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

Minimally important differences for interpreting the EORTC QLQ‐C30 in patients with advanced colorectal cancer treated with chemotherapy
Minimally important differences for interpreting the EORTC QLQ‐C30 in patients with advanced colorectal cancer treated with chemotherapy
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.
Advanced colorectal cancer, EORTC QLQ-C30, clinical anchors, health-related quality of life (HRQOL), minimally important difference (MID)
1462-8910
2278-2287
Musoro, J.Z.
da52f8ef-ac98-4f1e-8443-fdcdcb4d91b3
Sodergren, S. C.
d66fc3fa-2c98-403d-8ae5-410ef95de46e
Coens, C.
4728c7bb-3212-4e9d-8434-7c6a9840baaa
Pochesci, A.
21051ec1-439a-4aac-99d7-84b2787ce11b
Terada, M.
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King, M.T.
10744f6f-8d89-44e4-b695-b02edacd4c19
Sprangers, M.A.G.
dfbad60a-4b35-47e6-b63e-875468c9d2ec
Groenvold, M.
5b95b2af-3c57-44c3-9129-1ec98b6e6cdf
Cocks, K.
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Velikova, G.
60a74ab1-7fba-4d7a-8b40-598ed8398393
Flechtner, H.‐H.
d23b287a-fc50-40e4-8195-87523826c5b9
Bottomley, A.
aa0c035f-f787-4557-8b12-9e757c413cd0
the EORTC Quality of Life Group
Gastro‐intestinal Groups
Musoro, J.Z.
da52f8ef-ac98-4f1e-8443-fdcdcb4d91b3
Sodergren, S. C.
d66fc3fa-2c98-403d-8ae5-410ef95de46e
Coens, C.
4728c7bb-3212-4e9d-8434-7c6a9840baaa
Pochesci, A.
21051ec1-439a-4aac-99d7-84b2787ce11b
Terada, M.
20f87f82-8693-4387-ae05-2d5d08cc76dc
King, M.T.
10744f6f-8d89-44e4-b695-b02edacd4c19
Sprangers, M.A.G.
dfbad60a-4b35-47e6-b63e-875468c9d2ec
Groenvold, M.
5b95b2af-3c57-44c3-9129-1ec98b6e6cdf
Cocks, K.
9cb82201-8baf-4a89-b7f7-53d22417f41f
Velikova, G.
60a74ab1-7fba-4d7a-8b40-598ed8398393
Flechtner, H.‐H.
d23b287a-fc50-40e4-8195-87523826c5b9
Bottomley, A.
aa0c035f-f787-4557-8b12-9e757c413cd0

Musoro, J.Z., Sodergren, S. C., Coens, C., Pochesci, A., Terada, M., King, M.T., Sprangers, M.A.G., Groenvold, M., Cocks, K., Velikova, G., Flechtner, H.‐H. and Bottomley, A. , the EORTC Quality of Life Group and Gastro‐intestinal Groups (2020) Minimally important differences for interpreting the EORTC QLQ‐C30 in patients with advanced colorectal cancer treated with chemotherapy. Colorectal Disease, 22 (12), 2278-2287. (doi:10.1111/codi.15295).

Record type: Article

Abstract

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.

Text
Minimally important differences for interpreting the EORTC QLQ-C30 in advanced colorectal cancer patients treated with chemotherapy. - Accepted Manuscript
Available under License University of Southampton Accepted Manuscript Licence.
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More information

Accepted/In Press date: 28 July 2020
e-pub ahead of print date: 7 August 2020
Published date: December 2020
Additional Information: Funding Information: We thank the members of the EORTC gastrointestinal cancer group and their clinical investigators, as well as all patients who participated in the analysed trials. This study was funded by an academic grant from the EORTC Quality of Life Group. Publisher Copyright: © 2020 The Association of Coloproctology of Great Britain and Ireland
Keywords: Advanced colorectal cancer, EORTC QLQ-C30, clinical anchors, health-related quality of life (HRQOL), minimally important difference (MID)

Identifiers

Local EPrints ID: 443781
URI: http://eprints.soton.ac.uk/id/eprint/443781
DOI: doi:10.1111/codi.15295
ISSN: 1462-8910
PURE UUID: f39d2d5f-3325-4968-a6aa-2860e7e5d3ad
ORCID for S. C. Sodergren: ORCID iD orcid.org/0000-0001-8755-146X

Catalogue record

Date deposited: 11 Sep 2020 16:41
Last modified: 30 Nov 2022 05:01

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Contributors

Author: J.Z. Musoro
Author: S. C. Sodergren ORCID iD
Author: C. Coens
Author: A. Pochesci
Author: M. Terada
Author: M.T. King
Author: M.A.G. Sprangers
Author: M. Groenvold
Author: K. Cocks
Author: G. Velikova
Author: H.‐H. Flechtner
Author: A. Bottomley
Corporate Author: the EORTC Quality of Life Group
Corporate Author: Gastro‐intestinal Groups

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