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1.
Trials ; 22(1): 627, 2021 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-34526095

RESUMO

BACKGROUND: Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Although both pharmacological and/or surgical treatment are effective in PDA closure, this has not resulted in an improved neonatal outcome. In most preterm infants, a PDA will eventually close spontaneously, hence PDA treatment potentially increases the risk of iatrogenic adverse effects. Therefore, expectant management is gaining interest, even in the absence of convincing evidence to support this strategy. METHODS/DESIGN: The BeNeDuctus trial is a multicentre, randomised, non-inferiority trial assessing early pharmacological treatment (24-72 h postnatal age) with ibuprofen versus expectant management of PDA in preterm infants in Europe. Preterm infants with a gestational age of less than 28 weeks and an echocardiographic-confirmed PDA with a transductal diameter of > 1.5 mm are randomly allocated to early pharmacological treatment with ibuprofen or expectant management after parental informed consent. The primary outcome measure is the composite outcome of mortality, and/or necrotizing enterocolitis Bell stage ≥ IIa, and/or bronchopulmonary dysplasia, all established at a postmenstrual age of 36 weeks. Secondary short-term outcomes are comorbidity and adverse events assessed during hospitalization and long-term neurodevelopmental outcome assessed at a corrected age of 2 years. This statistical analysis plan focusses on the short-term outcome and is written and submitted without knowledge of the data. TRIAL REGISTRATION: ClinicalTrials.gov NTR5479. Registered on October 19, 2015, with the Dutch Trial Registry, sponsored by the United States National Library of Medicine Clinicaltrials.gov NCT02884219 (registered May 2016) and the European Clinical Trials Database EudraCT 2017-001376-28.


Assuntos
Permeabilidade do Canal Arterial , Pré-Escolar , Permeabilidade do Canal Arterial/diagnóstico por imagem , Permeabilidade do Canal Arterial/terapia , Humanos , Ibuprofeno/efeitos adversos , Lactente , Recém-Nascido de Baixo Peso , Recém-Nascido , Recém-Nascido Prematuro , Conduta Expectante
2.
Pan Afr Med J ; 39(Suppl 1): 2, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548894

RESUMO

Introduction: intussusception is a condition in which one segment of the bowel prolapses into another causing obstruction. Information on the epidemiology of intussusception in sub-Saharan Africa is limited. We describe the sociodemographic and clinical characteristics of children with intussusception in Ethiopia. Methods: active surveillance for children < 12 months of age with intussusception was conducted at six sentinel hospitals in Ethiopia. Limited socio-economic and clinical data were collected from enrolled children. Characteristics among children who died and children who survived were compared using the Wilcoxon rank sum test for continuous variables and Chi-square tests for categorical variables. Results: total of 164 children < 12 months of age with intussusception were enrolled; 62% were male. The median age at symptom onset was 6 months with only 12 (7%) of cases occurring in the first 3 months of life. Intussusception was reduced by surgery in 90% of cases and 10% were reduced by enema; 13% of cases died. Compared to survivors, children who died had a significantly longer time to presentation to the first health care facility and to the treating health care facility (median 3 days versus 2 days, p = 0.02, respectively). Conclusion: the high mortality rate, late presentation of intussusception cases, and lack of modalities for non-surgical management at some facilities highlight the need for better management of intussusception cases in Ethiopia.


Assuntos
Enema/métodos , Intussuscepção/epidemiologia , Distribuição por Idade , Etiópia/epidemiologia , Feminino , Humanos , Lactente , Recém-Nascido , Intussuscepção/mortalidade , Intussuscepção/terapia , Masculino , Fatores Socioeconômicos , Estatísticas não Paramétricas , Taxa de Sobrevida , Fatores de Tempo , Tempo para o Tratamento , Conduta Expectante
3.
Pan Afr Med J ; 39(Suppl 1): 4, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548896

RESUMO

Introduction: intussusception surveillance was initiated in Tanzania in 2013 after monovalent rotavirus vaccine was introduced, as part of the 7-country African evaluation to assess whether the vaccine was associated with an increased risk of intussusception. An increased risk from vaccine was not identified. Published data on intussusception in Tanzanian infants are limited. Methods: prospective intussusception surveillance was conducted at 7 referral hospitals during 2013-2016 to identify all infants with intussusception meeting Brighton Level 1 criteria. Demographic, household and clinical data were collected by hospital clinicians and analyzed. Results: a total of 207 intussusception cases were identified. The median age of cases was 5.8 months and nearly three-quarters were aged 4-7 months. Median number of days from symptom onset to admission at treatment hospital was 3 (IQR 2-5). Seventy-eight percent (152/195) of cases had been admitted at another hospital before transfer to the treating hospital. Enema reduction was not available; all infants were treated surgically and 55% (114/207) had intestinal resection. The overall case-fatality rate was 30% (62/206). Compared with infants who survived, those who died had longer duration of symptoms before admission to treatment hospital (median 4 vs 3 days; p < 0.01), higher rate of intestinal resection (81% [60/82] vs 44% [64/144], p < 0.001), and from families with lower incomes (i.e., less likely to own a television [p < 0.01] and refrigerator [p < 0.05). Conclusion: Tanzanian infants who develop intussusception have a high case-fatality rate. Raising the index of suspicion among healthcare providers, allocating resources to allow wider availability of abdominal ultrasound for earlier diagnosis, and training teams in ultrasound-guided enema reduction techniques used in other African countries could reduce the fatality rate.


Assuntos
Hospitalização/estatística & dados numéricos , Intussuscepção/epidemiologia , Feminino , Humanos , Lactente , Recém-Nascido , Intussuscepção/mortalidade , Intussuscepção/terapia , Masculino , Estudos Prospectivos , Vacinas contra Rotavirus/administração & dosagem , Vacinas contra Rotavirus/efeitos adversos , Taxa de Sobrevida , Tanzânia/epidemiologia , Fatores de Tempo , Tempo para o Tratamento , Conduta Expectante
4.
Pan Afr Med J ; 39(Suppl 1): 6, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548898

RESUMO

Introduction: recipients of monovalent rotavirus vaccine have a low risk of developing intussusception (IS) in high- to medium-high-income countries. In sub-Saharan Africa, Zambia included, this risk of IS has not been assessed. Two-dose monovalent rotavirus vaccine, introduced in Zambia in 2012 in the capital of Lusaka, and rolled out countrywide in 2013, is administered at 6 and 10 weeks of age with no catch-up dose. Active IS surveillance monitoring in children < 2 years has been ongoing in Zambia since July 2009 and additional retrospective review was conducted from 2007- June 2009. Methods: retrospective review (January 2007-June 2009) and prospective (July 2009-December 2018) IS surveillance was conducted at nine hospitals and four large paediatric hospital departments in Zambia, respectively. Demographic and clinical data were collected from medical folder abstraction and supplemented by parental interview during prospective surveillance. Results: a total of 248 children < 2 years with IS were identified; 57.3% were male. Most cases with IS were infants (85.5%). IS admissions remained stable during the surveillance period with no seasonality pattern although an increase in cases occurred between August and October, hot dry season. The median time from symptom onset to presentation for treatment was 2 days and 63.6% (154/242) of IS diagnoses were made during surgery. The bowel resection rate was 46.6%. A high CFR of 23.3% was observed. Conclusion: the number of intussusception cases in Zambia was relatively small and remained stable over the 12-year study period. However, a high CFR was observed among cases.


Assuntos
Hospitalização/estatística & dados numéricos , Intussuscepção/epidemiologia , Vacinas contra Rotavirus/administração & dosagem , Distribuição por Idade , Estudos Transversais , Feminino , Humanos , Lactente , Recém-Nascido , Intussuscepção/mortalidade , Intussuscepção/terapia , Masculino , Estudos Prospectivos , Estudos Retrospectivos , Vigilância de Evento Sentinela , Tempo para o Tratamento , Conduta Expectante , Zâmbia/epidemiologia
5.
Pan Afr Med J ; 39(Suppl 1): 7, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548899

RESUMO

Introduction: intussusception is the leading cause of bowel obstruction in infants and young children. We describe the epidemiology and diagnostic and treatment characteristics of intussusception among Togolese infants over a 4-year period. Methods: we implemented active surveillance among infants younger than 1 year of age admitted with intussusception from 2015 to 2018 at Sylvanus Olympio Teaching Hospital and in 2018 at Campus Teaching Hospital. Brighton Collaboration Level 1 case definition criteria were used to confirm the diagnosis of intussusception. Results: during four years, 41 cases of intussusception, with an annual range of 8 to 14 cases (median: 10) were reported; and the highest number of cases (89%) was enrolled at Sylvanus Olympio teaching hospital. Intussusception was uncommon in the first 2 months of life, peaked from 5 to 7 months old (63%), with male predominance (63%), and showed no significant seasonality. One third of cases (34%) were transferred to the sentinel surveillance site from another health facility; and the median delay in seeking care was 4 days (range: 0-11) with ≥ 48-hour delay in 59% of cases. Clinical symptoms, ultrasound and surgery were combined to diagnose intussusception in all the cases (100%). The treatment was exclusively surgical, and intestinal resection was common (28/41, 68%). A high case fatality rate (23%) was observed and the average length of hospital stay was 10 days (range: 1-23). Conclusion: active surveillance for intussusception in Togo has highlighted exclusive use of surgical therapy; often associated to an intestinal resection with a very high case fatality rate.


Assuntos
Hospitalização/estatística & dados numéricos , Intussuscepção/epidemiologia , Conduta Expectante , Feminino , Hospitais de Ensino , Humanos , Lactente , Recém-Nascido , Intussuscepção/diagnóstico , Intussuscepção/cirurgia , Tempo de Internação/estatística & dados numéricos , Masculino , Vigilância de Evento Sentinela , Tempo para o Tratamento , Togo/epidemiologia
6.
Pan Afr Med J ; 39(Suppl 1): 8, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548900

RESUMO

Introduction: we examined the epidemiology, clinical and demographic characteristics of intussusception in Ghanaian infants. Methods: active sentinel surveillance for pediatric intussusception was conducted at Komfo Anokye Teaching Hospital in Kumasi and Korle Bu Teaching Hospital in Accra. From March 2012 to December 2016, infants < 1 year of age who met the Brighton Collaboration level 1 diagnostic criteria for intussusception were enrolled. Data were collected through parental interviews and medical records abstraction. Results: a total of 378 children < 1 year of age were enrolled. Median age at onset of intussusception was 27 weeks; only 12 cases (1%) occurred in infants < 12 weeks while most occurred in infants aged 22-34 weeks. Median time from symptom onset until referral to a tertiary hospital was 2 days (IQR: 1-4 days). Overall, 35% of infants were treated by enema, 33% had surgical reduction and 32% required surgical reduction and bowel resection. Median length of hospital stay was 5 days (IQR: 3-8 days) with most patients (95%) discharged home. Eleven (3%) infants died. Infants undergoing enema reduction were more likely than those treated surgically to present for treatment sooner after symptom onset (median 1 vs 3 days; p < 0.0001) and have shorter hospital stays (median 3 vs 7 days; p < 0.001). Conclusion: Ghanaian infants had a relatively low case fatality rate due to intussusception, with a substantial proportion of cases treated non-surgically. Early presentation for treatment, possibly enhanced by community-based health education programs and health information from various media platforms during the study period might contribute to both the low fatality rate and high number of successful non-surgical treatments in this population.


Assuntos
Enema/métodos , Hospitalização/estatística & dados numéricos , Intussuscepção/epidemiologia , Feminino , Gana/epidemiologia , Hospitais de Ensino , Humanos , Lactente , Recém-Nascido , Intussuscepção/diagnóstico , Intussuscepção/terapia , Tempo de Internação/estatística & dados numéricos , Masculino , Vigilância de Evento Sentinela , Centros de Atenção Terciária , Fatores de Tempo , Tempo para o Tratamento , Conduta Expectante
7.
Pan Afr Med J ; 39(Suppl 1): 9, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34548901

RESUMO

Introduction: intussusception is the invagination of a segment of the bowel into a distal segment. It occurs predominantly in infants worldwide. Following documentation of increased incidence after introduction of the first rotavirus vaccine (Rotashield, Wyeth-Lederle), it has become a standard recommendation to maintain surveillance for intussusception as newer rotavirus vaccines are introduced into EPI. Nigeria plans to introduce rotavirus vaccine in 2020. Pre-vaccine introduction surveillance will serve as a baseline to understand the epidemiology of intussusception in Nigeria. Methods: from 2013 to 2017, prospective enrolment of under five children with intussusception was done following the WHO protocol and using the WHO case report form. Only children who met the Pan American Health Organization/World Health Organization (PAHO/WHO) protocol case definition for intussusception were enrolled. These children were monitored until discharge or death. Clinical features and outcome were recorded in the case report form. Results: a total of 63 cases were enrolled, with age range of 3 to 42 months (median: 6 months, IQR: 5-9 months). Majority were within 4-6 months and 96% were < 12 months old. There were 41 males and 22 females (male to female ratio of 1.9:1). Duration of symptoms before presentation ranged from 2 hours to 15 days (median: 72 hours). Fifty-seven patients had abdominal ultrasound and 52 patients (83%) had surgery. Case fatality rate was 9% and duration of hospitalization ranged from 1 to 30 days (median 10 days, IQR 8-15 days). Conclusion: intussusception occurred most commonly in infants but well beyond the proposed age for rotavirus vaccination in the population studied. Late presentation and surgical intervention were common. This data provides a good baseline description of the epidemiology of intussusception.


Assuntos
Hospitalização/estatística & dados numéricos , Intussuscepção/epidemiologia , Conduta Expectante , Distribuição por Idade , Pré-Escolar , Feminino , Humanos , Lactente , Intussuscepção/diagnóstico , Intussuscepção/terapia , Tempo de Internação , Masculino , Nigéria/epidemiologia , Estudos Prospectivos , Vacinas contra Rotavirus/administração & dosagem , Vacinas contra Rotavirus/efeitos adversos , Fatores de Tempo
8.
MMWR Morb Mortal Wkly Rep ; 70(38): 1332-1336, 2021 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-34555002

RESUMO

Foodborne illnesses are a substantial and largely preventable public health problem; before 2020 the incidence of most infections transmitted commonly through food had not declined for many years. To evaluate progress toward prevention of foodborne illnesses in the United States, the Foodborne Diseases Active Surveillance Network (FoodNet) of CDC's Emerging Infections Program monitors the incidence of laboratory-diagnosed infections caused by eight pathogens transmitted commonly through food reported by 10 U.S. sites.* FoodNet is a collaboration among CDC, 10 state health departments, the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS), and the Food and Drug Administration. This report summarizes preliminary 2020 data and describes changes in incidence with those during 2017-2019. During 2020, observed incidences of infections caused by enteric pathogens decreased 26% compared with 2017-2019; infections associated with international travel decreased markedly. The extent to which these reductions reflect actual decreases in illness or decreases in case detection is unknown. On March 13, 2020, the United States declared a national emergency in response to the COVID-19 pandemic. After the declaration, state and local officials implemented stay-at-home orders, restaurant closures, school and child care center closures, and other public health interventions to slow the spread of SARS-CoV-2, the virus that causes COVID-19 (1). Federal travel restrictions were declared (1). These widespread interventions as well as other changes to daily life and hygiene behaviors, including increased handwashing, have likely changed exposures to foodborne pathogens. Other factors, such as changes in health care delivery, health care-seeking behaviors, and laboratory testing practices, might have decreased the detection of enteric infections. As the pandemic continues, surveillance of illness combined with data from other sources might help to elucidate the factors that led to the large changes in 2020; this understanding could lead to improved strategies to prevent illness. To reduce the incidence of these infections concerted efforts are needed, from farm to processing plant to restaurants and homes. Consumers can reduce their risk of foodborne illness by following safe food-handling and preparation recommendations.


Assuntos
COVID-19/epidemiologia , Microbiologia de Alimentos/estatística & dados numéricos , Parasitologia de Alimentos/estatística & dados numéricos , Doenças Transmitidas por Alimentos/epidemiologia , Pandemias , Conduta Expectante , Adolescente , Criança , Pré-Escolar , Doenças Transmitidas por Alimentos/microbiologia , Doenças Transmitidas por Alimentos/parasitologia , Humanos , Incidência , Lactente , Estados Unidos/epidemiologia
9.
BMJ ; 374: n2103, 2021 09 22.
Artigo em Inglês | MEDLINE | ID: mdl-34551918

RESUMO

OBJECTIVE: To evaluate whether extended release metformin could be used to prolong gestation in women being expectantly managed for preterm pre-eclampsia. DESIGN: Randomised, double blind, placebo controlled trial. SETTING: Referral hospital in Cape Town, South Africa. PARTICIPANTS: 180 women with preterm pre-eclampsia between 26+0 to 31+6 weeks' gestation undergoing expectant management: 90 were randomised to extended release metformin and 90 to placebo. INTERVENTION: 3 g of oral extended release metformin or placebo daily, in divided doses, until delivery. MAIN OUTCOME MEASURE: The primary outcome was prolongation of gestation. RESULTS: Of 180 participants, one woman delivered before taking any trial drug. The median time from randomisation to delivery was 17.7 days (interquartile range 5.4-29.4 days; n=89) in the metformin arm and 10.1 (3.7-24.1; n=90) days in the placebo arm, a median difference of 7.6 days (geometric mean ratio 1.39, 95% confidence interval 0.99 to 1.95; P=0.057). Among those who continued to take the trial drug at any dose, the median prolongation of gestation in the metformin arm was 17.5 (interquartile range 5.4-28.7; n=76) days compared with 7.9 (3.0-22.2; n=74) days in the placebo arm, a median difference of 9.6 days (geometric mean ratio 1.67, 95% confidence interval 1.16 to 2.42). Among those who took the full dosage, the median prolongation of gestation in the metformin arm was 16.3 (interquartile range 4.8-28.8; n=40) days compared with 4.8 (2.5-15.4; n=61) days in the placebo arm, a median difference of 11.5 days (geometric mean ratio 1.85, 95% confidence interval 1.14 to 2.88). Composite maternal, fetal, and neonatal outcomes and circulating concentrations of soluble fms-like tyrosine kinase-1, placental growth factor, and soluble endoglin did not differ. In the metformin arm, birth weight increased non-significantly and length of stay decreased in the neonatal nursery. No serious adverse events related to trial drugs were observed, although diarrhoea was more common in the metformin arm. CONCLUSIONS: This trial suggests that extended release metformin can prolong gestation in women with preterm pre-eclampsia, although further trials are needed. It provides proof of concept that treatment of preterm pre-eclampsia is possible. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR201608001752102 https://pactr.samrc.ac.za/.


Assuntos
Metformina/administração & dosagem , Pré-Eclâmpsia/tratamento farmacológico , Nascimento Prematuro/prevenção & controle , Adulto , Preparações de Ação Retardada , Método Duplo-Cego , Endoglina/sangue , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Fator de Crescimento Placentário/sangue , Gravidez , Nascimento Prematuro/etiologia , Estudo de Prova de Conceito , Fatores de Tempo , Resultado do Tratamento , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/sangue , Conduta Expectante
10.
BMJ Open ; 11(8): e049298, 2021 08 27.
Artigo em Inglês | MEDLINE | ID: mdl-34452964

RESUMO

INTRODUCTION: Hallux rigidus is a common problem of pain and stiffness of the first metatarsophalangeal joint (MTPJ) caused mainly by degenerative osteoarthritis. Several operative techniques have been introduced for the treatment of this condition without high-quality evidence comparing surgical to non-surgical care. In this trial, the most common surgical procedure, arthrodesis, will be compared with watchful waiting in the management of hallux rigidus. METHODS AND ANALYSIS: Ninety patients (40 years or older) with symptomatic first MTPJ osteoarthritis will be randomised to arthrodesis or watchful waiting in a ratio of 1:1. The primary outcome will be pain during walking, assessed using the 0-10 Numerical Rating Scale (NRS) at 1 year after randomisation. The secondary outcomes will be pain at rest (NRS), physical function (Manchester-Oxford Foot Questionnaire), patient satisfaction in terms of the patient-acceptable symptom state, health-related quality of life (EQ-5D-5L), activity level (The Foot and Ankle Ability Measure Sports subscale), use of analgesics or orthoses and the rate of complications. Our null hypothesis is that there will be no difference equal to or greater than the minimal important difference of the primary outcome measure between arthrodesis and watchful waiting. Our primary analysis follows an intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Committee of Helsinki and Uusimaa Hospital District, Finland. Written informed consent will be obtained from all the participants. We will disseminate the findings of this study through peer-reviewed publications and conference presentations. PROTOCOL VERSION: 21 June 2021 V.2.0. TRIAL REGISTRATION NUMBER: NCT04590313.


Assuntos
Hallux Rigidus , Articulação Metatarsofalângica , Artrodese , Hallux Rigidus/cirurgia , Humanos , Dor , Estudos Prospectivos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Conduta Expectante
11.
JAMA ; 326(5): 390-400, 2021 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-34342619

RESUMO

Importance: Women with an early nonviable pregnancy of unknown location are at high risk of ectopic pregnancy and its inherent morbidity and mortality. Successful and timely resolution of the gestation, while minimizing unscheduled interventions, are important priorities. Objective: To determine if active management is more effective in achieving pregnancy resolution than expectant management and whether the use of empirical methotrexate is noninferior to uterine evacuation followed by methotrexate if needed. Design, Setting, and Participants: This multicenter randomized clinical trial recruited 255 hemodynamically stable women with a diagnosed persisting pregnancy of unknown location between July 25, 2014, and June 4, 2019, in 12 medical centers in the United States (final follow up, August 19, 2019). Interventions: Eligible patients were randomized in a 1:1:1 ratio to expectant management (n = 86), active management with uterine evacuation followed by methotrexate if needed (n = 87), or active management with empirical methotrexate using a 2-dose protocol (n = 82). Main Outcomes and Measures: The primary outcome was successful resolution of the pregnancy without change from initial strategy. The primary hypothesis tested for superiority of the active groups combined vs expectant management, and a secondary hypothesis tested for noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed using a noninferiority margin of -12%. Results: Among 255 patients who were randomized (median age, 31 years; interquartile range, 27-36 years), 253 (99.2%) completed the trial. Ninety-nine patients (39%) declined their randomized allocation (26.7% declined expectant management, 48.3% declined uterine evacuation, and 41.5% declined empirical methotrexate) and crossed over to a different group. Compared with patients randomized to receive expectant management (n = 86), women randomized to receive active management (n = 169) were significantly more likely to experience successful pregnancy resolution without change in their initial management strategy (51.5% vs 36.0%; difference, 15.4% [95% CI, 2.8% to 28.1%]; rate ratio, 1.43 [95% CI, 1.04 to 1.96]). Among active management strategies, empirical methotrexate was noninferior to uterine evacuation followed by methotrexate if needed with regard to successful pregnancy resolution without change in management strategy (54.9% vs 48.3%; difference, 6.6% [1-sided 97.5% CI, -8.4% to ∞]). The most common adverse event was vaginal bleeding for all of the 3 management groups (44.2%-52.9%). Conclusions and Relevance: Among patients with a persisting pregnancy of unknown location, patients randomized to receive active management, compared with those randomized to receive expectant management, more frequently achieved successful pregnancy resolution without change from the initial management strategy. The substantial crossover between groups should be considered when interpreting the results. Trial Registration: ClinicalTrials.gov Identifier: NCT02152696.


Assuntos
Abortivos não Esteroides/administração & dosagem , Metotrexato/administração & dosagem , Gravidez Ectópica/tratamento farmacológico , Gravidez Ectópica/cirurgia , Conduta Expectante , Aborto Espontâneo , Adulto , Gonadotropina Coriônica/sangue , Terapia Combinada , Dilatação e Curetagem , Feminino , Humanos , Satisfação do Paciente , Gravidez , Ultrassonografia Pré-Natal , Hemorragia Uterina
12.
Artigo em Inglês | MEDLINE | ID: mdl-34360156

RESUMO

BACKGROUND: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. METHODS: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CONCLUSIONS: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.


Assuntos
COVID-19 , Vacinas , Vacinas contra COVID-19 , Estudos Transversais , Humanos , Estudos Prospectivos , SARS-CoV-2 , Vacinas/efeitos adversos , Conduta Expectante
13.
BMJ Case Rep ; 14(8)2021 Aug 10.
Artigo em Inglês | MEDLINE | ID: mdl-34376415

RESUMO

Perforation of the pharynx is a rare occurrence but has the potential to cause mediastinitis and has an attendant mortality risk. Though numerous mechanisms have been described, we report a unique case of a young woman who presented with a sore throat, odynophagia and subcutaneous emphysema, a short time after performing fellatio. A contrast swallow confirmed hypopharyngeal perforation. She was managed expectantly with nasogastric feeding and empirical antibiotics. The perforation took 4 weeks to heal, but there were no residual swallowing problems at 3-month follow-up. We will explore the incidence and causes of pharyngeal perforation and discuss the options for and risks of surgical repair. This case highlights that non-surgical management of such injuries can be both safe and feasible, and reinforces the importance of ensuring confidentiality and the need for vigilance regarding potential non-consensual injury.


Assuntos
Perfuração Esofágica , Mediastinite , Enfisema Subcutâneo , Ferimentos não Penetrantes , Perfuração Esofágica/diagnóstico por imagem , Perfuração Esofágica/etiologia , Perfuração Esofágica/terapia , Feminino , Humanos , Hipofaringe/diagnóstico por imagem , Hipofaringe/lesões , Enfisema Subcutâneo/diagnóstico por imagem , Enfisema Subcutâneo/etiologia , Enfisema Subcutâneo/terapia , Conduta Expectante , Ferimentos não Penetrantes/complicações , Ferimentos não Penetrantes/diagnóstico por imagem
14.
Cancer Radiother ; 25(6-7): 526-532, 2021 Oct.
Artigo em Francês | MEDLINE | ID: mdl-34400086

RESUMO

Oligometastatic prostate cancer is among the most studied oligometastatic cancers in the literature. However few prospective studies have assessed stereotactic body radiotherapy (SBRT) for prostate cancer oligometastases. Two randomised phase II trials show a progression-free survival benefit compared with observation. Prospective registry data show very good local control and low toxicity too. Inclusion in ongoing trials should be strongly encouraged to define the role of SBRT in addition to systemic therapy. Radiation therapy to the primary tumour has been studied in randomised trials and provides an overall survival benefit in patients with low metastatic burden. The benefit is inversely correlated with the number of bone lesions using conventional imaging, up to three metastases. Radiotherapy to the primary tumour is recommended by the learned societies for patients with low metastatic burden. Its role in combination with second generation anti androgen therapy needs to be clarified.


Assuntos
Neoplasias da Próstata/radioterapia , Radiocirurgia , Neoplasias Ósseas/radioterapia , Neoplasias Ósseas/secundário , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto , Humanos , Metástase Linfática/radioterapia , Masculino , Intervalo Livre de Progressão , Estudos Prospectivos , Neoplasias da Próstata/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Conduta Expectante
15.
J Urol ; 206(4): 903-913, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34412510

RESUMO

PURPOSE: The purpose of this study was to describe the uptake, discontinuation and variation of active surveillance (AS) by provider and patient level characteristics. MATERIALS AND METHODS: This observational, population-based study used linked administrative databases and pathology reports to identify all men diagnosed with Gleason score ≤6 prostate cancer (PC) between January 1, 2008 and December 31, 2014 in Ontario, Canada. The Cochran-Armitage test was used for AS trend over time. Treatment-free survival was estimated using cumulative incidence function. Factors associated with discontinuation of AS were evaluated using Cox proportional hazard models. RESULTS: Active surveillance was the initial management strategy for 8,541 cases (51%). Use of AS significantly increased from 38% in 2008 to 69% in 2014 (p=0.001). Men on AS were significantly older (64 years, SD 8.0) than those on initial treatment (62 years, SD 7.7; p=0.001). After a median followup of 48 months, 4,337 (51%) patients had discontinued AS. Treatment-free survival for AS patients at 1, 3, and 5 years were 85%, 58% and 52%, respectively. Median time to definitive treatment after initial AS was 16 months (IQR 11-25 months). Factors associated with AS discontinuation were younger age at diagnosis, year of diagnosis, higher comorbidities, treatment at academic center, treatment by physician and institution in the highest volume tertile, and adverse cancer-specific characteristics (higher prostate specific antigen [PSA], higher number of positive cores and higher percentage of core involvement at diagnosis). CONCLUSIONS: Although the uptake of AS significantly increased over time, there has been a relatively high rate of discontinuation over 5 years. Factors associated with transition to definitive treatment were younger age, care provided by higher volume physicians and institutions, higher PSA and greater PC volume at diagnosis. These results may help guide policy making, developing quality indicators, and developing targeted continued education for physician and patients embarking on AS to establish realistic expectations.


Assuntos
Prostatectomia/estatística & dados numéricos , Neoplasias da Próstata/terapia , Conduta Expectante/estatística & dados numéricos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Progressão da Doença , Humanos , Calicreínas/sangue , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Ontário/epidemiologia , Intervalo Livre de Progressão , Próstata/patologia , Próstata/cirurgia , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/sangue , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/mortalidade
16.
Cochrane Database Syst Rev ; 7: CD013424, 2021 Jul 07.
Artigo em Inglês | MEDLINE | ID: mdl-34231877

RESUMO

BACKGROUND: Chronic kidney disease (CKD) is an independent risk factor for osteoporosis and is more prevalent among people with CKD than among people who do not have CKD. Although several drugs have been used to effectively treat osteoporosis in the general population, it is unclear whether they are also effective and safe for people with CKD, who have altered systemic mineral and bone metabolism. OBJECTIVES: To assess the efficacy and safety of pharmacological interventions for osteoporosis in patients with CKD stages 3-5, and those undergoing dialysis (5D). SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to 25 January 2021 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials comparing any anti-osteoporotic drugs with a placebo, no treatment or usual care in patients with osteoporosis and CKD stages 3 to 5D were included. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed their quality using the risk of bias tool, and extracted data. The main outcomes were the incidence of fracture at any sites; mean change in the bone mineral density (BMD; measured using dual-energy radiographic absorptiometry (DXA)) of the femoral neck, total hip, lumbar spine, and distal radius; death from all causes; incidence of adverse events; and quality of life (QoL). Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: Seven studies involving 9164 randomised participants with osteoporosis and CKD stages 3 to 5D met the inclusion criteria; all participants were postmenopausal women. Five studies included patients with CKD stages 3-4, and two studies included patients with CKD stages 5 or 5D. Five pharmacological interventions were identified (abaloparatide, alendronate, denosumab, raloxifene, and teriparatide). All studies were judged to be at an overall high risk of bias. Among patients with CKD stages 3-4, anti-osteoporotic drugs may reduce the risk of vertebral fracture (RR 0.52, 95% CI 0.39 to 0.69; low certainty evidence). Anti-osteoporotic drugs probably makes little or no difference to the risk of clinical fracture (RR 0.91, 95% CI 0.79 to 1.05; moderate certainty evidence) and adverse events (RR 0.99, 95% CI 0.98 to 1.00; moderate certainty evidence). We were unable to incorporate studies into the meta-analyses for BMD at the femoral neck, lumbar spine and total hip as they only reported the percentage change in the BMD in the intervention group. Among patients with severe CKD stages 5 or 5D, it is uncertain whether anti-osteoporotic drug reduces the risk of clinical fracture (RR 0.33, 95% CI 0.01 to 7.87; very low certainty evidence). It is uncertain whether anti-osteoporotic drug improves the BMD at the femoral neck because the certainty of this evidence is very low (MD 0.01, 95% CI 0.00 to 0.02). Anti-osteoporotic drug may slightly improve the BMD at the lumbar spine (MD 0.03, 95% CI 0.03 to 0.04, low certainty evidence). No adverse events were reported in the included studies. It is uncertain whether anti-osteoporotic drug reduces the risk of death (RR 1.00, 95% CI 0.22 to 4.56; very low certainty evidence). AUTHORS' CONCLUSIONS: Among patients with CKD stages 3-4, anti-osteoporotic drugs may reduce the risk of vertebral fracture in low certainty evidence. Anti-osteoporotic drugs make little or no difference to the risk of clinical fracture and adverse events in moderate certainty evidence. Among patients with CKD stages 5 and 5D, it is uncertain whether anti-osteoporotic drug reduces the risk of clinical fracture and death because the certainty of this evidence is very low. Anti-osteoporotic drug may slightly improve the BMD at the lumbar spine in low certainty evidence. It is uncertain whether anti-osteoporotic drug improves the BMD at the femoral neck because the certainty of this evidence is very low. Larger studies including men, paediatric patients or individuals with unstable CKD-mineral and bone disorder are required to assess the effect of each anti-osteoporotic drug at each stage of CKD.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Osteoporose Pós-Menopausa/terapia , Insuficiência Renal Crônica/complicações , Conduta Expectante , Anticorpos Monoclonais/efeitos adversos , Anticorpos Monoclonais/uso terapêutico , Viés , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/efeitos adversos , Denosumab/efeitos adversos , Denosumab/uso terapêutico , Feminino , Colo do Fêmur/efeitos dos fármacos , Fraturas Espontâneas/epidemiologia , Fraturas Espontâneas/prevenção & controle , Quadril , Humanos , Indóis/efeitos adversos , Indóis/uso terapêutico , Vértebras Lombares/efeitos dos fármacos , Osteoporose Pós-Menopausa/tratamento farmacológico , Osteoporose Pós-Menopausa/mortalidade , Proteína Relacionada ao Hormônio Paratireóideo/efeitos adversos , Proteína Relacionada ao Hormônio Paratireóideo/uso terapêutico , Cloridrato de Raloxifeno/efeitos adversos , Cloridrato de Raloxifeno/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Diálise Renal , Insuficiência Renal Crônica/terapia , Fraturas da Coluna Vertebral/diagnóstico por imagem , Fraturas da Coluna Vertebral/prevenção & controle , Teriparatida/efeitos adversos , Teriparatida/uso terapêutico , Tiofenos/efeitos adversos , Tiofenos/uso terapêutico
17.
Cochrane Database Syst Rev ; 7: CD013433, 2021 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-34286511

RESUMO

BACKGROUND: Stem cell therapy (SCT) has been proposed as an alternative treatment for dilated cardiomyopathy (DCM), nonetheless its effectiveness remains debatable. OBJECTIVES: To assess the effectiveness and safety of SCT in adults with non-ischaemic DCM. SEARCH METHODS: We searched CENTRAL in the Cochrane Library, MEDLINE, and Embase for relevant trials in November 2020. We also searched two clinical trials registers in May 2020. SELECTION CRITERIA: Eligible studies were randomized controlled trials (RCT) comparing stem/progenitor cells with no cells in adults with non-ischaemic DCM. We included co-interventions such as the administration of stem cell mobilizing agents. Studies were classified and analysed into three categories according to the comparison intervention, which consisted of no intervention/placebo, cell mobilization with cytokines, or a different mode of SCT. The first two comparisons (no cells in the control group) served to assess the efficacy of SCT while the third (different mode of SCT) served to complement the review with information about safety and other information of potential utility for a better understanding of the effects of SCT. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all references for eligibility, assessed trial quality, and extracted data. We undertook a quantitative evaluation of data using random-effects meta-analyses. We evaluated heterogeneity using the I² statistic. We could not explore potential effect modifiers through subgroup analyses as they were deemed uninformative due to the scarce number of trials available. We assessed the certainty of the evidence using the GRADE approach. We created summary of findings tables using GRADEpro GDT. We focused our summary of findings on all-cause mortality, safety, health-related quality of life (HRQoL), performance status, and major adverse cardiovascular events. MAIN RESULTS: We included 13 RCTs involving 762 participants (452 cell therapy and 310 controls). Only one study was at low risk of bias in all domains. There were many shortcomings in the publications that did not allow a precise assessment of the risk of bias in many domains. Due to the nature of the intervention, the main source of potential bias was lack of blinding of participants (performance bias). Frequently, the format of the continuous data available was not ideal for use in the meta-analysis and forced us to seek strategies for transforming data in a usable format. We are uncertain whether SCT reduces all-cause mortality in people with DCM compared to no intervention/placebo (mean follow-up 12 months) (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.54 to 1.31; I² = 0%; studies = 7, participants = 361; very low-certainty evidence). We are uncertain whether SCT increases the risk of procedural complications associated with cells injection in people with DCM (data could not be pooled; studies = 7; participants = 361; very low-certainty evidence). We are uncertain whether SCT improves HRQoL (standardized mean difference (SMD) 0.62, 95% CI 0.01 to 1.23; I² = 72%; studies = 5, participants = 272; very low-certainty evidence) and functional capacity (6-minute walk test) (mean difference (MD) 70.12 m, 95% CI -5.28 to 145.51; I² = 87%; studies = 5, participants = 230; very low-certainty evidence). SCT may result in a slight functional class (New York Heart Association) improvement (data could not be pooled; studies = 6, participants = 398; low-certainty evidence). None of the included studies reported major adverse cardiovascular events as defined in our protocol. SCT may not increase the risk of ventricular arrhythmia (data could not be pooled; studies = 8, participants = 504; low-certainty evidence). When comparing SCT to cell mobilization with granulocyte-colony stimulating factor (G-CSF), we are uncertain whether SCT reduces all-cause mortality (RR 0.46, 95% CI 0.16 to 1.31; I² = 39%; studies = 3, participants = 195; very low-certainty evidence). We are uncertain whether SCT increases the risk of procedural complications associated with cells injection (studies = 1, participants = 60; very low-certainty evidence). SCT may not improve HRQoL (MD 4.61 points, 95% CI -5.62 to 14.83; studies = 1, participants = 22; low-certainty evidence). SCT may improve functional capacity (6-minute walk test) (MD 140.14 m, 95% CI 119.51 to 160.77; I² = 0%; studies = 2, participants = 155; low-certainty evidence). None of the included studies reported MACE as defined in our protocol or ventricular arrhythmia. The most commonly reported outcomes across studies were based on physiological measures of cardiac function where there were some beneficial effects suggesting potential benefits of SCT in people with non-ischaemic DCM. However, it is unclear if this intermediate effects translates into clinical benefits for these patients. With regard to specific aspects related to the modality of cell therapy and its delivery, uncertainties remain as subgroup analyses could not be performed as planned, making it necessary to wait for the publication of several studies that are currently in progress before any firm conclusion can be reached. AUTHORS' CONCLUSIONS: We are uncertain whether SCT in people with DCM reduces the risk of all-cause mortality and procedural complications, improves HRQoL, and performance status (exercise capacity). SCT may improve functional class (NYHA), compared to usual care (no cells). Similarly, when compared to G-CSF, we are also uncertain whether SCT in people with DCM reduces the risk of all-cause mortality although some studies within this comparison observed a favourable effect that should be interpreted with caution. SCT may not improve HRQoL but may improve to some extent performance status (exercise capacity). Very low-quality evidence reflects uncertainty regarding procedural complications. These suggested beneficial effects of SCT, although uncertain due to the very low certainty of the evidence, are accompanied by favourable effects on some physiological measures of cardiac function. Presently, the most effective mode of administration of SCT and the population that could benefit the most is unclear. Therefore, it seems reasonable that use of SCT in people with DCM is limited to clinical research settings. Results of ongoing studies are likely to modify these conclusions.


Assuntos
Cardiomiopatia Dilatada/terapia , Transplante de Células-Tronco , Arritmias Cardíacas/epidemiologia , Viés , Cardiomiopatia Dilatada/mortalidade , Causas de Morte , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Placebos/uso terapêutico , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Transplante de Células-Tronco/efeitos adversos , Transplante de Células-Tronco/mortalidade , Teste de Caminhada , Conduta Expectante
18.
Urol Clin North Am ; 48(3): 401-409, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34210494

RESUMO

Available evidence supports routine implementation of germline genetic testing for many aspects of prostate cancer (PCa) decision making. The purpose of obtaining genetic testing for newly diagnosed men would be focused on identifying mutations that predispose to aggressive PCa. Based on an evidence-based review, the authors review germline rare pathogenic mutations in several genes that are significantly associated with aggressiveness, metastases, and mortality. Then recent studies of these germline mutations in predicting tumor grade reclassification among patients undergoing active surveillance are discussed. Single nucleotide polymorphisms-based polygenic risk scores in differentiating PCa aggressiveness and prognosis are reviewed.


Assuntos
Testes Genéticos , Mutação em Linhagem Germinativa , Neoplasias da Próstata/genética , Biomarcadores Tumorais/genética , Humanos , Masculino , Gradação de Tumores , Prognóstico , Neoplasias da Próstata/patologia , Medição de Risco , Conduta Expectante
19.
Lakartidningen ; 1182021 07 06.
Artigo em Sueco | MEDLINE | ID: mdl-34228808

RESUMO

Besides clinical evaluation, all patients with rectal cancer must be examined with CT of the chest and abdomen to assess the presence of metastases, pelvic MRI to stage the tumour locally, and if possible, colonoscopy to detect synchronous lesions. The recommended treatment is then discussed at an MDT conference and neoadjuvant radio- or chemoradiotherapy given according to national guidelines. A new digital rectal examination (DRE) and proctoscopy, CT and pelvic MRI should be performed around six weeks after treatment. The purpose is to detect potential new metastases and to assess tumour response after treatment. It is crucial to do a second MDT with careful MRI evaluation to detect a possible clinical complete response. If the post-treatment MRI shows a complete or near complete response, corresponding to clinical findings on DRE and endoscopy, the patient should be offered a prospective watch and wait protocol in a dedicated institution. With proper management of patients with rectal cancer, 20-25 procent may be saved from a rectal resection and the potential risk of a permanent stoma.


Assuntos
Neoplasias Retais , Quimiorradioterapia , Exame Retal Digital , Humanos , Terapia Neoadjuvante , Estadiamento de Neoplasias , Estudos Prospectivos , Neoplasias Retais/diagnóstico por imagem , Neoplasias Retais/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Conduta Expectante
20.
Cent Eur J Public Health ; 29(2): 96-101, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34245548

RESUMO

OBJECTIVE: Despite advancing technology, national TB surveillance systems are still inadequate in terms of patient detection around the world. It was aimed to investigate suspicious cases detected by active surveillance method in pathology laboratories and to evaluate the effectiveness of this method in terms of finding new TB cases. METHODS: This is a descriptive cross-sectional study. It was administrated in Samsun, Turkey, between January 2012-December 2017. Within the scope of active surveillance, pathology laboratories were regularly visited and reported cases with granulomatous inflammation were assessed. The obtained patient list was compared with the records of the Electronic Tuberculosis Management System (ETMS). Patients who were not included in these records were invited to the dispensary and evaluated for TB. They were also referred to the relevant hospitals for diagnosis if necessary. Frequency values and descriptive statistics were calculated using SPSS method. RESULTS: It was found that 35.6% of 703 patients with the diagnosis of granulomatous inflammation were previously diagnosed, treated or currently undergoing treatment in the ETMS registry. As a result of the assessment of remaining 453 cases, 46 patients (10.1%) were newly diagnosed with TB. Newly diagnosed TB patients were reported, and their treatment started. CONCLUSION: As a result, active surveillance method conducted in pathology laboratories are used to detect unknown or late reported TB cases and allows to start treatment without further delay.


Assuntos
Tuberculose , Conduta Expectante , Estudos Transversais , Humanos , Tuberculose/tratamento farmacológico , Tuberculose/epidemiologia , Turquia/epidemiologia
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