Outcomes of End-User Testing of a Care Coordination Mobile App With Families of Children With Special Health Care Needs: Simulation Study.

BACKGROUND: Care for children with special health care needs relies on a network of providers who work to address the medical, behavioral, developmental, educational, social, and economic needs of the child and their family. Family-directed, manually created visual depictions of care team composition (ie, care mapping) and detailed note-taking curated by caregivers (eg, care binders) have been shown to enhance care coordination for families of these children, but they are difficult to implement in clinical settings owing to a lack of integration with electronic health records and limited visibility of family-generated insights for care providers. Caremap is an electronic health record-integrated digital personal health record mobile app designed to integrate the benefits of care mapping and care binders. Currently, there is sparse literature describing end-user participation in the co-design of digital health tools. In this paper, we describe a project that evaluated the usability and proof of concept of the Caremap app through end-user simulation. OBJECTIVE: This study aimed to conduct proof-of-concept testing of the Caremap app to coordinate care for children with special health care needs and explore early end-user engagement in simulation testing. The specific aims included engaging end users in app co-design via app simulation, evaluating the usability of the app using validated measures, and exploring user perspectives on how to make further improvements to the app. METHODS: Caregivers of children with special health care needs were recruited to participate in a simulation exercise using Caremap to coordinate care for a simulated case of a child with complex medical and behavioral needs. Participants completed a postsimulation questionnaire adapted from 2 validated surveys: the Pediatric Integrated Care Survey (PICS) and the user version of the Mobile Application Rating Scale (uMARS). A key informant interview was also conducted with a liaison to Spanish-speaking families regarding app accessibility for non-English-speaking users. RESULTS: A Caremap simulation was successfully developed in partnership with families of children with special health care needs. Overall, 38 families recruited from 19 different US states participated in the simulation exercise and completed the survey. The average rating for the survey adapted from the PICS was 4.1 (SD 0.82) out of 5, and the average rating for the adapted uMARS survey was 4 (SD 0.83) out of 5. The highest-rated app feature was the ability to track progress toward short-term, patient- and family-defined care goals. CONCLUSIONS: Internet-based simulation successfully facilitated end-user engagement and feedback for a digital health care coordination app for families of children with special health care needs. The families who completed simulation with Caremap rated it highly across several domains related to care coordination. The simulation study results elucidated key areas for improvement that translated into actionable next steps in app development.

Higher alpha diversity and Lactobacillus blooms are associated with better engraftment after Fecal Microbiota Transplant in Inflammatory Bowel Disease.

Background: Fecal Microbiota Transplant (FMT) has proven effective in treating recurrent Clostridioides difficile infection (rCDI) and has shown some success in treating inflammatory bowel diseases (IBD). There is emerging evidence that host engraftment of donor taxa is a tenet of successful FMT. However, there is little known regarding predictors of engraftment. We undertook a double-blind, randomized, placebo-controlled pilot study to characterize the response to FMT in children and young adults with mild to moderate active Crohn's disease (CD) and ulcerative colitis (UC). Results: Subjects with CD or UC were randomized to receive antibiotics and weekly FMT or placebo in addition to baseline medications. The treatment arm received seven days of antibiotics followed by FMT enema and then capsules weekly for seven weeks. We enrolled four subjects with CD and 11 with UC, ages 14-29 years. Due to weekly stool sampling, we were able to create a time series of alpha diversity, beta diversity and engraftment as they related to clinical response. Subjects exhibited a wide range of microbial diversity and donor engraftment as FMT progressed. Specifically, engraftment ranged from 26% to 90% at week 2 and 3% to 92% at two months. Consistent with the current literature, increases over time of both alpha diversity (p< 0.05) and donor engraftment (p< 0.05) correlated with improved clinical response. Additionally, our weekly time series enabled an investigation into the clinical and microbial correlates of engraftment at various time points. We discovered that the post-antibiotic but pre-FMT time point, often overlooked in FMT trials, was rich in microbial correlates of eventual engraftment. Greater residual alpha diversity after antibiotic treatment was positively correlated with engraftment and subsequent clinical response. Interestingly, a transient rise in the relative abundance of Lactobacillus was also positively correlated with engraftment, a finding that we recapitulated with our analysis of another FMT trial with publicly available weekly sequencing data. Conclusions: We found that higher residual alpha diversity and Lactobacillus blooms after antibiotic treatment correlated with improved engraftment and clinical response to FMT. Future studies should closely examine the host microbial communities pre-FMT and the impact of antibiotic preconditioning on engraftment and response.

Efficacy and Outcomes of Faecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection in Children with Inflammatory Bowel Disease.

BACKGROUND: Children with inflammatory bowel disease [IBD] are disproportionally affected by recurrent Clostridioides difficile infection [rCDI]. Although faecal microbiota transplantation [FMT] has been used with good efficacy in adults with IBD, little is known about outcomes associated with FMT in paediatric IBD. METHODS: We performed a retrospective review of FMT at 20 paediatric centres in the USA from March 2012 to March 2020. Children with and without IBD were compared with determined differences in the efficacy of FMT for rCDI. In addition, children with IBD with and without a successful outcome were compared with determined predictors of success. Safety data and IBD-specific outcomes were obtained. RESULTS: A total of 396 paediatric patients, including 148 with IBD, were included. Children with IBD were no less likely to have a successful first FMT then the non-IBD affected cohort [76% vs 81%, p = 0.17]. Among children with IBD, patients were more likely to have a successful FMT if they received FMT with fresh stool [p = 0.03], were without diarrhoea prior to FMT [p = 0.03], or had a shorter time from rCDI diagnosis until FMT [p = 0.04]. Children with a failed FMT were more likely to have clinically active IBD post-FMT [p = 0.002] and 19 [13%] patients had an IBD-related hospitalisation in the 3-month follow-up. CONCLUSIONS: Based on the findings from this large US multicentre cohort, the efficacy of FMT for the treatment of rCDI did not differ in children with IBD. Failed FMT among children with IBD was possibly related to the presence of clinically active IBD.

Identifying patterns in administrative tasks through structural topic modeling: A study of task definitions, prevalence, and shifts in a mental health practice's operations during the COVID-19 pandemic.

OBJECTIVE: This case study illustrates the use of natural language processing for identifying administrative task categories, prevalence, and shifts necessitated by a major event (the COVID-19 [coronavirus disease 2019] pandemic) from user-generated data stored as free text in a task management system for a multisite mental health practice with 40 clinicians and 13 administrative staff members. MATERIALS AND METHODS: Structural topic modeling was applied on 7079 task sequences from 13 administrative users of a Health Insurance Portability and Accountability Act-compliant task management platform. Context was obtained through interviews with an expert panel. RESULTS: Ten task definitions spanning 3 major categories were identified, and their prevalence estimated. Significant shifts in task prevalence due to the pandemic were detected for tasks like billing inquiries to insurers, appointment cancellations, patient balances, and new patient follow-up. CONCLUSIONS: Structural topic modeling effectively detects task categories, prevalence, and shifts, providing opportunities for healthcare providers to reconsider staff roles and to optimize workflows and resource allocation.

The Need for Artificial Intelligence in Digital Therapeutics.

Digital therapeutics is a newly described concept in healthcare which is proposed to change patient behavior and treat medical conditions using a variety of digital technologies. However, the term is rarely defined with criteria that make it distinct from simply digitizedversions of traditional therapeutics. Our objective is to describe a more valuable characteristic of digital therapeutics, which is distinct from traditional medicine or therapy: that is, the utilization of artificial intelligence and machine learning systems to monitor and predict individual patient symptom data in an adaptive clinical feedback loop via digital biomarkers to provide a precision medicine approach to healthcare. Artificial intelligence platforms can learn and predict effective interventions for individuals using a multitude of personal variables to provide a customized and more tailored therapy regimen. Digital therapeutics coupled with artificial intelligence and machine learning also allows more effective clinical observations and management at the population level for various health conditions and cohorts. This vital differentiation of digital therapeutics compared to other forms of therapeutics enables a more personalized form of healthcare that actively adapts to patients' individual clinical needs, goals, and lifestyles. Importantly, these characteristics are what needs to be emphasized to patients, physicians, and policy makers to advance the entire field of digital healthcare.

Efficacy of Fecal Microbiota Transplantation for Clostridium difficile Infection in Children.

BACKGROUND & AIMS: Fecal microbiota transplantation (FMT) is commonly used to treat Clostridium difficile infection (CDI). CDI is an increasing cause of diarrheal illness in pediatric patients, but the effects of FMT have not been well studied in children. We performed a multi-center retrospective cohort study of pediatric and young adult patients to evaluate the efficacy, safety, and factors associated with a successful FMT for the treatment of CDI. METHODS: We performed a retrospective study of 372 patients, 11 months to 23 years old, who underwent FMT at 18 pediatric centers, from February 1, 2004, to February 28, 2017; 2-month outcome data were available from 335 patients. Successful FMT was defined as no recurrence of CDI in the 2 months following FMT. We performed stepwise logistic regression to identify factors associated with successful FMT. RESULTS: Of 335 patients who underwent FMT and were followed for 2 months or more, 271 (81%) had a successful outcome following a single FMT and 86.6% had a successful outcome following a first or repeated FMT. Patients who received FMT with fresh donor stool (odds ratio [OR], 2.66; 95% CI, 1.39-5.08), underwent FMT via colonoscopy (OR, 2.41; 95% CI, 1.26-4.61), did not have a feeding tube (OR, 2.08; 95% CI, 1.05-4.11), or had 1 less episode of CDI before FMT (OR, 1.20; 95% CI, 1.04-1.39) had increased odds for successful FMT. Seventeen patients (4.7%) had a severe adverse event during the 3-month follow-up period, including 10 hospitalizations. CONCLUSIONS: Based on the findings from a large multi-center retrospective cohort, FMT is effective and safe for the treatment of CDI in children and young adults. Further studies are required to optimize the timing and method of FMT for pediatric patients-factors associated with success differ from those of adult patients.

Enhancing the Patient Experience for Individuals Undergoing Endoscopic Procedures Using Virtual Reality.

The results of medical procedures can often be difficult to translate into comprehensible and engaging information for patients. This randomized controlled trial evaluated the satisfaction and perceived value of a technology, called HealthVoyager, which creates a personalized virtual reality (VR) experience of a patient's endoscopy or colonoscopy findings in comparison to the standard practice (ie, reviewing printed reports). The platform allows gastroenterologists to create a customized VR patient report to help translate medical knowledge and procedural information to the patient. Forty-one patients (17 HealthVoyager [test]; 24 standard practice [control]) completed a self-report survey assessing their experience for receiving medical information. Results demonstrated that patients were significantly more satisfied in learning about their gastrointestinal condition and procedural results using HealthVoyager rather than with the standard of care. These results have implications for improving the knowledge translation of medical findings between healthcare providers and patients in various disease states and patient populations.

Using mobile virtual reality to enhance medical comprehension and satisfaction in patients and their families.

Patients are typically debriefed by their healthcare provider after any medical procedure or surgery to discuss their findings and any next steps involving medication or treatment instructions. However, without any medical or scientific background knowledge, it can feel overwhelming and esoteric for a patient to listen to a physician describe a complex operation. Instead, providing patients with engaging visuals and a virtual reality (VR) simulation of their individual clinical findings could lead to more effective transfer of medical knowledge and comprehension of treatment information. A newly developed VR technology is described, called HealthVoyager, which is designed to help facilitate this knowledge transfer between physicians and patients. The platform represents a customizable, VR software system utilizing a smartphone or tablet computer to portray personalized surgical or procedural findings as well as representations of normal anatomy. The use of such technology for eliciting medical understanding and patient satisfaction can have many practical and clinical applications for a variety of disease states and patient populations.

Non-invasive mapping of the gastrointestinal microbiota identifies children with inflammatory bowel disease.

BACKGROUND: Pediatric inflammatory bowel disease (IBD) is challenging to diagnose because of the non-specificity of symptoms; an unequivocal diagnosis can only be made using colonoscopy, which clinicians are reluctant to recommend for children. Diagnosis of pediatric IBD is therefore frequently delayed, leading to inappropriate treatment plans and poor outcomes. We investigated the use of 16S rRNA sequencing of fecal samples and new analytical methods to assess differences in the microbiota of children with IBD and other gastrointestinal disorders. METHODOLOGY/PRINCIPAL FINDINGS: We applied synthetic learning in microbial ecology (SLiME) analysis to 16S sequencing data obtained from i) published surveys of microbiota diversity in IBD and ii) fecal samples from 91 children and young adults who were treated in the gastroenterology program of Children's Hospital (Boston, USA). The developed method accurately distinguished control samples from those of patients with IBD; the area under the receiver-operating-characteristic curve (AUC) value was 0.83 (corresponding to 80.3% sensitivity and 69.7% specificity at a set threshold). The accuracy was maintained among data sets collected by different sampling and sequencing methods. The method identified taxa associated with disease states and distinguished patients with Crohn's disease from those with ulcerative colitis with reasonable accuracy. The findings were validated using samples from an additional group of 68 patients; the validation test identified patients with IBD with an AUC value of 0.84 (e.g. 92% sensitivity, 58.5% specificity). CONCLUSIONS/SIGNIFICANCE: Microbiome-based diagnostics can distinguish pediatric patients with IBD from patients with similar symptoms. Although this test can not replace endoscopy and histological examination as diagnostic tools, classification based on microbial diversity is an effective complementary technique for IBD detection in pediatric patients.

Alterations in diversity of the oral microbiome in pediatric inflammatory bowel disease.

BACKGROUND: Oral pathology is a commonly reported extraintestinal manifestation of Crohn's disease (CD). The host-microbe interaction has been implicated in the pathogenesis of inflammatory bowel disease (IBD) in genetically susceptible hosts, yet limited information exists about oral microbes in IBD. We hypothesize that the microbiology of the oral cavity may differ in patients with IBD. Our laboratory has developed a 16S rRNA-based technique known as the Human Oral Microbe Identification Microarray (HOMIM) to study the oral microbiome of children and young adults with IBD. METHODS: Tongue and buccal mucosal brushings from healthy controls, CD, and ulcerative colitis (UC) patients were analyzed using HOMIM. Shannon Diversity Index (SDI) and Principal Component Analysis (PCA) were employed to compare population and phylum-level changes among our study groups. RESULTS: In all, 114 unique subjects from the Children's Hospital Boston were enrolled. Tongue samples from patients with CD showed a significant decrease in overall microbial diversity as compared with the same location in healthy controls (P = 0.015) with significant changes seen in Fusobacteria (P < 0.0002) and Firmicutes (P = 0.022). Tongue samples from patients with UC did not show a significant change in overall microbial diversity as compared with healthy controls (P = 0.418). CONCLUSIONS: As detected by HOMIM, we found a significant decrease in overall diversity in the oral microbiome of pediatric CD. Considering the proposed microbe-host interaction in IBD, the ease of visualization and direct oral mucosal sampling of the oral cavity, further study of the oral microbiome in IBD is of potential diagnostic and prognostic value.