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Abstract Introduction Modern medicine offers a wide spectrum of different hearing devices, and bone conduction implants can be found among them. Objective The presentation of the outcomes of the implantation of a new active bone conduction hearing implant - the Osia®, and its comparison with the well-known passive transcutaneous system - the Baha® Attract. Methods Eight adult patients with bilateral mixed hearing loss were randomly divided into two groups. Group 1 was implanted with the Osia®, and group 2 was implanted with the Baha® Attract. The details of the surgery were analyzed, along with the functional and audiological results. Results In all the cases, the surgery was successful, and the healing uneventful. In both groups, it was observed that pure tone audiometry and speech audiometry in free field improved significantly after the implantation (mean gain in pure tone audiometry for the Osia group 42.8 dB SPL and for the Baha group 38.8 dB SPL). In the Osia group, the results after the surgery were much better than with the Baha® 5 Power processor on the Softband. The patients implanted with the Osia® evaluated the quality of their hearing as being superior to those implanted with the Baha® Attract. There was an evident improvement in the abbreviated profile of hearing aid benefit questionnaire and in the speech, spatial and qualities of hearing scale for both systems. In the abbreviated profile of hearing aid benefit, changes were more evident in the Osia group (in global score 49% vs. 37.2%). Conclusion Implantation of the Osia® is an effective treatment option for the patients with bilateral mixed hearing loss. The surgery is safe but more complex and time-consuming than the Baha® Attract implantation. The preliminary audiological results as well as the overall quality of life indicate that the Osia® is a better solution than the Baha® Attract. However, future studies should be carried out to make further observations in a larger group of patients, and with longer follow-up.
Resumo Introdução A medicina moderna oferece um amplo espectro de diferentes aparelhos auditivos, e implantes de condução óssea estão entre eles. Objetivo Apresentação dos resultados do uso de um novo implante auditivo de condução óssea ativa - o Osia® e sua comparação com o conhecido sistema transcutâneo passivo - o sistema Baha® Attract. Método Oito pacientes adultos com perda auditiva mista bilateral foram divididos aleatoriamente em dois grupos. O grupo 1 foi implantado com o Osia® e o grupo 2 foi implantado com o sistema Baha® Attract. Os detalhes da cirurgia foram analisados, juntamente com os resultados funcionais e audiológicos. Resultados Em todos os casos, a cirurgia foi bem-sucedida e a cicatrização ocorreu sem intercorrências. Nos dois grupos, observou-se que a audiometria de tons puros e a audiometria de fala em campo livre melhoraram significativamente após o implante (ganho médio na audiometria para tons puros para o grupo Osia® de 42,8 dB NPS e para o grupo Baha®, 38,8 dB NPS). No grupo Osia®, os resultados após a cirurgia foram muito melhores do que com o processador Baha® 5 Power no sistema SoftBand. Os pacientes implantados com o Osia® avaliaram melhor a qualidade de sua audição do que os implantados com o sistema Baha® Attract. Houve uma melhoria evidente no questionário abbreviated profile of hearing aid benefit e na escala speech, spatial and qualities of hearing, para ambos os sistemas. No questionario abbreviated profile of hearing aid benefit, as mudanças foram mais evidentes no grupo Osia® (escore global 49% vs. 37,2%). Conclusão O sistema Osia® é uma opção de tratamento eficaz para pacientes com perda auditiva mista bilateral. A cirurgia é segura, mas mais complexa e demorada que a implantação do sistema Baha® Attract. Os resultados audiológicos preliminares, bem como aqueles avaliando a qualidade de vida, indicam que o Osia® é uma alternativa melhor que o Baha® Attract. Entretanto, mais observações são necessárias em grupos maiores de pacientes e com tempo de seguimento mais longo.
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We report Zika virus (ZIKV) vertical transmission in 130 infants born to PCR+ mothers at the time of the Rio de Janeiro epidemic of 2015-2016. Serum and urine collected from birth through the first year of life were tested by quantitative reverse transcriptase polymerase chain reaction (PCR) and/or IgM Zika MAC-ELISA. Four hundred and seven specimens are evaluated; 161 sera tested by PCR and IgM assays, 85 urines by PCR. Sixty-five percent of children (N = 84) are positive in at least one assay. Of 94 children tested within 3 months of age, 70% are positive. Positivity declines to 33% after 3 months. Five children are PCR+ beyond 200 days of life. Concordance between IgM and PCR results is 52%, sensitivity 65%, specificity 40% (positive PCR results as gold standard). IgM and serum PCR are 61% concordant; serum and urine PCR 55%. Most children (65%) are clinically normal. Equal numbers of children with abnormal findings (29 of 45, 64%) and normal findings (55 of 85, 65%) have positive results, p = 0.98. Earlier maternal trimester of infection is associated with positive results (p = 0.04) but not clinical disease (p = 0.98). ZIKV vertical transmission is frequent but laboratory confirmed infection is not necessarily associated with infant abnormalities.
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Doenças Transmissíveis/transmissão , Doenças Transmissíveis/virologia , Infecção por Zika virus/transmissão , Infecção por Zika virus/virologia , Zika virus/patogenicidade , Feminino , Humanos , Imunoglobulina M/metabolismo , Reação em Cadeia da Polimerase , Gravidez , Viroses/virologiaRESUMO
BACKGROUND: Zika-exposed infants with microcephaly (proportional or disproportional) and those who are small for gestational age without microcephaly should be closely followed, particularly their growth trajectories. They are at high risk of adverse outcomes in the first year of life.Antenatal Zika virus (ZIKV) exposure may lead to adverse infant outcomes including microcephaly and being small for gestational age (SGA). ZIKV-exposed infants with a diagnosis of microcephaly (proportional [PM] or disproportional [DM]) or SGA at birth were evaluated with anthropometric measurements and health outcomes. METHODS: Infants had laboratory-confirmed ZIKV exposure in Brazil. PM, DM, or SGA classification was based on head circumference and weight. First-year growth parameters and clinical outcomes were recorded with analyses performed. RESULTS: Among the 156 ZIKV-exposed infants, 14 (9.0%) were SGA, 13 (8.3%) PM, 13 (8.3%) DM, and 116 (74.4%) were neither SGA nor had microcephaly (NSNM). High rates of any neurologic, ophthalmologic, and hearing abnormalities were observed for PM (100%), DM (100%), and SGA (42.9%) vs NSNM infants (18.3%; P <.001); odds ratio [OR], 3.4 (95% confidence interval [CI], 1.1-10.7) for SGA vs NSNM. Neuroimaging abnormalities were seen in 100% of PM and DM and in 42.9% of SGA vs NSNM infants 16%; (P <.001); OR 3.9 (95% CI, 1.2-12.8) for SGA vs NSNM. Growth rates by z score, particularly for microcephaly infants, were poor after birth but showed improvement beyond 4 months of life. CONCLUSIONS: ZIKV-exposed infants with microcephaly (PM and DM) had similarly high rates of adverse outcomes but showed improvement in growth measurements beyond 4 months of life. While SGA infants had fewer adverse outcomes compared with microcephaly infants, notable adverse outcomes were observed in some; their odds of having adverse outcomes were 3 to 4 times greater compared to NSNM infants.Zika-exposed infants with microcephaly, irrespective of being proportional or disproportional, and those who are small for gestational age without microcephaly should be closely followed, particularly their growth trajectories. They are at high risk of adverse outcomes in the first year of life.
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Microcefalia , Complicações Infecciosas na Gravidez , Infecção por Zika virus , Zika virus , Brasil/epidemiologia , Feminino , Idade Gestacional , Humanos , Lactente , Microcefalia/epidemiologia , Gravidez , Complicações Infecciosas na Gravidez/epidemiologia , Infecção por Zika virus/complicações , Infecção por Zika virus/epidemiologiaRESUMO
Abstract Introduction: Bone-anchored hearing aids are currently well-established solutions for treatment of hearing-impaired patients. Objective: To evaluate the surgery of the Baha® Attract system, healing process and soft tissue condition after the processor activation. Methods: 125 patients implanted with the Baha® Attract system during a 3 year period in a single ENT department were analysed. Evaluated parameters comprised: details of surgery, healing process and soft tissue condition at the time of the processor activation and on subsequent follow-up visits. Results: The implantation was conducted under local anaesthesia in 96% of patients. The mean surgery time was 42 min. Soft tissue reduction was performed in 43.2% of cases; bone polishing in 23.2% and bipolar coagulation in all the cases. Healing was uneventful in 92.8%. 10 days after the surgery, pain was reported in 48% of cases. On subsequent follow-up visits, 1 month and 3 months after the surgery, pain was present in 18.4% and 2.4% of cases respectively. Similarly, numbness and paresthesia, initially reported in 84% and 15.2%, were present in 60% and 11.2% after a month, and in 17.6% and 1.6% after three months. After the processor attachment, no serious problems were observed in the analysed group during follow-up visits. However, mild redness and/or mild pain over the magnet were observed in 9.6% of patients. Conclusion: Implantation of the Baha® Attract system is an easy and safe procedure. It can be performed under local anaesthesia in adults. There are no major surgical problems or complications, and the healing process proceeds efficiently in most patients. Postoperative pain is usually mild and gradually decreases in the following months. Numbness in the operated area is frequent, but as reinnervation occurs in time, the numb patch decreases in size and finally completely disappears in most cases.
Resumo Introdução: Os processadores de implantes auditivos de ancoragem óssea são atualmente soluções bem estabelecidas para o tratamento de pacientes com deficiência auditiva. Objetivo: Avaliar a cirurgia de implante do sistema Baha® Attract, o processo de cicatrização e a condição dos tecidos moles após a ativação do processador. Método: Foram analisados 125 pacientes implantados com o sistema Baha® Attract durante um período de 3 anos em um único departamento de otorrinolaringologia. Os parâmetros avaliados compreenderam: detalhes da cirurgia, processo de cicatrização e condição dos tecidos moles no momento da ativação do processador e nas consultas de seguimento subsequentes. Resultados: O implante foi realizado sob anestesia local em 96% dos pacientes. O tempo médio de cirurgia foi de 42 minutos. A redução de tecido mole foi realizada em 43,2% dos casos; polimento ósseo em 23,2% e coagulação bipolar em todos os casos. A cicatrização transcorreu sem complicações em 92,8%. Dez dias após a cirurgia, dor foi relatada em 48% dos casos. Nas consultas de seguimento subsequentes, 1 mês e 3 meses após a cirurgia, a dor esteve presente em 18,4% e 2,4% dos casos, respectivamente. Da mesma forma, dormência e parestesia, inicialmente relatados em 84% e 15,2%, estavam presentes em 60% e 11,2% dos casos após um mês, e em 17,6% e 1,6% após três meses. Após a fixação do processador, nenhum problema grave foi observado no grupo analisado durante as consultas de seguimento. No entanto, vermelhidão leve e/ou dor leve sobre o ímã foram observados em 9,6% dos pacientes. Conclusão: O implante do sistema Baha® Attract é um procedimento fácil e seguro. Ele pode ser realizado sob anestesia local em adultos. Não há grandes problemas ou complicações cirúrgicas, e o processo de cicatrização é contínuo e eficaz na maioria dos pacientes. No pós-operatório, a dor é geralmente leve e diminui gradualmente nos meses seguintes. A dormência na área operada é freqüente, mas como a reinervação ocorre com o tempo, a área dormente diminui de tamanho e finalmente desaparece por completo na maioria dos casos.
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Humanos , Masculino , Feminino , Criança , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Adulto Jovem , Implante Coclear/métodos , Perda Auditiva/cirurgia , Condução Óssea/fisiologia , Resultado do Tratamento , Auxiliares de AudiçãoRESUMO
Importance: Congenital Zika virus (ZIKV) infection may present with a spectrum of clinical and neuroradiographic findings. Objective: To determine whether neuroimaging findings for infants with a history of ZIKV exposure are associated with infant clinical outcomes and gestational age at antenatal ZIKV infection. Design, Setting, and Participants: This cohort study retrospectively reviewed neuroimaging results (computed tomography and/or magnetic resonance imaging scans) of 110 ZIKV-exposed infants from a maternity and children's hospital in Rio de Janeiro, Brazil, following the 2015 to 2016 ZIKV epidemic. Neuroimaging from March 1, 2016, to June 30, 2017, was evaluated to determine whether findings were associated with clinical outcomes and the timing of maternal ZIKV infection. Data were analyzed from July 1, 2017, to August 30, 2018. Exposures: Neuroimaging (computed tomography and/or magnetic resonance imaging) was performed on ZIKV-exposed infants after birth. Blood and/or urine specimens from mothers and infants were tested for ZIKV by polymerase chain reaction assay. Main Outcomes and Measures: Neuroimaging studies were evaluated for structural abnormalities and other forms of brain injury. Results: A total of 110 infants with a mean (SD) gestational age of 38.4 (2.1) weeks had neuroimaging and clinical outcome data reviewed. Of these, 71 (65%) had abnormal neuroimaging findings, with the majority (96%) classified as having severe ZIKV infection at birth. The most common neuroimaging abnormalities were structural abnormalities including brain calcifications, especially at the cortico-subcortical white matter junction, cortex malformations, ventriculomegaly, and reduced brain volumes, followed by brainstem hypoplasia, cerebellar hypoplasia, and corpus callosum abnormalities. Frequency of abnormal imaging was higher in infants with specific clinical findings as opposed to those without them; these findings included fetal brain disruption sequence (100% vs 35%), microcephaly (100% vs 30%), congenital contractures (100% vs 58%), ophthalmologic abnormalities (95% vs 44%), hearing abnormalities (100% vs 58%), and neurologic symptoms (94% vs 10%). Four of 39 infants (10%) without initial evidence of severe ZIKV infection and normal findings on neurologic evaluation at birth had abnormal neuroimaging findings. Neuroimaging abnormalities differed by trimester of maternal ZIKV infection, with 63% of infants born to mothers infected in the first trimester, 13% of infants born to mothers infected in the second trimester, and 1% of infants born to mothers infected in the third trimester exhibiting neuroimaging abnormalities. The odds of abnormal neuroimaging were 7.9 times greater for infants with first trimester ZIKV exposure compared with other trimesters combined (odds ratio, 7.9; 95% CI, 3.0-20.4; P < .001). Conclusions and Relevance: Neuroimaging abnormalities of computed tomography and/or magnetic resonance imaging scans were common in ZIKV-exposed infants. While neuroimaging abnormalities were seen in 10% of infants without clinically severe ZIKV, most occurred almost exclusively among those with clinically severe ZIKV, especially among those with a history of ZIKV exposure in the first trimester.
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Encéfalo/anormalidades , Exposição Materna/efeitos adversos , Neuroimagem/métodos , Complicações Infecciosas na Gravidez/virologia , Infecção por Zika virus/diagnóstico por imagem , Zika virus , Encéfalo/diagnóstico por imagem , Encéfalo/virologia , Brasil , Feminino , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Imageamento por Ressonância Magnética/métodos , Masculino , Gravidez , Estudos Retrospectivos , Tomografia Computadorizada por Raios X/métodos , Infecção por Zika virus/congênito , Infecção por Zika virus/virologiaRESUMO
There are limited data on amniocentesis as a diagnostic tool for congenital Zika syndrome. Here we report on a prospective cohort of 16 women with suspected Zika virus infection in a highly endemic area, and discuss the role of amniocentesis in the prenatal diagnosis of fetal Zika infection.
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Amniocentese , Doenças Fetais/diagnóstico , Complicações Infecciosas na Gravidez/diagnóstico , Infecção por Zika virus/congênito , Infecção por Zika virus/diagnóstico , Feminino , Humanos , Transmissão Vertical de Doenças Infecciosas , Gravidez , Estudos ProspectivosAssuntos
Encéfalo/diagnóstico por imagem , Desenvolvimento Infantil , Infecção por Zika virus , Brasil , Linguagem Infantil , Cognição , Deficiências do Desenvolvimento/virologia , Feminino , Humanos , Lactente , Estudos Longitudinais , Neuroimagem , Testes Neuropsicológicos , Gravidez , Complicações Infecciosas na Gravidez , Zika virus , Infecção por Zika virus/congênitoRESUMO
PURPOSE: To report the findings of a cross-sectional study of visual function in infants with confirmed or suspected antenatal Zika virus (ZIKV) infection seen at a single referral center in Rio de Janeiro. METHODS: Infants were examined following the ZIKV outbreak period at Instituto Fernandes Figueira/FIOCRUZ. Visual function was considered abnormal if an infant could not fix and follow a standardized high-contrast target (10 cm) by 3-6 months of age. Visual function and associations with structural eye abnormalities, central nervous system (CNS) abnormalities, microcephaly, and nystagmus were assessed. Sensitivity and specificity of screening criteria for structural eye abnormalities was assessed. RESULTS: A total of 173 infants met inclusion criteria. Abnormal visual function was found in 52 infants (30.0%) and was significantly associated with eye abnormalities (40/52; OR = 44.2; 95% CI, 16.6-117.6), CNS abnormalities (50/52; OR = 64.0; 95% CI, 14.7-277.6), microcephaly (44/52; OR = 31.5; 95% CI, 12.7-77.8), and nystagmus (26/52; OR = 120.0; 95% CI, 15.6-924.5). Using microcephaly as screening criteria for the detection of eye abnormalities provided a sensitivity of 88.9% (95% CI, 76.0-96.3) and specificity of 82.8% (95% CI, 75.1-88.9). Using both abnormal visual function and microcephaly increased sensitivity to 100% (95% CI, 92.1-100.0) and decreased specificity to 80.5% (95% CI, 72.5-86.9). CONCLUSIONS: Infants with suspected antenatal ZIKV infection and reduced visual function should be referred to an ophthalmologist. Visual function assessments are helpful in screening for antenatal ZIKV exposure in resource-limited settings and can identify infants who may benefit from visual habilitation.
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DNA Viral/análise , Anormalidades do Olho/fisiopatologia , Complicações Infecciosas na Gravidez/epidemiologia , Efeitos Tardios da Exposição Pré-Natal/fisiopatologia , Acuidade Visual/fisiologia , Infecção por Zika virus/complicações , Zika virus/genética , Brasil/epidemiologia , Estudos Transversais , Anormalidades do Olho/epidemiologia , Anormalidades do Olho/etiologia , Feminino , Seguimentos , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Gravidez , Complicações Infecciosas na Gravidez/fisiopatologia , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Estudos Retrospectivos , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Infecção por Zika virus/epidemiologia , Infecção por Zika virus/virologiaRESUMO
: media-1vid110.1542/5804915134001PEDS-VA_2018-1104Video Abstract OBJECTIVES: To characterize ophthalmic manifestations of confirmed or suspected antenatal Zika virus (ZIKV) exposure. METHODS: Infants with antenatal ZIKV exposure were referred for evaluation during the 2015-2016 Rio de Janeiro outbreak. Mothers with symptomatic ZIKV infection during pregnancy and/or infants with microcephaly or other findings that were suggestive of suspected antenatal exposure were tested with reverse transcriptase polymerase chain reaction (RT-PCR). Complete eye examinations were performed by pediatric ophthalmologists between January 2016 and February 2017. The main outcome measure was eye abnormalities in RT-PCR-positive and suspected (ie, not tested or RT-PCR-negative) antenatal ZIKV cases. RESULTS: Of 224 infants, 189 had RT-PCR testing performed. Of 189 patients, 156 had positive RT-PCR results in their blood, urine, and/or placenta. Of 224 infants, 90 had central nervous system (CNS) abnormalities, including microcephaly (62 infants). Eye abnormalities were present in 57 of 224 (25.4%) infants. Optic nerve (44 of 57; 77.2%) and retina abnormalities (37 of 57; 64.9%) were the most common. The group with suspected ZIKV infection (68 infants) had proportionally more eye (36.8% vs 20.5%; P = .022) and CNS abnormalities (68.3% vs 28.1%; P = .008), likely because of referral patterns. Eye abnormalities consistent with ZIKV infection were clinically comparable in both RT-PCR-positive and unconfirmed groups, including 4 RT-PCR-positive infants of 5 without any CNS abnormalities. CONCLUSIONS: Similar eye manifestations were identified regardless of laboratory confirmation. Well-appearing infants were also found to have eye abnormalities. Therefore, all infants born after ZIKV outbreaks should be universally screened for eye abnormalities.
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Surtos de Doenças , Anormalidades do Olho/diagnóstico , Complicações Infecciosas na Gravidez/diagnóstico , Efeitos Tardios da Exposição Pré-Natal/diagnóstico , Infecção por Zika virus/diagnóstico , Zika virus , Brasil/epidemiologia , Estudos de Coortes , Anormalidades do Olho/epidemiologia , Anormalidades do Olho/virologia , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Gravidez , Complicações Infecciosas na Gravidez/epidemiologia , Complicações Infecciosas na Gravidez/virologia , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Estudos Prospectivos , Zika virus/isolamento & purificação , Infecção por Zika virus/epidemiologiaRESUMO
Importance: Congenital Zika virus infection causes a spectrum of adverse birth outcomes, including severe birth defects of the central nervous system. The association of prenatal ultrasonographic findings with adverse neonatal outcomes, beyond structural anomalies such as microcephaly, has not been described to date. Objective: To determine whether prenatal ultrasonographic examination results are associated with abnormal neonatal outcomes in Zika virus-affected pregnancies. Design, Setting, and Participants: A prospective cohort study conducted at a single regional referral center in Rio de Janeiro, Brazil, from September 1, 2015, to May 31, 2016, among 92 pregnant women diagnosed during pregnancy with Zika virus infection by reverse-transcription polymerase chain reaction, who underwent subsequent prenatal ultrasonographic and neonatal evaluation. Exposures: Prenatal ultrasonography. Main Outcomes and Measures: The primary outcome measure was composite adverse neonatal outcome (perinatal death, abnormal finding on neonatal examination, or abnormal finding on postnatal neuroimaging). Secondary outcomes include association of specific findings with neonatal outcomes. Results: Of 92 mother-neonate dyads (mean [SD] maternal age, 29.4 [6.3] years), 55 (60%) had normal results and 37 (40%) had abnormal results on prenatal ultrasonographic examinations. The median gestational age at delivery was 38.6 weeks (interquartile range, 37.9-39.3). Of the 45 neonates with composite adverse outcome, 23 (51%) had normal results on prenatal ultrasonography. Eleven pregnant women (12%) had a Zika virus-associated finding that was associated with an abnormal result on neonatal examination (adjusted odds ratio [aOR], 11.6; 95% CI, 1.8-72.8), abnormal result on postnatal neuroimaging (aOR, 6.7; 95% CI, 1.1-38.9), and composite adverse neonatal outcome (aOR, 27.2; 95% CI, 2.5-296.6). Abnormal results on middle cerebral artery Doppler ultrasonography were associated with neonatal examination abnormalities (aOR, 12.8; 95% CI, 2.6-63.2), postnatal neuroimaging abnormalities (aOR, 8.8; 95% CI, 1.7-45.9), and composite adverse neonatal outcome (aOR, 20.5; 95% CI, 3.2-132.6). There were 2 perinatal deaths. Abnormal findings on prenatal ultrasonography had a sensitivity of 48.9% (95% CI, 33.7%-64.2%) and a specificity of 68.1% (95% CI, 52.9%-80.1%) for association with composite adverse neonatal outcomes. For a Zika virus-associated abnormal result on prenatal ultrasonography, the sensitivity was lower (22.2%; 95% CI, 11.2%-37.1%) but the specificity was higher (97.9%; 95% CI, 88.7%-99.9%). Conclusions and Relevance: Abnormal results on prenatal ultrasonography were associated with adverse outcomes in congenital Zika infection. The absence of abnormal findings on prenatal ultrasonography was not associated with a normal neonatal outcome. Comprehensive evaluation is recommended for all neonates with prenatal Zika virus exposure.
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Anormalidades Congênitas , Complicações Infecciosas na Gravidez , Resultado da Gravidez/epidemiologia , Ultrassonografia Pré-Natal/estatística & dados numéricos , Infecção por Zika virus , Adulto , Brasil/epidemiologia , Anormalidades Congênitas/diagnóstico por imagem , Anormalidades Congênitas/epidemiologia , Anormalidades Congênitas/virologia , Feminino , Humanos , Recém-Nascido , Masculino , Neuroimagem , Gravidez , Complicações Infecciosas na Gravidez/diagnóstico por imagem , Complicações Infecciosas na Gravidez/epidemiologia , Complicações Infecciosas na Gravidez/virologia , Estudos Prospectivos , Adulto Jovem , Infecção por Zika virus/complicações , Infecção por Zika virus/diagnóstico por imagem , Infecção por Zika virus/epidemiologia , Infecção por Zika virus/virologiaRESUMO
BACKGROUND: Congenital Zika virus (ZIKV) syndrome is a newly identified condition resulting from infection during pregnancy. We analyzed outcome data from a mother-infant cohort in Rio de Janeiro in order to assess whether clinical severity of maternal ZIKV infection was associated with maternal virus load, prior dengue antibodies, or abnormal pregnancy/infant outcomes. METHODS: A clinical severity assessment tool was developed based on duration of fever, severity of rash, multisystem involvement, and duration of symptoms during ZIKV infection. ZIKV-RNA load was quantified by polymerase chain reaction (PCR) cycles in blood/ urine. Dengue immunoglobulin G (IgG) antibodies were measured at baseline. Adverse outcomes were defined as fetal loss or a live infant with grossly abnormal clinical or brain imaging findings. Regression models were used to study potential associations. RESULTS: 131 ZIKV-PCR positive pregnant women were scored for clinical disease severity, 6 (4.6%) had mild disease, 98 (74.8%) had moderate disease, and 27 (20.6%) severe manifestations of ZIKV infection. There were 58 (46.4%) abnormal outcomes with 9 fetal losses (7.2%) in 125 pregnancies. No associations were found between: disease severity and abnormal outcomes (P = .961; odds ratio [OR]: 1.00; 95% confidence interval [CI]: 0.796-1.270); disease severity and viral load (P = .994); viral load and adverse outcomes (P = .667; OR: 1.02; 95% CI: 0.922-1.135); or existence of prior dengue antibodies (88% subjects) with severity score, ZIKV-RNA load or adverse outcomes (P = .667; OR: 0.78; 95% CI: 0.255-2.397). CONCLUSIONS: Congenital ZIKV syndrome does not appear to be associated with maternal disease severity, ZIKV-RNA load at time of infection or existence of prior dengue antibodies.
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Morte Fetal , Doenças do Sistema Nervoso/epidemiologia , Malformações do Sistema Nervoso/epidemiologia , Complicações Infecciosas na Gravidez/sangue , Infecção por Zika virus/sangue , Infecção por Zika virus/complicações , Adolescente , Adulto , Anticorpos Antivirais/sangue , Encéfalo/anormalidades , Encéfalo/diagnóstico por imagem , Brasil/epidemiologia , Vírus da Dengue/imunologia , Feminino , Humanos , Nascido Vivo/epidemiologia , Pessoa de Meia-Idade , Doenças do Sistema Nervoso/congênito , Doenças do Sistema Nervoso/diagnóstico , Doenças do Sistema Nervoso/fisiopatologia , Malformações do Sistema Nervoso/diagnóstico , Neuroimagem , Exame Neurológico , Gravidez , Complicações Infecciosas na Gravidez/virologia , Estudos Prospectivos , RNA Viral/sangue , Índice de Gravidade de Doença , Carga Viral , Adulto Jovem , Zika virus/genéticaRESUMO
OBJETIVO: Comparação retrospectiva das dificuldades do tratamento e de seus resultados em lesões na articulação de Lisfranc com diagnóstico tardio e precoce.MÉTODOS: O grupo de estudo consistiu em 10 pacientes diagnosticados e tratados adequadamente em seis meses a 20 anos do acidente que causou a lesão (média de seis anos). O grupo de controle foi composto por igual número de pacientes selecionados randomicamente, com o mesmo tipo de lesão tratada de imediato e após o acidente. A média de acompanhamento foi de 13 anos no grupo de estudo e oito anos no grupo de controle. A análise avaliou as causas do atraso e a função do pé no momento do acompanhamento, medidos pela escala AOFAS para o mediopé e pelo escore funcional do pé de Lublin. Os escores dos pacientes foram analisados utilizando o teste não-paramétrico de Mann-Whitney U e o teste não-paramétrico de Wilcoxon.RESULTADOS: O grupo de controle apresentou resultados melhores com significância estatística em ambas as escalas.CONCLUSÃO: A principal causa de atraso do tratamento foi diagnóstico errado pelo médico de atendimento primário. Nível de Evidência III, Estudo Comparativo Retrospectivo.
OBJECTIVE: A retrospective comparison of treatment difficulties and treatment outcomes in Lisfranc joint injuries with late and early diagnosis.METHODS: The study group consisted of 10 patients diagnosed and treated properly within six months to 20 years of the accident causing the injury (mean six years). The control group consisted of the same number of randomly selected patients with a similar type of injury treated immediately after the accident. Mean follow-up was 13 years in the study group and eight years in the control group. The analysis evaluated the causes of the delay and the foot function at the time of follow up, measured using the AOFAS Midfoot Scale and the Lublin Foot Functional Score. The scores of the patients were analyzed using the non-parametric Mann-Whitney U test and the non-parametric Wilcoxon test.RESULTS: The control group had statistically significantly better scores on both scales.CONCLUSION: The main cause of treatment delay was misdiagnosis by the primary care physician. Level of Evidence III, Retrospective Comparative Study.
Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto Jovem , Pessoa de Meia-Idade , Fixação Interna de Fraturas/métodos , Luxações Articulares/cirurgia , Estudos Retrospectivos , Pesos e Medidas , Interpretação Estatística de DadosRESUMO
BACKGROUND: The UK Clinical Trial Regulations and Good Clinical Practice guidelines specify that the study sponsor must ensure clinical trial data are accurately reported, recorded and verified to ensure patient safety and scientific integrity. The methods that are utilised to assess data quality and the results of any reviews undertaken are rarely reported in the literature. We have recently undertaken a quality review of trial data submitted to a Clinical Endpoint Committee for adjudication. The purpose of the review was to identify areas that could be improved for future clinical trials. The results are reported in this paper. METHODS: Throughout the course of the study, all data queries were logged. Following study close out, queries were coded and categorised. A descriptive and comparative analysis was conducted to determine the frequency of occurrence for each category by country of origin. RESULTS: From 1595 endpoint packages reviewed, 782 queries were generated. No source data queries were generated for countries with ≤ 25 recruited subjects, but both low recruiting and high recruiting countries had a high number of queries relating to subject identifiers. CONCLUSIONS: The implementation of some simple measures could help improve data quality and lead to significant savings.
Assuntos
Comitês Consultivos/normas , Coleta de Dados/normas , Projetos de Pesquisa/normas , Austrália , Canadá , Método Duplo-Cego , Determinação de Ponto Final , Europa (Continente) , Fidelidade a Diretrizes , Guias como Assunto , Humanos , Coreia (Geográfico) , México , Controle de Qualidade , Fatores de Tempo , Resultado do TratamentoRESUMO
The interplay of multiple genes and environmental factors generates interindividual variation in plasma low density lipoprotein-cholesterol (LDL-C) concentrations. As a result, it has been difficult to identify individual genes that contribute to variation in plasma LDL-C levels using classical linkage analysis. We have exploited a genetic defect in the gene encoding the LDL receptor that is associated with a dramatically elevated plasma LDL-C level to unmask an allele at another locus that lowers plasma LDL-C levels. The existence of such an allele was implied by the analysis of a human pedigree with familial hypercholesterolaemia in which a third of the familial hypercholesterolaemia heterozygotes had normal levels of LDL-C. To develop an animal model of this LDL-C lowering effect and to identify genes that modify the plasma LDL-C level, we crossed LDL receptor-deficient mice with other strains of mice.