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Content Validity of Patient-Reported Outcome Measures Developed for Assessing Disease-Specific Quality of Life in
Isabelle Williams1, Oloruntobi Rotimi2, Lisa Burrows3
1Core Surgical Trainee, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Insights
Existing pediatric sinonasal disease patient-reported outcome measures (PROMs) lack validation. Only the PCD-QoL demonstrated adequate development for clinical trials, indicating a need for better tools for children.
Area of Science:
- Otolaryngology
- Pediatric Health
- Health Outcomes Research
Background:
- Pediatric sinonasal disease is common globally, causing significant morbidity and healthcare costs.
- Currently, there is a lack of validated, child-specific patient-reported outcome measures (PROMs) for sinonasal conditions.
- This gap hinders accurate assessment of disease status and quality of life in children.
Purpose of the Study:
- To systematically evaluate existing PROMs for pediatric sinonasal disease.
- To determine if any current PROMs meet established validation criteria for clinical use.
- To identify the need for developing new, validated instruments.
Main Methods:
- A comprehensive literature search was conducted across major databases (Medline, Embase, Emcare, Cochrane Library) up to January 2024.
- Studies focusing on PROM development or content validity in children with sinonasal disease were included.
- The COSMIN methodology was used to assess content validity, with evidence graded using a modified GRADE approach.
Main Results:
- Five PROMs were identified: Sinus-5 (S5), Paediatric Rhinosinusitis Symptom Scale (PRSS), Sinonasal-5 (SN-5), Modified Sinonasal Outcome Test-20 Young Persons Questionnaire (MSYPQ), and PCD quality of life (PCD-QoL).
- The development of S5, PRSS, SN-5, and MSYPQ was found to be inadequate, based on low-quality evidence.
- The PCD-QoL was identified as a well-developed tool, created using evidence-based guidelines.
Conclusions:
- Only the PCD-QoL met the required standards for use in clinical trials.
- There is a clear need for a dedicated, validated PROM to assess disease status and quality of life in otherwise healthy children with sinonasal disease.
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.
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