癌症疼痛随机对照试验的患者报告结果报告质量和相关试验特征：基于CONSORT-PRO扩展的系统综述
Quality of patient-reported outcome reporting and related trial characteristics in randomized controlled trials of cancer pain: A systematic review based on the CONSORT-PRO extension.
摘要(中文译文)
系统评价癌症疼痛随机对照试验中患者报告结局（PROs）报告完整性的情况，并描述性分析报告完整性在不同试验特征间的差异。系统检索四个中文文献数据库（CNKI、SinoMed、维普、万方）和三个国际数据库（PubMed、Cochrane Library、Embase）以识别相关试验。纳入2015年1月1日至2026年3月1日发表的、以PROs作为主要或次要结局的癌症疼痛随机对照试验（RCTs）。采用患者报告结局报告试验统一标准（CONSORT-PRO）扩展版评价每项试验中PRO的报告质量。进行描述性亚组分析以探讨CONSORT-PRO报告完整性在不同试验特征间的分布。共纳入20项研究，涉及3841例患者。其中，14项研究（70.00%）将PROs作为主要结局，6项研究（30.00%）将其作为次要结局。主要的PRO测量工具为简明疼痛评估量表（BPI）及其简表（BPI-SF）、数字评定量表（NRS）和数字评定量表疼痛评分（NRPS），以及欧洲癌症研究与治疗组织生活质量核心问卷30（EORTC QLQ-C30）。CONSORT-PRO报告完整性的总体平均值为65.65%，处于中等水平。描述性亚组分析发现若干试验特征似乎与较高的CONSORT-PRO报告完整性相关。癌症疼痛RCTs中PROs的报告完整性为中等水平，在PRO假设、目标领域和缺失数据等方面仍有改进空间。未来研究应注重遵循CONSORT-PRO指南，尤其是在报告PRO假设和目标领域方面，并确保适当的随访时长，以提高数据质量和临床适用性。PROSPERO（CRD420261281620）。
Abstract
To systematically evaluate the reporting completeness of patient-reported outcomes (PROs) in randomized controlled trials of cancer pain and to descriptively examine how reporting completeness varied across trial characteristics. A systematic search of four Chinese literature databases (CNKI, SinoMed, VIP, Wanfang) and three international databases (PubMed, Cochrane Library, Embase) was conducted to identify relevant trials. Randomized controlled trials (RCTs) on cancer pain published from 1 January 2015 to 1 March 2026 that used PROs as either primary or secondary outcomes were included. The Consolidated Standards of Reporting Trials for PRO (CONSORT-PRO) extension was used to evaluate the quality of PRO reporting in each trial. Descriptive subgroup analyses were conducted to explore the distribution of CONSORT-PRO reporting completeness across trial characteristics. A total of 20 studies involving 3841 patients were identified. Among these, PROs were used as primary outcomes in 14 studies (70.00%) and as secondary outcomes in 6 studies (30.00%). The main PRO instruments were the Brief Pain Inventory (BPI) and Brief Pain Inventory-Short Form (BPI-SF), the Numeric Rating Scale (NRS) and Numeric Rating Pain Scale (NRPS), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The overall mean CONSORT-PRO reporting completeness was 65.65%, indicating a moderate level. Descriptive subgroup analyses identified several trial characteristics that appeared to correspond to higher CONSORT-PRO reporting completeness. The reporting completeness of PROs in cancer pain RCTs is moderate, with room for improvement in areas such as PRO hypotheses, target domains, and missing data. Future studies should focus on adhering to CONSORT-PRO guidelines, particularly in reporting PRO hypotheses and target domains, and ensure appropriate follow-up durations to improve data quality and clinical applicability. PROSPERO (CRD420261281620).
如何引用
AMA
Yu Zhang, Xia Li, Lujuan Wu, Xianqi Wei, Shiying Kang, Jinxia Ding. Quality of patient-reported outcome reporting and related trial characteristics in randomized controlled trials of cancer pain: A systematic review based on the CONSORT-PRO extension.. Asia-Pacific journal of oncology nursing. 2026; doi:10.1016/j.apjon.2026.100983.
APA
Yu Zhang, Xia Li, Lujuan Wu, Xianqi Wei, Shiying Kang, Jinxia Ding (2026). Quality of patient-reported outcome reporting and related trial characteristics in randomized controlled trials of cancer pain: A systematic review based on the CONSORT-PRO extension.. Asia-Pacific journal of oncology nursing. https://doi.org/10.1016/j.apjon.2026.100983
GB/T 7714
Yu Zhang, Xia Li, Lujuan Wu, Xianqi Wei, Shiying Kang, Jinxia Ding. Quality of patient-reported outcome reporting and related trial characteristics in randomized controlled trials of cancer pain: A systematic review based on the CONSORT-PRO extension.[J]. Asia-Pacific journal of oncology nursing, 2026 doi:10.1016/j.apjon.2026.100983.
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