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[REVEIL Trial: Study validity, information and logistics. Preliminary results. Quality measures]
Abstract:
Self blood pressure measurement (SBPM) is not fully applied because of the cost of devices and the lack of efficient dedicated medical networks. The aim of the REVEIL study was to allow patients to freely rent SBPM devices by their pharmacist after initial medical prescription. Practitioners taught SBPM methods to the patients with a booklet and the pharmacist explained them how to use the device. This preliminary report focuses on the 428 first patients included from September 1999 to June 2000 by their general practitioner (n = 59) or cardiologist (n = 12) in the centre of the city of Reims (France), when he thought there was an indication for a SBPM period. The patient received a medical prescription and took a validated device (Omron 705CP) by one of the 44 pharmacists who accepted to participate. After 7 days the patient consulted his practitioner with the filled booklet. The prescription was for 7 days with 3 measurements each morning (before intake of antihypertensive drugs) and each evening (12 hours later). Patients reported the results on the booklet and enclosed the report printed by the device. From the 428 included patients, 362 (85%) gave analyzable data, the difference being explained by refusals (n = 39) and by the lag between inclusion and completion. Mean age was 55.2 (range 20 to 90). Education levels were: no graduation (n = 71), primary school (n = 172), college (n = 59), university (n = 86) [no answer in n = 40]. Seventy nine percent (n = 286) performed at least 12 measurements on three consecutive days. There is no significant difference between morning and evening completions. According to themselves, 294 patients fully succeeded in SBPM. Eighteen failed (6 reported a failure of the device, 2 had not understood the procedure, 5 had forgotten, 5 reported another cause), 50 did not answer. These results establish the fair applicability of SBPM under the realistic conditions of the REVEIL study (free rent of devices after medical prescription) as 85% of patients gave contributive information with a good quality in 79% of them.