As initial steps in a broader effort to develop and test pediatric Pain Behavior and Pain Quality item banks for the Patient Reported Outcomes Measurement Information System (PROMIS), was employed, qualitative interview and item review methods to 1) evaluate the overall conceptual scope and content validity of the PROMIS pain domain framework among children with chronic /recurrent pain conditions, and 2) develop item candidates for further psychometric testing. To elicit the experiential and conceptual scope of pain outcomes across a variety of pediatric recurrent/chronic pain conditions, semi-structured individual (32) and focus-group interviews (2) with children and adolescents (8-17 years), and parents of children with pain (individual (32) and focus group (2)) were conducted. Interviews with pain experts (10) explored the operational limits of pain measurement in children. For item bank development, we identified existing items from measures in the literature, grouped them by concept, removed redundancies, and modified remaining items to match PROMIS formatting. New items were written as needed and cognitive debriefing was completed with children and their parents, resulting in 98 Pain Behavior (47 self, 51 proxy), 54 Quality and 4 Intensity items for further testing. Qualitative content analyses suggest that reportable pain outcomes that matter to children with pain are captured within and consistent with the pain domain framework in PROMIS.
PROMIS Pediatric Pain Behavior, Quality and Intensity items were developed based on a theoretical framework of pain that was evaluated by multiple stakeholders in measurement of pediatric pain, including researchers, clinicians, and children with pain and their parents, and the appropriateness of the framework was verified.