EORTC Module Thresholds
Research type
Research Study
Full title
Establishing thresholds for clinical importance for disease specific EORTC questionnaire modules (UK)
IRAS ID
315471
Contact name
Rishma Bhatti
Contact email
Sponsor organisation
East & North Herts NHS Trust
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Patient reported outcomes (PROs) such as quality of life (QL) are increasingly used in clinical trials and routine care. However clinicians and patients are often unfamiliar with how to interpret such data when it is presented as a numerical value on a scale. Determination of “cut-off” values (thresholds) would enable clinicians to recognise when their patients have a relevant concern for which an intervention could be offered. In an earlier project these values were determined for a core cancer questionnaire (EORTC QLQ-C30). This project intends to determine the thresholds for scales within additional disease specific questionnaires (modules).
Patients will be asked to complete appropriate modules from which numerical scores for say a urinary problems scale (Prostate Cancer QLQ-PR25) will be calculated. Additional direct questioning will determine whether patients have limitations to their daily life, a need for help or worries because of the issue. Those reporting "Quite a bit" will be self-classified as "cases" (i.e. the problem is clinically important and requires further investigation and possibly the offer of help or an intervention.) Statistical analysis of the range of scores at which patient self-classify as a case will be used to determine the optimum value for a threshold score for each particular symptom or problem in each particular questionnaire.
Enabling clinicians to use PROs as screening tools and empowering patients to understand their QL results should lead to improved patient care
REC name
London - Queen Square Research Ethics Committee
REC reference
24/PR/0560
Date of REC Opinion
30 May 2024
REC opinion
Further Information Favourable Opinion