Smith Allan 'Ben', Agar Meera, Delaney Geoff, Descallar Joseph, Dobell-Brown Kelsey, Grand Melissa, Aung Jennifer, Patel Pinky, Kaadan Nasreen, Girgis Afaf
Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research & University of New South Wales, Liverpool, NSW, Australia.
South Western Sydney Clinical School, University of New South Wales, Liverpool, NSW, Australia.
Asia Pac J Clin Oncol. 2018 Feb;14(1):52-60. doi: 10.1111/ajco.12818. Epub 2017 Oct 30.
Clinical trials play a critical role in advancing cancer care, but international research shows that few cancer patients, particularly culturally and linguistically diverse (CALD) patients, participate in trials. This limits generalizability of trial results and increases health disparities. This study aimed to establish rates and correlates of trial participation among CALD patients in South Western Sydney Local Health District (SWSLHD), a highly culturally diverse area.
Data from all cancer patients diagnosed and/or treated in SWSLHD from January 2006 to July 2016 were analyzed retrospectively. The primary outcome was trial enrolment among patients born in non-English speaking countries (CALD) versus English speaking countries (non-CALD). Multivariable logistic regression evaluated CALD status as a predictor of trial participation. Moderators of trial participation by the different CALD groups, namely those whose preferred language was English (CALD-PLE) or was not English (CALD-PLNE), were examined by testing interactions between CALD status and other demographic and clinical variables.
A total of 19 453 patients were analyzed (54.9% non-CALD, 16.5% CALD-PLE, 18.5% CALD-PLNE). Overall, 7.4% of patients were enrolled in a trial. Trial participation was significantly lower in CALD patients than non-CALD patients (5.7% vs 8.4%; odds ratio [OR] = 0.80; 95% confidence interval [CI], 0.69-0.91; P = 0.001). CALD-PLNE patients were less likely to participate in trials than non-CALD (OR = 0.45; 95% CI, 0.36-0.56; P < 0.0001) and CALD-PLE patients (OR = 0.53; 95% CI, 0.67-0.41; P < 0.0001).
Limited English proficiency seems particularly unfavorable to trial participation. Development and evaluation of strategies to overcome language barriers (e.g. simplified and translated multimedia participant information materials) is needed.
临床试验在推动癌症治疗方面发挥着关键作用，但国际研究表明，很少有癌症患者，尤其是文化和语言背景多样（CALD）的患者参与试验。这限制了试验结果的普遍性，并加剧了健康差距。本研究旨在确定悉尼西南部地方卫生区（SWSLHD）这一文化高度多元地区CALD患者的试验参与率及其相关因素。
对2006年1月至2016年7月在SWSLHD诊断和/或治疗的所有癌症患者的数据进行回顾性分析。主要结果是出生在非英语国家（CALD）与英语国家（非CALD）的患者的试验入组情况。多变量逻辑回归评估CALD状态作为试验参与的预测因素。通过测试CALD状态与其他人口统计学和临床变量之间的相互作用，研究了不同CALD组（即首选语言为英语的CALD患者（CALD-PLE）和首选语言不是英语的CALD患者（CALD-PLNE））试验参与的调节因素。
共分析了19453例患者（54.9%为非CALD患者，16.5%为CALD-PLE患者，18.5%为CALD-PLNE患者）。总体而言，7.4%的患者参加了试验。CALD患者的试验参与率显著低于非CALD患者（5.7%对8.4%；优势比[OR]=0.80；95%置信区间[CI]，0.69-0.91；P=0.001）。CALD-PLNE患者比非CALD患者（OR=0.45；95%CI，0.36-0.56；P<0.0001）和CALD-PLE患者（OR=0.53；95%CI，0.67-0.41；P<0.0001）参与试验的可能性更小。
英语水平有限似乎对试验参与特别不利。需要制定和评估克服语言障碍的策略（如简化和翻译的多媒体参与者信息材料）。
