Kaupp-Roberts S D, Yadegarfar G, Friend E, O'Donnell C M, Valle J W, Byrne C, Bahar I, Finch-Jones M, Gillmore R, Johnson C D, Pereira S P, Wiggers J K, Pinto M, Al-Sarireh B, Ramage J K
Department of Gastroenterology and Hepatology, Hampshire Hospitals NHS Foundation Trust, Aldermaston Road, Basingstoke RG24 9NA, UK.
Faculty of Humanities and Social Sciences, University of Winchester, Sparkford Road, Winchester SO22 4NR, UK.
Br J Cancer. 2016 Oct 25;115(9):1032-1038. doi: 10.1038/bjc.2016.284. Epub 2016 Sep 27.
There is no specific quality of life (QoL) measurement tool to quantify QoL in patients with biliary tract cancer. Quality of life measurement is an increasingly crucial trial end point and is now being incorporated into clinical practice.
This International Multicentre Phase IV Validation Study assessed the QLQ-BIL21 module in 172 patients with cholangiocarcinoma and 91 patients with cancer of the gallbladder. Patients completed the questionnaire at baseline pretherapy and subsequently at 2 months. Following this, the psychometric properties of reliability, validity, scale structure and responsiveness to change were analysed.
Analysis of the QLQ-BIL21 scales showed appropriate reliability with Cronbach's α-coefficients >0.70 for all scales overall. Intraclass correlations exceeded 0.80 for all scales. Convergent validity >0.40 was demonstrated for all items within scales, and discriminant validity was confirmed with values <0.70 for all scales compared with each other. Scale scores changed in accordance with Karnofsky performance status and in response to clinical change.
The QLQ-BIL21 is a valid tool for the assessment of QoL in patients with cholangiocarcinoma and cancer of the gallbladder.
目前尚无专门用于量化胆管癌患者生活质量（QoL）的测量工具。生活质量测量在试验终点方面愈发关键，如今已被纳入临床实践。
这项国际多中心IV期验证研究对172例胆管癌患者和91例胆囊癌患者的QLQ - BIL21模块进行了评估。患者在基线治疗前以及随后的2个月时完成问卷。在此之后，分析了该问卷在可靠性、有效性、量表结构以及对变化的反应性等方面的心理测量特性。
对QLQ - BIL21量表的分析表明，总体而言所有量表的克朗巴哈α系数>0.70，具有适当的可靠性。所有量表的组内相关系数均超过0.80。各量表内所有项目的收敛效度>0.40，并且相互比较时所有量表的值<0.70，证实了区分效度。量表得分根据卡诺夫斯基功能状态评分以及临床变化而改变。
QLQ - BIL21是评估胆管癌和胆囊癌患者生活质量的有效工具。
