Sara Larsen

Background and Objective The reliability of a decision model to guide decision making depends on its ability to accurately predict patient outcomes. We present results of an external validation of the MicroSimulation Core Obesity Model (MS-COM) that was developed to compare the cost effectiveness of obesity management interventions in adults. Methods We updated a 2018 systematic literature review of economic models in overweight and obesity and conducted additional targeted searches to identify suitable sources and outcomes to validate against MS-COM in people with overweight or obesity with or without type 2 diabetes. We extracted baseline characteristics and cardiovascular and mortality outcomes, where these were closely matched with MS-COM, and incidence of type 2 diabetes. We performed external-dependent (sources used in MS-COM) and external-independent (sources not used in MS-COM) validation. The extent of concordance between predicted and observed outcomes was assessed using the coefficient of determination (R²), ordinary least-squares linear regression line (OLS LRL), mean absolute percentage error, root mean square percentage error and mean squared log of accuracy ratio. Results Ninety-nine potential independent validation sources were identified from 6381 screened records, of which nine studies reported cardiovascular and mortality outcomes that were closely matched with MS-COM, along with two studies that reported type 2 diabetes incidence (number of endpoints = 106). The dependent validation of cardiovascular and mortality outcomes (N = 18), based on the QRisk3 risk equation (normoglycaemia/prediabetes population) and UKPDS 82 (type 2 diabetes population), showed a good linear correlation with observed outcomes (R² = 0.99 and 0.98, respectively). There was some slight overprediction of QRisk3 (OLS LRL slope = 1.11) and underprediction of UKPDS 82 (OLS LRL slope = 0.97). The independent validation of cardiovascular and mortality outcomes also showed a good linear correlation with observed outcomes, particularly in adults with normoglycaemia/prediabetes (R² = 0.90; OLS LRL slope = 0.86); however, an independent validation of type 2 diabetes incidence showed a poorer fit with some degree of underprediction (R² = 0.74; OLS LRL slope = 0.66). Mean error estimates were lower in the dependent validation, showing good concordance between predicted and observed values. Conclusions External validation of MS-COM showed good concordance with dependent and independent sources, suggesting the model accurately predicts obesity-related complications in an overweight/obese population with normoglycaemia/prediabetes and type 2 diabetes.

Prediabetes and type 2 diabetes (T2D) are more prevalent amongst people living with obesity (PwO). T2D and obesity increase the risk of cardiovascular disease. In the STEP clinical development program, once-weekly subcutaneous semaglutide (2.4mg) reduced body weight by 10-15% and reversed prediabetes in about 80% of patients. The aim of this study was to assess the cost-effectiveness of semaglutide plus diet and exercise (D&E) compared with D&E alone in PwO and prediabetes in England based on the STEP-10 trial. The published Core Obesity Model was populated with baseline characteristics and treatment efficacy from STEP-10. This study assessed the reversal of prediabetes at 52 weeks. Baseline age and body mass index (BMI) were 53 (SD:11) years and 40.1 (6.9) kg/m². At 52 weeks, semaglutide plus D&E and D&E alone reversed prediabetes in 80% and 12% of patients, and decreased BMI by 13.9% and 2.7%, respectively. The perspective of the NHS was considered using annual discounting rates of 3.5% on costs and outcomes. Several subgroups were assessed: Different baseline BMI, number of comorbidities, proportions of prediabetes and different treatment durations. Individuals losing ≥5% of body weight after 20 weeks (responders) were analysed separately. The treatment duration in the base case analysis was 20 years. The use of semaglutide resulted in 1.105 QALY gained at an additional cost of 19,391GBP. The resulting ICER was 17,547GBP/QALY gained. Treatment with semaglutide extended life expectancy by 1.68 years. Ranging treatment duration between 1 year as per STEP 10 trial and lifelong, resulted in an ICER of 7,152 to 17,695GBP/QALY. Results did not differ significantly by subgroup. The probabilistic sensitivity analysis indicated a 90% chance of semaglutide being cost-effective at a willingness-to-pay threshold of 20,000GBP/QALY. Semaglutide is a cost-effective treatment option for PwO and prediabetes in England based on the results of the STEP-10 trial.

Summary: A cross‐sectional, online survey was conducted in the United Kingdom, France, Germany, and the United States (14 November–22 December 2022) to investigate preferences for anti‐obesity medication (AOM) among people with obesity (PwO) and healthcare providers (HCPs). Eligibility: Adult PwO who self‐defined their body type as overweight/obese, were trying to lose weight and had BMI ≥30.0 or 27.0–29.9 kg/m² with ≥1 obesity‐related complication; HCPs had to see ≥30 PwO in a typical month and be a decision‐maker regarding their weight loss. The survey included 2500 PwO and 500 HCPs. Exercise (96%) and diet (90%) were the most common weight management methods; AOM use was low (8%). Key barriers to use of prescribed AOMs among PwO were not wanting to take AOM (34%), side effects concerns (33%), and not trusting AOM (26%). Most HCPs (79%) had prescribed/recommended AOMs. Efficacy was the most common reason for preferring one of the shown product profiles among PwO (60%) and HCPs (86%); improving cardiovascular risk was also important to 95% of HCPs when deciding which AOM to prescribe. AOM preference is largely driven by efficacy. Increasing knowledge could help to address barriers to AOM use and improve outcomes for PwO.

Introduction The correlation between body mass index (BMI) and utility in participants with obesity was assessed using health-related quality-of-life data collected in two weight loss intervention studies, SCALE and STEP 1. Methods Short Form Health Survey 36-Item (SF-36) scores from SCALE and STEP 1 were mapped to EuroQoL-5 dimensions-3 levels (EQ-5D-3L) using an established algorithm to derive utilities for the UK. SF-36 scores from STEP 1 were converted into Short Form 6 dimension (SF-6D) utilities for Portugal using the tool developed by the University of Sheffield. The correlation between baseline BMI and utility was assessed by multiple linear regression analyses, controlling for demographic and clinical parameters. Results A higher baseline BMI correlated with lower EQ-5D-3L and SF-6D utilities, although the trend was non-significant. Assuming linearity between BMI ranges 30–40 kg/m², an additional unit of BMI correlated with 0.0041 and 0.0031 lower EQ-5D-3L scores in SCALE and 0.0039 and 0.0047 lower EQ-5D-3L and 0.0027 and 0.0020 lower SF-6D scores in STEP 1 for men and women, respectively. Conclusion In individuals with comparable demographic characteristics and weight-related comorbidities, a 1 unit change in BMI leads to a difference of up to 0.005 in utility indices. Trial Registration ClinicalTrials.gov identifiers: SCALE (NCT01272219) and STEP 1 (NCT03548935).

Aim: To assess health utility values in the Semaglutide Treatment Effect in People with obesity (STEP) 1‐4 trials. Materials and Methods: The STEP 1‐4 phase 3a, 68‐week, double‐blind randomized controlled trials assessed the efficacy and safety of semaglutide 2.4 mg versus placebo in individuals with a body mass index (BMI) of 30 kg/m ² or higher or a BMI of 27 kg/m ² or higher and at least one comorbidity (STEP 1, 3 and 4), or a BMI of 27 kg/m ² or higher and type 2 diabetes (STEP 2). Patients received lifestyle intervention plus intensive behavioural therapy in STEP 3. Health‐related quality of life was assessed using the Short Form 36‐item Health Survey version 2 (SF‐36v2) at baseline and week 68. Scores were converted into Short Form Six‐Dimension version 2 (SF‐6Dv2) utility scores or mapped onto the European Quality of Life Five‐Dimension Three‐Level (EQ‐5D‐3L) utility index using UK health utility weights. Results: At week 68, semaglutide 2.4 mg was associated with minor health utility score improvements from baseline (all trials), while scores for placebo typically decreased. SF‐6Dv2 treatment differences by week 68 for semaglutide 2.4 mg versus placebo were significant in STEP 1 and 4 ( P ≤ .001), but not STEP 2 or 3. EQ‐5D‐3L treatment differences by week 68 for semaglutide 2.4 mg versus placebo were significant in STEP 1, 2 and 4 ( P < .001 for all), but not STEP 3. Conclusions: Semaglutide 2.4 mg was associated with improvement in health utility scores compared with placebo, reaching statistical significance in STEP 1, 2 and 4.

Background: Obesity and overweight are major risk factors for several chronic diseases. There is limited systematic evaluation of risk equations that predict the likelihood of developing an obesity or overweight associated complication. Predicting future risk is essential for health economic modelling. Availability of future treatments rests upon a model’s ability to inform clinical and decision-making bodies. This systematic literature review aimed to identify studies reporting (1) equations that calculate the risk for individuals with obesity, or overweight with a weight-related complication (OWRC), of developing additional complications, namely T2D, cardiovascular (CV) disease (CVD), acute coronary syndrome, stroke, musculoskeletal disorders, knee replacement/arthroplasty, or obstructive sleep apnea; (2) absolute or proportional risk for individuals with severe obesity, obesity or OWRC developing T2D, a CV event or mortality from knee surgery, stroke, or an acute CV event.Methods: Databases (MEDLINE and Embase) were searched for English language reports of population-based cohort analyses or large-scale studies in Australia, Canada, Europe, the UK, and the USA between January 1, 2011, and March 29, 2021. Included reports were quality assessed using an adapted version of the Newcastle Ottawa Scale.Results: Of the 60 included studies, the majority used European cohorts. Twenty-nine reported a risk prediction equation for developing an additional complication. The most common risk prediction equations were logistic regression models that did not differentiate between body mass index (BMI) groups (particularly above 40 kg/m²) and lacked external validation. The remaining included studies (31 studies) reported the absolute or proportional risk of mortality (29 studies), or the risk of developing T2D in a population with obesity and with prediabetes or normal glucose tolerance (NGT) (three studies), or a CV event in populations with severe obesity with NGT or T2D (three studies). Most reported proportional risk, predominantly a hazard ratio.Conclusion: More work is needed to develop and validate these risk equations, specifically in non-European cohorts and that distinguish between BMI class II and III obesity. New data or adjustment of the current risk equations by calibration would allow for more accurate decision making at an individual and population level.

Purpose The correlation between body mass index (BMI) and utility in patients with overweight or obesity was assessed using health-related quality of life (HRQoL) data collected in two weight-loss interventional studies, SCALE and STEP 1. Methods Short-Form Health Survey 36-Item (SF-36) scores from SCALE and STEP 1 were mapped to EuroQoL-5 dimensions-3 levels (EQ-5D-3L) using an established algorithm to derive utilities for the UK. SF-36 scores from STEP 1 were converted into Short-Form six-dimensions (SF-6D) utilities for Portugal, using the tool developed by the University of Sheffield. Correlations between utility scores and BMI at baseline were assessed by multiple linear regression analyses, controlling for demographic and clinical parameters. Results Higher baseline BMI was correlated with lower EQ-5D-3L/SF-6D utilities in all analyses, although the correlation was nonsignificant. Assuming linearity between BMI ranges 30–40 kg/m², a unit increase predicted a utility loss of − 0.0041 and − 0.0031 on EQ-5D-3L for males and females, respectively, in SCALE, − 0.0039 and − 0.0047 in STEP 1, and − 0.0027 and − 0.002 on SF-6D males and females, respectively. Presence of hypertension and older age were significantly negatively correlated with SCALE EQ-5D-3L. Age, presence of coronary artery diseases (CADs) and previous smoking were significantly negatively correlated with STEP 1 EQ-5D-3L. Only presence of CADs was significantly negatively correlated with STEP 1 SF-6D. Males had significantly higher utilities compared with females in the UK analyses. Conclusion These findings are useful to inform cost-effectiveness analyses in obesity whereby multiple factors, along with BMI, are used to calculate quality-adjusted life-years.

Corrigendum for the article Market Readiness for Single-Use Cystoscopes According to Urologists and Procurement Managers Worldwide

Multiple studies have documented a high rate of contaminated colonoscopes after reprocessing. Contaminated reusable colonoscopes may increase the risk of device-related patient infections. As disposable colonoscopes enter the market, they may play a role in infection prevention and may be cost-effective at some facilities or in high-risk patients. Using a micro-costing approach, this study found that the cost per colonoscopy including purchase, maintenance and reprocessing ranges from US$188.64 at high volume centres (3000 annual procedures) to US$501.16 at low volume centres (1000 annual procedures). Accordingly, per-procedure capital costs range from US$87.48 to US$262.45; repair costs range from US$68.77 to US$206.32; cleaning supplies and labour costs US$32.39 and infections requiring hospitalisation cost US$20.12 to US$46.52. As disposable colonoscopes enter the market, low volume centres are most likely to achieve cost savings. Determining if post-procedural infection rates differ with reusable vs disposable colonoscopes is needed.