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Waste in clinical trials remains rife. We developed an economic model to predict the cost of trials based on input costs, duration, power, number of sites, recruitment eligibility and consenting rates.We parameterised the model for three proxy placebo-controlled surgical trials using data from a systematic review, a bespoke cost survey, and from the literature. We used the model to compare target and actual trial performance for (i) a trial that was completed on time but with more sites, (ii) a trial that completed after a time extension, and (iii) an incomplete trial.Successful trials more accurately anticipated the true recruitment rate that they achieved and those that overestimated this were most likely to fail. The costs of overestimating recruitment rates were dramatic: all proxy trials had significantly higher costs than planned, with additional funding of at least AUD$600,000 (50% above budget) required for trials that completed after adding more sites or more time, and over AUD$2 million (260% above budget) for incomplete trials.This model shows the trade-offs between time and cost, or both, when recruitment is lower than anticipated. Greater consideration is needed to improve trial planning, reviewing, and funding of these trials to avoid costly overruns and incomplete trials.

Abstract. This study uses a phenomenological approach to explore the experience of choking (underperformance) among commercial pilots. Semi-structured interviews were conducted with eight pilots, including three examiners (as observers of choking). Findings revealed three superordinate themes: choking under pressure, short-term consequences of choking, and long-term consequences of choking. Collectively, choking was found to be a traumatic event with negative short-term consequences and a potential to lead to constructive long-term outcomes. Practical implications of the findings are discussed, suggesting ways to optimize pilots’ performance through focusing more on psychoeducation and emotional support of employees after choking.

We implemented a clustered randomized controlled trial with 7,227 residents in six rural Ghana Districts to determine whether financial incentives produce substantial increases in COVID-19 vaccine uptake. Villages were randomly assigned to receive one of four video treatment arms: a placebo, a standard health message, a high cash incentive ($10) and a low cash incentive ($3). Non-vaccinated subjects, assigned to the Cash incentive treatments had an average COVID-19 vaccine intention rate of 81% compared to the 71% for those in the Placebo treatment arm. Two months after the initial intervention the average self-reported vaccination rates for subjects in the Cash treatment were 3.5% higher than those for subjects in the Placebo treatment (95% CI: 0.001, 6.9; P < 0.03) - 40% versus 36.5%. We verified the vaccination status of subjects: in the Cash treatment arm, 36.6% of verified subjects had at least one dose of the COVID-19 vaccine compared to 30.3% for those in Placebo - a difference of 6.3% (95% CI: 2.4, 10.2; P < 0.0001). For all three outcomes, the low cash incentive ($3.00) had a larger positive effect on COVID-19 vaccine uptake than the high cash incentive ($10.00). There is no evidence of spillover effects of the financial incentives that depress the vaccine uptake of subjects in non-financial treatment arms nor of non-treated proximate residents.

The efficacy of nanomedicines is dependent on their access to target sites in the body, and this in turn is affected by their size, shape and transport properties in tissue. Although there have been many studies, the ability to design nanomaterials with optimal physicochemical properties for in vivo efficacy remains a significant challenge. In particular, it is difficult to quantify the detailed effects of cancer drug delivery systems in vivo as tumour volume reduction, a commonly reported marker of efficacy, does not always correlate with cytotoxicity in tumour tissue. Here, we studied the behaviour in vivo of two specific poly(2-hydroxypropyl methacrylamide) (pHPMA) pro-drugs, with the same chemical compositions of redox-responsive backbone components and pH-sensitive linkers to the anti-cancer drug doxorubicin but with varying architectures, in this case hyperbranched and star-shaped. Evaluation of the biodistribution of these polymers following systemic injection indicated differences in the circulation time and organ distribution of the two polymers, despite their very similar hydrodynamic radii (~ 10 and 15 nm) and underlying chemistry of backbone, side-chain and pro-drug linkers. In addition, both polymers showed improved tumour accumulation in orthotopic triple-negative breast cancers in mice, and decreased accumulation in healthy tissue, as compared to free doxorubicin. Importantly, there was a significant increase in tumour accumulation for the hyper-branched polymer compared to the star polymer, suggesting a possible role for solution conformations of these materials, rather than the chemistries, in mediating their performance. The results of haematoxylin and eosin assays, and TUNEL staining indicated a higher population of apoptotic cells in the tumours for both polymer pro-drug treatments, and in turn a lower population of apoptotic cells in the heart, liver and spleen, as compared to free doxorubicin. In particular, the hyperbranched polymer demonstrated significantly higher tumour deposition and apoptosis levels than its star shaped counterpart. Taken together, these data suggest that the penetration of both of these polymer pro-drugs was enhanced in tumour tissue relative to free doxorubicin, and that the combination of size, architecture, bioresponsive backbone and drug linker degradation yielded greater efficacy for the polymers as measured by biomarkers other than that of tumour volume.

BackgroundAotearoa-New Zealand (A/NZ) is the first country to pass a comprehensive commercial tobacco endgame strategy into law. Key components include the denicotinisation of smoked tobacco products and a major reduction in tobacco retail outlets. Understanding the potential long-term economic impacts of these measures is important for government planning.MethodsA tobacco policy simulation model that evaluated the health impacts of the A/NZ Smokefree Action Plan was extended to evaluate the economic effect of the new measures from both Government and citizen perspectives. Estimates were discounted at 3% per annum and presented in 2021 purchasing power parities US$.FindingsThe modelled endgame policy package generates considerable growth in income for the A/NZ population with a total cumulative gain by 2050 amounting to US$31 billion. From a government perspective, the policy results in foregone tobacco excise tax revenue with a negative net financial position estimated at US$11.5 billion by 2050. In a sensitivity analysis considering future changes to labour workforce, the government’s cumulative net position remained negative by 2050, but only by US$1.9 billion.InterpretationOur modelling suggests the Smokefree Aotearoa 2025 Action Plan is likely to produce substantial economic benefits for the A/NZ population, and modest impacts on government revenue and expenditure related to the reduction in tobacco tax and increases in aged pensions due to increased life expectancy. Such costs can be anticipated and planned for and might be largely offset by future increases in labour force and the proportion of 65+ year olds working in the formal economy.FundingThis study was funded by a grant from the Australian National Health and Medical Research Council (GNT1198301)Research in ContextEvidence before this studyMultiple countries have set targets to achieve a commercial tobacco endgame. Most simulation modelling studies have evaluated ‘traditional’ tobacco control interventions (e.g., tobacco excise tax increases, indoor smoking bans, smoking cessation health services). Very few have modelled the economic effects of endgame strategies. We searched PubMed with no language restrictions for articles published from 1 January 2000 to 8 February 2023 using the following search terms: (smoking[TW] OR tobacco[TW]) AND (endgame[TW] OR eliminat*[TW] OR “phasing out”[TW] OR “phase out”[TW] OR aboli*[TW] OR prohibit*[TW] OR ban[TW] OR “smoke free”[TW] OR “smoke-free”[TW]) AND (model*[TW] OR simulat*[TW]) AND (cost[TW] OR economic[TW]).We identified six economic evaluations of commercial tobacco endgame strategies, including different interventions and cost perspectives. Five studies modelled interventions in the Aotearoa/New Zealand (A/NZ) context and one in the UK. Four studies were conducted from a healthcare system perspective, estimating the costs to the health system associated with tobacco-related diseases. One of these studies additionally estimated ‘non-health social costs’, as the productivity loss resulting from smoking-associated morbidity and mortality. Another study estimated the cost to consumers resulting from a policy in which retail outlets selling tobacco were significantly reduced, considering both the actual cost of a pack of cigarettes and the cost of increased travel to retailers, and the last estimated excise tax revenue to the government resulting from increases to tobacco taxation (compared to no increases to current tobacco tax levels). Of the identified literature, none evaluated the effect of endgame strategies on citizen income nor the fiscal impacts to government revenue and expenditure.Added value of this studyThis study evaluates the economic impacts of a recently introduced commercial tobacco endgame legislation in A/NZ. We modelled the economic impacts by 2050 of a policy package that includes the four key measures in the new legislation (i.e., denicotinisation of smoked tobacco products, enhanced antismoking mass media campaigns, 90% reduction in the number of tobacco retail outlets, and a smoke-free generation law that bans sale of tobacco to anyone born after 2008). The analysis presents both a government and citizen perspective. The government fiscal impacts extend beyond health system expenditure to also include differences between business as usual (BAU) – i.e., no endgame strategy – and endgame scenarios in excise tax revenue, goods and services tax (GST) revenue, income tax revenue, and superannuation expenditure. A net government position is also calculated. The citizen perspective estimates the impact of the policy on population income and savings that may result from reduced tobacco consumption. Our model projects large economic gains for consumers from the tobacco endgame package resulting from a sharp reduction in smoking prevalence, morbidity and mortality. For the A/NZ Government, the policy is projected to result in reduced healthcare costs, and increased income tax and GST revenue. These gains are offset by increased superannuation payments resulting from a greater number of individuals living past the age at which superannuation is provided to all citizens (65 years in A/NZ and described in this article as “retirement age” for simplicity), as well as large reductions in excise tax revenue.Implication of all the available evidenceOur findings support previous evidence indicating that ambitious tobacco control policies can produce large heath and economic benefits. Our model suggests that a commercial tobacco endgame strategy is likely to result in a large revenue transfer to the benefit of the A/NZ population. An endgame approach moves beyond the BAU model of incremental policy change to a deliberate strategy to permanently reduce tobacco smoking to minimal levels within a short timeframe. A logical result of such a strategy is a significant decrease in excise tax revenue for governments. Under the endgame scenario, the net position of the A/NZ Government is likely to be negative due mainly to the foregone excise tax revenue. In a sensitivity analysis of the endgame scenario that takes into account recent projections from Stats NZ of a future larger and older labour force in A/NZ, our model suggests that the net government position might become positive as early as 2036 – less than 15 years after the introduction of the endgame policy.

Limited research into professional rugby union players’ experiences of seeking formal support for their mental health exists, despite comparable rates of mental health issues among elite rugby players with the general population. This qualitative study explored professional players’ actual experiences of accessing Rugby Players Ireland’s mental well-being service, via separate focus group discussions with professional players (n = 5) and player development managers (n = 4) who refer players into the service. An inductive reflexive thematic analysis identified three themes detailing players’ (a) journey to disclosure of their mental health difficulties, (b) their expectations and engagement with the well-being service, and (c) participants’ reflections on mental health experiences in a high-performance environment. Embedding mental health as a key component of player development in high-performance environments, improving mental health literacy, normalizing mental health experiences, and encouraging help-seeking would help promote player well-being and support holistic development alongside sporting performance.

Since the person behind the practitioner has been recognised as a core foundation of professional practice in sport psychology, research attention has diffused to focus on navigating the ‘rocky road’ towards individuation. As such, this study extended the literature by illuminating the importance of developing personal qualities during the embryonic stages of supervised experience (SE) in sport psychology to help support the individuation process occurring throughout the training journey. Specifically, the aim of the current study was to explore the contribution of personal qualities to the personal and professional development of trainee sport psychology practitioners, within the individuation process. Seven semi-structured interviews were conducted with probationary sport and exercise scientists (psychology) working in a range of elite and professional sports (i.e., premier league football, rugby league, golf, gymnastics, swimming, and several other Olympic sports). The interview schedule was refined following a pilot study. Interview transcripts were content analysed and trustworthiness criteria applied. Interpretative phenomenological analysis identified three main superordinate themes, labelled ‘self-development of personal qualities’, ‘facilitators of supervisee individuation’, and ‘initial consulting experiences of practitioners’. This study extends the literature by illuminating the importance of developing personal qualities during the embryonic stages of SE to help support the individuation process occurring throughout the training journey, thus better preparing sport psychologist’s for self-governed practice once accredited. Considerations are given in relation to how sport psychology education and training programmes could aid the individuation process via the development of personal qualities.

During 2020 and 2021, Australia implemented relatively stringent government restrictions yet had few COVID-19 deaths. This provides an opportunity to understand the effects of lockdowns and quarantining restrictions on short-term mortality and to help provide evidence in understanding how such public health policies can impact on health. Our analysis is based on preliminary mortality data collected by the Australian Bureau of Statistics. Rates were estimated by disease and over time and compared with mortality statistics in the period 2015–2019. Comparing deaths in 2020-2021 with 2015–2019 show the annual mortality rate (per 100 000 people) fell by 5.9% from 528.4 in 2015–2019 to 497.0 in 2020–2021. Declines in mortality are across many disease categories including respiratory diseases (down 9.4 deaths per 100 000), cancer (down 7.5 deaths per 100 000) and heart disease (down 8.4 deaths per 100 000). During 2020 and 2021, Australian age-standardised mortality rates fell by 6%. This drop was similar for men and women, and was driven by a reduction in both communicable and non-communicable causes of death. Such evidence can help inform public health policies designed to both control COVID-19 and other infectious diseases.

In the early part of the 20th century the disease pellagra, now almost unknown, affected and killed thousands of people in the United States. Some claimed it was an infection, while others maintained it was due to a dietary deficiency. The economist Edgar Sydenstricker (1881-1936), who was a member of a US Public Health Service team examining the disease, argued it was critical to understand how pellagra varied by levels of income. Collecting survey data, he realized equivalence scales were needed to adjust household incomes. His research demonstrated that there was a strong negative correlation between the incidence of pellagra and equivalized household income. Further analysis of the dietary differences between households suggested that a dietary deficiency associated to a restricted availability of animal protein food was the cause of pellagra. This was confirmed more than a decade later when a deficiency of vitamin B-3 was identified as the cause.

Australia is home to many distinctive species of birds, and Aboriginal peoples have developed close alliances with them over the millennia of their custodianship of this country. Aboriginal Peoples and Birds in Australia: Historical and Cultural Relationships provides a review of the broad physical, historical and cultural relationships that Aboriginal people have had with the Australian avifauna. This book aims to raise awareness of the alternative bodies of ornithological knowledge that reside outside of Western science. It describes the role of birds as totemic ancestors and spirit beings, and explores Aboriginal bird nomenclature, foraging techniques and the use of avian materials to make food, medicine and artefacts. Through a historical perspective, this book examines the gaps between knowledge systems of Indigenous peoples and Western science, to encourage greater collaboration and acknowledgment in the future. Cultural sensitivity Readers are warned that there may be words, descriptions and terms used in this book that are culturally sensitive, and which might not normally be used in certain public or community contexts. While this information may not reflect current understanding, it is provided by the author in a historical context. This publication may also contain quotations, terms and annotations that reflect the historical attitude of the original author or that of the period in which the item was written, and may be considered inappropriate today. Aboriginal and Torres Strait Islander peoples are advised that this publication may contain the names and images of people who have passed away.

Background Many high-income countries (HICs) have now vaccinated a substantial proportion of their population against COVID-19. Many low-income countries (LICs) may need to wait until at least 2022 before even the most vulnerable 20% of their populations are vaccinated. Beyond ethical considerations, some redistribution of doses would reduce the risk of the emergence and spread of new variants and benefit the economy, both globally and in donor countries. However, the willingness of HIC governments to donate vaccine doses is likely to depend on public support. While previous work has indicated strong average levels of public support in HIC for donation, little is known about how broad-based this support is. Objective To investigate the extent to which support for donation holds across both pre-specified and exploratory subgroups. Methods From 24 November–28 December 2020 we conducted an online survey of 8209 members of the general public in seven HIC (Australia, Canada, France, Italy, Spain, UK and USA). We conducted tests of proportions and used Bayesian ordinal logistic regression models to assess the extent of support for donation across population subgroups. Results We found broad-based support for donations in terms of age, gender, socio-economic status and political ideology. We found no strong evidence that support for donations was higher among those with greater income or a university education. Support for donation among those on the political right and centre was lower than on the left, but 51% (95% confidence interval 48–53%) of respondents who identified with the right supported some level of donation. Those in the more altruistic half of the sample (as captured by willingness to donate money to a good cause) were more likely to support donation than those who were not, but around half of the less altruistic group supported some level of donation. Conclusion There is broad-based support for policymakers in HICs to donate some of their countries’ COVID-19 vaccine doses for distribution to LICs. Supplementary Information The online version contains supplementary material available at 10.1007/s40258-021-00696-8.

The aim of this study was to elicit the willingness-to-pay (WTP) for genomic testing, using contingent valuation, among people with lived experience of genetic conditions in Australia. Parents of children with suspected mitochondrial disorders, epileptic encephalopathy, leukodystrophy, or malformations of cortical development completed a dynamic triple-bounded dichotomous choice (DC) contingent valuation. Adult patients or parents of children with suspected genetic kidney disease or complex neurological and neurodegenerative conditions completed a payment card (PC) contingent valuation. DC data were analyzed using a multilevel interval regression and a multilevel probit model. PC data were analyzed using a Heckman selection model. In total, 360 individuals participated in the contingent valuation (CV), with 141 (39%) and 219 (61%) completing the DC and PC questions, respectively. The mean WTP for genomic testing was estimated at AU$2830 (95% confidence interval [CI] 2236–3424) based on the DC data and AU$1914 (95% CI 1532–2296) based on the PC data. The mean WTP across the six cohorts ranged from AU$1879 (genetic kidney disease) to AU$4554 (leukodystrophy). Genomic testing is highly valued by people experiencing rare genetic conditions. Our findings can inform cost–benefit analyses and the prioritization of genomics into mainstream clinical care. While our WTP estimates for adult-onset genetic conditions aligned with estimates derived from discrete choice experiments (DCEs), for childhood-onset conditions our estimates were significantly lower. Research is urgently required to directly compare, and critically evaluate, the performance of CV and DCE methods.

Objective Ischaemic heart disease (IHD) is a major source of disease burden worldwide. Recent trends show incidence is declining but it is unclear whether the trends are similar in urban and rural populations. This study examines the trends of IHD events (i.e. hospitalisations and deaths) in New South Wales, Australia by rurality. Methods This was a retrospective analysis of linked administrative data for hospitalisation and death records across NSW between 2001 and 2015. Participants were NSW residents aged 15–105 years who died or were hospitalised with a principal diagnosis of IHD. The main outcome measures were annual age-standardised mortality and hospitalisations for IHD by calendar year and rurality. Results Between 2001 and 2015, age-standardised annual IHD hospitalisations declined in urban areas from 587 to 260 and in rural areas from 766 to 395 per 100,000 people. The annual decline in hospitalisations was greater in urban than rural areas, with Annual Percentage Change (APC) of −5.6% (95% CI, −6.1%, −5.0%) and −4.5% (95% CI, −5.0%, −4.0%), respectively (p=0.012). Ischaemic heart disease mortality declined at a similar rate in urban and rural regions (APC −7.6% and −6.7% per annum, p=0.28). Absolute inequalities in IHD deaths persisted until 2015 when there were 49 (urban) and 70 (rural) IHD deaths per 100,000 people. Conclusions Ischaemic heart disease hospitalisations and mortality have declined considerably between 2001 and 2015 in both rural and urban areas, yet inequalities persist, suggesting more intensive preventive efforts are required to further reduce the burden of IHD in rural populations.

Purpose: The purpose of this study is to develop a diabetes outcomes model for the US (DOMUS) using a multi-ethnic, real-world-data cohort of newly diagnosed Type II diabetics that can predict outcomes for a U.S. multi-ethnic type 2 diabetes population. Methods: The Kaiser Permanente Northern California (KPNC) Diabetes Registry, which is a well-described epidemiologic cohort with up to 13 years of follow-up from EMR and claims, were used to identify over 150,000 newly diagnosed diabetes patients between 2005-2016 with up to 13-year follow-up. The DOMUS model integrates separate, but interdependent risk equations to predict events for each of the micro and macro-vascular events, hypoglycemia, dementia, depression, and death, and predictive models for eight biomarker levels. Model accounted for static demographic factors (e.g., race) , neighborhood deprivation, and dynamic factors, such as age, duration of diabetes, fifteen-possible glucose -lowering treatment combinations, biomarker levels, and history of diabetes-related events. Moreover, the models explicitly allow for a legacy effect (average A1c in the first year after diagnosis) for all outcomes. Results: Data were randomly split into 75,000, 18,750, and 18,750 patients to perform estimation, out-of-sample calibration, and validation respectively. Model predictions in the validation sample closely aligned with the observed longitudinal trajectory of biomarkers and outcomes. Moreover, we examine the model performance within by age, race/ethnicity, and sex and found excellent predictive performance within subgroups. Conclusion: The DOMUS Model is able to simulate event histories and biomarker trajectories that closely match observed outcomes in a real-world, multi-ethnic population of newly diagnosed diabetics. DOMUS has the potential to carry out many complex analyses that examine the effectiveness and cost-effectiveness of new medications, value of diabetes prevention, and serve as decision support tools in health care settings. Disclosure A.N.Winn: Consultant; Takeda Pharmaceutical Company Limited. E.Huang: Advisory Panel; Twin Health, Stock/Shareholder; AbbVie Inc. P.Clarke: None. A.J.Karter: Research Support; Dexcom, Inc. W.Wan: n/a. D.R.Miller: None. M.Franco: None. A.Deckard: None. N.Laiteerapong: None.

ObjectiveTo evaluate the effect of comorbid conditions on direct healthcare expenditure and work-related outcomes in patients with rheumatoid arthritis (RA).MethodsThis is a retrospective analysis of the Medical Expenditure Panel Survey from 2006 to 2015 in 4967 adults with RA in the United States. Generalized linear models were used for healthcare expenditure and income, logistic models for employment status, and zero-inflated negative binomial models for absenteeism. Thirteen comorbid conditions were included as potential predictors of direct cost- and work-related outcomes. The models were adjusted for sociodemographic factors including sex, age, region, marital status, race/ethnicity, income, education, and smoking status.ResultsPatients with RA with heart failure (HF) had the highest incremental annual healthcare expenditure (US$8205, 95% CI $3683–$12,726) compared to those without the condition. Many comorbid conditions including hypertension (HTN), diabetes, depression, chronic obstructive pulmonary disease, cancer, stroke, and HF reduced the chance of patients with RA aged between 18–64 years being employed. Absenteeism of employed patients with RA was significantly affected by HTN, depression, disorders of the eye and adnexa, or stroke. On average, RA patients with HF earned US$15,833 (95% CI $4435–$27,231) per year less than RA patients without HF.ConclusionComorbid conditions in patients with RA were associated with higher annual healthcare expenditure, lower likelihood of employment, higher rates of absenteeism, and lower income. Despite its low prevalence, HF was associated with the highest incremental healthcare expenditure and the lowest likelihood of being employed compared to other common comorbid conditions.

Defined as the successful adaptation to dynamic environments, resilience is considered a cornerstone of mental health. However, with the underpinnings of resilience not yet fully understood, this manuscript tests the potential contribution of self-efficacy and embeddedness on resilience (explored through validated measures of future time perspective, body awareness, and social connectedness). The convenience sample of 18-to-77-year-old adults included 297 individuals, of which 36 were men and 171 were female. Participants completed online surveys composed of fifty-two questions in total, measuring self-efficacy, resilience, social connectedness, FTP, and body awareness. Resilience was positively related to self-efficacy, future time perspective, and social connectedness—but not to body awareness—and self-efficacy was positively associated with indices of embeddedness. Considering these correlations, and that only self-efficacy significantly predicted resilience, an exploratory model was proposed to test whether embeddedness directly predicted self-efficacy, and whether self-efficacy directly predicted resilience. Structural Equation Modelling suggested a good fit of this model, elucidating the interplay of psychological mechanisms underlying resilience. Thus, we identify potential variables of interest for clinical interventions aimed at increasing resilience and self-efficacy. Theoretical implications and future research are suggested based on these findings.

Purpose As patient-reported outcome measures (PROMs) are increasingly integrated into clinical practice, there is a need to translate collected data into valuable information to guide and improve the quality and value of patient care. The purpose of this study was to investigate health-related quality-of-life (QoL) trajectories in the 5 years following total knee replacement (TKR) and the patient characteristics associated with these trajectories. The feasibility of translating QoL trajectories into valuable information for guiding patient-centered care was also explored. Methods Data on patients who underwent TKR between 2006 and 2011 from a single-institution registry were extracted including patient-reported QoL (captured using the Short Form Survey (SF-12) instrument) up to 5 years post-surgery. QoL trajectories were modelled using latent class growth analysis. Quality-adjusted life-years (QALYs) were calculated to illustrate longer term health benefit. Multinomial logistic regression analyses were performed to examine the association between trajectory groups and baseline patient characteristics. Results After exclusions, 1553 patients out of 1892 were included in the analysis. Six unique QoL trajectories were identified; with differing levels at baseline and improvement patterns post-surgery. Only 18.4% of patients were identified to be in the most positive QoL trajectory (low baseline, large sustainable improvement after surgery) associated with the greatest gain in QALY. These patients were likely to be younger, have no co-morbidities and report greater pain at pre-surgery than most in other QoL trajectories. Conclusions Our findings demonstrate the importance of underlying heterogeneity in QoL trajectories, resulting in variable QALY gains. There is scope in translating routinely collected PROMs to improve shared decision-making allowing for more patient engagement. However, further research is required to identify suitable approaches of its implementation into practice to guide clinical care and maximize patient outcomes.

Background Elevated serum urate levels are associated with progression of chronic kidney disease. Whether urate-lowering treatment with allopurinol can attenuate the decline of the estimat...

OBJECTIVE To develop a patient-level simulation model for predicting lifetime health outcomes of patients with type 1 diabetes and as a tool for economic evaluation of type 1 diabetes treatment based on data from a large, longitudinal cohort. RESEARCH DESIGN AND METHODS Data for model development were obtained from the Swedish National Diabetes Register. We derived parametric proportional hazards models predicting absolute risk of diabetes complications and death based on a wide range of clinical variables and history of complications. We used linear regression models to predict risk factor progression. Internal validation was performed, estimates of life expectancies for different age-sex strata were computed, and the impact of key risk factors on life expectancy was assessed. RESULTS The study population consisted of 27,841 patients with type 1 diabetes with a mean duration of follow-up of 7 years. Internal validation showed good agreement between predicted and observed cumulative incidence of death and 10 complications. Simulated life expectancy was approximately 13 years lower than that of the sex- and age-matched general population, and patients with type 1 diabetes could expect to live with one or more complications for approximately 40% of their remaining life. Sensitivity analysis showed the importance of preventing renal dysfunction, hypoglycaemia and hyperglycaemia, and lowering HbA1c in reducing the risk of complications and death. CONCLUSIONS Our model was able to simulate risk factor progression and event histories that closely match the observed outcomes, and project events occurring over patients’ lifetimes. The model can serve as a tool to estimate the impact of changing clinical risk factors on health outcomes to inform economic evaluations of interventions in type 1 diabetes.

Background. There is growing evidence that quality of life (QoL) has a strong association with mortality. However, incorporation of QoL is uncommon in standard survival modeling. Methods. Using data extracted from a registry of patients undergoing total knee replacement (TKR), the impact of incorporating QoL in survival modeling was explored using 4 parametric survival models. QoL was incorporated and tested in 2 forms, which are baseline and change in QoL due to intervention. Life expectancy and quality-adjusted life years (QALYs) were calculated and comparisons made to a reference model (no QoL) to translate the findings in the context of modeled economic evaluations. Results. A total of 2858 TKR cases (2309 patients) who had TKR between 2006 and 2015 were included in this analysis. Increases in baseline and change in QoL were associated with a reduction in mortality. Compared to the reference model, differences of up to 0.32 life years and 0.53 QALYs were observed, and these translated into a 9.5% change in incremental effectiveness. These differences were much larger as the strength of the association between QoL and mortality increased. Conclusions. This work has demonstrated that the inclusion of QoL measures (at baseline and change from baseline) when extrapolating survival does matter. It can influence health outcomes such as life expectancy and QALYs, which are relevant in cost-effectiveness analysis. This is important because neglecting the correlation between QoL and mortality can lead to imprecise extrapolations and thus risk misleading results affecting subsequent decisions made by policy makers.

Background Structural uncertainty can affect model-based economic simulation estimates and study conclusions. Unfortunately, unlike parameter uncertainty, relatively little is known about its magnitude of impact on life-years (LYs) and quality-adjusted life-years (QALYs) in modeling of diabetes. We leveraged the Mount Hood Diabetes Challenge Network, a biennial conference attended by international diabetes modeling groups, to assess structural uncertainty in simulating QALYs in type 2 diabetes simulation models. Methods Eleven type 2 diabetes simulation modeling groups participated in the 9th Mount Hood Diabetes Challenge. Modeling groups simulated 5 diabetes-related intervention profiles using predefined baseline characteristics and a standard utility value set for diabetes-related complications. LYs and QALYs were reported. Simulations were repeated using lower and upper limits of the 95% confidence intervals of utility inputs. Changes in LYs and QALYs from tested interventions were compared across models. Additional analyses were conducted postchallenge to investigate drivers of cross-model differences. Results Substantial cross-model variability in incremental LYs and QALYs was observed, particularly for HbA1c and body mass index (BMI) intervention profiles. For a 0.5%-point permanent HbA1c reduction, LY gains ranged from 0.050 to 0.750. For a 1-unit permanent BMI reduction, incremental QALYs varied from a small decrease in QALYs (−0.024) to an increase of 0.203. Changes in utility values of health states had a much smaller impact (to the hundredth of a decimal place) on incremental QALYs. Microsimulation models were found to generate a mean of 3.41 more LYs than cohort simulation models ( P = 0.049). Conclusions Variations in utility values contribute to a lesser extent than uncertainty captured as structural uncertainty. These findings reinforce the importance of assessing structural uncertainty thoroughly because the choice of model (or models) can influence study results, which can serve as evidence for resource allocation decisions. Highlights The findings indicate substantial cross-model variability in QALY predictions for a standardized set of simulation scenarios and is considerably larger than within model variability to alternative health state utility values (e.g., lower and upper limits of the 95% confidence intervals of utility inputs). There is a need to understand and assess structural uncertainty, as the choice of model to inform resource allocation decisions can matter more than the choice of health state utility values.

Life Plan Communities, also known as Continuing Care Retirement Communities, typically offer a wide range of wellness programs and services, including fitness classes, educational lectures, volunteer opportunities, and social events. Despite the convenience of onsite wellness resources, some residents choose not to participate in wellness offerings available at the community. One factor that may influence engagement in wellness behaviors is older adults’ attitudes toward aging, which has been associated with differences in health and well-being over time. The purpose of this research was to examine the relationship between attitudes toward aging and wellness engagement among residents of Life Plan Communities. A total of 447 residents (ages 59 to 97; M = 81.82, SD = 6.55; 65% female) of 10 communities completed surveys that measured their attitudes toward aging, self-reported wellness, interest in improving wellness, participation in wellness programs, and barriers to wellness participation. Multiple regression analyses revealed that more positive attitudes toward aging were associated with better wellness, higher interest, more frequent participation, and fewer barriers, controlling for age, gender health, education, and marital status. Follow-up analyses revealed that these effects could be accounted for by specific types of aging attitudes (i.e., psychological growth, psychosocial loss, and physical change). For example, greater psychological growth was associated with greater wellness, interest in improving wellness, and wellness participation, whereas greater psychosocial losses was associated with greater perceived barriers and lower wellness. These findings have implications for the development, implementation, and promotion of wellness programs for older adults.

Purpose To investigate the effects of rapid weight loss (RWL), incorporating comparison of hot water immersion (HWI) in fresh or salt water, on changes in body mass, blood markers, and indices of performance in mixed martial arts athletes. Methods In a crossover design comparing fresh water (FWB) to salt water (SWB; 5.0%wt/vol Epsom salt) bathing, 13 males performed 20 min of HWI (~ 40.3 °C) followed by 40 min wrapped in a heated blanket, twice in sequence (2 h total). Before bathing, ~ 26 to ~ 28 h of fluid and dietary restriction was undertaken, and ~ 24 to ~ 26 h of a high carbohydrate diet and rehydration was undertaken as recovery. Results During the entire RWL process, participants lost ~ 5.3% body mass. Body mass lost during the 2 h hot bath protocol was 2.17 ± 0.81 kg (~ 2.7% body mass) and 2.24 ± 0.64 kg (~ 2.8% body mass) for FWB and SWB, respectively (P = 0.647 between trials). Blood urea nitrogen, creatinine, sodium, chloride, hemoglobin, and hematocrit were increased (all P P Conclusion Under the conditions of this hot bath protocol, fluid loss was not augmented by the addition of ~ 5.0%wt/vol of Epsom salt during HWI, and RWL of ~ 5.3% body mass followed by > 24 h of recovery did not impact indices of performance.