The Telemedicine Takeover: Lessons Learned During an Emerging Pandemic.

Introduction: Health care systems rose to the challenges of COVID-19 by creating or expanding telehealth programs to ensure that patients could access care without an in-person appointment. Traditionally, physicians receive limited formal telemedicine training, making preparedness for this transition uneven. To describe challenges to and attitudes toward providing virtual patient care, we distributed a survey to physicians within our system who largely had no formal prior training/experience with telemedicine, but transitioned to routine telemedicine use. Data collected are then used to offer actionable recommendations for health system leaders and medical educators. Materials and Methods: Surveys were distributed to all faculty outpatient general internal medicine physicians working at any New York University Langone Health, New York City Health + Hospitals/Bellevue and Gouverneur, and the VA NY Harbor Health System (n = 378) in mid-2020. Survey items consisted of Likert and open-ended questions related to experience with televisits (13 items) and attitudes toward care (24 items). Results: Telehealth-related challenges varied by site and modality. Primary challenges included establishing a connection from the patient's (98%) or physician's end (84%) and difficulty in the following domains: working with team members (39%), physical examinations (95%), establishing new patient relationships (70%), and taking history (40%), among others. In thematic analysis, significant themes with illustrative qualitative commentary emerged related to technological challenges, new systems issues, and new patient/physician communication experiences. Discussion: Experience differences were rooted in the type of technology employed. Safety-net practices conducted mostly telephonic visits, whereas private outpatient sites utilized video, despite both using identical electronic medical records. As we consider a "new normal" and prolonged community transmission of COVID-19 infection, it is essential to establish telemedicine training, tools, and protocols that meet the needs of both patients and physicians.

Early Results from Severe Acute Respiratory Syndrome Coronavirus 2 Polymerase Chain Reaction Testing of Healthcare Workers at an Academic Medical Center in New York City.

Coronavirus disease 2019 (COVID-19) reverse-transcription polymerase chain reaction employee testing was implemented across New York University Langone Health. Over 8 weeks, 14 764 employees were tested; 33% of symptomatic employees, 8% of asymptomatic employees reporting COVID-19 exposure, and 3% of employees returning to work were positive. Positivity rates declined over time, possibly reflecting the importance of community transmission and efficacy of personal protective equipment.

High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial.

BACKGROUND: Over 6 million esophagogastroduodenoscopy (EGD) procedures are performed in the United States each year. Patients having anesthesia for advanced EGD procedures, such as interventional procedures, are at high risk for hypoxemia. METHODS: Our primary study aim was to evaluate whether high-flow nasal cannula (HFNC) oxygen reduces the incidence of hypoxemia during anesthesia for advanced EGD. Secondarily, we studied whether HFNC oxygen reduces hypercarbia or hypotension. After obtaining written informed consent, adults having anesthesia for advanced EGD, expected to last longer than 15 minutes, were randomly assigned to receive HFNC oxygen or standard nasal cannula (SNC) oxygen. The primary outcome was occurrence of one or more hypoxemia events during anesthesia, defined by arterial oxygen saturation <92% for at least 15 consecutive seconds. Secondary outcomes were occurrence of one or more hypercarbia or hypotension events. A hypercarbia event was defined by a transcutaneous CO2 measurement 20 mm Hg or more above baseline, and a hypotension event was defined by a mean arterial blood pressure measurement 25% or more below baseline. RESULTS: Two hundred seventy-one adult patients were enrolled and randomized, and 262 patients completed study procedures. Eight randomized patients did not complete study procedures due to changes in their anesthesia or endoscopy plan. One patient was excluded from analysis because their procedure was aborted after 1 minute. Patients who received HFNC oxygen (N = 132) had a significantly lower incidence of hypoxemia than those who received SNC oxygen (N = 130; 21.2% vs 33.1%; hazard ratio [HR] = 0.59 [95% confidence interval {CI}, 0.36-0.95]; P = .03). There was no difference in the incidence of hypercarbia or hypotension between the groups. The HR for hypercarbia with HFNC oxygen was 1.29 (95% CI, 0.89-1.88; P = .17), and the HR for hypotension was 1.25 (95% CI, 0.86-1.82; P = .25). CONCLUSIONS: HFNC oxygen reduces the incidence of hypoxemia during anesthesia for advanced EGD and may offer an opportunity to enhance patient safety during these procedures.

Age-dependency of terminal ileum tissue resident memory T cell responsiveness profiles to S. Typhi following oral Ty21a immunization in humans.

BACKGROUND: The impact of aging on the immune system is unequivocal and results in an altered immune status termed immunosenescence. In humans, the mechanisms of immunosenescence have been examined almost exclusively in blood. However, most immune cells are present in tissue compartments and exhibit differential cell (e.g., memory T cells -TM) subset distributions. Thus, it is crucial to understand immunosenescence in tissues, especially those that are exposed to pathogens (e.g., intestine). Using a human model of oral live attenuated typhoid vaccine, Ty21a, we investigated the effect of aging on terminal ileum (TI) tissue resident memory T (TRM) cells. TRM provide immediate adaptive effector immune responsiveness at the infection site. However, it is unknown whether aging impacts TRM S. Typhi-responsive cells at the site of infection (e.g., TI). Here, we determined the effect of aging on the induction of TI S. Typhi-responsive TRM subsets elicited by Ty21a immunization. RESULTS: We observed that aging impacts the frequencies of TI-lamina propria mononuclear cells (LPMC) TM and TRM in both Ty21a-vaccinated and control groups. In unvaccinated volunteers, the frequencies of LPMC CD103- CD4+ TRM displayed a positive correlation with age whilst the CD4/CD8 ratio in LPMC displayed a negative correlation with age. We observed that elderly volunteers have weaker S. Typhi-specific mucosal immune responses following Ty21a immunization compared to adults. For example, CD103+ CD4+ TRM showed reduced IL-17A production, while CD103- CD4+ TRM exhibited lower levels of IL-17A and IL-2 in the elderly than in adults following Ty21a immunization. Similar results were observed in LPMC CD8+ TRM and CD103- CD8+ T cell subsets. A comparison of multifunctional (MF) profiles of both CD4+ and CD8+ TRM subsets between elderly and adults also showed significant differences in the quality and quantity of elicited single (S) and MF responses. CONCLUSIONS: Aging influences tissue resident TM S. Typhi-specific responses in the terminal ileum following oral Ty21a-immunization. This study is the first to provide insights in the generation of local vaccine-specific responses in the elderly population and highlights the importance of evaluating tissue immune responses in the context of infection and aging. TRIAL REGISTRATION: This study was approved by the Institutional Review Board and registered on ClinicalTrials.gov (identifier NCT03970304 , Registered 29 May 2019 - Retrospectively registered).

Comparing models of delivery for cancer genetics services among patients receiving primary care who meet criteria for genetic evaluation in two healthcare systems: BRIDGE randomized controlled trial.

BACKGROUND: Advances in genetics and sequencing technologies are enabling the identification of more individuals with inherited cancer susceptibility who could benefit from tailored screening and prevention recommendations. While cancer family history information is used in primary care settings to identify unaffected patients who could benefit from a cancer genetics evaluation, this information is underutilized. System-level population health management strategies are needed to assist health care systems in identifying patients who may benefit from genetic services. In addition, because of the limited number of trained genetics specialists and increasing patient volume, the development of innovative and sustainable approaches to delivering cancer genetic services is essential. METHODS: We are conducting a randomized controlled trial, entitled Broadening the Reach, Impact, and Delivery of Genetic Services (BRIDGE), to address these needs. The trial is comparing uptake of genetic counseling, uptake of genetic testing, and patient adherence to management recommendations for automated, patient-directed versus enhanced standard of care cancer genetics services delivery models. An algorithm-based system that utilizes structured cancer family history data available in the electronic health record (EHR) is used to identify unaffected patients who receive primary care at the study sites and meet current guidelines for cancer genetic testing. We are enrolling eligible patients at two healthcare systems (University of Utah Health and New York University Langone Health) through outreach to a randomly selected sample of 2780 eligible patients in the two sites, with 1:1 randomization to the genetic services delivery arms within sites. Study outcomes are assessed through genetics clinic records, EHR, and two follow-up questionnaires at 4 weeks and 12 months after last genetic counseling contactpre-test genetic counseling. DISCUSSION: BRIDGE is being conducted in two healthcare systems with different clinical structures and patient populations. Innovative aspects of the trial include a randomized comparison of a chatbot-based genetic services delivery model to standard of care, as well as identification of at-risk individuals through a sustainable EHR-based system. The findings from the BRIDGE trial will advance the state of the science in identification of unaffected patients with inherited cancer susceptibility and delivery of genetic services to those patients. TRIAL REGISTRATION: BRIDGE is registered as NCT03985852 . The trial was registered on June 6, 2019 at clinicaltrials.gov .

Patient Interactions With an Automated Conversational Agent Delivering Pretest Genetics Education: Descriptive Study.

BACKGROUND: Cancer genetic testing to assess an individual's cancer risk and to enable genomics-informed cancer treatment has grown exponentially in the past decade. Because of this continued growth and a shortage of health care workers, there is a need for automated strategies that provide high-quality genetics services to patients to reduce the clinical demand for genetics providers. Conversational agents have shown promise in managing mental health, pain, and other chronic conditions and are increasingly being used in cancer genetic services. However, research on how patients interact with these agents to satisfy their information needs is limited. OBJECTIVE: Our primary aim is to assess user interactions with a conversational agent for pretest genetics education. METHODS: We conducted a feasibility study of user interactions with a conversational agent who delivers pretest genetics education to primary care patients without cancer who are eligible for cancer genetic evaluation. The conversational agent provided scripted content similar to that delivered in a pretest genetic counseling visit for cancer genetic testing. Outside of a core set of information delivered to all patients, users were able to navigate within the chat to request additional content in their areas of interest. An artificial intelligence-based preprogrammed library was also established to allow users to ask open-ended questions to the conversational agent. Transcripts of the interactions were recorded. Here, we describe the information selected, time spent to complete the chat, and use of the open-ended question feature. Descriptive statistics were used for quantitative measures, and thematic analyses were used for qualitative responses. RESULTS: We invited 103 patients to participate, of which 88.3% (91/103) were offered access to the conversational agent, 39% (36/91) started the chat, and 32% (30/91) completed the chat. Most users who completed the chat indicated that they wanted to continue with genetic testing (21/30, 70%), few were unsure (9/30, 30%), and no patient declined to move forward with testing. Those who decided to test spent an average of 10 (SD 2.57) minutes on the chat, selected an average of 1.87 (SD 1.2) additional pieces of information, and generally did not ask open-ended questions. Those who were unsure spent 4 more minutes on average (mean 14.1, SD 7.41; P=.03) on the chat, selected an average of 3.67 (SD 2.9) additional pieces of information, and asked at least one open-ended question. CONCLUSIONS: The pretest chat provided enough information for most patients to decide on cancer genetic testing, as indicated by the small number of open-ended questions. A subset of participants were still unsure about receiving genetic testing and may require additional education or interpersonal support before making a testing decision. Conversational agents have the potential to become a scalable alternative for pretest genetics education, reducing the clinical demand on genetics providers.

Oral typhoid vaccine Ty21a elicits antigen-specific resident memory CD4+ T cells in the human terminal ileum lamina propria and epithelial compartments.

BACKGROUND: Salmonella enterica serovar Typhi (S. Typhi) is a highly invasive bacterium that infects the human intestinal mucosa and causes ~ 11.9-20.6 million infections and ~ 130,000-223,000 deaths annually worldwide. Oral typhoid vaccine Ty21a confers a moderate level of long-lived protection (5-7 years) in the field. New and improved vaccines against enteric pathogens are needed but their development is hindered by a lack of the immunological correlates of protection especially at the site of infection. Tissue resident memory T (TRM) cells provide immediate adaptive effector immune responsiveness at the infection site. However, the mechanism(s) by which S. Typhi induces TRM in the intestinal mucosa are unknown. Here, we focus on the induction of S. Typhi-specific CD4+TRM subsets by Ty21a in the human terminal ileum lamina propria and epithelial compartments. METHODS: Terminal ileum biopsies were obtained from consenting volunteers undergoing routine colonoscopy who were either immunized orally with 4 doses of Ty21a or not. Isolated lamina propria mononuclear cells (LPMC) and intraepithelial lymphocytes (IEL) CD4+TRM immune responses were determined using either S. Typhi-infected or non-infected autologous EBV-B cell lines as stimulator cells. T-CMI was assessed by the production of 4 cytokines [interferon (IFN)γ, interleukin (IL)-2, IL-17A and tumor necrosis factor (TNF)α] in 36 volunteers (18 vaccinees and 18 controls volunteers). RESULTS: Although the frequencies of LPMC CD103+ CD4+TRM were significant decreased, both CD103+ and CD103- CD4+TRM subsets spontaneously produced significantly higher levels of cytokines (IFNγ and IL-17A) following Ty21a-immunization. Importantly, we observed significant increases in S. Typhi-specific LPMC CD103+ CD4+TRM (IFNγ and IL-17A) and CD103- CD4+TRM (IL-2 and IL-17A) responses following Ty21a-immunization. Further, differences in S. Typhi-specific responses between these two CD4+TRM subsets were observed following multifunctional analysis. In addition, we determined the effect of Ty21a-immunization on IEL and observed significant changes in the frequencies of IEL CD103+ (decrease) and CD103- CD4+TRM (increase) following immunization. Finally, we observed that IEL CD103- CD4+TRM, but not CD103+ CD4+TRM, produced increased cytokines (IFNγ, TNFα and IL-17A) to S. Typhi-specific stimulation following Ty21a-immunization. CONCLUSIONS: Oral Ty21a-immunization elicits distinct compartment specific immune responses in CD4+TRM (CD103+ and CD103-) subsets. This study provides novel insights in the generation of local vaccine-specific responses. Trial registration This study was approved by the Institutional Review Board and registered on ClinicalTrials.gov (identifier NCT03970304, Registered 29 May 2019-Retrospectively registered, http://www.ClinicalTrials.gov/NCT03970304).

Effect of the live oral attenuated typhoid vaccine, Ty21a, on systemic and terminal ileum mucosal CD4+ T memory responses in humans.

Our current understanding of CD4+ T-cell-mediated immunity (CMI) elicited by the oral live attenuated typhoid vaccine Ty21a is primarily derived from studies using peripheral blood. Very limited data are available in humans regarding mucosal immunity (especially CD4+ T) at the site of infection (e.g. terminal ileum; TI). Here using multiparametric flow cytometry, we examined the effect of Ty21a immunization on TI-lamina propria mononuclear cells (LPMC) and peripheral blood CD4+ T memory (TM) subsets in volunteers undergoing routine colonoscopy. Interestingly, we observed significant increases in the frequencies of LPMC CD4+ T cells following Ty21a immunization, restricted to the T effector/memory (TEM)-CD45RA+ (TEMRA) subset. Importantly, Ty21a immunization elicited Salmonella Typhi-responsive LPMC CD4+ T cells in all major TM subsets [interferon (IFN)γ and interleukin (IL)-17A in TEM; IFNγ and macrophage inflammatory protein (MIP)1ß in T central/memory (TCM); and IL-2 in TEMRA]. Subsequently, we analyzed LPMC S. Typhi-responsive CD4+ T cells in depth for multifunctional (MF) effectors. We found that LPMC CD4+ TEM responses were mostly MF, except for those cells exhibiting the characteristics associated with IL-17A responses. Finally, we compared mucosal to systemic responses and observed that LPMC CD4+S. Typhi-specific responses were unique and distinct from their systemic counterparts. This study provides the first demonstration of S. Typhi-specific CD4+ TM responses in the human TI mucosa and provides valuable information about the generation of mucosal immune responses following oral Ty21a immunization.

Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial.

OBJECTIVE: Scalable, accessible forms of behavioral therapy for migraine prevention are needed. We assessed the feasibility and acceptability of progressive muscle relaxation (PMR) delivered by a smartphone application (app) in the Primary Care setting. METHODS: This pilot study was a non-blinded, randomized, parallel-arm controlled trial of adults with migraine and 4+ headache days/month. Eligible participants spoke English and owned a smartphone. All participants were given the RELAXaHEAD app which includes an electronic headache diary. Participants were randomized to receive 1 of the 2 versions of the app-one with PMR and the other without PMR. The primary outcomes were measures of feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). We conducted exploratory analyses to determine whether there was a change in Migraine Disability Assessment Scale (MIDAS) scores or a change in headache days. RESULTS: Of 139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7 ± 12.8 years. Most patients 108/139 (78%) had moderate-severe disability. Using a 1-5 Likert scale, participants found the app easy to use (mean 4.2 ± 0.7) and stated that they would be happy to engage in the PMR intervention again (mean 4.3 ± 0.6). For the first 6 weeks, participants practiced PMR 2-4 days/week. Mean per session duration was 11.1 ± 8.3 minutes. Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38). CONCLUSION: Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability scores.

A Telemedicine Approach to Covid-19 Assessment and Triage.

Covid-19 is a new highly contagious RNA viral disease that has caused a global pandemic. Human-to-human transmission occurs primarily through oral and nasal droplets and possibly through the airborne route. The disease may be asymptomatic or the course may be mild with upper respiratory symptoms, moderate with non-life-threatening pneumonia, or severe with pneumonia and acute respiratory distress syndrome. The severe form is associated with significant morbidity and mortality. While patients who are unstable and in acute distress need immediate in-person attention, many patients can be evaluated at home by telemedicine or videoconferencing. The more benign manifestations of Covid-19 may be managed from home to maintain quarantine, thus avoiding spread to other patients and health care workers. This document provides an overview of the clinical presentation of Covid-19, emphasizing telemedicine strategies for assessment and triage of patients. Advantages of the virtual visit during this time of social distancing are highlighted.

International multicenter experience with an over-the-scope clipping device for endoscopic management of GI defects (with video).

BACKGROUND: The over-the-scope clip (OTSC) provides more durable and full-thickness closure as compared with standard clips. Only case reports and small case series have reported on outcomes of OTSC closure of GI defects. OBJECTIVE: To describe a large, multicenter experience with OTSCs for the management of GI defects. Secondary goals were to determine success rate by type of defect and type of therapy and to determine predictors of treatment outcomes. DESIGN: Multicenter, retrospective study. SETTING: Multiple, international, academic centers. PATIENTS: Consecutive patients who underwent attempted OTSC placement for GI defects, either as a primary or as a rescue therapy. INTERVENTIONS: OTSC placement to attempt closure of GI defects. MAIN OUTCOME MEASUREMENTS: Long-term success of the procedure. RESULTS: A total of 188 patients (108 fistulae, 48 perforations, 32 leaks) were included. Long-term success was achieved in 60.2% of patients during a median follow-up of 146 days. Rate of successful closure of perforations (90%) and leaks (73.3%) was significantly higher than that of fistulae (42.9%) (P < .05). Long-term success was significantly higher when OTSCs were applied as primary therapy (primary 69.1% vs rescue 46.9%; P = .004). On multivariate analysis, patients who had OTSC placement for perforations and leaks had significantly higher long-term success compared with those who had fistulae (OR 51.4 and 8.36, respectively). LIMITATIONS: Retrospective design and multiple operators with variable expertise with the OTSC device. CONCLUSION: OTSC is safe and effective therapy for closure of GI defects. Clinical success is best achieved in patients undergoing closure of perforations or leaks when OTSC is used for primary or rescue therapy. Type of defect is the best predictor of successful long-term closure.

Use of Over-the-Scope Clips in the Management of Refractory Postbanding Ulcer Bleed in a Patient After Liver Transplant.

Postbanding ulcer bleeds (PBUBs) are an uncommon complication of variceal band ligation. They are often treated with proton pump inhibitors in addition to endoscopic interventions such as epinephrine injections, hemostatic clips, electrothermal cautery, or further band ligation. Over-the-scope clips are being increasingly used for the management of acute nonvariceal upper gastrointestinal bleeds, but their use in the management of PBUBs has been reported only once before. We present a 24-year-old man with alcohol-associated decompensated cirrhosis with recurrent PBUB, despite multiple endoscopic interventions, transjugular intrahepatic portosystemic shunt, and liver transplant, treated successfully with an Ovesco clip.

The Efficacy and Safety of Treatment Outcomes for Refractory Benign Esophageal Strictures Using a Novel Combination of Needle-Knife Stricturoplasty, Balloon Dilation, and Steroid Injection (with Video).

Background and Aims: Benign esophageal strictures often present with dysphagia and can significantly impair a patient's quality of life, especially when refractory to standard endoscopic techniques. When repeat dilations fail to achieve an adequate luminal diameter or resolve dysphagia, further therapy with needle-knife or steroid injections is needed. However, patients can still clinically fail. To manage such strictures, we employed a novel combination of all three techniques. Methods: Single-center case series of adult patients with benign strictures that were refractory to conventional endoscopic therapy and removable self-expanding metal stenting. Primary clinical success was defined as complete resolution in dysphagia. Secondary outcomes included periodic dilation index (frequency of dilations over the follow-up time), esophageal diameter changes, technical success, and complications. Results: Four patients (median age 49.7 years old, interquartile range [IQR] 30-59) underwent endoscopic therapy for complex, benign strictures using our triple therapy technique. Etiologies of the strictures included peptic strictures (n = 3) and an anastomotic stricture (n = 1). There was 100% technical success rate with no associated adverse events. There was a 50% clinical success rate, with 1 additional patient having partial improvement in dysphagia. The median diameter of the esophagus before and after triple therapy was 3.2 mm (IQR 3.5-5.5) and 12.8 mm (IQR 11.7-14.2), respectively. The periodic dilation index was 6.3 before and 1.5 after triple therapy. The median length of follow-up was 362.5 days. Conclusion: Triple combination therapy may be useful in benign strictures that are refractory to standard techniques. Larger studies are needed to validate these findings.

Introdução e objectivos: As estenoses esofágicas benignas apresentam-se frequentemente com disfagia e podem prejudicar significativamente a qualidade de vida, especialmente quando refractárias às técnicas de dilatação endoscópicas padrão. Quando as dilatações não conseguem isoladamente atingir um diâmetro luminal adequado ou resolver a disfagia, são necessárias terapêuticas adicionais (incisão com faca ou injecções de esteróides), embora a taxa de falha clínica não seja desprezível. Para abordagem destas estenoses refratárias utilizámos uma nova combinação das três técnicas. Métodos: Série de casos incluindo doentes adultos com estenoses benignas refractárias à dilatação convencional e à colocação de prótese metálica auto-expansível removível. O endpoint primário foi definido como resolução completa da disfagia. Os endpoints secundários incluíram o índice de dilatação periódica (frequência de dilatações ao longo do tempo de seguimento), alterações do diâmetro esofágico, sucesso técnico e complicações. Resultados: Quatro doentes (idade média 49.7 anos, intervalo interquartil [IQR] 30­59) foram submetidos a terapia endoscópica para estenoses benignas complexas utilizando a técnica de terapêutica tripla. As etiologias das estenoses incluíam estenoses pépticas (n = 3) e estenose anastomótica (n = 1). A taxa de sucesso técnico foi de 100%, sem eventos adversos associados. A taxa de sucesso clínico foi 50%, com um doente adicional apresentando melhoria parcial da disfagia. O diâmetro médio do esófago antes e depois da terapêutica tripla foi de 3,2 mm (IQR 3.5­5.5) e 12.8 mm (IQR 11.7­14.2), respetivamente. O índice de dilatação periódica foi de 6.3 antes e 1.5 após a terapêutica tripla. A duração média do seguimento foi de 362.5 dias. Conclusão: A terapêutica tripla de combinação pode ser útil em estenoses benignas refractários às técnicas convencionais embora sejam necessários estudos adicionais de validação da técnica.

Low-dose pulsed vs standard pulsed fluoroscopy during ERCP to reduce radiation without change in image quality: Prospective randomized study.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) poses the risk of radiation exposure (RE) to patients and staff and increases the risk of adverse biological effects such as cataracts, sterility, and cancer. Newer fluoroscopy equipment (C-Arm) provides options to limit radiation in the form of lower radiation dose and frame rate or time-limited "pulsed" settings. However, the impact of lower settings on image quality has not been assessed, and no standard protocol exists for fluoroscopy settings used during ERCP. Patients and methods This was a single-center, double-blind, prospective randomized study of consecutive adult patients undergoing standard-of-care ERCP at a tertiary academic medical center. Patients were randomized into two groups: 1) standard-dose pulsed and 2) low-dose pulsed. Pulsed mode (8 fps) was defined as x-ray exposure either in the manufacturer standard-dose or low-dose settings limited to 3 seconds each time the foot-operated switch was depressed. Results Seventy-eight patients undergoing ERCP were enrolled and randomized. No difference in age, gender, or body mass index was found between the two groups. No significant difference in image quality was found between standard-dose and low-dose fluoroscopy P = 0.925). The low-dose group was exposed to significantly less radiation when compared with standard-dose P < 0.05). Fluoroscopy time (minutes) was similar in both groups (2.0 vs 1.9), further suggesting that group assignment had no impact on image quality or procedure time. Conclusions Low-dose pulsed fluoroscopy is a reliable method that substantially reduces radiation without compromising image quality or affecting procedure or fluoroscopy times. This underscores the need for standardization in ERCP fluoroscopy settings to limit radiation exposure.

The safety and efficacy of therapeutic ERCP in the pediatric population performed by adult gastroenterologists.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is much less commonly performed in the pediatric population compared to adults. As a result, few pediatric gastroenterologists receive adequate training in ERCP. At many institutions, pediatric ERCP is performed by adult gastroenterologists not formally trained in pediatric gastroenterology. AIM: The purpose of this study was to assess the efficacy and safety of ERCP performed in pediatric patients by adult gastroenterologists in a single tertiary care center. METHODS: We performed a retrospective analysis of pooled endoscopic procedures in pediatric patients (age<18 years) at the University of Maryland Medical Center, between 2003 and 2011, by two adult therapeutic endoscopists. Neither endoscopist had formal training in pediatric ERCP prior to 2003. Outcome measures included the procedure indications, cannulation success rates, procedure success rates, type of anesthesia, therapeutic interventions, frequency and type of procedure related complications, and technical complexity. RESULTS: Forty-five patients were included with a mean age of 12 years (range 6-17). There were a total of 70 ERCP procedures. Choledocholithiasis was the most common indication. Modes of anesthesia included monitored anesthesia care (31, 44.3%), general anesthesia (22, 31.4%) and moderate conscious sedation (17, 24.3%). The papilla cannulation success rate was 98.6% (69/70). Therapeutic maneuvers included 31 biliary sphincterotomies, ten pancreatic sphincterotomies, 17 pancreatic duct stents, 16 bile duct stents, two cystgastrostomy stents, four biliary stricture dilations, one minor papillotomy site dilation, one mechanical lithotripsy and one ampullectomy. The procedural success rate was 97.1% (68/70). The overall complication rate was 7.1% (5/70) with a post-ERCP pancreatitis rate of 4.3% (3/70). Complications included infection (moderate-1), bleeding (moderate-1), and post-ERCP pancreatitis (mild-1, moderate-2). CONCLUSIONS: ERCP procedures in pediatric patients can be safely and efficaciously performed by adult gastroenterologists trained in advanced endoscopy.

Study protocol: BRInging the Diabetes prevention program to GEriatric Populations.

In the Diabetes Prevention Program (DPP) randomized, controlled clinical trial, participants who were ≥ 60 years of age in the intensive lifestyle (diet and physical activity) intervention had a 71% reduction in incident diabetes over the 3-year trial. However, few of the 26.4 million American adults age ≥65 years with prediabetes are participating in the National DPP. The BRInging the Diabetes prevention program to GEriatric Populations (BRIDGE) randomized trial compares an in-person DPP program Tailored for Older AdulTs (DPP-TOAT) to a DPP-TOAT delivered via group virtual sessions (V-DPP-TOAT) in a randomized, controlled trial design (N = 230). Eligible patients are recruited through electronic health records (EHRs) and randomized to the DPP-TOAT or V-DPP-TOAT arm. The primary effectiveness outcome is 6-month weight loss and the primary implementation outcome is intervention session attendance with a non-inferiority design. Findings will inform best practices in the delivery of an evidence-based intervention.

Detection of lesions during capsule endoscopy: physician performance is disappointing.

OBJECTIVES: Limited data guide capsule endoscopists on how to view the many images collected in each capsule. The objective of this study was to compare the detection rates of clinically significant findings in different capsule endoscopy reading modes and speeds. METHODS: Seventeen capsule endoscopists with experience from 23 to > 1,000 total capsule procedures read 24 clips, 18 of which were abnormal. Clips were read in two different reading modes utilizing two speeds, including SingleView at 15 at frames per second (f.p.s.), SingleView 25 f.p.s., QuadView 20 f.p.s., and QuadView 30 f.p.s. The main outcome measurements were pathology detection rates correlated with reading mode, lesion type, reader experience, and timing order. RESULTS: SingleView 15, QuadView 20, and QuadView 30 had no significant difference in overall detection rate (45, 47, and 43%, respectively). SingleView 25 had a 26% detection rate, which was significantly lower than SingleView 15 (P = 0.04) and QuadView 20 (P = 0.002). The detection rates of angioectasias, ulcers/erosions, masses/polyps, and blood were 69, 38, 46, and 17%, respectively. Reader experience and timing of interpretation did not significantly impact detection rate. LIMITATIONS: Pathology was present on a few frames. Limited modes and speeds were assessed. Lesion types were not confirmed with surgical or deep enteroscopic methods. A relatively small number of readers provided interpretations. CONCLUSIONS: Overall, the detection rates in this study are lower than previously reported and not influenced by increasing experience. Detection rates are significantly higher when reading in SingleView 15 and QuadView 20 compared with reading in SingleView 25. Increasing viewing speed from QuadView 20 to QuadView 30 appears to have no significant effect on detection. Quality control measures to compare and improve lesion detection rates need further study.

The diagnostic utility of endocytoscopy for the detection of gastric cancer: a systematic review and meta-analysis.

BACKGROUND/AIMS: Endocytoscopy (ECS) is an evolving technology that utilizes ultra-high power magnification for real time cellular imaging without the need for physical biopsy. Its application for gastric cancer (GC) detection is not well evaluated at the current time, but there is potential that ECS can make a real time histopathological diagnosis to differentiate neoplastic from benign lesions. We aimed to investigate the diagnostic utility of ECS for GC detection. METHODS: Literature searches through multiple databases were performed for studies using ECS for GC detection until November 2021. Measured outcomes included the pooled sensitivity, specificity and accuracy. Quality assessment of diagnostic studies tool was used to assess the risk of bias. RESULTS: Four studies (n=245) were included. The pooled sensitivity was 83.5% (95% CI: 75% - 89%, I2: 0) and specificity was 91.7% (95% CI: 79% - 97%, I2: 58%). The pooled accuracy was 89.2% (95% CI: 83% - 94%, I2: 38%). There was a low risk of bias. CONCLUSIONS: ECS is an accurate diagnostic modality and has the potential to serve as a complimentary tool in screening for GC. Larger prospective studies are needed to validate these findings before its further widespread use.

Does it get better? An ongoing exploration of physician experiences with and acceptance of telehealth utilization.

INTRODUCTION: COVID-19 forced health systems to rapidly implement telehealth for routine practice, often without sufficient training or standards. We conducted a longitudinal survey of physicians to explore changes in their perceptions of the challenges and benefits of telehealth and identify recommendations for future practice. METHODS: An anonymous online survey was distributed to a cohort of internal medicine physicians in May to June 2020 and March to June 2021. Changes in responses between 2020 and 2021 and by site (private vs. public) were described. These findings, along with those of a thematic analysis of open-ended responses to questions on telehealth experiences, informed a set of recommendations. RESULTS: The survey response rate was 111/391 in 2021 compared to 122/378 in 2020. Fewer physicians reported that telehealth was more difficult than in person with regards to taking a history (49% in 2020, 33% in 2021, p= 0.015), maximizing patient adherence (33% in 2020, 19% in 2021, p = 0.028), and maintaining patient relationships (31%, 25%, p = 0.009) in 2021. Similar proportions of physicians reported continued challenges with building new patient relationships (75%, 77%, p = 0.075), educating patients (40%, 32%, p = 0.393), and working collaboratively with their team (38%, 41%, p = 0.794). Physicians reported increased satisfaction with tele-visits over in-person visits (13%, 27%, p = 0.006) and less worry over doing future tele-visits (45%, 31%, p = 0.027). Physicians' open-ended responses identified recommendations for further improving the design and use of telehealth. DISCUSSION: Results suggest that physician experience with telehealth improved but opportunities for training and improved integration remain. Longitudinal assessment can deepen understanding of the evolution of telehealth care.

A nanoengineered topical transmucosal cisplatin delivery system induces anti-tumor response in animal models and patients with oral cancer.

Despite therapeutic advancements, oral cavity squamous cell carcinoma (OCSCC) remains a difficult disease to treat. Systemic platinum-based chemotherapy often leads to dose-limiting toxicity (DLT), affecting quality of life. PRV111 is a nanotechnology-based system for local delivery of cisplatin loaded chitosan particles, that penetrate tumor tissue and lymphatic channels while avoiding systemic circulation and toxicity. Here we evaluate PRV111 using animal models of oral cancer, followed by a clinical trial in patients with OCSCC. In vivo, PRV111 results in elevated cisplatin retention in tumors and negligible systemic levels, compared to the intravenous, intraperitoneal or intratumoral delivery. Furthermore, PRV111 produces robust anti-tumor responses in subcutaneous and orthotopic cancer models and results in complete regression of carcinogen-induced premalignant lesions. In a phase 1/2, open-label, single-arm trial (NCT03502148), primary endpoints of efficacy (≥30% tumor volume reduction) and safety (incidence of DLTs) of neoadjuvant PRV111 were reached, with 69% tumor reduction in ~7 days and over 87% response rate. Secondary endpoints (cisplatin biodistribution, loco-regional control, and technical success) were achieved. No DLTs or drug-related serious adverse events were reported. No locoregional recurrences were evident in 6 months. Integration of PRV111 with current standard of care may improve health outcomes and survival of patients with OCSCC.