TY - JOUR
T1 - Measuring change in health-related quality of life
T2 - the impact of different analytical methods on the interpretation of treatment effects in glioma patients
AU - Coomans, Marijke B.
AU - Taphoorn, Martin J. B.
AU - Aaronson, Neil K.
AU - Baumert, Brigitta G.
AU - van den Bent, Martin
AU - Bottomley, Andrew
AU - Brandes, Alba A.
AU - Chinot, Olivier
AU - Coens, Corneel
AU - Gorlia, Thierry
AU - Herrlinger, Ulrich
AU - Keime-Guibert, Florence
AU - Malmstrom, Annika
AU - Martinelli, Francesca
AU - Stupp, Roger
AU - Talacchi, Andrea
AU - Weller, Michael
AU - Wick, Wolfgang
AU - Reijneveld, Jaap C.
AU - Dirven, Linda
AU - EORTC Quality Life Grp
AU - EORTC Brain Tumor Group
PY - 2020/12
Y1 - 2020/12
N2 - Background. Different analytical methods may lead to different conclusions about the impact of treatment on health-related quality of life (HRQoL). This study aimed to examine 3 different methods to evaluate change in HRQoL and to study whether these methods result in different conclusions.Methods. HRQoL data from 15 randomized clinical trials were combined (CODAGLIO project). Change in HRQoL scores, measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN20 questionnaires, was analyzed in 3 ways: (1) at the group level, comparing mean changes in scale/item scores between treatment arms, (2) at the patient level per scale/item, calculating the percentage of patients that deteriorated, improved, or remained stable per scale/item, and (3) at the individual patient level, combining all scales/items.Results. Baseline and first follow-up HRQoL data were available for 3727 patients. At the group scale/item level, only the item "hair loss" showed a significant and clinically relevant change (ie, >= 10 points) over time, whereas change scores on the other scales/items were statistically significant only (all PConclusions. Different analytical methods of changes in HRQoL result in distinct conclusions of treatment effects, all of which may be relevant for informing clinical decision making.
AB - Background. Different analytical methods may lead to different conclusions about the impact of treatment on health-related quality of life (HRQoL). This study aimed to examine 3 different methods to evaluate change in HRQoL and to study whether these methods result in different conclusions.Methods. HRQoL data from 15 randomized clinical trials were combined (CODAGLIO project). Change in HRQoL scores, measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN20 questionnaires, was analyzed in 3 ways: (1) at the group level, comparing mean changes in scale/item scores between treatment arms, (2) at the patient level per scale/item, calculating the percentage of patients that deteriorated, improved, or remained stable per scale/item, and (3) at the individual patient level, combining all scales/items.Results. Baseline and first follow-up HRQoL data were available for 3727 patients. At the group scale/item level, only the item "hair loss" showed a significant and clinically relevant change (ie, >= 10 points) over time, whereas change scores on the other scales/items were statistically significant only (all PConclusions. Different analytical methods of changes in HRQoL result in distinct conclusions of treatment effects, all of which may be relevant for informing clinical decision making.
KW - brain tumor
KW - patient-reported outcome
KW - quality of life
KW - questionnaire
KW - BEVACIZUMAB
KW - VALIDATION
U2 - 10.1093/nop/npaa033
DO - 10.1093/nop/npaa033
M3 - Article
C2 - 33304601
VL - 7
SP - 668
EP - 675
JO - Neuro-Oncology Practice
JF - Neuro-Oncology Practice
SN - 2054-2585
IS - 6
ER -