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Development of a validated PROM set for children with tinnitus using the Patient-Reported Outcomes Measurement
Denise Fuchten1,2, Inge Stegeman1,2, Adriana L Smit1,2
1Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Insights
This study aims to develop a child-centered Patient-Reported Outcome Measure (PROM) set for pediatric tinnitus. This new tool will standardize assessment of tinnitus impact in children, improving clinical care and research.
Area of Science:
- Pediatric Audiology
- Clinical Research Methodology
- Patient-Reported Outcomes
Background:
- Pediatric tinnitus research is limited, with current impact assessments lacking standardization and child-centered perspectives.
- Existing methods rely on subjective interviews and adult proxy reports, failing to capture children's experiences.
- A validated, child-centered measure is needed to accurately assess pediatric tinnitus impact.
Purpose of the Study:
- To develop and validate a child-centered Patient-Reported Outcome Measure (PROM) set for pediatric tinnitus.
- To utilize the Patient-Reported Outcomes Measurement Information System (PROMIS) framework for a condition-specific measure.
- To enhance the understanding and assessment of tinnitus's impact on children's daily lives.
Main Methods:
- A mixed-methods, multi-phase observational study involving children aged 8-18 years.
- Focus groups to identify patient-important outcomes, followed by expert panel input.
- Feasibility, content validity, and reliability assessments of the developed PROM set.
Main Results:
- The study proposes a novel methodology for developing a pediatric tinnitus PROM.
- The process involves iterative refinement with children and expert input.
- The final PROM set will be assessed for validity and reliability in children with tinnitus.
Conclusions:
- A standardized, child-centered PROM set for pediatric tinnitus will be developed using the PROMIS framework.
- This measure will improve the evaluation of tinnitus impact and treatment effectiveness in children.
- The PROM set will facilitate consistent data collection for clinical care and research.
Introduction:
Tinnitus in children remains an underexplored area of research, with limited knowledge about its prevalence and impact on daily lives. Current assessments of the impact of tinnitus in children predominantly rely on open-ended questioning during clinical interviews, inconsistent use of structured tools, and data reported by adult proxies. These methods often fail to fully capture the child's personal experience of tinnitus, underscoring the need for a standardized, child-centered measure to more accurately assess its impact and improve understanding of children's experience. To address this gap, this study proposes the development of a validated PROM set using the Patient-Reported Outcomes Measurement Information System (PROMIS).
Methods:
The proposed study is a monocenter, mixed-methods, multi-phase observational study. The study will consist of six consecutive steps: (1) identifying patient-important outcomes through focus groups with children aged 8-18 years; (2) defining the underlying constructs of the outcomes and linking them to relevant PROMIS domains; (3) gathering input form an expert panel to refine the outcomes and domains; (4) discussing the PROM set with the focus groups and assess its feasibility; (5) assessing content validity in the expert panel; and (6) assessing the reliability in a sample of children with tinnitus.
Discussion:
By using the generic PROMIS framework to develop a condition-specific measure, the proposed study aims to create a standardized, child-centered PROM set that captures the specific impact of pediatric tinnitus, while maintaining the ability to compare outcomes across different conditions and populations. This PROM set could ultimately be used in both clinical care and research to evaluate tinnitus impact and assess the effects of treatments.
