@article{4cadcccfa8d24610b341ff1ac093fc6c,
title = "Variation in time to notification of enrollment and rates of withdrawal in resuscitation trials conducted under exception from informed consent",
abstract = "Importance: Emergency research is challenging to do well as it involves time sensitive interventions in unstable patients. There is limited time to obtain informed consent from the patient or their legally authorized representative (LAR). Such research is permitted under exception from informed consent (EFIC) if specific criteria are met, including notification after enrollment. Some question whether the risks of EFIC outweighs its benefits. To date, there is limited empiric information about time to notification (TTN) and rates of withdrawal in such trials. Objective: To describe variation in TTN and rates of withdrawal among that patients enrolled in EFIC trials over a twelve-year period. Design: We performed post hoc descriptive analyses of data from five trials conducted under EFIC. Setting: Emergency medical services and receiving hospitals participating in the Resuscitation Outcomes Consortium in the United States and Canada. Participants: Patients with out-of-hospital cardiac arrest or life-threatening traumatic injury. Exposures: Notification strategies were specified at each site before initiation of enrollment by a local institutional review board. We monitored TTN within each site centrally throughout each study's enrollment period. Outcomes: TTN was defined as time from randomization to first-reported notification of patient or LAR of enrollment. Withdrawal was defined as patient or LAR opt out of ongoing participation at the time of notification. Results: Of 35,442 patients enrolled in five trials, 33,805 had cardiac arrest; and 1636 had traumatic injury. TTN varied overall and by patient outcome. Among those with cardiac arrest, TTN ranged from median (5%ile, 95%ile) of 6 (1,27) days to 28 (2, 53) days across sites. 0.3% of notified patients with cardiac arrest withdrew. Among those with traumatic injury, TTN ranged from 0 (0, 5) days to 36 (5, 68) days across sites. 7.7% of notified patients with traumatic injury withdrew. Conclusions and Relevance: There is large variation in TTN in trials conducted under EFIC for emergency research. This may be due to several factors. It may or may not be modifiable. Overall rates of withdrawal are low, which suggests current practices related to EFIC are acceptable to those who have participated in emergency research.",
keywords = "Cardiac arrest, Randomized trials, Traumatic injury",
author = "Graham Nichol and Rui Zhuang and Renee Russell and Holcomb, {John B.} and Kudenchuk, {Peter J.} and Aufderheide, {Tom P.} and Laurie Morrison and Jeremy Sugarman and Ornato, {Joseph P.} and Callaway, {Clifton W.} and Christian Vaillancourt and Eileen Bulger and Jim Christenson and Daya, {Mohamud R.} and Marty Schreiber and Ahamed Idris and Podbielski, {Jeanette M.} and George Sopko and Henry Wang and Wade, {Charles E.} and David Hoyt and Weisfeldt, {Myron L.} and Susanne May",
note = "Funding Information: The Resuscitation Outcomes Consortium is supported by a series of cooperative agreements within nine regional clinical centers and one Data Coordinating Center (5U01 HL077863-University of Washington Data Coordinating Center, HL077866-Medical College of Wisconsin, HL077867-University of Washington, HL077871- University of Pittsburgh, HL077872-St. Michael's Hospital, HL077873-Oregon Health and Science University, HL077881-University of Alabama at Birmingham, HL077885-Ottawa Hospital Research Institute, HL077887- University of Texas Southwestern Medical Center/Dallas, HL077908-University of California San Diego). The agreements stem from the National Heart, Lung and Blood Institute in partnership with the National Institute of Neurological Disorders and Stroke, U.S. Army Medical Research & Material Command, The Canadian Institutes of Health Research - Institute of Circulatory and Respiratory Health, Defence Research and Development Canada and the Heart, Stroke Foundation of Canada and the American Heart Association. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung and Blood Institute or the National Institutes of Health. Funding Information: The Resuscitation Outcomes Consortium is supported by a series of cooperative agreements within nine regional clinical centers and one Data Coordinating Center (5U01 HL077863 - University of Washington Data Coordinating Center , HL077866 - Medical College of Wisconsin , HL077867 - University of Washington , HL077871 - University of Pittsburgh , HL077872 - St. Michael's Hospital , HL077873 - Oregon Health and Science University , HL077881 - University of Alabama at Birmingham , HL077885 - Ottawa Hospital Research Institute , HL077887 - University of Texas Southwestern Medical Center /Dallas, HL077908 - University of California San Diego ). The agreements stem from the National Heart, Lung and Blood Institute in partnership with the National Institute of Neurological Disorders and Stroke, U.S. Army Medical Research & Material Command, The Canadian Institutes of Health Research - Institute of Circulatory and Respiratory Health, Defence Research and Development Canada and the Heart, Stroke Foundation of Canada and the American Heart Association. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung and Blood Institute or the National Institutes of Health. Publisher Copyright: {\textcopyright} 2021",
year = "2021",
month = nov,
doi = "10.1016/j.resuscitation.2021.07.039",
language = "English (US)",
volume = "168",
pages = "160--166",
journal = "Resuscitation",
issn = "0300-9572",
publisher = "Elsevier Ireland Ltd",
}