ESTRO 2020 Abstract book

S143 ESTRO 2020

together. [1] The NCRI Clinical and Translational Radiotherapy Research working group (CTRad): Review of progress and strategic vision 2018 - 2021

integration of PROs in clinical trials and practice (e.g. CONSORT-PRO, SISAQOL).

SP-0253 When to measure PROMs, which tools to use, and how to use them M. Halyard (USA) Mayo Clinic, Phoenix, Arizona, USA

Joint Symposium: ESTRO-ASTRO: Patient reported outcomes in radiation oncology - time to make them mandatory in clinical practice?

Abstract not received

SP-0252 PROMs versus clinician scored toxicity. Do we need both? A. Gilbert 1,2 1 leeds Cancer Centre, Clinical Oncology, Leeds, United Kingdom ; 2 university Of Leeds, Medicine, Leeds, United Kingdom Abstract text Whilst the gold standard for adverse event reporting in clinical trials is the clinician-graded Common Terminology Criteria for Adverse Events (CTCAE) system, the inclusion of patient reported outcomes (PRO) measurement is recommended by the FDA to improve the quality of adverse event/toxicity measurement. PROs are considered the gold standard for measurement of symptom toxicity; those adverse events that are not directly observable or measurable by a clinician. PROs may also be used to evaluate the impact of treatment on more complex multi- dimensional concepts such as health related quality of life (HRQOL). Validated PROs are often developed through robust methodological and statistical techniques to ensure that are sensitive to differences between interventions and changes over time (e.g. EORTC QLQ guidance). However, whilst PROs provide a robust and systematic method for symptom measurement, they are not diagnostic. In a trial setting, numerous studies have found that patients report on a wider range and milder symptoms and found the inclusion of PROs has led to practice changing results. Recently, benefits for the inclusion of PRO-CTCAE in a phase I clinical trial setting were noted, with patients reporting a greater frequency of symptom reporting over clinicians. PARSPORT, a phase III RCT in head and neck intensity modulated radiotherapy (IMRT), demonstrated the benefit of IMRT over 3D conformal, through reduction in patient-reported xerostomia. In the same trial, optimal beam arrangements were investigated following the finding that patients treated with IMRT reported worse acute patient-reported fatigue, associated with greater dose to posterior fossa, brainstem and cerebellum. PROs may also be helpful in trials comparing treatments which use different adverse event grading systems (e.g. surgery vs. radiotherapy); they are able to provide detailed information on symptomatic toxicity to supplement the clinician reporting and allow direct comparisons between treatments. Within clinical practice, routine collection of PROs can provide a robust method to systematically record toxicity, particularly if collected electronically. At an individual level, integration of PROs into clinical consultations in oncology has been found repeatedly to improve communication and well-being. At a systemic level, PRO toxicity information could be used to supplement existing big data clinical datasets to develop predictive models of radiotherapy toxicity and improve targeting of survivorship care. Whilst there are challenges to PRO data collection and reporting (e.g. EPIC review results), there are a number of excellent guidance documents aimed at standardising the

SP-0254 Implementation of ePROMs in a clinical workflow D. Vordermark 1 1 Martin Luther University Halle-Wittenberg, Dept. of Radiation Oncology, Halle/Saale, Germany Abstract text The implementation of a routine use of electronic patient- reported outcoume measures (ePROMs) has shown clinically relevant benefits for cancer patients in randomized clinical trials, but poses significant challenges in the context of a standard radiation oncology workflow. The roles of different disciplines within the multiprofessional treatment team in informing patients about the process of ePROM collection, the evaluation of individual patients┬┤ ePROM data and the decision-making on clinical consequences need to be clarified. This includes the definition of thresholds for intervention for defined scales of quality of life, functions and symptoms as measured by ePROMs.. Initially, ePROM assessment may be viewed as an additional time-consuming burden. Ideally, ePROMs may serve to use the time of contact between patients and health-care professionals more efficiently. Training of staff of all professions on patient-reported outcomes in general and on ePROM administration in particular is required. This can be achived by web-based training modules and Hands-on training sessions. In Addition, it needs to be clarified which patients cannot be evaluated by ePROMs due to e. g. impaired neurocognitive function or general condition and which alternative ways of assessment are used in these. The technical challenge lies in the integration of the ePROM system into the hospital information system and the easy and permanent accessiblity of ePROM scores for all members of the team. Particular technical Problems may arise from patients switching between inpatient and outpatient setting during a course of treatment and sequential follow-up. SP-0255 Time to generate new NTCP Models based on PROMs? A. Chen 1 1 The University of Texas MD Anderson Cancer Center, Radiation Oncology and Health Services Research, Houston, USA Abstract text Normal-tissue complication probability models in radiation oncology have historically been generated using physician- reported toxicity data. This session will review common NTCP models, including how outcomes have been defined. The potential for patient-reported outcome based models to improve on our understanding of complications from treatment will be discussed, as well as the limitations of such models. Examples from the literature will be given. Finally, there will be discussion about current and future efforts, gaps in knowledge, and challenges to implementation in routine clinical practice.

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