Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients
J Maringwa, C Quinten, M King, J Ringash, D Osoba, C Coens, F Martinelli, B B Reeve, C Gotay, E Greimel, H Flechtner, C S Cleeland, J Schmucker-Von Koch, J Weis, M J Van Den Bent, R Stupp, M J Taphoorn, A Bottomley, EORTC PROBE Project and Brain Cancer Group, J Maringwa, C Quinten, M King, J Ringash, D Osoba, C Coens, F Martinelli, B B Reeve, C Gotay, E Greimel, H Flechtner, C S Cleeland, J Schmucker-Von Koch, J Weis, M J Van Den Bent, R Stupp, M J Taphoorn, A Bottomley, EORTC PROBE Project and Brain Cancer Group
Abstract
Background: We aimed to determine the smallest changes in health-related quality of life (HRQoL) scores in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 and the Brain Cancer Module (QLQ-BN20), which could be considered as clinically meaningful in brain cancer patients.
Materials and methods: World Health Organisation performance status (PS) and mini-mental state examination (MMSE) were used as clinical anchors appropriate to related subscales to determine the minimal clinically important differences (MCIDs) in HRQoL change scores (range 0-100) in the QLQ-C30 and QLQ-BN20. A threshold of 0.2 standard deviation (SD) (small effect) was used to exclude anchor-based MCID estimates considered too small to inform interpretation.
Results: Based on PS, our findings support the following integer estimates of the MCID for improvement and deterioration, respectively: physical (6, 9), role (14, 12), and cognitive functioning (8, 8); global health status (7, 4*), fatigue (12, 9), and motor dysfunction (4*, 5). Anchoring with MMSE, cognitive functioning MCID estimates for improvement and deterioration were (11, 2*) and for communication deficit were (9, 7). Estimates with asterisks were <0.2 SD and were excluded from our MCID range of 5-14.
Conclusion: These estimates can help clinicians evaluate changes in HRQoL over time, assess the value of a health care intervention and can be useful in determining sample sizes in designing future clinical trials.
Source: PubMed