Kodounis Michalis, Liampas Ioannis N, Constantinidis Theodoros S, Siokas Vasileios, Mentis Alexios-Fotios A, Aloizou Athina-Maria, Xiromerisiou Georgia, Zintzaras Elias, Hadjigeorgiou Georgios M, Dardiotis Efthimios
Department of Neurology, University Hospital of Larissa, School of Medicine, University of Thessaly, Larissa, Greece.
Department of Neurology, University Hospital of Larissa, School of Medicine, University of Thessaly, Larissa, Greece.
J Neurol Sci. 2020 Aug 15;415:116938. doi: 10.1016/j.jns.2020.116938. Epub 2020 May 27.
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.
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.
随机对照试验（RCT）提供完整且透明的报告至关重要。本研究旨在根据2010年CONSORT声明，确定缺血性中风患者药物干预双盲RCT的报告质量。
全面检索MEDLINE。CONSORT期间划定为2000年至2019年，将≥75%的依从性定义为良好-充分。对可能的决定因素进行单变量和多变量分析以寻找关联。
总体而言，197篇文章被认为符合条件，其中143篇在2000年后发表，54篇在2000年前发表。CONSORT依从性分别为68.11%±11.56%（标准差）和55.65%±11.57%。在检索到的文章中，相应地有56/143（39.16%）和1/54（1.85%）被评为报告质量良好[p <.001，OR = 34.115，95%CI =（4.586，253.762）]。McNemar检验表明2010年CONSORT修订前后报告充分/不充分项目具有一致性（p = 1.00）。单变量分析揭示了与报告质量的两个显著关联：高影响因子（IF）[高与中；p =.007，OR = 3.521，95%CI =（1.396，8.879），高与低；p <.001，OR = 7.583，95%CI =（3.063，18.762），中与低；p =.078，OR = 2.154，95%CI =（0.911，5.093）]和样本量[p <.001，OR = 4.297，95%CI =（2.081，8.874）]。发表期（p =.742）和资金（p =.280）无显著关联。多变量分析减弱了样本量的影响，结果不显著，而高IF的影响仍然显著[中与高；p =.029，OR = 0.337，95%CI =（0.127，0.895），低与高；p =.012，OR = 0.199，95%CI =（0.057，0.699）]。一项探索性分析表明报告质量与IF之间存在显著的、弱到中等的正线性相关[Pearson相关系数r = 0.418，p <.001]。
需要进一步认可并将遵守CONSORT声明纳入每个期刊的作者须知中。
