Clinical measurement, statistical analysis, and risk-benefit: controversies from trials of spinal injury.

Bracken MB; Aldrich EF; Herr DL; Hitchon PW; Holford TR; Marshall LF; Nockels RP; Pascale V; Shepard MJ; Sonntag VK; Winn HR; Young W

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Clinical measurement, statistical analysis, and risk-benefit: controversies from trials of spinal injury.

机译：临床测量，统计分析和风险收益：来自脊髓损伤试验的争议。

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BACKGROUND: The National Acute Spinal Cord Injury Studies have been a series of trials assessing the role of pharmacologic agents in the prevention of secondary neuronal damage after acute spinal cord injury. METHODS: The trials were multicenter randomized, controlled studies. RESULTS: Two trials have demonstrated the efficacy of high-dose methylprednisolone in improving neurologic and functional recovery and have shown a reassuring safety profile. CONCLUSION: This study responds to a recent commentary on these trials and examines in particular the roles of clinical measurement, statistical analysis, and risk benefit in assembling evidence for or against innovative therapies.

机译：背景：国家急性脊髓损伤研究是一系列评估药物在预防急性脊髓损伤后继发神经元损害中的作用的试验。方法：试验是多中心随机对照研究。结果：两项试验证明了大剂量甲基强的松龙可改善神经和功能恢复，并显示出令人放心的安全性。结论：本研究回应了有关这些试验的最新评论，并特别研究了临床测量，统计分析和风险收益在收集支持或反对创新疗法的证据方面的作用。

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《The Journal of trauma》 |2000年第3期|共4页
作者
Bracken MB; Aldrich EF; Herr DL; Hitchon PW; Holford TR; Marshall LF; Nockels RP; Pascale V; Shepard MJ; Sonntag VK; Winn HR; Young W;
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正文语种 eng
中图分类外科学;
关键词
Anti-Inflammatory Agents; Steroidal; Methylprednisolone; Spinal Cord Injuries; 消炎药; 甾类; 甲泼尼龙; 脊髓损伤;

机译：Anti-Inflammatory Agents;Steroidal;Methylprednisolone;Spinal Cord Injuries;消炎药;甾类;甲泼尼龙;脊髓损伤;

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1. Clinical measurement, statistical analysis, and risk-benefit: controversies from trials of spinal injury. [J] . Bracken MB, Aldrich EF, Herr DL, The Journal of trauma . 2000,第3期

机译：临床测量，统计分析和风险收益：来自脊髓损伤试验的争议。
2. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials. [J] . Fawcett JW, Curt A, Steeves JD, Spinal cord: the official journal of the International Medical Society of Paraplegia . 2007,第3期

机译：ICCP专家组制定的脊髓损伤临床试验进行指南：脊髓损伤后的自发恢复和治疗性临床试验所需的统计能力。
3. Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials [J] . Perlmutter A. S., Tran V. -T., Dechartres A., Annals of oncology: official journal of the European Society for Medical Oncology . 2017,第4期

机译：临床研究中的统计争议：课程中主要结果的比较，公共临床 - 试验登记和出版物：肿瘤学审判的举例
4. Evaluating risk: A revisit of the scales, measurement theory, and statistical analysis controversy [C] . J. D. Solomon, Daniel Vallero, Kathryn Benson Annual Reliability and Maintainability Symposium . 2017

机译：评估风险：重新评估量表，测量理论和统计分析争议
5. A simulation study using the hybrid statistic and the meta-analysis t-test for data with matched and unmatched subjects in the interim analysis of clinical trials [D] . Wang, Yunfei. 2012

机译：在临床试验的中期分析中，使用混合统计量和荟萃分析t检验对匹配对象和不匹配对象的数据进行的模拟研究
6. Statistical controversies in clinical research: basket trials umbrella trials and other master protocols: a review and examples [O] . L. A. Renfro, D. J. Sargent -1

机译：临床研究中的统计争议：篮子试验综合试验和其他主要方案：评论和实例
7. Statistical Controversies in Reporting of Clinical Trials Part 2 of a 4-Part Series on Statistics for Clinical Trials [O] . Pocock Stuart J., McMurray John J.V., Collier Tim J. 2015

机译：临床试验报告中的统计争议4个部分的临床试验统计系列的第2部分

Clinical measurement, statistical analysis, and risk-benefit: controversies from trials of spinal injury.

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