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.

中文翻译：

---

基于 CONSORT 声明的缺血性卒中双盲 RCT 报告质量评估

背景-目的 随机对照试验 (RCT) 提供完整和透明的报告至关重要。本研究旨在根据 2010 年 CONSORT 声明确定用于缺血性卒中患者药物干预的双盲 RCT 的报告质量。METHODOLOGY MEDLINE 进行了全面检索。CONSORT 期在 2000 年至 2019 年之间划定，而依从性≥75 被定义为足够。对可能的决定因素进行了单变量和多变量的关联检查。结果 总体而言，197 篇文章被认为符合条件，其中 143 篇在 2000 年之后发表，54 篇在 2000 年之前发表。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，56/143（39.16%）和 1/54（1.85%）相应被评为报告质量良好[p < .001，OR = 34.115, 95%CI = (4.586, 253.762)]。McNemar 的检验表明 2010 年 CONSORT 修订前后充分/不充分报告项目的一致性（p = 1.00）。单变量分析揭示了与报告质量的两个显着关联：高影响因子 (IF) [高 vs. 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)，中度与低度；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)]。出版期 (p = .742) 和资助 (p = .280) 没有显着相关性。多变量分析减弱了样本量的影响，提供了微不足道的结果，而高 IF 的影响仍然显着 [中等 vs. 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 之间存在显着的、弱到中度的正线性相关性 [Pearson's r = 0.418, p < .001]。结论 遵守 CONSORT 声明需要得到进一步的认可，并纳入每本期刊对作者的说明中。