Abstract:
:In 2008, the GEC ESTRO Gyn network launched the first multiinstitutional, observational, and prospective international study on MRI-guided brachytherapy in locally advanced cervical cancer patients (EMBRACE-I). EMBRACE-I was followed by EMBRACE-II from 2016 and ongoing. Among the aims of the EMBRACE studies are to benchmark morbidity outcomes and develop dose-volume effects and predictive models for morbidity. The EMBRACE studies collect both physician (CTCAE v.3) and patient (EORTC QLQ-C30/CX24) reported outcomes, including baseline information, in a regular follow-up schedule. The EMBRACE studies feature high numbers of patients (EMBRACE-I N = 1416, EMBRACE-II N = 1500 expected) enrolled from many institutions worldwide (EMBRACE-I n = 23, EMBRACE-II n = 45). This large-scale multiinstitutional approach offers a unique opportunity to investigate and develop new strategies for improving the quality of assessment and reporting of morbidity. This report presents an overview of the challenges and pitfalls regarding the assessment and reporting of morbidity encountered during more than a decade of development and research activities within the EMBRACE consortium. This includes the recognition and evaluation of inconsistencies in the morbidity assessment, and consequently, the provision of assistance and training in the scoring procedure to reduce systematic assessment bias. In parallel, a variety of methodological approaches were tested to comprehensively summarize morbidity outcomes, and a novel approach was developed to refine dose-effect models and risk factor analyses. The purpose of this report is to present an overview of these findings, describe the learning process, and the strategies that have consequently been implemented regarding educational activities, training, and dissemination.
journal_name
Brachytherapyjournal_title
Brachytherapyauthors
Kirchheiner K,Smet S,Spampinato S,Jensen NBK,Vittrup AS,Fokdal L,Najjari-Jamal D,Westerveld HG,Lindegaard JC,Kirisits C,De Leeuw A,Schmid MP,Tan LT,Nout RA,Jürgenliemk-Schulz IM,Pötter R,Tanderup K,EMBRACE Collaborativedoi
10.1016/j.brachy.2020.08.011subject
Has Abstractpub_date
2020-01-01 00:00:00pages
837-849issue
6eissn
1538-4721issn
1873-1449pii
S1538-4721(20)30186-0journal_volume
19pub_type
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