A B S T R A C TObjective: To derive a US-based value set for the EQ-5D-5L questionnaire using an international, standardized protocol developed by the EuroQol Group.Methods: Respondents from the US adult population were quota-sampled on the basis of age, sex, ethnicity, and race. Trained interviewers guided participants in completing composite time trade-off (cTTO) and discrete choice experiment (DCE) tasks using the EuroQol Valuation Technology software and routine quality control measures. Data were modeled using a Tobit model for cTTO data, a mixed logit model for DCE data, and a hybrid model that combined cTTO and DCE data. Model performance was compared on the basis of logical ordering of coefficients, statistical significance, parsimony, and theoretical considerations.Results: Of 1134 respondents, 1062, 1099, and 1102 respondents provided useable cTTO, DCE, and cTTO or DCE responses, respectively, on the basis of quality control criteria and interviewer judgment. Respondent demographic characteristics and health status were similar to the 2015 US Census. The Tobit model was selected as the preferred model to generate the value set. Values ranged from 20.573 (55 555) to 1 (11111), with 20% of all predicted health states scores less than 0 (ie, worse than dead). Conclusions:A societal value set for the EQ-5D-5L was developed that can be used for economic evaluations and decision making in US health systems. The internationally established, standardized protocol used to develop this US-based value set was recommended by the EuroQol Group and can facilitate cross-country comparisons.

The wording of the Hungarian EQ-5D-3L and EQ-5D-5L descriptive systems differ a great deal. This study aimed to (1) develop EQ-5D-3L and EQ-5D-5L value sets for Hungary from a common sample, and (2) compare how level wording affected valuations.Methods: In 2018 to 2019, 1000 respondents, representative of the Hungarian general population, completed composite time trade-off tasks. Pooled heteroscedastic Tobit models were used to estimate value sets. Value set characteristics, single-level transition utilities from adjacent corner health states, and mean transition utilities for all possible health states were compared between the EQ-5D-3L and EQ-5D-5L.Results: Health utilities ranged from -0.865 to 1 for the EQ-5D-3L and -0.848 to 1 for the EQ-5D-5L. The relative importance of the 5 EQ-5D-5L dimensions was as follows: mobility, pain/discomfort, self-care, anxiety/depression, and usual activities. A similar preference ranking was observed for the EQ-5D-3L with self-care being more important than pain/discomfort. The EQ-5D-5L demonstrated lower ceiling effects (range of utilities for the mildest states: 0.900-0.958 [3L] vs 0.955-0.965 [5L]) and better consistency of mean transition utilities across the range of scale. Changing "confined to bed" (3L) to "unable to walk" (5L) had a large positive impact on utilities. Smaller changes with more negative wording in the other dimensions (eg, "very much anxious/feeling down a lot" [3L] vs "extremely anxious/depressed" [5L]) had a modest negative impact on utilities. Conclusion:This study developed value sets of the EQ-5D-3L and EQ-5D-5L for Hungary. Our findings contribute to the understanding of how the wording of descriptive systems affects the estimates of utilities.

Lower estimated insulin sensitivity was associated with risk for hyperfiltration over time, whereas increased albumin excretion was associated with hyperglycemia in youth-onset T2DM.

A review of the current evidence reveals a need for prospective, randomized controlled studies to provide more definitive conclusions on steroid use in patients with SJS, TEN, and/or overlap.

There is a need for large observational studies of high quality to examine the differential effect of specific PPIs and whether the magnitude of association is dose dependent. Given their widespread use, clinicians should routinely question whether patients are receiving unnecessary treatment with PPIs and discontinue therapy where appropriate.

Objective. To compare and contrast EQ-5D-5L (5L) and EQ-5D-3L (3L) health state values derived from a common sample. Methods. Data from the 2017 US EQ-5D valuation study were analyzed. Value sets were estimated with random-effects linear regression based on composite time trade-off (cTTO) valuations for 3L and 5L health states with 2 approaches to model specification: main effects only and additional N3/N45 terms. Properties of the descriptive system and value set characteristics were compared by examining distributions of predicted index scores, ceiling effects, and single-level transition values from adjacent corner health states. Mean transition values were calculated for all predicted 3L and 5L health states and plotted against baseline index scores. Results. A total of 1062 respondents were included in the analysis. The observed mean cTTO values for the worst possible 3L and 5L health states were 20.423 and 20.343, respectively. The range of scale was larger with the 3L, compared to the 5L, for both main effects and N term models. Values for the mildest 5L health states (range, 0.85720.924) were similar to 11111 for the 3L. Parameter estimates for matched dimension levels differed by \|0.07| except for the most severe level of Mobility. For the main effects model, 3L mean transition values were greater for more severe baseline 3L index scores, whereas 5L mean transition values remained constant irrespective of the baseline index score. Conclusions. Compared to the 3L, the 5L exhibited a lower ceiling effect and improved measurement properties. There was a larger range of scale for the 3L compared to 5L; however, this difference was driven by differences in preference for the most severe level of problems in Mobility.

IntroductionDiabetic nephropathy (DN) is a progressive kidney disease resulting as a complication of diabetes mellitus. This study evaluated the disease progression and economic burden of DN among commercially insured patients with type 2 diabetes in the USA.MethodsThe research design was a retrospective observational study based on healthcare claims data. The Truven MarketScan Databases (2004–2014) were queried for adults with type 2 diabetes with at least one urine albumin test (index, randomly selected) after diagnosis and at least one test after the index. On the basis of the index test, patients were classified into normoalbuminuria, microalbuminuria, or macroalbuminuria groups. Nephropathy-related treatment use was measured in the 6 months after the index, disease progression was assessed from the index to the end of data availability, and annual all-cause and nephropathy-related costs and healthcare resource use (HRU) were assessed up to 2 years from the index. Outcomes were compared between any two groups, controlling for baseline demographics.ResultsA total of 23,235 patients were identified and classified into normoalbuminuria (N = 18,409), microalbuminuria (N = 3863), or macroalbuminuria (N = 963) groups. Patients with albuminuria were more likely to be older, male, and have a higher burden of baseline comorbidities and HRU. Within 6 months following the index, 12–20% of patients with albuminuria were not treated with any relevant recommended treatment. Compared to the normoalbuminuria group, patients with macroalbuminuria had a significantly greater risk of disease progression (hazard ratio [HR] = 1.44), and both albuminuria groups were more likely to require dialysis (HR = 4.23 and 40.14 for micro- and macroalbuminuria, respectively; all p < 0.05). Annual all-cause (2016 US dollars, $3580 and $12,830 higher for micro- and macroalbuminuria vs. normoalbuminuria, respectively) and nephropathy-related ($362 and $3716) costs increased significantly with increasing nephropathy severity, consistent with the trend in increased HRU.ConclusionsDiabetic nephropathy may be undertreated or inappropriately treated. It was also associated with significantly higher costs, HRU, and risk of disease progression among commercially insured patients with type 2 diabetes in the USA.FundingTakeda Development Center Americas, Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0256-5) contains supplementary material, which is available to authorized users.

Purpose Disparities exist in breast cancer (BC) outcomes between racial/ethnic groups in the United States. Reasons for these disparities are multifactorial including differences in genetics, stage at presentation, access to care and socioeconomic factors. Less is documented on racial/ethnic differences in subsequent risk of second primary cancers (SPC). The purpose of this study is to evaluate the risk of SPC among different racial/ethnic groups of women with BC. Methods Retrospective cohort of 134,868 Non-Hispanic White (NHW), 17,484 Black, 18,034 Hispanic and 19,802 Asian/Pacific Islander (API) women with stages I-III BC in twelve Surveillance, Epidemiology and End Results Program registries between 2001–2010. Standardized incidence ratios (SIR), 95% confidence intervals (CI) and absolute excess risks were calculated by comparing incidence of SPC in the cohort to incidence in the general population for specific cancer sites by race/ethnicity and stratified by index BC characteristics. Results All women were at increased risks of second primary BC and acute myeloid leukemia (AML), with higher risk among more advanced stage index BC. Black and API women had higher SIRs for AML [4.86 (95% CI 3.05–7.36) and 5.00 (95% CI 3.26–7.32) respectively] which remained elevated among early-stage (I) BC cases. Conclusions Women with a history of invasive BC have increased risk of SPC, most notable for second primary BC and AML. These risks for secondary cancers differ by race/ethnicity. Studies evaluating possible genetic and biobehavioral mechanisms underlying these differences are warranted. Strategies for BC adjuvant treatment and survivorship care may require further individualization with consideration given to race/ethnicity.