Bogduk Nikolai
The University of Newcastle, Newcastle, Australia, PO Box 431, East Maitland, NSW, 2323, Australia.
Interv Pain Med. 2022 Aug 15;1(Suppl 2):100126. doi: 10.1016/j.inpm.2022.100126. eCollection 2022.
Studies of pain treatment involve comparing groups. In observational studies scores for outcome variables in the one group are compared before and after treatment. In controlled trials, scores are compared between groups undergoing different treatments. Statistics based on group scores might show that a statistically significant change has occurred but they do not reveal how well a treatment works. That is revealed by categorical data that show the proportion of patients that benefitted by how much after treatment. Those proportions are qualified by the 95% confidence interval of the proportion. In observational studies the magnitude of the success rate, and its 95% confidence interval, is enough to indicate how well the treatment worked. In controlled trials, success rates can be compared to determine how more often is one treatment successful than another. Statistical significance of the difference is established if the confidence intervals of the respective success rates do not overlap, or if the 95% confidence interval of the difference between success rates does not include zero. Pragmatic trials compare one treatment with another, but the comparison does not show if either treatment works well. Each arm of a pragmatic trial constitutes an observational study and the data in each ach show how well each treatment works. Explanatory trials investigate the extent to which the observed success rate is provided by responses to non-specific effects of treatment. The extent to which active treatment is more often effective than is sham treatment can be demonstrated by comparing the success rates of the two treatments, by comparing their survival curves, and by calculating the attributable effect and the number needed to treat of the active treatment.
疼痛治疗研究涉及组间比较。在观察性研究中，一组的结局变量得分在治疗前后进行比较。在对照试验中，不同治疗组之间的得分进行比较。基于组得分的统计数据可能表明发生了具有统计学意义的变化，但它们并未揭示一种治疗方法的效果如何。这由分类数据揭示，该数据显示治疗后受益的患者比例以及受益程度。这些比例由该比例的95%置信区间来限定。在观察性研究中，成功率及其95%置信区间足以表明治疗的效果如何。在对照试验中，可以比较成功率以确定一种治疗比另一种治疗更成功的频率。如果各自成功率的置信区间不重叠，或者成功率差异的95%置信区间不包括零，则可确定差异具有统计学意义。实用性试验将一种治疗与另一种治疗进行比较，但这种比较并未表明任何一种治疗是否效果良好。实用性试验的每个组构成一项观察性研究，每个组中的数据显示每种治疗的效果如何。解释性试验研究观察到的成功率在多大程度上是由对治疗非特异性效应的反应所提供的。通过比较两种治疗的成功率、比较它们的生存曲线以及计算活性治疗的归因效应和治疗所需人数，可以证明活性治疗比假治疗更有效的程度。
