Use and Interpretation of Patient-Reported Outcome Measures in Randomized Controlled Trials in Prosthodontics.

Abstract

Background: Despite growing emphasis on patient-centered care, the extent to which patient-reported outcome measures (PROMs) are used, reported, and interpreted in prosthodontic randomized controlled trials (RCTs) remains unclear. This study evaluates the frequency, reporting quality, and interpretability of PROMs in RCTs in prosthodontics published between 2020 and 2025.

Material and methods: 228 RCTs from high-impact dental and prosthodontic-specific journals were included. Date were extracted on PROM inclusion and use as primary outcomes, reporting of point estimates and confidence intervals, evidence of validity, reliability, and responsiveness, and use of minimal important difference (MID). Univariable and multivariable logistic regression assessed factors associated with PROM inclusion.

Results: Among 228 trials, 44.3% (n=101) reported PROMs in abstracts and 49.6 % (n=113) in the main text; 39.8 % (n=45) used them as primary outcomes. Only 38.1 % (n=43) reported point estimates with confidence intervals. Evidence of PROM validity, reliability and responsiveness was rarely (15%, n=17) reported. Only two studies (1.8 %) used a MID to interpret trial results. PROM use was more likely in studies assessing the effect of complete denture and esthetic interventions. A slight upward trend in PROM use was observed over time. However, it was not statistically significant.

Conclusion: The use of PROMs is increasing slightly but remains inconsistent and lacks methodological rigor. The absence of PROM data in RCTs limits clinical applicability. Greater adherence to methodological standards and reporting statements, including the use of MID and core outcome sets, is essential to improve the quality and relevance of future prosthodontic research.