Utilization of patient-reported outcome measures in plastic surgery clinical trials: A systematic review.

[BACKGROUND] Patient-reported outcomes (PROs) have evolved to validated questionnaires assessing health-related quality of life. This systematic review evaluates the utilization of PROs in United States plastic and reconstructive surgery (PRS) clinical trials (CTs).

[METHODS] A medical librarian conducted a search strategy for PRS CTs from 2012 to 2022. CTs were identified and assessed for PRO utilization. Summary statistics were performed, and Fisher's exact test was used for subgroup analysis.

[RESULTS] Of the 3609 studies initially identified, 154 were PRS CTs. Approximately half (80 studies) employed PROs, encompassing 13,190 participants, 95% (12,229) of whom were female. Among the CTs, 37 (48%) were in the field of reconstruction, while 25 (32%) were cosmetic. Pain (35%) and patient satisfaction (24%) were the most common primary outcomes. Validated PROs were the main outcome in 61% of these trials, with the visual analog scale (19%) and BREAST-Q (15%) as the top instruments. Funding was primarily private (34%) or not reported (49%). No significant trend in validated PRO usage was observed over the examined decade.

[CONCLUSIONS] The use of PROs is relevant for healthcare delivery and improvement as they provide insight into the efficacy of treatments from a patient-centered viewpoint. PROs are reported in just over half of PRS CTs, and within those CTs, the use of validated questionnaires is inconsistent. Therefore, emerging CTs should strive to incorporate PRO measures and utilize the existing validated tools to assess novel interventions and ensure that the data reported is objective.