Real world performance of the 21st Century Cures Act population-level application programming interface.

OBJECTIVE: To evaluate the real-world performance of the SMART/HL7 Bulk Fast Health Interoperability Resources (FHIR) Access Application Programming Interface (API), developed to enable push button access to electronic health record data on large populations, and required under the 21st Century Cures Act Rule. MATERIALS AND METHODS: We used an open-source Bulk FHIR Testing Suite at 5 healthcare sites from April to September 2023, including 4 hospitals using electronic health records (EHRs) certified for interoperability, and 1 Health Information Exchange (HIE) using a custom, standards-compliant API build. We measured export speeds, data sizes, and completeness across 6 types of FHIR. RESULTS: Among the certified platforms, Oracle Cerner led in speed, managing 5-16 million resources at over 8000 resources/min. Three Epic sites exported a FHIR data subset, achieving 1-12 million resources at 1555-2500 resources/min. Notably, the HIE's custom API outperformed, generating over 141 million resources at 12 000 resources/min. DISCUSSION: The HIE's custom API showcased superior performance, endorsing the effectiveness of SMART/HL7 Bulk FHIR in enabling large-scale data exchange while underlining the need for optimization in existing EHR platforms. Agility and scalability are essential for diverse health, research, and public health use cases. CONCLUSION: To fully realize the interoperability goals of the 21st Century Cures Act, addressing the performance limitations of Bulk FHIR API is critical. It would be beneficial to include performance metrics in both certification and reporting processes.

Cumulus: A federated EHR-based learning system powered by FHIR and AI.

Objective: To address challenges in large-scale electronic health record (EHR) data exchange, we sought to develop, deploy, and test an open source, cloud-hosted app 'listener' that accesses standardized data across the SMART/HL7 Bulk FHIR Access application programming interface (API). Methods: We advance a model for scalable, federated, data sharing and learning. Cumulus software is designed to address key technology and policy desiderata including local utility, control, and administrative simplicity as well as privacy preservation during robust data sharing, and AI for processing unstructured text. Results: Cumulus relies on containerized, cloud-hosted software, installed within a healthcare organization's security envelope. Cumulus accesses EHR data via the Bulk FHIR interface and streamlines automated processing and sharing. The modular design enables use of the latest AI and natural language processing tools and supports provider autonomy and administrative simplicity. In an initial test, Cumulus was deployed across five healthcare systems each partnered with public health. Cumulus output is patient counts which were aggregated into a table stratifying variables of interest to enable population health studies. All code is available open source. A policy stipulating that only aggregate data leave the institution greatly facilitated data sharing agreements. Discussion and Conclusion: Cumulus addresses barriers to data sharing based on (1) federally required support for standard APIs (2), increasing use of cloud computing, and (3) advances in AI. There is potential for scalability to support learning across myriad network configurations and use cases.

Gastrointestinal Manifestations and Outcomes of COVID-19: A Comprehensive Systematic Review and Meta-analysis.

Introduction Pulmonary symptoms are the most prominent manifestations of Coronavirus disease 2019 (COVID-19). However, gastrointestinal (GI) symptoms have been reported widely as well. Literature describing the relation of these symptoms with outcomes of COVID-19 patients is limited in terms of sample size, geographic diversity, and the spectrum of GI symptoms included. We aim to evaluate the association of GI symptoms with outcomes of hospitalized COVID-19 patients. Methods A systematic review and meta-analysis of observational studies assessing GI symptoms and outcomes in COVID-19 patients were undertaken using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and the Meta-analysis of Observational Studies in Epidemiology (MOOSE) checklist. Details on outcomes included ICU vs. non-ICU admission, severe vs. non-severe disease, invasive mechanical ventilation (IMV) vs. no-IMV use, oxygen saturation <90% vs. >90%, in-hospital mortality vs. discharged alive and survivors. We obtained the odds ratio (OR), 95% confidence interval (95%CI), and forest plots. Sensitivity analysis was used to analyze publication bias and heterogeneity. Results In 35 studies with 7931 confirmed COVID-19 patients, we found that anorexia (pooled OR:2.05; 95%CI: 1.36-3.09, p=0.0006) and abdominal pain (OR 2.80; 95%CI: 1.41-5.54, p=0.003) were associated with a higher risk of poor outcomes and no such association was found for diarrhea (OR 1.04; 95%CI: 0.85-1.26, p=0.71), nausea (OR 0.73; 95%CI: 0.38-1.39, p=0.34) and vomiting (OR 1.24; 95%CI 0.86-1.79, p=0.25). Conclusion The meta-analysis concludes that anorexia and abdominal pain are associated with poor outcomes in hospitalized COVID-19 patients, while diarrhea, nausea, and vomiting have no association. Future research should focus on whether detecting GI invasion in conjunction with fecal polymerase chain reaction (PCR) testing can aid in the early triage of high-risk individuals and improve outcomes.

Evaluating the use of a customized digital navigation program to optimize bowel preparation in pediatric colonsocopy.

Introduction: Adequate bowel preparation is essential for optimal colonoscopy diagnosis and/or intervention. However, suboptimal bowel preparation occurs in as many as 1 in 3 pediatric colonoscopies, leading to missed diagnoses, procedural complications, wasted resources, and increased costs. We aimed to evaluate the effect of an automated Pediatric Colonoscopy Digital Navigation Program (PC-DNP) on the quality of colonoscopy preparation among pediatric patients. Methods: The PC-DNP sent patients timely weight-based bowel preparation instructions, video and text-based educational modules, logistical information, and appointment reminders prior to their scheduled diagnostic and/or therapeutic colonoscopies. Physician reported bowel preparation quality among patients/caregivers who were prescribed the PC-DNP were compared to bowel preparation quality of a historical sample of patients/caregivers who received standard care instructions. Results: We found that the PC-DNP group had significantly higher bowel preparation quality than the standard care group. Conclusions: These results demonstrated that automated DNPs may be easily implemented into the pediatric gastroenterologists' practice and may help streamline and improve bowel preparation in pediatric patients.

Real World Performance of the 21st Century Cures Act Population Level Application Programming Interface.

Objective: To evaluate the real-world performance in delivering patient data on populations, of the SMART/HL7 Bulk FHIR Access API, required in Electronic Health Records (EHRs) under the 21st Century Cures Act Rule. Materials and Methods: We used an open-source Bulk FHIR Testing Suite at five healthcare sites from April to September 2023, including four hospitals using EHRs certified for interoperability, and one Health Information Exchange (HIE) using a custom, standards-compliant API build. We measured export speeds, data sizes, and completeness across six types of FHIR resources. Results: Among the certified platforms, Oracle Cerner led in speed, managing 5-16 million resources at over 8,000 resources/min. Three Epic sites exported a FHIR data subset, achieving 1-12 million resources at 1,555-2,500 resources/min. Notably, the HIE's custom API outperformed, generating over 141 million resources at 12,000 resources/min. Discussion: The HIE's custom API showcased superior performance, endorsing the effectiveness of SMART/HL7 Bulk FHIR in enabling large-scale data exchange while underlining the need for optimization in existing EHR platforms. Agility and scalability are essential for diverse health, research, and public health use cases. Conclusion: To fully realize the interoperability goals of the 21st Century Cures Act, addressing the performance limitations of Bulk FHIR API is critical. It would be beneficial to include performance metrics in both certification and reporting processes.

Biopsy and blood-based molecular biomarker of inflammation in IBD.

OBJECTIVE: IBD therapies and treatments are evolving to deeper levels of remission. Molecular measures of disease may augment current endpoints including the potential for less invasive assessments. DESIGN: Transcriptome analysis on 712 endoscopically defined inflamed (Inf) and 1778 non-inflamed (Non-Inf) intestinal biopsies (n=498 Crohn's disease, n=421 UC and 243 controls) in the Mount Sinai Crohn's and Colitis Registry were used to identify genes differentially expressed between Inf and Non-Inf biopsies and to generate a molecular inflammation score (bMIS) via gene set variance analysis. A circulating MIS (cirMIS) score, reflecting intestinal molecular inflammation, was generated using blood transcriptome data. bMIS/cirMIS was validated as indicators of intestinal inflammation in four independent IBD cohorts. RESULTS: bMIS/cirMIS was strongly associated with clinical, endoscopic and histological disease activity indices. Patients with the same histologic score of inflammation had variable bMIS scores, indicating that bMIS describes a deeper range of inflammation. In available clinical trial data sets, both scores were responsive to IBD treatment. Despite similar baseline endoscopic and histologic activity, UC patients with lower baseline bMIS levels were more likely treatment responders compared with those with higher levels. Finally, among patients with UC in endoscopic and histologic remission, those with lower bMIS levels were less likely to have a disease flare over time. CONCLUSION: Transcriptionally based scores provide an alternative objective and deeper quantification of intestinal inflammation, which could augment current clinical assessments used for disease monitoring and have potential for predicting therapeutic response and patients at higher risk of disease flares.

Real-world impact of vaccination on coronavirus disease 2019 (COVID-19) incidence in healthcare personnel at an academic medical center.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) vaccination effectiveness in healthcare personnel (HCP) has been established. However, questions remain regarding its performance in high-risk healthcare occupations and work locations. We describe the effect of a COVID-19 HCP vaccination campaign on SARS-CoV-2 infection by timing of vaccination, job type, and work location. METHODS: We conducted a retrospective review of COVID-19 vaccination acceptance, incidence of postvaccination COVID-19, hospitalization, and mortality among 16,156 faculty, students, and staff at a large academic medical center. Data were collected 8 weeks prior to the start of phase 1a vaccination of frontline employees and ended 11 weeks after campaign onset. RESULTS: The COVID-19 incidence rate among HCP at our institution decreased from 3.2% during the 8 weeks prior to the start of vaccinations to 0.38% by 4 weeks after campaign initiation. COVID-19 risk was reduced among individuals who received a single vaccination (hazard ratio [HR], 0.52; 95% confidence interval [CI], 0.40-0.68; P < .0001) and was further reduced with 2 doses of vaccine (HR, 0.17; 95% CI, 0.09-0.32; P < .0001). By 2 weeks after the second dose, the observed case positivity rate was 0.04%. Among phase 1a HCP, we observed a lower risk of COVID-19 among physicians and a trend toward higher risk for respiratory therapists independent of vaccination status. Rates of infection were similar in a subgroup of nurses when examined by work location. CONCLUSIONS: Our findings show the real-world effectiveness of COVID-19 vaccination in HCP. Despite these encouraging results, unvaccinated HCP remain at an elevated risk of infection, highlighting the need for targeted outreach to combat vaccine hesitancy.

Digital Health Technologies for Remote Monitoring and Management of Inflammatory Bowel Disease: A Systematic Review.

INTRODUCTION: Digital health technologies may be useful tools in the management of chronic diseases. We performed a systematic review of digital health interventions in the management of patients with inflammatory bowel diseases (IBD) and evaluated its impact on (i) disease activity monitoring, (ii) treatment adherence, (iii) quality of life (QoL) measures, and/or (iv) health care utilization. METHODS: Through a systematic review of multiple databases through August 31, 2020, we identified randomized controlled trials in patients with IBD comparing digital health technologies vs standard of care (SoC) for clinical management and monitoring and reporting impact on IBD disease activity, treatment adherence, QoL, and/or health care utilization or cost-effectiveness. We performed critical qualitative synthesis of the evidence supporting digital health interventions in patients with IBD and rated certainty of evidence using Grading of Recommendations Assessment, Development and Evaluation. RESULTS: Overall, we included 14 randomized controlled trials (median, 98 patients; range 34-909 patients; follow-up <12 months) that compared web-based interventions, mobile applications, and different telemedicine platforms with SoC (clinic-based encounters). Although overall disease activity and risk of relapse were comparable between digital health technologies and SoC (very low certainty of evidence), digital health interventions were associated with lower rate of health care utilization and health care costs (low certainty of evidence). Digital health interventions did not significantly improve patients' QoL and treatment adherence compared with SoC (very low certainty of evidence). Trials may have intrinsic selection bias due to nature of digital interventions. DISCUSSION: Digital health technologies may be effective in decreasing health care utilization and costs, though may not offer advantage in reducing risk of relapse, QoL, and improving treatment adherence in patients with IBD. These techniques may offer value-based care for population health management.

Impact of Digital Health Monitoring in the Management of Inflammatory Bowel Disease.

Technological advances now permit self-management strategies using mobile applications which could greatly benefit patient care. The purpose of this study was to investigate whether the use of the inflammatory bowel disease (IBD) digital health monitoring platform, HealthPROMISE, leads to better quality of care and improved health outcomes in IBD patients. IBD patients were recruited in gastroenterology clinics and asked to install the HealthPROMISE application onto their smartphones. Patient satisfaction, quality of care, quality of life, patient symptoms, and resource utilization metrics were collected throughout the study and sent directly to their healthcare teams. Patients with abnormal symptom/SIBDQ scores were flagged for their physicians to follow up. After one-year, patient outcome metrics were compared to baseline values. Overall, out of 59 patients enrolled in the study, 32 patients (54%) logged into the application at least once during the study period. The number of IBD-related ER visits/hospitalizations in the year of use compared to the prior year demonstrated a significant decrease from 25% of patients (8/32) to 3% (1/32) (p = 0.03). Patients also reported an increase in their understanding of the nature/causes of their condition after using the application (p = 0.026). No significant changes were observed in the number of quality indicators met (p = 0.67) or in SIBDQ scores (p = 0.48). Given the significant burden of IBD, there is a need to develop effective management strategies. This study demonstrated that digital health monitoring platforms may aid in reducing the number of ER visits and hospitalizations in IBD patients.

Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry.

BACKGROUND & AIMS: Fecal microbiota transplantation (FMT) is used commonly for treatment of Clostridioides difficile infections (CDIs), although prospective safety data are limited and real-world FMT practice and outcomes are not well described. The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers. METHODS: Patients undergoing FMT in clinical practices across North America were eligible. Participating investigators enter de-identified data into an online platform, including FMT protocol, baseline patient characteristics, CDI cure and recurrence, and short and long-term safety outcomes. RESULTS: Of the first 259 participants enrolled at 20 sites, 222 had completed short-term follow-up at 1 month and 123 had follow-up to 6 months; 171 (66%) were female. All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank). One-month cure occurred in 200 patients (90%); of these, 197 (98%) received only 1 FMT. Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (1%). CONCLUSIONS: This prospective real-world study demonstrated high effectiveness of FMT for CDI with a good safety profile. Assessment of new conditions at long-term follow-up is planned as this registry grows and will be important for determining the full safety profile of FMT.

Telemedicine Across the Globe-Position Paper From the COVID-19 Pandemic Health System Resilience PROGRAM (REPROGRAM) International Consortium (Part 1).

Coronavirus disease 2019 (COVID-19) has accelerated the adoption of telemedicine globally. The current consortium critically examines the telemedicine frameworks, identifies gaps in its implementation and investigates the changes in telemedicine framework/s during COVID-19 across the globe. Streamlining of global public health preparedness framework that is interoperable and allow for collaboration and sharing of resources, in which telemedicine is an integral part of the public health response during outbreaks such as COVID-19, should be pursued. With adequate reinforcement, telemedicine has the potential to act as the "safety-net" of our public health response to an outbreak. Our focus on telemedicine must shift to the developing and under-developing nations, which carry a disproportionate burden of vulnerable communities who are at risk due to COVID-19.

Project TOPS: Team-Based Oversight of Patient Satisfaction Through Real-Time Interdisciplinary Feedback.

BACKGROUND: Despite the financial incentives to improve patient experience, measured through the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, few interventions have led to sustained improvement. METHODS: A real-time survey (RTS) designed to capture multiple domains was conducted on medical inpatients in a tertiary care center from July 2017 to June 2018. Answers were reviewed by a multidisciplinary team, and interventions to improve experience were completed. RESULTS: A total of 235 RTSs resulted in 94 (40.0%) interventions. HCAHPS were compared 12 months pre-and postintervention, with an increase in the percentage of "always" for the responsiveness domain, 38.9% vs. 59.7%, p = 0.005. Several other domains showed an increase that did not reach statistical significance. CONCLUSION: Conducting RTSs may allow for a better understanding of patient experience and active service recovery.

Digital triage for people with multiple sclerosis in the age of COVID-19 pandemic.

We propose a possible approach for the remote monitoring of infection risk in people with multiple sclerosis, especially those on immunosuppressant drugs, during COVID-19 pandemic. We developed a digital triage tool to be sent to patients to quickly identify people with high risk of COVID-19 infection. This tool will also limit unnecessary accesses to the MS centers reducing the risk of spreading the infection.

Home vs Hospital Infusion of Biologic Agents for Patients With Inflammatory Bowel Diseases.

Inflammatory bowel disease (IBD) therapy often requires biologic medications delivered by intravenous infusion.1-4 Historically, intravenous infusions of infliximab and vedolizumab in patients with IBD were delivered under direct supervision of clinicians in infusion centers at hospitals or clinics. Recently, intravenous infusions have transitioned into patient homes. Professional societies have differed on their recommendations for biologic home infusions (HI),5,6 yet limited data exist on the safety and efficacy of HI programs.7,8 Therefore, the primary aim of this study was to compare adverse outcomes (AOs), as defined as a composite of stopping therapy, IBD-related emergency-room (ER) visit, or IBD-related hospitalization, in patients with IBD receiving biologics as HI or at a hospital-based infusion center.

Digital Medicine and Evolution of Remote Patient Monitoring in Cardiac Electrophysiology: A State-of-the-Art Perspective.

PURPOSE OF REVIEW: With the evolution in digital medicine to identify and monitor cardiac electrophysiological (EP) conditions, increased access to cardiac implantable electronic devices (CIEDs), and reimbursements for non-face-to-face care, remote patient monitoring (RPM) is becoming a key part of the EP service line. RPM of cardiac electrophysiological conditions including the use of CIEDs has improved the quality of care and high patient satisfaction and proved to be cost-effective. The focus of this review is literature on RPM in EP, evidence from randomized trials, and observational studies including those of Apple Watch and future of CIEDs. RECENT FINDINGS: RPM has progressed to use implantable devices and wearable technologies like sensors embedded in smartphones and apps. American College of Cardiology recently launched a digital transformation network to support digital navigation and RPM across different cardiovascular diseases. The information presented here can inform healthcare providers of the most widely implemented and effective forms of RPM for patients with chronic EP conditions.

Impact on Readmission Reduction Among Heart Failure Patients Using Digital Health Monitoring: Feasibility and Adoptability Study.

BACKGROUND: Heart failure (HF) is a condition that affects approximately 6.2 million people in the United States and has a 5-year mortality rate of approximately 42%. With the prevalence expected to exceed 8 million cases by 2030, projections estimate that total annual HF costs will increase to nearly US $70 billion. Recently, the advent of remote monitoring technology has significantly broadened the scope of the physician's reach in chronic disease management. OBJECTIVE: The goal of our program, named the Heart Health Program, was to examine the feasibility of using digital health monitoring in real-world home settings, ascertain patient adoption, and evaluate impact on 30-day readmission rate. METHODS: A digital medicine software platform developed at Mount Sinai Health System, called RxUniverse, was used to prescribe a digital care pathway including the HealthPROMISE digital therapeutic and iHealth mobile apps to patients' personal smartphones. Vital sign data, including blood pressure (BP) and weight, were collected through an ambulatory remote monitoring system that comprised a mobile app and complementary consumer-grade Bluetooth-connected smart devices (BP cuff and digital scale) that send data to the provider care teams. Care teams were alerted via a Web-based dashboard of abnormal patient BP and weight change readings, and further action was taken at the clinicians' discretion. We used statistical analyses to determine risk factors associated with 30-day all-cause readmission. RESULTS: Overall, the Heart Health Program included 58 patients admitted to the Mount Sinai Hospital for HF. The 30-day hospital readmission rate was 10% (6/58), compared with the national readmission rates of approximately 25% and the Mount Sinai Hospital's average of approximately 23%. Single marital status (P=.06) and history of percutaneous coronary intervention (P=.08) were associated with readmission. Readmitted patients were also less likely to have been previously prescribed angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (P=.02). Notably, readmitted patients utilized the BP and weight monitors less than nonreadmitted patients, and patients aged younger than 70 years used the monitors more frequently on average than those aged over 70 years, though these trends did not reach statistical significance. The percentage of the 58 patients using the monitors at least once dropped from 83% (42/58) in the first week after discharge to 46% (23/58) in the fourth week. CONCLUSIONS: Given the increasing burden of HF, there is a need for an effective and sustainable remote monitoring system for HF patients following hospital discharge. We identified clinical and social factors as well as remote monitoring usage trends that identify targetable patient populations that could benefit most from integration of daily remote monitoring. In addition, we demonstrated that interventions driven by real-time vital sign data may greatly aid in reducing hospital readmissions and costs while improving patient outcomes.

Gut microbiota density influences host physiology and is shaped by host and microbial factors.

To identify factors that regulate gut microbiota density and the impact of varied microbiota density on health, we assayed this fundamental ecosystem property in fecal samples across mammals, human disease, and therapeutic interventions. Physiologic features of the host (carrying capacity) and the fitness of the gut microbiota shape microbiota density. Therapeutic manipulation of microbiota density in mice altered host metabolic and immune homeostasis. In humans, gut microbiota density was reduced in Crohn's disease, ulcerative colitis, and ileal pouch-anal anastomosis. The gut microbiota in recurrent Clostridium difficile infection had lower density and reduced fitness that were restored by fecal microbiota transplantation. Understanding the interplay between microbiota and disease in terms of microbiota density, host carrying capacity, and microbiota fitness provide new insights into microbiome structure and microbiome targeted therapeutics. Editorial note: This article has been through an editorial process in which the authors decide how to respond to the issues raised during peer review. The Reviewing Editor's assessment is that all the issues have been addressed (see decision letter).

Developing a Mobile Application for Global Cardiovascular Education.

Technological revolution in the field of medical education is here, and it is time to embrace it. Adoption of on-the-go learning style, portability of smartphones, and expression of concepts with interactive illustrations and their global reach have made application (app)-based learning an effective medium. An educational mobile app, BIFURCAID, was developed to simplify and teach complex coronary bifurcation intervention. This app has been downloaded worldwide. The survey results revealed its widespread acceptance and success. The authors believe that educational apps can have a significant impact on shaping the future of cardiovascular education in the 21st century. This experience with developing and testing the app could work as a template for other medical educators.