Jane T. Osterhaus

Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis

OBJECTIVE To define clinically meaningful changes in 2 widely used health-related quality of life (HQL) instruments in studies of patients with rheumatoid arthritis (RA). METHODS Patients with RA (n = 693) who were enrolled in 2 double-blind, placebo-controlled clinical trials completed the Short Form 36 (SF-36) modified health survey and the Health Assessment Questionnaire (HAQ) disability index at baseline and 6-week followup assessments. Data on 5 RA severity measures were also collected at baseline and at 6 weeks (patient and physician global assessments, joint swelling and tenderness counts, and global pain assessment). Comparison of changes in the SF-36 scales and HAQ scores was made between groups of patients known to differ in the level of change on each RA severity measure. RESULTS With few exceptions, changes in the SF-36 and HAQ scores were different between patients who differed in the level of change on each RA severity measure. Changes in the SF-36 and HAQ scores were more strongly related to changes in the patient and physician global assessments and patient pain assessment than to changes in the joint swelling and tenderness counts. CONCLUSION Based on these results, minimally important changes in the SF-36 scales and HAQ disability scores were determined, which will be useful in interpreting HQL results in clinical trials.

Impact of migraine in the United States: data from the National Health Interview Survey.

SYNOPSIS

Healthcare resource and lost labour costs of migraine headache in the US.

SummaryMigraine headache is responsible for significantly more healthcare resource and lost labour costs than previously reported. Costs associated with migraine were assessed via a survey conducted in 940 patients, 70% of whom responded. All met the International Headache Society’s diagnostic criteria for migraine and had participated in one of two multicentre, single-dose, parallel-group, randomised, placebo-controlled clinical trials designed to assess the efficacy of an anti-migraine compound. Migraine frequency and costs, in terms of healthcare resource utilisation and lost labour (decreased productivity and missed workdays), were assessed. Over 90% of respondents visited a clinic and nearly 50% presented to an emergency room for treatment of migraine-related symptoms at least once in the year prior to the survey. These 648 respondents used an estimated

Measuring the functional status and well-being of patients with migraine headache.

US529 199 per year in healthcare services. 89% of employed respondents reported that job performance was adversely affected by migraine and over 50% of them missed at least two days of work per month. Depending on the estimates used for migraine prevalence and using 1986 estimates of median earnings for the US work force, the extrapolated costs to employers ranged from

Development and validation of the migraine-specific quality of life questionnaire

US5.6 billion to

Healthcare Resource Use and Costs Associated with Migraine in a Managed Healthcare Setting

US17.2 billion dollars annually due to decreased productivity and missed work days. The cost of migraine is not fully appreciated by the medical community or by society.

Evaluation of the functional status aspects of health-related quality of life of patients with Osteoarthritis treated with celecoxib

SYNOPSIS

Methodological and Conduct Principles for Pharmacoeconomic Research

This paper describes the development and validation of a migraine‐specific quality‐of‐life instrument that is capable of measuring health‐related quality‐of‐life impairments attributed to migraine. Item selection, item reduction, and pretesting and finalization of items during the instrument development phase resulted in a total of 16 questions which were incorporated into the Migraine‐Specific Quality of Life Questionnaire (Version 1:0) (©1992 Glaxo Wellcome Inc). Three meaningful dimensions were hypothesized: Role Function‐Restrictive, Role Function‐Preventive, and Emotional Function. In the instrument validation phase, the Migraine‐Specific Quality of Life Questionnaire was mailed to 1109 migraine patients, providing a response rate of 45% (n=458). Initial psychometric evaluation of the questionnaire indicated that it possessed adequate reliability with Cronbachs alpha for the three dimensions ranging between 0.70 to 0.85. The Migraine‐Specific Quality of Life Questionnaire possessed adequate content and criterion validity. All but three items satisfied the test of construct validity. In conclusion, the Migraine‐Specific Quality of Life Questionnaire has acceptable psychometric properties and can be used to estimate the effect of migraine and its treatment on the patients health‐related quality of life.

A Development and Validation Process for a Disease-Specific Quality of Life Instrument*

OBJECTIVE: To compare healthcare use and associated costs in patients with migraine and patients without migraine headache. DESIGN: Retrospective review of a managed care organizations medical and pharmacy claims databases for claims filed between January 1, 1989 and June 30, 1990. PATIENTS: Patients between 18 and 64 years old with a 12-month minimum enrollment in the health plan, including enrollment for the prescription drug benefit. Migraine group (n=1336) inclusion required a medical claim with the diagnosis of migraine headache and a pharmacy claim for a medication potentially used for migraine treatment. Comparison group (n=1336) inclusion required at least one medical claim with no diagnosis of migraine; a pharmacy claim was not required. Comparison group patients were matched to migraine group patients by age, gender, enrollment status, and subscriber or dependent enrollment status. OUTCOME MEASURES: Total health services use, diagnosis-specific use of services, diagnostic procedures performed, comorbid conditions, medication use, and associated costs were tallied. RESULTS: Migraineurs generated nearly twice as many medical claims as comparison group patients, and nearly 2.5 times as many pharmacy claims. Number of claims generated and numbers of patients who generated claims within each of 19 diagnostic categories indicated greater comorbidity in the migraine group. Migraineurs used emergency services more than did patients in the comparison group. Total medical and pharmacy claims costs were

Evaluation of health‐related quality of life of rheumatoid arthritis patients treated with celecoxib

3.4 million for the migraine group and