Patient-reported outcomes in clinical trials
نویسندگان
چکیده
منابع مشابه
Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials.
OBJECTIVES Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group...
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There is general acceptance of the importance of incorporating patient-reported outcome (PRO) measures including health-related quality of life (HRQOL) into clinical trials, and there are now a number of guidance documents available on how to use PRO's for regulatory authorities and in comparative effectiveness research. The methods used to collect, analyse and report PRO data in clinical trial...
متن کاملMeasuring clinical benefit: use of patient-reported outcomes (PRO) in primary brain tumor clinical trials.
Primary brain tumors and their treatment are associated with a significant impact on function and quality of life (QOL). Patient-reported outcomes (PROs) are measures that allow report of the impact directly from the patient. Instruments to measure both QOL and symptom burden have been developed for use in the primary brain tumor patient population. Use of these instruments coupled with tumor r...
متن کاملPatient reported outcomes and patient empowerment in clinical genetics services.
Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how health...
متن کاملPatient Reported Outcomes (PROs) in Clinical Trials: Is ‘In-Trial’ Guidance Lacking? A Systematic Review
BACKGROUND Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting) and the management of 'concerning' PRO data (i.e., data which raises co...
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ژورنال
عنوان ژورنال: Cancer Breaking News
سال: 2016
ISSN: 2283-6594
DOI: 10.19156/cbn.2016.0019