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Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials

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  • Eva M Gamper
  • Jammbe Z Musoro
  • Corneel Coens
  • Jean-Jacques Stelmes
  • Claudette Falato
  • Mogens Groenvold
  • Galina Velikova
  • Kim Cocks
  • Hans-Henning Flechtner
  • Madeleine T King
  • Andrew Bottomley
  • EORTC Genito-Urinary Tract Cancer Group and Quality of Life Groups
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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.

Original languageEnglish
Article number1083
JournalBMC Cancer
Volume21
Issue number1
Pages (from-to)1083
Number of pages8
ISSN1471-2407
DOIs
Publication statusPublished - 7 Oct 2021

Bibliographical note

© 2021. The Author(s).

    Research areas

  • Aged, Cancer Pain, Clinical Deterioration, Clinical Trials, Phase III as Topic/statistics & numerical data, Denture Liners, Diarrhea, Europe, Fatigue, Health Surveys, Humans, Male, Middle Aged, Patient Reported Outcome Measures, Physical Functional Performance, Prostatic Neoplasms, Quality of Life, Severity of Illness Index, Social Interaction, Time Factors

ID: 69265103