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.

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.

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.

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.

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.

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.

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.

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.

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.

Evaluation of the acceptability of patient-reported outcome measures in women following pelvic floor procedures.

PURPOSE: Patient-reported outcome measures (PROMs) are valuable tools in evaluating the outcomes of surgical treatment health-related quality of life (HRQoL) of women with stress urinary incontinence (SUI) and may be incorporated into related clinical quality registries. The aim of this study was to assess the feasibility and acceptability of incorporating PROMs into the Australian Pelvic Floor Procedure Registry (APFPR). METHODS: Semi-structured qualitative interviews were conducted with women with SUI (N = 12) and their managing clinicians (N = 11) in Victoria, Australia. Interview topics covered content and face validity, appropriateness, and acceptability of three incontinence-specific, two pain, one anxiety and depression, one sexual function and one patient global impression of improvement instruments identified through the literature to determine their suitability and acceptability for the APFPR. We analysed interview data into topics using conventional content analysis. RESULTS: Study participants agreed that PROMs were needed for the APFPR. Both participant groups suggested that some of the instruments were ambiguous, therefore only three instruments (one incontinence-specific, sexual function and patient global impression of improvement) will be included in the APFPR. Both clinicians and women agreed it would be appropriate to answer PROMs at baseline and then at 6- and 12-month postsurgically. Email, phone call and mail-out of the instruments were the preferred options for administration. CONCLUSION: Most women and clinicians supported the feasibility of incorporating PROMs in the APFPR. Participants believed the PROMs would demonstrate useful aggregate HRQoL data and have potential for use in individual care.

Health-related quality of life following percutaneous coronary intervention during the COVID-19 pandemic.

PURPOSE: During the COVID-19 pandemic, widespread public health measures were implemented to control community transmission. The association between these measures and health-related quality of life (HRQOL) among patients following percutaneous coronary intervention has not been studied. METHODS: We included consecutive patients undergoing percutaneous coronary intervention (PCI) in the state-wide Victorian Cardiac Outcomes Registry between 1/3/2020 and 30/9/2020 (COVID-19 period; n = 5024), with a historical control group from the identical period one year prior (control period; n = 5041). HRQOL assessment was performed via telephone follow-up 30 days following PCI using the 3-level EQ-5D questionnaire and Australian-specific index values. RESULTS: Baseline characteristics were similar between groups, but during the COVID-19 period indication for PCI was more common for acute coronary syndromes. No patients undergoing PCI were infected with COVID-19 at the time of their procedure. EQ-5D visual analogue score (VAS), index score, and individual components were higher at 30 days following PCI during the COVID-19 period (all P < 0.01). In multivariable analysis, the COVID-19 period was independently associated with higher VAS and index scores. No differences were observed between regions or stage of restrictions in categorical analysis. Similarly, in subgroup analysis, no significant interactions were observed. CONCLUSION: Measures of HRQOL following PCI were higher during the COVID-19 pandemic compared to the previous year. These data suggest that challenging community circumstances may not always be associated with poor patient quality of life.

Patient-reported outcome measures for pain in women with pelvic floor disorders: a systematic review.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measures (PROMs) are helpful instruments when measuring and reporting changes in patient health status (Al Sayah et al. J Patient Rep Outcomes 5 (Suppl 2):99, 2021) such as the health-related quality of life (HrQoL) of women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The Australasian Pelvic Floor Procedure Registry (APFPR) aims to increase capacity for women to report surgical outcomes through the collection of HrQoL data (Ruseckaite et al. Qual Life Res. 2021) but currently lacks a pain-specific PROM for women with pelvic floor disorders (PFDs), particularly POP and SUI. This review aims to systematically review the existing literature and identify instruments that measure pain in women with POP and SUI for inclusion within the APFPR, which reports on complications from these conditions. METHODS: We conducted a literature search on OVID MEDLINE, Embase, CINAHL, PsycINFO and EMCARE databases in addition to Google Scholar and grey literature to identify studies from inception to April 2021. Full-text studies were included if they used PROMs to measure pain in women with POP and SUI. Two authors independently screened articles, extracted data and assessed methodological quality. RESULTS: From 2001 studies, 23 publications describing 19 different PROMs were included for analysis. Eight of these instruments were specific to the pelvic floor; four were only specific to pain and used across multiple disorders; three were generic quality of life instruments and four were other non-validated instruments such as focus group interviews. These instruments were not specific to pain in women with POP or SUI, as they did not identify all relevant domains such as the sensation, region and duration of pain, or incidents where onset of pain occurs. CONCLUSIONS: The findings of this review suggest there are no current PROMs that are suitable pain-specific instruments for women with POP or SUI. This knowledge may inform and assist in the development of a new PROM to be implemented into the APFPR.

Preliminary development of recommendations for the inclusion of patient-reported outcome measures in clinical quality registries.

BACKGROUND: Clinical quality registries (CQRs) monitor compliance against optimal practice and provide feedback to the clinical community and wider stakeholder groups. Despite a number of CQRs having incorporated the patient perspective to support the evaluation of healthcare delivery, no recommendations for inclusion of patient-reported outcome measures (PROMs) in CQRs exist. The aim of this study was to develop a core set of recommendations for PROMs inclusion of in CQRs. METHOD: An online two-round Delphi survey was performed among CQR data custodians, quality of life researchers, biostatisticians and clinicians largely recruited in Australia. A list of statements for the recommendations was identified from a literature and survey of the Australian registries conducted in 2019. The statements were grouped into the following domains: rationale, setting, ethics, instrument, administration, data management, statistical methods, and feedback and reporting. Eighteen experts were invited to participate, 11 agreed to undertake the first online survey (round 1). Of these, nine experts completed the online survey for round 2. RESULTS: From 117 statements presented to the Delphi panel in round 1, a total of 72 recommendations (55 from round 1 and 17 from round 2) with median importance (MI) ≥ 7 and disagreement index (DI) < 1 were proposed for inclusion into the final draft set and were reviewed by the project team. Recommendations were refined for clarity and to read as stand-alone statements. Ten overlapped conceptually and, therefore, were merged to reduce repetition. The final 62 recommendations were sent for review to the panel members for their feedback, which was incorporated into the final set. CONCLUSION: This is the first study to develop preliminary recommendations for PROMs inclusion in CQRs. Recommendations for PROMs implementation are critically important for registries to assure meaningful PROMs data capture, use, interpretation, and reporting to improve health outcomes and healthcare value.

Forecasting of overall and aggressive prostate cancer incident counts at the small area level.

OBJECTIVES: This study aims to forecast overall and aggressive prostate cancer counts at the local government area (LGA) level over 10 years (2019-2028) in Victoria, Australia, using Victorian Cancer Registry (2001-2018) data. METHODS: We used the Age-Period-Cohort approach to estimate the annual age-specific incidence in each LGA and used Bayesian spatiotemporal models that account for non-linear temporal trends and area-level risk factors. We evaluated the models' performance by withholding and comparing forecasts with the 2014-2018 data. RESULTS: There were 80,449 prostate cancer cases between 2001 and 2018, with an overall increasing trend. Compared to 2001, prostate cancer incidence increased by 69%, from 3049 to 5167 cases in 2018. Prostate cancer counts are expected to reach 7631 cases in 2028, a further 48% increase. Unexplained area-level spatial variation was substantially reduced after adjusting for the area-level elderly population. Aggressive prostate cancer cases increased by 107% between 2001 and 2018 and are expected to rise by 123% increase in 2028. The proportion of aggressive prostate cancer cases will increase to 31% in 2028 from 20% in 2018. By 2028, overall and aggressive prostate cancer cases are projected to be increasing in 66% and 61% of LGAs. CONCLUSION: Prostate cancer cases are projected to rise at the state level and most LGAs in the next 10 years, with much steeper increases in aggressive cases. Population growth and an ageing population have primarily contributed to this rise besides prostate-specific antigen testing. These prediction estimates help inform prostate cancer burden and facilitate efficient healthcare delivery.

The role of Australian clinical quality registries in pregnancy care: A scoping review.

BACKGROUND: Pregnancy represents a time of increased morbidity and mortality for women and their infants. Clinical quality registries (CQRs) collect, analyse and report key healthcare quality indicators for patient cohorts to improve patient care. There are limited data regarding existing CQRs in pregnancy. This scoping review aimed to: (1) identify Australian CQRs specific to pregnancy care and describe their general characteristics; and (2) outline their aims and measured outcomes METHODS: The scoping review was undertaken according to Joanna Briggs Institute guidelines. CQRs were identified using a systematic approach from publications (Ovid MEDLINE, PubMed, Google Scholar), peer consultation, the Australian register of clinical registries and web searches. Details surrounding general characteristics, aims and outcomes were collated. RESULTS: We identified two primary sources of information about pregnancy care. (1) Six CQRs are specific to pregnancy (Australia and New Zealand twin-twin transfusion syndrome registry, Australian Pregnancy Register for women with epilepsy and those taking anti-epileptic drugs, National Register of Antipsychotic Medication in Pregnancy, Australasian Maternity Outcomes Surveillance System, Neonatal Alloimmune Thrombocytopaenia Registry and the Diabetes in Pregnancy clinical register). (2) Fourteen observational cohort studies were facilitated by non-pregnancy-specific CQRs where a subsection of patients underwent pregnancy. CONCLUSIONS: Australian CQRs currently report varied information regarding some selected conditions during pregnancy and offer therapeutic and epidemiological insight into their care. Further research into their effectiveness is warranted. We note the lack of a CQR spanning the common problems of pregnancy in general, where significant health, service and economic gains are possible.

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.

Influence of timeliness and receipt of first treatment on geographic variation in non-small cell lung cancer mortality.

Mortality from non-small cell lung cancer (NSCLC) exhibits substantial geographical disparities. However, there is little evidence on whether this variation could be attributed to patients' clinical characteristics and/or socioeconomic inequalities. This study evaluated the independent and relative contribution of the individual- and area-level risk factors on geographic variation in 2-year all-cause mortality among NSCLC patients. In the Hierarchical-related regression approach, we used the Bayesian spatial multilevel logistic regression model to combine individual- and area-level predictors with outcomes while accounting for geographically structured and unstructured correlation. Individual-level data included 3330 NSCLC cases reported to the Victoria Lung Cancer Registry between 2011 and 2016. Area-level data comprised socioeconomic disadvantage, remoteness and pollution data at the postal area level in Victoria, Australia. With the inclusion of significant individual- and area-level risk factors, timely (≤14 days) first definitive treatment (odds ratio [OR] = 0.73, 95% credible interval [Crl] = 0.56-0.94) and multidisciplinary meetings (MDM) (OR = 0.74, 95% Crl = 0.59-0.93) showed an independent association with a lower likelihood of NSCLC 2-year all-cause mortality. Timely and delayed (>14 days) first nondefinitive treatment, no treatment, advanced clinical stage, smoking, poor performance status, public hospital insurance and area-level deprivation were independently associated with a higher likelihood of 2- and 5-year all-cause mortality. NSCLC's 2-year all-cause mortality exhibited substantial geographic variation, mainly associated with timeliness and receipt of first definitive treatment, no treatment followed by patient prognostic factors with some contribution from area-level deprivation, MDM and public hospital insurance. This study highlights NSCLC patients should receive the first definitive treatment within the recommended 14-days from diagnosis.

Measurement properties of the 12-item Short Form Health Survey version 2 in Australians with lung cancer: a Rasch analysis.

BACKGROUND: The 12-item Short-Form Health Survey version 2 (SF-12v2), a widely used, generic patient-reported measure of health status that provides summary scores of physical and mental health. No study to date has examined the measurement properties of the SF-12v2 in patients with lung cancer using Rasch analysis. The aim of this study was to extend the psychometric evaluations of the SF-12 within the lung cancer population to ensure its validity and reliability to assess the health status in this population. METHODS: Participants in the Victorian Lung Cancer Registry (VLCR) who completed the SF-12v2 between 2012 and 2016 were included in this study. The structural validity of the SF-12v2 was assessed using Rasch analysis. Overall fit to the Rasch measurement model was examined as well as five key measurement properties: uni-dimensionality, response thresholds, internal consistency, measurement invariance and targeting. RESULTS: A total of 342 participants completed the SF-12v2 three months following their lung cancer diagnosis. The SF-12 Physical Component Score (PCS-12) did not fit the overall Rasch measurement model (χ2 107.0; p < 0.001). Three items deviated significantly from the Rasch model (item fit residual beyond ± 2.5) with signs of dependency between item responses and disordered thresholds. Nevertheless, the PCS-12 was uni-dimensional with good internal consistency (person separation index [PSI] 0.83) and reasonable targeting. In contrast, the SF-12 Mental Component Score (MCS-12) had good overall model fit (χ2 35.1; p = 0.07), reasonable targeting and good internal consistency (PSI 0.81). CONCLUSIONS: Rasch analysis suggests that there is general support for the reliability of the SF-12v2 as a measure of physical and mental health in people with lung cancer. However, the appropriateness of some items (e.g. pain) in the PCS-12 is questionable and further refinement of the scale including changing the response options may be required to improve the ability of the SF-12v2 to more appropriately assess the health status of this population.

Redesign of the Australian Cystic Fibrosis Data Registry: A multidisciplinary collaboration.

Clinical registries that monitor and review outcomes for patients with cystic fibrosis have existed internationally for many decades. However, their purpose continues to evolve and now includes the capability to support clinical effectiveness research, clinical trials and Phase IV studies, and international data comparisons and projects. To achieve this, registries must regularly update the information that they collect and ensure design that is adaptable and flexible to changing needs. The Australian Cystic Fibrosis Data Registry commenced in 1998, and in 2018-19 undertook a transformation to enable it to meet the needs of multiple stakeholders into the future. This included a comprehensive, multidisciplinary review of the registry's data elements, and a redesign and rebuild of the registry's database. The data element review comprised the processes of alignment, comparison, selection, consolidation, revision and definition of finalised data elements. The database redesign included attention to each of the registry functions of data collection, storage and management, and reporting. The revision of a national data collection system is a time-intensive process, and requires significant clinical and other expert engagement. The resulting database, while being continually refined, is now fit for purpose to support Australian clinicians and patients with CF to receive best practice care.

Outcomes collected in female pelvic floor surgical procedure registries and databases: a scoping review.

INTRODUCTION AND HYPOTHESIS: The objective was to overview the literature on the existing pelvic floor procedure registries and databases and to identify patient demographic, clinical and/or patient-reported data items for inclusion in the Australasian Pelvic Floor Procedure Registry (APFPR) Minimum Data Set (MDS). METHODS: We conducted a literature search on the MEDLINE, Embase, CINAHL and PsycINFO databases in addition to Google Scholar and grey literature to identify studies in the period January 2008 to January 2020. All were English studies of registries and databases on female adults undergoing surgery for pelvic floor disorders including stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Studies were assessed on demographic and clinical patient characteristics, procedure or treatment type, health-related quality of life, adverse events and safety outcomes, captured by pelvic floor procedure registries or databases that have been established to date. RESULTS: From 1662 studies, 29 publications describing 22 different pelvic floor registries and databases were included for analysis, 12 (55%) of which were multicentre. Six (27%) registries and databases involved solely SUI, eight (36%) were regarding POP, and the remaining eight (36%) focussed on both conditions. The majority of registries and databases captured similar details on patient characteristics, comorbidities and other clinical features, procedure or treatment type, health-related quality of life, adverse events, safety and efficacy. CONCLUSION: The findings of this scoping review will assist in determining the MDS for the APFPR, an initiative of the Australian government, to improve health and quality of life outcomes of women who undergo pelvic floor reconstructive procedures.