Responsiveness of migraine-ACT and MIDAS questionnaires for assessing migraine therapy.
ABSTRACT Migraine is frequently undertreated. The 4-item Migraine Assessment of Current Therapy (Migraine-ACT) questionnaire is a simple and reliable tool to identify patients requiring a change in current acute migraine treatment. Objective: To investigate the responsiveness of the Migraine-ACT tool, and compare it with that of the Migraine Disability Assessment (MIDAS) questionnaire, for patients with migraine at 1100 primary care sites in Spain.
Patients eligible for this open-label, 2-visit prospective study reported migraine for >1 year and >or=1 migraine attack per month and were new to the clinic or on follow-up care for <6 months. Validated Spanish versions of the Migraine-ACT and MIDAS questionnaires were administered, and patient satisfaction with treatment was recorded, at baseline and at 3 months.
A total of 3272 patients, 78% female, were enrolled, and 2877 (88%) returned for the 3-month visit. Investigators changed baseline migraine treatment for 72% of returning patients; 85% and 80% of these patients had improved Migraine-ACT and MIDAS scores at 3 months, respectively. Patients who reported being completely or very satisfied with migraine treatment numbered 492 (15%) at baseline and 1406 (49%) at 3 months. Migraine-ACT and MIDAS score agreement for improvement at 3 months was poor (kappa = 0.339). Both the mean MIDAS score and the distribution of Migraine-ACT scores improved over the course of 3 months; however, Migraine-ACT scores were significantly (P < .001) more sensitive (83% vs 75%) and specific (72% vs 58%) than MIDAS scores. The area under the curve in the receiver-operating characteristic analysis was significantly (P < .0001) greater for Migraine-ACT (0.82) as compared with the MIDAS (0.70) questionnaire.
These results suggest that the Migraine-ACT questionnaire can be used more reliably than the MIDAS questionnaire for detecting improvements in treatment of new and follow-up patients with migraine.
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ABSTRACT: The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period. The MIDAS score has been shown to have moderately high test-retest reliability in headache sufferers and is correlated with clinical judgment regarding the need for medical care. The aim of the study was to examine the validity of the MIDAS score, and the five items comprising the score, compared to data from a 90 day daily diary used, in part, to record acute disability from headache. In a population-based sample, 144 clinically diagnosed migraine headache sufferers were enrolled in a 90 day diary study and completed the MIDAS questionnaire at the end of the study. The daily diary was used to record detailed information on headache features as well as activity limitations in work, household chores, and non-work activities (social, family and leisure activities). The MIDAS score was the sum of missed work or school days, missed household chores days, missed non-work activity days, and days at work or school plus days of household chores where productivity was reduced by half or more in the last 3 months. Validity was assessed by comparing MIDAS items and the MIDAS score with equivalent measures derived from the diary. The MIDAS items for missed days of work or school (mean 0.96, median 0) and for missed days of household work (mean 3.64, median 2.0) were similar to the corresponding diary-based estimates of missed work or school (mean 1.23, median 0) and of missed household work (mean 3.93, median 2.01). Values for missed days of non-work activities (MIDAS mean 2.6 and median 1 versus diary mean 2.22 and median 0.95) were also similar. Responses to MIDAS questions about number of days where productivity was reduced by half or more in work (mean 3.77, median 2.00) and in household work (mean 3.92, median 2.00) significantly overestimated the corresponding diary-based measures for work (mean 2.94, median 1.06) and household work (mean 2.22, median 0.98). Nonetheless, the overall MIDAS score (mean 14.53, median 9.0) was not significantly different form the reference diary-based measure (mean 13.5, median 8.4). The correlation between the MIDAS summary score and an equivalent diary score was 0.63. The group estimate of the MIDAS score was found to be a valid estimate of a rigorous diary-based measure of disability. The mean and median values for the MIDAS score in a population-based sample of migraine cases were similar to equivalent diary measures. The correlation between the two measures was in the low moderate range, but expected given that two very different methods of data collection were compared.Pain 11/2000; 88(1):41-52. · 5.64 Impact Factor
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ABSTRACT: This review discusses emerging treatments of migraine in the context of what is now available. At present, patients are treated with a range of acute attack medicines or preventive treatments, with many having significant drawbacks. Important unmet needs are acute attack treatments that act by exclusively neural mechanisms with no vascular effects, and effective, well tolerated preventive medicines. Calcitonin gene-related peptide receptor antagonist, vanilloid receptor antagonists and nitric oxide synthase inhibitors are all in clinical trials for acute migraine. Tonaberset (a gap-junction blocker), an inducible nitric oxide synthase inhibitor and botulinum toxin A are in clinical trials for preventive therapy. Device-based approaches using neurostimulation of the occipital nerve are being studied, although the first study of patent foramen ovale closure for migraine prevention failed.Expert Opinion on Emerging Drugs 10/2006; 11(3):419-27. · 2.48 Impact Factor
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ABSTRACT: Context Various guidelines recommend different strategies for selecting and sequencing acute treatments for migraine. In step care, treatment is escalated after first-line medications fail. In stratified care, initial treatment is based on measurement of the severity of illness or other factors. These strategies for migraine have not been rigorously evaluated.Objective To compare the clinical benefits of 3 strategies: stratified care, step care within attacks, and step care across attacks, among patients with migraine.Design and Setting Randomized, controlled, parallel-group clinical trial conducted by the Disability in Strategies Study group from December 1997 to March 1999 in 88 clinical centers in 13 countries.Patients A total of 835 adult migraine patients with a Migraine Disability Assessment Scale (MIDAS) grade of II, III, or IV were analyzed as the efficacy population; the safety analysis included 930 patients.Interventions Patients were randomly assigned to receive (1) stratified care (n = 279), in which patients with MIDAS grade II treated up to 6 attacks with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg, and patients with MIDAS grade III and IV treated up to 6 attacks with zolmitriptan, 2.5 mg; (2) step care across attacks (n = 271), in which initial treatment was with aspirin, 800 to 1000 mg, plus metoclopramide, 10 mg. Patients not responding in at least 2 of the first 3 attacks switched to zolmitriptan, 2.5 mg, to treat the remaining 3 attacks; and (3) step care within attacks (n = 285), in which initial treatment for all attacks was with aspirin, 800 to 1000 mg, plus metoclopramide, 20 mg. Patients not responding to treatment after 2 hours in each attack escalated treatment to zolmitriptan, 2.5 mg.Main Outcome Measures Headache response, achieved if pain intensity was reduced from severe or moderate at baseline to mild or no pain at 2 hours; and disability time per treated attack at 4 hours for all 6 attacks, compared among the 3 groups.Results Headache response at 2 hours was significantly greater across 6 attacks in the stratified care treatment group (52.7%) than in either the step care across attacks group (40.6%; P<.001) or the step care within attacks group (36.4%; P<.001). Disability time (6 attacks) was significantly lower in the stratified care group (mean area under the curve [AUC], 185.0 mm · h) than in the step care across attacks group (mean AUC, 209.4 mm · h; P<.001) or the step care within attacks group (mean AUC, 199.7 mm · h; P<.001). The incidence of adverse events was higher in the stratified care group (321 events) vs both step care groups (159 events in across-attack group; 217 in within-attack group), although most events were of mild-to-moderate intensity.Conclusion Our results indicate that as a treatment strategy, stratified care provides significantly better clinical outcomes than step care strategies within or across attacks as measured by headache response and disability time. Figures in this Article As the therapeutic armamentarium for migraine expands, clinicians and patients have an unprecedented range of treatment choices.1- 4 Emerging treatment guidelines recommend strategies for selecting and sequencing acute treatments without empirical evidence.2- 4 Ultimately, the goal of optimal migraine care is to initiate effective treatment strategies as early as possible, thereby minimizing pain and disability.4 At least 3 different acute treatment strategies have been proposed for migraine: step care across attacks, step care within attacks, and stratified care.2- 6 In step care across attacks, patients begin with a nonspecific therapy (ie, a simple or combination analgesic). After treating several attacks, if the treatment result is unsatisfactory, patients recontact their clinician for treatment escalation. The process is repeated until a satisfactory treatment result is achieved. This approach, often advocated in managed care treatment guidelines, has a number of advantages and disadvantages.5- 6 In step care within attacks, patients initially treat an attack with a nonspecific therapy. At a specific timepoint posttreatment, usually 2 hours, patients assess their response and, if needed, take another medication, often migraine-specific. This approach provides patients with a real-time strategy for managing treatment failure.5 In stratified care, the initial treatment is selected based on the patient's treatment needs. Variants of stratified care are recommended in various treatment guidelines.3- 4 We have suggested that headache-related disability (activity limitations in various domains of function) may serve as the basis for stratification in migraine care.5- 6 In clinical simulations, physicians use headache-related disability to determine severity of illness and to inform the choice of treatment.7 Although this approach of matching treatment to severity of illness is intuitive7 and used for other conditions (eg, asthma8), it has not been tested empirically in migraine. To date, stratified care based on the Migraine Disability Assessment Scale (MIDAS) grade and step-care strategies for the acute treatment of migraine have not been rigorously evaluated. Therefore, we conducted a randomized clinical trial of 3 treatment strategies. In this study, patients were randomized, not to a drug, but to a strategy of care.JAMA The Journal of the American Medical Association 01/2000; 284(20):2599-2605. · 29.98 Impact Factor