Development of algorithms for estimating the Child Health Utility 9D from Caregiver Priorities and Child Health Index of Life with Disability.

PURPOSE: The primary aim was to determine Child Health Utility 9D (CHU9D) utilities from the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) for non-ambulatory children with cerebral palsy (CP). METHODS: One hundred and eight surveys completed by Australian parents/caregivers of children with CP were analysed. Spearman's coefficients were used to investigate the correlations between the two instruments. Ordinary least square, robust MM-estimator, and generalised linear models (GLM) with four combinations of families and links were developed to estimate CHU9D utilities from either the CPCHILD total score or CPCHILD domains scores. Internal validation was performed using 5-fold cross-validation and random sampling validation. The best performing algorithms were identified based on mean absolute error (MAE), concordance correlation coefficient (CCC), and the difference between predicted and observed means of CHU9D. RESULTS: Moderate correlations (ρ 0.4-0.6) were observed between domains of the CHU9D and CPCHILD instruments. The best performing algorithm when considering the CPCHILD total score was a generalised linear regression (GLM) Gamma family and logit link (MAE = 0.156, CCC = 0.508). Additionally, the GLM Gamma family logit link using CPCHILD comfort and emotion, quality of life, and health domain scores also performed well (MAE = 0.152, CCC = 0.552). CONCLUSION: This study established algorithms for estimating CHU9D utilities from CPCHILD scores for non-ambulatory children with CP. The determined algorithms can be valuable for estimating quality-adjusted life years for cost-utility analysis when only the CPCHILD instrument is available. However, further studies with larger sample sizes and external validation are recommended to validate these findings.

Participant and GP perspectives and experiences of screening for undiagnosed type 2 diabetes in community pharmacy during the Pharmacy Diabetes Screening Trial.

BACKGROUND: The Pharmacy Diabetes Screening Trial (PDST) evaluated three approaches to screening for undiagnosed type 2 diabetes mellitus (T2DM) in community pharmacy: (1) paper-based risk assessment (AUSDRISK) alone; and AUSDRISK followed by a point of care test if AUSDRISK ≥ 12; with either (2) HbA1c; or (3) small capillary blood glucose Test (scBGT). This paper reports the perspectives and experiences of the pharmacy screening service of two key stakeholder groups: screening participants and general practitioners (GPs). METHODS: All referred participants (n = 2242) received an online survey to determine the outcome of the referral, as well as their level of satisfaction with the service. In addition, a random sample of 2,989 (20%) of non-referred participants were surveyed to determine their overall experience and level of satisfaction with the service. GPs to whom participants were referred were contacted to establish if, since the date of the screening service, their patient had (1) been to see them; (2) had further tests performed (FBG, RBG, OGTT, HbA1c); or (3) been diagnosed with diabetes or prediabetes. Descriptive statistics were reported for quantitative data. Factors associated with visiting the GP following screening were assessed using multivariable logistic regression. Qualitative data were analysed using content analysis. RESULTS: Response rates 16% (n = 369) and 17% (n = 520) were achieved for the three-month referred and non-referred participant surveys, respectively. Over 90% of respondents were very positive about the screening service (n = 784/853) and would recommend it to a family member or friend (n = 784/853). Participants also reported making significant improvements in diet and exercise, because of the screening. Among referred respondents, those who received a POC test were twice as likely to visit their GP compared to those who received a risk assessment only (OR 2.11 95% CI 1.46-3.06). GPs (15.8% response rate, n = 57/361) indicated that the referral worked well and that recommendations for follow-up care by the pharmacist were appropriate. CONCLUSION: Opportunistic screening of individuals during routine encounters with the community pharmacy in a previously undiagnosed population has been shown to foster positive engagement with consumers and GPs, which may assist in reducing the burden of T2DM on the individual and the community.

Electronic patient-reported monitoring of symptoms during follow-up of ovarian cancer patients: a feasibility study.

BACKGROUND: Ovarian cancer patients require monitoring for relapse. Innovative follow-up methods are increasingly being explored. An electronic patient-reported outcome (ePRO) follow-up pathway was developed for women treated for ovarian cancer. This feasibility study explored patient acceptability and compliance. METHODS: A single-arm non-blinded prospective feasibility study was undertaken at two hospitals. Participants were women who had completed treatment for ovarian cancer whose clinician was happy for them to be monitored remotely. Automated 3-monthly reminders were sent to participants to complete an ePRO questionnaire and obtain blood tests. Participants were reviewed over the phone by their clinical nurse specialist instead of attending clinic-based follow-up. The primary outcome was compliance (expected ePRO completions/blood tests) across the 12-month study period. Secondary outcomes were recruitment, attrition, resource use, symptom severity/alerts and patient acceptability. RESULTS: Twenty-four women consented (50% consent rate), and 13 remained on study at 12 months. Seven women relapsed, 3 chose to withdraw, and 1 withdrew for other clinical reasons. ePRO compliance was high and consistent at 75-82%, although the two hospitals differed. Adherence to the clinical protocol was evident for blood tests and contacts with staff (fewer visits, more phonecalls compared to an earlier audit). End-of-study feedback indicated high patient satisfaction. CONCLUSIONS: Remote ePRO follow-up for ovarian cancer is feasible and acceptable to patients who are able and willing to participate. However, the low recruitment rate (ineligible + declined) indicate it is not suitable/acceptable to all patients immediately post-treatment. Further large-scale research and implementation work is required, especially in a post-COVID era. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02847715 (first registered 19/05/2016).

Evaluation of Communities That Care-Effects on Municipal Youth Crime Rates in Victoria, Australia: 2010-2019.

Internationally, youth crime is a significant social problem. Violent youth crime has been rising over the past decade in the state of Victoria, Australia. Communities That Care (CTC) is a coalition training process designed to prevent youth crime. There has been limited evaluation outside the USA. Using a non-experimental design, this study employed official state crime statistics to evaluate the impact on crime as the five-phase CTC process was implemented between 2010 and 2019 across communities in Victoria. The standard five-phase CTC implementation cycle was supplemented with universal programs to reduce sales and supply of alcohol to underage youth (under 18 years). Growth models evaluated community trends in youth crime (all, person, property and deception and other), comparing communities that implemented CTC at phase 4 or greater with communities that had not implemented CTC. In accord with the hypotheses, the study found significant reductions in crimes associated with CTC over the period between 2010 and 2019. A 2% annual reduction in risk was observed for crimes against persons for all age groups (IRR = 0.98, 95% CI [0.96, 0.998]). A 5% annual reduction was observed for crimes of property and deception for adolescents aged between 10 and 17 years (IRR = 0.95, 95% CI [0.90, 0.99]). These findings support CTC as an intervention for preventing youth crime at a population level. Future studies should evaluate intervention mechanisms and economic benefits.

An integrated multicomponent care model for men affected by prostate cancer: A feasibility study of TrueNTH Australia.

OBJECTIVE: To evaluate the feasibility of implementing an integrated multicomponent survivorship care model for men affected by prostate cancer. METHODS: Using a single arm prospective cohort study design, men with prostate cancer were recruited from two regional public hospitals in Australia for a 6-months program that provided information and decision support, exercise and nutrition management, specialised clinical support, and practical support through localised and central care coordination. Carers of the men were also invited to the program. Data were collected from multiple sources to evaluate: (1) recruitment capability and participant characteristics; (2) appropriateness and feasibility of delivering the specific intervention components using an electronic care management tool; and (3) suitability of data collection procedures and proposed outcome measures. RESULTS: Of the 105 eligible men, 51 (consent rate 49%) participated in the program. Of the 31 carers nominated by the men, 13 consented (consent rate 42%). All carers and 50 (98%) men completed the program. Most (92%) men were newly diagnosed with localised prostate cancer. All men attended initial screening and assessment for supportive care needs; a total of 838 episodes of contact/consultation were made by the intervention team either in person (9%) or remotely (91%). The intervention was implemented as proposed with no adverse events. The proposed outcome measures and evaluation procedures were found to be appropriate. CONCLUSIONS: Our results support the feasibility of implementing this integrated multicomponent care model for men affected by prostate cancer.

A cost-benefit analysis framework for preventive health interventions to aid decision-making in Australian governments.

BACKGROUND: Australian governments are increasingly mandating the use of cost-benefit analysis (CBA) to inform the efficient allocation of government resources. CBA is likely to be useful when evaluating preventive health interventions that are often cross-sectoral in nature and require Cabinet approval prior to implementation. This study outlines a CBA framework for the evaluation of preventive health interventions that balances the need for consistency with other agency guidelines whilst adhering to guidelines and conventions for health economic evaluations. METHODS: We analysed CBA and other evaluation guidance documents published by Australian federal and New South Wales (NSW) government departments. Data extraction compared the recommendations made by different agencies and the impact on the analysis of preventive health interventions. The framework specifies a reference case and sensitivity analyses based on the following considerations: (1) applied economic evaluation theory; (2) consistency between CBA across different government departments; (3) the ease of moving from a CBA to a more conventional cost-effectiveness/cost-utility analysis framework often used for health interventions; (4) the practicalities of application; and (5) the needs of end users being both Cabinet decision-makers and health policy-makers. RESULTS: Nine documents provided CBA or relevant economic evaluation guidance. There were differences in terminology and areas of agreement and disagreement between the guidelines. Disagreement between guidelines involved (1) the community included in the societal perspective; (2) the number of options that should be appraised in ex ante analyses; (3) the appropriate time horizon for interventions with longer economic lives; (4) the theoretical basis and value of the discount rate; (5) parameter values for variables such as the value of a statistical life; and (6) the summary measure for decision-making. CONCLUSIONS: This paper addresses some of the methodological challenges that have hindered the use of CBA in prevention by outlining a framework that is consistent with treasury department guidelines whilst considering the unique features of prevention policies. The effective use and implementation of a preventive health CBA framework is likely to require considerable investment of time and resources from state and federal government departments of health and treasury but has the potential to improve decision-making related to preventive health policies and programmes.

Correction: Modelled health benefits of a sugar-sweetened beverage tax across different socioeconomic groups in Australia: A cost-effectiveness and equity analysis.

[This corrects the article DOI: 10.1371/journal.pmed.1002326.].

Health-related quality of life and upper-limb impairment in children with cerebral palsy: developing a mapping algorithm.

AIM: To: (1) investigate the relationship between upper-limb impairment and health-related quality of life (HRQoL) for children with cerebral palsy and (2) develop a mapping algorithm from the Cerebral Palsy Quality of Life Questionnaire for Children (CPQoL-Child) onto the Child Health Utility 9D (CHU9D) measure. METHOD: The associations between physical and upper-limb classifications and HRQoL of 76 children (40 females, 36 males) aged 6 to 15 years (mean age 9 years 7 months [SD 3y]) were assessed. Five statistical techniques were developed and tested, which predicted the CHU9D scores from the CPQoL-Child total/domain scores, age, and sex. RESULTS: Most participants had mild impairments. The Manual Ability Classification System (MACS) level was significantly negatively correlated with CHU9D and CPQoL-Child (r=-0.388 and r=-0.464 respectively). There was a negative correlation between the Neurological Hand Deformity Classification (NHDC) and CPQoL-Child (r=-0.476, p<0.05). The generalized linear model with participation, pain domain, and age had the highest predictive accuracy. INTERPRETATION: The weak negative correlations between classification levels and HRQoL measures may be explained by the restricted range of impairment levels of the participants. The MACS and NHDC explained the impact of upper-limb impairment on HRQoL better than the other classifications. The generalized linear model with participation, pain, and age is the suggested mapping algorithm. The suggested mapping algorithm will facilitate the use of CPQoL-Child for economic evaluation and can be used to conduct cost-utility analyses. WHAT THIS PAPER ADDS: The Manual Ability Classification System and Neurological Hand Deformity Classification were the best predictors of health-related quality of life measures. Age and Cerebral Palsy Quality of Life Questionnaire for Children participation and pain domain scores can predict Child Health Utility 9D scores.

Equity Weights for Socioeconomic Position: Two Methods-Survey of Stated Preferences and Epidemiological Data.

BACKGROUND: There is an implicit equity approach in cost-effectiveness analysis that values health gains of socioeconomic position groups equally. An alternative approach is to integrate equity by weighting quality-adjusted life-years according to the socioeconomic position group. OBJECTIVES: To use two approaches to derive equity weights for use in cost-effectiveness analysis in Australia, in contexts in which the use of the traditional nonweighted quality-adjusted life-years could increase health inequalities between already disadvantaged groups. METHODS: Equity weights derived using epidemiological data used burden of disease and mortality data by Socio-Economic Indexes for Areas quintiles from the Australian Institute of Health and Welfare. Two ratios were calculated comparing quintile 1 (lowest) to the total Australian population, and comparing quintile 1 to quintile 5 (highest). Preference-based weights were derived using a discrete choice experiment survey (n = 710). Respondents chose between two programs, with varying gains in life expectancy going to a low- or a high-income group. A probit model incorporating nominal values of the difference in life expectancy was estimated to calculate the equity weights. RESULTS: The epidemiological weights ranged from 1.2 to 1.5, with larger weights when quintile 5 was the denominator. The preference-based weights ranged from 1.3 (95% confidence interval 1.2-1.4) to 1.8 (95% confidence interval 1.6-2.0), with a tendency for increasing weights as the gains to the low-income group increased. CONCLUSIONS: Both methods derived plausible and consistent weights. Using weights of different magnitudes in sensitivity analysis would allow the appropriate weight to be considered by decision makers and stakeholders to reflect policy objectives.

A systematic review of utility values in children with cerebral palsy.

PURPOSE: Project aims include the following: (i) to identify reported utility values associated with CP in children aged ≤ 18 years; (ii) to explore utility value elicitation techniques in published studies; and (iii) to examine performance of the measures and/or elicitation approaches. METHODS: Peer-reviewed studies published prior to March 2017 were identified from six electronic databases. Construct validity, convergent validity, responsiveness, and reliability of instruments were assessed. RESULTS: Five studies met the inclusion criteria. Utility values of hypothetical general CP states obtained from a general population of parents ranged from 0.55 to 0.88 using time trade off (TTO) and 0.60-0.87 using standard gamble (SG) techniques. Utility values reported by clinicians of three hypothetical spastic quadriplegic CP states, using the Health Utility Index Mark 2 (HUI-2), ranged from 0.40 to 0.13. Other sources of utilities identified were based on both proxy and child ratings using Health Utility Index Mark 3 (HUI-3) (values ranged from - 0.013 to 0.84 depending on the valuation source) and the Assessment of Quality of Life 4 Dimension instrument, with values ranging from 0.01 to 0.58. Construct validity of the HUI-3 varied from moderate to strong, whereas mixed results were found for convergent validity. Responsiveness and reliability were not reported. CONCLUSION: There was substantial variation in reported utilities. Indirect techniques (i.e. via multi-attribute utility instruments) were more frequently used than direct techniques (e.g. TTO, SG). Further research is required to improve the robustness of utility valuation of health-related quality of life in children with CP for use in economic evaluation.

Economic evaluation of simulated and traditional clinical placements in occupational therapy education.

INTRODUCTION: This economic evaluation complements results of the randomised controlled trial that established non-inferiority of the learning outcomes of a one-week simulated clinical placement (SCP) in occupational therapy qualifying degrees in comparison to an equivalent traditional clinical placement (TCP). This companion study presents detailed cost analyses of two placement alternatives and a cost-benefit study to assess the value for money of SCP. An economic evaluation of simulated versus traditional placements has not previously been conducted in Australia. METHODS: Nine SCP/TCP rounds were conducted by six Australian universities. Costs were collected using study-specific instruments. Public health sector costs were sourced from available literature. Willingness-to-pay for SCP/TCP was estimated using both a Discrete Choice Experiment and a Contingent Valuation method. These methods were employed to assess a comparative 'value' of SCP/TCP from the perspective of heads of occupational therapy departments (N = 28), who were asked to put a monetary value on the broader range of benefits associated with SCP/TCP. RESULTS: From the universities' perspective the average cost per student ranged from AUD$460 to AUD$1511 for simulated and AUD$144 to AUD$1112 for traditional placement. From the health care sector perspective, the difference in costs favoured simulated placements for four implementations and traditional placements for five. In the Discrete Choice Experiment respondents preferred traditional rather than simulated placement and would pay additional AUD$533. The estimated monetary value of simulated placements from a contingent valuation ranged from AUD$200 to AUD$1600. CONCLUSIONS: For universities that procure TCPs predominately at public health care facilities and sustain high administrative overheads, the SCP program could be a cost-saving alternative. From a broader value-for-money perspective, respondents favoured TCP over SCP, yet placed importance on placement availability and opportunity to demonstrate competence for students during the placement. Results should be interpreted with caution and further research with larger sample sizes is required.

Economic evaluation and cost of interventions for cerebral palsy: a systematic review.

AIM: Economic appraisal can help guide policy-making for purchasing decisions, and treatment and management algorithms for health interventions. We conducted a systematic review of economic studies in cerebral palsy (CP) to inform future research. METHOD: Economic studies published since 1970 were identified from seven databases. Two reviewers independently screened abstracts and extracted data following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Any discrepancies were resolved by discussion. RESULTS: Of 980 identified references, 115 were included for full-text assessment. Thirteen articles met standard criteria for a full economic evaluation, two as partial economic evaluations, and 18 as cost studies. Six were full economic evaluations alongside clinical studies or randomized controlled trials, whereas seven involved modelling simulations. The economic case for administration of magnesium sulfate for imminent preterm birth is compelling, achieving both health gain and cost savings. Current literature suggests intrathecal baclofen therapy and botulinum toxin injection are cost-effective, but stronger evidence for long-term effects is needed. Lifestyle and web-based interventions are inexpensive, but broader measurement of outcomes is required. INTERPRETATION: Prevention of CP would avoid significant economic burden. Some treatments and interventions have been shown to be cost-effective, although stronger evidence of clinical effectiveness is needed. What this paper adds Cost-effectiveness evidence shows prevention is the most significant strategy. Some treatments are cost-effective, but stronger evidence for long-term effectiveness is required. Comparison of treatment costs is challenging owing to variations in methodologies and varying clinical indications.

Extending the paradigm: a policy framework for healthy and equitable eating (HE2).

OBJECTIVE: The current short communication aimed to provide a new conceptualisation of the policy drivers of inequities in healthy eating and to make a call to action to begin populating this framework with evidence of actions that can be taken to reduce the inequities in healthy eating. DESIGN: The Healthy and Equitable Eating (HE2) Framework derives from a systems-based analytical approach involving expert workshops. SETTING: Australia. SUBJECTS: Academics, government officials and non-government organisations in Australia. RESULTS: The HE2 Framework extends previous conceptualisations of policy responses to healthy eating to include the social determinants of healthy eating and its social distribution, encompassing policy areas including housing, social protection, employment, education, transport, urban planning, plus the food system and environment. CONCLUSIONS: As the burden of non-communicable diseases continues to grow globally, it is important that governments, practitioners and researchers focus attention on the development and implementation of policies beyond the food system and environment that can address the social determinants of inequities in healthy eating.

Simulated versus traditional occupational therapy placements: A randomised controlled trial.

BACKGROUND/AIM: Professional practise placements in occupational therapy education are critical to ensuring graduate competence. Australian occupational therapy accreditation standards allow up to 200 of a mandated 1000 placement hours to include simulation-based learning. There is, however, minimal evidence about the effectiveness of simulation-based placements compared to traditional placements in occupational therapy. We evaluated whether occupational therapy students completing a 40 hour (one week block) Simulated Clinical Placement (SCP) attained non-inferior learning outcomes to students attending a 40 hour Traditional Clinical Placement (TCP). METHODS: A pragmatic, non-inferiority, assessor-blinded, multicentre, randomised controlled trial involving students from six Australian universities was conducted. Statistical power analysis estimated a required sample of 425. Concealed random allocation was undertaken with a 1:1 ratio within each university. Students were assigned to SCP or TCP in one of three settings: vocational rehabilitation, mental health or physical rehabilitation. SCP materials were developed, manualised and staff training provided. TCPs were in equivalent practice areas. Outcomes were assessed using a standardised examination, unit grades, the Student Practice Evaluation Form-Revised and student confidence survey. A generalised estimating equation approach was used to assess non-inferiority of the SCP to the TCP. RESULTS: Of 570 randomised students (84% female), 275 attended the SCP and 265 the TCP (n = 540, 94.7% retention). There were no significant differences between the TCP and SCP on (i) examination results (marginal mean difference 1.85, 95% CI: 0.46-3.24; P = 0.087); (ii) unit score (mean (SD) SCP: 71.9 (8.8), TCP: 70.34 (9.1); P = 0.066); or (iii) placement fail rate, assessed using the Student Practice Evaluation Form-Revised (100% passed both groups). CONCLUSION: Students can achieve equivalent learning outcomes in a 40 hour simulated placement to those achieved in a 40 hour traditional placement. These findings provide assurance to students, educators and professional accreditation bodies that simulation can be embedded in occupational therapy education with good effect.

Modelled health benefits of a sugar-sweetened beverage tax across different socioeconomic groups in Australia: A cost-effectiveness and equity analysis.

BACKGROUND: A sugar-sweetened beverage (SSB) tax in Mexico has been effective in reducing consumption of SSBs, with larger decreases for low-income households. The health and financial effects across socioeconomic groups are important considerations for policy-makers. From a societal perspective, we assessed the potential cost-effectiveness, health gains, and financial impacts by socioeconomic position (SEP) of a 20% SSB tax for Australia. METHODS AND FINDINGS: Australia-specific price elasticities were used to predict decreases in SSB consumption for each Socio-Economic Indexes for Areas (SEIFA) quintile. Changes in body mass index (BMI) were based on SSB consumption, BMI from the Australian Health Survey 2011-12, and energy balance equations. Markov cohort models were used to estimate the health impact for the Australian population, taking into account obesity-related diseases. Health-adjusted life years (HALYs) gained, healthcare costs saved, and out-of-pocket costs were estimated for each SEIFA quintile. Loss of economic welfare was calculated as the amount of deadweight loss in excess of taxation revenue. A 20% SSB tax would lead to HALY gains of 175,300 (95% CI: 68,700; 277,800) and healthcare cost savings of AU$1,733 million (m) (95% CI: $650m; $2,744m) over the lifetime of the population, with 49.5% of the total health gains accruing to the 2 lowest quintiles. We estimated the increase in annual expenditure on SSBs to be AU$35.40/capita (0.54% of expenditure on food and non-alcoholic drinks) in the lowest SEIFA quintile, a difference of AU$3.80/capita (0.32%) compared to the highest quintile. Annual tax revenue was estimated at AU$642.9m (95% CI: $348.2m; $1,117.2m). The main limitations of this study, as with all simulation models, is that the results represent only the best estimate of a potential effect in the absence of stronger direct evidence. CONCLUSIONS: This study demonstrates that from a 20% tax on SSBs, the most HALYs gained and healthcare costs saved would accrue to the most disadvantaged quintiles in Australia. Whilst those in more disadvantaged areas would pay more SSB tax, the difference between areas is small. The equity of the tax could be further improved if the tax revenue were used to fund initiatives benefiting those with greater disadvantage.

Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study.

BACKGROUND: The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology. We aimed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks. METHOD: In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women's Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patient's condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976. FINDINGS: Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. 121 assigned to radical retropubic prostatectomy completed the 12 week questionnaire versus 131 assigned to robot-assisted laparoscopic prostatectomy. Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (74·50 vs 71·10; p=0·09) or 12 weeks post-surgery (83·80 vs 82·50; p=0·48). Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (30·70 vs 32·70; p=0·45) or 12 weeks post-surgery (35·00 vs 38·90; p=0·18). Equivalence testing on the difference between the proportion of positive surgical margins between the two groups (15 [10%] in the radical retropubic prostatectomy group vs 23 [15%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a Δ of 10%. However, a superiority test showed that the two proportions were not significantly different (p=0·21). 14 patients (9%) in the radical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0·052). 12 (8%) men receiving radical retropubic prostatectomy and three (2%) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events. INTERPRETATION: These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach. FUNDING: Cancer Council Queensland.

Informed decision making and psychosocial outcomes in pregnant and nonpregnant women offered population fragile X carrier screening.

PurposePopulation-based carrier screening for fragile X syndrome (FXS) is still not universally endorsed by professional organizations due to concerns around genetic counseling for complex information and potential for psychosocial harms.MethodsWe determined uptake levels, decision making, and psychosocial impact in a prospective study of pregnant and nonpregnant Australian women offered FXS carrier screening in clinical settings. Women received pretest genetic counseling, and completed questionnaires when deciding and one month later.ResultsOf 1,156 women recruited, 83.1% returned the first questionnaire with 70.6% nonpregnant and 58.8% pregnant women choosing testing (χ2=16.98, P<0.001). Overall, informed choice was high in both nonpregnant (77.4%) and pregnant (72.9%) women (χ2=0.21, P=0.644), and more tested (76.0%) than not-tested (66.7%) women (χ2=6.35, P=0.012) made an informed choice. Measures of depression, stress, and anxiety were similar to population norms for ~85% of women. Decisional conflict and regret were generally low; however, decisional uncertainty and regret were greater in pregnant than nonpregnant women, and not-tested than tested women (uncertainty: χ2=18.51, P<0.001 and χ2=43.11, P<0.001, respectively; regret: χ2=6.61, P<0.037 and χ2=35.54, P<0.001, respectively).ConclusionWe provide evidence to inform guidelines that population FXS carrier screening can be implemented with minimal psychosocial harms following appropriate information and prescreening genetic counseling.

Psychosocial therapies for the adjunctive treatment of bipolar disorder in adults: network meta-analysis.

BackgroundFew trials have compared psychosocial therapies for people with bipolar affective disorder, and conventional meta-analyses provided limited comparisons between therapies.AimsTo combine evidence for the efficacy of psychosocial interventions used as adjunctive treatment of bipolar disorder in adults, using network meta-analysis (NMA).MethodSystematic review identified studies and NMA was used to pool data on relapse to mania or depression, medication adherence, and symptom scales for mania, depression and Global Assessment of Functioning (GAF).ResultsCarer-focused interventions significantly reduced the risk of depressive or manic relapse. Psychoeducation alone and in combination with cognitive-behavioural therapy (CBT) significantly reduced medication non-adherence. Psychoeducation plus CBT significantly reduced manic symptoms and increased GAF. No intervention was associated with a significant reduction in depression symptom scale scores.ConclusionsOnly interventions for family members affected relapse rates. Psychoeducation plus CBT reduced medication non-adherence, improved mania symptoms and GAF. Novel methods for addressing depressive symptoms are required.

Economic evaluation of future skin cancer prevention in Australia.

Public health programs to reduce the significant burden of skin cancer have been implemented in Australia and around the world. The economic rationale for prevention needs to be kept up-to-date as relevant disease patterns, risk factors and expenditure patterns change through time. The aim of this study was to update and extend the economic credentials for skin cancer prevention in Australia. Economic evaluations were conducted in 2015 with multiple methods applied, including cost-effectiveness and cost-benefit analysis, multiple study perspectives ('societal', 'health sector', '3rd party funder') and counterfactual analysis sourced from cancer incidence between 1982 and 2011. Modelled outcomes included 'cases prevented', 'deaths averted' and 'health-adjusted life-years'. Cost-benefit Analysis, including productivity impacts in the general economy, was conducted. With an additional $AUD 0.16 ($USD 0.12) per capita investment into future skin cancer prevention across Australia, 140,000 skin cancer cases would be prevented over the 20year reference period (2011 to 2030). Depending on study perspective and method, the upgraded program is either dominant (achieving both health gains and cost offsets) or highly cost-effective (health gain at modest net cost). Return on investment (ROI) was $AUD 3.20 per dollar invested, with net social benefit of $AUD 1.43 billion. The study confirmed the strong economic credentials for skin cancer prevention and provided sound arguments for increased investment in Australia. The reference case analysis provides a useful benchmark for other countries to consider in the design and funding of their prevention programs.

Mothers after Gestational Diabetes in Australia (MAGDA): A Randomised Controlled Trial of a Postnatal Diabetes Prevention Program.

BACKGROUND: Gestational diabetes mellitus (GDM) is an increasingly prevalent risk factor for type 2 diabetes. We evaluated the effectiveness of a group-based lifestyle modification program in mothers with prior GDM within their first postnatal year. METHODS AND FINDINGS: In this study, 573 women were randomised to either the intervention (n = 284) or usual care (n = 289). At baseline, 10% had impaired glucose tolerance and 2% impaired fasting glucose. The diabetes prevention intervention comprised one individual session, five group sessions, and two telephone sessions. Primary outcomes were changes in diabetes risk factors (weight, waist circumference, and fasting blood glucose), and secondary outcomes included achievement of lifestyle modification goals and changes in depression score and cardiovascular disease risk factors. The mean changes (intention-to-treat [ITT] analysis) over 12 mo were as follows: -0.23 kg body weight in intervention group (95% CI -0.89, 0.43) compared with +0.72 kg in usual care group (95% CI 0.09, 1.35) (change difference -0.95 kg, 95% CI -1.87, -0.04; group by treatment interaction p = 0.04); -2.24 cm waist measurement in intervention group (95% CI -3.01, -1.42) compared with -1.74 cm in usual care group (95% CI -2.52, -0.96) (change difference -0.50 cm, 95% CI -1.63, 0.63; group by treatment interaction p = 0.389); and +0.18 mmol/l fasting blood glucose in intervention group (95% CI 0.11, 0.24) compared with +0.22 mmol/l in usual care group (95% CI 0.16, 0.29) (change difference -0.05 mmol/l, 95% CI -0.14, 0.05; group by treatment interaction p = 0.331). Only 10% of women attended all sessions, 53% attended one individual and at least one group session, and 34% attended no sessions. Loss to follow-up was 27% and 21% for the intervention and control groups, respectively, primarily due to subsequent pregnancies. Study limitations include low exposure to the full intervention and glucose metabolism profiles being near normal at baseline. CONCLUSIONS: Although a 1-kg weight difference has the potential to be significant for reducing diabetes risk, the level of engagement during the first postnatal year was low. Further research is needed to improve engagement, including participant involvement in study design; it is potentially more effective to implement annual diabetes screening until women develop prediabetes before offering an intervention. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12610000338066.