Inter-rater reliability of CTCAE assessments with or without EORTC patient-reported outcome data in a mixed cancer population: a multinational, open-label, randomised controlled trial.

Patient-reported outcome (PRO) data might improve the inter-rater reliability of CTCAE assessments.

患者报告的结果（PRO）数据可能会提高CTCAE评估的评价者间信度。

We investigated whether providers' access to PRO data enhances the inter-rater reliability of CTCAE ratings and the detection of symptomatic adverse events.

我们调查了提供者获取患者报告结果（PRO）数据是否增强了CTCAE评分的评价者间信度以及症状性不良事件的检测。

Methods

This multinational, open-label, randomised controlled trialwas done in 11 hospitals in ten countries.

这项多国、开放标签、随机对照试验在十个不同国家的11家医院进行。

Adults (aged ≥18 years) with any cancer diagnosis receiving chemotherapy, immunotherapy, or radiotherapy of curative or palliative intent were eligible.

符合条件的成人（年龄≥18岁）包括任何癌症诊断，接受化疗、免疫治疗或旨在治愈或姑息的放疗。

Patients were randomly assigned (1:1) to the intervention group (in which providers saw patients' PRO data as they were doing CTCAE assessments) or the control group (in which providers did not have access to PRO data) within each centre through a minimisation algorithm and a weighted cutoff; no additional stratification factors were applied.

患者通过最小化算法和加权截止值在每个中心随机分配（1:1）到干预组（在该组中，提供者在进行CTCAE评估时可以看到患者的PRO数据）或对照组（在该组中，提供者无法访问PRO数据）；没有应用额外的分层因素。

Patients completed the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 16 additional items from the EORTC Item Library, covering 17 symptomatic adverse events.

患者完成了欧洲癌症研究与治疗组织（EORTC）QLQ-C30量表和来自EORTC项目库的16个附加条目，涵盖了17种症状性不良事件。

Two independent providers (oncologists or trained nurses) did CTCAE ratings.

两位独立的评估者（肿瘤科医生或经过培训的护士）进行了CTCAE评级。

The primary endpoint was the inter-rater reliability of CTCAE ratings, expressed as intraclass correlation coefficients (ICCs), for all patients with complete assessments.

主要终点是所有完成评估的患者的CTCAE评分的评价者间信度，以类内相关系数（ICCs）表示。

The trial was registered at ClinicalTrials.gov (NCT04066868) and is now closed.

该试验已在ClinicalTrials.gov上注册（NCT04066868），目前已关闭。

Results

Between Feb 10, 2020, and Dec 6, 2024, a total of 1067 patients were enrolled (538 in the control group and 529 in the intervention group), with full data from 512 patients in the control group and 501 in the intervention group included in the analysis.

2020年2月10日至2024年12月6日期间，共有1067名患者被纳入研究（对照组538名，干预组529名），对照组512名患者和干预组501名患者的完整数据被纳入分析。

Median age was 59 years (IQR 46-68); 558 (55·1%) of 1013 were female and 455 (44·9%) were male.

中位年龄为59岁（四分位数间距46-68）；在1013名患者中，558名（55.1%）为女性，455名（44.9%）为男性。

Most had good functional status (403 [79%] of 512 had ECOG 0-1 in the control group and 371 [74%] of 501 in the intervention group).

大多数患者功能状态良好（对照组512名患者中有403名[79%]的ECOG评分为0-1，干预组501名患者中有371名[74%]的ECOG评分为0-1）。

The most common cancer types were haematological (control group: 137 [27%] of 512; intervention group: 131 [26%] of 501), breast (control group: 118 [23%]; intervention group: 107 [21%]), and gastrointestinal (control group: 98 [19%]; intervention group: 89 [18%]).

最常见的癌症类型是血液系统肿瘤（对照组512名患者中有137名[27%]，干预组501名患者中有131名[26%]），乳腺癌（对照组118名[23%]，干预组107名[21%]），以及胃肠道肿瘤（对照组98名[19%]，干预组89名[18%]）。

Inter-rater reliability was significantly higher in the intervention group for 13 of 17 symptomatic adverse events, with the largest differences for memory impairment (ICC 0·176; p<0·0001), irritability (0·161; p<0·0001), concentration impairment (0·157; p<0·0001), depression (0·126; p=0·0012), and anxiety (0·109; p=0·0018).

干预组在17种症状性不良事件中有13种的评价者间信度显著更高，其中记忆障碍（ICC 0·176; p<0.0001）、易怒（0.161; p<0.0001）、注意力受损（0.157; p<0.0001）、抑郁（0.126; p=0.0012）和焦虑（0.109; p=0.0018）的差异最大。

There was no significant difference for pain, rash, and peripheral sensory neuropathy and the reliability was significantly higher in the control group than the intervention group for diarrhoea (ICC -0·066; p=0·013).

对于疼痛、皮疹和周围感觉神经病变没有显著差异，而对于腹泻，对照组的信度显著高于干预组（ICC -0.066; p=0.013）。

interpretation

Availability of PRO data to providers for CTCAE rating improves the consistency of provider-based symptomatic adverse eventdetection in patients with cancer.

将患者报告的结果(PRO)数据提供给临床医生用于CTCAE评级，可以提高癌症患者基于临床医生的主观症状性不良事件检测的一致性。

PRO data supports reliable assessment of treatment-related toxicity, highlighting the value of integrating PRO data into clinical evaluations within cancer trials.

PRO数据支持对治疗相关毒性的可靠评估，强调了将PRO数据整合到癌症试验中的临床评估中的价值。

funding

EORTC Quality of Life Group.

欧洲癌症研究与治疗组织生活质量研究组。