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Uterine fibroids and risk of hypertensive disorders of pregnancy; results from a racially diverse high-risk cohort 子宫肌瘤与妊娠高血压疾病的风险;来自不同种族高风险人群的结果
Pub Date : 2024-03-07 DOI: 10.1101/2024.03.05.24303830
Katherine Cameron, Mostafa Borahay, Xiumei Hong, Valerie Baker, Arthur Vaught, Xiaobin Wang
Study Question: What is the impact of the presence of uterine fibroids on the risk of developing hypertensive disorders of pregnancy (HDP) in a predominantly urban, low-income, Black, and Hispanic population of women with ultrasound or clinically diagnosed uterine fibroids with rich phenotypic data to carefully control for potential confounders?Summary answers: The odds of HDP were 39% higher in women with uterine fibroids compared to those without when controlled for age at delivery, race, prepregnancy BMI, education, parity, and smoking status; neither fibroid location or size modified this risk.What is known already: Studies are conflicting regarding the impact of uterine fibroids on risk of HDP; limitations of prior studies include primarily Western European populations and lack of measurement of potential confounders. Study design, size, and duration: A total of 7030 women from the Boston Birth Cohort (a racially diverse cohort recruited from 1998 to 2018) that had clinical and ultrasound data regarding uterine fibroid status were included in this analysis. Participants/materials, setting, and methods: Four hundred eighty-nine women with uterine fibroids and 6541 women without were included. Hypertensive disorders of pregnancy were ascertained from medical records. Logistic regression was performed to assess the risk of HDP in women with and without uterine fibroids. Covariates adjusted for included age at delivery, race, pre-pregnancy BMI, education, parity, and smoking status during pregnancy. Sub-analyses were performed to assess the impact of specific fibroid location and overall fibroid volume burden.Main results and the role of chance: The incidence of uterine fibroids in the cohort was 7% (N=489). Twelve percent of women without uterine fibroids and 17% of women with fibroids developed HDP; in multivariate analyses adjusted for the potential confounders above, the odds of HDP were 39% higher in women with uterine fibroids compared to those without (p=0.03). Women with a uterine fibroid diagnosis based on ICD code (n=297) versus asymptomatic incidental ultrasound diagnosis (n=192) had a significantly greater chance of developing HDP (20 vs 15%, p=0.006). There did not appear to be an association between number of fibroids or total fibroid volume and the risk of developing HDP. Limitations, reasons for caution: This study has a relatively small sample size. While post-hoc power calculation determined that there was adequate power to detect a 4.6% difference in the incidence of development of HDP between participants with uterine fibroids and those without, the sub-analyses based on fibroid size, location, and method of diagnosis were underpowered to determine a similar level of difference.Wider implications of the findings: In a racially diverse cohort, presence of uterine fibroids was a significant risk factor for developing HDP, regardless of uterine fibroid size or location. This may have implications for additional monitoring an
研究问题:在一个以城市、低收入、黑人和西班牙裔为主的人群中,超声或临床诊断出子宫肌瘤的妇女具有丰富的表型数据,可以仔细控制潜在的混杂因素,那么子宫肌瘤的存在对妊娠高血压疾病(HDP)的发病风险有何影响?在控制了分娩年龄、种族、孕前体重指数、教育程度、胎次和吸烟状况后,与无子宫肌瘤的妇女相比,有子宫肌瘤的妇女发生 HDP 的几率要高出 39%;肌瘤的位置或大小都不会改变这种风险:关于子宫肌瘤对 HDP 风险的影响,研究结果相互矛盾;以往研究的局限性包括研究对象主要是西欧人,以及缺乏对潜在混杂因素的测量。研究设计、规模和持续时间:共有 7030 名来自波士顿出生队列(1998 年至 2018 年期间招募的种族多元化队列)、拥有子宫肌瘤状态相关临床和超声波数据的女性被纳入本次分析。参与者/材料、环境和方法:纳入了 489 名患有子宫肌瘤的女性和 6541 名未患有子宫肌瘤的女性。从医疗记录中确定了妊娠高血压疾病。通过逻辑回归评估了患有和未患有子宫肌瘤的妇女罹患 HDP 的风险。调整的协变量包括分娩年龄、种族、孕前体重指数、教育程度、胎次和孕期吸烟状况。还进行了子分析,以评估特定肌瘤位置和总体肌瘤体积负担的影响:队列中子宫肌瘤的发病率为 7%(N=489)。12%的无子宫肌瘤妇女和17%的有子宫肌瘤妇女发生了HDP;在对上述潜在混杂因素进行调整的多变量分析中,与无子宫肌瘤的妇女相比,有子宫肌瘤的妇女发生HDP的几率要高出39%(P=0.03)。根据 ICD 编码诊断出子宫肌瘤的妇女(人数=297)与无症状偶然超声诊断出子宫肌瘤的妇女(人数=192)相比,患 HDP 的几率明显更高(20 比 15%,P=0.006)。子宫肌瘤数目或肌瘤总体积与罹患HDP的风险之间似乎没有关联。局限性,需谨慎的原因:本研究的样本量相对较小。虽然事后功率计算确定有足够的功率来检测有子宫肌瘤和没有子宫肌瘤的参与者之间4.6%的HDP发病率差异,但基于肌瘤大小、位置和诊断方法的子分析功率不足,无法确定类似程度的差异:研究结果的广泛意义:在一个种族多元化的队列中,无论子宫肌瘤的大小或位置如何,子宫肌瘤的存在都是罹患HDP的一个重要风险因素。这可能会对患有子宫肌瘤的妇女进行额外监测和风险分层产生影响:KC由WRHR NIH NICHD Award # K12 HD103036支持,PI为Andrew Satin,RD为James Segars。波士顿出生队列(母研究)部分由美国国立卫生研究院(NIH)资助(2R01HD041702、R01HD098232、R01ES031272、R01ES031521 和 U01 ES034983);以及美国卫生与公众服务部(HHS)卫生资源与服务管理局(HRSA)资助(UT7MC45949)。这些信息或内容及结论仅代表作者个人观点,不应被视为任何资助机构的官方立场或政策,也不应被推断为任何资助机构的认可。试验注册号:BBC 已在 clinicaltrials.gov NCT03228875 注册。
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引用次数: 0
Development and Evaluation of Deep Learning Models for Cardiotocography Interpretation 开发和评估用于心动图解读的深度学习模型
Pub Date : 2024-03-06 DOI: 10.1101/2024.03.05.24303805
Nicole Chiou, Nichole Young-Lin, Christopher Kelly, Tiya Tiyasirichokchai, Abdoulaye Diack, Sanmi Koyejo, Katherine Heller, Mercy Nyamewaa Asiedu
The inherent variability in the visual interpretation of cardiotocograms (CTGs) by obstetric clinical experts, both intra- and inter-observer, presents a substantial challenge in obstetric care. In response, we investigate automated CTG interpretation as a potential solution to enhance the early detection of fetal hypoxia during labor, which has the potential to reduce unnecessary operative interventions and improve overall maternal and neonatal care. This study employs deep learning techniques to reduce the subjectivity associated with visual CTG interpretation. Our results demonstrate that using objective umbilical cord blood pH outcome measurements, rather than clinician-defined Apgar scores, yields more consistent and robust model performance. Additionally, through a series of ablation studies, we explore the impact of temporal distribution shifts on the performance of these deep learning models. We examine tradeoffs between performance and fairness, specifically evaluating performance across demographic and clinical subgroups. Finally, we discuss the practical implications of our findings for the real-world deployment of such systems, emphasizing their potential utility in medical settings with limited resources.
产科临床专家在对胎心图(CTG)进行肉眼判读时,会出现观察者内部和观察者之间的固有差异,这给产科护理带来了巨大挑战。为此,我们将研究自动 CTG 解读作为一种潜在的解决方案,以加强分娩过程中胎儿缺氧的早期检测,这有可能减少不必要的手术干预,并改善孕产妇和新生儿的整体护理。这项研究采用了深度学习技术,以减少与可视 CTG 解读相关的主观性。我们的研究结果表明,使用客观的脐带血 pH 值结果测量,而不是临床医生定义的 Apgar 评分,能产生更一致、更稳健的模型性能。此外,通过一系列消融研究,我们探索了时间分布变化对这些深度学习模型性能的影响。我们研究了性能和公平性之间的权衡,特别是评估了不同人口和临床亚群的性能。最后,我们讨论了我们的研究结果对现实世界部署此类系统的实际影响,强调了它们在资源有限的医疗环境中的潜在用途。
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引用次数: 0
Perceived acceptability of self-administered topical therapy for cervical precancer treatment among women undergoing cervical cancer screening in Kenya 肯尼亚接受宫颈癌筛查的妇女对宫颈癌前病变自我局部治疗的接受程度
Pub Date : 2024-03-06 DOI: 10.1101/2024.03.05.24303779
Chemtai Mungo, Grace Ellis, Mercy Rop, Yating Zou, Jackton Omoto, Lisa Rahangdale
Purpose: Innovative strategies are urgently needed to meet the World Health Organizations 2030 target of treating 90% of women with precancerous cervical lesions, especially in countries most affected by cervical cancer. We assessed the acceptability of self-administered intravaginal therapies for treating cervical precancer in women undergoing cervical cancer screening and precancer treatment in Kenya. Methods: We conducted a cross-sectional study among women aged 18 to 65 years undergoing cervical cancer screening or precancer treatment between January and October 2023 in Kisumu County, Kenya. Participants completed a questionnaire about their perceptions and perceived acceptability of self- or provider-administered topical therapies for cervical precancer treatment. Quantitative data were summarized using descriptive statistics. Results: A total of 379 questionnaires were completed. The median age of participants was 35 years (IQR 25-62), 62% had a primary education or less, and 71% earned $5 or less daily. All participants had been screened for cervical cancer, and 191 (51%) had received precancer treatment, primarily thermal ablation. Ninety-eight percent of participants were willing to use a self-administered intravaginal therapy for cervical precancer, if available. The majority, 91%, believed their male partner would support their use. Given a choice, 63% preferred self-admiration at home compared to provider-administration of a topical therapy in the clinic, citing time and cost savings. In multivariate analysis, married women were more likely to expect partner support for self-administration than single women. Participants preferred a therapy used less frequently but for a longer duration, compared to daily use therapy with a shorter duration of use. Conclusions: Self-administered intravaginal therapies for cervical precancer treatment are highly acceptable among women undergoing screening and precancer treatment in Kenya.
目的:要实现世界卫生组织提出的 2030 年治疗 90% 宫颈癌前病变妇女的目标,迫切需要创新策略,尤其是在受宫颈癌影响最严重的国家。我们评估了肯尼亚接受宫颈癌筛查和癌前病变治疗的妇女对自控阴道内疗法治疗宫颈癌前病变的接受程度。研究方法我们对 2023 年 1 月至 10 月期间在肯尼亚基苏木县接受宫颈癌筛查或癌前病变治疗的 18 至 65 岁女性进行了一项横断面研究。参与者填写了一份调查问卷,内容涉及她们对宫颈癌前病变治疗的自我或医疗服务提供者提供的局部疗法的看法和可接受性。采用描述性统计对定量数据进行了总结。结果:共完成 379 份问卷。参与者的年龄中位数为 35 岁(IQR 25-62),62% 接受过初等教育或以下,71% 每日收入在 5 美元或以下。所有参与者都接受过宫颈癌筛查,191 人(51%)接受过癌前治疗,主要是热消融治疗。如果有阴道内自控疗法,98% 的参与者愿意使用这种疗法治疗宫颈癌前病变。大多数人(91%)认为他们的男性伴侣会支持他们使用这种疗法。如果可以选择,63%的人愿意在家自行使用,而不愿意在诊所接受外用疗法,理由是可以节省时间和费用。在多变量分析中,与单身女性相比,已婚女性更希望得到伴侣的支持。与每天使用但持续时间较短的疗法相比,参与者更倾向于使用频率较低但持续时间较长的疗法。结论在肯尼亚,接受筛查和宫颈癌前病变治疗的妇女对阴道内自控疗法治疗宫颈癌前病变的接受度很高。
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引用次数: 0
Fetal Growth Associated with Maternal Rheumatoid Arthritis and Juvenile Idiopathic Arthritis. 胎儿发育与母体类风湿关节炎和幼年特发性关节炎有关。
Pub Date : 2024-03-04 DOI: 10.1101/2024.02.29.24303573
Eugenia Y Chock, Zeyan Liew, Lars Henning Pedersen, Mette Oestergaard Thunbo
Background: Prior studies indicated that women with rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA) are at twice higher risk of developing adverse pregnancy outcomes, this include preterm births and infants with low birth weight. A wide knowledge gap exists in our current understanding of how RA and JIA affect fetal growth during pregnancy. Objective: We aimed to evaluate fetal growth among patients with RA/JIA by comparing fetal growth indicators of offspring born to this population, compared to individuals without RA/JIA. We hypothesized that fetal growth among patients with RA/JIA is reduced, compared to individuals without RA/JIA. Study Design: We conducted a population-based cohort study in Denmark from 2008-2018 which included 503,491 individuals with singleton pregnancies. Among them, 2,206 were patients with RA and JIA. We linked several nationwide databases and clinical registries in Denmark to achieve our aim. Through the Danish Fetal Medicine Database (DFMD), we obtained fetal biometric measurements gathered from second trimester fetal ultrasound scans. We used International Classification of Diseases (ICD)-10 codes to identify pregnant patients with RA/JIA from the Danish National Patient Registry and linked them to the DFMD, other variables of interest were obtained from different Danish clinical registries. Next, we computed fetal growth gradient between second trimester and birth, using the mean difference in Z-score distances for each fetal growth indicator. We also estimated the risk of small for gestational age (SGA), all outcomes were compared between pregnant individuals with and without RA/JIA and adjusted for confounders. Results: Maternal RA and JIA was not associated with a reduction of estimated fetal weight (EFW) at mid-pregnancy [adjusted mean EFW Z-score difference of 0.05 (95% CI 0.01, 0.10; p=0.022)], but lower birth weights were observed among offspring [adjusted mean Z-score difference of -0.08 (95% CI -0.13, -0.04; p<0.001)]. We observed reduced mean Z-score differences in weight gradient from second trimester to birth among offspring of patients with RA/JIA who also used corticosteroids [-0.26 (95% CI -0.11, -0.41; p<0.001)], and sulfasalazine [-0.61 (95% CI -0.45, -0.77; p<0.001)] during pregnancy. Maternal RA/JIA was also associated with SGA [aOR of 1.47 (95% CI 1.16, 1.83; p<0.001)]. Similarly, the risk estimates were higher among corticosteroid [aOR 3.44 (95% CI 2.14, 5.25; p<0.001)] and sulfasalazine [(aOR 2.28 (95% CI 1.22, 3.88; p=0.005) users. Conclusion: Among pregnant patients with RA/JIA, fetal growth restriction may be most apparent after 18 to 22 weeks of gestational age. Closer antenatal monitoring around this period should be considered for this population.
背景:先前的研究表明,患有类风湿性关节炎(RA)和幼年特发性关节炎(JIA)的妇女发生不良妊娠结局的风险比正常人高一倍,其中包括早产和出生体重不足的婴儿。目前,我们对 RA 和 JIA 如何影响孕期胎儿生长的认识还存在很大差距。研究目的我们旨在通过比较RA/JIA患者与非RA/JIA患者的后代的胎儿生长指标,评估RA/JIA患者的胎儿生长情况。我们假设,与未患有 RA/JIA 的个体相比,RA/JIA 患者的胎儿发育会减慢。研究设计:我们于 2008-2018 年在丹麦开展了一项基于人群的队列研究,共纳入 503,491 名单胎妊娠者。其中,2206 人为 RA 和 JIA 患者。为了达到研究目的,我们将丹麦多个全国性数据库和临床登记处联系起来。通过丹麦胎儿医学数据库(Danish Fetal Medicine Database,DFMD),我们获得了从第二孕期胎儿超声扫描中收集到的胎儿生物测量数据。我们使用国际疾病分类(ICD)-10代码从丹麦全国患者登记册中识别出患有RA/JIA的孕妇,并将他们与DFMD连接起来,其他相关变量则从丹麦不同的临床登记册中获得。接下来,我们利用每个胎儿生长指标的 Z 评分距离的平均差,计算了第二孕期到出生时的胎儿生长梯度。我们还估算了胎龄过小(SGA)的风险,所有结果都在患有和未患有RA/JIA的孕妇之间进行了比较,并对混杂因素进行了调整。结果显示母体RA和JIA与孕中期估计胎儿体重(EFW)的降低无关[调整后的平均EFW Z-score差异为0.05(95% CI为0.01,0.10;p=0.022)],但观察到后代出生体重较低[调整后的平均Z-score差异为-0.08(95% CI为-0.13,-0.04;p<0.001)]。我们观察到,在怀孕期间使用皮质类固醇[-0.26 (95% CI -0.11, -0.41;p<0.001)]和柳氮磺胺吡啶[-0.61 (95% CI -0.45, -0.77;p<0.001)]的RA/JIA患者,其后代从怀孕后三个月到出生时体重梯度的平均Z-score差异减小。母体 RA/JIA 也与 SGA 相关[aOR 为 1.47 (95% CI 1.16, 1.83; p<0.001)]。同样,皮质类固醇[aOR 3.44 (95% CI 2.14, 5.25; p<0.001)]和柳氮磺胺吡啶[(aOR 2.28 (95% CI 1.22, 3.88; p=0.005)]使用者的风险估计值更高。结论在患有 RA/JIA 的孕妇中,胎儿生长受限可能在胎龄 18-22 周后最为明显。应考虑在这一时期对该人群进行更密切的产前监测。
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引用次数: 0
Exploring the Capabilities of ChatGPT in Women's Health 探索 ChatGPT 在妇女健康方面的功能
Pub Date : 2024-02-28 DOI: 10.1101/2024.02.27.23300005
Magdalena Elisabeth Bachmann, Ioana Duta, Emily Mazey, William Cooke, Manu Vatish, Gabriel Davis Jones
Introduction: Artificial Intelligence (AI) is redefining healthcare, with Large Language Models (LLMs) like ChatGPT offering novel and powerful capabilities in processing and generating human-like information. These advancements offer potential improvements in Women's Health, particularly Obstetrics and Gynaecology (O&G), where diagnostic and treatment gaps have long existed. Despite its generalist nature, ChatGPT is increasingly being tested in healthcare, necessitating a critical analysis of its utility, limitations and safety. This study examines ChatGPT's performance in interpreting and responding to international gold standard benchmark assessments in O&G: the RCOG's MRCOG Part One and Two examinations. We evaluate ChatGPT's domain- and knowledge area-specific accuracy, the influence of linguistic complexity on performance and its self-assessment confidence and uncertainty, essential for safe clinical decision-making. Methods: A dataset of MRCOG examination questions from sources beyond the reach of LLMs was developed to mitigate the risk of ChatGPT's prior exposure. A dual-review process validated the technical and clinical accuracy of the questions, omitting those dependent on previous content, duplicates, or requiring image interpretation. Single Best Answer (SBA) and Extended Matching (EMQ) Questions were converted to JSON format to facilitate ChatGPT's interpretation, incorporating question types and background information. Interaction with ChatGPT was conducted via OpenAI's API, structured to ensure consistent, contextually informed responses from ChatGPT. The response from ChatGPT was recorded and compared against the known accurate response. Linguistic complexity was evaluated using unique token counts and Type-Token ratios (vocabulary breadth and diversity) to explore their influence on performance. ChatGPT was instructed to assign confidence scores to its answers (0-100%), reflecting its self-perceived accuracy. Responses were categorized by correctness and statistically analysed through entropy calculation, assessing ChatGPT's capacity for self-evaluating certainty and knowledge boundaries. Findings: Of 1,824 MRCOG Part One and Two questions, ChatGPT's accuracy on MRCOG Part One was 72.2% (95% CI 69.2-75.3). For Part Two, it achieved 50.4% accuracy (95% CI 47.2-53.5) with 534 correct out of 989 questions, performing better on SBAs (54.0%, 95% CI 50.0-58.0) than on EMQs (45.0%, 95% CI 40.1-49.9). In domain-specific performance, the highest accuracy was in Biochemistry (79.8%, 95% CI 71.4-88.1) and the lowest in Biophysics (51.4%, 95% CI 35.2-67.5). The best-performing subject in Part Two was Urogynaecology (63.0%, 95% CI 50.1-75.8) and the worst was Management of Labour (35.6%, 95% CI 21.6-49.5). Linguistic complexity analysis showed a marginal increase in unique token count for correct answers in Part One (median 122, IQR 114-134) compared to incorrect (median 120, IQR 112-131, p=0.05). TTR analysis revealed higher medians
简介人工智能(AI)正在重新定义医疗保健,像 ChatGPT 这样的大型语言模型(LLM)在处理和生成类人信息方面提供了新颖而强大的功能。这些进步为改善妇女健康,特别是妇产科(O&G)提供了可能,因为妇产科在诊断和治疗方面长期存在差距。尽管 ChatGPT 具有通用性,但它正越来越多地应用于医疗保健领域,因此有必要对其实用性、局限性和安全性进行批判性分析。本研究考察了 ChatGPT 在解释和应对国际妇产科黄金标准基准评估(RCOG 的 MRCOG 第一和第二部分考试)方面的性能。我们评估了 ChatGPT 在特定领域和知识领域的准确性、语言复杂性对性能的影响及其自我评估的信心和不确定性,这对安全的临床决策至关重要。方法:为了降低 ChatGPT 事先暴露的风险,我们开发了一个 MRCOG 考试试题数据集,该数据集的来源超出了 LLM 的能力范围。双重审查过程验证了问题的技术和临床准确性,剔除了那些依赖于先前内容、重复或需要图像解读的问题。单一最佳答案(SBA)和扩展匹配(EMQ)问题被转换为 JSON 格式,以方便 ChatGPT 解释,并纳入了问题类型和背景信息。与 ChatGPT 的交互是通过 OpenAI 的应用程序接口进行的,其结构可确保 ChatGPT 能做出一致且符合上下文的回应。ChatGPT 的回答会被记录下来,并与已知的准确回答进行比较。语言复杂性使用独特标记计数和类型-标记比率(词汇广度和多样性)进行评估,以探索它们对性能的影响。ChatGPT 被指示对其答案进行置信度评分(0-100%),以反映其自我感觉的准确性。回答按正确性分类,并通过熵计算进行统计分析,评估 ChatGPT 自我评估确定性和知识边界的能力。研究结果:在 1824 个 MRCOG 第一部分和第二部分问题中,ChatGPT 在 MRCOG 第一部分的正确率为 72.2% (95% CI 69.2-75.3)。对于第二部分,它的准确率为 50.4%(95% CI 47.2-53.5),989 道问题中有 534 道正确,在 SBA(54.0%,95% CI 50.0-58.0)方面的表现优于 EMQ(45.0%,95% CI 40.1-49.9)。在特定领域的成绩方面,生物化学的准确率最高(79.8%,95% CI 71.4-88.1),生物物理的准确率最低(51.4%,95% CI 35.2-67.5)。第二部分表现最好的科目是泌尿妇科(63.0%,95% CI 50.1-75.8),最差的科目是劳动管理(35.6%,95% CI 21.6-49.5)。语言复杂性分析表明,与错误答案(中位数 120,IQR 112-131,P=0.05)相比,第一部分正确答案的唯一标记数略有增加(中位数 122,IQR 114-134)。TTR分析显示,正确答案的中位数较高,但影响大小可忽略不计(第一部分:0.66,IQR 0.63-0.68;第二部分:0.62,IQR 0.57-0.67),P值为0.001。关于自我评估的信心,正确答案的信心中位数为 70.0%(IQR 60-90),与被认定为正确的错误选项的信心中位数相同(p<0.001)。被认为是错误的正确答案的信心中位数为 10.0% (IQR0-10),而被准确识别的错误答案的信心中位数为 5.0% (IQR 0-10,p<0.001)。正确答案和错误答案的熵值相同(中位数为 1.46,IQR 为 0.44-1.77),表明 ChatGPT 的预测确定性没有明显区别。结论:在 MRCOG 第一部分考试中,ChatGPT 在基本医学问题上表现出了值得称赞的准确性,但在临床要求较高的第二部分考试中,其表现却明显下降。该模型对正确和错误回答的自信度都很高,因此有必要对其在临床决策中的应用进行仔细研究。这些研究结果表明,虽然 ChatGPT 具有潜力,但其目前的形式还需要进一步改进,才能提高妇女健康的诊断效率和临床工作流程。
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引用次数: 0
Identifying high-risk pre-term pregnancies using the fetal heart rate and machine learning 利用胎儿心率和机器学习识别高风险早产妊娠
Pub Date : 2024-02-27 DOI: 10.1101/2024.02.26.24303280
Gabriel Davis Jones, William Cooke, Manu Vatish
Introduction: Fetal heart rate (FHR) monitoring is one of the commonest and most affordable tests performed during pregnancy worldwide. It is critical for evaluating the health status of the baby, providing real-time insights into the physiology of the fetus. While the relationship between patterns in these signals and adverse pregnancy outcomes is well-established, human identification of these complex patterns remains sub-optimal, with experts often failing to recognise babies at high-risk of outcomes such as asphyxia, growth restriction and stillbirth. These outcomes are especially relevant in low- and middle-income countries where an estimated 98% of perinatal deaths occur. Pre-term birth complications are also the leading cause of death in children <5 years of age, 75% of which can be prevented. While advances have been made in developing low-cost digital solutions for antenatal fetal monitoring, there is still substantial progress to be made in developing tools for the identification of high-risk, adverse outcome pre-term pregnancies using these FHR systems. In this study, we have developed the first machine learning algorithm for the identification of high-risk preterm pregnancies with associated adverse outcomes using fetal heart rate monitoring. Methods: We sourced antepartum fetal heart rate traces from high-risk, pre-term pregnancies that were assigned at least one of ten adverse conditions. These were matched with normal pregnancies delivered at term. Using an automated, clinically-validated algorithm, seven distinct fetal heart rate patterns were extracted from each trace, subsequently filtered for outliers and normalized. The data were split into 80% for model development and 20% for validation. Six machine learning algorithms were trained using k-fold cross-validation to identify each trace as either normal or high-risk preterm. The best-performing algorithm was further evaluated using the validation dataset based on metrics including the AUC, sensitivity, and specificity at three distinct classification thresholds. Additional assessments included decision curve analysis and gestational age-specific and outcome-specific performance evaluations. Results: We analysed antepartum fetal heart rate recordings from 4,867 high-risk, pre-term pregnancies with adverse outcomes and 4,014 normal pregnancies. Feature extraction and preprocessing revealed significant differences between the groups (p<0.001). The random forest classifier was the most effective model, achieving an AUC of 0.88 (95% CI 0.87-0.88). When evaluating specific adverse outcomes, the median AUC was 0.85 (IQR 0.81-0.89) and the model consistently exceeded an AUC of 0.80 across all gestational ages. The model's robustness was confirmed on the validation dataset with an AUC of 0.88 (95% CI 0.86-0.90) and a Brier score of 0.14. Decision curve analysis showed the model surpassed both the treat-none and treat-all strategies over most probability thresholds (0.11-1.0). Perf
简介胎儿心率(FHR)监测是全球最常见、最经济实惠的孕期检查之一。它对评估胎儿的健康状况至关重要,能实时了解胎儿的生理状况。虽然这些信号的模式与不良妊娠结局之间的关系已得到证实,但人类对这些复杂模式的识别能力仍未达到最佳水平,专家们往往无法识别窒息、生长受限和死胎等高风险胎儿。这些结果与中低收入国家的关系尤为密切,估计有 98% 的围产期死亡发生在这些国家。早产并发症也是导致 5 岁儿童死亡的主要原因,其中 75% 是可以预防的。虽然在开发用于产前胎儿监护的低成本数字解决方案方面取得了进展,但在开发使用这些 FHR 系统识别高风险、不良结局早产妊娠的工具方面仍有待取得重大进展。在本研究中,我们开发了首个机器学习算法,利用胎儿心率监测识别高风险早产及相关不良结局。研究方法我们从高危早产孕妇的产前胎心率追踪中获取了至少十种不良情况中的一种。这些孕妇与足月分娩的正常孕妇进行了比对。使用经临床验证的自动算法,从每个跟踪数据中提取出七种不同的胎儿心率模式,随后过滤异常值并进行归一化处理。数据分为 80% 用于模型开发,20% 用于验证。使用 k 倍交叉验证对六种机器学习算法进行了训练,以将每个迹线识别为正常或高风险早产。根据三个不同分类阈值下的 AUC、灵敏度和特异性等指标,使用验证数据集对表现最佳的算法进行了进一步评估。其他评估包括决策曲线分析以及特定孕龄和特定结果的性能评估。结果:我们分析了产前胎儿心率记录,这些记录来自 4867 例有不良预后的高危早产妊娠和 4014 例正常妊娠。特征提取和预处理显示两组之间存在显著差异(p<0.001)。随机森林分类器是最有效的模型,AUC 为 0.88(95% CI 0.87-0.88)。在评估特定不良结局时,AUC 的中位数为 0.85(IQR 0.81-0.89),该模型在所有妊娠年龄段的 AUC 均超过了 0.80。该模型的稳健性在验证数据集上得到了证实,AUC 为 0.88 (95% CI 0.86-0.90),Brier 得分为 0.14。决策曲线分析表明,在大多数概率阈值(0.11-1.0)上,该模型都超过了 "不治疗 "和 "全部治疗 "策略。使用 Youden 指数的性能指标如下:灵敏度 76.2% (95% CI 72.6-80.5%)、特异度 87.5% (95% CI 83.3-91.0)、F1 分数 81.7 (95% CI 79.6-83.9)、Cohen's kappa 62.8 (95% CI 59.6-66.4),表明妊娠结局之间具有很高的鉴别能力。结论我们的研究成功地证明了机器学习算法能够通过胎儿心率监测识别高风险早产妊娠及相关不良妊娠结局。这些研究结果证明了机器学习在提高产前胎儿监护的准确性和有效性方面的潜力,尤其是对于及时干预至关重要的高风险病例。这种算法可以大大改善妊娠结局预测,从而改善孕产妇和新生儿护理,尤其是在不良结局负担较重的中低收入国家。
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引用次数: 0
Postpartum hormonal contraceptive use in Denmark during 1997-2021 1997-2021 年丹麦产后激素避孕药的使用情况
Pub Date : 2024-02-23 DOI: 10.1101/2024.02.21.24302996
Soren Vinther Larsen, Anders Pretzmann Mikkelsen, Kathrine Bang Madsen, Xiaoqin Liu, Trine Munk-Olsen, Vibe Gedso Frokjaer, Oejvind Lidegaard
Introduction: Hormonal contraception is used by over a quarter of a billion worldwide. In Denmark, 84% have used it before their first pregnancy. After pregnancy, mothers are routinely advised to consider contraception to avoid short interpregnancy intervals due to perinatal and maternal health risks. Yet, mothers are not recommended to start combined hormonal contraception within six weeks postpartum due to an increased thromboembolic risk. This study provides an overview of postpartum hormonal contraceptive use in Denmark.Material and methods: This descriptive study is based on Danish national health registries on mothers who delivered during 1997-2021. The cumulative incidence of HC initiation one year after delivery is reported by calendar year and age group. Timing of initiation is reported as the median time from delivery. Hormonal contraception was categorized according to hormone type and method of administration. Results: A total of 676 759 first-time and 552 142 second-time mothers were registered, with a cumulative incidence of hormonal contraceptive initiation of 41.0% (95% CI, 40.9-41.1) and 40.5% (95% CI, 40.4-40.6), respectively. From 1997 to 2021, the cumulative incidence of first-time mothers who initially used progestogen-only pills increased from 3.8% (95% CI, 3.5-4.0) to 14.4% (95% CI, 13.9-14.8) and intrauterine levonorgestrel-releasing systems from 0.1% (95% CI, 0.1-0.2) to 12.6% (95% CI, 12.3-13.0). In contrast, combined oral contraception initiation decreased from 31.3% (95% CI, 30.7-31.8) to 7.8% (95% CI, 7.5-8.2). Among first-time mothers initiating hormonal contraception, the median time of initiation decreased from 4.7 (Q1-Q3, 2.5-7.5) months during 1997-2001 to 2.5 (Q1-Q3, 2-0-4.0) months during 2017-2021. The cumulative incidence of first-time mothers using combined hormonal contraception six weeks after delivery decreased from 1.5% (95% CI, 1.5-1.6) during 2007-2011 to 0.5% (95% CI, 0.5-0.5) during 2017-2021.Conclusions: Within the first year after childbirth, 41% of first- and second-time mothers initiated hormonal contraception in Denmark during 1997-2021. Throughout 1997-2021, mothers started earlier after delivery and more often used progestogen-only contraception. Few started combined hormonal contraception within 6 weeks after delivery in accordance with national guidelines. Taken together, the pattern of HC use over time reflects a change to safer contraceptive methods postpartum which minimizes thromboembolic risk.
导言:全世界有超过 25 亿人使用荷尔蒙避孕法。在丹麦,84%的人在首次怀孕前使用过避孕药具。怀孕后,由于围产期和孕产期的健康风险,母亲们通常会被建议考虑避孕,以避免间隔期过短。然而,由于血栓栓塞风险增加,不建议母亲在产后六周内开始联合激素避孕。本研究概述了丹麦产后激素避孕药具的使用情况:这项描述性研究基于丹麦国家健康登记,对象是 1997-2021 年间分娩的母亲。按日历年和年龄组报告了产后一年开始使用 HC 的累积发生率。开始使用的时间以分娩后的中位时间报告。荷尔蒙避孕根据荷尔蒙类型和使用方法进行分类。结果:共登记了 676 759 名初产妇和 552 142 名二胎产妇,她们开始使用激素避孕药的累积发生率分别为 41.0%(95% CI,40.9-41.1)和 40.5%(95% CI,40.4-40.6)。从 1997 年到 2021 年,最初使用纯孕激素避孕药的初产妇累计发生率从 3.8%(95% CI,3.5-4.0)上升到 14.4%(95% CI,13.9-14.8),宫内左炔诺孕酮释放系统的累计发生率从 0.1%(95% CI,0.1-0.2)上升到 12.6%(95% CI,12.3-13.0)。相比之下,复合口服避孕药的使用率从 31.3%(95% CI,30.7-31.8)降至 7.8%(95% CI,7.5-8.2)。在开始使用激素避孕的初产妇中,开始使用激素避孕的中位时间从1997-2001年的4.7(Q1-Q3,2.5-7.5)个月下降到2017-2021年的2.5(Q1-Q3,2-0-4.0)个月。初产妇在产后六周使用联合激素避孕法的累计发生率从2007-2011年的1.5%(95% CI,1.5-1.6)下降到2017-2021年的0.5%(95% CI,0.5-0.5):1997-2021年间,丹麦41%的初产和二胎母亲在产后第一年内开始使用激素避孕药具。在整个 1997-2021 年期间,母亲们在产后更早地开始避孕,并且更经常地使用纯孕激素避孕法。很少有母亲在产后 6 周内根据国家指导方针开始使用复合激素避孕药具。总之,随着时间的推移,使用 HC 的模式反映了产后向更安全的避孕方法的转变,从而将血栓栓塞风险降至最低。
{"title":"Postpartum hormonal contraceptive use in Denmark during 1997-2021","authors":"Soren Vinther Larsen, Anders Pretzmann Mikkelsen, Kathrine Bang Madsen, Xiaoqin Liu, Trine Munk-Olsen, Vibe Gedso Frokjaer, Oejvind Lidegaard","doi":"10.1101/2024.02.21.24302996","DOIUrl":"https://doi.org/10.1101/2024.02.21.24302996","url":null,"abstract":"Introduction: Hormonal contraception is used by over a quarter of a billion worldwide. In Denmark, 84% have used it before their first pregnancy. After pregnancy, mothers are routinely advised to consider contraception to avoid short interpregnancy intervals due to perinatal and maternal health risks. Yet, mothers are not recommended to start combined hormonal contraception within six weeks postpartum due to an increased thromboembolic risk. This study provides an overview of postpartum hormonal contraceptive use in Denmark.\u0000Material and methods: This descriptive study is based on Danish national health registries on mothers who delivered during 1997-2021. The cumulative incidence of HC initiation one year after delivery is reported by calendar year and age group. Timing of initiation is reported as the median time from delivery. Hormonal contraception was categorized according to hormone type and method of administration. Results: A total of 676 759 first-time and 552 142 second-time mothers were registered, with a cumulative incidence of hormonal contraceptive initiation of 41.0% (95% CI, 40.9-41.1) and 40.5% (95% CI, 40.4-40.6), respectively. From 1997 to 2021, the cumulative incidence of first-time mothers who initially used progestogen-only pills increased from 3.8% (95% CI, 3.5-4.0) to 14.4% (95% CI, 13.9-14.8) and intrauterine levonorgestrel-releasing systems from 0.1% (95% CI, 0.1-0.2) to 12.6% (95% CI, 12.3-13.0). In contrast, combined oral contraception initiation decreased from 31.3% (95% CI, 30.7-31.8) to 7.8% (95% CI, 7.5-8.2). Among first-time mothers initiating hormonal contraception, the median time of initiation decreased from 4.7 (Q1-Q3, 2.5-7.5) months during 1997-2001 to 2.5 (Q1-Q3, 2-0-4.0) months during 2017-2021. The cumulative incidence of first-time mothers using combined hormonal contraception six weeks after delivery decreased from 1.5% (95% CI, 1.5-1.6) during 2007-2011 to 0.5% (95% CI, 0.5-0.5) during 2017-2021.\u0000Conclusions: Within the first year after childbirth, 41% of first- and second-time mothers initiated hormonal contraception in Denmark during 1997-2021. Throughout 1997-2021, mothers started earlier after delivery and more often used progestogen-only contraception. Few started combined hormonal contraception within 6 weeks after delivery in accordance with national guidelines. Taken together, the pattern of HC use over time reflects a change to safer contraceptive methods postpartum which minimizes thromboembolic risk.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"299 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139946598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi 比较 ScreenFire 和 Xpert HPV 检测法在马拉维感染艾滋病毒的妇女中检测人类乳头瘤病毒和宫颈癌前病变的效果
Pub Date : 2024-02-23 DOI: 10.1101/2024.02.21.24303142
Chemtai Mungo, Anagha Guliam, Lameck Chinula, Federica Inturrisi, Lizzie Msowoya, Tawonga Mkochi, Sinyia Jawadu, Silvia de Sanjose, Mark Schiffman, Jennifer H Tang, Jennifer S Smith
Background: The World Health Organization (WHO) recommends human papillomavirus (HPV) testing for primary cervical cancer screening, including among women living with HIV (WLWH). Low-and-middle-income countries (LMICs) account for 85% of the cervical cancer burden globally, yet have limited access to HPV-based screening, largely due to cost. This study aims to compare the performance of a rapid, isothermal amplification HPV assay (ScreenFire) to that of the Xpert HPV assay for the detection of HPV and cervical precancer among WLWH in Malawi. Methods: We utilized stored self- and provider-collected specimens from a prospective cohort study of WLWH in Malawi from July 2020 to February 2022. Specimens were tested with both Xpert and ScreenFire HPV assays. The overall and within-channel non-hierarchical agreement between ScreenFire and Xpert was determined for both self- and provider-collected specimens. Hierarchical ScreenFire HPV positivity by channel was compared to Xpert for each histological diagnosis - cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared to <CIN2. Results: 315 matched self- and provider-collected specimens had valid results from both Xpert and ScreenFire testing and were included in analyses. Of these, 245 (78%) had normal pathology, 21 CIN1 (7%), 14 CIN2 (4%), and 35 CIN3 (11%). Among provider-collected specimens, the assays had 80% agreement on overall HPV positivity (unweighted kappa 0.59, 95% 0.50-0.69). ScreenFire was HPV-positive in 90% of self-collected specimens that were HPV-positive on Xpert. Channel agreement between the assays was high for both self- and provider-collected specimens, but slightly lower for HPV18/45. In hierarchical analysis, ScreenFire demonstrated high concordance with Xpert testing for detecting CIN2+ cases in all channels, missing no HPV 16 or HPV 18/45 positive CIN2+ case that was positive on Xpert, in both self- and provider-collected specimens. Conclusion: In this study of stored specimens, the ScreenFire HPV assay performed well in the detection of HPV and CIN2+ among WLWH compared to the Xpert HPV assay. If supported by larger validation studies, ScreenFire could be an affordable alternative point-of-care HPV assay for use in LMICs.
背景:世界卫生组织(WHO)建议将人类乳头瘤病毒(HPV)检测用于宫颈癌初筛,包括感染艾滋病毒的妇女(WLWH)。中低收入国家(LMICs)的宫颈癌患者占全球宫颈癌患者的85%,但主要由于成本原因,这些国家接受HPV筛查的机会有限。本研究旨在比较快速等温扩增 HPV 检测法(ScreenFire)与 Xpert HPV 检测法在马拉维 WLWH 中检测 HPV 和宫颈癌前病变的性能。方法:我们利用了从 2020 年 7 月到 2022 年 2 月马拉维 WLWH 前瞻性队列研究中储存的自取和提供者收集的标本。标本采用 Xpert 和 ScreenFire HPV 检测法进行检测。针对自取和提供者采集的标本,确定了 ScreenFire 和 Xpert 之间的总体一致性和通道内非层次一致性。就每种组织学诊断--宫颈上皮内瘤变 2 级或更差(CIN2+)与 CIN2 进行比较,按通道将 ScreenFire HPV 阳性率与 Xpert 进行分层比较。结果:315 份自行采集和医疗机构采集的匹配标本在 Xpert 和 ScreenFire 检测中均得到了有效结果,并纳入了分析。其中,245 例(78%)病理结果正常,21 例 CIN1(7%),14 例 CIN2(4%),35 例 CIN3(11%)。在医疗服务提供者采集的标本中,两种检测方法在总体 HPV 阳性率上的一致性为 80%(非加权卡帕值为 0.59,95% 为 0.50-0.69)。在 Xpert 检测为 HPV 阳性的自取标本中,ScreenFire 检测的 HPV 阳性率为 90%。对于自取和提供者采集的标本,两种检测方法的通道一致性都很高,但对于 HPV18/45 的通道一致性略低。在分层分析中,ScreenFire 与 Xpert 检测在所有通道中检测 CIN2+ 病例的一致性都很高,无论是自取标本还是医疗机构采集的标本,都没有漏检 Xpert 检测为阳性的 HPV 16 或 HPV 18/45 阳性 CIN2+ 病例。结论:在这项储存标本的研究中,与 Xpert HPV 检测法相比,ScreenFire HPV 检测法在检测 WLWH 中的 HPV 和 CIN2+ 方面表现良好。如果能得到更大规模验证研究的支持,ScreenFire 将成为一种经济实惠的护理点 HPV 检测方法,可用于低收入国家。
{"title":"Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi","authors":"Chemtai Mungo, Anagha Guliam, Lameck Chinula, Federica Inturrisi, Lizzie Msowoya, Tawonga Mkochi, Sinyia Jawadu, Silvia de Sanjose, Mark Schiffman, Jennifer H Tang, Jennifer S Smith","doi":"10.1101/2024.02.21.24303142","DOIUrl":"https://doi.org/10.1101/2024.02.21.24303142","url":null,"abstract":"Background: The World Health Organization (WHO) recommends human papillomavirus (HPV) testing for primary cervical cancer screening, including among women living with HIV (WLWH). Low-and-middle-income countries (LMICs) account for 85% of the cervical cancer burden globally, yet have limited access to HPV-based screening, largely due to cost. This study aims to compare the performance of a rapid, isothermal amplification HPV assay (ScreenFire) to that of the Xpert HPV assay for the detection of HPV and cervical precancer among WLWH in Malawi. Methods: We utilized stored self- and provider-collected specimens from a prospective cohort study of WLWH in Malawi from July 2020 to February 2022. Specimens were tested with both Xpert and ScreenFire HPV assays. The overall and within-channel non-hierarchical agreement between ScreenFire and Xpert was determined for both self- and provider-collected specimens. Hierarchical ScreenFire HPV positivity by channel was compared to Xpert for each histological diagnosis - cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared to &lt;CIN2. Results: 315 matched self- and provider-collected specimens had valid results from both Xpert and ScreenFire testing and were included in analyses. Of these, 245 (78%) had normal pathology, 21 CIN1 (7%), 14 CIN2 (4%), and 35 CIN3 (11%). Among provider-collected specimens, the assays had 80% agreement on overall HPV positivity (unweighted kappa 0.59, 95% 0.50-0.69). ScreenFire was HPV-positive in 90% of self-collected specimens that were HPV-positive on Xpert. Channel agreement between the assays was high for both self- and provider-collected specimens, but slightly lower for HPV18/45. In hierarchical analysis, ScreenFire demonstrated high concordance with Xpert testing for detecting CIN2+ cases in all channels, missing no HPV 16 or HPV 18/45 positive CIN2+ case that was positive on Xpert, in both self- and provider-collected specimens. Conclusion: In this study of stored specimens, the ScreenFire HPV assay performed well in the detection of HPV and CIN2+ among WLWH compared to the Xpert HPV assay. If supported by larger validation studies, ScreenFire could be an affordable alternative point-of-care HPV assay for use in LMICs.","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"46 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139946627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The benefits and harms of oral iron supplementation in non-anaemic pregnant women: A systematic review and meta-analysis. 非贫血孕妇口服铁补充剂的益处和害处:系统回顾与荟萃分析。
Pub Date : 2024-02-13 DOI: 10.1101/2024.02.13.24302756
Archie Watt, Holden Eaton, Kate Eastwick-Jones, Elizabeth T Thomas, Annette Pluddemann
Objective: Iron deficiency during pregnancy poses a significant risk to both maternal and foetal health. Despite increased iron requirements during pregnancy, current UK NICE guidelines do not give clear advice on antenatal iron supplementation for non-anaemic women. We aimed to assess whether the benefits of routine antenatal supplementation outweigh potential harms for non-anaemic women.Methods: The Cochrane Library, MEDLINE, Embase and clinical trial registries were searched for randomised control trials (RCTs) and observational studies comparing oral iron supplementation with placebo or no supplement in non-anaemic pregnant women. The relevant data were extracted, and the risk of bias for included studies was assessed using the Cochrane Risk of Bias tool and the Newcastle-Ottawa Scale. Where appropriate, meta analysis was conducted using R.Results: 23 eligible studies were identified including 4492 non-anaemic women who were followed through pregnancy. Haemoglobin and ferritin levels were consistently higher in individuals receiving iron compared with control groups, although both findings were associated with a high degree of heterogeneity (I2 = 92% and 87% respectively) and therefore did not warrant a pooled analysis. Iron supplementation was associated with a significant reduction in rate of maternal anaemia (OR = 0.36; 95% CI = 0.22 - 0.61, p<.001; I2 = 54%; moderate certainty, NNT 8). There was no significant effect of intervention on birth weight (MD = 22.97g, 95% CI = -56.27 to 102.22, p = 0.57; I2 = 64%; very low certainty). Of the 18 studies reporting adverse effects, none found a significant influence of supplementation on GI disturbance, caesarean sections or preterm births.Conclusions: Prophylactic iron supplementation reduces the risk of maternal anaemia in pregnancy. Limited evidence was found relating to the harms of supplementation in non-anaemic pregnant women, highlighting the need for further research to inform practice guidelines and support clinical decision making.Registration: The study protocol was registered on the Open Science Framework (DOI 10.17605/OSF.IO/HKZ4C).
目的:孕期缺铁对母体和胎儿的健康都有很大风险。尽管孕期对铁的需求量增加,但目前英国 NICE 指南并未就非贫血妇女的产前铁补充给出明确建议。我们旨在评估常规产前补充剂对非贫血妇女的益处是否大于潜在危害:方法:我们在 Cochrane 图书馆、MEDLINE、Embase 和临床试验登记处检索了随机对照试验 (RCT) 和观察性研究,这些研究对非贫血孕妇进行了口服铁补充剂与安慰剂或无补充剂的比较。提取了相关数据,并使用 Cochrane 偏倚风险工具和纽卡斯尔-渥太华量表评估了纳入研究的偏倚风险。结果:共确定了 23 项符合条件的研究,包括 4492 名在整个孕期接受随访的非贫血妇女。与对照组相比,接受铁剂治疗者的血红蛋白和铁蛋白水平一直较高,但这两项研究结果存在高度异质性(I2 分别为 92% 和 87%),因此不值得进行汇总分析。补铁可显著降低产妇贫血率(OR = 0.36; 95% CI = 0.22 - 0.61, p<.001; I2 = 54%; 中等确定性,NNT 8)。干预对出生体重没有明显影响(MD = 22.97g,95% CI = -56.27 to 102.22,p = 0.57;I2 = 64%;极低确定性)。在 18 项报告不良影响的研究中,没有一项研究发现补充铁剂对消化道紊乱、剖腹产或早产有显著影响:结论:预防性补铁可降低妊娠期孕产妇贫血的风险。在非贫血孕妇中发现的与补充铁剂的危害有关的证据有限,这凸显了进一步研究的必要性,以便为实践指南提供信息并支持临床决策:研究方案已在开放科学框架(DOI 10.17605/OSF.IO/HKZ4C)上注册。
{"title":"The benefits and harms of oral iron supplementation in non-anaemic pregnant women: A systematic review and meta-analysis.","authors":"Archie Watt, Holden Eaton, Kate Eastwick-Jones, Elizabeth T Thomas, Annette Pluddemann","doi":"10.1101/2024.02.13.24302756","DOIUrl":"https://doi.org/10.1101/2024.02.13.24302756","url":null,"abstract":"Objective: Iron deficiency during pregnancy poses a significant risk to both maternal and foetal health. Despite increased iron requirements during pregnancy, current UK NICE guidelines do not give clear advice on antenatal iron supplementation for non-anaemic women. We aimed to assess whether the benefits of routine antenatal supplementation outweigh potential harms for non-anaemic women.\u0000Methods: The Cochrane Library, MEDLINE, Embase and clinical trial registries were searched for randomised control trials (RCTs) and observational studies comparing oral iron supplementation with placebo or no supplement in non-anaemic pregnant women. The relevant data were extracted, and the risk of bias for included studies was assessed using the Cochrane Risk of Bias tool and the Newcastle-Ottawa Scale. Where appropriate, meta analysis was conducted using R.\u0000Results: 23 eligible studies were identified including 4492 non-anaemic women who were followed through pregnancy. Haemoglobin and ferritin levels were consistently higher in individuals receiving iron compared with control groups, although both findings were associated with a high degree of heterogeneity (I2 = 92% and 87% respectively) and therefore did not warrant a pooled analysis. Iron supplementation was associated with a significant reduction in rate of maternal anaemia (OR = 0.36; 95% CI = 0.22 - 0.61, p&lt;.001; I2 = 54%; moderate certainty, NNT 8). There was no significant effect of intervention on birth weight (MD = 22.97g, 95% CI = -56.27 to 102.22, p = 0.57; I2 = 64%; very low certainty). Of the 18 studies reporting adverse effects, none found a significant influence of supplementation on GI disturbance, caesarean sections or preterm births.\u0000Conclusions: Prophylactic iron supplementation reduces the risk of maternal anaemia in pregnancy. Limited evidence was found relating to the harms of supplementation in non-anaemic pregnant women, highlighting the need for further research to inform practice guidelines and support clinical decision making.\u0000Registration: The study protocol was registered on the Open Science Framework (DOI 10.17605/OSF.IO/HKZ4C).","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"64 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139751902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Performance Evaluation of Computerised Antepartum Fetal Heart Rate Monitoring: The Dawes-Redman Algorithm at Term 计算机化产前胎儿心率监测的性能评估:临产时的道斯-雷德曼算法
Pub Date : 2024-02-13 DOI: 10.1101/2024.02.12.24302705
Gabriel Davis Jones, Beth Albert, William Cooke, Manu Vatish
Objectives: This study aims to rigorously evaluate the Dawes-Redman computerised cardiotocography algorithm's effectiveness in assessing antepartum fetal wellbeing. It focuses on analysing the algorithm's performance using extensive clinical data, examining accuracy, sensitivity, specificity, and predictive values in various scenarios. The objectives include assessing the algorithm's reliability in identifying fetal wellbeing across different risk prevalences, its efficacy in the context of temporal proximity to delivery, and its performance across ten specific adverse pregnancy outcomes. This comprehensive evaluation seeks to clarify the algorithm's utility and limitations in contemporary obstetric practice, particularly in high-risk pregnancy scenarios. Methods: Antepartum fetal heart rate recordings from term singleton pregnancies between 37 and 42 gestational weeks were extracted from the Oxford University Hospitals database, spanning 1991 to 2021. Traces with significant data gaps or incomplete Dawes-Redman analyses were excluded. For the ten adverse outcomes, only traces performed within 48 hours prior to delivery were considered, aligning with clinical decision-making practices. A healthy cohort was established using rigorous inclusion and exclusion criteria based on clinical indicators. Propensity score matching, controlling for gestational age and fetal sex, ensured balanced comparisons between healthy and adverse outcome cohorts. The Dawes-Redman algorithm's categorisation of FHR traces as either 'criteria met' (an indicator of wellbeing) or 'criteria not met' (indicating a need for further evaluation) informed the evaluation of predictive performance metrics. Performance was assessed using accuracy, sensitivity, specificity, and predictive values (PPV, NPV), adjusted for various risk prevalences. Results: 4,196 term antepartum FHR traces were identified, matched by fetal sex and gestational age. The Dawes-Redman algorithm showed a high sensitivity of 91.7% for detecting fetal wellbeing. However, specificity for adverse outcomes was low at 15.6%. The PPV varied with population prevalence, high in very low-risk settings (99.1%) and declined with increased risk. Temporal proximity to delivery indicated robust sensitivity (>91.0%). Specificity notably decreased over time, impacting the algorithm's discriminative power for identifying adverse outcomes. Across different adverse conditions, the algorithm's performance remained consistent, with high sensitivity but varying NPVs, confirming its utility in detecting fetal wellbeing rather than adverse outcomes. Conclusion: These findings reveal the Dawes-Redman algorithm is effective for detecting fetal wellbeing in term pregnancies, evidenced by its high sensitivity and PPV. However, its low specificity suggests limitations in its ability to identify fetuses at risk of adverse outcomes. The predictive accuracy of the algorithm is significantly affected by the prevalence of healthy pregnancie
研究目的本研究旨在严格评估 Dawes-Redman 计算机化胎心造影算法在评估产前胎儿健康状况方面的有效性。研究重点是利用大量临床数据分析该算法的性能,检查各种情况下的准确性、灵敏度、特异性和预测值。目标包括评估该算法在不同风险发生率下识别胎儿健康状况的可靠性、在临近分娩的时间范围内的有效性以及在十种特定不良妊娠结局中的表现。这项综合评估旨在明确该算法在当代产科实践中的实用性和局限性,尤其是在高危妊娠情况下。方法从牛津大学医院的数据库中提取了37至42孕周的足月单胎孕妇的产前胎心率记录,时间跨度为1991年至2021年。排除了存在重大数据缺口或 Dawes-Redman 分析不完整的记录。对于十种不良结局,根据临床决策惯例,只考虑分娩前 48 小时内进行的追踪。根据临床指标,采用严格的纳入和排除标准建立了健康队列。倾向得分匹配控制了胎龄和胎儿性别,确保了健康组群和不良结果组群之间的平衡比较。Dawes-Redman 算法将 FHR 迹线分为 "符合标准"(健康指标)或 "不符合标准"(表明需要进一步评估)两类,为评估预测性能指标提供了依据。使用准确性、灵敏度、特异性和预测值(PPV、NPV)对性能进行评估,并根据各种风险发生率进行调整。结果根据胎儿性别和胎龄进行匹配后,共鉴定出 4196 个足月产前 FHR 迹线。Dawes-Redman 算法检测胎儿健康的灵敏度高达 91.7%。然而,不良结果的特异性较低,仅为 15.6%。PPV随人群患病率的变化而变化,在风险极低的情况下高(99.1%),随着风险的增加而下降。与分娩时间的临近度显示了较高的灵敏度(91.0%)。随着时间的推移,特异性明显下降,影响了该算法识别不良后果的鉴别力。在不同的不良情况下,该算法的表现保持一致,灵敏度高,但净现值各不相同,这证实了该算法在检测胎儿健康状况而非不良结局方面的实用性。结论这些研究结果表明,Dawes-Redman 算法具有较高的灵敏度和 PPV,可有效检测足月妊娠胎儿的健康状况。然而,该算法的特异性较低,表明其在识别有不良结局风险的胎儿方面存在局限性。该算法的预测准确性在很大程度上受到人群中健康孕妇比例的影响。临床解释不符合 Dawes-Redman 标准的 FHR 迹线时应谨慎,因为它们并不一定与高风险相关。虽然该算法在低风险情况下的主要目标被证明是可靠的,但针对高风险妊娠情况优化算法的开发仍是未来需要改进的领域。
{"title":"A Performance Evaluation of Computerised Antepartum Fetal Heart Rate Monitoring: The Dawes-Redman Algorithm at Term","authors":"Gabriel Davis Jones, Beth Albert, William Cooke, Manu Vatish","doi":"10.1101/2024.02.12.24302705","DOIUrl":"https://doi.org/10.1101/2024.02.12.24302705","url":null,"abstract":"Objectives: This study aims to rigorously evaluate the Dawes-Redman computerised cardiotocography algorithm's effectiveness in assessing antepartum fetal wellbeing. It focuses on analysing the algorithm's performance using extensive clinical data, examining accuracy, sensitivity, specificity, and predictive values in various scenarios. The objectives include assessing the algorithm's reliability in identifying fetal wellbeing across different risk prevalences, its efficacy in the context of temporal proximity to delivery, and its performance across ten specific adverse pregnancy outcomes. This comprehensive evaluation seeks to clarify the algorithm's utility and limitations in contemporary obstetric practice, particularly in high-risk pregnancy scenarios. Methods: Antepartum fetal heart rate recordings from term singleton pregnancies between 37 and 42 gestational weeks were extracted from the Oxford University Hospitals database, spanning 1991 to 2021. Traces with significant data gaps or incomplete Dawes-Redman analyses were excluded. For the ten adverse outcomes, only traces performed within 48 hours prior to delivery were considered, aligning with clinical decision-making practices. A healthy cohort was established using rigorous inclusion and exclusion criteria based on clinical indicators. Propensity score matching, controlling for gestational age and fetal sex, ensured balanced comparisons between healthy and adverse outcome cohorts. The Dawes-Redman algorithm's categorisation of FHR traces as either 'criteria met' (an indicator of wellbeing) or 'criteria not met' (indicating a need for further evaluation) informed the evaluation of predictive performance metrics. Performance was assessed using accuracy, sensitivity, specificity, and predictive values (PPV, NPV), adjusted for various risk prevalences. Results: 4,196 term antepartum FHR traces were identified, matched by fetal sex and gestational age. The Dawes-Redman algorithm showed a high sensitivity of 91.7% for detecting fetal wellbeing. However, specificity for adverse outcomes was low at 15.6%. The PPV varied with population prevalence, high in very low-risk settings (99.1%) and declined with increased risk. Temporal proximity to delivery indicated robust sensitivity (&gt;91.0%). Specificity notably decreased over time, impacting the algorithm's discriminative power for identifying adverse outcomes. Across different adverse conditions, the algorithm's performance remained consistent, with high sensitivity but varying NPVs, confirming its utility in detecting fetal wellbeing rather than adverse outcomes. Conclusion: These findings reveal the Dawes-Redman algorithm is effective for detecting fetal wellbeing in term pregnancies, evidenced by its high sensitivity and PPV. However, its low specificity suggests limitations in its ability to identify fetuses at risk of adverse outcomes. The predictive accuracy of the algorithm is significantly affected by the prevalence of healthy pregnancie","PeriodicalId":501409,"journal":{"name":"medRxiv - Obstetrics and Gynecology","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139751648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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medRxiv - Obstetrics and Gynecology
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