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Development of a Cocreated Decision Aid for Patients With Depression—Combining Data-Driven Prediction With Patients’ and Clinicians’ Needs and Perspectives: Mixed Methods Study

Development of a Cocreated Decision Aid for Patients With Depression—Combining Data-Driven Prediction With Patients’ and Clinicians’ Needs and Perspectives: Mixed Methods Study

In cases with more than two measurements, the last score within 365 days was used (see Section C in Multimedia Appendix 1). Prediction modeling was based on validated Dutch OQ-45 cutoff scores to assess a clinically relevant decrease in symptoms between two measurements (reliable change index: a decrease of at least 14 points in total score) [45,47].

Kaying Kan, Frederike Jörg, Klaas J Wardenaar, Frank J Blaauw, Maarten F Brilman, Ellen Visser, Dennis Raven, Dwayne Meijnckens, Erik Buskens, Danielle C Cath, Bennard Doornbos, Robert A Schoevers, Talitha L Feenstra

J Particip Med 2025;17:e67170

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

The Guidance of Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C mentions referencing 21 CFR 820.100(a)(2), which requires procedures for implementing corrections or preventive actions to include an investigation of the causes for nonconformities related to the product, processes, and quality systems.

Wei-Pin Chen, Wei-Guang Teng, C Benson Kuo, Yu-Jui Yen, Jian-Yu Lian, Matthew Sing, Peng-Ting Chen

JMIR Med Inform 2025;13:e67552

Association Between COVID-19 During Pregnancy and Preterm Birth by Trimester of Infection: Retrospective Cohort Study Using Large-Scale Social Media Data

Association Between COVID-19 During Pregnancy and Preterm Birth by Trimester of Infection: Retrospective Cohort Study Using Large-Scale Social Media Data

To assess the association between COVID-19 infection during pregnancy and preterm birth, we used the frequencies of these 2 categorical variables in a 2 × 2 contingency table to calculate the odds ratio (OR) with a 95% CI, where OR = (A/B) / (C/D) (Table 2).

Ari Z Klein, Shriya Kunatharaju, Su Golder, Lisa D Levine, Jane C Figueiredo, Graciela Gonzalez-Hernandez

J Med Internet Res 2025;27:e66097