Use of on-line medical command to randomize patients in a prehospital research study.
OBJECTIVE
To describe the efficiency of using on-line medical command (OLMC) to conduct a prospective, randomized clinical trial addressing safety and patient enrollment.


METHODS
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.
Tortella
B J
BJ
New Jersey Trauma and EMS Research Center, UMDNJ-University Hospital, Department of Surgery, Section of Trauma and EMS, Newark, New Jersey 07103-2406, USA.
Lavery
R F
RF
Quadrel
M
M
Cody
R P
RP
Heyt
G
G
D000293:Adolescent; D000328:Adult; D000488:Allied Health Personnel; D001249:Asthma / Q000628:therapy; D004417:Dyspnea / Q000628:therapy; D004632:Emergency Medical Services; D006801:Humans; D008875:Middle Aged; D009862:Online Systems; D018579:Patient Selection; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D012135:Respiratory Sounds