{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T05:24:11Z","timestamp":1788413051027,"version":"build-2803163510"},"reference-count":14,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2015,2,25]],"date-time":"2015-02-25T00:00:00Z","timestamp":1424822400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100000850","name":"National Heart and Lung Institute","doi-asserted-by":"publisher","award":["R44-HL065851-03"],"award-info":[{"award-number":["R44-HL065851-03"]}],"id":[{"id":"10.13039\/501100000850","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Academic Emergency Medicine"],"published-print":{"date-parts":[[2015,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Emergency medical research performed under federal regulation 21 \u00a7 <jats:styled-content style=\"fixed-case\">CFR<\/jats:styled-content> 50.24 provides a means to protect human subjects and investigate novel time\u2010sensitive treatments. Although prospective individual consent is not required for studies conducted under this regulation, consent from a legally authorized representative (<jats:styled-content style=\"fixed-case\">LAR<\/jats:styled-content>) or the patient at the earliest feasible opportunity is required to obtain short\u2010 and long\u2010term outcome data. The objective of this study was to determine which demographic, cardiac arrest, and patient outcome characteristics predicted the likelihood of obtaining informed consent following enrollment under exception from informed consent in a multicenter cardiac arrest study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This investigation was an analysis of data collected during a multisite, randomized, controlled, out\u2010of\u2010hospital cardiac arrest clinical trial performed under 21 \u00a7 <jats:styled-content style=\"fixed-case\">CFR<\/jats:styled-content> 50.24. Research personnel attempted to obtain informed consent from <jats:styled-content style=\"fixed-case\">LAR<\/jats:styled-content>s and subjects for medical records review of primary outcome data, as well as consent for neurologic outcome assessments up to 1\u00a0year post\u2013cardiac arrest. Hospital discharge and neurologic status were obtained from public records and\/or medical records up until the time consent was formally denied, in accordance with federal regulations and guidance. Local institutional review boards also allowed medical records review for cases where consent was neither obtained nor declined despite multiple consent attempts. Patient demographic, cardiac arrest, and clinical outcome characteristics were analyzed in univariate multinomial regression models, with consent status (obtained, denied, neither obtained nor denied) as the dependent variable. A multivariate multinomial logistic regression was then performed. An exploratory secondary analysis following the same process was performed after assigning patients who neither consented nor declined to the declined consent group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among a total study population of 1,655 cardiac arrest subjects, 457 were transported and had consent attempted (27.6%). The survival status and neurologic function at the time of hospital discharge were known in 440 of 457 (96%) subjects. In the multivariate analysis, initial rhythm of ventricular fibrillation\/ventricular tachycardia (<jats:styled-content style=\"fixed-case\">VF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">VT<\/jats:styled-content>) and survival with good neurologic outcome were strong predictors of obtaining consent (odds ratio [<jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content>]\u00a0=\u00a03.15, 95% confidence interval [<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>]\u00a0=\u00a01.73 to 5.75; <jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content>\u00a0=\u00a07.64, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\u00a0=\u00a02.28 to 25.63, respectively). The exploratory secondary analysis also showed initial rhythm of <jats:styled-content style=\"fixed-case\">VF<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">VT<\/jats:styled-content> and survival with good neurologic outcome as strong predictors of obtaining consent (<jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content>\u00a0=\u00a01.86, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\u00a0=\u00a01.17 to 2.95; <jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content>\u00a0=\u00a04.52, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\u00a0=\u00a02.21 to 9.26, respectively).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Initial arrest rhythm and survival with good neurologic outcome were highly predictive of obtaining consent in this cardiac arrest trial. This phenomenon could result in underrepresentation of outcome data in the study arm with the worse outcome and represents a significant potential confounder in studies performed under 21 \u00a7 <jats:styled-content style=\"fixed-case\">CFR<\/jats:styled-content> 50.24. Future revisions to the exception from informed consent regulations should allow access to critical survival data recorded as part of standard documentation, regardless of patient consent status.<\/jats:p><\/jats:sec>","DOI":"10.1111\/acem.12613","type":"journal-article","created":{"date-parts":[[2015,2,25]],"date-time":"2015-02-25T19:40:24Z","timestamp":1424893224000},"page":"347-353","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["The Association of Health Status and Providing Consent to Continued Participation in an Out\u2010of\u2010hospital Cardiac Arrest Trial Performed Under Exception From Informed Consent"],"prefix":"10.1111","volume":"22","author":[{"given":"Joshua G.","family":"Salzman","sequence":"first","affiliation":[{"name":"Critical Care Research Center Regions Hospital St. Paul MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralph J.","family":"Frascone","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine Regions Hospital St. Paul MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Burkhart","sequence":"additional","affiliation":[{"name":"Advanced Circulatory Systems, Inc. Roseville MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Holcomb","sequence":"additional","affiliation":[{"name":"Quintiles Consulting Rockville MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandi S.","family":"Wewerka","sequence":"additional","affiliation":[{"name":"Critical Care Research Center Regions Hospital St. Paul MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Swor","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine William Beaumont Hospital Royal Oak MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian D.","family":"Mahoney","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine Hennepin County Medical Center Minneapolis MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marvin A.","family":"Wayne","sequence":"additional","affiliation":[{"name":"Whatcom County Emergency Medical Services Department of Emergency Medicine PeaceHealth St. Joseph Medical Center Bellingham WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert M.","family":"Domeier","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine St. Joseph Hospital Ann Arbor MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael L.","family":"Olinger","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine Indiana University School of Medicine Indianapolis IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom P.","family":"Aufderheide","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine Medical College of Wisconsin Milwaukee WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith G.","family":"Lurie","sequence":"additional","affiliation":[{"name":"Department of Medicine Cardiovascular Division University of Minnesota Medical Center Minneapolis MN"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,2,25]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Food and Drug Administration Department of Health and Human Services.Code of Federal Regulations 21 \u00a7 CFR 50.24. Exception from Informed Consent Requirements for Emergency Research. Available at:http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=50.24. Accessed Dec 6 2014."},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)62103-4"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.resuscitation.2013.05.002"},{"key":"e_1_2_8_5_1","unstructured":"Food and Drug Administration Department of Health and Human Services.Guidance for Institutional Review Boards Clinical Investigators and Sponsors: Exception from Informed Consent Requirements for Emergency Research. Available at:http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM249673.pdf. Accessed Dec 6 2014."},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.1.50"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1010821"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1010076"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.282538"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200102223440803"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)66552-X"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.3171\/jns.1998.89.4.0519"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(06)70630-5"},{"key":"e_1_2_8_14_1","doi-asserted-by":"crossref","first-page":"538","DOI":"10.1001\/jama.1996.03540070034027","article-title":"Effects of pegorgotein on neurologic outcome of patients with severe head injury: a multicenter, randomized controlled trial","volume":"276","author":"Young B","year":"1996","journal-title":"JAMA"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1089\/neu.2013.3122"}],"container-title":["Academic Emergency Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Facem.12613","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/acem.12613","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T13:42:07Z","timestamp":1694439727000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/acem.12613"}},"subtitle":[],"editor":[{"given":"Michelle","family":"Biros","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2015,2,25]]},"references-count":14,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2015,3]]}},"alternative-id":["10.1111\/acem.12613"],"URL":"https:\/\/doi.org\/10.1111\/acem.12613","archive":["Portico"],"relation":{},"ISSN":["1069-6563","1553-2712"],"issn-type":[{"value":"1069-6563","type":"print"},{"value":"1553-2712","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,2,25]]},"assertion":[{"value":"2014-09-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2014-11-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2015-02-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}