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 Cronbach's 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 patient's health-related quality of life.

Aim: In this study of patients with irritable bowel syndrome (IBS), we evaluated the relationship between patient‐rated severity of IBS and patients' physical and psychological symptoms, health care resource use and quality of life. Methods: One hundred and twenty‐six patients diagnosed with IBS were administered a series of questionnaires, including the Bowel Symptom Checklist, the Symptom Checklist‐90 R (a psychological symptom checklist), the IBSQOL (a disease‐specific quality of life instrument), the SF‐36 (a general health status instrument), and a health resource utilization assessment that measured health care use, time loss from work, impact on productivity, and days worked with symptoms. Results: No relationship was found between IBS severity and gastrointestinal symptoms, except for a feeling of unpassed stool. IBS severity was also not related to psychological symptom severity. Direct traditional indicators of resource use (e.g. physician visits, hospital admissions and emergency room visits) were not significantly associated by severity level; however, indirect measures of resource use (e.g. number of days with pain, productivity and number of bed days) were related to severity. Quality of life was clearly associated with perceived IBS severity. Patients who rated themselves as very severe reported the lowest scores and had the poorest health for all quality of life dimensions measured. Conclusions: These findings suggest that perceived IBS severity is defined by the limitations the disease imposes, rather than by the symptoms. Patients with reduced productivity and decreased functioning for most of the quality of life indicators were those who rated their IBS as very severe.

Background: We describe the development and evaluation of a new disease‐specific instrument, the Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL), which was designed for use in patients with irritable bowel syndrome. The IBSQOL measures 10 domains found to be relevant to patients with irritable bowel syndrome: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role, and sexual relations. Methods: During its development and evaluation, the IBSQOL was administered to over 500 patients with irritable bowel syndrome—two groups of patients from tertiary care centres, three focus groups of 8–12 patients each, and 287 patients in a national irritable bowel syndrome support network. As a control, the IBSQOL was also administered to 37 patients who did not have irritable bowel syndrome but had other gastrointestinal disorders. Statistical analyses to test the reliability and validity of the IBSQOL were performed using Cronbach's α coefficient. Results: Responses from the focus groups indicated that the IBSQOL was easy to complete and did not require too much time to fill out (≈ 25 min). Statistical analyses of the final 30‐item version of the IBSQOL demonstrated that it had both adequate validity and reliability (α ≥ 0.60). A comparison of mean IBSQOL scores of persons with and without irritable bowel syndrome (but with other gastrointestinal conditions) showed no difference between the two groups with irritable bowel syndrome; however, scores for both irritable bowel syndrome groups were considerably lower than for the non‐irritable bowel syndrome group, suggesting better health‐related quality of life in patients who do not have irritable bowel syndrome. This further demonstrated the validity of the IBSQOL in targeting questions and domains specific to patients with irritable bowel syndrome. Conclusions: Evaluation of the IBSQOL included testing the questionnaire in a large number of patients, which resulted in a revised and well‐constructed instrument that demonstrated both adequate validity and reliability. The IBSQOL is currently being used in large‐scale clinical trials to measure changes in quality of life in patients with irritable bowel syndrome following treatment intervention.

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A heartburn-specific quality of life instrument was developed using an approach which involves several steps: generating and selecting items, pretesting, reproducibility testing, and validity testing. These last two steps were performed in a randomized, double blind, placebo-controlled, six-week clinical trial evaluating ranitidine 150 mg twice daily on the clinical, economic, and humanistic outcomes of patients witqgastroesophageal reflux disease. Reliability, content validity, and construct validity were assessed. Scales had high values for Cronbach's alpha and item to scale and scale to scale correlations were as predicted. The SF-3@ questionnaire was administered to patients in this trial, and results provided further evidence of validity for the heartburn-speci$c qualify of life instrument. The instrument development and validation process used in this trial can serve as a model to researchers who wish to assess quality of life in a clinical trial. The pragmatic approach usedproduced an instrument that is both reliable and responsive, with characteristics of a valid instrument.

Clinical trials that rely solely on physiologic outcomes may underestimate effects of interventions on patients' symptoms and well-being. We sought to develop and validate an instrument to reliably assess symptom severity and frequency in therapeutic trials for patients with chronic bronchitis. We performed a series of psychometric studies that determined instrument content and assessed validity and reliability. The final version of the Chronic Bronchitis Symptoms Assessment Scale (CBSAS) comprised 15 scored items (16 items total). The instrument demonstrated strong reliability with moderate to high item correlations with total scores (0.41-0.80) and an overall Cronbach's alpha of 0.91. As expected, scores were at the bottom of the range for patients without a history of previous lung disease, and no ceiling effect was seen in the most severely obstructed patients. The CBSAS demonstrated statistically significant and moderate to strong association with spirometry, (post bronchodilator, % pred FEV1, r = -0.42, % pred FVC, r = -0.50), SGRQ (total, r = 0.67) and SOBQ (r = 0.50). The Chronic Bronchitis Symptoms Assessment Scale is an easy to administer, once daily or once weekly, valid and reliable outcome measure for assessing symptom severity among patients with chronic bronchitis.

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Clinical trials that rely solely on physiologic outcomes may underestimate effects of interventions on patients' symptoms and well-being. We sought to develop and validate an instrument to reliably assess symptom severity and frequency in therapeutic trials for patients with chronic bronchitis. We performed a series of psychometric studies that determined instrument content and assessed validity and reliability. The final version of the Chronic Bronchitis Symptoms Assessment Scale (CBSAS) comprised 15 scored items (16 items total). The instrument demonstrated strong reliability with moderate to high item correlations with total scores (0.41-0.80) and an overall Cronbach's alpha of 0.91. As expected, scores were at the bottom of the range for patients without a history of previous lung disease, and no ceiling effect was seen in the most severely obstructed patients. The CBSAS demonstrated statistically significant and moderate to strong association with spirometry, (post bronchodilator, % pred FEV1, r = -0.42, % pred FVC, r = -0.50), SGRQ (total, r = 0.67) and SOBQ (r = 0.50). The Chronic Bronchitis Symptoms Assessment Scale is an easy to administer, once daily or once weekly, valid and reliable outcome measure for assessing symptom severity among patients with chronic bronchitis.