EClinicalMedicine · 2025
The EORTC QLQ-F17 as a shortened version of the EORTC QLQ-C30 to assess self-reported functioning in cancer patients: investigating equivalence and psychometric properties in a randomized cross-over trial.
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Zeman Florian, Giesinger Johannes M, Pukrop Tobias, Petersen Morten Aa, Groenvold Mogens, Nolte Sandra, Kuliś Dagmara, Shrestha Sunil, Leysen Laurence, Cocks Kim, Coens Corneel, Ioannidis Georgios, Pompili Cecilia, Koller Michael, of the EORTC QLG
Аннотация
BACKGROUND: The EORTC QLQ-F17, a shortened version of the EORTC QLQ-C30, solely contains the items related to functioning and omits symptom scales. The QLQ-F17 is conceived an equivalent to the functional part of the QLQ-C30, but to date there is no empirical evidence to support this rationale.
METHODS: This randomized, cross-over, multi-national, questionnaire-based study investigates the equivalence and psychometric properties of the QLQ-F17 compared to the functional scales of the QLQ-C30. Respondents had to fill in both questionnaires, the order of which was presented in a randomized and balanced manner (QLQ-C30-QLQ-F17 vs. QLQ-F17-QLQ-C30). Equivalence testing used Differential Item Functioning (DIF) and linear models. The margin of equivalence was set at ]-5, 5[ points. The study is registered with ClinicalTrials.gov (NCT05479682). Patients were enrolled between February 17 and March 28, 2023.
FINDINGS: A total of 2672 cancer patients of all major cancer types, aged between 18 and 92 years with an equal gender distribution (50/50) from 11 countries, were recruited between 17 February and 28 March 2023. Adjusted mean differences between QLQ-C30 and QLQ-F17 ranged between -1·55 and 3·25 for all scales, and the limits of the 95%-CIs, ranging from -3·11 to 4·87, were all within the equivalence margin. All effect sizes of the DIF analyses were <0·01. For the scales of the QLQ-F17, Cronbach's Alpha ranged from 0·73 to 0·89, item-own scale correlations from 0·47 to 0·78 and item-other scale correlations from 0·19 to 0·70.
INTERPRETATION: The QLQ-F17 yielded score values that are equivalent to the functional part of the QLQ-C30. Consequently, future clinical studies can employ the QLQ-F17 as a generic tool without losing comparability to studies using the QLQ-C30. Supplementing the QLQ-F17 with relevant symptom items from the EORTC Item Library allows for a time-efficient and flexible measurement strategy.
FUNDING: This research was funded by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group, grant number 010/2021.
METHODS: This randomized, cross-over, multi-national, questionnaire-based study investigates the equivalence and psychometric properties of the QLQ-F17 compared to the functional scales of the QLQ-C30. Respondents had to fill in both questionnaires, the order of which was presented in a randomized and balanced manner (QLQ-C30-QLQ-F17 vs. QLQ-F17-QLQ-C30). Equivalence testing used Differential Item Functioning (DIF) and linear models. The margin of equivalence was set at ]-5, 5[ points. The study is registered with ClinicalTrials.gov (NCT05479682). Patients were enrolled between February 17 and March 28, 2023.
FINDINGS: A total of 2672 cancer patients of all major cancer types, aged between 18 and 92 years with an equal gender distribution (50/50) from 11 countries, were recruited between 17 February and 28 March 2023. Adjusted mean differences between QLQ-C30 and QLQ-F17 ranged between -1·55 and 3·25 for all scales, and the limits of the 95%-CIs, ranging from -3·11 to 4·87, were all within the equivalence margin. All effect sizes of the DIF analyses were <0·01. For the scales of the QLQ-F17, Cronbach's Alpha ranged from 0·73 to 0·89, item-own scale correlations from 0·47 to 0·78 and item-other scale correlations from 0·19 to 0·70.
INTERPRETATION: The QLQ-F17 yielded score values that are equivalent to the functional part of the QLQ-C30. Consequently, future clinical studies can employ the QLQ-F17 as a generic tool without losing comparability to studies using the QLQ-C30. Supplementing the QLQ-F17 with relevant symptom items from the EORTC Item Library allows for a time-efficient and flexible measurement strategy.
FUNDING: This research was funded by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group, grant number 010/2021.