Evidence map›Paper›PMID 35301134›Full record

SynthesisContemporary clinical trials2022

Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices.

Mehnaz Bader, Linda Zheng, Deepika Rao, Olayinka Shiyanbola, Laurie Myers, Terry Davis, Catina O'Leary, Michael McKee, Michael Wolf, Annlouise R Assaf

Abstract readSystematic Review
In one paragraph

Synthesis in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing 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

32 citing papers in PubMed.

  1. Trial
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  3. Improving cancer clinical trial enrollment and patient understanding using TrialTalk, a structured communication method: a pilot randomized controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Health Literacy Applications in Patients With Cancer.Clinical journal of oncology nursing · 2025
    Review
  17. Article
  18. Article
  19. Assessment of readability of gynecologic cancer clinical trials literature at National Cancer Institute-designated Comprehensive Cancer Centers.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2025
    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

10 authors.

Mehnaz BaderWorldwide Medical and Safety, Pfizer Inc, New York, NY, USA. Electronic address: Mehnaz.Bader@pfizer.com.
Linda ZhengSchool of Pharmacy, University of Wisconsin-Madison, Madison, WI, USA.
Deepika RaoSchool of Pharmacy, University of Wisconsin-Madison, Madison, WI, USA.
Olayinka ShiyanbolaSchool of Pharmacy, University of Wisconsin-Madison, Madison, WI, USA.
Laurie MyersGlobal Health Literacy and Oncology Health Equity, Merck & Co., Inc., Kenilworth, NJ, USA.
Terry DavisDepartment of Medicine, Louisiana State University Health - Shreveport, Shreveport, LA, USA.
Catina O'LearyHealth Literacy Media, St. Louis, MO, USA.
Michael McKeeDepartment of Family Medicine, University of Michigan/Michigan Medicine, Ann Arbor, MI, USA.
Michael WolfFeinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Annlouise R AssafWorldwide Medical and Safety, Pfizer Inc, New York, NY, USA; School of Public Health, Brown University, Providence, RI, USA.

Funding

Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI Peter Todd Katzmarzyk · 2012 to 2026
$69.1M
Research Design, Data, and Analytics CoreP30DK092949 · NIDDK · UNIVERSITY OF CHICAGO · PI MILDA Renne SAUNDERS · 2011 to 2026
$10.0M
NIDDK NIH HHS P30 DK092949NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

backgroundA 2019 public workshop convened by the National Academies of Sciences, Engineering and Medicine (NASEM) Roundtable on Health Literacy identified a need to develop evidence-based guidance for best practices for health literacy and patient activation in clinical trials. PURPOSE: To identify studies of health literacy interventions within medical care or clinical trial settings that were associated with improved measures of health literacy or patient activation, to help inform best practices in the clinical trial process. DATA SOURCES: Literature searches were conducted in PubMed, the Cumulative Index to Nursing and Allied Health Literature, SCOPUS, Cochrane, and Web of Science from January 2009 to June 2021. STUDY SELECTION: Of 3592 records screened, 22 records investigating 27 unique health literacy interventions in randomized controlled studies were included for qualitative synthesis. DATA EXTRACTION: Data screening and abstraction were performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. DATA SYNTHESIS: Types of health literacy interventions were multimedia or technology-based (11 studies), simplification of written material (six studies) and in-person sessions (five studies). These interventions were applied at various stages in the healthcare and clinical trial process. All studies used unique outcome measures, including patient comprehension, quality of informed consent, and patient activation and engagement.

conclusionsThe findings of our study suggest that best practice guidelines recommend health literacy interventions during the clinical trial process, presentation of information in multiple forms, involvement of patients in information optimization, and improved standardization in health literacy outcome measures.

Indexed as

Health LiteracyComprehensionHumansInformed ConsentPatient-Centered CareClinical trial processHealth literacyPatient-centeredQualitative synthesisSystematic literature review

Identifiers

PMID35301134
PMCPMC9196949

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.