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1.  The Relationship between Diabetes Mellitus and Health-Related Quality of Life in Korean Adults: The Fourth Korea National Health and Nutrition Examination Survey (2007-2009) 
Diabetes & Metabolism Journal  2011;35(6):587-594.
Diabetes is a major health problem in Korea. However, interest in the quality of life in patients with diabetes is low. We examined the effects of diabetes on health-related quality of life (HRQoL) and compared it with HRQoL in the general Korean population using the Fourth Korea National Health and Nutrition Examination Survey (KNHANES IV) (2007-2009).
Using KNHANES IV data, we compared EuroQol (EQ)-5D and EQ-visual analogue scale (VAS) scores after adjusting for sociodemographic and psychosocial factors as well as for comorbidities (hypertension, heart disease, stroke, arthritis, and chronic renal disease). Logistic regressions were used to explore determinants for the lowest quintile HRQoL scales in the diabetes group.
The mean age of the 14,441 enrolled subjects (6,129 men and 8,312 women) was 52.5±14.5 years. The mean EQ-5D and EQ-VAS scores were significantly lower in the diabetes group (EQ-5D. 0.87; EQ-VAS, 71.94) than in the non-diabetes group (EQ-5D, 0.94; EQ-VAS, 77.40) (P<0.001). Self-reported depressive symptom had a significant effect on lowering the EQ-VAS (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1 to 2.6) in the diabetes group. Stress level had a significant effect in lowering both the EQ-5D (OR, 2.0; 95% CI, 1.3 to 2.9) and the EQ-VAS (OR, 1.9; 95% CI, 1.3 to 2.9). HbA1c, diabetes duration, and treatment modalities had no significant effect on lowering HRQoL.
Diabetes was clearly associated with impaired HRQoL compared with the non-diabetic population regardless of comorbidities. Therapeutic approaches should focus much more on the subjective perception of health in patients with diabetes.
PMCID: PMC3253969  PMID: 22247901
Diabetes; EQ-5D; Health-related quality of life; Korea National Health and Nutrition Examination Survey
2.  Underlying Dimensions of the Five Health-Related Quality-of-Life Measures Used in Utility Assessment 
Medical care  2010;48(8):718-725.
Preference-weighted health-related quality-of-life (HRQoL) indexes produce a summary score from discrete health states determined by questions falling into several attributes, such as pain and mobility. Values of HRQoL are used alongside other health outcomes to monitor the health of populations.
The purpose of this study was to examine among US adults, the underlying factor structure of HRQoL attribute scores across 5 indexes of HRQoL: EuroQol-5 Dimension, Health Utilities Index Mark 2, Health Utilities Index Mark 3, Short Form-6 Dimension, and Quality of Well-Being Scale Self-Administered form.
The National Health Measurement Study surveyed a nationally representative sample of 3844 noninstitutionalized adults aged 35 to 89 years residing in the continental US. Simultaneous data on all 5 indexes were collected cross-sectionally from June 2005 to August 2006. Exploration of underlying dimensions of HRQoL was done by categorical exploratory factor analysis of HRQoL indexes' attribute scores. Item response theory was applied to explore the amount of information HRQoL attributes contribute to the underlying latent dimensions.
Three main dimensions of HRQoL emerged: physical, psychosocial, and pain. Most HRQoL index attributes contributed to the physical or psychosocial dimension. The 3 dimensions were correlated: 0.47 (physical and psychosocial), 0.57 (physical and pain), 0.46 (psychosocial and pain). Some HRQoL index attributes displayed relatively more unique variance: HUI3 hearing, speech, and vision, and some contributed to more than 1 dimension The identified factor structure fit the HRQoL data well (Comparative Fit Index = 0.98, Tucker-Lewis Index = 0.98, and Root Mean Square Error of Approximation = 0.042).
The attributes of 5 commonly used HRQoL indexes share 3 underlying latent dimensions of HRQoL, physical, psychosocial, and pain.
PMCID: PMC3635481  PMID: 20613664
health-related quality-of-life; patient reported outcomes; factor analysis; item response theory; health dimensions; EQ-5D; HUI2; HUI3; SF-6D; QWB-SA
3.  Gender differences in health-related quality of life associated with abdominal obesity in a Korean population 
BMJ Open  2014;4(1):e003954.
Overall obesity, as measured by body mass index (BMI), has been associated with a low level of health-related quality of life (HRQOL), but little is known about abdominal obesity. This cross-sectional study aimed to determine whether abdominal obesity, as measured by waist circumference (WC), would be significantly associated with HRQOL independent of overall obesity, and if so, whether the association would differ by gender among the Korean population.
Cross-sectional study.
South Korea.
Using data from the 2007–2009 Korea National Health and Nutrition Examination Survey, a total of 13 754 men and women aged 19–65 years were selected, and information about height (cm), weight (kg), WC (cm) and the EuroQOL-5 Dimensions (EQ-5D) scores for HRQOL were taken.
Not only an overall obesity (as categorised into obese, overweight or non-overweight groups based on BMI) but also an abdominal obesity (defined by WC ≥90 cm for men and ≥85 cm for women) was significantly associated with lower EQ-5D scores, after adjusting for age, gender, socioeconomic variables and a number of comorbidities. Even after adjusting BMI effect, the association between abdominal obesity and lower EQ-5D scores remained significant for women, but not for men.
Among the Korean population aged 19–65 years, abdominal obesity was associated with impaired HRQOL, independently of overall obesity. Furthermore, this association differed by gender, being significant only for women. Therefore, primary healthcare professionals should pay attention to gender differences in the impact of obesity on HRQOL when evaluating population-based health programmes.
PMCID: PMC3902435  PMID: 24464522
Public Health; General Medicine (see Internal Medicine)
4.  Evaluation of health-related quality of life using EQ-5D in Takamatsu, Japan 
Healthy Japan 21 (Japanese National Health Promotion in the 21st Century) was started in 2000 to promote extension of healthy life expectancy and improve health-related quality of life (HRQOL). The present study aims to describe HRQOL of Japanese subjects using the EuroQol questionnaire (EQ-5D) and investigate the influence of social background, health-related behaviors, and chronic conditions on HRQOL using representatives in Takamatsu, Japan.
Data were obtained from a 2005 Takamatsu City health survey mailed to 2,500 randomly selected Japanese individuals in Takamatsu, a medium-sized city. We examined data from 915 Japanese adults. The questionnaire addressed social background, health-related behaviors, chronic conditions, EQ-5D items, and self-rated health. The impact of social background, health-related behaviors, and chronic conditions on Japanese HRQOL was examined through multivariate regression, adjusting for age and sex.
EQ-5D scores decreased with age, particularly for respondents who were unemployed or retired. Adjusting for sex and age, the results showed that age, unemployment/retirement, feeling severe stress, and musculoskeletal and gastrointestinal diseases were significantly associated with decreased HRQOL. Conversely, sufficient sleep (7–8 h/day) and having a hobby were significantly associated with increased HRQOL.
Information is lacking regarding HRQOL in Japanese populations. This study furthers our understanding of some important determinants influencing Japanese HRQOL, using the EQ-5D in Takamatsu, Japan. Our results also resembled some findings from similar studies in other countries. We hope to use the EQ-5D with other health survey questionnaires to gather more data about HRQOL of Japanese people.
PMCID: PMC2999682  PMID: 21432214
HRQOL; Healthy Japan 21; EQ-5D; Health-related behaviors; Chronic conditions
5.  Health-Related Quality of Life Using the EuroQol 5D Questionnaire in Korean Patients with Type 2 Diabetes 
Journal of Korean Medical Science  2012;27(3):255-260.
We aimed; 1) to determine the validity of the EuroQol 5D (EQ-5D) for the health-related quality of life (HRQOL) of Korean patients with type 2 diabetes, and 2) to identify associated factors of the HRQOL of these patients. Follow-up surveys were conducted for consecutive patients with type 2 diabetes. HRQOL was assessed using the EQ-5D and the Short Form-36 (SF-36). The validity of EQ-5D was assessed with the perspectives of known group, convergent and discriminant validity. Additionally, a linear mixed model using a backward elimination was used for identify associated factors. Of the 1,072 patients included in the first survey, 858 (80.0%) completed the questionnaires in the follow-up. In the known group validity, the problem rates in each EQ-5D dimension were highest among women, elderly people, and less-educated subjects. The Spearman's ρ between the EQ-5D and the SF-36 scales were larger in the comparable dimensions than those in the less comparable dimensions. In the final model, we found that sex, age, education, body mass index, atrial fibrillation, stroke, and retinopathy were statistically significant. Our data suggest that the EQ-5D is a valid tool for Korean patients with type 2 diabetes and that various factors could affect their HRQOL.
PMCID: PMC3286771  PMID: 22379335
EQ-5D; Health-Related Quality of Life; Diabetes Mellitus, Type 2
6.  Assessment of severity and frequency of self-reported hypoglycemia on quality of life in patients with type 2 diabetes treated with oral antihyperglycemic agents: A survey study 
BMC Research Notes  2011;4:251.
Some oral antihyperglycemic agents may increase risk of hypoglycemia and thereby reduce patient quality of life. Our objective was to assess the impact of the severity and frequency of self-reported hypoglycemia on health-related quality of life (HRQoL) among patients with type 2 diabetes treated with oral antihyperglycemic agents.
A follow-up survey was conducted in participants with self-reported type 2 diabetes treated with oral antihyperglycemic agents from the US National Health and Wellness Survey 2007. Data were collected on the severity and frequency of hypoglycemic episodes in the 6 months prior to the survey, with severity defined as mild (no interruption of activities), moderate (some interruption of activities), severe (needed assistance of others), or very severe (needed medical attention). HRQoL was assessed using the EuroQol-5D Questionnaire (EQ-5D) US weighted summary score (utility) and Worry subscale of the Hypoglycemia Fear Survey (HFS). Of the participants who completed the survey (N = 1,984), mean age was 58 years, 57% were male, 72% reported an HbA1c <7.0%, and 50% reported treatment with a sulfonylurea-containing regimen. Hypoglycemic episodes were reported by 63% of patients (46% mild, 37% moderate, 13% severe and 4% very severe). For patients reporting hypoglycemia, mean utility score was significantly lower (0.78 versus 0.86, p < 0.0001) and mean HFS score was significantly higher (17.5 versus 6.2, p < 0.0001) compared to patients not reporting hypoglycemia. Differences in mean scores between those with and without hypoglycemia increased with the level of severity (mild, moderate, severe, very severe) for utility (0.03, 0.09, 0.18, 0.23) and HFS (6.1, 13.9, 20.1, 25.6), respectively. After adjusting for age, gender, weight gain, HbA1c, microvascular complications, and selected cardiovascular conditions, the utility decrement was 0.045 (by level of severity: 0.009, 0.055, 0.131, 0.208), and the HFS increase was 9.6 (by severity: 5.3, 12.4, 17.6, 23.2). HRQoL further decreased with greater frequency of hypoglycemic episodes.
Self-reported hypoglycemia is independently associated with lower HRQoL, and the magnitude of this reduction increases with both severity and frequency of episodes in patients with type 2 diabetes treated with oral antihyperglycemic agents.
PMCID: PMC3148563  PMID: 21777428
7.  Health-Related Quality of Life in Adults Reporting Arthritis: Analysis from the National Health Measurement Study 
Arthritis is the leading cause of disability in the United States. We assess the generic health-related quality-of-life (HRQOL) among a nationally representative sample of US adults with and without self-reported arthritis.
The NHMS, a cross-sectional survey of 3844 adults (35–89 years) administered EuroQol-5D (EQ-5D), Health Utilities Index Mark 2 (HUI2) and 3 (HUI3), SF-36v2™, Quality of Well-being Scale self-administered form (QWB-SA), and the Health and Activities Limitations index (HALex) to each respondent via a telephone interview. Weighted multiple linear regression was used to generate age-gender-arthritis stratified unadjusted HRQOL means and means adjusted for sociodemographic, socioeconomic covariates and co-morbidities by arthritis-age category.
The estimated population prevalence of self-reported arthritis was 31%. People with arthritis were more likely to be female, older, of lower socioeconomic status, and had more self-reported comorbidities than were those not reporting arthritis. Adults with arthritis had lower HRQOL on six different indexes compared to adults without arthritis, , with overall differences ranging from 0.03 (QWB-SA, age group 65–74), to 0.17 (HUI3, age group 35–44; all p-value < .05),.
Arthritis in adults is associated with poorer HRQOL. We provide age-related reference values for six generic HRQOL measures in people with arthritis.
PMCID: PMC3156343  PMID: 21298347
8.  Health-related quality of life in adults reporting arthritis: analysis from the National Health Measurement Study 
Quality of Life Research  2011;20(7):1131-1140.
Arthritis is the leading cause of disability in the United States. We assess the generic health-related quality-of-life (HRQOL) among a nationally representative sample of US adults with and without self-reported arthritis.
The NHMS, a cross-sectional survey of 3,844 adults (35–89 years) administered EuroQol-5D (EQ-5D), Health Utilities Index Mark 2 (HUI2) and 3 (HUI3), SF-36v2™, Quality of Well-being Scale self-administered form (QWB-SA), and the Health and Activities Limitations index (HALex) to each respondent via a telephone interview. Weighted multiple linear regression was used to generate age-gender-arthritis-stratified unadjusted HRQOL means and means adjusted for sociodemographic, socioeconomic covariates and comorbidities by arthritis–age category.
The estimated population prevalence of self-reported arthritis was 31%. People with arthritis were more likely to be woman, older, of lower socioeconomic status, and had more self-reported comorbidities than were those not reporting arthritis. Adults with arthritis had lower HRQOL on six different indexes compared with adults without arthritis, with overall differences ranging from 0.03 (QWB-SA, age-group 65–74) to 0.17 (HUI3, age-group 35–44; all P-value < .05).
Arthritis in adults is associated with poorer HRQOL. We provide age-related reference values for six generic HRQOL measures in people with arthritis.
PMCID: PMC3156343  PMID: 21298347
Health-Related Quality of Life; HRQOL; Arthritis; National Health Measurement Study; Self-reported arthritis; EQ-5D; SF-6D; HUI2; HUI3; HALex; QWB; QWB-SA
9.  Socioeconomic Status and Age Variations in Health-Related Quality of Life: Results From the National Health Measurement Study 
We examine whether multiple health-related quality of life (HRQoL) measures are stratified by socioeconomic status (SES) and age in the United States.
Data are from the 2005/2006 National Health Measurement Study, a telephone survey of a nationally representative sample of U.S. adults. We plot mean HRQoL scores by SES within age groups. Regression analyses test whether education, income, and assets each have independent associations with three “preference-based” HRQoL measures and self-rated health (SRH). We test whether these associations vary by age.
There are SES disparities in HRQoL and SRH among adults in the United States at all age groups. Income differentials in HRQoL are strong across current adult age cohorts, except the 75–89 age cohort. Education and assets have statistically significant but weaker associations with HRQoL. All three SES measures are associated with SRH (net of each other) at every age group. Those in the lowest income and education groups in the 35–44 age cohort have worse HRQoL and SRH than those in higher SES groups in the 65+ age cohort.
Significant improvements in HRQoL at the population level will only be possible if we improve the HRQoL of people at the lowest end of the socioeconomic distribution.
PMCID: PMC2670253  PMID: 19307286
Health disparities; Health-related quality of life; Health status; Socioeconomic status
10.  Association between Sarcopenia, Bone Density, and Health-Related Quality of Life in Korean Men 
Korean Journal of Family Medicine  2013;34(4):281-288.
Sarcopenia is the loss of muscle mass leading to decreased muscle strength, physical disability, and increased mortality. The genesis of both sarcopenia and osteoporosis is multifactorial, and several factors that play a role in osteoporosis are thought to contribute to sarcopenia. This study evaluated the association between sarcopenia and bone density and health-related quality of life in Korean men.
We used the data of 1,397 men over 50 years of age from the 2009 Korean National Health and Nutrition Examination Survey. Sarcopenia was defined as the appendicular skeletal muscle mass divided by height2 (kg/m2) < 2 standard deviations below the sex-specific mean for young adults. Health-related quality of life was measured by the EuroQol-5 dimension (EQ-5D) instrument. Logistic regression analysis was performed to evaluate the relationship between sarcopenia, bone density, and health-related quality of life.
The T-score of the lumbar spine, total femur, and femur neck in bone mineral density in subjects with sarcopenia were lower than those in subjects without sarcopenia. The score of the EQ-5D index was significantly lower and the rate of having problems with individual components of health-related quality of life was higher in the sarcopenic group. After adjustment for age and body mass index, the odds ratios (ORs) (95% confidence interval [CI]) for sarcopenia were 2.06 (1.07-3.96) in osteopenic subjects and 3.49 (1.52-8.02) in osteoporotic subjects, respectively. After adjustment, the total score of the EQ-5D index was significantly lower in the sarcopenic subjects. The ORs (95% CI) for having problems of mobility and usual activity of the EQ-5D descriptive system were 1.70 (1.02-2.84) and 1.90 (1.09-3.31), respectively.
Sarcopenia was associated with decreased bone mineral density in Korean men. In addition, sarcopenia was related to poor quality of life, especially with regard to mobility and usual activity. Greater attention to and evaluation for sarcopenia are needed in subjects showing low bone mineral density to prevent and manage poor quality of life.
PMCID: PMC3726796  PMID: 23904958
Sarcopenia; Osteoporosis; Metabolic Bone Diseases; Quality of Life
11.  Relationship between menopause and health-related quality of life in middle-aged Chinese women: a cross-sectional study 
BMC Women's Health  2014;14:7.
Chinese menopausal women comprise a large population and the women in it experience menopausal symptoms in many different ways. Their health related quality of life (HRQOL) is not particularly well studied. Our study intends to evaluate the influence of menopause on HRQOL and explore other risk factors for HRQOL in rural China.
An interview study was conducted from June to August 2010 in Beijing based on cross-sectional design. 1,351 women aged 40–59 were included in the study. HRQOL was measured using the EuroQol Group’s 5-domain (EQ5D) questionnaire. Comparison of HRQOL measures (EQ5D index and EQ5D-VAS scores) was done between different menopausal groups. Logistic regression and multiple regression analysis were performed to adjust potential confounders and explore other risk factors for health problems and HRQOL measures.
Postmenopausal women who had menopause for 2–5 years (+1b stage) were more likely to suffer mobility problems (OR = 1.835, p = 0.008) after multiple adjustment. Menopause was also related to impaired EQ5D index and EQ5D-VAS scores after adjustment for age. Among menopausal groups categorized by menopausal duration, a consistent decrement in EQ5D index and EQ5D-VAS scores, that is, worsening HRQOL, was observed (p < 0.05). Multiple regression analysis revealed low education level and physical activity were associated with EQ5D index (β = -0.080, p = 0.003, and β = 0.056, p = 0.040, respectively). Cigarette smoking and chronic disease were associated with EQ5D index (β = -0.135, p < 0.001 and β = -0.104, p < 0.001, respectively) and EQ5D-VAS (β = -0.057, P = 0.034 and β = -0.214, p < 0.001, respectively).
Reduction in physical function was found within the first five years after menopause. Worsening EQ5D index and EQ5D-VAS scores were related to menopause. Education level, physical activity, cigarette smoking, and chronic disease history were associated with HRQOL in middle aged Chinese rural women.
PMCID: PMC3893455  PMID: 24410885
12.  Gender differences in health-related quality-of-life are partly explained by sociodemographic and socioeconomic variation between adult men and women in the US: evidence from four US nationally representative data sets 
Quality of Life Research  2010;19(8):1115-1124.
The purpose of this study was to describe gender differences in self-reported health-related quality-of-life (HRQoL) and to examine whether differences are explained by sociodemographic and socioeconomic status (SES) differentials between men and women.
Data were from four US nationally representative surveys: US Valuation of the EuroQol EQ-5D Health States Survey (USVEQ), Medical Expenditure Panel Survey (MEPS), National Health Measurement Study (NHMS) and Joint Canada/US Survey of Health (JCUSH). Gender differences were estimated with and without adjustment for sociodemographic and SES indicators using regression within and across data sets with SF-6D, EQ-5D, HUI2, HUI3 and QWB-SA scores as outcomes.
Women have lower HRQoL scores than men on all indexes prior to adjustment. Adjusting for age, race, marital status, education and income reduced but did not remove the gender differences, except with HUI3. Adjusting for marital status or income had the largest impact on estimated gender differences.
There are clear gender differences in HRQoL in the United States. These differences are partly explained by sociodemographic and SES differentials.
PMCID: PMC2940034  PMID: 20496168
Sex differences; Men’s health; Women’s health; Quality of life; Outcome assessment; Health status; Gender differences; SF-6D; EQ-5D; HUI2; HUI3; QWB-SA; Population study
13.  Does Health-Related Quality of Life Improve for Advanced Pancreas Cancer Patients Who Respond to Gemcitabine? Analysis of a Randomized Phase III Trial of the Cancer and Leukemia Group B (CALGB 80303) 
Gemcitabine for advanced pancreas cancer (APC) is palliative and prognosis is poor, making health-related quality of life (HRQOL) particularly important.
We evaluated HRQOL with the EuroQol EQ-5D™, in patients with APC participating in Cancer and Leukemia Group B (CALGB) 80303, a multicenter, double-blind, randomized trial comparing overall survival (OS) between two treatment arms, gemcitabine with bevacizumab, or gemcitabine with placebo.
A consecutive subsample of patients was invited to complete the EQ-5D surveys. Because neither clinical nor HRQOL outcomes differed based on study arm, analyses were pooled. Changes in mean scores from baseline to eight weeks and the prognostic value of the EQ-5D were evaluated.
Mean index scores remained stable (0.78 at baseline [n=267], 0.79 at eight weeks [n=186], P-value=0.34, Wilcoxon signed rank test), attributable to a modest deterioration of physical function domain scores coincident with small improvements in pain and anxiety/depression scores. A small decline in visual analogue scale (VAS) scores was observed (70.7 vs. 68.2, P-value=0.026). HRQOL changes within chemotherapy response strata revealed stable index scores, but a trend of worsened physical function among patients with disease progression compared with those with stable or improved disease. VAS scores trended downward over time irrespective of chemotherapy response status, with a statistically meaningful deterioration in patients who progressed (68.9 vs. 64.4, P-value=0.029). Baseline scores from both EQ-5D scales were significant predictors of OS in Cox proportional hazard models.
Response to gemcitabine treatment in APC is not associated with appreciable improvement of global HRQOL. Small improvements in pain and mood are observed despite progressive functional decline. Those who respond to gemcitabine may experience a slight slowing of functional deterioration.
PMCID: PMC3658140  PMID: 22104618
Advanced pancreas cancer; gemcitabine; quality of life
14.  Health-Related Quality of Life of Children with Mild to Moderate Chronic Kidney Disease 
Pediatrics  2010;125(2):e349-e357.
To compare the health related quality of life (HRQOL) of children with chronic kidney disease (CKD) to healthy children; to evaluate the association between CKD severity and HRQOL; to identity demographic, socioeconomic and health-status variables associated with impairment in HRQOL in children with mild to moderate CKD.
Patients and Methods
This is a cross-sectional assessment of HRQOL in children aged 2-16 with mild to moderate CKD using the Varni PedsQL™. Overall HRQOL and PedsQL domain means for parents and youth were compared to previously published norms using independent sample t-tests. Study participants were categorized according to kidney disease stage (measured by iohexol based glomerular filtration rate, iGFR) and group differences in HRQOL were evaluated using ANOVA and Cuzick trend tests. The association between hypothesized predictors of HRQOL and PedsQL scores was evaluated with linear and logistic regression analyses.
The study sample was comprised of 402 participants (Mean age =11 yrs, 60% male, 70% Caucasian, 40% anemic, median iGFR=42.5 ml/min/1.73m2, median CKD duration= 7 yrs). Youth with CKD had significantly lower physical, school, emotional and social domain scores than healthy youth (p<.001). IGFR was not associated with HRQOL. Longer disease duration and older age was associated with higher PedsQL scores in the domains of physical, emotional and social functioning (p<.05). Older age was associated with lower school functioning domain scores (p<.05). Maternal education ≥16 years was associated with higher PedsQL scores in the domains of physical, school, and social functioning (p<.05). Short stature was associated with lower scores in the physical functioning domain (p<.05).
Children with mild to moderate CKD, in comparison to healthy children, report poorer overall HRQOL as well as poorer physical, school, emotional and social functioning. Early intervention to improve linear growth and to address school functioning difficulties is recommended.
PMCID: PMC3663134  PMID: 20083528
HRQOL; kidney disease; QOL; short-stature
15.  Evolution of Health-Related Quality of Life in Breast Cancer Patients during the First Year of Follow-Up 
Journal of Breast Cancer  2013;16(1):104-111.
The objective of this study was to describe the evolution of health-related quality of life (HRQOL) in a cohort of breast cancer patients over 1 year after surgery and to analyse the predictive ability of HRQOL measurement instruments.
Observational, multicenter and prospective study of a cohort of breast cancer patients, assessing HRQOL at 1, 6, and 12 months after surgery using three questionnaires: EuroQol-5D-3L, EORTC QLQ-C30, and EORTC QLQ-BR23.
A total of 364 women participated in the study. Visual Analogue Scale (VAS) scores from the EuroQol improved (1 month vs. 1 year: 70 vs. 80; p<0.0001); however, the EuroQol score showed no significant change (0.81 vs. 0.83; p=0.1323). In contrast, Global Health Status on the EORTC QLQ-C30 improved (66.67 vs. 100.00; p<0.0001), as did all of this instrument's scales and most of its independent items. The EORTC QLQ-BR23 dimensions showed improvement, except for sexual functioning (100.00 vs. 86.67; p=0.0030) and future perspective (33.33 vs. 66.67; p<0.0001). Patients with good HRQOL outcomes at 1 month showed improved levels of HRQOL at 1 year; HRQOL measured at 1 month was predictive of HRQOL at 1 year.
HRQOL improved during the follow-up period. Likewise, HRQOL measurement instruments can predict early HRQOL.
PMCID: PMC3625756  PMID: 23593090
Breast neoplasms; Quality of life; Questionnaires
16.  Validation study of the prototype of a disease-specific index measure for health-related quality of life in dementia 
Index measures for health-related quality of life (HRQoL) quantify the desirability (utility) of a certain health state. The commonly used generic index measure, e.g. EuroQol: EQ-5D, may underestimate relevant areas of specific diseases, resulting in lower validity. Disease-specific index measures on the other hand combine disease-specificity and quantification of perceived quality on several health domains of a certain disease into one single figure. These instruments have been developed for several diseases, but a dementia-specific HRQoL index instrument was not yet available. Facing the increasing individual and societal burden of dementia, specific HRQoL values with metric characteristics are especially useful because they will provide vital information for health outcome research and economic evaluations.
Aims of the study
To develop and validate the prototype of a dementia-specific HRQoL index measure: Dementia Quality of life Instrument (DQI), as the first step towards valuation of the dementia health state.
For development of the DQI we created a conceptual framework based on a review of the literature, qualitative interviews with people with dementia and their carers, expert opinion and team discussion. To assess validity we undertook a survey under 241 dementia professionals. Measurements consisted of ranking (1–5) and rating (1–10) of 5 dementia-specific DQI domains (memory, orientation, independence, social activities and mood) and simultaneously rating of 9 DQI-derived health states on a visual analogue scale (VAS). We also performed a cross-sectional study in a large sample of people with very mild to moderate dementia and their caregivers (N = 145) to assess feasibility and concurrent validity. In addition, caregivers valued 10 DQI and 10 EQ-5D + C derived health states of the patient simultaneously on the same VAS. Setting: outpatient clinics, nursing homes and patient residences.
All professionals judged the selected DQI domains to be relevant. Differences in ranking and rating behaviors were small. Mood was ranked (≥3.3) and rated (≥8.2) as most, orientation as least important (rank ≤2.6, value 7.5) health domain for dementia. For the validation part of this study the completion rates for all domains were above 98% for patients and 100% for caregivers on patients. A priori hypothesized DQI versus QOL-AD correlations that were significant in both patients and caregivers were: memory/memory, orientation/memory, independence/physical health, social activities/energy and mood/mood. Patient/caregiver inter-rater agreement was low (K < 0.2) for memory/independence, fair (K 0.2-0.4) for orientation/mood, and moderate (K 0.4-0.6) for social activities. Concurrent validity of the DQI with the EQ-5D + C was moderate. The fact that most of the correlations between the domains of these two instruments were low (≤0.40) showed that both instruments measure different elements of health status. As expected, modest correlations (≥0.40) were observed between corresponding domains of the two instruments.
Professionals judged all domains as relevant. The DQI prototype proved valid and feasible for patients and caregivers and is appropriate for very mild to moderate dementia. The differences in concurrent correlations with generic health status instruments imply that the dementia-specific DQI health domains indeed provide different information. The finding that patient HRQoL measured with the DQI was lower supports this notion. The new DQI shows comparable psychometric properties to the best available dementia-specific (QOL-AD) and generic (EQ-5D + C) measures. Further research is needed to generate values in the general population for each of the possible DQI states and to derive an algorithm that converts the 5 separate DQI domain scores into one single DQI Index score. Introducing the DQI Index will advance dementia-related HRQoL measurement by overcoming the shortcomings of generic and non-index instruments. This will allow more unequivocal interpretation of subjective dementia HRQoL states in dementia research.
PMCID: PMC3503596  PMID: 23009579
Dementia; Health-related quality of life; Dementia Quality of life Instrument (DQI); Disease-specific index instrument; Cost-effectiveness
17.  Risk of malnutrition and health-related quality of life in community-living elderly men and women: The Tromsø study 
Quality of Life Research  2010;20(4):575-582.
To explore the association between risk of malnutrition as well as current body mass index (BMI) and health-related quality of life (HRQoL) in elderly men and women from the general population.
In a cross-sectional population survey including 1,632 men and 1,654 women aged 65 to 87 years from the municipality of Tromsø, Norway, we assessed HRQoL by using the EuroQol (EQ-5D) instrument in three risk groups of malnutrition and in different categories of BMI. The Malnutrition Universal Screening Tool (‘MUST’) was used to evaluate the risk of malnutrition.
We found a significant reduction in HRQoL with an increasing risk of malnutrition, and this was more pronounced in men than in women. The relationship between BMI and HRQoL was dome shaped, with the highest score values in the BMI category being 25–27.5 kg/m2.
HRQoL was significantly reduced in elderly men and women at risk of malnutrition. The highest HRQoL was seen in moderately overweight individuals.
PMCID: PMC3075394  PMID: 21076942
HRQoL; EQ-5D; Body mass index; Elderly; Malnutrition universal screening tool; Nutrition assessment
18.  Health-Related Quality of Life Measures for Physically Active Elderly in Community Exercise Programs in Catalonia: Comparative Analysis with Sedentary People 
Objective. To evaluate Health-Related Quality of Life (HRQoL), medication used, and Stock of Health Capital (SHC) in physically active elderly participants in Community Exercise Programs (CEPs) compared to a sedentary group. Methods. EuroQol standardized instrument was completed by physically active elderly (n = 2,185) who participated in CEPs. Common items were compared to HRQoL data of 1,874 sedentary elderly people, taken from the Catalan Health Survey 2006 (CHS'06). Visual Analogue Scale (VAS) outcomes and medication used were assessed through parametric statistics. Dimensions of health conditions were compared, between sedentary people and physically active elderly participants in CEPs. SHC results were obtained combining the EuroQol scores and Life Expectancy (LE) values. An economic value of €34,858.70 was assigned to these years of LE. Results. Physically active subjects had better HRQoL values (75.36 in males and 70.71 in females) than CHS'06 sedentary subjects (58.35 in males and 50.59 in females). Medication used was different between physically active subjects (1.89 in males and 2.87 in females) and CHS'06 sedentary subjects (4.34 in males and 4.21 in females). SHC data for physically active elderly (€465,988.31/QALY in males and €522,550.31/QALY in females) were higher than for CHS'06 sedentary subjects (€363,689.33/QALY in males and €346,615.91/QALY in females).
PMCID: PMC3884613  PMID: 24454357
19.  Health Related Quality of Life in Patients with Type 2 Diabetes Mellitus in Iran: A National Survey 
PLoS ONE  2012;7(8):e44526.
The aim of this study was to measure health-related quality of life (HRQoL) in Iranian people with Type 2 Diabetes Mellitus using two different measures and examines which socio-demographic and diabetes-related characteristics are associated with better quality of life based on a nationally distributed sample.
A multi-stage cluster sampling method was used to select 3472 subjects as a part of Iranian surveillance of risk factors of non-communicable disease (ISRFNCD). EuroQol-5 Dimensions questionnaire (EQ-5D) and Visual Analog Scale (VAS) were employed to measure HRQoL. Binary logistic and Tobit regression models were used to investigate factors associated with EQ-5D results.
The mean age of subjects was 59.4 years (SD = 11.7), 61.3% were female and had 8.08 years (SD = 6.7) known duration of diabetes. The patients reported “some or extreme problems” most frequently in Pain/Discomfort (69.3%) and Anxiety/Depression (56.6%) dimensions of EQ-5D. The mean EQ-5D and VAS score were 0.70 (95% CI 0.69–0.71) and 56.8 (95% CI 56.15–57.5) respectively. Female gender, lower education, unemployment, long duration of diabetes, diabetes-related hospitalization in past years and having nephropathy and lower extremity lesions were associated with higher probabilities of reporting “some or extreme problems” in most dimensions of EQ-5D in binary logistic regression models. The same factors in addition to retinopathy were significantly associated with lower levels of HRQoL in Tobit regression analysis too.
The study findings indicate that patients with diabetes in Iran suffer from relatively poor HRQoL. Therefore much more attention should be paid to main determinants of HRQoL to identify and implement appropriate policies for achieving better management of diabetes and ultimately improving the quality of life of diabetic patients in this region.
PMCID: PMC3431351  PMID: 22952989
20.  Posttraumatic stress symptoms and health-related quality of life: a two year follow up study of injury treated at the emergency department 
BMC Psychiatry  2012;12:1.
Among injury victims relatively high prevalence rates of posttraumatic stress disorder (PTSD) have been found. PTSD is associated with functional impairments and decreased health-related quality of life (HRQoL). Previous studies that addressed the latter were restricted to injuries at the higher end of the severity spectrum. This study examined the association between PTSD symptoms and health-related quality of life (HRQoL) in a comprehensive population of injury patients of all severity levels and external causes.
We conducted a self-assessment survey which included items regarding demographics of the patient, accident type, sustained injuries, EuroQol health classification system (EQ-5D) and Health Utilities Index (HUI) to measure functional outcome and HRQoL, and the Impact of Event Scale (IES) to measure PTSD symptoms. An IES-score of 35 or higher was used as indication for the presence of PTSD. The survey was completed by 1,781 injury patients two years after they were treated at the Emergency Department (ED), followed by either hospital admission or direct discharge to the home environment.
Symptoms indicative of PTSD were associated with more problems on all EQ-5D and HUI3 domains of functional outcome and a considerable utility loss in both hospitalized (0.23-0.24) and non-hospitalized (0.32-0.33) patients. Differences in reported problems between patients with IES scores higher or lower than 35 were largest for EQ-5D health domains pain/discomfort (82% versus 28%) and anxiety/depression (53% versus 11%) and HUI domains emotion (92% versus 33%) and pain (84% versus 38%). After adjusting for potential confounders, PTSD remained strongly associated with adverse HRQoL.
Among patients treated at an ED posttraumatic stress symptoms indicative of PTSD were associated with a considerable decrease in HRQoL in both hospitalized and non-hospitalized patients. PTSD symptoms may therefore raise a major barrier for full recovery of injury patients of even minor levels of severity.
PMCID: PMC3276433  PMID: 22230388
posttraumatic stress disorder; injury; functional outcome; quality of life
21.  Highly active antiretroviral treatment and health related quality of life in South African adults with human immunodeficiency virus infection: A cross-sectional analytical study 
BMC Public Health  2007;7:244.
Health Related Quality of Life (HRQoL) is an important outcome in times of Highly Active Antiretroviral Treatment (HAART). We compared the HRQoL of HIV positive patients receiving HAART with those awaiting treatment in public sector facilities in the Free State province in South Africa.
A stratified random sample of 371 patients receiving or awaiting HAART were interviewed and the EuroQol-profile, EuroQol-index and Visual Analogue Scale (VAS) were compared. Independent associations between these outcomes and HAART, socio-demographic, clinical and health service variables were estimated using linear and ordinal logistic regression, adjusted for intra-clinic clustering of outcomes.
Patients receiving HAART reported better HRQoL for 3 of the 5 EuroQol-dimensions, for the VAS score and for the EuroQol index in bivariable analysis. They had a higher mean EuroQol index (0.11 difference, 95% confidence interval [CI] 0.04; 0.23), and were more likely to have a higher index (odds ratio 1.9, 95% CI 1.1; 1.3), compared to those awaiting HAART, in multivariate analysis. Higher mean VAS scores were reported for patients who were receiving HAART (6.5 difference, 95% CI 1.3; 11.7), were employed (9.1, 95% CI 4.3; 13.7) or were female (4.7, 95% CI 0.79; 8.5).
HAART was associated with improved HRQoL in patients enrolled in a public sector treatment program in South Africa. Our finding that the EuroQol instrument was sensitive to HAART supports its use in future evaluation of HIV/AIDS care in South Africa. Longitudinal studies are needed to evaluate changes in individuals' HRQoL.
PMCID: PMC2194770  PMID: 17854510
22.  T20QoL: an observational multicenter cohort study to evaluate the quality of life in HIV-patients treated with enfuvirtide (ENF, T-20) in combination with an optimized background therapy 
Biologics : Targets & Therapy  2008;2(3):577-581.
To evaluate the impact of health-related quality of life (HRQoL) enfuvirtide-based (ENF-based) salvage regimens of treatment-experienced HIV patients, in an observational multicenter cohort study.
HRQoL was measured in a cohort of 16 patients over a 6-month follow-up using 2 instruments: the ISSQoL (Istituto Superiore di Sanità Quality of Life), a recently validated HIV-specific questionnaire; the EQ-5D (EuroQol), a generic widely used instrument. ENF was given at standard dosage along with an optimized background regimen.
Most of HRQoL dimensions showed improvement in ENF-treated patients at the post-baseline time points. Social functioning was the only dimension showing a negative effect. Monthly care costs of antiretroviral drugs for HIV patients taking ENF plus an optimized background regimen were approximately €2,348 per patient-month (range €382–€2,940).
Our results show that the addition of ENF to an optimized background salvage-HAART may positively affect HRQoL not only in clinical trials but also in a sample population of patients used in a routine clinical practice.
PMCID: PMC2721382  PMID: 19707388
enfuvirtide; HRQoL; HIV
23.  Impact of urinary incontinence on health-related quality of life, daily activities, and healthcare resource utilization in patients with neurogenic detrusor overactivity 
BMC Neurology  2014;14:74.
Neurogenic detrusor overactivity (NDO) leads to impaired health-related quality of life (HRQoL), productivity, and greater healthcare resource burden. The humanistic and economic burden may be more apparent in NDO patients with urinary incontinence (UI). The objective of this study was to compare the HRQoL, productivity, and health resource use (HRU) between continent and incontinent NDO patients.
A retrospective database analysis was conducted using the Adelphi Overactive Bladder (OAB)/UI Disease Specific Programme, a multi-national, cross-sectional survey reported from both patients’ and physicians’ perspectives. The population for this analysis included NDO patients with or without UI. General and disease-specific HRQoL were assessed using the EuroQoL-5D (EQ-5D), Incontinence Quality of Life questionnaire (I-QOL), and the Overactive Bladder Questionnaire (OAB-q). Productivity and daily activity impairment were measured using the Work Productivity and Activity Impairment (WPAI) questionnaire. HRU indicators included OAB-related surgery, OAB-related hospitalizations, incontinence pad usage, switching anticholinergics used for OAB due to inadequate response or adverse effects, and OAB-related physician visits. Bivariate analyses, multivariate ordinary least squares (OLS) regression analyses and published minimal clinically important differences (MCID) were used to assess relationships between incontinent status and the aforementioned outcome measures.
A total of 324 NDO patients with or without urinary incontinence were included, averaging 54 years of age (SD 16), of whom 43.8 percent were male. Bivariate analyses detected no significant relationship between incontinent status and HRU variables. Regression analyses revealed that incontinent patients had clinically and statistically lower disease-specific HRQoL and greater impairment in daily activities as compared to continent patients. On average, incontinent patients scored 10 points lower on the I-QOL total score, 9 points lower on the OAB-q HRQoL score, 15 points higher on OAB-q symptom severity, and experienced 8.2 percent higher activity impairment due to their bladder condition (all p < 0.001).
Incontinent NDO patients experience significantly lower HRQoL and activity impairment as compared to continent NDO patients.
PMCID: PMC3984584  PMID: 24708598
Neurogenic detrusor overactivity; Incontinence; Burden of illness; Quality of life; Productivity
24.  Development, validation, and evaluation of the PBC-40, a disease specific health related quality of life measure for primary biliary cirrhosis 
Gut  2005;54(11):1622-1629.
Background and aims: Study of health related quality of life (HRQOL) and the factors responsible for its impairment in primary biliary cirrhosis (PBC) has, to date, been limited. There is increasing need for a HRQOL questionnaire which is specific to PBC. The aim of this study was to develop, validate, and evaluate a patient based PBC specific HRQOL measure.
Subjects and methods: A pool of potential questions was derived from thematic analysis of indepth interviews carried out with 30 PBC patients selected to represent demographically the PBC patient population as a whole. This pool was systematically reduced, pretested, and cross validated with other HRQOL measures in national surveys involving a total of 900 PBC patients, to produce a quality of life profile measure, the PBC-40, consisting of 40 questions distributed across six domains. The PBC-40 was then evaluated in a blinded comparison with other HRQOL measures in a further cohort of 40 PBC patients.
Results: The six domains of PBC-40 relate to fatigue, emotional, social, and cognitive function, general symptoms, and itch. The highest mean domain score was seen for fatigue and the lowest for itch. The measure has been fully validated for use in PBC and shown to be scientifically sound. PBC patient satisfaction, measured in terms of the extent to which a questionnaire addresses the problems that they experience, was significantly higher for the PBC-40 than for other HRQOL measures.
Conclusion: The PBC-40 is a short easy to complete measure which is acceptable to PBC patients and has significantly greater relevance to their problems than other frequently used HRQOL measures. Its scientific soundness, shown in extensive testing, makes it a valuable instrument for future use in clinical and research settings.
PMCID: PMC1774759  PMID: 15961522
primary biliary cirrhosis; health related quality of life; patient based measure
25.  Lower Residual Renal Function is a Risk Factor for Depression and Impaired Health-Related Quality of Life in Korean Peritoneal Dialysis Patients 
We retrospectively evaluated demographic and biochemical parameters associated with depression and health-related quality of life (HRQOL) in maintenance peritoneal dialysis (PD) patients. This study included 105 patients maintaining PD at Seoul National University Hospital. Data were collected from electronic medical record. Korean Beck's Depression Inventory and Korean version of Kidney Disease Quality of Life short form, version 1.3 were used to evaluate depression and HRQOL, respectively. Moderate to severe depression was found in 24.8% of patients. Patients with lower normalized protein equivalent of nitrogen appearance (nPNA) (< 1.2 g/kg/day), lower weekly renal Kt/Vurea (< 0.2), and lower serum albumin level (≤ 4.0 g/dL) were associated with depression (P < 0.05). Among them, lower weekly renal Kt/Vurea was the only independent risk factor associated with depression (OR = 3.1, P = 0.007). Depressed patients showed significantly lower scores in every dimension of HRQOL (P < 0.001). Lower weekly renal Kt/Vurea (β = 0.24, P = 0.005) and lower nPNA (β = 0.15, P = 0.03) were the independent risk factors associated with lower kidney dialysis component summary, whereas lower plasma hemoglobin level was the consistent risk factor for lower physical component summary (β = 0.22, P = 0.03) and mental component summary (β = 0.22, P = 0.01). Depression is a prevalent psychological problem in PD population. Residual renal function is the most important factor associated with depression and impaired HRQOL in PD patients.
PMCID: PMC3247777  PMID: 22219616
Peritoneal Dialysis; Depression; Health-Related Quality of Life; Residual Renal Function; Beck's Depression Inventory; KDQOL-SF

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