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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.

To assess the comparative effectiveness and temporal changes in quality of life (QoL) outcomes after revascularisation, major lower extremity amputation (MLEA), and conservative management (CM) in chronic limb threatening ischaemia (CLTI).MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science.A systematic review and meta-analysis were performed on QoL measured by any QoL instrument in adult patients with CLTI after open surgery (OS), endovascular intervention (EVI), MLEA, or CM. Randomised controlled trials and prospective observational studies published in any language between 1 January 1990 and 21 May 2021 were included. There was a pre-specified measurement time point of six months. Random effects meta-analysis was conducted on total scores for each QoL instrument. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach (PROSPERO registration: CRD42021253953).Fifty-five studies with 8 909 patients were included. There was significant heterogeneity in the methods used to measure QoL, and the study characteristics. In particular, 14 different QoL instruments were used with various combinations of disease specific and generic instruments within each study. A narrative summary is therefore presented. Comparative effectiveness data showed there was reasonable certainty that QoL was similar between OS and EVI at six months. Temporal outcomes suggested small to moderate improvements in QOL six months after OS and EVI compared with baseline. Limited data indicated that QoL can be maintained or slightly improved after MLEA or CM. Treatment effects were overestimated owing to small study effects, selective non-reporting, attrition, and survivorship bias.QoL after OS and EVI appears to be similar. Revascularisation may provide modest QoL benefits, while MLEA or CM can maintain QoL. However, certainty of evidence is generally low or very low, and interpretation is hampered by significant heterogeneity. There is a need for a CLTI specific QoL instrument and methodological standardisation in QoL studies.

To review and describe the available literature on cost-utility analysis of revascularization and non-revascularization treatment approaches in chronic limb-threatening ischemia.A systematic review was performed on cost-utility analysis studies evaluating revascularization (open surgery or endovascular), major lower extremity amputation, or conservative management in adult chronic limb-threatening ischemia patients. Six bibliographic databases and online registries were searched for English language articles up to August 2021. The outcome for cost-utility analysis was quality-adjusted in life years. Procedures were compared using incremental cost-effectiveness ratios which were converted to 2021 United States dollars. Study reporting quality was assessed using the 2022 Consolidated Health Economic Evaluation Reporting Standards statement. The study was registered in International Prospective Register of Systematic Reviews (CRD42021273602).Three trial-based and five model-based studies were included for review. Studies met between 14/28 and 20/28 criteria of the Consolidated Health Economic Evaluation Reporting Standards CHEERS statement. Only one study was written according to standardized reporting guidelines. Most studies evaluated infrainguinal disease, and adopted a health care provider perspective. There was a large variation in the incremental cost-effectiveness ratios presented across studies. Open surgical revascularization (incremental cost-effectiveness ratios: $3,678, $58,828, and $72,937), endovascular revascularization (incremental cost-effectiveness ratios: $52,036, $125,329, and $149,123), and mixed open or endovascular revascularization (incremental cost-effectiveness ratio: $8,094) maybe more cost-effective than conservative management.The application of cost-utility analyses in chronic limb-threatening ischemia is in its infancy. Revascularization in infrainguinal disease may be favored over major lower extremity amputation or conservative management. However, data is inadequate to support recommendations for a specific treatment. This review identifies short and long-term considerations to address the current state of evidence. Cost-utility analysis is an important tool in healthcare policy and should be encouraged amongst the vascular surgical community.

To review quality of life (QOL) instruments for chronic limb-threatening ischemia (CLTI) patients and informal carers, and their use in QOL and cost-utility analysis (CUA) studies.CLTI is a global health problem with significant morbidity affecting patients and informal carers. QOL is increasingly measured for holistic outcomes assessment and CUA. However, measurement instruments in CLTI are poorly understood.MEDLINE, EMBASE, PsycINFO, CINAHL, COSMIN, PROQOLID, CEA registry, and NHS EED databases were searched for all English language studies up to May 2021. Features of instruments, evidence of measurement property appraisal, and trends in use were assessed. Prospective protocol registration (Open Science Framework: https://doi.org/10.17605/OSF.IO/KNG9U ).A total of 146 studies on QOL instruments (n=43), QOL outcomes (n=97), and CUA (n=9) were included. Four disease-specific QOL instruments are available for lower extremity arterial disease (intermittent claudication or CLTI). VascuQoL-25 and VascuQoL-6 have been used in CLTI. There is no CLTI-specific instrument. Of 14 generic instruments, SF-36, EQ-5D-3L, NHP, and WHOQOL-BREF were most common. Studies reporting partial measurement property appraisal favored VascuQoL-25, VascuQoL-6, and SF-36. Feasibility considerations include mode of administration and responder burden. None of 4 available carer-specific instruments have been used in CLTI. Since 1992, the number of QOL studies has increased considerably, but CUA studies are scarce. Informal carers have not been assessed.This review provides a comprehensive reference for QOL measurement in CLTI that helps end-users with instrument selection, use, and interpretation. However, a CLTI-specific instrument is needed. There is an opportunity to benefit society through future CUA studies and evaluation of QOL in informal carers.

Aim: This study aims to compare the financial and clinical outcomes of robotic and laparoscopic proctectomy within a public healthcare system. Methods:Consecutive patients undergoing laparoscopic and robotic proctectomy between January 2017 and June 2020 in a public quaternary centre were included. Demographic characteristics, baseline clinical, tumour and operative variables, perioperative, histopathological outcomes and costs were compared between the laparoscopic and robotic groups. Simple linear regression and generalised linear model analyses with gamma distribution and log-link function were used to determine the impact of the surgical approach on overall costs. Results: During the study period, 113 patients underwent minimally invasive proctectomy. Of these, 81 (71.7%) underwent a robotic proctectomy. A taTME component was more often utilised in the laparoscopic group (34.4% versus 13.6%;P=0.003). Demographic and baseline clinical variables were otherwise similar between groups. A robotic approach was associated with a lower conversion rate (2.5% versus 21.8%;P=0.002) at the expense of longer operating times (284±83.4 versus 243±89.8 minutes;P=0.025). Regarding financial outcomes, robotic surgery was associated with increased theatre costs (A$23019±8235 versus A$15525±6382; PConclusion: Robotic proctectomy was associated with increased theatre costs but not with increased overall inpatient costs within a public healthcare setting. Conversion was less common for robotic proctectomy at the expense of increased operating time. Larger studies will be needed to confirm these findings and examine the cost-effectiveness of robotic proctectomy to further justify its penetration in the public healthcare system.

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.

The aim of this study is to review illness perceptions (IPs) in chronic limb-threatening ischemia (CLTI) patients undergoing revascularization (open surgical or endovascular), major lower extremity amputation, or conservative management.MEDLINE, EMBASE, PsycINFO, CINAHL, WOS, and Scopus databases were searched from inception to August 20, 2021 for studies evaluating IP in CLTI according to Leventhal's common sense model (CSM). Since only 1 study was identified, a post hoc secondary literature search of MEDLINE was performed for reviews of IP in cardiovascular disease and diabetes to identify potential learning points for future research. All studies underwent narrative synthesis guided by tabulated data.One study and 7 reviews were included from the primary and secondary literature searches, respectively. Timeline and controllability were the main aspects of IP that predict prosthetic use in CLTI patients, more so at 6 months than 1 month. Other reviews in cardiovascular disease and diabetes identified important targets for future research: (1) factors that affect IP and whether IP can be used as an outcome measure, (2) relationship between IP and clinician-reported and patient-reported outcomes, and (3) methods to educate and change maladaptive IP. The importance of using valid and reliable measures of IP that encompass all components of Leventhal's' CSM was stressed.Knowledge of IP in CLTI patients is severely limited in contrast to other fields in cardiovascular disease and diabetes. This review helps to close this gap by raising awareness of IP and its importance within the vascular surgical community, and by providing a framework for future studies.

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. 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.

INTRODUCTION Home-based treatment of febrile neutropenia (FN) in children with cancer with oral or intravenous antibiotics is safe and effective. There are limited data on the economic impact of this model of care. We evaluated the cost-effectiveness of implementing an FN programme, incorporating home-based intravenous antibiotics for carefully selected patients, in a tertiary paediatric hospital. METHODS A decision analytic model was constructed to compare costs and outcomes of the home-based FN programme, with usual in-hospital treatment with intravenous antibiotics. The programme included a clinical decision rule to stratify patients by risk for severe infection and home-based eligibility criteria using disease, chemotherapy and patient-level factors. Health outcomes (quality of life) and probabilities of FN risk classification and home-based eligibility were based on prospectively collected data between 2017 and 2019. Patient-level costs were extracted from hospital administrative records. Cost-effectiveness was expressed as the incremental cost per quality-adjusted life year (QALY). FINDINGS The mean health care cost of home-based FN treatment in low-risk patients was Australian dollars (A$) 7765 per patient compared to A$20,396 for in-hospital treatment (mean difference A$12,632 [95% CI: 12,496-12,767]). Overall, the home-based FN programme was the dominant strategy, being more effective (0.0011 QALY [95% CI: 0.0011-0.0012]) and less costly. Results of the model were most sensitive to proportion of children eligible for home-based care programme. CONCLUSION Compared to in-hospital FN care, the home-based FN programme is cost-effective, with savings arising from cheaper cost of caring for children at home. These savings could increase as more patients eligible for home-based care are included in the programme.

INTRODUCTION: Home-based treatment of febrile neutropenia (FN) in children with cancer with oral or intravenous antibiotics is safe and effective. There are limited data on the economic impact of this model of care. We evaluated the cost-effectiveness of implementing an FN programme, incorporating home-based intravenous antibiotics for carefully selected patients, in a tertiary paediatric hospital. METHODS: A decision analytic model was constructed to compare costs and outcomes of the home-based FN programme, with usual in-hospital treatment with intravenous antibiotics. The programme included a clinical decision rule to stratify patients by risk for severe infection and home-based eligibility criteria using disease, chemotherapy and patient-level factors. Health outcomes (quality of life) and probabilities of FN risk classification and home-based eligibility were based on prospectively collected data between 2017 and 2019. Patient-level costs were extracted from hospital administrative records. Cost-effectiveness was expressed as the incremental cost per quality-adjusted life year (QALY). FINDINGS: The mean health care cost of home-based FN treatment in low-risk patients was Australian dollars (A$) 7765 per patient compared to A$20,396 for in-hospital treatment (mean difference A$12,632 [95% CI: 12,496-12,767]). Overall, the home-based FN programme was the dominant strategy, being more effective (0.0011 QALY [95% CI: 0.0011-0.0012]) and less costly. Results of the model were most sensitive to proportion of children eligible for home-based care programme. CONCLUSION: Compared to in-hospital FN care, the home-based FN programme is cost-effective, with savings arising from cheaper cost of caring for children at home. These savings could increase as more patients eligible for home-based care are included in the programme.

Transparency in health economic decision modelling is important for engendering confidence in the models and in the reliability of model-based cost-effectiveness analyses. The Mount Hood Diabetes Challenge Network has taken a lead in promoting transparency through validation with biennial conferences in which diabetes modelling groups meet to compare simulated outcomes of pre-specified scenarios often based on the results of pivotal clinical trials. Model registration is a potential method for promoting transparency, while also reducing the duplication of effort. An important network initiative is the ongoing construction of a diabetes model registry (https://www.mthooddiabeteschallenge.com). Following the 2012 International Society for Pharmacoeconomics and Outcomes Research and the Society of Medical Decision Making (ISPOR-SMDM) guidelines, we recommend that modelling groups provide technical and non-technical documentation sufficient to enable model reproduction, but not necessarily provide the model code. We also request that modelling groups upload documentation on the methods and outcomes of validation efforts, and run reference case simulations so that model outcomes can be compared. In this paper, we discuss conflicting definitions of transparency in health economic modelling, and describe the ongoing development of a registry of economic models for diabetes through the Mount Hood Diabetes Challenge Network, its objectives and potential further developments, and highlight the challenges in its construction and maintenance. The support of key stakeholders such as decision-making bodies and journals is key to ensuring the success of this and other registries. In the absence of public funding, the development of a network of modellers is of huge value in enhancing transparency, whether through registries or other means.

The inclusion of future medical costs in cost-effectiveness analyses remains a controversial issue. The impact of capturing future medical costs is likely to be particularly important in patients with cancer where costly lifelong medical care is necessary. The lack of clear, definitive pharmacoeconomic guidelines can limit comparability and has implications for decision making. The aim of this study was to demonstrate the impact of incorporating future medical costs through an applied example using original data from a clinical study evaluating the cost effectiveness of a sepsis intervention in cancer patients. A decision analytic model was used to capture quality-adjusted life-years (QALYs) and lifetime costs of cancer patients from an Australian healthcare system perspective over a lifetime horizon. The evaluation considered three scenarios: (1) intervention-related costs (no future medical cost), (2) lifetime cancer costs and (3) all future healthcare costs. Inputs to the model included patient-level data from the clinical study, relative risk of death due to sepsis, cancer mortality and future medical costs sourced from published literature. All costs are expressed in 2017 Australian dollars and discounted at 5%. To further assess the impact of future costs on cancer heterogeneity, variation in survival and lifetime costs between cancer types and the implications for cost-effectiveness analysis were explored. The inclusion of future medical costs increased incremental cost-effectiveness ratios (ICERs) resulting in a shift from the intervention being a dominant strategy (cheaper and more effective) to an ICER of $7526/QALY. Across different cancer types, longer life expectancies did not necessarily result in greater lifetime healthcare costs. Incremental costs differed across cancers depending on the respective costs of managing cancer and survivorship, thus resulting in variations in ICERs. There is scope for including costs beyond intervention costs in economic evaluations. The inclusion of future medical costs can result in markedly different cost-effectiveness results, leading to higher ICERs in a cancer population, with possible implications for funding decisions.

Background Cancer patients are at significant risk of developing sepsis due to underlying malignancy and necessary treatments. Little is known about the economic burden of sepsis in this high-risk population. We estimate the short- and long-term healthcare costs of care of cancer patients with and without sepsis using individual-level linked-administrative data. Methods We conducted a population-based matched cohort study of cancer patients aged ≥18, diagnosed between 2010 and 2017. Cases were identified if diagnosed with sepsis during the study period, and were matched 1:1 by age, sex, cancer type and other variables to controls without sepsis. Mean costs (2018 Canadian dollars) for patients with and without sepsis up to 5 years were estimated adjusted using survival probabilities at partitioned intervals. We estimated excess cost associated with sepsis presented as a cost difference between the two cohorts. Haematological and solid cancers were analysed separately. Results 77,483 cancer patients with sepsis were identified and matched. 64.3% of the cohort were aged ≥65, 46.3% female and 17.8% with haematological malignancies. Among solid tumour patients, the excess cost of care among patients who developed sepsis was $29,081 (95%CI, $28,404-$29,757) in the first year, rising to $60,714 (95%CI, $59,729-$61,698) over 5 years. This was higher for haematology patients; $46,154 (95%CI, $45,505-$46,804) in year 1, increasing to $75,931 (95%CI, $74,895-$76,968). Conclusions Sepsis imposes substantial economic burden and can result in a doubling of cancer care costs, particularly during the first year of cancer diagnosis. These estimates are helpful in improving our understanding of burden of sepsis along the cancer pathway and to deploy targeted strategies to alleviate this burden.

Objectives: The cardiovascular outcomes challenge examined the predictive accuracy of 10 diabetes models in estimating hard outcomes in 2 recent cardiovascular outcomes trials (CVOTs) and whether recalibration can be used to improve replication. Methods: Participating groups were asked to reproduce the results of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program. Calibration was performed and additional analyses assessed model ability to replicate absolute event rates, hazard ratios (HRs), and the generalizability of calibration across CVOTs within a drug class. Results: Ten groups submitted results. Models underestimated treatment effects (ie, HRs) using uncalibrated models for both trials. Calibration to the placebo arm of EMPA-REG OUTCOME greatly improved the prediction of event rates in the placebo, but less so in the active comparator arm. Calibrating to both arms of EMPA-REG OUTCOME individually enabled replication of the observed outcomes. Using EMPA-REG OUTCOME–calibrated models to predict CANVAS Program outcomes was an improvement over uncalibrated models but failed to capture treatment effects adequately. Applying canagliflozin HRs directly provided the best fit. Conclusions: The Ninth Mount Hood Diabetes Challenge demonstrated that commonly used risk equations were generally unable to capture recent CVOT treatment effects but that calibration of the risk equations can improve predictive accuracy. Although calibration serves as a practical approach to improve predictive accuracy for CVOT outcomes, it does not extrapolate generally to other settings, time horizons, and comparators. New methods and/or new risk equations for capturing these CV benefits are needed.

ObjectivesTo investigate associations between maternal body mass index (BMI) at delivery (using pregnancy-specific BMI cut-off values 5 kg/m2higher in each of the WHO groups) and clinical, theatre utilisation and health economic outcomes for women undergoing caesarean section (CS). DesignA prospective multicentre observational study. SettingSeven secondary or tertiary referral obstetric hospitals. ParticipantsOne thousand and four hundred and fifty-seven women undergoing all categories of CS. Data collectionHeight and weight were recorded at the initial antenatal visit and at delivery. We analysed the associations between delivery BMI (continuous and pregnancy-specific cut-off values) and total theatre time, surgical time, anaesthesia time, maternal and neonatal adverse outcomes, total hospital admission and theatre costs. ResultsMean participant characteristics were: age 32 years, gestation at delivery 38.4 weeks and delivery BMI 32.2 kg/m2. Fifty-five per cent of participants were overweight, obese or super-obese using delivery pregnancy-specific BMI cut-off values. As BMI increased, total theatre time, surgical time and anaesthesia time increased. Super-obese participants had approximately 27% (17 min, p ConclusionsIncreased maternal BMI was associated with increased total theatre time, surgical and anaesthesia time, increased total hospital admission costs and theatre costs. Clinicians and health administrators should consider these clinical risks, time implications and financial costs when managing pregnant women.

Objectives\ud The Eighth Mount Hood Challenge (held in St. Gallen, Switzerland, in September 2016) evaluated the transparency of model input documentation from two published health economics studies and developed guidelines for improving transparency in the reporting of input data underlying model-based economic analyses in diabetes.\ud \ud Methods\ud Participating modeling groups were asked to reproduce the results of two published studies using the input data described in those articles. Gaps in input data were filled with assumptions reported by the modeling groups. Goodness of fit between the results reported in the target studies and the groups’ replicated outputs was evaluated using the slope of linear regression line and the coefficient of determination (R2). After a general discussion of the results, a diabetes-specific checklist for the transparency of model input was developed.\ud \ud Results\ud Seven groups participated in the transparency challenge. The reporting of key model input parameters in the two studies, including the baseline characteristics of simulated patients, treatment effect and treatment intensification threshold assumptions, treatment effect evolution, prediction of complications and costs data, was inadequately transparent (and often missing altogether). Not surprisingly, goodness of fit was better for the study that reported its input data with more transparency. To improve the transparency in diabetes modeling, the Diabetes Modeling Input Checklist listing the minimal input data required for reproducibility in most diabetes modeling applications was developed.\ud \ud Conclusions\ud Transparency of diabetes model inputs is important to the reproducibility and credibility of simulation results. In the Eighth Mount Hood Challenge, the Diabetes Modeling Input Checklist was developed with the goal of improving the transparency of input data reporting and reproducibility of diabetes simulation model results.

Objective The management of low-risk febrile neutropenia (FN) patients through ambulatory programs has demonstrated comparative safety and effectiveness to in-patient strategies. However, there is limited evidence of benefits of changing practice, particularly on a national scale. The aim of this study was to estimate costs and benefits of the program over a 10-year time horizon. Methods A comparative cost analysis from a health system perspective was performed, comparing costs and length of stay (LOS) of patients enrolled in an ambulatory program to a historical cohort who did not receive the program. Generalised linear models were used for analysis and bootstrapped to account for uncertainty. National data of identified FN admissions were used to inform future projections, with varying proportions of low-risk patients and eligibility for the ambulatory program. Results The overall LOS for patients in ambulatory cohort was 1.9 days shorter (95% confidence interval (CI) 1.0–2.8 days), a 50% reduction in in-patient bed-days. Although patients in the ambulatory cohort incurred additional costs due to care received outside hospital (mean (± s.d.) A$828.03 ± 124.30), the mean total cost incurred remained substantially lower than that of the historical cohort (A$2979 lower; 95% CI A$772–5391). On a national scale, this could translate into A$62.7 million in costs averted and 41 347 bed-days saved over 10 years if the low-risk prediction rate and eligibility for ambulatory programs remained at currently observed rates. Conclusions The wider implementation of a safe and effective ambulatory program to manage low-risk FN patients can result in significant return-on-investment for the healthcare system by eliminating avoidable costs due to unnecessary lengthy hospital admissions. What is known about the topic? There is strong evidence demonstrating out-patient treatment of low-risk FN patients to be an effective and cost-effective strategy compared with continued in-patient hospitalisation. What does this paper add? This study demonstrates the sustainability of the ambulatory program in ensuring cost benefits and in-patient beds through real-life implementation data. It also provides evidence of the substantial cost and bed-days potentially averted when the cost savings and difference in LOS are estimated on a national scale over a 10-year time horizon. What are the implications for practitioners? The management of low-risk FN patients through ambulatory or out-patient programs is a safe and effective approach. There is strong evidence demonstrating the likely cost savings and considerable bed-days saved, which can be reallocated to meet other medical demands.

Infection and sepsis are common problems in cancer management affecting up to 45% of patients and are associated with significant morbidity, mortality and healthcare utilisation.ObjectiveTo develop and implement a whole of hospital clinical pathway for the management of sepsis (SP) in a specialised cancer hospital and to measure the impact on patient outcomes and healthcare utilisation.MethodsA multidisciplinary sepsis working party was established. Process mapping of practices for recognition and management of sepsis was undertaken across all clinical areas. A clinical pathway document that supported nurse-initiated sepsis care, prompt antibiotic and fluid resuscitation was implemented. Process and outcome measures for patients with sepsis were collected preimplementation (April–December 2012), postimplementation cohorts (April–December 2013), and from January to December 2014.Results323 patients were evaluated (111 preimplementation, 212 postimplementation). More patients with sepsis had lactate measured (75.0% vs 17.2%) and appropriate first dose antibiotic (90.1% vs 76.1%) (all pConclusionsThe SP was associated with significant improvement in patient outcomes and reduced costs. The SP has been sustained since 2013, and has been successfully implemented in another hospital with further implementations underway in Victoria.

Improved understanding of quality-of-life (QoL) outcomes can provide valuable information on intervention effectiveness and guide better patient care. The aim of this study was to examine whether QoL trajectories differ between patients with and without diabetes and identify to what extent patient characteristics are related to poor QoL outcomes after total joint replacement (TKR). Multilevel modelling was used to analyse long-term QoL patterns of patients undergoing TKR between 2006 and 2011. Patient-reported QoL at baseline and up to 5 years post-surgery were included. Of the 1553 TKR patients, one-fifth (n = 319) had diabetes. Despite there being no significant differences in QoL at baseline, patients with diabetes consistently reported lower QoL (on average by 0.028, p &lt, 0.001) and did not improve to the same level as patients without the disease following surgery. Compared to males, females had significantly lower QoL (by 0.03, p &lt, 0.001). Other baseline patient characteristics associated with important differences in QoL included presence of respiratory disease and mental health disorder. Patients with diabetes exhibit significantly poorer QoL compared to patients without diabetes, particularly among females. Knowledge of risk factors that impact on QoL can be useful for clinicians in identifying characteristics related to poor QoL outcomes and be used to guide patient-centered care.

BACKGROUND The objective of this study was to examine the physical and emotional health status, self-perceived problems, and needs of newly diagnosed cancer patients to determine and plan supportive care strategies. METHODS A cross-sectional survey of newly diagnosed cancer patients attending a regional cancer center during a 6-month period was performed. Patients with breast, colorectal, head and neck, lung, and prostate carcinoma as well as nonmelanoma of the skin were selected randomly. Patients were interviewed prior to their first appointment at the clinic. Physical health status was assessed using the Symptom Distress Scale, psychologic health status was assessed with the General Health Questionnaire (GHQ), day-to-day functioning with the Rapid Disability Scale, and social support with the modified Sarason's Social Support Scale. Perceived needs were assessed in a number of ways, including identification of patients' specific social concerns and informational needs, and by asking them to list their current problems or concerns. RESULTS Of 156 eligible patients, 134 completed the interview. One hundred and twenty-nine patients (96%) reported current symptoms that included fatigue (66%), worried outlook (61%), difficulty sleeping (48%), and pain (42%). Forty-four patients (33%) were identified as psychologically distressed with a GHQ score of ≥ 6. One hundred and fourteen patients (85%) had informational needs, 89 (66%) indicated ≥ 1 social concerns, and 55 (41%) reported a need for assistance with day-to-day living. CONCLUSIONS Patients with newly diagnosed cancer commonly report symptoms related to fatigue, pain, and psychologic distress. Other frequently reported issues relate to the need for information and social concerns regarding the patients' ability to take care of their home and maintain family and other relationships. Awareness of these issues is important for planning supportive care interventions for newly diagnosed cancer patients. Cancer 1997; 80:1518-24. © 1997 American Cancer Society.

A recent study demonstrated widespread substitution of analog for human insulin and rising out-of-pocket costs in privately insured people with type 2 diabetes in the United States.1 Medicaid reimbursements have increased for both human insulin and more costly analog insulins.2 Although studies have described per-person changes in excess medical spending of US adults with diabetes on prescription medications,3 they have not reported trends in expenditures for different classes of antihyperglycemic medications that simultaneously consider changes in use and price.

The first step in effective supportive care delivery is an assessment of patient needs. The Initial Health Assessment Form (IHA) was developed to aid clinicians in recognition and documentation of a patient's supportive care needs during their first visit to a comprehensive cancer centre. The purpose of this study was to determine the relative effectiveness of this instrument as compared to routine practice.A before-after study was performed. Charts of consecutive patients with newly diagnosed cancer attending the Hamilton Regional Cancer Centre were selected randomly. Each chart was reviewed to determine the documentation at the initial patient assessment of 22 supportive care items under eight domains of need: physical, psychological, daily living, social, financial, informational, special needs and personal resources. The pre-intervention evaluation (T1) occurred over a 3-month period followed by the introduction of the IHA into clinical practice. Three months after its introduction, the post-intervention (T2) evaluation took place over the ensuing 3 months.A total of 306 charts were evaluated (153 each in T1 and T2). Patients from the two time periods were comparable with respect to background demographic variables. Introduction of the IHA increased the mean documentation of supportive care needs and resources from 26% in T1 to 49% in T2 ( p=0.001). Significant improvements were found in all domains of need. Despite improvements, documentation of assessment continued to remain low for daily living, social, financial, and informational needs.The IHA improved documentation of supportive care needs and resources. There is still room for improvement.

We compared the quality-of-life (QOL) dimensions after laryngectomy in patients with advanced larynx or pharynx cancer that were elicited from 20 consecutive laryngectomy patients and 20 health care professionals working in the Regional Head and Neck Oncology Service. Subjects in both groups were asked to identify important QOL items after recovery from laryngectomy and to rank and rate each on a vertical visual analogue scale. Health care professionals ranked impaired communication and self-image/self-esteem as the two most important QOL dimensions, whereas patients ranked the physical consequences of surgery, e.g., tracheal mucous production, and interference with social activities as the two most important items. The results indicate that the responses of health care professionals do not fully correlate with patient priorities. These findings are relevant to researchers developing treatment-specific QOL measures and to health care professionals when presenting treatment options to patients.

An economic evaluation was undertaken concurrently with a randomized trial comparing a Caregiver Support Program (CSP) with existing conventional community nursing care for those caring for elderly relatives at home. The differences in resource consumption were compared with changes in caregiver quality of life, as measured by the Caregiver Quality of Life Instrument (CQLI). A 20% difference from baseline in the CQLI favored the experimental (CSP) group, although this did not reach conventional levels of statistical significance. A comparison of improvement in quality of life with costs implies an incremental cost per quality-adjusted life year gained of Canadian $20,000 for the CSP, which compares favorably with other health care interventions. Further, larger studies are required to confirm this result.