Resuscitation
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Randomized Controlled Trial Multicenter Study Clinical Trial
Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience.
The Public Access Defibrillation (PAD) Trial, a prospective, multicenter, randomized clinical trial comparing two prehospital resuscitation strategies, was conducted under the regulations for exception from informed consent (21CFR50.24) in 24 communities in North America. These regulations place additional requirements for human subject protection on investigators and Institutional Review Boards (IRBs), including conducting community consultation (CC) and public disclosure (PD). ⋯ The length of time to obtain IRB approval and the extent of community consultation and public disclosure varied greatly among trial sites in meeting the current regulations for conducting emergency research with exception from informed consent. This suggests that more specific guidance may be useful and that determination of effective strategies for community consultation and public disclosure is needed.
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Randomized Controlled Trial Comparative Study Clinical Trial
Trials of teaching methods in basic life support (4): comparison of simulated CPR performance at unannounced home testing after conventional or staged training.
This study compares the retention of basic life support (BLS) skills after 6 and 12 months by lay persons trained either in a conventional manner, or using a staged approach. Three classes, each of 2h, were offered to volunteers over a period of 4 months. For the conventional group, the second and third classes consisted of review of skills. ⋯ At 12 months, those taught by the staged method were significantly better at shouting for help (P = 0.005), time to first compression (P < 0.0001), and compression depth (P = 0.003). Those taught conventionally were significantly better at checking for a carotid pulse at both 6 and 12 months (P < 0.0001). These results suggest that training lay persons in basic life support skills using a staged approach leads to overall better skill retention at 6 and 12 months, and has other advantages including a greater willingness to re-attend follow-up classes.