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Acceptance of health status as an outcome in clinical trials of new treatments for HIV disease has been hampered by the lack of valid and clinically relevant means of summarizing differences across multiple dimensions. We formed a summary Perceived Health Index from health status measures adapted from RAND Medical Outcomes Study scale and contained in the HIV-PARSE survey instrument, which had been administered to a large number of participants in clinical trials for advanced HIV disease. The psychometric properties of the included health status scales were assessed using multitrait scaling and test-retest stability. Weights for the index were derived from regressions of Current Health Perceptions on the domain-specific health status scales. The effect of participant characteristics on weights was tested. Finally, the reliability and known-clinical groups validity of the index was assessed. Data were obtained from 1,862 clinical trial participants who provided a total of 7,352 observations. The mean CD4 count was 131. The internal consistency reliability of the multi-item scales ranged from 0.86 to 0.90, and items demonstrated excellent discrimination across scales. The domain-specific scales explained 59% of the variation in the Current Health Perceptions scale (P < 0.00001). The resulting Perceived Health Index was equal to 0.20 Physical Functioning + 0.15 Pain + 0.41 Energy/Fatigue + 0.10 Emotional Well-being + 0.05 Social Functioning + 0.09 Role Functioning. The strong positive bivariate relationship between the Cognitive Function/Distress scale and the Current Health Perceptions scale was subsumed by the combination of the other domain-specific scales in multiple regressions, so it does not appear independently in the index. The proportional weights used in the index were insensitive to variations in demographics. The reliability of the index was conservatively estimated to be 0.94. Patients with index scores in the lowest quartile had a 2- to 11-fold higher probability than those in the highest quartile of reporting various specific clinical events, and the index correlated significantly more highly with the number of such events than did the current health perceptions scale. The modified MOS health status scales included in the HIV-PARSE are reliable and valid in patients with advanced HIV disease. The Perceived Health Index provides a reliable and valid means of summarizing self-reported current health, correlates strongly with clinical indicators, and should be useful as a outcome measure in patients enrolling into clinical trials of therapies for advanced HIV disease. Regression based weights are a useful means of summarizing multidimensional measures.
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PMID:A Perceived Health Index for use in persons with advanced HIV disease: derivation, reliability, and validity. 802 6

Recently, Ware and Sherbourne published a new short-form health survey, the MOS 36-Item Short-Form Health Survey (SF-36), consisting of 36 items included in long-form measures developed for the Medical Outcomes Study. The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The SF-36 items and scoring rules are distributed by MOS Trust, Inc. Strict adherence to item wording and scoring recommendations is required in order to use the SF-36 trademark. The RAND 36-Item Health Survey 1.0 (distributed by RAND) includes the same items as those in the SF-36, but the recommended scoring algorithm is somewhat different from that of the SF-36. Scoring differences are discussed here and new T-scores are presented for the 8 multi-item scales and two factor analytically-derived physical and mental health composite scores.
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PMID:The RAND 36-Item Health Survey 1.0. 827 66

Two measures of health-related quality of life in 65 HIV-infected individuals were compared in a cross-sectional design. The Quality of Well-Being Scale (QWB) results in a single score ranging from death to perfect health. The MOS-HIV Health Survey (MOS-HIV, 34-item version) gives scores in 11 dimensions. The QWB score distinguished subjects with AIDS from those who were asymptomatic (p = 0.027). For the seven multi-item scales of the MOS-HIV, Cronbach's alpha ranged from 0.85-0.95, indicating good internal consistency reliability. Clinical HIV-infection status was significantly associated with the dimensions of Overall Health (p = 0.002), Role Function (p = 0.022), Social Function (p = 0.037), Energy/Fatigue (p = 0.027) and Health Distress (p = 0.025). All eleven dimensions of the MOS-HIV were significantly correlated with the QWB score (Spearman's coefficient = 0.405-0.670; for all, p < 0.01) and the QWB score could be predicted from the MOS-HIV dimension scores using multiple regression. The QWB and the MOS-HIV may be useful in assessing health-related quality of life in patients infected with HIV.
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PMID:The use of two measures of health-related quality of life in HIV-infected individuals: a cross-sectional comparison. 899 97

Although enthusiasm for measuring health-related quality of life (HRQL) in clinical trials exists, information is limited on the meaning of scores. We examined the relation between scores from the 34-item Medical Outcomes Study HIV Health Survey (MOS-HIV) and the more detailed HIV Overview of Problems-Evaluation System (HOPES) using the responses of 318 HIV-infected outpatients being treated in Los Angeles and Baltimore. With the HOPES problem statements as independent variables, statistically significant predictors of the variation in MOS-HIV scores for the Physical Function, Mental Health, and Energy/Fatigue scales were identified using stepwise regression. Approximately 60% to 70% of the variation in each of the scores was explained by five to seven different HOPES problem statements, with a single item explaining 47% to 59% of the variation. We created illustrative profiles for each of the three MOS-HIV scales using the HOPES items identified in the regressions. Independent of the scale, persons scoring in the top MOS-HIV quartile tended to report few if any problems, whereas a decline in score to the next quartile was characterized by functional difficulties (e.g., "HIV interferes with work"). The onset of specific problems might trigger further evaluation and potential intervention from health care providers to help maintain patient functioning.
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PMID:Toward a better understanding of health-related quality of life: a comparison of the Medical Outcomes Study HIV Health Survey (MOS-HIV) and the HIV Overview of Problems-Evaluation System (HOPES). 956 46

Associations between self-reported 'low iron', general health and well-being, vitality and tiredness in women, were examined using physical (PCS) and mental (MCS) component summary and vitality (VT) scores from the MOS short-form survey (SF-36). 14,762 young (18-23 years) and 14,072 mid-age (45-50 years) women, randomly selected from the national health insurance commission (Medicare) database, completed a baseline mailed self-report questionnaire and 12,328 mid-age women completed a follow-up questionnaire 2 years later. Young and mid-age women who reported (ever) having had 'low iron' reported significantly lower mean PCS, MCS and VT scores, and greater prevalence of 'constant tiredness' at baseline than women with no history of iron deficiency [Differences: young PCS = -2.2, MCS = -4.8, VT = -8.7; constant tiredness: 67% vs. 45%; mid-age PCS = -1.4, MCS = -3.1, VT = -5.9; constant tiredness: 63% vs. 48%]. After adjusting for number of children, chronic conditions, symptoms and sociodemographic variables, mean PCS, MCS and VT scores for mid-age women at follow-up were significantly lower for women who reported recent iron deficiency (in the last 2 years) than for women who reported past iron deficiency or no history of iron deficiency [Means: PCS--recent = 46.6, past = 47.8, never = 47.7; MCS--recent = 45.4, past = 46.9, never = 47.4; VT--recent = 54.8, past = 57.6, never = 58.6]. The adjusted mean change in PCS, MCS and VT scores between baseline and follow-up were also significantly lower among mid-age women who reported iron deficiency only in the last 2 years (i.e. recent iron deficiency) [Mean change: PCS = -3.2; MCS = -2.1; VT = -4.2]. The results suggest that iron deficiency is associated with decreased general health and well-being and increased fatigue.
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PMID:Iron deficiency, general health and fatigue: results from the Australian Longitudinal Study on Women's Health. 1119 4

Chronic back tiredness or fatigue is a common complaint of people who have a history of osteoporotic vertebral fracture. Trunk muscle endurance has not been studied in people with vertebral osteoporosis, partly due to the lack of assessment tools. We developed a measure of combined trunk and arm endurance suitable for people with vertebral osteoporosis, timed loaded standing (TLS). TLS measures the time a person can stand while holding a two-pound dumbbell in each hand with the arms at 90 degrees of shoulder flexion and the elbows extended. Intraclass correlation coefficients (ICCs) for same day inter-trial and six to ten day test-retest reliability were 0.89 (lower bound 95% confidence interval [LB 95% CI] 0.79) and 0.84 (LB 95% CI 0.68), respectively, in a sample of 21 older women with no known osteoporosis. In 127 women with vertebral fractures, the ICC for same day inter-trial reliability was 0.81 (LB 95% CI 0.75). In a sub-sample of 30 of these women with vertebral fractures, the six to ten day test-retest reliability was 0.85 (LB 95% CI 0.75). Moderately strong and statistically significant (p < or = 0.05) correlations were found between TLS and sixteen of eighteen measures of physical impairment and function. Functional reach distance, gait velocity, MOS-36 Physical Function Subscale, shoulder flexion strength, and six minute walk distance were most strongly associated with TLS time. Women with vertebral fractures who endorsed having back tiredness when standing and working with the arms in front of the body, sitting to rest because of back tiredness or pain, and planning rest periods because of back tiredness or pain had significantly lower TLS times. TLS is a simple, safe physical performance measure of combined trunk and arm endurance that demonstrates acceptable reliability (inter-trial and test- retest) and concurrent validity.
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PMID:Timed loaded standing: a measure of combined trunk and arm endurance suitable for people with vertebral osteoporosis. 1119 43

The purpose of this study was to compare the quality of life (QOL) of male and female allogeneic BMT recipients. One hundred and nine BMT patients participated in this cross-sectional survey and completed the following instruments: Functional Assessment of Cancer Treatment (FACT-BMT version 3), shortened version of Profile of Mood States (POMS), MOS Survey of Social Support, and A Brief Measure of Social Support (SSQ6). Independent of the time post-BMT, perceived physical well-being, age at BMT, and education, females reported worse emotional well-being and more fatigue than males. Females also indicated more tiredness and less quality sleep. Males were found to experience less satisfaction with social support regardless of marital status. On the other hand, married males were more satisfied with their sexual life, more interested in sexual relationships, and more sexually active compared to married females. However, no significant differences between males and females were found in terms of overall physical, functional, and social well-being assessed by the FACT-BMT. The present results indicated that important gender differences exist among allogeneic BMT recipients which need to be addressed when designing post-treatment intervention programs for BMT recipients.
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PMID:Gender-associated differences in the quality of life after allogeneic BMT. 1159 25

Early disability and its rapid progression emphasize the medico-social importance of MS. The widely used disease-modifying treatments allowed to delay the time of severe disability, but this way of treatment is very expensive. The cost of MS is discussed based on literature data. The level of the cost of MS greatly depends on the disease severity and activity. Thus the studies of quality of life (QL) and pharmacoeconomical analysis, besides neurological scales, can give important additional information for clinical trials. First such studies in Europe in patients with secondary progressive MS showed a delay in progression of QL indexes in patients under Betaferon treatment in comparison to placebo. We studied changes in MOS SF-36 and WHO QL scales in groups of 60 MS patients, receiving Rebif or Copaxone. After 3 months of Rebif significant positive changes in scales, reflecting physical and social activity of MS patients, were found. At the same time negative changes in the "Pain" scale might reflect the presence of local side effects of beta-interferons treatment. No statistically significant changes in QL indexes under treatment with Copaxone were seen. The results of QL testing were associated with data of neuropsychological tests, characterizing chronic fatigue and depression. Thus the measurement of QL indexes may be a source of significant additional information, estimating the effecis of treatment and is the basic for pharmacoeconomical analysis.
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PMID:[Quality of life in multiple sclerosis and pharmaco-economic studies]. 1241 97

A growing body of evidence is documenting the multidimensional nature of cancer-related fatigue. Although several multidimensional measures of fatigue have been developed, further validation of these scales is needed. To this end, the current study sought to evaluate the factorial and construct validity of the 30-item Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). A heterogeneous sample of 304 cancer patients (mean age 55 years) completed the MFSI-SF, along with several other measures of psychosocial functioning including the MOS-SF-36 and Fatigue Symptom Inventory, following the fourth cycle of chemotherapy treatment. The results of a confirmatory factor analysis indicated the 5-factor model provided a good fit to the data as evidenced by commonly used goodness of fit indices (CFI 0.90 and IFI 0.90). Additional evidence for the validity of the MFSI-SF was provided via correlations with other relevant instruments (range -0.21 to 0.82). In sum, the current study provides support for the MFSI-SF as a valuable tool for the multidimensional assessment of cancer-related fatigue.
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PMID:Further validation of the multidimensional fatigue symptom inventory-short form. 1471 65

Routine clinical assessment of health-related quality of life in persons with HIV infection has the potential to improve care by assessing and monitoring treatment effects, enhancing communication between patient and provider, and tracking changes in functional status over time. Currently available research-based assessment tools may be inadequate for routine clinical use because of the lack of inclusion of HIV-relevant aspects of quality of life and the impracticality of the use of such tools in the clinical setting. There may be a need for a new, clinically relevant, HIV-specific assessment tool that would be easy to incorporate into clinical practice to briefly, yet comprehensively, assess characteristics frequently found in HIV-infected persons, such as fatigue, pain, nausea and vomiting, sleep disturbances, sexual dysfunction, and body image issues. Until such a tool is developed, the Linear Analogue Self-Assessment questionnaire and the Medical Outcomes Study Short Form-12 (MOS SF-12) are short enough for routine use in a clinical setting. Slightly longer measures, such as the MOS-HIV Health Survey (MOS-HIV), can provide information in a greater number of domains.
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PMID:Quality of life and HIV: current assessment tools and future directions for clinical practice. 1495 93


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