Evidence map›Paper›PMID 26990899›Full record

Trial reportAcademic emergency medicine : official journal of the Society for Academic Emergency Medicine2016

Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial.

Morgan R Bobb, Paul G Van Heukelom, Brett A Faine, Azeemuddin Ahmed, Jeffrey T Messerly, Gregory Bell, Karisa K Harland, Christian Simon, Nicholas M Mohr

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
2.4field-weighted citation impact, top 10% of its field
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

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2026
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Informed Consent for Pediatric Lyme Meningitis Study: In-Person Versus Remote Approach.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026
    Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Narrative review of telemedicine applications in decentralized research.Journal of clinical and translational science · 2024
    Review
  15. Article
  16. Article
  17. Interventions to improve access to clinical trials in urologic oncology.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2023
    Article
  18. Article
  19. Article
  20. Article
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

9 authors at 1 institution in 1 country.

Morgan R BobbDepartment of Emergency Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.
Paul G Van HeukelomDepartment of Emergency Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.
Brett A FaineDepartment of Emergency Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.
Azeemuddin AhmedDepartment of Emergency Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.
Jeffrey T MesserlyDepartment of Emergency Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.
Gregory BellDepartment of Emergency Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.
Karisa K HarlandDepartment of Emergency Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.
Christian SimonProgram in Bioethics and Humanities, Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.
Nicholas M MohrDepartment of Emergency Medicine, University of Iowa Carver College of Medicine, Iowa City, IA.
University of Iowa · US

Funding

SHORT-TERM TRAINING: STUDENTS IN HEALTH PROF. SCHOOLST35HL007485 · NHLBI · UNIVERSITY OF IOWA · PI ROGHAIR, ROBERT D · 1985 to 2019
$4.3M
NHLBI NIH HHS T35 HL007485
6 · The paper itself

Abstract

objectiveTelemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study was to determine whether patient comprehension of telemedicine-enabled research informed consent is noninferior to standard face-to-face (F2F) research informed consent.

methodsA prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic emergency department (ED) to test whether telemedicine-enabled research informed consent provided noninferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of 0.12% oral chlorhexidine gluconate in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard F2F consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc.) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified quality of informed consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes.

resultsA total of 131 patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to F2F consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p = 0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar.

conclusionTelemedicine is noninferior to F2F consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials.

Indexed as

Informed ConsentTelemedicineAdultAgedComprehensionFemaleHumansMaleMiddle AgedMidwestern United StatesProspective StudiesResearch DesignSurveys and Questionnaires

Identifiers

PMID26990899
PMCPMC4938779
OpenAlexW2299321005

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.