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PURPOSE: Performance status (PS) is a crucial assessment for research and clinical practice in lung cancer (LC), including its usage for the assessment of the suitability and toxicity of treatment or eligibility for clinical trials of patients with LC. These PS assessments are subjective and lead to substantial discrepancies between observers. To improve the objectivity of PS assessments, Electronic Activity Monitoring devices (EAMs) are increasingly used in oncology, but how these devices are used for PS assessments in LC is an issue that remains unclear. The goal of this study is to address the challenges and opportunities of the use of digital tools to support PS assessments in patients with LC. METHODS: The literature review followed PRISMA-ScR methodology. Searches were performed in the ScienceDirect, PsycInfo, ACM, IEEE Xplore, and PubMed databases. Furthermore, a panel discussion was performed to address the clinical use cases. RESULTS: Thirty-two publications were found. Most of the studies used wrist accelerometry-based wearables (59%) and monitored sleep activity (SA; 28%) or physical activity (PA; 72%). Critical findings include positive usefulness of the use of wearables to categorize moderate-to-vigorous/light PA, which was associated with better sleep and health. In addition, steps and time awake immobile were found to be associated with risk of hospitalization and survival. Use cases identified included the health assessment of patients and clinical research. CONCLUSION: There are positive experiences in the use of EAM to complement PS assessment in LC. However, there is a need for adapting thresholds to the particularities of patients with LC, for example, differentiating moderate-to-vigorous and light. Moreover, developing methodologies combining PS assessments and the use of EAM adapted to clinical and research practice is needed.
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Neoplasias Pulmonares , Dispositivos Electrónicos Vestibles , Humanos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/terapia , Ejercicio Físico , Acelerometría , SueñoRESUMEN
Background and purpose: Radiation-induced toxicities are common adverse events in lung cancer (LC) patients undergoing radiotherapy (RT). An accurate prediction of these adverse events might facilitate an informed and shared decision-making process between patient and radiation oncologist with a clearer view of life-balance implications in treatment choices. This work provides a benchmark of machine learning (ML) approaches to predict radiation-induced toxicities in LC patients built upon a real-world health dataset based on a generalizable methodology for their implementation and external validation. Materials and Methods: Ten feature selection (FS) methods were combined with five ML-based classifiers to predict six RT-induced toxicities (acute esophagitis, acute cough, acute dyspnea, acute pneumonitis, chronic dyspnea, and chronic pneumonitis). A real-world health dataset (RWHD) built from 875 consecutive LC patients was used to train and validate the resulting 300 predictive models. Internal and external accuracy was calculated in terms of AUC per clinical endpoint, FS method, and ML-based classifier under analysis. Results: Best performing predictive models obtained per clinical endpoint achieved comparable performances to methods from state-of-the-art at internal validation (AUC ≥ 0.81 in all cases) and at external validation (AUC ≥ 0.73 in 5 out of 6 cases). Conclusion: A benchmark of 300 different ML-based approaches has been tested against a RWHD achieving satisfactory results following a generalizable methodology. The outcomes suggest potential relationships between underrecognized clinical factors and the onset of acute esophagitis or chronic dyspnea, thus demonstrating the potential that ML-based approaches have to generate novel data-driven hypotheses in the field.
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Mobile Health (mHealth) has a great potential to enhance the self-management of cancer patients and survivors. Our study aimed to perform a scoping review to evaluate the impact and trends of mobile application-based interventions on adherence and their effects on health outcomes among the cancer population. In addition, we aimed to develop a taxonomy of mobile-app-based interventions to assist app developers and healthcare researchers in creating future mHealth cancer care solutions. Relevant articles were screened from the online databases PubMed, EMBASE, and Scopus, spanning the time period from 1 January 2016 to 31 December 2022. Of the 4135 articles initially identified, 55 were finally selected for the review. In the selected studies, breast cancer was the focus of 20 studies (36%), while mixed cancers were the subject of 23 studies (42%). The studies revealed that the usage rate of mHealth was over 80% in 41 of the 55 studies, with factors such as guided supervision, personalized suggestions, theoretical intervention foundations, and wearable technology enhancing adherence and efficacy. However, cancer progression, technical challenges, and unfamiliarity with devices were common factors that led to dropouts. We also proposed a taxonomy based on diverse theoretical foundations of mHealth interventions, delivery methods, psycho-educational programs, and social platforms. We suggest that future research should investigate, improve, and verify this taxonomy classification to enhance the design and efficacy of mHealth interventions.
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BACKGROUND: Stress and anxiety are psychophysiological responses commonly experienced by patients during the perioperative process that can increase presurgical and postsurgical complications to a comprehensive and positive recovery. Preventing and intervening in stress and anxiety can help patients achieve positive health and well-being outcomes. Similarly, the provision of education about surgery can be a crucial component and is inversely correlated with preoperative anxiety levels. However, few patients receive stress and anxiety relief support before surgery, and resource constraints make face-to-face education sessions untenable. Digital health interventions can be helpful in empowering patients and enhancing a more positive experience. Digital health interventions have been shown to help patients feel informed about the possible benefits and risks of available treatment options. However, they currently focus only on providing informative content, neglecting the importance of personalization and patient empowerment. OBJECTIVE: This study aimed to explore the feasibility of a digital health intervention called the Adhera CARINAE Digital Health Program, designed to provide evidence-based, personalized stress- and anxiety-management methods enabled by a comprehensive digital ecosystem that incorporates wearable, mobile, and virtual reality technologies. The intervention program includes the use of advanced data-driven techniques for tailored patient education and lifestyle support. METHODS: The trial will include 5 hospitals across 3 European countries and will use a randomized controlled design including 30 intervention participants and 30 control group participants. The involved surgeries are cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacement, prostate or bladder cancer surgeries, hip and knee replacement, maxillofacial surgery, or scoliosis. The control group will receive standard care, and the intervention group will additionally be exposed to the digital health intervention program. RESULTS: The recruitment process started in January 2022 and has been completed. The primary impact analysis is currently ongoing. The expected results will be published in early 2023. CONCLUSIONS: This manuscript details a comprehensive protocol for a study that will provide valuable information about the intervention program, such as the measurement of comparative intervention effects on stress; anxiety and pain management; and usability by patients, caregivers, and health care professionals. This will contribute to the evidence planning process for the future adoption of diverse digital health solutions in the field of surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT05184725; https://www.clinicaltrials.gov/ct2/show/NCT05184725. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38536.
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BACKGROUND: Patients with chronic disease represent an at-risk group in the face of the COVID-19 crisis as they need to regularly monitor their lifestyle and emotional management. Coping with the illness becomes a challenge due to supply problems and lack of access to health care facilities. It is expected these limitations, along with lockdown and social distancing measures, have affected the routine disease management of these patients, being more pronounced in low- and middle-income countries with a flawed health care system. OBJECTIVES: The purpose of this study is to describe a protocol for a randomized controlled trial to test the efficacy of the Adhera® MejoraCare Digital Program, an mHealth intervention aimed at improving the quality of life of patients with chronic diseases during the COVID-19 outbreak in Paraguay. METHOD: A two-arm randomized controlled trial will be carried out, with repeated measures (baseline, 1-month, 3-month, 6-month, and 12-month) under two conditions: Adhera® MejoraCare Digital Program or waiting list. The primary outcome is a change in the quality of life on the EuroQol 5-Dimensions 3-Levels Questionnaire (EQ-5D-3L). Other secondary outcomes, as the effect on anxiety and health empowerment, will be considered. All participants must be 18 years of age or older and meet the criteria for chronic disease. A total of 96 participants will be recruited (48 per arm). CONCLUSIONS: It is expected that the Adhera® MejoraCare Digital Program will show significant improvements in quality of life and emotional distress compared to the waiting list condition. Additionally, it is hypothesized that this intervention will be positively evaluated by the participants in terms of usability and satisfaction. The findings will provide new insights into the viability and efficacy of mHealth solutions for chronic disease management in developing countries and in times of pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT04659746.
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COVID-19 , Telemedicina , Humanos , Adolescente , Adulto , COVID-19/epidemiología , Calidad de Vida , SARS-CoV-2 , Paraguay/epidemiología , Control de Enfermedades Transmisibles , Enfermedad Crónica , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: COVID-19 pandemic has revealed the weaknesses of most health systems around the world, collapsing them and depleting their available health care resources. Fortunately, the development and enforcement of specific public health policies, such as vaccination, mask wearing, and social distancing, among others, has reduced the prevalence and complications associated with COVID-19 in its acute phase. However, the aftermath of the global pandemic has called for an efficient approach to manage patients with long COVID-19. This is a great opportunity to leverage on innovative digital health solutions to provide exhausted health care systems with the most cost-effective and efficient tools available to support the clinical management of this population. In this context, the SENSING-AI project is focused on the research toward the implementation of an artificial intelligence-driven digital health solution that supports both the adaptive self-management of people living with long COVID-19 and the health care staff in charge of the management and follow-up of this population. OBJECTIVE: The objective of this protocol is the prospective collection of psychometric and biometric data from 10 patients for training algorithms and prediction models to complement the SENSING-AI cohort. METHODS: Publicly available health and lifestyle data registries will be consulted and complemented with a retrospective cohort of anonymized data collected from clinical information of patients diagnosed with long COVID-19. Furthermore, a prospective patient-generated data set will be captured using wearable devices and validated patient-reported outcomes questionnaires to complement the retrospective cohort. Finally, the 'Findability, Accessibility, Interoperability, and Reuse' guiding principles for scientific data management and stewardship will be applied to the resulting data set to encourage the continuous process of discovery, evaluation, and reuse of information for the research community at large. RESULTS: The SENSING-AI cohort is expected to be completed during 2022. It is expected that sufficient data will be obtained to generate artificial intelligence models based on behavior change and mental well-being techniques to improve patients' self-management, while providing useful and timely clinical decision support services to health care professionals based on risk stratification models and early detection of exacerbations. CONCLUSIONS: SENSING-AI focuses on obtaining high-quality data of patients with long COVID-19 during their daily life. Supporting these patients is of paramount importance in the current pandemic situation, including supporting their health care professionals in a cost-effective and efficient management of long COVID-19. TRIAL REGISTRATION: Clinicaltrials.gov NCT05204615; https://clinicaltrials.gov/ct2/show/NCT05204615. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37704.
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BACKGROUND: Physical activity (PA) is the most well-established lifestyle factor associated with breast cancer (BC) survival. Even women with advanced BC may benefit from moderate PA. However, most BC symptoms and treatment side effects are barriers to PA. Mobile health coaching systems can implement functionalities and features based on behavioral change theories to promote healthier behaviors. However, to increase its acceptability among women with BC, it is essential that these digital persuasive systems are designed considering their contextual characteristics, needs, and preferences. OBJECTIVE: This study aimed to examine the potential acceptability and feasibility of a mobile-based intervention to promote PA in patients with BC; assess usability and other aspects of the user experience; and identify key considerations and aspects for future improvements, which may help increase and sustain acceptability and engagement. METHODS: A mixed methods case series evaluation of usability and acceptability was conducted in this study. The study comprised 3 sessions: initial, home, and final sessions. Two standardized scales were used: the Satisfaction with Life Scale and the International Physical Activity Questionnaire-Short Form. Participants were asked to use the app at home for approximately 2 weeks. App use and PA data were collected from the app and stored on a secure server during this period. In the final session, the participants filled in 2 app evaluation scales and took part in a short individual interview. They also completed the System Usability Scale and the user version of the Mobile App Rating Scale. Participants were provided with a waist pocket, wired in-ear headphones, and a smartphone. They also received printed instructions. A content analysis of the qualitative data collected in the interviews was conducted iteratively, ensuring that no critical information was overlooked. RESULTS: The International Physical Activity Questionnaire-Short Form found that all participants (n=4) were moderately active; however, half of them did not reach the recommended levels in the guidelines. System Usability Scale scores were all >70 out of 100 (72.5, 77.5, 95, and 80), whereas the overall user version of the Mobile App Rating Scale scores were 4, 4.3, 4.4, and 3.6 out of 5. The app was perceived to be nice, user-friendly, straightforward, and easy to understand. Recognition of achievements, the possibility of checking activity history, and the rescheduling option were positively highlighted. Technical difficulties with system data collection, particularly with the miscount of steps, could make users feel frustrated. The participants suggested improvements and indicated that the app has the potential to work well for survivors of BC. CONCLUSIONS: Early results presented in this study point to the potential of this tool concept to provide a friendly and satisfying coaching experience to users, which may help improve PA adherence in survivors of BC.
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Within the most recent years, most of the cancer patients are older age, which implies the necessity to a better understanding of aging and cancer connection. This work presents the LifeChamps solution built on top of cutting-edge Big Data architecture and HPC infrastructure concepts. An innovative architecture was envisioned supported by the Big Data Value Reference Model and answering the system requirements from high to low level and from logical to physical perspective, following the "4+1 architectural model".
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Supervivientes de Cáncer , Nombres , Neoplasias , Inteligencia Artificial , Macrodatos , Humanos , InteligenciaRESUMEN
Mobile health technology holds great promise for the clinical management of patients with chronic disease. However, evidence on the implementation of projects involving digital health solutions in rheumatology is scarce. We aimed to study the feasibility of a hybrid (virtual and face-to-face) monitoring strategy for personalized care in rheumatoid arthritis (RA) and spondyloarthritis (SpA). This project included the development of a remote monitoring model and its assessment. After a focus group with patients and rheumatologists, relevant concerns regarding the management of RA and SpA were raised, leading to the development of the Mixed Attention Model (MAM), which combined hybrid (virtual and face-to-face) monitoring. Then, a prospective study using the mobile solution Adhera for Rheumatology was conducted. Over a 3-month follow-up period, patients were given the opportunity to complete disease-specific electronic patient reported outcomes (ePROs) for RA and SpA with a pre-established frequency, as well as flares and changes in medication at any time. Number of interactions and alerts were assessed. The usability of the mobile solution was measured by the Net-Promoter Score (NPS) and through a 5-star Likert scale. Following the MAM development, forty-six patients were recruited to utilize the mobile solution, of whom 22 had RA and 24 SpA. There were 4,019 total interactions in the RA group, and 3,160 in the SpA group. Fifteen patients generated a total of 26 alerts, of which 24 were flares and 2 were medication-related problems; most (69%) were managed remotely. Regarding patient satisfaction, 65% of the respondents were considered to have endorsed Adhera for Rheumatology, yielding a NPS of 57 and an overall rating was 4.3 out of 5 stars. We concluded that the use of the digital health solution is feasible in clinical practice to monitor ePROs for RA and SpA. Next steps involve the implementation of this telemonitoring method in a multicentric setting.
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The authors wish to make the following erratum to this paper [...].
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Breast and prostate cancer patients may experience physical and psychological distress, and a possible decrease in sleep quality. Subjective and objective methods measure different aspects of sleep quality. Our study attempted to determine differences between objective and subjective measurements of sleep quality using bivariate and Pearson's correlation data analysis. Forty breast (n = 20) and prostate (n = 20) cancer patients were recruited in this observational study. Participants were given an actigraphy device (ACT) and asked to continuously wear it for seven consecutive days, for objective data collection. Following this period, they filled out the Pittsburgh Sleep Quality Index Questionnaire (PSQI) to collect subjective data on sleep quality. The correlation results showed that, for breast cancer patients, PSQI sleep duration was moderately correlated with ACT total sleeping time (TST) (r = -0.534, p < 0.05), and PSQI daytime dysfunction was related to ACT efficiency (r = 0.521, p < 0.05). For prostate cancer patients, PSQI sleep disturbances were related to ACT TST (r = 0.626, p < 0.05). Both objective and subjective measurements are important in validating and determining details of sleep quality, with combined results being more insightful, and can also help in personalized care to further improve quality of life among cancer patients.
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BACKGROUND: FAIR (findability, accessibility, interoperability, and reusability) guiding principles seek the reuse of data and other digital research input, output, and objects (algorithms, tools, and workflows that led to that data) making them findable, accessible, interoperable, and reusable. GO FAIR - a bottom-up, stakeholder driven and self-governed initiative - defined a seven-step FAIRification process focusing on data, but also indicating the required work for metadata. This FAIRification process aims at addressing the translation of raw datasets into FAIR datasets in a general way, without considering specific requirements and challenges that may arise when dealing with some particular types of data. OBJECTIVES: This scientific contribution addresses the architecture design of an open technological solution built upon the FAIRification process proposed by "GO FAIR" which addresses the identified gaps that such process has when dealing with health datasets. METHODS: A common FAIRification workflow was developed by applying restrictions on existing steps and introducing new steps for specific requirements of health data. These requirements have been elicited after analyzing the FAIRification workflow from different perspectives: technical barriers, ethical implications, and legal framework. This analysis identified gaps when applying the FAIRification process proposed by GO FAIR to health research data management in terms of data curation, validation, deidentification, versioning, and indexing. RESULTS: A technological architecture based on the use of Health Level Seven International (HL7) FHIR (fast health care interoperability resources) resources is proposed to support the revised FAIRification workflow. DISCUSSION: Research funding agencies all over the world increasingly demand the application of the FAIR guiding principles to health research output. Existing tools do not fully address the identified needs for health data management. Therefore, researchers may benefit in the coming years from a common framework that supports the proposed FAIRification workflow applied to health datasets. CONCLUSION: Routine health care datasets or data resulting from health research can be FAIRified, shared and reused within the health research community following the proposed FAIRification workflow and implementing technical architecture.
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Investigación Biomédica , Gestión de la Información , Diseño de Software , Acceso a la Información , Interoperabilidad de la Información en Salud , Estándar HL7 , Metadatos , Flujo de TrabajoRESUMEN
The digital era, that we are living nowadays, is transforming health, health care models and services, and the role of society in this new reality. We currently have a large amount of stored health data, including clinical, biometric, and scientific research data. Nonetheless, its potential is not being fully exploited. It is essential to foster the sharing and reuse of this data not only in research but also towards the development of health technologies in order to improve health care efficiency, as well as products, services or digital health apps, to promote preventive and individualized medicine and to empower citizens in health literacy and self-management. In this sense, the FAIR concept has emerged, which implies that health data is findable, accessible, shared and reusable, facilitating interoperability between systems, ensuring the protection of personal and sensitive data. In this paper we review the FAIR concept, 'FAIRification' process, FAIR data versus open access data, ethical issues and the general data protection regulation, and digital health and citizen science.
Vivemos uma nova era digital que está a transformar a saúde, os modelos de cuidados e serviços de saúde, e o próprio papel da sociedade nesta realidade. Atualmente dispomos de uma grande quantidade de dados de saúde armazenados, incluindo dados clínicos, biométricos e de investigação científica, cuja potencialidade não está a ser devidamente explorada. É essencial favorecer a partilha e reutilização destes dados não só na investigação, como também para o desenvolvimento de tecnologias para melhorar a eficiência dos cuidados de saúde, de produtos ou serviços de saúde digitais, promover uma medicina preventiva e individualizada, mas também o empoderamento da população em literacia em saúde e na gestão da doença. Recentemente, surgiu o conceito FAIR que implica que os dados de saúde sejam facilmente localizáveis, acessíveis, partilhados e reutilizáveis, facilitando desta forma a interoperacionalidade entre sistemas e assegurando a proteção de dados pessoais e sensíveis. Neste artigo é feita uma revisão do conceito FAIR, processo de 'FAIRificação', dados FAIR versus dados de acesso livre, questões de éticas e o regulamento geral de proteção de dados, e saúde digital e ciência cidadã.
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Acceso a la Información , Investigación Biomédica , Manejo de Datos , Bases de Datos Factuales , Interoperabilidad de la Información en Salud , Manejo de Datos/ética , HumanosRESUMEN
This work addresses a scoping review of Feature Selection (FS) methods applied to a Lung Cancer dataset to elucidate parameters' relevance when predicting radiotherapy (RT) induced toxicity. Subsetting-based and Ranking-based FS methods were implemented along with 4 advanced classifiers to predict the onset of RT-induced acute esophagitis, cough, pneumonitis and dyspnea. Their prediction performance was measured in terms of the AUC for each model to find the best FS.
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Neoplasias Pulmonares , Traumatismos por Radiación , Radioterapia , Minería de Datos , Trastornos de Deglución/etiología , Disnea/etiología , Esofagitis/etiología , Predicción , Humanos , Neoplasias Pulmonares/radioterapia , Neumonía/etiología , Radioterapia/efectos adversosRESUMEN
BACKGROUND: Smoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. OBJECTIVE: We present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group). METHODS: The target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits. RESULTS: Of 548 patients identified using the hospital's electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019. CONCLUSIONS: Social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking. TRIAL REGISTRATION: ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/12464.
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This paper addresses a fully automatic landmarks detection method for breast reconstruction aesthetic assessment. The set of landmarks detected are the supraesternal notch (SSN), armpits, nipples, and inframammary fold (IMF). These landmarks are commonly used in order to perform anthropometric measurements for aesthetic assessment. The methodological approach is based on both illumination and morphological analysis. The proposed method has been tested with 21 images. A good overall performance is observed, although several improvements must be achieved in order to refine the detection of nipples and SSNs.
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Puntos Anatómicos de Referencia/anatomía & histología , Mama/anatomía & histología , Mama/cirugía , Interpretación de Imagen Asistida por Computador/métodos , Fotograbar/métodos , Procedimientos de Cirugía Plástica/métodos , Femenino , Humanos , Imagenología Tridimensional/métodos , Reconocimiento de Normas Patrones Automatizadas/métodos , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Resultado del TratamientoRESUMEN
Given that acceptance of systems within the healthcare domain multiple papers highlighted the importance of integrating tools with the clinical workflow. This paper analyse how clinical context management could be deployed in order to promote the adoption of cloud advanced services and within the clinical workflow. This deployment will be able to be integrated with the eHealth European Interoperability Framework promoted specifications. Throughout this paper, it is proposed a cloud-based service-oriented architecture. This architecture will implement a context management system aligned with the HL7 standard known as CCOW.