What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primary-care population of migraine patients.

OBJECTIVE: To interpret questionnaire scores, clinicians and researchers need to know what change in score reflects a meaningful change in the condition of an individual patient, and what difference reflects a meaningful difference between groups. These values differ between different populations. We determined the within-person minimally important change (MIC) and the between-group minimally important difference (MID) of the Headache Impact Test-6 (HIT-6) questionnaire in a primary-care population of migraine patients. METHODS: We included 490 patients who participated in a clinical trial on the treatment of migraine in primary care. We compared their change scores on the HIT-6 questionnaire between baseline and at three-months follow-up with the answers to two anchor questions according to the 'mean change approach' and the 'ROC curve approach'. RESULTS: The within-person MIC was estimated to be between -2.5 points (mean change approach) and -6 points (ROC curve approach). The choice for the within-person MIC value depends on the consequences of false positives and false negatives in a particular setting. The between-group MID was estimated at -1.5 points. CONCLUSIONS: We determined the within-person MIC and between-group MID for the HIT-6 in a primary-care population of migraine patients. We recommend the use of these values for clinical care and for research.

Triptan use after starting prophylactic migraine treatment: a retrospective cohort study in a primary care population.

BACKGROUND: Clinical trials on the prophylactic effect of propranolol and metoprolol for migraine show that starting this medication leads to a decrease in the use of attack medication of 0.9-8.9 doses per month. However, studies in daily practice are lacking. METHODS: We compared the number of triptans prescribed in the six months before and the six months after the start of propranolol/metoprolol in a Dutch national representative primary care cohort. RESULTS: Of the 168 triptan-using patients who started with propranolol or metoprolol, the number of triptans prescribed before starting was 4.6 doses per month. The number of triptans prescribed six months before compared with six months after starting propranolol/metoprolol decreased with 1.0 dose per month (Wilcoxon rank test; p = 0.000). CONCLUSION: In this primary care population, although the number of triptans prescribed decreased after starting propranolol or metoprolol, the decrease is relatively small compared to data from clinical trials.

A proactive approach to migraine in primary care: a pragmatic randomized controlled trial.

BACKGROUND: Migraine is a common, disabling headache disorder that leads to lost quality of life and productivity. We investigated whether a proactive approach to patients with migraine, including an educational intervention for general practitioners, led to a decrease in headache and associated costs. METHODS: We conducted a pragmatic randomized controlled trial. Participants were randomized to one of two groups: practices receiving the intervention and control practices. Participants were prescribed two or more doses of triptan per month. General practitioners in the intervention group received training on treating migraine and invited participating patients for a consultation and evaluation of the therapy they were receiving. Physicians in the control group continued with usual care. Our primary outcome was patients' scores on the Headache Impact Test (HIT-6) at six months. We considered a reduction in score of 2.3 points to be clinically relevant. We used the Kessler Psychological Distress Scale (K10) questionnaire to determine if such distress was a possible effect modifier. We also examined the interventions' cost-effectiveness. RESULTS: We enrolled 490 patients in the trial (233 to the intervention group and 257 to the control group). Of the 233 patients in the intervention group, 192 (82.4%) attended the consultation to evaluate the treatment of their migraines. Of these patients, 43 (22.3%) started prophylaxis. The difference in change in score on the HIT-6 between the intervention and control groups was 0.81 (p = 0.07, calculated from modelling using generalized estimating equations). For patients with low levels of psychological distress (baseline score on the K10 ≤ 20) this change was -1.51 (p = 0.008), compared with a change of 0.16 (p = 0.494) for patients with greater psychological distress. For patients who were not using prophylaxis at baseline and had two or more migraines per month, the mean HIT-6 score improved by 1.37 points compared with controls (p = 0.04). We did not find the intervention to be cost-effective. INTERPRETATION: An educational intervention for general practitioners and a proactive approach to patients with migraine did not result in a clinically relevant improvement of symptoms. Psychological distress was an important confounder of success. (Current Controlled Trials registration no. ISRCTN72421511.).

What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study.

BACKGROUND: The outcome measures most frequently used in studies on the effectiveness of migraine treatment are whether the patient is free of pain, nausea, and free of photophobia/phonophobia within two hours. However, no patient-centred outcome measures are available. Therefore, we performed an online Delphi procedure to compile a list of outcome measures deemed most important to migraine patients. METHODS: From a large database of migraine patients, we randomly selected 150 males and 150 females patients. We asked the open-ended question: 'If a new medicine was developed for migraine attacks, what would you wish the effect of this medication to be?' In the second and third rounds, we presented the answers of the first round and asked the patients to rate the importance of each item. RESULTS: The initial response rate was 56% (n = 169). In the subsequent rounds the response rates were 90% (n = 152), and 97% (n = 147), respectively. Patients wanted their attack medication to treat the headache within 30 min, to prevent the attack from getting worse, to ensure they could function properly within 1 h, and prevent the recurrence of symptoms during the same day. CONCLUSIONS: The currently used outcome measures in migraine research do not sufficiently reflect the wishes of patients. Patients want the medication to work faster, to take away pain at an earlier stage, to make them able to function properly quickly, and to prevent recurrence. These aspects should be considered in future evaluation of new attack medication for migraine.

Acceptance of preventive treatment in migraine patients: results of a survey.

BACKGROUND: The number of migraine patients eligible for preventive treatment is considerably higher than the number of patients actually using it. This study explores reasons for this discrepancy. METHODS: An explorative survey among patients and their general practitioners (GPs) participating in a trial on preventive medication. Migraine patients who were eligible for preventive treatment (n = 75) attended an evaluation consultation with their GP to optimize migraine treatment. GPs and patients who did not start preventive treatment were asked if they had discussed the possibility of preventive treatment and, if so, why they decided not to start it. RESULTS: Of the 32 GPs, 8 (25%) did not discuss the possibility of preventive treatment with their patients; in 4 because of perceived lack of effectiveness. Patients who did not start preventive treatment (n = 43) used less triptans and had less psychological distress compared to those who did start (n = 32). Main reasons for patients not starting were negative attitudes towards medication in general, fear of medication side-effects, previous unsuccessful attempts, attacks not being severe enough, and impact of migraine on daily life acceptable. CONCLUSION: The decision of the individual patient and their GP to start preventive treatment is not only determined by attack frequency, but also depends on the impact of the headache attacks on their daily life and their negative attitude towards medication.

How usual is usual care in pragmatic intervention studies in primary care? An overview of recent trials.

BACKGROUND: Because pragmatic trials are performed to determine if an intervention can improve current practice, they often have a control group receiving 'usual care'. The behaviour of caregivers and patients in this control group should be influenced by the actions of researchers as little as possible. Guidelines for describing the composition and management of a usual care control group are lacking. AIM: To explore the variety of approaches to the usual care concept in pragmatic trials, and evaluate the influence of the study design on the behaviour of caregivers and patients in a usual care control group. DESIGN OF STUDY: Review of 73 pragmatic trials in primary care with a usual care control group published between January 2005 and December 2009 in the British Medical Journal, the British Journal of General Practice, and Family Practice. Outcome measures were: description of the factors influencing caregiver and patients in a usual care control group related to an individual randomised design versus cluster randomisation. RESULTS: In total, 38 individually randomised trials and 35 cluster randomised trials were included. In most trials, caregivers had the freedom to treat control patients according to their own insight; in two studies, treatment options were restricted. Although possible influences on the behaviour of control caregivers and control patients were more often identified in individually randomised trials, these influences were also present in cluster randomised trials. The description of instructions and information provided to the control group was often insufficient, which made evaluation of the trials difficult. CONCLUSION: Researchers in primary care medicine should carefully consider the design of a usual care control group, especially with regard to minimising the risk of study-induced behavioural change. It is recommended that an adequate description of the information is provided to control caregivers and control patients. A proposal is made for an extension to the CONSORT statement that requires authors to specify details of the usual care control group.