RESUMEN
INTRODUCTION: The Privacy Rule, a follow-up to the Health Insurance Portability and Accountability Act, limits distribution of protected health information. Compliance with the Privacy Rule is particularly challenging for prehospital research, because investigators often seek data from multiple emergency medical services (EMS) and receiving hospitals. OBJECTIVE: To describe the impact of the Privacy Rule on prehospital research and to present strategies to optimize data collection in compliance with the Privacy Rule. Methods. The CanAm Pediatric Cardiopulmonary Arrest Study Group has previously conducted a multicentered observational study involving children with out-of-hospital cardiac arrest. In the current study, we used a survey to assess site-specific methods of compliance with the Privacy Rule and the extent to which such strategies were successful. RESULTS: The previously conducted observational study included collection of data from a total of 66 EMS agencies (range of 1-37 per site). Data collection from EMS providers was complicated by the lack of a systematic approval mechanism for the research use of EMS records and by incomplete resuscitation records. Agencies approached for approval to release EMS data for study purposes included Department of Health Institutional Review Boards, Fire Commissioners, and Commissioners of Health. The observational study included collection of data from a total of 164 receiving hospitals (range of 1-63 per site). Data collection from receiving hospitals was complicated by the varying requirements of receiving hospitals for the release of patient survival data. CONCLUSIONS: Obtaining complete EMS and hospital data is challenging but is vital to the conduct of prehospital research. Obtaining approval from city or state level IRBs or Privacy Boards may help optimize data collection. Uniformity of methods to adhere to regulatory requirements would ease the conduct of prehospital research.
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Servicios Médicos de Urgencia , Paro Cardíaco , Pediatría , Privacidad/legislación & jurisprudencia , Encuestas de Atención de la Salud , Health Insurance Portability and Accountability Act , Humanos , Estados UnidosRESUMEN
BACKGROUND: Pediatric cardiopulmonary arrest (CPA) outside of the hospital has a very high mortality rate. OBJECTIVES: To evaluate the etiology and initial compromise of pediatric CPA cases in hopes of developing strategies to improve out-of-hospital resuscitation. METHODS: The Ontario Prehospital Advanced Life Support (OPALS) study was a large multicenter initiative to evaluate the impact of emergency medical services (EMS) programs on 17 communities with 40,000 critically ill and injured patients who were older than 11 years. As part of this study, the authors conducted a retrospective observational cohort study that included all children younger than 18 years of age with out-of-hospital CPA, during an 11-year period from 1991-2002. CPA was defined as patient being pulseless, apneic, and requiring chest compressions. Data were collected from ambulance call reports and centralized dispatch data and were reviewed by two independent investigators. RESULTS: There were 503 children with CPA in the sample. Mean age was 5.6 years (range, 0-17 yr); 58.4% of patients were male, and 37.8% were younger than 1 year of age. Cardiopulmonary resuscitation (CPR) first was started by a bystander in 32.4% of cases, whereas 66.0% were unwitnessed arrests. Initial rhythms were asystole 77.2% of the time, pulseless electrical activity 16.4% of the time, and ventricular fibrillation or ventricular tachycardia 4% of the time. Annual incidence was 9.1/100,000 children. CPA was witnessed in 34.0% of cases; 80.7% of these were bystander-witnessed, and 18.1% were EMS-witnessed. Primary pathogenic cause of arrest was medical in 61.2% of cases, trauma in 37.2% of cases, and indeterminate in 1.6% of cases. Initial underlying physiologic compromise of witnessed arrests was judged to be respiratory in 39.8% of cases, sudden collapse (presumed electrical) in 16.4% of cases, progressive shock in 1.2% of cases, and indeterminate in 42.6% of cases. Presumed etiology was trauma, 37.6%; sudden infant death syndrome (SIDS), 20.3%; and respiratory disease, 11.6%, most commonly. Survival to hospital discharge was 2.0%. CONCLUSIONS: This is one of the largest population-based, prospective cohorts of pediatric CPA reported to date, and it reveals that most pediatric arrests are unwitnessed and receive no bystander CPR. Those that are witnessed most often are caused by respiratory arrests or trauma. Trauma, SIDS, and respiratory disease are the most common etiologies overall. These data are vital to planning large resuscitation trials looking at specific interventions (i.e., increasing bystander CPR) and highlight the need for better strategies for prevention and early recognition.