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BACKGROUND: Although positive airway pressure (PAP) therapy is considered first-line treatment for obstructive sleep apnea (OSA), nonadherence is common. Numerous factors influence PAP use, including a belief that the therapy is important and effective. In theory, providing information to patients about their blood oxygen levels during sleep (which may be low when PAP is not used), juxtaposed to information about their PAP use, may influence a patient's beliefs about therapy and increase PAP use. With the advent of consumer wearable smartwatches' blood oxygen saturation monitoring capability (and the existing routine availability of PAP use data transmitted via modem to clinical dashboards), there is an opportunity to provide this combination of information to patients. OBJECTIVE: This study aims to test the feasibility, acceptability, and preliminary efficacy of the Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP), a program that augments current PAP therapy data with consumer-grade wearable device to promote self-management of PAP therapy for OSA in a pilot randomized waitlist-controlled clinical trial. METHODS: This is a single-blinded randomized controlled trial. We will randomize 50 individuals with a history of OSA, who receive care from a Department of Veterans Affairs medical center in the Los Angeles area and are nonadherent to prescribed PAP therapy, into either an immediate intervention group or a waitlist control group. During a 28-day intervention, the participants will wear a study-provided consumer wearable device and complete a weekly survey about their OSA symptoms. A report that summarizes consumer wearable-provided oxygen saturation values, PAP use derived from modem data, and patient-reported OSA symptoms will be prepared weekly and shared with the patient. The immediate intervention group will begin intervention immediately after randomization (T1). Assessments will occur at week 5 (T3; 1 week after treatment for the immediate intervention group and repeat baseline for the waitlist control group) and week 11 (T5; follow-up for the immediate intervention group and 1 week after treatment for the waitlist control group). The primary outcome will be the change in 7-day PAP adherence (average minutes per night) from T1 to T3. The primary analysis will be a comparison of the primary outcome between the immediate intervention and the waitlist control groups (intention-to-treat design), using a 2-sample, 2-sided t test on change scores (unadjusted). RESULTS: Recruitment began in October 2023. Data analysis is expected to begin in October 2024 when all follow-ups are complete, and a manuscript summarizing trial results will be submitted following completion of data analysis. CONCLUSIONS: Findings from the study may provide additional insights on how patients with OSA might use patient-generated health data collected by consumer wearables to inform self-management of OSA and possibly increase their use of PAP therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT06039865; https://clinicaltrials.gov/study/NCT06039865. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60769.

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BACKGROUND: The BRAVO pH monitor system can benefit patients with ongoing GERD symptoms despite treatment and/or atypical symptoms. We aim to investigate the number and type of complications associated with the BRAVO pH capsule. METHODS: From April 2016 through February 2021, we analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. RESULTS: During the study period, approximately 1,651 reports were identified with 2391 cases associated with a device failure, and 254 reporting a patient-related adverse event. Most device complications were due to aspiration n = 153), followed by reported pain (n = 79), injury (unspecified) (n = 63), and additional radiologic imaging (n = 44). Laceration and bleeding accounted for 29 and 19 cases. Furthermore, three patients suffered perforation. Most device failures were due to loss or failure of the Bravo capsule to bond or adhere to the esophageal mucosa as planned (n = 1269), followed by an activation or positioning failure (n = 972), premature detachment of device (n = 284), and failure of the device to record or transmit data (n = 158). CONCLUSIONS: Findings from the MAUDE database highlight the risk of aspiration, hemorrhage/bleeding, perforation, injury, and retention as potential complications of BRAVO capsule placement.

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Objective: The goal of the study is to quantify the reduction in the cases of influenza and how this decrease in incidence correlates with the execution of masking requirements in public as well as social distancing. Methods: Influenza statistics were collected from Northwell Health, a 23-hospital system located throughout New York State. Positive influenza results were collected representing the 2018-2019 Flu season, 2019-2020 Flu season, and compared to the 2020-2021 Flu season, which corresponded to the mask mandates and social distancing measures implemented in NYS. Results: Our data showed a dramatic decrease in influenza rates during the 2020-2021 Flu season, which corresponded to NYS's strict social distancing and mask requirements during the pandemic. This shows a steep decline correlating with the implementation of public health mandates directed at decreasing the spread of aerosolized particles between members of the population. Conclusion: Our data show a significant decrease in the number of positive influenza tests during the same period of time when COVID-19 social distancing and mask-wearing requirements were in effect.

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OBJECTIVE: Different classes of medication have been reported in the literature to be associated with an increased risk of gastrointestinal perforation. However, little is known about the risk of drug-induced perforated appendicitis. METHODS: We analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS), a large national database of reported adverse events associated with post-market FDA-approved medications from January 2011 to October 2021. Patients of any age group with appendiceal perforation were included. Duplicated reports and other anatomical areas of gastrointestinal tract perforation outside the appendix were excluded. RESULTS: During the study period, 474 event cases met inclusion criteria, of which 284 were females. Most reports of perforation occurred in patients 40-49 years (n = 110) and 50-59 years (n = 144). Cases of perforated appendicitis occurred in patients being treated for multiple sclerosis (31.5%) and rheumatoid arthritis (17.1%). Perforation occurred in patients receiving interferon beta 1a (23.6%), adalimumab (17.9%), etanercept (14.1%), natalizumab (12.2%), clozapine (10.1%), infliximab (9.9%), bevacizumab (7.2%), and calcium chloride (4.9%). Sixteen fatal outcomes were reported. CONCLUSION: Findings from the FAERS database highlight the risk of appendiceal perforation in the context of different classes of drugs. Larger pharmacovigilance studies are needed to confirm these observations.

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Bebtelovimab is a monoclonal antibody used to prevent progression of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Complications of SARS-CoV-2 infection can include cardiac effects including sinus bradycardia. CASE SUMMARY: We describe the case of an 86-year-old male infected with SARS-CoV-2 who experienced bradycardia with cardiac arrest immediately following infusion of Bebtelovimab with return of spontaneous circulation obtained following 1 minute of chest compressions and administration of atropine. His bradycardia resolved, and he was extubated on hospital day 1, found to be neurologically intact, and discharged on hospital day 9. CONCLUSIONS: Due to the time course of the patient's symptomatology, we attribute the bradycardic arrest to the Bebtelovimab infusion. This case illustrates the need for further research into the etiology of bradycardia due to SARS-CoV-2 infection and to examine potential links to monoclonal antibody infusion. It also serves as important caution to maintain close cardiac monitoring while administering monoclonal antibodies for SARS-CoV-2.

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Frailty represents a state of vulnerability to multiple internal physiologic factors, as well as external pressures, and has been associated with clinical outcomes. We aim to understand the impact of frailty on patients admitted with hepatocellular carcinoma (HCC) by using the validated Hospital Frailty Risk Score, which is implemented in several hospitals worldwide. We conducted a nation-wide retrospective cohort study to determine the effect of frailty on the risk of in-patient mortality, hepatic encephalopathy, length of stay and cost. Frailty was associated with a 4.5-fold increased risk of mortality and a 2.3-fold increased risk of hepatic encephalopathy. Adjusted Cox regression showed that frailty was correlated with increased risk of in-patient mortality (hazard ratio: 2.3, 95% CI 1.9-2.8, p < 0.001). Frail HCC patients had longer hospital stay (median 5 days) vs. non-frail HCC patients (median 3 days). Additionally, frail patients had higher total costs of hospitalization ($40,875) compared with non-frail patients ($31,667). Frailty is an independent predictor of hepatic encephalopathy and in-patient mortality. Frailty is a surrogate marker of hospital length of stay and cost.