title: Clinical trials in the out-of-hospital setting: rationale and strategies for successful implementation.
abstract: Cardiopulmonary arrest and trauma are two of the major epidemics of our time. In most cases, the final outcome is altered, for better or for worse, by how interventions are provided in the prehospital setting, making that venue critical for lifesaving community research efforts. In certain venues, out-of-hospital emergency medical services personnel are highly skilled at managing resuscitations and routinely operate under strict, highly scrutinized protocols, resulting in extraordinary study compliance. Larger patient enrollment derived from population-based investigations can lead to faster study completion, less selection bias, higher-powered data, and enhanced subgroup analysis. Most importantly, the concomitant training, expert protocol development, and rigid scrutiny all lead to improved patient outcomes, regardless of study intervention. For successful implementation, emergency medical services personnel should be involved in study design, and utilize routine, automated data collection. Technologies should be provided that simplify tasks and diminish confounding variables. Considering that exception to informed consent is a critical component, prospective education and involvement of the medical community, community leaders, employee groups and the media, long before protocol implementation, is essential. Such efforts should be led by respected, academically authoritative, grassroots emergency medical services medical directors and trauma chiefs, preferably those based at the main trauma centers or public receiving facilities.
authors.affiliation: Department of Medicine, School of Public Health, University of Texas Southwestern Medical Center at Dallas, Dallas, TX, USA. paul.pepe@utsw.edu
authors.forename: Paul E
authors.initials: PE
authors.lastname: Pepe
authors.forename: Michael K
authors.initials: MK
authors.lastname: Copass
authors.forename: George
authors.initials: G
authors.lastname: Sopko
mesh_terms: D001291:Attitude of Health Personnel; D016887:Cardiopulmonary Resuscitation; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods*; D003625:Data Collection; D003627:Data Interpretation, Statistical; D004632:Emergency Medical Services; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent; D011057:Politics; D035502:Trust