Validation of the EORTC QLQ-BIL21 questionnaire for measuring quality of life in patients with cholangiocarcinoma and cancer of the gallbladder.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
The QLQ-BIL21 is a valid tool for the assessment of QoL in patients with cholangiocarcinoma and cancer of the gallbladder.
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.
S D
SD
Kaupp-Roberts
School of Public Health, Isfahan University of Medical Sciences, Isfahan, Iran.
G
G
Yadegarfar
Department of Gastroenterology and Hepatology, Hampshire Hospitals NHS Foundation Trust, Aldermaston Road, Basingstoke RG24 9NA, UK.
E
E
Friend
Department of Gastroenterology and Hepatology, Hampshire Hospitals NHS Foundation Trust, Aldermaston Road, Basingstoke RG24 9NA, UK.
C M
CM
O'Donnell
Department of Medical Oncology, The Christie NHS Foundation Trust, Wilmslow Road, Withington, Manchester M20 4BX, UK.
J W
JW
Valle
Hepatobiliary Cancer Services, Aintree University Hospital, Longmoor Lane, Liverpool, Merseyside L9 7AL, UK.
C
C
Byrne
Cachar Cancer Hospital and Research Centre, Meherpur, Silchar, Assam, India.
I
I
Bahar
Department of Surgery, University Hospitals Bristol NHS Foundation Trust, Upper Maudlin Street, Bristol BS2 8HW, UK.
M
M
Finch-Jones
Department of Medical Oncology, Royal Free Hospital, Pond Street, London NW3 2QG, UK.
R
R
Gillmore
Department of Surgery, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton SO16 6YD, UK.
C D
CD
Johnson
UCL Institute for Liver and Digestive Health, Royal Free Hospital Campus, London NW3 2QG, UK.
S P
SP
Pereira
Academic Medical Center, Meibergdreef 9, Amsterdam 1105 AZ, Netherlands.
J K
JK
Wiggers
National Cancer Institute and G. Pascale Foundation of Naples, Naples, Italy.
M
M
Pinto
Morriston Hospital, ABM University Health Board, Heol Maes Eglwys, Morriston, Swansea SA6 6NL, UK.
B
B
Al-Sarireh
Department of Gastroenterology and Hepatology, Hampshire Hospitals NHS Foundation Trust, Aldermaston Road, Basingstoke RG24 9NA, UK.|Institute of Liver Studies, King's College Hospital, Denmark Hill, London SE5 9RS, UK.
J K
JK
Ramage
D000328:Adult; D000368:Aged; D001650:Bile Duct Neoplasms / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy; D001653:Bile Ducts, Intrahepatic / Q000473:pathology; D018281:Cholangiocarcinoma / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy; D005260:Female; D005706:Gallbladder Neoplasms / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
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