Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer

Received 5 August 2009; accepted 20 August 2009. published online 18 September 2009.

Abstract

This international study aimed to test the measurement properties of the updated European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module for colorectal cancer, the QLQ-CR29.

The QLQ-CR29 was administered with the QLQ-C30, core questionnaire, to 351 patients from seven countries. Questionnaire scaling and reliability were established and clinical and psychometric validity examined. Patient acceptability and understanding were assessed with a debriefing questionnaire.

Multi-trait scaling analyses and face validity refined the module to four scales assessing urinary frequency, faecal seepage, stool consistency and body image and single items assessing other common problems following treatment for colorectal cancer. Scales distinguished between clinically distinct groups of patients and did not correlate with QLQ-C30 scales, demonstrating construct validity. The QLQ-CR29 scores were reproducible over time in stable health.

The EORTC QLQ-CR29 demonstrates sufficient validity and reliability to support its use to supplement the EORTC QLQ-C30 to assess patient-reported outcomes during treatment for colorectal cancer in clinical trials and other settings.

Keywords: Questionnaire, Quality of life, Colorectal cancer, EORTC, Validation

a Department of Social Medicine, University of Bristol, Bristol, UK

b Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK

c Department of General Surgery, North Bristol Trust, Bristol, UK

d Department of Medical Oncology, Centre Alexis Vautrin, EA 4360, Nancy University, Vandoeuvre-les-Nancy, France

e School of Public Health and Graduate Institute of Preventive Medicine, National Taiwan University, Taiwan

f Psycho-oncology Unit, Sant’Andrea Hospital, Sapienza University of Rome, Italy

g Department of Oncology and Haematology, Charite´ – Universitätsmedizin Berlin, Germany

h Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany

i University Surgical Unit, Southampton University Hospitals NHS Trust, Southampton, UK

j Department of Oncology, Hospital De Navarra, Pamplona, Spain

k Department of Radiation Oncology, University of Michigan, USA

l Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK

m Department of Cancer Research and Molecular Medicine, Norwegian University of Technology and Science, Trondheim, Norway

Corresponding author: Address: Department of Social Medicine, Canynge Hall, University of Bristol, Bristol, UK. Tel.: +0117 928 3495; fax: +0117 925 2736.

PII: S0959-8049(09)00651-0

doi:10.1016/j.ejca.2009.08.014

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