Literature DB >> 30527501

Impact of Social Media on Community Consultation in Exception From Informed Consent Clinical Trials.

John A Harvin1, Jeanette M Podbielski2, Laura E Vincent2, Mike K Liang2, Lillian S Kao2, Charles E Wade2, John B Holcomb2.   

Abstract

BACKGROUND: Exception from informed consent (EFIC) allows clinician scientists to perform much needed emergency research. Obtaining this exception, however, requires many meetings with community groups for consultation, which can make the process time-consuming and expensive. We aim to determine the impact of using social media in lieu of some community meetings in an effort to obtain an EFIC.
MATERIALS AND METHODS: An economic analysis of four randomized clinical trials was performed. Costs were conservatively estimated using personnel costs, social media costs, and adjusted to 2016 US dollars. People were considered reached if they attended a community meeting or were directed to the study website by social media and spent ≥1 min.
RESULTS: The Early Whole Blood study required 14 meetings, reached 272 people, and cost $8260 ($30/person reached). The Pragmatic, Randomized Optimal Platelet and Plasma Ratios study required 14 meetings, reached 260 people, and cost $7479 overall ($29/person reached). The Prehospital Tranexamic Acid Use for Traumatic Brain Injury study required 12 meetings, reached 198 people, and cost $6340 ($32/person reached). Only the damage control laparotomy trial utilized social media in lieu of some community meetings. The damage control laparotomy trial required six meetings at which 137 people were reached. The $1000 social media campaign reached 229 people. The cost was $3977 overall and $11/person reached.
CONCLUSIONS: Including a social media campaign during the EFIC process increased the number of potential patients reached and reduced total and per person costs reached costs. Obtaining an EFIC for future emergency clinical trials may be facilitated by the inclusion of a social media campaign.
Copyright © 2018 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Community consultation; Emergency research; Exception from informed consent; Informed consent; Trauma

Mesh:

Year:  2018        PMID: 30527501      PMCID: PMC6291833          DOI: 10.1016/j.jss.2018.09.007

Source DB:  PubMed          Journal:  J Surg Res        ISSN: 0022-4804            Impact factor:   2.192


  9 in total

1.  Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial.

Authors:  Maija Holsti; Roger Zemek; Jill Baren; Rachel M Stanley; Prashant Mahajan; Cheryl Vance; Kathleen M Brown; Victor Gonzalez; Denise King; Kammy Jacobsen; Kate Shreve; Katrina van de Bruinhorst; Anne Marie Jones; James M Chamberlain
Journal:  Clin Trials       Date:  2014-11-04       Impact factor: 2.486

2.  Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial.

Authors:  John B Holcomb; Barbara C Tilley; Sarah Baraniuk; Erin E Fox; Charles E Wade; Jeanette M Podbielski; Deborah J del Junco; Karen J Brasel; Eileen M Bulger; Rachael A Callcut; Mitchell Jay Cohen; Bryan A Cotton; Timothy C Fabian; Kenji Inaba; Jeffrey D Kerby; Peter Muskat; Terence O'Keeffe; Sandro Rizoli; Bryce R H Robinson; Thomas M Scalea; Martin A Schreiber; Deborah M Stein; Jordan A Weinberg; Jeannie L Callum; John R Hess; Nena Matijevic; Christopher N Miller; Jean-Francois Pittet; David B Hoyt; Gail D Pearson; Brian Leroux; Gerald van Belle
Journal:  JAMA       Date:  2015-02-03       Impact factor: 56.272

3.  Position statement of the American College of Surgeons Committee on Trauma on the National Academies of Sciences, Engineering and Medicine Report, A National Trauma Care System: Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury.

Authors:  Donald H Jenkins; Robert J Winchell; Raul Coimbra; Michael F Rotondo; Leonard J Weireter; Eileen M Bulger; Rosemary A Kozar; Avery B Nathens; Patrick M Reilly; Sharon M Henry; Maria F Jimenez; Michael C Chang; Michael Coburn; Jimm Dodd; Melanie L Neal; Justin Rosen; Jean Clemency; David B Hoyt; Ronald M Stewart
Journal:  J Trauma Acute Care Surg       Date:  2016-11       Impact factor: 3.313

4.  The digital divide in adoption and use of mobile health technology among caregivers of pediatric surgery patients.

Authors:  Emma C Hamilton; Faiez Saiyed; Charles C Miller; Arturo Eguia; Alexandra C Fonseca; George P Baum; KuoJen Tsao; Mary T Austin
Journal:  J Pediatr Surg       Date:  2017-09-01       Impact factor: 2.545

5.  Preliminary experience with social media for community consultation and public disclosure in exception from informed consent trials.

Authors:  Shannon W Stephens; Carolyn Williams; Randal Gray; Jeffrey D Kerby; Henry E Wang
Journal:  Circulation       Date:  2013-07-16       Impact factor: 29.690

6.  Using social media for community consultation and public disclosure in exception from informed consent trials.

Authors:  Shannon W Stephens; Carolyn Williams; Randal Gray; Jeffrey D Kerby; Henry E Wang; Patrick L Bosarge
Journal:  J Trauma Acute Care Surg       Date:  2016-06       Impact factor: 3.313

7.  Utility of routine postoperative visit after appendectomy and cholecystectomy with evaluation of mobile technology access in an urban safety net population.

Authors:  Diane W Chen; Rachel W Davis; Courtney J Balentine; Aaron R Scott; Yue Gao; Nicole M Tapia; David H Berger; James W Suliburk
Journal:  J Surg Res       Date:  2014-04-21       Impact factor: 2.192

8.  A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions.

Authors:  Bryan A Cotton; Jeanette Podbielski; Elizabeth Camp; Timothy Welch; Deborah del Junco; Yu Bai; Rhonda Hobbs; Jamie Scroggins; Beth Hartwell; Rosemary A Kozar; Charles E Wade; John B Holcomb
Journal:  Ann Surg       Date:  2013-10       Impact factor: 12.969

9.  Damage control laparotomy trial: design, rationale and implementation of a randomized controlled trial.

Authors:  John A Harvin; Jeanette Podbielski; Laura E Vincent; Erin E Fox; Laura J Moore; Bryan A Cotton; Charles E Wade; John B Holcomb
Journal:  Trauma Surg Acute Care Open       Date:  2017-04-13
  9 in total
  6 in total

Review 1.  Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.

Authors:  Neal W Dickert; Kathleen Metz; Michael D Fetters; Adrianne N Haggins; Deneil K Harney; Candace D Speight; Robert Silbergleit
Journal:  Acad Emerg Med       Date:  2021-05-26       Impact factor: 5.221

2.  Damage control laparotomy in trauma: a pilot randomized controlled trial. The DCL trial.

Authors:  John A Harvin; Sasha D Adams; Shah-Jahan M Dodwad; Kayla D Isbell; Claudia Pedroza; Charles Green; Jon E Tyson; Ethan A Taub; David E Meyer; Laura J Moore; Rondel Albarado; Michelle K McNutt; Lillian S Kao; Charles E Wade; John B Holcomb
Journal:  Trauma Surg Acute Care Open       Date:  2021-07-29

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

Authors:  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; Alexander Ambrocik; Peng Roc Chen
Journal:  Brain Circ       Date:  2021-12-21

4.  Exception from informed consent trials: social-media-based community consultation campaigns are representative of target communities.

Authors:  Paige Farley; Shannon W Stephens; Brandon Crowley; Sean P Collins; Monica D Wong; Ashley B Panas; Bradley M Dennis; Neal Richmond; Kenji Inaba; Karen N Brown; John B Holcomb; Jan O Jansen
Journal:  Trauma Surg Acute Care Open       Date:  2021-11-29

5.  PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial.

Authors:  Scott L Weiss; Fran Balamuth; Elliot Long; Graham C Thompson; Katie L Hayes; Hannah Katcoff; Marlena Cook; Elena Tsemberis; Christopher P Hickey; Amanda Williams; Sarah Williamson-Urquhart; Meredith L Borland; Stuart R Dalziel; Ben Gelbart; Stephen B Freedman; Franz E Babl; Jing Huang; Nathan Kuppermann
Journal:  Trials       Date:  2021-11-06       Impact factor: 2.728

6.  Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in the Prehospital Air Medical Plasma (PAMPer) trial.

Authors:  Insiyah Campwala; Francis X Guyette; Joshua B Brown; Peter W Adams; Barbara J Early; Mark H Yazer; Matthew D Neal; Brian S Zuckerbraun; Jason L Sperry
Journal:  BMC Emerg Med       Date:  2020-10-01
  6 in total

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