November 1998 - Volume 3 - Issue 4 A Publication for Members of Medical Outcomes Trust The prospective effect of access to medical care on health-related quality-of-life outcomes in patients with symptomatic HIV disease [see comments].
Cunningham WE, Hays RD, Ettl MK, Dixon WJ, Liu RC, Beck CK, Shapiro MF. Med Care 1998 Mar; 36(3):295-306.
This study examined the prospective effect of reported access to medical care on health-related quality-of-life outcomes in patients with symptomatic human immunodeficiency virus (HIV) disease. A cohort study was designed with interviews at baseline, follow-up interviews at 3 months after baseline, mortality follow-up through 6 months after baseline, and medical record reviews for selected baseline clinical data. Participants were HIV-infected patients who were receiving ambulatory and/or hospital care at one county-run municipal and one Veterans Administration hospital in metropolitan Los Angeles and were interviewed about access to medical care (using a reliable 9-item scale assessing affordability, availability, and convenience of medical care). Access to care reported by this sample was compared with that of 2,471 patients with other chronic diseases from the Medical Outcomes Study. The main outcome measures were composite scores for physical and mental health-related quality of life 3 months after baseline, derived from a validated 56-item instrument, scored from 0 to 100, and controlling for baseline health-related quality of life. Overall reported access to medical care in this sample was significantly poorer than that for patients with other chronic diseases (means scores were 63 and 73, respectively). The sample was categorized into tertiles of initial physical and mental health-related quality of life and into groups with initial high versus low access to care. Among those in the middle tertile of physical health-related quality of life at baseline, those with high access improved in physical health scores by 10 points relative to those with low access. Those in the low and middle tertiles of initial mental health improved in mental health to a significantly greater extent for those with high versus low access. The effects of access on health-related quality-of-life outcomes were generally robust in multivariate regression analyses that included CD4, hemoglobin, albumin, insurance status, and sociodemographic characteristics. It was concluded that access to care at baseline predicted better physical and mental health outcomes at 3 months for those in the middle tertile of physical health and for those in the bottom and middle tertiles of mental health at baseline.
A new HIV/AIDS-targeted quality of life (HAT-QoL) instrument: development, reliability, and validity.
Holmes WC, Shea JA. Med Care 1998 Feb; 36(2):138-54.
The objectives of this study were to identify quality-of-life concerns, as reported by human immunodeficiency virus (HIV) seropositive individuals, and to develop a measure to assess these concerns. The HIV/acquired immunodeficiency syndrome (AIDS)-targeted measure was developed in two linked studies. In study one, group discussions with 42 HIV seropositive individuals were used to generate item content for the new measure. In study two, 201 HIV seropositive individuals were cross-sectionally studied to identify dimensions and to reduce the number of items of the quality of life questionnaire resulting from study one. Study one subjects (76% male; 66% white; 55% gay/bisexual) identified concerns captured by 76 items. Factor analysis indicated that responses of study two subjects (78% male; 42% white; 55% gay/bisexual) could be summarized by nine dimensions. Overall function, sexual function, disclosure worries, health worries, financial worries, HIV mastery, life satisfaction, medication concerns, and provider trust dimensions were refined by removing items using methods to maximize internal consistency and to minimize item redundancy. Five dimensions of the new HIV/AIDS-targeted quality of life instrument (overall function, disclosure worries, health worries, financial worries, and life satisfaction) exhibited good psychometric properties, including low ceiling/floor effects, good internal consistency, and evidence for construct validity.
Reliability and validity of physical and mental health summary scores from the Medical Outcomes Study HIV Health Survey.
Revicki DA, Sorensen S, Wu AW. Med Care 1998 Feb; 36(2):126-37.
Health-related quality of life measures are used to evaluate patient outcomes in clinical trials of new treatments for human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). Summary index scores, rather than profiles of scale scores, would simplify data analysis and interpretation of findings from clinical trials and comparison across studies. In this study, baseline MOS HIV Health Survey scores from two clinical trials of new antiretroviral medications in HIV/AIDS patients (total n = 2253) and an observational study (n = 162) were used to develop physical health summary (PHS) and mental health summary ( MHS) scores. Exploratory and confirmatory factor analysis were used to identify the factor structure of the summary scores based on MOS HIV Health Survey scales. Physical health summary and MHS scores were derived and the factor structure proved invariant across the two groups. Reliability of the PHS score was 0.90 to 0.92 and MHS score was 0.91 to 0.94. Mean PHS and MHS scores differed in patient groups defined by HIV disease stage, HIV disease severity, Karnofsky performance status scores, and global ratings of health status. Mean PHS and MHS scores in patient reporting worsening health status were significantly lower than scores of patients reporting stable or improving health status. In conclusion, the PHS and MHS were reproducible across different samples of HIV/AIDS patients and are reliable and valid measures for demonstrating treatment impact on patient functioning and well-being.
A Clinical Trial of an Alternative Treatment for HIV/AIDS Peripheral Neuropathy: Pain Management through Electroacupuncture.
GalantinoML, Eke-Okoro St, Findley TW, Rehabilitation Oncology 1998 16(2).
The purpose of this study was to evaluate the effect of electroacupuncture in the management of pain in HIV/AIDS patients. Seven HIV/AIDS outpatients (6 males and 1 female) between the ages of 31 and 45 years (mean 37 SD 6 years) participated in the study of: 1)antiretroviral drug-induced neuropathy or 2) HIV-related distal sensory peripheral neuropathy. Suprathreshold electroacupuncture derived from the H-wave therapeutic unit was used. Noninvasive electrodes were paced on identified acupuncture points and suprathreshold current passed for 20 minutes every day for 30 days. The noninvasive method avoided the use of needles and allowed home stimulation. Patients were assessed pre and postintervention with the MOS-HIV questionnaire and tibia H-reflex was similarly recorded from the right calf muscle. MOS-HIV data were analyzed using MANOVA and matched pair t-test. In matched pair t-test total pre-intervention scores from pain scores were compared to postintervention scores. Pre-and post-treatment H-reflex parameters were compared with the t-test and also graphically using the 45 degrees line. There was a spontaneous improvement in the condition of the patients. Outcomes on the MOS-HIV showed significant overall improvement in functional activities (p=.02 MANOVA). Conclusion: Within the limits of the trial study, the results show that electroacupuncture reduced pain and improves functional status in the HIV/AIDS patient.
Measuring quality of life in early HIV disease: the modular approach.
Lenderking WR, Testa MA, Katzenstein D, Hammer S. Qual Life Res 1997 Aug; 6(6):515-30.
The rationale of this study was to examine the reliability and validity of the General Health Self-assessment, a modular questionnaire for self-assessment of quality of life (QoL) in human immunodeficiency virus (HIV) clinical trials and to describe the baseline QoL of participants in a large HIV clinical trial. The domains assessed in this study included health perceptions, physical, psychological and role/social functioning, health care utilization and symptom distress. Approximately 1700 subjects with early HIV infection enrolled in the AIDS Clinical Trials Group Protocol, and 175 completed the scale at baseline. The domains demonstrated reliability, construct and discriminant validity. A worse QoL was associated with recent hospitalization and symptomatic status. Prior antiretroviral therapy was associated with higher health perceptions and well-being. The presence of symptom distress was related to lower QoL on the other scales. There was no relationship between QoL scales and the baseline CD4 count. Women showed a lower QoL than men on all scales, while ethnicity was related to differences in health perceptions and physical and psychological functioning. In conclusion, the General Health Self-assessment shows excellent potential as a measure of QoL for HIV-infected patients in clinical trials. Further research is necessary to determine the responsiveness of the scale to clinical and immunological changes in HIV-infected individuals.
Assessment of quality of life in early stage HIV-infected persons: data from the AIDS Time-oriented Health Outcome Study (ATHOS).
Lubeck DP, Fries JF. Qual Life Res 1997 Aug; 6(6): 494-506.
The development of new pharmaceutical interventions for persons with human immunodeficiency virus (HIV) infection has resulted in extended survival and a need for valid, reliable and responsive instruments to assess health-related QoL (HRQoL). This paper reviews the reliability and validity of an HRQoL instrument, the AIDS Health Assessment Questionnaire (AIDS-HAQ), among persons participating in an observational database of HIV infection. The AIDS-HAQ includes nine subscales: disability, energy, general health, pain, cognitive functioning, mental health, social functioning, health distress and symptoms. Individuals complete the AIDS-HAQ quarterly. Data are reported for 440 individuals entering the study with early HIV infection. Fifty-nine progressed to symptomatic disease and 109 to AIDS after 1 year. The subscales of the instrument resulted in high internal consistency reliability (range = 0.79-0.88). Concurrent validity data reflected the ability to distinguish between patients with increasing disease severity. In all domains, except cognitive functioning, individuals who progressed to AIDS had significant decrements (p < 0.01) in HRQoL compared with symptomatic and asymptomatic patients. Significant decrements (p < 0.01) were observed for disability, general health, energy and symptoms for patients who progressed to symptomatic disease from an asymptomatic status. Individuals who had decreasing CD4+ counts also had significant declines (p < 0.001) in disability, general health, social functioning, pain and symptoms. The AIDS-HAQ is an instrument that can be used when comparing group differences and within group changes in observational databases, naturalistic studies and clinical trials.
Assessing health-related quality of life in HIV disease: key measurement issues.
Shumaker SA, Ellis S, Naughton M. Qual Life Res 1997 Aug; 6(6):475-80.
The reliable and valid assessment of health-related quality of life (HRQoL) in human immunodeficiency virus (HIV) clinical research presents both familiar and unique challenges. Consistent with HRQoL research in general, measures of HRQoL in HIV disease must meet a set of standard psychometric properties, produce interpretable results, and be responsive to relatively small treatment effects. Furthermore, as clinical research for a range of diseases and conditions becomes increasingly global, HRQoL investigators are confronted with the formidable task of developing measures that are applicable across a range of cultures and languages within and across national boundaries. In this paper, we present a model of HRQoL to be applied across disease and conditions, with a discussion of the key measurement issues. We then briefly consider the natural history and treatment aspects of HIV that are relevant to HRQoL research. In the final sections of the paper, we describe the elements needed in an 'ideal' HRQoL/HIV instrument and propose a method for evaluating the degree to which current HRQoL measures address the challenges posed by HIV clinical research.
Applications of the Medical Outcomes Study health-related quality of life measures in HIV/AIDS.
Wu AW, Hays RD, Kelly S, Malitz F, Bozzette SA. Qual Life Res 1997 Aug; 6(6):531-54.
The leading health status instruments in human immunodeficiency virus (HIV) research are based on the pool of items developed as part of the Medical Outcomes Study (MOS). The measures include the SF-20, MOS-HIV, SF-36, SF-12, SF-56, SF-38 (Patient Reported Status and Experience Survey (PARSE)), SF-21, and HIV Cost and Service Utilization Study (HCSUS) questionnaires. The instrument length ranges from 12 to 56 items, covering two to 11 dimensions. Completion requires from 2 to 14 minutes. Subscales are scored on a 0-100 scale (a higher score indicates better health); physical and mental health or overall summary scores are available for most of the measures. Three of the instruments are available in multiple languages. The instruments have been administered to over 20,000 persons with HIV in descriptive studies and clinical trials and there is substantial evidence for their reliability, construct and predictive validity and responsiveness. In several studies the measures have shown important differences between treatments. Although existing measures do not assess all domains relevant to HIV disease, additional subscales are available from the MOS pool. Some of the subscales may be prone to floor and ceiling effects, however, summary scales that encompass all of the subscales reduce this issue. Selection among MOS measures should be dictated by specific questions, the balance of available time and resources, and practical concerns.
Health values of patients infected with human immunodeficiency virus. Relationship to mental health and physical functioning.
Tsevat J, Solzan JG, Kuntz KM, Ragland J, Currier JS, Sell RL, Weinstein MC. Med Care 1996 Jan; 34(1):44-57.
By assessing the health values of patients infected with human immunodeficiency virus (HIV) and examining the relationships between their health values and health status at two points in time, the authors sought to determine whether patients' physical and mental health statuses were good predictors of how they valued their current state of health. One hundred thirty-nine patients with various stages of HIV infection were interviewed in a prospective cohort study based in a primary care practice of a community-based teaching hospital. Patients were interviewed twice at 6-month intervals using three health value measures—the time trade off, rating scale, and Quality of Well-being Scale—and three health status measures: the 18-item Mental Health Inventory, the Dyspnea-Fatigue Index, and the Medical Outcomes Study SF-36 Health Survey. The health status of HIV-infected patients was compromised and, with the exception of mental health, generally was worse among patients with more advanced HIV-infection. Rating scale and Quality of Well-being Scale scores were related inversely to disease stage, but time-trade off scores generally were higher regardless of disease stage. Health value measures showed moderate relationships with measures of physical functioning (r = 0.34- 0.68) but only a fair relationship with mental health (r = 0.00-0.48). The health status of HIV-infected patients who remained asymptomatic or remained symptomatic but without developing acquired immunodeficiency syndrome (AIDS) changed little over 6 months, whereas the health status of patients with AIDS and of patients manifesting progression of HIV-infection deteriorated over time. In contrast, health values, particularly time-tradeoff scores, remained stable even in the face of changes in health status and disease progression. With the exception of mental health, the impact of HIV infection on health status tends to parallel the clinical stage of disease. Health values of HIV-infected patients, however, generally are high and correlate better with physical functioning than with mental health.