Saving time and effort: Best practice for adapting existing patient-reported outcome measures in hepatology

Author:

Alrubaiy Laith,Hutchings Hayley A,Hughes Sarah E,Dobbs Thomas

Publisher

Baishideng Publishing Group Inc.

Subject

Hepatology

Reference70 articles.

1. Patient-Reported Outcome Measures in Routine Clinical Care: The PROMise of a Better Future?

2. U.S. Food and Drug Administration. Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. [cited 5 November 2019]. In: U.S. Food and Drug Administration [Internet]. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf

3. Outcome measurement in paediatric palliative care: lessons from the past and future developments

4. Patient-reported outcome measures (PROMs): how should I interpret reports of measurement properties? A practical guide for clinicians and researchers who are not biostatisticians

5. European Medicines Agency. Reflection paper on th regulatory guidance for the use of Health-Related Quality of Life (HRQL) measures in the evaluation of medicinal products. [cited 5 November 2019]. In: European Medicines Agency [Internet]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-regulatory-guidance-use-healthrelated-quality-life-hrql-measures-evaluation_en.pdf

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