Detection of obstetric anal sphincter injuries using machine learning-assisted impedance spectroscopy: a prospective, comparative, multicentre clinical study.

IF 3.9 2区 综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES
Katarzyna Borycka, Marcel Młyńczak, Maciej Rosoł, Kacper Korzeniewski, Piotr Iwanowski, Hynek Heřman, Petr Janku, Małgorzata Uchman-Musielak, Erik Dosedla, Enrique Gonzalez Diaz, Iwona Sudoł-Szopińska, Michał Mik, Carlo Ratto, Antonino Spinelli
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引用次数: 0

Abstract

To evaluate the clinical performance and safety of the ONIRY system for obstetric anal sphincter injuries (OASI) detection versus three-dimensional endoanal ultrasound (EAUS). A prospective, comparative, multicentre, international study. Poland, Czechia, Slovakia, and Spain. 152 women between the first moments up to 8 weeks after vaginal delivery. Participants underwent EAUS and were allocated to groups based on OASIS classification: A (no perineal tear), B (1st or 2nd degree tear), or C (3rd or 4th degree, anal sphincters affected). Electric impedance was measured in the anal canal using the ONIRY system. The primary endpoint was the diagnostic outcome of impedance spectroscopy versus EAUS. Adverse events were collected. Part II involved in silico modelling and 10-time 10-fold cross-validation for automated analysis. Accuracy, sensitivity, and specificity. 30 women were allocated to group A, 61 to group B, and 61 to group C. The diagnostic outcome was determined for 147 participants. The accuracy, sensitivity, and specificity of the ML-assisted impedance spectroscopy were 87.0 ± 0.5%, 90.6 ± 2.0%, and 84.6 ± 1.9%, respectively, compared with EAUS. After data cleaning, the performance metrics of the proposed final ML model for ONIRY were: 90.0 ± 0.4%, 90.0 ± 1.2%, and 90.0 ± 0.7%, respectively. No adverse device effects or deficiencies were observed. By enabling early identification of sphincter injuries, ML-assisted impedance spectroscopy facilitates timely diagnosis and intervention, potentially reducing long-term complications such as faecal incontinence. Its rapid, bedside application in obstetric settings supports immediate postpartum care, complementing digital rectal examination and optimizing clinical decision-making.

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利用机器学习辅助阻抗光谱检测产科肛门括约肌损伤:一项前瞻性、比较性、多中心临床研究。
评价ONIRY系统在产科肛门括约肌损伤(OASI)检测中的临床表现和安全性,与三维肛管超声(EAUS)相比。一个前瞻性的、比较的、多中心的、国际性的研究。波兰,捷克,斯洛伐克和西班牙。152名妇女在阴道分娩后的最初时刻到8周之间。参与者接受了EAUS,并根据OASIS分类分为A(无会阴撕裂),B(1或2度撕裂)或C(3或4度,肛门括约肌受影响)组。使用ONIRY系统测量肛管内电阻抗。主要终点是阻抗谱与EAUS的诊断结果。收集不良事件。第二部分涉及硅建模和10- 10倍交叉验证自动化分析。准确性、敏感性和特异性。30名女性被分配到A组,61名女性被分配到B组,61名女性被分配到c组。147名参与者的诊断结果被确定。与EAUS相比,ml辅助阻抗谱的准确性、灵敏度和特异性分别为87.0±0.5%、90.6±2.0%和84.6±1.9%。数据清洗后,最终提出的ONIRY ML模型的性能指标分别为:90.0±0.4%,90.0±1.2%和90.0±0.7%。没有观察到不良的器械效应或缺陷。通过早期识别括约肌损伤,ml辅助阻抗谱有助于及时诊断和干预,潜在地减少大便失禁等长期并发症。它的快速,床边应用在产科设置支持即时产后护理,补充直肠指检和优化临床决策。
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来源期刊
Scientific Reports
Scientific Reports Natural Science Disciplines-
CiteScore
7.50
自引率
4.30%
发文量
19567
审稿时长
3.9 months
期刊介绍: We publish original research from all areas of the natural sciences, psychology, medicine and engineering. You can learn more about what we publish by browsing our specific scientific subject areas below or explore Scientific Reports by browsing all articles and collections. Scientific Reports has a 2-year impact factor: 4.380 (2021), and is the 6th most-cited journal in the world, with more than 540,000 citations in 2020 (Clarivate Analytics, 2021). •Engineering Engineering covers all aspects of engineering, technology, and applied science. It plays a crucial role in the development of technologies to address some of the world''s biggest challenges, helping to save lives and improve the way we live. •Physical sciences Physical sciences are those academic disciplines that aim to uncover the underlying laws of nature — often written in the language of mathematics. It is a collective term for areas of study including astronomy, chemistry, materials science and physics. •Earth and environmental sciences Earth and environmental sciences cover all aspects of Earth and planetary science and broadly encompass solid Earth processes, surface and atmospheric dynamics, Earth system history, climate and climate change, marine and freshwater systems, and ecology. It also considers the interactions between humans and these systems. •Biological sciences Biological sciences encompass all the divisions of natural sciences examining various aspects of vital processes. The concept includes anatomy, physiology, cell biology, biochemistry and biophysics, and covers all organisms from microorganisms, animals to plants. •Health sciences The health sciences study health, disease and healthcare. This field of study aims to develop knowledge, interventions and technology for use in healthcare to improve the treatment of patients.
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