Evidence map›Paper›PMID 34410175›Full record

ArticleJournal of empirical research on human research ethics : JERHRE

Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials.

Erin D Solomon, Jessica Mozersky, Matthew P Wroblewski, Kari Baldwin, Meredith V Parsons, Melody Goodman, James M DuBois

Abstract read
In one paragraph

Article in Journal of empirical research on human research ethics : JERHRE. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. JAMIA open · 2022
    Article
  10. 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

7 authors.

Erin D Solomon12275Washington University School of Medicine, St Louis, MO, USA.ORCID 0000-0002-3295-0698
Jessica Mozersky12275Washington University School of Medicine, St Louis, MO, USA.
Matthew P Wroblewski12275Washington University School of Medicine, St Louis, MO, USA.
Kari Baldwin12275Washington University School of Medicine, St Louis, MO, USA.
Meredith V Parsons12275Washington University School of Medicine, St Louis, MO, USA.
Melody Goodman5894New York University, New York, NY, USA.ORCID 0000-0001-8932-624X
James M DuBois12275Washington University School of Medicine, St Louis, MO, USA.

Funding

WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Understanding and addressing challenges to informed consent and research compliance during Covid-19 researchR01AG058254 · NIA · WASHINGTON UNIVERSITY · PI DUBOIS, JAMES M · 2018 to 2022
$2.8M
NCATS NIH HHS UL1 TR002345NIA NIH HHS R01 AG058254
6 · The paper itself

Abstract

Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.

Indexed as

Informed ConsentLanguageAgedClinical Trials as TopicConsent FormsEthics Committees, ResearchHumansResearch Personnelevidence-based health communicationformattingimplementation scienceinformed consentkey informationplain languageresearch ethics

Identifiers

PMID34410175
PMCPMC8712347

What OpenQuestion holds

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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.