Evidence map›Paper›PMID 41409214›Full record

ArticleTrauma surgery & acute care open2025

Community consultation for exception from informed consent studies: are market research surveys representative of the target community populations?

Shannon W Stephens, Russell L Griffin, Christy Carroll-Ledbetter, Sarah Duckert, Margaret Nelson, Joel Rodgers, Adam McClintock, Sara F Goldkind, Luke Gelinas, Amanda E Higley and 9 more

Abstract read
In one paragraph

Article in Trauma surgery & acute care open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Shannon W StephensSurgery, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0001-5898-5170
Russell L GriffinDepartment of Epidemiology, The University of Alabama at Birmingham School of Public Health, Birmingham, Alabama, USA.
Christy Carroll-LedbetterSurgery, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.
Sarah DuckertSurgery, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.
Margaret NelsonSurgery, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.
Joel RodgersSurgery, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.
Adam McClintockUAB, Birmingham, Alabama, USA.
Sara F GoldkindGoldkind Consulting, LLC, Potomac, Maryland, USA.
Luke GelinasAdvarra Inc, Columbia, Maryland, USA.
Amanda E HigleyAdvarra Inc, Columbia, Maryland, USA.
Stacia DeSantisUniversity of Texas Health Sciences Center at Houston, Houston, Texas, USA.
Claudia PedrozaUniversity of Texas McGovern Medical School, Houston, Texas, USA.
Luis Leon-NoveloUniversity of Texas Health Sciences Center at Houston, Houston, Texas, USA.
James StubbsMayo Clinic, Rochester, Minnesota, USA.
Marissa B MarquesUniversity of Alabama at Birmingham, Birmingham, Alabama, USA.
Henry WangDepartment of Emergency Medicine, The Ohio State University, Columbus, Ohio, USA.
John B HolcombSurgery, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0001-8312-9157
Jan O JansenSurgery, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0001-8863-4398
TROOP Trial Investigators

Funding

1/2 Trauma Resuscitation with Group O Whole Blood Or Products (TROOP) TrialUH3HL157401 · NHLBI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI John B Holcomb, Jan O Jansen · 2023 to 2026
$6.5M
2/2 Trauma Resuscitation with Group O Whole Blood or Products (TROOP)U24HL157310 · NHLBI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI Stacia DeSantis, LUIS Gonzalo LEON-NOVELO · 2022 to 2026
$3.0M
NHLBI NIH HHS U24 HL157310NHLBI NIH HHS UH3 HL157401
6 · The paper itself

Abstract

Background: 'Exception from informed consent' research requires community consultation to ensure that the views of the local population have been considered. Using market research companies to distribute surveys across local populations is attractive because it ensures adequate response rates. It is not known whether individuals who respond to surveys are typical of the targeted communities. The purpose of this study is to compare the demographics of the survey respondents with that of the general population in the same area. Methods: This is an analysis of data collected as part of the 'Trauma Resuscitation with Group O Whole Blood or Products' (TROOP) trial. The surveys used a commercial market research service to reach the communities of interest and consisted of 18 questions designed to evaluate respondents' willingness to be enrolled in the TROOP trial and the demographics of survey respondents. Results: Catchment populations varied from 0.5 to 9.4 million residents, with a total of 33.5 million. The racial and ethnic composition of the population (and the survey respondents, in brackets) was 44.8% (57.0%) white, 25.7% (13.4%) Hispanic, 12.7% (19.4%) black, 8.0% (2.5%) multiracial, 7.9% (4.4%) Asian, 0.7% (0.9%) Native American, and 0.2% (0.5%) Islanders. Of the male population (and survey respondents, in brackets), 12.2% (15.3%) were aged 18years to 24 years, 20.5% (22.3%) aged 25 years to 34 years, 18.1% (24.9%) aged 35 years to 44 years, 16.3% (18.5%) aged 45 years to 54 years, 15.5% (14.8%) aged 55 years to 64 years, and 17.4% (4.3%) aged 65 years and over. Of the female population (and survey respondents, in brackets), 11.0% (18.5%) were aged 18 years to 24 years, 18.4% (22.6%) aged 25 years to 34 years, 16.4% (23.5%) aged 35 years to 44 years, 15.0% (17.3%) aged 45 years to 54 years, 18.5% (14.1%) aged 55 years to 64 years, and 20.6% (3.9%) aged 65 years and over. Conclusions: For this trial, using a market research company to distribute community surveys resulted in respondents that are broadly representative of the geographic areas where the trial will be conducted, except for individuals over the age of 65 years and older. This finding provides reassurance to investigators and institutional review boards that the views expressed by respondents are representative of the population where the trial will be conducted. Level of evidence: III.

Indexed as

Ethics, MedicalMultiple Traumarandomized controlled trial

Identifiers

PMID41409214
PMCPMC12706250

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.