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

Patient-reported outcomes (PROs) are reports directly from patients without interpretation by clinicians or others and captured using validated patient-reported outcome measures (PROMs). These measures are increasingly employed in clinical practice and can be incorporated into clinical trials. Benefits of using PROs include reducing observer bias; eliciting unique views on aspects important to patients and increasing public accountability. Despite inclusion in clinical trials PRO data is often under-reported and the results may not be adopted into clinical practice due to concerns about the data generated. This review discusses what PROs are and how to measure them; the benefits of using PROs; how to choose an appropriate PROM to answer the research question; considerations for using PROs in paediatric dentistry and reporting guidelines. Finally, some examples of how PROs have been included in paediatric dentistry trials are given along with discussion of the development of core outcome sets and how these may improve reporting of PROs in the future.