Health State Utility Scores Research Articles

Health State Utilities Associated with Attributes of Weekly Injection Devices and Subdermal Implant for Treatment of Type 2 Diabetes

Cost-utility analyses include health utilities to compare medical treatments. Health utilities, ranging from 0 to 1, represent the strength of a patient’s preference for a drug profile or health-related outcome. Recently glucagon-like peptide-1 (GLP-1) receptor agonists have been used for management of glycemic control in type 2 diabetes (T2DM). Many GLP-1 drugs have similar modes of administration. In contrast, ITCA 650 is an investigational product which is an implantable device that, following subdermal placement, provides continuous delivery of exenatide for 3 or 6 months. The study’s purpose was to estimate health utilities associated with treatment processes of GLP-1s for use in economic models. During a UK-based pilot study, 19 general population (general population) participants completed time trade-off (TTO) interviews to value health states (often called vignettes or scenarios) which were based on literature review, instructions for use, and clinician interviews. A follow-up pilot study was conducted in both general population and T2DM participants to value modified health states. Participants were recruited to ensure equal distribution across gender and education levels. A total of 20 general population and 18 T2DM patients completed face-to-face interviews (general population mean age= 50.7; T2DM mean age = 56.2). Mean utilities (SD) for ITCA-650 were 0.93 (0.06) for T2DM patients and 0.91 (0.11) for the general population. Mean utility scores for injection health states ranged from 0.83-0.92 for T2DM and 0.82-0.91 for general population. Results are higher than others found in the literature for diabetes treatment processes (range: 0.85 to 0.88). A main study with 200 participants will be conducted in early 2018. Results may be useful in cost-utility models comparing the value of treatment processes for patients with T2DM. Findings suggest the TTO method may be used to quantify preferences among different treatment processes. Disclosure A.M. Rentz: Other Relationship; Self; Intarcia Therapeutics, Inc., Servier. K. Cutts: None. K. Washington: None. M. Beillat: None. K. Yu-Isenberg: Employee; Self; Intarcia Therapeutics, Inc..

Patient preferences in Italy: health state utilities associated with attributes of weekly injection devices for treatment of type 2 diabetes.

ObjectivesSeveral glucagon-like peptide-1 receptor agonists are administered as weekly injections for treatment of type 2 diabetes (T2D). These medications vary in their injection processes, and a recent study in the UK found that these differences had an impact on patient preference and health state utilities. The purpose of this study was to replicate the UK study in Italy to examine preferences of an Italian patient sample, while allowing for comparison between utilities in the UK and Italy.Materials and methodsParticipants with T2D in Italy valued health states in time trade-off interviews. All health states had the same description of T2D, but differed in description of the treatment process. As in the original UK study, the first health state described an oral treatment regimen, while additional health states added a weekly injection. The injection health states differed in three injection-related attributes: requirements for reconstituting the medication, waiting during medication preparation, and needle handling.ResultsInterviews were completed by 238 patients (58.8% male; mean age = 60.2 years; 118 from Milan, 120 from Rome). The oral treatment health state had a mean (SD) utility of 0.90 (0.10). The injection health states had significantly (p < 0.0001) lower utilities, which ranged from 0.87 (requirements for reconstitution, waiting, and handling) to 0.89 (weekly injection with none of these requirements). Differences in health state utility scores suggest that each administration requirement was associated with a disutility (ie, negative utility difference): −0.006 (reconstitution), −0.006 (needle handling), −0.011 (reconstitution, needle handling), and −0.022 (reconstitution, waiting, needle handling).ConclusionDisutilities associated with the injection device characteristics were similar to those reported with the UK sample. Results suggest that injection device attributes may be important to some patients with T2D, and it may be useful for clinicians to consider these attributes when choosing medication for patients initiating these weekly treatments.

Comparing the 5-Year Health State Utility Value of Cervical Disc Replacement and Anterior Cervical Discectomy and Fusion.

Study Design:Health utility analysis.Objectives:To determine the health state utility (HSU) of 1- and 2-level anterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR).Methods:Data from the Medtronic Prestige Cervical Disc investigational device exemption studies was used. Four groups were defined: 1-level ACDF, 1-level CDR, 2-level ACDF, and 2-level CDR. The 36-item Short Form Health Survey (SF-36) was collected at baseline, 12 months, 24 months, 36 months, and 60 months postoperatively and converted into utility scores for each time point. A repeated-measures 1-way analysis of variance (ANOVA) was used to detect differences among groups. Tukey’s method for multiple comparisons was used to determine which means within the groups were statistically different (P < .05).Results:We found a statistically significant difference in HSU among groups as determined by repeated-measures 1-way ANOVA (P = .0008). Post hoc analysis indicated that 1-level ACDF had a statistically lower utility score compared with 1- and 2-level CDR (P = .04 and P = .02, respectively). Similarly, 2-level ACDF had lower utility values compared with 2-level CDR (P = .010). One-level ACDF utility values were not different from 2-level ACDF values (P = .55). Similarly, 1-level CDR and 2-level CDR did not have different utility values (P = .67).Conclusions:Overall, CDR had higher health state utility scores for 1- and 2-level procedures at every time point. This study indicates that CDR results in a higher postoperative health utility state than ACDF, and may therefore be an effective alternative to ACDF for treating degenerative conditions of the cervical spine.

Nephrectomy Complication Is a Risk Factor of Clinically Meaningful Decrease in Health Utility among Living Kidney Donors

ObjectivesTo assess the clinically relevant change in health state utility (HSU) in living kidney donors and whether this change value is constant across measures and clinical conditions and is useful for health economics studies. We aimed to 1) measure the change in the HSU score for living kidney donors from before donation to 3 months after donation and 2) estimate the minimal important decrease (MIDe) in the HSU score for living kidney donors and its associated clinical factors. MethodsData from a prospective multicenter observational study measuring quality of life of kidney donors by the three-level EuroQol five-dimensional questionnaire (EQ-5D-3L) and the six-dimensional health state short form (SF-6D) before donation and at 3 months after donation provided HSU scores. Two methods were used to derive the MIDe: the anchor-based method and the distribution-based (standard error of measurement) method. Logistic regression was used to identify clinical factors associated with the MIDe after donation. ResultsIn total, 228 and 216 donors completed the EQ-5D-3L and the SF-6D, respectively. Mean HSU scores were 0.932 and 0.823 before donation and 0.895 and 0.764 at 3 months after donation. HSU scores were significantly decreased at 3 months, and 18.5% of donors rated their global health as “somewhat worse.” By the EQ-5D-3L and the SF-6D, the MIDe was estimated at −0.113 and −0.116 with the anchor-based method and −0.075 and −0.077 with the distribution-based method. Risk of decreased HSU score was significantly associated with clinical complications but only marginally with surgical technique. ConclusionsA short-term clinically relevant decrease in HSU was significantly associated with clinical complications in kidney donors. Preventing perioperative complications is of prime importance in kidney donation.

Comparison of EQ-5D-5L health state utilities using four country-specific tariffs on a breast cancer patient sample in mainland China.

ObjectiveThe objective of this study was to compare the differences in the five-level EuroQol-5 dimensions (EQ-5D-5L) health state utility scores derived from Chinese, Japanese, Korean, and UK tariffs.MethodsSix hundred and twenty-one breast cancer patients were invited for a face-to-face interview in Qingdao Municipal Hospital, China. EQ-5D-5L was scored using tariffs from China, Japan, Korea, and the UK. The null hypothesis of normal distribution of the EQ-5D-5L utility score was tested by the Shapiro–Wilk test. Nonparametric Friedman test and Wilcoxon signed-rank test were used to determine the difference among the four tariffs. The intraclass correlation coefficients (ICCs) and Bland–Altman plots were used to study the agreement among the four EQ-5D-5L scores. Known-groups validity was studied using a regression framework.ResultsThere were 608 participants in the final analysis, with a mean ± standard deviation (SD) age of 48.0±9.6 years. EQ-5D-5L utility scores were non-normally distributed. The means (median) ± SD of EQ-5D-5L utilities derived from Chinese, Japanese, Korean, and UK tariffs were 0.828 (0.879) ±0.184, 0.802 (0.823) ±0.164, 0.831 (0.829) ±0.137, and 0.838 (0.866) ±0.154, respectively. Among pairwise comparisons, the difference of median EQ-5D-5L utility scores was only insignificant between Chinese and UK tariffs. Excellent agreements (with ICCs >0.9) were found among the four tariffs albeit the limits of agreement between each pair of tariffs were wide. Known-groups validity was supported.ConclusionAlthough four country-specific EQ-5D-5L tariffs have shown an overall high level of correlation and agreement, none of them could be regarded as interchangeable. The higher correlation and agreement between Chinese and UK tariffs may be due to the similar functions that were used in the tariff development. In the absence of Chinese-specific tariff, the UK tariff is the second-best option to be applied in the Chinese population. Results of this study further contribute to the explanation of variations among country-specific tariffs.

Sagittal craniosynostosis: a utility outcomes study.

OBJECTIVE Sagittal craniosynostosis results in a characteristic scaphocephalic head shape that is typically corrected surgically during a child's 1st year of life. The authors' objective was to determine the potential impact of being born with sagittal craniosynostosis by using validated health state utility assessment measures. METHODS An online utility assessment was designed to generate health utility scores for scaphocephaly, monocular blindness, and binocular blindness using standardized utility assessment tools, namely the visual analog scale (VAS) and the standard gamble (SG) and time trade-off (TTO) tests. Utility scores were compared between health states using the Wilcoxon and Kruskal-Wallis tests. Univariate regression was performed using age, sex, income, and education as independent predictors of utility scores. RESULTS Over a 2-month enrollment period, 122 participants completed the online survey. One hundred eighteen participants were eligible for analysis. Participants rated scaphocephaly due to sagittal craniosynostosis with significantly higher (p < 0.001) median utility scores (VAS 0.85, IQR 0.76-0.95; SG 0.92, IQR 0.84-0.98; TTO 0.91, IQR 0.84-0.95) than both monocular blindness (VAS 0.60, IQR 0.50-0.70; SG 0.84, IQR 0.68-0.94; TTO 0.84, IQR 0.67-0.91) and binocular blindness (VAS 0.25, IQR 0.20-0.40; SG 0.51, IQR 0.18-0.79; TTO 0.55, IQR 0.36-0.76). No differences were noted in utility scores based on participant age, sex, income, or education. CONCLUSIONS Using objective health state utility scores, authors of the current study demonstrated that the preoperatively perceived burden of scaphocephaly in a child's 1st year of life is less than that of monocular blindness. These relatively high utility scores for scaphocephaly suggest that the burden of disease as perceived by the general population is low and should inform surgeons' discussions when offering morbid corrective surgery, particularly when driven by aesthetic concerns.

Public Perception of the Burden of Microtia.

Microtia is associated with psychosocial burden and stigma. The authors' objective was to determine the potential impact of being born with microtia by using validated health state utility assessment measures. An online utility assessment using visual analogue scale, time tradeoff, and standard gamble was used to determine utilities for microtia with or without ipsilateral deafness, monocular blindness, and binocular blindness from a prospective sample of the general population. Utility scores were compared between health states using Wilcoxon and Kruskal-Wallis tests. Univariate regression was performed using sex, age, race, and education as independent predictors of utility scores. Over a 6-month enrollment period, 104 participants were included in the analysis. Visual analogue scale (median 0.80, interquartile range [0.72-0.85]), time tradeoff (0.88 [0.77-0.91]), and standard gamble (0.91 [0.84-0.97]) scores for microtia with ipsilateral deafness were higher (P <0.01) than those of binocular blindness (visual analogue scale, 0.30 [0.20-0.45]; time tradeoff, 0.42 [0.17-0.67]; and standard gamble, 0.52 [0.36-0.78]). Time trade-off scores for microtia with deafness were not different from monocular blindness (0.83 [0.67-0.91]). Higher level of education was associated with higher time tradeoff and standard gamble scores for microtia with or without deafness (P <0.05). Using objective health state utility scores, the current study demonstrates that the perceived burden of microtia with or without deafness is no different or less than monocular blindness. Given high utility scores for microtia, delaying autologous reconstruction beyond school entrance age may be justified.

Impact of Treatment with Naloxegol for Opioid-Induced Constipation on Patients' Health State Utility.

IntroductionOpioid-induced constipation (OIC) is the most common side effect of opioid treatment. Treatment for OIC typically involves a laxative. However, some patients have an inadequate response to these (laxative inadequate responders, or LIR). This has led to the development of treatments such as naloxegol. This analysis estimates the impact of naloxegol on the health state utility of LIR patients, examines if this utility impact is driven by the change in OIC status, and estimates the utility impact of relief of OIC.MethodsThe analysis was conducted using data from two 12-week randomized controlled trials, KODIAC 4 (ClinicalTrials.gov identifier, NCT01309841) and KODIAC 5 (ClinicalTrials.gov identifier, NCT01323790), plus KODIAC 7 (ClinicalTrials.gov identifier, NCT01395524), a 12-week extension to KODIAC 4. All were designed to assess the efficacy and safety of oral naloxegol (12.5 and 25 mg) compared to placebo. Health state utility data were collected through the EuroQol—five dimensions questionnaire (EQ-5D-3L). Descriptive analysis was undertaken to estimate how EQ-5D utility scores and EQ-5D domain responses varied with treatment, OIC status, and over time. A repeated measure mixed-effects model was used to predict the change from baseline in health state utility score over time.ResultsCompared with placebo, LIR patients treated with naloxegol 25 mg reported a 0.08 improvement in the EQ-5D overall score after 12 weeks of treatment. The analyses also suggest that change in OIC status is a key driver of the impact of OIC treatment on health state utility. When other factors are controlled, relieving OIC is associated with a 0.05 improvement in health state utility, although treatment with naloxegol is associated with an improvement in health state utility over and above the improvement in OIC status.ConclusionThese analyses suggest that treatment with naloxegol improves patients’ health state utility; driven predominantly by the relief of patients’ constipation.FundingAstraZeneca.

From clinically relevant outcome measures to quality of life in epilepsy: A time trade-off study

ObjectivesA proposed method for bridging the gap between clinically relevant epilepsy outcome measures and quality-adjusted life years is to derive utility scores for epilepsy health states. The aim of this study is to develop such a utility-function and to investigate the impact of the epilepsy outcome measures on utility. MethodsHealth states, based on clinically important epilepsy attributes (e.g. seizure frequency, seizure severity, side-effects), were valued by a sample of the Dutch population (N=525) based on the time trade-off method. In addition to standard demographics, every participant was asked to rate 10 or 11 different health state scenarios. A multilevel regression analysis was performed to account for the nested structure of the data. ResultsResults show that the best health state (no seizures and no side-effects) is estimated at 0.89 and the worst state (seizures type 5 twice a day plus severe side-effects) at 0.22 (scale: 0–1). An increase in seizure frequency, occurrence of side-effects, and seizure severity were all significantly associated with lower utility values. Furthermore, seizure severity has the largest impact on quality of life compared with seizure frequency and side-effects. ConclusionsThis study provides a utility-function for transforming clinically relevant epilepsy outcome measures into utility estimates. We advise using our utility-function in economic evaluations, when quality of life is not directly measured in a study and hence, no health state utilities are available, or when there is convincing empirical evidence of the insensitivity of a generic quality-of-life-instrument within epilepsy.

Preferences and Utilities for Health States after Treatment of Olfactory Groove Meningioma: Endoscopic vs Open

Background: Olfactory groove meningiomas (OGMs) have been treated with either transcranial approaches such as the bifrontal craniotomy or more recently, with the endonasal endoscopic approach. Preliminary outcomes for the endonasal approach seem promising. In choosing an appropriate approach, clinicians must weigh the indications for the approach, potential clinical outcomes, and resource implications. The purpose of this study is to report utility scores for various health states after treatment for OGM to allow for economic comparisons and better understanding of society’s treatment preferences.

Acute and chronic impact of cardiovascular events on health state utilities.

BackgroundCost-utility models are frequently used to compare treatments intended to prevent or delay the onset of cardiovascular events. Most published utilities represent post-event health states without incorporating the disutility of the event or reporting the time between the event and utility assessment. Therefore, this study estimated health state utilities representing cardiovascular conditions while distinguishing between acute impact including the cardiovascular event and the chronic post-event impact.MethodsHealth states were drafted and refined based on literature review, clinician interviews, and a pilot study. Three cardiovascular conditions were described: stroke, acute coronary syndrome (ACS), and heart failure. One-year acute health states represented the event and its immediate impact, and post-event health states represented chronic impact. UK general population respondents valued the health states in time trade-off tasks with time horizons of one year for acute states and ten years for chronic states.ResultsA total of 200 participants completed interviews (55% female; mean age = 46.6 y). Among acute health states, stroke had the lowest utility (0.33), followed by heart failure (0.60) and ACS (0.67). Utility scores for chronic health states followed the same pattern: stroke (0.52), heart failure (0.57), and ACS (0.82). For stroke and ACS, acute utilities were significantly lower than chronic post-event utilities (difference = 0.20 and 0.15, respectively; both p < 0.0001).ConclusionsResults add to previously published utilities for cardiovascular events by distinguishing between chronic post-event health states and acute health states that include the event and its immediate impact. Findings suggest that acute versus chronic impact should be considered when selecting scores for use in cost-utility models. Thus, the current utilities provide a unique option that may be used to represent the acute and chronic impact of cardiovascular conditions in economic models comparing treatments that may delay or prevent the onset of cardiovascular events.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-015-0772-9) contains supplementary material, which is available to authorized users.

The Integrated Care Pathway for Managing Post Stroke (ICAPPS) Patients in the Community: A Cost -Effectiveness Analysis.

Methods A cluster randomised controlled trial on 151 post stroke patients from 10 selected public healthcentres in Peninsular Malaysia was done to evaluate quality of life (QoL) of patients managed with iCaPPS (n=86) vs conventional care (n=65) for 6 months. Costs from provider and patient perspective were calculated. QoL was evaluated using EQ-5D health state utility scores. Cost per quality adjusted life year (QALY) gained and incremental cost effectiveness ratio (ICER) were determined. Differences within groups were determined using Mann-Whitney tests.

Impact of caregiver and parenting status on time trade-off and standard gamble utility scores for health state descriptions

BackgroundThe purpose of this study was to examine the effect of caregiver status on time trade-off (TTO) and standard gamble (SG) health state utility scores. Respondents were categorized as caregivers if they reported that either children or adults depended on them for care.MethodsThis study was a secondary analysis of data from three studies in which general population samples rated health state descriptions. Study 1: UK; four osteoarthritis health states. Study 2: UK; three adult ADHD health states. Study 3: US; 16 schizophrenia health states. All three studies included time trade-off assessment. Study 1 also included standard gamble. Descriptive statistics were calculated to examine willingness to trade in TTO or gamble in SG. Utilities for caregivers and non-caregivers were compared using t-tests and ANCOVA models.ResultsThere were 364 respondents including 106 caregivers (n = 30, 47, and 29 in Studies 1, 2, and 3) and 258 non-caregivers. Most caregivers were parents of dependent children (78.3%). Compared to non-caregivers, caregivers had more responses at the ceiling (i.e., utility = 0.95), indicating less willingness to trade time or gamble. All utilities were higher for caregivers than non-caregivers (mean utility difference between groups: 0.07 to 0.16 in Study 1 TTO; 0.03 to 0.17 in Study 1 SG; 0.06 to 0.10 in Study 2 TTO; 0.11 to 0.22 in Study 3 TTO). These differences were statistically significant for at least two health states in each study (p < 0.05). Results of sensitivity analyses with two caregiver subgroups (parents of dependent children and parents of any child regardless of whether the child was still dependent) followed the same pattern as results of the primary analysis. The parent subgroups were generally less willing to trade time or gamble (i.e., resulting in higher utility scores) than comparison groups of non-parents.ConclusionsResults indicate that caregiver status, including being a parent, influences responses in time trade-off health state valuation. Caregivers (i.e., predominantly parents) were less willing than non-caregivers to trade time, resulting in higher utility scores. This pattern was consistent across multiple health states in three studies. Standard gamble results followed similar patterns, but with less consistent differences between groups. It may be useful to consider parenting/caregiving status when collecting, interpreting, or using utility data because this demographic variable could influence results.

Burden of illness associated with painful diabetic peripheral neuropathy among adults seeking treatment in the US: results from a retrospective chart review and cross-sectional survey

BackgroundThe purpose of this study was to characterize the burden of illness among adult subjects with painful diabetic peripheral neuropathy (pDPN) seeking treatment in the US.MethodsThis observational study recruited 112 subjects with pDPN during routine visits from general practitioner and specialist sites. Subjects completed a one-time questionnaire, which included demographics, symptom duration, health care resource use, out-of-pocket costs, employment status, and validated measures that assessed pain, functioning, sleep, anxiety and depression, health status, and productivity. Investigators completed a case report form based on a 6-month retrospective chart review to capture clinical information, pDPN-related treatments, and other pDPN-related health care resource use over the past 6 months. Annualized costs were extrapolated based on reported 6-month health care resource use.ResultsThe mean age of the subjects was 61.1 years, 52.7% were female, and 17.9% were in paid employment. The most common comorbid conditions were sleep disturbance/insomnia (43.8%), depressive symptoms (41.1%), and anxiety (35.7%). The mean pain severity score was 5.2 (0–10 scale), and 79.5% reported moderate or severe pain. The mean pain interference with function score was 5.0 (0–10 scale) overall, with 2.0 among mild, 5.1 among moderate, and 7.0 among severe. The mean Medical Outcomes Study sleep problems index score was 48.5 (0–100 scale). The mean health state utility score was 0.61. Among subjects employed for pay, mean overall work impairment was 43.6%. Across all subjects, mean overall activity impairment was 52.3%. In total, 81.3% were prescribed at least one medication for their pDPN; 50.9% reported taking at least one nonprescription medication. Adjusted mean annualized total direct and indirect costs per subject were $4841 and $9730, respectively. Outcomes related to pain interference with function, sleep, health status, activity impairment, prescription medication use, and direct and indirect costs were significantly worse among subjects with more severe pain (P < 0.0020).ConclusionSubjects with pDPN exhibited high pain levels, which were associated with poor sleep, function, and productivity. Health care resource utilization in pDPN was prevalent and costs increased with greater pain severity. The burden of pDPN was greater among subjects with greater pain severity.

Revision lumbar surgery in elderly patients with symptomatic pseudarthrosis, adjacent-segment disease, or same-level recurrent stenosis. Part 1. Two-year outcomes and clinical efficacy

Same-level recurrent lumbar stenosis, pseudarthrosis, and adjacent-segment disease (ASD) are potential complications that can occur after index lumbar spine surgery, leading to significant discomfort and radicular pain. While numerous studies have demonstrated excellent results following index lumbar spine surgery in elderly patients (age > 65 years), the effectiveness of revision lumbar surgery in this cohort remains unclear. The aim of this study was to assess the long-term effectiveness of revision lumbar decompression and fusion in the treatment of symptomatic pseudarthrosis, ASD, and same-level recurrent stenosis, using validated patient-reported outcomes. After a review of the institutional database, 69 patients who had undergone revision neural decompression and instrumented fusion for ASD (28 patients), pseudarthrosis (17 patients), or same-level recurrent stenosis (24 patients) were included in this study. Baseline and 2-year scores on the visual analog scale for leg pain (VAS-LP), VAS for back pain (VAS-BP), Oswestry Disability Index (ODI), and Zung Self-Rating Depression Scale (SDS) as well as the time to narcotic independence, time to return to baseline activity level, health state utility (EQ-5D, the EuroQol-5D health survey), and physical and mental component summary scores of the 12-Item Short-Form Health Survey (SF-12 PCS and MCS) were assessed. Compared with the preoperative status, VAS-BP was significantly improved 2 years after surgery for ASD (mean ± standard deviation 9 ± 2 vs 4.01 ± 2.56, p = 0.001), pseudarthrosis (7.41 ± 1 vs 5.52 ± 3.08, p = 0.02), and same-level recurrent stenosis (7 ± 2.00 vs 5.00 ± 2.34, p = 0.003). The 2-year ODI was also significantly improved after surgery for ASD (29 ± 9 vs 23.10 ± 10.18, p = 0.001), pseudarthrosis (28.47 ± 5.85 vs 24.41 ± 7.75, p = 0.001), and same-level recurrent stenosis (30.83 ± 5.28 vs 26.29 ± 4.10, p = 0.003). The Zung SDS score and SF-12 MCS did not change appreciably after surgery in any of the cohorts, with an overall mean 2-year change of 1.01 ± 5.32 (p = 0.46) and 2.02 ± 9.25 (p = 0.22), respectively. Data in this study suggest that revision lumbar decompression and extension of fusion for symptomatic pseudarthrosis, ASD, and same-level recurrent stenosis provides improvement in low-back pain, disability, and quality of life and should be considered a viable treatment option for elderly patients with persistent or recurrent back and radicular pain. Mental health symptoms may be more refractory to revision surgery.

Cleft Lip and Palate

Cleft lip and/or palate is a debilitating condition if left unrepaired, resulting in significant speech, hearing, swallowing, feeding, and psychosocial impairments. The authors' objective was to determine the potential impact of being born with cleft lip and/or palate by using previously validated health state utility assessment measures. A utility assessment using the visual analogue scale, time trade-off, and standard gamble was used to obtain utilities for cleft lip and/or palate, monocular blindness, and binocular blindness from a prospective sample of the general population and medical students. Average utility scores were compared using paired t test. Linear regression was performed using age, race, and education as independent predictors of each of the utility scores. Over a 1-year prospective enrollment period, 110 participants were included in our utility analysis. The utility outcome scores for cleft lip and/or palate (visual analogue scale, time trade-off, and standard gamble, 0.69±0.18, 0.85±016, and 0.84±0.18, respectively) were statistically different from those of binocular blindness (visual analogue scale, time trade-off, and standard gamble: 0.38±0.17, 0.70±0.24, and 0.66±0.25, respectively; p<0.001) but not statistically different from those of monocular blindness (visual analogue scale, time trade-off, and standard gamble, 0.67±0.15, 0.86±0.15, and 0.84±0.18, respectively). There was no statistically significant difference in utility scores between male and female participants. The results of the study demonstrate objectively via health state utility scores that the perceived burden of being born with cleft lip and/or palate is comparable to living with monocular blindness.

Assessment of Health State in Patients With Tinnitus: A Comparison of the EQ-5D and HUI Mark III

Expressing the outcomes of treatment in quality-adjusted life years is increasingly important as a tool to aid decision makers concerning the allocation of scarce resources within the health care sector. A quality-adjusted life year is a measure of life expectancy that is weighted by health-related quality of life. These weights are referred to as utility scores and are usually measured by multiattribute utility measures. Several studies found that different utility measures provide different estimates of the same person's level of utility. The aim of this study was to investigate which of two widely used utility measures, the EQ-5D and the HUI mark III, is preferred in a tinnitus population. Baseline and follow-up data on EQ-5D and HUI mark III of 429 patients of a randomized controlled clinical trial, investigating cost-effectiveness of usual care versus specialized care of tinnitus, were included. Agreement, discriminative power, and responsiveness of the health state description and the utility scores were examined. Corresponding dimensions of the EQ-5D and HUI mark III showed large correlations; although ceiling effects were more frequently observed in the EQ-5D. Mean utility scores for EQ-5D (0.77; SD 0.22) and HUI mark III (0.64; SD 0.28) were significantly different (Wilcoxon signed ranks test, p < 0.001), and agreement was low to moderate (intraclass correlation coefficient = 0.53). Both health state description and utility scores of both measures discriminated between different severity groups. These groups were based on baseline scores of the Tinnitus Questionnaire. The HUI mark III had a higher ability than the EQ-5D to detect improved patients from randomly selected pairs of improved and unimproved patients. This study shows that different utility measures lead to different health state descriptions and utility scores among tinnitus patients. However, both measures are capable of discriminating between clinically different groups. The HUI mark III is more responsive than the EQ-5D, and therefore preferred in a tinnitus population.

A comparison of physician-rated disease severity and patient reported outcomes in mild to moderately active ulcerative colitis

Background and aimsThe aim was to derive health state utility scores in ulcerative colitis (UC) by establishing the relationship between the physician-rated ulcerative colitis disease activity index (UCDAI) and a patient reported EQ-5D by statistically mapping the two instruments. MethodsIn a randomised controlled trial comparing oral plus enema mesalazine treatment with oral mesalazine treatment alone (PINCE), UCDAI and EQ-5D scores were collected in parallel from patients with active UC. From these data, multinomial logistic regression was used to estimate response probabilities to each of the five domains of the EQ-5D index from assessment of UC disease severity using original and abbreviated (no endoscopy) versions of the UCDAI. Predicted EQ-5D responses were converted by Monte Carlo simulation to the EQ-5D index for predicting health-related quality of life (HRQoL). The reliability of the algorithm was tested using UCDAI scores from a second mesalazine RCT (PODIUM). ResultsThe abbreviated-UCDAI showed comparable explanatory performance to the full UCDAI. For patients in remission, mean utility was 0.939, 0.944, and 0.940U for PINCEestimated, PINCEobserved, and PODIUM, respectively. Mild/moderate and relapsing cases showed mean utilities of 0.801, 0.811, and 0.775, respectively; whilst for those in severe relapse, the mean utilities were 0.630, 0.700 and 0.660units, respectively. The mean squared error between actual and predicted utilities from observations in PINCE was 0.019. ConclusionResponse mapping of UC activity to EQ-5D domains produced reliable estimates of patient-rated health state utility consistent with UCDAI rated severity. Comparing abbreviated-UCDAI and full UCDAI suggests that inclusion of endoscopy scores has limited predictive value in estimating patient HRQoL.

Health State Utility Scores for Cancer-Related Anemia through Societal and Patient Valuations

Objectives Fatigue is recognized as the most serious complication of chemotherapy for the majority of patients. This study aims to determine preferences and utility values for health state descriptions of anemia associated with cancer treatment. Methods FACT-An clinical trial data were summarized to define health states associated with hemoglobin levels of 7.0–8.0, 8.0–9.0, 9.0–10.0, 10.0–10.5, 10.5–11.0, 11.0–12.0, and 12.0+ g/dL. Health state descriptions were reviewed by clinicians and two quality-of-life experts. Eighty-five members of the general public were asked to rate the health states using a visual analogue scale and standard gamble (SG). Twenty-six oncology patients were interviewed using the time trade-off (TTO). Results The mean societal SG derived utility values showed a significant linear change from 0.583 ± 0.067 (7–8 g/dL hemoglobin [Hb]) to 0.708 ± 0.057 (12+ g/dL Hb). The patient TTO data ranged from 0.297 ± 0.127 (7–8 g/dL Hb) to 0.611 ± 0.092 (12+ g/dL Hb). Conclusions The health state utility scores from both groups show a decrement in line with worsening anemia. Furthermore, patients who have experienced cancer-related fatigue rate the more severe levels of anemia much lower than the general public.

Health state utility scores in advanced non-small cell lung cancer

The aim of the study was to capture societal utility scores for health state descriptions of advanced, metastatic non-small cell lung cancer (NSCLC), as well as determine disutility associated with specific disease symptoms. NSCLC health states were produced based on an adaptation of existing health state descriptions for metastatic lung cancer. The health states were expanded to contrast disease state (responding disease and stable disease) and impact of specific severe symptoms (cough; dyspnoea; pain; or no additional severe symptoms). Interviews with five lung cancer clinicians were carried out to assess the content and face validity of the existing health states as descriptions specific to NSCLC. The interviews also sought to explore the impact of the disease symptoms of interest. The resulting health states were reviewed by two psychometric experts independently. The final health states were piloted in a conventional standard gamble interview which revealed no significant issues in interpretation or comprehension. In the main study, 101 members of the general public assessed their preference for each health state in a chained standard gamble (SG) interview and on a visual analogue scale (VAS) rating scale. All participants also completed the EQ-5D and a socio-demographic form. The study sample was a relatively good match to the characteristics of the general public in England and Wales. A mixed model analysis revealed that age, gender, and HRQL were not significant predictors of utility, but a treatment response and each of the disease symptoms were. When adjusted to match census data, stable disease with no additional symptoms had a utility value of 0.626. Health state values declined by 0.069 with the addition of pain; 0.050 for dyspnoea; or 0.046 for cough. A treatment response would result in a utility gain of 0.086. Members of the general public showed a preference for responding disease over stable disease and a stable health state with no additional symptoms over a stable health state with one of the three common NSCLC symptoms: cough, dyspnoea, and pain. The study highlights the value that society places on the avoidance of severe symptoms that some people with NSCLC can experience.