Evaluation of the short-form 36-item questionnaire to measure health-related quality of life in patients with COPD

STUDY OBJECTIVE: To evaluate the short-form 36-item questionnaire (SF-36) as an instrument for measuring health-related quality of life (HRQL) in patients with symptomatic COPD. DESIGN: Observational data at a single point in time. SETTING: Outpatient pulmonary clinic. PATIENTS: Fifty male patients with COPD and no significant comorbidity. MEASUREMENTS AND RESULTS: HRQL was assessed with the SF-36, which consists of 36 questions that cover nine health domains. Clinical ratings of dyspnea were measured by the multidimensional baseline dyspnea index (BDI). Pulmonary function tests included forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and maximal inspiratory mouth pressure (PImax). The mean (+/- SD) age of the patients was 72 +/- 8 years. The BDI focal score was 5.6 +/- 2.3, FEV1 was 1.32 +/- 0.60 L (48 +/- 22% pred), and PImax was 62 +/- 23 cm H2O. The BDI focal score was significantly correlated with seven of nine components of the SF-36 (range of r, 0.42 to 0.91; p < 0.05). The FEV1 percent of predicted and PImax were significantly correlated with five of nine health components (range of r, 0.30 to 0.65 and 0.31 to 0.61, respectively). Using linear regression model analysis with the different SF-36 components as the dependent variable and BDI, FVC, FEV1, and PImax as independent variables, the BDI score was the only significant predictor of social and physical functioning, role-physical, vitality, pain, health perceptions, and health transition (p < 0.05). CONCLUSIONS: The SF-36 is a valid instrument to measure HRQL in patients with COPD. The severity of dyspnea but not respiratory function was a significant predictor of various components of HRQL.     

Evaluation of health-related quality of life in hospitalized schizophrenics

N-ribohydrolases and transferases act on nucleosides, nucleotides and oligonucleotides to effect base removal. Advances in mechanistic and structural analysis have established that enzymes of N-riboside scission act by combinations of leaving-group and ribosyl activation. Alternative O-riboside substrates have been developed for mechanistic diagnosis. Transition-state structures have been determined, and powerful inhibitors have been designed from structural and transition-state information.     

Reliability of two measures of health-related quality of life in patients with multiple sclerosis

Fourty-five patients with progressive FIGO IIIc (36/45 pts.) and IV (9/45 pts.) ovarian cancer, who were in progression under prior cisplatin-based chemotherapy, were submitted to aortic infusion and stop flow infusion with the same drugs. 36/45 patients (80%) had four-quadrant and 9/45 patients (20%) had two-quadrant peritoneal carcinosis, 33/45 with severe ascites. Overall clinical response was 93%: 5/45 CR (11%), 21/45 PR (47%), 16/45 MR (35%). Complete resolution of ascites occurred in 9/33 patients (27%), a substantial reduction of ascites of more than 50% in 14/33 patients (43%). Median survival time was 12.5 months, median time to progression 8.6 months. Toxicity was minimal and in most patients performance and quality of life improved shortly after therapy.     

The impact of asthma on health-related quality of life

Although a substantial body of epidemiological and economic literature on asthma exists, relatively little is known about the impact of asthma on health-related quality of life (HRQL). The purpose of this review was to synthesize results from recent studies, profile the factors influencing HRQL in asthmatics, discuss the impact of treatment on HRQL outcomes, and offer recommendations for further research. The results of this review support the premise that asthma can adversely affect the physical, psychological, and social domains of HRQL. Published data suggest that females, those from lower socioeconomic groups, and ethnic minorities experience poorer quality of life as a result of their asthma symptoms. Results of published clinical trials indicate treatment regimens can have a significant impact on HRQL outcomes. Pharmacological interventions appear to effect change primarily in the physical domain and behavioral interventions lead to improvements in both physical and psychosocial domains. Future research should focus on precise a priori delineation of research hypotheses, including the selection of primary and secondary endpoints, the clarification and consistent application of criteria for defining asthma severity, thoughtful selection of HRQL instruments appropriate for the research hypotheses and target population, and careful delineation of clinically meaningful change scores of asthma-specific outcome measures.     

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.     

Sense of smell disorder and health-related quality of life.

Objectives: To compare health-related quality of life and depression between individuals with an inability to smell (anosmia) and a comparison group of individuals with a normal sense of smell. Methods: Ninety individuals from an anosmia organization (anosmia based on self-report) were compared to 89 individuals with a normal sense of smell. The SF-36 and Beck Depression Inventory-II-NL (BDI-II-NL) were administered, along with the Questionnaire for Olfactory Dysfunction (QOD) to assess the degree of problems in daily life related to the smell impairment. Results: Compared to the comparison group, scores in the anosmia group differed on: the QOD-subscale Life Quality (related to tasting and smelling: p p Social Functioning, Vitality, Mental Health and General Health (p’s p     

Effect of domperidone on the health-related quality of life of patients with symptoms of diabetic gastroparesis

OBJECTIVE: To describe the health-related quality of life (HRQOL) of patients with insulin-treated diabetes and symptoms of diabetic gastroparesis and to assess the impact of domperidone on HRQOL in these patients. RESEARCH DESIGN AND METHODS: This two-phase multicenter study was part of a safety and efficacy investigation. Phase I involved 4-week single-blind treatment with domperidone 20 mg q.i.d. (n=269). Patients demonstrating significant symptomatic improvement (n=208) continued to phase 11, a 4-week, double-blind, parallel-group study with patients receiving placebo (n=103) or domperidone (n=105). Patients completed the Medical Outcomes Study Short-Form-36 Health Survey at selection and at the end of each phase. Physical component summary (PCS) and mental component summary (MCS) scores served as primary parameters, and the eight subscales were secondary parameters. RESULTS: HRQOL scores of subjects enrolled in the trial were significantly lower than norms from the general population and people with diabetes (P < 0.001). Subjects experiencing symptomatic improvement after 4 weeks of single-blind treatment demonstrated significant improvement in all HRQOL parameters (P < 0.001); PCS, MCS, and six subscale scores of nonresponders did not change. Between-group change score differences were significant for PCS, MCS, and seven subscales (P < 0.05 to P < 0.001). During phase II, the domperidone group maintained their HRQOL; the placebo group showed a significant decline in PCS and four subscales (P < 0.05). The between-group difference in the PCS score change was statistically significant (-1.77 vs. 0.65, P=0.05). CONCLUSIONS: Results suggest that patients with symptoms of diabetic gastroparesis experience notable HRQOL impairment and that symptomatic relief with domperidone is accompanied by improvements in HRQOL that can be sustained over 4 weeks of treatment.     

Influence of glaucomatous visual field loss on health-related quality of life

We examined the influence of glaucomatous visual field defects on vision-targeted and generic health-related quality of life. Vision-targeted and generic health status were assessed across 5 glaucoma treatment categories and a normal reference group from 5 tertiary care ophthalmology practices during regularly scheduled eye care visits. The sample consisted of 147 patients who were members of specific glaucoma treatment categories and 44 reference group patients. For patients with glaucoma, eligibility included a diagnosis of glaucoma at least 1 year prior to enrollment and no evidence of other eye disease. Participants completed 2 vision-targeted surveys, the National Eye Institute Visual Functioning Questionnaire and the VF-14, and a generic health-related quality of life measure, the Medical Outcomes Study 36-Item Short Form. Data from automated perimetry (Humphrey Field Analyzer 24-2, Humphrey Instruments, San Leandro, Calif) were used to generate Advanced Glaucoma Intervention Study scores for all participants. The Medical Outcomes Study 36-Item Short Form scores from glaucoma and reference group participants collected on a random half of the sample were similar. However, comparisons of the vision-targeted surveys demonstrated significant mean differences on 7 of 11 National Eye Institute Visual Functioning Questionnaire scales, and a trend toward significant differences for the VF-14 (P < .07 by linear regression). Greater visual field defects in the better eye were significantly associated with poorer National Eye Institute Visual Functioning Questionnaire scores (P < .05), as well as with worse VF-14 scores. These findings were most dramatic for patients with the most severe field loss in the better eye. Vision-targeted questionnaires were more sensitive than a generic health-related quality of life measure to differences between glaucoma and normal reference participants. Our findings indicate that self-reports of vision-targeted health-related quality of life are sensitive to visual field loss and may be useful in tandem with the clinical examination to fully understand outcomes of treatment for glaucoma.     

Oral health-related quality of life: a model for dental hygiene

During the past decade, dental hygiene has been challenged to develop conceptual models to define the discipline. Such models can provide a common language and infrastructure for the discipline to define the process of care. Health-Related Quality of Life conceptual models have been adopted by many health professions to assist in planning health-related interventions and assessing outcomes to care. Based on the Natural History of Disease Schema, the Wilson & Cleary model, and Neuman's Systems Model, a new conceptual model for dental hygiene is proposed. The Oral Health-Related Quality of Life Model, composed of six primary domains: Health/Preclinical Disease, Biological/Clinical Disease, Symptom Status, Functional Status, Health Perceptions, and General Quality of Life. This model proposes a dynamic relationship among these domains and characteristics unique to individual clients or populations, and may have utility for interdisciplinary communication. As an integrated model, it may serve as a foundation for assessing, planning, implementing, and evaluating outcomes to dental hygiene care. This paper reviews possible application of the model for clinical practice, research, and education.     

Evaluating health-related quality of life in patients with facial acne: development of a self-administered questionnaire for clinical trials

Although psychosocial aspects of skin diseases are well known, disease-specific questionnaires validated for use in clinical trials are not available to assess the impact of facial acne on health-related quality of life or to evaluate therapeutic change. Development of such an instrument was undertaken and included item generation, reduction and pilot-testing phases. By interviewing acne subjects and dermatologists and literature review, 168 possible items were identified. Next, 165 acne subjects identified which items affected them and rated importance on a 5-point scale. Reduction to a brief questionnaire was performed by evaluating patient-perceived importance and factor analysis; four domains were identified (self-perception, role-emotional, role-social, acne symptoms). After pilot-testing for comprehension in acne subjects, further revisions were made to improve clarity and applicability. The resulting instrument takes 10 minutes to complete, and consists of 24 questions assessing how acne affected certain aspects of patients' lives during the past week on a 7-point scale. Thus, an instrument with excellent content validity was developed to assess health-related quality of life in patients with facial acne, and is comprised of statistically meaningful items of importance to patients. Other measurement characteristics are being assessed in a recently initiated study to evaluate test-retest reliability and responsiveness to therapy.     

Evaluation of the RFIPC, a disease-specific health-related quality of life questionnaire, in Swedish patients with ulcerative colitis

BACKGROUND: We wanted to characterize a Swedish version of the Rating Form of Inflammatory Bowel Disease Patient Concerns (RFIPC) with regard to validity, reliability, and responsiveness. METHODS: Two hundred and three consecutive patients with ulcerative colitis were studied. Health-related quality of life (HRQOL) was measured with the disease-specific questionnaire, the RFIPC, and a general questionnaire, the Sickness Impact Profile (SIP). Concerns about general well-being were also reported. Disease activity was measured by means of symptom cards, laboratory tests, and two clinical indices for disease activity. RESULTS: Test-retest reliability using Spearman's r (rs) was 0.79, and internal consistency measured with Cronbach's alpha was 0.95. RFIPC had a fair correlation with concerns about general well-being (rs = 0.69, P < 0.001). There was also a stronger correlation with another measure of HRQOL, the overall SIP score (rs = 0.43), than with measures of disease activity such as stool frequency (rs = 0.28) and sigmoidoscopic grading (NS). The group of patients in relapse had a higher RFIPC sum score than patients in remission (P = 0.001). Measures of HRQOL had a low correlation with disease activity and did not respond to changes in disease activity. CONCLUSION: The Swedish version of the RFIPC is a valid and reliable measure of HRQOL. The SIP and the RFIPC have a good discriminative ability between groups of patients in remission and in relapse. However, they do not seem to be useful in predicting the disease activity or change in disease activity over time in the individual patient.     

Development of a disease-specific health-related quality of life questionnaire for sleep apnea

The Calgary Sleep Apnea Quality of Life Index (SAQLI) was developed to record key elements of the disease that are important to patients. All items felt to influence the quality of life of these patients were identified. Final questionnaire items were selected by interviewing 113 patients with sleep apnea and 50 snorers who rated each item on whether it was a problem and the importance of it to their overall quality of life. Items for the final questionnaire were selected based on the rank order of the frequency ximportance product. The rank ordering was similar across strata of disease severity and between sexes. The Calgary SAQLI has 35 questions organized into four domains: daily functioning, social interactions, emotional functioning, and symptoms. A fifth domain, treatment-related symptoms, can be added for clinical intervention trials to record the possible negative impacts of treatment. The SAQLI has a high degree of internal consistency, face validity as judged by content experts and patients, and construct validity as shown by its positive correlations with the SF-36 and the improvement in scores in patients successfully completing a 4-wk trial of continuous positive airway pressure. It includes items shown to be important to patients with sleep apnea and is designed as a measure of outcome in clinical trials in sleep apnea. Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea.     

Assessing health-related quality of life in chronic hepatitis C using the Sickness Impact Profile

In a randomized, controlled trial that demonstrated the efficacy of interferon alfa-2b 3 million units three times a week for 24 weeks in controlling chronic hepatitic C (non-A, non-B), the Sickness Impact Profile (SIP) was used to evaluate the impact of disease and treatment on health-related quality of life (HRQOL). The SIP was self-administered by 160 patients before treatment, at the end of treatment, and at the study endpoint. Before treatment, patients with chronic hepatitis C scored significantly (P < 0.05) higher (worse) than an historical control group of the general population in mean total SIP score and in all categories except eating. The highest degree of impairment was observed in the work, sleep and rest, and recreation and pastimes categories. After treatment, patients who received interferon alfa-2b had significant (P < or = 0.05) improvement in work, sleep and rest, and recreation and pastimes scores. Numerical improvement was observed in total score, physical and psychosocial dimension scores, and most individual category scores. Mean SIP scores were unchanged or slightly worsened in untreated control patients. In responders (patients with improvement in serum alanine aminotransferase levels), the largest improvement was seen in work scores. The SIP appears to be a reliable and valid instrument for describing the impact of chronic hepatitis C on HRQOL but lacks disease-specificity and the ability to reflect clinically relevant changes. Thus the SIP is not the best instrument to evaluate the HRQOL effects of treatment with interferon alfa-2b in patients with chronic hepatitis C.     

Effect of interferon-alpha treatment of chronic hepatitis C on health-related quality of life

Studies of interferon-alpha (IFN-alpha) therapy for chronic hepatitis C have focused on viral clearance; however, few have evaluated patient's health-related quality of life during therapy. This study evaluates health-related quality of life and the prevalence of anxiety and depression in patients with chronic hepatitis C before, during, and following IFN-alpha therapy. Patients undergoing IFN-alpha therapy for chronic hepatitis C were asked to complete health status measures as well as anxiety and depression inventories before, during, and following IFN-alpha therapy. These measures were compared to the results of healthy adults in the general US population. Thirty-eight of forty-eight eligible patients (79%) with chronic hepatitis C completed the questionnaires. Respondents demonstrated a significant increase in depression during the sixth month of interferon therapy in comparison to pretreatment results. Anxiety scores improved significantly after one month of IFN-alpha in comparison to pretreatment results. Scores on the health status measures did not vary with IFN-alpha therapy. Patient responses were analyzed with respect to biochemical response (normalized transaminases) to IFN-alpha. IFN-alpha responders, who were aware of their transaminase results, exhibited lower scores on anxiety subscales during and after therapy (P = 0.02-0.04). Scores on the health status subscale, role emotional, improved in IFN-alpha responders compared to nonresponders during the sixth month of therapy (P = 0.02). Response to IFN-alpha therapy was not associated with any other differences on subscale analysis. Patients with chronic hepatitis C exhibited health perceptions similar to the general US population, and these were unchanged during IFN-alpha therapy. However, the incidence of depression significantly increased during the sixth month of IFN-alpha therapy. IFN-alpha responders exhibited fewer emotional problems as well as a lower incidence of anxiety during and following therapy.     

Measurement of health-related quality of life of patients receiving conservative treatment for limb lymphoedema using the Nottingham Health Profile

There is increasing interest in the health-related quality of life (HRQOL) of patients with chronic oedema. Studies in this area have tended to be exploratory and little work has examined the potential for HRQOL as a treatment outcome indicator in this context. This study aimed to ascertain whether or not conservative treatment for lymphoedema results in a measurable change in HRQOL, using the Nottingham Health Profile Part 1 (NHP-1) as the study instrument. Thirty-four patients participated. The patients received a range of conservative treatments. The participants completed the NHP-1 prior to treatment and 4 weeks after completion of the initial treatment phase. The overall post-treatment NHP-1 scores were significantly lower than the overall pre-treatment scores (z = 3.1 and p < 0.01), indicating an improvement in the HRQOL. The greatest change in a single dimension was in physical mobility (z = 2.3 and p < 0.05). The change in limb volume was not associated with a change in any NHP-1 subscale. A significant correlation was found between an improvement in skin condition and an improvement in scores on the 'pain' subscale (r = 0.53 and P < 0.01). It is concluded that the NHP-1 was useful in the assessment of the 'physical' domains of HRQOL in this context, but was less useful with regard to psychological and emotional domains.     

Outcome assessment for epilepsy surgery: the impact of measuring health-related quality of life

Epilepsy surgery is an increasingly common treatment for intractable epilepsy; yet there is no clear consensus among experts on how to report epilepsy surgery outcome. Most published outcome reporting systems focus on seizure frequency and type but differ in how they define clinically distinct outcome categories. We used a reliable and valid measure of self-reported health-related quality of life (HRQOL), the Epilepsy Surgery Inventory (ESI)-55, as an external standard by which to evaluate seven previously published, seizure-based outcome classification systems. The ESI-55 was administered to 133 adults who had previously undergone surgery for intractable epilepsy, and results were linked to data on their seizure occurrence before and after surgery (over the year prior to their HRQOL reports). These 133 patients were classified according to each seizure-based outcome system, and variation in HRQOL across outcome groups was evaluated using analysis of variance. Results reveal noteworthy variation in the extent to which different systems reflect patients' HRQOL at follow-up. We modified existing systems to derive a seizure-based surgery outcome system that most closely reflects HRQOL when applied over the latest 1-year postoperative interval.     

Life after breast cancer: understanding women's health-related quality of life and sexual functioning

PURPOSE: To describe the health-related quality of life (HRQL), partner relationships, sexual functioning, and body image concerns of breast cancer survivors (BCS) in relation to age, menopausal status, and type of cancer treatment. PATIENTS AND METHODS: A cross-sectional sample of BCS in two large metropolitan areas was invited to participate in a survey study that included the following standardized measures: the RAND 36-Item Health Survey; the Centers for Epidemiologic Studies-Depression Scale (CES-D); the Dyadic Adjustment Scale (DAS); the Breast Cancer Prevention Trial (BCPT) Symptom Checklist; the Watts Sexual Functioning Questionnaire (WSFQ); and subscales from the Cancer Rehabilitation Evaluation System (CARES). RESULTS: Eight hundred sixty-four BCS completed the survey. RAND Health Survey scores were as good or better than those of healthy, age-matched women, and the frequency of depression was similar to general population samples. Marital/partner adjustment was similar to normal healthy samples, and sexual functioning mirrored that of healthy, age-matched postmenopausal women. However, these BCS reported higher rates of physical symptoms (eg, joint pains, headaches, and hot flashes) than healthy women. Sexual dysfunction occurred more frequently in women who had received chemotherapy (all ages), and in younger women who were no longer menstruating. In women > or = 50 years, tamoxifen therapy was unrelated to sexual functioning. CONCLUSION: BCS report more frequent physical and menopausal symptoms than healthy women, yet report HRQL and sexual functioning comparable to that of healthy, age-matched women. Nevertheless, some survivors still experience poorer functioning, and clinicians should inquire about common symptoms to provide symptomatic management or counseling for these women.     

Personality, chronic medical morbidity, and health-related quality of life among older persons

We report the design of optimal linker geometries for the synthesis of stapled DNA-minor-groove-binding molecules. Netropsin, distamycin, and lexitropsins bind side-by-side to mixed-sequence DNA and offer an opportunity for the design of sequence-reading molecules. Stapled molecules, with two molecules covalently linked side-by-side, provide entropic gains and restrain the position of one molecule relative to its neighbor. Using a free-atom simulated annealing technique combined with a discrete mutable atom definition, optimal lengths and atomic composition for covalent linkages are determined, and a novel hydrogen bond 'zipper' is proposed to phase two molecules accurately side-by-side.