Author:
Schurr T,Loth F,Lidington E,Piccinin C,Arraras JI,Groenvold M,Holzner B,van Leeuwen M,Petersen MA,Schmidt H,Young T,Giesinger JM,Arraras Juan I.,Groenvold Mogens,van Leeuwen Marieke,
Abstract
Abstract
Background
Patient-reported physical function (PF) is a key endpoint in cancer clinical trials. Using complex statistical methods, common metrics have been developed to compare scores from different patient-reported outcome (PRO) measures, but such methods do not account for possible differences in questionnaire content. Therefore, the aim of our study was a content comparison of frequently used PRO measures for PF in cancer patients.
Methods
Relying on the framework of the International Classification of Functioning, Disability and Health (ICF) we categorized the item content of the physical domains of the following measures: EORTC CAT Core, EORTC QLQ-C30, SF-36, PROMIS Cancer Item Bank for Physical Function, PROMIS Short Form for Physical Function 20a, and the FACT-G. Item content was linked to ICF categories by two independent reviewers.
Results
The 118 items investigated were assigned to 3 components (‘d – Activities and Participation’, ‘b – Body Functions’, and ‘e – Environmental Factors’) and 11 first-level ICF categories. All PF items of the EORTC measures but one were assigned to the first-level ICF categories ‘d4 – Mobility’ and ‘d5 – Self-care’, all within the component ‘d – Activities and Participation’. The SF-36 additionally included item content related to ‘d9 – Community, social and civic life’ and the PROMIS Short Form for Physical Function 20a also included content related to ‘d6 – domestic life’. The PROMIS Cancer Item Bank (v1.1) covered, in addition, two first-level categories within the component ‘b – Body Functions’. The FACT-G Physical Well-being scale was found to be the most diverse scale with item content partly not covered by the ICF framework.
Discussion
Our results provide information about conceptual differences between common PRO measures for the assessment of PF in cancer patients. Our results complement quantitative information on psychometric characteristics of these measures and provide a better understanding of the possibilities of establishing common metrics.
Funder
European Organisation for Research and Treatment of Cancer Quality of Life Group
Publisher
Springer Science and Business Media LLC
Subject
Health Informatics,Epidemiology
Reference58 articles.
1. Garber CE, Greaney ML, Riebe D, Nigg CR, Burbank PA, Clark PG. Physical and mental health-related correlates of physical function in community dwelling older adults: A cross sectional study. BMC Geriatr. 2010;10:6. https://doi.org/10.1186/1471-2318-10-6.
2. Painter P, Stewart AL, Carey S. Physical Functioning: Definitions, Measurement, and Expectations. Adv Ren Replace Ther. 1999;6(2):110–23. https://doi.org/10.1016/s1073-4449(99)70028-2.
3. Gnanasakthy A, Barrett A, Evans E, D’Alessio D, Romano CD. A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012–2016). Value Health. 2019;22(2):203–9. https://doi.org/10.1016/j.jval.2018.09.2842.
4. Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen W-H, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R. Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms. Clin Cancer Res. 2016;22(7):1553–8. https://doi.org/10.1158/1078-0432.CCR-15-2035.
5. European Medicines Agency. (2016). The use of patient-reported outcome (PRO) measures in oncology studies - Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man. https://www.ema.europa.eu/en/documents/other/appendix-2-guideline-evaluation-anticancer-medicinal-products-man_en.pdf