Costs of care for irritable bowel syndrome patients in a health maintenance organization.

OBJECTIVES: The aims of this study were: 1) to determine the total costs of care and costs related to lower GI-related problems for patients who received a diagnosis of irritable bowel syndrome (IBS), and 2) to compare them to age- and sex-matched population controls and patients treated for inflammatory bowel disease (IBD) or gastroesophageal reflux disease (GERD). METHODS: Use and cost data were obtained through the computerized information systems of a large staff-model health maintenance organization on three groups of patients diagnosed in 1994 or 1995 with IBS, IBD, or GERD; and an age- and sex-matched control group of patients without any of these listed diagnoses. The IBS patient group was compared to the three comparison groups on components of total and IBS-related costs. RESULTS: Total costs of care for IBS patients were 49% higher than population controls during the year starting with the visit at which IBS patients were identified. In the index year, every component of total costs except inpatient care was significantly higher for IBS patients than for population controls. The costs of care for lower GI problems were significantly higher for patients with IBS than for population controls across a range of services. However, only 33% of the difference in total costs of care between IBS patients and population controls was due to lower GI-related services in the index year. In the subsequent years, lower GI-related services accounted for 18% and 20% of the total cost difference between IBS patients and population controls. The total costs of care as well as the components of costs of care were generally higher for IBD patients than for IBS patients, but were comparable for GERD and IBS patients. CONCLUSIONS: Patients with IBS show sustained increases in health care costs relative to population controls for both lower GI services and care unrelated to lower GI problems. However, the majority of the excess in health care costs resulted from medical care not directly related to lower GI problems.

Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome.

OBJECTIVES: Bowel urgency is one of the most bothersome symptoms for nonconstipated IBS patients. The efficacy of alosetron in control of bowel urgency and Global Improvement of IBS symptoms were evaluated in a multicenter double-blind, randomized, placebo-controlled study. METHODS: Female IBS patients with lack of satisfactory control of bowel urgency were randomized 2:1 to alosetron 1 mg twice daily or placebo treatment groups. The primary endpoint was the proportion of days with satisfactory control of bowel urgency during the 12-wk treatment period and 2-wk follow-up period. Secondary endpoints included IBS Global Improvement (responder defined as patient-reported moderate or substantial improvement in IBS symptoms) and improvements in bowel function (stool frequency, consistency, and sensation of incomplete evacuation). RESULTS: A total of 801 women were randomized to the alosetron (n = 532) or placebo groups (n = 269). Physicians classified 98% of patients with diarrhea-predominant IBS. Patients treated with alosetron had a significantly greater proportion of days with satisfactory control of urgency compared to placebo for the treatment period (73% vs 57%, p < 0.001). A significantly greater number of patients treated with alosetron were IBS Global Improvement responders compared to placebo at week 12 (76% vs 44%, p < 0.001). IBS Global Improvement responders had more days with satisfactory control of urgency at week 12 (88% vs 48%) as well as firmer stools, fewer stools/day, and fewer days with incomplete evacuation compared with nonresponders. Alosetron-treated patients showed improvements in bowel functions compared to placebo-treated patients. Constipation was the most commonly reported adverse event.

Validity and reliability of the migraine-specific quality of life questionnaire (MSQ Version 2.1).

OBJECTIVE: To assess the scaling properties, reliability, and validity of the revised Migraine-Specific Quality of Life Questionnaire (MSQ) (Version 2.1) BACKGROUND: The MSQ is a disease-specific, quality-of-life instrument with three hypothesized scales that has been developed, tested, and revised. METHODS: The study used a multicenter, nondrug, prospective, parallel group, quasi-experimental design. Patients with migraine were recruited at outpatient headache specialty practices and were administered the MSQ, the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), and migraine symptom questionnaires at baseline, 4 weeks, and 12 weeks. Internal consistency (Cronbach alpha) and 4-week test-retest reproducibility (intraclass correlation coefficients) were estimated to assess reliability. Construct validity was assessed using an adaptation of the Campbell and Fiske multitrait-multimethod approach and by correlating MSQ scores with symptom measures. RESULTS: A total of 267 subjects enrolled in the trial. The criteria for summated rating scales were all met. The internal consistency coefficients ranged from 0.86 to 0.96, and the intraclass correlation coefficients ranged from 0.57 to 0.63 across the three dimensions. As anticipated, the MSQ dimensions had low-to-modest correlations with the two component scores of the SF-36 and were modestly to moderately correlated with migraine symptoms. CONCLUSIONS: The MSQ is a reliable instrument in the assessment of quality of life for patients with migraine with items that can be summed without weights. The MSQ has demonstrated evidence of construct validity.

Sumatriptan injection reduces productivity loss during a migraine attack: results of a double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the impact of sumatriptan succinate injection compared with placebo on productivity loss during a migraine attack in the workplace. DESIGN: Randomized, double-blind, placebo-controlled, parallel-group clinical trial. SETTING: Fifteen clinical centers in the United States. PATIENTS: One hundred thirty-five patients 18 years and older diagnosed as having migraine according to International Headache Society criteria. INTERVENTIONS: Patients self-administered sumatriptan injection (6 mg) or matching placebo to treat a moderate or severe migraine occurring within the first 4 hours of a minimum 8-hour work shift. MAIN OUTCOME MEASURES: Mean productivity loss 2 hours after dosing and across the work shift; percentages of patients returning to normal work performance within 2 hours after dosing and across the work shift; percentages of patients experiencing headache relief (reduction of moderate or severe predose pain to mild or no pain) 1 and 2 hours after dosing. RESULTS: Mean productivity loss was significantly (P< or =.002) lower in the sumatriptan group compared with the placebo group both during the 2-hour postdose period (sumatriptan, 39 minutes; placebo, 54 minutes) and across the work shift (sumatriptan, 86 minutes; placebo, 168 minutes). Significantly (P<.001) greater percentages of patients in the sumatriptan group compared with the placebo group returned to normal work performance by 2 hours after dosing (sumatriptan, 52%; placebo, 9%) and across the work shift (sumatriptan, 66%; placebo, 18%). Significantly (P< or =.001) greater percentages of patients in the sumatriptan group compared with the placebo group experienced headache relief 1 hour after dosing (sumatriptan, 69%; placebo, 18%) and 2 hours after dosing (sumatriptan, 79%; placebo, 32%). CONCLUSION: Sumatriptan reduced migraine-associated productivity loss during a minimum 8-hour work shift by approximately 50% compared with placebo and alleviated headache in more than three fourths of patients.

Development and validation of the Migraine-Specific Quality of Life Questionnaire.

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.

MSQ: Migraine-Specific Quality-of-Life Questionnaire. Further investigation of the factor structure.

MSQ, the 16-item Migraine-Specific Quality-of-Life Questionnaire (Version 1.0), was developed by Glaxo Wellcome Inc. to assess the effect of migraine and its treatment on patients' health-related quality of life (HR-QOL). The MSQ was hypothesised to measure 3 meaningful dimensions: (i) Role Function-Restrictive; (ii) Role Function-Preventive; and (iii) Emotional Function. The objective of this research was to further investigate the number of dimensions as well as the items contained in each dimension through principal components factor analysis of clinical trial data. Secondary objectives were to determine whether the factor structure changed in post-treatment visits compared with screening visits, to make recommendations for coding the MSQ when the patient did not have a migraine in the previous 4 weeks, and to modify the MSQ if so indicated by this research. Results supported the existence of 3 distinct factors which agreed strongly with the hypothesised dimensions. The analysis of post-treatment data suggested that the underlying factor structure of the MSQ varies as a result of treatment. Based on evaluations of the 'did not have a migraine' response, it was concluded that it be dropped from the MSQ. All these changes have been incorporated into MSQ (Version 2.0) which is being evaluated in studies to determine if its psychometric properties are different than the properties of the previous version.

Improvements in health-related quality of life with sumatriptan treatment for migraine.

BACKGROUND: The debilitating effects of migraine might be reduced in patients using an effective migraine medication. The serotonin (5HT1) receptor agonist sumatriptan has been shown in clinical trials to alleviate headache and associated symptoms in the majority of patients treated. METHODS: Three hundred forty-four (344) patients with migraine were allowed to treat an unlimited number of migraine attacks for up to 24 months with subcutaneous sumatriptan (6 mg). Open-label oral sumatriptan (100 mg) could be used between 1 hour and 24 hours after the initial injection for treatment of recurrent or persistent headache. On four occasions during the treatment period, patients completed the Medical Outcomes Study Short Form-36 Health Survey, a general health status instrument; the Migraine-Specific Quality of Life Questionnaire, a disease-specific instrument; and a series of questions designed to measure the impact of migraine on productivity and disability. RESULTS: Treatment with sumatriptan was associated with significant (P < .05) improvements relative to baseline in three of the Short Form-36 Health Survey quality-of-life dimensions (Bodily Pain, General Health Perceptions, and Social Functioning) and three of the Migraine-Specific Quality of Life Questionnaire dimensions (Role Function-Restrictive, Role Function-Preventive, and Emotional Function). Significant (P < .05) improvements in patient-rated productivity and reductions in patient-rated disability also occurred during the trial. CONCLUSIONS: Patients using sumatriptan to treat migraines for up to 24 months experienced improvements in disability and productivity as well as in health-related quality of life as measured either by a general health status instrument or a disease-specific instrument.