Methods Used to Identify, Test, and Assess Impact on Preferences of Bolt-Ons: A Systematic Review.

OBJECTIVES: The question of whether additional dimensions should be added to the EQ-5D, so-called bolt-ons, has been researched since the 1990s. Several candidate bolt-ons have been tested. The aim of this systematic review was to provide an overview of EQ-5D bolt-on studies, including the origin of possible suitable bolt-ons, their format, and methods that were used to examine their value. METHODS: Studies were identified through database search and reference screening and assessed based on a set of inclusion criteria. All studies that investigated bolt-ons for the EQ-5D were eligible for inclusion. Two reviewers independently extracted information from all included studies on objectives, study design, EQ-5D version used, the investigated bolt-ons, methods used to achieve objectives, and outcomes. RESULTS: Of 308 initially identified studies, 28 studies met the inclusion criteria. Of these studies, 3 identified potentially suitable bolt-on dimensions, 13 investigated the psychometric performance of EQ-5D + bolt-on(s), and 6 investigated the impact of the bolt-on on health state preferences. In total, 26 bolt-ons were identified, of which cognition was the most frequently mentioned. A wide variety of bolt-on identification methods, psychometric performance tests, and health state valuation methods were used in the included studies. CONCLUSION: A range of bolt-on dimensions has been investigated using diverse methods. Guidelines are needed to standardize the wording of the bolt-on dimension and response options, evaluate minimal important gain of the bolt-on, and facilitate quality assessment of bolt-on studies. Subsequently, guidelines will facilitate decision making on whether or not to implement a bolt-on dimension to the EQ-5D.

Economic evaluation of operative versus nonoperative treatment of a humeral shaft fracture: economic analyses alongside a multicenter prospective cohort study (HUMMER).

PURPOSE: Operative treatment of a humeral shaft fracture results in faster recovery than nonoperative treatment. The cost-effectiveness, in terms of costs per Quality-Adjusted Life Year (QALY) gained (Dutch threshold €20,000-€80,000) or minimal important change (MIC) in disability reduced (DASH 6.7), is unknown. The aim of this study was to determine cost-utility and cost-effectiveness of operative versus nonoperative treatment in adults with a humeral shaft fracture type 12A or 12B. METHODS: This study was performed alongside a multicenter prospective cohort study. Costs for health care and lost productivity until one year after trauma were calculated. The incremental cost-utility ratio (ICUR) was reported in costs per QALY (based on the EuroQoL-5D-3L (EQ-5D)) gained. The incremental cost-effectiveness ratio (ICER) was reported in costs per MIC (based on the DASH score at three months) reduced. RESULTS: Overall, 245 patients were treated operatively and 145 nonoperatively. In the operative group, the mean total costs per patient (€11,925 versus €8793; p < 0.001) and QALYs (0.806 versus 0.778; p < 0.001) were higher. The ICUR of operative treatment was €111,860 per QALY gained (i.e., €3132/0.028). The DASH was 7.3 points (p < 0.001) lower in the operative group. The ICER of operative treatment was €2880 per MIC in disability reduced (i.e., €3132/7.3*6.7). CONCLUSION: Due to the limited effect of treatment on quality of life measured with the EQ-5D, the ICUR of operative treatment (€111,860 per QALY gained) exceeds the threshold. However, the incremental costs of €2880 per clinically meaningful difference in DASH are much lower and suggest that operative treatment for a humeral shaft fracture is cost-effective.

Cost Study of the PlasmaJet Surgical Device Versus Conventional Cytoreductive Surgery in Patients With Advanced-Stage Ovarian Cancer.

PURPOSE: Adjuvant use of Neutral Argon Plasma (PlasmaJet Surgical Device) during cytoreductive surgery (CRS) for advanced-stage epithelial ovarian cancer improves surgical outcomes. The aim of this study is to examine the costs of adjuvant use of the PlasmaJet during surgery compared with conventional CRS in advanced-stage epithelial ovarian cancer. MATERIALS AND METHODS: The patients were randomly assigned to surgery with or without the PlasmaJet. Analysis of the intra- and extramural health care costs was performed. Costs were divided into three categories: costs of the diagnostic phase (T1), inpatient care up to discharge including costs of surgery (T2), and outpatient care including chemotherapy until 6 weeks after the last cycle of chemotherapy (T3). RESULTS: Overall, 327 patients underwent CRS (surgery with PlasmaJet: n = 157; conventional surgery: n = 170). The mean total health costs were significantly higher for CRS with adjuvant use of PlasmaJet compared with conventional CRS (€19,414 v €18,165, P = .017). Costs are divided into costs of the diagnostic phase (€2,034 v €1,974, P = .890), costs of inpatient care (€10,956 v €9,556, P = .003), and costs of outpatient care (€6,417 v €6,628, P = .147). CONCLUSION: Mean total health care costs of the use of PlasmaJet in CRS were significantly higher than those for conventional CRS. This difference is fully explained by the additional surgery costs of the use of PlasmaJet. However, surgery with the use of the PlasmaJet leads to a significantly higher percentage of complete CRS and a halving of stomas. A cost-effectiveness analysis will be performed once survival data are available (funded by ZonMw, Trial Register NL62035.078.17).