THE KIDS' PROS MAY NOT BE ALRIGHT: NOVEL METHODS FOR ASSESSING THE SUITABILITY OF EXISTING PEDIATRIC PROS FOR USE WITH CHILDREN, AND DATA TO SUPPORT IMPROVED WORDING AND DESIGN

Author(s)

Tim Poepsel, MS, PhD1, Rachael Emily Browning, BA2, Chryso Hadjidemetriou, PhD3, Rebecca Israel, MS1, Kwanele Masuku, MS4.
1RWS, East Hartford, CT, USA, 2RWS, Bloxham, United Kingdom, 3RWS, Croydon, United Kingdom, 4RWS, Hartford, CT, USA.
OBJECTIVES: Previous investigations of PROs reveal many design and wording issues that impact patient comprehension and data validity. Here, we review existing pediatric PROs, characterizing the adequacy of their adaptation for pediatric use with novel qualitative and quantitative analyses, to promote and guide PRO development and revision efforts for improved patient experience and data validity.
METHODS: We identified 26 pediatric PROs from our project archive. We extracted all text segments (e.g., items, response sets), analyzing each for suitability for children. PROs were also holistically assessed for readability and effectiveness of pediatric adaptation (“adaptation score”).
RESULTS: 187 of 965 segments were flagged as problematic for pediatric patients. 1 PRO had no flagged segments; 17/26 had 1-33% of segments flagged; 6/26 had 34-66% flagged; 3/26 had 67%+ flagged. Flagged segments were grouped into five distinct categories (241 total codes): “adult wording” (N=95), “length” (N=14), “medical jargon” (N=24), “unexplained terms” (N=83), “confusing wording” (N=25). PRO readability was calculated with a structured heuristic model, patterning as follows: Grade 1-3: 5/26; Grade 3-5: 7/26, Grade 5-7: 7/26, Grade 7-9: 5/26, Grade 9-12: 2/26. Adaptation scores ranged from 1 (least appropriate) to 5 (fully appropriate) based on five considerations: language simplicity, cognitive load, emotional clarity, child-friendliness, ease of answering. The average adaptation score was 3.5, with 7/27 PROs in the 4-5 range (‘minor issues’), 10/27 from 3-4 (‘noticeable difficulty’), and 9/27 from 2-3 (‘hard for children’). A significant inverse relationship exists between readability and adaptation scores (-.91, p<.0001), showing convergence of the analytic approaches.
CONCLUSIONS: Results suggest a significant percentage of pediatric PROs are not optimized for pediatric use, with frequently identified issues being unchanged adult-oriented text, and unelaborated terms. The results highlight a pressing need for careful assessment and adaptation of existing and novel PROs for pediatric use, and urge awareness of potential impacts on data validity.

Conference/Value in Health Info

2026-11, ISPOR Europe 2026, Vienna, Austria

Value in Health, Volume 29, Issue 12S

Code

PCR190

Topic

Clinical Outcomes, Methodological & Statistical Research, Patient-Centered Research

Topic Subcategory

Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Pediatrics

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