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Background: The Acarbose Cardiovascular Evaluation (ACE) trial (ISRCTN91899513) evaluated the alpha‐glucosidase inhibitor acarbose, compared with placebo, in 6522 patients with coronary heart disease and impaired glucose tolerance in China and showed a reduced incidence of diabetes. We assessed the within‐trial medical resource use and costs, and quality‐adjusted life years (QALYs). Methods: Resource use data were collected prospectively within the ACE trial. Hospitalizations, medications, and outpatient visits were valued using Chinese unit costs. Medication use was measured in drug days, with cardiovascular and diabetes drugs summed across the trial by participant. Health‐related quality of life was captured using the EuroQol‐5 Dimension‐3 Level questionnaire. Regression analyses were used to compare resource use, costs, and QALYs, accounting for regional variation. Costs and QALYs were discounted at 3% yearly. Results: Hospitalizations were 6% higher in the acarbose arm during the trial (rate ratio 1.06, p =.009), but there were no significant differences in total inpatient days (rate ratio 1.04, p =.30). Total costs per participant, including study drug, were significantly higher for acarbose (¥ [Yuan] 56 480, £6213), compared with placebo (¥48 079, £5289; mean ratio 1.18, p < 0.001). QALYs reported by participants in the acarbose arm (3.96 QALYs) were marginally higher than in the placebo arm (3.95 QALYs), but the difference was not statistically significant (0.01 QALYs; p =.58). Conclusions: Acarbose, compared with placebo, participants cost more due to study drug costs and reported no statistically significant difference in QALYs. These higher within‐trial costs could potentially be offset in future by savings from the acarbose‐related lower incidence of diabetes. [ABSTRACT FROM AUTHOR]

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Background. Reliably mapping from generic or disease-specific health status measures into health state utilities would assist health economists. Existing studies mainly use ordinary least squares (OLS) regression equations to predict [...]

Robust methods are used to examine the effects of age and proximity to death on hospital costs. It is shown that the large tenfold increase in costs from 5 years prior to death to the last year of life overshadows the 30 percent increase in costs from age 65 to 85.

The successful development of an economic model for the evaluation of future Alzheimer's disease (AD) interventions is critical to accurately inform policy makers and payers. As our understanding of AD expands, this becomes an increasingly complex and challenging goal. Advances in diagnostic techniques for AD and the prospect of disease-modifying treatments raise an urgent need to define specifications for future economic models and to ensure that the necessary data to populate themare available. ThisPerspective article provides expert opinions from health economists and governmental agency representatives on how future economic models for AD might be structured, validated, and reported. We aim to stimulate much-needed discussion about the detailed specification of future health economic models for AD. [ABSTRACT FROM AUTHOR]

Objectives: To estimate 13 equations that predict clinically plausible risk factor time paths to inform the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model version 2 (UKPDS‐OM2). Methods: Data from 5102 UKPDS participants from the 20‐year trial, and the 4031 survivors with 10 years further post‐trial follow‐up, were used to derive equations for the time paths of 13 clinical risk factors: HbA1c, systolic blood pressure, LDL‐cholesterol, HDL‐cholesterol, BMI, micro‐ or macro‐albuminuria, creatinine, heart rate, white blood cell count, haemoglobin, estimated glomerular filter rate, atrial fibrillation and peripheral vascular disease (PVD). The incidence of events and death predicted by the UKPDS‐OM2 when informed by the new risk factor equations was compared with the observed cumulative rates up to 25 years. Results: The new equations were based on 24 years of follow‐up and up to 65,252 person‐years of data. Women were associated with higher values of all continuous risk factors except for haemoglobin. Older age and higher BMI at diagnosis were associated with higher rates of PVD (HR 1.06 and 1.02), atrial fibrillation (HR 1.10 and 1.08) and micro‐ or macro‐albuminuria (HR 1.01 and 1.18). Smoking was associated with higher rates of developing PVD (HR 2.38) and micro‐ and macro‐albuminuria (HR 1.39). The UKPDS‐OM2, informed by the new risk factor equations, predicted event rates for complications and death consistent with those observed. Conclusions: The new equations allow risk factor time paths beyond observed data, which should improve modelling of long‐term health outcomes for people with type 2 diabetes when using the UKPDS‐OM2 or other models. [ABSTRACT FROM AUTHOR]

I. INTRODUCTION Since its introduction in 1950, legal aid has been an important mechanism for improving access to British justice. As the Lord Chancellor's Department (LCD) put it, the scheme [...]

Abstract Background Coeliac disease is a common chronic autoimmune disorder. Underdiagnosis is common and the quality of life impact of symptoms may be severe. We report a study of symptom duration and quality of life before and after diagnosis in a representative sample of people with diagnosed coeliac disease in the UK. Methods Postal questionnaire of 2000 people with diagnosed coeliac disease, requesting information on date of diagnosis, type and duration of symptoms, and quality of life before and after diagnosis using the EQ-5D instrument. Results The survey response rate was 40% (788/2000). Mean duration of symptoms prior to diagnosis was 13.2 years, with some evidence of shorter duration in recent years. Respondents reported a mean of 13 consultations with their GP about their symptoms prior to diagnosis. The mean utility value of pre-diagnosis quality of life was 0.56, compared to 0.84 at time of survey, a highly statistically significant improvement of 0.27 (95% c.i. 0.25, 0.30). Conclusions The symptoms of undiagnosed coeliac disease are associated with a prolonged and substantial decrement to quality of life. These results strengthen the case for detailed examination of the cost-effectiveness of improved methods of detection and diagnosis, including population screening.

Objective: To estimate using the UK Prospective Diabetes Study Outcomes Model Version 2 (UKPDS-OM2) the impact of delaying type 2 diabetes onset on costs and quality-adjusted life expectancy using trial participants who developed diabetes in the NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) study.Research Design and Methods: We simulated the impact of delaying diabetes onset by 1-9 years, utilizing data from the 3,058 of 9,306 NAVIGATOR trial participants who developed type 2 diabetes. Costs and utility weights associated with diabetes and diabetes-related complications were obtained for the U.S. and U.K. settings, with costs expressed in 2017 values. We estimated discounted lifetime costs and quality-adjusted life years (QALYs) with 95% CIs.Results: Gains in QALYs increased from 0.02 (U.S. setting, 95% CI 0.01, 0.03) to 0.15 (U.S. setting, 95% CI 0.10, 0.21) as the imposed time to diabetes onset was increased from 1 to 9 years, respectively. Savings in complication costs increased from $1,388 (95% CI $1,092, $1,669) for a 1-year delay to $8,437 (95% CI $6,611, $10,197) for a delay of 9 years. Interventions costing up to $567-$2,680 and £201-£947 per year would be cost-effective at $100,000 per QALY and £20,000 per QALY thresholds in the U.S. and U.K., respectively, as the modeled delay in diabetes onset was increased from 1 to 9 years.Conclusions: Simulating a hypothetical diabetes-delaying intervention provides guidance concerning the maximum cost and minimum delay in diabetes onset needed to be cost-effective. These results can inform the ongoing debate about diabetes prevention strategies and the design of future intervention studies. [ABSTRACT FROM AUTHOR]

Selective internal radiotherapy (SIRT) is a liver‐directed treatment involving the injection of yttrium‐90 microspheres into the blood supply of liver tumours. There are very few studies assessing health‐related quality of life (HRQOL) in patients treated with SIRT. Patients with liver metastases from colorectal cancer (CRC) were randomised in the FOXFIRE (FFr; ISRCTN83867919), SIRFLOX (SF; NCT00724503) and FOXFIRE‐Global (FFrG; NCT01721954) trials of first‐line oxaliplatin–fluorouracil (FOLFOX) chemotherapy combined with SIRT versus FOLFOX alone. HRQOL was assessed using the three‐level EQ‐5D, European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ‐C30) and EORTC Colorectal Liver Metastases cancer module (EORTC QLQ‐LMC21) at baseline, ≤3 months, 6 months, 12 months and annually thereafter from randomisation, and at disease progression. Analyses were conducted on an intention‐to‐treat basis. In total, 554 patients were randomised to SIRT + FOLFOX and 549 patients to FOLFOX alone. HRQOL was statistically significant lower in SIRT + FOLFOX patients ≤3 months after SIRT administration in all three instruments, particularly global health, physical and role functioning and symptoms of fatigue, nausea/vomiting and appetite loss. By accepted thresholds, these differences were deemed not clinically important. Differences between SIRT + FOLFOX and FOLFOX alone over the 2‐year follow up and at disease progression were also not clinically important. Although there is some decrease in HRQOL for up to 3 months following SIRT, the addition of SIRT to FOLFOX chemotherapy does not change HRQOL to a clinically important degree in metastatic CRC patients. What's new? Selective internal radiotherapy (SIRT) is a liver‐directed treatment involving injection of yttrium‐90 microspheres into the blood supply of liver tumours. Few studies have assessed health‐related quality of life (HRQOL) in patients treated with SIRT. This study compared HRQOL between liver metastases from colorectal cancer patients receiving SIRT plus FOLFOX chemotherapy and FOLFOX alone. With a total of 1,103 patients, this is the largest analysis of patient‐reported outcomes for SIRT and the largest prospective QOL study in interventional oncology. Following non‐clinically important deterioration up to 3 months post‐SIRT, SIRT could be added to FOLFOX chemotherapy without a detrimental impact on QOL. [ABSTRACT FROM AUTHOR]

Aim: To perform post‐hoc analyses of the EMPA‐REG OUTCOME trial examining the degree to which empagliflozin‐induced changes in conventional cardiovascular (CV) risk factors might explain the observed CV benefits. Materials and methods: We estimated 3‐year EMPA‐REG OUTCOME CV event rates using a type 2 diabetes‐specific clinical outcomes simulation model applied to annual patient‐level data. Variables included were atrial fibrillation, smoking, albuminuria, HDL cholesterol, LDL cholesterol, systolic blood pressure, glycated haemoglobin, heart rate, white cell count, haemoglobin, estimated glomerular filtration rate, and histories of ischaemic heart disease, heart failure, amputation, blindness, renal failure, stroke, myocardial infarction or diabetic ulcer. Multiple simulations were performed for each participant to minimize uncertainty and optimize confidence interval precision around CV risk point estimates. Observed and simulated cardiovascular relative risk reductions were compared. Results: Model‐predicted relative risk reductions were smaller than those observed in the trial, with empagliflozin‐associated changes in conventional CV risk factor values appearing to explain only 12% of the observed relative risk reduction for all‐cause death (4% of 32%), 7% for CV death (3% of 39%) and 15% for heart failure (4% of 29%). Conclusions: Empagliflozin‐associated changes in conventional CV risk factors in EMPA‐REG OUTCOME appear to explain only a small proportion of the CV and all‐cause death reductions observed. Alternative risk‐reduction mechanisms need to be explored to determine if the observed CV risk changes can be explained by other factors, or possibly by a direct drug‐specific effect. [ABSTRACT FROM AUTHOR]

Background: Young women's attendance at cervical screening in the UK is continuing to fall, and the incidence of invasive cervical cancer is rising. Objectives: We assessed the preferences of non‐attending young women for alternative ways of delivering cervical screening. Design: Postal discrete choice experiment (DCE) conducted during the STRATEGIC study of interventions for increasing cervical screening uptake. Attributes included action required to arrange a test, location of the test, availability of a nurse navigator and cost to the National Health Service. Setting and participants: Non‐attending young women in two UK regions. Main outcome measures: Responses were analysed using a mixed multinomial logit model. A predictive analysis identified the most preferable strategy compared to current screening. Preferences from the DCE were compared with observed behaviours during the STRATEGIC trial. Results: The DCE response rate was 5.5% (222/4000), and 94% of respondents agreed screening is important. Preference heterogeneity existed around attributes with strong evidence for test location. Relative to current screening, unsolicited self‐sampling kits for home use appeared most preferable. The STRATEGIC trial showed this same intervention to be most effective although many women who received it and were screened, attended for conventional cytology instead. Conclusions: The DCE and trial identified the unsolicited self‐sampling kit as the most preferred/effective intervention. The DCE suggested that the decision of some women receiving the kit in the trial to attend for conventional cytology may be due to anxieties around home testing coupled with a knowledge that ignoring the kit could potentially have life‐changing consequences. [ABSTRACT FROM AUTHOR]

Objective: To compare medical resource use, costs, and health utilities for 14,752 patients with type 2 diabetes who were randomized to once-weekly exenatide (EQW) or placebo in addition to usual diabetes care in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).Research Design and Methods: Medical resource use data and responses to the EuroQol 5-Dimension (EQ-5D) instrument were collected at baseline and throughout the trial. Medical resources and medications were assigned values by using U.S. Medicare payments and wholesale acquisition costs, respectively. Secondary analyses used English costs.Results: Patients were followed for an average of 3.3 years, during which time those randomized to EQW experienced 0.41 fewer inpatient days (7.05 vs. 7.46 days; relative rate ratio 0.91; P = 0.05). Rates of outpatient medical visits were similar, as were total inpatient and outpatient costs. Mean costs for nonstudy diabetes medications over the study period were ∼$1,600 lower with EQW than with placebo (P = 0.01). Total within-study costs, excluding study medication, were lower in the EQW arm than in the placebo arm ($28,907 vs. $30,914; P ≤ 0.01). When including the estimated cost of EQW, total mean costs were significantly higher in the EQW group than in the placebo group ($42,697 vs. $30,914; P < 0.01). With English costs applied, mean total costs, including exenatide costs, were £1,670 higher in the EQW group than the placebo group (£10,874 vs. £9,204; P < 0.01). There were no significant differences in EQ-5D health utilities between arms over time.Conclusions: Medical costs were lower in the EQW arm than the placebo arm, but total costs were significantly higher once the cost of branded exenatide was incorporated. [ABSTRACT FROM AUTHOR]

Quantifying the value of investment in medical research can inform decision-making on the prioritisation of research programmes. Existing methodologies to estimate the rate of return of medical research are inappropriate for early-phase translational research due to censoring of health benefits and time lags. A strategy to improve the process of translational research for patient benefit has been initiated as part of the UK National Institute for Health Research (NIHR) investment in Biomedical Research Centres (BRCs) in England. By providing a platform for partnership between universities, NHS trusts and industry, successful BRCs should reduce time lags within translational research whilst also providing an impetus for local economic growth through industry collaboration. We present a novel contribution in the assessment of early-phase biomedical research by estimating the impact of the Oxford Biomedical Research Centre (OxBRC) on income and job creation following the initial NIHR investment. We adopt a macroeconomic assessment approach using Input-Output Analysis to estimate the value of medical research in terms of income and job creation during the early pathway towards translational biomedical research. Inter-industry linkages are assessed by building a model economy for the South East England region to estimate the return on investment of the OxBRC. The results from the input-output model estimate that the return on investment in biomedical research within the OxBRC is 46%. Each £1 invested in the OxBRC generates an additional £0.46 through income and job creation alone. Multiplicative employment effects following a marginal investment in the OxBRC of £98m during the period 2007-2017 result in an estimated additional 196 full time equivalent positions being created within the local economy on top of direct employment within OxBRC. Results from input-output analyses can be used to inform the prioritisation of biomedical research programmes when compared against national minimum thresholds of investment. [ABSTRACT FROM AUTHOR]

Aims: TECOS, a cardiovascular safety trial ( ClinicalTrials.gov identifier: NCT00790205) involving 14 671 patients with type 2 diabetes and cardiovascular disease, demonstrated that sitagliptin was non‐inferior to placebo for the primary composite cardiovascular outcome when added to best usual care. This study tested hypotheses that medical resource use and costs differed between these 2 treatment strategies. Materials and methods: Information concerning medical resource use was collected on case report forms throughout the trial and was valued using US costs for: Medicare payments for hospitalizations, medical procedures and outpatient visits, and wholesale acquisition costs (WAC) for diabetes‐related medications. Hierarchical generalized linear models were used to compare resource use and US costs, accounting for variable intercountry practice patterns. Sensitivity analyses included resource valuation using English costs for a UK perspective. Results: There were no significant differences in hospitalizations, inpatient days, medical procedures, or outpatient visits during follow‐up (mean and median 3.0 years in both groups). Hospitalization rates appeared to diverge after 2 years, with lower rates among sitagliptin‐treated vs placebo patients after 2.5 years (relative rate, 0.90 [95% CI, 0.83‐0.97]; P = .01). Mean medical costs, exclusive of study medication, were 11 937 USD in the sitagliptin arm and 12 409 USD in the placebo arm (P = .06). Mean sitagliptin costs based on undiscounted WAC were 9978 USD per patient. Differential UK total costs including study drug costs were smaller (911 GBP), primarily because of lower mean costs for sitagliptin (1072 GBP). Conclusions: Lower hospitalization rates across time with sitagliptin slightly offset sitagliptin treatment costs over 3 years in type 2 diabetes patients at high risk for cardiovascular events. [ABSTRACT FROM AUTHOR]