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1.
J Pediatr ; 272: 114099, 2024 May 14.
Artigo em Inglês | MEDLINE | ID: mdl-38754775

RESUMO

OBJECTIVE: To increase the percentage of patients who undergo rapid magnetic resonance imaging (rMRI) rather than computed tomography (CT) for evaluation of mild traumatic brain injury (TBI) from 45% in 2020 to 80% by December 2021. STUDY DESIGN: This was a quality improvement initiative targeted to patients presenting to the pediatric emergency department presenting with mild TBI, with baseline data collected from January 2020 to December 2020. From January 2021 to August 2021, we implemented a series of improvement interventions and tracked the percentage of patients undergoing neuroimaging who received rMRI as their initial study. Balancing measures included proportion of all patients with mild TBI who underwent neuroimaging of any kind, proportion of patients requiring sedation, emergency department length of stay, and percentage with clinically important TBI. RESULTS: The utilization of rMRI increased from a baseline of 45% to a mean of 92% in the intervention period. Overall neuroimaging rates did not change significantly after the intervention (19.8 vs 23.2%, P = .24). There was no difference in need for anxiolysis (12 vs 7%, P = .30) though emergency department length of stay was marginally increased (1.4 vs 1.7 hours, P = < 0.01). CONCLUSION: In this quality improvement initiative, transition to rMRI as the primary imaging modality for the evaluation of minor TBI was achieved at a level 1 pediatric trauma center with no significant increase in overall use of neuroimaging.

2.
Am J Emerg Med ; 69: 1-4, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37027956

RESUMO

OBJECTIVES: Pediatric mental health presentations continue to increase across the US. These patients often board for significant periods of time and may require more resources than other acute non-mental health patients. This has important implications for the overall function of the emergency department (ED) as well as care of all ED patients. METHODS: This study evaluated a policy developed to allow for inpatient hospital admission when 30% of the ED was occupied by boarding patients at a tertiary care children's hospital. RESULTS: We found an increase in the number of patients for whom this policy applied, and increased days/month this policy was executed over time. There was an increase in the average ED LOS and left without being seen rate during this time which we hypothesize would have been higher without this policy. CONCLUSIONS: A hospital policy allowing mental health patients to be admitted to the inpatient hospital once stabilized has the potential to improve ED flow and functionality.


Assuntos
Hospitalização , Admissão do Paciente , Humanos , Criança , Tempo de Internação , Estudos Retrospectivos , Serviço Hospitalar de Emergência
3.
Am J Emerg Med ; 70: 61-65, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37201452

RESUMO

OBJECTIVE: To evaluate the association between capillary refill time (CRT) measured by a medical device and sepsis among patients presenting to the Emergency Department (ED). METHODS: This prospective observational study enrolled adult and pediatric patients during ED triage when sepsis was considered a potential diagnosis by the triage nurse. Patients were enrolled at an academic medical center between December 2020 and June 2022. CRT was measured by a research assistant using an investigational medical device. The outcomes included sepsis and septic shock defined using sep-3 criteria, septic shock defined as IV antibiotics and a vasopressor requirement, ICU admission, and hospital mortality. Other measures included patient demographics and vital signs at ED triage. We evaluated univariate associations between CRT and sepsis outcomes. RESULTS: We enrolled 563 patients in the study, 48 met Sep-3 criteria, 5 met Sep-3 shock criteria, and 11 met prior septic shock criteria (IV antibiotics and vasopressors to maintain mean arterial pressure of 65). Sixteen patients were admitted to the ICU. The mean age was 49.1 years, and 51% of the cohort was female. The device measured CRT was significantly associated with the diagnosis of sepsis by sep-3 criteria (OR 1.23, 95% CI 1.06-1-43), septic shock by sep-3 criteria (OR 1.57, 95% CI 1.02-2.40), and septic shock defined as receipt of IV antibiotics and a vasopressor requirement (OR 1.37, 95% CI 1.03-1.82). Patients with CRT >3.5 s measured by the DCR device had an odds ratio of 4.67 (95%CI 1.31-16.1) of septic shock (prior definition), and an odds ratio of 3.97 (95% CI 1.99-7.92) of ICU admission, supporting the potential for the 3.5-s cutoff of the DCR measurement. CONCLUSIONS: CRT measured by a medical device at ED triage was associated with the diagnosis of sepsis. Objective CRT measurement using a medical device may be a relatively simple way to improve sepsis diagnosis during ED triage.


Assuntos
Sepse , Choque Séptico , Adulto , Humanos , Feminino , Criança , Pessoa de Meia-Idade , Triagem , Estudos Retrospectivos , Serviço Hospitalar de Emergência , Vasoconstritores/uso terapêutico , Mortalidade Hospitalar , Antibacterianos
4.
Pediatr Emerg Care ; 39(8): 569-573, 2023 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-36252055

RESUMO

OBJECTIVE: Dehydration is a commonly encountered problem worldwide. Current clinical assessment is limited by subjectivity and limited provider training with children. The objective of this study is to investigate a new noninvasive, point-of-care technology that measures capillary refill combined with patient factors to accurately diagnose dehydration. METHODS: This is a prospective observational study at a tertiary care children's hospital in Buenos Aires, Argentina. Patients were eligible if younger than 10 years who presented to the emergency department with vomiting and/or diarrhea whom the triage nurse deems to be potentially dehydrated. Patients had the digital capillary refill device done on presentation in addition to standard of care vital signs and weight. Patients had serial weights measured on hospital scales throughout their stay. The primary outcome was dehydration, which was calculated as a percent change in weight from admission to discharge. RESULTS: Seventy-six children were enrolled in the study with 56 included in the final analysis. A stepwise forward method selection chose malnutrition, temperature, and systolic blood pressure for the multivariable model. The area under the curve for the final model was fair (0.7431). To further look into the utility of such a device in the home setting where blood pressure is not available often, we reran the model without systolic blood pressure. The area under the curve for the final model was 0.7269. CONCLUSIONS: The digital capillary refill point-of-care device combined with readily available patient-specific factors may improve the ability to detect pediatric dehydration and facilitate earlier treatment or transfer to higher levels of care.


Assuntos
Desidratação , Sistemas Automatizados de Assistência Junto ao Leito , Criança , Humanos , Lactente , Desidratação/diagnóstico , Desidratação/terapia , Estudos Prospectivos , Diarreia , Tecnologia
5.
J Hepatol ; 77(2): 353-364, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35367282

RESUMO

BACKGROUND & AIMS: We examined the efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-delta agonist, in adults with primary biliary cholangitis (PBC) at risk of disease progression (alkaline phosphatase [ALP] ≥1.67xupper limit of normal [ULN]) who were receiving or intolerant to ursodeoxycholic acid. METHODS: In this 52-week, phase II, dose-ranging, open-label study, patients were randomized (1:1) to seladelpar 5 mg/day (n = 53) or 10 mg/day (n = 55) or assigned to 2 mg/day (n = 11; United Kingdom sites after interim analysis) for 12 weeks. Doses could then be uptitrated to 10 mg/day. The primary efficacy endpoint was ALP change from baseline to Week 8. RESULTS: Mean baseline ALP was 300, 345, and 295 U/L in the 2 mg, 5 mg, and 10 mg cohorts, respectively. Twenty-one percent of patients had cirrhosis, 71% had pruritus. At Week 8, mean ± standard error ALP reductions from baseline were 26 ± 2.8%, 33 ± 2.6%, and 41 ± 1.8% in the 2 mg (n = 11), 5 mg (n = 49), and 10 mg (n = 52) cohorts (all p ≤0.005), respectively. Responses were maintained or improved at Week 52, after dose escalation in 91% and 80% of the 2 mg and 5 mg cohorts, respectively. At Week 52, composite response (ALP <1.67xULN, ≥15% ALP decrease, and normal total bilirubin) rates were 64%, 53%, and 67%, and ALP normalization rates were 9%, 13%, and 33% in the 2 mg, 5 mg, and 10 mg cohorts, respectively. Pruritus visual analog scale score was decreased in the 5 mg and 10 mg cohorts. There were no treatment-related serious adverse events, and 4 patients discontinued due to adverse events. CONCLUSIONS: Seladelpar demonstrated robust, dose-dependent, clinically significant, and durable improvements in biochemical markers of cholestasis and inflammation in patients with PBC at risk of disease progression. Seladelpar appeared safe and well tolerated and was not associated with any increase in pruritus. GOV NUMBER: NCT02955602 CLINICALTRIALSREGISTER. EU NUMBER: 2016-002996-91 LAY SUMMARY: Current treatment options for patients living with primary biliary cholangitis (PBC) are not optimal due to inadequate effectiveness or undesirable side effects. Patients with PBC who took seladelpar, a new treatment being developed for PBC, at increasing doses (2, 5, or 10 mg/day) for 1 year had clinically significant, dose-dependent improvements in key liver tests. Treatment appeared safe and was not associated with any worsening in patient self-reported itch scores.


Assuntos
Cirrose Hepática Biliar , Acetatos , Adulto , Fosfatase Alcalina , Progressão da Doença , Humanos , Cirrose Hepática Biliar/tratamento farmacológico , Prurido/induzido quimicamente , Prurido/etiologia , Ácido Ursodesoxicólico/efeitos adversos
6.
J Intensive Care Med ; 37(7): 849-856, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34967252

RESUMO

Early detection of sepsis is challenging to achieve with current diagnostic methods, leading to expenditures of $27 billion annually in the United States with significant associated mortality. Various scoring systems have been proposed such as the sequential organ failure assessment (SOFA) and systemic inflammatory response syndrome (SIRS) criteria for identification of sepsis, but their sensitivities range from 60% to 70% when used in the emergency department triage. Other methods for the recognition of sepsis may rely on laboratory work, in addition to vitals monitoring, and are often outpaced by the development of sepsis. Automated alerts have not shown any reduction in mortality thus far. New technology may fill a critical gap in the early detection of sepsis. The ideal bedside screening device for would demonstrate rapid time to result, high portability, and high sensitivity to not miss cases, but also reasonable specificity to prevent provider fatigue from excessive false alerts. Non-invasive end-organ perfusion devices analyzing lactate and capillary refill time (CRT) tend to perform well in speed and portability, but may be less sensitive. Biomarker devices demonstrate a wider array of performance metrics. Those analyzing a single biomarker tend to be more sensitive but are less specific to the diagnosis of sepsis than technologies that assess multiple biomarkers, which in turn have lower sensitivity. Additionally, biomarker devices are generally invasive requiring blood samples, which may or may not be feasible in all patients especially when serial draws are needed. Sepsis is a complex disease process and most likely will require a combination of improved technology in addition to vital signs and high-risk patient history for better recognition. This review examines recent advances in the device-based early detection of sepsis between 2017 and 2020 with emphasis on bedside diagnostics, divided into markers of perfusion and biomarkers commonly implicated in sepsis.


Assuntos
Sepse , Biomarcadores , Serviço Hospitalar de Emergência , Humanos , Ácido Láctico , Síndrome de Resposta Inflamatória Sistêmica , Triagem
7.
J Intensive Care Med ; 37(9): 1159-1164, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35306923

RESUMO

Background: Monitoring of capillary refill time (CRT) is a common bedside assessment used to ascertain peripheral perfusion in a patient for a vast array of conditions. The literature has shown that a change in CRT can be used to recognize life-threatening conditions that cause decreased perfusion, such as sepsis, and aid in resuscitation. The current practice for calculating CRT invites subjectivity and produces a highly variable result. Innovative technology may be able to standardize this process and provide a reliable and accurate value for use in diagnostics and treatment. This study aimed to assess a new technology (DCR by ProMedix Inc.) for rapid, bedside, and noninvasive detection of CRT. Methods: This was a secondary analysis of a prospective observational study evaluating the accuracy of new technology towards CRT-guided diagnosis of sepsis. It was carried out in the adult emergency departments (ED) of an academic tertiary care medical center. Patients seeking care in the ED were determined eligible if they were > 18 years in age and exhibited chief complaints suggestive of possible sepsis. The CRT produced by the technology was compared to the gold standard manual waveform assessment. Results: 218 consecutive subject enrollments were included and multiple measurements were made on each patient. Data with irregular waveforms were excluded. A total of 692 waveforms were evaluated for CRT values by a pair of trained PhD biomedical engineers. The average age of the cohort was 50.62 and 51.4% female. Results showed a Pearson correlation coefficient of 0.91 for the device CRT compared to the CRT gold standard. The Pearson correlation coefficient for the two independent engineering review of the waveform data was 0.98. This device produces accurate, consistent results and eliminates the subjectivity of CRT measurements that is in practice currently.


Assuntos
Sepse , Adulto , Feminino , Hemodinâmica , Humanos , Masculino , Microcirculação , Perfusão , Sepse/diagnóstico , Sepse/terapia , Tecnologia
8.
Pediatr Emerg Care ; 38(2): e458-e461, 2022 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-35100750

RESUMO

OBJECTIVE: Adolescent mental health is a rapidly escalating presentation to emergency departments in the United States with depression and suicidal thoughts being the most prevalent condition. Much of the research and focus has been on preventing future attempts. However, one outcome that may be very important in addition to focus on is the impact of presentations for thoughts without self-injury. The aim was to evaluate outcomes of interest for a larger prospective observational adolescent suicidal trial including frequency of suicide attempts versus thoughts and factors associated with each outcome. METHODS: This is a prospective pilot study of adolescents at a single pediatric emergency department between December 2016 and September 2017 with acute suicidality. We used descriptive statistics to compare chief complaint, medical history, Patient Health Questionnaire-9 (PHQ-9), and outcomes including final disposition and total emergency department length of stay (LOS). We used t tests for continuous outcomes, χ2 test for categorical data, and Fisher exact tests for categorical and sparse data (20% of cell sizes of <5). RESULTS: Forty-one patients were enrolled, with 43.9% having an attempt; 72.2% of attempts were the result of an ingestion, and approximately 54% were over-the-counter medications. The average (SD) LOS was 30.8 (31.2) hours, and 63% were discharged home to outpatient services. There were no significant differences in age, chief complaint (except overdose), medical history, final disposition, total LOS in the ED, and the PHQ-9. Scores of the PHQ-9 were, on average (SD), 18.51 (4.7) across the entire cohort, 18.06 (5.75) in patients with an attempt, and 18.87 (3.77) in patients without an attempt (P = 0.59). CONCLUSIONS: Adolescent mental health is a growing issue for pediatric emergency departments nationally. Prospective research to identify factors associated with worsening outcomes is important to identify and potentially modify if possible. This study did not find any specific factors associated with a suicide attempt, but found that less than half of patients presenting with suicidality actual made an attempt. Future research should focus on not only limiting suicide attempts but also using decreased emergency department visits for worsening thoughts as an outcome of interest.


Assuntos
Ideação Suicida , Suicídio , Adolescente , Serviço Hospitalar de Emergência , Humanos , Projetos Piloto , Estudos Prospectivos , Estados Unidos
9.
Pediatr Emerg Care ; 38(6): e1304-e1308, 2022 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-35510725

RESUMO

OBJECTIVE: The aim of this study was to assess national trends in recreational and suicidal ingestions of over-the-counter cough preparations that contain Coricidin. METHODS: Using the American Association of Poison Control Center's National Poison Data System, we obtained data from 2004 to 2017 on patients aged 13 to 19 years with an ingestion of "Coricidin." We examined trends over time overall and ingestion intent (recreational vs suicidal) using linear regression. We compared patient characteristics, substances ingested, clinical effects and therapies, and outcomes by suicidal versus misuse or recreational intention. RESULTS: An initial search with the inclusion criteria found 19,213 calls that matched study inclusion criteria. On average, there was a yearly linear increase of 180.0 (95% confidence interval [CI], 136.6-223.3; P < 0.01) ingestions per year. Within suicide ingestions, there was an average yearly increase of 97.9 (95% CI, 66.9-128.9; P < 0.01) ingestions, and within misuse/recreational ingestions, there was an average yearly increase of 82.1 (95% CI, 60.3-103.9; P < 0.01) ingestions. The most common clinical effect was tachycardia, which occurred in 42.4% of ingestions. Altered mental status, mydriasis, and ataxia were all more common in misuse/recreational ingestions. Suicidal ingestions resulted in more hospital admissions and need for medical treatment. Recreational-use coded calls peaked in 2013, whereas calls coded for suicide attempts have continued to rise dramatically, with a 50% increase in the 14-year study period. CONCLUSION: Combination Coricidin products are a major source of morbidity in adolescents. Targeted preventive measures in primary care offices or larger-scale policy/legislative efforts may be helpful to address this.


Assuntos
Centros de Controle de Intoxicações , Ideação Suicida , Adolescente , Ingestão de Alimentos , Humanos , Medicamentos sem Prescrição , Estudos Retrospectivos , Tentativa de Suicídio , Estados Unidos/epidemiologia
10.
Pediatr Emerg Care ; 38(4): e1213-e1216, 2022 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-34608059

RESUMO

INTRODUCTION: Suicide is a leading cause of death among adolescents. Oregon ranks 17th nationally for youth suicide rates, and ingestion of medications as a means of suicide is common. Despite the high prevalence of intentional poisoning among youth in Oregon, information about medications used by children and adolescents for attempted suicide, in particular the sources of medications, is not readily available. METHODS: The objective of this study is to describe types and sources of medications used for intentional ingestion among patients seen by the Doernbecher Children's Hospital Child and Adolescent Psychiatry Consultation-Liaison Service. This was a retrospective analysis of patients seen by the Child and Adolescent Psychiatry Consultation-Liaison Service for intentional ingestion from 2015 to 2017. Data on 434 total intentional ingestions were collected, including demographic information, types of medications ingested, and sources of both over-the-counter (OTC) and prescription (Rx) medications. Ingestions without intent of suicide were excluded. Descriptive analysis of ingestion data was performed. RESULTS: Intentional ingestions included Rx and OTC medications in similar frequencies. For Rx medications, 68% of ingestions included patients' own Rxs. Eighty-eight percent of ingestions that were not the patients' own Rx belonged to someone else living in their home. For OTC medications, 66% of medications were available at home. CONCLUSIONS: Intentional ingestions among adolescents most frequently involve medications that are readily available in their homes, and these include both OTC and Rx medications. This study highlights the importance of securing medications at home as a preventative measure and the importance of anticipatory guidance for primary care providers.


Assuntos
Medicamentos sem Prescrição , Intoxicação , Adolescente , Criança , Ingestão de Alimentos , Hospitais Pediátricos , Humanos , Intoxicação/epidemiologia , Estudos Retrospectivos , Tentativa de Suicídio
11.
J Viral Hepat ; 28(2): 420-430, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33073452

RESUMO

The first clinical case of persistent HEV infection in England was reported in 2009. We describe the demography, virology and outcomes of patients identified with persistent HEV infection in England and Wales between 2009 and 2017. A series of 94 patients with persistent HEV infection, defined by HEV viraemia of more than 12 weeks, was identified through routine reference laboratory testing. Virology, serology and clinical data were recorded through an approved PHE Enhanced Surveillance System. Sixty-six cases (70.2%) were transplant recipients, 16 (17.0%) had an underlying haematological malignancy without stem cell transplantation, six (6.4%) had advanced HIV infection, five (5.3%) were otherwise immunosuppressed, and one patient (1.1%) had no identified immunosuppression. Retrospective analysis of 46 patients demonstrated a median 38 weeks of viraemia before diagnostic HEV testing. At initial diagnosis, 16 patients (17.0%) had no detectable anti-HEV serological response. Of 65 patients treated with ribavirin monotherapy, 11 (16.9%) suffered virological relapse despite undetectable RNA in plasma or stool at treatment cessation. Persistent HEV infection remains a rare diagnosis, but we demonstrate that a broad range of immunocompromised patients are susceptible. Both lack of awareness and the pauci-symptomatic nature of persistent HEV infection likely contribute to significant delays in diagnosis. Diagnosis should rely on molecular testing since anti-HEV serology is insufficient to exclude persistent HEV infection. Finally, despite treatment with ribavirin, relapses occur even after cessation of detectable faecal shedding of HEV RNA, further emphasising the requirement to demonstrate sustained virological responses to treatment.


Assuntos
Infecções por HIV , Vírus da Hepatite E , Hepatite E , Demografia , Hepatite E/diagnóstico , Hepatite E/epidemiologia , Vírus da Hepatite E/genética , Humanos , Hospedeiro Imunocomprometido , Recidiva Local de Neoplasia , RNA Viral , Estudos Retrospectivos , País de Gales/epidemiologia
12.
Pediatr Emerg Care ; 37(12): e1388-e1391, 2021 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-32150001

RESUMO

OBJECTIVES: Pediatric mental health presentations to emergency departments (EDs) have shown dramatic increases nationally. This study aimed to identify the ability of patients discharged with mental health from the ED to establish outpatient care. METHODS: This was a cross-sectional study of all mental health patients aged 7 to 19 years who were seen by a child psychiatry consult team in a tertiary care pediatric ED from September 2016 to January 2017. Patients were contacted by phone at least 6 months after discharge. Data obtained included time to follow-up, reasons for delayed follow-up, type of provider seen, and frequency of outpatient visits. RESULTS: Two hundred twenty-eight charts were reviewed and 51 were successfully interviewed. The median age was 14 years and 61% were female. Most patients (61%) reported seeing a psychiatrist or therapist, whereas 19% reported a primary care provider and 19% reporting "other." The majority were able to establish care within 1 month (73%), whereas 9% reported never obtaining outpatient follow-up. Most patients (58%) were able to be seen more than once per month. The most common reason for delayed follow-up was provider availability. CONCLUSIONS: This study found that a large number of patients were able to be seen within 1 month of discharge for mental health care. However, almost 10% of patients never established outpatient care, which is concerning and is an area needing further research.


Assuntos
Saúde Mental , Alta do Paciente , Adolescente , Criança , Estudos Transversais , Serviço Hospitalar de Emergência , Feminino , Humanos , Pacientes Ambulatoriais
13.
Lancet ; 394(10215): 2184-2196, 2019 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-31813633

RESUMO

BACKGROUND: Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. METHODS: In this multicentre, randomised, double-blind, placebo-controlled study, adult patients with definite NASH, non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2-F3, or F1 with at least one accompanying comorbidity, were randomly assigned using an interactive web response system in a 1:1:1 ratio to receive oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily. Patients were excluded if cirrhosis, other chronic liver disease, elevated alcohol consumption, or confounding conditions were present. The primary endpoints for the month-18 interim analysis were fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of fibrosis, with the study considered successful if either primary endpoint was met. Primary analyses were done by intention to treat, in patients with fibrosis stage F2-F3 who received at least one dose of treatment and reached, or would have reached, the month 18 visit by the prespecified interim analysis cutoff date. The study also evaluated other histological and biochemical markers of NASH and fibrosis, and safety. This study is ongoing, and registered with ClinicalTrials.gov, NCT02548351, and EudraCT, 20150-025601-6. FINDINGS: Between Dec 9, 2015, and Oct 26, 2018, 1968 patients with stage F1-F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2-F3 fibrosis were included in the primary analysis (311 in the placebo group, 312 in the obeticholic acid 10 mg group, and 308 in the obeticholic acid 25 mg group). The fibrosis improvement endpoint was achieved by 37 (12%) patients in the placebo group, 55 (18%) in the obeticholic acid 10 mg group (p=0·045), and 71 (23%) in the obeticholic acid 25 mg group (p=0·0002). The NASH resolution endpoint was not met (25 [8%] patients in the placebo group, 35 [11%] in the obeticholic acid 10 mg group [p=0·18], and 36 [12%] in the obeticholic acid 25 mg group [p=0·13]). In the safety population (1968 patients with fibrosis stages F1-F3), the most common adverse event was pruritus (123 [19%] in the placebo group, 183 [28%] in the obeticholic acid 10 mg group, and 336 [51%] in the obeticholic acid 25 mg group); incidence was generally mild to moderate in severity. The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group). INTERPRETATION: Obeticholic acid 25 mg significantly improved fibrosis and key components of NASH disease activity among patients with NASH. The results from this planned interim analysis show clinically significant histological improvement that is reasonably likely to predict clinical benefit. This study is ongoing to assess clinical outcomes. FUNDING: Intercept Pharmaceuticals.


Assuntos
Ácido Quenodesoxicólico/análogos & derivados , Hepatopatia Gordurosa não Alcoólica/tratamento farmacológico , Administração Oral , Biomarcadores/análise , Biópsia , Ácido Quenodesoxicólico/administração & dosagem , Ácido Quenodesoxicólico/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Testes de Função Hepática , Masculino , Pessoa de Meia-Idade
14.
Gastroenterology ; 156(6): 1717-1730, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30689971

RESUMO

BACKGROUND & AIMS: We estimated the accuracy of FibroScan vibration-controlled transient elastography controlled attenuation parameter (CAP) and liver stiffness measurement (LSMs) in assessing steatosis and fibrosis in patients with suspected nonalcoholic liver disease (NAFLD). METHODS: We collected data from 450 consecutive adults who underwent liver biopsy analysis for suspected NAFLD at 7 centers in the United Kingdom from March 2014 through January 2017. FibroScan examinations with M or XL probe were completed within the 2 weeks of the biopsy analysis (404 had a valid examination). The biopsies were scored by 2 blinded expert pathologists according to nonalcoholic steatohepatitis clinical research network criteria. Diagnostic accuracy was estimated using the area under the receiver operating characteristic curves (AUROCs) for the categories of steatosis and fibrosis. We assessed effects of disease prevalence on positive and negative predictive values. For LSM, the effects of histological parameters and probe type were appraised using multivariable analysis. RESULTS: Using biopsy analysis as the reference standard, we found that CAP identified patients with steatosis with an AUROC of 0.87 (95% confidence interval [CI] 0.82-0.92) for S≥S1, 0.77 (95% CI 0.71-0.82) for S≥S2, and 0.70 (95% CI 0.64-0.75) for S=S3. Youden cutoff values for S≥S1, S≥S2, and S≥S3 were 302 dB/m, 331 dB/m, and 337 dB/m, respectively. LSM identified patients with fibrosis with AUROCs of 0.77 (95% CI 0.72-0.82) for F≥F2, 0.80 (95% CI 0.75-0.84) for F≥F3, and 0.89 (95% CI 0.84-0.93) for F=F4. Youden cutoff values for F≥F2, F≥F3, and F=F4 were 8.2 kPa, 9.7 kPa, and 13.6 kPa, respectively. Applying the optimal cutoff values, determined from this cohort, to populations of lower fibrosis prevalence increased negative predictive values and reduced positive predictive values. Multivariable analysis found that the only parameter that significantly affected LSMs was fibrosis stage (P<10-16); we found no association with steatosis or probe type. CONCLUSIONS: In a prospective analysis of patients with NAFLD, we found CAP and LSM by FibroScan to assess liver steatosis and fibrosis, respectively, with AUROC values ranging from 0.70 to 0.89. Probe type and steatosis did not affect LSM. STUDY REGISTRATION: ClinicalTrials.gov Identifier: NCT01985009.


Assuntos
Técnicas de Imagem por Elasticidade/métodos , Elasticidade , Cirrose Hepática/diagnóstico por imagem , Hepatopatia Gordurosa não Alcoólica/diagnóstico por imagem , Adulto , Idoso , Área Sob a Curva , Biópsia , Técnicas de Imagem por Elasticidade/instrumentação , Feminino , Humanos , Fígado/diagnóstico por imagem , Fígado/patologia , Cirrose Hepática/etiologia , Cirrose Hepática/patologia , Masculino , Pessoa de Meia-Idade , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/patologia , Valor Preditivo dos Testes , Estudos Prospectivos , Curva ROC , Adulto Jovem
15.
Pediatr Emerg Care ; 36(12): e720-e725, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31929393

RESUMO

OBJECTIVE: This study aimed to assess the association between the degree of headache relief obtained in the pediatric emergency department (PED) with abortive treatment and unscheduled return visits to the PED for a recurrent or persistent headache within 72 hours. METHODS: This was a retrospective observational study with 369 patients, all younger than 18 years, who presented to the PED with a primary complaint of either a headache or migraine. Patient and visit details were collected from the medical chart, along with presenting and discharge pain score. Percent pain reduction at discharge was determined through the following calculation: (Presenting Pain Score - Discharge Pain Score)/Presenting Pain Score. Associations were assessed using multivariable logistic regression. RESULTS: No significant association was found between the percent pain reduction and return to the PED (P = 0.49). Mean presenting pain score at the index visit was statistically higher for those who ended up returning to the PED versus those who did not (8.1 vs 7.4; P = 0.02). A trend toward increase in return visits was seen among patients who had a headache duration greater than 3 days (odds ratio, 1.99) and patients who experienced less than 50% pain reduction in the PED (odds ratio, 1.77). CONCLUSIONS: Complete resolution in the PED may not be necessary, given the lack of association between the degree of pain relief and revisit rates. Perhaps, the goal should be to achieve at least 50% pain reduction before discharge.


Assuntos
Serviço Hospitalar de Emergência , Cefaleia , Transtornos de Enxaqueca , Manejo da Dor/normas , Criança , Cefaleia/terapia , Humanos , Transtornos de Enxaqueca/terapia , Alta do Paciente , Readmissão do Paciente , Estudos Retrospectivos , Resultado do Tratamento
16.
Pediatr Emerg Care ; 36(10): 459-463, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29135901

RESUMO

OBJECTIVE: Pediatric headaches are a common presentation to emergency departments accounting for almost half a million annual visits. Providers are left with the difficult task of deciding who has a secondary headache etiology that warrants neuroimaging. METHODS: We conducted a retrospective case-control study. Patients from a pediatric neuro-oncology clinic database with brain cancer and a headache at presentation were identified as cases. Controls were patients from 2 local pediatric tertiary care emergency departments with a final diagnosis of headache after negative neuroimaging. Clinical factors were decided a priori, and logistic regression was used to determine which clinical factors were related to case/control status. RESULTS: A total of 334 patients (203 controls and 131 cases) were included. Patients with a history of headaches had 0.5 (95% confidence interval [CI]: 0.3-0.9; P = 0.03) times the odds of being a case. Patients with vomiting had increased odds of being a case compared with controls regardless of the time of day (early morning 1.8 [95% CI: 1.0-3.2; P = 0.04] and non-early morning 6.6 [95% CI: 2.0-21.7; P < 0.01]). Patients with neurological signs had 10.3 (95% CI: 5.4-19.4; P < 0.01) times the odds of being a case, and patients with an associated seizure had 10.9 (95% CI: 3.8-30.7; P < 0.01) times the odds of being a case. CONCLUSIONS: This study identified clinical factors associated with pediatric brain neoplasms that may guide acute neuroimaging decisions. This study also provides insight into potential clinical factors to be studied prospectively to derive a clinical decision rule.


Assuntos
Neoplasias Encefálicas/diagnóstico por imagem , Serviço Hospitalar de Emergência , Cefaleia/diagnóstico por imagem , Neuroimagem/métodos , Adolescente , Estudos de Casos e Controles , Criança , Diagnóstico Diferencial , Feminino , Humanos , Masculino , Estudos Retrospectivos , Convulsões , Vômito , Adulto Jovem
17.
J Pediatr ; 204: 240-244.e2, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30274923

RESUMO

OBJECTIVES: To characterize the frequency of opioid prescribing for pediatric headache in both ambulatory and emergency department (ED) settings, including prescribing rates by provider type. STUDY DESIGN: A retrospective cohort study of Washington State Medicaid beneficiaries, aged 7-17 years, with an ambulatory care or ED visit for headache between January 1, 2012, and September 30, 2015. The primary outcome was any opioid prescribed within 1 day of the visit. RESULTS: A total of 51 720 visits were included, 83% outpatient and 17% ED. There was a predominance of female (63.2%) and adolescent (59.4%) patients, and 30.5% of encounters involved a pediatrician. An opioid was prescribed in 3.9% of ED and 1.0% of ambulatory care visits (P < .001). Pediatricians were less likely to prescribe opioids in both ED (-2.70 percentage point; 95% CI, -3.53 to -1.88) and ambulatory settings (-0.31 percentage point; 95% CI, -0.54 to -0.08; P < .001). CONCLUSIONS: Opioid prescribing rates for pediatric headache were low, but significant variation was observed by setting and provider specialty. We identified opioid prescribing by nonpediatricians as a potential target for quality improvement efforts.


Assuntos
Analgésicos Opioides/administração & dosagem , Cefaleia/tratamento farmacológico , Padrões de Prática Médica/estatística & dados numéricos , Adolescente , Assistência Ambulatorial/estatística & dados numéricos , Criança , Estudos de Coortes , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Masculino , Estudos Retrospectivos , Washington
19.
Pediatr Emerg Care ; 35(3): 176-179, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27749797

RESUMO

OBJECTIVE: Adolescent intentional ingestions remain a significant public health problem in the United States with little research to date on the over-the-counter or prescription medicines that adolescents abuse. These data are important for anticipatory guidance by primary care providers, preventive health, and poison center outreach. METHODS: This was an observational study using the American Association of Poison Control Centers National Poison Data System. The study population consisted of all cases of patients aged 13 to 19 years from 2004 to 2013 with a coding of "intentional abuse." RESULTS: There were 95,695 patient calls that were coded for intentional abuse between 2004 and 2013 for adolescents aged 13 to 19 years. The most common agent reportedly ingested in intentional-abuse cases was antihistamine and/or decongestant with dextromethorphan, and this agent remained the most common throughout the 10-year study period. The next 4 most common agents remained similar across the study period as well and included ethanol, benzodiazepines, dextromethorphan alone, and marijuana. These 5 agents remained the most commonly reported across the study period for all US regions (West, Midwest, South Northeast, and US territories). CONCLUSIONS: Over a recent 10-year period, common cough preparations remain the most commonly reported intentional abuse ingestion among all years and regions for adolescents.


Assuntos
Centros de Controle de Intoxicações/tendências , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Adolescente , Comportamento do Adolescente , Bases de Dados Factuais , Ingestão de Alimentos , Feminino , Humanos , Masculino , Medicamentos sem Prescrição/intoxicação , Medicamentos sob Prescrição/intoxicação , Estados Unidos/epidemiologia , Adulto Jovem
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