Measurement properties of the short form (SF)-12 applied to patients with stroke

The purpose of this study was to examine the reliability and validity of the Short Form (SF)-12 and to determine its ability to detect changes in health related quality of life (HRQOL) following stroke. The study involved a cohort of 90 patients admitted with an ischemic stroke to a hospital in the northeastern United States. The items of the SF-12 were found to be reliable (alpha=0.833-0.894) and to load on a physical and mental component. Three months post-stroke the physical component summary (PCS) scores of the SF-12 were significantly less than population norms. The PCS scores were also lower after stroke (3 month=42.5, 12 month=46.3) than before stroke (48.8). Mental component summary (MCS) scores did not differ significantly from population norms or across time (range=53.6 to 54.9). We conclude that the reliability and validity of the SF-12, as well as its brevity and capacity to document changes in the physical component of HRQOL, provide support for its use in patients with stroke.     

Homeless chronicity and health-related quality of life trajectories among adults with addictions

BACKGROUND: New federal initiatives target funds toward chronically homeless as distinct from other homeless persons. Few data exist, however, to substantiate the implications of chronic homelessness for major health outcomes. OBJECTIVES: Using data from a 2-year cohort of addicted persons, we tested whether changes in mental and physical health-related quality of life (HRQOL) differed according to homeless chronicity. METHODS: Using self-reported homelessness, we classified subjects as chronically homeless (CH; n = 60), transitionally homeless (TRANS; n = 108), or as housed comparison subjects (HSD; n = 106). The Short Form-36 Health Survey, administered at baseline and 2 follow-ups over a period of 2 years, provided a Mental Component Summary (MCS) and a Physical Component Summary (PCS) for HRQOL. Mixed model linear regression was used to test the association between housing status, MCS, and PCS. Additional models assessed whether medical, psychiatric, addiction, and social support measures could account for HRQOL differences. RESULTS: All subjects had low MCS scores at study entry (mean, 31.2; SD, 12.6). However, there was a significant housing status-by-time interaction (P = 0.01). At final follow-up, CH and TRANS subjects had lower adjusted MCS scores than HSD subjects (33.4, 38.8, and 43.7 for the 3 groups, respectively; all P < or = 0.01). By contrast, housing status and PCS were not significantly associated (P = 0.19). Medical, psychiatric, addiction, and social support variables had significant associations with MCS, and their inclusion in the regression reduced the apparent effect of housing status on MCS. CONCLUSIONS: Chronic homelessness was associated with especially poor mental but not physical HRQOL over time. These findings reinforce a new typology of homelessness.     

Health-related quality-of-life effects of oxaprozin and nabumetone in patients with osteoarthritis of the knee

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed for the treatment of signs and symptoms of osteoarthritis (OA). Nabumetone and oxaprozin are 2 of the newer NSAIDs and have been shown to have similar safety and efficacy profiles. Nabumetone 1000 mg to 1500 mg once a day (QD) and oxaprozin 1200 mg QD are commonly recommended doses. This study compared the health-related quality of life (HRQOL) of patients receiving oxaprozin 1200 mg QD with that of patients receiving nabumetone 1000 mg QD or nabumetone 1500 mg QD for the treatment of signs and symptoms of OA of the knee. Two similarly designed, independent, randomized, double-masked, placebo-controlled clinical trials were conducted. In trial 1, patients were randomized to receive oxaprozin 1200 mg QD (n = 109), nabumetone 1000 mg QD (n = 110), or placebo (n = 109); in trial 2, patients received oxaprozin 1200 mg QD (n = 116), nabumetone 1500 mg QD (n = 115), or placebo (n = 116). HRQOL was measured by the Medical Outcomes Study Short-Form-36 Health Survey (1-week recall period) at baseline and weeks 2 and 6. Data from the 2 trials were combined to assess differences across the 4 groups in 8 domains and 2 summary scores at baseline, and changes in HRQOL scores at weeks 2 and 6. At week 2, the oxaprozin group showed significantly greater improvement than the placebo group in role physical, vitality, and mental component summary (MCS) scores (P < 0.05), and in physical functioning, bodily pain, social functioning, and physical component summary (PCS) scores (P < 0.01). The nabumetone 1500-mg group showed significantly greater improvement than the placebo group in bodily pain and social functioning (P < 0.05), and in vitality and MCS score (P < 0.01). No significant differences were observed between the nabumetone 1000-mg and placebo groups. At week 2, the oxaprozin group showed a greater change than the nabumetone 1000-mg group in PCS score (P < 0.05). At week 6, oxaprozin treatment resulted in significantly greater improvement than placebo in physical functioning, role physical, and bodily pain (P < 0.05); social functioning, role emotional, and mental health (P < 0.01); and vitality and MCS score (P < 0.001). The nabumetone 1500-mg group showed significantly greater responses than the placebo group in vitality (P < 0.05), mental health (P < 0.01), and MCS score (P < 0.001). The oxaprozin group had significantly better scores than the nabumetone 1500-mg group in the PCS (P < 0.05), and it showed significantly greater improvement than the nabumetone 1000 mg group in role physical and PCS score (P < 0.01) and in role emotional (P < 0.05). No statistically significant differences were found between placebo and nabumetone 1000 mg at week 6. Results of this study suggest that oxaprozin 1200 mg QD has a significant positive impact on the HRQOL of patients with OA of the knee compared with nabumetone 1000 mg QD and placebo.     

Quality-of-life assessment in an outpatient parenteral antibiotic program

OBJECTIVE: To measure changes and to identify predictors of change of health-related quality of life (HRQoL) for enrollees into an outpatient parenteral antibiotic therapy (OPAT) program. METHODS: A multidisciplinary, single-center, prospective investigation was conducted at a 1000-bed Canadian adult tertiary-care teaching hospital. Over a 15-month study period, consenting patients who were enrolled in the OPAT program completed paired Short Form-36 (SF-36) questionnaires within 48 hours prior to discharge from the hospital and again 26-30 days after discharge. Sociodemographic data and clinical variables were also collected for the purpose of determining potential predictors of change in quality of life. RESULTS: During the study period, 134 patients were enrolled in the OPAT program and 82 completed the paired SF-36 questionnaires. Study participants experienced a significant improvement in 3 SF-36 domains (physical functioning, bodily pain, role emotional) and the mental component summary scale (MCS) scores when they were transferred from the hospital to home setting. The SF-36 scores for all domains and summary scales were lower than the Canadian population average (all p < 0.001). Multiple linear-regression analysis revealed that infectious disease diagnosis and baseline physical component summary scale (PCS) scores were predictors of the change in the PCS score when patients transferred from the hospital to the home setting. Length of hospital stay and baseline MCS scores were predictors of the change in MCS scores when patients transferred from the hospital to the home setting. CONCLUSIONS: This study reveals that some domains in HRQoL appear to improve 4 weeks after discharge for adults enrolled in an OPAT program and that there are different predictors for changes in physical and mental health.     

Apathy and Health-Related Quality of Life in Stroke

Objective

To examine differences in health-related quality of life (HRQOL) in stroke survivors with and without apathy.

Design

Cross-sectional study.

Setting

Acute stroke unit in a regional hospital.

Participants

Stroke survivors (N=391) recruited from the acute stroke unit.

Interventions

Not applicable.

Main Outcome Measures

Participants were divided into apathy and nonapathy groups. Participants who scored ≥36 on the Apathy Evaluation Scale, clinician's version formed the apathy group. HRQOL was measured with the 2 component scores, mental component summary (MCS) and physical component summary (PCS), of the Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12). Demographic and clinical information were obtained with the National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), Mini-Mental State Examination (MMSE), and Geriatric Depression Scale (GDS).

Results

Thirty-six (9%) participants had apathy. The apathy group had significantly lower MCS and PCS scores. After adjusting for sex, education, diabetes mellitus, and NIHSS, MMSE, GDS, and BI scores, the MCS score in the apathy group remained significantly lower.

Conclusions

Apathy has a significant negative effect on HRQOL in stroke survivors, particularly on their mental health. Interventions for apathy could improve the HRQOL of stroke survivors.     

环肺静脉消融术对心房颤动患者生活质量的影响

目的:评价环肺静脉消融术(CPVA)对心房颤动患者生活质量的影响。方法:应用SF-36量表对56例接受CPVA的心房颤动患者,分别于入院时和消融后6个月进行生活质量评价。结果:随访(13±4)个月,43例(77%)患者维持窦性心律。6个月后SF-36量表中除肌体疼痛差异无统计学意义外,躯体功能、躯体角色、总体健康状况、活力、社会功能、精神角色和精神健康均较消融前有明显改善(P<0.05)。总躯体健康评分从(68±15)分提高至(76±15)分(P<0.01),总精神健康评分从(63±16)分提高至(73±17)分(P<0.01)。结论:CPVA能明显改善心房颤动患者的生活质量,尤其在消融成功者中,CPVA可使患者生活质量明显改善。     

Functional measures across neurologic disease states: analysis of factors in common

OBJECTIVE: To describe the underlying dimensions for a range of functional measures across 3 neurologic diseases at different time points. DESIGN: Multiple cohort study. SETTING: Combination of public hospital wards and community. PARTICIPANTS: Patients (N=308) from 3 cohorts: paralytic poliomyelitis (n=38), mean of 25 years previously, assessed once; acute stroke admitted to hospital and followed up for 12 months postdischarge (n=181); and traumatic brain injury (TBI), admitted to hospital and followed up for 12 months postdischarge (n=89). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The Barthel Index, FIM instrument, Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical component score (PCS) and mental component score (MCS), Community Integration Questionnaire (CIQ), and the London Handicap Score (LHS). Measures were compared at 2 time points: pre-event status for stroke, TBI and the polio cohort, and 12-month postdischarge status for stroke and TBI. RESULTS: The different measures generally correlated highly within disease states at each time point. Principal components analysis revealed 2 underlying dimensions, a physical dimension onto which loaded the Barthel Index, FIM, PCS, and LHS and a cognitive/emotional dimension onto which loaded the MCS and, for subjects with polio, the CIQ. These 2 dimensions accounted for 69% of the variance in measures at the pre-event time point and 85% of the variance at the 12-month time point. CONCLUSIONS: These data suggest 2 basic underlying dimensions across a wide range of measures in 3 different neurologic conditions even at different time points. Most of the variation in the measures can be captured using the 2 component summary scores (PCS, MCS) of the SF-36.     

Depression symptoms have a greater impact on the 1-year health-related quality of life outcomes of women post-myocardial infarction compared to men.

OBJECTIVE: Several studies report that women with CAD have a poorer prognosis than men and suggest that depressive symptoms may be a contributing factor. The purpose of this study was to examine gender differences in depressive symptoms, as they relate to health-related quality of life outcomes following an AMI. METHODS: Patients with documented AMI completed a questionnaire including the Short Form 36 physical (PCS), and mental component summary (MCS) scores, and Beck Depression Inventory at baseline and at 1 year after AMI admission. RESULTS: 486 (82%) patients completed the follow-up questionnaire. Females had significantly worse PCS and MCS scores at baseline and 1-year follow-up compared to males The mean 1-year Beck scores were significantly higher (p=0.01) for females (10.02+/-8.23) compared to males (7.78+/-8.01) indicating more reported depressive symptomatology. Multivariate analyses showed significant gender-related differences in the PCS scores at 1 year, but no gender-related differences in the 1-year MCS scores. CONCLUSIONS: These results suggest that gender differences in mental health at 1 year relate to gender-related differences at 1-year depression levels. The higher level of depression in women may be a consequence of gender differences in recovery patterns from an AMI and requires further investigation.     

Evaluating the performance of medicare fee-for-service providers using the health outcomes survey: a comparison of two methods

BACKGROUND: Health status measures are now being used for evaluating the performance of health care organizations. Trends in SF-36 component scores have previously been examined for Medicare-managed care plans but not for providers serving Medicare fee-for-service (FFS) beneficiaries. We compared 2 methods for evaluating the performance of Medicare FFS providers, the Research Triangle Institute (RTI) and Health Assessment Laboratory (HAL) methods. METHODS: Data were collected from 6547 Medicare FFS beneficiaries in 10 cohorts. SF-36 Physical Health (PCS) and Mental Health (MCS) component scores were computed at baseline and after a 2-year follow-up. The RTI approach predicts follow-up scores based on a standard care regression model. The HAL approach determines the percentage of beneficiaries whose status is the "same or better" at follow-up. Both approaches then compare observed to expected scores for each cohort. RESULTS: The HAL method did not detect any statistically significant differences for the PCS; the RTI method detected a small PCS difference for one cohort. The HAL method identified 4 cohorts that had significantly higher MCS scores; the RTI approach identified one cohort with significantly lower scores. CONCLUSIONS: The 2 approaches provided consistent assessments of provider performance for the PCS but not for the MCS. The differences in the MCS results may have been affected by differing treatment of deaths during follow-up. The HAL approach disregards deaths for the MCS, whereas the RTI method imputes values for death. Implications of using self-reported health status for monitoring provider performance are discussed.     

Treatment-related side effects and quality of life in cancer patients

Background

Cancer leads to a complicated pattern of change in quality of life (QoL).

Objective

The aims of this study were to assess the impact of treatment-related side effects on QoL in cancer patients and to explore which other factors, and to what extent, contribute to explain low QoL scores.

Methods

One hundred twenty-three cancer patients receiving chemotherapy completed the self-administered questionnaires (Medical Outcomes Short-Form-36 (SF-36) and 12-item General Health Questionnaire). Multiple regression analyses were conducted with the SF-36 physical component summary (PCS) and SF-36 mental component summary (MCS) scores as the dependent variables and demographic and clinical factors as independent variables.

Results

Seventy-two percent of patients experienced treatment-related side effects, and 32% resulted positive for psychiatric diseases. Two multivariate analyses showed that worse PCS scores, like worse MCS scores, were significantly and independently predicted by treatment-related side effects (odds ratio (OR)?=?5.00, 95%CI 1.29–19.45; OR?=?8.08, 95%CI 2.03–32.22, respectively) and changes in health over the last 12?months (OR =2.34, 95%CI 1.47–3.76; OR?=?3.21, 95%CI 1.90–5.41, respectively), after adjustment for age, gender, years of school, time from cancer diagnosis, and psychiatric disease.

Conclusions

Given the new emphasis on QoL, we suggest that physicians have a responsibility to openly discuss therapy efficacy, prognosis as well as the potential for adverse events with their patients. Changes in health, as perceived by patient, should also be monitored at follow-up.     

Health status rated with the Medical Outcomes Study 36-Item Short-Form Health Survey after spinal cord injury

OBJECTIVE: To describe the health status of Australians with spinal cord injury (SCI). DESIGN: Survey. SETTING: Australian population-based sample. PARTICIPANTS: Participants (N=305) with SCI at recruitment to a randomized trial. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) health questionnaire. RESULTS: Compared with the general population, our sample reported significantly lower scores in 6 SF-36 domains (physical function, role-physical, bodily pain, general health, social function, vitality) and the physical component summary (PCS) score, but unexpectedly higher mental component summary (MCS) scores (difference in mean MCS scores, 4.6; 95% confidence interval [CI], 2.4-6.8). Compared with people with tetraplegia, those with paraplegia had better physical function and PCS scores (difference, 21; 95% CI, 17-24; difference, 3; 95% CI, 1-5, respectively), and worse bodily pain scores (difference, 9; 95% CI, 2-15). Recent urinary infections were associated with worse general health, vitality, mental health, and MCS scores. Receiving family or external physical care was associated with worse physical function and PCS scores, but better mental health and MCS scores. Older age at injury was associated with lower bodily pain and PCS scores. CONCLUSIONS: Using the SF-36, Australians with SCI rate their physical (not mental) health status as worse than the general population.     

Determination of ameliorable health impairment influencing health-related quality of life among patients with silicosis in China: a cross-sectional study

The association between health-related quality of life (HRQOL) and ameliorable health impairment was examined in 208 Chinese in-patients with silicosis, in April 2010. Median St George's Respiratory Questionnaire scores for symptom and activity impairment, social support rating scale and geriatric depression scale scores for patients were 57.24, 59.45, 35 and 5, respectively. Median 36-item short-form health survey physical component (PCS) and mental component (MCS) scores were 47.17 and 51.05, respectively. Lower than median PCS scores (< 47) were significantly associated with high levels of symptom and activity impairment. Lower than median MCS scores (< 51) were significantly associated with high levels of depression and activity impairment. Encouraging patients to participate in daily activities may alleviate activity impairment. Reasonable financial compensation may help to maintain and improve social support levels.     

Effects of Delayed-Release Dimethyl Fumarate (DMF) on Health-Related Quality of Life in Patients With Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies

PurposeDelayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) has been reported to have clinical and neuroradiologic efficacy in people with relapsing-remitting multiple sclerosis (RRMS) in the Phase 3 DEFINE and CONFIRM studies. An integrated analysis of data from DEFINE and CONFIRM was conducted to estimate more precisely the therapeutic effects of delayed-release DMF. Here we describe the impact of RRMS on health-related quality of life (HRQoL) at baseline and assess the effects of delayed-release DMF on prespecified HRQoL end points over 2 years.MethodsPatients with RRMS were randomly assigned to receive delayed-release DMF 240 mg PO BID or TID or matching placebo for up to 2 years (96 weeks). As a tertiary end point in both studies, patient-reported HRQoL was assessed using the Physical and Mental Component Summaries (PCS and MCS, respectively) of the 36-item Short Form Health Survey (SF-36); global assessment of well-being, as measured on a visual analog scale (VAS); and the EuroQoL-5D (EQ-5D) VAS, administered at baseline and at weeks 24, 48, and 96. Higher scores suggested better HRQoL.FindingsThe integrated analysis included 2301 patients treated with delayed-release DMF BID (n = 769) or TID (n = 761) or placebo (n = 771). The mean PCS and MCS scores at baseline were lower overall compared with those reported in the general US population and were ≥5 points lower (a clinically meaningful difference) in patients with a baseline Expanded Disability Status Scale (EDSS) score of ≥2.5 compared with those in patients with a baseline EDSS score of 0. At 2 years, mean PCS and MCS scores were increased from baseline in the patients treated with delayed-release DMF, whereas the mean PCS and MCS scores were decreased from baseline in the placebo group; the difference in PCS and MCS scores was significant for the delayed-release DMF BID and TID groups compared with placebo. SF-36 subscale scores generally remained stable or were improved relative to baseline in patients treated with delayed-release DMF and decreased in patients receiving placebo; improvements were significant for delayed-release DMF BID and TID versus placebo on most subscales. Compared with that in the placebo group, the proportions of patients in the delayed-release DMF groups exhibiting a ≥5-point improvement in SF-36 score were significantly higher. The following factors were found to be predictive of improved PCS and MCS scores at 2 years: delayed-release DMF treatment, lower baseline EDSS score, age ≤40 years (PCS only), and corresponding lower baseline PCS or MCS score. Changes from baseline in VAS and EuroQoL-5D scores were generally consistent with changes in SF-36 scores.ImplicationsThese HRQoL benefits parallel the improvements in clinical and magnetic resonance imaging end points with delayed-release DMF, suggesting that delayed-release DMF treatment improves patient-perceived health status as well as neurologic and physical functioning. ClinicalTrials.gov identifiers: NCT00420212; NCT00451451.     

Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn's disease

Background: Crohn's disease (CD) is a chronic inflammatory bowel disease usually diagnosed in early adult life and characterized by unpredictable flares and debilitating symptoms such as diarrhea, abdominal pain, and fever, which can interfere with a patient's ability to work and perform daily activities. Objective: The aim of this study was to assess the validity, reliability, and responsiveness of the Work Productivity and Activity Impairment questionnaire in CD (WPAI:CD). Methods: The WPAI:CD was tested in CD patients enrolled in a 26-week randomized clinical trial of cer-tolizumab pegol versus placebo. Discriminative validity of WPAI:CD absenteeism, presenteeism(reduced on-the-job effectiveness), overall work productivity loss (absenteeism + presenteeism), and activity impairment scores was assessed relative to 5 measures of disease severity and health status: CD Activity Index (CDAI), Short Form-36 physical component summary (PCS) and mental health component summary (MCS) scores, Inflammatory Bowel Disease Questionnaire (IBDQ), and the 5-dimensional EuroQoL health-related quality-of-life visual analog scale (EQ-VAS). Responsiveness was assessed by comparing changes in WPAI:CD scores from baseline to week 26 for patients in remission (CDAI <150 points) versus no remission. Standardized Response Means (SRMs) were calculated to evaluate the magnitude of the changes. Results: A total of 662 patients (mean [range] age, 37.4 [18-77] years; male, 288 [43.5%]; white, 629 [95.0%]) were enrolled in the study. Patients with CD of the worst severity (CDAI > median) showed significantly higher impairment in work (+10.5%) and activities (+10.4%) versus patients with "best health" (no problems) (both, P 0.5) for patients in remission. Conclusions: The discriminative validity, reliability, and responsiveness of the WPAI:CD were demonstrated. The WPAI:CD may be useful for evaluating drug impact on CD.     

维持性血液透析患者睡眠质量、抑郁和生活质量相关关系的研究

目的探讨维持性血液透析患者睡眠质量、抑郁与生活质量之间的关系。方法收集符合标准维持性血液透析患者71例,采用匹兹堡睡眠质量指数（PSQI）评估睡眠质量,以简明健康状况调查表（SF-36量表）和BECK抑郁自评问卷（BDI）分别评估生活质量和抑郁情况。记录年龄、性别、婚姻、干体重、血红蛋白、铁蛋白、转铁蛋白饱和度、钙、磷、全段甲状旁腺激素、白蛋白、C-反应蛋白、透析前及透析后血肌酐、尿素氮。结果睡眠质量较差（PSQI评分〉5）的血液透析患者占76.1%;睡眠质量较好组患者的生活质量总分、生理及心理健康总分均高于睡眠质量较差组（P〈0.01）,睡眠质量较差组的抑郁评分高于睡眠质量较好组（P〈0.05）;中-重度抑郁患者（BDI评分≥8分）占63.4%,该组患者生活质量总分、生理及心理健康总分均低于非中-重度抑郁组（P〈0.01）,且睡眠质量差（P〈0.01）;SF-36生活质量总分、生理健康总分及心理健康总分和睡眠质量及抑郁相关（P〈0.01）,睡眠质量和抑郁是生活质量独立的危险因素。结论维持性血液透析患者睡眠质量较差、抑郁较为常见,睡眠和抑郁之间相互影响,并且降低了患者的生活质量。     

Construct and criterion validity of the SF‐12 health questionnaire in patients with acute myocardial infarction and unstable angina

Background The aim of the study was to determine the construct and criterion validity of the 12‐item short‐form questionnaire (SF‐12) in coronary patients with either acute myocardial infarction or unstable angina in Spain. Method A total of 186 patients hospitalized with coronary heart disease have been studied. The construct validity has been analysed by means of the association between the SF‐12v.1 and sociodemographic and clinical variables; and the criterion validity was tested by the correlations between 36‐item short‐form question (SF‐36) and SF‐12 summary scores. The equivalence between both health questionnaires was examined by means of the proportion of variance in the SF‐36 physical and mental component summary (PCS‐36 and MCS‐36) scores explained by the 12 items adjusted by age and sex. Results The validation result was as expected: female patients and those with poor education level, worse mental health, unstable angina, cardiovascular risk factor and co‐morbidity obtained a lower score in the SF‐12. The correlations between SF‐36 and SF‐12 summary scores were high. The equivalence between the SF‐12 and SF‐36 was good, because the models explained 87% of the variation in PCS‐36 score and 93% of the variation in MCS‐36. Conclusion The SF‐12 is a valid tool in studies assessing health‐related quality of life in coronary patients. The use of the SF‐12 may be especially useful in patients where the clinical situation make difficult the application of the longer instrument.     

Do Elder Emergency Department Patients and Their Informants Agree about the Elder's Functioning?

OBJECTIVE: To compare elder patients' and their informants' ratings of the elder's physical and mental function measured by a standard instrument, the Medical Outcomes Study Short Form 12 (SF-12). METHODS: This was a randomized, cross-sectional study conducted at a university-affiliated community teaching hospital emergency department (census 65,000/year). Patients >69 years old, arriving on weekdays between 10 AM and 7 PM, able to engage in English conversation, and consenting to participate were eligible. Patients too ill to participate were excluded. Informants were people who accompanied and knew the patient. Elder patients were randomized 1:1 to receive an interview or questionnaire version of the SF-12. The questionnaire was read to people unable to read. Two trained medical students administered the instrument. The SF-12 algorithm was used to calculate physical (PCS) and mental (MCS) component scores. Oral and written versions were compared using analysis of variance. The PCS and MCS scores between patient-informant pairs were compared with a matched t-test. Alpha was 0.05. RESULTS: One hundred six patients and 55 informants were enrolled. The patients' average (+/-SD) age was 77 +/- 5 years; 59 (56%; 95% CI = 46% to 65%) were women. There was no significant difference for mode of administration in PCS (p = 0.53) or MCS (p = 0.14) scores. Patients rated themselves higher on physical function than did their proxies. There was a 4.1 (95% CI = 99 to 7.2) point difference between patients' and their proxies' physical component scores (p = 0.01). Scores on the mental component were quite similar. The mean difference between patients and proxies was 0.49 (95% CI = 3.17 to 4.16). The half point higher rating by patients was not statistically significant (p = 0.79). CONCLUSIONS: Elders' self-ratings of physical function were higher than those of proxies who knew them. There was no difference in mental function ratings between patients and their proxies. Switching from informants' to patients' reports in evaluating elders' physical function in longitudinal studies may introduce error.     

A cost-utility analysis of adult group audiologic rehabilitation: are the benefits worth the cost?

The purpose of this study was to conduct a cost-utility analysis comparing two treatment approaches: (1) hearing aid use alone (HA) and (2) hearing aid use with short-term group postfitting audiologic rehabilitation (HA + AR). A total of 105 veterans, 67 males and 38 females, with at least a mild sensorineural hearing loss participated in this study. The SF-36V was administered to each participant before and after treatment. This instrument measures both mental component summary (MCS) scales and physical component summary (PCS) scales of quality of life. As a whole, the participants exhibited a statistically significant improvement in mean MCS scores pre- to postintervention, with average improvements of 1.4 and 3.0 points for the HA and HA + AR groups, respectively. With the use of the MCS scores, the results of a cost-utility analysis revealed that HA treatment cost $60.00 per quality-adjusted life year (QALY) gained, while HA + AR cost only $31.91 per QALY gained, making HA + AR the more cost-effective treatment.     

Effects of olanzapine alone and olanzapine/fluoxetine combination on health-related quality of life in patients with bipolar depression: secondary analyses of a double-blind, placebo-controlled, randomized clinical trial

BACKGROUND: Improving patients' health-related quality of life (HRQOL) could be a treatment goal for bipolar depression. OBJECTIVES: The objectives of these secondary analyses of a previous report were to determine the benefits of olanzapine alone and olanzapine-fluoxetine combination (OFC) for improving HRQOL in patients with bipolar depression using both a generic and a depression-specific HRQOL instrument, and to examine the association between the 2 HRQOL instruments and the construct validity of the depression-specific HRQOL instrument. METHODS: This was a double-blind, placebo-controlled, 83-site, international, randomized trial. Adults with bipolar I disorder, most recent episode depressed (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), were randomly assigned to receive olanzapine (6-20 mg/d), OFC (6/25, 12/25, or 12/50 mg/d), or placebo for 8 weeks. HRQOL improvement was calculated as last-observation-carried-forward changes in dimension and component summary scores on Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and total score on the Quality of Life in Depression Scale (QLDS). Results: Patients were assigned to receive olanzapine (n = 370), [corrected] OFC (n = 86), or placebo (n = 377) [corrected] for 8 weeks. Of 833 enrolled patients, 454 discontinued (olanzapine, 191/370 [51.6%] [corrected]OFC, 31/86 [36.0%]; and placebo, 232/377 [61.6%]) [corrected] Compared with placebo, olanzapine-treated patients exhibited greater improvements on SF-36 mental component summary (MCS) score ( P=0.002) and 3 of 8 SF-36 dimension scores (mental health [P=0.015], role-emotional [P=0.046], and social functioning [P=0.006). OFC-treated patients exhibited greater improvements on MCS score ( P<0.001) vs both placebo and olanzapine), 5 SF-36 dimension scores (general health perception (P<0.001) vs placebo; (P<0.001) vs olanzapinel, mental health [ P=0.001] vs both placebo and olanzapine], role-emotional [ P<0.001] vs placebo; [P=0.007] vs olanzapine], social functioning [ P=0.001] vs placebo; [P=0.032] vs olanzapine], and vitality [P=0.002] vs placebo; [P=0.011] vs olanzapine]), and QLDS total score ( P<0.001] vs both placebo and olanzapine). Changes in SF-36 scores of mental health, social functioning, role-emotional, and vitality were highly correlated to changes in the QLDS total score (all p < -0.5). CONCLUSIONS: Based on these analyses, patients with bipolar depression receiving olanzapine or OFC for 8 weeks had greater improvement in HRQOL than those receiving placebo. OFC treatment was associated with greater improvement in HRQOL than olanzapine alone. The correlation results support the construct validity of the QLDS.     

Change in health‐related quality of life of opiate users in low‐threshold methadone programs

Aim: To assess changes in the health‐related quality of life (HRQOL) among opiate users in the first 6 months upon entering a low‐threshold methadone treatment program. Changes were evaluated from the perspectives of both statistical and clinical significance.

Design: A prospective cohort study of low‐threshold methadone participants who had completed interviews at baseline and 6 months post enrollment.

Participants: 183 opiate users who started low‐threshold methadone treatment between December 2000 and January 2004.

Measurements: Data on HRQOL were collected by a trained interviewer using the SF‐36 instrument to determine baseline and 6 months post treatment scale scores.

Findings: Statistically significant improvements were found in the study group for seven out of ten SF‐36 scales: role physical, bodily pain, vitality, social functioning, role emotional, mental health and the mental health component summary scale. At an individual patient level, clinically significant improvements were most commonly observed with the mental health scale, the vitality scale and the mental health component summary scales.

Conclusions: Enrolment in low‐threshold methadone treatment programs is associated with improved HRQOL, particularly in the mental health domains of the SF‐36 during the first 6 months of treatment. Further follow‐up of this cohort will allow us to determine if a levelling or reversal in HRQOL occurs, permitting an evaluation of the potential long‐terms benefits of low‐threshold methadone programs.