To ensure the questionnaire captures relevant themes from clinical and patient perspectives, a series of focus group discussions will be held. They will involve key stakeholders, including healthcare professionals and patients/families, to generate qualitative data on important QoL issues. Insights from these discussions will contribute to the development of a theme bank for the generation of the questionnaire.

A pilot study will be conducted with CNP patients to assess the questionnaire’s readability, comprehensibility, content validity. Statistical analyses will be performed on the pilot data to examine the questionnaire’s structure and identify correlations/patterns within the responses. The pilot study will yield a refined, population-specific QoL assessment tool, with initial validation of its psychometric properties. In addition to refining the population-specific QoL assessment tool, the PROs will be structured into a digital format, resulting in electronic PROs (ePROs). These ePROs will enable seamless digital access for patients, allowing them to report their QoL and well-being via online platforms or mobile applications. This digital transformation will increase accessibility, ease of use, and real-time monitoring, providing healthcare professionals with timely insights into PRO. Initial validation of the ePROs will include an assessment of their reliability and usability in a digital environment, ensuring that they maintain robustness and accuracy.