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2017 ; 8
(4
): 167-171
Nephropedia Template TP
gab.com Text
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Twit Text #
English Wikipedia
A study comparing trial registry entries of randomized controlled trials with
publications of their results in a high impact factor journal: The Journal of the
American Medical Association
#MMPMID29109933
Wandalkar P
; Gandhe P
; Pai A
; Limaye M
; Chauthankar S
; Gogtay NJ
; Thatte UM
Perspect Clin Res
2017[Oct]; 8
(4
): 167-171
PMID29109933
show ga
PURPOSE: The International Committee of Medical Journal Editors mandates trial
registration as a precondition for publication. Growing evidence indicates that
information in registry may not correlate with eventual publication. The present
study was carried out with the objective of comparing content of Randomized
Controlled Trials (RCTs) published in one year in the Journal of the American
Medical Association (JAMA), with the information contained in trial registries.
METHODS: All RCTs published in JAMA in 2013 were included. 11 data set items were
matched for content between registry entry and published RCT: Title, Primary and
Secondary Objectives, Study type, Inclusion and Exclusion Criteria, Treatment Age
Group, Follow up, Sample Size, Primary and Secondary Outcomes. A fully correct
match was scored 2, partially correct 1 and incorrect 0. Thus, maximum possible
score for each paper was number of items multiplied by 2, i.e., 22. RESULTS: The
median [range] total score achieved by RCTs was 15. No RCT achieved a perfect
score of 22. The largest proportion of RCTs reported secondary objectives, study
type, treatment age group, follow up, sample size and primary outcomes fully
correctly. However, only 13.5 %, 12 % and 13.5 % of RCTs were a perfect match
with registry entries in terms of title, primary objective and secondary outcomes
respectively. Almost three quarters did not match perfectly in selection
criteria. CONCLUSION: There exist discrepancies between trial registration and
published paper even in a high impact factor journal. Both authors and editors
should adhere to CONSORT guidelines to ensure transparency of published research.