(P257) PATIENT-REPORTED OUTCOMES ARE UNDERUTILIZED IN VALVULAR CARDIAC SURGERY RANDOMIZED CLINICAL TRIALS: A SCOPING REVIEW

Background: The importance of using patient-reported outcome (PRO) measures in clinical trials is being increasingly recognized. However, there is a paucity of knowledge on the extent to which PROs are incorporated and adequately reported in the cardiac surgery literature. This study aims to establish the proportion of recent randomized controlled trials (RCTs) in adult valvular cardiac surgery RCTs that include PRO measures in their trial endpoints and to evaluate the completeness of PRO reporting in this setting.

METHODS AND RESULTS: A scoping review was conducted searching MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL). Studies were eligible for inclusion if they were RCTs in cardiac surgery comparing intraoperative valvular interventions in adult patients (≥ 18 years old), published between January 2014 and February 2024. Non-English studies and studies comparing valve surgeries to interventional cardiology procedures were excluded. Screening, full-text review and data extraction was carried out in duplicate. Studies including PROs as primary or secondary outcomes were evaluated for completeness of reporting as per the recommendations of the CONSORT-PRO extension guideline. Data was synthesized descriptively and summarized in tables and figures.

Of the 51 studies included, one-third of trials (31.4%) incorporated PROs (Figure 1). The most commonly reported PRO measure was the EuroQoL 5 dimensions (EQ-5D) (36.7%). Most PRO measures (73.3%) used were generic rather than disease-specific, and the majority were secondary endpoints (80.0%). Completeness of reporting in reference to the CONSORT-PRO was limited (Table 1). Overall, only 7 of 14 trials reported 50% or more of the relevant CONSORT-PRO specific items. No studies met all reporting criteria. The domain of PROs most frequently evaluated was quality of life, representing 76.7% of all PRO measures used.

Conclusion: In this scoping review, the use of PROs in valvular cardiac surgery RCTs was low and reporting on PROs is incomplete in reference to the CONSORT-PRO extension. Reported PROs primarily focus on quality-of-life measures, potentially missing other important domains relevant to the design of a patient-centered trial. The results of this study highlight the need for improvement in PRO incorporation and reporting in valvular cardiac surgery trials. Further review of PRO inclusion in other cardiac surgery subspecialties is required.