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3.
JAMA ; 2020 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-32129797
4.
Nat Med ; 25(11): 1728-1732, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31700189

RESUMO

Probiotics are routinely administered to hospitalized patients for many potential indications1 but have been associated with adverse effects that may outweigh their potential benefits2-7. It is particularly alarming that probiotic strains can cause bacteremia8,9, yet direct evidence for an ancestral link between blood isolates and administered probiotics is lacking. Here we report a markedly higher risk of Lactobacillus bacteremia for intensive care unit (ICU) patients treated with probiotics compared to those not treated, and provide genomics data that support the idea of direct clonal transmission of probiotics to the bloodstream. Whole-genome-based phylogeny showed that Lactobacilli isolated from treated patients' blood were phylogenetically inseparable from Lactobacilli isolated from the associated probiotic product. Indeed, the minute genetic diversity among the blood isolates mostly mirrored pre-existing genetic heterogeneity found in the probiotic product. Some blood isolates also contained de novo mutations, including a non-synonymous SNP conferring antibiotic resistance in one patient. Our findings support that probiotic strains can directly cause bacteremia and adaptively evolve within ICU patients.


Assuntos
Bacteriemia/genética , Farmacorresistência Bacteriana/genética , Lactobacillus/patogenicidade , Probióticos/efeitos adversos , Bacteriemia/sangue , Bacteriemia/etiologia , Bacteriemia/microbiologia , Diarreia/sangue , Diarreia/etiologia , Diarreia/genética , Diarreia/microbiologia , Variação Genética/genética , Genoma Bacteriano/genética , Genômica , Humanos , Unidades de Terapia Intensiva , Lactobacillus/genética , Mutação , Filogenia , Polimorfismo de Nucleotídeo Único/genética , Probióticos/uso terapêutico , Sequenciamento Completo do Genoma
5.
JAMA Intern Med ; 2019 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-31710344

RESUMO

Importance: Regulatory and scientific guidelines stipulate that indirect, surrogate measures of patient benefit, such as a change in microbial culture status, should be used as primary end points only in pivotal trials of chronic conditions that are serious or life threatening and when the experimental therapy is expected to offer substantial benefit compared with available therapy. However, many recent US Food and Drug Administration (FDA) anti-infective drug approvals for acute and/or non-life-threatening diseases have been based on pivotal trials using surrogate measures as primary end points rather than clinical outcomes, such as symptom resolution or survival. Objectives: To review FDA recommendations for primary end points in pivotal trials of new anti-infective drugs and assess the concordance of those recommendations with the regulatory and scientific conditions for the appropriate use of surrogate measures as primary trial outcomes. Evidence Review: All guidance documents for antimicrobial drug development hosted on the FDA website were searched in November 2017; the search was updated in June 2018. For each document, 2 reviewers independently extracted data on the recommended primary end points for a pivotal or phase 3 trial. Findings: Twenty-two FDA guidance documents met the inclusion criteria, which included recommendations for primary end points in pivotal clinical trials in 27 infectious disease indications. Twenty-one of 27 indications recommended surrogate outcomes as either the sole primary end point or as components of composite end points. None of the recommendations for the use of surrogate measures matched the regulatory and scientific conditions favoring indirect outcomes in place of clinical outcomes. Conclusions and Relevance: The FDA guidance documents for developing new anti-infective agents frequently recommend indirect measures of patient benefit, rather than direct measures of patient benefit, as sole primary end points or components of primary end points. Existing guidance documents should be updated and revised to recommend appropriate clinical outcomes consistent with general scientific and regulatory parameters.

6.
Pediatr Blood Cancer ; 66(4): e27568, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30537106

RESUMO

BACKGROUND: Bacillus species are known to cause severe infection in immunocompromised hosts. The incidence of Bacillus bloodstream infections and characteristics of infection among children with cancer or indication for hematopoietic cell transplant (HCT) is unknown. METHODS: We performed a retrospective medical record review of all cases of Bacillus bacteremia between January 1, 2005, and December 31, 2014, at Boston Children's Hospital. We report average incidences from 2012 to 2014. We performed a detailed review of infections among children with cancer or undergoing HCT and a case-control study to evaluate whether neutropenia at diagnosis caries higher risk of Bacillus infection for children with acute lymphoblastic leukemia (ALL). RESULTS: One hundred fourteen children developed Bacillus bacteremia during the study period, with an estimated incidence of 0.27/1,000 patients. Among children treated for cancer or undergoing HCT, there were 37 bloodstream infections (2.0/1,000 patients). Of the 37 oncology/HCT patients, oncologic diagnoses included ALL (18), acute myeloid leukemia (3), myelodysplastic syndrome (1), solid tumors (8), and 7 children were undergoing HCT. The incidence of infection among children with ALL was 34/1,000 patients and all central nervous system (CNS) infections (6) and deaths (3) occurred in this population. Neutropenia at time of diagnosis in children with ALL was not associated with risk of infection (P = 0.17). DISCUSSION: We report the first hospital-wide analysis of Bacillus infection and found that immunocompromised children experience a significant proportion of Bacillus infections. Children with ALL have a high incidence of infection and are at higher risk of CNS involvement and death.


Assuntos
Bacillus , Bacteriemia/epidemiologia , Neoplasias Hematológicas/epidemiologia , Neoplasias Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas , Neutropenia/epidemiologia , Adolescente , Adulto , Criança , Pré-Escolar , Feminino , Humanos , Incidência , Lactente , Masculino , Neutropenia/etiologia , Estudos Retrospectivos
7.
Infect Control Hosp Epidemiol ; 38(12): 1472-1477, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-29173236

RESUMO

OBJECTIVES The attributable cost of Clostridium difficile infection (CDI) in children is unknown. We sought to determine a national estimate of attributable cost and length of stay (LOS) of CDI occurring during hospitalization in children. DESIGN AND METHODS We analyzed discharge records of patients between 2 and 18 years of age from the Agency for Healthcare Research and Quality (AHRQ) Kids' Inpatient Database. We created a logistic regression model to predict CDI during hospitalization based on demographic and clinical characteristics. Predicted probabilities from the logistic regression model were then used as propensity scores to match 1:2 CDI to non-CDI cases. Charges were converted to costs and compared between patients with CDI and propensity-score-matched controls. In a sensitivity analysis, we adjusted for LOS as a confounder by including it in both the propensity score and a generalized linear model predicting cost. RESULTS We identified 8,527 pediatric hospitalizations (0.53%) with a diagnosis of CDI and 1,597,513 discharges without CDI. In our matched cohorts, the attributable cost of CDI occurring during a hospitalization ranged from $1,917 to $8,317, depending on whether model was adjusted for LOS. When not adjusting for LOS, CDI-associated hospitalizations cost 1.6 times more than non-CDI associated hospitalizations. Attributable LOS of CDI was approximately 4 days. CONCLUSIONS Clostridium difficile infection in hospitalized children is associated with an economic burden similar to adult estimates. This finding supports a continued focus on preventing CDI in children as a priority. Pediatric CDI cost analyses should account for LOS as an important confounder of cost. Infect Control Hosp Epidemiol 2017;38:1472-1477.


Assuntos
Infecções por Clostridium/economia , Infecção Hospitalar/economia , Custos de Cuidados de Saúde , Tempo de Internação/economia , Adolescente , Criança , Pré-Escolar , Infecções por Clostridium/epidemiologia , Clostridium difficile , Infecção Hospitalar/epidemiologia , Feminino , Mortalidade Hospitalar , Humanos , Modelos Logísticos , Masculino , Análise Multivariada , Pontuação de Propensão , Estados Unidos/epidemiologia
8.
Infect Control Hosp Epidemiol ; 38(4): 496-498, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-28103958

RESUMO

Infection prevention in electrophysiology (EP) laboratories is poorly characterized; thus, we conducted a cross-sectional survey using the SHEA Research Network. We found limited uptake of basic interventions, such as surveillance and appropriate peri-procedural antimicrobial use. Further study is needed to identify ways to improve infection prevention in this setting.


Assuntos
Antibacterianos/uso terapêutico , Antibioticoprofilaxia , Gestão de Antimicrobianos , Infecções Bacterianas/prevenção & controle , Laboratórios Hospitalares/organização & administração , Desenvolvimento de Programas/estatística & dados numéricos , Estudos Transversais , Técnicas Eletrofisiológicas Cardíacas , Humanos , Inquéritos e Questionários
9.
J Pediatric Infect Dis Soc ; 6(2): 202-204, 2017 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-27242191

RESUMO

Institutional practice at our hospital (Boston Children's Hospital) is to culture homografts before implantation during congenital cardiac surgery. Over a 4-year period, 5% (73 of 1376) of these cultures were positive, but the results had minimal clinical impact. Our experience demonstrates that there is limited utility in preimplantation cultures of cardiac homografts.


Assuntos
Aloenxertos/microbiologia , Cardiopatias Congênitas/cirurgia , Transplante de Coração/métodos , Transplante de Coração/efeitos adversos , Humanos , Cuidados Pré-Operatórios , Estudos Retrospectivos
10.
South Med J ; 109(10): 631-635, 2016 10.
Artigo em Inglês | MEDLINE | ID: mdl-27706501

RESUMO

OBJECTIVES: Adverse events (AEs) are unintended physical injuries resulting from or contributed to by medical or surgical care. We determined the frequency and type of AEs before, during, and after hospital admission. METHODS: We conducted a cohort study of 296 adult hospital patients. We used the standardized Institute for Healthcare Improvement Global Trigger Tool for Measuring Adverse Events to review the medical records of the hospital patients for occurrence, timing relative to hospital admission, severity, and preventability of AEs. We also identified the primary physiologic system affected by the AE. RESULTS: Among 296 patients, we identified 338 AEs. AEs occurred with similar frequency before (n = 148; 43.8%) and during hospital admission (n = 162; 47.9%). Fewer AEs occurred after discharge (n = 28; 8.3%). Half of all AEs (n = 169; 50.0%) were severe, whereas 47.9% (n = 162) were preventable. CONCLUSIONS: AEs occur with similar frequency before and during hospitalization and may contribute more to hospital admissions than previously recognized. These findings suggest that efforts to improve patient safety should include outpatient settings in addition to the more commonly targeted acute care settings.


Assuntos
Hospitalização , Erros Médicos/estatística & dados numéricos , Estudos de Coortes , Infecção Hospitalar/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Feminino , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Complicações Pós-Operatórias/epidemiologia , Estados Unidos/epidemiologia , Ferimentos e Lesões/epidemiologia
13.
Infect Control Hosp Epidemiol ; 36(11): 1268-74, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26278419

RESUMO

OBJECTIVE: To determine whether use of contact precautions on hospital ward patients is associated with patient adverse events DESIGN: Individually matched prospective cohort study SETTING: The University of Maryland Medical Center, a tertiary care hospital in Baltimore, Maryland METHODS: A total of 296 medical or surgical inpatients admitted to non-intensive care unit hospital wards were enrolled at admission from January to November 2010. Patients on contact precautions were individually matched by hospital unit after an initial 3-day length of stay to patients not on contact precautions. Adverse events were detected by physician chart review and categorized as noninfectious, preventable and severe noninfectious, and infectious adverse events during the patient's stay using the standardized Institute for Healthcare Improvement's Global Trigger Tool. RESULTS: The cohort of 148 patients on contact precautions at admission was matched with a cohort of 148 patients not on contact precautions. Of the total 296 subjects, 104 (35.1%) experienced at least 1 adverse event during their hospital stay. Contact precautions were associated with fewer noninfectious adverse events (rate ratio [RtR], 0.70; 95% confidence interval [CI], 0.51-0.95; P=.02) and although not statistically significant, with fewer severe adverse events (RtR, 0.69; 95% CI, 0.46-1.03; P=.07). Preventable adverse events did not significantly differ between patients on contact precautions and patients not on contact precautions (RtR, 0.85; 95% CI, 0.59-1.24; P=.41). CONCLUSIONS: Hospital ward patients on contact precautions were less likely to experience noninfectious adverse events during their hospital stay than patients not on contact precautions.


Assuntos
Infecção Hospitalar/epidemiologia , Controle de Infecções/normas , Idoso , Baltimore , Infecção Hospitalar/prevenção & controle , Feminino , Unidades Hospitalares , Humanos , Pacientes Internados , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Centros de Atenção Terciária
14.
Am J Infect Control ; 43(2): 169-70, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25516218

RESUMO

Health care providers sometimes choose not to use face protection even when indicated as part of standard precautions. We performed a survey of pediatric health care providers to determine barriers to the routine use of face protection. Lack of availability at the point of care and a perceived lack of need were the most commonly cited issues. Continuing education is needed regarding situations in which face protection is indicated for standard precautions.


Assuntos
Fidelidade a Diretrizes , Pessoal de Saúde , Controle de Infecções/métodos , Máscaras/normas , Exposição Ocupacional/prevenção & controle , Conhecimentos, Atitudes e Prática em Saúde , Humanos
15.
Infect Control Hosp Epidemiol ; 34(10): 1087-93, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-24018926

RESUMO

OBJECTIVE: Contact precautions decrease healthcare worker-patient contact and may impact patient satisfaction. To determine the association between contact precautions and patient satisfaction, we used a standardized interview for perceived issues with care. DESIGN: Prospective cohort study of inpatients, evaluated at admission and on hospital days 3, 7, and 14 (until discharged). At each point, patients underwent a standardized interview to identify perceived problems with care. After discharge, the standardized interview and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey were administered by telephone. Responses were recorded, transcribed, and coded by 2 physician reviewers. PARTICIPANTS: A total of 528 medical or surgical patients not admitted to the intensive care unit. RESULTS: A total of 528 patients were included in the primary analysis, of whom 104 (20%) perceived some issue with their care. On multivariable logistic regression, contact precautions were independently associated with a greater number of perceived concerns with care (odds ratio, 2.05 [95% confidence interval, 1.31-3.21]; P < .01), including poor coordination of care (P = .02) and a lack of respect for patient needs and preferences (P = .001). Eighty-eight patients were included in the secondary analysis of HCAHPS. Patients under contact precautions did not have different HCAHPS scores than those not under contact precautions (odds ratio, 1.79 [95% confidence interval, 0.64-5.00]; P = .27). CONCLUSIONS: Patients under contact precautions were more likely to perceive problems with their care, especially poor coordination of care and a lack of respect for patient preferences.


Assuntos
Infecção Hospitalar/prevenção & controle , Controle de Infecções , Satisfação do Paciente , Qualidade da Assistência à Saúde , Adulto , Idoso , Feminino , Luvas Protetoras , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Planejamento de Assistência ao Paciente , Isolamento de Pacientes/psicologia , Percepção , Estudos Prospectivos
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