【060602读书笔记】【医学】【spine】随机对照实验结果的适用范围及其临床相关性
Spine - Abstract Volume 31(13) June 1, 2006 p 1405-1409Applicability and Clinical Relevance of Results in Randomized Controlled Trials: The Cochrane Review on Exercise Therapy for Low Back Pain as an Example.
Randomized Trial
Spine. 31(13):1405-1409, June 1, 2006.
Malmivaara, Antti MC, PhD *; Koes, Bart W. PhD +; Bouter, Lex M. PhD ++; van Tulder, Maurits W. PhD ++
Abstract:
Study Design. A critical appraisal of the literature.
Objectives. To increase awareness of the importance of applicability and clinical relevance of the results of randomized controlled trials (RCTs) in the field of spinal disorders by formulating a list of items for assessment of applicability and clinical relevance of results of RCTs.
Summary of Background Data. In systematic reviews of randomized controlled trials (RCTs), critical appraisal of methodologic quality is considered important. Less attention has been paid to the assessment of the applicability and the clinical relevance of the results.
Methods. RCTs in an update of the Cochrane review on exercise therapy for low back pain were used. Most of the trials did not score positively on the five Cochrane Back Review Group basic items describing patients: intervention and setting, outcome, effect size, and benefits related to adverse effects. Item 1 was met by 88% of the trials, but item 2 only by 51%, item 3 by 67%, item 4 by 35%, and item 5 by 0%. Subsequently, a more comprehensive list of items for the assessment of applicability and clinical relevance of results of RCTs was developed. These criteria were pilot tested on the RCTs. After pilot testing and a subsequent consensus meeting, the list of items was drafted and circulated among the members of the Editorial Board of the Cochrane Back Review Group. Changes were made in response to comments.
Results. The final list consists of 40 items. The items are ordered on two headings: Does the report enable the assessment of applicability? Are the study results clinically relevant? We present examples of informative and noninformative reporting of RCTs in order to illustrate how information on applicability and clinical relevance of results can be assessed.
Conclusions. Authors of RCTs should adequately report on items that are essential to assess the applicability and clinical relevance of results. The presented list of items may help clinicians reading RCTs and authors of systematic reviews to draw more balanced conclusions on applicability and clinical relevance of results.
随机对照实验结果的适用范围及其临床相关性：以腰背痛的运动疗法的循证医学综述为例
摘要：
实验设计：对文献的关键性评估
目的：在脊柱疾病方面制定一系列项目用以评估随机对照实验（RCTs）结果的适用范围及其临床相关性，以提高（医务工作者）对RCTs结果的适用范围及临床相关性的重要性的认识。
背景数据信息概要：在RCTs的系统性回顾中，（我们常常）着重于对实验方法质量的评判性评估，而不注意对实验结果的适用范围及临床相关性进行分析评估。
方法：我们使用了腰背痛运动疗法的循证医学综述的最新资料的RCTs。大部分实验在描述患者基本情况的5个回顾性循证分析标准上都没有显著性意义：实验设计及干涉，结果，作用大小和对副作用的影响。第1项符合的实验占88%，第2项仅占51%，第3项占67%，第4项占35%，第5项则为0%。随后，（我们）又设计了更加广泛的评估随机对照实验（RCTs）结果适用范围及其临床相关性的一些标准。这些标准是对RCTs的探索试验。在完成探索试验后，回顾性循证分析评估委员会成员选用上述标准并循环使用。（各成员的）评论有差异。
结果：最后确定了40个标准并分为两类：1。文献能否进行适用范围评估？2。实验结果有没有临床相关性？我们（分别）提供了满足以及不满足上述标准的范例，以说明如何对实验结果进行适用范围和临床相关性评估。
小结：随机对照实验（RCTs）文献的作者应该详细说明实验情况，这样才能对实验结果的适用范围和临床相关性进行评估。（我们）提供的这些标准能够帮助临床医生了解RCTs，也能够帮助系统回顾性文献的作者们发表更加合理的实验结果适用范围和临床相关性评估。
[color=red] 记得上医学统计学时，一位老师说过，绝大多数临床医生发表的文章里用的统计方法都是不恰当的，有的甚至是错误的。临床医生，大部分都不重视，也不懂统计学及其方法。这在国内尤为突出，这可能也是国内的文献质量总体不高的原因之一吧？！[/color] systematic reviews 应该翻译成 系统评价(定量分析的话就是所谓的meta 分析)
感觉这篇文章不错,但只看摘要,不能说明什么问题!
文章的内容可能更有意义! 因为我们临床工作中经常遇到这样的, RCT的实验结果是否适合我的病人! 这也叫循征实践! 但这篇文章可能主要列举了几十条相关项目,可以方便我们运用RCT实验结果.
所以还是请兄弟有时间将原文找到与大家分享一下! 上传全文，各位有兴趣的可以一看！ 40个标准：
Table 1. Reporting of Items Related to Applicability and
Clinical Relevance of Results of RCTs
Methods: Does the report enable the assessment of applicability?
Study population
1. Age
2. Gender
3. Setting
4. Type of disease/disorder
5. Duration of disease/disorder
6. Severity of disease/disorder
7. Recruitment procedure
8. Description of inclusion and exclusion criteria
Index intervention
9. Type/content
10. Intensity/dosage
11. Frequency
12. Duration
13. Experience of provider
14. Proper intervention to answer the research question
Comparator (control intervention)
15. Type/content
16. Intensity/dosage
17. Frequency
18. Duration
19. Experience of provider
20. Proper control group to answer the research question
Cointerventions per study group
21. Type/content
22. Intensity/dosage
23. Frequency
24. Duration
25. Experience of provider
Outcome measures
26. Main symptom, disease-specific disability, and generic disability
27. Validity and reliability of instruments
28. Follow-up moment
29. All potential adverse effects
Analysis
30. Intention-to-treat analysis
31. Confounding considered
32. Effect modification considered
33. Economic evaluation
Results: Are the study results clinically relevant?
34. Baseline values of main symptoms and disability plus measure of
variance
35. Adherence in all study groups
36. Dropout rate
37. Follow-up values of main symptoms and disability plus measure of
variance
38. Confidence intervals of between-group differences
39. Magnitude of difference between groups
40. Incidence of all adverse effects 精彩的文章，感谢楼主的分享！
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