Content Validity of Patient-Reported Outcome Measures Developed for Assessing Disease-Specific Quality of Life in Children With Sinonasal Disease: A Systematic Review.

Abstract

Objectives: Paediatric sinonasal disease is prevalent worldwide, giving rise to substantial healthcare costs and morbidity. However, there is a lack of sinus-specific patient-reported outcome measures (PROMs) tailored for children. This study aimed to evaluate existing PROMs against established validation criteria to determine whether a paediatric-specific, validated instrument for assessing sinonasal disease currently exists.

Methods: Medline (Ovid), Embase (Ovid), Emcare (Ovid), and the Cochrane Library were searched from inception to January 2024. Eligibility was restricted to PROM development or content validity studies conducted in all children with sinonasal disease. Content validity was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology, with evidence graded using a modified GRADE approach.

Results: Five PROMs were identified: two for acute sinus disease (Sinus-5 [S5] and Paediatric Rhinosinusitis Symptom Scale [PRSS]), two for general rhinosinusitis (Sinonasal-5 [SN-5] and Modified Sinonasal Outcome Test-20 Young Persons Questionnaire [MSYPQ]) and one specific to primary ciliary dyskinesia (PCD; PCD quality of life [PCD-QoL]). No content validity studies were included in the final analysis. The development of the S5, PRSS, SN-5 and MSYPQ was found to be inadequate, supported by low-quality evidence, whereas the PCD-QoL stood out as a well-developed tool created using established evidence-based guidelines.

Conclusions: Among the assessed tools, only the PCD-QoL met standards for use in clinical trials, highlighting the need for a dedicated instrument to track disease status and QoL in otherwise healthy children with sinonasal disease.