TY - JOUR
T1 - Minimal important differences of EORTC QLQ-C30 for metastatic breast cancer patients
T2 - Results from a randomized clinical trial
AU - Kawahara, Takuya
AU - Taira, Naruto
AU - Shiroiwa, Takeru
AU - Hagiwara, Yasuhiro
AU - Fukuda, Takashi
AU - Uemura, Yukari
AU - Mukai, Hirofumi
N1 - Funding Information:
Dr. Mukai received honoraria from Pfizer, Takeda, Daiichi Sankyo and Taiho, and research grants from the Japanese government, Daiichi Sankyo, and Pfizer outside the submitted work. Dr. Mukai is a member of the Board of Directors of the Japan Breast Cancer Society.
Funding Information:
This study was sponsored by the Comprehensive Support Project for Oncology Research (CSPOR) of the Public Health Research Foundation. Research funds were provided to CSPOR by Taiho Pharmaceutical Company Limited under the study contract. Taiho Pharmaceutical took no part in this study other than providing information relevant to proper use of the study drug.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/6
Y1 - 2022/6
N2 - Purpose: To establish minimal important differences (MIDs) for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) in patients with metastatic breast cancer. Methods: The dataset was obtained from the SELECT BC-CONFIRM randomized clinical trial. Anchors obtained from patients (transition items) and clinicians (performance status) were used for anchor-based methods. Anchors obtained through 6 months after starting treatment were used for this analysis. Correlation coefficients of anchor and change in QLQ-C30 and effect size were used to qualify for estimating MIDs. Mean change method and generalized estimating equation were applied to estimate MIDs. Distribution-based methods were used for comparison. Results: We analyzed a dataset of 154 metastatic breast cancer patients. MIDs were estimated in 8 of 15 scales of QLQ-C30. Estimated MIDs for within-group improvement varied from 7 to 15 and those for deterioration varied from − 7 to − 17. Estimated MIDs for between-group improvement varied from 5 to 11 and those for deterioration varied from − 5 to − 8 across QLQ-C30 scales. Patient-reported anchors were more susceptible to early changes in health status than clinician-reported anchors. Conclusion: We provided the MIDs of the QLQ-C30 using both patient- and clinicians-reported anchors measured in a randomized trial of Japanese patients with metastatic breast cancer. We recommend patient-reported anchors for anchor-based estimation of MID. Our results can aid patients and clinicians, as well as researchers, in the interpretation of QLQ-C30.
AB - Purpose: To establish minimal important differences (MIDs) for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) in patients with metastatic breast cancer. Methods: The dataset was obtained from the SELECT BC-CONFIRM randomized clinical trial. Anchors obtained from patients (transition items) and clinicians (performance status) were used for anchor-based methods. Anchors obtained through 6 months after starting treatment were used for this analysis. Correlation coefficients of anchor and change in QLQ-C30 and effect size were used to qualify for estimating MIDs. Mean change method and generalized estimating equation were applied to estimate MIDs. Distribution-based methods were used for comparison. Results: We analyzed a dataset of 154 metastatic breast cancer patients. MIDs were estimated in 8 of 15 scales of QLQ-C30. Estimated MIDs for within-group improvement varied from 7 to 15 and those for deterioration varied from − 7 to − 17. Estimated MIDs for between-group improvement varied from 5 to 11 and those for deterioration varied from − 5 to − 8 across QLQ-C30 scales. Patient-reported anchors were more susceptible to early changes in health status than clinician-reported anchors. Conclusion: We provided the MIDs of the QLQ-C30 using both patient- and clinicians-reported anchors measured in a randomized trial of Japanese patients with metastatic breast cancer. We recommend patient-reported anchors for anchor-based estimation of MID. Our results can aid patients and clinicians, as well as researchers, in the interpretation of QLQ-C30.
KW - Anchoring
KW - EORTC QLQ-C30
KW - Health-related quality of life
KW - Minimal important difference
KW - Patient-reported outcomes
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U2 - 10.1007/s11136-021-03074-y
DO - 10.1007/s11136-021-03074-y
M3 - Article
C2 - 34982354
AN - SCOPUS:85122265365
VL - 31
SP - 1829
EP - 1836
JO - Quality of Life Research
JF - Quality of Life Research
SN - 0962-9343
IS - 6
ER -
