progress and Plans.

In 2018, the Australian Dementia Network (ADNeT) was established to bring together Australia's leading dementia researchers, people with living experience and clinicians to transform research and clinical care in the field. To address dementia diagnosis, treatment, and care, ADNeT has established three core initiatives: the Clinical Quality Registry (CQR), Memory Clinics, and Screening for Trials. Collectively, the initiatives have developed an integrated clinical and research community, driving practice excellence in this field, leading to novel innovations in diagnostics, clinical care, professional development, quality and harmonization of healthcare, clinical trials, and translation of research into practice. Australia now has a national Registry for Mild Cognitive Impairment and dementia with 55 participating clinical sites, an extensive map of memory clinic services, national Memory and Cognition Clinic Guidelines and specialized screening for trials sites in five states. This paper provides an overview of ADNeT's achievements to date and future directions. With the increase in dementia cases expected over coming decades, and with recent advances in plasma biomarkers and amyloid lowering therapies, the nationally coordinated initiatives and partnerships ADNeT has established are critical for increased national prevention efforts, co-ordinated implementation of emerging treatments for Alzheimer's disease, innovation of early and accurate diagnosis, driving continuous improvements in clinical care and patient outcome and access to post-diagnostic support and clinical trials. For a heterogenous disorder such as dementia, which is now the second leading cause of death in Australia following cardiovascular disease, the case for adequate investment into research and development has grown even more compelling.

Evaluations of statistical methods for outlier detection when benchmarking in clinical registries: a systematic review.

OBJECTIVES: Benchmarking is common in clinical registries to support the improvement of health outcomes by identifying underperforming clinician or health service providers. Despite the rise in clinical registries and interest in publicly reporting benchmarking results, appropriate methods for benchmarking and outlier detection within clinical registries are not well established, and the current application of methods is inconsistent. The aim of this review was to determine the current statistical methods of outlier detection that have been evaluated in the context of clinical registry benchmarking. DESIGN: A systematic search for studies evaluating the performance of methods to detect outliers when benchmarking in clinical registries was conducted in five databases: EMBASE, ProQuest, Scopus, Web of Science and Google Scholar. A modified healthcare modelling evaluation tool was used to assess quality; data extracted from each study were summarised and presented in a narrative synthesis. RESULTS: Nineteen studies evaluating a variety of statistical methods in 20 clinical registries were included. The majority of studies conducted application studies comparing outliers without statistical performance assessment (79%), while only few studies used simulations to conduct more rigorous evaluations (21%). A common comparison was between random effects and fixed effects regression, which provided mixed results. Registry population coverage, provider case volume minimum and missing data handling were all poorly reported. CONCLUSIONS: The optimal methods for detecting outliers when benchmarking clinical registry data remains unclear, and the use of different models may provide vastly different results. Further research is needed to address the unresolved methodological considerations and evaluate methods across a range of registry conditions. PROSPERO REGISTRATION NUMBER: CRD42022296520.

Current state of rare disease registries and databases in Australia: a scoping review.

BACKGROUND: Rare diseases (RDs) affect approximately 8% of all people or > 400 million people globally. The Australian Government's National Strategic Action Plan for Rare Diseases has identified the need for a national, coordinated, and systematic approach to the collection and use of RD data, including registries. Rare disease registries (RDRs) are established for epidemiological, quality improvement and research purposes, and they are critical infrastructure for clinical trials. The aim of this scoping review was to review literature on the current state of RDRs in Australia; to describe how they are funded; what data they collect; and their impact on patient outcomes. METHODS: We conducted a literature search on MEDLINE, EMBASE, CINAHL and PsychINFO databases, in addition to Google Scholar and grey literature. Dissertations, government reports, randomised control trials, conference proceedings, conference posters and meeting abstracts were also included. Articles were excluded if they did not discuss RDs or if they were written in a language other than English. Studies were assessed on demographic and clinical patient characteristics, procedure or treatment type and health-related quality of life captured by RDRs or databases that have been established to date. RESULTS: Seventy-four RDRs were identified; 19 were global registries in which Australians participated, 24 were Australian-only registries, 10 were Australia and New Zealand based, and five were Australian jurisdiction-based registries. Sixteen "umbrella" registries collected data on several different conditions, which included some RDs, and thirteen RDRs stored rare cancer-specific information. Most RDRs and databases captured similar types of information related to patient characteristics, comorbidities and other clinical features, procedure or treatment type and health-related quality of life measures. We found considerable heterogeneity among existing RDRs in Australia, especially with regards to data collection, scope and quality of registries, suggesting a national coordinated approach to RDRs is required. CONCLUSION: This scoping review highlights the current state of Australian RDRs, identifying several important gaps and opportunities for improvement through national coordination and increased investment.

A Systematic Review of Areal Units and Adjacency Used in Bayesian Spatial and Spatio-Temporal Conditional Autoregressive Models in Health Research.

Advancements in Bayesian spatial and spatio-temporal modelling have been observed in recent years. Despite this, there are unresolved issues about the choice of appropriate spatial unit and adjacency matrix in disease mapping. There is limited systematic review evidence on this topic. This review aimed to address these problems. We searched seven databases to find published articles on this topic. A modified quality assessment tool was used to assess the quality of studies. A total of 52 studies were included, of which 26 (50.0%) were on infectious diseases, 10 (19.2%) on chronic diseases, 8 (15.5%) on maternal and child health, and 8 (15.5%) on other health-related outcomes. Only 6 studies reported the reasons for using the specified spatial unit, 8 (15.3%) studies conducted sensitivity analysis for prior selection, and 39 (75%) of the studies used Queen contiguity adjacency. This review highlights existing variation and limitations in the specification of Bayesian spatial and spatio-temporal models used in health research. We found that majority of the studies failed to report the rationale for the choice of spatial units, perform sensitivity analyses on the priors, or evaluate the choice of neighbourhood adjacency, all of which can potentially affect findings in their studies.

The Mandatory German Breast Implant Registry Law: A Model for Sustainable Implant Registries.

BACKGROUND: Recurrent scandals involving breast implants have revealed that scientific evidence on the performance of these devices is lacking, and passive monitoring systems are not capable of detecting problems at an early stage. The German health authorities therefore decided to implement a prospective, mandatory registry. OBJECTIVES: The aim of this article was to provide information about the advantages of implementing a mandatory registry, the potential hurdles involved, and to establish structural requirements that future registries can use. METHODS: Since 2018, the authors have assisted the German Ministry of Health in refining the Implant Law and its implementation. They adapted an internationally consented dataset, promoted international data amplification and conducted monthly trial inputs for over 2 years. By identifying several key issues they were able to assist in developing solutions. RESULTS: The cooperation with the authorities was characterized by appreciation of the authors' expertise and previous international work. Challenges included data privacy issues, federal competence, longitudinal follow-up, and contact data; as well as associated costs and technical solutions for data inclusion and the use of information technology to communicate with stakeholders. Addressing these challenges required considerable interference with personal rights and complementary measures for all stakeholders. Extensive structural precautions were taken to safeguard personal data privacy as far as possible. CONCLUSIONS: The authors' experience and lessons learned can guide registries seeking to engage in high levels of evidence data. The authors describe their approach, the obstacles they encountered, and the strategies employed to overcome the setbacks of other registries.

Response rates in clinical quality registries and databases that collect patient reported outcome measures: a scoping review.

BACKGROUND: Patient Reported Outcome Measures (PROMs) are being increasingly introduced in clinical registries, providing a personal perspective on the expectations and impact of treatment. The aim of this study was to describe response rates (RR) to PROMs in clinical registries and databases and to examine the trends over time, and how they change with the registry type, region and disease or condition captured. METHODS: We conducted a scoping literature review of MEDLINE and EMBASE databases, in addition to Google Scholar and grey literature. All English studies on clinical registries capturing PROMs at one or more time points were included. Follow up time points were defined as follows: baseline (if available), < 1 year, 1 to < 2 years, 2 to < 5 years, 5 to < 10 years and 10 + years. Registries were grouped according to regions of the world and health conditions. Subgroup analyses were conducted to identify trends in RRs over time. These included calculating average RRs, standard deviation and change in RRs according to total follow up time. RESULTS: The search strategy yielded 1,767 publications. Combined with 20 reports and four websites, a total of 141 sources were used in the data extraction and analysis process. Following the data extraction, 121 registries capturing PROMs were identified. The overall average RR at baseline started at 71% and decreased to 56% at 10 + year at follow up. The highest average baseline RR of 99% was observed in Asian registries and in registries capturing data on chronic conditions (85%). Overall, the average RR declined as follow up time increased. CONCLUSION: A large variation and downward trend in PROMs RRs was observed in most of the registries identified in our review. Formal recommendations are required for consistent collection, follow up and reporting of PROMs data in a registry setting to improve patient care and clinical practice. Further research studies are needed to determine acceptable RRs for PROMs captured in clinical registries.

Evaluation and acceptability of patient-reported outcome measures in women following pelvic organ prolapse procedures.

BACKGROUND: The Australasian Pelvic Floor Procedure Registry (APFPR) captures clinical and surgical data in women undergoing pelvic floor procedures. The inclusion of patient reported outcome measures (PROMs) in the APFPR is a critical activity providing the additional patient perspective of their condition prior to surgery as well as monitoring beyond the usual post-surgical follow-up time. This study aimed to evaluate the acceptability of seven PROMs for women with pelvic organ prolapse (POP) and to determine the most suitable instrument for the APFPR. METHODS: Semi-structured qualitative interviews were conducted with women with POP (n = 15) and their treating clinicians (n = 11) in Victoria, Australia. Interview topics covered appropriateness, content, and acceptability of seven POP-specific instruments identified through the literature to determine their suitability and acceptability for inclusion in the APFPR. We analysed the interview data using conventional content analysis. RESULTS: All study participants agreed that PROMs were needed for the APFPR. Both women and clinicians suggested that some of the instruments were ambiguous, too long and confusing. The Australian Pelvic Floor Questionnaire was accepted widely amongst women and clinicians and recommended for inclusion in the APFPR. All participants agreed it would be appropriate to capture PROMs before surgery, and then followed up post-surgically. Email, phone call or postal mail-out were the preferred options for PROMs data collection. CONCLUSION: Most women and clinicians supported incorporating PROMs in the APFPR. Study participants believed that capturing PROMs would have potential use in individual care and improve outcomes of women with POP.

The Australian Early Psychosis Collaborative Consortium (AEPCC): Improving Clinical Care in Early Psychosis.

OBJECTIVES: The field of early psychosis has undergone considerable expansion over the last few decades and has a strong evidence base of effectiveness. Like all areas of healthcare, however, early psychosis services need to more consistently deliver higher quality care to achieve better outcomes for patients and families. A national clinical research infrastructure is urgently required to enable the sector to deliver the highest quality care and expand and translate evidence more quickly and efficiently. This paper describes the establishment of the Australian Early Psychosis Collaborative Consortium (AEPCC) that aims to achieve this. CONCLUSION: AEPCC is the first of its kind in Australia (and internationally). It will deliver the required clinical research infrastructure through the implementation of a clinical quality registry, clinical trials and translation network, and lived experience network. AEPCC will provide a critical resource to better understand the state of early psychosis care, and trial new interventions on a scale that has not previously been possible in Australia.

Registry randomised trials: a methodological perspective.

Registry randomised clinical trials (RRCTs) have the potential to provide pragmatic answers to important clinical questions. RRCTs can be embedded into large population-based registries or smaller single site registries to provide timely answers at a reduced cost compared with traditional randomised controlled trials. RRCTs can take a number of forms in addition to the traditional individual-level randomised trial, including parallel group trials, platform or adaptive trials, cluster randomised trials and cluster randomised stepped-wedge trials. From an implementation perspective, initially it is advantageous to embed RRCT into well-established registries as these have typically already overcome any issues with end point validation and adjudication. With advances in data linkage and data quality, RRCTs can play an important role in answering clinical questions in a pragmatic, cost-effective way.

Hereditary Endocrine Tumor Registries.

Context: Endocrine neoplasia syndromes are phenotypically complex, and there is a misconception that they are universally rare. Genetic alterations are increasingly recognized; however, true prevalence is unknown. The purpose of a clinical registry is to monitor the quality of health care delivered to a specified group of patients through the collection, analysis, and reporting of relevant health-related information. This leads to improved clinical practice, decision-making, patient satisfaction, and outcome. Objective: This review aims to identify, compare, and contrast active registries worldwide that capture data relevant to hereditary endocrine tumors (HETs). Methods: Clinical registries were identified using a systematic approach from publications (Ovid MEDLINE, EMBASE) peer consultation, clinical trials, and web searches. Inclusion criteria were hereditary endocrine tumors, clinical registries, and English language. Exclusion criteria were institutional audits, absence of clinical data, or inactivity. Details surrounding general characteristics, funding, data fields, collection periods, and entry methods were collated. Results: Fifteen registries specific for HET were shortlisted with 136 affiliated peer-reviewed manuscripts. Conclusion: There are few clinical registries specific to HET. Most of these are European, and the data collected are highly variable. Further research into their effectiveness is warranted. We note the absence of an Australian registry for all HET, which would provide potential health and economic gains. This review presents a unique opportunity to harmonize registry data for HET locally and further afield.

Comorbidity data collection across different spine registries: an evidence map.

INTRODUCTION: Comorbidities are significant patient factors that contribute to outcomes after surgery. There is highly variable collection of this information across the literature. To help guide the systematic collection of best practice data, the Australian Spine Registry conducted an evidence map to investigate (i) what comorbidities are collected by spine registries, (ii) how they are collected and (iii) the compliance and completeness in collecting comorbidity data. METHOD: A literature search was performed to identify published studies of adult spine registry data reporting comorbidities. In addition, targeted questionnaires were sent to existing global spine registries to identify the maximum number of relevant results to build the evidence map. RESULTS: Thirty-six full-text studies met the inclusion criteria. There was substantial variation in the reporting of comorbidity data; 55% of studies reported comorbidity collection, but only 25% reported the data collection method and 20% reported use of a comorbidity index. The variation in the literature was confirmed with responses from 50% of the invited registries (7/14). Of seven, three use a recognised comorbidity index and the extent and methods of comorbidity collection varied by registry. CONCLUSION: This evidence map identified variations in the methodology, data points and reporting of comorbidity collection in studies using spine registry data, with no consistent approach. A standardised set of comorbidities and data collection methods would encourage collaboration and data comparisons between patient cohorts and could facilitate improved patient outcomes following spine surgery by allowing data comparisons and predictive modelling of risk factors.

Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common pelvic floor disorders (PFDs). Owing to significant adverse events associated with mesh-related pelvic floor procedures (PFPs) in a proportion of the surgically treated population, and deficits in collection and reporting of these events, the Australian Government identified an urgent need for a tracking mechanism to improve safety and quality of care. The Australasian Pelvic Floor Procedure Registry (APFPR) was recently established following the 2018 Senate Committee Inquiry with the aim of tracking outcomes of PFP involving the use of devices and/or prostheses, with the objective of improving the health outcomes of women who undergo these procedures. This paper will describe the APFPR's aims, development, implementation and possible challenges on the way to its establishment. METHODS: The APFPR has been developed and implemented in accordance with the national operating principles of clinical quality registries (CQRs). The minimum datasets (MDS) for the registry's database have been developed using a modified Delphi process, and data are primarily being collected from participating surgeons. Patient recruitment is based on an opt-out approach or a waiver of consent. Patient-reported outcome measures (PROMs) providing additional health and outcome information will be obtained from participating women to support safety monitoring of mesh-related adverse events. RESULTS: Currently in the Australasian Pelvic Floor Procedure Registry (APFPR) there are 32 sites from various jurisdictions across Australia, that have obtained relevant ethics and governance approvals to start patient recruitment and data collection as of January 2023. Additionally, there are two sites that are awaiting governance review and five sites that are having documentation compiled for submission. Seventeen sites have commenced patient registration and have entered data into the database. Thus far, we have 308 patients registered in the APFPR database. The registry also published its first status report and a consumer-friendly public report in 2022. CONCLUSIONS: The registry will act as a systematic tracking mechanism by collecting outcomes on PFP, especially those involving devices and/or prostheses to improve safety and quality of care.

Development of a conceptual framework for a new patient-reported outcome measure for pain in women following mesh surgery for pelvic floor disorders: a qualitative study.

INTRODUCTION AND HYPOTHESIS: The Australasian Pelvic Floor Procedure Registry (APFPR) collects both clinical and health-related quality of life (HRQoL) data on women undergoing surgery using a prosthesis such as mesh for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The registry lacks a suitable instrument to assess pain in women following mesh surgery for SUI and POP. This qualitative study describes the views on pain following mesh surgery in women and clinicians through the development of a conceptual framework, which may inform the development of a new instrument for the APFPR. METHODS: We conducted semi-structured interviews with women following mesh surgery for POP and SUI (n=17) and clinicians (n=6) in Victoria, Australia. We sought to reveal aspects of any sort of pain after a pelvic floor procedure. Interviews covered sensation, region, continuity of pain, triggers, and the mode and method of administration for a new pain-specific patient-reported outcome measure. Data were analysed using thematic analysis. RESULTS: We identified the important components of pain felt by women with POP and SUI after surgery using mesh. From the seven themes outlined, a conceptual framework was developed compiling related components of pain into six specific domains. CONCLUSIONS: This study identifies the important components of pain felt by women following mesh surgery. It is hoped that the development of a pain-specific PROM, as supported by clinicians, will assist in the timely and appropriate diagnosis and management of POP and SUI.

Carer-reported measures for a dementia registry: A systematic scoping review and a qualitative study.

OBJECTIVES: Informal carers play a critical role in supporting people with dementia. We conducted a scoping review and a qualitative study to inform the identification and development of carer-reported measures for a dementia clinical quality registry. METHODS: Phase 1-Scoping review: Searches to identify carer-reported health and well-being measures were conducted in three databases (MEDLINE, PsycINFO and Embase). Data were extracted to record how the measures were administered, the domains of quality-of-life addressed and whether they had been used in a registry context. Phase 2-Qualitative study: Four focus groups were conducted with carers to examine the acceptability of selected measures and to identify outcomes that were important but missing from these measures. RESULTS: Phase 1: Ninety-nine carer measures were identified with the top four being the Zarit Burden Interview (n = 39), the Short-Form12/36 (n = 14), the Brief Coping Orientation to Problems Experienced scale and the Sense of Coherence scale (both n = 9). Modes of administration included face-to-face (n = 50), postal (n = 11), telephone (n = 8) and online (n = 5). No measure had been used in a registry context. Phase 2: Carers preferred brief measures that included both outcome and experience questions, reflected changes in carers' circumstances and included open-ended questions. CONCLUSIONS: Carer-reported measures for a dementia clinical quality registry need to include both outcome and experience questions to capture carers' perceptions of the process and outcomes of care and services. Existing carer-reported measures have not been used in a dementia registry context and adaption and further research are required.