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BACKGROUND AND AIMS: Although EUS is highly accurate for the evaluation of common bile duct (CBD) dilation, the yield of EUS in patients with incidental CBD dilation is unclear. METHODS: Serial patients undergoing EUS for incidental, dilated CBD (per radiologist, minimum of >6 mm objectively) from 2 academic medical centers without active pancreaticobiliary disease or significantly elevated liver function test results were evaluated. Multivariable logistic regression identified predictors of EUS with significant findings and a novel prediction model was derived from one center, internally validated with bootstrapping, and externally validated at the second center. RESULTS: Of 375 patients evaluated, 31 (8.3%) had significant findings, including 26 choledocholithiasis, 1 ampullary adenoma, and 1 pancreatic mass. Predictors of significant findings with EUS included age of ≥70 years (odds ratio [OR], 3.7; 95% confidence interval [CI], 1.5-10.0), non-biliary-type abdominal pain without chronic pain (OR, 6.1; 95% CI, 2.3-17.3), CBD diameter of ≥15 mm or ≥17 mm with cholecystectomy (OR, 6.9; 95% CI, 2.7-18.7), and prior ERCP (OR, 6.8; 95% CI, 2.1-22.5). A point-based novel clinical prediction model was created: age of ≥70 years = 1, non-biliary-type abdominal pain without chronic pain = 2, prior ERCP = 2, and CBD dilation = 2. A score of <1 had 93% (development) and 100% (validation) sensitivity and predicted a <2% chance of having a significant finding in both cohorts while excluding the need for EUS in â¼30% of both cohorts. Conversely, a score of ≥4 was >90% specific for the presence of significant pathology. CONCLUSIONS: Less than 10% of patients undergoing EUS for incidental CBD dilation had pathologic findings. This novel, externally validated, clinical prediction model may reduce low-yield, invasive evaluation in nearly one-third of patients.
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BACKGROUND & AIMS: Fecal microbiota-based therapies include conventional fecal microbiota transplant and US Food and Drug Administration-approved therapies, fecal microbiota live-jslm and fecal microbiota spores live-brpk. The American Gastroenterological Association (AGA) developed this guideline to provide recommendations on the use of fecal microbiota-based therapies in adults with recurrent Clostridioides difficile infection; severe to fulminant C difficile infection; inflammatory bowel diseases, including pouchitis; and irritable bowel syndrome. METHODS: The guideline was developed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis. The guideline panel used the Evidence-to-Decision framework to develop recommendations for the use of fecal microbiota-based therapies in the specified gastrointestinal conditions and provided implementation considerations for clinical practice. RESULTS: The guideline panel made 7 recommendations. In immunocompetent adults with recurrent C difficile infection, the AGA suggests select use of fecal microbiota-based therapies on completion of standard of care antibiotics to prevent recurrence. In mildly or moderately immunocompromised adults with recurrent C difficile infection, the AGA suggests select use of conventional fecal microbiota transplant. In severely immunocompromised adults, the AGA suggests against the use of any fecal microbiota-based therapies to prevent recurrent C difficile. In adults hospitalized with severe or fulminant C difficile not responding to standard of care antibiotics, the AGA suggests select use of conventional fecal microbiota transplant. The AGA suggests against the use of conventional fecal microbiota transplant as treatment for inflammatory bowel diseases or irritable bowel syndrome, except in the context of clinical trials. CONCLUSIONS: Fecal microbiota-based therapies are effective therapy to prevent recurrent C difficile in select patients. Conventional fecal microbiota transplant is an adjuvant treatment for select adults hospitalized with severe or fulminant C difficile infection not responding to standard of care antibiotics. Fecal microbiota transplant cannot yet be recommended in other gastrointestinal conditions.
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Clostridioides difficile , Infecciones por Clostridium , Enfermedades Gastrointestinales , Enfermedades Inflamatorias del Intestino , Síndrome del Colon Irritable , Microbiota , Adulto , Humanos , Síndrome del Colon Irritable/tratamiento farmacológico , Resultado del Tratamiento , Enfermedades Gastrointestinales/terapia , Enfermedades Gastrointestinales/tratamiento farmacológico , Trasplante de Microbiota Fecal/efectos adversos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Infecciones por Clostridium/terapia , Infecciones por Clostridium/tratamiento farmacológico , Antibacterianos/uso terapéutico , RecurrenciaRESUMEN
Body mass index (BMI) is a function of weight and height, but changing height has not been emphasized. Using the Framingham Heart Study with 5 decades of data on anthropomorphic measurements and disease states, changing height with age was extracted, and BMI was calculated using current and "young" height (calculated as height at age < 40 years). Decreased height began at age 40, with a mean loss from ages 40 to 80 of 4.8 cm for women and 3.6 cm for men. Using cutoff values of 25 and 30 for overweight and obesity, ~12.5% of women and ~10% of men were misclassified. Comparable figures for obesity classification were ~10 and 8%. At age 70, ~20% of women and ~15% of men were misclassified. Using the BMI corrected to "young" height, obese subjects had an increased risk for developing pre-diabetes and diabetes, with a higher risk for women than men. Using corrected BMI, obese subjects had a higher risk for developing hypertension, lower than for diabetes and higher for men than for women. These data do not establish whether the increased disease risk is clinically important but demonstrate that there is an advantage to using BMI corrected for "young" height when compared with BMI using current age-related height.
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Diabetes Mellitus , Obesidad , Masculino , Humanos , Femenino , Adulto , Anciano , Índice de Masa Corporal , Peso Corporal , Diabetes Mellitus/etiología , Enfermedad Crónica , EstaturaRESUMEN
BACKGROUND AND AIMS: The gas-filled intragastric balloon (IGB) system (Obalon) and the fluid-filled IGB system (Orbera) are the current FDA-approved IGB systems to treat obesity; however, they have not been previously compared in clinical practice. The aims of this study were to compare their efficacy, tolerance, and safety in a clinical setting. MATERIALS AND METHODS: This is a retrospective cohort study of consecutive patients treated with the gas-filled IGB or fluid-filled IGB between October 2015 and May 2020 at 2 academic centers. The primary endpoints included percent total body weight loss at balloon removal in patients who completed at least 20 weeks of therapy, the difference in adverse events that required urgent evaluation or hospitalization, and early removal in the 2 groups. RESULTS: A total of 87 patients underwent successful IGB placement (gas-filled IGB n=57, age 48.9±8.8, body mass index 35.5±5 kg/m 2 ; fluid-filled IGB n=30, age 49.2±14.3, body mass index 38.8±6 kg/m 2 ). Eleven patients underwent early device removal. There were no differences in percent total body weight loss at balloon removal and 12 months between the balloon systems ( P =0.39). Patients who received the fluid-filled IGB were more likely to require urgent evaluation or treatment, require hospital stay >24 hours, and need early balloon system removal compared with patients treated with the gas-filled IGB. CONCLUSION: In this 2-center cohort, both FDA-approved gastric balloon systems had the same effectiveness, but the gas-filled IGB had fewer serious adverse events and better tolerability than the fluid-filled IGB.
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Balón Gástrico , Obesidad Mórbida , Humanos , Adulto , Persona de Mediana Edad , Balón Gástrico/efectos adversos , Estudios Retrospectivos , Pérdida de Peso , Obesidad/terapia , Tiempo de Internación , Obesidad Mórbida/cirugía , Resultado del TratamientoRESUMEN
Background and Aims: Gastrointestinal (GI) symptoms occur among patients diagnosed with coronavirus disease 2019 (COVID-19), and there is clear evidence that SARS-CoV-2, the causative pathogen, infects the GI tract. In this large, multicenter cohort study, we evaluated variations in gastrointestinal and hepatic manifestations of COVID-19 throughout the United States (US). Methods: Patients hospitalized with a positive COVID-19 test prior to October 2020 were identified at 7 US academic centers. Demographics, presenting symptoms, laboratory data, and hospitalization outcomes were abstracted. Descriptive and regression analyses were used to evaluate GI manifestations and their potential predictors. Results: Among 2031 hospitalized patients with COVID-19, GI symptoms were present in 18.9%; diarrhea was the most common (15.2%), followed by nausea and/or vomiting (12.6%) and abdominal pain (6.0%). GI symptoms were less common in the Western cohort (16.0%) than the Northeastern (25.6%) and Midwestern (26.7%) cohorts. Compared to nonintensive care unit (ICU) patients, ICU patients had a higher prevalence of abnormal aspartate aminotransferase (58.1% vs 37.3%; P < .01), alanine aminotransferase (37.5% vs 29.3%; P = .01), and total bilirubin (12.7% vs 9.0%; P < .01). ICU patients also had a higher mortality rate (22.7% vs 4.7%; P < .01). Chronic liver disease was associated with the development of GI symptoms. Abnormal aspartate aminotransferase or alanine aminotransferase was associated with an increased risk of ICU admission. Conclusion: We present the largest multicenter cohort of patients with COVID-19 across the United States. GI manifestations were common among patients hospitalized with COVID-19, although there was significant variability in prevalence and predictors across the United States.
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Background: Combining biologics and small molecules could potentially overcome the plateau of drug efficacy in inflammatory bowel disease (IBD). We conducted a systematic review and meta-analysis to assess the safety and effectiveness of dual biologic therapy (DBT), or small molecule combined with a biologic therapy (SBT) in IBD patients. Methods: We searched MEDLINE, EMBASE, Scopus, Web of Science, Cochrane Database of Systematic Reviews, and Clinical trials.gov until November 3, 2020, including studies with 2 or more IBD patients on DBT or SBT. Main outcome was safety assessed as pooled rates of adverse events (AEs) and serious AEs (SAEs) for each combination. Effectiveness was reported as pooled rates of clinical, endoscopic, and/or radiographic response and remission. The certainty of evidence was rated according to the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework. Results: Of the 3688 publications identified, 13 studies (1 clinical trial, 12 observational studies) involving 266 patients on 7 different combinations were included. Median number of prior biologics ranged from 0 to 4, and median duration of follow-up was 16-68 weeks. Most common DBT and SBT were vedolizumab (VDZ) with anti-tumor necrosis factor (aTNF, n = 56) or tofacitinib (Tofa, n = 57), respectively. Pooled rates of SAE for these were 9.6% (95% confidence interval [CI], 1.5-21.4) for VDZ-aTNF and 1.0% (95% CI, 0.0-7.6) for Tofa-VDZ. The overall certainty of evidence was very low due to the observational nature of the studies, and very serious imprecision and inconsistency. Conclusions: DBT or SBT appears to be generally safe and may be effective in IBD patients, but the evidence is very uncertain.
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Antineoplásicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma Hepatocelular/tratamiento farmacológico , Neoplasias Hepáticas/tratamiento farmacológico , Anilidas/uso terapéutico , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/uso terapéutico , Bevacizumab/administración & dosificación , Carcinoma Hepatocelular/fisiopatología , Carcinoma Hepatocelular/secundario , Carcinoma Hepatocelular/cirugía , Quimioembolización Terapéutica , Quimioterapia Adyuvante , Hepatectomía , Humanos , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/fisiopatología , Neoplasias Hepáticas/cirugía , Trasplante de Hígado , Compuestos de Fenilurea/uso terapéutico , Piridinas/uso terapéutico , Quinolinas/uso terapéutico , Retratamiento , Sorafenib/uso terapéutico , RamucirumabRESUMEN
BACKGROUND & AIMS: Hepatocellular carcinoma (HCC), the most common primary liver cancer, remains a deadly cancer, with an incidence that has tripled in the United States since 1980. In recent years, new systemic therapies for HCC have been approved and a critical assessment of the existing data is necessary to balance benefits and harms and inform the development of evidence-based guidelines. METHODS: The American Gastroenterological Association formed a multidisciplinary group consisting of a Technical Review Panel and a Guideline Panel. The Technical Review Panel prioritized clinical questions and outcomes according to their importance for clinicians and patients and conducted an evidence review of systemic therapies in patients with advanced-stage HCC. The Grading of Recommendations Assessment, Development and Evaluation framework was used to assess evidence. The Guideline Panel reviewed the evidence and used the Evidence-to-Decision Framework to develop recommendations. RESULTS: The Panel reviewed the evidence, summarized in the Technical Review, for the following medications approved by the US Food and Drug Administration for HCC: first-line therapies: bevacizumab+atezolizumab, sorafenib, and lenvatinib; second-line therapies: cabozantinib, pembrolizumab, ramucirumab, and regorafenib; and other agents: bevacizumab, nivolumab, and nivolumab+ipilimumab. CONCLUSIONS: The Panel agreed on 11 recommendations focused on systemic therapy for HCC in patients who are not eligible for locoregional therapy or resection, those with metastatic disease and preserved liver function, those with poor liver function, and those on systemic therapy as adjuvant therapy.
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Antineoplásicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma Hepatocelular/tratamiento farmacológico , Neoplasias Hepáticas/tratamiento farmacológico , Anilidas/uso terapéutico , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/uso terapéutico , Bevacizumab/administración & dosificación , Carcinoma Hepatocelular/fisiopatología , Carcinoma Hepatocelular/secundario , Carcinoma Hepatocelular/cirugía , Quimioembolización Terapéutica , Quimioterapia Adyuvante , Hepatectomía , Humanos , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/fisiopatología , Neoplasias Hepáticas/cirugía , Trasplante de Hígado , Compuestos de Fenilurea/uso terapéutico , Piridinas/uso terapéutico , Quinolinas/uso terapéutico , Retratamiento , Sorafenib/uso terapéutico , RamucirumabRESUMEN
This guideline provides updated recommendations on the role of preprocedure testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) in individuals undergoing endoscopy in the post-vaccination period and replaces the prior guideline from the American Gastroenterological Association (AGA) (released July 29, 2020). Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety. Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a re-evaluation of AGA's prior recommendations was warranted. In order to update the role of preprocedure testing for SARS-CoV2, the AGA guideline panel reviewed the evidence on prevalence of asymptomatic SARS-CoV2 infections in individuals undergoing endoscopy; patient and HCW risk of infections that may be acquired immediately before, during, or after endoscopy; effectiveness of COVID-19 vaccine in reducing risk of infections and transmission; patient and HCW anxiety; patient delays in care and potential impact on cancer burden; and endoscopy volumes. The panel considered the certainty of the evidence, weighed the benefits and harms of routine preprocedure testing, and considered burden, equity, and cost using the Grading of Recommendations Assessment, Development and Evaluation framework. Based on very low certainty evidence, the panel made a conditional recommendation against routine preprocedure testing for SARS-CoV2 in patients scheduled to undergo endoscopy. The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients.
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Humanos , Prueba de COVID-19 , COVID-19/prevención & control , Portador Sano , Endoscopía/normas , Vacunas contra la COVID-19/inmunología , COVID-19/transmisiónRESUMEN
BACKGROUND: Immunoassays designed to detect SARS-CoV-2 protein antigens are now commercially available. The most widely used tests are rapid lateral flow assays that generate results in approximately 15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 antigen (Ag) assays have also been developed. The overall accuracy of SARS-CoV-2 Ag tests, however, is not well defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the literature and develop best practice guidance related to SARS-CoV-2 Ag testing. This guideline is the third in a series of rapid, frequently updated COVID-19 diagnostic guidelines developed by IDSA. OBJECTIVE: IDSA's goal was to develop evidence-based recommendations or suggestions that assist clinicians, clinical laboratories, patients, public health authorities, administrators and policymakers in decisions related to the optimal use of SARS-CoV-2 Ag tests in both medical and non-medical settings. METHODS: A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 Ag tests. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. RESULTS: The panel agreed on five diagnostic recommendations. These recommendations address antigen testing in symptomatic and asymptomatic individuals as well as assess single versus repeat testing strategies. CONCLUSIONS: Data on the clinical performance of U.S. Food and Drug Administration SARS-CoV-2 Ag tests with Emergency Use Authorization is mostly limited to single, one-time testing versus standard nucleic acid amplification testing (NAAT) as the reference standard. Rapid Ag tests have high specificity and low to modest sensitivity compared to reference NAAT methods. Antigen test sensitivity is heavily dependent on viral load, with differences observed between symptomatic compared to asymptomatic individuals and the time of testing post onset of symptoms. Based on these observations, rapid RT-PCR or laboratory-based NAAT remain the diagnostic methods of choice for diagnosing SARS-CoV-2 infection. However, when molecular testing is not readily available or is logistically infeasible, Ag testing can help identify some individuals with SARS-CoV-2 infection. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate.
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This guideline provides updated recommendations on the role of preprocedure testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) in individuals undergoing endoscopy in the post-vaccination period and replaces the prior guideline from the American Gastroenterological Association (AGA) (released July 29, 2020). Since the start of the pandemic, our increased understanding of transmission has facilitated the implementation of practices to promote patient and health care worker (HCW) safety. Simultaneously, there has been increasing recognition of the potential harm associated with delays in patient care, as well as inefficiency of endoscopy units. With widespread vaccination of HCWs and the general population, a re-evaluation of AGA's prior recommendations was warranted. In order to update the role of preprocedure testing for SARS-CoV2, the AGA guideline panel reviewed the evidence on prevalence of asymptomatic SARS-CoV2 infections in individuals undergoing endoscopy; patient and HCW risk of infections that may be acquired immediately before, during, or after endoscopy; effectiveness of COVID-19 vaccine in reducing risk of infections and transmission; patient and HCW anxiety; patient delays in care and potential impact on cancer burden; and endoscopy volumes. The panel considered the certainty of the evidence, weighed the benefits and harms of routine preprocedure testing, and considered burden, equity, and cost using the Grading of Recommendations Assessment, Development and Evaluation framework. Based on very low certainty evidence, the panel made a conditional recommendation against routine preprocedure testing for SARS-CoV2 in patients scheduled to undergo endoscopy. The panel placed a high value on minimizing additional delays in patient care, acknowledging the reduced endoscopy volumes, downstream impact on delayed cancer diagnoses, and burden of testing on patients.
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COVID-19 , Endoscopía , Tamizaje Masivo/normas , Pandemias , COVID-19/diagnóstico , COVID-19/terapia , Vacunas contra la COVID-19/uso terapéutico , Endoscopía/normas , Gastroenterología/normas , Humanos , SARS-CoV-2 , VacunaciónRESUMEN
BACKGROUND: Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance. OBJECTIVE: The IDSA's goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings and highlight important unmet research needs in the COVID-19 diagnostic testing space. METHODS: IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. RESULTS: The panel agreed on 17 diagnostic recommendations. CONCLUSIONS: Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform solid organ or hematopoietic stem cell transplantation timing. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations.
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Background and objective Direct access endoscopy (DAE) allows hospitalists to refer patients for endoscopy without a gastroenterologist (GI) evaluation, potentially decreasing wait time and facilitating earlier discharge from the hospital. This study aimed to evaluate the efficacy and safety of DAE for average-risk endoscopic procedures. Methods A retrospective chart review was performed by comparing patients who underwent a DAE with patients who underwent an endoscopy ordered by GI physicians at a tertiary care hospital. The procedure indications were obtained from the endoscopy reports and hospitalist progress notes. Appropriateness of each procedure was determined based on the guidelines from the American Society for Gastrointestinal Endoscopy (ASGE). Findings, procedure-related complications, and clinical significance were recorded. Results A total of 110 patients were included in this study; 40 were DAE and 70 were ordered by GI. The mean age of the patients was 55.5 years with 69 males and 41 females. In the DAE group, there were 31 esophagogastroduodenoscopies (EGD) and nine colonoscopies performed, while in the GI group, there were 58 EGDs, 11 colonoscopies, and one push enteroscopy. All procedures fulfilled ASGE criteria; 20/40 DAE and 53/70 GI-ordered procedures had clinically significant findings. There was one complication in each group. Conclusion DAE allows a hospitalist to order an endoscopy without consultation with a GI physician. This study showed that all DAE procedures had met ASGE criteria for appropriateness, with 50% having clinically significant findings and no difference in adverse events. These results suggest that DAE is safe and effective in evaluating hospitalized patients for average-risk endoscopy.
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BACKGROUND: The availability of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic testing has rapidly increased. Current assays use a variety of technologies, measure different classes of immunoglobulin or immunoglobulin combinations and detect antibodies directed against different portions of the virus. The overall accuracy of these tests, however, has not been well-defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the coronavirus disease 2019 (COVID-19) serology literature and construct best practice guidance related to SARS-CoV-2 serologic testing. This guideline is the fourth in a series of rapid, frequently updated COVID-19 guidelines developed by IDSA. OBJECTIVE: IDSA's goal was to develop evidence-based recommendations that assist clinicians, clinical laboratories, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 serologic tests in a variety of settings. We also highlight important unmet research needs pertaining to the use of anti-SARS-CoV-2 antibody tests for diagnosis, public health surveillance, vaccine development and the selection of convalescent plasma donors. METHODS: A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 serologic tests. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. RESULTS: The panel agreed on eight diagnostic recommendations. CONCLUSIONS: Information on the clinical performance and utility of SARS-CoV-2 serologic tests are rapidly emerging. Based on available evidence, detection of anti-SARS-CoV-2 antibodies may be useful for confirming the presence of current or past infection in selected situations. The panel identified three potential indications for serologic testing including: 1) evaluation of patients with a high clinical suspicion for COVID-19 when molecular diagnostic testing is negative and at least two weeks have passed since symptom onset; 2) assessment of multisystem inflammatory syndrome in children; and 3) for conducting serosurveillance studies. The certainty of available evidence supporting the use of serology for either diagnosis or epidemiology was, however, graded as very low to moderate.
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Anemia Ferropénica/diagnóstico , Endoscopía Gastrointestinal/normas , Medicina Basada en la Evidencia/normas , Enfermedades Gastrointestinales/diagnóstico , Hierro/sangre , Anemia Ferropénica/sangre , Anemia Ferropénica/etiología , Biopsia/normas , Femenino , Mucosa Gástrica/diagnóstico por imagen , Mucosa Gástrica/metabolismo , Mucosa Gástrica/patología , Gastroenterología/normas , Enfermedades Gastrointestinales/sangre , Enfermedades Gastrointestinales/complicaciones , Enfermedades Gastrointestinales/patología , Hemoglobinas/análisis , Humanos , Mucosa Intestinal/diagnóstico por imagen , Mucosa Intestinal/metabolismo , Mucosa Intestinal/patología , Hierro/metabolismo , Masculino , Posmenopausia , Premenopausia , Valores de Referencia , Derivación y Consulta/normas , Factores Sexuales , Sociedades Médicas/normas , Estados UnidosAsunto(s)
Anemia Ferropénica/diagnóstico , Medicina Basada en la Evidencia/normas , Gastroenterología/normas , Enfermedades Gastrointestinales/diagnóstico , Hierro/sangre , Adolescente , Adulto , Factores de Edad , Anemia Ferropénica/sangre , Anemia Ferropénica/etiología , Biopsia , Niño , Endoscopía Gastrointestinal/normas , Femenino , Mucosa Gástrica/diagnóstico por imagen , Mucosa Gástrica/metabolismo , Mucosa Gástrica/patología , Enfermedades Gastrointestinales/sangre , Enfermedades Gastrointestinales/complicaciones , Enfermedades Gastrointestinales/patología , Hemoglobinas/análisis , Humanos , Mucosa Intestinal/diagnóstico por imagen , Mucosa Intestinal/metabolismo , Mucosa Intestinal/patología , Hierro/metabolismo , Masculino , Persona de Mediana Edad , Prevalencia , Valores de Referencia , Factores Sexuales , Sociedades Médicas/normas , Estados Unidos , Adulto JovenAsunto(s)
Anemia Ferropénica/diagnóstico , Enfermedades Gastrointestinales/diagnóstico , Hierro/sangre , Adolescente , Adulto , Factores de Edad , Anemia Ferropénica/sangre , Anemia Ferropénica/epidemiología , Anemia Ferropénica/etiología , Biopsia , Niño , Endoscopía Gastrointestinal/normas , Medicina Basada en la Evidencia/normas , Femenino , Mucosa Gástrica/diagnóstico por imagen , Mucosa Gástrica/metabolismo , Mucosa Gástrica/patología , Gastroenterología/normas , Enfermedades Gastrointestinales/sangre , Enfermedades Gastrointestinales/complicaciones , Enfermedades Gastrointestinales/patología , Hemoglobinas/análisis , Humanos , Mucosa Intestinal/diagnóstico por imagen , Mucosa Intestinal/metabolismo , Mucosa Intestinal/patología , Hierro/metabolismo , Masculino , Persona de Mediana Edad , Prevalencia , Valores de Referencia , Factores Sexuales , Sociedades Médicas/normas , Estados Unidos/epidemiología , Adulto JovenAsunto(s)
Betacoronavirus/aislamiento & purificación , Técnicas de Laboratorio Clínico/normas , Infecciones por Coronavirus/diagnóstico , Endoscopía/normas , Neumonía Viral/diagnóstico , Cuidados Preoperatorios/normas , Anticuerpos Antivirales/aislamiento & purificación , Infecciones Asintomáticas/epidemiología , Betacoronavirus/genética , Betacoronavirus/inmunología , COVID-19 , Prueba de COVID-19 , Control de Enfermedades Transmisibles/instrumentación , Control de Enfermedades Transmisibles/normas , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/prevención & control , Infecciones por Coronavirus/transmisión , Gastroenterología/normas , Humanos , Transmisión de Enfermedad Infecciosa de Paciente a Profesional/prevención & control , Pandemias/prevención & control , Equipo de Protección Personal/normas , Neumonía Viral/epidemiología , Neumonía Viral/prevención & control , Neumonía Viral/transmisión , Guías de Práctica Clínica como Asunto , Valor Predictivo de las Pruebas , Prevalencia , ARN Viral/aislamiento & purificación , SARS-CoV-2 , Sociedades Médicas/normas , Estados UnidosAsunto(s)
Infecciones por Coronavirus/prevención & control , Transmisión de Enfermedad Infecciosa/prevención & control , Endoscopía/normas , Pandemias/prevención & control , Equipo de Protección Personal/normas , Neumonía Viral/prevención & control , Guías de Práctica Clínica como Asunto , Betacoronavirus , COVID-19 , Infecciones por Coronavirus/transmisión , Endoscopía/efectos adversos , Humanos , Neumonía Viral/transmisión , SARS-CoV-2RESUMEN
BACKGROUND & AIMS: Multiple gastrointestinal (GI) symptoms, including diarrhea, nausea/vomiting, and abdominal pain, as well as liver enzyme abnormalities, have been variably reported in patients with coronavirus disease 2019 (COVID-19). This document provides best practice statements and recommendations for consultative management based on a systematic review and meta-analysis of international data on GI and liver manifestations of COVID-19. METHODS: We performed a systematic literature search to identify published and unpublished studies using OVID Medline and preprint servers (medRxiv, LitCovid, and SSRN) up until April 5, 2020; major journal sites were monitored for US publications until April 19, 2020. We pooled the prevalence of diarrhea, nausea, vomiting, and abdominal pain, as well as liver function tests abnormalities, using a fixed-effect model and assessed the certainty of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. RESULTS: We identified 118 studies and used a hierarchal study selection process to identify unique cohorts. We performed a meta-analysis of 47 studies including 10,890 unique patients. Pooled prevalence estimates of GI symptoms were as follows: diarrhea 7.7% (95% confidence interval [CI], 7.2%-8.2%), nausea/vomiting 7.8% (95% CI, 7.1%-8.5%), and abdominal pain 2.7% (95% CI, 2.0%-3.4%). Most studies reported on hospitalized patients. The pooled prevalence estimates of elevated liver abnormalities were as follows: aspartate transaminase 15.0% (95% CI, 13.6%-16.5%) and alanine transaminase 15.0% (95% CI, 13.6%-16.4%). When we compared studies from China to studies from other countries in subgroup analyses, diarrhea, nausea/vomiting, and liver abnormalities were more prevalent outside of China, with diarrhea reported in 18.3% (95% CI, 16.6%-20.1%). Isolated GI symptoms were reported rarely. We also summarized the Gl and liver adverse effects of the most commonly utilized medications for COVID-19. CONCLUSIONS: GI symptoms are associated with COVID-19 in <10% of patients. In studies outside of China, estimates are higher. Further studies are needed with standardized GI symptoms questionnaires and liver function test checks on admission to better quantify and qualify the association of these symptoms with COVID-19. Based on findings from our meta-analysis, we provide several Best Practice Statements for the consultative management of COVID-19.