Evaluation of different recall periods for the US National Cancer Institute's PRO-CTCAE
Evaluation of different recall periods for the US National Cancer Institute's PRO-CTCAE
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DOI：
10.1177/1740774517698645
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发表时间：
2017-06-01
期刊：
影响因子：
2.7
通讯作者：
Basch, Ethan
中科院分区：
文献类型：
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作者：
Mendoza, Tito R.;Dueck, Amylou C.;Basch, Ethan
目的：美国国家癌症研究所最近开发了PRO-CTCAE(患者报告的不良事件通用术语标准版本)。PRO-CTCAE是临床试验参与者自我报告症状不良事件(例如恶心)的问题库。这项研究的目的是为循证选择召回期间提供信息，当支持CTCAE纳入试验时。我们以每日报告为参照，评估了1周、2周、3周和4周回忆期的差异。方法：英语癌症患者接受化疗和/或放射治疗，在美国四个癌症中心和附属社区诊所登记。参与者使用1周、2周、3周和4周的回忆期，每天以电子方式完成27个CTCAE项目，持续28天，然后在4周内每周完成一次。对于每个回忆周期，计算平均差异、效应大小和组内相关系数，以评估每日评分的最大值与使用较长回忆时段获得的相应评分之间的一致性(例如，超过7天的每日分数与1周的回忆分数的最大值)之间的一致性。结果：共有127名受试者完成了问卷调查(男性占57%，年龄中位数57岁)。在PRO-CTCAE 5分反应量表上比较每日最大回忆时间和较长回忆时间(以及相应的影响大小)的27个平均分差值的中位数分别为：1周回忆-0.20(-0.20)，2周回忆-0.36(-0.31)，3周回忆-0.45(-0.39)，4周回忆-0.47(-0.40)。在27个条目中，1周回忆的每日评分最高值与相应的较长回忆评分之间的组内相关中位数为0.70(范围：0.54-0.82)，2周的相关系数为0.74(范围：0.58-0.83)，3周的相关系数为0.72(范围：0.61-0.84)，4周的相关系数为0.72(范围：0.64-0.86)。使用每日得分的平均值而不是每日得分的最大值的所有分析都观察到了类似的结果。结论：1周的召回最符合每日报告。尽管组内相关性随着时间的推移保持稳定，但在2周、3周和4周的每日回忆时间和较长回忆时间之间的差异很小，但逐渐增大。支持CTCAE的首选召回期限是过去7天，尽管调查人员可能会选择2周、3周或4周的召回期限，但前提是可能会丢失一些信息。
Aims: The US National Cancer Institute recently developed the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events). PRO-CTCAE is a library of questions for clinical trial participants to self-report symptomatic adverse events (e.g. nausea). The objective of this study is to inform evidence-based selection of a recall period when PRO-CTCAE is included in a trial. We evaluated differences between 1-, 2-, 3-, and 4-week recall periods, using daily reporting as the reference.Methods: English-speaking patients with cancer receiving chemotherapy and/or radiotherapy were enrolled at four US cancer centers and affiliated community clinics. Participants completed 27 PRO-CTCAE items electronically daily for 28days, and then weekly over 4weeks, using 1-, 2-, 3-, and 4-week recall periods. For each recall period, mean differences, effect sizes, and intraclass correlation coefficients were calculated to evaluate agreement between the maximum of daily ratings and the corresponding ratings obtained using longer recall periods (e.g. maximum of daily scores over 7days vs 1-week recall). Analyses were repeated using the average of daily scores within each recall period rather than the maximum of daily scores.Results: A total of 127 subjects completed questionnaires (57% male; median age: 57). The median of the 27 mean differences in scores on the PRO-CTCAE 5-point response scale comparing the maximum daily versus the longer recall period (and corresponding effect size) was -0.20 (-0.20) for 1-week recall, -0.36 (-0.31) for 2-week recall, -0.45 (-0.39) for 3-week recall, and -0.47 (-0.40) for 4-week recall. The median intraclass correlation across 27 items between the maximum of daily ratings and the corresponding longer recall ratings for 1-week recall was 0.70 (range: 0.54-0.82), for 2-week recall was 0.74 (range: 0.58-0.83), for 3-week recall was 0.72 (range: 0.61-0.84), and for 4-week recall was 0.72 (range: 0.64-0.86). Similar results were observed for all analyses using the average of daily scores rather than the maximum of daily scores.Conclusion: A 1-week recall corresponds best to daily reporting. Although intraclass correlations remain stable over time, there are small but progressively larger differences between daily and longer recall periods at 2, 3, and 4weeks, respectively. The preferred recall period for the PRO-CTCAE is the past 7days, although investigators may opt for recall periods of 2, 3, or 4weeks with an understanding that there may be some information loss.