Evidence map›Paper›PMID 42011212›Full record

ArticleEClinicalMedicine2026

Development and validation of a customised PRO-CTCAE scale for adult-type diffuse gliomas (VERONICA): a multicentre, prospective, observational cohort study in China.

Sida Song, Xiefeng Wang, Xiangyi Cao, Chen Luo, Kunpeng Na, Chengcheng Guo, Jiankun Xu, Menglin Nie, Chaoxi Li, Qingting Huang and 35 more

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In one paragraph

Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05486923 (Validity and Reliability Evaluation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05486923 completednot on this map

Validity and Reliability Evaluation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for Adult-type Diffuse Gliomas Patients in Chinese Population

TypeobservationalSponsorHuashan HospitalRan2022 to 2025Enrolled450ConditionsGlioma, Patient Reported Outcome Measures, Self Report, Adverse Effects
3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

45 authors.

Sida SongDepartment of Neurosurgery, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Xiefeng WangDepartment of Neurosurgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Xiangyi CaoDepartment of Oncology, Guangdong Sanjiu Brain Hospital, Guangzhou, Guangdong, China.
Chen LuoDepartment of Neurosurgery, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Kunpeng NaDepartment of Neurosurgery, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.
Chengcheng GuoDepartment of Neurosurgery/Neuro-Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China.
Jiankun XuDepartment of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
Menglin NieDepartment of Radiation Oncology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Chaoxi LiDepartment of Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Qingting HuangDepartment of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
Sanzhong LiDepartment of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China.
Hucheng WangDepartment of Neurosurgery, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Hongxiang WangDepartment of Neurosurgery, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Min LiuDepartment of Neurosurgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Yongjie WangDepartment of Neurosurgery, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Chongran SunDepartment of Neurosurgery, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Zhang XiongDepartment of Neurosurgery, The Affiliated Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China.
Zhenyu WuDepartment of Biostatistics, School of Public Health, Fudan University, Shanghai, China.
Yajie SunDepartment of Neurosurgery, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.
Chunxia NiDepartment of Radiation Oncology, Shanghai Gamma Hospital, Shanghai, China.
Wei ZhangDepartment of Neurosurgery, Tsinghua University Beijing Tsinghua Changgung Hospital, Beijing, China.
Zanyi WuDepartment of Neurosurgery, Neurosurgery Research Institute, The First Affiliated Hospital, Fujian Medical University, Fuzhou, Fujian, China.
Song ChenDepartment of Neurosurgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Yourui ZouDepartment of Neurosurgery, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.
Xiaochuan SunDepartment of Neurosurgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Hui MaDepartment of Neurosurgery, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.
Jianmin ZhangDepartment of Neurosurgery, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Chunlong ZhongDepartment of Neurosurgery, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Juxiang ChenDepartment of Neurosurgery, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Zhou FeiDepartment of Neurosurgery, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China.
Lin KongDepartment of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
Yongping YouDepartment of Neurosurgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Jinsong ShenNursing Department, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Ying CaoNursing Department, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Lu ZhangNursing Department, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Shuai WuDepartment of Neurosurgery, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
Ye YaoDepartment of Biostatistics, School of Public Health, Fudan University, Shanghai, China.
Kai ShuDepartment of Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Xiaoguang QiuDepartment of Radiation Oncology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Jie TangDepartment of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
Yonggao MouDepartment of Neurosurgery/Neuro-Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China.
Zhiwei TangDepartment of Neurosurgery, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.
Linbo CaiDepartment of Oncology, Guangdong Sanjiu Brain Hospital, Guangzhou, Guangdong, China.
Junxia ZhangDepartment of Neurosurgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Jinsong WuDepartment of Neurosurgery, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Patient-reported outcomes (PROs) are essential for assessing symptomatic adverse events (AEs) from a patient perspective, which significantly impact the quality of life and clinical outcomes in patients with glioma. However, no validated patient-reported outcome measures (PROMs) exist to quantify symptomatic AEs in adult-type diffuse gliomas. Methods: The study was conducted in two parts. First, we developed a customised Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) scale for adult-type diffuse gliomas using the Simplified Chinese PRO-CTCAE® item library, informed by initial item screening, patient pilot testing, and a two-round Delphi survey. Delphi experts were recruited through the National Glioma Multidisciplinary Team (MDT) Alliance (NGMA) and invited by email in June 2022 (1st round) and August 2022 (2nd round). We subsequently conducted a multicentre, prospective, observational cohort study (VERONICA) at 13 glioma treatment centres in China between September 2022 and March 2025. Eligible participants were adults aged 18 years or older with a diagnosis of adult-type diffuse glioma, who were able to understand and complete the questionnaires; patients with severe cognitive impairment, severe language dysfunction, or other conditions precluding questionnaire completion were excluded. The primary outcome was the psychometric performance of the customised PRO-CTCAE scale, including test-retest reliability, convergent validity, known-groups validity, and responsiveness, evaluated longitudinally across repeated study visits. VERONICA is registered with ClinicalTrials.gov, NCT05486923. Findings: For the Delphi survey, all seven invited experts from six centres participated in 1st round (response rate 100·0%), with moderate agreement in symptom rankings (Kendall's W = 0·415; p < 0·001). In 2nd round, 16 of 20 invited experts from 14 centres participated (response rate 80·0%), with consistent agreement in expert ratings (Kendall's W = 0·351; p < 0·001). The final version of the customised PRO-CTCAE scale comprised 53 items covering 31 symptoms, together with one open-ended free-text item. For VERONICA, 450 participants were enrolled across 13 glioma treatment centres. Mean age was 49·1 years (SD 12·8), and the mean Karnofsky Performance Status (KPS) at baseline (Visit 2) was 72·2 (SD 17·1). 424 provided data eligible for at least one prespecified psychometric analysis. Test-retest reliability was acceptable (intraclass correlation coefficient [ICC] ≥0·70 for 47 of 53 items). Convergent validity was supported by correlations in the expected direction with matched European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) domains, with predominantly moderate-to-strong associations (25 items with r ≥ 0·50). Known-groups validity was supported by discrimination between KPS <70 and ≥70 (Cohen's d ≥ 0·20 for 49 of 53 items; p < 0·05 for 43 of 49 items). In Global Impression of Change (GIC)-anchored responsiveness analyses, 37 items showed standardised response means (SRMs) ≥0·20 among participants reporting worsened overall status. Interpretation: The customised PRO-CTCAE scale showed robust psychometric performance for adult-type diffuse gliomas. Remote, longitudinal administration supports low-burden quantification of patient-reported symptomatic AEs in clinical trials and routine neuro-oncology practice. Future work should assess implementation in routine care and clinical trials, and extend translation, cultural adaptation, and validation across different languages. Funding: Beijing Medical Award Foundation; Shanghai Municipal Health Commission; Department of Science and Technology of Ningxia Hui Autonomous Region; Huashan Hospital, Fudan University (Clinical Research Project).

Indexed as

Adult-type diffuse gliomaObservational cohort studyPatient-reported outcomesPRO-CTCAEPsychometric validationSymptomatic adverse events

Identifiers

PMID42011212
PMCPMC13091834

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.