Evidence map›Paper›PMID 28470683›Full record

ArticleHepatology (Baltimore, Md.)2017

How healthy are the "Healthy volunteers"? Penetrance of NAFLD in the biomedical research volunteer pool.

Varun Takyar, Anand Nath, Andrea Beri, Ahmed M Gharib, Yaron Rotman

Open access · greenAbstract readComparative Study
In one paragraph

Article in Hepatology (Baltimore, Md.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Dietary fatty acid oxidation is decreased in non-alcoholic fatty liver disease: A palmitate breath test study.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Reply.Hepatology (Baltimore, Md.) · 2017
    Article
  13. Natural History of NAFLD/NASH.Current hepatology reports · 2017
    Review
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Varun TakyarLiver & Energy Metabolism Unit, Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.ORCID 0000-0002-2895-3095
Anand NathLiver & Energy Metabolism Unit, Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
Andrea BeriLaboratory for Informatics Development, Biomedical Translational Research Information System, Clinical Center, National Institutes of Health, Bethesda, MD.
Ahmed M GharibBiomedical and Metabolic Imaging Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.
Yaron RotmanLiver & Energy Metabolism Unit, Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
National Institutes of Health · USMedStar Washington Hospital Center · USNational Institute of Diabetes and Digestive and Kidney Diseases · USNational Institutes of Health Clinical Center · US

Funding

Advanced Non Invasive Vascular Imaging MethodsZIADK075083 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI GHARIB, AHMED · 2013 to 2025
$34.7M
Nonalcoholic Steatohepatitis: Natural History, Pathogenesis and TherapyZIADK075013 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI ROTMAN, YARON · 2009 to 2025
$19.1M
Intramural NIH HHS Z99 DK999999Intramural NIH HHS ZIA DK075013
6 · The paper itself

Abstract

Healthy volunteers are crucial for biomedical research. Inadvertent inclusion of subjects with nonalcoholic fatty liver disease (NAFLD) as controls can compromise study validity and subject safety. Given the rising prevalence of NAFLD in the general population, we sought to identify its prevalence and potential impact in volunteers for clinical trials. We conducted a cross-sectional study of subjects who were classified as healthy volunteers between 2011 and 2015 and had no known liver disease. Subjects were classified as presumed NAFLD (pNF; alanine aminotransferase [ALT] level ≥ 20 for women or ≥ 31 for men and body mass index [BMI] > 25 kg/m

conclusionNAFLD is common and often overlooked in volunteers for clinical trials, despite its potential impact on subject safety and validity of study findings. Increased awareness of NAFLD prevalence and stricter ALT cutoffs may ameliorate this problem. (Hepatology 2017;66:825-833).

Indexed as

Biomedical ResearchAdultAgedAged, 80 and overBody Mass IndexCase-Control StudiesClinical Trials as TopicCross-Sectional StudiesHealthy VolunteersHumansLiver Function TestsMaleMiddle AgedNon-alcoholic Fatty Liver DiseasePredictive Value of TestsReference Values

Identifiers

PMID28470683
PMCPMC5570632
OpenAlexW2611109209

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.