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反对意见:随机对照试验(RCT)在透析方法的研究中失败了。

Con: Randomized controlled trials (RCT) have failed in the study of dialysis methods.

机构信息

Division of Nephrology, Department of Medicine, University of Missouri, Columbia, MO, USA.

出版信息

Nephrol Dial Transplant. 2013 Apr;28(4):826-32; discussion 832. doi: 10.1093/ndt/gfs307.

Abstract

All progress in dialysis methods was made in research presented in case reports, case-control studies and other observational studies. On the contrary, randomized controlled trials (RCTs) did not bring any valuable results. Comparison of the value of peritoneal dialysis and hemodialysis (HD) in RCTs was not completed because of recruitment problems. Four RCTs in HD did not provide any useful data. The worst example was the National Cooperative Dialysis Study, which committed a Type II statistical error rejecting the time of dialysis as an important factor determining the quality of dialysis. This study also provided the basis for the establishment of the Kt/V index as a measure of dialysis adequacy. This index was accepted by the HD community, having been established in a sacrosanct RCT, led to short dialysis, and possibly higher mortality in the USA. The second trial (the HEMO study) committed a Type III statistical error asking the wrong question and did not bring any valuable results, but at least it did not lead to deterioration of dialysis outcomes in the USA. The third, the Frequent Hemodialysis Network Trial Group, did not bring forth any valuable results, but at least confirmed what was already known. The fourth, the Frequent Hemodialysis Network Nocturnal Trial, committed a Type II statistical error because of tremendous recruitment problems leading to an inadequate number of subjects. Moreover, the study methodology was absolutely unreliable.

摘要

所有透析方法的进展都是在病例报告、病例对照研究和其他观察性研究中提出的研究结果。相反,随机对照试验(RCT)并没有带来任何有价值的结果。由于招募问题,腹膜透析和血液透析(HD)的 RCT 比较未能完成。四项 HD 的 RCT 没有提供任何有用的数据。最糟糕的例子是国家合作透析研究,该研究犯了 II 类统计错误,拒绝将透析时间作为确定透析质量的重要因素。这项研究还为 Kt/V 指数作为透析充分性的衡量标准提供了依据。该指数被 HD 社区接受,在一项神圣的 RCT 中建立,导致美国透析时间缩短,死亡率可能更高。第二项试验(HEMO 研究)犯了 III 类统计错误,提出了错误的问题,没有带来任何有价值的结果,但至少没有导致美国透析结果恶化。第三项,频繁血液透析网络试验组,没有带来任何有价值的结果,但至少证实了已经知道的情况。第四项,频繁血液透析网络夜间试验,由于招募问题巨大,导致受试者数量不足,犯了 II 类统计错误。此外,该研究方法完全不可靠。

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