Development of a questionnaire (EORTC module) to measure quality of life in patients with cholangiocarcinoma and gallbladder cancer, the EORTC QLQ-BIL21.
BACKGROUND
Quality of life measurement in cholangiocarcinoma and gallbladder cancer involves the assessment of patient-reported issues related to the symptoms, disease and treatment of these tumours. This study describes the development of the disease-specific quality of life (QoL) questionnaire for patients with cholangiocarcinoma and gallbladder cancer to supplement the European Organization for Research and Treatment of Cancer (EORTC)-QLQ C30 core cancer questionnaire.


METHODS
Phases 1-3 of the guidelines for module development published by the EORTC were followed, with adaptations for incorporation of questions from existing modules.


RESULTS
A total of 47 QoL issues (questions) were identified; 44 questions from the two related validated questionnaires, the EORTC QLQ-PAN26 (pancreatic module) and the EORTC QLQ-LMC21 (liver metastases module), two from the Functional Assessment of Cancer Therapy hepatobiliary module questionnaire in the literature search and one from healthcare professional interviews. Following phase 1 and 2 interviews with patients (n=101) and health care professionals (n=6), a 23-question provisional questionnaire was formulated. There were five questions from PAN26, 15 from LMC21 and three extra questions. In phase 3, the provisional item list was pre-tested in 52 patients in four languages and this resulted in a 21-item module.


CONCLUSIONS
This is the only disease-specific QoL questionnaire for patients with cholangiocarcinoma and gallbladder cancer, and initial assessments show it to be accurate and acceptable to patients in reflecting QoL in these diseases.
Department of Gastroenterology and Hepatology, BNHFT Hospital Basingstoke, Aldermaston Road, Basingstoke RG24 9NA, UK
E
E
Friend
G
G
Yadegarfar
C
C
Byrne
C D
CD
Johnson
O
O
Sezer
S
S
Pucciarelli
S P
SP
Pereira
W-C
WC
Chie
A
A
Banfield
J K
JK
Ramage
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000523:psychology* / Q000628:therapy; D001653:Bile Ducts, Intrahepatic / Q000473:pathology; D018281:Cholangiocarcinoma / Q000453:epidemiology / Q000473:pathology / Q000523:psychology* / Q000628:therapy; D005060:Europe / Q000453:epidemiology; D005260:Female; D005706:Gallbladder Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000523:psychology* / Q000628:therapy; D006801:Humans; D008113:Liver Neoplasms / Q000453:epidemiology / Q000523:psychology / Q000556:secondary / Q000628:therapy; D008297:Male; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology; D012107:Research Design; D011795:Surveys and Questionnaires / Q000592:standards; D054928:Validation Studies as Topic
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