TY - JOUR

T1 - Minimally important differences for interpreting the EORTC QLQ-C30 in patients with advanced colorectal cancer treated with chemotherapy

AU - Musoro, J. Z.

AU - Sodergren, S. C.

AU - Coens, C.

AU - Pochesci, A.

AU - Terada, M.

AU - King, M. T.

AU - Sprangers, M. A.G.

AU - Grønvold, M.

AU - Cocks, K.

AU - Velikova, G.

AU - Flechtner, H. H.

AU - Bottomley, A.

PY - 2020

Y1 - 2020

N2 - Aim: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) assesses the health-related quality of life of patients in cancer trials. There are currently no minimally important difference (MID) guidelines for the EORTC QLQ-C30 for colorectal cancer (CRC). This study aims to estimate MIDs for the EORTC QLQ-C30 scales in patients with advanced CRC treated with chemotherapy and enrolled in clinical trials. Method: The data were obtained from three published EORTC trials that treated CRC patients using chemotherapy. Potential anchors were selected from clinical variables based on their correlation with EORTC QLQ-C30 scales. Anchor-based MIDs for within-group change and between-group change were estimated via the mean change method and linear regression, respectively, and summarized using weighted correlation. Distribution-based MIDs were also examined. Results: Anchor-based MIDs were determined for deterioration in 8 of the 14 EORTC QLQ-C30 scales and in 9 scales for improvement, and varied by scale, direction of change and anchor. MIDs for improvement (deterioration) ranged from 6 to 18 (−11 to −5) points for within-group change and 5 to 15 (−10 to −4) for between-group change. Summarized MIDs (in absolute values) per scale mostly ranged from 5 to 10 points. Conclusions: These findings have clinical relevance for the interpretation of treatment efficacy and the design of clinical trials by informing sample size requirements.

AB - Aim: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) assesses the health-related quality of life of patients in cancer trials. There are currently no minimally important difference (MID) guidelines for the EORTC QLQ-C30 for colorectal cancer (CRC). This study aims to estimate MIDs for the EORTC QLQ-C30 scales in patients with advanced CRC treated with chemotherapy and enrolled in clinical trials. Method: The data were obtained from three published EORTC trials that treated CRC patients using chemotherapy. Potential anchors were selected from clinical variables based on their correlation with EORTC QLQ-C30 scales. Anchor-based MIDs for within-group change and between-group change were estimated via the mean change method and linear regression, respectively, and summarized using weighted correlation. Distribution-based MIDs were also examined. Results: Anchor-based MIDs were determined for deterioration in 8 of the 14 EORTC QLQ-C30 scales and in 9 scales for improvement, and varied by scale, direction of change and anchor. MIDs for improvement (deterioration) ranged from 6 to 18 (−11 to −5) points for within-group change and 5 to 15 (−10 to −4) for between-group change. Summarized MIDs (in absolute values) per scale mostly ranged from 5 to 10 points. Conclusions: These findings have clinical relevance for the interpretation of treatment efficacy and the design of clinical trials by informing sample size requirements.

KW - Advanced colorectal cancer

KW - clinical anchors

KW - EORTC QLQ-C30

KW - health-related quality of life (HRQOL)

KW - minimally important difference (MID)

U2 - 10.1111/codi.15295

DO - 10.1111/codi.15295

M3 - Journal article

C2 - 32767619

AN - SCOPUS:85089917201

VL - 22

SP - 2278

EP - 2287

JO - Colorectal Disease

JF - Colorectal Disease

SN - 1462-8910

IS - 12

ER -