Evidence map›Paper›PMID 24778175›Full record

SynthesisBMJ (Clinical research ed.)2014

Discrepancies in autologous bone marrow stem cell trials and enhancement of ejection fraction (DAMASCENE): weighted regression and meta-analysis.

Alexandra N Nowbar, Michael Mielewczik, Maria Karavassilis, Hakim-Moulay Dehbi, Matthew J Shun-Shin, Siana Jones, James P Howard, Graham D Cole, Darrel P Francis, DAMASCENE writing group

Registry-linked trialAbstract readMeta-AnalysisReview
In one paragraph

Synthesis in BMJ (Clinical research ed.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01901523 (Phase II Study of Response of Medical Journal Editorial Boards to Notification of Serious Discrepancies in Published Clinical Trials in Human Patients.), which is not on this map. Cited by 93 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 5 pooled it
–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.

NCT01901523 naunknown statusnot on this map

Phase II Study of Response of Medical Journal Editorial Boards to Notification of Serious Discrepancies in Published Clinical Trials in Human Patients.

TypeinterventionalSponsorImperial College LondonRan2014 to 2015Enrolled15ConditionsHeart FailureArmsReporting of discrepancy to journal
3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Stem cell treatment for acute myocardial infarction.The Cochrane database of systematic reviews · 2015
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Pluripotent stem cell-based approaches for heart repair and the potential of genetic modifications.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  8. Review
  9. Article
  10. N-CADHERINStem cell research & therapy · 2024
    Article
  11. Human Endothelial Colony-Forming Cells.Cold Spring Harbor perspectives in medicine · 2022
    Article
  12. Review
  13. [Cardiac cell therapy-Lost in translation?]Zeitschrift fur Herz-, Thorax- und Gefasschirurgie · 2022
    Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Review

33 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Alexandra N NowbarInternational Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London W2 1LA, UK.
Michael Mielewczik
Maria Karavassilis
Hakim-Moulay Dehbi
Matthew J Shun-Shin
Siana Jones
James P Howard
Graham D Cole
Darrel P Francis
DAMASCENE writing group

Funding

British Heart Foundation FS/10/038British Heart Foundation FS/10/38/28268British Heart Foundation FS/12/12/29294British Heart Foundation FS/14/27/30752British Heart Foundation SP/10/002/28189
6 · The paper itself

Abstract

objectiveTo investigate whether discrepancies in trials of use of bone marrow stem cells in patients with heart disease account for the variation in reported effect size in improvement of left ventricular function.

designIdentification and counting of factual discrepancies in trial reports, and sample size weighted regression against therapeutic effect size. Meta-analysis of trials that provided sufficient information. DATA SOURCES: PubMed and Embase from inception to April 2013. ELIGIBILITY FOR SELECTING STUDIES: Randomised controlled trials evaluating the effect of autologous bone marrow stem cells for heart disease on mean left ventricular ejection fraction.

resultsThere were over 600 discrepancies in 133 reports from 49 trials. There was a significant association between the number of discrepancies and the reported increment in EF with bone marrow stem cell therapy (Spearman's r=0.4, P=0.005). Trials with no discrepancies were a small minority (five trials) and showed a mean EF effect size of -0.4%. The 24 trials with 1-10 discrepancies showed a mean effect size of 2.1%. The 12 with 11-20 discrepancies showed a mean effect of size 3.0%. The three with 21-30 discrepancies showed a mean effect size of 5.7%. The high discrepancy group, comprising five trials with over 30 discrepancies each, showed a mean effect size of 7.7%.

conclusionsAvoiding discrepancies is difficult but is important because discrepancy count is related to effect size. The mechanism is unknown but should be explored in the design of future trials because in the five trials without discrepancies the effect of bone marrow stem cell therapy on ejection fraction is zero.

Indexed as

Bone Marrow TransplantationHeart DiseasesHumansPublication BiasRandomized Controlled Trials as TopicStem Cell TransplantationStroke VolumeTransplantation, Autologous

Identifiers

PMID24778175
PMCPMC4002982

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.