Elcivan Meltem, Kowark Ana, Coburn Mark, Hamou Hussam Aldin, Kremer Benedikt, Clusmann Hans, Höllig Anke
Department of Neurosurgery, University Hospital RWTH Aachen, Pauwelsstr. 30, D-52074 Aachen, Germany.
Department of Anaesthesiology, University Hospital RWTH Aachen, Pauwelsstr. 30, D-52074 Aachen, Germany.
Brain Sci. 2021 Nov 13;11(11):1504. doi: 10.3390/brainsci11111504.
Traumatic brain injury (TBI) contributes to death and disability, resulting in an enormous individual and socio-economic challenges. Despite huge efforts, there are still controversies on treatment strategies and early outcome estimation. We evaluate current randomized controlled trials (RCTs) on TBI according to their fulfillment of the CONSORT (Consolidated Statement of Reporting Trials) statement's criteria as a marker of transparency and the quality of study planning and realization. A PubMed search for RCTs on TBI (January 2014-December 2019) was carried out. After screening of the abstracts ( = 1.926), the suitable full text manuscripts ( = 72) were assessed for the fulfillment of the CONSORT criteria. The mean ratio of consort statement fulfillment was 59% (±13%), 31% of the included studies ( = 22) complied with less than 50% of the CONSORT criteria. Citation frequency was moderately related to ratio of CONSORT item fulfillment ( = 0.4877; < 0.0001) and citation frequency per year ( = 0.5249; < 0.0001). The ratio of CONSORT criteria fulfillment was associated with the impact factor of the publishing journal ( = 0.6428; < 0.0001). Essential data for study interpretation, such as sample size determination (item 7a), participant flow (item 13a) as well as losses and exclusions (item 13b), were only reported in 53%, 60% and 63%, respectively. Reporting and methodological aspects in RCTs on TBI still may be improved. Thus, the interpretation of study results may be hampered due to methodological weaknesses.
创伤性脑损伤（TBI）会导致死亡和残疾，给个人和社会经济带来巨大挑战。尽管付出了巨大努力，但在治疗策略和早期预后评估方面仍存在争议。我们根据创伤性脑损伤的随机对照试验（RCT）是否符合CONSORT（试验报告统一标准）声明的标准，来评估其透明度以及研究规划和实施的质量。我们在PubMed上搜索了2014年1月至2019年12月期间关于创伤性脑损伤的随机对照试验。在筛选摘要（n = 1926）后，对合适的全文手稿（n = 72）进行了CONSORT标准符合情况的评估。CONSORT声明的平均符合率为59%（±13%），31%的纳入研究（n = 22）符合的CONSORT标准不到50%。引用频率与CONSORT项目符合率呈中度相关（r = 0.4877；P < 0.0001），与每年的引用频率也呈中度相关（r = 0.5249；P < 0.0001）。CONSORT标准的符合率与发表期刊的影响因子相关（r = 0.6428；P < 0.0001）。对于研究解读的关键数据，如样本量确定（项目7a）、参与者流程（项目13a）以及失访和排除情况（项目13b），分别只有53%、60%和63%的研究进行了报告。创伤性脑损伤随机对照试验的报告和方法学方面仍有改进空间。因此，由于方法学上的不足，可能会妨碍对研究结果的解读。
