Assessment of the reporting quality of double-blind RCTs for ischemic stroke based on the CONSORT statement.
CONSORT
Cerebrovascular event
Randomized controlled trials
Stroke
Journal
Journal of the neurological sciences
ISSN: 1878-5883
Titre abrégé: J Neurol Sci
Pays: Netherlands
ID NLM: 0375403
Informations de publication
Date de publication:
15 08 2020
15 08 2020
Historique:
received:
22
04
2020
revised:
10
05
2020
accepted:
18
05
2020
pubmed:
4
6
2020
medline:
15
5
2021
entrez:
4
6
2020
Statut:
ppublish
Résumé
It is critical that Randomized Controlled Trials(RCTs) present complete and transparent reporting. The present study aims to determine the reporting quality of double-blind RCTs for medicinal interventions in patients with ischemic stroke, based on the 2010 CONSORT-statement. MEDLINE was comprehensively searched. The CONSORT period was demarcated between 2000 and 2019, while compliance ≥75 was defined as good-adequate. Possible determinants were univariately and multivariately examined for associations. Overall, 197 articles were considered eligible, 143 published after and 54 before 2000. CONSORT compliance was 68.11% ± 11.56% (standard deviation) and 55.65% ± 11.57% respectively. Among retrieved articles 56/143(39.16%) and 1/54(1.85%) were rated as of good reporting quality correspondingly [p < .001, OR = 34.115, 95%CI = (4.586, 253.762)]. McNemar's test was indicative of consistency regarding the adequately/inadequately reported items before and after the 2010 CONSORT-revision (p = 1.00). Univariate analysis revealed two significant associations with the reporting quality: high impact factor(IF) [high vs. moderate; p = .007, OR = 3.521, 95%CI = (1.396, 8.879), high vs. low; p < .001, OR = 7.583, 95%CI = (3.063, 18.762), moderate vs. low; p = .078, OR = 2.154, 95%CI = (0.911, 5.093)] and sample size [p < .001, OR = 4.297, 95%CI = (2.081, 8.874)]. Publication period (p = .742) and funding (p = .280) were not significantly associated. Multivariate analysis attenuated the impact of sample size providing insignificant results, whereas the effect of high IF remained significant [moderate vs. high; p = .029, OR = 0.337, 95%CI = (0.127, 0.895), low vs. high; p = .012, OR = 0.199, 95%CI = (0.057, 0.699)]. An exploratory analysis demonstrated significant, weak to moderate, positive linear correlation between reporting quality and IF [Pearson's r = 0.418, p < .001]. Adherence to the CONSORT-statement needs to be further endorsed and incorporated in every journal's instructions-to-authors.
Sections du résumé
BACKGROUND-PURPOSE
It is critical that Randomized Controlled Trials(RCTs) present complete and transparent reporting. The present study aims to determine the reporting quality of double-blind RCTs for medicinal interventions in patients with ischemic stroke, based on the 2010 CONSORT-statement.
METHODOLOGY
MEDLINE was comprehensively searched. The CONSORT period was demarcated between 2000 and 2019, while compliance ≥75 was defined as good-adequate. Possible determinants were univariately and multivariately examined for associations.
RESULTS
Overall, 197 articles were considered eligible, 143 published after and 54 before 2000. CONSORT compliance was 68.11% ± 11.56% (standard deviation) and 55.65% ± 11.57% respectively. Among retrieved articles 56/143(39.16%) and 1/54(1.85%) were rated as of good reporting quality correspondingly [p < .001, OR = 34.115, 95%CI = (4.586, 253.762)]. McNemar's test was indicative of consistency regarding the adequately/inadequately reported items before and after the 2010 CONSORT-revision (p = 1.00). Univariate analysis revealed two significant associations with the reporting quality: high impact factor(IF) [high vs. moderate; p = .007, OR = 3.521, 95%CI = (1.396, 8.879), high vs. low; p < .001, OR = 7.583, 95%CI = (3.063, 18.762), moderate vs. low; p = .078, OR = 2.154, 95%CI = (0.911, 5.093)] and sample size [p < .001, OR = 4.297, 95%CI = (2.081, 8.874)]. Publication period (p = .742) and funding (p = .280) were not significantly associated. Multivariate analysis attenuated the impact of sample size providing insignificant results, whereas the effect of high IF remained significant [moderate vs. high; p = .029, OR = 0.337, 95%CI = (0.127, 0.895), low vs. high; p = .012, OR = 0.199, 95%CI = (0.057, 0.699)]. An exploratory analysis demonstrated significant, weak to moderate, positive linear correlation between reporting quality and IF [Pearson's r = 0.418, p < .001].
CONCLUSIONS
Adherence to the CONSORT-statement needs to be further endorsed and incorporated in every journal's instructions-to-authors.
Identifiants
pubmed: 32492609
pii: S0022-510X(20)30275-6
doi: 10.1016/j.jns.2020.116938
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
116938Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.