- Tytuł:
- Methodological approach for determining the Minimal Important Difference and Minimal Important Change scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-HN43) exemplified by the Swallowing scale
- Autorzy:
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Santos, Marcos
Fabian, Alexander
Boehm, Andreas
Licitra, Lisa
Fullerton, Amy
Baumann, Ingo
Herlofson, Bente Brokstad
Arraras, Juan Ignacio
Taylor, Katherine
Silva, Joaquim Castro
Brannan, Christine
Raber-Durlacher, Judith
Krejovic-Trivic, Sanja
Mehanna, Hisham
Nicolatou-Galitis, Ourania
Bjordal, Kristin
Inhestern, Johanna
Sherman, Allen C.
Pinto, Monica
Tomaszewska, Iwona
Simon, Christian
Hammerlid, Eva
Singer, Susanne
Gonzalez, Loreto Fernandez
Chie, Wei-Chu
Amdal, Cecilie Delphin
Yarom, Noam
Galalae, Razvan
Kiyota, Naomi
Salem, Dina
Bonomo, Pierluigi - Opis:
- Purpose: The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. Methods: In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. Results: From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|< 0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from − 3 to − 14. Conclusions: For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.
- Dostawca treści:
- Repozytorium Uniwersytetu Jagiellońskiego
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