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Cited by 208

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

Open access
Nowbar, A. N., Mielewczik, M., Karavassilis, M., Dehbi, H.-M., Shun-Shin, M. J., Jones, S., Howard, J. P., Cole, G. D., Francis, D. P., on behalf of the DAMASCENE writing group·2014·BMJ

Abstract

OBJECTIVE: To 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. DESIGN: Identification 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. RESULTS: There 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%. CONCLUSIONS: Avoiding 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.

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Metadata

Authors
Nowbar, A. N., Mielewczik, M., Karavassilis, M., Dehbi, H.-M., Shun-Shin, M. J., Jones, S., Howard, J. P., Cole, G. D., Francis, D. P., & on behalf of the DAMASCENE writing group
Venue
BMJ
Publisher
BMJ
Published
2014-04-28
Volume
348
Issue
apr28 1
Pages
g2688-g2688
ISSN
1756-1833 (ISSN-L)
OpenAlex
W1971076129
Cited by
208
References
2
FWCI
45.49
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Discrepancies in autologous bone marrow stem cell trials and enhancement of ejection fraction (DAMASCENE): weighted regression and meta-analysis. https://app.cochat.ai/papers/10.1136/bmj.g2688
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Nowbar, A. N., Mielewczik, M., Karavassilis, M., Dehbi, H.-M., Shun-Shin, M. J., Jones, S., Howard, J. P., Cole, G. D., Francis, D. P., & on behalf of the DAMASCENE writing group. (2014). Discrepancies in autologous bone marrow stem cell trials and enhancement of ejection fraction (DAMASCENE): weighted regression and meta-analysis. BMJ. https://doi.org/10.1136/bmj.g2688

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