Development and validation of the ITG Health-Related Quality-of-Life Short-Form measure for use in patients with coronary artery disease. Integrated Therapeutics Group.

BACKGROUND: Available coronary artery disease (CAD)-specific health-related quality-of-life (HRQL) measures are not ideally suited for routine clinical practice. We report development of a valid and reliable CAD-specific short-form measure. HYPOTHESIS: The Integrated Therapeutics Group (ITG) CAD-specific short-form HRQL measure is reliable and valid for assessing the health status of patients with CAD. METHODS: In all, 409 patients (mean age 62.4 years) completed the 24-item CAD-specific HRQL questionnaire. Factor analysis was used to identify the scaling of the 24 CAD-specific items. Analysis of variance was used to reduce the number of items within each scale, and reliability (Cronbach's alpha), discriminant validity, and ceiling and floor effects of short-form scales were evaluated. Short-form scales were compared with the longer scales using relative validity coefficients. The CAD severity was assessed using New York Heart Association criteria, physician assessment, electrocardiogram results, the number of myocardial infarctions, and the number of CAD-specific medications. Clinical validity of short-form scales was then assessed based on their ability to discriminate across severity levels of these clinical criteria. RESULTS: Four scales were identified: Extent of Chest Pain, Functioning and Well-Being, Activities Level-Physical, and Activities Level-Social. The 24-item questionnaire was reduced to a 13-item short form, with reliability exceeding 0.70 for all four scales. Relative validity estimates comparing short-form to original scales ranged from 0.68 to 2.58. Mean scores varied significantly (p < 0.05) by clinical severity, supporting the discriminant validity of the ITG CAD short-form scales. CONCLUSIONS: The ITG CAD short form (used alone or with a general HRQL measure) is valid and practical for assessing patients with CAD.

Evaluation of a short form for measuring health-related quality of life among pediatric asthma patients.

BACKGROUND: This study was undertaken to derive and validate a short form parent-completed questionnaire to measure health-related quality of life (HRQL) in pediatric asthma patients. OBJECTIVE: The objectives of this study were to (1) use stepwise analysis to derive a shorter questionnaire from the original long-form questionnaire and (2) determine the tradeoff in precision between the long- and short-form surveys. METHODS: One hundred eighty-one pediatric asthma patients were enrolled from 4 sites. A parent of each patient completed a general and an asthma-specific questionnaire during routine office visits from June 1995 to January 1997. The questionnaire included the Child Health Questionnaire Parent Form 50, a general HRQL survey, and a 17-item asthma-specific battery assessing daytime symptoms, nighttime symptoms, and functional limitations. All scales were scored from 0 to 100, with higher scores indicating better HRQL. Analysis of variance models were used to derive short-form scales from the 17-item long-form scales, and the final asthma-specific short-form scale structure was confirmed with use of stepwise regression. Scale reliability was assessed with Cronbach's alpha. Validity of the short-form questionnaire was assessed by comparing mean scale scores according to the level of asthma severity defined by several clinical criteria. Asthma severity was assessed with use of percent predicted FEV(1), frequency and type of symptoms, parent rating of disease severity, physician rating of disease severity, and resource use (emergency department use and hospitalizations). The relative validity of each of the short-form scales was measured by comparing the proportion of variance explained by each of the short-form scales compared with the respective long-form scales. RESULTS: The 17-item asthma-specific battery was reduced to 8 items, the Integrated Therapeutics Group Child Asthma Short Form. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Reliability was greater than 0.70 for each of the short-form scales. The absence of ceiling and floor effects indicates each scale's ability to detect changes at both low and high levels of functioning. Lower (poorer) mean HRQL scores for severe cases compared with mild cases, for all disease severity indicators, demonstrated clinical validity. Relative validity estimates, comparing the proportion of explained variance of the short-form scales with that of the long-form scales, ranged from 0. 85 to 1.20, indicating a similar ability to measure change. CONCLUSIONS: This study documents the development of a brief, multidimensional, 8-item questionnaire for measuring HRQL in pediatric asthma patients. The brevity of the questionnaire makes it practical for use in practice settings and to monitor patients.

The member satisfaction survey as a measure of health plan accountability.

In its 1996 study of St. Louis area health maintenance organization members, Gateway Purchasers for Health closely analyzed member responses to the National Committee for Quality Assurance's annual member health care survey. The analysis of specific questions regarding overall satisfaction levels and member health status afforded insight into the factors that contribute to an individual's reported satisfaction with health care services and into variations by subgroups within the population. Ultimately, consumer information that allows choice of a health plan that best suits specific needs and preferences will drive accountability, quality, and value in the health care market.

Effects of an asthma management program on the asthmatic member: patient-centered results of a 2-year study in a managed care organization.

OBJECTIVE: To report the results of a 2-year pilot program of asthma education based on National Heart, Lung, and Blood Institute treatment guidelines. PATIENTS AND METHODS: Asthmatic members (n = 6698) of a managed care organization received education about their condition directly or through their primary care physician. Medical and pharmacy administrative claims data were reviewed to measure acute asthma events and prescribed therapies in the first (the baseline) and second years of the study. The claims data were augmented by member surveys from a stratified random sample of 2734 asthmatic patients who were members (6 years of age or older) in the baseline year. RESULTS: Compared with the first year, asthmatic members received fewer inpatient services and the proportion of asthmatic members prescribed oral inhaled corticosteroids increased 30% in the second year. Health-related quality of life, measured with validated general and disease-specific instruments; satisfaction with the quality of care; exposure to patient education; knowledge of the disease; and member's confidence in their ability to manage their disease showed statistically significant improvements during the follow-up year of the program for both adult and child asthmatic members. CONCLUSION: For asthmatic members of this health plan, a comprehensive asthma health management program improved processes of care and outcomes.

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

The effectiveness of one-on-one nurse education on the outcomes of high-risk adult and pediatric patients with asthma.

The effects of an asthma self-management program on asthma outcomes were evaluated in adult and pediatric patients with asthma who were considered at high risk (i.e., those who were not in control of their disease as determined by resource utilization, medication use, or lack of use). The program consisted of one-on-one nurse-to-patient ("nurse champion") education and subsequent assessment of asthma outcomes using the Asthma Quality Assessment System (AQAS) questionnaire, which measured asthma severity, patient quality of life, asthma awareness and knowledge, confidence in managing asthma, use of peak flow meters, asthma symptoms, medication use, lost work or school days, and affect of asthma. Over the course of six months, nurse champions educated 201 patients from four managed care plans and collected data at baseline and during four follow-up sessions. Adult patients and pediatric patient caregivers reported significant improvements in quality of life, and clinical and process measures. Significant increases in asthma knowledge were observed immediately after patient education, including greater than 89% increase in the proportion of patients who reported that they know "a lot" about the "things that cause asthma symptoms." Significant decreases were also found in work or school days missed, urgent care utilization, and hospital admission rates. Appropriate preventive care visits increased by more than 40%. These results indicate that the nurse champion program was associated with an improvement in asthma outcomes in high-risk adult and pediatric patients and warrant further evaluation in controlled studies. Incorporating one-on-one education programs into asthma management is an effective and rapid means of improving asthma outcomes.

Approaches to prostate cancer by managed care organizations.

OBJECTIVES: Managed care organizations (MCOs) are developing population-based approaches to illnesses with large numbers of patients, wide variations in care and outcomes, and high costs. This is the first survey that evaluates current prostate cancer approaches by MCOs. METHODS: Case studies and a survey of corporate medical directors at large MCOs were conducted. RESULTS: Two approaches, broadly based on disease management strategies for men with prostate cancer, have been implemented in managed care settings on the West Coast. While both have provided comprehensive approaches to the disease, assessment of improvement in outcomes will require longer follow-up. A survey of corporate medical directors of MCOs indicates that population-based disease approaches nationwide for malignant prostate disease lag behind more well-developed efforts for nonmalignant illnesses such as diabetes and asthma. CONCLUSIONS: Prostate cancer may be a feasible area for development and evaluation of population-based approaches. MCOs have the potential to improve clinical care and outcomes for large numbers of men with prostate cancer. While limitations exist related to specific managed care considerations of data needs and lack of medical and surgical consensus on disease management, programs based on shared decision making have the potential to improve patient care and outcomes.

Asthma: benchmarking for quality improvement.

BACKGROUND: Linked medical and pharmacy claims can be used to identify patients with asthma and benchmark current practice standards. METHOD: This was a 3-year study of five independent practice association style health maintenance organizations with an annual enrollment of 870,000. More than 28,000 members were identified with claims for asthma. OBJECTIVE: The intent of this study was to benchmark current asthma practice. Before quality improvement projects can be implemented baseline data are required. RESULTS: The prevalence of asthma varied by geographic regions. Specialty care was associated with greater use of anti-inflammatory medications and more refills of these drugs. Refill rates for inhaled corticosteroids for all patients was low. Specialty care of asthmatic members was associated with a lower rate of emergency service events and hospitalizations. CONCLUSIONS: Linked medical and pharmacy claims' databases can be used to benchmark current practice performance and serve as a reference for quality improvement programs. Appropriate use of specialty care may improve asthma outcomes.

Patterns of anti-inflammatory therapy in the post-guidelines era: a retrospective claims analysis of managed care members.

Published and widely disseminated guidelines for the care and management of asthma characterize asthma as a chronic, inflammatory disease and propose specific recommendations for therapy with inhaled anti-inflammatory medications. In a retrospective analysis of medical and pharmacy claims data of approximately 28,000 asthmatic members from five managed care settings, the dominant pattern of pharmacologic therapy that emerged was the use of bronchodilators without inhaled anti-inflammatory drug therapy. In addition, a significant proportion of asthmatic patients received no prescription drug therapy for asthma. Less than one third of asthmatic patients received any anti-inflammatory therapy and the majority of these received one or two prescriptions per year. Specialist physicians were two to three times more likely than non-specialists during a study period of 1 year to prescribe an anti-inflammatory medication, and were half as likely to have their asthmatic patients experience an emergency department or hospital event. This database analysis suggests that greater conformity with guidelines and/or access to specialist physician care for asthmatic members will lead to improved patient outcomes.