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2016 ; 17
(1
): 430
Nephropedia Template TP
gab.com Text
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English Wikipedia
Major discrepancies between what clinical trial registries record and paediatric
randomised controlled trials publish
#MMPMID27659549
Rosati P
; Porzsolt F
; Ricciotti G
; Testa G
; Inglese R
; Giustini F
; Fiscarelli E
; Zazza M
; Carlino C
; Balassone V
; Fiorito R
; D'Amico R
Trials
2016[Sep]; 17
(1
): 430
PMID27659549
show ga
BACKGROUND: Whether information from clinical trial registries (CTRs) and
published randomised controlled trial (RCTs) differs remains unknown. Knowing
more about discrepancies should alert those who rely on RCTs for medical
decision-making to possible dissemination or reporting bias. To provide help in
critically appraising research relevant for clinical practice we sought possible
discrepancies between what CTRs record and paediatric RCTs actually publish. For
this purpose, after identifying six reporting domains including funding, design,
and outcomes, we collected data from 20 consecutive RCTs published in a widely
read peer-reviewed paediatric journal and cross-checked reported features with
those in the corresponding CTRs. METHODS: We collected data for 20 unselected,
consecutive paediatric RCTs published in a widely read peer-reviewed journal from
July to November 2013. To assess discrepancies, two reviewers identified and
scored six reporting domains: funding and conflict of interests; sample size,
inclusion and exclusion criteria or crossover; primary and secondary outcomes,
early study completion, and main outcome reporting. After applying the Critical
Appraisal Skills Programme (CASP) checklist, five reviewer pairs cross-checked
CTRs and matching RCTs, then mapped and coded the reporting domains and scored
combined discrepancy as low, medium and high. RESULTS: The 20 RCTs were
registered in five different CTRs. Even though the 20 RCTs fulfilled the CASP
general criteria for assessing internal validity, 19 clinical trials had medium
or high combined discrepancy scores for what the 20 RCTs reported and the matched
five CTRs stated. All 20 RCTs selectively reported or failed to report main
outcomes, 9 had discrepancies in declaring sponsorship, 8 discrepancies in the
sample size, 9 failed to respect inclusion or exclusion criteria, 11 downgraded
or modified primary outcome or upgraded secondary outcomes, and 13 completed
early without justification. The CTRs for seven trials failed to index
automatically the URL address or the RCT reference, and for 12 recorded RCT
details, but the authors failed to report the results. CONCLUSIONS: Major
discrepancies between what CTRs record and paediatric RCTs publish raise concern
about what clinical trials conclude. Our findings should make clinicians, who
rely on RCT results for medical decision-making, aware of dissemination or
reporting bias. Trialists need to bring CTR data and reported protocols into line
with published data.