Guidance to develop a multidisciplinary, international, pediatric registry: a systematic review

Area of Science:

• Medical research
• Public health
• Health informatics

Background:

• The European Reference Network for craniofacial anomalies and ear, nose and throat disorders (ERN-CRANIO) aims to enhance craniofacial care across Europe.
• The cleft lip and palate (CL/P) work stream within ERN-CRANIO identified the necessity for a European registry to standardize outcome measures and therapy endpoints.
• This review provides a foundation for conceptualizing such a registry by examining prior registry initiatives.

Approach:

• A thematic analysis was conducted on twenty-four articles using narrative synthesis.
• An iterative process was employed to pinpoint critical themes essential for the long-term success of a registry.
• Both quantitative and qualitative data were analyzed, with quantitative findings presented in a table and qualitative themes summarized in guidance.

Key Points:

• Twenty-one distinct headings emerged from the literature analysis, encompassing both quantitative and qualitative data.
• Fourteen key themes crucial for registry success were identified through qualitative data analysis.
• The identified themes provide a framework for developing a robust registry.

Conclusions:

• This review successfully identified essential themes for creating an international, multidisciplinary pediatric registry for pan-European cleft care.
• The guidance derived from this review is applicable to ERN-CRANIO's objectives and can benefit other registry development initiatives.
• The findings support the establishment of a comprehensive registry to improve outcomes for patients with cleft lip and palate.