The 5-level version of the EQ-5D (EQ-5D-5L) was recently developed. A number of preference-based scoring systems are being developed for several countries around the world. To develop a value set for the EQ-5D-5L based on societal preferences in Canada. We used age, sex, and education quota sampling from the general population from 4 cities across Canada. Composite time trade-off (cTTO) and traditional time trade-off (tTTO) were used as the main elicitation technique. A total of 86 EQ-5D-5L health states grouped into 10 blocks were valued using cTTO, whereas a subset of 18 severe states was also valued using tTTO. Participants meeting predefined inconsistency criteria were excluded from the analyses. For the value set development, we used tTTO and positive cTTO values, while censoring negative and zero cTTO values at zero. Models with the main effects presented using linear terms combined with various additional terms were estimated. The preferred model was selected based primarily on logically ordered coefficients, and secondly model fit. Of the 1209 participants who completed the interview, 136 met criteria that excluded them from the primary analyses. The demographics and socioeconomic status of the remaining 1073 participants were similar to the Canadian general population. The preferred model has 5 linear terms for the main effects, a term for level 4 or 5 for each dimension, and a term for the squared total number of level 4 or 5 beyond the first. For this preferred model, the health utilities ranged from -0.148 for the worst (55555) to 0.949 for the best (11111) EQ-5D-5L states. This is the first TTO-based value set of the EQ-5D-5L for Canada. It can be used to support the health utility estimation in economic evaluations for reimbursement decision making in Canada.
Systematic reviews of randomized trials that include measurements of health-related quality of life potentially provide critical information for patient and clinicians facing challenging health care decisions. When, as is most often the case, individual randomized trials use different measurement instruments for the same construct (such as physical or emotional function), authors typically report differences between intervention and control in standard deviation units (so-called "standardized mean difference" or "effect size"). This approach has statistical limitations (it is influenced by the heterogeneity of the population) and is non-intuitive for decision makers. We suggest an alternative approach: reporting results in minimal important difference units (the smallest difference patients experience as important). This approach provides a potential solution to both the statistical and interpretational problems of existing methods.
Whether proton-pump inhibitors are beneficial or harmful for stress ulcer prophylaxis in critically ill patients undergoing invasive ventilation is unclear. In this international, randomized trial, we assigned critically ill adults who were undergoing invasive ventilation to receive intravenous pantoprazole (at a dose of 40 mg daily) or matching placebo. The primary efficacy outcome was clinically important upper gastrointestinal bleeding in the intensive care unit (ICU) at 90 days, and the primary safety outcome was death from any cause at 90 days. Multiplicity-adjusted key secondary outcomes were ventilator-associated pneumonia, Clostridioides difficile infection, and patient-important bleeding. A total of 4821 patients underwent randomization in 68 ICUs. Clinically important upper gastrointestinal bleeding occurred in 25 of 2385 patients (1.0%) receiving pantoprazole and in 84 of 2377 patients (3.5%) receiving placebo (hazard ratio, 0.30; 95% confidence interval [CI], 0.19 to 0.47; P<0.001). At 90 days, death was reported in 696 of 2390 patients (29.1%) in the pantoprazole group and in 734 of 2379 patients (30.9%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.85 to 1.04; P = 0.25). Patient-important bleeding was reduced with pantoprazole; all other key secondary outcomes were similar in the two groups. Among patients undergoing invasive ventilation, pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding than placebo, with no significant effect on mortality. (Funded by the Canadian Institutes of Health Research and others; REVISE ClinicalTrials.gov number, NCT03374800.).
Background. There has been a growing interest around the world in developing country-specific scoring algorithms for the EQ-5D. This study systematically reviews all existing EQ-5D valuation studies to highlight their strengths and limitations, explores heterogeneity in observed utilities using meta-regression, and proposes a methodological checklist for reporting EQ-5D valuation studies. Methods. We searched Medline, EMBASE, the National Health Service Economic Evaluation Database (NHS EED) via Wiley’s Cochrane Library, and Wiley’s Health Economic Evaluation Database from inception through November 2012, as well as bibliographies of key papers and the EuroQol Plenary Meeting Proceedings from 1991 to 2012 for English-language reports of EQ-5D valuation studies. Two reviewers independently screened the titles and abstracts for relevance. Three reviewers performed data extraction and compared the characteristics and scoring algorithms developed in the included valuation studies. Results. Of the 31 studies included in the review, 19 used the time trade-off (TTO) technique, 10 used the visual analogue scale (VAS) technique, and 2 used both TTO and VAS. Most studies included respondents from the general population selected by random or quota sampling and used face-to-face interviews or postal surveys. Studies valued between 7 and 198 total states, with 1–23 states valued per respondent. Different model specifications have been proposed for scoring. Some sample or demographic factors, including gender, education, percentage urban population, and national health care expenditure, were associated with differences in observed utilities for moderate or severe health states. Conclusions. EQ-5D valuation studies conducted to date have varied widely in their design and in the resulting scoring algorithms. Therefore, we propose the Checklist for Reporting Valuation Studies of the EQ-5D (CREATE) for those conducting valuation studies.