Détermination du sens clinique d'un changement pour les questionnaires de qualité de vie relative à la santé en cancérologie

Abstract : In oncology, the health-related quality of life (HRQOL) is generally considered as a second endpoint in the clinical trials. The interpretation of the results of the longitudinal analysis of such data must be made in both statistical and clinical point of view in order to produce meaningful results for both patients and clinicians. The main objective is to assess the impact of the treatment on patient’s HRQOL level over time. The minimal clinically important difference (MCID) was defined as the smallest change between two scores in a treatment outcome that a patient would identify as important. Indeed, the longitudinal analysis of HRQOL remains complex, particularly due to the potential occurrence of a Response Shift effect characterizing the process of adaptation of the patient in relation to the illness and its treatment. Hence, the first objective of this work is a literature review concerning the determination of the MCID by the most commonly used methods: anchor-based and distribution-based methods. Secondly, calculating the MCID using anchor-based and distribution-based methods by applying different distribution criteria and several different anchors. The objective is to compare the results obtained by the different methods and to compare them to others obtained by previous studies. Finally, studying the impact of the Response Shift effect on the determination of MCID for the HRQOL questionnaires in cancer research using several data corresponding to different therapeutic situations and cancer locations.
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Ahmad Ousmen. Détermination du sens clinique d'un changement pour les questionnaires de qualité de vie relative à la santé en cancérologie. Médecine humaine et pathologie. Université Bourgogne Franche-Comté, 2019. Français. ⟨NNT : 2019UBFCE001⟩. ⟨tel-02159403⟩

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