Abstract：
Pain intensity is the most commonly used outcome domain in pain clinical trials. To minimize the chances of type II error (ie, concluding that a treatment does not have beneficial effects, when in fact it does), the measure of pain intensity used should be sensitive to changes produced by effective pain treatments. Here we sought to identify the combination of pain intensity ratings that would balance the need for reliability and validity against the need to minimize assessment burden. We conducted secondary analyses using data from a completed 4-arm clinical trial of psychological pain treatments (N = 164 adults). Current, worst, least, and average pain intensity in the past 24 hours were assessed 4 times before and after treatment using 0 to 10 numerical rating scale-11. We created a variety of composite scores using these ratings and evaluated their reliability (Cronbach\'s alphas) and validity (ie, associations with a gold standard score created by averaging 16 ratings and sensitivity for detecting between-group differences in treatment efficacy). We found that for each measure, reliability increased as the number of ratings used to create the measures increased and that ratings from 3 or more days were needed to have adequately strong associations with the gold standard. Regarding sensitivity, the findings suggest that composite scores made up of ratings from 4 days are needed to maximize the chances of detecting treatment effects, especially with smaller sample sizes. In conclusion, using data from 3 or 4 days of assessment may be the best practice. PERSPECTIVE: Composite scores made up of at least 3 days of pain ratings appear to be needed to maximize reliability and validity while minimizing the assessment burden. TRIAL REGISTRATION: clinicaltrials.gov NCT01800604.
摘要：
疼痛强度是疼痛临床试验中最常用的结果域。为了最小化II型错误的机会(即，得出结论认为治疗没有有益效果，事实上，它确实如此)，所使用的疼痛强度测量应该对有效疼痛治疗产生的变化敏感。在这里，我们试图确定疼痛强度等级的组合，以平衡可靠性和有效性的需求与最小化评估负担的需求。我们使用来自完成的4臂心理疼痛治疗临床试验（N=164名成年人）的数据进行了二次分析。Current,最坏,至少,在治疗前后使用0至10个数值评定量表(NRS-11)对过去24小时的平均疼痛强度进行4次评估。我们使用这些评级创建了各种综合评分，并评估了它们的可靠性(克朗巴赫的阿尔法)和有效性(即，与黄金标准评分的关联是通过平均16个评分和检测治疗疗效组间差异的敏感性)。我们发现，对于每一项措施，可靠性随着用于创建度量的评级数量的增加而增加，并且需要三天或更长时间的评级才能与黄金标准有足够的联系。关于敏感性，研究结果表明，需要由四天的评分组成的综合评分，以最大限度地提高检测治疗效果的机会，特别是在样本量较小的情况下。总之,使用3天或4天的评估数据可能是最佳做法.结果：由至少三天的疼痛评分组成的综合评分似乎需要最大限度地提高可靠性和有效性，同时最大限度地减少评估负担。试验注册：clinicaltrials.govNCT01800604。
