Project summary
As patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to aggregated HRQOL scores, whether differences in HRQOL scores between groups or within-patient changes in HRQOL over time. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention (e.g., a new treatment) or the design of future clinical trials (e.g., determining sample sizes).
The aim of this project was to establish MIDs (interpretation thresholds) for interpreting group-level change across all QLQ-C30 scales based on cancer sites, using individual patient data from archived EORTC trials. The project focused on an anchor-based approach and relied on constructing clinical anchors using available clinical variables. An independent disease-oriented and methodological panel provided guidance on anchor selection. Additionally, the project examined how the estimated MIDs compared with previously published guidelines, further contributing to the development of robust MID guidelines for the EORTC QLQ-C30.
Achievements
References for published manuscripts and conference abstracts are listed under the publications heading.
Future plans
The project was completed in 2023 with the publication of a synthesis paper identifying MID patterns for interpreting group-level changes in EORTC QLQ-C30 scores across nine cancer types. Since the study relied solely on clinical anchors and provided guidelines for group-level differences and changes, a future project will incorporate patient-based anchors, collected prospectively, to establish interpretation guidelines for patient-level change.
For patients
In a cancer trial, it is common, to use questionnaires in order to get an evaluation of a therapeutic intervention (e.g. a new treatment) by the patient him/herself. However, it is often unclear how much better should the score given by a patient be in order to influence decision about treatment. The concept of “minimal important difference (MID)” is the size of a difference in a Quality of Life score that would be comparable to a change normally considered by clinicians as relevant (i.e. warranting a change in treatment or examinations). Our project aimed to estimate disease-specific MIDs for the most widely used cancer-specific questionnaire (the EORTC-QLQ-C30) to facilitate the interpretation of QoL scores in a clinically meaningful way for doctors and patients. This project supplemented previously published MID guidelines research by using individual patient data to estimate MIDs for different cancer sites separately, thereby further contributing to the development of robust and practical MID guidelines for the EORTC QLQ-C30.
Publications
• Musoro JZ, Coens C, Sprangers MAG, Brandberg Y, Groenvold M, Flechtner HH, Cocks K, Velikova G, Dirven L, Greimel E, Singer S, Pogoda K, Gamper EM, Sodergren SC, Eggermont A, Koller M, Reijneveld JC, Taphoorn MJB, King MT, Bottomley A; EORTC Melanoma, Breast, Head and Neck, Genito-urinary, Gynecological, Gastro-intestinal, Brain, Lung and Quality of Life Groups. Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types. Eur J Cancer. 2023 Jul;188:171-182. doi: 10.1016/j.ejca.2023.04.027. Epub 2023 May 7. PMID: 37257278.
• Dirven L, Musoro JZ, Coens C, Reijneveld JC, Taphoorn MJB, Boele FW, Groenvold M, van den Bent MJ, Stupp R, Velikova G, Cocks K, Sprangers MAG, King MT, Flechtner HH, Bottomley A. Establishing anchor-based minimally important differences for the EORTC QLQ-C30 in glioma patients. Neuro Oncol. 2021 Feb 18:noab037. doi: 10.1093/neuonc/noab037. Epub ahead of print. PMID: 33598685.
• Musoro JZ, Coens C, Greimel E, King MT, Sprangers MAG, Nordin A, van Dorst EBL, Groenvold M, Cocks K, Velikova G, Flechtner HH, Bottomley A; EORTC Gynecological and Quality of Life Groups. Minimally important differences for interpreting European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire core 30 scores in patients with ovarian cancer. Gynecol Oncol. 2020 Nov;159(2):515-521. doi: 10.1016/j.ygyno.2020.09.007. Epub 2020 Sep 21. PMID: 32972782.
• 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., Bottomley, A. and (2020), Minimally important differences for interpreting the EORTC QLQ‐C30 in patients with advanced colorectal cancer treated with chemotherapy. Colorectal Dis. doi:10.1111/codi.15295
• Musoro JZ, Coens C, Singer S, et al. Minimally important differences for interpreting European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 scores in patients with head and neck cancer. Head Neck. 2020;10.1002/hed.26363. doi:10.1002/hed.26363
• Jammbe Z Musoro, Corneel Coens, Frederic Fiteni et al. Minimally Important Differences for Interpreting EORTC QLQ-C30 Scores in Patients With Advanced Breast Cancer. JNCI Cancer Spectrum (2019). https://doi.org/10.1093/jncics/pkz037
• Musoro J, Coens C, Fiteni F, et al. Evidence-based approach to determine meaningful change in scores of the EORTC QLQ-C30 in breast and head and neck cancer: on behalf of the EORTC Breast, Head and Neck and Quality of Life Groups. 25th annual conference of the international society for quality of life research, Dublin, Ireland. Qual Life Res 2018;27 (Suppl 1): ab101.4, 18. https://doi.org/10.1007/s11136-018-1946-9
• Musoro ZJ, Bottomley A, Coens C, et al. Interpreting European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 scores as minimally importantly different for patients with malignant melanoma. European Journal of Cancer (2018) 104, 169-181. doi.org/10.1016/j.ejca.2018.09.005
• Musoro J, Coens C, Fiteni F, et al. Minimally important differences for interpreting EORTC QLQ-C30 scores in melanoma, breast cancer and head and neck cancer patients on behalf of the EORTC breast, Head and Neck, Melanoma and Quality of life groups. ISPOR Europe 2018 Barcelona, November, 2018. Https://tools.ispor.org/scientificpresentationsdatabase/presentation/84566?pdfid=58732
• Musoro ZJ, Hamel J-F,Ediebah DE, et al. Establishing anchor-based minimally important differences (MID) with the EORTC quality of life measures: a meta-analysis protocol. BMJ Open 2017; 7:e019117. doi:10.1136/bmjopen-2017-019117
• Fiteni F, Musoro J, Coens C, Sprangers M, Eggermont A, Bottomley A, Brandberg Y. Selection of anchors for the EORTC QLQ-C30 scales in adjuvant melanoma studies: on Behalf of the EORTC melanoma Group and EORTC Quality of Life Department. Qual Life Res (2017) 26(Suppl 1): ab202.2.
• Musoro J, Coens C, Ediabah DE, et al. Evidence-based approach to determine meaningful change in HRQOL scores of the EORTC QLQ-C30 in adjuvant melanoma cancer: on Behalf of the EORTC Melanoma Group and EORTC Quality of Life Group. 24th Annual Conference of the International Society for Quality of Life Research, Philadelphia (PA), USA, October 2017. Qual Life Res (2017) 26(Suppl 1): ab105.5.
• Musoro J, Coens C, Ediebah D, Eggermont A, et all. Empirical Evaluation of the Minimal Important Differences (MID) with the EORTC Quality of Life Group Measures: Embarking on a New Research Initiative on behalf of the EORTC Quality of Life Group and EORTC Quality of Life Department. Oral presented at 23rd International Society for Quality of Life Research (ISOQOL), Copenhagen, Denmark, 19 – 22 October 2016.