Precision Nutrition Management in Continuous Care: Leveraging AI for User-Reported Dietary Data Analysis.

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.

Patient Generated Health Data Among Older Adults with Cancer in Home Setting: Scoping Review.

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.

Patient-centered clinical decision support challenges and opportunities identified from workflow execution models.

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. RESULTS AND DISCUSSION: 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. CONCLUSION: 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.

Use of Patient-Generated Health Data From Consumer-Grade Devices by Health Care Professionals in the Clinic: Systematic Review.

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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/39389.

Person-Generated Health Data in Women's Health: Scoping Review.

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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/26110.

Assessing Quality of Life Using FHIR - How to Combine Patient Reported Outcome with Patient Generated Data for Better Compliance.

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.

Impact of Digital Health upon the Surgical Patient Experience: The Patient as Consumer.

The adoption of digital health services in surgical care delivery is changing the patient experience. The goal of patient-generated health data monitoring incorporated with patient-centered education and feedback is to optimally prepare patients for surgery and personalize postoperative care to improve outcomes that matter to both patients and surgeons. Challenges include the need for the adoption of new methods for implementation and evaluation and equitable application of surgical digital health interventions, with considerations for accessibility as well as the development of new diagnostics and decision support that include the needs and characteristics of all populations served.

Autopercepción de salud de adolescentes escolarizados en tiempos de pandemia por COVID-19 / Self-perception of health among school-aged adolescents in times of pandemic by COVID-19 / Auto-percepção da saúde entre adolescentes em idade escolar em tempos de pandemia pela COVID-19

Introducción: La adolescencia es una etapa esencial dentro del ciclo de vida humano. La presencia de enfermedades en esta etapa puede afectar la capacidad para crecer y desarrollarse a plenitud, sobre todo cuando son de índole física, psicológica y ocurren en contextos escolares. Objetivo: Evaluar la autopercepción de salud que tienen los estudiantes adolescentes matriculados en instituciones educativas en tiempos de pandemia por Covid-19. Cartagena 2021. Materiales y métodos: Estudio cuantitativo, de corte transversal, y correlacional. Población de 1188 estudiantes de 12-17 años de dos instituciones educativas en Cartagena (Colombia). Muestra estimada de 319 sujetos, seleccionados a través de muestreo aleatorio simple. Se aplicó encuesta sociodemográfica diseñada por el equipo investigador y validada por expertos y para el estado de salud percibido se usó el Cuestionario de Salud SF-36, la versión en español adaptada culturalmente al contexto colombiano por Lugo, García y Gómez la cual cuenta con alfas de Cronbach entre 0,7 y 0,94. Resultados: Los adolescentes fueron principalmente de 15 años (21,9%), de octavo (21,7%) y noveno (27,7%), se dedican a estudiar (95,9%), en sus familias se devengan menos del salario mínimo (42,3%) y entre 1-2 (40,8%). Viven con padre y madre, con o sin hermanos (72,7%), los padres están casados o en unión libre (60,5%) y han estudiado hasta bachillerato tanto madres (54,9%) como padres (49,2%). La autopercepción de la salud fue buena (32,6%) y excelente (33,9%). Se observaron correlaciones estadísticamente significativas (p < 0,05) entre dicha autopercepción y edad, grado, escolaridad del padre y valoración del rendimiento académico. Conclusión: Pese a la emergencia sanitaria ocasionada por la pandemia de covid-19, la autopercepción de salud que tienen un grupo de estudiantes adolescentes resulta ser favorable y positiva.

Introduction: Adolescence is an essential stage within the human life cycle. The presence of diseases at this stage can affect the ability to grow and develop to the fullest, especially when they are physical, psychological and occur in school contexts. Objective: To evaluate the self-perception of health of adolescent students enrolled in educational institutions in times of the Covid-19 pandemic. Cartagena 2021. Materials and methods: Quantitative, cross-sectional, correlational study. Population of 1188 students aged 12-17 years from two educational institutions in Cartagena (Colombia). Estimated sample of 319 subjects, selected through simple random sampling. A sociodemographic survey designed by the research team and validated by experts was applied and for perceived health status the SF-36 Health Questionnaire was used, the Spanish version culturally adapted to the Colombian context by Lugo, García and Gómez, which has Cronbach's alphas between 0.7 and 0.94. Results: The adolescents were mainly 15 years old (21.9%), in eighth grade (21.7%) and ninth grade (27.7%), they are dedicated to study (95.9%), in their families they earn less than the minimum wage (42.3%) and between 1-2 (40.8%). They live with father and mother, with or without siblings (72.7%), the parents are married or in union (60.5%) and both mothers (54.9%) and fathers (49.2%) have studied up to high school. Self-perception of health was good (32.6%) and excellent (33.9%). Statistically significant correlations (p < 0.05) were observed between self-perception and age, grade, father's schooling and assessment of academic performance. Conclusion: Despite the health emergency caused by the covid-19 pandemic, the self-perception of health of a group of adolescent students was favorable and positive.

Introdução: A adolescência é uma etapa essencial no ciclo de vida humana. A presença de doenças nesta fase pode afetar a capacidade de crescimento e desenvolvimento pleno, especialmente quando elas são físicas, psicológicas e ocorrem em contextos escolares. Objetivo: Avaliar a autopercepção da saúde entre os estudantes adolescentes matriculados em instituições educacionais em tempos da pandemia de Covid-19. Cartagena 2021. Materiais e métodos: Estudo quantitativo, transversal, correlacional. População de 1188 estudantes de 12-17 anos de duas instituições educacionais em Cartagena (Colômbia). Amostra estimada de 319 sujeitos, selecionados através de amostragem aleatória simples. Foi aplicada uma pesquisa sociodemográfica projetada pela equipe de pesquisa e validada por especialistas e para a percepção do estado de saúde foi utilizado o questionário de saúde SF-36, a versão espanhola culturalmente adaptada ao contexto colombiano por Lugo, García e Gómez que tem a alfabetização de Cronbach entre 0,7 e 0,94. Resultados: Os adolescentes tinham principalmente 15 anos (21,9%), na oitava série (21,7%) e na nona série (27,7%), dedicam-se aos estudos (95,9%), em suas famílias ganham menos do que o salário mínimo (42,3%) e entre 1-2 (40,8%). Eles vivem com ambos os pais, com ou sem irmãos (72,7%), os pais são casados ou em união (60,5%) e ambas as mães (54,9%) e os pais (49,2%) estudaram até o ensino médio. A auto-percepção da saúde foi boa (32,6%) e excelente (33,9%). Foram observadas correlações estatisticamente significativas (p < 0,05) entre autopercepção e idade, série, escolaridade do pai e avaliação do desempenho acadêmico. Conclusão: Apesar da emergência sanitária causada pela pandemia de covid-19, a autopercepção da saúde de um grupo de estudantes adolescentes é favorável e positiva.

Remote sampling of biomarkers of inflammation with linked patient generated health data in patients with rheumatic and musculoskeletal diseases: an Ecological Momentary Assessment feasibility study.

BACKGROUND: People with rheumatic diseases experience troublesome fluctuations in fatigue. Debated causes include pain, mood and inflammation. To determine the relationships between these potential causes, serial assessments are required but are methodologically challenging. This mobile health (mHealth) study explored the viability of using a smartphone app to collect patient-reported symptoms with contemporaneous Dried Blood Spot Sampling (DBSS) for inflammation. METHODS: Over 30 days, thirty-eight participants (12 RA, 13 OA, and 13 FM) used uMotif, a smartphone app, to report fatigue, pain and mood, on 5-point ordinal scales, twice daily. Daily DBSS, from which C-reactive Protein (CRP) values were extracted, were completed on days 1-7, 14 and 30. Participant engagement was determined based on frequency of data entry and ability to calculate within- and between-day symptom changes. DBSS feasibility and engagement was determined based on the proportion of samples returned and usable for extraction, and the number of days between which between-day changes in CRP which could be calculated (days 1-7). RESULTS: Fatigue was reported at least once on 1085/1140 days (95.2%). Approximately 65% of within- and between-day fatigue changes could be calculated. Rates were similar for pain and mood. A total of 287/342 (83.9%) DBSS, were returned, and all samples were viable for CRP extraction. Fatigue, pain and mood varied considerably, but clinically meaningful (≥ 5 mg/L) CRP changes were uncommon. CONCLUSIONS: Embedding DBSS in mHealth studies will enable researchers to obtain serial symptom assessments with matched biological samples. This provides exciting opportunities to address hitherto unanswerable questions, such as elucidating the mechanisms of fatigue fluctuations.

Influenza Screening Using Patient-Generated Health Data in Post COVID-19 Pandemic.

It is very important to ensure reliable performance of deep learning model for future dataset for healthcare. This is more pronounced in the case of patient generated health data such as patient reported symptoms, which are not collected in a controlled environment. Since there has been a big difference in influenza incidence since the COVID-19 pandemic, we evaluated whether the deep learning model can maintain sufficiently robust performance against these changes. We have collected 226,655 episodes from 110,893 users since June 2020 and tested the influenza screening model, our model showed 87.02% sensitivity and 0.8670 of AUROC. The results of COVID-19 pandemic are comparable to that of before COVID-19 pandemic.

Remote Monitoring of Patient- and Family-Generated Health Data in Pediatrics.

In this article, we provide an overview of remote monitoring of pediatric PGHD and family-generated health data, including its current uses, future opportunities, and implementation resources.

Chemoradiotherapy Followed by Active Surveillance Versus Standard Esophagectomy for Esophageal Cancer: A Systematic Review and Individual Patient Data Meta-analysis.

OBJECTIVE: To compare overall survival of patients with a cCR undergoing active surveillance versus standard esophagectomy. SUMMARY OF BACKGROUND DATA: One-third of patients with esophageal cancer have a pathologically complete response in the resection specimen after neoadjuvant chemoradiotherapy. Active surveillance may be of benefit in patients with cCR, determined with diagnostics during response evaluations after chemoradiotherapy. METHODS: A systematic review and meta-analysis was performed comparing overall survival between patients with cCR after chemoradiotherapy undergoing active surveillance versus standard esophagectomy. Authors were contacted to supply individual patient data. Overall and progression-free survival were compared using random effects meta-analysis of randomized or propensity score matched data. Locoregional recurrence rate was assessed. The study-protocol was registered (PROSPERO: CRD42020167070). RESULTS: Seven studies were identified comprising 788 patients, of which after randomization or propensity score matching yielded 196 active surveillance and 257 standard esophagectomy patients. All authors provided individual patient data. The risk of all-cause mortality for active surveillance was 1.08 [95% confidence interval (CI): 0.62-1.87, P = 0.75] after intention-to-treat analysis and 0.93 (95% CI: 0.56-1.54, P = 0.75) after per-protocol analysis. The risk of progression or all-cause mortality for active surveillance was 1.14 (95% CI: 0.83-1.58, P = 0.36). Five-year locoregional recurrence rate during active surveillance was 40% (95% CI: 26%-59%). 95% of active surveillance patients undergoing postponed esophagectomy for locoregional recurrence had radical resection. CONCLUSIONS: Overall survival was comparable in patients with cCR after chemoradiotherapy undergoing active surveillance or standard esophagectomy. Diagnostic follow-up is mandatory in active surveillance and postponed esophagectomy should be offered to operable patients in case of locoregional recurrence.

Colorectal cancer patients with malnutrition suffer poor physical and mental health before surgery.

BACKGROUND: To determine whether there is an association between preoperative nutritional status and preoperative physical function, patient-reported quality of life, and body composition in colorectal cancer patients awaiting elective surgery. METHODS: We conducted a pooled analysis of individual baseline patient data (n = 266) collected from 5 prehabilitation trials in colorectal cancer surgery. All data were collected approximately 4 weeks before surgery. Each patient's nutritional status was evaluated using the Patient-Generated Subjective Global Assessment: scores 4-8 indicated need for nutritional treatment, whereas ≥9 indicated critical need for a nutrition intervention. Physical function was measured with the 6-minute walk test; patient-reported quality of life was captured with the SF-36; body mass and composition were determined using multifrequency bioelectrical impedance. RESULTS: Mean Patient-Generated Subjective Global Assessment score was 5.3 (standard deviation: 3.9). Approximately two-thirds of patients had a Patient-Generated Subjective Global Assessment of 4-8 or ≥9 (n = 162/266). The 6-minute walk test was progressively worse with higher Patient-Generated Subjective Global Assessment scores (PG-SGA <4: 471(119) m; PG-SGA 4-8: 417(125) m; PG-SGA ≥9: 311(125) m, P < .001). Every component of the SF-36 was lower in those with a Patient-Generated Subjective Global Assessment ≥9 compared to Patient-Generated Subjective Global Assessment <4, indicating that malnourished patients suffer worse quality of life. Interestingly, only the male patients with a Patient-Generated Subjective Global Assessment ≥9 presented with statistically significant lower body mass, reduced fat-free mass index, and a lower percent body fat relative to those with Patient-Generated Subjective Global Assessment <4, in part due to the higher variability among the females. CONCLUSION: The consequences of malnutrition are far-reaching and are strongly associated with the physical and mental health of colorectal cancer patients awaiting elective resection.

The impact of electronic health record-integrated patient-generated health data on clinician burnout.

Patient-generated health data (PGHD), such as patient-reported outcomes and mobile health data, have been increasingly used to improve health care delivery and outcomes. Integrating PGHD into electronic health records (EHRs) further expands the capacities to monitor patients' health status without requiring office visits or hospitalizations. By reviewing and discussing PGHD with patients remotely, clinicians could address the clinical issues efficiently outside of clinical settings. However, EHR-integrated PGHD may create a burden for clinicians, leading to burnout. This study aims to investigate how interactions with EHR-integrated PGHD may result in clinician burnout. We identify the potential contributing factors to clinician burnout using a modified FITT (Fit between Individuals, Task and Technology) framework. We found that technostress, time pressure, and workflow-related issues need to be addressed to accelerate the integration of PGHD into clinical care. The roles of artificial intelligence, algorithm-based clinical decision support, visualization format, human-computer interaction mechanism, workflow optimization, and financial reimbursement in reducing burnout are highlighted.

Impact of Age, Education Level and Occupation on the Ability to Use the ICIQ-bladder Diary: Results From A Community Cohort Study Using a Predefined Clinical History.

OBJECTIVE: To assess difficulties in filling the International Consultation on Incontinence Questionnaire Bladder Diary (ICIQ-BD), determining the most troublesome items and patients' characteristics (age, education level, and professional activity) related to these difficulties. METHODS: A text composed of a clinical history of a fictitious patient with Lower Urinary Tract Symptoms (LUTS) was designed. 95 healthy volunteers (49 females, 46 males, mean age 45.6 ± 17.3 years) were asked to fill in the ICIQ-BD according to the data from the fictitious clinical history. Filling errors were analyzed, and patients' demographic characteristics tested as predictors. RESULTS: Bladder Sensation Score is the most problematic item of the ICIQ-BD, with only 38% of patients accurately filling this item. No association was found between total number of errors and age or education level, but participants working in less specialized professions had more difficulty in filling the BD (mean: 7.00 vs 3.94 errors, P= .002). CONCLUSION: ICIQ-BD is a reliable tool to assess for LUTS, but filling the Bladder Sensation Score item was more likely to be incorrectly filled by manual workers and volunteers with less intellectually demanding current professions.

A framework for practical issues was developed to inform shared decision-making tools and clinical guidelines.

OBJECTIVES: The objective of the study was to develop and test feasibility of a framework of patient-important practical issues. STUDY DESIGN AND SETTING: Guidelines and shared decision-making tools help facilitate discussions about patient-important outcomes of care alternatives, but typically ignore practical issues patients consider when implementing care into their daily routines. Using grounded theory, practical issues in the HealthTalk.org registry and in Option Grids were identified and categorized into a framework. We integrated the framework into the MAGIC authoring and publication platform and digitally structured authoring and publication platform and appraised its use in The BMJ Rapid Recommendations. RESULTS: The framework included the following 15 categories: medication routine, tests and visits, procedure and device, recovery and adaptation, coordination of care, adverse effects, interactions and antidote, physical well-being, emotional well-being, pregnancy and nursing, costs and access, food and drinks, exercise and activities, social life and relationships, work and education, travel and driving. Implementation in 15 BMJ Rapid Recommendations added 283 issues to 35 recommendations. The most frequently used category was procedure and device, and the least frequent was social life and relationship. CONCLUSION: Adding practical issues systematically to evidence summaries is feasible and can inform guidelines and tools for shared decision-making. How this inclusion can improve patient-centered care remains to be determined.

Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry.

BACKGROUND: Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) is the largest cardiovascular genotype-based randomized pragmatic trial (NCT#01742117) to evaluate the role of genotype-guided selection of oral P2Y12 inhibitor therapy in improving ischemic outcomes after PCI. The trial has been extended from the original 12- to 24-month follow-up, using study coordinator-initiated telephone visits. TAILOR-PCI Digital Study tests the feasibility of extending the trial follow-up in a subset of patients for up to 24 months using state-of-the-art digital solutions. The rationale, design, and approach of extended digital study of patients recruited into a large, international, multi-center clinical trial has not been previously described. METHODS: A total of 930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls. Eureka, a direct-to-participant digital research platform, is used to consent and collect prospective data on patients for the digital study. Patients are asked to answer health-related surveys at fixed intervals using the Eureka mobile app and or desktop platform. The likelihood of patients enrolled in a randomized clinical trial transitioning to a registry using digital technology, the reasons for nonparticipation and engagement rates are evaluated. To capture hospitalizations, patients may optionally enable geofencing, a process that allows background location tracking and triggering of surveys if a hospital visit greater than 4 hours is detected. In addition, patients answer digital hospitalization surveys every month. Hospitalization data received from the Digital Study will be compared to data collected from study coordinator telephone visits during the same time frame. CONCLUSIONS: The TAILOR-PCI Digital Study evaluates the feasibility of transitioning a large multicenter randomized clinical trial to a digital registry. The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials. Such a digital approach may be especially pertinent in the era of COVID-19.