Patient Generated Health Data

患者生成的健康数据
  • 文章类型: Journal Article
    本范围审查旨在识别和综合与家庭环境中患有癌症的老年人中患者生成的健康数据(PGHD)相关的文献。在通过六个数据库搜索提取的1090篇文章中,53人被选中。研究发表于2007年至2022年,生成PGHD的设备类型包括研究级和消费级可穿戴设备。PGHD被评估为身体活动,生命体征,和睡眠。PGHD利用率进行了分类:1)识别,监测,review,和分析(100%);2)反馈和信息报告(32.1%);3)动机(26.4%);和4)教育和指导(17.0%)。我们的研究表明,来自癌症老年人的各种PGHD主要是被动收集的,与医疗保健提供者的互动使用有限。这些结果可能为医疗保健提供者提供有价值的见解,以了解PGHD在老年癌症护理中的潜在应用。
    This scoping review aimed to identify and synthesize the literature related to patient-generated health data (PGHD) among older adults with cancer in home setting. Of the 1,090 articles extracted through six databases searches, 53 were selected. Studies were published from 2007 to 2022 and the types of devices to generate PGHD included research-grade and consumer-grade wearable devices. PGHD was assessed for physical activity, vital signs, and sleep. PGHD utilization was categorized: 1) identification, monitoring, review, and analysis (100%); 2) feedback and information report (32.1%); 3) motivation (26.4%); and 4) education and coaching (17.0%). Our study reveals that various PGHDs from older adults with cancer are mainly collected passively, with limited use for interaction with healthcare providers. These results may provide valuable insights for healthcare providers into potential PGHD applications in geriatric cancer care.
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  • 文章类型: Journal Article
    随着卫生技术的进步,这项研究旨在开发一种创新的营养摄入管理系统,该系统集成了人工智能技术和社交媒体软件,以实现对患者生成数据的精确分析和持续护理的全面管理。我们的系统建立在LineBot平台上,允许用户通过报告饮食信息轻松直观地获得他们个人营养摄入的详细分析。当用户通过LineBot报告他们的饮食习惯时,我们的人工智能模型对营养素摄入量进行实时分析,提供个性化的营养建议。这种即时反馈不仅增强了用户对营养管理的参与度,而且有助于建立健康的习惯。此外,通过与社交媒体软件的整合,我们的系统促进了用户之间的信息共享和社区支持,促进营养知识交流和互助。本研究进一步探讨慢性病患者的具体需求,收集有关慢性病和总营养摄入量的个人数据。根据台湾健康促进署提出的营养摄入指引,我们提供更精确的营养管理建议,以满足每位患者独特的健康需求.本研究介绍了一个全面的,基于患者生成的基于数据的方法,用于连续护理中的精确营养管理。通过整合人工智能,社交媒体软件,和数据分析,我们的系统不仅为监测和管理患者的营养摄入提供了有效的工具,而且还促进了患者之间的互动和支持,推动实施持续护理实践。
    A As health technology advances, this study aims to develop an innovative nutritional intake management system that integrates artificial intelligence technology and social media software to achieve precise analysis of patient-generated data and comprehensive management in continuous care. Our system is built on the Line Bot platform, allowing users to easily and intuitively obtain detailed analyses of their individual nutritional intake by reporting dietary information. While users report their dietary habits through the Line Bot, our AI model conducts real-time analysis of nutrient intake, providing personalized nutritional recommendations. This instantaneous feedback not only enhances user engagement in nutritional management but also aids in establishing healthy habits. Additionally, through integration with social media software, our system facilitates information sharing and community support among users, promoting the exchange of nutritional knowledge and mutual assistance. This study further explores the specific needs of patients with chronic diseases, collecting individual data on chronic conditions and total nutritional intake. Based on the nutritional intake guidelines proposed by the Health Promotion Administration in Taiwan, more precise nutritional management recommendations are provided to meet the unique health needs of each patient. This study introduces a comprehensive, patient-generated data-based approach for precision nutrition management in continuous care. By integrating artificial intelligence, social media software, and data analysis, our system not only offers effective tools for monitoring and managing patients\' nutritional intake but also fosters interaction and support among patients, driving the implementation of continuous care practices.
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  • 文章类型: Journal Article
    目标:使用工作流执行模型来突出以患者为中心的临床决策支持策略(PCCDS)的新考虑因素,进程,程序,技术,以及支持新工作流所需的专业知识。
    方法:要生成和完善模型,我们使用(1)有针对性的文献综述;(2)与6名外部PCCDS专家进行的关键信息访谈;(3)基于作者经验的模型改进;(4)由26名成员组成的指导委员会对模型进行验证.
    结论:我们确定了7个主要问题,这些问题为医疗保健系统带来了重大挑战和机遇,研究人员,管理员,以及健康的IT和应用程序开发人员。克服这些挑战为新的或修改的政策提供了机会,进程,程序,技术,和专业知识:(1)确保患者生成的健康数据(PGHD),包括患者报告的结果(PRO),被记录在案,reviewed,并由训练有素的临床医生管理,在访问之间和正常工作时间之后。(2)教育患者使用连接的医疗器械,处理技术问题。(3)促进PGHD的收集和合并,PROs,患者偏好,并将健康的社会决定因素纳入现有的电子健康记录。(4)对从设备接收到的错误数据进行故障排除。(5)开发显示纵向患者报告数据的仪表板。(6)提供报销以支持新的护理模式。(7)支持患者参与远程设备。
    结论:几项新政策,进程,技术,和专业知识需要确保PCCDS的安全和有效实施和使用。随着我们获得更多实施和使用PCCDS的经验,我们应该能够开始意识到医疗保健中以患者为中心的运动对患者健康的长期积极影响。
    OBJECTIVE: To use workflow execution models to highlight new considerations for patient-centered clinical decision support policies (PC CDS), processes, procedures, technology, and expertise required to support new workflows.
    METHODS: To generate and refine models, we used (1) targeted literature reviews; (2) key informant interviews with 6 external PC CDS experts; (3) model refinement based on authors\' experience; and (4) validation of the models by a 26-member steering committee.
    CONCLUSIONS: We identified 7 major issues that provide significant challenges and opportunities for healthcare systems, researchers, administrators, and health IT and app developers. Overcoming these challenges presents opportunities for new or modified policies, processes, procedures, technology, and expertise to: (1) Ensure patient-generated health data (PGHD), including patient-reported outcomes (PROs), are documented, reviewed, and managed by appropriately trained clinicians, between visits and after regular working hours. (2) Educate patients to use connected medical devices and handle technical issues. (3) Facilitate collection and incorporation of PGHD, PROs, patient preferences, and social determinants of health into existing electronic health records. (4) Troubleshoot erroneous data received from devices. (5) Develop dashboards to display longitudinal patient-reported data. (6) Provide reimbursement to support new models of care. (7) Support patient engagement with remote devices.
    CONCLUSIONS: Several new policies, processes, technologies, and expertise are required to ensure safe and effective implementation and use of PC CDS. As we gain more experience implementing and working with PC CDS, we should be able to begin realizing the long-term positive impact on patient health that the patient-centered movement in healthcare promises.
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  • 文章类型: Journal Article
    Mogamulizumab是靶向CC趋化因子受体4(CCR4)的人源化抗体。这项上市后监测是在2014年至2020年在日本作为监管要求进行的,以确保莫加穆利珠单抗在复发或难治性(r/r)CCR4阳性外周T细胞淋巴瘤(PTCL)或r/r皮肤T细胞淋巴瘤(CTCL)患者中的安全性和有效性。在治疗开始后31周内收集安全性和有效性数据。共有142名患者登记;对136名患者进行了安全性评估。剂量的中位数为8.0(范围,1-18).终止治疗的主要原因为应答不足(22.1%)和不良事件(13.2%)。任何级别的药物不良反应发生率为57.4%,包括皮肤病(26.5%),感染和免疫系统紊乱(16.2%),和输液相关反应(13.2%)。移植物抗宿主病,2级,在接受mogamulizumab后接受异基因造血干细胞移植的两名患者中的一名中发展。对131例患者(103例PTCL;28例CTCL)进行了有效性评估。最佳总有效率为45.8%(PTCL,47.6%;CTCL,39.3%)。在第31周,生存率为69.0%(95%置信区间,59.8%-76.5%)[PTCL,64.4%(54.0%-73.0%);CTCL,90.5%(67.0%-97.5%)]。<70岁和≥70岁的患者以及复发和难治性疾病患者之间的安全性和有效性相当。在现实世界中,mogamulizumab用于PTCL和CTCL的安全性和有效性与先前临床试验中报告的数据相当。临床试验注册。
    Mogamulizumab is a humanized antibody targeting CC chemokine receptor 4 (CCR4). This post-marketing surveillance was conducted in Japan as a regulatory requirement from 2014 to 2020 to ensure the safety and effectiveness of mogamulizumab in patients with relapsed or refractory (r/r) CCR4-positive peripheral T-cell lymphoma (PTCL) or r/r cutaneous T-cell lymphoma (CTCL). Safety and effectiveness data were collected for up to 31 weeks after treatment initiation. A total of 142 patients were registered; safety was evaluated in 136 patients. The median number of doses was 8.0 (range, 1-18). The main reasons for treatment termination were insufficient response (22.1%) and adverse events (13.2%). The frequency of any grade adverse drug reaction was 57.4%, including skin disorders (26.5%), infections and immune system disorders (16.2%), and infusion-related reactions (13.2%). Graft-versus-host disease, grade 2, developed in one of two patients who underwent allogeneic-hematopoietic stem cell transplantation after receiving mogamulizumab. Effectiveness was evaluated in 131 patients (103 with PTCL; 28 with CTCL). The best overall response rate was 45.8% (PTCL, 47.6%; CTCL, 39.3%). At week 31, the survival rate was 69.0% (95% confidence interval, 59.8%-76.5%) [PTCL, 64.4% (54.0%-73.0%); CTCL, 90.5% (67.0%-97.5%)]. Safety and effectiveness were comparable between patients <70 and ≥ 70 years old and between those with relapsed and refractory disease. The safety and effectiveness of mogamulizumab for PTCL and CTCL in the real world were comparable with the data reported in previous clinical trials. Clinical Trial Registration.
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  • 文章类型: Systematic Review
    背景:移动健康(mHealth)使用移动技术来促进健康并帮助疾病管理。尽管在临床环境中使用的mHealth解决方案通常是医疗级设备,智能手机和活动跟踪器等消费级设备的被动和主动感知功能有可能弥合有关患者行为的信息差距,环境,生活方式,和其他无处不在的数据。个人越来越多地采用mHealth解决方案,这有助于收集患者生成的健康数据(PGHD)。医疗保健专业人员(HCP)可能会使用这些数据来支持慢性病的护理。然而,在临床背景下,对使用来自消费级mHealth解决方案的PGHD的HPC的现实生活体验的研究有限。
    目的:本系统综述旨在分析现有文献,以确定HCP如何在临床环境中使用来自消费级移动设备的PGHD。目标是确定HCP使用的PGHD类型,他们使用它们的健康状况,并了解他们使用它们的动机。
    方法:系统的文献综述是综合前人研究的主要研究方法。通过全面的健康搜索确定了合格的研究,生物医学,和计算机科学数据库,并进行了互补的手搜索。搜索策略是根据与PGHD相关的关键主题迭代构建的,HCP,和移动技术。筛选过程包括2个阶段。使用预定义的形式进行数据提取。使用描述性和叙述性综合方法对提取的数据进行总结。
    结果:该综述包括16项研究。这些研究从2015年到2021年,大部分发表在2019年或更晚。研究表明,HCP一直在通过各种渠道审查PGHD,包括解决方案门户和患者设备。关于患者行为的PGHD似乎对HCP特别有用。我们的研究结果表明,PGHD更常用于HCP治疗与生活方式相关的疾病。比如糖尿病和肥胖症。医生是最常报告的PGHD用户,参与80%以上的研究。
    结论:通过mHealth解决方案收集PGHD已证明对患者有益,也可以支持HCP。PGHD对于治疗与生活方式相关的疾病特别有用,比如糖尿病,心血管疾病,肥胖,或者在高度不确定性的领域,比如不孕症。将PGHD集成到临床护理中带来了与隐私和可访问性相关的挑战。一些HCP已经发现,尽管来自消费设备的PGHD可能并不完美或完全准确,他们的感知临床价值超过了没有数据的选择.尽管他们的感知价值,我们的研究结果表明,它们在临床实践中的使用仍然很少。
    RR2-10.2196/39389。
    BACKGROUND: Mobile health (mHealth) uses mobile technologies to promote wellness and help disease management. Although mHealth solutions used in the clinical setting have typically been medical-grade devices, passive and active sensing capabilities of consumer-grade devices like smartphones and activity trackers have the potential to bridge information gaps regarding patients\' behaviors, environment, lifestyle, and other ubiquitous data. Individuals are increasingly adopting mHealth solutions, which facilitate the collection of patient-generated health data (PGHD). Health care professionals (HCPs) could potentially use these data to support care of chronic conditions. However, there is limited research on real-life experiences of HPCs using PGHD from consumer-grade mHealth solutions in the clinical context.
    OBJECTIVE: This systematic review aims to analyze existing literature to identify how HCPs have used PGHD from consumer-grade mobile devices in the clinical setting. The objectives are to determine the types of PGHD used by HCPs, in which health conditions they use them, and to understand the motivations behind their willingness to use them.
    METHODS: A systematic literature review was the main research method to synthesize prior research. Eligible studies were identified through comprehensive searches in health, biomedicine, and computer science databases, and a complementary hand search was performed. The search strategy was constructed iteratively based on key topics related to PGHD, HCPs, and mobile technologies. The screening process involved 2 stages. Data extraction was performed using a predefined form. The extracted data were summarized using a combination of descriptive and narrative syntheses.
    RESULTS: The review included 16 studies. The studies spanned from 2015 to 2021, with a majority published in 2019 or later. Studies showed that HCPs have been reviewing PGHD through various channels, including solutions portals and patients\' devices. PGHD about patients\' behavior seem particularly useful for HCPs. Our findings suggest that PGHD are more commonly used by HCPs to treat conditions related to lifestyle, such as diabetes and obesity. Physicians were the most frequently reported users of PGHD, participating in more than 80% of the studies.
    CONCLUSIONS: PGHD collection through mHealth solutions has proven beneficial for patients and can also support HCPs. PGHD have been particularly useful to treat conditions related to lifestyle, such as diabetes, cardiovascular diseases, and obesity, or in domains with high levels of uncertainty, such as infertility. Integrating PGHD into clinical care poses challenges related to privacy and accessibility. Some HCPs have identified that though PGHD from consumer devices might not be perfect or completely accurate, their perceived clinical value outweighs the alternative of having no data. Despite their perceived value, our findings reveal their use in clinical practice is still scarce.
    UNASSIGNED: RR2-10.2196/39389.
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  • 文章类型: Journal Article
    背景:数字健康技术的普及正在产生大量的人生成的健康数据(PGHD)。这些数据可以使人们能够监测自己的健康状况,以促进疾病的预防和管理。女性是数字自我跟踪技术最大的消费者群体之一。
    目的:在本范围审查中,我们的目的是(1)确定使用PGHD从连接的健康设备监测妇女健康的不同领域,(2)探索通过这些技术收集的个人指标,和(3)综合促进和障碍妇女采用和使用连接的健康设备。
    方法:遵循PRISMA(系统审查和荟萃分析的首选报告项目)范围审查指南,我们在5个数据库中搜索了2015年1月1日至2020年2月29日发表的文章.如果论文针对女性或女性个人,并纳入了在临床环境之外收集PGHD的数字健康工具,则包括在内。
    结果:本综述共纳入406篇论文。从2015年到2020年,关于女性使用PGHD的文章稳步增加。文章关注的健康领域跨越了几个主题,妊娠和产后是最普遍的,其次是癌症。用于收集PGHD的数字健康类型包括移动应用程序,可穿戴设备,网站,物联网或智能设备,双向消息传递,交互式语音响应,和可植入装置。对41.4%(168/406)的论文进行的主题分析显示,有关妇女使用数字健康技术收集PGHD的促进者和障碍的6个主题:(1)可访问性和连通性,(2)设计和功能,(3)准确性和可信度,(4)观众和收养,(5)对社区卫生服务的影响,(6)对健康和行为的影响。
    结论:在COVID-19大流行之前,数字健康工具的采用,以解决妇女的健康问题正在稳步上升。与怀孕和产后相关的工具的突出反映了妇女健康研究对生殖健康的强烈关注,并突出了其他妇女健康主题中数字技术开发的机会。当数字健康技术与目标受众相关时,它是最可接受的,被认为是用户友好的,并考虑了女性的个性化偏好,同时还确保了测量的准确性和信息的可信度。将数字技术整合到临床护理中将继续发展,以及诸如责任和医疗保健提供者工作量等因素需要考虑。在承认个人需求的多样性的同时,PGHD的使用可以对众多女性健康旅程的自我护理管理产生积极影响。COVID-19大流行带来了越来越多的数字医疗技术的采用和接受。这项研究可以作为该领域如何演变的结果的基线比较。
    RR2-10.2196/26110。
    BACKGROUND: The increased pervasiveness of digital health technology is producing large amounts of person-generated health data (PGHD). These data can empower people to monitor their health to promote prevention and management of disease. Women make up one of the largest groups of consumers of digital self-tracking technology.
    OBJECTIVE: In this scoping review, we aimed to (1) identify the different areas of women\'s health monitored using PGHD from connected health devices, (2) explore personal metrics collected through these technologies, and (3) synthesize facilitators of and barriers to women\'s adoption and use of connected health devices.
    METHODS: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for scoping reviews, we searched 5 databases for articles published between January 1, 2015, and February 29, 2020. Papers were included if they targeted women or female individuals and incorporated digital health tools that collected PGHD outside a clinical setting.
    RESULTS: We included a total of 406 papers in this review. Articles on the use of PGHD for women steadily increased from 2015 to 2020. The health areas that the articles focused on spanned several topics, with pregnancy and the postpartum period being the most prevalent followed by cancer. Types of digital health used to collect PGHD included mobile apps, wearables, websites, the Internet of Things or smart devices, 2-way messaging, interactive voice response, and implantable devices. A thematic analysis of 41.4% (168/406) of the papers revealed 6 themes regarding facilitators of and barriers to women\'s use of digital health technology for collecting PGHD: (1) accessibility and connectivity, (2) design and functionality, (3) accuracy and credibility, (4) audience and adoption, (5) impact on community and health service, and (6) impact on health and behavior.
    CONCLUSIONS: Leading up to the COVID-19 pandemic, the adoption of digital health tools to address women\'s health concerns was on a steady rise. The prominence of tools related to pregnancy and the postpartum period reflects the strong focus on reproductive health in women\'s health research and highlights opportunities for digital technology development in other women\'s health topics. Digital health technology was most acceptable when it was relevant to the target audience, was seen as user-friendly, and considered women\'s personalization preferences while also ensuring accuracy of measurements and credibility of information. The integration of digital technologies into clinical care will continue to evolve, and factors such as liability and health care provider workload need to be considered. While acknowledging the diversity of individual needs, the use of PGHD can positively impact the self-care management of numerous women\'s health journeys. The COVID-19 pandemic has ushered in increased adoption and acceptance of digital health technology. This study could serve as a baseline comparison for how this field has evolved as a result.
    UNASSIGNED: RR2-10.2196/26110.
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  • 文章类型: Randomized Controlled Trial
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  • 文章类型: Journal Article
    建立不仅包括临床数据而且包括个人健康记录的集成数据模型变得越来越重要。我们旨在通过开发可用于医疗保健领域的通用数据模型来构建大数据医疗保健平台。为此,我们从各个社区获取健康数据,以建立社区护理数字医疗服务模型。Further,为了提高个人健康数据的互操作性,我们确保符合国际标准,即,医学临床术语系统化命名法(SNOMED-CT)和传输标准,即,健康等级7快速医疗保健互操作性资源(HL7FHIR)。此外,FHIR资源分析旨在传输和接收数据,遵循HL7FHIRR4指南。
    Building an integrated data model that includes not only clinical data but also personal health records has become increasingly important. We aimed to build a big data healthcare platform by developing a common data model that can be utilized in the healthcare field. To this end, we acquired health data from various communities to establish community care digital healthcare service models. Further, to improve personal health data interoperability, we ensured conformance to international standards, namely, the Systemized Nomenclature of Medicine Clinical Terms (SNOMED-CT) and transmission standards, namely, Health Level 7 Fast Healthcare Interoperability Resource (HL7 FHIR). Furthermore, FHIR resource profiling was designed to transmit and receive data, following the HL7 FHIR R4 guidelines.
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  • 文章类型: Journal Article
    生活质量(QoL)受环境影响,患者之间存在差异。通过患者报告结果(PRO)和患者生成数据(PGD)的组合测量可以通过纵向调查增强对QoL损伤的检测。利用不同的QoL测量技术方法,挑战是将数据组合在一个标准化的,可互操作的方式。我们开发了一个应用程序(Lion-App),以语义上注释来自传感器系统的数据以及要在QoL的整体分析中合并的PRO。为标准化评估定义了FHIR实施指南。要访问传感器数据,使用AppleHealth或GoogleFit的接口,而不是将各种提供商直接集成到系统中。由于QoL不能仅通过传感器值收集,PRO和PGD的组合是必要的。PGD实现了QoL的发展,从而提供了对个人限制的更多见解,而PRO则提供了对个人负担的见解。FHIR的使用实现了数据的结构化交换,而个性化分析可能会改善治疗和结果。
    Quality of life (QoL) is affected by environmental influences and varies between patients. A combined measurement through Patient Reported Outcomes (PROs) and Patient Generated Data (PGD) may enhance the detection of QoL impairments by a longitudinal survey. Leveraging different approaches of QoL measurement techniques, the challenge is to combine data in a standardized, interoperable way. We developed an app (Lion-App) to semantically annotate data from sensor systems as well as PROs to be merged in an overall analysis of QoL. A FHIR implementation guide was defined for a standardized assessment. To access sensor data the interfaces of Apple Health or Google Fit are used instead of integrating various provider directly into the system. Since QoL cannot be collected exclusively via sensor values, a combination of PROs and PGD is necessary. PGD enable a progression of QoL which offers more insight into personal limitations whereas PROs give insight about personal burden. The use of FHIR enables structured exchange of data while personalized analyses might improve therapy and outcome.
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  • 文章类型: Journal Article
    患有与糖尿病相关的足部溃疡(DFU)的人需要在数月内持续进行自我护理,以促进愈合并减轻住院和截肢的风险。然而,在此期间,他们的DFU的改善可能很难检测到。因此,需要一种在家中自监测DFU的可访问方法。我们开发了一个新的手机应用程序,\"MyFootCare\",从脚部的照片自我监控DFU的治疗进展。这项研究的目的是评估MyFootCare对足底DFU持续时间超过3个月的人的参与度和感知价值。通过应用程序日志数据和半结构化访谈(第0、3和12周)收集数据,并通过描述性统计和主题分析进行分析。12名参与者中有10人认为MyFootCare对监测进展和反思影响自我护理的事件很有价值。七名与会者认为这对加强磋商具有潜在的价值。出现了三种应用程序参与模式:连续、temporary,订婚失败。这些模式突出显示了自我监控的推动者(例如在参与者的电话上安装了MyFootCare)和障碍(例如可用性问题和缺乏治疗进展)。我们得出的结论是,尽管许多使用DFU的人认为基于应用程序的自我监控很有价值,由于各种促进者和障碍,某些人可以实现实际参与,但并非所有人都可以实现。进一步的研究应以提高可用性为目标,准确性和与医疗保健专业人员共享,并在使用该应用程序时测试临床结果。
    People with diabetes-related foot ulcers (DFUs) need to perform self-care consistently over many months to promote healing and to mitigate risks of hospitalisation and amputation. However, during that time, improvement in their DFU can be hard to detect. Hence, there is a need for an accessible method to self-monitor DFUs at home. We developed a new mobile phone app, \"MyFootCare\", to self-monitor DFU healing progression from photos of the foot. The aim of this study is to evaluate the engagement and perceived value of MyFootCare for people with a plantar DFU over 3 months\' duration. Data are collected through app log data and semi-structured interviews (weeks 0, 3, and 12) and analysed through descriptive statistics and thematic analysis. Ten out of 12 participants perceive MyFootCare as valuable to monitor progress and to reflect on events that affected self-care, and seven participants see it as potentially valuable to enhance consultations. Three app engagement patterns emerge: continuous, temporary, and failed engagement. These patterns highlight enablers for self-monitoring (such as having MyFootCare installed on the participant\'s phone) and barriers (such as usability issues and lack of healing progress). We conclude that while many people with DFUs perceive app-based self-monitoring as valuable, actual engagement can be achieved for some but not for all people because of various facilitators and barriers. Further research should target improving usability, accuracy and sharing with healthcare professionals and test clinical outcomes when using the app.
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