Measuring Health-related Quality of Life in Teens With and Without Depression.

PURPOSE: To provide empirical evidence on the performance of common measures in assessing health-related quality of life (HRQL) in depressed and nondepressed youth. These measures can be used in research trials, cost-effectiveness studies, and to help develop policy for treating youth depression. BACKGROUND: Depression is one of the most common mental disorders among adolescents, with a chronic, episodic course marked by considerable impairment. Data on HRQL for teens with depression could more fully demonstrate the burden of depression and help to evaluate the comparative effectiveness of teen depression services, which in turn can be used to inform public and clinical policies. METHODS: We collected data on depression and HRQL from 392 depressed and nondepressed teens aged 13-17. RESULTS: Generic mental health, disease-specific, and generic preference-based measures of HRQL all do a reasonable job of distinguishing teens with and without depression and between teens with differing levels of depression. Generic mental health and disease-specific measures provide valuable information on burden of disease and perform well. For the purpose of economic evaluation, the HUI-3 and EQ-5D perform somewhat better than other preference-based measures. These results can aid future research on teens with depression by helping to guide which HRQL instruments are most useful in this population and can help to quantify the burden of depression in teens for policy and clinical planning.

The time horizon matters: results of an exploratory study varying the timeframe in time trade-off and standard gamble utility elicitation.

INTRODUCTION: The purpose of this study was to examine whether the time horizon of time trade-off (TTO) and standard gamble (SG) utility assessment influences utility scores and discrimination between health states. METHODS: In two phases, UK general population participants rated three osteoarthritis health states in TTO and SG procedures with two time horizons: (1) 10-year and (2) a time horizon derived from self-reported additional life expectancy (ALE). The two time horizons were compared in terms of mean utilities and discrimination among health states. RESULTS: In Phase 1, the 10-year tasks were completed by 80 participants, 35 of whom also completed utility assessment with the ALE. In Phase 2, all 101 participants completed procedures with both time horizons. Utility scores tended to be lower with the ALE than the 10-year, a difference that was statistically significant for two health states with SG in Phase 1 (P < 0.05), two health states with TTO in Phase 2 (P < 0.01), and one health state with SG in Phase 2 (P < 0.001). In Phase 1, rates of discrimination between mild and moderate osteoarthritis health states were significantly higher with the ALE than the 10-year (TTO: P = 0.03; SG: P = 0.001). This pattern of discrimination was similar in Phase 2. DISCUSSION: Results suggest that the time horizon could influence utility scores and discrimination among health states. When designing utility evaluations, researchers should carefully consider the time horizon so that the value of health states is accurately represented in cost-utility models.

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

BACKGROUND: Cost-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. METHODS: Health 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. RESULTS: A 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). CONCLUSIONS: Results 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.

Health state utilities associated with attributes of treatments for hepatitis C.

BACKGROUND: Cost-utility analyses are frequently conducted to compare treatments for hepatitis C, which are often associated with complex regimens and serious adverse events. Thus, the purpose of this study was to estimate the utility associated with treatment administration and adverse events of hepatitis C treatments. DESIGN: Health states were drafted based on literature review and clinician interviews. General population participants in the UK valued the health states in time trade-off (TTO) interviews with 10- and 1-year time horizons. The 14 health states described hepatitis C with variations in treatment regimen and adverse events. RESULTS: A total of 182 participants completed interviews (50% female; mean age = 39.3 years). Utilities for health states describing treatment regimens without injections ranged from 0.80 (1 tablet) to 0.79 (7 tablets). Utilities for health states describing oral plus injectable regimens were 0.77 (7 tablets), 0.75 (12 tablets), and 0.71 (18 tablets). Addition of a weekly injection had a disutility of -0.02. A requirement to take medication with fatty food had a disutility of -0.04. Adverse events were associated with substantial disutilities: mild anemia, -0.12; severe anemia, -0.32; flu-like symptoms, -0.21; mild rash, -0.13; severe rash, -0.48; depression, -0.47. One-year TTO scores were similar to these 10-year values. CONCLUSIONS: Adverse events and greater treatment regimen complexity were associated with lower utility scores, suggesting a perceived decrease in quality of life beyond the impact of hepatitis C. The resulting utilities may be used in models estimating and comparing the value of treatments for hepatitis C.

Challenges to time trade-off utility assessment methods: when should you consider alternative approaches?

In recent years, the time trade-off (TTO) method, most commonly with a 10-year time horizon, has been the most frequently used approach for direct health state utility assessment, likely due to National Institute for Health and Care Excellence (NICE) preference for comparability with the EQ-5D, which has a utility scoring algorithm derived via this method. Although comparability to previous utility studies is important, there are situations when the TTO method may not be appropriate. The purpose of the current review is to highlight challenges to the TTO method. Five challenges to the TTO method are discussed: mild health states, small differences among health states, temporary health states, pediatric health states, and assessment of samples with particular characteristics. Some of these challenges are associated with the 10-year time horizon, while other situations may raise issues for TTO methods regardless of the time horizon. Alternative approaches for valuing health states are suggested.

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

BACKGROUND: The 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. METHODS: This 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. RESULTS: There 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. CONCLUSIONS: Results 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.

Longitudinal construct validity of the Health Utilities Indices Mark 2 and Mark 3 in hip fracture.

PURPOSE: The objective of this study is to evaluate the longitudinal construct validity of the Health Utilities Index Mark 2 (HUI2) and Health Utilities Index Mark 3 (HUI3) using a convergent/divergent validity approach in patients recovering from hip fracture, with the Functional Independence Measure (FIM) as the comparator. METHODS: A total of 278 patients with a primary diagnosis of hip fracture were interviewed 3-5 days after surgery and then at 1 and 6 months using the HUI2, HUI3 and the FIM and a Likert-type rating of hip pain. A priori hypotheses were formulated. Convergent and divergent correlations between HUI2, HUI3 and FIM change scores for the baseline to 1-month and baseline to 6-month intervals were examined. RESULTS: Overall HUI2 detected continued gain in health-related quality of life between 1 and 6 months after fracture, as the change increased from 0.20 to 0.29 units. The correlation between change in the overall HUI2 score and total FIM score was moderate (r = 0.50) over the 6-month interval, but larger than the observed correlation over the 1-month interval (r = 0.36). The correlation between change in overall HUI3 score and total FIM over the 1-month interval was small (r = 0.32), and the correlation between change in overall HUI3 score and total FIM was moderate (r = 0.37) over the 6-month interval. All hypotheses for the divergent correlations were supported. CONCLUSIONS: Weaker correlations were reported for change over 1 month as compared to change over the 6 months after fracture. Findings supported the longitudinal construct validity of the overall HUI2 and HUI3 for the assessment of recovery following hip fracture, particularly for change over the 6 months following fracture.

Trajectories of health-related quality of life by socio-economic status in a nationally representative Canadian cohort.

BACKGROUND: Mortality and morbidity have been shown to follow a 'social gradient' in Canada and many other countries around the world. Comparatively little, however, is known about whether ageing amplifies, diminishes or sustains socio-economic inequalities in health. METHODS: Growth curve analysis of seven cycles of the Canadian National Population Health Survey (n=13,682) for adults aged 20 and older at baseline (1994/95). The outcome of interest is the Health Utilities Index Mark 3, a measure of health-related quality of life (HRQL). Models include the deceased so as not to present overly optimistic HRQL values. Socio-economic position is measured separately by household-size-adjusted income and highest level of education attained. RESULTS: HRQL is consistently highest for the most affluent and the most highly educated men and women, and is lower, in turn, for middle and lower income and education groups. HRQL declines with age for both men and women. The rate of the decline in HRQL, however, was related neither to income nor to education for men, suggesting stability in the social gradient in HRQL over time for men. There was a sharper decline in HRQL for upper-middle and highest-income groups for women than for the poorest women. CONCLUSION: HRQL is graded by both income and education in Canadian men and women. The grading of HRQL by social position appears to be 'set' in early adulthood and is stable through mid- and later life.

Self-reported hypertension prevalence and income among older adults in Canada and the United States.

Hypertension is one of the most common chronic conditions worldwide. There is strong evidence that low socioeconomic status is associated with elevated rates of blood pressure-related cardiovascular disease. Few studies have examined the association between socioeconomic circumstances and hypertension among people aged 65 years and older. The purpose of this study was to examine the relationship between household income and self-reported hypertension prevalence among persons aged 65 and older in the United States and Canada. Data were obtained from the 2002-2003 Joint Canada/United States Survey of Health for 755 Canadian and 1151 US adults aged 65 and older. Aggregate hypertension prevalence rates in the United States and Canada were generally similar (53.8% versus 48.0%). We found a significant inverse linear relationship between household income and the hypertension prevalence rate in the United States, but no evidence of such a relationship in Canada. In Canada, unlike the United States, the burden of hypertension is approximately equal for socioeconomically advantaged and disadvantaged older adults. It is important to consider these findings in the context of long-term and broader institutional policies. Social disparities and barriers to health care access and primary prevention among non-elderly persons in the United States may play a role in the higher hypertension prevalence rate among low-income older adults.

Comparing the Health Utilities Index Mark 3 (HUI3) with the Short Form-36 preference-based SF-6D in chronic kidney disease.

OBJECTIVE: Assess within-subject agreement and compare discriminative abilities between the SF-6D and the Health Utilities Index Mark 3 (HUI3) in patients with chronic kidney disease (CKD). METHODS: The HUI3 and Short Form-36 were self-completed by 185 CKD patients enrolled in a prospective study of incident patients with stage 4 and 5 CKD. RESULTS: The mean preference-based score for the SF-6D was 0.67 +/- 0.13 compared to 0.58 +/- 0.26 for the HUI3 (P < 0.01). There was a strong association between SF-6D and HUI3 scores (Pearson correlation coefficient 0.55, 95% CI 0.43-0.65) and moderate agreement with an intraclass correlation coefficient of 0.44. The HUI3 was better able to capture more severe burden of illness with fewer floor effects. The SF-6D was better at capturing differences among patients at the top range of the scale with fewer ceiling effects. Both the HUI3 and SF-6D were able to discriminate between patient groups differing in disease severity defined as predialysis versus dialysis dependent and depressive symptoms using a Beck Depression Inventory II score of >or=14 as the cutoff. The HUI3 was better able to discriminate greater depressive symptoms. CONCLUSION: The SF-6D and the HUI3 generate different preference-based scores for patients with CKD and any comparison between their scores should be made with caution. The HUI3 appears more suitable for measuring the health of populations with greater disability such as patients with CKD. It remains to be determined whether these differences will remain when one compares within-instrument differences in preference scores over time.

Evidence on the construct validity of the Health Utilities Index Mark 2 and Mark 3 in patients with chronic kidney disease.

OBJECTIVE: This study assessed the construct validity of the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) in the context of chronic kidney disease (CKD) and compared their ability to discriminate between groups of patients with varying disease severity. STUDY DESIGN AND SETTING: The HUI2 and HUI3 were correlated with the Medical Outcomes 36-Item Short-Form, Kidney Disease Quality of Life Questionnaire, and the Beck Depression Inventory II in 185 patients with stage 4 and 5 CKD. RESULTS: About 86% of a priori hypotheses were confirmed for HUI2 and 95% for HUI3, providing support for the construct validity of both measures. Mean (SD) overall utility score for the HUI2 was 0.74 (0.20), significantly higher than that for the HUI3, 0.58 (0.26) (P<0.001). The cognitive, emotion, and pain attributes of the HUI3 were able to identify a significantly greater proportion of patients with impairment compared to the HUI2. CONCLUSION: The results are consistent with construct validity for the HUI2 and HUI3 in patients with stage 4 and 5 CKD. However, the HUI3 appears to have superior psychometric properties compared with the HUI2 in this patient population.

Misinterpretation with norm-based scoring of health status in adults with type 1 diabetes.

BACKGROUND: Interpretations of profile and preference based measure scores can differ. Profile measures often use a norm-based scoring algorithm where each scale is scored to have a standardized mean and standard deviation, relative to the general population scores/norms (i.e., norm-based). Preference-based index measures generate an overall scores on the conventional scale in which 0.00 is assigned to dead and 1.00 is assigned to perfect health. Our objective was to investigate the interpretation of norm-based scoring of generic health status measures in a population of adults with type 1 diabetes by comparing norm-based health status scores and preference-based health-related quality of life (HRQL) scores. METHODS: Data were collected through self-complete questionnaires sent to patients with type 1 diabetes. The RAND-36 and the Health Utilities Index Mark 3 (HUI3) were included. RESULTS: A total of 216 (61%) questionnaires were returned. The respondent sample was predominantly female (58.8%); had a mean (SD) age of 37.1 (14.3) years and a mean duration of diabetes of 20.9 (12.4) years. Mean (SD) health status scores were: RAND-36 PHC 47.9 (9.4), RAND-36 MHC 47.2 (11.8), and HUI3 0.78 (0.23). Histograms of these scores show substantial left skew. HUI3 scores were similar to those previously reported for diabetes in the general Canadian population. Physical and mental health summary scores of the RAND-36 suggest that this population is as healthy as the general adult population. CONCLUSION: In this sample, a preference-based measure indicated poorer health, consistent with clinical evidence, whereas a norm-based measure indicated health similar to the average for the general population. Norm-based scoring measure may provide misleading interpretations in populations when health status is not normally distributed.

A structured review of studies on health-related quality of life and economic evaluation in pediatric acute lymphoblastic leukemia.

BACKGROUND: A comprehensive review was made of the literature on the health-related quality of life (HRQL) and economic outcomes of children with acute lymphoblastic leukemia (ALL), the most common of all cancers in childhood. OBJECTIVES: The primary objectives of the review were to locate and describe measures of HRQL used in pediatrics and in pediatric oncology that might be applicable to ALL, to summarize studies that have applied HRQL measures to ALL, to identify and summarize economic evaluations of the costs and consequences of care for pediatric ALL, and to identify areas requiring further research. DATA SOURCES: To identify the HRQL literature in pediatric ALL, searches were run on the major biomedical and social science bibliographic databases. Search terms included a variety of MeSH and other thesaurus terms, text words, names of HRQL instruments, and the names of key authors in the field. The economic literature searches included most of the same databases, with the addition of the National Health Service Economic Evaluation Database and EconLit. Searches on specific authors and instruments and hand searches were also conducted. STUDY SELECTION: Only English language studies published from 1975 through 2000 were included. DATA EXTRACTION: Standardized data extraction forms were used to abstract information from HRQL and economic evaluation studies. Two reviewers independently screened the search results, and differences were resolved by consensus. DATA SYNTHESIS: A number of generic HRQL measures, both adult and pediatric, have been applied in pediatric ALL. In addition, a number of pediatric oncology-specific instruments and pediatric oncology disease-specific instruments have been developed. Most of these instruments have been used to measure the health status of patients undergoing therapy. Despite the limited numbers of patients and resources available to assess HRQL measures in children with cancer, a fairly substantial body of literature has been published. Economic studies of pediatric ALL have only recently been undertaken. Most studies focus on a particular, narrow aspect of costs associated with the disease. There are relatively few cost-effectiveness studies that compare the costs and consequences of two or more treatment options. There are no published, comprehensive economic evaluations of pediatric ALL. CONCLUSIONS: HRQL measures provide not only important information on the improvements offered by new therapies but also an outcome measure for economic evaluations. Recently developed HRQL measures and applications that include the direct assessments of children are important contributions. By the age of 7 or 8 years, children can generally provide reliable responses. Furthermore, children often provide information that is not available from parental reports (e.g., in the more subjective areas of pain and emotion). However, the use of multiple viewpoints, such as the patient, parent, and health professional perspectives, can provide valid and important complementary information. Expertise in HRQL measurement should be included in the design of most future trials. Funds for HRQL research should be made available to enhance the scope of HRQL activities by organizations such as the Children's Oncology Group. In the near future, further work to generate evidence of validity for available HRQL measures for use in children with ALL will be a high priority. Continuation of inquiries into the methods for HRQL assessment of younger children (i.e., preschoolers) is also a priority.

Health-related quality of life deficits associated with varying degrees of disease severity in type 2 diabetes.

BACKGROUND: Diabetes is a chronic medical condition accompanied by a considerable health-related quality of life (HRQL) burden. The purpose of this analysis was to use generic measures of HRQL to describe HRQL deficits associated with varying degrees of severity of type 2 diabetes. METHODS: The RAND-12 physical and mental health composites (PHC and MHC, respectively) and Health Utilities Index Mark 3 (HUI3) were self-completed by 372 subjects enrolled in a prospective, controlled study of an intervention to improve care for individuals with type 2 diabetes in rural communities. Analysis of covariance was used to assess differences in HRQL according to disease severity and control of blood glucose. Disease severity was defined in terms of treatment intensity, emergency room visits and absenteeism from work specifically attributable to diabetes. To control for potential confounding, the analysis was adjusted for important sociodemographic and clinical characteristics. RESULTS: The PHC and MHC were significantly lower for individuals treated with insulin as compared to diet alone (PHC: 41.01 vs 45.11, MHC: 43.23 vs 47.00, p < 0.05). Individuals treated with insulin had lower scores on the vision, emotion and pain attributes of the HUI3 than individuals managed with oral medication or diet. The PHC, MHC, pain attribute and overall score on the HUI3 captured substantial decrements in HRQL associated with absenteeism from work due to diabetes, while the burden associated with emergency room utilization for diabetes was seen in the PHC and HUI3 pain attribute. CONCLUSIONS: We concluded that generic measures of HRQL captured deficits associated with more severe disease in type 2 diabetes.