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2015 ; 13
(ä): 221
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Impact of an online writing aid tool for writing a randomized trial report: the
COBWEB (Consort-based WEB tool) randomized controlled trial
#MMPMID26370288
Barnes C
; Boutron I
; Giraudeau B
; Porcher R
; Altman DG
; Ravaud P
BMC Med
2015[Sep]; 13
(ä): 221
PMID26370288
show ga
BACKGROUND: Incomplete reporting is a frequent waste in research. Our aim was to
evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement
and its extension for non-pharmacologic treatments on the completeness of
reporting of randomized controlled trials (RCTs). METHODS: We performed a
'split-manuscript' RCT with blinded outcome assessment. Participants were masters
and doctoral students in public health. They were asked to write, over a 4-hour
period, the methods section of a manuscript based on a real RCT protocol, with a
different protocol provided to each participant. Methods sections were divided
into six different domains: 'trial design', 'randomization', 'blinding',
'participants', 'interventions', and 'outcomes'. Participants had to draft all
six domains with access to the WAT for a random three of six domains. The random
sequence was computer-generated and concealed. For each domain, the WAT comprised
reminders of the corresponding CONSORT item(s), bullet points detailing all the
key elements to be reported, and examples of good reporting. The control
intervention consisted of no reminders. The primary outcome was the mean global
score for completeness of reporting (scale 0-10) for all domains written with or
without the WAT. RESULTS: Forty-one participants wrote 41 different manuscripts
of RCT methods sections, corresponding to 246 domains (six for each of the 41
protocols). All domains were analyzed. For the primary outcome, the mean (SD)
global score for completeness of reporting was higher with than without use of
the WAT: 7.1 (1.2) versus 5.0 (1.6), with a mean (95 % CI) difference 2.1
(1.5-2.7; P <0.01). Completeness of reporting was significantly higher with the
WAT for all domains except for blinding and outcomes. CONCLUSION: Use of the WAT
could improve the completeness of manuscripts reporting the results of RCTs.
TRIAL REGISTRATION: Clinicaltrials.gov ( http://clinicaltrials.gov NCT02127567 ,
registration date first received April 29, 2014).
|*Software
[MESH]
|Adult
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Male
[MESH]
|Medical Writing/*standards
[MESH]
|Periodicals as Topic/*standards
[MESH]
|Publishing/standards
[MESH]
|Randomized Controlled Trials as Topic/*standards
[MESH]