Including Young Children in the Development and Testing of Patient Reported Outcome (PRO) Instruments: A Scoping Review of Children’s Involvement and Qualitative Methods

Author:

Gale VictoriaORCID,Carlton JillORCID

Funder

This research was conducted as part of PhD research funded by SF-6D royalty income

Publisher

Springer Science and Business Media LLC

Subject

General Engineering

Reference60 articles.

1. Cremeens J, Eiser C, Blades M. Characteristics of health-related self-report measures for children aged three to eight years: a review of the literature. Qual Life Res. 2006. https://doi.org/10.1007/s11136-005-4184-x.

2. Germain N, Aballéa S, Toumi M. Measuring health-related quality of life in young children: how far have we come? J Market Access Health Policy. 2019. https://doi.org/10.1080/20016689.2019.1618661.

3. Matza LS, et al. Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force. Value Health. 2013. https://doi.org/10.1016/j.jval.2013.04.004.

4. Food and Drug Administration. Guidance for Industry-Patient-reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Silver Spring, MD: Food and Drug Administration, 2009.

5. European Medicines Agency. Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products. London, United Kingdom: European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP), 2005.

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