The Public Access Defibrillation (PAD) trial: study design and rationale.
The PAD Trial is a prospective, multicenter, randomized clinical study testing whether volunteer, non-medical responders can improve survival from out-of-hospital cardiac arrest (OOH-CA) by using automated external defibrillators (AEDs). These lay volunteers, who have no traditional responsibility to respond to a medical emergency as part of their primary job description, will form part of a comprehensive, integrated community approach to the treatment of OOH-CA. The study is being conducted at 24 field centers in the United States and Canada. Approximately 1000 community units (e.g. apartment or office buildings, gated communities, sports facilities, senior centers, shopping malls, etc.) were randomized to treatment by trained laypersons who will provide either cardiopulmonary resuscitation (CPR) alone or CPR plus use of an AED, while awaiting arrival of the community's emergency medical services responders. The primary endpoint is the number of OOH-CA victims who survive to hospital discharge. Secondary endpoints include neurological status, health-related quality of life (HRQL), cost, and cost-effectiveness. Data collection will last approximately 15 months and is expected to be completed in September 2003.
Ornato
Joseph P
JP
Department of Emergency Medicine, Medical College of Virginia, Virginia Commonwealth University Health Center, 401 North 12th Street, Box 525, Room G-248, Richmond, VA 23298-0525, USA. ornato@aol.com
McBurnie
Mary Ann
MA
Nichol
Graham
G
Salive
Marcel
M
Weisfeldt
Myron
M
Riegel
Barbara
B
Christenson
James
J
Terndrup
Thomas
T
Daya
Mohamud
M
D002170:Canada; D016887:Cardiopulmonary Resuscitation / Q000592:standards* / Q000639:trends; D004554:Electric Countershock / Q000295:instrumentation*; D004630:Emergencies; D004632:Emergency Medical Services / Q000592:standards / Q000639:trends; D005260:Female; D006323:Heart Arrest / Q000401:mortality* / Q000628:therapy*; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D011633:Public Facilities; D016032:Randomized Controlled Trials as Topic; D012680:Sensitivity and Specificity; D016019:Survival Analysis; D014481:United States; D014838:Volunteers