Inhomogeneity and temporal effects in AutoPulse Assisted Prehospital International Resuscitation-an exception from consent trial terminated early

American Journal of Emergency Medicine

Volumn 28, Issue 4, 2010, Pages 391-398

  Paradis, Norman A ^a   Young, Gregory ^b   Lemeshow, Stanley ^b   Brewer, James E ^a,b,c   Halperin, Henry R ^c  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b OHIO STATE UNIVERSITY   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; AUTOPULSE CARDIOPULMONARY RESUSCITATION DEVICE; CLINICAL EFFECTIVENESS; CLINICAL PROTOCOL; CLINICAL TRIAL; HUMAN; INFORMATION PROCESSING; INTERMETHOD COMPARISON; MEDICAL DOCUMENTATION; MEDICAL INSTRUMENTATION; MEDICAL RESEARCH; METHODOLOGY; POST HOC ANALYSIS; PRIORITY JOURNAL; RESUSCITATION; SAFETY; SURVIVAL RATE; THERAPY DELAY; TREATMENT OUTCOME;

CARDIOPULMONARY RESUSCITATION; CLINICAL PROTOCOLS; CONFIDENCE INTERVALS; EARLY TERMINATION OF CLINICAL TRIALS; EMERGENCY MEDICAL SERVICES; EQUIPMENT AND SUPPLIES; HEART ARREST; HUMANS; LOGISTIC MODELS; ODDS RATIO; PROSPECTIVE STUDIES; SURVIVAL ANALYSIS; TIME FACTORS; TREATMENT OUTCOME;

EID: 77951962288     PISSN: 07356757     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ajem.2010.02.002     Document Type: Article

References (18)

1. Hallstrom A., Rea T.D., Sayre M.R., et al. Manual chest compression vs use of an automated chest compression device during resuscitation following out-of-hospital cardiac arrest: a randomized trial. JAMA 295 22 (2006) 2620-2628
2. Halperin H., Paradis N., Mosesso Jr. V., et al. Recommendations for implementation of community consultation and public disclosure under the Food and Drug Administration's "Exception from informed consent requirements for emergency research": a special report from the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care: endorsed by the American College of Emergency Physicians and the Society for Academic Emergency Medicine. Circulation 116 16 (2007) 1855-1863
3. Halperin H.R., Paradis N., Ornato J.P., et al. Cardiopulmonary resuscitation with a novel chest compression device in a porcine model of cardiac arrest: improved hemodynamics and mechanisms. J Am Coll Cardiol 44 11 (2004) 2214-2220
4. Ong M.E., Ornato J.P., Edwards D.P., et al. Use of an automated, load-distributing band chest compression device for out-of-hospital cardiac arrest resuscitation. JAMA 295 22 (2006) 2629-2637
5. Casner M., Andersen D., and Isaacs S.M. The impact of a new CPR assist device on rate of return of spontaneous circulation in out-of-hospital cardiac arrest. Prehosp Emerg Care 9 1 (2005) 61-67
6. Timerman S., Cardoso L.F., Ramires J.A., and Halperin H. Improved hemodynamic performance with a novel chest compression device during treatment of in-hospital cardiac arrest. Resuscitation 61 3 (2004) 273-280
7. Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 3: adult basic life support. The American Heart Association in collaboration with the International Liaison Committee on Resuscitation. Circulation 102 8 Suppl (2000) I22-I59
8. Dixon Jr. J.R. The International Conference on Harmonization Good Clinical Practice guideline. Qual Assur 6 2 (1998) 65-74
9. Localio A.R., Berlin J.A., Ten Have T.R., and Kimmel S.E. Adjustments for center in multicenter studies: an overview. Ann Intern Med 135 2 (2001) 112-123
10. Hosmer D.W., and Lemeshow S. Applied Logistic Regression. 2nd ed (2000), John Wiley and Sons, New York
11. Lewis J.A. Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline. Stat Med 18 15 (1999) 1903-1942
12. Brostrom G. A martingale approach to the change point problem. J Am Stat Assoc 439 (1997) 1177-1183
13. Pettitt A.N. A simple cumulative sum type statistic for the change point problem with zero-one observations. Biometrika 67 (1980) 79-84
14. Basseville M., and Nikiforov I.V. Detection of abrupt changes: theory and application (1993), Prentice-Hall, Engelwood (NJ)
15. Puffer S., Torgerson D., and Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ 327 7418 (2003) 785-789
16. Ellenberg S., Fleming T.R., and Demets D.L. Data Monitoring Committees in Clinical Trials: a practical perspective (2002), John Wiley and Sons
17. Lewis R.J., and Niemann J.T. Manual vs device-assisted CPR: reconciling apparently contradictory results. JAMA 295 22 (2006) 2661-2664
18. Nissen S.E. ADAPT: the wrong way to stop a clinical trial. PLoS Clin Trials 1 7 (2006) e35