Psychology Group, School of Social Sciences, Leeds Beckett University, Leeds, UK; Patient Reported Outcomes Group, Leeds Institute of Cancer Studies and Pathology, University of Leeds, St James's Hospital, Leeds, UK.
Patient Reported Outcomes Group, Leeds Institute of Cancer Studies and Pathology, University of Leeds, St James's Hospital, Leeds, UK; Leeds Teaching Hospitals NHS Trust, St James's Institute of Oncology, St James's Hospital, Leeds, UK.
Int J Radiat Oncol Biol Phys. 2017 Mar 1;97(3):495-510. doi: 10.1016/j.ijrobp.2016.11.008. Epub 2016 Nov 18.
This review aimed to determine the clinician and patient reported outcome (PRO) instruments currently usedin randomized controlled trials (RCTs) of radical radiation therapy for nonmetastatic prostate cancer to report acute and late adverse events (AEs), review the quality of methodology and PRO reporting, and report the prevalence of acute and late AEs.
The MEDLINE, EMBASE, and Cochrane databases were searched between April and August 2014 according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Identified reports were reviewed according to the PRO Consolidated Standards of Reporting Trials (CONSORT) guidelines and the Cochrane Risk of Bias tool. In all, 1149 records were screened, and 21 articles were included in the final review.
We determined the acute and late AEs for 9040 patients enrolled in 15 different RCTs. Only clinician reported instruments were used to report acute AEs <3 months (eg, Radiation Therapy Oncology Group [RTOG] and Common Terminology Criteria for Adverse Events [CTCAE]). For late clinician reporting, the Late Effects on Normal Tissues-Subjective, Objective, Management and Analytic scale and RTOG were used and were often augmented with additional items to provide comprehensive coverage of sexual functioning and anorectal symptoms. Some late AEs were reported (48% articles) using PROs (eg, ULCA-PCI [University of California, Los Angeles Prostate Cancer Index], FACT-G and P [Functional Assessment of Cancer Therapy General & Prostate Module], EORTC QLQC-30 + PR25 [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire & Prostate Module]); however, a definitive "preferred" instrument was not evident.
Our findings are at odds with recent movements toward including patient voices in reporting of AEs and patient engagement in clinical research. We recommend including PRO to evaluate radical radiation therapy before, during, and after the treatment to fully capture patient experiences, and we support the development of predictive models for late effects based on the severity of early toxicity.
Patient reporting of acute and late AEs is underrepresented in radiation therapy trials. We recommend working toward a consistent approach to PRO assessment of radiation therapy-related AEs.
本研究旨在确定目前在非转移性前列腺癌根治性放疗的随机对照试验（RCT）中用于报告急性和晚期不良事件（AEs）的临床医生和患者报告结局（PRO）工具，评价方法学和 PRO 报告的质量，并报告急性和晚期 AEs 的发生率。
根据系统评价和荟萃分析的 Preferred Reporting Items（PRISMA）声明，我们于 2014 年 4 月至 8 月间检索了 MEDLINE、EMBASE 和 Cochrane 数据库。根据 PRO 统一报告标准（CONSORT）指南和 Cochrane 偏倚风险工具对识别出的报告进行了回顾。共筛选了 1149 份记录，最终有 21 篇文章纳入了综述。
我们确定了 15 项不同 RCT 中纳入的 9040 例患者的急性和晚期 AEs。仅使用临床医生报告的工具报告了<3 个月的急性 AEs（如放射治疗肿瘤学组[RTOG]和常见不良事件术语标准[CTCAE]）。对于晚期的临床医生报告，使用了晚期正常组织主观、客观、管理和分析量表和 RTOG，并且经常使用额外的项目来全面涵盖性功能和肛肠症状。一些晚期 AEs 使用了 PRO（如加州大学洛杉矶分校前列腺癌指数[ULCA-PCI]、FACT-G 和 P[癌症治疗功能评估一般和前列腺模块]、EORTC QLQ-C30+PR25[欧洲癌症研究与治疗组织生活质量问卷和前列腺模块]）进行了报告（48%的文章）；然而，没有明确的“首选”工具。
我们的发现与最近将患者声音纳入 AE 报告和患者参与临床研究的趋势不一致。我们建议在治疗前、治疗中和治疗后使用 PRO 来评估根治性放疗，以充分捕捉患者的体验，并支持基于早期毒性严重程度开发晚期效应的预测模型。
在放疗试验中，患者对急性和晚期 AEs 的报告代表性不足。我们建议努力实现一致的方法来评估与放疗相关的 AEs 的 PRO。
