Patient-reported Outcomes (PROs) in clinical trials in paediatric dentistry

Area of Science:

• Health Services Research
• Clinical Trials Methodology
• Patient-Centered Care

Background:

• Patient-reported outcomes (PROs) are direct patient reports using validated measures (PROMs).
• PROs are increasingly used in clinical practice and research, offering benefits like reduced bias and enhanced accountability.
• Despite benefits, PRO data in clinical trials is frequently under-reported, hindering clinical practice adoption.

Purpose of the Study:

• To define PROs and PROMs and discuss their benefits.
• To guide the selection of appropriate PROMs for research questions.
• To address considerations for PRO use in pediatric dentistry and improve future reporting.

Main Methods:

• Literature review of PROs and PROMs in clinical research.
• Analysis of benefits and challenges associated with PRO data.
• Examination of reporting guidelines and case examples in pediatric dentistry.

Main Results:

• PROs provide valuable patient perspectives often missed by traditional assessments.
• Choosing the right PROM is crucial for valid and reliable data collection.
• Standardized reporting and core outcome sets can enhance PRO data utilization.

Conclusions:

• PROs are essential for patient-centered research, particularly in pediatric dentistry.
• Addressing under-reporting and improving data interpretation are key for clinical integration.
• Future research should focus on developing and implementing core outcome sets for consistent PRO reporting.