PDF(Pubmed)
Abstract：
Recent signs of fraudulent behaviour in spine RCTs have queried the integrity of trials in the field. RCTs are particularly important due to the weight they are accorded in guiding treatment decisions, and thus, ensuring RCTs\' reliability is crucial. This study investigates the presence of non-random baseline frequency data in purported RCTs published in spine journals.
A PubMed search was performed to obtain all RCTs published in four spine journals (Spine, The Spine Journal, the Journal of Neurosurgery Spine, and European Spine Journal) between Jan-2016 and Dec-2020. Baseline frequency data were extracted, and variable-wise p values were calculated using the Pearson Chi-squared test. These p values were combined for each study into study-wise p values using the Stouffer method. Studies with p values below 0.01 and 0.05 and those above 0.95 and 0.99 were reviewed. Results were compared to Carlisle\'s 2017 survey of anaesthesia and critical care medicine RCTs.
One hundred sixty-seven of the 228 studies identified were included. Study-wise p values were largely consistent with expected genuine randomized experiments. Slightly more study-wise p values above 0.99 were observed than expected, but a number of these had good explanations to account for that excess. The distribution of observed study-wise p values was more closely matched to the expected distribution than those in a similar survey of the anaesthesia and critical care medicine literature.
The data surveyed do not show evidence of systemic fraudulent behaviour. Spine RCTs in major spine journals were found to be consistent with genuine random allocation and experimentally derived data.
A PubMed search was performed to obtain all RCTs published in four spine journals (Spine, The Spine Journal, the Journal of Neurosurgery Spine, and European Spine Journal) between Jan-2016 and Dec-2020. Baseline frequency data were extracted, and variable-wise p values were calculated using the Pearson Chi-squared test. These p values were combined for each study into study-wise p values using the Stouffer method. Studies with p values below 0.01 and 0.05 and those above 0.95 and 0.99 were reviewed. Results were compared to Carlisle\'s 2017 survey of anaesthesia and critical care medicine RCTs.
One hundred sixty-seven of the 228 studies identified were included. Study-wise p values were largely consistent with expected genuine randomized experiments. Slightly more study-wise p values above 0.99 were observed than expected, but a number of these had good explanations to account for that excess. The distribution of observed study-wise p values was more closely matched to the expected distribution than those in a similar survey of the anaesthesia and critical care medicine literature.
The data surveyed do not show evidence of systemic fraudulent behaviour. Spine RCTs in major spine journals were found to be consistent with genuine random allocation and experimentally derived data.
摘要：
背景：脊柱随机对照试验中最近的欺诈行为迹象质疑该领域试验的完整性。RCT特别重要，因为它们在指导治疗决策方面具有重要意义，因此，确保RCT的可靠性至关重要。这项研究调查了发表在脊柱期刊上的所谓RCT中存在非随机基线频率数据。
方法：进行了PubMed搜索，以获取在四个脊柱期刊上发表的所有RCT（Spine，脊柱杂志,神经外科脊柱杂志,和欧洲脊柱杂志)在2016年1月至2020年12月之间。提取基线频率数据，和可变p值使用皮尔逊卡方检验计算。使用Stouffer方法将每个研究的这些p值组合成研究的p值。对p值低于0.01和0.05以及高于0.95和0.99的研究进行了综述。将结果与卡莱尔2017年的麻醉和重症监护医学随机对照调查进行比较。
结果：纳入了228项研究中的147项。研究方面的p值与预期的真正随机实验基本一致。观察到高于0.99的研究p值略高于预期，但是其中一些有很好的解释来解释这种过剩。与麻醉和重症监护医学文献的类似调查相比，观察到的按研究p值的分布与预期分布更接近。
结论：调查的数据没有显示系统性欺诈行为的证据。发现主要脊柱期刊中的脊柱随机对照试验与真正的随机分配和实验得出的数据一致。
方法：进行了PubMed搜索，以获取在四个脊柱期刊上发表的所有RCT（Spine，脊柱杂志,神经外科脊柱杂志,和欧洲脊柱杂志)在2016年1月至2020年12月之间。提取基线频率数据，和可变p值使用皮尔逊卡方检验计算。使用Stouffer方法将每个研究的这些p值组合成研究的p值。对p值低于0.01和0.05以及高于0.95和0.99的研究进行了综述。将结果与卡莱尔2017年的麻醉和重症监护医学随机对照调查进行比较。
结果：纳入了228项研究中的147项。研究方面的p值与预期的真正随机实验基本一致。观察到高于0.99的研究p值略高于预期，但是其中一些有很好的解释来解释这种过剩。与麻醉和重症监护医学文献的类似调查相比，观察到的按研究p值的分布与预期分布更接近。
结论：调查的数据没有显示系统性欺诈行为的证据。发现主要脊柱期刊中的脊柱随机对照试验与真正的随机分配和实验得出的数据一致。
