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Guidelines for the Use and Reporting of Patient-Reported Outcomes in Multiple Myeloma Clinical Trials

Authors :
Laane, Edward
Salek, Sam
Oliva, Esther Natalie
Bennink, Christine
Clavreul, Solène
Richardson, Paul G.
Scheid, Christof
Weisel, Katja
Ionova, Tatyana
Laane, Edward
Salek, Sam
Oliva, Esther Natalie
Bennink, Christine
Clavreul, Solène
Richardson, Paul G.
Scheid, Christof
Weisel, Katja
Ionova, Tatyana
Source :
Laane , E , Salek , S , Oliva , E N , Bennink , C , Clavreul , S , Richardson , P G , Scheid , C , Weisel , K , Ionova , T & on behalf of the European Hematology Association Specialized Working Group on Quality of Life and Symptoms 2023 , ' Guidelines for the Use and Reporting of Patient-Reported Outcomes in Multiple Myeloma Clinical Trials ' , Cancers , vol. 15 , no. 24 , 5764 .
Publication Year :
2023

Abstract

In the era of personalized medicine there is an increasing need for the assessment of patient-reported outcomes (PROs) to become a standard of patient care. Patient-reported outcome measures (PROM) are important in assessing significant and meaningful changes as a result of an intervention based on a patient’s own perspective. It is well established that active multiple myeloma (MM) can be characterized by a high burden of disease and treatment-related symptoms, with considerable worsening of quality of life (QoL). In general, and over the past decade, the focus has shifted to obtaining the most durable remissions with the best QoL as primary goals for MM treatment. Patients place considerable value on their QoL and communicating about QoL data prior to treatment decisions allows them to make informed treatment choices. Consequently, optimization of QoL of patients with MM is an important therapeutic goal and the incorporation of PROs into clinical trials has the potential of improving treatment outcomes. In this regard, guidance for the use and reporting of PROMs in MM in clinical trials is warranted. Under the auspices of the European Hematology Association, evidence-based guidelines for the use and reporting of PROs in patients with MM have been developed according to the EHA’s core Guidelines Development Methodology. This document provides general considerations for the choice of PROMs in MM clinical trials as well as a series of recommendations covering a selection of PROMs in MM clinical trials; the mode of administration; timing of assessments; strategies to minimize missing data; sample size calculation; reporting of results; and interpretation of results.

Details

Database :
OAIster
Journal :
Laane , E , Salek , S , Oliva , E N , Bennink , C , Clavreul , S , Richardson , P G , Scheid , C , Weisel , K , Ionova , T & on behalf of the European Hematology Association Specialized Working Group on Quality of Life and Symptoms 2023 , ' Guidelines for the Use and Reporting of Patient-Reported Outcomes in Multiple Myeloma Clinical Trials ' , Cancers , vol. 15 , no. 24 , 5764 .
Notes :
application/pdf, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1417972658
Document Type :
Electronic Resource