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Comparison of weekly and daily recall of pain as an endpoint in a randomized phase 3 trial of cabozantinib for metastatic castration-resistant prostate cancer
Clinical Trials ( IF 2.7 ) Pub Date : 2021-04-22 , DOI: 10.1177/17407745211009547
Elisabeth M Schaffer 1 , Ethan M Basch 2 , Gisela M Schwab 3 , Antonia V Bennett 4
Affiliation  

Introduction

Scant evidence reveals whether the use of weekly versus daily pain ratings leads to meaningful differences when measuring pain as a clinical trial outcome. We compared the ability of weekly ratings and descriptors of daily ratings to evaluate pain as an endpoint in a randomized phase 3 drug trial.

Methods

Participants (n = 119) with metastatic castration-resistant prostate cancer were randomized to treatment arms and rated their pain on the average and at its worst during a baseline week and at weeks 3, 6, and 12 of study treatment. For each reporting period, participants rated their pain daily for 7 days. On day 7, participants rated their pain over the prior 7 days. We estimated mean differences and intraclass correlation coefficients of the weekly ratings and the mean and the maximum daily ratings. We compared the ability of the weekly ratings and the daily rating descriptors to detect change in pain and evaluated the agreement of the weekly rating and the mean daily rating of pain at its worst to detect treatment response.

Results

For both pain constructs, the weekly rating was consistently higher than the mean daily rating and lower than the maximum daily rating yet was moderately to highly correlated with both daily rating descriptors (intraclass correlation coefficient range = 0.55–0.94). The weekly rating and the daily rating descriptors consistently detected change in pain for the study sample and participant subgroups. Substantial agreement existed between the weekly rating and the mean daily rating of pain at its worst when used with trial protocol opioid criteria to detect treatment response (Cohen’s κ = 0.71).

Conclusion

Use of daily over weekly ratings delivered no added benefit in evaluating pain in this clinical trial. This study is the first to compare weekly and daily recall to measure pain as an endpoint in a randomized phase 3 drug trial, and the pattern of differences in ratings that we observed is consistent with other recent evaluations of weekly and daily symptom reporting.



中文翻译:

在卡博替尼治疗转移性去势抵抗性前列腺癌的随机 3 期试验中,每周和每日疼痛回忆作为终点的比较

介绍

很少有证据表明,在测量疼痛作为临床试验结果时,使用每周和每天的疼痛评级是否会导致有意义的差异。在随机 3 期药物试验中,我们比较了每周评级和每日评级描述符在评估疼痛作为终点的能力。

方法

 患有转移性去势抵抗性前列腺癌的参与者 ( n = 119) 被随机分配到治疗组,并评估他们在基线周和研究治疗的第 3、6 和 12 周期间的平均疼痛和最严重疼痛。对于每个报告期,参与者每天对他们的疼痛进行评分,持续 7 天。在第 7 天,参与者对前 7 天的疼痛进行评分。我们估计了每周评级以及平均和最大每日评级的平均差异和类内相关系数。我们比较了每周评级和每日评级描述符检测疼痛变化的能力,并评估了每周评级和最严重疼痛的平均每日评级在检测治疗反应方面的一致性。

结果

对于两种疼痛结构,每周评级始终高于平均每日评级并低于最大每日评级,但与两个每日评级描述符中度至高度相关(组内相关系数范围 = 0.55-0.94)。每周评级和每日评级描述符一致地检测到研究样本和参与者亚组的疼痛变化。当与试验方案阿片类药物标准一起使用以检测治疗反应时,每周评分和平均每日疼痛评分之间存在实质性一致(Cohen's κ  = 0.71)。

结论

在这项临床试验中,使用每日超过每周评级在评估疼痛方面没有带来额外的好处。这项研究是第一个比较每周和每天回忆以测量疼痛作为随机 3 期药物试验的终点的研究,我们观察到的评级差异模式与最近对每周和每日症状报告的其他评估一致。

更新日期:2021-04-22
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