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1.
Pharmacoepidemiol Drug Saf ; 33(6): e5820, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38783407

RESUMEN

PURPOSE: Our objective is to describe how the U.S. Food and Drug Administration (FDA)'s Sentinel System implements best practices to ensure trust in drug safety studies using real-world data from disparate sources. METHODS: We present a stepwise schematic for Sentinel's data harmonization, data quality check, query design and implementation, and reporting practices, and describe approaches to enhancing the transparency, reproducibility, and replicability of studies at each step. CONCLUSIONS: Each Sentinel data partner converts its source data into the Sentinel Common Data Model. The transformed data undergoes rigorous quality checks before it can be used for Sentinel queries. The Sentinel Common Data Model framework, data transformation codes for several data sources, and data quality assurance packages are publicly available. Designed to run against the Sentinel Common Data Model, Sentinel's querying system comprises a suite of pre-tested, parametrizable computer programs that allow users to perform sophisticated descriptive and inferential analysis without having to exchange individual-level data across sites. Detailed documentation of capabilities of the programs as well as the codes and information required to execute them are publicly available on the Sentinel website. Sentinel also provides public trainings and online resources to facilitate use of its data model and querying system. Its study specifications conform to established reporting frameworks aimed at facilitating reproducibility and replicability of real-world data studies. Reports from Sentinel queries and associated design and analytic specifications are available for download on the Sentinel website. Sentinel is an example of how real-world data can be used to generate regulatory-grade evidence at scale using a transparent, reproducible, and replicable process.


Asunto(s)
Farmacoepidemiología , United States Food and Drug Administration , Farmacoepidemiología/métodos , Reproducibilidad de los Resultados , United States Food and Drug Administration/normas , Humanos , Estados Unidos , Exactitud de los Datos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Sistemas de Registro de Reacción Adversa a Medicamentos/normas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Bases de Datos Factuales/normas , Proyectos de Investigación/normas
2.
Pharmacoepidemiol Drug Saf ; 33(4): e5785, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38565526

RESUMEN

INTRODUCTION: During the COVID-19 pandemic, inpatient electronic health records (EHRs) have been used to conduct public health surveillance and assess treatments and outcomes. Invasive mechanical ventilation (MV) and supplemental oxygen (O2) use are markers of severe illness in hospitalized COVID-19 patients. In a large US system (n = 142 hospitals), we assessed documentation of MV and O2 use during COVID-19 hospitalization in administrative data versus nursing documentation. METHODS: We identified 319 553 adult hospitalizations with a COVID-19 diagnosis, February 2020-October 2022, and extracted coded, administrative data for MV or O2. Separately, we developed classification rules for MV or O2 supplementation from semi-structured nursing documentation. We assessed MV and O2 supplementation in administrative data versus nursing documentation and calculated ordinal endpoints of decreasing COVID-19 disease severity. Nursing documentation was considered the gold standard in sensitivity and positive predictive value (PPV) analyses. RESULTS: In nursing documentation, the prevalence of MV and O2 supplementation among COVID-19 hospitalizations was 14% and 75%, respectively. The sensitivity of administrative data was 83% for MV and 41% for O2, with both PPVs above 91%. Concordance between sources was 97% for MV (κ = 0.85), and 54% for O2 (κ = 0.21). For ordinal endpoints, administrative data accurately identified intensive care and MV but underestimated hospitalizations with O2 requirements (42% vs. 18%). CONCLUSIONS: In comparison to nursing documentation, administrative data under-ascertained O2 supplementation but accurately estimated severe endpoints such as MV. Nursing documentation improved ascertainment of O2 among COVID-19 hospitalizations and can capture oxygen requirements in adults hospitalized with COVID-19 or other respiratory illnesses.


Asunto(s)
COVID-19 , Adulto , Humanos , Estados Unidos/epidemiología , COVID-19/epidemiología , Registros Electrónicos de Salud , Pacientes Internos , Pandemias , Prueba de COVID-19 , Oxígeno
3.
PLoS One ; 18(7): e0288284, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37432951

RESUMEN

We described care received by hospitalized children with COVID-19 or multi-system inflammatory syndrome (MIS-C) prior to the 2021 COVID-19 Omicron variant surge in the US. We identified hospitalized children <18 years of age with a COVID-19 or MIS-C diagnosis (COVID-19 not required), separately, from February 2020-September 2021 (n = 126 hospitals). We described high-risk conditions, inpatient treatments, and complications among these groups. Among 383,083 pediatric hospitalizations, 2,186 had COVID-19 and 395 had MIS-C diagnosis. Less than 1% had both COVID-19 and MIS-C diagnosis (n = 154). Over half were >6 years old (54% COVID-19, 70% MIS-C). High-risk conditions included asthma (14% COVID-19, 11% MIS-C), and obesity (9% COVID-19, 10% MIS-C). Pulmonary complications in children with COVID-19 included viral pneumonia (24%) and acute respiratory failure (11%). In reference to children with COVID-19, those with MIS-C had more hematological disorders (62% vs 34%), sepsis (16% vs 6%), pericarditis (13% vs 2%), myocarditis (8% vs 1%). Few were ventilated or died, but some required oxygen support (38% COVID-19, 45% MIS-C) or intensive care (42% COVID-19, 69% MIS-C). Treatments included: methylprednisolone (34% COVID-19, 75% MIS-C), dexamethasone (25% COVID-19, 15% MIS-C), remdesivir (13% COVID-19, 5% MIS-C). Antibiotics (50% COVID-19, 68% MIS-C) and low-molecular weight heparin (17% COVID-19, 34% MIS-C) were frequently administered. Markers of illness severity among hospitalized children with COVID-19 prior to the 2021 Omicron surge are consistent with previous studies. We report important trends on treatments in hospitalized children with COVID-19 to improve the understanding of real-world treatment patterns in this population.


Asunto(s)
COVID-19 , Humanos , Estados Unidos/epidemiología , Niño , COVID-19/epidemiología , COVID-19/terapia , SARS-CoV-2 , Hospitales
4.
J Med Ethics ; 38(11): 672-6, 2012 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-22562947

RESUMEN

A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure. The model lends itself to a decision tree that can be adapted to the local context and resources so as to provide procedural guidance. This approach can help in planning and establishing organisational policies that govern the provision of ancillary care.


Asunto(s)
Ensayos Clínicos como Asunto/ética , Atención a la Salud/ética , Países en Desarrollo , Asignación de Recursos para la Atención de Salud/ética , Recursos en Salud , Accesibilidad a los Servicios de Salud/ética , Obligaciones Morales , Planificación de Atención al Paciente , Investigadores/ética , Relaciones Investigador-Sujeto/ética , Árboles de Decisión , Atención a la Salud/métodos , Atención a la Salud/normas , Ética en Investigación , Accesibilidad a los Servicios de Salud/economía , Accesibilidad a los Servicios de Salud/normas , Necesidades y Demandas de Servicios de Salud/economía , Necesidades y Demandas de Servicios de Salud/ética , Humanos , Planificación de Atención al Paciente/ética , Planificación de Atención al Paciente/normas , Sujetos de Investigación
5.
Handb Exp Pharmacol ; 205: 219-44, 2011.
Artículo en Inglés | MEDLINE | ID: mdl-21882114

RESUMEN

The critical need for pediatric research on drugs and biological products underscores the responsibility to ensure that children are enrolled in clinical research that is both scientifically necessary and ethically sound. In this chapter, we review key ethical considerations concerning the participation of children in clinical research. We propose a basic ethical framework to guide pediatric research, and suggest how this framework might be operationalized in linking science and ethics. Topics examined include: the status of children as a vulnerable population; the appropriate balance of risk and potential benefit in research; ethical considerations underlying study design, including clinical equipoise, placebo controls, and non-inferiority designs; the use of data monitoring committees; compensation; and parental permission and child assent to participate in research. We incorporate selected national (USA) and international guidelines, as well as regulatory approaches to pediatric studies that have been adopted in the USA, Canada, and Europe.


Asunto(s)
Ensayos Clínicos como Asunto/ética , Diseño de Investigaciones Epidemiológicas , Pediatría/ética , Algoritmos , Canadá , Comités de Monitoreo de Datos de Ensayos Clínicos/legislación & jurisprudencia , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Ensayos Clínicos como Asunto/normas , Ensayos Clínicos Fase I como Asunto/ética , Ensayos Clínicos Fase I como Asunto/normas , Compensación y Reparación/ética , Ensayos Clínicos Controlados como Asunto/ética , Ensayos Clínicos Controlados como Asunto/legislación & jurisprudencia , Ensayos Clínicos Controlados como Asunto/normas , Europa (Continente) , Humanos , Consentimiento Informado de Menores/legislación & jurisprudencia , Consentimiento Paterno/legislación & jurisprudencia , Placebos , Medición de Riesgo/métodos , Equipoise Terapéutico , Estados Unidos , United States Food and Drug Administration
6.
Diabetes Care ; 43(4): 785-792, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-32075848

RESUMEN

OBJECTIVE: To assess whether initiation of insulin glargine (glargine), compared with initiation of NPH or insulin detemir (detemir), was associated with an increased risk of breast cancer in women with diabetes. RESEARCH DESIGN AND METHODS: This was a retrospective new-user cohort study of female Medicare beneficiaries aged ≥65 years initiating glargine (203,159), detemir (67,012), or NPH (47,388) from September 2006 to September 2015, with follow-up through May 2017. Weighted Cox proportional hazards regression was used to estimate hazard ratios (HRs) and 95% CIs for incidence of breast cancer according to ever use, cumulative duration of use, cumulative dose of insulin, length of follow-up time, and a combination of dose and length of follow-up time. RESULTS: Ever use of glargine was not associated with an increased risk of breast cancer compared with NPH (HR 0.97; 95% CI 0.88-1.06) or detemir (HR 0.98; 95% CI 0.92-1.05). No increased risk was seen with glargine use compared with either NPH or detemir by duration of insulin use, length of follow-up, or cumulative dose of insulin. No increased risk of breast cancer was observed in medium- or high-dose glargine users compared with low-dose users. CONCLUSIONS: Overall, glargine use was not associated with an increased risk of breast cancer compared with NPH or detemir in female Medicare beneficiaries.


Asunto(s)
Neoplasias de la Mama/etiología , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Insulina Detemir/efectos adversos , Insulina Glargina/efectos adversos , Insulina Isófana/efectos adversos , Factores de Edad , Edad de Inicio , Anciano , Anciano de 80 o más Años , Neoplasias de la Mama/epidemiología , Estudios de Cohortes , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/epidemiología , Femenino , Humanos , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Incidencia , Insulina Detemir/administración & dosificación , Insulina Glargina/administración & dosificación , Insulina Isófana/administración & dosificación , Medicare/estadística & datos numéricos , Estudios Retrospectivos , Estados Unidos/epidemiología
7.
Lancet ; 372(9635): 300-13, 2008 Jul 26.
Artículo en Inglés | MEDLINE | ID: mdl-18657709

RESUMEN

BACKGROUND: UNICEF/WHO recommends that infants born to HIV-infected mothers who do not have access to acceptable, feasible, affordable, sustainable, and safe replacement feeding should be exclusively breastfed for at least 6 months. The aim of three trials in Ethiopia, India, and Uganda was to assess whether daily nevirapine given to breastfed infants through 6 weeks of age can decrease HIV transmission via breastfeeding. METHODS: HIV-infected women breastfeeding their infants were eligible for participation. Participants were randomly assigned to receive either single-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborns after birth) or 6 week extended-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborn babies after birth plus nevirapine 5 mg daily from days 8-42 for the infant). The randomisation sequences were generated by computer at a central data coordinating centre. The primary endpoint was HIV infection at 6 months of age in infants who were HIV PCR negative at birth. Analyses were by modified intention to treat, excluding infants with missing specimens and those with indeterminate or confirmed HIV infection at birth. These studies are registered with ClinicalTrials.gov, numbers NCT00074399, NCT00061321, and NCT00639938. FINDINGS: 2024 liveborn infants randomised in the study had at least one specimen tested before 6 months of age (1047 infants in the single-dose group and 977 infants in the extended-dose group). The modified intention-to-treat population included 986 infants in the single-dose group and 901 in the extended-dose group. At 6 months, 87 children in the single-dose group and 62 in the extended-dose group were infected with HIV (relative risk 0.80, 95% CI 0.58-1.10; p=0.16). At 6 weeks of age, 54 children in the single-dose group and 25 in the extended-dose group were HIV positive (0.54, 0.34-0.85; p=0.009). 393 infants in the single-dose group and 346 in the extended-dose group experienced grade 3 or 4 serious adverse events during the study (p=0.54). INTERPRETATION: Although a 6-week regimen of daily nevirapine might be associated with a reduction in the risk of HIV transmission at 6 weeks of age, the lack of a significant reduction in the primary endpoint-risk of HIV transmission at 6 months-suggests that a longer course of daily infant nevirapine to prevent HIV transmission via breast milk might be more effective where access to affordable and safe replacement feeding is not yet available and where the risks of replacement feeding are high. FUNDING: US National Institutes of Health; US National Institute of Allergy and Infectious Diseases; Fogarty International Center.


Asunto(s)
Fármacos Anti-VIH/uso terapéutico , Lactancia Materna/efectos adversos , Infecciones por VIH/prevención & control , Nevirapina/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Adulto , Fármacos Anti-VIH/administración & dosificación , Fármacos Anti-VIH/efectos adversos , Esquema de Medicación , Etiopía , Femenino , Infecciones por VIH/etiología , Humanos , India , Lactante , Recién Nacido , Masculino , Estudios Multicéntricos como Asunto , Nevirapina/administración & dosificación , Nevirapina/efectos adversos , Embarazo , Uganda
8.
Avian Dis ; 51(2): 573-7, 2007 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-17626486

RESUMEN

The New York 1999 strain of West Nile virus (WNV) is nearly 100% fatal in the American crow (Corvus brachyrhynchos). We evaluated four WNV vaccine formulations in American crows, including intramuscular (i.m.) DNA vaccine, i.m. DNA vaccine with adjuvant, orally administered microencapsulated DNA vaccine, and i.m. killed vaccine. Neutralizing antibodies developed in approximately 80% of crows that received the DNA vaccine i.m. (with or without adjuvant), and in 44% that received the killed vaccine. However, no crows that received the oral microencapsulated DNA vaccine or the placebo developed WNV antibodies. All crows were challenged 10 wk after initial vaccination. No unvaccinated crows survived challenge, and survival rates were 44% (i.m. DNA vaccine), 60% (i.m. DNA vaccine with adjuvant), 0% (oral microencapsulated DNA vaccine), and 11% (killed vaccine). Peak viremia titers in the birds that survived were significantly lower as compared to titers in birds that died. Parenteral administration of a WNV DNA vaccine was associated with reduced mortality but did not provide sterile immunity.


Asunto(s)
Enfermedades de las Aves/prevención & control , Enfermedades de las Aves/virología , Cuervos , Vacunas de ADN/inmunología , Fiebre del Nilo Occidental/veterinaria , Vacunas contra el Virus del Nilo Occidental/inmunología , Animales , Enfermedades de las Aves/inmunología , Enfermedades de las Aves/mortalidad , ADN Viral/inmunología , Fiebre del Nilo Occidental/inmunología , Fiebre del Nilo Occidental/mortalidad , Fiebre del Nilo Occidental/prevención & control
9.
Avian Dis ; 50(3): 454-5, 2006 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-17039850

RESUMEN

Transovarial antibody transfer in owls has not been demonstrated for West Nile virus (WNV). We sampled chicks from captive adult WNV-antibody-positive Eastern Screech-Owls (Megascops asio) to evaluate the prevalence of transovarial maternal antibody transfer, as well as titers and duration of maternal antibodies. Twenty-four owlets aged 1 to 27 days old circulated detectable antibodies with neutralizing antibody titers ranging from 20 to 1600 (median 1:40). Demonstrating that WNV antibodies are passively transferred transovarially is important for accurate interpretation of serologic data from young birds.


Asunto(s)
Anticuerpos Antivirales/sangre , Enfermedades de las Aves/inmunología , Inmunidad Materno-Adquirida , Estrigiformes/inmunología , Virus del Nilo Occidental/inmunología , Animales , Enfermedades de las Aves/virología , Femenino , Masculino , Fiebre del Nilo Occidental/inmunología , Fiebre del Nilo Occidental/veterinaria
10.
J Vet Intern Med ; 16(5): 565-9, 2002.
Artículo en Inglés | MEDLINE | ID: mdl-12322707

RESUMEN

Endostatin prevents angiogenesis and tumor growth by inhibiting endothelial cell proliferation and migration. The purpose of this study was to determine serum endostatin concentrations in 53 healthy dogs and in 38 dogs with confirmed malignant neoplasms. Endostatin concentration was determined with a competitive enzymatic immunoassay (EIA) with rabbit polyclonal antibody generated against a recombinant canine endostatin protein. Both the presence of cancer and increasing age were associated with increased serum concentration of endostatin. Endostatin concentration in healthy dogs was 87.7 +/- 3.5 ng/mL. Upper and lower limits of the reference range for serum endostatin concentration in healthy dogs were 60 and 113 ng/mL. Dogs with lymphoma (LSA) and hemangiosarcoma (HSA) had endostatin concentrations of 107 +/- 9.3 ng/mL. In conclusion, this study demonstrates that endostatin can be quantified in dogs and that endostatin concentrations are high in dogs with HSA and LSA.


Asunto(s)
Colágeno/sangre , Enfermedades de los Perros/sangre , Perros/sangre , Neoplasias/sangre , Neoplasias/veterinaria , Fragmentos de Péptidos/sangre , Envejecimiento , Animales , Endostatinas , Femenino , Salud , Hemangiosarcoma/sangre , Hemangiosarcoma/veterinaria , Linfoma/sangre , Linfoma/veterinaria , Masculino
11.
Contraception ; 84(5): 512-9, 2011 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-22018127

RESUMEN

BACKGROUND: The effect of combined oral contraceptives (COCs) and depot-medroxyprogesterone acetate (DMPA) on the area of cervical ectopy is not well understood. STUDY DESIGN: From 1996 to 1999, we recruited women not using hormonal contraception from two family planning centers in Baltimore, MD. Upon study entry and 3, 6 and 12 months after the initial visit, participants were interviewed and received visual cervical examinations with photography. Ectopy was measured from digitized photographs and was analyzed both continuously and categorically (small [≤0.48 cm(2)] vs. large [>0.48 cm(2)]). RESULTS: Of 1003 enrolled women, 802 returned for at least one follow-up visit. At 12 months, the numbers of women using COCs, DMPA or no hormonal method at least 50% of the time since the prior visit were 230, 76 and 229, respectively. After multivariable adjustment, COC use (vs. no hormonal use) was associated with large area of ectopy (odds ratio [OR]: 1.8, 95% confidence interval [CI]: 1.0-3.3). No significant relationship was observed between DMPA and large area of ectopy (OR: 0.5, 95% CI: 0.2-1.3). The incidence of large area of ectopy by contraceptive exposure (COC, DMPA or no hormonal method) was 17.4 (CI: 11.8-24.6), 10.9 (CI: 4.4-22.4) and 4.6 (CI: 2.2-8.4) per 100 woman-years, respectively. CONCLUSIONS: Use of COCs, but not DMPA, was associated with large area of cervical ectopy. Area of ectopy at baseline was the strongest predictor of area of ectopy at follow-up.


Asunto(s)
Anticonceptivos Femeninos/administración & dosificación , Anticonceptivos Orales Combinados/administración & dosificación , Acetato de Medroxiprogesterona/administración & dosificación , Displasia del Cuello del Útero/epidemiología , Adolescente , Adulto , Baltimore/epidemiología , Estudios de Cohortes , Femenino , Humanos , Estudios Longitudinales , Estudios Prospectivos , Displasia del Cuello del Útero/etiología , Displasia del Cuello del Útero/prevención & control , Adulto Joven
12.
Sex Transm Dis ; 31(9): 561-7, 2004 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-15480119

RESUMEN

BACKGROUND AND OBJECTIVES: Several previous studies have suggested that hormonal contraception could be associated with increased risk of cervical infections. However, few high-quality prospective studies have examined this relationship. GOAL: The goal of this study was to measure the effect of oral contraceptives (OC) and depot-medroxyprogesterone acetate (DMPA) on the acquisition of cervical chlamydial and gonococcal infections. STUDY: Women attending 2 reproductive health centers in Baltimore, MD, were enrolled into a prospective cohort study. Participants were 15 to 45 years and were initiating OCs or DMPA or not using hormonal contraception. Interviews, physical examinations, and testing for incident cervical infections were conducted at 3, 6, and 12 months. RESULTS: The analysis included 819 women. Most were single (77%) and nulliparous (75%); 43% were black. Median age was 22 years. During the study, 45 women acquired a chlamydial or gonococcal infection (6.2 per 100 women-years). DMPA use (hazard ratio [HR], 3.6; 95% confidence interval [CI], 1.6-8.5), but not OC use (HR, 1.5; 95% CI, 0.6-3.5), was significantly associated with increased acquisition of cervical infections after adjusting for other risk factors. Cervical ectopy was not an important mediator of cervical infection risk. CONCLUSIONS: DMPA use, but not OC use, appeared to be significantly associated with increased acquisition of cervical chlamydial and gonococcal infections.


Asunto(s)
Anticoncepción/estadística & datos numéricos , Anticonceptivos Hormonales Orales/uso terapéutico , Enfermedades de Transmisión Sexual/epidemiología , Enfermedades del Cuello del Útero/epidemiología , Administración Oral , Adolescente , Adulto , Baltimore/epidemiología , Cuello del Útero/patología , Estudios de Cohortes , Anticonceptivos Hormonales Orales/administración & dosificación , Preparaciones de Acción Retardada , Femenino , Humanos , Acetato de Medroxiprogesterona/administración & dosificación , Acetato de Medroxiprogesterona/uso terapéutico , Estudios Prospectivos , Factores de Riesgo , Enfermedades de Transmisión Sexual/etiología , Enfermedades de Transmisión Sexual/prevención & control , Enfermedades del Cuello del Útero/etiología , Enfermedades del Cuello del Útero/prevención & control
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