Glioma patient-reported outcome assessment in clinical care and research: a Response Assessment in Neuro-Oncology collaborative report.

Autor:	Armstrong TS; Neuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. Electronic address: terri.armstrong@nih.gov., Dirven L; Department of Neurology, Leiden University Medical Center, Leiden, Netherlands., Arons D; National Brain Tumor Society, Newton, MA, USA., Bates A; National Brain Tumor Society, Newton, MA, USA., Chang SM; Division of Neuro Oncology, Department of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA., Coens C; Statistical Department, European Organization for the Outcomes and Treatment of Cancer Headquarters, Brussels, Belgium., Espinasse C; Scientific and Regulatory Management, European Medicines Agency, Amsterdam, Netherlands., Gilbert MR; Neuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Jenkinson D; The Brain Tumour Charity, Farnborough, UK., Kluetz P; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Mendoza T; Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Rubinstein L; Biometric Research Program, National Cancer Institute, Bethesda, MD, USA., Sul J; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Weller M; Department of Neurology, Institution University Hospital and University of Zurich, Zurich, Switzerland., Wen PY; Center For Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA, USA., van den Bent MJ; Erasmus University MC Cancer Institute, Rotterdam, Netherlands., Taphoorn MJB; Department of Neurology, Leiden University Medical Center, Leiden, Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, Netherlands.
Jazyk:	angličtina
Zdroj:	The Lancet. Oncology [Lancet Oncol] 2020 Feb; Vol. 21 (2), pp. e97-e103.
DOI:	10.1016/S1470-2045(19)30796-X
Abstrakt:	Clinical trials of treatments for high-grade gliomas have traditionally relied on measures of response or time-dependent metrics; however, these endpoints have limitations because they do not characterise the functional or symptomatic effect of the condition on the person. Including clinical outcome assessments, such as patient- reported outcomes (PROs), to determine net clinical benefit of a treatment strategy is needed because of the substantial burden of symptoms and impaired functioning in this patient population. The US National Cancer Institute convened a meeting to review previous recommendations and existing PRO measures of symptoms and function that can be applied to current trials and clinical practice for high-grade gliomas. Measures were assessed for relevance, relationship to disease and therapy, sensitivity to change, psychometric properties, response format, patient acceptability, and use of self-report. The group also relied on patient input including the results of an online survey, a literature review on available clinical outcomes, expert opinion, and alignment with work done by other organisations. A core set of priority constructs was proposed that allows more comprehensive evaluation of therapies and comparison of outcomes among studies, and enhances efforts to improve the measurement of these core clinical outcomes. The proposed set of constructs was then presented to the Society for Neuro-Oncology Response Assessment in Neuro-Oncology Working Group and feedback was solicited. (Copyright © 2020 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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