Variation in the utilization of medical devices across Germany, Italy, and the Netherlands: a multilevel approach

: Variation in healthcare utilization has been discussed extensively, with many studies showing that variation exists, but fewer studies investigating the underlying factors. In our study, we used a logistic multilevel-model at the patient, hospital, and regional levels to investigate (i) the levels to which variation could be attributed and (ii) the hospital and regional factors associated with treatment decisions. To do so, we used hospital discharge records for the years 2012-2016 in Germany and Italy and for 2014-2016 in the Netherlands combined with hospital and regional characteristics in nine case studies. We used a theoretical framework to categorize these case studies into effective, preference-sensitive, and supply-sensitive care. Our results suggest that most variation in the treatment decision can be attributed to the hospital level (e.g., case volume), whereas only a minor part is explained by regional characteristics. Italy had the highest share attributable to the regional level, whereas the Netherlands had the lowest. We observed less variation for procedures in the effective-care category compared to the preference- and supply-sensitive categories. Although our results were heterogeneous, we identified patterns in line with the theoretical framework for treatment categories, underlining the need to address variation differently depending on the category in question

Surrogate endpoints in health technology assessment: an international review of methodological guidelines

Decision uncertainty associated with reliance on surrogate endpoints is a risk to patients and society. HTA agencies may develop more detailed methodological guidance for consistent selection and evaluation of health technologies without definitive final patient-relevant outcome evidence at the time of the assessment

Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies

BackgroundSurrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA).Objectives1) To map methodologies for the validation of surrogate endpoints and 2) to determine their impact on acceptability of surrogates and coverage decisions made by HTA agencies.MethodsWe sought HTA reports where evaluation relied on a surrogate from 8 HTA agencies. We extracted data on the methods applied for surrogate validation. We assessed the level of agreement between agencies and fitted mixed-effects logistic regression models to test the impact of validation approaches on the agency’s acceptability of the surrogate endpoint and their coverage recommendation.ResultsOf the 124 included reports, 61 (49%) discussed the level of evidence to support the relationship between the surrogate and the patient-centered endpoint, 27 (22%) reported a correlation coefficient/association measure, and 40 (32%) quantified the expected effect on the patient-centered outcome. Overall, the surrogate endpoint was deemed acceptable in 49 (40%) reports (k-coefficient 0.10, P = 0.004). Any consideration of the level of evidence was associated with accepting the surrogate endpoint as valid (odds ratio [OR], 4.60; 95% confidence interval [CI], 1.60–13.18, P = 0.005). However, we did not find strong evidence of an association between accepting the surrogate endpoint and agency coverage recommendation (OR, 0.71; 95% CI, 0.23–2.20; P = 0.55).ConclusionsHandling of surrogate endpoint evidence in reports varied greatly across HTA agencies, with inconsistent consideration of the level of evidence and statistical validation. Our findings call for careful reconsideration of the issue of surrogacy and the need for harmonization of practices across international HTA agencies