Artificial Intelligence for Identifying Patient-Reported Outcome and Experience Measures in Oncology: Retrospective Cross-Sectional Study Using ClinicalTrials.gov

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Abstract
Background: Traditional health care systems have evolved to increasingly recognize patients’ perspectives as key to improving the quality of care, especially in oncology. Hence, patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) can enhance patient–health care provider communication while facilitating individualized care. This tailored approach improves patient outcomes and highlights the need for research methods to account for variability in patient experiences across diverse sociodemographic and clinical backgrounds while proposing artificial intelligence (AI) to automate and accelerate the identification of PROMs and PREMs. Objective: This study aimed to estimate the proportion of clinical studies including PROMs or PREMs, using either a traditional expert-based identification method or an AI-enriched approach. Methods: In a retrospective cross-sectional study using the ClinicalTrial.gov database, we focused on oncology studies between 2012 and 2022. Two methods were used to identify PROMs and PREMs: (1) a traditional expert-based method, where an algorithm identified PROMs and PREMs from a list of 346 oncology-specific PROMs and PREMs (extracted from the PROQOLID database, Mapi Research Trust) and/or 11 PROM- and PREM-specific terms, and (2) an AI-enriched method using a bidirectional encoder representations from transformers model, trained on 2399 outcomes labeled by experts. To evaluate algorithm performance, results were compared with expert decisions. Studies were classified by PROM/PREM use, analyzed using logistic regression to identify drivers, and a named entity recognition model identified frequently used measures. Results: A total of 24,491 studies were included. According to the traditional expert-based algorithm, 7549 (31%) studies used at least one PROM or PREM, as compared to 8029 (33%) studies identified by the AI-enriched algorithm, increasing from 2012 to 2022 (P<.001). With 90% (95% CI 88%-92%) accuracy, the AI-enriched algorithm outperformed (P<.001) the expert-based algorithm (84%, 95% CI 82%-86%) in identifying PROMs and PREMs. Breast and digestive cancers accounted for nearly 50% of all oncology studies using PROMs and PREMs, with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 being the most frequently used. As expected, trials in phases 2 to 4 more frequently included PROMs and PREMs than preclinical or early phase 1 studies (odds ratio [OR] 1.8, 95% CI 1.1-2.8 for phase 2; OR 3.6, 95% CI 2.3-5.8 for phase 3; and OR 2.6, 95% CI 1.6-4.4 for phase 4). In observational studies, cross-sectional and prospective studies incorporated more PROMs and PREMs than retrospective studies (OR 4.6, 95% CI 3.3-6.4 and OR 3.2, 95% CI 2.5-4.1, respectively). Conclusions: Our study shows that an AI-enriched algorithm outperforms traditional expert methods in identifying PROMs and PREMs in oncology. Combining expert-labeled data with AI enables scalable, automated trial monitoring, supports efficient research, informs stakeholders, enhances patient-centered decisions, and can be extended to other diseases and databases.

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