The Random Dialing Survey as a Tool for Community Consultation for Research Involving the Emergency Medicine Exception From Informed Consent

被引:41
作者
Bulger, Eileen M. [1 ]
Schmidt, Terri A. [2 ]
Cook, Andrea J.
Brasel, Karen J. [3 ]
Griffiths, Denise E. [2 ]
Kudenchuk, Peter J.
Davis, Daniel [4 ]
Bardarson, Berit
Idris, Ahamed H. [5 ]
Aufderheide, Tom P. [3 ]
机构
[1] Univ Washington, Harborview Med Ctr, Seattle, WA 98104 USA
[2] Oregon Hlth & Sci Univ, Portland, OR 97201 USA
[3] Med Coll Wisconsin, Milwaukee, WI 53226 USA
[4] Univ Calif San Diego, San Diego, CA 92103 USA
[5] Univ Texas SW Med Ctr Dallas, Dallas, TX 75390 USA
基金
加拿大健康研究院;
关键词
HYPERTONIC RESUSCITATION; IMPLEMENTATION; ATTITUDES; WAIVER;
D O I
10.1016/j.annemergmed.2008.07.021
中图分类号
R4 [临床医学];
学科分类号
100218 [急诊医学];
摘要
Study objective: in 1996, the Food and Drug Administration and the Department of Health and Human Services enacted rules allowing a narrow exception from informed consent for critically ill patients enrolled in emergency research. These include requirements for community consultation prior to trial implementation. Previous studies have noted difficulty in engaging the community. We seek to describe the experience with random dialing surveys as a tool for community consultation across 5 metropolitan regions in the United States. Methods: Random dialing surveys were used as part of the community consultation for an out-of-hospital clinical trial sponsored by the Resuscitation Outcomes Consortium. The survey method was designed to obtain a representative sample of the community according to population demographics and geography. Logistics of survey administration, role of the survey in community consultation, and survey results by population demographics are discussed. Results: Random dialing surveys were conducted in 5 of 8 US Resuscitation Outcomes Consortium sites. Overall, 70% to 79% of respondents indicated they would be willing to be enrolled in this study. Support for the inclusion of children (aged 15 to 18 years) ranged from 52% to 71%. Respondents aged 18 to 34 years were more willing to participate in the trial than older age groups. Women and racial minorities were less likely to favor the inclusion of minors. Conclusion: Random dialing surveys provide an additional tool to engage the community and obtain a sample of the opinion of the population about research conducted under the emergency exception from informed consent regulations. Similar results were obtained across 5 diverse communities in the United States. [Ann Emerg Med. 2009;53:341-350.]
引用
收藏
页码:341 / 350
页数:10
相关论文
共 24 条
[1]
Baddeley A.D., 2004, ESSENTIAL HDB MEMORY
[2]
Biemer P., 1991, MEASUREMENT ERRORS S
[3]
Struggling with the rule: The exception from informed consent in resuscitation research [J].
Biros, Michelle .
ACADEMIC EMERGENCY MEDICINE, 2007, 14 (04) :344-345
[4]
Hypertonic resuscitation: Design and implementation of a prehospital intervention trial [J].
Brasel, Karen J. ;
Bulger, Eileen ;
Cook, Andrea J. ;
Morrison, Laurie J. ;
Newgard, Craig D. ;
Tisherman, Sam A. ;
Kerby, Jeffrey D. ;
Coimbra, Raul ;
Hata, J. Steven ;
Hoyt, David B. .
JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS, 2008, 206 (02) :220-232
[5]
Hypertonic resuscitation of hypovolemic shock after blunt trauma - A randomized controlled trial [J].
Bulger, Eileen M. ;
Jurkovich, Gregory J. ;
Nathens, Avery B. ;
Copass, Michael K. ;
Hanson, Sandy ;
Cooper, Claudette ;
Liu, Ping-Yu ;
Neff, Margaret ;
Awan, Asaad B. ;
Warner, Keir ;
Maier, Ronald V. .
ARCHIVES OF SURGERY, 2008, 143 (02) :139-148
[6]
Dix ES, 2004, J INVEST MED, V52, P113, DOI 10.1136/jim-52-02-20
[7]
Fowler FJ, 2012, Survey research methods, V4th, DOI [DOI 10.4135/9781452230184, 10.4135/9781452230184]
[8]
Nonresponse rates and nonresponse bias in household surveys [J].
Groves, Robert M. .
PUBLIC OPINION QUARTERLY, 2006, 70 (05) :646-675
[9]
Leukocyte-endothelial interactions: Clinical trials of anti-adhesion therapy [J].
Harlan, JM ;
Winn, RK .
CRITICAL CARE MEDICINE, 2002, 30 (05) :S214-S219
[10]
Initial experience using the Food and Drug Administration guidelines for emergency research without consent [J].
Kremers, MS ;
Whisnant, DR ;
Lowder, LS ;
Gregg, L .
ANNALS OF EMERGENCY MEDICINE, 1999, 33 (02) :224-229