Evidence map›Paper›PMID 35071841›Full record

ArticleBrain circulation

Exception from informed consent in the era of social media: The SEGA stroke trial experience.

Mehmet Enes Inam, Aditya Sanzgiri, Elvira Lekka, Sunil A Sheth, Andrew D Barreto, Sean I Savitz, Carlos Artime, Claudia Pedroza, Allison Engstrom, Faheem G Sheriff and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Brain circulation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Measuring the efficacy of community consultation in a pediatric exception from informed consent trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2025
    Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Mehmet Enes InamDepartment of Neurosurgery, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Aditya SanzgiriDepartment of Research Operations and Conduct, University of Chicago, Chicago, Illinois, USA.
Elvira LekkaDepartment of Neurosurgery, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Sunil A ShethDepartment of Neurology, Institute for Stroke and Cerebrovascular Disease, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Andrew D BarretoDepartment of Neurology, Institute for Stroke and Cerebrovascular Disease, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Sean I SavitzDepartment Neurology, Texas Institute for Restorative Neurotechnologies, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Carlos ArtimeDepartment of Anesthesiology, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Claudia PedrozaDepartment of Pediatrics, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Allison EngstromDepartment of Neurosurgery, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Faheem G SheriffDepartment of Neurosurgery, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Alexander AmbrocikDepartment of Neurosurgery, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.
Peng Roc ChenDepartment of Neurosurgery, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.

Funding

Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
NCATS NIH HHS UL1 TR003167
6 · The paper itself

Abstract

introductionPatients with acute ischemic stroke (AIS) and neurologic deficits are often unable to provide consent and excluded from emergency research participation. Experiences with exception from informed consent (EFIC) to facilitate research on potentially life-saving emergency interventions are limited. Here, we describe our multifaceted approach to EFIC approval for an ongoing randomized clinical trial that compares sedation versus general anesthesia (SEGA) approaches for endovascular thrombectomy during AIS.

methodsWe published a university clinical trial website with EFIC information. We initiated a social media campaign on Facebook within a 50 mile radius of Texas Medical Center. Advertisements were linked to our website, and a press release was issued with information about the trial. In-person community consultations were performed, and voluntary survey information was collected.

resultsA total of 193 individuals (65% female, age 46.7 ± 16.6 years) participated in seven focus group community consultations. Of the 144 (75%) that completed surveys, 88.7% agreed that they would be willing to have themselves or family enrolled in this trial under EFIC. Facebook advertisements had 134,481 (52% females; 60% ≥45 years old) views followed by 1,630 clicks to learn more. The website had 1130 views (56% regional and 44% national) with an average of 3.85 min spent. Our Institutional Review Board received zero e-mails requesting additional information or to optout.

conclusionOur social media campaign and community consultation methods provide a significant outreach to potential stroke patients. We hope that our experience will inform and help future efforts for trials seeking EFIC.

Indexed as

Acute stroke therapyclinical trialcommunity consultationemergency consentendovascular therapyexception from informed consentfocus groupsocial mediastroke

Identifiers

PMID35071841
PMCPMC8757510

What OpenQuestion holds

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LicenceCC BY-NC-SA
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.