Denys Andreas, van Nieuwenhove Yves, Van de Putte Dirk, Pape Eva, Pattyn Piet, Ceelen Wim, van Ramshorst Gabriëlle H
Department of Gastrointestinal Surgery, Ghent University Hospital, Ghent, Belgium.
Colorectal Dis. 2022 Apr;24(4):353-368. doi: 10.1111/codi.16028. Epub 2022 Jan 30.
Pelvic exenteration (PE) carries high morbidity. Our aim was to analyse the use of patient-reported outcome measures (PROMs) in PE patients.
Search strategies were protocolized and registered in PROSPERO. PubMed, Embase, Cochrane Library, Google Scholar, Web of Science and ClinicalTrials.gov were searched with the terms 'patient reported outcomes', 'pelvic exenteration' and 'colorectal cancer'. Studies published after 1980 reporting on PROMs for at least 10 PE patients were considered. Study selection, data extraction, rating of certainty of evidence (GRADE) and risk of bias (ROBINS-I) were performed independently by two reviewers.
Nineteen of 173 studies were included (13 retrospective, six prospective). All studies were low to very low quality, with an overall moderate/serious risk of bias. Studies included data on 878 patients with locally advanced rectal cancer (n = 344), recurrent rectal cancer (n = 411) or cancer of unknown type (n = 123). Thirteen studies used validated questionnaires, four used non-validated measures and two used both. Questionnaires included the Functional Assessment of Cancer Therapy-Colorectal questionnaire (n = 6), Short Form Health Survey (n = 6), European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire C30 (n = 6), EORTC-CR38 (n = 4), EORTC-BLM30 (n = 1), Brief Pain Inventory (n = 2), Short Form 12 (n = 1), Assessment of Quality of Life (n = 1), Short Form Six-Dimension (n = 1), the Memorial Sloan Kettering Cancer Center Sphincter Function Scale (n = 1), the Cleveland Global Quality of Life (n = 1) or other (n = 4). Timing varied between studies.
Whilst the use of validated questionnaires increased over time, this study shows that there is a need for uniform use and timing of PROMs to enable multicentre studies.
盆腔脏器清除术(PE)的发病率很高。我们的目的是分析患者报告结局量表(PROMs)在PE患者中的应用情况。
检索策略已制定并在国际前瞻性系统评价注册库(PROSPERO)中登记。在PubMed、Embase、Cochrane图书馆、谷歌学术、科学网和美国国立医学图书馆临床试验数据库(ClinicalTrials.gov)中检索了“患者报告结局”“盆腔脏器清除术”和“结直肠癌”等术语。纳入1980年以后发表的、报告至少10例PE患者PROMs情况的研究。由两名 reviewers 独立进行研究选择、数据提取、证据确定性分级(GRADE)和偏倚风险评估(ROBINS-I)。
173项研究中有19项被纳入(13项回顾性研究,6项前瞻性研究)。所有研究质量均为低到极低,总体存在中度/严重偏倚风险。研究纳入了878例局部晚期直肠癌患者(n = 344)、复发性直肠癌患者(n = 411)或类型不明癌症患者(n = 123)的数据。13项研究使用了经过验证的问卷,4项研究使用了未经验证的量表,2项研究两者都使用了。问卷包括癌症治疗功能评估-结直肠问卷(n = 6)、简明健康调查问卷(n = 6)、欧洲癌症研究与治疗组织(EORTC)生活质量问卷C30(n = 6)、EORTC-CR38(n = 4)、EORTC-BLM30(n = 1)、简明疼痛量表(n = 2)、简明健康问卷12项版(n = 1)、生活质量评估量表(n = 1)、简明六维健康量表(n = 1)、纪念斯隆凯特琳癌症中心括约肌功能量表(n = 1)、克利夫兰全球生活质量量表(n = 1)或其他量表(n = 4)。不同研究之间的时间安排各不相同。
虽然随着时间推移,经过验证的问卷使用有所增加,但本研究表明,需要统一PROMs的使用和时间安排,以便开展多中心研究。