Outcomes of oral food challenges in a real-world setting, with predictors of outcomes.

BACKGROUND: Oral food challenge (OFC) remains the reference standard for food allergy (FA) diagnosis. OBJECTIVE: This study reports a single-center observational experience with all OFCs conducted over 3 years. METHODS: All OFCs performed at an outpatient office were tracked. The OFCs were conducted without strict prespecified inclusion or exclusion criteria. Demographic information along with results of diagnostic testing and results of the OFCs were recorded. RESULTS: A total of 1132 OFCs were performed, with a median age of 4 years (interquartile range = 2.0-10.0). Of the 1132 OFCs, 862 (76.1%) tolerated the food, whereas 232 (20.5%) experienced a reaction, and 38 (3.4%) did not complete the OFC because of food refusal. The highest percentage of tolerated food was shellfish (91.1%), with the lowest percentage of tolerated food being baked egg (66.1%). There were 66 (5.8%) OFCs that were deemed to be high risk, of which 35 (53.0%) tolerated the food. More than 50% of reactions occurred on the first or second dose, with the most common clinical symptom being urticaria or angioedema, with 29.2% of reactions treated with epinephrine. There were several factors that predicted tolerating an OFC, including the food challenge, the reason for food avoidance, older age at the time of OFC and less reactive skin prick testing, and lower food-specific immunoglobulin E levels. CONCLUSION: Certain factors can predict tolerating an OFC, and even those considered to be high risk can be safely completed in an outpatient setting, with most tolerating the food, and most reactions not requiring treatment with epinephrine.

Benefit and cost of repeating a severe acute respiratory coronavirus virus 2 (SARS-CoV-2) polymerase chain reaction (PCR) test after the second day of hospitalization in five hospitals during various community prevalences and vaccination rates.

At our hospital, universal severe acute respiratory coronavirus virus 2 (SARS-CoV-2) polymerase chain reaction (PCR) testing was performed upon admission and again after 2 inpatient days. As community-wide prevalence, admission, and vaccination rates varied, the number needed to benefit fluctuated between 16 and 769 and the cost per additional detection fluctuated between $800 and $29,400. These 2 metrics were negatively associated with new hospital admissions. No other community indicator was associated with the number needed to benefit and cost per additional detection.

Lateral Subdermic Venous Plexus Insufficiency: The Association of Varicose Veins with Restless Legs Syndrome and Nocturnal Leg Cramps.

PURPOSE: To determine whether nocturnal symptoms of restless legs syndrome (RLS) and muscle cramps in the legs are associated specifically with lateral subdermic venous plexus (LSVP) insufficiency and whether treatment can provide symptomatic relief. MATERIALS AND METHODS: A retrospective cross-sectional observational study of 506 patients at a single site analyzed whether RLS or nighttime leg cramping symptoms were associated with venous reflux in the LSVP using comprehensive venous ultrasound. The treatment outcomes of ultrasound-guided foam sclerotherapy (USGFS) were followed up for 1 year. RESULTS: Of 209 patients who reported restless legs symptoms, 179 (85%) demonstrated an abnormal LSVP. A total of 214 patients reported nighttime muscle cramping, of whom 197 (92%) demonstrated an abnormal LSVP. Among 124 patients presenting with both the symptoms, 113 (91%) demonstrated an abnormal LSVP. Conversely, of 83 patients who presented with neither RLS nor nocturnal cramping, 2 (2%) had an abnormal LSVP. Among 242 symptomatic patients with an abnormal LSVP who underwent treatment, the technical success rate was 100%. At 90-day follow-up, 224 patients (93%) reported continued relief, which was maintained at 93% (224/242) at follow-up at 1 year. When substratified, 90 patients presented primarily with RLS or cramping and showed only LSVP reflux, and when treated, all 90 (100%) had significant or complete relief of the symptoms. CONCLUSIONS: LSVP insufficiency demonstrates an association with symptoms of RLS and nocturnal leg cramps. LSVP treatment using USGFS demonstrated high technical and clinical success rates, with symptomatic relief up to 1 year, most pronounced when the LSVP was the only treated vein.

Effect of Ibrutinib on Hmphocytic Leukemia: a Single-Center Experience.

OBJECTIVE/BACKGROUND: In the era of novel agents, Bruton tyrosine kinase (BTK) inhibitors have changed the dynamics of treating chronic lymphocytic leukemia. However, small studies have shown conflicting results regarding the additive humoral dysfunction with their use. METHODS: We prospectively compared vaccine responses in patients on ibrutinib (n = 10) with matched controls (n = 16) and analyzed whether a protein-based (tetanus-diphtheria toxoid) or a carbohydrate (Pneumovax) moiety will result in an improved immunological response. RESULTS: An appropriate serological response in IgG titers for diphtheria was seen in 40% of patients on ibrutinib and 31% of patients in the control group. About 30% of patients on ibrutinib and 44% of patients in the control group had an adequate response to tetanus toxoid. None of the patients on ibrutinib mounted an adequate response to Pneumovax, while 31% of patients in the control arm responded appropriately. These differences in the results were considered insignificant as all p values were greater than the cut-off of 0.05. CONCLUSION: Our study did not show significant detrimental vaccine responses with ibrutinib and calls for larger multicenter studies to elucidate long-term effects, especially in patients with prior exposure to anti-CD20 monoclonal antibodies.

THE VALUE OF A REGIONAL 'LIVING' COVID-19 REGISTRY AND THE CHALLENGES OF KEEPING IT ALIVE.

Background: The availability of accurate, reliable, and timely clinical data is crucial for clinicians, researchers, and policymakers so that they can respond effectively to emerging public health threats. This was typified by the recent SARS-CoV-2 pandemic and the critical knowledge and data gaps associated with novel Coronavirus 2019 disease (COVID-19).We sought to create an adaptive, living data mart containing detailed clinical, epidemiologic, and outcome data from COVID-19 patients in our healthcare system. If successful, the approach could then be used for any future outbreak or disease. Methods: From 3/13/2020 onward, demographics, comorbidities, outpatient medications, along with 75 laboratory, 2 imaging, 19 therapeutic, and 4 outcome-related parameters, were manually extracted from the electronic medical record (EMR) of SARS-CoV-2 positive patients. These parameters were entered on a registry featuring calculation, graphing tools, pivot tables, and a macro programming language. Initially, two internal medicine residents populated the database, then professional data abstractors populated the registry. Clinical parameters were developed with input from infectious diseases and critical care physicians and using a modified COVID-19 worksheet from the U.S. Centers for Disease Control and Prevention (CDC). Registry contents were migrated to a browser-based, metadata-driven electronic data capture software platform. Eventually, we developed queries and used various business intelligence (BI) tools which enabled us to semi-automate data ingestion of 147 clinical and outcome parameters from the EMR, via a large U.S. hospital-based, service-level, all-payer database. Statistics were performed in R and Minitab. Results: From March 13, 2020 to May 17, 2021, 549,691 SARS-CoV-2 test results on 236,144 distinct patients, along with location, admission status, and other epidemiologic details are stored on the cloud-based BI platform. From March 2020 until May 2021, extraction of clinical-epidemiologic parameter had to be performed manually. Of those, 543 have had >/=75 parameters fully entered in the registry. Ten clinical characteristics were significantly associated with the need for hospital admission. Only one characteristic was associated with a need for ICU admission. Use of supplemental oxygen, vasopressors and outpatient statin were associated with increased mortality.Initially, 0.5hrs -1.5 hours per patient chart (approximately 450-575 person hours) were required to manually extract the parameters and populate the registry. As of May 17, 2021, semi-automated data ingestion from the U.S. hospital all-payer database, employing user-defined queries, was implemented. That process can ingest and populate the registry with 147 clinical, epidemiologic, and outcome parameters at a rate of 2 hours per 100 patient charts. Conclusion: A living COVID-19 registry represents a mechanism to facilitate optimal sharing of data between providers, consumers, health information networks, and health plans through technology-enabled, secure-access electronic health information. Our approach also involves a diversity of new roles in the field, such as using residents, staff, and the quality department, in addition to professional data extractors and the health informatics team.Initially, due to the overwhelming number of infections that continues to accelerate, and the labor/time intense nature of the project, only a small fraction of all patients with COVID-19 had all parameters entered in the registry. Therefore, this report also offers lessons learned and discusses sustainability issues, should others wish to establish a registry. It also highlights the registry's local and broader public health significance. Beginning in June 2021, whole-genome sequencing results such as lineages harboring important viral mutations, or variants of concern will be linked to the clinical meta-data.

A cluster-control approach to a coronavirus disease 2019 (COVID-19) outbreak on a stroke ward with infection control considerations for dementia and vascular units.

OBJECTIVE: We sought to contain a healthcare-associated coronavirus disease 2019 (COVID-19) outbreak, to evaluate contributory factors, and to prevent future outbreaks. DESIGN: Quasi-experimental cluster-control outbreak evaluation. METHODS: All patients and staff on the outbreak ward (case cluster), and randomly selected patients and staff on COVID-19 wards (positive control cluster) and a non-COVID-19 wards (negative control cluster) underwent reverse-transcriptase polymerase chain reaction (RT-PCR) testing. Hand hygiene and personal protective equipment (PPE) compliance, detection of environmental SARS-COV-2 RNA, patient behavior, and SARS-CoV-2 IgG antibody prevalence were assessed. RESULTS: In total, 145 staff and 26 patients were exposed, resulting in 24 secondary cases. Also, 4 of 14 (29%) staff and 7 of 10 (70%) patients were asymptomatic or presymptomatic. There was no difference in mean cycle threshold between asymptomatic or presymptomatic versus symptomatic individuals. None of 32 randomly selected staff from the control wards tested positive. Environmental RNA detection levels were higher on the COVID-19 ward than on the negative control ward (OR, 19.98; 95% CI, 2.63-906.38; P < .001). RNA levels on the COVID-19 ward (where there were no outbreaks) and the outbreak ward were similar (OR, 2.38; P = .18). Mean monthly hand hygiene compliance, based on 20,146 observations (over preceding year), was lower on the outbreak ward (P < .006). Compared to both control wards, the proportion of staff with detectable antibodies was higher on the outbreak ward (OR, 3.78; 95% CI, 1.01-14.25; P = .008). CONCLUSION: Staff seroconversion was more likely during a short-term outbreak than from sustained duty on a COVID-19 ward. Environmental contamination and PPE use were similar on the outbreak and control wards. Patient noncompliance, decreased hand hygiene, and asymptomatic or presymptomatic transmission were more frequent on the outbreak ward.

Temporal, Spatial, and Epidemiologic Relationships of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Gene Cycle Thresholds: A Pragmatic Ambi-directional Observation.

Prospective serial sampling of 70 patients revealed clinically relevant cycle thresholds (Ct) occurring 9, 26, and 36 days after symptom onset. Race, gender, and corticosteroids apparently did not influence RNA positivity. In a retrospective analysis of 180 patients, initial Ct did not correlate with requirements for admission or intensive care.

Pharmacokinetics of Vancomycin in Critically Ill Patients Undergoing Sustained Low-Efficiency Dialysis.

INTRODUCTION: Vancomycin pharmacokinetic data in critically ill patients receiving sustained low-efficiency dialysis (SLED) is limited. Published data using vancomycin with intermittent hemodialysis and continuous renal replacement therapy may not be applicable to hybrid dialysis modalities such as SLED. Current drug references lack recommendations for vancomycin dosing in patients receiving SLED. OBJECTIVE: The objective of this study was to determine vancomycin pharmacokinetics during SLED. METHODS: A total of 20 patients who were critically ill with oliguric or anuric renal failure who received vancomycin and SLED were included in the study. Surrounding one SLED session, serum vancomycin blood samples were drawn before the initiation of SLED, at the termination of SLED, and 4 hours after completion of SLED treatment. Following this, patients received vancomycin, dosed to target a goal peak of 20-30 mcg/ml. A vancomycin peak level was drawn 1 hour after the end of the infusion. SLED treatment duration was at least 7 hours. Continuous data are reported as median (interquartile range) and categorical data as percentage. RESULTS: The vancomycin elimination rate and half-life were 0.051 hours (0.042-0.074 hours) and 13.6 hours (9.4-16.6 hours), respectively. SLED reduced vancomycin serum concentrations by 35.4% (31.5-43.8%), and vancomycin rebound was 9.8% (2.5-13.7%). The vancomycin dose administered post-SLED was 1000 mg (875-1125 mg). For 18 patients, the patient-specific volume of distribution was 0.88 L/kg (0.67-1.1 L/kg), vancomycin clearance was 3.5 L/hr (2.2-5.2 L/hr), and the area under the concentration-time curve during the study time period was 280.8 mg·hr/L (254.7-297.3 mg·hr/L). CONCLUSION: Vancomycin is significantly removed during SLED with little rebound in serum concentrations 4 hours after completion of SLED. Based on study findings, patients who are critically ill require additional vancomycin dosing after each SLED session to maintain therapeutic post-SLED vancomycin concentrations. Therapeutic drug monitoring of vancomycin is recommended during SLED.

Screening for Humoral Immunodeficiency in Patients with Community-Acquired Pneumonia.

BACKGROUND: Immunodeficiency is an underrecognized risk factor for infections, such as community-acquired pneumonia (CAP). OBJECTIVE: We evaluated patients admitted with CAP for humoral immunodeficiency. DESIGN: Prospective Cohort Study. SETTING: Inpatients. PATIENTS, INTERVENTION, AND MEASUREMENTS: We enrolled 100 consecutive patients admitted with a diagnosis of CAP from February 2017 to April 2017. Serum IgG, IgM, IgA, and IgE levels were obtained within the first 24 hours of admission. CURB-65 score and length of hospital stay were calculated. The Wilcoxon rank-sum test, Kruskal-Wallis test, and simple linear regression analysis were used in data analysis. RESULTS: The prevalence of hypogammaglobinemia in patients with CAP was 38% (95% confidence interval: 28.47% to 48.25%). Twenty-seven of 100 patients had IgG hypogammaglobinemia (median: 598 mg/dL, IQ range: 459-654), 23 of 100 had IgM hypogammaglobinemia (median: 38 mg/dL, IQ range: 25-43), and 6 of 100 had IgA hypogammaglobinemia (median: 36 mg/dL, IQ range: 18-50). The median hospital length of stay for patients with IgG hypogammaglobinemia was significantly higher when compared to patients with normal IgG levels (five days, IQ range [3-10] vs three days, IQ range [2-5], P = .0085). Fourteen patients underwent further immune evaluation, resulting in one diagnosis of multiple myeloma, three patients diagnosed with specific antibody deficiency, and one patient diagnosed with selective IgA deficiency. CONCLUSION: There is a high prevalence of hypogammaglobinemia in patients hospitalized with CAP, with IgG and IgM being the most commonly affected classes. IgG hypogammaglobinemia was associated with an increased length of hospitalization. Screening immunoglobulin levels in CAP patients may also uncover underlying humoral immunodeficiency or immunoproliferative disorders.

Response to PCV13 vaccination in patients with multiple myeloma versus healthy controls.

Infections are a major cause of morbidity and mortality in individuals with multiple myeloma (MM). These individuals exhibit humoral dysfunction and show a suboptimal response to pneumococcal polysaccharide vaccine (PPV23). Since pneumococcal conjugate vaccine (PCV13) elicits a T cell dependent response, it is recommended in patients with multiple myeloma. This study compares the initial response to PCV13 and durability of the response at 6 months in patients with multiple myeloma versus normal controls. Seven patients with multiple myeloma and 18 control patients were enrolled in the study. Streptococcal pneumonia serotype IgG titers were drawn at baseline, day 30, and day 180 after MM patients and controls received PCV13. Although vaccination with PCV13 produced a similar initial response in patients with multiple myeloma compared to control subjects, the duration of response may have waned in patients with multiple myeloma as compared to control subjects.

Where Do the Salt and Water Go? A Case of Profound Hyponatremia.

Treatment of profound hyponatremia is challenging. Severe symptoms mandate correction by 4 to 6 mEq/L within hours, but with risk factors for osmotic demyelination, daily correction should be <8 mEq/L. With a therapeutic window this narrow, clinicians would like to know how serum sodium (SNa) concentration will respond to their therapy. Based on isotopic measurements, Edelman showed SNa level to be a function of exchangeable sodium and potassium divided by total-body water. Edelman defined this relationship with linear regression yielding an equation of the form y = mx + b, where y is SNa level, x is exchangeable sodium and potassium divided by total-body water, m is the slope, and b is the intercept. Edelman said that the intercept of his regression "probably is a measure of the quantity of osmotically inactive exchangeable sodium and potassium per unit of body water." Predictive formulas are derived from Edelman's original linear regression, some including and some omitting the regression's intercept. We illustrate the performance and limitations of these formulas using comprehensive data for electrolyte and fluid balance obtained during the treatment of a critically patient who presented with an SNa concentration of 101 mEq/L.

Limitations of current validation protocols for home blood pressure monitors for individual patients.

BACKGROUND: Automatic blood pressure monitoring conducted at home is increasingly used in the diagnosis and management of hypertension. We assessed the adequacy of existing British Hypertension Society (BHS) and Association for the Advancement of Medical Instrumentation (AAMI) validation standards for automatic blood pressure monitoring devices. SUBJECT AND METHODS: A theoretical study and an empirical test are presented to estimate the proportion of persons for whom a blood pressure monitor validated according to existing BHS and AAMI standards would be inaccurate. RESULTS: The results suggest that a major limitation of both protocols is the lack of attention given to the number of individual patients for whom a monitor may be inaccurate. A blood pressure monitor that meets the AAMI and BHS validation criteria may report blood pressures in error by more than 5 mmHg for more than half of the people. CONCLUSIONS: A validation standard that does not take account of the person-effects on error will lead to a substantial proportion of persons using self-monitors that are systematically inaccurate for that person.