Reduction of health-related quality of life in chronic hepatitis C and improvement with interferon therapy. The Consensus Interferon Study Group

The natural history, prognosis, and clinical significance of chronic hepatitis C are highly variable and somewhat controversial. The purpose of this study was to evaluate the effect of chronic hepatitis C infection on patients' perceptions of health-related quality of life (HRQOL) and to evaluate whether treatment with interferon improves HRQOL. A total of 642 patients with compensated liver disease who were enrolled in a multicenter trial of interferon therapy for chronic hepatitis C had evaluation of HRQOL using the SF-36 and other instruments derived from the Medical Outcomes Study (MOS). These instruments were self-administered by patients at baseline and at the end of a 24-week post-treatment observation period after 24 weeks of interferon treatment. Patients with chronic hepatitis C were compared with healthy controls (n = 750) selected from a representative sample of adults in the United States. Unadjusted and age/gender-adjusted results were similar, as were analyses using parametric or nonparametric methods. Compared with healthy controls, patients with chronic hepatitis C at baseline had lower HRQOL on all eight scales of the SF-36 (P <.001 for all). Patients without cirrhosis (n = 284 ) showed similar although slightly smaller differences. The differences were highly significant, clinically and socially relevant, and greatest for those scales that were more reflective of physical than mental or emotional disease. Patients who had a sustained viral response to interferon therapy (n = 41) exhibited marked improvements in HRQOL, and these improvements exceeded those of nonresponders on 13 of 14 HRQOL scales (8 were statistically significant). Similar improvements were noted in patients with sustained biochemical responses. The authors concluded that patients with chronic hepatitis C with or without cirrhosis have markedly reduced HRQOL. Patients who had a sustained response (virological or biochemical) to interferon therapy experienced significant improvements in perceived wellness and functional status. Successful interferon therapy provides meaningful improvements in HRQOL in patients with chronic hepatitis C.     

Tests of scaling assumptions and construct validity of the Chinese (HK) version of the SF-36 Health Survey

Few health-related quality of life (HRQOL) survey instruments are available to the Chinese, although many have been developed for Western populations. This article describes the testing of the acceptability, conceptual equivalence, scaling assumptions and construct validity of a Chinese (HK [Hong Kong]) version fo the MOS SF-36 Health Survey. A Chinese (HK) SF-36 survey form was developed by an iterative translation process. It was administered to 236 Chinese subjects who also rated the understanding, difficulty, relevance, and acceptability of each question. The scores were tested against the original scaling assumptions. The SF-36 profile of our subjects was compared to U.S. results for conceptual equivalence. Most subjects did not have any problem in understanding and answering the SF-36. Item means were generally clustered as hypothesized. All but a few items satisfied all scaling assumptions. The shape of the eight-scale SF-36 profile was similar to that of American patients, suggesting conceptual equivalence. We conclude that the Chinese (HK) version of the SF-36 Health Survey has achieved conceptual equivalence and satisfied the psychometric scaling assumptions well enough to warrant further use and testing, using the standard scoring algorithms.     

Health-related quality of life after epilepsy surgery: a Swedish multicenter study

PURPOSE: To investigate health-related quality of life (HRQOL) in relation to seizure outcome as part of a multicenter follow-up of epilepsy surgery in Sweden. METHODS: A battery including the SF-36 Health Survey and the Hospital Anxiety and Depression scale (HAD) was distributed to all patients older than 16 years. Mean follow-up time was 4 years (range, 2-13 years) and response rate, 91% (103 of 113 patients). HRQOL data were related to seizure frequency and severity (Chalfont Seizure Severity Scale). RESULTS: Seventy-six percent considered their global health to be better than it was before surgery. Degree of improvement in seizure control correlated with improved satisfaction with health (Spearman's r = 0.44). Higher SF-36 scores (higher HRQOL ratings) correlated with percentage reduction of seizure frequency for all scales and was strongest for perception of general health (Spearman's r = 0.46). When the patients were divided into four categories [A, completely seizure free (n = 29); B, seizure free with aura (n = 18); C, > or =75% reduction in seizure frequency (n = 24); and D, <75% reduction in seizure frequency (n = 32)], a strong positive association was found between higher SF-36 scores (with the exception of physical functioning) and better seizure control. Health-related limitations in role performance differentiated best between the outcome categories. For patients with > or =75% reduction in seizure frequency, low seizure severity correlated with higher HRQOL ratings for scales measuring social function, vitality, and mental health. Depression levels (HAD scale scores) were on average low. Anxiety (HAD) increased significantly from A to D. CONCLUSIONS: HRQOL seems to be scored as a continuum in relation to seizure frequency. Seizure severity measures give complementary information.     

The relationship between glycemic control and health-related quality of life in patients with non-insulin-dependent diabetes mellitus

The relationship between glycemic control and health-related quality of life was examined in patients with non-insulin-dependent diabetes mellitus (NIDDM). Within the context of a randomized controlled trial, 275 patients with NIDDM receiving primary care from a Veteran's Administration general medical clinic were enrolled and monitored for 1 year. Glycemic control (glycosylated hemoglobin levels) and health-related quality of life (Medical Outcomes Study Short-Form 36-item Health Survey [SF-36]) were assessed at baseline and at 1 year. Multivariate regression modeling using baseline and change scores during a 1-year period did not find a linear or curvilinear relationship between glycosylated hemoglobin and SF-36 scores (P = .15); this was true even after controlling for five covariates identified a priori (insulin use, number of diabetic complications, duration of diabetes, education, number of hyper-, or hypoglycemic episodes during the preceding month). Health services researchers and clinicians alike need to be aware that these two important outcomes may not be directly related. This lack of association could contribute to the high noncompliance rates observed among patients prescribed complex diabetic regimens. Unless patients perceive a benefit from following such regimens, good glycemic control may continue to be an elusive therapeutic goal, especially in patients with long-standing disease.     

Health-related quality of life assessment in clinical practice

Assessment of biochemical responses to therapy is routine in the management of patients with end stage renal disease (ESRD). Assessment of health-related quality of life (HRQOL), however, is less common. Previous research indicates that HRQOL is a meaningful indicator that should be integrated into clinical practice. HRQOL is longitudinally evaluated in in-centre hemodialysis patients using the RAND 36-item Health Survey 1.0. Caregivers incorporate scores from this instrument into their assessment of patient functioning and well-being. HRQOL scores can be utilized to evaluate responses to changes in therapy, and to direct clinical decision-making, adding an important dimension to holistic, quality care for ESRD patients.     

Involvement in decision-making and breast cancer survivor quality of life.

Objective: This study examined the long-term effects on women's health related quality of life (HRQOL) of involvement in decision-making about their treatment for breast cancer and about follow-up care after treatment. Methods: Using a cross-sectional survey design, a sample of breast cancer survivors from Western Washington who were 2, 5, and 10 years postdiagnosis were recruited via a cancer registry and interviewed about their HRQOL and their involvement in decision-making about their cancer treatment and follow-up care. Main Outcome Measures: HRQOL was assessed using the SF-36. Results: Multiple regression analyses examining demographic and disease characteristics revealed age, and education, but not stage of cancer at diagnosis, to be significant predictors of perceived involvement in decision-making about cancer treatment and follow-up. Controlling for demographic and disease characteristics, perceived involvement in decision-making about treatment overall, surgery, chemotherapeutic treatment, and follow-up care were each associated with improved HRQOL, including the general health and vitality subscales of the SF-36 (p     

Performance of a self-administered mailed version of the Quality of Well-Being (QWB-SA) questionnaire among older adults

OBJECTIVES: The Quality of Well-Being questionnaire is a measure of health-related quality of life (HRQoL) that has several desirable properties. Its widespread use has been hindered because it is difficult to administer. To overcome this limitation, a new self-administered form has recently been developed. This study examined the feasibility of using the Quality of Well-Being-Self-Administered (QWB-SA) questionnaire in an older population. METHODS: The Quality of Well-Being-Self-Administered questionnaire was sent to 430 community-dwelling individuals aged 65 years and older who were randomly selected from primary care physicians' offices. Response patterns, scaling distributions, and the acceptability of the survey were examined for all respondents. The results of the QWB-SA questionnaire were compared to the Sickness Impact Profile (SIP) and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) for those individuals who also had completed the latter two surveys approximately 10 months earlier and whose health had not changed substantially in the meantime. RESULTS: Three hundred and one older adults (70%) responded. The mean QWB-SA questionnaire score was 0.7035. The scores were not skewed, and there were no floor or ceiling effects. The mean time to complete the QWB-SA questionnaire was 14.2 minutes, which was significantly shorter than for the SIP (19.3 minutes) but significantly longer than for the SF-36 (12.5 minutes). Subjects rated their satisfaction with the QWB-SA questionnaire somewhat lower than for the SIP and similar to SF-36. Correlations between the QWB-SA questionnaire and the SIP and SF-36 were moderate and were generally stronger for measures of physical health than for other domains such as mental health. CONCLUSIONS: The self-administered QWB questionnaire was acceptable to older respondents, and it correlated with other measures of health-related quality of life. It can be considered as a candidate for some research applications among older adults.     

Health-related quality of life among the least dependent institutional elderly compared with the non-institutional elderly population

The purpose of this study was to investigate health-related quality of life (HRQOL) and functional ability among the least dependent elderly in residential care, and to compare them with information on the general population. A stratified systematic sample (n = 1,587) was drawn from a one-day census of patients in all public residential homes in Finland on December 2, 1991. Sixty-nine per cent of residents in 1992 were able to participate (n = 1,097) and 86% of them returned the questionnaire (n = 948), of which n = 795 were acceptable, the response rate being 72%. A postal survey was used for data collection. The personnel of residential homes were allowed to help residents complete the questionnaire, and 90% of respondents received such help. HRQOL was measured by the Nottingham Health Profile (NHP) and functional ability by a 14-item questionnaire. Finnish studies among the general population were used for comparisons. According to the NHP, the HRQOL appeared lower in institutional care and this was associated with the dependency level. Similarly, for most ADL items the general population had less restrictions than the least dependent residential care patients. In general, women expressed more difficulties in physical mobility and lack of energy than men. The longest stay elderly expressed better HRQOL. In multivariate models adjusted for age and gender those with poor vision had worse HRQOL in almost every dimension of NHP. Difficulties in speech were connected with emotional reactions and social isolation. Chronic illness limiting normal daily life predicted more problems in energy, pain, physical mobility, and emotional reactions. The married or widowed experienced less social isolation than single elderly. Higher education was related to better HRQOL in all NHP dimensions. Poorer perceived health was associated with lack of energy, pain, and emotional reactions. We conclude from these results that there are only a few clients in residential care whose HRQOL or functional ability compare with the non-institutionalized population.     

Antitumor effect of positively charged resin in the hamster cheek pouch model

This paper presents the results of a detailed study of the pain epidemiology and health related quality of life (HRQL) in 150 chronic non-malignant pain patients consecutively referred to a Danish multidisciplinary pain center. Mean pain severity was 71.6 (SD = 18.5) on the VAS scale. Forty-two percent reported poor quality of sleep. HRQL was evaluated with the Medical Outcome Study-Short Form (SF-36), the Hospital Anxiety and Depression scale (HAD) and the Psychological General Well-Being Scale (PGWB). Compared with the normal population (NP) both SF-36 scores and PGWB scores were significantly reduced (P < 0.001) indicating that physical, psychological and social well-being were severely reduced. On the HAD scale 58% were found to have a depressive or anxiety disorder. Statistically significant but modest correlations were found between pain severity and HRQL. Psychological and social well-being was closely correlated. Sixty-three percent of the referred patients had neurogenic pain conditions. Of these, only 25% were treated with antidepressants or anticonvulsants at referral. Seventy-three percent were treated with opioids at referral. Mean opioid consumption was 64 mg of morphine per day (range 1-280 mg). Compared with the NP the chronic pain patients had used the health care system five times more often in the years prior to referral (P < 0.001). The study confirms the severe multidimensional impact of chronic pain and demonstrates that HRQL of chronic non-malignant pain patients is among the lowest observed for any medical condition.     

Quality of life in migraine and chronic daily headache patients

Primary chronic headache can affect a patient's health-related quality of life (HQL). The Medical Outcomes Study Short Form (SF-36) questionnaire has been used to address this issue. We compare the impact of headache on the HQL of patients with migraine and chronic daily headache (CDH) using the SF-36 instrument. We analyzed a group of 115 consecutive patients; 62 migraine patients and 53 CDH patients completed the questionnaire. Patterns of disability were similar between the two groups, but CDH was marked by a lower level of health scales. Patients with CDH had a significantly worse pain score in physical functioning, role functioning (physical), bodily pain, general health perceptions, and mental health than patients with migraine headache. Our results in the migraine group were similar to findings in other publications, with the lowest scores in role functioning (physical) and bodily pain. There is no previous experience in CDH patients, but the present data suggest that the SF-36 questionnaire is valuable in determining the differences in functional status among headache types. These data suggest that the SF-36 is a reliable and valid measure of the HQL of patients with CDH, and may indeed prove to be valuable in studying the efficacy of therapeutic agents for this type of headache.     

Do indications remain for total mastectomy for cancer?

PURPOSE: To compare results of using the SF-36 Short Form 36 (SF-36) and the Quality of Well-being Scale (QWB) in characterizing health outcomes over time in patients having serious illnesses, including cancer and AIDS. BACKGROUND: The SF-36 and the QWB are alternative measures of health-related quality of life. The SF-36 is a morbidity measure that features a profile of nine dimensions. The QWB is a preference-based measure that combines morbidity and mortality into a single number. However, the QWB can also be scored and used as a profile. We compare SF-36 and QWB scores with different scoring methods to assess validity and sensitivity to change over time in health outcomes for adult patients with HIV infection, cancer, and other serious illnesses. SUBJECTS: 201 adults with serious illnesses, including 99 with AIDS and 102 with cancer or other illnesses. PROCEDURE: All subjects received both measures at baseline and at 6-month intervals thereafter, over a period of 21/2 years. RESULTS: In the profile mode, the QWB captured outcomes that characterize the AIDS syndrome. The SF-36 differentiated between the AIDS and other illnesses patients on some scales, but without consistent direction. However, the overall QWB showed a decrease in quality of life over time for both the AIDS and other illnesses patients while the SF-36 did not. This is because many patients died and these were counted as outcomes by the QWB and as missing data by the SF-36. CONCLUSIONS: The QWB appears to be better able to capture outcomes of serious illness over time than does the SF-36.     

Reduced quality of life in survivors of acute respiratory distress syndrome compared with critically ill control patients

CONTEXT: Health-related quality of life (HRQL) is reduced in patients who survive acute respiratory distress (ARDS), but whether this decline in HRQL is caused by ARDS or other aspects of the patient's illness or injury is unknown. OBJECTIVE: To determine if there are differences in the HRQL of ARDS survivors and comparably ill or injured controls without ARDS. DESIGN: Prospective, matched, parallel cohort study. SETTING: A 411-bed municipal medical and regional level I trauma center. PATIENTS: Seventy-three pairs of ARDS survivors and severity-matched controls with the clinical risk factors for ARDS of sepsis and trauma admitted between January 1, 1994, and July 30, 1996. MAIN OUTCOME MEASURES: The HRQL of ARDS survivors and controls, assessed by generic and pulmonary disease-specific HRQL instruments (Medical Outcomes Study 36-Item Short Form Health Survey, Standard Form [SF-36] and St George's Respiratory Questionnaire [SGRQ], respectively). RESULTS: Clinically meaningful and statistically significant reductions in HRQL scores of ARDS survivors (n = 73) were seen in 7 of 8 SF-36 domains and 3 of 3 SGRQ domains compared with matched controls (P<.001 for all reductions). The largest decrements in the HRQL were seen in physical function and pulmonary symptoms and limitations. Analysis of trauma-matched pairs (n = 46) revealed significant reductions in 7 of 8 SF-36 domains (P< or =.02) and 3 of 3 SGRQ domains (P< or =.003). Analysis of sepsis-matched pairs (n = 27) revealed significant reductions in 6 of 8 SF-36 domains (P< or =.05) and 3 of 3 SGRQ domains (P< or =.002). CONCLUSIONS: Survivors of ARDS have a clinically significant reduction in HRQL that appears to be caused exclusively by ARDS and its sequelae. Reductions were primarily noted in physical functioning and pulmonary disease-specific domains.     

Measuring health status in patients with skeletal metastases treated by surgery

Since the introduction of the Functional Living Index-Cancer (FLIC) > 10 years ago, a variety of general as well as disease-specific quality of life (QOL) instruments have been developed and used as a means of assessing the success of clinical interventions. Clinicians faced with selecting an appropriate QOL measurement tool will need guidance in both the selection of the instrument and its evaluation for applicability to the patient group under study. In our examination of this issue, we analyzed the results of administering the FLIC and the more general SF-36 questionnaire to a group of 17 patients who had undergone orthopaedic surgery to correct problems associated with bone metastatic cancer. Because the SF-36 has been widely adopted as a general Health Status evaluation tool and because of its extensive validation it may be considered a gold standard providing a means of assessing the validity of disease-specific instruments such as the FLIC. Using multivariate regression, we built a model in which five of the eight health status dimensions of the SF-36 account for 77% of the variation in the FLIC scores for this group of patients (R2 = 0.77). The implication of this result is that most of the information (i.e., 77%) provided by the FLIC could be equivalently obtained using the more general, more widely validated SF-36. Despite the small sample size, half of the regression coefficients in this model achieved a high level of statistical significance (p < 0.001). In addition, when applied to new patients, the model showed good predictive capability with relative error 2-20%. If these results can be replicated for other patient disease groups and in larger study populations, it may be possible to use the SF-36 as the primary QOL evaluation tool for cancer patients. The burden of this disease could then be more easily compared with that of other disease groups and the resulting standardization of QOL analysis would be simpler and more cost effective.     

Cancer metastasis: a search for therapeutic inhibition

Parkinson's disease (PD) has no cure and is a progressive neurological disorder with treatment aimed at the maintenance of function and limitation of the symptoms. No extensive studies of the disease's impact on health-related quality of life (HRQoL) have been conducted. The purpose of this study was to assess the potential usefulness of the Medical Outcomes Study Short Form (SF-36) and the Functional Status Questionnaire (FSQ) in Parkinson's disease research. This cross-sectional study of 193 PD patients who visited two hospital-based neurology clinics used self-administered in-clinic and take-home questionnaires to ascertain the demographic and environmental characteristics of the subjects and to gain health profile measures from the SF-36 and the FSQ. The two health profiles provide important HRQoL information supplementary to the traditional signs and symptoms evaluated by the Unified Parkinson's Disease Rating Scale (UPDRS). Many of the HRQoL measures discriminate progressive stages of disease in this study group and distinguish those with complications of therapy from subjects without complications.     

Long-term quality of life after treatment of laryngeal cancer. The Veterans Affairs Laryngeal Cancer Study Group

OBJECTIVE: To assess long-term quality of life in surviving patients with advanced laryngeal cancer. DESIGN: A follow-up long-term quality-of-life survey of patients randomized to the Veterans Affairs Laryngeal Cancer Study No. 268 on induction chemotherapy and radiation (CT + RT) vs surgery and RT. SETTING AND PATIENTS: Forty-six (71%) of the 65 surviving patients with prior stage III or IV laryngeal cancer who could be contacted completed the survey: 25 from the surgery and RT group and 21 from the CT + RT group. Baseline demographic and clinical characteristics among survey respondents were similar, except that those in the CT + RT group were significantly older (mean, 61.2 years) than those in the surgery and RT group (mean, 55.7 years; P<.05). INTERVENTIONS AND MAIN OUTCOME MEASURES: Patients completed the University of Michigan Head and Neck Quality of Life (HNQOL) instrument, the Medical Outcomes Studies Short-Form 36 (SF-36) general health survey, the Beck Depression Inventory as well as smoking and alcohol consumption surveys. RESULTS: Patients randomized to the CT + RT group had significantly better (P<.05) quality-of-life scores on the SF-36 mental health domain (76.0) than the surgery and RT group (63.0), and also had better HNQOL pain scores (81.3 vs 64.3). Compared with patients who underwent laryngectomy, patients with intact larynges (CT + RT with larynx) had significantly less bodily pain (88.5 vs 56.5), better scores on the SF-36 mental health (79.8 vs 64.7), and better HNQOL emotion (89.7 vs 79.4) scores. More patients in the surgery and RT group (28%) were depressed than in the CT + RT group (15%). CONCLUSION: Better quality-of-life scores in the CT + RT groups appear to be related to more freedom from pain, better emotional well-being, and lower levels of depression than to preservation of speech function.     

Adjuvant whole body acupuncture in depression. A placebo-controlled study with standardized mianserin therapy

This article reports on the process undertaken to adapt the U.S. version of the SF-36 to an Australian setting. In addition, the results of psychometric testing, using the International Quality of Life Assessment (IQOLA) Project process and standards, is also reported. The adaptation process involved a number of steps including: a series of forward and backward translations; ratings of the difficulty of translating the SF-36 and the quality of the resulting translation. To assess the psychometric properties of the Australian form, a random sample of people residing in the Hunter region of New South Wales, Australia, were invited to complete the SF-36 with 855 respondents consenting to complete the measure. Principal components analyses supported the assumption of two factors underlying the measure with the percentage of variance explained by these factors ranging from between 0.66 and 0.77. Demonstrable internal consistency (both item and scale) and test-retest reliability were also found.     

Doctors and patients don't agree: cross sectional study of patients' and doctors' perceptions and assessments of disability in multiple sclerosis

OBJECTIVES: To compare the judgments of clinicians on which domains of health in the short form questionnaire (SF-36) would be most important to patients with multiple sclerosis with the opinions of patients themselves; to compare assessment of physical disability in multiple sclerosis by a clinician using Kurtzke's expanded disability status scale and a non-clinically qualified assistant using the Office of Population Census and Surveys' (OPCS) disability scale with self assessment of disability and other domains of health related quality of life by patients using the SF-36 and the EuroQol questionnaire; and to compare the scores of patients for each domain of the SF-36 with control data matched for age and sex. DESIGN: Cross sectional study. SETTING: Clinical department of neurology, Edinburgh. SUBJECTS: 42 consecutive patients with multiple sclerosis attending a neurology outpatient clinic for review or a neurology ward for rehabilitation. MAIN OUTCOME MEASURES: Scores on the SF-36; EuroQol; Kurtzke's expanded disability status scale; the OPCS disability scale. RESULTS: Patients and clinicians disagreed on which domains of health status were most important (chi 2 = 21, df = 7, P = 0.003). Patients' assessment of their physical disability using the physical functioning domain of the SF-36 was highly correlated with the clinicians' assessment (r = -0.87, P < 0.001) and the non-clinical assessment (r = -0.90, P < 0.001). However, none of the measures of physical disability correlated with overall health related quality of life measured with EuroQol, Quality of life correlated with vitality, general health, and mental health in the SF-36, each of which patients rated as more important than clinicians and for each of which patients scored lower than the controls. CONCLUSIONS: Patients with multiple sclerosis and possibly those with other chronic diseases are less concerned than their clinicians about physical disability in their illness. Clinical trials in multiple sclerosis should assess the effect of treatment on the other elements of health status that patients consider important, which are also affected by the disease process, are more closely related to overall health related quality of life, and may well be adversely affected by side effects of treatment.     

Residential segregation and disparities in health-related quality of life among Black and White cancer survivors.

Objective: Studies of health-related quality of life (HRQOL) among Black and White cancer survivors have been based on small convenience samples and yielded inconsistent results. We examined Black–White disparities in survivors' HRQOL with a population-based sample, and tested the hypothesis that area-level segregation accounts for those disparities. Design: A sample of survivors of 10 types of cancer was drawn from 11 U.S. state cancer registries and surveyed 12–15 months after diagnosis. The current sample consisted of 5195 survivors (415 Black, 4780 White) who resided in 584 counties. Main Outcome Measures: SF-36 General Health subscale scores were used as the measure of HRQOL. Results: Bivariate results revealed that Black survivors had significantly poorer HRQOL than did White survivors. Multilevel regression including individual-level (gender, age, marital status, education, cancer type, stage at diagnosis, cancer progression, comorbidities, race/ethnicity) and area-level (county segregation and poverty) variables found that HRQOL was poorer among survivors who resided in high-Black-segregated counties, whereas race/ethnicity was no longer significant. Conclusion: These findings indicate that Black–White disparities in HRQOL among cancer survivors might be a function, not of race/ethnicity, but of area-level variables associated with race/ethnicity. The strong role of segregation highlights the need for interventions to target Black-segregated areas. (PsycINFO Database Record (c) 2011 APA, all rights reserved)