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Abstract：
BACKGROUND: International health policies and researchers have emphasized the value of evaluating patient-reported outcomes (PROs) in clinical studies. However, the characteristics of PROs in adult tumor clinical trials in China remain insufficiently elucidated.
OBJECTIVE: This study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China.
METHODS: This cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition.
RESULTS: Among the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire-30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index.
CONCLUSIONS: Over recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient\'s voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points.
OBJECTIVE: This study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China.
METHODS: This cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition.
RESULTS: Among the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire-30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index.
CONCLUSIONS: Over recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient\'s voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points.
摘要：
背景：国际卫生政策和研究人员强调在临床研究中评估患者报告结果（PRO）的价值。然而,中国成人肿瘤临床试验中PROs的特点仍未得到充分阐明。
目的：本研究旨在评估PRO仪器在中国与肿瘤相关的成人随机临床试验中作为主要或次要结局的应用和特点。
方法：这项横断面研究确定了2010年1月1日至2022年6月30日在中国进行的以肿瘤为中心的随机临床试验。选择ClinicalTrials.gov数据库和中国临床试验注册中心作为数据库。根据PRO仪器的使用将试验分为四组：（1）将PRO仪器列为主要结果的试验，(2)将PRO仪器列为次要结果的试验，(3)将PRO仪器列为共同主要结果的试验，(4)没有提及PRO仪器的试验。相关数据，包括研究阶段，设置，地理区域,中心,参与者人口统计学(年龄和性别)，资金来源,干预类型，目标疾病，以及PRO乐器的名称，是从这些试验中提取的。试验中涉及的目标疾病根据美国癌症分期联合委员会手册进行分组，第8版。
结果：在所检查的6445项试验中，2390（37.08%）将PRO工具作为其结果的一部分。在这个子集内，26.82%(641/2390)将PRO仪器列为主要结果，52.72%（1260/2390）作为次要结果，和20.46%(489/2390)为共同主要结局。在这些试验中包括的2,155,306名参与者中，PRO仪器用于收集613,648例（28.47％）患者的数据作为主要或次要结果，并收集74,287例（3.45％）患者的数据作为共同主要结果。明确使用指定PRO仪器的最常见条件包括胸部肿瘤（217/1280，16.95％），乳腺肿瘤（176/1280，13.75%），和下消化道肿瘤（173/1280，13.52%）。经常使用的PRO仪器包括欧洲癌症研究和治疗组织的生活质量核心问卷-30，视觉模拟量表，数字评级量表，中医症状量表,匹兹堡睡眠质量指数。
结论：近年来，在中国针对肿瘤的成人随机临床试验中,PROs的掺入已显示出上升轨迹.尽管如此，不经常测量病人的声音仍然值得注意。在临床试验中，疾病特异性PRO仪器应更有效地纳入各种肿瘤疾病类别，在纳入PRO仪器作为临床试验终点方面还有改进的空间.
目的：本研究旨在评估PRO仪器在中国与肿瘤相关的成人随机临床试验中作为主要或次要结局的应用和特点。
方法：这项横断面研究确定了2010年1月1日至2022年6月30日在中国进行的以肿瘤为中心的随机临床试验。选择ClinicalTrials.gov数据库和中国临床试验注册中心作为数据库。根据PRO仪器的使用将试验分为四组：（1）将PRO仪器列为主要结果的试验，(2)将PRO仪器列为次要结果的试验，(3)将PRO仪器列为共同主要结果的试验，(4)没有提及PRO仪器的试验。相关数据，包括研究阶段，设置，地理区域,中心,参与者人口统计学(年龄和性别)，资金来源,干预类型，目标疾病，以及PRO乐器的名称，是从这些试验中提取的。试验中涉及的目标疾病根据美国癌症分期联合委员会手册进行分组，第8版。
结果：在所检查的6445项试验中，2390（37.08%）将PRO工具作为其结果的一部分。在这个子集内，26.82%(641/2390)将PRO仪器列为主要结果，52.72%（1260/2390）作为次要结果，和20.46%(489/2390)为共同主要结局。在这些试验中包括的2,155,306名参与者中，PRO仪器用于收集613,648例（28.47％）患者的数据作为主要或次要结果，并收集74,287例（3.45％）患者的数据作为共同主要结果。明确使用指定PRO仪器的最常见条件包括胸部肿瘤（217/1280，16.95％），乳腺肿瘤（176/1280，13.75%），和下消化道肿瘤（173/1280，13.52%）。经常使用的PRO仪器包括欧洲癌症研究和治疗组织的生活质量核心问卷-30，视觉模拟量表，数字评级量表，中医症状量表,匹兹堡睡眠质量指数。
结论：近年来，在中国针对肿瘤的成人随机临床试验中,PROs的掺入已显示出上升轨迹.尽管如此，不经常测量病人的声音仍然值得注意。在临床试验中，疾病特异性PRO仪器应更有效地纳入各种肿瘤疾病类别，在纳入PRO仪器作为临床试验终点方面还有改进的空间.
