@article{6bdb24bbc1b440a1aef9496d8aa7d1f0,
title = "The Random Dialing Survey as a Tool for Community Consultation for Research Involving the Emergency Medicine Exception From Informed Consent",
abstract = "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.",
author = "Bulger, {Eileen M.} and Schmidt, {Terri A.} and Cook, {Andrea J.} and Brasel, {Karen J.} and Griffiths, {Denise E.} and Kudenchuk, {Peter J.} and Daniel Davis and Berit Bardarson and Idris, {Ahamed H.} and Aufderheide, {Tom P.}",
note = "Funding Information: The Resuscitation Outcomes Consortium is a clinical trials network funded by the National Institutes of Health and the Canadian Institute for Health Research (available at https://roc.uwctc.org/tiki/tiki-index.php ). The mission of this network is to conduct phase 3 multicenter, clinical trials of promising therapeutic options for the management of out-of-hospital cardiac arrest and life-threatening traumatic injury. The network consists of 8 sites in the United States and 2 in Canada. The first trial to be implemented by this network involves the out-of-hospital administration of hypertonic fluids as the initial resuscitation fluid for patients with evidence of either severe traumatic brain injury or hemorrhagic shock. 10 The predicted mortality for these cohorts is 30% to 50%. Patients are randomized to receive 250 mL of either 7.5% saline/6% dextran70 (HSD), 7.5% saline without dextran, or normal saline solution (0.9%) as the initial resuscitation fluid administered by out-of-hospital providers. All subsequent care is unchanged. Previous studies of hypertonic fluids in this patient population suggest minimal risks, with the potential for direct benefit to the individual. There is a potential risk of allergic reaction to dextran, estimated to occur in 1 in 100,000 patients. However, this has never been observed in a trauma patient receiving HSD. 11 Investigational drug approval was obtained from the FDA. The local institutional review boards in each community were responsible for oversight of the community consultation and notification process. As part of the community consultation process, 5 of the 8 US sites elected to include a random dialing survey. The other 3 sites chose not to use a random dialing survey because of financial concerns. This report outlines the experience with a random dialing survey at these 5 sites. All sites have institutional review board approval for publication of these data. Funding Information: Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article, that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. This study was supported by a cooperative agreement (5U01 HL077863) with the National Heart, Lung and Blood Institute in partnership with the National Institute of Neurological Disorders and Stroke, The Canadian Institutes of Health Research (CIHR)–Institute of Circulatory and Respiratory Health, Defense Research and Development Canada, and the Heart and Stroke Foundation of Canada. ",
year = "2009",
month = mar,
doi = "10.1016/j.annemergmed.2008.07.021",
language = "English (US)",
volume = "53",
pages = "341--350.e2",
journal = "Annals of emergency medicine",
issn = "0196-0644",
publisher = "Mosby Inc.",
number = "3",
}