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Use of on-line medical command to randomize patients in a prehospital research study
B J Tortella1, R F Lavery, M Quadrel
1New Jersey Trauma and EMS Research Center, UMDNJ-University Hospital, Department of Surgery, Section of Trauma and EMS, Newark, New Jersey 07103-2406, USA.
Objective:
To describe the efficiency of using on-line medical command (OLMC) to conduct a prospective, randomized clinical trial addressing safety and patient enrollment.
Design, Setting, And Participants:
Prospective design using OLMC to randomize adult asthmatics into one of three treatment groups. After verifying inclusion and exclusion criteria, OLMC physicians removed a covering label on study sheets and ordered the treatment specified underneath the label that had been assigned in a random sequence.
Results:
A total of 204 patients were seen with dyspnea and wheezing during the three-month study. Of these, 68 (33%) were excluded from the study. Of the 136 (67%) patients who were eligible for study, 87 were enrolled (enrollment efficiency 64%), with 79 fully evaluable (evaluable efficiency 91%). The study safety was 100% because no enrolled patients met any exclusion criteria.
Conclusions:
The design was random and prospective, with patient entry blinded, using paramedics to enroll patients and OLMC physicians as gatekeepers, thus ensuring appropriate patient eligibility and study-arm assignment. Use of OLMC physicians to perform prospective randomized studies is safe and efficient, and results in a high yield of evaluable patients.