Beyond borders: cystic fibrosis survival between Australia, Canada, France and New Zealand.

BACKGROUND: Life expectancy for people with cystic fibrosis (CF) varies considerably both within and between countries. The objective of this study was to compare survival among countries with single-payer healthcare systems while accounting for markers of disease severity. METHODS: This cohort study used data from established national CF registries in Australia, Canada, France and New Zealand from 2015 to 2019. Median age of survival for each of the four countries was estimated using the Kaplan-Meier method. A Cox proportional hazards model was used to compare risk of death between Canada, France and Australia after adjusting for prognostic factors. Due to low number of deaths, New Zealand was not included in final adjusted models. RESULTS: Between 2015 and 2019, a total of 14 842 people (3537 Australia, 4434 Canada, 6411 France and 460 New Zealand) were included. The median age of survival was highest in France 65.9 years (95% CI: 59.8 to 76.0) versus 53.3 years (95% CI: 48.9 to 59.8) for Australia, 55.4 years (95% CI: 51.3 to 59.2) for Canada and 54.8 years (95% CI: 40.7 to not available) for New Zealand. After adjusting for individual-level factors, the risk of death was significantly higher in Canada (HR 1.85, 95% CI: 1.48 to 2.32; p<0.001) and Australia (HR 2.08, 95% CI: 1.64 to 2.64; p<0.001) versus France. INTERPRETATION: We observed significantly higher survival in France compared with countries with single-payer healthcare systems. The median age of survival in France exceeded 60 years of age despite having the highest proportion of underweight patients which may be due to differences in availability of transplant.

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.

The inequity of targeted cystic fibrosis reproductive carrier screening tests in Australia.

OBJECTIVE: European and Australian guidelines for cystic fibrosis (CF) reproductive carrier screening recommend testing a small number of high frequency CF causing variants, rather than comprehensive CFTR sequencing. The study objective was to determine variant detection rates of commercially available targeted reproductive carrier screening tests in Australia. METHODS: Next-generation DNA sequencing of the CFTR gene was performed on 2552 individuals from a whole population sample to identify CF causing variants. The variant detection rates of two commercially available Australian reproductive carrier screening tests, which target 50 or 175 CF causing variants, in this population were calculated. The ethnicity of individuals was determined using principal component analysis. RESULTS: Variant detection rates of the tests for 50 and 175 CF causing variants were 88.2% and 90.8%, respectively. No CF causing variants in individuals of East Asian ethnicity (n = 3) were detected by either test, while >86.6% (n = 69) of CF causing variants in Europeans would be identified by either test. CONCLUSIONS: Reproductive carrier screening tests for a targeted set of high frequency CF variants are unable to detect approximately 10% of CF variants in a multiethnic Australian population, and individuals of East Asian ethnicity are disproportionally affected by this test limitation.

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.

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.

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.

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.

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.

Hereditary Endocrine Tumors and Associated Syndromes: A Narrative Review for Endocrinologists and Endocrine Surgeons.

OBJECTIVE: Hereditary endocrine tumors (HET) were among the first group of tumors where predisposition syndromes were recognized. The utility of genetic awareness is having the capacity to treat at an earlier stage, screen for other manifestations and initiate family cascade testing. The aim of this narrative review is to describe the most common hereditary syndromes associated with frequently encountered endocrine tumors, with an emphasis on screening and surveillance. METHODS: A MEDLINE search of articles for relevance to endocrine tumors and hereditary syndromes was performed. RESULTS: The most common hereditary syndromes associated with frequently encountered endocrine tumors are described in terms of prevalence, genotype, phenotype, penetrance of malignancy, surgical management, screening, and surveillance. CONCLUSION: Medical practitioners involved in the care of patients with endocrine tumors should have an index of suspicion for an underlying hereditary syndrome. Interdisciplinary care is integral to successful, long-term management of such patients and affected family members.

A conceptual framework of patient-reported outcomes in people with venous leg ulcers.

Venous leg ulcers (VLUs) are a common chronic often undertreated condition, which affects individual's health-related quality of life (HRQoL). Numerous patient-reported outcome measures (PROMs) have been validated to capture HRQoL in patients with VLUs. However, available instruments contain many items, are hard to use in clinical practice, and present with weak responsiveness. This study aims to determine clinical utility of an existing VLU-QoL instrument and to develop a comprehensive PROs assessment framework to guide clinical practice treatment in people with VLUs in Australia. Semi-structured qualitative interviews were conducted with VLU patients (N = 13) and their managing clinicians (N = 6) in Victoria, Australia. Interview topics covered content and face validity, appropriateness, and acceptability of the VLU-QoL instrument to determine suitable and appropriate for use in clinical practice. Clinicians and patients agreed that a VLU-QoL instrument was needed in clinical practice. Both clinicians and patients agreed it would be appropriate to answer PROMs questions prior to consultation with clinicians every 3-6 months. However, patients considered that some of the questions are ambiguous and too technical. Patients reported that it would be useful to include additional items relating to daily wound care, compression bandaging, and dressings. Clinicians reported that the VLU-QoL instrument was too long and required restructuring to facilitate utility in practice. A conceptual framework for HRQoL in VLUs included traditional HRQoL components and VLU-specific issues. Overall, the VLU-QoL was well accepted, although changes to make it more concise, comprehensive, and to clearly reflect consumers' perspectives were lacking. The proposed conceptual framework will inform the development of a new PROM for use by clinicians and patients in clinical settings.

Impact of comorbidity on health outcome after a transport-related injury.

INTRODUCTION: Understanding the impact of comorbidity on health outcomes is important given that comorbidities can affect survival, morbidity, service delivery costs and healthcare utilisation. However, little is known about the types of comorbidities affecting specific health outcomes after minor to moderate road trauma. METHODS: This study involved 1574 participants who claimed injury compensation following transport-related injury. Cross sectional data were collected. Health outcomes were assessed using the EQ-5D-3L specific domains and summary score. Twelve self-reported pre-existing chronic conditions were assessed using a multivariate logistic regression, adjusting for demographic and injury characteristics. RESULTS: Out of 1574 participants, only 17 (1%) participants reported no pre-existing comorbidities, 72% reported one, 13% reported two and 14% reported three or more comorbidities. Hypertension (15%), depression (14%) and anxiety (14%) were the most commonly reported comorbidities, followed by arthritis (13%), chronic pain (11%) and asthma (11%). Participants with a history of arthritis (adjusted odds ratio [AOR] 1.90, 95% CI 1.24 to 2.91); chronic back pain (AOR 1.59, 95% CI, 1.04 to 2.43); other chronic pain (AOR 2.73, 95% CI 1.42 to 4.24); depression (AOR 2.55, 95% CI 1.60 to 4.05) and anxiety (AOR 2.08, 95% CI 1.32 to 3.26) were at increased risk of poorer health outcomes, after controlling for age, gender, type of injury and time since injury. CONCLUSION: This study found that comorbidities such as arthritis, chronic back pain, other chronic pain, depression and anxiety significantly increase the odds of poorer health postinjury, regardless of the time since injury. Regular screening of comorbid conditions may help identify people likely to have poorer outcomes, thereby enabling the implementation of interventions to optimise health despite the presence of comorbidities.

Development of a percutaneous coronary intervention patient level composite measure for a clinical quality registry.

BACKGROUND: Composite measures combine data to provide a comprehensive view of patient outcomes. Despite composite measures being a valuable tool to assess post-intervention outcomes, the patient perspective is often missing. The purpose of this study was to develop a composite measure for an established cardiac outcome registry, by combining clinical outcomes following percutaneous coronary interventions (PCI) with a patient-reported outcome measure (PROM) developed specifically for this population (MC-PROM). METHODS: Two studies were undertaken. Study 1: Patients who had undergone a PCI at one of the three participating registry hospital sites completed the 5-item MC-PROM. Clinical outcome data for the patients (e.g. death, myocardial infarction, repeat vascularisation, new bleeding event) were collected 30 days post-intervention as part of routine data collection for the cardiac registry. Exploratory factor analysis of clinical outcomes and MC-PROM data was conducted to determine the minimum number of constructs to be included in a composite measure. Study 2: Clinical experts participated in a Delphi technique, consisting of three rounds of online surveys, to determine the clinical outcomes to be included and the weighting of the clinical outcomes and MC-PROM score for the composite measure. RESULTS: Study 1: Routine clinical outcomes and the MC-PROM data were collected from 266 patients 30 days post PCI. The MC-PROM score was not significantly correlated with any clinical outcomes. Study 2: There was a relatively consistent approach to the weighting of the clinical outcomes and MC-PROM items by the expert panel (n = 18) across the three surveys with the exception of the clinical outcome of 'deceased at 30 days'. The final composite measure included five clinical outcomes within 30 days weighted at 90% (new heart failure, new myocardial infarction, new stent thrombosis, major bleeding event, new stroke, unplanned cardiac rehospitalisation) and the MC-PROM score (comprising 10% of the total weighting). CONCLUSIONS: A single patient level composite score, which incorporates weighted clinical outcomes and a PROM was developed. This composite score provides a more comprehensive reported measure of individual patient wellbeing at 30 days post their PCI-procedure, and may assist clinicians to further assess and address patient level factors that potentially impact on clinical recovery.

A randomised controlled trial comparing completeness of responses of three methods of collecting patient-reported outcome measures in men diagnosed with prostate cancer.

PURPOSE: The purpose of the study was to compare completeness, timeliness and cost of patient-reported outcome measures (PROMs) collection using telephone, email and post in men with prostate cancer. METHODS: A parallel, three-arm randomised controlled equivalence trial. 1168 patients were randomised to telephone (n = 295), postal (n = 388) and email (n = 385) arms. Participants were asked to provide self-reported responses for 26 items of Expanded Prostate Cancer Index Composite. Cost and resource data were collected from a provider perspective. RESULTS: Equivalence tests showed no difference in completeness in the three arms within a 10% equivalence margin. Men diagnosed in public hospitals were less likely to complete the survey compared to those in private hospitals, OR = 0.19 (95% CI 0.04-0.89) (p = 0.035). The email survey required significantly less time to complete than telephone and postal methods [median time of 2 min (IQR 1,8) vs. 7 min (IQR 6,9) vs. 10 min (IQR 9,12), respectively (p < 0.001)]. The incremental cost effectiveness ratio for email compared to telephone was AUD$1.90, cost-effective if users valued an additional 1% improvement in survey completion greater than AUD$1.90. CONCLUSION: Email method took less time and cost and should be used as the primary PROMs collection, with telephone if men without email or do not respond to email.

Biopsychosocial barriers affecting recovery after a minor transport-related injury: A qualitative study from Victoria.

OBJECTIVE: The aim of the study was to understand the recovery phenomena and to explore participants' perspectives on the biopsychosocial facilitators and barriers affecting their recovery after a minor transport injury. METHODS: A qualitative method was used involving semi-structured interviews with 23 participants who sustained a minor transport injury. Interviews and analysis were guided by the biopsychosocial model (BPS) of health. The outcomes were themes capturing biopsychosocial barriers to, and personal experiences of, recovery using a previously defined framework. RESULTS: The themes indicate that recovery is a multifaceted phenomenon affected by comorbidities such as chronic pain, depression and anxiety. A range of subsequent complexities such as the inability to self-care and undertaking daily domestic duties, and incapacity to participate in recreational activities were major barriers to recovery. These barriers were found to be an on-going source of frustration, dissatisfaction and a perceived cause of depressive symptomatology in many participants. Most participants reported mixed feelings of the care received. Other common issues raised included a lack of understanding of the assessment time, regular follow-up, guidance and on-going support. CONCLUSION: This study revealed that recovery after a minor transport-related injury was a challenging, complex, demanding and a long-term process for the individuals in this study. Findings from this limited cohort suggested that, for participants to return to their pre-accident health status, a more coordinated approach to information and care delivery may be required.

Do Health Service Use and Return-to-Work Outcomes Differ with GPs' Injured-Worker Caseload?

Purpose To determine whether healthcare use and return-to-work (RTW) outcomes differ with GPs' injured-worker caseload. Methods Retrospective analyses of the Compensation Research Database, which captures approximately 85% of all injured worker claims in Victoria, Australia was conducted. Four injured-worker caseload groups were examined that represented the 25th, 50th, 75th, and 100th percentiles of claimants seen per GP over the 8-year study period (2003-2010): (i) 1-13 claimants; (ii) 14-26 claimants; (iii) 27-48 claimants; and (iv) 49+ claimants (total claims, n = 124,342; total GPs, n = 9748).The characteristics of claimants in each caseload group, as well as the influence of caseload on three outcomes relevant to RTW (weekly compensation paid, work incapacity days, medical-and-like costs), were examined. Results Distinct profiles for high versus low caseload groups emerged. High caseload GPs treated significantly more men in blue collar occupations and issued significantly more 'alternate duties' certificates. Conversely, low caseload GPs treated significantly more women in white collar occupations, predominantly for mental health injuries, and issued significantly more 'unfit-for-work' certificates. Few significant differences were found between the two intermediate GP caseload groups. High caseload was associated with significantly greater medical-and-like costs, however, no caseload group differences were detected for weekly compensation paid or duration of time-off-work. Conclusions Training GPs who have a low injured-worker caseload in workers' compensation processes, utilising high caseload GPs in initiatives involving peer-to-peer support, or system changes where employers are encouraged to provide preventive or rehabilitative support in the workplace may improve RTW outcomes for injured workers.

Cross-sectional study of characteristics of clinical registries in Australia: a resource for clinicians and policy makers.

OBJECTIVES: To investigate the attributes of Australian clinical quality registries (CQR). DESIGN AND SETTING: Survey of 40 CQRs between September 2015 and April 2016. PARTICIPANTS: CQR lead investigators/project managers. INTERVENTION: None. MAIN OUTCOME MEASURES: Registry organization, geographical coverage, data quality, management, characteristics, output and outcomes. RESULTS: Of those who responded (34/40; 85.0%), 12 (34.3%) were binational (Australia and New Zealand); 22 (64.7%) were Australian-only registries; and 13 (38.2%) had national coverage. CQRs covered critical care, infection control, cardiovascular diseases, cancer, chronic diseases, procedures and devices, and transplants. Overall, 24/34 CQRs (70.6%) were public sector funded. In total, 14 (41.2%) scored >75% on a composite score developed to assess data quality. Overall, 29/34 (85.3%) produced an annual multi-centred report; only 15/34 (44.1%) produced provider-specific reports. Mortality/survival and quality of life were collected by 82.4 and 32.4% of CQRs, respectively. Most CQRs displayed data in bar/column charts (28/34, 82.4%) and funnel plots (17/34, 50%). Most CQRs adopted an opt-out consent process (n = 17/31; 54.8%). Linear regression indicated that longer duration of CQR was associated with higher data quality (>20 vs 0-5 years coefficient = 4.76, 95% CI: 0.26, 9.26). Opt-in consent was associated with lower data quality (no active consent vs opt-in approval method, coefficient = -5.22, 95% CI: -8.71, -1.72). Six CQRs self-reported having undertaken an economic evaluation of their registry. CONCLUSION: CQRs varied in geographical coverage; stage of development, approach to recruitment; method and frequency of reporting their output; and data quality assurance. An accreditation system for CQRs would likely assist in recognizing high-quality registries.