Content validity of the EORTC QLQ-C30
Research type
Research Study
Full title
An international qualitative patient interview study to confirm content validity of the EORTC QLQ-C30
IRAS ID
211835
Contact name
Colin Johnson
Contact email
Sponsor organisation
University Hospital Southampton (UHS)
Duration of Study in the UK
1 years, 0 months, days
Research summary
The EORTC QLQ-C30 is a widely used and well validated instrument. Since the development of the original QLQ-C30 more detailed guidelines and standards have been established for demonstrating content validity of patient reported outcome (PRO) instruments. According to these guidelines, evidence from qualitative studies that the instructions, items and domains, response options and recall period of an instrument are appropriate and comprehensive relative to its intended measurement concept, population, and use is required. In order to collect additional information to support the content validity of the EORTC QLQ-C30, qualitative interviews will be conducted with patients to retrospectively explore the content validity of the QLQ-C30. The overall objective of the study is to collect evidence to address the extent to which the QLQ-C30 reflects the issues relevant to cancer patients given the intended conceptual framework. A total of 20, face-to-face qualitative interviews will be conducted with patients with breast, prostate, colorectal or lung cancer. All interviews will be conducted by trained interviewers. Interviews will also be conducted in four other European countries and ten patients will recruited from each of the following countries: Poland, Denmark, Netherlands and Spain. Across the five countries, a total of 60 patients will take part in the study.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0305
Date of REC Opinion
14 Jul 2017
REC opinion
Further Information Favourable Opinion