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2.
Isr Med Assoc J ; 23(1): 48-51, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33443343

RESUMO

BACKGROUND: Adnexal torsion in pregnancy is often associated with functional adnexal cysts, especially in pregnancies conceived by ovulation induction (OI) or in-vitro fertilization (IVF). During laparoscopy for adnexal de-torsion, drainage of the functional cysts can be attempted, although this procedure may cause bleeding. OBJECTIVES: To investigate the characteristics of ovarian torsion in pregnancy associated with functional cysts and to compare the rate of torsion recurrence following de-torsion alone versus cyst drainage. METHODS: All cases of surgically diagnosed adnexal torsion occurring during pregnancy between January 2007 and April 2019 in our department were retrospectively analyzed. The cases of torsion associated with presumed functional ovarian cysts were selected. The rate of recurrent torsion during the same pregnancy was compared for de-torsion alone versus de-torsion and cyst aspiration. RESULTS: Of the 113 women who experienced adnexal torsion during pregnancy, 71 (67.0%) of torsion cases were caused by presumed functional ovarian cysts. Among women with torsion of functional ovarian cysts, the rate of torsion recurrence was significantly higher in patients who underwent de-torsion alone (n=28) compared to women who underwent aspiration and drainage of the ovarian cysts (n=43) (14.3% vs. 0, P = 0.021). There were no cases of intra- or post-operative bleeding in the study cohort. CONCLUSIONS: Functional ovarian cysts are the most common adnexal pathology encountered in pregnant women with torsion. Intra-operative cyst aspiration and drainage may reduce the risk of recurrent torsion. Further multi-center studies are required to validate our data prospectively.


Assuntos
Doenças dos Anexos , Drenagem/métodos , Cistos Ovarianos , Paracentese/métodos , Complicações na Gravidez , Doenças dos Anexos/diagnóstico , Doenças dos Anexos/etiologia , Doenças dos Anexos/cirurgia , Adulto , Feminino , Humanos , Cistos Ovarianos/complicações , Cistos Ovarianos/diagnóstico , Cistos Ovarianos/cirurgia , Gravidez , Complicações na Gravidez/diagnóstico , Complicações na Gravidez/etiologia , Complicações na Gravidez/cirurgia , Risco Ajustado/métodos , Prevenção Secundária/métodos , Anormalidade Torcional/diagnóstico , Anormalidade Torcional/etiologia , Anormalidade Torcional/cirurgia
3.
Med Care ; 59(1): 38-45, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33165147

RESUMO

BACKGROUND: Higher risk-adjusted rate of emergency department (ED) visits might reflect poor quality of nursing home (NH) care; however, existing evidence is limited regarding rural-urban differences in ED rates of NHs, especially for long-stay residents. OBJECTIVES: To determine and quantify sources of rural-urban differences in NH risk-adjusted rates of any ED visit, ED without hospitalization or observation stay (outpatient ED), and potentially avoidable ED visits (PAED) of long-stay residents. RESEARCH DESIGN: We calculated quarterly NH risk-adjusted rates using 2011-2013 national Medicare claims and Minimum Data Set 3.0, and then implemented Generalized Estimating Equation models to examine rural-urban differences in ED rates and Blinder-Oaxaca decomposition to quantify the contributions of NH and market factors. SUBJECTS: Privately owned, free-standing NHs in the United States (N=13,260). RESULTS: Over the study period, risk-adjusted rates averaged 9.8% for any ED, 3.3% for outpatient ED, and 3.2% for PAED. Compared with urban NHs, rural NHs were associated with significantly lower rates of any ED, outpatient ED, and PAED (ß=-1.67%, -0.44%, and -0.28%; all P<0.01). Observable differences in market factors (nursing home bed concentration, hospital beds, and the existence of a critical access hospital) explained about half of the rural-urban differences in rates of any ED and PAED, but not outpatient ED. CONCLUSIONS: Decomposition analyses suggested that lower ED rates in rural NHs appear to be related to market availability of hospital resources. Policymakers may focus on not only reducing unnecessary ED visits but also ensuring equitable hospital access in rural areas.


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Modelos Estatísticos , Casas de Saúde/estatística & dados numéricos , Risco Ajustado , População Rural/estatística & dados numéricos , População Urbana/estatística & dados numéricos , Idoso , Feminino , Humanos , Revisão da Utilização de Seguros/estatística & dados numéricos , Masculino , Sobremedicalização/estatística & dados numéricos , Medicare , Estados Unidos
4.
JAMA Netw Open ; 3(12): e2030207, 2020 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-33355674

RESUMO

Importance: Prepregnancy diabetes is associated with higher perinatal and maternal morbidity, especially if periconception glycemic control is suboptimal. It is not known whether improved glycemic control from preconception to early pregnancy and midpregnancy periods can reduce the risk of adverse perinatal and maternal outcomes. Objective: To determine whether a net decline in glycated hemoglobin A1c (HbA1c) from preconception to the first half of pregnancy is associated with a lower risk of adverse outcomes for mother and child. Design, Setting, and Participants: This population-based cohort study was completed in all of Ontario, Canada, from 2007 to 2018. Included were births among women with prepregnancy diabetes whose HbA1c was measured within 90 days preconception and again from conception through 21 weeks completed gestation (early pregnancy to midpregnancy). Statistical analysis was performed from July to September 2020. Exposures: Net decrease in HbA1c from preconception to early pregnancy and midpregnancy. Main Outcomes and Measures: The main outcome was a congenital anomaly from birth to age 1 year. Other outcomes included preterm birth or perinatal mortality among offspring as well as severe maternal morbidity (SMM) or death among mothers. Adjusted relative risks (aRRs) were calculated per 0.5% absolute net decline in HbA1c from preconception up to early pregnancy and midpregnancy, adjusting for maternal age at conception, preconception HbA1c and hemoglobin concentration, and gestational age at HbA1c measurement. Results: A total of 3459 births were included, with a mean (SD) maternal age of 32.6 (5.0) years at conception. Overall, the mean (SD) HbA1c decreased from 7.2% (1.6%) preconception to 6.4% (1.1%) in early pregnancy to midpregnancy. There were 497 pregnancies (14.4%) with a congenital anomaly, with an aRR of 0.94 (95% CI, 0.89-0.98) per 0.5% net decrease in HbA1c, including for cardiac anomalies (237 infants; aRR, 0.89; 95% CI, 0.84-0.95). The risk was also reduced for preterm birth (847 events; aRR, 0.89; 95% CI, 0.86-0.91). SMM or death occurred among 191 women (5.5%), with an aRR of 0.90 (95% CI, 0.84-0.96) per 0.5% net decrease in HbA1c. Conclusions and Relevance: These findings suggest that women with prepregnancy diabetes who achieve a reduction in HbA1c may have improved perinatal and maternal outcomes. Further study is recommended to determine the best combination of factors, such as lifestyle changes and/or glucose-lowering medications, that can influence periconception HbA1c reduction.


Assuntos
Diabetes Mellitus Tipo 2 , Hemoglobina A Glicada/análise , Cuidado Pré-Concepcional/métodos , Complicações na Gravidez , Risco Ajustado/métodos , Adulto , Anormalidades Congênitas/epidemiologia , Anormalidades Congênitas/prevenção & controle , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Ontário/epidemiologia , Gravidez , Complicações na Gravidez/sangue , Complicações na Gravidez/diagnóstico , Complicações na Gravidez/prevenção & controle , Resultado da Gravidez/epidemiologia , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/prevenção & controle
5.
BMJ Case Rep ; 13(12)2020 Dec 29.
Artigo em Inglês | MEDLINE | ID: mdl-33376091

RESUMO

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving treatment option with an inherent risk of causing cerebral infarctions. The mechanism of cerebral infarction during TAVI mainly involves embolisms from the aortic wall and valve. Transoesophageal echocardiography (TEE) is useful for detecting aortic atheromas. We present the case of a patient in whom the dispersal of aortic atheromas was monitored by TEE during TAVI. This report demonstrates the importance of preoperatively predicting embolisms from aortic atheromas in patients with severe aortic stenosis.


Assuntos
Aorta/diagnóstico por imagem , Estenose da Valva Aórtica , Aterosclerose , Infarto Cerebral , Ecocardiografia Transesofagiana/métodos , Complicações Intraoperatórias/diagnóstico por imagem , Placa Aterosclerótica/diagnóstico por imagem , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/cirurgia , Aterosclerose/complicações , Aterosclerose/diagnóstico , Infarto Cerebral/diagnóstico por imagem , Infarto Cerebral/etiologia , Humanos , Complicações Intraoperatórias/prevenção & controle , Masculino , Monitorização Intraoperatória/métodos , Cuidados Pré-Operatórios/métodos , Risco Ajustado , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
6.
Trials ; 21(1): 920, 2020 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-33176886

RESUMO

OBJECTIVES: The primary objective is to test if heparin added to a standard regional anticoagulation protocol based on citrate is able to reduce dialysis circuit losses by clotting without increasing the risk of thrombocytopenia or bleeding, in patients with COVID-19 with acute kidney injury requiring dialysis. TRIAL DESIGN: Randomized, parallel-group, open-label trial, with two arms (ratio 1:1) comparing different continuous renal replacement therapy anticoagulation strategies. PARTICIPANTS: Eligibility conditions: All ICU patients of University of Sao Paulo General Hospital (Hospital das Clínicas), Brazil will be screened for eligibility conditions. Adults (> 18 years old) with confirmed COVID-19 and acute kidney injury requiring dialysis with agreement between ICU and nephrology teams for the introduction of renal continuous replacement therapy in daily ICU rounds. Continuous renal replacement therapy will be prescribed by consulting nephrologists based on standard clinical guidelines, including acute kidney injury with hemodynamic instability plus hyperkalemia, severe acidosis, volume overload, respiratory distress, multiorgan failure or some combination of these factors. DATA COLLECTION: Patients demographics and associated clinical data and comorbidities will be recorded at ICU entry. Demographic information will include the patient's age, sex, and admission dates. Clinical data comprise comorbidities, APACHE 2, SAPS 3, need for mechanical ventilation, and use of vasopressor drugs. Physiological data collected by the day of CRRT start will be vital signs, the arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) index, and serum creatinine, blood urea nitrogen, bilirubin, hemoglobin, hematocrit, platelets, white blood cell count levels and Peak D-dimer levels. Patients will be analyzed for the first 72h of CRRT, and they will be evaluated regarding clinical variables, filter patency and any adverse events that could be related to the anticoagulation choice, as bleeding (mild or major) or low platelets counts (<100.000 ui/uL) during treatment period. Mild and major bleeding will be defined by hemorrhagic event without clinical impact or hemoglobin (Hb) fall lesser than 1g/dL and hemorrhagic event with clinical impact or Hb fall higher than 1g/dL, respectively. EXCLUSION CRITERIA: Hypersensitivity to any of the substances going to be used in the study (Citric acid dextrosol 2.2% and unfractionated heparin); Previous diagnosis of coagulopathy or thrombophilia; Contraindication to the use of unfractionated heparin; Risk of citrate poisoning - (Lactate> 30 mg/dL, international normalized ratio > 2.5, Total bilirubin> 15 mg/dL); Pregnancy; Patients unlikely to survive for more than 24 hours. The trial is being undertaken at the University of Sao Paulo General Hospital (Hospital das Clinicas), Brazil. INTERVENTION AND COMPARATOR: Group A (control) - Patients on continuous renal replacement therapy (blood flow 150 ml/min, dose of 30 mL/Kg/h) receiving anticoagulation with sodium citrate at 4 mmol/L Group B (experiment): Patients on continuous hemodialysis (blood flow 150 mL/min, dose of 30 mL/Kg/h) receiving anticoagulation with sodium citrate at 4 mmol/L associated with unfractionated heparin at 10 U/Kg/h. MAIN OUTCOMES: The percentage of clotted dialyzers within 72 hours in each of the studied groups (Primary outcome) Secondary outcomes: Number of dialyzers used in the first 72 hours of dialysis protocol, Mortality in the first 72 h of dialysis protocol, Bleeding events (Major or minor) in the first 72 h of dialysis protocol, Thrombocytopenia (less than 50.000 platelets) proportion in the first 72 h of dialysis protocol, Dialysis efficiency (Urea sieving) - variation in urea sieving between the first, second and third days of dialysis protocol, Continuous renal replacement therapy pressures (Arterial, Venous, dialysate and pre-filter pressure) in the first 72 h of dialysis protocol, in-hospital mortality. RANDOMIZATION: RedCap→ randomization - 2 blocks randomization by D-dimer level (5000ng/dL cut-off) and catheter site (Right Internal Jugular versus other sites) with 1:1 allocation ratio. BLINDING (MASKING): No blinding - Open label format NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): Total number of patients 90 (45 per group) TRIAL STATUS: Trial version 2.0 - ongoing recruitment. First recruitment: June 29, 2020 Estimated date for last recruitment: December 31, 2020 TRIAL REGISTRATION: Responsible Party: University of Sao Paulo General Hospital (Hospital das Clinicas) ClinicalTrials.gov Identifier: NCT04487990 , registered July 27, 2020, ReBec www.ensaiosclinicos.gov.br/rg/RBR-45kf9p/ Other Study ID Numbers: U1111-1252-0194 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1) In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Lesão Renal Aguda , Infecções por Coronavirus , Monitoramento de Medicamentos/métodos , Heparina , Pandemias , Pneumonia Viral , Diálise Renal , Trombose/prevenção & controle , Lesão Renal Aguda/etiologia , Lesão Renal Aguda/terapia , Adulto , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Coagulação Sanguínea/efeitos dos fármacos , Infecções por Coronavirus/sangue , Infecções por Coronavirus/complicações , Infecções por Coronavirus/tratamento farmacológico , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Hemoglobinas/análise , Hemorragia/etiologia , Hemorragia/prevenção & controle , Heparina/administração & dosagem , Heparina/efeitos adversos , Humanos , Masculino , Avaliação de Resultados em Cuidados de Saúde , Pneumonia Viral/sangue , Pneumonia Viral/complicações , Pneumonia Viral/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Diálise Renal/efeitos adversos , Diálise Renal/métodos , Risco Ajustado/métodos , Trombocitopenia/etiologia , Trombocitopenia/prevenção & controle , Trombose/complicações
7.
BMJ ; 371: m3503, 2020 10 07.
Artigo em Inglês | MEDLINE | ID: mdl-33028540

RESUMO

OBJECTIVE: To assess treatment related changes in quality of life up to 15 years after diagnosis of localised prostate cancer. DESIGN: Population based, prospective cohort study with follow-up over 15 years. SETTING: New South Wales, Australia. PARTICIPANTS: 1642 men with localised prostate cancer, aged less than 70, and 786 controls randomly recruited from the New South Wales electoral roll into the New South Wales Prostate Cancer Care and Outcomes Study (PCOS). MAIN OUTCOME MEASURES: General health and disease specific quality of life were self-reported at seven time points over a 15 year period, using the 12-item Short Form Health Survey scale, University of California, Los Angeles prostate cancer index, and expanded prostate cancer index composite short form (EPIC-26). Adjusted mean differences were calculated with controls as the comparison group. Clinical significance of adjusted mean differences was assessed by the minimally important difference, defined as one third of the standard deviation (SD) from the baseline score. RESULTS: At 15 years, all treatment groups reported high levels of erectile dysfunction, depending on treatment (62.3% (active surveillance/watchful waiting, n=33/53) to 83.0% (non-nerve sparing radical prostatectomy, n=117/141)) compared with controls (42.7% (n=44/103)). Men who had external beam radiation therapy or high dose rate brachytherapy or androgen deprivation therapy as primary treatment reported more bowel problems. Self-reported urinary incontinence was particularly prevalent and persistent for men who underwent surgery, and an increase in urinary bother was reported in the group receiving androgen deprivation therapy from 10 to 15 years (year 10: adjusted mean difference -5.3, 95% confidence interval -10.8 to 0.2; year 15: -15.9; -25.1 to -6.7). CONCLUSIONS: Patients receiving initial active treatment for localised prostate cancer had generally worse long term self-reported quality of life than men without a diagnosis of prostate cancer. Men treated with radical prostatectomy faired especially badly, particularly in relation to long term sexual outcomes. Clinicians and patients should consider these long term quality of life outcomes when making treatment decisions.


Assuntos
Antagonistas de Androgênios , Braquiterapia , Efeitos Adversos de Longa Duração , Prostatectomia , Neoplasias da Próstata , Qualidade de Vida , Idoso , Antagonistas de Androgênios/efeitos adversos , Antagonistas de Androgênios/uso terapêutico , Austrália/epidemiologia , Braquiterapia/efeitos adversos , Braquiterapia/métodos , Estudos de Coortes , Disfunção Erétil/epidemiologia , Disfunção Erétil/etiologia , Humanos , Efeitos Adversos de Longa Duração/epidemiologia , Efeitos Adversos de Longa Duração/etiologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Estudos Prospectivos , Prostatectomia/efeitos adversos , Prostatectomia/métodos , Neoplasias da Próstata/epidemiologia , Neoplasias da Próstata/patologia , Neoplasias da Próstata/psicologia , Neoplasias da Próstata/terapia , Risco Ajustado , Incontinência Urinária/epidemiologia , Incontinência Urinária/etiologia
8.
Oncology (Williston Park) ; 34(10): 432-441, 2020 10 09.
Artigo em Inglês | MEDLINE | ID: mdl-33058111

RESUMO

Worldwide incidence and mortality due to the coronavirus disease 2019 (COVID-19) pandemic is greatest in the United States, with the initial epicenter in New York. In Nassau County, New York, where we practice, our institution has had more than 2500 cases and has discharged from the hospital more than 1000 patients. As many academic and private institutions have swiftly shifted their clinical and research priorities to address the pandemic, data are emerging regarding both the impact of malignancy on COVID-19 outcomes as well as the challenges faced in assuring that cancer care remains unimpeded. Of concern, recent studies of cancer patients primarily in China and Italy have suggested that advanced malignancy is associated with increased susceptibility to severe COVID-19 infection. At present, more than 500 clinical trials are underway investigating the pathogenesis and treatment of COVID-19, including expanded use of oncology drugs, such as small molecular inhibitors of cytokine pathways. Here, we begin by reviewing the latest understanding of COVID-19 pathophysiology and then focus our attention on the impact of this virus on hematologic and oncologic practice. Finally, we highlight ongoing investigational treatment approaches that are so relevant to the care of oncology patients during this extraordinary pandemic.


Assuntos
Antineoplásicos , Betacoronavirus , Infecções por Coronavirus , Assistência à Saúde , Controle de Infecções , Oncologia , Neoplasias , Pandemias , Pneumonia Viral , Antineoplásicos/classificação , Antineoplásicos/farmacologia , Betacoronavirus/efeitos dos fármacos , Betacoronavirus/patogenicidade , Betacoronavirus/fisiologia , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Infecções por Coronavirus/virologia , Assistência à Saúde/organização & administração , Assistência à Saúde/normas , Assistência à Saúde/tendências , Drogas em Investigação/farmacologia , Humanos , Controle de Infecções/métodos , Controle de Infecções/organização & administração , Oncologia/métodos , Oncologia/normas , Neoplasias/epidemiologia , Neoplasias/terapia , New York/epidemiologia , Pandemias/prevenção & controle , Assistência ao Paciente/métodos , Assistência ao Paciente/normas , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , Pneumonia Viral/virologia , Risco Ajustado/métodos , Medição de Risco
9.
Trials ; 21(1): 828, 2020 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-33023671

RESUMO

OBJECTIVES: Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. • To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge. TRIAL DESIGN: Randomised, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent plasma or standard of care. PARTICIPANTS: High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorised in 4 groups: • Group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. • Group 2, chronic immunosuppression not meeting the criteria of group 1. • Group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1µg/mL. • Group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2. Observation time for all patients is expected to be at least 3 months after entry into the study. Patients receive convalescent plasma for two days (day 1 and day 2) or standard of care. For patients in the standard arm, cross over is allowed from day 10 in case of not improving or worsening clinical condition. Nose/throat swabs for determination of viral load are collected at day 0 and day 1 (before first CP administration) and subsequently at day 2, 3, 5, 7, 10, 14, 28 or until discharge. Serum for SARS-Cov-2 diagnostic is collected at baseline and subsequently at day 3, 7, 14 and once during the follow-up period (between day 35 and day 84). There is a regular follow-up of 3 months. All discharged patients are followed by regular phone calls. All visits, time points and study assessments are summarized in the Trial Schedule (see full protocol Table 1). All participating trial sites will be supplied with study specific visit worksheets that list all assessments and procedures to be completed at each visit. All findings including clinical and laboratory data are documented by the investigator or an authorized member of the study team in the patient's medical record and in the electronic case report forms (eCRFs). INTERVENTION AND COMPARATOR: This trial will analyze the effects of convalescent plasma from recovered subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection. Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment. In addition, eligible patients have a confirmed SARS-CoV-2 infection and O2 saturation ≤ 94% while breathing ambient air. Patients are randomised to receive (experimental arm) or not receive (standard arm) convalescent plasma in two bags (238 - 337 ml plasma each) from different donors (day 1, day 2). A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition. MAIN OUTCOMES: Primary endpoints: The main purpose of the study is to assess the time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of a SARS-CoV-2 infection or standard of care. Secondary endpoints: • Overall survival, defined as the time from randomisation until death from any cause 28-day, 56-day and 84-day overall survival rates. • SARS-CoV-2 viral clearance and load as well as antibody titres. • Requirement mechanical ventilation at any time during hospital stay (yes/no). • Time until discharge from randomisation. • Viral load, changes in antibody titers and cytokine profiles are analysed in an exploratory manner using paired non-parametric tests (before - after treatment). RANDOMISATION: Upon confirmation of eligibility (patients must meet all inclusion criteria and must not meet exclusion criteria described in section 5.3 and 5.4 of the full protocol), the clinical site must contact a centralized internet randomization system ( https://randomizer.at/ ). Patients are randomized using block randomisation to one of the two arms, experimental arm or standard arm, in a 1:1 ratio considering a stratification according to the 4 risk groups (see Participants). BLINDING (MASKING): The study is open-label, no blinding will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total number of 174 patients is required for the entire trial, n=87 per group. TRIAL STATUS: Protocol version 1.2 dated 09/07/2020. A recruitment period of approximately 9 months and an overall study duration of approximately 12 months is anticipated. Recruitment of patients starts in the third quarter of 2020. The study duration of an individual patient is planned to be 3 months. After finishing all study-relevant procedures, therapy, and follow-up period, the patient is followed in terms of routine care and treated if necessary. Total trial duration: 18 months Duration of the clinical phase: 12 months First patient first visit (FPFV): 3rd Quarter 2020 Last patient first visit (LPFV): 2nd Quarter 2021 Last patient last visit (LPLV): 3rd Quarter 2021 Trial Report completed: 4th Quarter 2021 TRIAL REGISTRATION: EudraCT Number: 2020-001632-10, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE , registered on 04/04/2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). The eCRF is attached (Additional file 3).


Assuntos
Anticorpos Antivirais/sangue , Betacoronavirus , Infecções por Coronavirus , Pandemias , Plasma/imunologia , Pneumonia Viral , Idoso , Betacoronavirus/imunologia , Betacoronavirus/isolamento & purificação , Ensaios Clínicos Fase II como Assunto , Convalescença , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/terapia , Feminino , Humanos , Imunização Passiva/métodos , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Estudos Multicêntricos como Assunto , Pneumonia Viral/diagnóstico , Pneumonia Viral/imunologia , Pneumonia Viral/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco Ajustado , Índice de Gravidade de Doença
11.
Am Heart J ; 228: 65-71, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32866927

RESUMO

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.


Assuntos
Doença da Artéria Coronariana , Vasos Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea , Complicações Pós-Operatórias , Risco Ajustado/métodos , Ultrassonografia de Intervenção , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Cirurgia Assistida por Computador/métodos , Ultrassonografia de Intervenção/economia , Ultrassonografia de Intervenção/métodos
12.
Am J Perinatol ; 37(13): 1377-1384, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32898920

RESUMO

The novel coronavirus disease 2019 (COVID-19) pandemic has resulted in changes to perinatal and neonatal care, concentrating on minimizing risks of transmission to the newborn and health care staff while ensuring medical care is not compromised for both mother and infant. Current recommendations on infant care and feeding when mother has COVID-19 ranges from mother-infant separation and avoidance of human milk feeding, to initiation of early skin-to-skin contact and direct breastfeeding. Health care providers fearing risks of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) maternal-infant transmission may veer toward restricted breastfeeding practices. We reviewed guidelines and published literature and propose three options for infant feeding depending on various scenarios. Option A involves direct breastfeeding with the infant being cared for by the mother or caregiver. In option B, the infant is cared for by another caregiver and receives mother's expressed milk. In the third option, the infant is not breastfed directly and does not receive mother's expressed milk. We recommend joint decision making by parents and the health care team. This decision is also flexible as situation changes. We also provide a framework for counseling mothers on these options using a visual aid and a corresponding structured training program for health care providers. Future research questions are also proposed. We conclude that evidence and knowledge about COVID-19 and breastfeeding are still evolving. Our options can provide a quick and flexible reference guide that can be adapted to local needs. KEY POINTS: · SARS-CoV-2 is unlikely transmitted via human milk.. · A shared decision making on infant feeding is the preferred approach.. · Mothers can safely breastfeed with appropriate infection control measures..


Assuntos
Aleitamento Materno/métodos , Infecções por Coronavirus , Controle de Infecções/métodos , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Leite Humano/virologia , Pandemias , Pneumonia Viral , Complicações Infecciosas na Gravidez , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Aconselhamento/métodos , Tomada de Decisões , Feminino , Humanos , Recém-Nascido , Comportamento Materno , Mães/psicologia , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Gravidez , Complicações Infecciosas na Gravidez/epidemiologia , Complicações Infecciosas na Gravidez/prevenção & controle , Risco Ajustado/métodos
13.
R I Med J (2013) ; 103(8): 29-33, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32900009

RESUMO

In 2020, the COVID-19 pandemic has ravaged the world. Individuals with end-stage kidney disease (ESKD) are at higher risk due to impaired immunity, comorbid conditions, and dependence on travel to medical care settings. We review the salient features of COVID-19 in this population, including the risk of infection, disease course, changes in dialysis unit management, use of investigatory medications, access considerations, home dialysis, and capacity planning.


Assuntos
Infecções por Coronavirus , Unidades Hospitalares de Hemodiálise/organização & administração , Hemodiálise no Domicílio/métodos , Falência Renal Crônica , Pandemias , Pneumonia Viral , Diálise Renal/métodos , Risco Ajustado/métodos , Betacoronavirus , Comorbidade , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Transmissão de Doença Infecciosa/prevenção & controle , Humanos , Controle de Infecções/métodos , Falência Renal Crônica/epidemiologia , Falência Renal Crônica/terapia , Inovação Organizacional , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle
15.
Am Heart J ; 228: 109-115, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32882569

RESUMO

BACKGROUND: Patients aged ≥80 years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients. METHODS: We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials. The main clinical end point was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization. RESULTS: The 671 octogenarian trial participants had significantly more comorbidities. TVF was higher in octogenarians than in 8,533 patients <80 years (7.3% vs 5.3%, hazard ratio [HR]: 1.36, 95% CI: 1.0-1.83, P = .04). The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001). There was no significant between-group difference in target vessel MI (2.3% vs 2.3%, P = .88) and repeat target vessel revascularization (1.9% vs 2.8%, P = .16). In multivariate analyses, age ≥ 80 years showed no independent association with TVF (adjusted HR: 1.04, 95% CI: 0.76-1.42), whereas the risk of cardiac death remained higher in octogenarians (adjusted HR: 3.38, 95% CI: 2.07-5.52, P < .001). In 6,002 trial participants, in whom data on major bleeding were recorded, octogenarians (n = 459) showed a higher major bleeding risk (5.9% vs 1.9%; HR: 3.08, 95% CI: 2.01-4.74, P < .001). CONCLUSIONS: Octogenarian participants in 4 large-scale randomized DES trials had more comorbidities and a higher incidence of the main end point TVF. Cardiac mortality was higher in octogenarians, whereas there was no increase in MI or target vessel revascularization rates. Treatment of octogenarian patients with new-generation DES appears to be safe and effective.


Assuntos
Stents Farmacológicos/classificação , Everolimo/farmacologia , Infarto do Miocárdio , Complicações Pós-Operatórias , Sirolimo/análogos & derivados , Sirolimo/farmacologia , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Feminino , Humanos , Imunossupressores/farmacologia , Masculino , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/mortalidade , Reoperação/métodos , Reoperação/estatística & dados numéricos , Risco Ajustado/métodos , Fatores de Risco , Resultado do Tratamento
16.
Semin Arthritis Rheum ; 50(5): 1049-1054, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32911282

RESUMO

OBJECTIVE: To investigate the perceptions and behaviors of rheumatologists in the United States (US) regarding the risk of COVID-19 for their autoimmune patients and the subsequent management of immunosuppressive and anti-inflammatory medications. METHODS: We administered an online survey to a convenience sample of rheumatologists in the US from 4/8/20-5/4/20 via social media and group emails. Survey respondents provided demographic information such as, age, gender, state of practice, and practice type. We asked questions about COVID-19 risk in rheumatic patients, as well as their medication management during the pandemic. We conducted descriptive analysis and Multivariable regression models. RESULTS: 271 respondents completed the survey nationally. 48% of respondents either agreed or strongly agreed with the statement "Patients with rheumatic diseases are at a higher risk of COVID-19 irrespective of their immunosuppressive medications". 50% disagreed or strongly disagreed with the statement "The pandemic has led you to reduce the use/dosage/frequency of biologics", while 56% agreed or strongly agreed with the statement "The pandemic has led you to reduce the use/dosage/frequency of steroids". A third of respondents indicated that at least 10% of their patients had self-discontinued or reduced at least one immunosuppressive medication to mitigate their risk of COVID-19. Responses to these questions as well as to questions regarding NSAID prescription patterns were significantly different in the Northeast region of US compared to other regions. CONCLUSION: In this national sample of rheumatologists, there are variations regarding perceptions of patients' risk of COVID-19, and how to manage medications such as NSAIDs, biologics and steroids during the pandemic. These variations are more pronounced in geographical areas where COVID-19 disease burden was high.


Assuntos
Infecções por Coronavirus , Conduta do Tratamento Medicamentoso/estatística & dados numéricos , Pandemias , Pneumonia Viral , Doenças Reumáticas , Reumatologistas/estatística & dados numéricos , Risco Ajustado/métodos , Adulto , Atitude do Pessoal de Saúde , Betacoronavirus , Produtos Biológicos/uso terapêutico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Assistência à Saúde/tendências , Feminino , Glucocorticoides/uso terapêutico , Humanos , Masculino , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Área de Atuação Profissional/estatística & dados numéricos , Doenças Reumáticas/epidemiologia , Doenças Reumáticas/terapia , Medição de Risco , Percepção Social , Estados Unidos/epidemiologia
18.
Obstet Gynecol ; 136(4): 792-801, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32925609

RESUMO

OBJECTIVE: To assess whether resting genital hiatus, perineal body, and total vaginal length measured intraoperatively at the conclusion of surgery are associated with prolapse recurrence 2 years after native tissue pelvic organ prolapse reconstruction. METHODS: This ancillary analysis of the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial included women who had an immediate postoperative pelvic organ prolapse quantification (POP-Q) examination and 2-year follow-up. Primary outcome was bothersome bulge symptoms. Secondary outcomes were anatomic failure, surgical failure (either anatomic failure or bothersome bulge symptoms), and sexual function. Descriptive statistics assessed relationships between postprocedure POP-Q measures and these four outcomes. Multivariable models were fit to the data to control for baseline differences in bivariate comparisons. Receiver operating characteristic curves were generated to identify an optimal genital hiatus cut point associated with bothersome bulge, and this threshold was explored. RESULTS: This analysis included 368 participants. Bivariate analyses identified age, body mass index, vaginal deliveries, baseline genital hiatus, perineal body, and advanced POP-Q stage (3 or higher vs 2) as clinically relevant variables to include in multivariable models. After adjusting for these variables, the association between immediate postoperative genital hiatus and bothersome bulge (adjusted odds ratio [aOR] 1.4; 95% CI 0.9-2.1) was not significant at the P<.05 level; however, immediate postoperative genital hiatus was associated with anatomic (aOR 1.6; 95% CI 1.1-2.3) and surgical failure (aOR 1.5; 95% CI 1.0-2.1). Immediate postoperative genital hiatus of 3.5 cm was the selected cutoff (area under the curve 0.58, 95% CI 0.50-0.66 from the bothersome bulge model). Women with genital hiatus 3.5 cm or greater were more likely to have anatomic and surgical failures at 2 years. No POP-Q measures were correlated with 2-year sexual function. CONCLUSION: A larger immediate postoperative genital hiatus measurement of 3.5 cm or greater is not associated with bothersome bulge symptoms or sexual dysfunction but is associated with anatomic and surgical failures 2 years after native tissue vaginal reconstructive surgery.


Assuntos
Procedimentos Cirúrgicos em Ginecologia , Prolapso de Órgão Pélvico , Complicações Pós-Operatórias/diagnóstico , Procedimentos Cirúrgicos Reconstrutivos , Risco Ajustado/métodos , Disfunções Sexuais Fisiológicas , Feminino , Seguimentos , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Diafragma da Pelve/cirurgia , Prolapso de Órgão Pélvico/diagnóstico , Prolapso de Órgão Pélvico/fisiopatologia , Prolapso de Órgão Pélvico/cirurgia , Prognóstico , Procedimentos Cirúrgicos Reconstrutivos/efeitos adversos , Procedimentos Cirúrgicos Reconstrutivos/métodos , Recidiva , Índice de Gravidade de Doença , Disfunções Sexuais Fisiológicas/diagnóstico , Disfunções Sexuais Fisiológicas/etiologia , Avaliação de Sintomas/métodos
19.
Obstet Gynecol ; 136(4): 745-755, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32925617

RESUMO

OBJECTIVE: To investigate subsequent birth rates, maternal and neonatal outcomes for women with a history of placenta accreta spectrum (placenta accreta, increta, and percreta). METHODS: A population-based record linkage study of women who had a first, second, or third birth in New South Wales from 2003 to 2016 was conducted. Data were obtained from birth and hospital records and death registrations. Women with a history of placenta accreta spectrum were matched to women without, on propensity score and parity, to compare outcomes with women who had similar risk profiles. Modified Poisson regression models were used to calculate adjusted relative risk (aRR) for a range of maternal and neonatal outcomes. RESULTS: We identified recurrent placenta accreta spectrum in 27/570 (4.7%, 95% CI 3.0-6.5%) of second and 9/119 (7.6%, 95% CI 2.8-12.3%) of third pregnancies after placenta accreta spectrum in the preceding birth, with an overall recurrence rate of 38/689 (5.5%, 95% CI 3.9-7.5%, compared with the population prevalence of 25.5/10,000 births (95% CI 24.6-26.4). Subsequent births after placenta accreta spectrum had higher risk of postpartum hemorrhage (aRR 1.51, 95% CI 1.19-1.92), transfusion (aRR 2.13, 95% CI 1.17-3.90), cesarean delivery (aRR 1.19, 95% CI 1.02-1.37), manual removal of placenta (aRR 6.92, 95% CI 3.81-12.55), and preterm birth (aRR 1.43, 95% CI 1.03-1.98), with lower risk of small for gestational age (aRR 0.64, 95% CI 0.43-0.96), compared with similar-risk births. CONCLUSION: Women with a history of placenta accreta spectrum have increased risk of maternal morbidity, preterm birth, and placenta accreta spectrum in the subsequent pregnancy compared with similar-risk women with no previous placenta accreta spectrum, although the absolute risks are generally low. These findings may be used to inform counseling of women on the risks of future pregnancies.


Assuntos
Cesárea , Parto Obstétrico , Histerectomia , Placenta Acreta , Hemorragia Pós-Parto , Nascimento Prematuro , Adulto , Austrália/epidemiologia , Transfusão de Sangue/estatística & dados numéricos , Cesárea/métodos , Cesárea/estatística & dados numéricos , Parto Obstétrico/efeitos adversos , Parto Obstétrico/métodos , Parto Obstétrico/estatística & dados numéricos , Feminino , Humanos , Histerectomia/métodos , Histerectomia/estatística & dados numéricos , Recém-Nascido , Masculino , Placenta Acreta/epidemiologia , Placenta Acreta/terapia , Hemorragia Pós-Parto/epidemiologia , Hemorragia Pós-Parto/etiologia , Hemorragia Pós-Parto/terapia , Gravidez , Resultado da Gravidez/epidemiologia , Gravidez de Alto Risco , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/etiologia , Sistema de Registros/estatística & dados numéricos , História Reprodutiva , Risco Ajustado/métodos , Fatores de Risco
20.
Am Heart J ; 228: 72-80, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32871327

RESUMO

BACKGROUND: The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown. METHODS AND DESIGN: The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year. RESULTS: Up to the end of July 2020, approximately 1,200 "real-world" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023. CONCLUSION: This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.


Assuntos
Vasos Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/prevenção & controle , Cirurgia Assistida por Computador/métodos , Tomografia de Coerência Óptica/métodos , Ultrassonografia de Intervenção/métodos , Pesquisa Comparativa da Efetividade , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco Ajustado/métodos
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