With more pediatric clinical trials being conducted in the US, there is a need to identify and address the challenges of developing patient-reported outcome measures (PROMs) for use in a younger population. This is according to an article published by three RTI-HS researchers—Carla DeMuro, MS, Head of Patient-Reported Outcomes, Sandy Lewis, Director of Patient-Reported Outcomes and Valerie Williams, PhD, Senior Director of Psychometrics—in the Spring 2015 American Academy of Pediatrics' Section on Advances in Therapeutics and Technology Newsletter.
Read the full article: Why Didn’t Anyone Ask Me? Use of Pediatric Patient-Reported Outcomes
The article titled Why Didn’t Anyone Ask Me? Use of Pediatric Patient-Reported Outcomes details the key criteria that need to be addressed for appropriate pediatric PROM development that were identified by a working group convened by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). These criteria include determing a recommended age for self-report, establishing content validity and using children as experts, determining the appropriate information reporter for a child (self- vs. proxy-report), designing instruments to facilitate accurate reporting, and cross-cultural differences.
To add to the challenge, the group also noted that "attention must be paid to the developmental stages and cognitive abilities of the individual children planned for interview, as procedures that are appropriate for children at one developmental stage may not be appropriate for those at another developmental stage."