Comparison of the Quality of Well-being Scale and the SF-36 results among two samples of ill adults: AIDS and other illnesses.

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.

Disease management: definitions and exploration of issues.

Disease management (DM) appears to be sweeping the health care industry. Its supporters claim that it can produce optimal health care outcomes through enhancements in the quality of care provided to patients and effective control of costs. This paper examines the primary reasons for the recent popularity of DM, discusses several thematic components common to various definitions of DM, and compares the often overly optimistic claims made for DM with the realities of how such programs are actually implemented. Finally, it examines critical issues and controversies that participants in DM must consider as this approach to managing patient care evolves.

The role of colleges of pharmacy in meeting the pharmacoeconomic needs of the pharmaceutical industry: a conference report.

To provide a forum for the exchange of ideas regarding the role of colleges of pharmacy in meeting the pharmaceutical industry's pharmacoeconomic needs, an invitational conference was conducted by the University of Arizona's Center for Pharmaceutical Economics on January 14 and 15, 1993, in Tucson, Arizona. This article represents the program design, program types, and consensus development portions of that conference. A description of current needs in pharmacoeconomics was obtained through transcripts of industry and university presentations, panel discussions, and question-and-answer sessions. Conference participants generally agreed that pharmacoeconomics holds great potential for making significant contributions to health care but that it will not flourish without deliberate and cooperative efforts. Participants from both industry and academia voiced the need for the two parties to work together to increase the visibility and understanding of pharmacoeconomics and to meet the training and staffing challenges facing the discipline.

Pharmacoeconomic research--facilitating collaboration among academic institutions, managed-care organizations, and the pharmaceutical industry: a conference report.

To provide a venue to allow for the exchange of information among parties interested in pharmacoeconomic research opportunities within managed-care organizations, an invitational conference was conducted by The University of Arizona's Center for Pharmaceutical Economics on January 20 and 21, 1994, in Tucson, Arizona. The purpose of the conference was to bring together representatives from managed-care organizations, academic institutions, and the pharmaceutical industry to discuss opportunities for collaboration, as well as consider the barriers to conducting pharmacoeconomic research in the managed-care setting. Challenges to collaboration include database development, the need for an integrated perspective, sensitivity to marketing matters, and a variety of technical and organizational barriers. To overcome these barriers, the interested groups must develop trust, recognize common ground, share risk, and communicate effectively. This article describes the emerging themes of the conference based on transcripts of formal presentations and participants' comments.

Assessing health-related quality of life: application to drug therapy.

There is growing awareness among the principal stakeholders in health care that health outcomes data should be used in the evaluation of medical care interventions. Health-related quality of life is a patient-reported health outcome that is gaining increasing attention. In fact, in certain diseases, quality of life may be the most important health outcome to consider in assessing treatment efficacy. Quality of life is a construct commonly viewed as having several dimensions or domains. Although the terminology may differ depending on the author, the basic dimensions of health-related quality of life are physical status and functioning, emotional/psychological status, social functioning, and disease- or treatment-related symptomatology. There are a number of methodologic issues in the measurement of quality of life that must be carefully considered when designing a study or evaluating existing research. These issues include general or disease-specific measures, index or profile outcome measures, dimensions measured, relative importance of dimensions, reliability of the measure, and validity of the measure. This paper provides a brief overview of health-related quality of life and its measurement in the context of drug therapy.

The discriminative ability of the 12-item short form health survey (SF-12) in a sample of persons infected with HIV.

BACKGROUND: Self-reported health-related quality of life (HRQOL) assesses constructs that transcend laboratory-based clinical parameters. Corroboration of the hypothesized relationships between the 2 types of health indicators (ie, clinical and HRQOL) could provide evidence of the validity of an HRQOL measurement tool. OBJECTIVE: The purpose of this study was to evaluate the ability of scores on the mental component summary (MCS-12) and physical component summary (PCS-12) of the 12-Item Short Form Health Survey (SF-12) to discriminate between HIV-infected persons in predefined disease-severity groups based on surrogate markers. METHODS: This cross-sectional study involved the collection of clinical data (ie, CD4 cell count, viral load [HIV-1 RNA copies/mL]) from patients' medical records and HRQOL data from the SF-12 at 2 HIV specialty clinics. The ability of SF-12 summary scores to discriminate between patients stratified by disease severity (ie, CD4 cell count <200 vs > or = 200/mm3; HIV-1 RNA >55,000 vs < or = 55,000 copies/mL) was assessed by receiver operating characteristic curve analysis. RESULTS: Data were collected from 478 patients. The scores from the PCS-12 were able to discriminate between groups of patients stratified by disease severity based on CD4 cell count (P < 0.001) and HIV-1 RNA copies/mL (P < 0.01). MCS-12 scores did not discriminate between disease-severity groups. CONCLUSIONS: Although the SF-12 is a brief generic measure of HRQOL, these findings provide further evidence of the validity of the SF-12 and suggest that it may be a practical way to monitor health status from the perspective of the HIV-infected patient.

Selective serotonin reuptake inhibitor dose titration in the naturalistic setting.

Little information exists regarding the use of selective serotonin reuptake inhibitors (SSRIs) in the naturalistic setting. The Regenstrief Medical Record System was used to analyze the dosing of SSRIs in the outpatient population of an urban teaching hospital. A cohort of 3350 patients was extracted, of whom 2859 had received fluoxetine and 460 sertraline. This cohort received 21,079 prescriptions. (The 31 patients who were prescribed paroxetine were eliminated from further analysis.) The mean daily dose for all patients receiving fluoxetine was 21 +/- 6 mg for the first prescription dispensed and 25 +/- 11 mg for the ninth. For fluoxetine-treated patients with depression included on their computerized medical problem list, the mean daily dose was 21 +/- 6 mg for the first prescription and 26 +/- 12 mg for the ninth. A mean of 5.0% of all patients continuing fluoxetine therapy had their daily dose increased with each prescription refill during the first nine prescriptions. The mean daily dose for all patients receiving sertraline was 59 +/- 28 mg for the first prescription and 117 +/- 66 mg for the ninth. For sertraline-treated patients with depression included on their computerized medical problem list, the mean daily dose was 57 +/- 25 mg for the first prescription and 110 +/- 65 mg for the ninth. A mean of 14.9% of all patients continuing sertraline therapy had their daily dose increased with each prescription refill during the first nine prescriptions. The frequency of sertraline dose increases was 2 to 3 times the rate for fluoxetine. Because increases in daily doses typically result from inadequate control of symptoms of depression, these findings may reflect fluoxetine's greater effectiveness in controlling symptoms during the initial stages of therapy in the naturalistic setting.

Responsiveness of the Smoking Cessation Quality of Life (SCQoL) questionnaire.

BACKGROUND: The Smoking Cessation Quality of Life (SCQoL) questionnaire was developed to quantify changes in self-reported functioning and well-being associated with the smoking cessation process and to facilitate comparisons among smokers, former smokers, and nonsmokers. The SCQoL includes 5 cessation-targeted scales and the 8 multi-item scales of the Medical Outcomes Study 36-Item Short-Form Health Survey. OBJECTIVE: This study was conducted to assess the responsiveness of the SCQoL by analyzing associations between SCQoL scale scores and duration of smoking abstinence. METHODS: The SCQoL was administered at a screening visit and 2 to 6 weeks after screening as part of a longitudinal study. Study participants included smokers who intended to quit smoking. Subjects were required to purchase nicotine inhalers and were prompted to quit smoking before follow-up. Based on self-reported duration of abstinence at follow-up, subjects were categorized as recidivists (0 days smoke free), short-term abstainers (1-7 days smoke free), or longer-term abstainers (>7 days smoke free). Kruskal-Wallis tests were used to compare changes in scale scores from screening to follow-up among the 3 groups. RESULTS: The internal consistency reliability of the 13 SCQoL scales ranged from 0.67 to 0.92. Subjects who maintained abstinence for longer periods experienced smaller declines in health-related quality of life between the screening and follow-up assessments. Differences among the 3 groups were driven primarily by differences between recidivists and longer-term abstainers. CONCLUSIONS: The results are consistent with research indicating that recidivists report a greater number of (and more severe) cessation-related symptoms than abstainers. The findings of this investigation provide evidence for the responsiveness of the SCQoL.

Predictors of medication noncompliance in a sample of older adults.

The subjects were 1028 respondents from a randomly selected sample of independently living adults aged 55 years and older in the southeastern United States. Data on background characteristics, physical health, life satisfaction, psychological distress, and medication compliance were gathered from structured interviews. Among the 785 subjects in the analysis who were taking prescribed medications, 75% were women, 83% were white, their median income was $12,500 annually, 66% lived alone, their mean age was 73.9 years, and their mean number of years of education was 11.4. Twenty-one percent of all respondents taking medications had been noncompliant during the month preceding the study interview. Noncompliance with prescribed medications was significantly associated with higher socioeconomic status (P < 0.01), greater number of prescribed medications (P < 0.01), and higher psychological stress (P < 0.05). There was no relationship between compliance and living arrangements, health, life satisfaction, number of illnesses, age, or sex.

A review of health-related quality-of-life measures used in end-stage renal disease.

Health-related quality of life (HRQOL) is a critical issue in the treatment of end-stage renal disease (ESRD) patients. The variety of symptoms, comorbidities, and treatments of ESRD over the course of its chronic disease trajectory necessitate comprehensive assessment of the impact of interventions on HRQOL. A literature review of ESRD HRQOL studies was performed to provide an overview of the instruments used and to provide recommendations for HRQOL assessment in future studies. Instruments were classified based on the health domains they assess and whether they are generic or disease targeted. The instruments were judged in terms of their comprehensiveness, reliability, and validity.

Development of the Smoking Cessation Quality of Life questionnaire.

This paper describes the development of the Smoking Cessation Quality of Life (SCQoL) questionnaire, a self-reported measure designed to quantify the impact of smoking cessation on perceived functioning and well-being in adults. In addition to incorporating the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) as a generic core, the SCQoL contains 5 multi-item cessation-targeted scales: social interactions, self-control, sleep, cognitive functioning, and anxiety. The draft SCQoL was developed through a series of focus groups and was pilot-tested in a sample of 101 adults. Respondents were predominantly male (59.2%), with a mean (SD) age of (48.6) (12.7) years and a mean (SD) smoking history of 29.3 (14.7) years. Of the respondents, 76.5% identified themselves as current smokers and 23.5% indicated that they were former smokers. The majority of former smokers (82.6%) reported being abstinent for > or =2 weeks. Multivariate analysis of variance was used to compare scale scores between smokers and former smokers who had been abstinent for > or =2 weeks. Former smokers reported significantly higher scores than did current smokers on 3 of 8 SF-36 scales and 3 of 5 cessation-targeted scales (P < 0.05). In no case did current smokers report significantly higher scale scores than did former smokers. The internal-consistency reliability of the SCQoL scales ranged from 0.68 to 0.96, exceeding 0.70 on 12 of 13 scales. These findings provide preliminary evidence for the reliability and construct validity of the SCQoL.

Quality of life and policy analysis in arthritis.

Problems in the American health care system have stimulated interest in cost-effectiveness methodologies. However, there is little consensus on how to define a common unit of health outcome. Many measures used in policy studies consider only mortality and do not fully capture the significant impact of disease-related dysfunction. The impact of conditions, such as osteoarthritis, that have little impact on mortality rates but substantial impact on functioning and well-being may be underestimated in these analyses. In this article, we propose a measurement and policy model that is based on a theoretical conceptualization of health outcome. The model considers the impact of disease and its treatment in terms of both morbidity and mortality. The value of the model for clinical trials, population assessments, and policy analysis is reviewed. A public policy application of the model in Oregon is briefly described.

Home monitoring of theophylline levels: a novel therapeutic approach.

This pilot clinical investigation was conducted to compare a home therapeutic drug-monitoring (TDM) method for theophylline blood levels and a traditional TDM method with respect to various patient outcome factors. Outpatients with chronic obstructive pulmonary diseases (COPD) or asthma who were receiving long-term theophylline therapy were randomized to one of two groups: home TDM or traditional TDM (controls). Patients in the former group monitored their serum theophylline levels at home over 6 months. Patients in both groups completed survey instruments, including questionnaires, visual analog scales, and other psychosocial measures, at designated times throughout the study period. Pulmonary function tests and dyspnea index scores were evaluated at each clinic visit. Results indicated a significantly lower (p less than 0.05) number of changes in concomitant drug therapy in the home TDM group compared with controls. Other indicators that showed a trend toward more favorable outcomes in the home TDM group included symptomology, percentage of levels within the therapeutic range, patient attitudes regarding participation in health care management, and pulmonary function test results. Home monitoring prevented unnecessary clinic visits in several instances when theophylline dosage adjustments were based on telephone reports from patients. The utility of a home TDM method for theophylline has not been reported previously despite potential for broad applications. Findings from this preliminary study may support the use and feasibility of state-of-the-art methodologies in carefully selected subpopulations outside the confines of the hospital or clinic setting.

Peripheral vascular disorders. A pharmacoeconomic and quality-of-life review.

The purpose of this article is to review the literature on the pharmacoeconomics and quality of life of therapy interventions for patients with peripheral vascular disorders. The paper is in 4 parts. The first presents a framework for the analysis of such drug interventions, which contrasts studies that have a clinical focus with those that take a system or modelling focus and presents a research typology for studies in this area. The second part of the paper reviews pharmacoeconomic studies of selected interventions and assesses their contribution to decision-making within healthcare systems. The particular focus is on the pharmacoeconomics of therapy for atherosclerosis. While there are no studies which have evaluated the overall costs of treatment in this disease area or considered the cost effectiveness of the range of alternative treatment strategies, the issues of good clinical practice and the implicit cost effectiveness of identifying patients for treatment options and prevention strategies has been addressed. The few studies which have considered the cost consequences of particular intervention strategies, specifically pentoxifylline therapy and surgical options, are limited in scope and are difficult to generalise due to their age, their study design or the treating environment from which data are drawn. The third part reviews quality-of-life studies and, once again, assesses their contribution to formulary decision-making. There are no published studies which have compared quality-of-life outcomes associated with alternative treatment approaches or which have reported changes associated with pharmacotherapy in patients with peripheral vascular disorders. Finally, given the dearth of studies in this area, a research agenda is proposed for ongoing investigations.

A comparative review of generic quality-of-life instruments.

The assessment of health-related quality of life (HR-QOL) is an essential element of healthcare evaluation. Hundreds of generic and specific HR-QOL instruments have been developed. Generic HR-QOL instruments are designed to be applicable across a wide range of populations and interventions. Specific HR-QOL measures are designed to be relevant to particular interventions or in certain subpopulations (e.g. individuals with rheumatoid arthritis). This review examines 7 generic HR-QOL instruments: (i) the Medical Outcomes Study 36-Item Short Form (SF-36) health survey; (ii) the Nottingham Health Profile (NHP); (iii) the Sickness Impact Profile (SIP); (iv) the Dartmouth Primary care Cooperative Information Project (COOP) Charts; (v) the Quality of Well-Being (QWB) Scale; (vi) the Health Utilities Index (HUI); and (vii) the EuroQol Instrument (EQ-5D). These instruments were selected because they are commonly used and/or cited in the English language literature. The 6 characteristics of an instrument addressed by this review are: (i) conceptual and measurement model; (ii) reliability; (iii) validity; (iv) respondent and administrative burden; (v) alternative forms; and (vi) cultural and language adaptations. Of the instruments reviewed, the SF-36 health survey is the most commonly used HR-QOL measure. It was developed as a short-form measure of functioning and well-being in the Medical Outcomes Study. The Dartmouth COOP Charts were designed to be used in everyday clinical practice to provide immediate feedback to clinicians about the health status of their patients. The NHP was developed to reflect lay rather than professional perceptions of health. The SIP was constructed as a measure of sickness in relation to impact on behaviour. The QWB, HUI and EQ-5D are preference-based measures designed to summarise HR-QOL in a single number ranging from 0 to 1. We found that there are no uniformly 'worst' or 'best' performing instruments. The decision to use one over another, to use a combination of 2 or more, to use a profile and/or a preference-based measure or to use a generic measure along with a targeted measure will be driven by the purpose of the measurement. In addition, the choice will depend on a variety of factors including the characteristics of the population (e.g. age, health status, language/culture) and the environment in which the measurement is undertaken (e.g. clinical trial, routine physician visit). We provide our summary of the level of evidence in the literature regarding each instrument's characteristics based on the review criteria. The potential user of these instruments should base their instrument selection decision on the characteristics that are most relevant to their particular HR-QOL measurement needs.

Valuation of EuroQOL (EQ-5D) health states in an adult US sample.

While the EuroQOL instrument (EQ-5D) is being considered and used in clinical trials in the United States and Canada, and in large international multicentre studies, population weights for the instrument have never been established in North America. The primary purpose of this investigation was to derive a set of US-based population weights for the standard set of health states described in the EQ-5D health questionnaire. Valuations for EQ-5D health states were obtained via a postal survey using the visual analogue scale (VAS) format. A sample of 3,500 adults from the continental US were surveyed. A response rate of 25.8% was obtained. Mean and median valuations for 45 distinct health states, including dead and unconscious, were calculated. An ordinary least squares (OLS) regression-based weighting scheme was constructed to impute scores for states not directly valued in the questionnaire formats. Valuations for the standard EQ-5D health states displayed similar characteristics to VAS valuations obtained in previous investigations in European countries. The OLS model fit the observed data relatively well, achieving an adjusted R2 of 0.42. However, the diagnostic testing indicated that the initial model was misspecified. Subsequent alternative models alleviated some, but not all, of the problems of misspecification. The EQ-5D valuations from adult Americans in this sample appeared to behave in much the same fashion as in previous valuation studies. However, the generalisability of results to the entire adult American population may be limited. Violations of assumptions of the OLS regression model indicate the need for further investigation into the modelling technique used in deriving a single index score.

Initial treatment choice in depression: impact on medical expenditures.

OBJECTIVE: The purpose of this study was to examine the economic outcomes associated with initial treatment choice following a diagnosis of depression. METHODS: Insurance claims data were used to classify patients into one of 4 treatment cohorts: no therapy, psychotherapy, drug therapy and combination therapy. Potential sample selection bias was accounted for by using a 2-stage econometric estimation procedure where initial treatment choice was estimated using a multinomial logistic regression model in the first stage, and total and mental healthcare costs were estimated in ordinary least squares regression models in the second stage. Log predicted costs from the second stage were compared to determine the relative costs associated with each cohort. RESULTS: Significant differences (p < 0.008) in total costs were found between the combination therapy (log predicted cost = 9.526) and psychotherapy cohorts (log predicted cost = 8.120) in the analysis that included all observations (n = 9110). In the analysis that included patients who initiated therapy with a non-mental health provider (n = 2673), the drug therapy cohort (log predicted cost = 8.238) was found to be significantly more costly as compared to the no therapy cohort (log predicted cost = 7.788). CONCLUSIONS: These results indicate that after controlling for both observed and unobserved factors, total healthcare costs may be higher in patients who initiate therapy with drug therapy and combination therapy as opposed to no therapy or psychotherapy. In addition, the finding that patients initially receiving psychotherapy alone tend to have higher mental healthcare costs but lower total healthcare costs than other patients may indicate that psychotherapy has an impact on comorbid illness and may subsequently reduce total healthcare costs.

Comparison of Finnish and U.S.-based visual analog scale valuations of the EQ-5D measure.

The EQ-5D is a multiattribute health status measure that can be used to derive preference-based index scores for health-related quality-of-life (HRQOL) assessment. Valuations for EQ-5D health states using different techniques have been obtained in a number of countries. It is not clear how valuations from different countries compare. Using an ordinary least-squares regression, visual analog scale valuations for EQ-5D health states obtained in postal surveys in Finland and the United States were compared. The regression model estimates indicated that Finnish and U.S. respondents did provide different preference valuations for different levels of health. However, the country-specific differences were not large and depended on the dimension and the level of problem on that dimension. Differences in health-state valuations are unlikely to have important implications when using the EQ-5D in international studies.

Construct validities of the Quality of Well-Being Scale and the MOS-HIV-34 Health Survey for HIV-infected patients.

This research assessed the construct validities of two health-related quality-of-life instruments: the Quality of Well-Being Scale (QWB) and the Medical Outcomes Study 34-item HIV Health Survey (MOS-HIV-34). A sample of 100 adult male, HIV-infected patients, across six HIV disease classifications, was used as subjects. Four convergent validity measures of health-related quality of life were used: CD4 cell counts, beta-2 microglobulin levels, disease classification, and age. All convergent validity measures were significant for the QWB. Forty percent of the convergent validity comparisons with the MOS-HIV-34 were statistically significant. Because the two measures provide different perspectives on health-related quality of life, both instruments appear to be useful in measuring health-related quality of life in this patient population.

Health status and satisfaction with pharmacy services.

OBJECTIVE: To evaluate the relationship between self-reported health status and satisfaction with pharmacy services. STUDY DESIGN: Secondary analysis of data previously collected via a computer-assisted telephone interview system. PATIENTS AND METHODS: Survey respondents were enrollees in a large managed care organization who were recent patrons of either traditional or mail pharmacy services. Satisfaction data were gathered using an existing satisfaction with pharmacy services survey. Health status was measured using the Medical Outcome Study's Short-Form 12-Item Health Survey. The relationships between satisfaction with pharmacy services and health status were analyzed using structural equation modeling. RESULTS: A significant positive relationship between mental health status and satisfaction with pharmacy services was hypothesized and confirmed. The correlations between mental health status and satisfaction, however, were not strong (r = .10 to .18). No relationship between physical health status and satisfaction with pharmacy services was observed. Similar results were observed in patrons of both traditional and mail pharmacy services. CONCLUSION: This investigation offers evidence that satisfaction with healthcare services is more closely related to mental health status than to physical health status. This has important implications for case-mix adjustments in the measurement of satisfaction with care.