Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Qual Life Res. 2023 Jul;32(7):2047-2058. doi: 10.1007/s11136-023-03374-5. Epub 2023 Mar 10.
The standard recall period for the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®) is the past 7 days, but there are contexts where a 24-hour recall may be desirable. The purpose of this analysis was to investigate the reliability and validity of a subset of PRO-CTCAE items captured using a 24-hour recall.
27 PRO-CTCAE items representing 14 symptomatic adverse events (AEs) were collected using both a 24-hour recall (24 h) and the standard 7 day recall (7d) in a sample of patients receiving active cancer treatment (n = 113). Using data captured with a PRO-CTCAE-24h on days 6 and 7, and 20 and 21, we computed intra-class correlation coefficients (ICC); an ICC ≥ 0.70 was interpreted as demonstrating high test-retest reliability. Correlations between PRO-CTCAE-24h items on day 7 and conceptually relevant EORTC QLQ-C30 domains were examined. In responsiveness analysis, patients were deemed changed if they had a one-point or greater change in the corresponding PRO-CTCAE-7d item (from week 0 to week 1).
PRO-CTCAE-24h captured on two consecutive days demonstrated that 21 of 27 items (78%) had ICCs ≥ 0.70 (day 6/7 median ICC 0.76), (day 20/21 median ICC 0.84). Median correlation between attributes within a common AE was 0.75, and the median correlation between conceptually relevant EORTC QLQ-C30 domains and PRO-CTCAE-24 h items captured on day 7 was 0.44. In the analysis of responsiveness to change, the median standardized response mean (SRM) for patients with improvement was - 0.52 and that for patients with worsening was 0.71.
A 24-hour recall period for PRO-CTCAE items has acceptable measurement properties and can inform day-to-day variations in symptomatic AEs when daily PRO-CTCAE administration is implemented in a clinical trial.
患者报告结局版通用不良事件术语标准（PRO-CTCAE®）的标准回顾期为过去 7 天，但在某些情况下，24 小时回顾可能更可取。本分析的目的是研究使用 24 小时回顾收集的 PRO-CTCAE 项目子集的可靠性和有效性。
在接受积极癌症治疗的患者样本中（n=113），使用 24 小时回顾（24h）和标准 7 天回顾（7d）收集了 27 个代表 14 种症状性不良事件（AE）的 PRO-CTCAE 项目。使用 PRO-CTCAE-24h 在第 6 天和第 7 天、第 20 天和第 21 天捕获的数据，我们计算了组内相关系数（ICC）；ICC≥0.70 被解释为具有高测试-重测可靠性。检查了 PRO-CTCAE-24h 项目在第 7 天与概念上相关的 EORTC QLQ-C30 域之间的相关性。在反应性分析中，如果相应的 PRO-CTCAE-7d 项目有一个或更多的变化（从第 0 周到第 1 周），则认为患者有变化。
在连续两天内捕获的 PRO-CTCAE-24h 表明，27 个项目中的 21 个（78%）具有 ICC≥0.70（第 6/7 天中位数 ICC 0.76），（第 20/21 天中位数 ICC 0.84）。常见 AE 内属性之间的中位数相关性为 0.75，概念上相关的 EORTC QLQ-C30 域与第 7 天捕获的 PRO-CTCAE-24h 项目之间的中位数相关性为 0.44。在对变化的反应性分析中，改善患者的中位标准化反应均值（SRM）为-0.52，恶化患者的 SRM 为 0.71。
PRO-CTCAE 项目的 24 小时回顾期具有可接受的测量特性，当在临床试验中实施每日 PRO-CTCAE 管理时，可以提供症状性不良事件的日常变化信息。
