Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK; Cancer Epidemiology Group, University of Leeds, Leeds, UK.
Eur J Surg Oncol. 2024 Dec;50(12):108736. doi: 10.1016/j.ejso.2024.108736. Epub 2024 Oct 2.
National clinical registries offer the benefits of a comprehensive dataset, particularly when linked with patient-reported outcome (PRO) data. This aim of this study was to utilise UK registry data to assess cross-sectional differences in health-related quality of life (HrQoL) in patients with primary rectal (PRC) and locally recurrent rectal cancer (LRRC).
Data were extracted from the COloRECTal cancer Repository (CORECT-R) and the Locally Recurrent Rectal Cancer - Quality of Life (LRRC-QoL) datasets. Propensity score matching was undertaken in a 1:1 ratio using two covariates: age and sex. The primary outcome was the FACT-C Colorectal Cancer Subscale (CCS). Statistical significance was determined using p < 0.05 and clinical significance using effect size (ES) and minimally important clinical difference (MCID).
A matched cohort with 72 patients in each group was identified. Overall FACT-C CCS scores were worse in patients with LRRC from a statistical (11.80 vs 18.03, p < 0.001) and clinically meaningful perspective (ES 1.63, MCID 6.23). Patients with PRC reported better digestion (p < 0.001, ES 0.85), better control over their bowels (p < 0.001, ES 1.03) and increased appetite (p < 0.001, ES 1.74, MCID 2.08). Patients with LRRC reported worse stomach swelling (p < 0,001, ES 0.97) and more diarrhoea (p < 0.001, ES 0.92), however they reported better body image (p < 0.001, ES 0.80).
Patients with LRRC reported significantly worse overall scores in the FACT-C CCS from both a statistical and clinical perspective, demonstrating the ability of the FACT-C to distinguish between these patient groups and the benefits of the inclusion of PROs within colorectal cancer registries, specifically including patients with advanced/recurrent disease.
国家临床登记处提供了综合数据集的优势,特别是当与患者报告的结局(PRO)数据相结合时。本研究的目的是利用英国登记处的数据评估原发性直肠(PRC)和局部复发性直肠癌症(LRRC)患者的健康相关生活质量(HrQoL)的横断面差异。
从 COloRECTal 癌症存储库(CORECT-R)和局部复发性直肠癌症 - 生活质量(LRRC-QoL)数据库中提取数据。使用年龄和性别这两个协变量以 1:1 的比例进行倾向评分匹配。主要结局是 FACT-C 结直肠癌子量表(CCS)。使用 p < 0.05 确定统计学显著性,使用效应量(ES)和最小临床重要差异(MCID)确定临床显著性。
在每组 72 名患者中确定了匹配的队列。从统计学(11.80 对 18.03,p < 0.001)和临床有意义的角度来看,LRRC 患者的总体 FACT-C CCS 评分更差(ES 1.63,MCID 6.23)。PRC 患者报告更好的消化(p < 0.001,ES 0.85)、更好的肠道控制(p < 0.001,ES 1.03)和增加的食欲(p < 0.001,ES 1.74,MCID 2.08)。LRRC 患者报告更严重的胃部肿胀(p < 0.001,ES 0.97)和更多的腹泻(p < 0.001,ES 0.92),但他们报告了更好的身体形象(p < 0.001,ES 0.80)。
从统计学和临床角度来看,LRRC 患者的 FACT-C CCS 总体评分明显更差,这表明 FACT-C 能够区分这些患者群体,并且在结直肠癌登记处中包含 PRO 具有优势,特别是包括患有晚期/复发性疾病的患者。