Quality of life impacts associated with comorbid insomnia and depression in adult population.

PURPOSE: Health-related quality of life (HRQoL) impacts of insomnia and depression (as separated entities) have been well investigated in previous studies. However, little is known about the effect of comorbid insomnia and depression on HRQoL. This study aimed to assess the impacts of insomnia and depression, in combination or alone, on HRQoL in Australian adults. METHODS: Data used in this study were obtained from the large-scale longitudinal Household, Income and Labour Dynamics in Australia (HILDA) survey. Insomnia was defined using key insomnia criteria of DSM-V. Depression was based on validated cut-off points of the Mental Health Inventory-5 (MHI-5) (scores ≤ 62) in the base case analysis. HRQoL expressed as utility scores (ranging from 0 to 1) were measured using the Short-Form 6-Dimension (SF-6D) converted from the SF-36 and valued using an Australian scoring algorithm. Multi-level modelling was applied to assess the effect of insomnia and/or depression on utility scores. RESULTS: The study analysed 30,972 observations from 10,324 individuals (age [mean ± SD]: 45.7 ± 16.5, female: 54.6%). The proportion of individuals with insomnia only, depression only, and comorbid insomnia and depression was 11.3%, 11.6%, and 8.2%, respectively. The interaction effect suggested the combined impact of insomnia and depression on health-related quality of life beyond the sum of their individual effects. Marginal mean difference in utility scores for insomnia only, depression only, and the comorbidity relative to no insomnia or depression was -0.058 (SE: 0.003, Cohen's d: 0.420, small effect), -0.210 (SE: 0.003, Cohen's d: 1.530, large effect), and -0.291 (SE: 0.004, Cohen's d: 2.120, large effect), respectively. CONCLUSION: Comorbid depression and insomnia appear to have very large quality-of-life impacts. Furthermore, this is the first study that has estimated the magnitude of the impact of comorbid insomnia and depression on utility scores which can be utilised in future clinical or economic studies.

Insomnia and depression often occur together and have an evidence-based bidirectional relationship. The impairment of health-related quality of life (HRQoL) associated with insomnia or depression, as an individual effect, has been previously examined by several studies. However, the reduction in HRQoL associated with comorbid insomnia and depression has been understudied. With the use of representative longitudinal data containing a large sample size of 10,324 Australian adults, we found that insomnia and depression were associated with statistically significant reductions in health-related quality of life, whether occurring individually or concurrently. The effect of comorbid insomnia and depression on quality of life was significantly larger than the summative effect of insomnia and depression. This study provides new insights into the quality-of-life burden of insomnia and/or depression and emphasises the importance of addressing insomnia in adults with depression.

Development of a disease-specific health utility score for chronic obstructive pulmonary disease from a discrete choice experiment patient preference study.

OBJECTIVES: While patient input to health technology assessment (HTA) has traditionally been of a qualitative nature, there is increasing interest to integrate quantitative evidence from patient preference studies into HTA decision making. Preference data can be used to generate disease-specific health utility data. We generated a health utility score for patients with chronic obstructive pulmonary disease (COPD) and consider its use within HTAs. METHODS: Based on qualitative research, six symptoms were identified as important to COPD patients: shortness of breath, exacerbations, chronic cough, mucus secretion, sleep disturbance, and urinary incontinence. We employed a discrete choice experiment (DCE) and the random parameter logistic regression technique to estimate utility scores for all COPD health states. The relationship between patients' COPD health utility scores, self-perceived COPD severity, and EQ-5D-3L utility scores was analyzed, with data stratified according to disease severity and comorbidity subgroups. RESULTS: The COPD health utility score had face validity, with utility scores negatively correlated with patients' self-perceived COPD severity. The correlation between the COPD health utility scores and EQ-5D-3L values was only moderate. While patient EQ-5D-3L scores were impacted by comorbidities, the COPD health utility score was less impacted by comorbid conditions. CONCLUSIONS: Our COPD utility measure, derived from a DCE, provides a patient-centered health utility score and is more sensitive to the COPD health of the individual and less sensitive to other comorbidities. This disease-specific instrument should be considered alongside generic health-related quality of life instruments when valuing new COPD therapies in submissions to licensing and reimbursement agencies.

Cancer population norms using a new value set for the SF-6Dv2 based on the preferences of patients with breast or colorectal cancer in Quebec.

BACKGROUND: Because health resources are limited, health programs should be compared to allow the most efficient ones to emerge. To that aim, health utility instruments have been developed to allow the calculation of quality-adjusted life-year (QALY). However, generic instruments, which can be used by any individual regardless of their health profile, typically consider the preferences of the general population when developing their value set. Consequently, they are often criticized for lacking sensitivity in certain domains, such as cancer. In response, the latest version of the Short Form 6-Dimension (SF-6Dv2) has been adapted to suit the preferences of patients with breast or colorectal cancer in the Canadian province of Quebec. By extension, our study's aim was to determine cancer population norms of utility among patients with breast or colorectal cancer in Quebec using the SF-6Dv2. METHOD: To determine the cancer population norms, we exploited the data that were used in the development of a new value set for the SF-6Dv2. This value set was developed considering the preferences of patients with breast or colorectal cancer. Stratification by time of data collection (i.e., T1 and T2), sociodemographic variables (i.e., age, sex, body mass index, and self-reported health problems affecting quality of life), and clinical aspects (i.e., cancer site, histopathological classification, cancer stage at diagnosis, modality, and treatment characteristics) was performed. RESULTS: In 353 observations, patients were more likely to have negative utility scores at T1 than at T2. Males had higher mean utility scores than females considering type of cancer and comorbidities. Considering the SF-6Dv2's dimensions, more females than males reported having health issues, most which concerned physical functioning. Significant differences by sex surfaced for all dimensions except "Role Limitation" and "Mental health." Patients with multifocal cancer had the highest mean and median utility values in all cancer sites considered. CONCLUSION: Cancer population norms can serve as a baseline for interpreting the scores obtained by a given population in comparison to the situation of another group. In this way, our results can assist in comparing utility scores among cancer patients with different sociodemographic groups to other patients/populations groups. To our knowledge, our identified utility norms are the first for patients with breast or colorectal cancer from Quebec.

Health-related quality of life measured using the EQ-5D-3L: iranian population norms.

BACKGROUND: Normative values are valuable for comparing a specific population with the general population, making them particularly useful in disease burden studies and cost-effectiveness analysis. The objective of this study was to estimate HRQoL normative values for the EQ-5D measure in Iran. METHODS: The analysis was performed using a sample (n = 27,704) of the Iranian adult population, which was extracted from a nationwide survey conducted in 2021. Participants assessed their health-related quality of life using the EQ-5D-3 L instrument and a visual analogue scale (EQ VAS). Multivariable regression analyses were performed to examine the relationships between utility scores, EQ VAS scores, and various socio-demographic factors. RESULTS: The mean utility and EQ VAS scores of the total sample were 0.87 (95% CI: 0.86, 0.88) and 72.9 (95% CI: 72.7, 73.1), respectively. Almost half of the respondents (46.8%) reported a health state without any problems. The most prevalent problems were pain/discomfort (38.3%) and anxiety/depression (35.2%). Furthermore, EQ-5D values and EQ VAS scores were associated with gender, age, employment status, education level, marital status, and chronic illness. CONCLUSIONS: This study provided normative values for the general population in Iran. Policymakers and researchers can use these values as a reference for population norms in economic assessments and studies focusing on the population's health.

Measurement of Health-Related Quality of Life in Individuals With Rare Diseases in China: Nation-Wide Online Survey.

BACKGROUND: Rare diseases (RDs) affect millions of people worldwide, and these diseases can severely impact the health-related quality of life (HRQoL) of those affected. Despite this, there is a lack of research measuring HRQoL using the EQ-5D-5L, which is one of the most widely used generic preference-based instruments to measure HRQoL in populations living with RDs. OBJECTIVE: This study aimed to measure HRQoL using the EQ-5D-5L in a large number of patients with various types of RDs in China, and to examine the relationship between respondents' socioeconomic characteristics and preference-based health utility scores. METHODS: The data used in this study were obtained from a web-based survey conducted in China. The survey aimed to explore and understand the health and socioeconomic status of patients with RDs in China. We recruited registered and eligible members, including patients or their primary caregivers, from 33 RD patient associations to complete the questionnaires via their internal social networks. HRQoL was measured using the EQ-5D-5L utility score, which was calculated based on an established Chinese value set. Utility scores have been presented based on demographics and disease-related information. Univariate linear regression analysis was used to assess the differences in the EQ-5D-5L utility scores between subgroups. RESULTS: A total of 12,502 respondents completed the questionnaire and provided valid responses, including 6919 self-completed respondents and 5583 proxy-completed respondents. Data from 10,102 participants over the age of 12 years were elicited for analysis. Among patients with RDs, 65.3% (6599/10,102), 47.5% (4799/10,102), 47.0% (4746/10,102), 24.8% (2506/10,102), and 18.4% (1855/10,102) reported no problems for "self-care," "usual activities," "mobility," "pain/discomfort," and "anxiety/depression," respectively. A full health state was reported by 6.0% (413/6902) and 9.2% (295/3200) of self- and proxy-completed patients, respectively. Among self-completed patients, 69.9% (4826/6902) and 50.4% (3478/6902) reported no problems for "self-care" and "usual activities," respectively, whereas only 17.7% (1223/6902) reported problems for "anxiety/depression." Proxy-completed respondents showed a higher proportion of reporting extreme problems than self-completed respondents in all 5 dimensions. The mean utility scores reported by self- and proxy-completed respondents were 0.691 and 0.590, respectively. Different types of caregivers reported different utility scores, and among them, proxy-completed (mother) respondents reported the highest mean utility score. CONCLUSIONS: The establishment of a normative profile for RD patients can facilitate patients' adaptation and assess the effectiveness of interventions to improve the HRQoL and well-being of this population. Differences between self- and proxy-completed HRQoL assessed by the EQ-5D-5L have been identified in this study. This finding highlights the importance of incorporating perspectives from both patients and their proxies in clinical practice. Further development of the patient cohort is necessary to assess long-term changes in HRQoL in the RD population.

Assessment of Health-Related Quality of Life Using EQ-5D-5L Tool With Indian Tariffs Among Reproductive Age Group Women Living With HIV in India.

OBJECTIVE: India is witnessing declining HIV prevalence because of dedicated efforts by the government. The highly active antiretroviral therapy has improved life span of people living with HIV but bearing many side effects. Women living with HIV (WLHIV) in reproductive age group have additional burden of pregnancy-related issues. This study aimed to estimate the health utility score among WLHIV in India, particularly in context of their contraceptive use, during pregnancy and postpartum period. METHODS: A primary cross-sectional study was conducted among 195 WLHIV availing antiretroviral treatment services at public health facilities of Mumbai. The EQ-5D-5L interview-based questionnaire in local language and Indian value set was used to estimate health-related quality of life (QOL) reported as mean (± SD) utility and visual analog scale (VAS) scores. The relationship between utility values and VAS scores was assessed. RESULTS: The WLHIV with mean age of 31.6 (6.4) years were on antiretroviral medication for nearly 7 years, and 63% had CD4+ cell count > 500 cells/mm3. Response of "11111," that is, in full health state, was reported by 66.7%. The mean utility and VAS scores were 0.976 (± 0.0519) and 82.21 (± 15.77). Reduced health-related QOL scores were associated with pain and discomfort dimension. Utility scores among contraceptive users (0.986 [± 0.029]) was higher than nonusers (0.976 [± 0.028]). Currently pregnant WLHIV had least utility score (0.959 [± 0.088]). CONCLUSIONS: WLHIV had better QOL while using contraceptives more so when they were sterilized. Pregnancy reduces the QOL. This emphasizes the need to promote effective contraceptive methods among WLHIV and prevent unintended pregnancies.

EQ-5D and SF-6D health utility scores in patients with spinal and bulbar muscular atrophy.

OBJECTIVE: This study assessed patient-reported health-related quality of life (HRQoL) using two generic preference-based measures in Chinese patients with spinal and bulbar muscular atrophy (SBMA) and identified demographic and clinical determinants of health utility scores in this population. METHODS: This study used cross-sectional data of 212 Chinese patients with SBMA who completed both the EQ-5D and SF-6D. Association between response to EQ-5D and SF-6D dimensions was examined using Spearman's correlation coefficient, and the association between the two utility scores was assessed using Pearson's correlation coefficient. The variations in utility scores across patients in different subgroups were compared using one-way ANOVA. Bland-Altman (B-A) plot was used to assess the agreement of utility scores between EQ-5D and SF-6D. A multivariate Tobit regression model was employed to estimate the association between utility scores and the presence of symptoms and chronic conditions. RESULTS: The mean utility scores for the EQ-5D and SF-6D were 0.54 and 0.56, respectively. The hypothesized correlation between the EQ-5D and SF-6D dimensions ranged from 0.31 to 0.58, and the correlation between their utility scores was 0.64. An acceptable agreement between EQ-5D and SF-6D utility scores was identified by B-A plot. Patients with chronic diseases, misdiagnosis, high financial burden, and several clinical symptoms were highly likely to report a low health utility score. CONCLUSIONS: This study is the first to investigate the HRQoL of patients with SBMA worldwide. The estimated health utility scores for EQ-5D and SF-6D can be utilized as baseline data for future cost-utility analyses of SBMA-related interventions.

Health-related quality of life among breast cancer patients in India.

PURPOSE: This study evaluated the health-related quality of life (HRQoL) among breast cancer patients during various phases of treatment and with different treatment modalities, which helps in monitoring treatment outcomes, assessing the well-being of patients, and conducting health technology assessments. METHODS: A total of 534 interviews were conducted among the patients of breast cancer recruited at different stages of disease and with different treatment modalities. HRQoL was determined using EuroQoL five dimensions questionnaire with five levels (EQ-5D-5L), EuroQoL Visual Analogue Scale (EQ VAS), and the EORTC QLQ-BR23 instrument. The utility values were determined based on the Indian EQ-5D-5L value set. The socio-demographic and clinico-therapeutic determinants of HRQoL were evaluated using multiple linear regression. RESULTS: The mean utility value of breast cancer patients was 0.602 (SD = 0.311) and mean EQ VAS score was 75 (SD = 12.3). The mean utility value at diagnosis was 0.628, whereas utility value was 0.55, 0.595, and 0.64 for post-surgery, post-chemotherapy, and post-radiotherapy treatment groups, respectively. The most frequently reported problem was pain/discomfort (in 84.3% patients), followed by anxiety/depression (83.5%). On EORTC QLQ-BR23, the maximum symptom scale scores for systemic therapy side effects were reported in the post chemotherapy group. The body image score and future perspective score were better in patients undergoing breast conservative surgery (BCS) compared to patients undergoing modified radical mastectomy. Age, education, and employment status of the patient, type of treatment modality, and use of taxanes are the determinants of HRQoL in breast cancer patients. CONCLUSION: Clinical interventions should focus upon management of pain and anxiety. BCS should be offered to all eligible patients as it is associated with better HRQoL. Addressing the factors that independently affect the HRQoL will help in improving the treatment compliance and outcomes.

Evaluating the Health-Related Quality of Life of the Rare Disease Population in Hong Kong Using EQ-5D 3-Level.

OBJECTIVES: This study aimed to establish a normative profile of health-related quality of life (HRQOL) of the rare disease (RD) population in Hong Kong (HK) and identify potential predictors. METHODS: Between March 2020 and October 2020, patients with RD and caregivers were recruited through Rare Disease Hong Kong, the largest RD patient group alliance in HK. HRQOL was derived using the EQ-5D 3-Level with reference to the established HK value set. Utility scores were stratified according to demographics and disease-related information. Multiple linear regression was performed to explore the associations between patient characteristics and HRQOL. RESULTS: A total of 286 patients, covering 107 unique RDs, reported a mean utility score of 0.53 (SD 0.36). Thirty patients (10.5%) reported negative utility scores, indicating worse-than-death health states. More problems were recorded in the "usual activities" and "self-care" dimensions. Univariate analyses revealed that neurologic diseases, high out-of-pocket expenditure, home modification, and living in public housing or subdivided flats/units were significantly associated with lower HRQOL. A total of 99 caregivers reported a mean utility score of 0.78 (SD 0.17), which was significantly associated with the utility score of patients they took care of (r = 0.32; P = .001). CONCLUSIONS: The normative profile of the RD population was established, which revealed lower HRQOL in the RD population than other chronic disease groups and general population in HK. Findings were corroborated by evidence from other cohorts using EQ-5D, combined as part of a meta-analysis. Identifying predictors highlight areas that should be prioritized to improve HRQOL of RD population through clinical and psychosocial dimensions.

Development of the SF-6Dv2 health utility survey: comprehensibility and patient preference.

BACKGROUND: The SF-6Dv2 classification system assesses health states in six domains-physical functioning, role function, bodily pain, vitality, social functioning, and mental health. Scores have previously been derived from the SF-36v2® Health Survey. We aimed to develop a six-item stand-alone SF-6Dv2 Health Utility Survey (SF-6Dv2 HUS) and evaluate its comprehensibility. METHODS: Two forms of a stand-alone SF-6Dv2 HUS were developed for evaluation. Form A had 6 questions with 5-6 response choices, while Form B used 6 headings and 5-6 statements describing the health levels within each domain. The two forms were evaluated by 40 participants, recruited from the general population. Participants were randomized to debrief one form of the stand-alone SF-6Dv2 HUS during a 75-min interview, using think-aloud techniques followed by an interviewer-led detailed review. Participants then reviewed the other form of SF-6Dv2 and determined which they preferred. Any issues or confusion with items was recorded, as was as overall preference. Data were analyzed using Microsoft Excel and NVivo Software (v12). RESULTS: Participants were able to easily complete both forms. Participant feedback supported the comprehensibility of the SF-6Dv2 HUS. When comparing forms, 25/40 participants preferred Form A, finding it clearer and easier to answer when presented in question/response format. The numbered questions and underlining of key words in Form A fostered quick and easy comprehension and completion of the survey. However, despite an overall preference for Form A, almost half of participants (n = 19) preferred the physical functioning item in Form B, with more descriptive response choices. CONCLUSION: The results support using Form A, with modifications to the physical functioning item, as the stand-alone SF-6Dv2 HUS. The stand-alone SF-6Dv2 HUS is brief, easy to administer, and comprehensible to the general population.

A Systematic Literature Review of Health Utility Values in Breast Cancer.

BACKGROUND: Health utility values (HUVs) are important inputs to the cost-utility analysis of breast cancer interventions. PURPOSE: Provide a catalog of breast cancer-related published HUVs across different stages of breast cancer and treatment interventions. DATA SOURCES: Systematic searches of MEDLINE, MEDLINE In-Process, EMBASE, Web of Science, CINAHL, PsycINFO, EconLit, and Cochrane databases (2005-2017). STUDY SELECTION: Studies published in English that reported mean or median HUVs using direct or indirect methods of utility elicitation for breast cancer. DATA EXTRACTION: Independent reviewers extracted data on a preestablished and piloted form; disagreements were resolved through discussion. DATA ANALYSIS: Mixed-effects meta-regression using restricted maximum likelihood modeling was conducted for intervention type, stage of breast cancer, and typical clinical and treatment trajectory of breast cancer patients to assess the effect of study characteristics (i.e., sample size, utility elicitation method, and respondent type) on HUVs. DATA SYNTHESIS: Seventy-nine studies were included in the review. Most articles (n = 52, 66%) derived HUVs using the EQ-5D. Patients with advanced-stage breast cancer (range, 0.08 to 0.82) reported lower HUVs as compared with patients with early-stage breast cancer (range, 0.58 to 0.99). The meta-regression analysis found that undergoing chemotherapy and surgery and radiation, being diagnosed with an advanced stage of breast cancer, and recurrent cancer were associated with lower HUVs. The members of the general public reported lower HUVs as compared with patients. LIMITATIONS: There was considerable heterogeneity in the study population, health states assessed, and utility elicitation methods. CONCLUSION: This review provides a catalog of published HUVs related to breast cancer. The substantial heterogeneity in the health utility studies makes it challenging for researchers to choose which HUVs to use in cost-utility analyses for breast cancer interventions.

Quality of Life of Family Caregivers of Critically Ill Patients With Cancer Before and After Intensive Care Unit Admission Measured by EQ-5D 3-Level: A Longitudinal Prospective Cohort Study.

OBJECTIVES: Admission to the Intensive Care Unit (ICU) is considered a distress journey with an increased demand and cost for informal caregiving. This study aimed to generate utility values through assessing the quality of life (QoL) of family caregivers using the EQ-5D-3L measure before and after ICU admission of their family members. METHODS: A 1-year prospective cohort study (January 2017 to February 2018) was conducted at a comprehensive cancer center in Jordan. Caregivers of adult patients who were in the ICU for ≥ 24 hours were included. The QoL was assessed using the EQ-5D-3L instrument. Caregivers' health profiles were described, and single summary index value for their health status were calculated before ICU admission and were compared with 1-week, 1-month, and 3-month utility index scores after ICU discharge. Predictors of the change of caregivers' QoL were also reported. RESULTS: During the study period, 126 caregivers completed the QoL assessment at baseline. The mean age ± SD of the cohort was 55 years ± 14, and 52% were males. The mean utility scores ± SD were 0.70 ± 0.32, 0.73 ± 0.29, 0.71 ± 0.31, and 0.78 ± 0.31 at baseline, 1 week, 1 month, and 3 months after discharge, respectively. A significant relationship between the patient's Acute Physiology and Chronic Health Evaluation (APACHE II) score and the change in caregiver's utility score index after 3 months was reported. CONCLUSIONS: Improvement in caregivers' QoL has been seen 3 months after ICU discharge. Patients' APACHE II score at baseline is a predictor of the change of caregivers' QoL 3 months after discharge.

Assessment of health-related quality of life in cancer patients undergoing treatment using Health Utilities Index (HUI-3®) in East Delhi, India.

Background: Health-related quality of life (HRQOL) is a construct that focuses on the capacity for living afforded by the health status of a patient. Measurement of HRQOL allows a composite estimation of the capacity for living of a patient and can help capture the suffering experienced by the patient due to adverse effects of therapeutic interventions. This study was conducted to understand the health-related quality of life of cancer patients undergoing various modalities of treatment to generate evidence source for need-based intervention, to assess patients diagnosed with cancers, using Health Utilities Index - 3 (HUI-3®) and assign them single-score values to gauge HRQOL and to measure the various domains of HRQOL and change in HRQOL after a period of three months of treatment. Methods: A descriptive, longitudinal study was conducted amongst patients aged more than 18 years, who were diagnosed with cancer at a tertiary care multispecialty hospital in New Delhi. They were administered a standardized HUI-3 Questionnaire® and their responses were recorded, simultaneously. Statistical significance for change in HRQOL score was assessed with paired t-test. Multivariate linear regression was used to identify the various correlates of HRQOL. Results: The mean (± standard deviation) overall HRQOL score for all participants was 0.71 (± 0.262) [range=-0.09 to 1.00]. A follow-up assessment was carried out after three months and changes in health scores were subsequently recorded. A significant decrease in mean overall HRQOL score was seen for the entire group after three months of having been administered treatment. Single-attributes of emotion and ambulation were maximally affected amongst cancer patients after three months of treatment. On linear regression analyses, baseline HRQOL was a significant correlate of HRQOL at follow-up after three months. Conclusion: ">Addressing the HRQOL of a cancer patient before starting treatment would address morbidity that might be present even after three months.

Cost-Effectiveness Assessment of Different Glucosamines in Patients with Knee Osteoarthritis: A Simulation Model Adapted to Germany.

BACKGROUND: The use of symptomatic slow-acting drugs for osteoarthritis (OA) (e.g., glucosamine, chondroitin) is largely debated in the scientific literature. Indeed, multiple formulations of these agents are available, both as pharmaceutical-grade products and as nutritional supplements , but while all preparations may claim to deliver a therapeutic effect, not all are supported by clinical evidence. Moreover, few data are available regarding the cost-effectiveness of all these formulations. Usually, access to individual patient data is required to perform economic evaluations of treatments, but it can be challenging to obtain. We previously developed a model to simulate individual health utility scores from aggregated data obtained from published OA trials. OBJECTIVE: In the present study, using our new simulation model, we investigated the costeffectiveness of different glucosamines used in Germany. METHODS: We used our validated model to simulate the utility scores of 10 published trials that used different glucosamine preparations. Using the simulated utility scores, the quality-adjusted life years (QALYs) were calculated using the area-under-the-curve method. We used the 2018 public costs of glucosamine products available in Germany to calculate the Incremental Cost/Effectiveness Ratio (ICER). We performed analyses for pharmaceutical-grade Crystalline Glucosamine Sulfate (pCGS) and other formulations of glucosamine (OFG). A cost-effectiveness cut-off of 30,000 €/QALY was considered. RESULTS: Of 10 studies in which utility was simulated, four used pCGS, and six used OFG. The ICER analyses showed that pCGS was cost-effective compared to a placebo, with an ICER of 4489 €/QALY at month 3, 4112 €/QALY at month 6, and 9983 €/QALY at year 3. The use of OFG was not cost-effective at any of the time points considered. CONCLUSION: Using our previously published model to simulate the individual health utility scores of patients, we showed that, in the German context, the use of pCGS could be considered costeffective, while the use of OFG could not. These results highlight the importance of the formulation of glucosamine.

Health-Related Quality of Life and Its Influencing Factors for Elderly Patients With Hypertension: Evidence From Heilongjiang Province, China.

Objective: Hypertension is one of the most common public health issues worldwide. However, few existing studies examining health-related quality of life (HRQoL) were conducted on elderly patients with hypertension in China. Hence, this study aimed to assess the HRQoL of elderly patients with hypertension and its influencing factors using EuroQol five-dimensional-three-level (EQ-5D-3L) in China. Methods: Data were obtained from the 6th National Health Service Survey in Heilongjiang province from June to July 2018, with a stratified multistage random cluster sampling method. All eligible participants were interviewed using a standardized questionnaire, which included the EQ-5D-3L, socio-demographics characteristics, clinical and lifestyle characteristics. The mean EQ-5D index scores for the different subgroups were evaluated using ANOVA. A Tobit regression model was also employed to analyze the potential factors influencing HRQoL. Results: A total of 705 elderly patients with hypertension were included in this study. The mean EQ-5D utility score was 0.79 [standard deviation (SD) = 0.23]. The proportion of participants reporting pain/discomfort problems was the highest (57.0%), while problems in self-care was the lowest (17.2%). Influencing factors of HRQoL for elderly patients with hypertension included gender, age, income, education level, physical activity, health examination and coexisting diseases. Specifically, the female gender, being above 80 years old, having a lower education and/or higher income, and the presence of coexisting diseases were associated with lower utility index. In contrast, regular physical activity and medical examination had a positive impact on the HRQoL of elderly hypertension patients. Conclusion: Overall, elderly patients with hypertension in China have a lower HRQoL than the general population. To improve the HRQoL of elderly patients with hypertension, it is imperative that better public health education is provided to enhance the knowledge of hypertension, encourage the adoption of healthy habits such as regular physical activity and medical examination, and improve the management of coexisting diseases. More care should also be directed to males with hypertension who are above 80 years old.

Health state utility and quality of life measures in patients with chronic myeloid leukemia in France.

PURPOSE: Tyrosine kinase inhibitors (TKIs) have dramatically improved the prognosis of chronic myeloid leukemia (CML). We aimed to assess health state utility and quality of life (QoL) in French patients with CML in real-life setting, to study the determinants of utility score and to compare health-related QoL values to general population norms. METHODS: We conducted a cross-sectional study in 412 patients with CML. Data were collected by electronic survey. Three patient-reported outcomes questionnaires were used: EORTC QLQ-C30, EORTC QLQ-CML24 and EuroQol EQ-5D-3L. Health state utility values were computed using the French value set. We computed deviations from reference norms from the general population. We studied the determinants of health utility score using multiple regression models. RESULTS: The mean utility score (SD) was 0.72 (0.25) in the chronic phase and 0.84 (0.21) in treatment-free remission, with marked variations by gender. Patients with CML had a deviation from the reference norm of -0.15 on average (SD: 0.25). In terms of QoL, social functioning, role functioning and cognitive functioning were notably impacted with a mean difference of -16.0, -13.1 and -11.7 respectively. Fatigue, dyspnea and pain were the symptoms with the highest deviation from general population norms (mean difference of 20.6, 14.0 and 8.3 respectively). In the multiple regression analysis, fatigue was the most important independent predictor of the utility score. CONCLUSION: Although TKIs prevent the disease from progressing and even allow remission without treatment, QoL in patients with CML is notably altered. The utility scores deteriorate with CML symptoms.

Utility estimation for neurogenic bowel dysfunction in the general population.

BACKGROUND: Neurogenic bowel dysfunction (NBD) affects over 80% of individuals with spina bifida causing bowel incontinence and/or constipation. NBD is also associated with decreased quality of life, depression, anxiety, and decreased employment/educational attainment. Because NBD is a life-altering condition without a cure, understanding the utility of different health states related to NBD would aid clinicians as they try to counsel families regarding management options and to better understand the quality of life associated with disease management. OBJECTIVE: To elicit utility scores for NBD using an online community sample. STUDY DESIGN: A cross-sectional anonymous survey was completed by 1534 voluntary participants via an online platform (Amazon Mechanical Turk (MTurk, http://www.mturk.com/)), representing an 87% response rate. The survey presented hypothetical scenarios that asked respondents to imagine themselves as an individual living with NBD or as the caretaker of a child with NBD. The time trade-off (TTO) method was used to estimate a utility score, and outcomes for each scenario were calculated using median and IQR. Univariate comparisons of distributions of TTO for demographic data were made using Kruskal-Wallis tests. RESULTS: The median utility score for NBD was 0.84 [0.70-0.92]. Participants reported that they would give up a median of 5 years of their own life, to prevent NBD in themselves of their child. Utility values for child scenarios were significantly different when stratified by age, gender, race, parental status, marital status, and income. Stratification by current health status did not yield significantly different utility values. DISCUSSION: Study findings are comparable with other TTO-determined utility values of moderately severe disease states, including severe persistent asthma (0.83), moderate seizure disorder (0.84) and mild mental retardation (0.84). The significant variations in utility values based on age, gender, race, parent status, partner/marital status and income variables existed in our study, which is similar to findings in other health fields. Study limitations include lack of unanimous agreement about TTO's validity in measuring utility values, and MTurk participant reports can be generalized to greater population. CONCLUSION: NBD is perceived by the community as having a substantial impact on the lives of children with spina bifida, representing a 16% reduction from perfect health. In general, health state utilities have been increasingly used in healthcare systems to understand how burdensome a population perceives a disease is and to evaluate whether interventions improve quality of life years.

Predicting SF-6Dv2 utility scores for chronic low back pain using the Oswestry Disability Index and Roland-Morris Disability Questionnaire.

Background: Generic preference-based measures are used to evaluate disability and health-related quality of life (HRQoL). Objective: To evaluate if Short Form Six-Dimensions (SF-6Dv2) is correlated with specific current questionnaires used in chronic low back pain (CLBP) and if a predictive equation of SF-6Dv2 could be established. Methods: Between October 2018 and January 2019, an online survey on CLBP was conducted. HRQoL was measured with two specific questionnaires, i.e. Oswestry Disability Index (ODI) and Roland-Morris Disability Questionnaire (RMDQ), and with the new version of the SF-6Dv2 as a generic preference-based measure. Results: 402 subjects completed at least two of the three HRQoL questionnaires. Mean (95% confidence interval) of SF-6Dv2, ODI, or RMDQ were, respectively, 0.561 (0.553-0.569), 43.7 (42.1-45.2), and 10.3 (9.8-10.8). SF-6Dv2 was moderately correlated with ODI and RMDQ (r = -0.635 and r = -0.542, p < 0.001). The best model to predict SF-6Dv2 explained 50.6% of variability and included ODI. The correlation between actual and predicted SF-6Dv2 was 0.71. Conclusion: This study demonstrated that SF-6Dv2 was moderately correlated with ODI and RMDQ and that ODI was a better predictor. There was a strong correlation between actual and predicted SF-6Dv2 from multivariate models. These results suggest that the model can be used in similar studies to estimate the SF-6Dv2 when it was not measured.

The impact of symptoms and comorbidity on health utility scores and health-related quality of life in small cell lung cancer using real world data.

PURPOSE: Small cell lung cancer (SCLC) is a highly fatal disease associated with significant morbidity, with a need for real-world symptom and health utility score (HUS) data. HUS can be measured using an EQ-5D-5L questionnaire, however most captured data is available in non-SCLC (NSCLC) only. As new treatment regimens become available in SCLC it becomes important to understand factors which influence health-related quality of life and health utility. METHODS: A prospective observational cohort study (2012-2017) of ambulatory histologically confirmed SCLC evaluated patient-reported EQ-5D-5L-derived HUS, toxicity and symptoms. A set of NSCLC patients was used to compare differential factors affecting HUS. Clinical and demographic factors were evaluated for differential interactions between lung cancer types. Comorbidity scores were documented for each patient. RESULTS: In 75 SCLC and 150 NSCLC patients, those with SCLC had lower mean HUS ((SCLC vs NSCLC: mean 0.69 vs 0.79); (p < 0.001)) when clinically stable and with progressive disease: ((SCLC mean HUS = 0.60 vs NSCLC mean HUS = 0.77), (p = 0.04)). SCLC patients also had higher comorbidity scores ((1.11 vs 0.73); (p < 0.015)). In multivariable analyses, increased symptom severity and comorbidity scores decreased HUS in both SCLC and NSCLC (p < 0.001); however, only comorbidity scores differentially affected HUS (p < 0.0001), with a greater reduction of HUS adjusted per unit of comorbidity in SCLC. CONCLUSION: Patients with advanced SCLC had significantly lower HUS than NSCLC. Both patient cohorts are impacted by symptoms and comorbidity, however, comorbidity had a greater negative effect in SCLC patients.

Predicting EQ-5D-5L Utility Scores from the Oswestry Disability Index and Roland-Morris Disability Questionnaire for Low Back Pain.

BACKGROUND: Cost utility analysis is important for measuring the impact of chronic disease and helps clinicians and policymakers in patient management and policy decisions, but generic preference-based measures are not always considered in clinical studies. OBJECTIVE: To evaluate if health-related quality-of-life (HRQoL)-specific questionnaires used in chronic low back pain (CLBP) can predict EQ-5D-5L utility scores. METHODS: The data come from an online survey on low back pain conducted between October 2018 and January 2019. Health utility scores for EuroQol Five Dimensions Five Levels (EQ-5D-5L) were calculated with the recommended model of Xie et al. The EQ-5D-5L health states ranged from -0.148 for the worst (55555) to 0.949 for the best (11111). Univariate and multivariate linear regression were performed to predict EQ-5D-5L with Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ) and clinical variables. RESULTS: Analyses were performed in 408 subjects who completed the questionnaires EQ-5D-5L, ODI or RMDQ. Median (range) of EQ-5D-5L was 0.622 (-0.072 to 0.905). There was high correlation between EQ-5D-5L and ODI (r=-0.78, p<0.001), while it was moderate with RMDQ (r=-0.62, p<0.001). The multivariate model to predict EQ-5D-5L with ODI explained 67.6% of variability, and the correlation between actual and predicted EQ-5D-5L was 0.82. Principal predictors were ODI, duration of LBP, invalidity, health satisfaction (0-10 cm), life satisfaction (0-10 cm), and intensity of pain today (0-10 cm). CONCLUSION: Data from this study demonstrated that individual correlation between ODI and EQ-5D-5L was high, but moderate with RMDQ. Correlations between actual and predicted EQ-5D-5L from multivariate models were higher and very high. Considering these results, the multivariate model can be used in similar studies for patient with CLBP to estimate the utility scores from the ODI when the EQ-5D-5L was not measured.