A randomized multicenter trial of a chronic disease management intervention for decompensated cirrhosis. The Australian Liver Failure (ALFIE) trial.

BACKGROUND AND AIMS: Improving the care of decompensated cirrhosis is a significant clinical challenge. The primary aim of this trial was to assess the efficacy of a chronic disease management (CDM) model to reduce liver-related emergency admissions (LREA). The secondary aims were to assess model effects on quality-of-care and patient-reported outcomes. APPROACH AND RESULTS: The study design was a 2-year, multicenter, randomized controlled study with 1:1 allocation of a CDM model versus usual care. The study setting involved both tertiary and community care. Participants were randomly allocated following a decompensated cirrhosis admission. The intervention was a multifaceted CDM model coordinated by a liver nurse. A total of 147 participants (intervention=75, control=71) were recruited with a median Model for End-Stage Liver Disease score of 19. For the primary outcome, there was no difference in the overall LREA rate for the intervention group versus the control group (incident rate ratio 0.89; 95% CI: 0.53-1.50, p=0.666) or in actuarial survival (HR=1.14; 95% CI: 0.66-1.96, p=0.646). However, there was a reduced risk of LREA due to encephalopathy in the intervention versus control group (HR=1.87; 95% CI: 1.18-2.96, p=0.007). Significant improvement in quality-of-care measures was seen for the performance of bone density (p<0.001), vitamin D testing (p<0.001), and HCC surveillance adherence (p=0.050). For assessable participants (44/74 intervention, 32/71 controls) significant improvements in patient-reported outcomes at 3 months were seen in self-management ability and quality of life as assessed by visual analog scale (p=0.044). CONCLUSIONS: This CDM intervention did not reduce overall LREA events and may not be effective in decompensated cirrhosis for this end point.

An empirical comparison of sleep-specific versus generic quality of life instruments among Australians with sleep disorders.

PURPOSE: In Australian adults diagnosed with a sleep disorder(s), this cross-sectional study compares the empirical relationships between two generic QoL instruments, the EuroQoL 5-dimension 5-level (EQ-5D-5L) and ICEpop CAPability measure for Adults (ICECAP-A), and three sleep-specific metrics, the Epworth Sleepiness Scale (ESS), 10-item Functional Outcomes of Sleep Questionnaire (FOSQ-10), and Pittsburgh Sleep Quality Index (PSQI). METHODS: Convergent and divergent validity between item/dimension scores was examined using Kendall's Tau-B correlation, with correlations below 0.30 considered weak, between 0.30 and 0.50 moderate and those above 0.50 strong (indicating that instruments were measuring similar constructs). Exploratory factor analysis (EFA) was conducted to identify shared underlying constructs. RESULTS: A total of 1509 participants (aged 18-86 years) were included in the analysis. Convergent validity between dimensions/items of different instruments was weak to moderate. A 5-factor EFA solution, representing 'daytime dysfunction', 'fatigue', 'wellbeing', 'physical health', and 'perceived sleep quality', was simplest with close fit and fewest cross-loadings. Each instrument's dimensions/items primarily loaded onto their own factor, except for the EQ-5D-5L and PSQI. Nearly two-thirds of salient loadings were of excellent magnitude (0.72 to 0.91). CONCLUSION: Moderate overlap between the constructs assessed by generic and sleep-specific instruments indicates that neither can fully capture the complexity of QoL alone in general disordered sleep populations. Therefore, both are required within economic evaluations. A combination of the EQ-5D-5L and, depending on context, ESS or PSQI offers the broadest measurement of QoL in evaluating sleep health interventions.

Measurement properties of utility-based health-related quality of life measures in cardiac rehabilitation and secondary prevention programs: a systematic review.

PURPOSE: To identify utility-based patient-reported outcome measures (PROMs) for assessing health-related quality of life (HRQoL) in cardiac rehabilitation and secondary prevention programs (CR) and appraise existing evidence on their measurement properties. Secondly, to link their items to the International Classification of Functioning Disability and Health (ICF) and the International Consortium of Health Outcome Measures (ICHOM) domains for cardiovascular disease (CVD). METHODS: Eight databases were searched. The review followed the COSMIN and JBI guidelines for measurement properties systematic reviews and PRISMA 2020 reporting guidelines. Non-experimental and observational empirical studies of patients ≥ 18 years of age with CVD undergoing CR and assessed quality of life (QoL) or HRQoL using utility-based PROMs or one accompanied by health state utilities were included. RESULTS: Nine PROMs were identified with evidence on measurement properties for three measures: the German translations of SF-12, EQ-5D-5L, and MacNew heart disease HRQoL questionnaire. There was moderate quality evidence for responsiveness and hypothesis testing of the SF-12 and EQ-5D-5L, and high-quality evidence for responsiveness and hypothesis testing for the MacNew. All items of SF-12 and EQ-5D were linked to ICF categories, but four items of the MacNew were not classified or defined. All the PROM domains were mapped onto similar constructs from the ICHOM global sets. CONCLUSION: Three utility-based PROMs validated in CR were identified: the German versions of the EQ-5D and SF-12 and the MacNew questionnaire. These PROMs are linked to a breadth of ICF categories and all ICHOM global sets. Additional validation studies of PROMs in CR are required.

Two-year follow-up of a clustered randomised controlled trial of a multicomponent general practice intervention for people at risk of poor health outcomes.

BACKGROUND: This study was a two-year follow-up evaluation of health service use and the cost-effectiveness of a multicomponent general practice intervention targeted at people at high risk of poor health outcomes. METHODS: A two-year follow-up study of a clustered randomised controlled trial was conducted in South Australia during 2018-19, recruiting 1044 patients from three cohorts: children; adults (aged 18-64 years with two or more chronic diseases); and older adults (aged ≥ 65 years). Intervention group practices (n = 10) provided a multicomponent general practice intervention for 12 months. The intervention comprised patient enrolment to a preferred general practitioner (GP), access to longer GP appointments and timely general practice follow-up after episodes of hospital care. Health service outcomes included hospital use, specialist services and pharmaceuticals. The economic evaluation was based on quality-adjusted life years (QALYs) calculated from EuroQoL 5 dimensions, 5 level utility scores and used an A$50,000 per QALY gained threshold for determining cost-effectiveness. RESULTS: Over the two years, there were no statistically significant intervention effects for health service use. In the total sample, the mean total cost per patient was greater for the intervention than control group, but the number of QALYs gained in the intervention group was higher. The estimated incremental cost-effectiveness ratio (ICER) was A$18,211 per QALY gained, which is lower than the A$50,000 per QALY gained threshold used in Australia. However, the intervention's cost-effectiveness was shown to differ by cohort. For the adult cohort, the intervention was associated with higher costs and lower QALYs gained (vs the total cohort) and was not cost-effective. For the older adults cohort, the intervention was associated with lower costs (A$540 per patient), due primarily to lower hospital costs, and was more effective than usual care. CONCLUSIONS: The positive cost-effectiveness results from the 24-month follow-up warrant replication in a study appropriately powered for outcomes such as hospital use, with an intervention period of at least two years, and targeted to older people at high risk of poor health outcomes.

Responsiveness and construct validity of EPIC-26, AQoL-6D and SF-6D following treatment in prostate cancer.

PURPOSE: To assess construct validity and responsiveness of the Expanded Prostate Cancer Index Composite Instrument (EPIC-26) relative to the Short-Form Six-Dimension (SF-6D) and Assessment of Quality of Life 6-Dimension (AQoL-6D) in patients following treatment for prostate cancer. METHODS: Retrospective prostate cancer registry data were used. The SF-6D, AQoL-6D, and EPIC-26 were collected at baseline and one year post treatment. Analyses were based on Spearman's correlation coefficient, Bland-Altman plots and intra-class correlation coefficient, Kruskal Wallis, and Effect Size and the Standardised Response Mean for responsiveness. RESULTS: The study sample was comprised of 1915 patients. Complete case analysis of 3,697 observations showed moderate evidence of convergent validity between EPIC-26 vitality/hormonal domain and AQoL-6D (r = 0.45 and 0.54) and SF-6D (r = 0.52 and 0.56) at both timepoints. Vitality/hormonal domain also showed moderate convergent validity with coping domain of AQoL-6D (r = 0.45 and 0.54) and with role (r = 0.41 and 0.49) and social function (r = 0.47 and 0.50) domains of SF-6D at both timepoints, and with independent living (r = 0.40) and mental health (r = 0.43) of AQoL-6D at one year. EPIC-26 sexual domain had moderate convergent validity with relationship domain (r = 0.42 and 0.41) of AQoL-6D at both timepoints. Both AQoL-6D and SF-6D did not discriminate between age groups and tumour stage at both timepoints but AQoL-6D discriminated between outcomes for different treatments at one year. All EPIC-26 domains discriminated between age groups and treatment at both timepoints. The EPIC-26 was more responsive than AQoL-6D and SF-6D between baseline and one year following treatment. CONCLUSIONS: AQoL-6D can be used in combination with EPIC-26 in place of SF-12. Although EPIC-26 is not utility based, its popularity amongst clinicians and ability to discriminate between disease-specific characteristics and post-treatment outcomes in clinical trials makes it a candidate for use within cost-effectiveness analyses. The generic measure provides a holistic assessment of quality of life and is suitable for generating quality adjusted life years (QALYs).

Mortality and costs related to severe acute pancreatitis in the intensive care units of Australia and New Zealand (ANZ), 2003-2020.

BACKGROUND AND OBJECTIVE: Comprehensive data on the burden of severe acute pancreatitis (SAP) in global intensive care units (ICUs) and trends over time are lacking. Our objective was to compare trends in hospital and ICU mortality, in-hospital and ICU length of stay, and costs related to ICU admission in Australia and New Zealand (ANZ) for SAP. METHODS: We performed a retrospective, observational, cohort study of ICU admissions reported to the ANZ Intensive Care Society Adult Patient Database over three consecutive six-year time periods from 2003 to 2020. RESULTS: 12,635 patients with SAP from 189 ICUs in ANZ were analysed. No difference in adjusted hospital mortality (11.4% vs 11.5% vs 11.0%, p = 0.85) and ICU mortality rates (7.5% vs 8.0% vs 8.1%, p = 0.73) were noted over the study period. Median length of hospital admission reduced over time (13.9 days in 2003-08, 13.1 days in 2009-14 and 12.5 days in 2015-20; p < 0.01). No difference in length of ICU stay was noted over the study period (p = 0.13). The cost of managing SAP in ANZ ICUs remained constant over the three time periods. CONCLUSIONS: In critically-ill SAP patients in ANZ, no change in mortality has been noted over nearly two decades. There was a slight reduction in hospital stay (1 day), while the length of ICU stay remained unchanged. Given the significant costs related to care of patients with SAP in ICU, these findings highlight the need to prioritise resource allocation for healthcare delivery and targeted clinical research to identify treatments aimed at reducing mortality.

Evaluation of the EQ-5D-5L, EQ-VAS stand-alone component and Oxford knee score in the Australian knee arthroplasty population utilising minimally important difference, concurrent validity, predictive validity and responsiveness.

PURPOSE: To evaluate the Oxford Knee Score (OKS), EQ-5D-5L utility index and EQ-5D visual analogue scale (EQ-VAS) for health-related quality of life outcome measurement in patients undergoing elective total knee arthroplasty (TKA) surgery. METHODS: In this prospective multi-centre study, the OKS and EQ-5D-5L index scores were collected preoperatively, six weeks (6w) and six months (6 m) following TKA. The OKS, EQ-VAS and EQ-5D-5L index were evaluated for minimally important difference (MID), concurrent validity, predictive validity (Spearman's Rho of predicted and observed values from a generalised linear regression model (GLM)), responsiveness (effect size (ES) and standard response mean (SRM)). The MID for the individual patient was determined utilising two approaches; distribution-based and anchor-based. RESULTS: 533 patients were analysed. The EQ-5D-5L utility index showed good concurrent validity with the OKS (r = 0.72 preoperatively, 0.65 at 6w and 0.69 at 6 m). Predictive validity for the EQ-5D-5L index was lower than OKS when regressed. Responsiveness was large for all fields at 6w for the EQ-5D-5L and OKS (EQ-5D-5L ES 0.87, SRM 0.84; OKS ES 1.35, SRM 1.05) and 6 m (EQ-5D-5L index ES 1.31, SRM 0.95; OKS ES 1.69, SRM 1.59). The EQ-VAS returned poorer results, at 6w an ES of 0.37 (small) and SRM of 0.36 (small). At 6 m, the EQ-VAS had an ES of 0.59 (moderate) and SRM of 0.47 (small). It, however, had similar predictive validity to the OKS, and better than the EQ-5D-5L index. MID determined using anchor approach, was shown that for OKS at 6 weeks it was 8.84 ± 9.28 and at 6 months 13.37 ± 9.89. For the EQ-5D-5L index at 6 weeks MID was 0.23 ± 0.39, and at 6 months 0.26 ± 0.36. CONCLUSIONS: The EQ-5D-5L index score and the OKS demonstrate good concurrent validity. The EQ-5D-5L index demonstrated lower predictive validity at 6w, and 6 m than the OKS, and both PROMs had adequate responsiveness. The EQ-VAS had poorer responsiveness but better predictive validity than the EQ-5D-5L index. This article includes MID estimates for the Australian knee arthroplasty population.

Assessing the validity and responsiveness of a generic preference quality of life measure in the context of posttraumatic stress disorder.

PURPOSE: There is limited research exploring the usefulness of generic preference-based quality of life (GPQoL) measures used to facilitate economic evaluation in the context of posttraumatic stress disorder (PTSD). The aim of the current study was to explore the validity and responsiveness of a common GPQoL measure (Assessment of Quality of Life 8 Dimension [AQoL-8D]) in relation to a PTSD condition-specific outcome measure (Posttraumatic Stress Disorder Checklist for the DSM-5 [PCL-5]). METHOD: This aim was investigated in a sample of individuals (N = 147) who received trauma-focused cognitive-behavioural therapies for posttraumatic stress disorder. Convergent validity was investigated using spearman's correlations, and the level of agreement was investigated using Bland-Altman plots. Responsiveness was investigated by exploring the standardised response means (SRM) from pre-post-treatment across the two measures, which allow the comparison of the magnitude of change between the measures over time. RESULTS: Correlations between the AQoL-8D (dimensions, utility and summary total scores) and the PCL-5 total score ranged from small to large and agreement between the measures was considered moderate to good. While SRMs were large for the AQoL-8D and PCL-5 total scores, the SRM for the PCL-5 was nearly double that of the AQoL-8D. CONCLUSION: Our findings demonstrate that the AQoL-8D has good construct validity but present preliminary evidence that economic evaluations using only GPQoL measures may not fully capture the effectiveness of PTSD treatments.

Does socioeconomic status impact the relationship between school absence and outcomes?

Absence from school, especially frequent or prolonged absence, is acknowledged as a potential factor in school dropout and suboptimal academic achievement. The issue of absence from school took on added significance in 2020 with the onset of the COVID-19 crisis, which resulted in schooling interruptions in several jurisdictions. However, there is little agreement in the literature on the exact relationship between absence and school outcomes as a function of socioeconomic status (SES). Using nationally representative pre-COVID longitudinal data of young Australians aged 12-13 and 14-15, this paper examines the relationship between absence from school on the one hand and school belonging and academic achievement (numeracy and reading test scores) on the other. The paper also examines whether SES intersects this relationship. Controlling for gender, prior educational achievement, computer access, and time spent doing homework, the study finds that absence impacts belonging, but that SES does not significantly influence this relationship. The effect of absence on reading is not significant either. However, absence is associated with numeracy outcomes, with the strongest associations among low SES young people at age 14. Policy implications of these findings are discussed. Supplementary Information: The online version contains supplementary material available at 10.1007/s13384-022-00535-2.

Finding My Way-Advanced: can a web-based psychosocial intervention improve the mental quality of life for women with metastatic breast cancer vs attention-control? Study protocol of a randomised controlled trial.

BACKGROUND: Women living with metastatic breast cancer (MBC) are at risk of significantly impaired quality of life (QOL), symptom burden, distress and fear of progression, and unmet needs, yet they face barriers to accessing evidence-based psychosocial treatments. Our group therefore developed Finding My Way-Advanced (FMW-A), a web-based self-guided psychosocial program for women with MBC. This study aims to assess its efficacy in improving mental and other QOL domains, distress, fear of progression, unmet needs, and health service utilisation. METHODS: The multi-site randomised controlled trial (RCT) will enrol 370 Australian participants. Eligible participants are adult (18 years +) women diagnosed with MBC, with a life expectancy of 6 months or more, with sufficient English-language literacy to provide informed consent. Participants will be identified, screened and referred from one of 10 Australian sites, or via self-referral in response to advertisements. Participants complete four online questionnaires: prior to accessing their program ('baseline'), 6 weeks later ('post-intervention'), then 3 months and 6 months post-intervention. Consenting participants will be randomised to either FMW-A (intervention), or Breast Cancer Network Australia's (BCNA) online/app resource My Journey (minimal intervention attention-control). This is a single-blind study, with randomisation computer-generated and stratified by site. FMW-A is a 6-module program addressing some of the most common issues experienced by women with MBC, with BCNA control resources integrated within the 'resources' section. All modules are immediately accessible, with an additional booster module released 10 weeks later. The primary outcome is mental QOL; statistical criteria for superiority is defined as a 4-point difference between groups at post-treatment. Secondary outcomes include other QOL domains, distress, fear of progression, health service use, intervention adherence, and user satisfaction. DISCUSSION: This will be the first adequately powered RCT of a self-directed online intervention for women with MBC. If efficacious, FMW-A will help address two national key priorities for management of MBC - enhancing QOL and reducing symptom burden. FMW-A has the potential to address unmet needs and overcome access barriers for this overlooked population, while reducing health system burden. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 29/10/2021. Trial ID ACTRN12621001482853p.  https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382714&isReview=true.

Incidence and causes of early unplanned readmission after hospitalisation with peripheral arterial disease in Australia and New Zealand.

OBJECTIVE: To evaluate the characteristics and predictors of unplanned readmission within 30 days of hospitalisation for the treatment of peripheral arterial disease (PAD) in Australia and New Zealand. DESIGN: Analysis of hospitalisations data in the Admitted Patient Collection for each Australian state and territory and the New Zealand National Minimum Dataset (Hospital Events). SETTING: All public and 80% of private hospitals in Australia and New Zealand. PARTICIPANTS: Adults (18 years or older) hospitalised with a primary or conditional secondary diagnosis of PAD during 1 January 2010 - 31 December 2015. MAIN OUTCOME MEASURE: Rate of unplanned readmission (any cause) within 30 days of hospitalisation with PAD. RESULTS: Of 104 979 admissions included in our analysis (mean patient age, 73.7 years; SD, 12.4 years), 9765 were followed by at least one unplanned readmission within 30 days of discharge (9.3%): 3395 within one week (34.8%) and 7828 within three weeks (80.2%). The most frequent readmission primary diagnoses were atherosclerosis (1477, 15.3%), type 2 diabetes (1057, 10.8%), and "complications of procedures not elsewhere classified" (963, 9.9%). Readmission was more frequent after acute (4830 of 26 304, 18.4%) than elective PAD hospitalisations (4935 of 78 675, 6.3%), but the readmission characteristics were similar. Factors associated with greater likelihood of readmission included acute PAD hospitalisations (odds ratio [OR], 2.04; 95% CI, 1.96-2.17), surgical intervention during the PAD hospitalisation (OR, 1.74; 95% CI, 1.64-1.84), and chronic limb-threatening ischaemia (OR, 1.55; 95% CI, 1.47-1.63). CONCLUSION: Unplanned readmissions within 30 days of hospitalisation for PAD are often for potentially preventable reasons. Their number should be reduced to improve clinical outcomes for people with PAD.

A general practice intervention for people at risk of poor health outcomes: the Flinders QUEST cluster randomised controlled trial and economic evaluation.

OBJECTIVE: To determine whether a multicomponent general practice intervention cost-effectively improves health outcomes and reduces health service use for patients at high risk of poor health outcomes. DESIGN, SETTING: Clustered randomised controlled trial in general practices in metropolitan Adelaide. PARTICIPANTS: Three age-based groups of patients identified by their general practitioners as being at high risk of poor health outcomes: children and young people (under 18 years), adults (18-64 years) with two or more chronic diseases, and older people (65 years or more). INTERVENTION: Enrolment of patients with a preferred GP, longer general practice appointments, and general practice follow-up within seven days of emergency department and hospital care episodes. Intervention practices received payment of $1000 per enrolled participant. MAIN OUTCOME MEASURES: Primary outcome: change in self-rated health between baseline and 12-month follow-up for control (usual care) and intervention groups. SECONDARY OUTCOMES: numbers of emergency department presentations and hospital admissions, Medicare specialist claims and Pharmaceutical Benefits Scheme (PBS) items supplied, Health Literacy Questionnaire scores, and cost-effectiveness of the intervention (based on the number of quality-adjusted life-years [QALYs] gained over 12 months, derived from EQ-5D-5L utility scores for the two adult groups). RESULTS: Twenty practices with a total of 92 GPs were recruited, and 1044 eligible patients participated. The intervention did not improve self-rated health (coefficient, -0.29; 95% CI, -2.32 to 1.73), nor did it have significant effects on the numbers of emergency department presentations (incidence rate ratio [IRR], 0.90; 95% CI, 0.69-1.17), hospital admissions (IRR, 0.90; 95% CI, 0.66-1.22), Medicare specialist claims (IRR, 1.00; 95% CI, 0.91-1.09), or PBS items supplied (IRR, 0.99; 95% CI, 0.96-1.03), nor on Health Literacy Questionnaire scores. The intervention was effective in terms of QALYs gained (v usual care: difference, 0.032 QALYs; 95% CI, 0.001-0.063), but the incremental cost-effectiveness ratio was $69 585 (95% CI, $22 968-$116 201) per QALY gained, beyond the willingness-to-pay threshold. CONCLUSIONS: Our multicomponent intervention did not improve self-rated health, health service use, or health literacy. It achieved greater improvement in quality of life than usual care, but not cost-effectively. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617001589370 (prospective).

Thirty-Day Unplanned Readmissions Following Hospitalisation for Atrial Fibrillation in Australia and New Zealand.

AIMS: Atrial fibrillation (AF) is a leading cause of hospitalisations, yet little is known about 30-day readmissions following discharge despite increasing policy focus on reducing readmissions. We assessed the rate, timing, causes and predictors of 30-day unplanned readmission following an acute and elective AF hospitalisation using population-wide data. METHODS: We studied all patients hospitalised for AF from 2010 to 2015 at all public and most private hospitals in Australia and New Zealand. The main outcome measures were unplanned readmissions within 30 days of discharge, primary diagnosis associated with these readmissions, and their predictors as modelled by logistic regression. RESULTS: Among 301,654 patients hospitalised for AF (mean age 69.2±13.6 yrs, 55.6% female, 65.2% acute presentations), 29,750 (9.9%) experienced an unplanned readmission within 30 days with 62.6% occurring by 14 days. Unplanned readmissions occurred more frequently following an acute versus elective AF hospitalisations (12.5% vs 4.9%, p<0.001). The most common diagnoses associated with readmissions were recurrence of AF (n=9,890, 33.2%), and preventable conditions including heart failure (n=2,683, 9.0%), pneumonia (n=724, 2.4%) and acute myocardial infarction (n=510, 1.7%). A higher risk of 30-day readmission was associated with congenital cardiac/circulatory defect (OR 2.18, CI 1.44-3.30), congestive heart failure (OR 1.34, CI 1.30-1.39), and arrhythmia/conduction disorders (OR 1.25, CI 1.21-1.28). CONCLUSION: Almost 1 in 10 AF hospitalisations resulted in unplanned readmission within 30-days, mostly for AF recurrence. Improved clinical management of AF and transitional care planning are required to reduce unplanned readmissions following AF hospitalisations.

Nurse Led Clinics; a Novel Model of Care for Compensated Liver Cirrhosis: A Qualitative Analysis.

A nurse-led cirrhosis clinic model for management of stable, compensated cirrhotic patients is practised in our unit since 2013, wherein these patients are reviewed every six months by specialist nurses in community clinics under remote supervision of hepatologists. We evaluated the experiences of patients and healthcare providers involved in the model to understand the acceptability, strengths, and limitations of the model and obtain suggestions to improve. A qualitative design using in-depth interviews was employed, followed by thematic analysis of eight patients, one attending physician both nurse and hospital clinics, four hepatologists, and three experienced specialist nurses running the nurse-led cirrhosis clinic. Patients expressed satisfaction and a good understanding of the nurse-led cirrhosis clinic, preferring it to hospital clinics for better accessibility and the unique nurse-patient relationship. Upskilling and provision of professional care in a holistic manner were appreciated by specialist nurses. The hepatologists expressed confidence and satisfaction, although they acknowledged the difference between the medical training of specialist nurses and hepatologists. The greater availability of hospital clinic time for sick patients was welcomed. Increased specialist nurse staffing, regular forums to promote specialist nurse learning, and formalization of the referral process were suggested. No adverse experiences were reported by patients or staff. The nurse-led cirrhosis clinic model for compensated liver cirrhosis was well received by patients, hepatologists, and specialist nurses. Wider implementation of the model could be considered after further investigations in other settings.

Enhancing the cost-effectiveness of surgical care in pancreatic cancer: a systematic review and cost meta-analysis with trial sequential analysis.

BACKGROUND: Clinical pathways (CP) based on Enhanced recovery after surgery (ERAS®) are increasingly utilised in patients undergoing pancreatoduodenectomy (PD). This systematic review aimed to compare the impact of CPs versus conventional care (CC) on peri-PD costs. METHODS: A systematic review of major reference databases was undertaken. Quality assessment was performed using the CHEERS checklist. Incremental cost-effectiveness ratios were calculated as part of the cost-effectiveness analysis. A meta-analysis was performed using random-effects models and Trial sequential analysis (TSA) was used to assess the precision and conclusiveness of the results. RESULTS: 14 studies meeting inclusion criteria were included for full qualitative synthesis. All studies reported a reduction in overall costs, length of stay and overall complication rates for CPs when compared to CC. Meta-analysis performed on nine studies demonstrated significantly reduced costs in the CP group, with considerable heterogeneity (Pooled mean difference of $ 4.28 × 103, p < 0.01, I2 = 95%). Cost-effectiveness analysis in relation to complications demonstrated dominance of CPs over CC in being cheaper as well as more effective. TSA supported the cost benefit of enhanced-recovery CPs, displaying minimal type 1 error. CONCLUSION: Peri-PD CPs result in significant cost-reduction in comparison to CC.

Late mortality in people with cancer: a population-based Australian study.

OBJECTIVES: To investigate causes of death of people with cancer alive five years after diagnosis, and to compare mortality rates for this group with those of the general population. DESIGN, SETTING, PARTICIPANTS: Retrospective cohort study; analysis of South Australian Cancer Registry data for all people diagnosed with cancer during 1990-1999 and alive five years after diagnosis, with follow-up to 31 December 2016. MAIN OUTCOME MEASURES: All-cause and cancer cause-specific mortality, by cancer diagnosis; standardised mortality ratios (study group v SA general population) by sex, age at diagnosis, follow-up period, and index cancer. RESULTS: Of 32 646 people with cancer alive five years after diagnosis, 30 309 were of European background (93%) and 16 400 were males (50%); the mean age at diagnosis was 60.3 years (SD, 15.7 years). The median follow-up time was 17 years (IQR, 11-21 years); 17 268 deaths were recorded (53% of patients; mean age, 80.6 years; SD, 11.4 years): 7845 attributed to cancer (45% of deaths) and 9423 attributed to non-cancer causes (55%). Ischaemic heart disease was the leading cause of death (2393 deaths), followed by prostate cancer (1424), cerebrovascular disease (1175), and breast cancer (1118). The overall standardised mortality ratio (adjusted for age, sex, and year of diagnosis) was 1.24 (95% CI, 1.22-1.25). The cumulative number of cardiovascular deaths exceeded that of cancer cause-specific deaths from 13 years after cancer diagnosis. CONCLUSIONS: Mortality among people with cancer who are alive at least five years after diagnosis was higher than for the general population, particularly cardiovascular disease-related mortality. Survivorship care should include early recognition and management of risk factors for cardiovascular disease.

External validation of a model to identify cardiometabolic predictors of mortality in cancer survivors.

PURPOSE: Cancer survivors are at risk of cardiovascular disease because of shared risk factors and effects of treatment. There are few tools to assist in estimating the risk of poor outcomes relating to cardiovascular disease in cancer survivors and identifying those at risk. The purpose of this study was to externally validate a model for predicting the risk of increased mortality in female cancer survivors. METHODS: A risk prediction model originally developed using data from the general population of older adults from the Australian Longitudinal Study of Ageing was externally validated using data from two Australian Longitudinal Study on Women's Health (ALSWH) cohorts. Three measures of discrimination were calculated. Calibration was assessed by visualising a graph of the model predictions and observed events. RESULTS: The ALSWH cohorts consisted of 1764 women (aged 73-78 years) and 1833 women (aged 47-52 years). Discrimination was acceptable with the Harrell C-index and the Gonen and Heller K statistic both greater than 0.5. The model explained up to 30% of the variation in mortality. Calibration showed that the recalibrated model performed best in years 8-10 suggesting that the model is better at predicting survival for those with a higher probability of surviving. Overall, model performance was better in the 47-52 years cohort than in the older cohort. CONCLUSION: We have externally validated a model of cardiometabolic predictors of mortality in female cancer survivors. The model can serve as a basis of clinical tool to assist with decision-making regarding potential risk reduction strategies in this population.

Psychometric validation of the Partners in Health scale as a self-management tool in patients with liver cirrhosis.

BACKGROUND AND AIM: Liver cirrhosis is a chronic disease complicated by recurrent hospital admissions. Self-management skills could facilitate optimal disease management. At present there is no validated instrument for measuring self-management in these patients. Hence, we evaluated the internal reliability and construct validity of the Partners in Health (PIH) scale, a chronic condition self-management tool in cirrhotic patients. METHODS: In this prospective cohort study, the PIH scale was administered to 133 consenting patients within a Chronic Liver Failure Program of a tertiary hospital from February 2017 to May 2018. A Bayesian confirmatory factor analysis was used to evaluate a priori four-factor structure. Omega coefficients and 95% credible intervals (CrI) were used to assess internal reliability. Known-group validity was assessed in patients receiving active case management (n = 60) versus those without (n = 73). RESULTS: The mean (± standard deviation (SD)) age of the participants was 62 (±11) years. Model fit for the hypothesised model was adequate (posterior predictive P-value = 0.073) and all hypothesised factor loadings were substantial (>0.6) and significant (P < 0.001). Omega coefficients (95% CrI) for the PIH subscales of Knowledge, Partnership, Management and Coping were 0.88 (0.82-0.91), 0.68 (0.57-0.76), 0.92 (0.89-0.94) and 0.89 (0.85-0.92) respectively. The mean (±SD) overall PIH score was higher in patients receiving case management compared to those without case management (81 ± 12 vs 73 ± 17, P < 0.001). CONCLUSION: The dimensionality, known-group validity and reliability of the PIH scale for measuring self-management in patients with liver cirrhosis were confirmed. Its clinical predictive value requires further assessment.

Validation of Knowledge Questionnaire for Patients With Liver Cirrhosis.

BACKGROUND & AIMS: There is no validated questionnaire to assess disease knowledge and self-management in patients with liver cirrhosis. We developed and validated a Cirrhosis Knowledge Questionnaire (CKQ). METHODS: We created a preliminary CKQ comprising 10 questions relevant to self-management of cirrhosis, based on publications and clinical experiences. The CKQ was given to a pilot sample of 17 patients with decompensated cirrhosis to assess its face validity. In consultation with experts, we developed a second version of CKQ, comprising 14 multiple choice questions, and administered it to 116 patients with cirrhosis participating in a Chronic Liver Failure Program. The dimensionality of the construct was assessed using exploratory factor analysis and internal consistency was assessed with Cronbach's alpha. Known-group validity of the resulting instrument was assessed by comparing the performance of the CKQ in 69 patients with decompensated cirrhosis (mean age, 62 ± 13 years; 109 responses), with (n = 42) vs without (n = 67) case management. RESULTS: A 3-factor model with 7 questions related to variceal bleeding, ascites, and hepatic encephalopathy was considered the optimal dimensionality with excellent internal consistency (Cronbach's alpha = 0.82). The mean knowledge score was higher in patients with case management (5.6 ± 1.1) than in patients without case management (4.3 ± 2.1) (P = .002). CONCLUSIONS: We developed and validated a questionnaire with 7 questions on ascites, variceal bleeding, and hepatic encephalopathy to assess knowledge and self-management in patients with liver cirrhosis. Studies are needed to confirm its dimensionality and assess association of scores with patient outcomes.

Financial toxicity and employment status in cancer survivors. A systematic literature review.

BACKGROUND: Financial toxicity has traditionally been attributed to the rising costs of cancer care. As ability to work impacts one's financial situation, limited employment and reduced income may also contribute to financial toxicity. We examined evidence of the association between financial toxicity and employment status in cancer survivors. METHODS: A systematic literature review was performed via PubMed, Web of Science, CINAHL, and PsycINFO with search terms including "Cancer," "Financial toxicity," and "Employment" on September 25, 2019. RESULTS: Thirty-one papers met eligibility criteria. Thirteen studies were rated as having high quality, 16 as adequate, and two as low. Being actively treated for cancer had serious negative consequences on employment and medical expenditures. Unemployment, changed or reduced employment, lost days at work, poor work ability, and changes to employment were associated with a higher risk of financial toxicity. Patients who were younger, non-white, unmarried, of low education, living with dependents, residing in non-metropolitan service areas, with lower income, and of low socioeconomic status were more at risk of financial toxicity. Other variables associated with financial toxicity included having a mortgage/personal loan, higher out of pocket costs and household bills, limited health insurance, more severely ill, on active treatment, and lower functioning or quality of life. CONCLUSION: Cancer negatively affects employment, and these changes are significant contributors to financial toxicity. Researchers, healthcare professionals, and patients themselves should all cooperate to tackle these complex issues.