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Transforming women's health, empowerment, and gender equality with digital health: evidence-based policy and practice 以数字健康改变妇女健康、赋权和性别平等:基于证据的政策和实践。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-06-01 DOI: 10.1016/j.landig.2025.01.014
Prof Israel Júnior Borges do Nascimento MD ClinPath , Hebatullah Mohamed Abdulazeem MD MSc , Ishanka Weerasekara PhD , Prof Jodie Marquez PhD , Lenny T Vasanthan PhD , Genevieve Deeken MSc , Prof Rosemary Morgan PhD , Heang-Lee Tan MPH , Isabel Yordi Aguirre PhD , Lasse Østeengaard MSc , Indunil Kularathne BSc , Natasha Azzopardi-Muscat PhD , Prof Robin van Kessel PhD , Edson Zangiacomi Martinez PhD , Govin Permanand PhD , David Novillo-Ortiz PhD MLIS
We evaluated the effects of digital health technologies (DHTs) on women's health, empowerment, and gender equality, using the scoping review method. Following a search across five databases and grey literature, we analysed 80 studies published up to Aug 18, 2023. The thematic appraisal and quantitative analysis found that DHTs positively affect women's access to health-care services, self-care, and tailored self-monitoring enabling the acquisition of health-related interventions. Use of these technologies is beneficial across various medical fields, including gynaecology, endocrinology, and psychiatry. DHTs also improve women's empowerment and gender equality by facilitating skills acquisition, health education, and social interaction, while allowing cost-effective health services. Overall, DHTs contribute to better health outcomes for women and support the UN Sustainable Development Goals by improving access to health care and financial literacy.
我们使用范围审查方法评估了数字卫生技术(dht)对妇女健康、赋权和性别平等的影响。通过对五个数据库和灰色文献的搜索,我们分析了截至2023年8月18日发表的80项研究。专题评价和定量分析发现,dht对妇女获得保健服务、自我保健和量身定制的自我监测产生了积极影响,从而能够获得与健康有关的干预措施。这些技术的使用在各个医学领域都是有益的,包括妇科、内分泌学和精神病学。卫生保健部门还通过促进技能获取、卫生教育和社会互动,改善妇女赋权和性别平等,同时提供具有成本效益的卫生服务。总体而言,卫生保健技术有助于改善妇女的健康结果,并通过改善获得卫生保健和金融知识的机会来支持联合国可持续发展目标。
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引用次数: 0
Artificial intelligence-assisted detection of nasopharyngeal carcinoma on endoscopic images: a national, multicentre, model development and validation study 人工智能辅助鼻咽癌内镜图像检测:一项全国性、多中心、模型开发和验证研究。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-06-01 DOI: 10.1016/j.landig.2025.03.001
Yuxuan Shi PhD , Zhen Li PhD , Li Wang PhD , Hong Wang PhD , Prof Xiaofeng Liu PhD , Dantong Gu MS , Xiao Chen MS , Xueli Liu PhD , Wentao Gong MS , Xiaowen Jiang MD , Wenquan Li MD , Yongdong Lin BS , Ke Liu MD , Deyan Luo MD , Tao Peng PhD , Xuemei Peng BS , Meimei Tong BS , Huizhen Zheng MD , Xuanchen Zhou MD , Jianrong Wu PhD , Prof Hongmeng Yu PhD
<div><h3>Background</h3><div>Nasopharyngeal carcinoma is highly curable when diagnosed early. However, the nasopharynx’s obscure anatomical position and the similarity of local imaging manifestations with those of other nasopharyngeal diseases often lead to diagnostic challenges, resulting in delayed or missed diagnoses. Our aim was to develop a deep learning algorithm to enhance an otolaryngologist’s diagnostic capabilities by differentiating between nasopharyngeal carcinoma, benign hyperplasia, and normal nasopharynx during endoscopic examination.</div></div><div><h3>Methods</h3><div>In this national, multicentre, model development and validation study, we developed a Swin Transformer-based Nasopharyngeal Diagnostic (STND) system to identify nasopharyngeal carcinoma, benign hyperplasia, and normal nasopharynx. STND was developed with 27 362 nasopharyngeal endoscopic images (10 693 biopsy-proven nasopharyngeal carcinoma, 7073 biopsy-proven benign hyperplasia, and 9596 normal nasopharynx) sourced from eight prominent nasopharyngeal carcinoma centres (stage 1), and externally validated with 1885 prospectively acquired images from ten comprehensive hospitals with a high incidence of nasopharyngeal carcinoma (stage 2). Furthermore, we did a fully crossed, multireader, multicase study involving four expert otolaryngologists from four regional leading nasopharyngeal carcinoma centres, and 24 general otolaryngologists from 24 geographically diverse primary hospitals. This study included 400 images to evaluate the diagnostic capabilities of the experts and general otolaryngologists both with and without the aid of the STND system in a real-world environment.</div></div><div><h3>Findings</h3><div>Endoscopic images used in the internal study (Jan 1, 2017, to Jan 31, 2023) were from 15 521 individuals (9033 [58·2%] men and 6488 [41·8%] women; mean age 47·6 years [IQR 38·4–56·8]). Images from 945 participants (538 [56·9%] men and 407 [43·1%] women; mean age 45·2 years [IQR 35·2– 55·2]) were used in the external validation. STND in the internal dataset discriminated normal nasopharynx images from abnormalities (benign hyperplasia and nasopharyngeal carcinoma) with an area under the curve (AUC) of 0·99 (95% CI 0·99–0·99) and malignant images (ie, nasopharyngeal carcinoma) from non-malignant images (ie, benign hyperplasia and normal nasopharynx) with an AUC of 0·99 (95% CI 0·98–0·99). In the external validation, the system had an AUC for the detection of nasopharyngeal carcinoma of 0·95 (95% CI 0·94–0·96), a sensitivity of 91·6% (95% CI 89·3–93·5), and a specificity of 86·1% (95% CI 84·1–87·9). In the multireader, multicase study, the artificial intelligence (AI)-assisted strategy enhanced otolaryngologists’ diagnostic accuracy by 7·9%, increasing from 83·4% (95% CI 80·1–86·7, without AI assistance) to 91·2% (95% CI 88·6–93·9, with AI assistance; p<0·0001) for primary care otolaryngologists. Reading time per image decreased with the aid of the AI model (mea
背景:鼻咽癌早期诊断治愈率高。然而,鼻咽部解剖位置模糊,局部影像学表现与其他鼻咽部疾病相似,往往导致诊断困难,导致延误或漏诊。我们的目标是开发一种深度学习算法,通过在内窥镜检查中区分鼻咽癌、良性增生和正常鼻咽来提高耳鼻喉科医生的诊断能力。方法:在这项全国性、多中心的模型开发和验证研究中,我们开发了一种基于Swin变压器的鼻咽癌诊断(STND)系统,用于识别鼻咽癌、良性增生和正常鼻咽癌。STND采用来自8个著名鼻咽癌中心(1期)的27 362张鼻咽内镜图像(10 693张活检证实的鼻咽癌,7073张活检证实的良性增生,9596张正常鼻咽癌),并通过来自10家鼻咽癌高发综合医院(2期)的1885张前瞻性图像进行外部验证。此外,我们进行了一项完全交叉、多读者、多病例的研究,涉及来自四个地区领先的鼻咽癌中心的四名专家耳鼻喉科医生,以及来自24个地理位置不同的初级医院的24名普通耳鼻喉科医生。该研究包括400张图像,以评估专家和普通耳鼻喉科医生在使用和不使用STND系统的情况下在现实环境中的诊断能力。结果:内部研究(2017年1月1日至2023年1月31日)使用的内镜图像来自15 521人(男性9033人[58.2%],女性6488人[41.8%];平均年龄47.6岁[IQR 38.4 ~ 56.8])。来自945名参与者的图像(男性538人[56.9%],女性407人[43.1%];平均年龄45·2岁[IQR 35.2 - 55.2])进行外部验证。内部数据集中的STND以曲线下面积(AUC)为0.99 (95% CI为0.99 ~ 0.99)区分正常鼻咽图像与异常(良性增生和鼻咽癌),以AUC为0.99 (95% CI为0.98 ~ 0.99)区分恶性图像(即鼻咽癌)与非恶性图像(即良性增生和正常鼻咽)。在外部验证中,该系统检测鼻咽癌的AUC为0.95 (95% CI为0.94 ~ 0.96),灵敏度为91.6% (95% CI为89.3 ~ 93.5),特异性为86.1% (95% CI为84.1 ~ 89.7)。在多读者、多病例研究中,人工智能(AI)辅助策略使耳鼻喉科医生的诊断准确性提高了7.9%,从83.4% (95% CI 801 - 86.7,无AI辅助)增加到91.2% (95% CI 88.6 - 99.3,有AI辅助);解释:我们的深度学习系统在鼻咽癌的内镜图像诊断方面显示出了巨大的临床应用潜力。该系统为基层医院的采用提供了实质性的好处,旨在提高特异性,避免额外的活检,并减少漏诊。资助项目:颅底肿瘤内窥镜手术新技术:CAMS医学科学创新基金;上海市科学技术委员会基金;上海市临床重点专科;国家临床重点专科;以及青年精英科学家资助计划。
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引用次数: 0
Health insights from face photographs 从面部照片看健康。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-06-01 DOI: 10.1016/j.landig.2025.100889
The Lancet Digital Health
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引用次数: 0
Online video versus face-to-face preoperative consultation for major abdominal surgery (VIDEOGO): a multicentre, open-label, randomised, controlled, non-inferiority trial 在线视频与腹部大手术术前面对面咨询(视频):一项多中心、开放标签、随机、对照、非劣效性试验。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-06-01 DOI: 10.1016/j.landig.2025.02.007
Britte H E A ten Haaft MD , Boris V Janssen BSc , Esther Z Barsom MD PhD , Prof Wouter J K Hehenkamp MD PhD , Prof Mark I van Berge Henegouwen MD PhD , Prof Olivier R Busch MD PhD , Susan van Dieren PhD , Joris I Erdmann MD PhD , Wietse J Eshuis MD PhD , Suzanne S Gisbertz MD PhD , Prof Misha D P Luyer MD PhD , Olga C Damman PhD , Prof Martine C de Bruijne MD PhD , Prof Geert Kazemier MD PhD , Prof Marlies P Schijven MD PhD , Prof Marc G Besselink MD PhD

Background

Online video consultation between patients and health-care providers rapidly gained popularity during the COVID-19 pandemic. However, to our knowledge, there is no high-quality comparative evidence regarding patient satisfaction and quality of information recall with online video consultation and traditional face-to-face consultation. This lack of evidence is especially concerning in the most demanding consultations. We aimed to assess whether online video consultation between patients and surgeons before major abdominal surgery was non-inferior to face-to-face consultation in terms of patient satisfaction, and to assess effects on patient information recall.

Methods

This open-label, randomised, controlled, non-inferiority trial (VIDEOGO) was conducted at two hospitals (one academic and one regional) in the Netherlands. Adult patients (aged ≥18 years) who required consultation with a surgeon to discuss major abdominal surgery and were able and willing to interact via both online video and face-to-face consultation were eligible for inclusion; patients were excluded if they were unable or unwilling to start or maintain online video consultation. Eligible patients were randomly allocated (1:1) to online video or face-to-face consultation by the study coordinator, using a computer-generated, concealed, permuted-block randomisation method with varying block sizes (two, four, and six patients), stratified by study site. Masking of patients and health-care providers was not possible owing to the nature of the study. The primary outcomes were patient satisfaction (score 0–100; assessed for non-inferiority with a predefined margin of −10%) and information recall (score 0–11), both of which were assessed with online questionnaires and analysed in the intention-to-treat population for whom outcome data were available. Technical adverse events were assessed directly after the consultation as part of the satisfaction questionnaire. This trial is registered with the International Clinical Trial Registry Platform and the Central Committee on Research Involving Human Subjects registry, NL-OMON20092, and is complete.

Findings

Between Feb 13, 2021, and Oct 2, 2023, 120 patients were randomly assigned: 60 to online video consultation and 60 to face-to-face consultation. Outcome data were available for 57 patients in the online video consultation group (20 [35%] female and 37 [65%] male; median age 64·0 [54·5–72·5] years) and 55 patients in the face-to-face group (22 [40%] female and 33 [60%] male; median age 62·0 [56·0–70·0] years). The mean patient satisfaction score was 85·4 out of 100 (SD 12·3) in the online video consultation group and 85·2 (14·2) in the face-to-face group (mean difference 0·2, 95% CI −4·8 to 5·1), which was within the non-inferiority margin of −10% (pnon-inferiority<0·0001). The mean information recall score was 7·30 out of 11 (SD 1·60) in the
背景:在2019冠状病毒病大流行期间,患者和卫生保健提供者之间的在线视频会诊迅速普及。然而,据我们所知,关于在线视频咨询和传统面对面咨询的患者满意度和信息回忆质量,没有高质量的比较证据。在要求最高的磋商中,这种证据的缺乏尤其令人关切。我们的目的是评估就患者满意度而言,腹部大手术前患者与外科医生之间的在线视频咨询是否不逊于面对面咨询,并评估对患者信息回忆的影响。方法:这项开放标签、随机、对照、非劣效性试验(video o)在荷兰的两家医院(一家是学术医院,一家是地区医院)进行。成年患者(年龄≥18岁)需要咨询外科医生讨论腹部大手术,并且能够并愿意通过在线视频和面对面咨询进行互动,符合纳入条件;如果患者不能或不愿意开始或维持在线视频咨询,则被排除在外。符合条件的患者被随机分配(1:1)进行在线视频或面对面咨询,由研究协调员使用计算机生成的,隐藏的,排列块随机化方法,不同块大小(2名,4名和6名患者),按研究地点分层。由于研究的性质,不可能掩盖患者和保健提供者。主要结局为患者满意度(0-100分;评估非劣效性(预先设定的差值为-10%)和信息召回(评分0-11),这两项均通过在线问卷进行评估,并在有结果数据的意向治疗人群中进行分析。技术不良事件在咨询后直接作为满意度问卷的一部分进行评估。该试验已在国际临床试验注册平台和涉及人类受试者的研究中央委员会注册,编号为NL-OMON20092,并已完成。研究结果:在2021年2月13日至2023年10月2日期间,120名患者被随机分配:60名患者进行在线视频咨询,60名患者进行面对面咨询。在线视频咨询组57例患者的结局数据可用(20例[35%]女性,37例[65%]男性;中位年龄64·0[55.4 ~ 72.5]岁),面对面组55例,其中女性22例[40%],男性33例[60%];中位年龄62岁[56岁~ 70岁]。在线视频咨询组的平均患者满意度得分为85.4分(SD为12.3),面对面咨询组的平均满意度得分为85.2分(14.2分)(平均差异为0.2,95% CI为- 4.8 ~ 5.1),均在-10%的非劣效范围内(pnon-劣效)。在腹部大手术的外科会诊中,使用在线视频会诊在患者满意度方面不低于面对面会诊,并且对信息回忆没有实质性影响。这些研究结果表明,在线视频会诊可以在外科门诊放心地实施。资助:荷兰卫生研究与发展组织。
{"title":"Online video versus face-to-face preoperative consultation for major abdominal surgery (VIDEOGO): a multicentre, open-label, randomised, controlled, non-inferiority trial","authors":"Britte H E A ten Haaft MD ,&nbsp;Boris V Janssen BSc ,&nbsp;Esther Z Barsom MD PhD ,&nbsp;Prof Wouter J K Hehenkamp MD PhD ,&nbsp;Prof Mark I van Berge Henegouwen MD PhD ,&nbsp;Prof Olivier R Busch MD PhD ,&nbsp;Susan van Dieren PhD ,&nbsp;Joris I Erdmann MD PhD ,&nbsp;Wietse J Eshuis MD PhD ,&nbsp;Suzanne S Gisbertz MD PhD ,&nbsp;Prof Misha D P Luyer MD PhD ,&nbsp;Olga C Damman PhD ,&nbsp;Prof Martine C de Bruijne MD PhD ,&nbsp;Prof Geert Kazemier MD PhD ,&nbsp;Prof Marlies P Schijven MD PhD ,&nbsp;Prof Marc G Besselink MD PhD","doi":"10.1016/j.landig.2025.02.007","DOIUrl":"10.1016/j.landig.2025.02.007","url":null,"abstract":"<div><h3>Background</h3><div>Online video consultation between patients and health-care providers rapidly gained popularity during the COVID-19 pandemic. However, to our knowledge, there is no high-quality comparative evidence regarding patient satisfaction and quality of information recall with online video consultation and traditional face-to-face consultation. This lack of evidence is especially concerning in the most demanding consultations. We aimed to assess whether online video consultation between patients and surgeons before major abdominal surgery was non-inferior to face-to-face consultation in terms of patient satisfaction, and to assess effects on patient information recall.</div></div><div><h3>Methods</h3><div>This open-label, randomised, controlled, non-inferiority trial (VIDEOGO) was conducted at two hospitals (one academic and one regional) in the Netherlands. Adult patients (aged ≥18 years) who required consultation with a surgeon to discuss major abdominal surgery and were able and willing to interact via both online video and face-to-face consultation were eligible for inclusion; patients were excluded if they were unable or unwilling to start or maintain online video consultation. Eligible patients were randomly allocated (1:1) to online video or face-to-face consultation by the study coordinator, using a computer-generated, concealed, permuted-block randomisation method with varying block sizes (two, four, and six patients), stratified by study site. Masking of patients and health-care providers was not possible owing to the nature of the study. The primary outcomes were patient satisfaction (score 0–100; assessed for non-inferiority with a predefined margin of −10%) and information recall (score 0–11), both of which were assessed with online questionnaires and analysed in the intention-to-treat population for whom outcome data were available. Technical adverse events were assessed directly after the consultation as part of the satisfaction questionnaire. This trial is registered with the International Clinical Trial Registry Platform and the Central Committee on Research Involving Human Subjects registry, NL-OMON20092, and is complete.</div></div><div><h3>Findings</h3><div>Between Feb 13, 2021, and Oct 2, 2023, 120 patients were randomly assigned: 60 to online video consultation and 60 to face-to-face consultation. Outcome data were available for 57 patients in the online video consultation group (20 [35%] female and 37 [65%] male; median age 64·0 [54·5–72·5] years) and 55 patients in the face-to-face group (22 [40%] female and 33 [60%] male; median age 62·0 [56·0–70·0] years). The mean patient satisfaction score was 85·4 out of 100 (SD 12·3) in the online video consultation group and 85·2 (14·2) in the face-to-face group (mean difference 0·2, 95% CI −4·8 to 5·1), which was within the non-inferiority margin of −10% (p<sub>non-inferiority</sub>&lt;0·0001). The mean information recall score was 7·30 out of 11 (SD 1·60) in the","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":"7 6","pages":"Article 100867"},"PeriodicalIF":23.8,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144310552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Video in the clinic: advancing care for patients, professionals, and the planet 视频在诊所:推进护理病人,专业人员和地球。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-06-01 DOI: 10.1016/j.landig.2025.100875
Lars Henrik Jensen
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引用次数: 0
Importance of sample size on the quality and utility of AI-based prediction models for healthcare 样本大小对基于人工智能的医疗保健预测模型的质量和效用的重要性。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-06-01 DOI: 10.1016/j.landig.2025.01.013
Prof Richard D Riley PhD , Joie Ensor PhD , Kym I E Snell PhD , Lucinda Archer PhD , Rebecca Whittle PhD , Paula Dhiman PhD , Joseph Alderman MBChB , Xiaoxuan Liu PhD , Laura Kirton MSc , Jay Manson-Whitton , Maarten van Smeden PhD , Prof Karel G Moons PhD , Prof Krishnarajah Nirantharakumar MD , Prof Jean-Baptiste Cazier PhD , Prof Alastair K Denniston PhD , Prof Ben Van Calster PhD , Prof Gary S Collins PhD
Rigorous study design and analytical standards are required to generate reliable findings in healthcare from artificial intelligence (AI) research. One crucial but often overlooked aspect is the determination of appropriate sample sizes for studies developing AI-based prediction models for individual diagnosis or prognosis. Specifically, the number of participants and outcome events required in datasets for model training and evaluation remains inadequately addressed. Most AI studies do not provide a rationale for their chosen sample sizes and frequently rely on datasets that are inadequate for training or evaluating a clinical prediction model. Among the ten principles of Good Machine Learning Practice established by the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency, and Health Canada, guidance on sample size is directly relevant to at least three principles. To reinforce this recommendation, we outline seven reasons why inadequate sample size negatively affects model training, evaluation, and performance. Using a range of examples, we illustrate these issues and discuss the potentially harmful consequences for patient care and clinical adoption. Additionally, we address challenges associated with increasing sample sizes in AI research and highlight existing approaches and software for calculating the minimum sample sizes required for model training and evaluation.
为了从人工智能(AI)研究中获得可靠的医疗保健结果,需要严格的研究设计和分析标准。一个关键但经常被忽视的方面是确定适当的样本量,用于开发基于人工智能的个体诊断或预后预测模型的研究。具体来说,模型训练和评估所需的数据集中的参与者和结果事件的数量仍然没有得到充分的解决。大多数人工智能研究没有为其选择的样本量提供基本原理,并且经常依赖于不足以训练或评估临床预测模型的数据集。在由美国食品和药物管理局、英国药品和保健产品监管局和加拿大卫生部建立的良好机器学习实践的十大原则中,关于样本量的指导至少与三项原则直接相关。为了加强这一建议,我们列出了七个原因,为什么样本量不足会对模型训练、评估和性能产生负面影响。通过一系列的例子,我们说明了这些问题,并讨论了对患者护理和临床采用的潜在有害后果。此外,我们还解决了与人工智能研究中样本量增加相关的挑战,并强调了用于计算模型训练和评估所需的最小样本量的现有方法和软件。
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引用次数: 0
Correction to Lancet Digit Health 2024; 6: e386–95 《柳叶刀数字健康2024》修正;6: e386 - 95。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-05-01 DOI: 10.1016/j.landig.2025.100877
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引用次数: 0
Efficacy of digital health technologies in the management of inflammatory bowel disease: an umbrella review 数字健康技术在炎症性肠病管理中的功效:概括性综述。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-05-01 DOI: 10.1016/j.landig.2024.12.007
Marco Gasparetto MD , Priya Narula MD , Charlotte Wong MBBS MSc , James Ashton MD PhD , Jochen Kammermeier MD PhD , Prof Marieke Pierik MD PhD , Prof Uri Kopylov MD , Prof Naila Arebi MD PhD
The use of digital health technology (DHT) is increasing worldwide. Clinical trials assessing available health tools for the management of patients with inflammatory bowel disease (IBD) are sparse, with limited evidence-based outcome data. In this umbrella review, we investigated the effectiveness of DHT in the care of patients with IBD and identified areas for future research following the Joanna Briggs Institute methodology. Systematic reviews published between January, 2012, and September, 2024, were identified through searches across nine databases (Ovid Embase, Ovid MEDLINE, ProQuest PsycINFO, Epistemonikos, Cochrane, Health Evidence, DoPHER, PROSPERO, and CINAHL via EBSCO), and the results were imported into Covidence software. Inclusion criteria included systematic reviews of randomised controlled trials (RCTs) involving patients of all ages with Crohn’s disease or ulcerative colitis, using DHT for diagnostics, treatment support, monitoring, self-management, or increasing participation in research studies, compared with standard care or alternative interventions. Outcomes included the efficacy and effectiveness of digital interventions, as reported in the studies. The primary outcome was clinical efficacy reported as one or more of the following: clinical response or remission, disease activity, flare-ups or relapses, and quality of life. Secondary outcomes included medication adherence, number of health-care visits, patient engagement (satisfaction and adherence or compliance with interventions), attendance for all terms of engagement, rate of interactions, knowledge improvement, psychological outcomes, and cost or cost–time effectiveness. The review protocol was registered in PROSPERO (registration number: CRD42023417525). AMSTAR-2 was used for methodological quality assessment. Nine relevant reviews were included, including five with meta-analyses comprising 13–19 RCTs in each review; four reviews were rated as high quality and five as critically low quality. DHT was not directly beneficial in achieving or maintaining clinical remission in IBD. In four trials, DHT use was associated with a reduced number of hospital attendances and increased treatment adherence, supporting its role as an adjuvant to standard clinical practice in IBD. Although current evidence from several RCTs and systematic reviews does not indicate better clinical outcomes with DHT in maintaining IBD remission and reducing relapse rates, DHT could be used as an adjuvant resource contributing towards treatment adherence and reducing hospital visits.
数字卫生技术(DHT)的使用在世界范围内不断增加。评估炎症性肠病(IBD)患者管理可用健康工具的临床试验很少,基于证据的结果数据有限。在这篇总结性综述中,我们调查了DHT在IBD患者护理中的有效性,并根据Joanna Briggs研究所的方法确定了未来研究的领域。通过对9个数据库(Ovid Embase、Ovid MEDLINE、ProQuest PsycINFO、Epistemonikos、Cochrane、Health Evidence、DoPHER、PROSPERO和通过EBSCO的CINAHL)的检索,对2012年1月至2024年9月间发表的系统评价进行识别,并将结果导入到Covidence软件中。纳入标准包括对随机对照试验(RCTs)的系统评价,这些试验涉及所有年龄的克罗恩病或溃疡性结肠炎患者,与标准治疗或替代干预措施相比,使用DHT进行诊断、治疗支持、监测、自我管理或增加研究参与。结果包括研究中报告的数字干预的功效和有效性。主要结局是临床疗效报告为以下一项或多项:临床反应或缓解,疾病活动性,发作或复发,生活质量。次要结果包括药物依从性、医疗保健就诊次数、患者参与(干预措施的满意度和依从性或依从性)、所有参与条款的出勤率、互动率、知识改善、心理结果以及成本或成本-时间效益。该审查方案已在PROSPERO注册(注册号:CRD42023417525)。采用AMSTAR-2进行方法学质量评价。纳入9篇相关综述,其中5篇荟萃分析,每篇综述包含13-19项rct;四篇评论被评为高质量,五篇评论被评为极低质量。DHT对实现或维持IBD的临床缓解没有直接益处。在四项试验中,DHT的使用与住院人数减少和治疗依从性增加有关,支持其作为IBD标准临床实践的辅助作用。虽然目前来自几项随机对照试验和系统评价的证据并没有表明DHT在维持IBD缓解和降低复发率方面有更好的临床结果,但DHT可以作为一种辅助资源,有助于治疗依从性和减少住院次数。
{"title":"Efficacy of digital health technologies in the management of inflammatory bowel disease: an umbrella review","authors":"Marco Gasparetto MD ,&nbsp;Priya Narula MD ,&nbsp;Charlotte Wong MBBS MSc ,&nbsp;James Ashton MD PhD ,&nbsp;Jochen Kammermeier MD PhD ,&nbsp;Prof Marieke Pierik MD PhD ,&nbsp;Prof Uri Kopylov MD ,&nbsp;Prof Naila Arebi MD PhD","doi":"10.1016/j.landig.2024.12.007","DOIUrl":"10.1016/j.landig.2024.12.007","url":null,"abstract":"<div><div>The use of digital health technology (DHT) is increasing worldwide. Clinical trials assessing available health tools for the management of patients with inflammatory bowel disease (IBD) are sparse, with limited evidence-based outcome data. In this umbrella review, we investigated the effectiveness of DHT in the care of patients with IBD and identified areas for future research following the Joanna Briggs Institute methodology. Systematic reviews published between January, 2012, and September, 2024, were identified through searches across nine databases (Ovid Embase, Ovid MEDLINE, ProQuest PsycINFO, Epistemonikos, Cochrane, Health Evidence, DoPHER, PROSPERO, and CINAHL via EBSCO), and the results were imported into Covidence software. Inclusion criteria included systematic reviews of randomised controlled trials (RCTs) involving patients of all ages with Crohn’s disease or ulcerative colitis, using DHT for diagnostics, treatment support, monitoring, self-management, or increasing participation in research studies, compared with standard care or alternative interventions. Outcomes included the efficacy and effectiveness of digital interventions, as reported in the studies. The primary outcome was clinical efficacy reported as one or more of the following: clinical response or remission, disease activity, flare-ups or relapses, and quality of life. Secondary outcomes included medication adherence, number of health-care visits, patient engagement (satisfaction and adherence or compliance with interventions), attendance for all terms of engagement, rate of interactions, knowledge improvement, psychological outcomes, and cost or cost–time effectiveness. The review protocol was registered in PROSPERO (registration number: CRD42023417525). AMSTAR-2 was used for methodological quality assessment. Nine relevant reviews were included, including five with meta-analyses comprising 13–19 RCTs in each review; four reviews were rated as high quality and five as critically low quality. DHT was not directly beneficial in achieving or maintaining clinical remission in IBD. In four trials, DHT use was associated with a reduced number of hospital attendances and increased treatment adherence, supporting its role as an adjuvant to standard clinical practice in IBD. Although current evidence from several RCTs and systematic reviews does not indicate better clinical outcomes with DHT in maintaining IBD remission and reducing relapse rates, DHT could be used as an adjuvant resource contributing towards treatment adherence and reducing hospital visits.</div></div>","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":"7 5","pages":"Article 100843"},"PeriodicalIF":23.8,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144081271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Utilising the Benefit Risk Assessment of Vaccines (BRAVE) toolkit to evaluate the benefits and risks of Vaxzevria in the EU: a population-based study 利用疫苗获益风险评估(BRAVE)工具包评估欧盟Vaxzevria的获益和风险:一项基于人群的研究。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-05-01 DOI: 10.1016/j.landig.2025.02.001
Hector Gonzalez Dorta MSc , Johan Verbeeck PhD , Jonas Crevecoeur PhD , Daniel R Morales PhD , Neilshan Loedy MSc , Catherine Cohet PhD , Lander Willem PhD , Prof Geert Molenberghs PhD , Prof Niel Hens PhD , Xavier Kurz PhD , Chantal Quinten PhD , Steven Abrams PhD

Background

Several COVID-19 vaccines have been licensed. To support the assessment of safety signals, we developed a toolkit to support COVID-19 vaccine monitoring and benefit–risk assessment. We aim to show the application of our toolkit in the EU using thrombosis with thrombocytopenia syndrome (TTS) associated with the Vaxzevria (AstraZeneca) vaccine as a use case.

Methods

In this population-based study, we used a model incorporating data from multiple EU sources such as The European Surveillance System and EudraVigilance, and estimated the benefits of COVID-19 vaccines by comparing the observed COVID-19 confirmed cases, hospitalisations, intensive care unit (ICU) admissions, and deaths across Europe to the expected numbers in the absence of Vaxzevria vaccination. Risks of TTS associated with Vaxzevria were calculated by comparing the observed number of TTS events in individuals who received Vaxzevria to the expected number of events based on background incidence rates. To visualise the results, we developed a toolkit with an interactive web application.

Findings

62 598 505 Vaxzevria vaccines (32 763 183 to females and 29 835 322 to males) had been administered in Europe by Feb 10, 2021. Our results showed that a first dose of Vaxzevria provided benefits across all age groups. Based on vaccine effectiveness estimates and reported coverage in Europe, from Dec 13, 2020 to Dec 31, 2021, vaccination with Vaxzevria was estimated to prevent (per 100 000 doses) 12 113 COVID-19 cases, 1140 hospitalisations, 184 ICU admissions, and 261 deaths. Women aged 30–59 years and males aged 20–29 years had the highest frequency of TTS events. The benefits of vaccination outweighed the risks of TTS in all age groups, with the highest benefits and risks observed in individuals aged 60–69 years.

Interpretation

Our toolkit and underlying model contextualised the risk of TTS associated with Vaxzevria relative to its benefits. The methodology employed could be applied to other serious adverse events related to COVID-19 or other vaccines. The adaptability and versatility of such toolkits might contribute to strengthening preparedness for future public health emergencies.

Funding

European Medicines Agency.
背景:几种COVID-19疫苗已获得许可。为了支持安全信号的评估,我们开发了一个工具包,以支持COVID-19疫苗监测和利益风险评估。我们的目标是展示我们的工具包在欧盟的应用,使用与Vaxzevria(阿斯利康)疫苗相关的血栓伴血小板减少综合征(TTS)作为用例。方法:在这项基于人群的研究中,我们使用了一个模型,该模型结合了来自多个欧盟来源(如欧洲监测系统和EudraVigilance)的数据,并通过比较欧洲各地观察到的COVID-19确诊病例、住院情况、重症监护病房(ICU)入院情况和死亡人数,与未接种Vaxzevria疫苗的预期数字,来估计COVID-19疫苗的益处。通过比较接受Vaxzevria的个体中观察到的TTS事件数量与基于背景发病率的预期事件数量,计算与Vaxzevria相关的TTS风险。为了使结果可视化,我们开发了一个带有交互式web应用程序的工具包。结果:截至2021年2月10日,欧洲共接种了62 598 505支Vaxzevria疫苗(女性接种32 763 183支,男性接种29 835 322支)。我们的研究结果表明,第一剂Vaxzevria对所有年龄组都有好处。根据疫苗有效性估计和欧洲报告的覆盖率,从2020年12月13日至2021年12月31日,估计接种Vaxzevria(每10万剂)可预防12113例COVID-19病例、1140例住院、184例ICU住院和261例死亡。30 ~ 59岁的女性和20 ~ 29岁的男性发生TTS的频率最高。在所有年龄组中,疫苗接种的益处超过TTS的风险,在60-69岁的个体中观察到的益处和风险最高。解释:我们的工具包和基础模型将与Vaxzevria相关的TTS风险与其益处相关联。所采用的方法可应用于与COVID-19或其他疫苗相关的其他严重不良事件。这些工具包的适应性和多功能性可能有助于加强对未来突发公共卫生事件的防范。资助:欧洲药品管理局。
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引用次数: 0
Technology for global immunisation 全球免疫技术。
IF 23.8 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-05-01 DOI: 10.1016/j.landig.2025.100881
The Lancet Digital Health
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引用次数: 0
期刊
Lancet Digital Health
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