Biomedical subjects

D A Revicki

Publications and source records attributed to D A Revicki.

At least 37 records · Page 2Linked to original sources

PubMed1999

Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease.

BACKGROUND: Medical treatments for gastro-oesophageal reflux disease (GERD) vary in their ability to completely resolve heartburn and other symptoms. Although GERD reduces health-related quality of life (HRQL) little is known about the relationship between resolution of heartburn symptoms with medical therapy and HRQL. We evaluated the association between complete resolution of heartburn symptoms and functioning and well-being in three samples of patients with GERD. METHODS: We analysed baseline and follow-up assessments of heartburn symptoms and HRQL scores from three clinical trials (total n=1351) comparing omeprazole and ranitidine for acute symptomatic treatment of GERD. Heartburn symptoms were measured using patient diaries and/or patient self-report. HRQL was assessed using the Psychological General Well-Being Index (PGWB) in all three clinical trials and the SF-36 Health Survey in two clinical trials. Resolution of heartburn symptoms was defined as no heartburn reported during the assessment period. RESULTS: We observed statistically significant differences favouring patients with no heartburn symptoms on the PGWB total score (P=0.018 to P < 0.0001) and anxiety (P=0.002 to P < 0.0001), general health (P=0.05 to P < 0. 0001), positive well-being (P=0.028 to P < 0.0001) and vitality (P=0. 05 to P < 0.0001) sub-scale scores at 4-14 weeks. Patients with no heartburn reported better SF-36 pain (P=0.005 to P < 0.0001) and general health perceptions (P=0.032 to P < 0.0001) compared with patients still experiencing heartburn symptoms at 4-24 weeks. SF-36 physical component summary scores were significantly better in patients with no heartburn symptoms compared with patients with heartburn symptoms at 4-24 weeks (P=0.013 to P=0.009), while mental component summary scores were only significantly different at 24 weeks (P=0.0005) in one of the two studies where the SF-36 was utilized. CONCLUSIONS: Complete resolution of heartburn symptoms was consistently associated with improvement in HRQL; the greatest impact was observed on measures of psychological well-being and physical functioning and well-being. Effective treatment of GERD that completely resolves heartburn results in clinically significant improvement in patient HRQL.

Anti-Ulcer Agents↗

PubMed1999

Health-related quality of life in primary care patients with gastroesophageal reflux disease.

OBJECTIVE: To describe the clinical characteristics and health-related quality of life of family medicine patients with clinically diagnosed gastroesophageal reflux disease (GERD). METHODS: The study involved the baseline assessment of 268 patients enrolled in a randomized clinical trial comparing treatments for GERD. The study was conducted in a five-center, university-based family practice in southeastern West Virginia. Patients with a clinical diagnosis of GERD and who had not received treatment in the past 30 days were eligible; pregnant and lactating women and patients with severe renal or hepatic insufficiency were excluded. RESULTS: Two hundred sixty-eight patients were included in the analysis. Mean +/- SD age was 44.9 +/- 14.1 years; 61.2% were women and 91.4% were white. Mean +/- SD body mass index was 30.3 +/- 6 kg/m2, and >15.3% of patients had no insurance. One hundred seventy-four (64.9%) patients were enrolled from nonurban primary care clinics. One hundred sixty-four patients (61.2%) were prescribed at least one medication prior to study enrollment (mean +/- SD 2.88 +/- 1.71; range 1-9). When adjusted for age, gender, comorbidity status, and rural status, severity of GERD was associated with decreased health-related quality of life. GERD patients without comorbidity demonstrated decrements in health-related quality of life when compared with the US general population. When compared with another GERD population, the study patients reported fairly consistent GERD symptomatology and health-related quality of life. CONCLUSIONS: GERD symptom severity was associated with impaired health-related quality of life in a predominantly rural primary care population.

Adult↗

PubMed1999

Pharmacoeconomic evaluation in the real world. Effectiveness versus efficacy studies.

Pharmacoeconomic data may be obtained within the context of randomised clinical trials (RCTs) and from effectiveness studies in the 'real world'. The differences between the 2 types of study design have implications for the types of data that can be obtained and the interpretation of the resulting findings. Because RCTs are designed to assess the safety and efficacy of pharmaceuticals, and because the study design of RCTs emphasises internal validity over generalisability, the pharmacoeconomic data collected from them are limited. The data may not be applicable to the more heterogeneous patients encountered in actual clinical practice, and cost estimates may be inaccurate because of protocol requirements. Effectiveness studies, in which treatments are studied under real-world conditions, remedy some of these limitations. Generalisability to actual users is generally enhanced in effectiveness designs, but data may be biased in other ways. This brief review compares the 2 study designs as they relate to pharmacoeconomic evaluations in terms of the research questions they address, design differences and their implications for study bias, data collection and data analysis and the generalisability of their results.

Clinical Trials as Topic↗

PubMed1999

Clinical and economic outcomes of olanzapine compared with haloperidol for schizophrenia. Results from a randomised clinical trial.

OBJECTIVE: The purpose of this study was to compare, from the payor perspective, the clinical and economic outcomes of olanzapine to those of haloperidol for the treatment of schizophrenia. DESIGN AND SETTING: Clinical, quality-of-life and resource utilisation data were prospectively collected for US-residing patients with schizophrenia who were participating in a multicentre, randomised, double-blind clinical trial comparing olanzapine and haloperidol. Direct medical costs were estimated by assigning standardised prices (1995 values) to the resource utilisation data. PATIENTS AND PARTICIPANTS: 817 patients with schizophrenia who had a baseline Brief Psychiatric Rating Scale score (BPRS) > or = 18 (items scored 0 to 6) and/or were no longer tolerating current antipsychotic therapy. INTERVENTIONS: Olanzapine 5 to 20 mg/day (n = 551) or haloperidol 5 to 20 mg/day (n = 266) for 6 weeks. Patients showing a predefined level of clinical response entered a 46-week maintenance phase. MAIN OUTCOME MEASURES AND RESULTS: After acute treatment, BPRS-based clinical improvements were seen in 38 and 27% of olanzapine and haloperidol patients, respectively (p = 0.002). Clinically important improvements on the Quality of Life Scale were achieved during acute treatment in 33% of olanzapine recipients and 25% of haloperidol recipients (p = 0.094). Olanzapine treatment in the acute phase led to significantly lower inpatient ($US5125 vs $US5795, p = 0.038) and outpatient ($US663 vs $US692, p = 0.001) costs, resulting in a significant overall reduction in mean total medical costs of $US388 (p = 0.033). This significant reduction in total costs was found despite olanzapine mean medication costs being significantly greater than haloperidol medication costs ($US326 vs $US15, p < 0.001). No significant differences in clinical improvement were observed in the maintenance phase. Maintenance phase olanzapine mean total medical costs were $US636 lower than haloperidol total costs (p = 0.128). Although olanzapine medication costs were significantly higher than haloperidol medication costs ($US3461 vs $US95, p < 0.001), this difference was offset by significantly lower inpatient ($US8322 vs $US10,662, p = 0.044) and outpatient ($US3810 vs $US5473, p = 0.038) costs. CONCLUSIONS: In this study, olanzapine treatment was more effective than haloperidol in producing clinical response in the acute phase. In addition, olanzapine treatment led to reductions in inpatient and outpatient costs that more than offset olanzapine's higher medication costs relative to haloperidol.

Adult↗

PubMed1999

Pharmacoeconomic evaluation of treatments for refractory schizophrenia: clozapine-related studies.

Cost-effectiveness analyses determine whether a new therapy will find a place in clinical practice, based on the cost of its use and the health outcomes it produces, compared with other available therapies. Clozapine, indicated for treatment-resistant schizophrenia, has been evaluated in uncontrolled, mirror-image studies; clinical decision analysis models; and prospective, randomized clinical trials. Results from randomized trials demonstrate that clozapine controls symptoms of psychopathology and improves quality of life slightly more effectively than traditional neuroleptic medications. It has a lower incidence of extrapyramidal side effects than traditional medications, resulting in a lower drop-out rate. Beginning in the second year of treatment, clozapine may produce cost savings for the health care system, when its higher acquisition cost begins to be offset by reduced hospitalization. Mirror-image studies and clinical decision analysis models provide further support for these findings.

Clozapine↗

PubMed1999

Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir plus zalcitabine therapy for adults with advanced HIV infection with CD4 counts between 50 and 300 cells/mm3.

BACKGROUND: Benefits in patient health-related quality of life (HRQL) have not yet been demonstrated for combination antiretroviral therapy with protease inhibitors and nucleoside analogues. This double-blind study evaluated zalcitabine or saquinavir monotherapy and combination saquinavir plus zalcitabine therapy on HROL of human immunodeficiency virus (HIV)-infected adults. METHODS: 940 HIV-infected patients (CD4 counts 50-300 cells/mm3) who had discontinued zidovudine therapy (for intolerance or treatment failure) were randomized to one of three regimens: zalcitabine 0.75 mg every 8 h; saquinavir 600 mg every 8 h; or combination zalcitabine 0.75 mg plus saquinavir 600 mg every 8 hours. HRQL was measured at baseline, 24 and 48 weeks using the Medical Outcome Study HIV Health Survey (MOS-HIV). The primary endpoints were the physical and mental health summary scores (PHS; MHS) of the MOS-HIV as well as a global visual analogue scale (VAS) score. RESULTS: After 24 weeks, the zalcitabine-treated patients demonstrated significantly greater decreases in PHS scores (-4.4 +/- 0.6; saquinavir: -1.3 +/- 0.6; zalcitabine plus saquinavir: -1.7 +/- 0.6; P < 0.0001) and MHS scores (-2.2 +/- 0.5; saquinavir: -1.0 +/- 0.5; zalcitabine plus saquinavir: -0.5 +/- 0.5; P = 0.032) compared to saquinavir and zalcitabine plus saquinavir treated patients. No differences were observed on the VAS (P = 0.172). Nine of 10 MOS-HIV subscales demonstrated results consistent with the primary endpoints. After 48 weeks, a statistically significant difference between the saquinavir-treated groups and the zalcitabine monotherapy group was observed for PHS scores (zalcitabine: -5.8 +/- 0.6; saquinavir: -4.1 +/- 0.6; zalcitabine plus saquinavir: -3.5 +/- 0.6; P = 0.014). CONCLUSIONS: Saquinavir monotherapy and combination saquinavir plus zalcitabine demonstrated a benefit in HRQL relative to zalcitabine monotherapy in patients with prior zidovudine therapy. The HRQL findings are concordant with improved survival and reduced clinical progression of HIV infection found in this study.

Anti-HIV Agents↗

PubMed1998

A randomized trial of the effect of ritonavir in maintaining quality of life in advanced HIV disease. Advanced HIV Disease Ritonavir Study Group.

BACKGROUND: The aim of treatment for HIV disease is prolonging survival and improvement in health-related quality of life. Ritonavir is a potent, orally bioavailable HIV protease inhibitor with demonstrated impact on surrogate endpoints, AIDS-defining disease, and mortality. OBJECTIVES: To evaluate the effect of ritonavir combined with reverse transcriptase inhibitor therapy on patient functioning and well-being. METHODS: An international, multicenter randomized placebo-controlled clinical trial of ritonavir was conducted in HIV-infected patients with CD4 cell counts < or = 100 x 10(6)/l. A total of 1090 patients were randomized to ritonavir and continued treatment with as many as two nucleoside agents (n=543) or placebo and continued treatment with as many as two nucleoside agents (n=547). Health-related quality of life was measured at baseline and after 3 and 6 months of treatment using the Medical Outcomes Study HIV Health Survey (MOS-HIV) and HIV-related symptoms scale. MOS-HIV contains 10 subscales and two summary scores (physical health and mental health). RESULTS: The two treatment groups were comparable on baseline CD4 cell counts, demographic characteristics, and MOS-HIV and HIV symptom subscale scores. After 3 months, statistically significant differences (P < 0.03) favoring the ritonavir-treated patients were seen on the physical health summary, mental health summary, and general health perceptions, social function, mental health, and energy/fatigue subscales. After 6 months of ritonavir therapy, significant differences were observed on physical health and mental health summary scores (P < 0.001), and on measures of general health perceptions, physical function, role function, social function, cognitive function, mental health, health distress, energy/fatigue, and overall ratings of quality of life (P < 0.01). Ritonavir-treated patients reported fewer fever symptoms and neurologic symptoms than the placebo group after 6 months of treatment (P < 0.005). CONCLUSIONS: Ritonavir therapy, combined with other antiretroviral treatments, significantly contributes to maintenance of functioning and well-being over at least 6 months in patients with advanced HIV disease.

Adult↗

PubMed1998

The impact of gastroesophageal reflux disease on health-related quality of life.

BACKGROUND: Gastroesophageal reflux disease (GERD) affects health-related quality of life. METHODS: We enrolled 533 adults with a history of heartburn symptoms for at least 6 months of moderate to severe heartburn in 4 of the 7 days before study entry. Patients were treated with ranitidine 150 mg twice a day for 6 weeks and Gelusil antacid tablets as needed. We measured physician-rated symptoms and the Medical Outcomes Study short-form 36 (SF-36) Health Survey at baseline and after 6 weeks of treatment. Baseline results were compared with normative data for the US population and for patients with selected chronic diseases. Treatment response was defined as no episode of moderate to severe heartburn for 7 days. Statistical significance was set at P <0.001. RESULTS: GERD patients reported significantly worse scores on all 8 SF-36 scales, physical function and well-being, and emotional well-being compared with the general population. Patients with GERD reported worse emotional well-being than patients with diabetes or hypertension. Treatment responders demonstrated significantly less pain and better physical function, social function, vitality, and emotional well-being compared with nonresponders. CONCLUSIONS: Patients with GERD experience decrements in health-related quality of life compared with the general population. The impact of GERD is most striking on measures of pain, mental health, and social function. Successful treatment for GERD results in improvements in health-related quality of life.

Adult↗

PubMed1998

Patient-assigned health state utilities for depression-related outcomes: differences by depression severity and antidepressant medications.

BACKGROUND: Major depressive disorder is a prevalent psychiatric disorder in primary care associated with impaired patient functioning and well-being. We compared patient utilities for hypothetical depression-related and current health states and to examine differences in utilities by patient demographic and clinical characteristics. METHODS: Seventy patients with DSM-III-R major depressive disorder or dysthymia who completed at least 8 weeks of antidepressant treatment were recruited from primary care practices. Patients assessments included the Hamilton Depression Rating Scale (HDRS), SF-36 Health Survey, and standard gamble interviews to obtain utilities for 11 hypothetical depression-related states, varying depression severity and antidepressant treatment, and the patient's current health state. RESULTS: The mean utility for severe depression was 0.30 and 25% of patients rated this state as worse than or equivalent to death. Utilities varied from 0.55 to 0.63 for moderate depression, 0.64 to 0.73 for mild depression, and 0.72 to 0.83 for antidepressant maintenance therapy. Statistically significant differences were observed in mean utilities by level of disease severity and by tricyclic antidepressants compared with the newer antidepressants (i.e., fluoxetine, nefazodone). There were no significant differences in utilities for hypothetical states by demographic variables. Mean patient-assigned utilities for current health varied by depression severity and presence of medication side effects. CONCLUSIONS: Health state utility scores can be provided by patients with depression and the utility scores provided by patients for hypothetical states demonstrate differences by disease severity and antidepressant treatment. LIMITATIONS: The sample size was small which may limit generalizability and statistical power for detecting important differences. The study findings are limited to patients who have successfully completed 8 weeks of antidepressant treatment. CLINICAL RELEVANCE: Understanding patient preferences for depression outcomes is important for economic evaluations of new antidepressants and for understanding patient behavior and adherence to antidepressant treatment regimens.

Adolescent↗

PubMed1998

Health-related quality of life assessment in euthymic and depressed patients with bipolar disorder. Psychometric performance of four self-report measures.

The purpose of this study was to evaluate the psychometric properties of selected health-related quality of life (HRQL) self-report measures in 62 euthymic and depressed patients diagnosed with bipolar disorder. Patients completed the Quality of Life in Depression Scale (QLDS), Mental Health Index-17 (MHI-17), Cognitive Function Scale, and Medical Outcomes Study Short Form-36 (SF-36) at baseline and 8 weeks following treatment. Hamilton and Young Rating Scales were used to assess clinical status and validate the HRQL measures. The MHI-17, Cognitive Function Scale, QLDS, and SF-36 social function, vitality, role limitations-emotional, and mental health scales have good reliability and validity, and are responsive to changes in clinical status in patients with bipolar disorder. Although the small sample size limits generalizablity, euthymic and depressed outpatients with bipolar disorder appear to contribute reliable self reports on selected aspects of their quality of life.

Adult↗

PubMed1998

Olanzapine versus placebo and haloperidol: quality of life and efficacy results of the North American double-blind trial.

This double-blind study evaluated the impact of treatment with olanzapine compared with haloperidol, and placebo on improvements in symptomatology and quality of life in patients with a DSM-III-R diagnosis of schizophrenia. A total of 335 patients was randomized to five treatment groups; olanzapine 5 +/- 2.5 mg/day, olanzapine 10 +/- 2.5 mg/day, olanzapine 15 +/- 2.5 mg/day, haloperidol 15 +/- 5 mg/day, and placebo. Patients responding to treatment during the 6-week acute phase were eligible to enter a 46-week extension. Efficacy measures included the brief psychiatric rating scale total, scale for assessment of negative symptoms summary, and clinical global impressions severity scores. Quality of life was evaluated using the quality of life scale. Data analyzed after 24 weeks of therapy showed that olanzapine was significantly superior to placebo in reducing clinical severity and significantly superior to haloperidol in reducing negative symptoms in patients responding to acute treatment. Furthermore, improvement in quality of life was observed in olanzapine-treated responders.

Adolescent↗

PubMed1998

Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease.

The objective of this study was to evaluate the reliability and validity of the gastrointestinal Symptom Rating Scale (GSRS) in US patients with gastroesophageal reflux disease (GERD). Five hundred and sixteen adults with predominant heartburn symptoms of GERD were recruited from gastroenterologist and family physician practices and treated with 6 weeks of 150 mg ranitidine twice daily to identify poorly responsive symptomatic GERD. The GSRS, the Medical Outcomes Study Short Form-36 (SF-36) Health Survey and the Psychological General Well-being (PGWB) scale were administered at baseline and after 6 weeks of treatment. Reported ratings of GERD-related symptoms from physician and patient diaries were measured. The GSRS contains five scales: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome. The internal consistency reliabilities for the GSRS scales ranged from 0.61 to 0.83 and the intraclass correlation coefficients ranged from 0.42 to 0.60. The GSRS scale scores were correlated with the SF-36 and PGWB scales and with the number and severity of heartburn symptoms. Patients with two or three clinician-rated GERD-related symptoms reported worse GSRS scale scores compared with patients with fewer symptoms (p < 0.0001). Statistically significant differences in the mean GSRS scale scores were observed between treatment responders and non-responders (p < 0.0001) and patients showing a response to treatment had larger mean changes in their GSRS scales than patients not showing a response to treatment (p < 0.0001). The standardized response means ranged from 0.42 to 1.43 for the GSRS scale scores. It was concluded that the GSRS is a brief, fairly comprehensive assessment of common gastrointestinal symptoms. The GSRS has good reliability and construct validity and the GSRS scales discriminate by GERD symptom severity and are responsive to treatment. The GSRS is a useful patient-rated symptom scale for evaluating the outcomes of treatment for GERD.

Adult↗

PubMed1998

Development and preliminary validation of the multiattribute Rhinitis Symptom Utility Index.

The Rhinitis Symptom Utility Index (RSUI) was developed as a preference-based measure of rhinitis symptoms. The RSUI consist of ten questions on the severity and frequency of stuffy or blocked nose, runny nose, sneezing, itching, watery eyes and itching nose or throat over a 14 day period. A cross-sectional survey of 100 adults with allergic rhinitis was completed, with data collected on rhinitis history and severity, physician-rated rhinitis severity, the Rhinitis Quality of Life Questionnaire (RQLQ) and the Health Utilities Index Mark 2 (HUI2). The mean age of the patients was 37 +/- 11 years and 60% were female and 38% had a diagnosis of asthma. A multiplicative multiattribute utility function was developed from patient-derived preferences for different rhinitis-related symptom states. The mean RSUI score for this sample was 0.72 +/- 0.23, with a range of 0.15-1.0. Two week reproducibility of the RSUI was weak (ICC = 0.40). The index differentiated patients by physician-rated severity (p < 0.05) and was correlated 0.35 (p < 0.001) with the HUI2 and -0.67 (p < 0.001) with the RQLQ total score. The RSUI is brief and easy to administer and the results of this study support its reliability and validity. The modest reproducibility reflects the day to day variability of rhinitis. The RSUI may be a useful patient outcome for clinical trials and for cost-effectiveness studies comparing medical treatments for rhinitis.

Adult↗

PubMed1998

Discriminant validity of the Medical Outcomes Study cognitive function scale in HIV disease patients.

Human immunodeficiency virus (HIV) infection results in a chronic course of disease progression and eventual death. With this disease progression comes decreases in health-related quality of life and cognitive function in many patients. We evaluated the construct and discriminant validity of the Medical Outcomes Study four-item and six-item cognitive function scale in a sample of 162 patients with HIV disease. The patients were assessed at baseline and after 4 months with the cognitive function scale, a cognitive functioning transition item, the Reitan trail making test (TMT) and the Centers for Epidemiologic Studies Depression (CES-D) scale. The results found that the four- and six-item cognitive function scales varied by HIV disease stage, CD4 count, self-reported change in cognitive function, TMT-based cognitive impairment and depression. The differences in the cognitive function scores were attenuated, but still remained statistically significant even after controlling for depression. The cognitive function scales predict cognitive impairment based on the TMT. The results support the construct validity of these self-report cognitive function scales.

Adult↗

PubMed1998

Relationship between health status and utility measures in older claudicants.

The purpose of this study was to examine the relationship between health status and health utility measures in 34 older claudicants and to determine which attributes of health status were significant predictors of health state valuation/preference. The MOS SF-36 was used to assess health status and the rating scale and multiattribute Health Utility Index (HUI) were used to assess utility scores. With regard to health status, the bodily pain and physical functioning subscales contributed the most to reductions in quality of life (QoL) with mean subscale scores substantially lower than reported population norms. Patients rated their health status approximately one-third below a state of perfect health on both utility measures. Moderate correlations were observed between the MOS SF-36 subscale scores and the HUI and rating scale scores. In multivariable regression models, physical functioning and mental health were the best predictors of HUI scores, whereas general health and vitality were the best predictors of rating scale scores. Approximately 50% of the variance in utility scores was explained by these attributes. This study provides further documentation that bodily pain and reductions in physical function contribute to reductions in QoL in older patients with intermittent claudication. Other attributes of health status, however, notably psychological distress, were predictive of patients' preference for health states. Recognized constructs of physical and mental health explained the substantial variation in the utility/preference assessment in this population. Furthermore, these data are consistent with those reported in the Dutch Iliac Stent Trial.

Aged↗

PubMed1998

Reliability and validity of physical and mental health summary scores from the Medical Outcomes Study HIV Health Survey.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Adult↗

PubMed1998

SF-36 summary scores: are physical and mental health truly distinct?

OBJECTIVES: Data from 536 primary care patients initiating antidepressant treatment were used to examine the performance of the Medical Outcomes Study SF-36 Physical Component and Mental Component summary scores. METHODS: The SF-36 was administered at baseline and readministered after 1 month and 3 months (n = 482). RESULTS: At the baseline assessment, patients reported modest impairment on the Physical Function, Role--Physical, Bodily Pain, and General Health Perceptions subscales (0.10 to 0.68 standard deviations below national norms), but the Physical Component summary (mean = 51) indicated no impairment based on a population norm of 50. During 3 months of follow-up evaluation, the Physical Function, Role--Physical, Bodily Pain, and General Health Perceptions subscales all showed moderate and statistically significant improvement (range from 0.28 to 0.49 standard deviation units), whereas the Physical Component summary score was essentially unchanged (mean = 50 at both 1-month and 3-month assessments). This pattern of results is a natural consequence of the assumptions and methods used to calculate these summary scores-orthogonal factor rotation and negative scoring coefficients. CONCLUSIONS: These findings suggest caution in the interpretation of Mental Component Summary and Physical Component Summary scores when the condition or treatment of interest has strong effects on scales with negative scoring coefficients (Mental Health and Role--Emotional for the Physical Component; Physical Function, Role--Physical, and Bodily Pain for the Mental Component).

Adolescent↗

PubMed1998

Changes in surrogate laboratory markers, clinical endpoints, and health-related quality of life in patients infected with the human immunodeficiency virus.

OBJECTIVE: To evaluate the relationship between laboratory markers of HIV, AIDS-defining events, study discontinuation, and summary scores from the MOS-HIV Health Survey. METHODS: Secondary analysis of data from a clinical trial of antiretroviral therapies in advanced HIV-infected patients (N = 940). Clinical and health-related quality-of-life data were collected over 48 weeks. Linear regression, logistic regression and survival analyses were performed to evaluate the relationships between MOS-HIV summary scores, clinical events, and laboratory markers. RESULTS: Each point increase in PHS resulted in a 3.0% decrease in the likelihood of developing an AIDS-defining event (p < .05) and a 2.7% decrease in likelihood of study discontinuation (p < .05). MHS did not significantly predict clinical events, but did predict study discontinuation (p < .05). From the linear regression analyses, the change in CD4 counts was a significant predictor of the change in MHS (p < .01). CONCLUSION: The MOS-HIV summary scores predict clinical events and study discontinuation in advanced HIV-infected patients.

Adult↗