Difference In Quality-adjusted Life-years Research Articles

Cost-effectiveness analysis of soft bandage and immediate discharge versus rigid immobilization in children with distal radius torus fractures.

The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of 'willingness-to-pay' thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment. The offer of a soft bandage significantly reduced cost per patient (saving £12.55 (95% confidence interval (CI) -£5.30 to £19.80)) while QALYs were similar (QALY difference between groups: 0.0013 (95% CI -0.0004 to 0.003)). The high probability (95%) that offering a bandage is a cost-effective option was consistent when examining the data in a range of sensitivity analyses. In addition to the known clinical equivalence, this study found that the offer of a bandage reduced cost compared with rigid immobilization among children with a torus fracture of the distal radius. While the cost saving was small for each patient, the high frequency of these injuries indicates a significant saving across the healthcare system.

Short-term cost-utility analysis of biventricular cardiac resynchronization therapy in comparison with left bundle branch area pacing cardiac resynchronization therapy

Abstract Background Cardiac resynchronisation therapy (CRT) is a well-established form of treatment for patients with heart failure and cardiac dyssynchrony. Recently, left bundle branch area pacing (LBBAP) has emerged as a more physiological alternative for biventricular pacing (BiVP) cardiac resynchronization therapy (1,2). Purpose The purpose of this study was to conduct a cost-utility analysis for LBBAP CRT, compared to BiVP CRT in a cohort of patients with heart failure from the Spanish health system perspective. Methods A multicenter prospective quasi-experimental study in which 44 consecutive patients underwent CRT was conducted. According to the study protocol, the four centers would perform their usual clinical practice: two out of them would perform conventional BiVP-CRT while the other half LBBAP-CRT. Intention-to-treat analysis was carried-out. Health outcomes were quality-adjusted life years (QALYs), measured by the EuroQol-5D-5L questionnaire, which the patients were asked to complete at baseline and 12 weeks after the CRT device implantation. The total direct costs include device, leads, guidewires, introducer kits, sheats and operating theater time. The results were expressed as the incremental cost-utility ratio (ICUR). In order to analyze the uncertainty of ICUR results, we performed a non-parametric bootstrapping with 1000 replications. Results The LBBAP procedure was attempted for a total of 26 consecutive patients (1 patient underwent rescue BiVP), while BiVP was attempted for 18 patients (2 patients switched to LBBAP). Mean QALYs over 3 months were 0.1914 ± 0.009 in the LBBAP CRT group and 0.1904 ± 0.0112 in the BiVP CRT. Improvements from baseline were greater in the LBBA CRT group but not statistically significant. The total costs at the end of the intervention were 7546.6 €± 602.15€ in the LBBAP CRT group and 16064.56€ ± 723.7€ in the BiVP CRT group. When excluding from the analysis the cases in which ICD was implanted, the mean difference in QALYs is 0.002; 95% confidence interval [95%CI]: -0.03 to 0.036) and the mean saving is -3.510.38 €. The LBBAP CRT leads to cost savings for the health system and similar QALYs outcomes; 95%CI: -6.660 to -360.71. Based on 1000 bootstrapping replication, the cost savings of using LBBAP vs BiVP occur in 99% of the simulations. Conclusion LBBAP CRT is an efficient alternative to BiVP CRT for cardiac resynchronization in patients with heart failure with similar results in terms of QALYs but with significant average savings per patient.Cost-utility plane for 1000 bootstrappedBaseline characteristics of patients

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial

ObjectiveTo evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare...

Health utility values of breast cancer treatments and the impact of varying quality of life assumptions on cost-effectiveness.

In breast cancer research, utility assumptions are outdated and inconsistent which may affect the results of quality adjusted life year (QALY) calculations and thereby cost-effectiveness analyses (CEAs). Four hundred sixty four female patients with breast cancer treated at Erasmus MC, the Netherlands, completed EQ-5D-5L questionnaires from diagnosis throughout their treatment. Average utilities were calculated stratified by age and treatment. These utilities were applied in CEAs analysing 920 breast cancer screening policies differing in eligible ages and screening interval simulated by the MISCAN-Breast microsimulation model, using a willingness-to-pay threshold of €20,000. The CEAs included varying sets on normative, breast cancer treatment and screening and follow-up utilities. Efficiency frontiers were compared to assess the impact of the utility sets. The calculated average patient utilities were reduced at breast cancer diagnosis and 6 months after surgery and increased toward normative utilities 12 months after surgery. When using normative utility values of 1 in CEAs, QALYs were overestimated compared to using average gender and age-specific values. Only small differences in QALYs gained were seen when varying treatment utilities in CEAs. The CEAs varying screening and follow-up utilities showed only small changes in QALYs gained and the efficiency frontier. Throughout all variations in utility sets, the optimal strategy remained robust; biennial for ages 40-76 years and occasionally biennial 40-74 years. In sum, we recommend to use gender and age stratified normative utilities in CEAs, and patient-based breast cancer utilities stratified by age and treatment or disease stage. Furthermore, despite varying utilities, the optimal screening scenario seems very robust.

Cost-effectiveness analysis of a pragmatic randomized trial evaluating surgical reconstruction versus rehabilitation in patients with long-standing anterior cruciate ligament injury.

The aim of this study was to estimate the incremental use of resources, costs, and quality of life outcomes associated with surgical reconstruction compared to rehabilitation for long-standing anterior cruciate ligament (ACL) injury in the NHS, and to estimate its cost-effectiveness. A total of 316 patients were recruited and randomly assigned to either surgical reconstruction or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment). Healthcare resource use and health-related quality of life data (EuroQol five-dimension five-level health questionnaire) were collected in the trial at six, 12, and 18 months using self-reported questionnaires and medical records. Using intention-to-treat analysis, differences in costs, and quality-adjusted life years (QALYs) between treatment arms were estimated adjusting for baseline differences and following multiple imputation of missing data. The incremental cost-effectiveness ratio (ICER) was estimated as the difference in costs divided by the difference in QALYs between reconstruction and rehabilitation. At 18 months, patients in the surgical reconstruction arm reported higher QALYs (0.052 (95% confidence interval (CI) -0.012 to 0.117); p = 0.177) and higher NHS costs (£1,017 (95% CI 557 to 1,476); p < 0.001) compared to rehabilitation. This resulted in an ICER of £19,346 per QALY with the probability of surgical reconstruction being cost-effective of 51% and 72% at a willingness-to-pay threshold of £20,000 and £30,000 per QALY, respectively. Surgical reconstruction as a management strategy for patients with long-standing ACL injury is more effective, but more expensive, at 18 months compared to rehabilitation management. In the UK setting, surgical reconstruction is cost-effective.

Cost-effectiveness of a primary healthcare intervention to treat male lower urinary tract symptoms: the TRIUMPH cluster randomised controlled trial

ObjectivesTo estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care.DesignEconomic evaluation alongside a cluster randomised controlled trial from a UK...

Evaluating the cost-effectiveness of [18F]FDG-PET/CT for investigation of persistent or recurrent neutropenic fever in high-risk haematology patients

BackgroundA recent randomised trial demonstrated [18F]fluorodeoxyglucose positron-emission tomography in combination with low-dose CT (FDG-PET/CT), compared to standard of care computed tomography (CT) imaging, positively impacted antimicrobial management and outcomes of acute leukaemia and haematopoietic stem cell transplant recipients with persistent and recurrent neutropenic fever. We conducted an economic evaluation from a healthcare perspective alongside the clinical trial.MethodsUnit costs in Australian dollars were applied to all resources used (antimicrobials, diagnostic tests, ICU and hospital bed days). Effectiveness was measured as number of patients with antimicrobial rationalisation, 6-month mortality and quality-adjusted life years (QALYs) derived from patient-reported trial-based health-related quality-of-life. Generalised linear models were used to analyse costs and outcomes. Incremental cost-effectiveness ratios (ICERs) for all outcomes and net monetary benefit (NMB) for QALYs were calculated. We performed bootstrapping with 1000 replications using the recycled predictions method.ResultsThe adjusted healthcare costs were lower for FDG-PET/CT (mean $49,563; 95%CI 36,867, 65,133) compared to CT (mean $57,574; 95% CI 44,837, 73,347). The difference in QALYs between the two groups was small (0.001; 95% CI -0.001, 0.004). When simulated 1000 times, FDG-PET/CT was the dominant strategy as it was cheaper with better outcomes than the standard CT group in 74% of simulations. The estimated NMBs at willingness-to-pay thresholds of $50,000 and $100,000 per QALY were positive, thus FDG-PET/CT remained cost-effective at these thresholds.ConclusionsFDG-PET/CT is cost effective when compared to CT for investigation of persistent/recurrent neutropenic fever in high-risk patients, providing further support for incorporation of FDG-PET/CT into clinical guidelines and funding.Trial registrationThis trial is registered with ClinicalTrials.gov, NCT03429387.

OP122 Economic Evidence To Support Expanding Use Of Existing Positron Emission Tomography Technology As A Diagnostic Tool For High-Risk Cancer Patients

IntroductionIn Australia, 18F-fluorodeoxyglucose positron emission tomography with low-dose computed tomography (FDG-PET/CT) is currently only funded for cancer staging-related indications. A recent multicenter randomized trial demonstrated that FDG-PET/CT, compared with standard of care computed tomography (CT) imaging, improved antimicrobial management and the outcomes of patients with persistent and recurrent neutropenic fever. There is potential value in expanding the use of FDG-PET/CT as a diagnostic tool for this high-risk population. We conducted an economic evaluation from a healthcare perspective alongside the randomized trial and compared FDG-PET/CT with standard CT up to 6 months after the scans.MethodsCase report forms were used to collect resource utilization data and length of hospitalization. Effectiveness was measured as the number of patients with antimicrobial rationalization and quality-adjusted life-years (QALYs) derived from patient-reported trial-based health-related quality of life. Generalized linear models (GLM) were used to analyze costs and outcomes. Incremental cost-effectiveness ratios (ICERs) for each of the outcomes were calculated and interpreted as the cost per patient with antimicrobial rationalization and cost per QALY gained. To account for sampling, we performed bootstrapping with 1,000 replications using the recycled predictions method.ResultsThe adjusted healthcare costs were lower in the FDG-PET/CT group (mean AUD49,563, 95% confidence interval [CI]: 36,867, 65,133; equivalent to USD34,268, 95% CI: 25,490, 45,033) compared with the standard CT group (mean AUD57,574, 95% CI: 44,837, 73,347; equivalent to USD39,807, 95% CI: 31,000, 50,712). The magnitude of differences in QALYs between the two groups was small (0.001; 95% CI: -0.001, -0.001). When simulated 1,000 times, our analysis showed that across both outcomes FDG-PET/CT was the dominant strategy as it was cheaper and had better outcomes than standard CT in 74 percent of simulations.ConclusionsFDG-PET/CT is cost effective when compared with standard CT for investigating persistent or recurrent neutropenic fever in high-risk patients. Aligning economic evaluations with clinical studies is key to an integrated evidence generation approach for supporting funding for FDG-PET/CT in this patient group.

Cost-effectiveness of continuous glucose monitoring with FreeStyle Libre® in Brazilian insulin-treated patients with types 1 and 2 diabetes mellitus

BackgroundHypoglycemia is a barrier to optimal glucose control in the treatment of both type 1 (T1DM) and type 2 diabetes mellitus (T2DM). Blood glucose monitoring is essential in diabetes management. Inappropriate glucose management is associated with high mortality and morbidity. FreeStyle Libre® (FSL) is a continuous glucose monitoring (CGM) system that provides effective, safe, and convenient glucose monitoring, without routine finger pricking. This study aims to estimate the incremental cost-effectiveness ratio (ICER) of the FSL system in comparison to conventional Self-monitoring of blood glucose (SMBG) in T1DM and T2DM patients that require intensive insulin therapy.MethodsA decision-tree model was developed to compare the cost-effectiveness ratio between FSL and conventional SMBG from the perspective of the Brazilian Public Healthcare System (SUS). The model captures the cumulative rates of acute complications such as severe hypoglicemia and diabetic ketoacidosis, per-event costs, and quality-adjusted life-years (QALYs) gained over a 1-year time horizon in adult and pediatric patients (≥ 4 years old) with T1DM or T2DM. Inputs from the Brazilian health databases, clinical trials, and real-world data were used in the study.ResultsThe results demonstrated that, regarding solely severe hypoglicemia and diabetic ketoacidosis events, T1DM have a QALY difference of 0.276, a cost difference of R$ 7.255, and an ICER of R$ 26,267.69 per QALY gained for CGM with FSL, when compared to conventional SMBG. T2DM results demonstrated equally a QALY difference of 0.184, a cost difference of R$ 7290, and an ICER of R$ 39,692.67 per QALY gained, in favour of CGM with FSL.ConclusionOur findings demonstrated that FSL is cost-effective in T1DM and T2DM for acute diabetic complications, from a SUS perspective. CGM with FSL can promote safe, convenient, and cost-effective glucose monitoring, therefore contributing to the improvement of the incidence of complications and quality of life.

Cost-effectiveness analysis of PCI in focal and diffuse coronary artery disease

Abstract Aims The pattern of CAD predicts angina relief after PCI. Our aim was to evaluate the cost-effectiveness of PCI in diffuse coronary artery disease (CAD) to deferral from PCI in these patients. Methods This is a sub-analysis of the TARGET-FFR randomized clinical trial (NCT03259815). The pullback pressure gradient (PPG) was calculated to differentiate focal from diffuse CAD. Healthcare resource use associated with the index hospitalization and with follow-up outpatient visits, medications, was recorded prospectively. We did not discount costs because of the limited follow-up period. Costs of procedures and follow-up consultations were derived from Healthcare Resource Group reference costs and drug costs from the National Health Service (NHS). Quality-adjusted life-years (QALYs) were derived from health-related quality of life and survival during the 3-month time horizon of the trial. Quality-of-life indexes (utilities) were evaluated at baseline and 3 months with the European Quality of Life–5 Dimensions (EQ-5D) instrument with UK weights scaled from 0 (death) to 1 (perfect health). The overall QALYs for each patient were estimated as the area under the curve determined by the utility values at baseline and 3 months. We computed confidence intervals for differences in costs and QALYs and in the incremental cost-effectiveness rate (ICER) using the bootstrap technique with the percentile method with 10 000 replications. A Markov model was used to simulate deferral of diffuse disease from PCI and not using PPG to select treatment. Probabilistic sensitivity analysis was undertaken to test the robustness of results to parameter uncertainty. Results Patients who underwent PCI for focal CAD had higher EQ-5D index values at follow-up (0.89 ± 0.18 vs 0.76 ± 0.28, p=0.004) and higher QALYs after 3 months follow-up (0.19 ± 0.06 vs 0.21 ± 0.04, p=0.022). Mean cumulative costs were £1574.3 ± 230.5 and significantly higher in patients treated for diffuse CAD as compared to patients treated for focal CAD (£1697 ± 293.4 vs £1393 ± 264.3; p&amp;lt;0.001). The ICER was £7746/QALY (95% CI 5024 – 11007). PCI in focal CAD saved £1522.2/QALY when compared to PCI in diffuse CAD (£7009.2 ± 1919.4 /QALY vs. £8531.4±2753.4 /QALY, p&amp;lt; 0.001). Deferring 30% of the diffuse CAD patients from PCI to optimized medical therapy would save £673.8/QALY (£7072.2 ± 1730.147 /QALY vs. £7746 ± 1943.5/QALY, p&amp;lt; 0.001). Conclusion PCI is more cost-effective in focal than diffuse CAD. Treatment of diffuse CAD results in worst QALYs and costlier procedures. Every 5% of the diffuse CAD patients that were deferred from PCI saved aproximately £100/QALY. Further trials are needed to determine if the cost-effectiveness of PCI can be improved by deferring patients with diffuse CAD.Quality of life in focal and diffuse CADCost-effectiveness focal vs diffuse CAD

Abstract 16635: Cost Effectiveness Analysis of the Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction REVIVED Trial Data

Introduction. Evidence on survival benefits of percutaneous coronary intervention (PCI) in patients with severe ischemic left ventricular systolic dysfunction (ILVD) is scant. The REVIVED trial showed that, compared to optimal medical therapy (OMT), revascularisation by PCI did not reduce the incidence of death from any cause or heart failure hospitalization (HF); it also failed to provide sustained improvements in health-related quality of life. REVIVED data are used to evaluate the economic consequences and health outcomes of PCI+OMT and OMT alone in HF patients in the UK. Methods. 700 patients with ILVD were randomised to either PCI+OMT or OMT. Healthcare resource use and patient-reported health outcomes data EuroQol on each patient were collected at baseline and over a period of 8 years post randomisation (median follow up of 3.5 years). Health resources were costed using publicly available national unit costs from the perspective of the UK health system. Within trial mean total costs and quality adjusted life years (QALYs) were estimated and incremental cost effectiveness was evaluated. Regression analysis on total costs and total QALYs was used to adjust for clinically relevant baseline covariables. Probabilistic sensitivity analysis was used to reflect parameter uncertainty. Results. Statistical modelling identified gender, BMI, hypertension, diabetes, NYHA grade and previous hospitalisation as the most relevant baseline predictors of costs and benefits. Over the 8 years of fu, patients undergoing PCI yielded, on average, similar health benefits (4.13 QALYs IC [4.10 - 4.16]) at higher costs (£14,674 IC[£14,334 - £15,014]), compared to OMT (4.16 QALYs [4.13 - 4.19]; £5154 IC [£5,034 - £5,273]). Conclusion. We found no difference in total QALYs between arms and PCI+OMT was not cost-effective compared to OMT, given its additional costs. Therefore, a strategy of routine PCI to treat ILVSD does not appear to be a justifiable use of healthcare resources.

Comparison of medical resources and costs among patients with coronary heart disease and impaired glucose tolerance in the Acarbose Cardiovascular Evaluation trial.

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). 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. 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). 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.

Characterization of quality of life among individuals with current treated, untreated, and past alcohol use disorder

ABSTRACTBackground: Understanding health-related quality of life (HRQOL) among those who seek treatment for their alcohol use disorder (AUD) and those not seeking AUD treatment is critical to decreasing morbidity and mortality, yet HRQOL in these groups has been little characterized.Objectives: Characterize HRQOL among those who meet diagnostic criteria for AUD, both receiving and not receiving treatment.Methods: This analysis used the NESARC-III database (n = 36,309; female = 56.3%), a nationally representative survey of US adults, to compare four groups: those treated for current AUD; those untreated for current AUD; those with past AUD only; and those who never met criteria for AUD. Multiple regression analysis was used to account for differences in sociodemographic and other behavioral factors across these groups. HRQOL was operationalized using annual quality-adjusted life years (QALYs).Results: Patients treated for past-year AUD had a deficit of 0.07 QALYs/year compared to those who never met criteria for AUD (P < .001). They retained a still clinically meaningful 0.03 QALYs/year deficit after controlling for concomitant psychiatric disorders and other behavioral health factors (P < .001). Those with past-year untreated AUD or past AUD had a near-zero difference in QALYs compared with those who never met criteria for AUD.Conclusion: These findings suggest that previously-reported differences in HRQOL associated with AUD may be due to the problems of the relatively small sub-group who seek treatment. Clinicians seeking to treat those with currently untreated AUD may do better to focus on the latent potential health effects of AUD instead of current HRQOL concerns.

Trial-based economic evaluation of mindfulness-based cognitive therapy compared to treatment as usual for bipolar disorder.

Aim of this study was to assess the cost-effectiveness and cost-utility of mindfulness-based cognitive therapy (MBCT) and treatment as usual (TAU) compared to TAU alone in adults with Bipolar disorder (BD). An economic evaluation with a time horizon of 15months was conducted from a societal perspective. Outcomes were expressed in costs per quality adjusted life years (QALYs) and costs per responder using the inventory of depressive symptomatology clinician rating score. People with BD (N=144) were included in this study. From a societal perspective, the difference of total costs between MBCT+TAU and TAU was €615, with lower costs in the MBCT+TAU group. Only healthcare costs differed significantly between the two groups. A small difference in QALYs in favor of MBCT+TAU was found combined with lower costs (-€836; baseline adjusted) for MBCT+TAU compared to TAU, resulting in a dominant incremental cost-utility ratio. The probability that the MBCT+TAU was cost-effective was 65%. All sensitivity analyses attested to the robustness of the base case analyses. Concludingly, MBCT+TAU seems to be cost-effective compared to TAU alone, indicated by a small or neglectable difference in effect, in favor of MBCT+TAU, while resulting in lower costs.

Robotic and laparoscopic gynaecological surgery: a prospective multicentre observational cohort study and economic evaluation in England

ObjectiveTo compare the health-related quality of life and cost-effectiveness of robot-assisted laparoscopic surgery (RALS) versus conventional ‘straight stick’ laparoscopic surgery (CLS) in women undergoing hysterectomy as part of their treatment...

Extracorporeal carbon dioxide removal compared to ventilation alone in patients with acute hypoxaemic respiratory failure: cost-utility analysis of the REST RCT.

Acute hypoxaemic respiratory failure requiring mechanical ventilation is a major cause of morbidity and mortality and has significant resource implications in terms of intensive care unit and hospital stay. To assess the cost-effectiveness of extracorporeal carbon dioxide removal compared to ventilation alone in patients with acute hypoxaemic respiratory failure. A cost-utility analysis embedded within a pragmatic, multicentre, allocation-concealed, open-label, randomised controlled trial. Four hundred and twelve (of a planned sample size of 1120) adult patients receiving mechanical ventilation for acute hypoxaemic respiratory failure, were recruited between May 2016 and December 2019 from 51 intensive care units in the UK. Participants were randomised (1 : 1) to receive extracorporeal carbon dioxide removal for at least 48 hours (n = 202) or standard care with ventilation alone (n = 210). Health-related quality of life via the EuroQol-5 Dimensions, five-level version, health resource use and associated costs were measured over the study period. The cost per quality-adjusted life-year was estimated at 12 months post randomisation. Mean EuroQol-5 Dimensions, five-level version utility scores were low and similar for each group. Quality-adjusted life-years were calculated for those patients with complete EuroQol-5 Dimensions, five-level version data (extracorporeal carbon dioxide removal n = 140, ventilation alone n = 143) and there was no discernible difference in quality-adjusted life-years at 12 months (mean difference -0.01; 95% confidence interval -0.06 to 0.05; 140). Total 12-month health resource use cost (including intervention costs) was calculated for those patients with complete cost data (extracorporeal carbon dioxide removal n = 125, ventilation alone n = 126) and costs were statistically significantly higher in the extracorporeal carbon dioxide removal group (mean difference £7668.76, 95% confidence interval 159.75, 15,177.77). Multiple imputation was used for missing total cost and quality-adjusted life-year data in the cost-utility analysis. Ventilation alone dominated extracorporeal carbon dioxide removal and there was 0% probability of extracorporeal carbon dioxide removal being cost-effective compared to ventilation alone for all willingness to pay thresholds per quality-adjusted life-year considered (£0-50,000). Extracorporeal carbon dioxide removal was associated with significantly higher costs, but no benefit in health-related quality of life. Given the data, extracorporeal carbon dioxide removal is not considered to be a cost-effective approach to treating patients with acute hypoxaemic respiratory failure. These included the absence of a baseline healthy utility score, minor data loss related to not obtaining complete intensive care unit readmission data for Scottish participants, and not estimating long-term cost-effectiveness due to the study closing early. Measuring baseline health-related quality of life in critical care studies is difficult; future economic evaluations in this setting should consider measuring health-related quality of life as soon as possible after the patients regain capacity. This trial is registered as NCT02654327 and ISRCTN 31262122. This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 13/143/02.

Cost Effectiveness of Concurrent Midurethral Sling at the Time of Prolapse Repair: Results From a Randomized Controlled Trial

ABSTRACT After pelvic reconstructive surgery for pelvic organ prolapse, postoperative stress urinary incontinence (SUI) commonly occurs, which leads many women to choose to have a midurethral sling placed at the time of surgery, even in cases without symptomatic preoperative urinary incontinence. Approximately 27.3% of women with a sling had de novo SUI despite this intervention. Full evaluation of the societal and economic implications brought by a midurethral sling placement attempting to prevent postoperative de novo SUI at the time of a pelvic reconstructive surgery have yet to be evaluated. This study aimed to evaluate the 1-year cost-effectiveness of a midurethral sling in the prevention of SUI at the time of prolapse surgery. This assessment was a randomized controlled trial based on patient resource utilization and patient-reported effectiveness. Study data were obtained via the OPUS randomized clinical trial, which was performed through the Pelvic Floor Disorders Network (a cooperative agreement network sponsored through the National Institute of Child Health and Human Development). A total of 337 women with anterior vaginal prolapse and without SUI symptoms set to undergo treatment from May 2007 to January 2011 were included in the study. Patients were randomly assigned to receive either sham incisions or a midurethral sling during vaginal prolapse surgery. Follow-up occurred at 3, 6, and 12 months postsurgery, with surveys, physical examinations, and medical history. Cost data were collected, and overall health utility in quality-adjusted life-years (QALYs) was calculated. Secondary outcomes were urinary incontinence-specific quality of life and cases of urinary incontinence, as defined by bothersome incontinence symptoms and positive cough stress tests. Initial surgical procedures and subsequent urinary incontinence-related health care were all used for recording health care sector costs. Total costs for study participants were collected via health care resource utilization data, including office visits, additional surgical procedures, and related procedures. The incremental cost-effectiveness ratio was the difference between the sham incision and midurethral sling groups in mean cost, divided by difference in mean QALYs. Data for health care resource utilization were collected during the trial period. Questionnaires at baseline, 3, 6, 9, and 12 months were used to collect other costs. At 1 year, one-way sensitivity analysis was performed for assessing the varying effectiveness of midurethral slings at 1 year, by noting the urinary incontinence-associated patient costs and by using varied QALY for the sling group. Results were taken from a study population of 337 women who underwent randomization to be included in the analysis of cost-effectiveness. No great variance of characteristics existed between groups. One year after surgery, a lower rate of urinary incontinence existed for those in the midurethral sling group. Notably, QALYs were not statistically different between midurethral sling and sham incision groups at baseline, but at 12 months, there was an improvement in both the UDI stress subscale and an overall reduction in the Incontinence Severity Index for the midurethral sling group. In conclusion, although prophylactic midurethral sling placements during vaginal prolapse surgery does reduce the rate of de novo SUI, based on this analysis of date from the OPUS trial, it is not a cost-effective intervention. The decision to place a sling in this setting is often driven by cost savings on the patient side, whereas midurethral sling health care costs are higher than when sling is not done.

Cost-effectiveness of root canal treatment compared with tooth extraction in a Swedish Public Dental Service: A prospective controlled cohort study.

To evaluate the cost-effectiveness of root canal treatment (RCT) compared with a tooth extraction in a general dental practice setting, with reference to cost per quality-adjusted life-year (QALY) gained over 1 year. This is a prospective controlled cohort study based on patients either starting RCT or undergoing extraction at one of six Public Dental Service clinics in the county of Västra Götaland, Sweden. From a total of 65 patients, 2 comparable groups were formed: 37 started RCT and 28 underwent extraction. A societal perspective was used for the cost calculations. QALYs were estimated, based on the EQ-5D-5L given to the patients at their first treatment appointment and then after 1, 6, and 12 months. The total mean cost of RCT ($689.1) was higher than for extraction ($280.1). For those patients whose extracted tooth was replaced, the costs were even higher ($1245.5). There were no significant intergroup differences in QALYs, but a significant improvement in health state values in the tooth-preserving group. In the short term, extraction was cost-effective compared with preserving a tooth with RCT. However, the potential need for future replacement of the extracted tooth, by an implant, fixed prosthesis, or removable partial dentures, may change the calculation in favor of RCT.

Does EQ-5D Tell the Whole Story? Statistical Methods for Comparing the Thematic Coverage of Clinical and Generic Outcome Measures, With Application to Breast Cancer

ObjectivesThis study aimed to develop the following: (1) methods for assessing claims in any specific application that a generic outcome measure, such as EQ-5D is deficient in its coverage of 1 or more specified domains, and (2) a simple method of judging whether any such deficiency is likely to be quantitatively important enough to call into question evaluations based on the generic instrument. Also to demonstrate the applicability of the methods in the important area of breast cancer. MethodsThe methodology requires a data set with observations from a generic instrument (eg, EQ-5D) and also a more comprehensive clinical instrument (eg, FACT-B [Functional Assessment of Cancer Therapy – Breast]). A standardized 3-component statistical analysis is proposed for investigating the claim that the generic measure inadequately captures some specified dimension covered by the latter instrument. A theoretically based upper bound on the bias induced by deficient coverage is derived based on the assumption that the designers of the (k-dimensional) generic instrument did succeed in identifying the k most important domains. ResultsData from the MARIANNE breast cancer trial were analyzed and results suggested that impacts on personal appearance and relationships may be inadequately represented by EQ-5D. Nevertheless, the indications are that the bias in quality-adjusted life-year differences from deficient coverage by EQ-5D is likely to be modest. ConclusionsThe methodology offers a systematic approach to determining whether there is clear evidence consistent with any claim that a generic outcome measure such as EQ-5D misses an important specific domain. The approach is readily implementable using data sets that are available in many randomized controlled trials.

Photodynamic Diagnosis-guided Transurethral Resection of Bladder Tumour in Participants with a First Suspected Diagnosis of Intermediate- or High-risk Non–muscle-invasive Bladder Cancer: Cost-effectiveness Analysis Alongside a Randomised Controlled Trial

BackgroundRecurrence of non–muscle-invasive bladder cancer (NMIBC) is common after transurethral resection of bladder tumour (TURBT). Photodynamic diagnosis (PDD) may reduce recurrence. PDD uses a photosensitiser in the bladder that causes the tumour to fluoresce to guide resection. PDD provides better diagnostic accuracy and allows more complete tumour resection. ObjectiveTo estimate the economic efficiency of PDD-guided TURBT (PDD-TURBT) in comparison to white light–guided TURNT (WL-TURBT) in individuals with a suspected first diagnosis of NMIBC at intermediate or high risk of recurrence on the basis of routine visual assessment before being scheduled for TURBT. Design, setting, and participantsThis is a health economic evaluation alongside a pragmatic, open-label, parallel-group randomised trial from a societal perspective. A total of 493 participants (aged ≥16 yr) were randomly allocated to PDD-TURBT (n = 244) or WL-TURBT (n = 249) in 22 UK National Health Service hospitals. Outcome measurements and statistical analysisCost effectiveness ratios were based on the use of health care resources associated with PDD-TURBT and WL-TURBT and quality-adjusted life years (QALYs) gained within the trial. Uncertainties in key parameters were assessed using sensitivity analyses. Results and limitationsOn the basis of the use of resources driven by the trial protocol, the incremental cost effectiveness of PDD-TURBT in comparison to WL-TURBT was not cost saving. At 3 yr, the total cost was £12 881 for PDD-TURBT and £12 005 for WL-TURBT. QALYs at three years were 2.087 for PDD-TURBT and 2.094 for WL-TURBT. The probability that PDD-TURBT is cost effective was never >30% above the range of societal cost-effectiveness thresholds. ConclusionsThere was no evidence of a difference in either costs or QALYs over 3-yr follow-up between PDD-TURBT and WL-TURBT in individuals with suspected intermediate- or high-risk NMIBC. PDD-TURBT is not supported for the management of primary intermediate- or high-risk NMIBC. Patient summaryWe assessed overall costs for two approaches for removal of bladder tumours in noninvasive cancer and measured quality-adjusted life years gained for each. We found that use of a photosensitiser in the bladder was not more cost effective than use of white light only during tumour removal.