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Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types.
Musoro, Jammbe Z; Coens, Corneel; Sprangers, Mirjam A G; Brandberg, Yvonne; Groenvold, Mogens; Flechtner, Hans-Henning; Cocks, Kim; Velikova, Galina; Dirven, Linda; Greimel, Elfriede; Singer, Susanne; Pogoda, Katarzyna; Gamper, Eva M; Sodergren, Samantha C; Eggermont, Alexander; Koller, Michael; Reijneveld, Jaap C; Taphoorn, Martin J B; King, Madeleine T; Bottomley, Andrew.
Affiliation
  • Musoro JZ; European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium. Electronic address: jammbe.musoro@eortc.org.
  • Coens C; European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
  • Sprangers MAG; Amsterdam UMC Location University of Amsterdam, Medical Psychology, Amsterdam, The Netherlands; Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, The Netherlands.
  • Brandberg Y; Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
  • Groenvold M; Department of Public Health, University of Copenhagen, and Bispebjerg Hospital, Copenhagen, Denmark.
  • Flechtner HH; Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany.
  • Cocks K; Adelphi Values, Bollington, Cheshire, UK.
  • Velikova G; Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, UK; Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, St James's University Hospital, Leeds, UK.
  • Dirven L; Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.
  • Greimel E; Medical University Graz, Graz, Austria.
  • Singer S; Institute of Medical Biostatistics, Epidemiology and Informatics, Division of Epidemiology and Health Services Research, University Medical Centre Mainz, Germany; University Cancer Centre Mainz, Germany.
  • Pogoda K; Departmenf of Breast Cancer and Reconstructive Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
  • Gamper EM; Innsbruck Institute of Patient-centered Outcome Research (IIPCOR), Innsbruck, Austria.
  • Sodergren SC; School of Health Sciences, University of Southampton, Southampton, UK.
  • Eggermont A; Princess Máxima Center, Utrecht and University Medical Center Utrecht, The Netherlands; Comprehensive Cancer Center Munich, Technical University Munich & Ludwig Maximiliaan University, Munich, Germany.
  • Koller M; Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
  • Reijneveld JC; Amsterdam University Medical Centers, location VU University Medical Center, Department of Neurology Brain Tumor Center, Amsterdam, The Netherlands.
  • Taphoorn MJB; Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.
  • King MT; University of Sydney, Faculty of Science, School of Psychology, Sydney, NSW, Australia.
  • Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
Eur J Cancer ; 188: 171-182, 2023 07.
Article in En | MEDLINE | ID: mdl-37257278
ABSTRACT

INTRODUCTION:

Early guidelines for minimally important differences (MIDs) for the EORTC QLQ-C30 proposed ≥10 points change as clinically meaningful for all scales. Increasing evidence that MIDs can vary by scale, direction of change, cancer type and estimation method has raised doubt about a single global standard. This paper identifies MID patterns for interpreting group-level change in EORTC QLQ-C30 scores across nine cancer types.

METHODS:

Data were obtained from 21 published EORTC Phase III trials that enroled 13,015 patients across nine cancer types (brain, colorectal, advanced breast, head/neck, lung, mesothelioma, melanoma, ovarian, and prostate). Anchor-based MIDs for within-group change and between-group differences in change over time were obtained via mean change method and linear regression, respectively. Separate MIDs were estimated for improvements and deteriorations. Distribution-based estimates were derived and compared with anchor-based MIDs.

RESULTS:

Anchor-based MIDs mostly ranged from 5 to 10 points. Differences in MIDs for improvement vs deterioration, for both within-group and between-group, were mostly within a 2-points range. Larger differences between within-group and between-group MIDs were observed for several scales in ovarian, lung and head/neck cancer. Most anchor-based MIDs ranged between 0.3 SD and 0.5 SD distribution-based estimates.

CONCLUSIONS:

Our results reinforce recent claims that no single MID can be applied to all EORTC QLQ-C30 scales and disease settings. MIDs varied by scale, improvement/deterioration, within/between comparisons and by cancer type. Researchers applying commonly used rules of thumb must be aware of the risk of dismissing changes that are clinically meaningful or underpowering analyses when smaller MIDs apply.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Head and Neck Neoplasms / Melanoma / Mesothelioma Type of study: Guideline / Prognostic_studies / Qualitative_research Aspects: Patient_preference Limits: Humans / Male Language: En Journal: Eur J Cancer Year: 2023 Document type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Head and Neck Neoplasms / Melanoma / Mesothelioma Type of study: Guideline / Prognostic_studies / Qualitative_research Aspects: Patient_preference Limits: Humans / Male Language: En Journal: Eur J Cancer Year: 2023 Document type: Article