Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials
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Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials. / Gamper, Eva M; Musoro, Jammbe Z; Coens, Corneel; Stelmes, Jean-Jacques; Falato, Claudette; Groenvold, Mogens; Velikova, Galina; Cocks, Kim; Flechtner, Hans-Henning; King, Madeleine T; Bottomley, Andrew; EORTC Genito-Urinary Tract Cancer Group and Quality of Life Groups.
In: BMC Cancer, Vol. 21, No. 1, 1083, 2021.Research output: Contribution to journal › Journal article › Research › peer-review
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T1 - Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials
AU - Gamper, Eva M
AU - Musoro, Jammbe Z
AU - Coens, Corneel
AU - Stelmes, Jean-Jacques
AU - Falato, Claudette
AU - Groenvold, Mogens
AU - Velikova, Galina
AU - Cocks, Kim
AU - Flechtner, Hans-Henning
AU - King, Madeleine T
AU - Bottomley, Andrew
AU - EORTC Genito-Urinary Tract Cancer Group and Quality of Life Groups
N1 - © 2021. The Author(s).
PY - 2021
Y1 - 2021
N2 - BACKGROUND: The aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer.METHODS: We used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians' input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated.RESULTS: Two clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and - 13 to - 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and - 10 to - 5 for deterioration.CONCLUSIONS: Our findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer.
AB - BACKGROUND: The aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer.METHODS: We used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians' input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated.RESULTS: Two clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and - 13 to - 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and - 10 to - 5 for deterioration.CONCLUSIONS: Our findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer.
U2 - 10.1186/s12885-021-08609-7
DO - 10.1186/s12885-021-08609-7
M3 - Journal article
C2 - 34620124
VL - 21
JO - B M C Cancer
JF - B M C Cancer
SN - 1471-2407
IS - 1
M1 - 1083
ER -
ID: 282097061