Patient Involvement

In the monitoring of sumatriptan it is estimated that 50% of the forms were completed by telephone interview (n = 10 918) and 15% (n = 3950) were completed by patients (see above). Patients completed the questionnaires carefully and competently and, in general, have described events in better detail than the doctors.

Two surveys of patients have been undertaken in order to investigate signals. The first was a comparative study of labetalol and metoprolol involving 593 patients to investigate signals of scalp tingling, polyuria and polydipsia with labetalol (Coulter, 1979). The second was a comparative study of nifedipine and captopril in order to validate a signal of eye pain with nifedipine and to characterise the reaction of taste disturbance with captopril (Coulter, 1988). A total of 1265 patients were involved in this study. Compliance with returning questionnaires was high: 87%, 77%, 84% and 86% for labetalol, metoprolol, nifedipine and captopril, respectively. The questionnaires were completed with care and both studies produced rational results with no evidence of spurious responses. Patients were willing to give personal information such as date of birth.

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