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评估外科创新的随机临床试验。

Randomized clinical trials in the evaluation of surgical innovation.

作者信息

Haines S J

出版信息

J Neurosurg. 1979 Jul;51(1):5-11. doi: 10.3171/jns.1979.51.1.0005.

DOI:10.3171/jns.1979.51.1.0005
PMID:376786
Abstract

Randomized clinical trials are widely accepted as the standard for evaluation of therapeutic innovation in many fields of medicine. The three basic components of such trials (concurrent comparison, random allocation, and objective observation) are designed to control four forms of bias (chronology bias, susceptibility bias, compliance bias, and observation bias) that may interfere with the interpretation of the results of a study. Only 2% of the articles evaluating therapeutic maneuvers published in the Journal of Neurosurgery have attempted to use concurrent controls. Only one of 863 such articles met the criteria for a randomized clinical trial. Reasons for underutilization of such trials in neurosurgery are discussed and suggestions for their wider use are offered.

摘要

随机临床试验在医学诸多领域被广泛认可为评估治疗创新的标准。此类试验的三个基本组成部分(同期对照、随机分配和客观观察)旨在控制可能干扰研究结果解读的四种偏倚形式(时间顺序偏倚、易感性偏倚、依从性偏倚和观察偏倚)。在《神经外科杂志》上发表的评估治疗手段的文章中,仅有2%尝试使用同期对照。在863篇此类文章中,只有一篇符合随机临床试验的标准。本文讨论了神经外科领域此类试验未得到充分利用的原因,并提出了更广泛应用此类试验的建议。

相似文献

1
Randomized clinical trials in the evaluation of surgical innovation.评估外科创新的随机临床试验。
J Neurosurg. 1979 Jul;51(1):5-11. doi: 10.3171/jns.1979.51.1.0005.
2
[Comparison of the fields of randomized therapeutic trials published in the New England Journal of Medicine with various health indicators].[《新英格兰医学杂志》发表的随机治疗试验领域与各项健康指标的比较]
Therapie. 1987 Mar-Apr;42(2):217-21.
3
Assessment of risk of bias in randomized clinical trials in surgery.外科随机临床试验中的偏倚风险评估
Br J Surg. 2009 Apr;96(4):342-9. doi: 10.1002/bjs.6558.
4
Ethical pitfalls in neonatal comparative effectiveness trials.新生儿比较疗效试验中的伦理陷阱。
Neonatology. 2014;105(4):350-1. doi: 10.1159/000360650. Epub 2014 May 30.
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Last-observation-carried-forward imputation method in clinical efficacy trials: review of 352 antidepressant studies.末次观测结转(LOCF)推断法在临床疗效试验中的应用:352 项抗抑郁研究综述。
Pharmacotherapy. 2009 Dec;29(12):1408-16. doi: 10.1592/phco.29.12.1408.
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The randomized clinical trial in orthopaedics: obligation or option?骨科领域的随机临床试验:是义务还是选择?
J Bone Joint Surg Am. 1985 Oct;67(8):1284-93.
7
Reporting on methods in clinical trials.临床试验方法报告。
N Engl J Med. 1982 Jun 3;306(22):1332-7. doi: 10.1056/NEJM198206033062204.
8
Pitfalls in randomized surgical trials.随机外科试验中的陷阱。
Surgery. 1980 Mar;87(3):258-62.
9
[Evaluation of the methodological quality of randomized therapeutic trials].[随机治疗试验的方法学质量评估]
Presse Med. 1988 Feb 27;17(7):315-8.
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Meta-analyses of randomized controlled trials.随机对照试验的荟萃分析。
N Engl J Med. 1987 Feb 19;316(8):450-5. doi: 10.1056/NEJM198702193160806.

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Are preoperative chlorhexidine gluconate showers associated with a reduction in surgical site infection following craniotomy? A retrospective cohort analysis of 3126 surgical procedures.术前使用葡萄糖酸氯己定沐浴是否与开颅术后手术部位感染的减少有关?对3126例外科手术的回顾性队列分析。
J Neurosurg. 2021 Apr 30;135(6):1889-1897. doi: 10.3171/2020.10.JNS201255. Print 2021 Dec 1.
2
Barriers and facilitators experienced in collaborative prospective research in orthopaedic oncology: A qualitative study.骨科肿瘤协作前瞻性研究中的障碍与促进因素:一项定性研究。
Bone Joint Res. 2017 May;6(5):307-314. doi: 10.1302/2046-3758.65.BJR-2016-0192.R1.
3
The challenges faced in the design, conduct and analysis of surgical randomised controlled trials.
外科随机对照试验在设计、实施和分析过程中所面临的挑战。
Trials. 2009 Feb 6;10:9. doi: 10.1186/1745-6215-10-9.
4
Adoption of an innovation to repair aortic aneurysms at a Canadian hospital: a qualitative case study and evaluation.加拿大一家医院采用创新方法修复主动脉瘤:一项定性案例研究与评估
BMC Health Serv Res. 2007 Nov 15;7:182. doi: 10.1186/1472-6963-7-182.
5
Clinical trials on trial: I. Must we always do a randomized trial?临床试验之审视:其一,我们是否必须总是进行随机试验?
Can Med Assoc J. 1981 Dec 15;125(12):1309-11.
6
Dependency on bypass circulation: a case study.对体外循环的依赖:一项病例研究。
Acta Neurochir (Wien). 1982;62(3-4):277-85. doi: 10.1007/BF01403635.
7
The randomised controlled trial in the evaluation of new technology: a case study.新技术评估中的随机对照试验:一个案例研究
Br Med J (Clin Res Ed). 1986 Mar 29;292(6524):877-9. doi: 10.1136/bmj.292.6524.877.