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J E Ware

Publications and source records attributed to J E Ware.

At least 55 records · Page 3Linked to original sources
PubMed1998

The health-related quality of life of adults with Gaucher's disease receiving enzyme replacement therapy: results from a retrospective study.

Few studies have reported on the effect of Gaucher's disease on patient-reported, health-related quality of life (HRQoL) and we do not know how the HRQoL burden of Gaucher's disease compares to that of other chronic conditions, what areas of HRQoL are most affected or how the course of change in HRQoL compares with that observed for other conditions or for the general adult population. The purpose of this study was to estimate (1) the HRQoL burden associated with Gaucher's disease managed by enzyme replacement therapy (ERT), (2) recalled changes in HRQoL since ERT initiation and (3) risk factors predictive of HRQoL outcomes. We sampled 212 patients with Gaucher's disease recruited from 146 physicians prescribing ERT in the US. The patients were at least 14 years of age and had been on ERT from 1 to 51 months. The mean (SD) age of the participants was 45 (17) years. Forty-nine percent had had a prior splenectomy and 26% had had a joint replacement. We administered the SF-36 Health Survey (SF-36) and three questions about changes in physical, mental and general HRQoL since starting ERT. The patients with Gaucher's disease scored significantly worse than the age- and gender-adjusted US norms on five of the eight SF-36 subscales (p < 0.05). Age (p < 0.0001) and joint replacement (p < 0.001) were negatively associated with physical health. The presence of an intact spleen (p < 0.01) and a longer duration of ERT (p < 0.01) were associated with better mental health. When asked about changes in HRQoL since starting ERT, at least half of the patients reported fewer limitations in physical activities (53%), better general health perceptions (77%) and less negative emotions (49%) at the time of the interview. Patients who had been receiving ERT for approximately 4 years recalled four and five times more improvement in general HRQoL in comparison with recalled changes over a 4 year period among adults in the general population (p < 0.001) and a congestive heart failure population (p < 0.01), respectively. Odds ratios (ORs) revealed that female patients were more likely to report improvements in general HRQoL than males (OR = 4.50 and 95% CI = 2.19-9.25) and 45 year old patients were less likely to report improvements than 35 year olds (OR = 0.76 and 95% CI = 0.62-0.94). Relative to patients who had been receiving ERT for 1 year, those who had been receiving ERT for 2 and 4 years were 1.40 (95% CI = 1.06-1.84) and 2.75 (95% CI = 1.20-6.27) times more likely to report improvements in general HRQoL, respectively. In summary, patients with Gaucher's disease on ERT reported an improvement in HRQoL that was greater than that reported by patients with other chronic diseases. However, Gaucher's patients treated for up to 51 months scored below equivalent adults in the general population. The risk factors, including age and history of splenectomy and joint replacement, warrant further study. Standardized HRQoL measures are likely to prove useful in understanding better the outcomes from the Gaucher's patient's perspective.

Adolescent↗
PubMed1998

A questionnaire to assess the generic and disease-specific health outcomes of patients with chronic hepatitis C.

A 69-item questionnaire measuring generic functioning and well-being and disease-specific health outcomes was developed and tested using the pre-treatment data from patients with chronic hepatitis C (CHC) participating in two randomized trials of interferon alpha-2b (n = 157). The questionnaire included all eight scales from the SF-36 and measures of nine other generic and disease-specific health concepts. Psychometric tests confirmed the assumptions underlying the construction and scoring of all generic and disease-specific scales. Cross-sectional tests of 'known groups' validity showed that CHC patients scored worse on the generic scales than patients with other chronic conditions and worse than a healthy general population. The generic and disease-specific scale scores were lower in the presence of physical findings of CHC, as hypothesized, but only the physical functioning and bodily pain scales were linked to cirrhosis or extreme alanine aminotransferase (ALT) ratios. This instrument will be useful in studies of health outcome among patients with CHC, a condition whose health burden appears to have been underestimated in studies to date.

Adult↗
PubMed1998

The responsiveness of disease-specific and generic health measures to changes in the severity of asthma among adults.

The objective of the study was to compare the validity of asthma-specific and generic health outcome measures in relation to changes in the severity of asthma and to treatment. Adult patients (n = 142) participating in a randomized placebo-controlled trial at six clinics were assessed at baseline, prior to the withdrawal (placebo) or continuation of treatment with Vanceril and again after 8 weeks. The criterion measures of change in severity included pulmonary function expressed as the percent predicted FEV1, five physician-assessed asthma severity measures (cough, chest tightness, wheezing, shortness of breath and overall condition) and two patient-assessed severity measures (night-time symptoms and overall symptoms). The 8 week change scores were estimated for all generic and specific measures and the results were compared across groups of patients who did and did not change in terms of clinical criteria of disease severity and across treatment groups. The responsiveness of each generic and specific measure was estimated independently using the relative validity (RV) methodology, which compares F-ratios for the mean change scores across measures in analyses of the same comparison groups. RV coefficients estimate how much worse each measure discriminated between comparison groups, relative to the best measure (RV = 1.0). Four standardized asthma-specific measures and a total scale score (based on the Marks questionnaire), an individualized asthma-specific scale measuring limitations in activities most important to each patient (based on the Juniper method) and two newly-developed scales measuring physical and psychosocial symptoms were used as outcome measures, generic health outcome measures included eight functional health and well-being scales as well as the physical and mental health summary scales from the SF-36 health survey. A standardized asthma-specific scale was most valid in discriminating between groups of patients who did and did not change according to all of the clinical criterion variables studied and in discriminating between treated and untreated groups. Different scales performed best, depending on the clinical criterion. The asthma-specific Marks breathlessness scale was significant in all nine comparisons (RV = 0.62-1.0) and was most valid in discriminating between groups in six of nine tests. The overall scale also performed well in all comparisons (RV = 0.58-1.0). The newly-developed physical symptoms scale was significant in discriminating between groups in eight out of nine tests (RV = 0.52-1.0) and was most valid in three of the nine, including the treatment comparison. The psychosocial impact scale discriminated significantly in eight of the nine comparisons (RV = 0.16-0.38), but was less valid than other specific measures. The asthma-specific individualized activities scale discriminated significantly in seven of the nine tests, but performed less well than the other specific measures (RV = 0.21-0.35) and was not significant in the treatment comparison. One or more SF-36 scales discriminated significantly between groups in all nine comparisons. Two of those scales (physical functioning and role-physical) were consistently more valid than the others (RV = 0.17 and 0.58, respectively) and were the only two generic scales that discriminated between groups of patients defined in terms of changes in FEV1 (RV = 0.26-0.58). The SF-36 physical summary scale discriminated significantly between groups in all nine comparisons (RV = 0.19-0.61) and was the most valid generic measure in the treatment comparison (RV = 0.55). The SF-36 mental summary scale was significant only for the two patient-assessed changes in disease severity (RV = 0.31 and 0.32) and for physician-assessed overall severity (RV = 0.12). A comprehensive battery of generic and specific measures is likely to be most useful in understanding the impact of changes in disease severity on the functional health and well-being of adults with asthma, a

Activities of Daily Living↗
PubMed1998

The Primary Care Assessment Survey: tests of data quality and measurement performance.

OBJECTIVES: The authors examine the data quality and measurement performance of the Primary Care Assessment Survey (PCAS), a patient-completed questionnaire that operationalizes formal definitions of primary care, including the definition recently proposed by the Institute of Medicine Committee on the Future of Primary Care. METHODS: The PCAS measures seven domains of care through 11 summary scales: accessibility (organizational, financial), continuity (longitudinal, visit-based), comprehensiveness (contextual knowledge of patient, preventive counseling), integration, clinical interaction (clinician-patient communication, thoroughness of physical examinations), interpersonal treatment, and trust. Data from a study of Massachusetts state employees (n = 6094) were used to evaluate key measurement properties of the 11 PCAS scales. Analyses were performed on the combined population and for each of the 16 subgroups defined according to sociodemographic and health characteristics. RESULTS: The 11 PCAS scales demonstrated consistently strong measurement characteristics across all subgroups of this adult population. Tests of scaling assumptions for summated rating scales were well satisfied by all Likert-scaled measures. Assessment of data completeness, scale score dispersion characteristics, and inter-scale correlations provide strong evidence for the soundness of all scales, and for the value of separately measuring and interpreting these concepts. CONCLUSIONS: With public and private sector policies increasingly emphasizing the importance of primary care, the need for tools to evaluate and improve primary care performance is clear. The PCAS has excellent measurement properties, and performs consistently well across varied segments of the adult population. Widespread application of an assessment methodology, such as the PCAS, will afford an empiric basis through which to measure, monitor, and continuously improve primary care.

Adult↗
PubMed1998

A longitudinal study of hospitalization rates for patients with chronic disease: results from the Medical Outcomes Study.

OBJECTIVE: To prospectively compare inpatient and outpatient utilization rates between prepaid (PPD) and fee-for-service (FFS) insurance coverage for patients with chronic disease. DATA SOURCE/STUDY SETTING: Data from the Medical Outcomes Study, a longitudinal observational study of chronic disease patients conducted in Boston, Chicago, and Los Angeles. STUDY DESIGN: A four-year prospective study of resource utilization among 1,681 patients under treatment for hypertension, diabetes, myocardial infarction, or congestive heart failure in the practices of 367 clinicians. DATA COLLECTION/EXTRACTION METHODS: Insurance payment system (PPD or FFS), hospitalizations, and office visits were obtained from patient reports. Disease and severity indicators, sociodemographics, and self-reported functional status were used to adjust for patient mix and to compute expected utilization rates. PRINCIPAL FINDINGS: Compared to FFS, PPD patients had 31 percent fewer observed hospitalizations before adjustment for patient differences (p = .005) and 15 percent fewer hospitalizations than expected after adjustment (p = .078). The observed rate of FFS hospitalizations exceeded the expected rate by 9 percent. These results are not explained by system differences in patient mix or trends in hospital use over four years. Half of the PPD/FFS difference in hospitalization rate is due to intrinsic characteristics of the payment system itself. CONCLUSIONS: PPD patients with chronic medical conditions followed prospectively over four years, after extensive patient-mix adjustment, had 15 percent fewer hospitalizations than their FFS counterparts owing to differences intrinsic to the insurance reimbursement system.

Adult↗
PubMed1998

Linking primary care performance to outcomes of care.

BACKGROUND: Substantial research links many of the defining characteristics of primary care to important outcomes; yet little is known about the relative importance of each characteristic, and several characteristics have not been examined. These analyses evaluate the relationship between seven defining elements of primary care (accessibility, continuity, comprehensiveness, integration, clinical interaction, interpersonal treatment, and trust) and three outcomes (adherence to physician's advice, patient satisfaction, and improved health status). METHODS: Data were derived from a cross-sectional observational study of adults employed by the Commonwealth of Massachusetts (N = 7204). All patients completed a validated questionnaire, the Primary Care Assessment Survey. Regression methods were used to examine the association between each primary care characteristic (11 summary scales measuring 7 elements of care) and each outcome. RESULTS: Physicians' comprehensive ("whole person") knowledge of patients and patients' trust in their physician were the variables most strongly associated with adherence, and trust was the variable most strongly associated with patients' satisfaction with their physician. With other factors equal, adherence rates were 2.6 times higher among patients with whole-person knowledge scores in the 95th percentile compared with the 5th percentile (44.0% adherence vs 16.8% adherence, P < .001). The likelihood of complete satisfaction was 87.5% for those with 95th percentile trust scores compared with 0.4% for patients with 5th percentile trust scores (P < .001). The leading correlates of self-reported health improvements were integration of care, thoroughness of physical examinations, communication, comprehensive knowledge of patients, and trust (P < .001). CONCLUSIONS: Patients' trust in their physician and physicians' knowledge of patients are leading correlates of three important outcomes of care. The results are noteworthy in the context of pervasive changes in our nation's health care system that are widely viewed as threatening to the quality of physician-patient relationships.

Adult↗
PubMed1997

Health-related quality of life among patients with metastatic prostate cancer.

OBJECTIVES: To assess and compare the quality of life of men with advanced prostate cancer who are in remission receiving treatment with a luteinizing hormone-releasing hormone (LHRH) agonist and flutamide or who are in progression. METHODS: We conducted a cross-sectional survey to measure health-related quality of life in a cohort of 113 patients with metastatic prostate cancer, 60 in remission and 53 with disease progression, using a battery of questionnaires, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, the Medical Outcomes Study Short Form Health Survey SF-36, and a prostate cancer-specific module. RESULTS: Patients in remission receiving an LHRH agonist and flutamide reported a significantly better quality of life compared with patients with disease progression (P < 0.011). Men with hormone-sensitive cancer had significantly less bodily pain, more vitality, more social interactions, and better mental health than patients with hormone-resistant disease. No differences were noted between the two groups concerning treatment-related problems such as diarrhea, constipation, urinary symptoms, sexual function, sexual satisfaction or hot flashes, although men in remission tended to rate each of these items more favorably than did men with disease progression. Men in remission have a health-related quality of life that is similar to an equivalent norm for men in the United States general population as compared with men with disease progression, who demonstrate significant compromise in all domains measured. CONCLUSIONS: Patients in remission receiving an LHRH agonist and flutamide have a quality of life that is indistinguishable from a matched male population without prostate cancer and a quality of life significantly better than that of men with androgen-resistant disease. Among patients who respond to total androgen ablation, flutamide and an LHRH agonist provide significant, measurable benefits to recipients independent of any possible improvement in longevity.

Adenocarcinoma↗
PubMed1997

Gender differences in medical treatment: the case of physician-prescribed activity restrictions.

A growing scientific literature highlights concern about the influence of social bias in medical care. Differential treatment of male and female patients has been among the documented concerns. Yet, little is known about the extent to which differential treatment of male and female patients reflects the influence of social bias or of more acceptable factors, such as different patient preferences or different anticipated outcomes of care. This paper attempts to ascertain the underlying basis for an observed differential in physicians' tendency to advice activity restrictions for male and female patients. We explore the extent to which the gender-based treatment differential is attributable to: (1) patients' health profile, (2) patients' role responsibilities, (3) patients' illness behaviors, and (4) physician characteristics. These four categories of variables correspond to four prominent social science hypotheses concerning gender differences in health and health care utilization (i.e, biological basis hypothesis, fixed role hypothesis, socialization hypothesis, physician bias hypothesis). Data are drawn from the Medical Outcomes Study (MOS), a longitudinal observational study of 1546 patients of 349 physicians practicing in three U.S. cities. Multivariate logistic regression is used to evaluate the likelihood of physician-prescribed activity restrictions for male and female patients, and to explore the absolute and relative influence of patient and physician factors on the observed treatment differential. Results reveal that the odds of prescribed activity restrictions are 3.6 times higher for female patients than for males with equivalent characteristics. The observed differential is not explained by differences in male and female patients' health or role responsibilities. Gender differences in illness behavior and physician gender biases both appear to contribute to the observed differential. Female patients exhibit more illness behavior than males, and these behaviors increase physicians' tendency to prescribe activity restrictions. After accounting for illness behavior differences and all other factors, the odds of prescribed activity restrictions among female patients of male physicians is four times that of equivalent male patients of those physicians. Medical practice, education, and research must strive to identify and remove the likely unconscious role of social bias in medical decision making.

Activities of Daily Living↗
PubMed1997

Evaluation of the MOS SF-36 Physical Functioning Scale (PF-10): II. Comparison of relative precision using Likert and Rasch scoring methods.

This study examined the relative precision (RP) of two methods of scoring the 10-item Physical Functioning Scale (PF-10) from a large sample of patients (n = 3445) of the Medical Outcomes Study. Based on a Likert scaling model, the PF-10 summated scoring method was compared with a Rasch Item Response Theory (IRT) scaling model in which raw scores were transformed into a latent trait variable of physical functioning. Potential differences between scoring methods were hypothesized to be attributed to: (1) the logarithmic nature of the Rasch transformation; (2) the unevenness of the PF-10 item distributions; and (3) reduction of within-group variance. RP ratios favored the Rasch model in discriminating between patients who differed in disease severity. The Rasch and Likert scoring models performed similarly for tests involving sensitivity to change over a two-year follow-up period. In all comparisons, differences between methods were most apparent in clinical groups whose scores most approximated the extremes of the score distribution. Further research is necessary to test for differences between scoring models in discrimination and sensitivity to change among clinical groups whose scores are sufficiently spread across the continuum of physical functioning, in particular patients with either very high or low physical functioning. The Rasch model of scoring may have important implications for the clinical interpretation of individual scores at all ranges of the scale.

Data Interpretation, Statistical↗
PubMed1997

Asian-American patient ratings of physician primary care performance.

OBJECTIVE: To examine how Asian-American patients' ratings of primary care performance differ from those of whites. Latinos, and African-Americans. DESIGN: Retrospective analyses of data collected in a cross-sectional study using patient questionnaires. SETTING: University hospital primary care group practice. PARTICIPANTS: In phase 1, successive patients who visited the study site for appointments were asked to complete the survey. In phase 2, successive patients were selected who had most recently visited each physician, going back as far as necessary to obtain 20 patients for each physician. In total, 502 patients were surveyed, 5% of whom were Asian-American. MAIN RESULTS: After adjusting for potential confounders, Asian-Americans rated overall satisfaction and 10 of 11 scales assessing primary care significantly lower than whites did. Dimensions of primary care that were assessed include access, comprehensiveness of care, integration, continuity, clinical quality, interpersonal treatment, and trust. There were no differences for the scale of longitudinal continuity. On average, the rating scale scores of Asian-Americans were 12 points lower than those of whites (on 100-point scales). CONCLUSIONS: We conclude that Asian-American patients rate physicians primary care performance lower than do whites, African-Americans, and Latinos. Future research needs to focus on Asian-Americans to determine the generalizability of these findings and the extent to which they reflect differences in survey response tendencies or actual quality differences.

Academic Medical Centers↗
PubMed1997

Comparison of responses to SF-36 Health Survey questions with one-week and four-week recall periods.

OBJECTIVE: To compare the measurement properties of acute (one-week recall) and standard (four-week recall) versions of SF-36 Health Survey (SF-36) scale scores. DATA SOURCES: SF-36 data collected from 142 participants (60% female, average age 39) in a clinical trial of an asthma medication: 74 patients randomized to the acute form and 68 to the standard. DATA COLLECTION: The SF-36 was self-administered at the time of a clinic visit (before clinical examination) to synchronize with clinical measures of disease severity at three different time points during the clinical trial: -2 weeks (two weeks before randomization to treatment), baseline (week 0 or randomization), and +4 weeks (four weeks after baseline). PRINCIPAL FINDINGS: The acute form yielded high-quality data; scales conformed to the assumptions of the summated ratings method used to score the standard SF-36; and scales had good distributional properties, were reliable, and had a factor content similar to the standard. The data indicated that while the acute form was more sensitive than the standard to change in health status associated with changes in acute symptoms, acute scale scores may not be comparable to national norms based on the standard, particularly for those scales that assess frequency of health events during a specified time period. CONCLUSIONS: Results support the use of the acute form in its intended applications; however, further research is required to document the generalizability of greater sensitivity of the acute form to recent changes in health and to explore whether norms based on the standard can be used to interpret the acute scale scores.

Adolescent↗
PubMed1996

Differences in 4-year health outcomes for elderly and poor, chronically ill patients treated in HMO and fee-for-service systems. Results from the Medical Outcomes Study.

OBJECTIVE: To compare physical and mental health outcomes of chronically ill adults, including elderly and poor subgroups, treated in health maintenance organization (HMO) and fee-for-service (FFS) systems. STUDY DESIGN: A 4-year observational study of 2235 patients (18 to 97 years of age) with hypertension, non-insulin-dependent diabetes mellitus (NIDDM), recent acute myocardial infarction, congestive heart failure, and depressive disorder sampled from HMO and FFS systems in 1986 and followed up through 1990. Those aged 65 years and older covered under Medicare and low-income patients (200% of poverty) were analyzed separately. SETTING AND PARTICIPANTS: Offices of physicians practicing family medicine, internal medicine, endocrinology, cardiology, and psychiatry, in HMO and FFS systems of care. Types of practices included both prepaid group (72% of patients) and independent practice association (28%) types of HMOs, large multispecialty groups, and solo or small, single-specialty practices in Boston, Mass, Chicago, Ill, and Los Angeles, Calif. OUTCOME MEASURES: Differences between initial and 4-year follow-up scores of summary physical and mental health scales from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) for all patients and practice settings. RESULTS: On average, physical health declined and mental health remained stable during the 4-year follow-up period, with physical declines larger for the elderly than for the nonelderly (P<.001). In comparisons between HMO and FFS systems, physical and mental health outcomes did not differ for the average patient; however, they did differ for subgroups of the population differing in age and poverty status. For elderly patients (those aged 65 years and older) treated under Medicare, declines in physical health were more common in HMOs than in FFS plans (54% vs 28%; P<.001). In 1 site, mental health outcomes were better (P<.05) for elderly patients in HMOs relative to FFS but not in 2 other sites. For patients differing in poverty status, opposite patterns of physical health (P<.05) and for mental health (P<.001) outcomes were observed across systems; outcomes favored FFS over HMOs for the poverty group and favored HMOs over FFS for the nonpoverty group. CONCLUSIONS: During the study period, elderly and poor chronically ill patients had worse physical health outcomes in HMOs than in FFS systems; mental health outcomes varied by study site and patient characteristics. Current health care plans should carefully monitor the health outcomes of these vulnerable subgroups.

Adult↗
PubMed1996

Characteristics of physicians with participatory decision-making styles.

OBJECTIVES: To identify physician and practice characteristics associated with a physician's propensity to involve patients in diagnostic and treatment decisions, or participatory decision-making style. DESIGN: A representative cross-sectional sample of patients participating in the Medical Outcomes Study characterized each physician's style by using a self-reported questionnaire. A single averaged style score was generated for each physician. Style scores were compared among physicians who differed in age, sex, minority status, specialty, primary care training or training in interviewing skills, satisfaction with professional autonomy, and practice volume. SETTINGS: Solo practices, multispecialty groups, and health maintenance organizations in Boston, Chicago, and Los Angeles. PARTICIPANTS: 7730 patients sampled over 9 days from the practices of 300 physicians. Physicians were practicing general internal medicine, family medicine, cardiology, and endocrinology. MEASUREMENTS: Participatory decision-making style was measured using a three-item scale on a questionnaire that was completed by patients after their office visit. Physician and practice characteristics were reported by physicians on self-administered questionnaires. RESULTS: Among patients of physicians who were rated in the lowest (least participatory) quartile, one third changed physicians in the following year; among patients of physicians who were rated in the highest quartile, only 15% changed physicians. Higher scores were associated with greater patient satisfaction. Physicians who had had primary care training or training in interviewing skills scored higher than those without such training. Physicians in higher-volume practices were rated as less participatory than those in lower-volume practices. Physicians who were satisfied with their level of professional autonomy were rates as more participatory than those who were dissatisfied. CONCLUSION: Participatory decision-making style is influenced by physicians' background, training, practice volume, and professional autonomy. Because participatory decision-making style is related to patient satisfaction and loyalty to the physician, cost-containment strategies that reduce time with patients and decrease physician autonomy may result in suboptimal patient outcomes.

Cross-Sectional Studies↗
PubMed1996

Health status in patients with chronic fatigue syndrome and in general population and disease comparison groups.

PURPOSE: To measure the functional status and well-being of patients with chronic fatigue syndrome (CFS), and compare them with those of a general population group and six disease comparison groups. PATIENTS AND METHODS: The subjects of the study were patients with CFS (n = 223) from a CFS clinic, a population-based control sample (n = 2,474), and disease comparison groups with hypertension (n = 2,089), congestive heart failure (n = 216), type II diabetes mellitus (n = 163), acute myocardial infarction (n = 107), multiple sclerosis (n = 25), and depression (n = 502). We measured functional status and well-being using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), which is a self-administered questionnaire in which lower scores are indicative of greater impairment. RESULTS: Patients with CFS had far lower mean scores than the general population control subjects on all eight SF-36 scales. They also scored significantly lower than patients in all the disease comparison groups other than depression on virtually all the scales. When compared with patients with depression, they scored significantly lower on all the scales except for scales measuring mental health and role disability due to emotional problems, on which they scored significantly higher. The two SF-36 scales reflecting mental health were not correlated with any of the symptoms of CFS except for irritability and depression. CONCLUSION: Patients with CFS had marked impairment, in comparison with the general population and disease comparison groups. Moreover, the degree and pattern of impairment was different from that seen in patients with depression.

Activities of Daily Living↗
PubMed1996

Improvement of quality of life by treatment with cetirizine in patients with perennial allergic rhinitis as determined by a French version of the SF-36 questionnaire.

BACKGROUND AND AIM: Perennial allergic rhinitis impairs social life, but it is not known whether quality of life may be improved when patients are treated with an H1-blocker. A randomized, double-blind, placebo-controlled study was carried out with cetirizine to assess the effect of this drug on quality of life. METHODS: Two hundred seventy-four patients with perennial allergic rhinitis were tested. Quality of life was measured by using the Medical Outcome Study Short-Form Health Survey (SF-36) questionnaire. After a 2-week run-in period, cetirizine, 10 mg once daily, (136 patients) or placebo (138 patients) was given for the next 6 weeks. The SF-36 questionnaire was administered after the run-in period (at the start of treatment) and after 1 and 6 weeks of treatment. Symptom-medication scores were measured daily during the study. RESULTS: After the run-in period (baseline), there were no significant differences between the cetirizine and placebo groups in terms of symptoms or quality-of-life scores. After 6 weeks of treatment, percentage of days without rhinitis or with only mild rhinitis symptoms was significantly greater in the cetirizine group in comparison with the placebo group (p < 0.0001, Mann-Whitney U test). All of the nine quality-of-life dimensions were significantly improved (from p = 0.01 to p < 0.0001, Mann-Whitney U test) after 1 and 6 weeks of cetirizine treatment compared with placebo. There was no improvement in the placebo group. CONCLUSIONS: This study is the first to demonstrate that an H1-blocker, cetirizine, can improve quality of life for patients with perennial allergic rhinitis.

Adolescent↗
PubMed1996

Usefulness of the SF-36 Health Survey in measuring health outcomes in the depressed elderly.

Longitudinal data from a clinical trial were analyzed to evaluate the usefulness of the SF-36 Health Survey in estimating the impact of depression and changes in severity over time on the functional health and well-being of 532 patients, 60 to 86 years of age, who met DSM-III-R criteria for major depressive disorder. The Hamilton Depression Rating Scale, the Clinician's Global Impression of Severity and Improvement, and the Geriatric Depression Scale were used to define clinical severity and changes in severity over a 6-week period. Answers to SF-36 questions tended to be complete and to satisfy assumptions underlying methods of scale construction and scoring. As hypothesized, the SF-36 Mental Health Scale and Mental Component Summary measure, shown in previous studies to be most valid in measuring differences in mental health, exhibited the strongest associations with severity of depression in cross-sectional analyses and were most responsive to changes in severity in longitudinal comparisons. We conclude that the SF-36 Health Survey is useful for estimating the burden of depression and in monitoring changes in functional health and well-being over time among the depressed elderly.

Activities of Daily Living↗
PubMed1996

The effects of recombinant human erythropoietin on functional health and well-being in chronic dialysis patients.

As a component of the open-label, multicenter National Cooperative Recombinant Human Erythropoietin (Epo) Study, the health-related quality-of-life effects of Epo therapy were assessed in 484 dialysis patients who had not previously been treated with Epo therapy (New-to-Epo) and 520 dialysis patients who were already receiving Epo therapy at the time of study enrollment (Old-to-Epo). Using scales from the Medical Outcomes Study 36-item Short Form Health Survey (SF-36), health-related quality of life was assessed on study enrollment (baseline) and at an average of 99 days follow-up. At baseline, SF-36 scores for Old- and New-to-Epo patients were well below those observed in the general population, reflecting substantial impairments in functional status and well-being among patients with chronic renal failure. Significant improvements from baseline to follow-up were observed among New-to-Epo patients in vitality, physical functioning, social functioning, mental health, looking after the home, social life, hobbies, and satisfaction with sexual activity (P < 0.05 for each). The mean improvements in hematocrit values among New-to-Epo and Old-to Epo patients were 4.6 and 0.3, respectively. At the time of follow-up, SF-36 scores for New-to-Epo patients were comparable with those observed among Old-to-Epo patients, whose scores did not change significantly from baseline to follow-up. Analysis of the relationship between Epo therapy, hematocrit values, and health-related quality of life suggest that some of the beneficial quality-of-life effects of Epo are mediated through a change in hematocrit level.

Activities of Daily Living↗