“Not just little adults”: Qualitative methods to support the development of pediatric patient-reported outcomes
Rob Arbuckle from Adelphi Values and Linda Abetz-Webb publish in The Patient – a journal focused on Patient-Centered Outcomes Research.
The US FDA and the European Medicines Agency (EMA) have issued incentives and laws mandating clinical research in pediatrics. While guidance for the development and validation of patient-reported outcomes (PROs) or health-related quality of life (HRQL) measures have been issued by these agencies, little attention has focused on pediatric PRO development methods. With reference to the literature, this article provides an overview of specific considerations that should be made with regard to the development of pediatric PRO measures, with a focus on performing qualitative research to ensure content validity.
Areas considered include:
- Age bands
- Interview techniques
- Cognitive debriefing approaches
- Self-reported (PRO) vs Observer-Reported Outcomes (ObsRO)
For further details of the full article, please go to: http://link.springer.com/article/10.1007%2Fs40271-013-0022-3