NPJ Digital Medicine最新文献

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Knowledge abstraction and filtering based federated learning over heterogeneous data views in healthcare 基于知识抽象和过滤的医疗保健领域异构数据视图联合学习
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-16 DOI: 10.1038/s41746-024-01272-9
Anshul Thakur, Soheila Molaei, Pafue Christy Nganjimi, Andrew Soltan, Patrick Schwab, Kim Branson, David A. Clifton
{"title":"Knowledge abstraction and filtering based federated learning over heterogeneous data views in healthcare","authors":"Anshul Thakur, Soheila Molaei, Pafue Christy Nganjimi, Andrew Soltan, Patrick Schwab, Kim Branson, David A. Clifton","doi":"10.1038/s41746-024-01272-9","DOIUrl":"10.1038/s41746-024-01272-9","url":null,"abstract":"Robust data privacy regulations hinder the exchange of healthcare data among institutions, crucial for global insights and developing generalised clinical models. Federated learning (FL) is ideal for training global models using datasets from different institutions without compromising privacy. However, disparities in electronic healthcare records (EHRs) lead to inconsistencies in ML-ready data views, making FL challenging without extensive preprocessing and information loss. These differences arise from variations in services, care standards, and record-keeping practices. This paper addresses data view heterogeneity by introducing a knowledge abstraction and filtering-based FL framework that allows FL over heterogeneous data views without manual alignment or information loss. The knowledge abstraction and filtering mechanism maps raw input representations to a unified, semantically rich shared space for effective global model training. Experiments on three healthcare datasets demonstrate the framework’s effectiveness in overcoming data view heterogeneity and facilitating information sharing in a federated setup.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-14"},"PeriodicalIF":12.4,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01272-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142440372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prospective clinical evaluation of deep learning for ultrasonographic screening of abdominal aortic aneurysms 用于腹主动脉瘤超声筛查的深度学习前瞻性临床评估
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-15 DOI: 10.1038/s41746-024-01269-4
I-Min Chiu, Tien-Yu Chen, You-Cheng Zheng, Xin-Hong Lin, Fu-Jen Cheng, David Ouyang, Chi-Yung Cheng
{"title":"Prospective clinical evaluation of deep learning for ultrasonographic screening of abdominal aortic aneurysms","authors":"I-Min Chiu, Tien-Yu Chen, You-Cheng Zheng, Xin-Hong Lin, Fu-Jen Cheng, David Ouyang, Chi-Yung Cheng","doi":"10.1038/s41746-024-01269-4","DOIUrl":"10.1038/s41746-024-01269-4","url":null,"abstract":"Abdominal aortic aneurysm (AAA) often remains undetected until rupture due to limited access to diagnostic ultrasound. This trial evaluated a deep learning (DL) algorithm to guide AAA screening by novice nurses with no prior ultrasonography experience. Ten nurses performed 15 scans each on patients over 65, assisted by a DL object detection algorithm, and compared against physician-performed scans. Ultrasound scan quality, assessed by three blinded expert physicians, was the primary outcome. Among 184 patients, DL-guided novices achieved adequate scan quality in 87.5% of cases, comparable to the 91.3% by physicians (p = 0.310). The DL model predicted AAA with an AUC of 0.975, 100% sensitivity, and 97.8% specificity, with a mean absolute error of 2.8 mm in predicting aortic width compared to physicians. This study demonstrates that DL-guided POCUS has the potential to democratize AAA screening, offering performance comparable to experienced physicians and improving early detection.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-6"},"PeriodicalIF":12.4,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01269-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142439732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Author Correction: Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning 作者更正:通过相互学习实现欧盟数字医疗器械评估和报销的协调统一
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-14 DOI: 10.1038/s41746-024-01285-4
Rosanna Tarricone, Francesco Petracca, Hannah-Marie Weller
{"title":"Author Correction: Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning","authors":"Rosanna Tarricone, Francesco Petracca, Hannah-Marie Weller","doi":"10.1038/s41746-024-01285-4","DOIUrl":"10.1038/s41746-024-01285-4","url":null,"abstract":"","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-1"},"PeriodicalIF":12.4,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01285-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142447883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Privacy-friendly evaluation of patient data with secure multiparty computation in a European pilot study 在一项欧洲试点研究中,通过安全的多方计算对患者数据进行隐私友好型评估
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-14 DOI: 10.1038/s41746-024-01293-4
Hendrik Ballhausen, Stefanie Corradini, Claus Belka, Dan Bogdanov, Luca Boldrini, Francesco Bono, Christian Goelz, Guillaume Landry, Giulia Panza, Katia Parodi, Riivo Talviste, Huong Elena Tran, Maria Antonietta Gambacorta, Sebastian Marschner
{"title":"Privacy-friendly evaluation of patient data with secure multiparty computation in a European pilot study","authors":"Hendrik Ballhausen, Stefanie Corradini, Claus Belka, Dan Bogdanov, Luca Boldrini, Francesco Bono, Christian Goelz, Guillaume Landry, Giulia Panza, Katia Parodi, Riivo Talviste, Huong Elena Tran, Maria Antonietta Gambacorta, Sebastian Marschner","doi":"10.1038/s41746-024-01293-4","DOIUrl":"10.1038/s41746-024-01293-4","url":null,"abstract":"In multicentric studies, data sharing between institutions might negatively impact patient privacy or data security. An alternative is federated analysis by secure multiparty computation. This pilot study demonstrates an architecture and implementation addressing both technical challenges and legal difficulties in the particularly demanding setting of clinical research on cancer patients within the strict European regulation on patient privacy and data protection: 24 patients from LMU University Hospital in Munich, Germany, and 24 patients from Policlinico Universitario Fondazione Agostino Gemelli, Rome, Italy, were treated for adrenal gland metastasis with typically 40 Gy in 3 or 5 fractions of online-adaptive radiotherapy guided by real-time MR. High local control (21% complete remission, 27% partial remission, 40% stable disease) and low toxicity (73% reporting no toxicity) were observed. Median overall survival was 19 months. Federated analysis was found to improve clinical science through privacy-friendly evaluation of patient data in the European health data space.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-12"},"PeriodicalIF":12.4,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01293-4.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142431356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A scoping review on advancements in noninvasive wearable technology for heart failure management 无创可穿戴技术在心力衰竭管理方面的进展范围综述
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-12 DOI: 10.1038/s41746-024-01268-5
Niels T. B. Scholte, Annemiek. E. van Ravensberg, Abdul Shakoor, Eric Boersma, Eelko Ronner, Rudolf A. de Boer, Jasper J. Brugts, Nico Bruining, Robert M. A. van der Boon
{"title":"A scoping review on advancements in noninvasive wearable technology for heart failure management","authors":"Niels T. B. Scholte, Annemiek. E. van Ravensberg, Abdul Shakoor, Eric Boersma, Eelko Ronner, Rudolf A. de Boer, Jasper J. Brugts, Nico Bruining, Robert M. A. van der Boon","doi":"10.1038/s41746-024-01268-5","DOIUrl":"10.1038/s41746-024-01268-5","url":null,"abstract":"Wearables offer a promising solution for enhancing remote monitoring (RM) of heart failure (HF) patients by tracking key physiological parameters. Despite their potential, their clinical integration faces challenges due to the lack of rigorous evaluations. This review aims to summarize the current evidence and assess the readiness of wearables for clinical practice using the Medical Device Readiness Level (MDRL). A systematic search identified 99 studies from 3112 found articles, with only eight being randomized controlled trials. Accelerometery was the most used measurement technique. Consumer-grade wearables, repurposed for HF monitoring, dominated the studies with most of them in the feasibility testing stage (MDRL 6). Only two of the described wearables were specifically designed for HF RM, and received FDA approval. Consequently, the actual impact of wearables on HF management remains uncertain due to limited robust evidence, posing a significant barrier to their integration into HF care.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-15"},"PeriodicalIF":12.4,"publicationDate":"2024-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01268-5.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142415369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Systematic review and meta-analysis of standalone digital interventions for cognitive symptoms in people without dementia 针对无痴呆症患者认知症状的独立数字干预措施的系统回顾和荟萃分析
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-10 DOI: 10.1038/s41746-024-01280-9
Veronica Cabreira, Tim Wilkinson, Lisbeth Frostholm, Jon Stone, Alan Carson
{"title":"Systematic review and meta-analysis of standalone digital interventions for cognitive symptoms in people without dementia","authors":"Veronica Cabreira, Tim Wilkinson, Lisbeth Frostholm, Jon Stone, Alan Carson","doi":"10.1038/s41746-024-01280-9","DOIUrl":"10.1038/s41746-024-01280-9","url":null,"abstract":"Cognitive symptoms are prevalent across neuropsychiatric disorders, increase distress and impair quality of life. Self-guided digital interventions offer accessibility, scalability, and may overcome the research-to-practice treatment gap. Seventy-six trials with 5214 participants were identified. A random-effects meta-analysis investigated the effects of all digital self-guided interventions, compared to controls, at post-treatment. We found a small-to-moderate positive pooled effect on cognition (k = 71; g = −0.51, 95%CI −0.64 to −0.37; p < 0.00001) and mental health (k = 30; g = −0.41, 95%CI −0.60 to −0.22; p < 0.0001). Positive treatment effects on fatigue (k = 8; g = −0.27, 95%CI −0.53 to −0.02; p = 0.03) and quality of life (k = 22; g = −0.17, 95%CI −0.34 to −0.00; p = 0.04) were only marginally significant. No significant benefit was found for performance on activities of daily living. Results were independent of control groups, treatment duration, risk of bias and delivery format. Self-guided digital transdiagnostic interventions may benefit at least a subset of patients in the short run, yet their impact on non-cognitive outcomes remains uncertain.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-21"},"PeriodicalIF":12.4,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01280-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142397857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Individualized decision making in on-scene resuscitation time for out-of-hospital cardiac arrest using reinforcement learning 利用强化学习在院外心脏骤停的现场复苏时间内做出个性化决策
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-09 DOI: 10.1038/s41746-024-01278-3
Dong Hyun Choi, Min Hyuk Lim, Ki Jeong Hong, Young Gyun Kim, Jeong Ho Park, Kyoung Jun Song, Sang Do Shin, Sungwan Kim
{"title":"Individualized decision making in on-scene resuscitation time for out-of-hospital cardiac arrest using reinforcement learning","authors":"Dong Hyun Choi, Min Hyuk Lim, Ki Jeong Hong, Young Gyun Kim, Jeong Ho Park, Kyoung Jun Song, Sang Do Shin, Sungwan Kim","doi":"10.1038/s41746-024-01278-3","DOIUrl":"10.1038/s41746-024-01278-3","url":null,"abstract":"On-scene resuscitation time is associated with out-of-hospital cardiac arrest (OHCA) outcomes. We developed and validated reinforcement learning models for individualized on-scene resuscitation times, leveraging nationwide Korean data. Adult OHCA patients with a medical cause of arrest were included (N = 73,905). The optimal policy was derived from conservative Q-learning to maximize survival. The on-scene return of spontaneous circulation hazard rates estimated from the Random Survival Forest were used as intermediate rewards to handle sparse rewards, while patients’ historical survival was reflected in the terminal rewards. The optimal policy increased the survival to hospital discharge rate from 9.6% to 12.5% (95% CI: 12.2–12.8) and the good neurological recovery rate from 5.4% to 7.5% (95% CI: 7.3–7.7). The recommended maximum on-scene resuscitation times for patients demonstrated a bimodal distribution, varying with patient, emergency medical services, and OHCA characteristics. Our survival analysis-based approach generates explainable rewards, reducing subjectivity in reinforcement learning.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-14"},"PeriodicalIF":12.4,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01278-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142385476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Screening chronic kidney disease through deep learning utilizing ultra-wide-field fundus images 通过深度学习利用超宽视场眼底图像筛查慢性肾病
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-07 DOI: 10.1038/s41746-024-01271-w
Xinyu Zhao, Xingwang Gu, Lihui Meng, Yongwei Chen, Qing Zhao, Shiyu Cheng, Wenfei Zhang, Tiantian Cheng, Chuting Wang, Zhengming Shi, Shengyin Jiao, Changlong Jiang, Guofang Jiao, Da Teng, Xiaolei Sun, Bilei Zhang, Yakun Li, Huiqin Lu, Changzheng Chen, Hao Zhang, Ling Yuan, Chang Su, Han Zhang, Song Xia, Anyi Liang, Mengda Li, Dan Zhu, Meirong Xue, Dawei Sun, Qiuming Li, Ziwu Zhang, Donglei Zhang, Hongbin Lv, Rishet Ahmat, Zilong Wang, Charumathi Sabanayagam, Xiaowei Ding, Tien Yin Wong, Youxin Chen
{"title":"Screening chronic kidney disease through deep learning utilizing ultra-wide-field fundus images","authors":"Xinyu Zhao, Xingwang Gu, Lihui Meng, Yongwei Chen, Qing Zhao, Shiyu Cheng, Wenfei Zhang, Tiantian Cheng, Chuting Wang, Zhengming Shi, Shengyin Jiao, Changlong Jiang, Guofang Jiao, Da Teng, Xiaolei Sun, Bilei Zhang, Yakun Li, Huiqin Lu, Changzheng Chen, Hao Zhang, Ling Yuan, Chang Su, Han Zhang, Song Xia, Anyi Liang, Mengda Li, Dan Zhu, Meirong Xue, Dawei Sun, Qiuming Li, Ziwu Zhang, Donglei Zhang, Hongbin Lv, Rishet Ahmat, Zilong Wang, Charumathi Sabanayagam, Xiaowei Ding, Tien Yin Wong, Youxin Chen","doi":"10.1038/s41746-024-01271-w","DOIUrl":"10.1038/s41746-024-01271-w","url":null,"abstract":"To address challenges in screening for chronic kidney disease (CKD), we devised a deep learning-based CKD screening model named UWF-CKDS. It utilizes ultra-wide-field (UWF) fundus images to predict the presence of CKD. We validated the model with data from 23 tertiary hospitals across China. Retinal vessels and retinal microvascular parameters (RMPs) were extracted to enhance model interpretability, which revealed a significant correlation between renal function and RMPs. UWF-CKDS, utilizing UWF images, RMPs, and relevant medical history, can accurately determine CKD status. Importantly, UWF-CKDS exhibited superior performance compared to CTR-CKDS, a model developed using the central region (CTR) cropped from UWF images, underscoring the contribution of the peripheral retina in predicting renal function. The study presents UWF-CKDS as a highly implementable method for large-scale and accurate CKD screening at the population level.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-11"},"PeriodicalIF":12.4,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01271-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142383835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Enabling data linkages for rare diseases in a resilient environment with the SERDIF framework 利用 SERDIF 框架,在弹性环境中实现罕见疾病的数据链接。
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-04 DOI: 10.1038/s41746-024-01267-6
Albert Navarro-Gallinad, Fabrizio Orlandi, Jennifer Scott, Enock Havyarimana, Neil Basu, Mark A. Little, Declan O’Sullivan
{"title":"Enabling data linkages for rare diseases in a resilient environment with the SERDIF framework","authors":"Albert Navarro-Gallinad, Fabrizio Orlandi, Jennifer Scott, Enock Havyarimana, Neil Basu, Mark A. Little, Declan O’Sullivan","doi":"10.1038/s41746-024-01267-6","DOIUrl":"10.1038/s41746-024-01267-6","url":null,"abstract":"Environmental factors amplified by climate change contribute significantly to the global burden of disease, disproportionately impacting vulnerable populations, such as individuals with rare diseases. Researchers require innovative, dynamic data linkage methods to enable the development of risk prediction models, particularly for diseases like vasculitis with unknown aetiology but potential environmental triggers. In response, we present the Semantic Environmental and Rare Disease Data Integration Framework (SERDIF). SERDIF was evaluated with researchers studying climate-related health hazards of vasculitis disease activity across European countries (NP1 = 10, NP2 = 17, NP3 = 23). Usability metrics consistently improved, indicating SERDIF’s effectiveness in linking complex environmental and health datasets. Furthermore, SERDIF-enabled epidemiologists to study environmental factors in a pregnancy cohort in Lombardy, showcasing its versatility beyond rare diseases. This framework offers for the first time a user-friendly, FAIR-compliant design for environment-health data linkage with export capabilities enabling data analysis to mitigate health risks posed by climate change.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-9"},"PeriodicalIF":12.4,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11452697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A scoping review of reporting gaps in FDA-approved AI medical devices 对 FDA 批准的人工智能医疗器械的报告差距进行范围审查
IF 12.4 1区 医学
NPJ Digital Medicine Pub Date : 2024-10-03 DOI: 10.1038/s41746-024-01270-x
Vijaytha Muralidharan, Boluwatife Adeleye Adewale, Caroline J. Huang, Mfon Thelma Nta, Peter Oluwaduyilemi Ademiju, Pirunthan Pathmarajah, Man Kien Hang, Oluwafolajimi Adesanya, Ridwanullah Olamide Abdullateef, Abdulhammed Opeyemi Babatunde, Abdulquddus Ajibade, Sonia Onyeka, Zhou Ran Cai, Roxana Daneshjou, Tobi Olatunji
{"title":"A scoping review of reporting gaps in FDA-approved AI medical devices","authors":"Vijaytha Muralidharan, Boluwatife Adeleye Adewale, Caroline J. Huang, Mfon Thelma Nta, Peter Oluwaduyilemi Ademiju, Pirunthan Pathmarajah, Man Kien Hang, Oluwafolajimi Adesanya, Ridwanullah Olamide Abdullateef, Abdulhammed Opeyemi Babatunde, Abdulquddus Ajibade, Sonia Onyeka, Zhou Ran Cai, Roxana Daneshjou, Tobi Olatunji","doi":"10.1038/s41746-024-01270-x","DOIUrl":"10.1038/s41746-024-01270-x","url":null,"abstract":"Machine learning and artificial intelligence (AI/ML) models in healthcare may exacerbate health biases. Regulatory oversight is critical in evaluating the safety and effectiveness of AI/ML devices in clinical settings. We conducted a scoping review on the 692 FDA-approved AI/ML-enabled medical devices approved from 1995-2023 to examine transparency, safety reporting, and sociodemographic representation. Only 3.6% of approvals reported race/ethnicity, 99.1% provided no socioeconomic data. 81.6% did not report the age of study subjects. Only 46.1% provided comprehensive detailed results of performance studies; only 1.9% included a link to a scientific publication with safety and efficacy data. Only 9.0% contained a prospective study for post-market surveillance. Despite the growing number of market-approved medical devices, our data shows that FDA reporting data remains inconsistent. Demographic and socioeconomic characteristics are underreported, exacerbating the risk of algorithmic bias and health disparity.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":" ","pages":"1-9"},"PeriodicalIF":12.4,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01270-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142368727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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