A view from the Bridge: agreement between the SF-6D utility algorithm and the Health utilities Index

BACKGROUND: The SF-6D is a new health state classification and utility scoring system based on 6 dimensions (‘6D’) of the Short Form 36, and permits a ‘‘bridging’’ transformation between SF-36 responses and utilities. The Health Utilities Index, mark 3 (HUI3) is a valid and reliable multi-attribute health utility scale that is widely used. We assessed within-subject agreement between SF-6D utilities and those from HUI3. METHODS: Patients at increased risk of sudden cardiac death and participating in a randomized trial of implantable defibrillator therapy completed both instruments at baseline. Score distributions were inspected by scatterplot and histogram and mean score differences compared by paired t-test. Pearson correlation was computed between instrument scores and also between dimension scores within instruments. Between-instrument agreement was by intra-class correlation coefficient (ICC). RESULTS: SF-6D and HUI3 forms were available from 246 patients. Mean scores for HUI3 and SF-6D were 0.61 (95% CI 0.60–0.63) and 0.58 (95% CI 0.54–0.62) respectively; a difference of 0.03 (p50.03). Score intervals for HUI3 and SF-6D were (-0.21 to 1.0) and (0.30–0.95). Correlation between the instrument scores was 0.58 (95% CI 0.48–0.68) and agreement by ICC was 0.42 (95% CI 0.31–0.52). Correlations between dimensions of SF-6D were higher than for HUI3. CONCLUSIONS: Our study casts doubt on the whether utilities and QALYs estimated via SF-6D are comparable with those from HUI3. Utility differences may be due to differences in underlying concepts of health being measured, or different measurement approaches, or both. No gold standard exists for utility measurement and the SF-6D is a valuable addition that permits SF-36 data to be transformed into utilities to estimate QALYs. The challenge is developing a better understanding as to why these classification-based utility instruments differ so markedly in their distributions and point estimates of derived utilities

Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study

Background: Managing emerging vaccine safety signals during an influenza pandemic is challenging. Federal regulators must balance vaccine risks against benefits while maintaining public confidence in the public health system. Methods: We developed a multi-criteria decision analysis model to explore regulatory decision-making in the context of emerging vaccine safety signals during a pandemic. We simulated vaccine safety surveillance system capabilities and used an age-structured compartmental model to develop potential pandemic scenarios. We used an expert-derived multi-attribute utility function to evaluate potential regulatory responses by combining four outcome measures into a single measure of interest: 1) expected vaccination benefit from averted influenza; 2) expected vaccination risk from vaccine-associated febrile seizures; 3) expected vaccination risk from vaccine-associated Guillain-Barre Syndrome; and 4) expected change in vaccine-seeking behavior in future influenza seasons. Results: Over multiple scenarios, risk communication, with or without suspension of vaccination of high-risk persons, were the consistently preferred regulatory responses over no action or general suspension when safety signals were detected during a pandemic influenza. On average, the expert panel valued near-term vaccine-related outcomes relative to long-term projected outcomes by 3∶1. However, when decision-makers had minimal ability to influence near-term outcomes, the response was selected primarily by projected impacts on future vaccine-seeking behavior. Conclusions: The selected regulatory response depends on how quickly a vaccine safety signal is identified relative to the peak of the pandemic and the initiation of vaccination. Our analysis suggested two areas for future investment: efforts to improve the size and timeliness of the surveillance system and behavioral research to understand changes in vaccine-seeking behavior

Impact of lung cancer screening results on participant health-related quality of life and state anxiety in the National Lung Screening Trial

BACKGROUND Low-dose computed tomography (LDCT) lung screening has been associated with a 20% reduction in lung cancer mortality. A major barrier to the adoption of lung screening is the potential negative psychological impact of a false-positive (FP) screen, occurring in 20% to 50% of those screened. The objective of this study was to assess the impact of abnormal findings on health-related quality of life (HRQoL) and anxiety in the American College of Radiology (ACRIN)/National Lung Screening Trial (NLST). METHODS The NLST was a randomized screening trial comparing LDCT with chest X-ray screening (CXR). This study was part of the original protocol. A total of 2812 participants at 16 of 23 ACRIN sites who had baseline HRQoL assessments were asked to complete the Short Form-36 and the State Trait Anxiety Inventory (form Y-1) questionnaires to assess short-term (1 month) and long-term (6 months) effects of screening. FP were lung cancer–free at 1 year, and true-positives (TP) were not. RESULTS Of the total participants, 1024 (36.4%) participants were FP, 63 (2.2%) were TP, 344 (12.2%) had significant incidental findings (SIFs), and 1381 (49.1%) had negative screens. Participants had been randomized to LDCT (n = 1947) and CXR (n = 865). Short-term and long-term HRQoL and state anxiety did not differ across participants with FP, SIF, or negative screens. Short-term and long-term HRQoL were lower and anxiety was higher for TP participants compared to participants with FP, SIF, and negative screens. CONCLUSIONS In a large multicenter lung screening trial, participants receiving a false-positive or SIF screen result experienced no significant difference in HRQoL or state anxiety at 1 or at 6 months after screening relative to those receiving a negative result. Cancer 2014;120:3401–3409. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. In a large multi-center lung screening trial, participants receiving a false positive or significant incidental finding screen result experienced no significant difference in health related quality of life or state anxiety at 1 or at 6 months after screening relative to those receiving a negative result

Comparison of the HUI3 with the SF-36 Preference Based SF-6D in a Clinical Trial Setting

AbstractObjectiveTo test the hypothesis that the Health Utilities Index Mark III (HUI3) and the SF-6D, based on the SF-36, generate similar health state values, and to test and compare their discriminant validity and responsiveness.MethodsThe HUI3 and SF-36 were administered to 331 patients enrolled in a double-blind, multinational phase III clinical trial in patients undergoing percutaneous coronary intervention before hospital discharge and 6 months thereafter.ResultsThe mean SF-6D baseline health state score was 0.67 compared to the HUI3 of 0.63 with r of 0.616 and intraclass correlation coefficient of 0.40. The relationship was nonlinear with greatest divergence found at the lower levels of health. Both measures were found to agree with known differences in health and to be responsive to changes over time. Nevertheless, disagreement resulted in different estimates of change from baseline (0.08 vs. 0.154).ConclusionBoth measures deployed in the present study were found to have discriminant validity, and to be responsive to changes over time in coronary artery disease conditions. Nevertheless, the measures generated different estimates of health state values for this patient population. These differences might in part be the consequence of the health status descriptive system for the HUI that may have been more in line with the hospitalized state than that for the SF-6D. These findings seemed to indicate that measures deployed are not interchangeable for use in cost-utility analysis. More head-to-head comparisons between these two measures are needed to further define and compare relationships in different patient populations

Impact of generic alendronate cost on the cost-effectiveness of osteoporosis screening and treatment

Introduction: Since alendronate became available in generic form in the Unites States in 2008, its price has been decreasing. The objective of this study was to investigate the impact of alendronate cost on the cost-effectiveness of osteoporosis screening and treatment in postmenopausal women. Methods: Microsimulation cost-effectiveness model of osteoporosis screening and treatment for U.S. women age 65 and older. We assumed screening initiation at age 65 with central dual-energy x-ray absorptiometry (DXA), and alendronate treatment for individuals with osteoporosis; with a comparator of "no screening" and treatment only after fracture occurrence. We evaluated annual alendronate costs of $20 through$800; outcome measures included fractures; nursing home admission; medication adverse events; death; costs; quality-adjusted life-years (QALYs); and incremental cost-effectiveness ratios (ICERs) in 2010 U.S. dollars per QALY gained. A lifetime time horizon was used, and direct costs were included. Base-case and sensitivity analyses were performed. Results: Base-case analysis results showed that at annual alendronate costs of $200 or less, osteoporosis screening followed by treatment was cost-saving, resulting in lower total costs than no screening as well as more QALYs (10.6 additional quality-adjusted life-days). When assuming alendronate costs of$400 through $800, screening and treatment resulted in greater lifetime costs than no screening but was highly cost-effective, with ICERs ranging from$714 per QALY gained through $13,902 per QALY gained. Probabilistic sensitivity analyses revealed that the cost-effectiveness of osteoporosis screening followed by alendronate treatment was robust to joint input parameter estimate variation at a willingness-to-pay threshold of$50,000/QALY at all alendronate costs evaluated. Conclusions: Osteoporosis screening followed by alendronate treatment is effective and highly cost-effective for postmenopausal women across a range of alendronate costs, and may be cost-saving at annual alendronate costs of $200 or less. © 2012 Nayak et al

Accounts from developers of generic health state utility instruments explain why they produce different QALYs: a qualitative study

Purpose and setting: Despite the label generic health state utility instruments (HSUIs), empirical evidence shows that different HSUIs generate different estimates of Health-Related Quality of Life (HRQoL) in the same person. Once a HSUI is used to generate a QALY, the difference between HSUIs is often ignored, and decision-makers act as if \u27a QALY is a QALY is a QALY\u27. Complementing evidence that different generic HSUIs produce different empirical values, this study addresses an important gap by exploring how HSUIs differ, and processes that produced this difference. 15 developers of six generic HSUIs used for estimating the QOL component of QALYs: Quality of Well-Being (QWB) scale; 15 Dimension instrument (15D); Health Utilities Index (HUI); EuroQol EQ-5D; Short Form-6 Dimension (SF-6D), and the Assessment of Quality of Life (AQoL) were interviewed in 2012-2013. Principal findings: We identified key factors involved in shaping each instrument, and the rationale for similarities and differences across measures. While HSUIs have a common purpose, they are distinctly discrete constructs. Developers recalled complex developmental processes, grounded in unique histories, and these backgrounds help to explain different pathways taken at key decision points during the HSUI development. The basis for the HSUIs was commonly not equivalent conceptually: differently valued concepts and goals drove instrument design and development, according to each HSUI\u27s defined purpose. Developers drew from different sources of knowledge to develop their measure depending on their conceptualisation of HRQoL. Major conclusions/contribution to knowledge: We generated and analysed first-hand accounts of the development of the HSUIs to provide insight, beyond face value, about how and why such instruments differ. Findings enhance our understanding of why the six instruments developed the way they did, from the perspective of key developers of those instruments. Importantly, we provide additional, original explanation for why a QALY is not a QALY is not a QALY

Health-state utilities in a prisoner population : a cross-sectional survey

Background: Health-state utilities for prisoners have not been described. Methods: We used data from a 1996 cross-sectional survey of Australian prisoners (n = 734). Respondent-level SF-36 data was transformed into utility scores by both the SF-6D and Nichol's method. Socio-demographic and clinical predictors of SF-6D utility were assessed in univariate analyses and a multivariate general linear model. Results: The overall mean SF-6D utility was 0.725 (SD 0.119). When subdivided by various medical conditions, prisoner SF-6D utilities ranged from 0.620 for angina to 0.764 for those with none/mild depressive symptoms. Utilities derived by the Nichol's method were higher than SF-6D scores, often by more than 0.1. In multivariate analysis, significant independent predictors of worse utility included female gender, increasing age, increasing number of comorbidities and more severe depressive symptoms. Conclusion: The utilities presented may prove useful for future economic and decision models evaluating prison-based health programs

Cost-effectiveness analysis of 3-D computerized tomography colonography versus optical colonoscopy for imaging symptomatic gastroenterology patients.

BACKGROUND: When symptomatic gastroenterology patients have an indication for colonic imaging, clinicians have a choice between optical colonoscopy (OC) and computerized tomography colonography with three-dimensional reconstruction (3-D CTC). 3-D CTC provides a minimally invasive and rapid evaluation of the entire colon, and it can be an efficient modality for diagnosing symptoms. It allows for a more targeted use of OC, which is associated with a higher risk of major adverse events and higher procedural costs. A case can be made for 3-D CTC as a primary test for colonic imaging followed if necessary by targeted therapeutic OC; however, the relative long-term costs and benefits of introducing 3-D CTC as a first-line investigation are unknown. AIM: The aim of this study was to assess the cost effectiveness of 3-D CTC versus OC for colonic imaging of symptomatic gastroenterology patients in the UK NHS. METHODS: We used a Markov model to follow a cohort of 100,000 symptomatic gastroenterology patients, aged 50 years or older, and estimate the expected lifetime outcomes, life years (LYs) and quality-adjusted life years (QALYs), and costs (£, 2010-2011) associated with 3-D CTC and OC. Sensitivity analyses were performed to assess the robustness of the base-case cost-effectiveness results to variation in input parameters and methodological assumptions. RESULTS: 3D-CTC provided a similar number of LYs (7.737 vs 7.739) and QALYs (7.013 vs 7.018) per individual compared with OC, and it was associated with substantially lower mean costs per patient (£467 vs £583), leading to a positive incremental net benefit. After accounting for the overall uncertainty, the probability of 3-D CTC being cost effective was around 60 %, at typical willingness-to-pay values of £20,000-£30,000 per QALY gained. CONCLUSION: 3-D CTC is a cost-saving and cost-effective option for colonic imaging of symptomatic gastroenterology patients compared with OC

Gender differences in health-related quality-of-life are partly explained by sociodemographic and socioeconomic variation between adult men and women in the US: evidence from four US nationally representative data sets

The purpose of this study was to describe gender differences in self-reported health-related quality-of-life (HRQoL) and to examine whether differences are explained by sociodemographic and socioeconomic status (SES) differentials between men and women. Data were from four US nationally representative surveys: US Valuation of the EuroQol EQ-5D Health States Survey (USVEQ), Medical Expenditure Panel Survey (MEPS), National Health Measurement Study (NHMS) and Joint Canada/US Survey of Health (JCUSH). Gender differences were estimated with and without adjustment for sociodemographic and SES indicators using regression within and across data sets with SF-6D, EQ-5D, HUI2, HUI3 and QWB-SA scores as outcomes. Women have lower HRQoL scores than men on all indexes prior to adjustment. Adjusting for age, race, marital status, education and income reduced but did not remove the gender differences, except with HUI3. Adjusting for marital status or income had the largest impact on estimated gender differences. There are clear gender differences in HRQoL in the United States. These differences are partly explained by sociodemographic and SES differentials

Experience-based utility and own health state valuation for a health state classification system: why do it and how to do it

In the estimation of population value sets for health state classification systems such as the EQ-5D, there is increasing interest in asking respondents to value their own health state, sometimes referred to as "experienced-based utility values" or more correctly ownrather than hypothetical health states. Own health state values differ to hypothetical health state values, and this may be attributed to many reasons. This paper critically examines: whose values matter; why there is a difference between own and hypothetical values; how to measure own health state values; and why to use own health state values. Finally, the paper also examines other ways that own health state values can be taken into account, such as including the use of informed general population preferences that may better take into account experience-based values