Menstrual cycle regularity as a predictor for heart disease and diabetes: Findings from a large population-based longitudinal cohort study.

OBJECTIVE: Menstrual cycle regularity underpins the diagnosis of polycystic ovary syndrome (PCOS), which is linked to adverse cardio-metabolic profile. However, links between menstrual disorders and metabolic conditions are often under-appreciated and not considered when assessing cardio-metabolic risk in women. We aimed to assess the risk of diabetes and heart disease in women with irregular menstrual cycles and those whose cycles were regular. METHODS: This was a community based longitudinal cohort study. We utilized the 1946 to 1951 birth cohort database (N = 13,714) of the Australian Longitudinal Study on Women's Health (ALSWH) over a 20-year follow-up period. Data were analysed using Cox regression models. RESULTS: Women with irregular menstrual cycles had 20% higher risk of developing heart disease [adjusted hazard ratio [HR]: 1.20, 95% confidence interval [CI]: 1.01-1.43) compared with those with regular menstrual cycles. We also observed 17% higher risk of diabetes (HR: 1.17, 95% CI: 1.00-1.38) in women who had irregular menstrual cycles than in women who had regular menstrual cycles. The diabetes risk was 30% higher (HR: 1.30, 95% CI: 1.09-1.55) if women had irregular cycles and did not use hormone replacement therapy, but this was not significant on adjustment for all covariates. CONCLUSION: Having irregular menstrual cycles appears to be an early indicator for heart disease and diabetes. These findings suggest that irregular cycles among women in their forties may be linked to adverse cardio-metabolic outcomes. These women may benefit from screening and prevention strategies as recommended by related guidelines such as the international evidence-based guideline for the assessment and management of PCOS.

A co-designed integrated kidney and diabetes model of care improves mortality, glycaemic control and self-care.

BACKGROUND: Current healthcare models are ill-equipped for managing people with diabetes and chronic kidney disease (CKD). We evaluated the impact of a new diabetes and kidney disease service (DKS) on hospitalization, mortality, clinical and patient-relevant outcomes. METHODS: Longitudinal analyses of adult patients with diabetes and CKD (Stages 3a-5) were performed using outpatient and hospitalization data from January 2015 to October 2018. Data were handled according to whether patients received the DKS intervention (n = 196) or standard care (n = 7511). The DKS provided patient-centred, coordinated multidisciplinary assessment and management of patients. Primary analyses examined hospitalization and mortality rates between the two groups. Secondary analyses evaluated the impact of the DKS on clinical target attainment, changes in estimated glomerular filtration rate (eGFR), glycated haemoglobin A1c (HbA1c), self-care and patient activation at 12 months. RESULTS: Patients who received the intervention had a higher hospitalization rate {incidence rate ratio [IRR] 1.20 [95% confidence interval (CI) 1.13-1.30]; P < 0.0001}, shorter median length of stay {2 days [interquartile range (IQR) 1-6] versus 4 days [IQR 1-9]; P < 0.0001} and lower all-cause mortality rate [IRR 0.4 (95% CI 0.29-0.64); P < 0.0001] than those who received standard care. Improvements in overall self-care [mean difference 2.26 (95% CI 0.83-3.69); P < 0.001] and in statin use and eye and feet examinations were observed. The mean eGFR did not change significantly after 12 months [mean difference 1.30 mL/min/1.73 m2 (95% CI -4.17-1.67); P = 0.40]. HbA1c levels significantly decreased by 0.40, 0.35, 0.34 and 0.23% at 3, 6, 9 and 12 months of follow-up, respectively. CONCLUSIONS: A co-designed, person-centred integrated model of care improved all-cause mortality, kidney function, glycaemic control and self-care for patients with diabetes and CKD.

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.

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.

Prognostic models to predict survival in patients with pancreatic cancer: a systematic review.

BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) has poor survival. Current treatments offer little likelihood of cure or long-term survival. This systematic review evaluates prognostic models predicting overall survival in patients diagnosed with PDAC. METHODS: We conducted a comprehensive search of eight electronic databases from their date of inception through to December 2019. Studies that published models predicting survival in patients with PDAC were identified. RESULTS: 3297 studies were identified; 187 full-text articles were retrieved and 54 studies of 49 unique prognostic models were included. Of these, 28 (57.1%) were conducted in patients with advanced disease, 17 (34.7%) with resectable disease, and four (8.2%) in all patients. 34 (69.4%) models were validated, and 35 (71.4%) reported model discrimination, with only five models reporting values >0.70 in both derivation and validation cohorts. Many (n = 27) had a moderate to high risk of bias and most (n = 33) were developed using retrospective data. No variables were unanimously found to be predictive of survival when included in more than one study. CONCLUSION: Most prognostic models were developed using retrospective data and performed poorly. Future research should validate instruments performing well locally in international cohorts and investigate other potential predictors of survival.

The association between quality care and outcomes for a real-world population of Australian patients diagnosed with pancreatic cancer.

BACKGROUND: This study: (i) assessed compliance with a consensus set of quality indicators (QIs) in pancreatic cancer (PC); and (ii) evaluated the association between compliance with these QIs and survival. METHODS: Four years of data were collected for patients diagnosed with PC. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). A multivariable analysis tested the relationship between significant patient and hospital characteristics, patient cluster effects within hospitals and survival. RESULTS: 1061 patients were eligible for this study. Significant association with improved survival were: (i) in the potentially resectable group having adjuvant chemotherapy administered following surgery or a reason documented (HR, 0.29; 95 CI, 0.19-0.46); (ii) in the locally advanced group included having chemotherapy ± chemoradiation, or a reason documented for not undergoing treatment (HR, 0.38; 95 CI, 0.25-0.58); and (iii) in the metastatic disease group included having documented performance status at presentation (HR, 0.65; 95 CI, 0.47-0.89), being seen by an oncologist in the absence of treatment (HR, 0.48; 95 CI, 0.31-0.77), and disease management discussed at a multidisciplinary team meeting (HR, 0.79; 95 CI, 0.64-0.96). CONCLUSION: Capture of a concise data set has enabled quality of care to be assessed.

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.

Hepatic lipidomic remodeling in severe obesity manifests with steatosis and does not evolve with non-alcoholic steatohepatitis.

BACKGROUNDS & AIMS: Obesity often leads to non-alcoholic fatty liver disease (NAFLD), which can progress from simple steatosis (non-alcoholic fatty liver (NAFL)) to non-alcoholic steatohepatitis (NASH). The accumulation of certain lipid subtypes is linked with worsening metabolic and liver disease, however, specific changes during progression from No-NAFL to NAFL then NASH are unresolved. Herein, we characterise the liver, adipose tissue and plasma lipidome of worsening NAFLD in obesity, and evaluate the utility of plasma lipids as biomarkers of NAFLD. METHODS: Venous blood, liver, visceral and subcutaneous adipose tissue samples were obtained from 181 patients undergoing bariatric surgery. NAFLD severity was assessed histologically. Lipidomic analysis was performed using liquid chromatography-tandem mass spectrometry. RESULTS: The liver lipidome showed substantial changes with increasing steatosis, with increased triacylglycerols, diacylglycerols and sphingolipids including ceramide, dihydroceramide, hexosyl-ceramide and GM3 ganglioside species. These lipid species were also increased in plasma with increasing hepatic steatosis and showed strong correlations with liver lipids. Adipose tissue lipidomes showed no correlation with NAFLD. There were no significant changes in liver lipids with NASH compared to NAFL. The addition of plasma lipid variables to routine markers yielded significant improvements in diagnostic accuracy for NASH (AUROC 0.667 vs. 0.785, p = 0.025). CONCLUSION: Overall, these data provide a detailed description of the lipidomic changes with worsening NAFLD, showing significant changes with steatosis but no additional changes with NASH. Alterations in the liver lipidome are paralleled by similar changes in plasma. Further investigation is warranted into the potential utility of plasma lipids as non-invasive biomarkers of NAFLD in obesity. LAY SUMMARY: Non-alcoholic fatty liver disease (NAFLD) is characterised by distinct changes in the liver lipidome with steatosis. The development of non-alcoholic steatohepatitis (NASH) does not result in further changes in the lipidome. Lipids within body fat do not appear to influence the lipid profile of the liver or blood. Changes in liver lipids are paralleled by changes in blood lipids. This has potential to be developed into a non-invasive biomarker for NAFLD. CLINICAL TRIAL NUMBER: ACTRN12615000875505.

Predictors of hypertensive disorders in pregnancy in women with and without polycystic ovary syndrome: The Australian Longitudinal Study of Women's Health.

OBJECTIVES: A higher risk of hypertensive disorders in pregnancy (HDP) is frequently reported in women with polycystic ovary syndrome (PCOS). These women, however, have a higher risk profile for HDP compared with women without PCOS. The aim of this study was to elucidate the impact of PCOS per se on the incidence of HDP through post hoc subgroup analyses of the Australian Longitudinal Study on Women's Health by level of risk. DESIGN: Longitudinal study. PATIENTS: Of a total of 14,247 participants, 5838 women met the inclusion criteria. Eligible women were required to report PCOS and HDP status in at least one pregnancy within the study. MEASUREMENTS: Included risk factors were age, body mass index, country of birth, parity, multiple pregnancy, subfertility, infertility treatment (hormonal vs. in vitro fertilization), gestational diabetes (GDM), family history of GDM and socioeconomic status. Longitudinal association between PCOS and HDP was assessed the using Cox proportional hazard regression with Efron's method. RESULTS: While PCOS was associated with a higher incidence of HDP in a univariate model [hazard ratio (HR): 1.34, 95% confidence interval (CI): 1.05, 1.72], the significance was not retained after adjustment for risk factors [HR: 1.19, 95% CI: 0.79, 1.79]. However in multivariate analysis of subgroups, PCOS remained significantly associated with higher risk of HDP in non-obese women only [HR: 1.77, 95% CI: 1.11, 2.82]. CONCLUSIONS: Higher risk of HDP in PCOS is likely related to risk factors other than PCOS.

Weight gain and lifestyle factors in women with and without polycystic ovary syndrome.

STUDY QUESTION: Do extrinsic factors including lifestyle, psychosocial factors and healthcare professional engagement independently contribute to weight gain in women with and without polycystic ovary syndrome (PCOS)? SUMMARY ANSWER: Women with PCOS had a higher rate of weight gain than women without PCOS which was most marked in those with unhealthy lifestyles. WHAT IS KNOWN ALREADY: Women with PCOS have a higher prevalence of overweight/obesity and greater weight gain than women without PCOS. The association of lifestyle factors with weight change in PCOS is not known. STUDY DESIGN, SIZE, DURATION: The study was a population-based observational study with data collected from seven surveys over 19 years (N = 14 127; Survey 1) involving women with and without PCOS. PARTICIPANTS/MATERIALS, SETTING, METHODS: We used data from the 1973-1978 birth cohort of the Australian Longitudinal Study on Women's Health. MAIN RESULTS AND THE ROLE OF CHANCE: Women with PCOS gained more weight annually (0.26 kg/year; 95% CI 0.12, 0.39; P < 0.0001) and over 19 years (4.62 kg; 95% CI 3.04, 6.21; P < 0.0001) than women without PCOS (adjusted analyses). For all women, there were positive associations between weight gain and energy intake, sitting time and stress; inverse associations with fibre intake and physical activity (PA); and no associations with diet quality, glycaemic index, healthcare utilization, depression or anxiety. There were interactions between lifestyle factors (energy intake P = 0.006, glycaemic index P = 0.025, sitting time P = 0.041 and PA P = 0.021), PCOS status and time such that weight gain varied between women with and without PCOS according to these factors. LIMITATIONS, REASONS FOR CAUTION: The limitations of this study include the use of self-reported measures such as diet, PA, sitting time, psychological factors and health care utilization. WIDER IMPLICATIONS OF THE FINDINGS: While women with PCOS are more prone to weight gain, lifestyle factors have a more profound impact on weight gain in women with PCOS than without PCOS. These study findings have implications for understanding the mechanisms of weight gain in women with PCOS. They also highlight the importance of early lifestyle intervention as soon as PCOS is diagnosed to address modifiable extrinsic factors and prevent excess weight gain and worsening of the clinical features of PCOS. STUDY FUNDING/COMPETING INTEREST(S): M.A.A. is funded by the Monash International Tuition Scholarship and Monash Graduate Scholarship and L.J.M. is funded by a National Heart Foundation Future Leader Fellowship. The authors declared no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.

Trends in glycaemic control and drug use in males and females with type 2 diabetes: Results of the Australian National Diabetes Audit from 2013 to 2019.

AIM: To investigate temporal changes in glycaemic control and the use of antihyperglycaemic therapies in females and males with type 2 diabetes from 2013 to 2019. METHODS: Data from adult patients with type 2 diabetes (n = 11 930; 44.9% females, mean [SD] age of 62.9 [12.9] years) were analysed from the 2013 to 2019 biennial cross-sectional Australian National Diabetes Audit. RESULTS: Mean HbA1c remained similar throughout the years examined and between the sexes (7.8%-8.3%, 62-67 mmol/mol; P > .05). The number of antihyperglycaemic agents used by both sexes increased from 2013 to 2019 (P < .001), with more agents used by males (P = .014). From 2013 to 2019, there were increasing proportions of both sexes using dipeptidyl peptidase-4 inhibitors (females: 11.7%-25.7%, P = .045; males: 11.6%-29.5%, P = .036) and glucagon-like peptide-1 receptor agonists (females: 5.9%-15.3%; males: 4.9%-11.1%; P = .043 for both). Sodium-glucose co-transporter-2 inhibitors were not available in 2013; however, their use increased substantially from 2015 to 2019 in both females (4.9%-26.3%, P = .013) and males (4.7%-32.2%, P = .019). CONCLUSIONS: From 2013 to 2019, mean HbA1c levels remained unchanged despite a concurrent increase in the number of antihyperglycaemic medications used. Overall, there was a trend towards preferencing newer agents with some differences in treatment regimens relating to sex and renal function.

Outcomes for patients with COVID-19 admitted to Australian intensive care units during the first four months of the pandemic.

OBJECTIVES: To describe the characteristics and outcomes of patients with COVID-19 admitted to intensive care units (ICUs) during the initial months of the pandemic in Australia. DESIGN, SETTING: Prospective, observational cohort study in 77 ICUs across Australia. PARTICIPANTS: Patients admitted to participating ICUs with laboratory-confirmed COVID-19 during 27 February - 30 June 2020. MAIN OUTCOME MEASURES: ICU mortality and resource use (ICU length of stay, peak bed occupancy). RESULTS: The median age of the 204 patients with COVID-19 admitted to intensive care was 63.5 years (IQR, 53-72 years); 140 were men (69%). The most frequent comorbid conditions were obesity (40% of patients), diabetes (28%), hypertension treated with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (24%), and chronic cardiac disease (20%); 73 patients (36%) reported no comorbidity. The most frequent source of infection was overseas travel (114 patients, 56%). Median peak ICU bed occupancy was 14% (IQR, 9-16%). Invasive ventilation was provided for 119 patients (58%). Median length of ICU stay was greater for invasively ventilated patients than for non-ventilated patients (16 days; IQR, 9-28 days v 3 days; IQR, 2-5 days), as was ICU mortality (26 deaths, 22%; 95% CI, 15-31% v four deaths, 5%; 95% CI, 1-12%). Higher Acute Physiology and Chronic Health Evaluation II (APACHE-II) scores on ICU day 1 (adjusted hazard ratio [aHR], 1.15; 95% CI, 1.09-1.21) and chronic cardiac disease (aHR, 3.38; 95% CI, 1.46-7.83) were each associated with higher ICU mortality. CONCLUSION: Until the end of June 2020, mortality among patients with COVID-19 who required invasive ventilation in Australian ICUs was lower and their ICU stay longer than reported overseas. Our findings highlight the importance of ensuring adequate local ICU capacity, particularly as the pandemic has not yet ended.

Victorian Lung Cancer Service Redesign Project: impacts of a quality improvement collaborative on timeliness and management in lung cancer.

BACKGROUND: Lung cancer management is characterised by a high disease burden, poor survival and substantial variation in management and outcomes. Service redesign provides opportunities for quality improvement (QI) and this improvement may be leveraged across multiple sites using QI collaboration. AIM: This initiative targeted Quality Improvement (QI) in lung cancer management, engaging a QI collaborative using service redesign methodologies in five Victorian hospitals. QI targets included timeliness from referral and diagnosis to treatment, multi-disciplinary meeting (MDM) presentation and supportive care screening. Redesign strategies targeted process sustainability through enhanced team capability. METHODS: This study engaged a prospective quality improvement cohort design targeting newly diagnosed tissue confirmed lung cancer with 6-month pre-intervention period and 6-month redesign implementation period, between September 2016 and August 2017, evaluated using Interrupted Time Series Analysis. Hospital sites included three regional and two metropolitan hospitals in Victoria. QI redesign targeted time intervals from referral to first specialist appointment (FSA), referral to diagnosis, diagnosis to first treatment (any intent), MDM documented in medical records and Supportive Care Screening Tool documented in medical records. RESULTS: There was a marked reduction in referral to FSA interval across all sites, with median (interquartile range) falling from 6 (0-15) to 4 (1-10) days, and proportion seen by a specialist within 14 days increased from 74.3% to 84.2%. The interval between diagnosis and treatment was not substantively changed in the 6-month implementation period. The proportion of subjects with documented presentation to the MDM increased from 61% to 67%. The proportion for which Supportive Care Screening documentation remained low at 26.3% post-intervention. CONCLUSIONS: Data-driven redesign initiatives enable identification and analysis of clinical practice variation and may be utilised to enhance timeliness of cancer care and improve local data service capabilities.

Geospatial and temporal variation of prostate cancer incidence.

OBJECTIVES: The objective of this study was to evaluate geographical and temporal variations in prostate cancer incidence in Victoria, Australia. STUDY DESIGN & METHODS: This study analysed 105,349 cases of incident prostate cancer between 1982 and 2016 from the population-based Victorian Cancer Registry. We performed Poisson regression analyses to identify an association between an annual number of prostate cancer counts, prostate-specific antigen (PSA) tests and the elderly male population (≥65) after adjusting for population at risk and years. We also applied Bayesian spatial-temporal models to determine any association with prostate cancer incidence and area-level factors. RESULTS: The overall trend of the age-standardized prostate cancer incidence was increasing. The highest age-specific incidence was observed among people aged 65-74 years in the pre- and post-PSA periods. Every increase in 1000 PSA tests per 100,000 population, prostate cancer incidence increased by 17% (relative risk [RR] = 1.17, 95% confidence interval [CI] = 1.13-1.22). A 1% increase in the proportion of the male population (≥65) correlated with a 7% increase in prostate cancer cases (RR = 1.07, 95% CI = 1.06-1.10). Compared with early PSA periods, decreasing trends of low-grade cases and growing trends of high- and intermediate-grade cases were observed after a decline in PSA test usage in late PSA periods. Men living in the most socioeconomically advantaged postal areas had a decreased risk of prostate cancer (RR = 0.914, 95% CI = 0.858-0.976). CONCLUSIONS: Age-specific risk of developing biological prostate cancer, temporal changes in PSA testing and an increasingly elderly population contributed to an increasing trend of prostate cancer incidence. When incidence trends were investigated at a more granular geographic level, socioeconomically advantaged status was associated with decreased prostate cancer risk.

Test-Retest Reliability of the BREAST-Q IS in the Australian Breast Device Registry.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly employed in healthcare to assess outcomes. The BREAST-Q Implant Surveillance module (BREAST-Q IS) is a 5-question PROM utilized by the Australian Breast Device Registry to monitor the performance of breast devices. Validation of this tool is needed to assess its utility in this setting. OBJECTIVES: The objective of this study was to assess the test-retest reliability of the BREAST-Q IS among breast implant recipients within a registry setting. METHODS: A test-retest reliability study was undertaken. Patients who underwent breast augmentation or breast reconstruction and registered with the Australian Breast Device Registry were eligible to participate. A total of 250 surveys were distributed. The BREAST-Q IS was administered to the same group of participants on 2 separate occasions with a 2-week test interval. Participants were divided into 2 groups: breast augmentation and breast reconstruction. A weighted kappa coefficient was calculated to assess the degree of test-retest reliability of the BREAST-Q IS. RESULTS: A total of 207 participants completed both tests. The response rate was 82% (n = 113) for the breast augmentation group and 94% (n = 94) for the breast reconstruction group. All 5 questions on the BREAST-Q IS obtained weighted kappa scores above 0.74 among both groups. CONCLUSIONS: The BREAST-Q IS has good to excellent test-retest reliability for utilization among breast implant recipients in a registry setting. Further validation of the BREAST-Q IS will be required to establish the BREAST-Q IS as a valid and reliable PROM tool for breast implant recipients following breast device surgery.

Updated adolescent diagnostic criteria for polycystic ovary syndrome: impact on prevalence and longitudinal body mass index trajectories from birth to adulthood.

BACKGROUND: Polycystic ovary syndrome (PCOS) is challenging to diagnose. While the 2003 Rotterdam criteria are widely used for adults, the 2018 international PCOS guideline recommended updated Rotterdam criteria with both hyperandrogenism and oligo-anovulation for adolescents based on evidence-informed expert consensus. This study compared the prevalence of PCOS using updated and original Rotterdam criteria in community-based adolescents and explored long-term body mass index (BMI) trajectories across different diagnostic phenotypes. METHODS: Overall, 227 postmenarchal adolescent females from the prospective cohort Raine Study undertook comprehensive PCOS assessment at age 14-16 years. Detailed anthropometric measurements were collected from birth until age 22 years. Cross-sectional and longitudinal BMI were analyzed using t tests and generalized estimating equations. RESULTS: PCOS was diagnosed in 66 (29.1%) participants using original criteria versus 37 (16.3%) participants using updated Rotterdam criteria. Using updated criteria, participants with PCOS had higher BMI than participants without PCOS from prepubertal. Only the phenotype meeting the updated criteria was significantly associated with higher long-term BMI gain whereas other PCOS phenotypes had similar BMI trajectories to participants without PCOS (p < 0.001). CONCLUSIONS: The use of the 2018 updated Rotterdam criteria reduces over-diagnosis of PCOS in adolescents and identifies those at the greatest risk of long-term weight gain, a key contributor to disease severity and long-term health implications. The BMI trajectories of females with PCOS on updated criteria diverge prepubertally compared to those without PCOS. This work supports targeting adolescents diagnosed with PCOS on the 2018 updated criteria for early lifestyle interventions to prevent long-term health complications.

Cancer patients' perceptions of palliative care.

PURPOSE: Despite clear benefits of early integration of palliative care (PC) and oncology, concerns remain about negative perceptions of PC. Our aim was to explore current knowledge and perceptions of PC in cancer patients. METHODS: We conducted a prospective, cross-sectional survey. A 16-item questionnaire was distributed to all cancer patients (N = 103) upon admission to the oncology ward of an Australian tertiary academic hospital. Chi-squared test was used to examine for significant factors related to patients' perceptions. RESULTS: Ninety-six patients (93%) completed the questionnaire; 76% had metastatic cancer. We explored the following domains:Experience and knowledge: 76% had heard of PC; 21% had received PC. Self-rated PC knowledge was varied. Forty-five percent believed that PC was only associated with EOLC; those more likely to disagree had received PC services (p = 0.039).Integration of PC and oncology: Majority believed that they could receive oncology care (86%) and anti-cancer treatment (81%) whilst receiving PC. Those who had heard of PC and with better self-rated knowledge were more likely to believe that they could receive concurrent anti-cancer treatment (p = 0.005, p = 0.045, respectively).Feelings: 77% felt comforted with PC involvement; this was significantly associated with older age (p = 0.047) and understanding that oncology (p < 0.005) and anti-cancer treatment (p = 0.013) could continue. However, some felt frightened (40%) and hopeless (29%) about referral to PC. Fifty percent felt more comfortable with referral to 'supportive care' services (versus PC). CONCLUSIONS: Our survey demonstrates reasonable understanding and relatively positive feelings about PC, associated with experience and knowledge. Nonetheless, there is ongoing need for better patient and public education about PC.

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.

Outcomes of people with severe hypoglycaemia requiring prehospital emergency medical services management: a prospective study.

AIMS/HYPOTHESIS: The aim of this work was to investigate clinical outcomes following severe hypoglycaemia requiring prehospital emergency medical services (EMS) management. METHODS: We carried out a prospective, observational study of adults with diabetes attended by prehospital EMS for management of severe hypoglycaemia between April 2016 and July 2017. Information on precipitants, hospitalisation, length of hospital stay and recurrence was collected at 1 and 3 months following the episode of severe hypoglycaemia. Median and logistic regression models examined predictive factors. RESULTS: Five hundred and five adults (61% male, median age 67 years) participated in the study. Fifty-two per cent had type 1 diabetes, 43% type 2 diabetes and 5% were unsure of their diabetes type. Following EMS management of the index episode of severe hypoglycaemia, 50.3% were transported to hospital. Of those transported, 41.3% were admitted to hospital for ongoing management (20.8% of all participants). The following factors predicted hospital admission: older age (OR 1.28 [95% CI 1.02, 1.60] per 10 years), greater number of comorbidities (OR 1.27 [95% CI 1.08, 1.48] per morbidity), moderate-severe injury accompanying the hypoglycaemia (OR 5.24 [95% CI 1.07, 25.8] compared with nil-mild injury) and unknown cause of hypoglycaemia (OR 2.21 [95% CI 1.24, 3.94] compared with known cause). The median (interquartile range) length of hospital stay was 4 (2-7) days. During follow-up, recurrent severe hypoglycaemia attended by prehospital EMS was experienced by 10.7% of participants. Predictive factors of recurrent severe hypoglycaemia in 3 months were decreased HbA1c (OR 1.97 [95% CI 1.27, 3.06] per 10 mmol/mol decrease) and a greater number of antecedent severe hypoglycaemia episodes (OR 1.12 [95% CI 1.03, 1.23] per episode). CONCLUSIONS/INTERPRETATION: Following an episode of severe hypoglycaemia managed by EMS, one-fifth of participants required hospital admission, more likely in those with advancing age, increasing comorbidities and injury and one-tenth required EMS again for severe hypoglycaemia in a 3 month period, more likely in those with a greater number of antecedent episodes and lower HbA1c. Knowledge of these factors associated with admission and recurrence provides an opportunity for development of targeted strategies aimed at prevention of severe hypoglycaemia in those most vulnerable.