Patient-reported outcomes in atrial fibrillation clinical trials: trends, utilisation, and implications

Abstract

Abstract Background/Introduction Atrial fibrillation (AF) is the most prevalent clinical arrhythmia, and it is associated with diverse and consequential adverse outcomes that significantly impact the quality of life (QoL) experienced by patients. The evaluation and quantification of QoL have become an important aspect of assessing AF patients, with patient-reported outcomes (PROs) increasingly used in cardiovascular clinical trials. However, there is no consensus on which PROs are most suitable to report, and there is a limited understanding of their prevalence in AF clinical trials. Purpose This study aims to characterise the utilisation of PROs in AF clinical trials. We distinguish between AF-specific and AF-agnostic PROs, with the goal of understanding the evolving role of PROs and emphasising the significance of precise measurement of patient QoL in AF research. Methods We queried the ClinicalTrials.gov database for all available clinical trials that focused on AF as the primary condition from inception to August 1, 2023. This search yielded 3,208 clinical trials, encompassing a total of 65,545,864 participants. We filtered and manually reviewed each clinical trial for their use of PROs within the "outcomes measures" field and divided the results between AF-specific and AF-agnostic PROs. We displayed these findings over time (Figure) and conducted a linear regression analysis for each PRO. Results Of the 3,208 AF clinical trials, 569 (17.7%) reported using at least one PRO, with 178 (5.5%) using AF-specific PROs. There was a statistically significant increase in the use of PROs between 2000 and 2023 (8 vs. 518; P < 0.001; R2= 0.959). This finding held for both AF-specific PROs between 2000 and 2023 (0 vs. 79; P < 0.001; R2=0.930) and AF-agnostic PROs between 2000 and 2023 (8 vs. 360; P < 0.001; R2=0.969). The Atrial Fibrillation Effect on Quality-of-life (AFEQT) was the most used AF-specific PRO, utilized 130 times, with its usage increasing between 2000 and 2023 (0 vs. 61; P = 0.003; R2= 0.888). The EQ-5D was the most frequently used AF-agnostic PRO, employed 131 times. Conclusion The study reveals a significant increase in the use of PROs in AF clinical trials over time. While most trials use AF-agnostic PROs for measuring QoL, several AF-specific PROs, especially AFEQT, have gained wide adoption. These findings underscore the importance of patient-centred outcomes and suggest the increasing emphasis on PROs in AF research. However, significant heterogeneity remains in the choice of PROs, with limited utilisation of validated, AF-specific measures. Future research should focus on understanding the distinct strengths and limitations of AF-specific PROs compared to AF-agnostic ones and promoting their appropriate integration into AF clinical trials to improve patient-centred care for AF patients.Figure