Hostname: page-component-cd9895bd7-gvvz8 Total loading time: 0 Render date: 2024-12-18T01:59:44.813Z Has data issue: false hasContentIssue false

Study Design and Pre-Trial, Peer Review in EMS Research

Published online by Cambridge University Press:  28 June 2012

Donald M. Yealy*
Affiliation:
The Division of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pa., USA The Center for Emergency Medicine of Western Pennsylvania, Pittsburgh, Pa., USA The Darnall Army Community Hospital, Department of Emergency Medicine, Fort Hood, Tex., USA
Kevin H. Scruggs
Affiliation:
The Center for Emergency Medicine of Western Pennsylvania, Pittsburgh, Pa., USA The University of Pittsburgh, Affiliated Residency in Emergency Medicine
*
Presented at the Fifth Annual NAEMSP National Meeting, San Francisco, Calif.

Abstract

In order to identify the study designs andthe type of pre-trial peer review in published EMS research, we reviewed three refereed emergency medicine journals during the period from 1985 through 1988. All original scientific manuscripts utilizing human subjects in prehospital care were analyzed. Ninety-six issues were examined, and 79 manuscripts met the criteria for analysis. The research design was cross-sectional in 7.5%, retrospective in 51%, and prospective in 41.5%. Pre-trial peer review had been sought in nine (11%). Each was performed by a hospital or university-based Institutional Review Board (IRB). Only four (5%) manuscripts contained statements about pre-trial peer review. All reviewed trials were prospective in design (9/33, 27%). A follow-up telephone survey of the authors of the non-reviewed prospective trials indicated that 96% were unaware of the potential need for pre-trial review, 16% anticipated difficulty obtaining approval from traditional IRB committees, and 11% feared that the protocol would be interfered with by the review committee.

We conclude that 92.5% of the current published EMS research is retrospective or prospective in design, and that pre-trial peer review is not obtained in the majority of prehospital EMS research. Guidelines should be developed to educate EMS researchers about the need for and the value of pre-trial peer review. Journal editors should clearly state and enforce policies about manuscripts lacking information about pre-trial peer review when human subjects are involved.

Type
Original Research
Copyright
Copyright © World Association for Disaster and Emergency Medicine 1990

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Iber, FL, Riley, WA, Murray, PJ: Conducting Clinical Trials. Plenum Medical, New York, 1987, pp 85103.CrossRefGoogle Scholar
2. Sanders, AB: Human subjects research in emergency medicine. Ann Emerg Med 1984;13:11701171. Letter.CrossRefGoogle Scholar
3. FDA IRB Information Sheets. Department of Health and Human Services Bulletin, 1987.Google Scholar
4. Protection of Human Subjects. 45 CFR Pt 46, 1983.Google Scholar
5. Smith, JP, Bodai, BI: The urban paramedic's scope of practice. JAMA 1985;253:544548.CrossRefGoogle ScholarPubMed
6. Shuster, M, Chong, J: Pharmacologic intervention in prehospital care: A critical appraisal. Ann Emerg Med 1989;18:192196.CrossRefGoogle ScholarPubMed
7. Bailar, JC, Louis, TA, Lavori, PW, Polansky, M: A classification for biomedical research reports. In Bailar, JC, Mosteller, F (eds): Medical Uses of Statistics. N Engl J Med books, Waltham, Mass, 1986.Google Scholar
8. Guidelines To The Use of Human Subjects in Biomedical Research. University of Pittsburgh, 1986.Google Scholar
9. Levine, RJ: Informed consent in research and practice. Arch Intern Med 1983; 143:12291231.CrossRefGoogle ScholarPubMed
10. Hill, GJ: Research on humans published in JAMA. JAMA 1987;258;1604. Letter.CrossRefGoogle Scholar
11. Bartelt, PL, Bowman, MA: Research on humans published in JAMA. JAMA 1987;258:16041605. Letter.CrossRefGoogle Scholar