Table 1:

Key issues to consider in the use of PROs in clinical trials

Benefits	Challenges
Essential to use in diseases where patient’s report of symptoms is only measure of treatment efficacy	General PRO measurements may be irrelevant or insensitive to certain disease aspects
Can be used as a secondary measure to support primary endpoint/biological markers	Disease-specific PROs are limited; new tools require proper design and validation; may be unable to generalize to other disease populations and/or other geographic regions (language/cultural differences)
Fosters patient-centered health care (improved communication, shared treatment decision making and adherence)	Current EHRs do not effectively record PRO data
Regulatory agencies support use of PRO data	Data analysis may be more difficult (subjective, biased, missing data, multiplicity)
Improved health care quality	When and how often to administer PRO?
	May be limited in pediatrics (need to utilize caregiver proxy report)