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1.
BMJ Open ; 14(2): e080408, 2024 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-38418244

RESUMO

OBJECTIVE: To evaluate the impact of mental health comorbidity in children and young adults with inflammatory bowel disease (IBD). DESIGN: Retrospective observational study. SETTING: Representative population, routinely collected primary care data from the UK Optimum Patient Care Research Database (2015-2019). PARTICIPANTS: Patients with IBD aged 5-25 years with mental health conditions were compared with patients with IBD of the same age without mental health conditions. PRIMARY AND SECONDARY OUTCOME MEASURES: Outcomes comprised quality-of-life indicators (low mood, self-harm, parasuicide, bowel symptoms, absence from school or work, unemployment, substance use and sleep disturbance), IBD interventions (medication, abdominal surgery, stoma formation and nutritional supplements) and healthcare utilisation (primary care interactions and hospital admissions). RESULTS: Of 1943 individuals aged 5-25 years with IBD, 295 (15%) had a mental health comorbidity. Mental health comorbidity was associated with increased bowel symptoms (adjusted incident rate ratio (aIRR) 1.82; 95% CI 1.33 to 2.52), sleep disturbance (adjusted HR (aHR) 1.63; 95% CI 1.02 to 2.62), substance use (aHR 3.63; 95% CI 1.69 to 7.78), primary care interactions (aIRR 1.33; 95% CI 1.12 to 1.58) and hospital admissions (aIRR 1.87; 95%CI 1.29 to 2.75). In individuals ≥18 years old, mental health comorbidity was associated with increased time off work (aHR 1.55; 95% CI 1.21 to 1.99). CONCLUSIONS: Mental health comorbidity in children and young adults with IBD is associated with poorer quality of life, higher healthcare utilisation and more time off work. It is imperative that affected young patients with IBD are monitored and receive early mental health support as part of their multidisciplinary care. TRIAL REGISTRATION NUMBER: The study protocol was specified and registered a priori (ClinicalTrials.gov study identifier: NCT05206734).


Assuntos
Doenças Inflamatórias Intestinais , Transtornos Relacionados ao Uso de Substâncias , Criança , Humanos , Adulto Jovem , Adolescente , Estudos de Coortes , Saúde Mental , Qualidade de Vida , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/epidemiologia , Doenças Inflamatórias Intestinais/terapia , Comorbidade , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Reino Unido/epidemiologia
2.
Int J Angiol ; 33(1): 36-45, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38352638

RESUMO

The study aims to review the sex differences with respect to transient ischemic attack (TIA)/stroke and death in the perioperative period and on long-term follow-up among asymptomatic patients treated with carotid stenting (CAS) in the vascular quality initiative (VQI). All cases reported to VQI of asymptomatic CAS (ACAS) patients were reviewed. The primary end point was risk of TIA/stroke and death in the in-hospital perioperative period and in the long-term follow-up. The secondary end point was to evaluate predictors of in-hospital perioperative TIA/stroke and mortality on long-term follow-up after CAS. There were 22,079 CAS procedures captured from January 2005 to April 2019. There were 5,785 (62.7%) patients in the ACAS group. The rate of in-hospital TIA/stroke was higher in female patients (2.7 vs. 1.87%, p = 0.005) and the rate of death was not significant (0.03 vs. 0.07%, p = 0.66). On multivariable logistic regression analysis, prior/current smoking history (odds ratio = 0.58 [95% confidence interval or CI = 0.39-0.87]; p = 0.008) is a predictor of in-hospital TIA/stroke in females. The long-term all-cause mortality is significantly higher in male patients (26.9 vs. 15.7%, p < 0.001). On multivariable Cox-regression analysis, prior/current smoking history (hazard ratio or HR = 1.17 [95% CI = 1.01-1.34]; p = 0.03), coronary artery disease or CAD (HR = 1.15 [95% CI = 1.03-1.28]; p = 0.009), chronic obstructive pulmonary disease or COPD (HR = 1.73 [95% CI = 1.55-1.93]; p < 0.001), threat to life American Society of Anesthesiologists (ASA) class (HR = 2.3 [95% CI = 1.43-3.70]; p = 0.0006), moribund ASA class (HR = 5.66 [95% CI = 2.24-14.29]; p = 0.0003), and low hemoglobin levels (HR = 0.84 [95% CI = 0.82-0.86]; p < 0.001) are the predictors of long-term mortality. In asymptomatic carotid disease patients, women had higher rates of in-hospital perioperative TIA/stroke and a predictor of TIA/stroke is a prior/current history of smoking. Meanwhile, long-term all-cause mortality is higher for male patients compared with their female counterparts. Predictors of long-term mortality are prior/current smoking history, CAD, COPD, higher ASA classification of physical status, and low hemoglobin level. These data should be considered prior to offering CAS to asymptomatic female and male patients and careful risks versus benefits discussion should be offered to each individual patient.

3.
Ann Vasc Surg ; 95: 224-232, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37164170

RESUMO

BACKGROUND: To perform a systematic literature review to assess the usefulness of performing magnetic resonance angiography (MRA) with vessel wall imaging (VWI) sequences for the assessment of symptomatic carotid artery plaques and the identification of risky plaque features predisposing for stroke. METHODS: We performed a systematic review of the literature pertaining to MRA with VWI techniques in patients with carotid artery disease, focusing on symptomatic patients' plaque features and morphology. Independent reviewers screened and analyzed data extracted from eligible studies, and a modified Newcastle-Ottawa Scale was used to appraise the quality of the design and content of the selected manuscripts to achieve an accurate interpretation. RESULTS: This review included nineteen peer-reviewed manuscripts, all of them including MRA and VWI assessments of the symptomatic carotid artery plaque. We focused on patients' comorbidities and reviewed plaque features, including intraplaque hemorrhage, a lipid-rich necrotic core, a ruptured fibrous cap, and plaque ulceration. CONCLUSIONS: MRA with VWI is a useful tool in the evaluation of carotid artery plaques. This imaging technique allows clinicians to identify plaques at risk of causing a neurovascular event. The presence of intraplaque hemorrhage, plaque ulceration, a ruptured fibrous cap, and a lipid-rich necrotic core are associated with neurovascular symptoms. The timely identification of these features could have a positive impact on neurovascular event prevention.


Assuntos
Estenose das Carótidas , Placa Aterosclerótica , Humanos , Estenose das Carótidas/complicações , Angiografia por Ressonância Magnética/métodos , Imageamento por Ressonância Magnética , Resultado do Tratamento , Placa Aterosclerótica/complicações , Hemorragia , Lipídeos , Artérias Carótidas/diagnóstico por imagem , Artérias Carótidas/patologia
4.
Ann Vasc Surg ; 93: 142-148, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36773931

RESUMO

BACKGROUND: Previous studies suggest a coprevalence of intracranial aneurysms (IA) in patients with infrarenal abdominal aortic aneurysms (AAA). We reviewed our multicenter experience in the detection/treatment of IAs in patients with ascending thoracic aortic aneurysms (ATAA) relative to patients without ATAA. METHODS: Surgical cases of ATAA repaired at 3 sites from January 1998 to December 2018 were retrospectively reviewed. Out of these patients, those with intracranial vascular imaging were selected for our study, and these individuals were concurrently randomly matched with a control group of patients who underwent intracranial vascular imaging without an ATAA in a 1:1 ratio by age, sex, smoking history, and year of intracranial vascular imaging. Conditional logistic regression was used to calculate odds ratios (OR). RESULTS: We reviewed 2176 ATAA repairs. 74% (n = 1,615) were men. Intracranial vascular imaging was available in 298 (13.7%) patients. Ninteen patients were found to have 22 IAs for a prevalence of 6.4%. Mean size of IA was 4.6 ± 3.3 mm; mean age at IA detection, 63.4 ± 12.1 years. IA was present on head imaging in 4.7% of male and 12.5% of female patients. Eleven (58%) patients were men. The OR of having IA in female versus male patients is 2.90, 95% confidence interval [CI] [1.08-7.50], P = 0.029. Time from IA diagnosis to ATAA repair was 1.7 ± 116.2 months. Two patients underwent treatment for IA, one ruptured and one unruptured. All were diagnosed before ATAA repair. Treatment included 1 clipping and 1 coiling with subsequent reintervention of the coiling using a flow diversion device. In the matched group of patients who had intracranial vascular imaging without ATAA, the rate of IA is 5.0%. IA was detected in 3.8% of males and 9.4% of female patients for an OR of 2.59, 95% CI [0.84-7.47], P = 0.083. Association within our study and matched groups, the OR of developing an IA with and without ATAA was not statistically significant 1.29, 95% CI [0.642.59], P = 0.48. There was also no evidence of sex differences in the association of ATAA with IA (interaction P = 0.88). The OR for the association of ATAA with IA was 1.33, 95% CI [0.46-3.84], P = 0.59 in females and 1.25, 95% CI [0.49-3.17], P = 0.64 in males. CONCLUSIONS: Our study found that IA was present in 6.4% of patients with ATAA who had intracranial vascular imaging available. The odds of IA were 1.29 times higher than a matched cohort of patients who had intracranial vascular imaging without ATAA but this failed to achieve statistical significance. We found that the odds of IA were more than 2 times higher in females than males for both those with ATAA (OR = 2.90) and those without ATAA (OR = 2.59); however, it only reached statistical significance in those with ATAA.


Assuntos
Aneurisma da Aorta Torácica , Aneurisma Aórtico , Aneurisma Intracraniano , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/epidemiologia , Aneurisma Intracraniano/cirurgia , Estudos Retrospectivos , Prevalência , Fatores de Risco , Resultado do Tratamento , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/epidemiologia , Aneurisma da Aorta Torácica/cirurgia , Aneurisma Aórtico/complicações , Estudos Multicêntricos como Assunto
5.
Neurology ; 99(9): 381-386, 2022 08 30.
Artigo em Inglês | MEDLINE | ID: mdl-35764399

RESUMO

Acute vision loss related to cerebral or retinal ischemia is a time-sensitive emergency with potential treatment options including IV or intra-arterial thrombolysis and mechanical thrombectomy. However, patients either present in a delayed fashion or present to an emergency department that lacks the subspecialty expertise to recognize and treat these conditions in a timely fashion. Moreover, health care systems in the United States are becoming increasingly reliant on telestroke and teleneurology services for acute neurologic care, making the accurate diagnosis of acute vision loss even more challenging due to critical limitations to the remote video evaluation, including the inability to perform routine ophthalmoscopy. The COVID-19 pandemic has led to a greater reliance on telemedicine services and helped to accelerate the development of novel tools and care pathways to improve remote ophthalmologic evaluation, but these tools have yet to be adapted for use in the remote evaluation of acute vision loss. Permanent vision loss can be disabling for patients, and efforts must be made to increase and improve early diagnosis and management. Herein, the authors outline the importance of improving acute ophthalmologic diagnosis, outline key limitations and barriers to the current video-based teleneurology assessments, highlight opportunities to leverage new tools to enhance the remote assessment of vision loss, and propose new avenues to improve access to emergent ophthalmology subspecialty.


Assuntos
COVID-19 , Oftalmologia , Telemedicina , Atenção à Saúde , Humanos , Pandemias , Estados Unidos
6.
Ann Vasc Surg ; 73: 1-14, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33373766

RESUMO

BACKGROUND: This study aimed to review short- and long-term outcomes of all carotid artery stenting (CAS) in patients with radiation-induced (RI) internal carotid artery (ICA) stenosis compared with patients with atherosclerotic stenosis (AS). METHODS: We performed a single-center, multisite case-control study of transfemoral carotid artery intervention in patients stented for RI or AS. Cases of stented RI carotid arteries were identified using a CAS database covering January 2000 to December 2019. These patients were randomly matched 2:1 with stented patients because of AS by age, sex, and year of CAS. A conditional logistic regression model was performed to estimate the odds of reintervention in the RI group. Finally, a systematic review was performed to assess the outcomes of RI stenosis treated with CAS. RESULTS: There were 120 CAS in 113 patients because of RI ICA stenosis. Eighty-nine patients (78.8%) were male, and 68 patients (60.2%) were symptomatic. The reasons for radiation included most commonly treatment for diverse malignancies of the head and neck in 109 patients (96.5%). The mean radiation dose was 58.9 ± 15.6 Gy, and the time from radiation to CAS was 175.3 ± 140.4 months. Symptoms included 31 transient ischemic attacks (TIAs), 21 strokes (7 acute and 14 subacute), and 17 amaurosis fugax. The mean National Institutes of Health Stroke Scale in acute strokes was 8.7 ± 11.2. In asymptomatic patients, the indication for CAS was high-grade stenosis determined by duplex ultrasound. All CAS were successfully completed. Reinterventions were more frequent in the RI ICA stenosis cohort compared with the AS cohort (10.1% vs. 1.4%). Reinterventions occurred in 14 vessels, and causes for reintervention were restenosis in 12 followed by TIA/stroke in two vessels. On conditional regression modeling, patients with RI ICA stenosis were at a higher risk for reintervention (odds ratio = 7.1, 95% confidence interval = 2.1-32.8; P = 0.004). The mean follow-up was 33.7 ± 36.9 months, and the mortality across groups was no different (P = 0.12). CONCLUSIONS: In our single-center, multisite cohort study, patients who underwent CAS for RI ICA stenosis experienced a higher rate of restenosis and a higher number of reinterventions compared with CAS for AS. Although CAS is safe and effective for this RI ICA stenosis cohort, further data are needed to reduce the risk of restenosis, and close patient surveillance is warranted. In our systematic review, CAS was considered an excellent alternative option for the treatment of patients with RI ICA stenosis. However, careful patient selection is warranted because of the increased risk of restenosis on long-term follow-up.


Assuntos
Artéria Carótida Interna/efeitos da radiação , Estenose das Carótidas/terapia , Procedimentos Endovasculares/instrumentação , Lesões por Radiação/terapia , Stents , Idoso , Artéria Carótida Interna/diagnóstico por imagem , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/etiologia , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Lesões por Radiação/diagnóstico , Lesões por Radiação/etiologia , Retratamento , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
7.
Int J Angiol ; 29(4): 229-236, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33268973

RESUMO

Prior studies suggest high prevalence of intracranial aneurysms (IA) in patients with infrarenal abdominal aortic aneurysms (AAA). We reviewed our multicenter experience in clinical detection/treatment of IAs in AAA patients and estimated the risk of IA in patients with AAA relative to patients without AAA. We reviewed cases of vascular surgery infrarenal AAA repairs at three Mayo Clinic sites from January 1998 to December 2018. Concurrent controls were randomly matched in a 1:1 ratio by age, sex, smoking history, and head imaging characteristics. Conditional logistic regression was used to calculate odds ratios. We reviewed 2,300 infrarenal AAA repairs. Mean size of AAA at repair was 56.9 ± 11.4 mm; mean age at repair, 75.8 ± 8.0 years. 87.5% of the cases ( n = 2014) were men. Head imaging was available in 421 patients. Thirty-seven patients were found to have 45 IAs for a prevalence of 8.8%. Mean size of IA was 4.6 ± 3.5 mm; mean age at IA detection, 72.0 ± 10.8 years. Thirty (81%) out of 37 patients were men. Six patients underwent treatment for IA: four for ruptured IAs and two for unruptured IAs. All were diagnosed before AAA repair. Treatment included five clippings and one coil-assisted stenting. Time from IA diagnosis to AAA repair was 16.4 ± 11.0 years. Two of these patients presented with ruptured AAA, one with successful repair and a second one that resulted in death. Odds of IA were higher for patients with AAA versus those without AAA (8.8% [37/421] vs. 3.1% [13/421]; OR 3.18; 95% confidence interval, 1.62-6.27, p < 0.001). Co-prevalence of IA among patients with AAA was 8.8% and is more than three times the rate seen in patients without AAA. All IAs were diagnosed prior to AAA repair. Surveillance for AAA after IA treatment could have prevented two AAA ruptures and one death.

8.
RMD Open ; 6(3)2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32994362

RESUMO

OBJECTIVES: To describe the risk of venous thromboembolism (VTE), and risk factors for VTE, in people with immune-mediated inflammatory diseases (IMID) (ulcerative colitis, Crohn's disease (CD), rheumatoid arthritis (RA) and psoriatic arthritis (PsA)), compared with a matched control population. METHODS: A total of 53 378 people with an IMID were identified over 1999-2019 in the UK Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) primary care database and were matched to 213 512 people without an IMID. The association between the presence of any IMID, and each IMID separately, and risk of VTE was estimated using unadjusted and multivariable-adjusted Cox proportional hazards models. The prevalence of VTE risk factors, and associations between VTE risk factors and risk of VTE, were estimated in people with and without an IMID. RESULTS: People with an IMID were at increased risk of VTE (adjusted HR [aHR] 1.46, 95% CI 1.36,1.56), compared with matched controls. When assessing individual diseases, risk was increased for CD (aHR 1.74, 95% CI 1.45 to 2.08), ulcerative colitis (aHR 1.27, 95% CI 1.10 to 1.45) and RA (aHR 1.54, 95% CI 1.40 to 1.70) but there was no evidence of an association for PsA (aHR 1.21, 95% CI 0.96 to 1.52). In people with an IMID, independent risk factors for VTE included male sex, overweight/obese body mass index, current smoking, history of fracture, and, across study follow-up, abnormal platelet count. CONCLUSIONS: VTE risk is increased in people with IMIDs. Routinely available clinical information may be helpful to identify individuals with an IMID at increased future risk of VTE. OBSERVATIONAL STUDY REGISTRATION NUMBER: Clinicaltrials.gov (NCT03835780).


Assuntos
Artrite Psoriásica , Artrite Reumatoide , Tromboembolia Venosa , Artrite Reumatoide/complicações , Artrite Reumatoide/epidemiologia , Estudos de Coortes , Humanos , Masculino , Reino Unido/epidemiologia , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia
9.
Frontline Gastroenterol ; 11(3): 178-187, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32419908

RESUMO

OBJECTIVE: Symptoms and clinical course during inflammatory bowel disease (IBD) vary among individuals. Personalised care is therefore essential to effective management, delivered by a strong patient-centred multidisciplinary team, working within a well-designed service. This study aimed to fully rewrite the UK Standards for the healthcare of adults and children with IBD, and to develop an IBD Service Benchmarking Tool to support current and future personalised care models. DESIGN: Led by IBD UK, a national multidisciplinary alliance of patients and nominated representatives from all major stakeholders in IBD care, Standards requirements were defined by survey data collated from 689 patients and 151 healthcare professionals. Standards were drafted and refined over three rounds of modified electronic-Delphi. RESULTS: Consensus was achieved for 59 Standards covering seven clinical domains; (1) design and delivery of the multidisciplinary IBD service; (2) prediagnostic referral pathways, protocols and timeframes; (3) holistic care of the newly diagnosed patient; (4) flare management to support patient empowerment, self-management and access to specialists where required; (5) surgery including appropriate expertise, preoperative information, psychological support and postoperative care; (6) inpatient medical care delivery (7) and ongoing long-term care in the outpatient department and primary care setting including shared care. Using these patient-centred Standards and informed by the IBD Quality Improvement Project (IBDQIP), this paper presents a national benchmarking framework. CONCLUSIONS: The Standards and Benchmarking Tool provide a framework for healthcare providers and patients to rate the quality of their service. This will recognise excellent care, and promote quality improvement, audit and service development in IBD.

10.
Ann Vasc Surg ; 66: 390-399, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32027990

RESUMO

BACKGROUND: To review the sex differences among symptomatic and asymptomatic patients treated with carotid endarterectomy (CEA) and carotid artery stenting (CAS) in the Southeastern Vascular Study Group (SEVSG), a regional quality group of the Vascular Quality Initiative (VQI). METHODS: All cases reported by the SEVSG members of symptomatic and asymptomatic patients were included in this retrospective review of CEA and CAS. Primary end point was 3-year survival difference between male and female patients. Secondary end points included in-hospital myocardial infarction (MI), transient ischemic attack (TIA)/stroke, and mortality differences between symptomatic and asymptomatic male and female patients. Cox proportional hazard regression was used to assess 3-year survival differences. RESULTS: There were 8,303 CEA and 1,876 CAS procedures performed in 29 centers from January 2011 to December 2018. From those, 4,650 (56.0%) and 938 (50.1%) were asymptomatic CEA and CAS, respectively. There were 2,760 (59.4%) male patients in the asymptomatic CEA and 597 (63.9%) in the asymptomatic CAS groups. After CEA, the rates of in-hospital MI (P = 0.034), TIA/stroke (P < 0.001), and death (P < 0.001) were significantly higher in symptomatic patients. MIs were more frequent in females with asymptomatic disease (P = 0.041). After CAS, the rate of TIA/stroke was higher in symptomatic patients (P = 0.030). There were no differences according to sex in the CAS group. On follow-up, asymptomatic male patients treated with CAS had a higher 3-year all-cause mortality compared with their female counterparts (7.0% vs. 1.8%; P = 0.015). On multivariable Cox regression analysis, male sex (HR = 2.63 [95% CI = 1.058-6.536]; P = 0.038) and lower hemoglobin levels (HR = 0.72 [95% CI = 0.597-0.857]; P < 0.001) were predictors of death in asymptomatic male patients treated with CAS. CONCLUSIONS: In our SEVSG region, postoperative MIs, TIA/stroke, and deaths were higher in symptomatic CEA patients. MIs were more frequent in asymptomatic CEA females. Postoperative TIA/stroke was more frequent in symptomatic CAS patients. After CAS, asymptomatic male patients had higher 3-year all-cause mortality than female patients. On multivariable Cox regression analysis, male sex and lower hemoglobin levels were predictors of death in these asymptomatic male patients treated with CAS. Long-term mortality risk in asymptomatic males should be considered before offering CAS. Further national VQI analysis of our asymptomatic and symptomatic male and female patients treated with CEA and CAS would be warranted.


Assuntos
Estenose das Carótidas/terapia , Endarterectomia das Carótidas/mortalidade , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/mortalidade , Stents , Idoso , Doenças Assintomáticas , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/mortalidade , Endarterectomia das Carótidas/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Feminino , Mortalidade Hospitalar , Humanos , Ataque Isquêmico Transitório/mortalidade , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores Sexuais , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do Tratamento
11.
N Engl J Med ; 381(24): 2293-2303, 2019 12 12.
Artigo em Inglês | MEDLINE | ID: mdl-31774950

RESUMO

BACKGROUND: Although several experimental therapeutics for Ebola virus disease (EVD) have been developed, the safety and efficacy of the most promising therapies need to be assessed in the context of a randomized, controlled trial. METHODS: We conducted a trial of four investigational therapies for EVD in the Democratic Republic of Congo, where an outbreak began in August 2018. Patients of any age who had a positive result for Ebola virus RNA on reverse-transcriptase-polymerase-chain-reaction assay were enrolled. All patients received standard care and were randomly assigned in a 1:1:1:1 ratio to intravenous administration of the triple monoclonal antibody ZMapp (the control group), the antiviral agent remdesivir, the single monoclonal antibody MAb114, or the triple monoclonal antibody REGN-EB3. The REGN-EB3 group was added in a later version of the protocol, so data from these patients were compared with those of patients in the ZMapp group who were enrolled at or after the time the REGN-EB3 group was added (the ZMapp subgroup). The primary end point was death at 28 days. RESULTS: A total of 681 patients were enrolled from November 20, 2018, to August 9, 2019, at which time the data and safety monitoring board recommended that patients be assigned only to the MAb114 and REGN-EB3 groups for the remainder of the trial; the recommendation was based on the results of an interim analysis that showed superiority of these groups to ZMapp and remdesivir with respect to mortality. At 28 days, death had occurred in 61 of 174 patients (35.1%) in the MAb114 group, as compared with 84 of 169 (49.7%) in the ZMapp group (P = 0.007), and in 52 of 155 (33.5%) in the REGN-EB3 group, as compared with 79 of 154 (51.3%) in the ZMapp subgroup (P = 0.002). A shorter duration of symptoms before admission and lower baseline values for viral load and for serum creatinine and aminotransferase levels each correlated with improved survival. Four serious adverse events were judged to be potentially related to the trial drugs. CONCLUSIONS: Both MAb114 and REGN-EB3 were superior to ZMapp in reducing mortality from EVD. Scientifically and ethically sound clinical research can be conducted during disease outbreaks and can help inform the outbreak response. (Funded by the National Institute of Allergy and Infectious Diseases and others; PALM ClinicalTrials.gov number, NCT03719586.).


Assuntos
Alanina/análogos & derivados , Anticorpos Monoclonais/uso terapêutico , Antivirais/uso terapêutico , Doença pelo Vírus Ebola/tratamento farmacológico , Ribonucleotídeos/uso terapêutico , Monofosfato de Adenosina/análogos & derivados , Adolescente , Adulto , Alanina/efeitos adversos , Alanina/uso terapêutico , Anticorpos Monoclonais/efeitos adversos , Antivirais/efeitos adversos , Criança , Pré-Escolar , República Democrática do Congo/epidemiologia , Surtos de Doenças , Ebolavirus/genética , Feminino , Doença pelo Vírus Ebola/mortalidade , Humanos , Lactente , Recém-Nascido , Infusões Intravenosas , Masculino , RNA Viral/sangue , Ribonucleotídeos/efeitos adversos , Método Simples-Cego , Adulto Jovem
12.
Gut ; 68(Suppl 3): s1-s106, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31562236

RESUMO

Ulcerative colitis and Crohn's disease are the principal forms of inflammatory bowel disease. Both represent chronic inflammation of the gastrointestinal tract, which displays heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management relies on understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This guideline for management of inflammatory bowel disease in adults over 16 years of age was developed by Stakeholders representing UK physicians (British Society of Gastroenterology), surgeons (Association of Coloproctology of Great Britain and Ireland), specialist nurses (Royal College of Nursing), paediatricians (British Society of Paediatric Gastroenterology, Hepatology and Nutrition), dietitians (British Dietetic Association), radiologists (British Society of Gastrointestinal and Abdominal Radiology), general practitioners (Primary Care Society for Gastroenterology) and patients (Crohn's and Colitis UK). A systematic review of 88 247 publications and a Delphi consensus process involving 81 multidisciplinary clinicians and patients was undertaken to develop 168 evidence- and expert opinion-based recommendations for pharmacological, non-pharmacological and surgical interventions, as well as optimal service delivery in the management of both ulcerative colitis and Crohn's disease. Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care. Twenty research priorities to inform future clinical management are presented, alongside objective measurement of priority importance, determined by 2379 electronic survey responses from individuals living with ulcerative colitis and Crohn's disease, including patients, their families and friends.


Assuntos
Consenso , Tratamento Conservador/normas , Gerenciamento Clínico , Gastroenterologia , Doenças Inflamatórias Intestinais/terapia , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas , Adulto , Humanos , Reino Unido
14.
JRSM Cardiovasc Dis ; 3: 2048004014529419, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25247072

RESUMO

Stroke remains an exceedingly incident and prevalent public health burden across the globe, with an estimated 16 million new strokes per annum and prevalence over 60 million, and extracranial internal carotid artery atherosclerotic disease is an important risk factor for stroke. Randomized trials of surgical treatment were conducted (North American Symptomatic Carotid Endarterectomy Trial, European Carotid Surgery Trial) and demonstrated efficacy of carotid endarterectomy for secondary prevention of stroke in patients with cerebrovascular events (e.g. ipsilateral stroke, transient ischemic attack, and/or amaurosis fugax) attributable to a diseased artery with 50-99% stenosis. Therapeutic clarity, however, proved elusive with asymptomatic carotid artery disease. Asymptomatic Carotid Atherosclerosis Study (ACAS), Asymptomatic Carotid Surgery Trial, and Veterans Affairs Cooperative Study (VACS) suggested only modest benefit from surgical intervention for primary stroke prevention and the best medical therapy at the time of these trials is not comparable to modern medical therapy. ACT-1, Asymptomatic Carotid Surgery Trial-2, Stent-Protected Angioplasty in asymptomatic Carotid artery stenosis versus Endarterectomy Trial-2, European Carotid Surgery Trial-2, Carotid Revascularization Endarterectomy Versus Stenting Trial-2 are trials that are recent, ongoing, or in development that include diverse populations across Europe and North America, complementary trial designs, and a collaborative spirit that should provide clinicians with evidence that informs best clinical practice for asymptomatic carotid artery disease.

15.
16.
J Lab Autom ; 19(3): 267-74, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24401822

RESUMO

While potentially powerful, access to molecular diagnostics is substantially limited in the developing world. Here we present an approach to reduced cost molecular diagnostic instrumentation that has the potential to empower developing world communities by reducing costs through streamlining the sample preparation process. In addition, this instrument is capable of producing its own consumable devices on demand, reducing reliance on assay suppliers. Furthermore, this instrument is designed with an "open" architecture, allowing users to visually observe the assay process and make modifications as necessary (as opposed to traditional "black box" systems). This open environment enables integration of microfluidic fabrication and viral RNA purification onto an easy-to-use modular system via the use of interchangeable trays. Here we employ this system to develop a protocol to fabricate microfluidic devices and then use these devices to isolate viral RNA from serum for the measurement of human immunodeficiency virus (HIV) viral load. Results obtained from this method show significantly reduced error compared with similar nonautomated sample preparation processes.


Assuntos
Métodos Analíticos de Preparação de Amostras/instrumentação , Dispositivos Lab-On-A-Chip , Técnicas Analíticas Microfluídicas/instrumentação , Técnicas de Diagnóstico Molecular/instrumentação , RNA Viral/análise , Robótica/instrumentação , Métodos Analíticos de Preparação de Amostras/economia , Benchmarking , Erros de Diagnóstico/prevenção & controle , HIV/isolamento & purificação , HIV/metabolismo , Infecções por HIV/sangue , Infecções por HIV/diagnóstico , Infecções por HIV/economia , Infecções por HIV/virologia , Custos de Cuidados de Saúde , Humanos , Dispositivos Lab-On-A-Chip/economia , Técnicas Analíticas Microfluídicas/economia , Técnicas de Diagnóstico Molecular/economia , Estudo de Prova de Conceito , RNA Viral/sangue , RNA Viral/isolamento & purificação , RNA Viral/metabolismo , Reação em Cadeia da Polimerase em Tempo Real/economia , Reação em Cadeia da Polimerase em Tempo Real/instrumentação , Reprodutibilidade dos Testes , Reação em Cadeia da Polimerase Via Transcriptase Reversa/economia , Reação em Cadeia da Polimerase Via Transcriptase Reversa/instrumentação , Robótica/economia , Carga Viral , Ceras/química
17.
Neurohospitalist ; 1(2): 67-70, 2011 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23983839

RESUMO

BACKGROUND: Neurohospitalists may improve the efficiency and quality of care delivered to hospitalized patients with neurological disease. However, there is limited systematic data to support this hypothesis. The primary purpose of this study was to compare length of stay (LOS) for patients with ischemic stroke cared for by either neurohospitalists or community-based neurologists at a single institution. METHODS: A retrospective chart review was performed for all patients with ischemic stroke discharged from St. Luke's Hospital in Jacksonville, Florida, between January 2006 and December 2007. The LOS for patients cared for by neurohospitalists was compared to the LOS for patients cared for by community neurologists. Compliance with Joint Commission inpatient stroke quality metrics was also compared. RESULTS: A total of 533 patients were discharged with a principal diagnosis of ischemic stroke over the 24-month study period. Neurohospitalists cared for 313 patients with mean (± SD) LOS of 4.9 (5.2) days (95% CI: 4.3-5.5 days), and community-based neurologists cared for 220 patients with a mean LOS of 6.5 (8.2) days (95% CI: 5.4-7.6 days). The mean LOS was significantly less for the neurohospitalists compared to the community-based neurologists (P = .005). Neurohospitalists achieved a higher compliance rate in 10 of 11 inpatient stroke quality metrics and achieved significantly higher compliance rate of smoking cessation education (P = .019). CONCLUSIONS: Neurohospitalists achieved significantly shorter LOS for patients with ischemic stroke compared to community-based neurologists. These data suggest that neurohospitalists can also improve compliance with quality metrics necessary for Joint Commission Primary Stroke Center designation.

18.
Neurosurg Clin N Am ; 19(3): 447-58, vi, 2008 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-18790380

RESUMO

Carotid occlusive disease remains an important cause of ischemic stroke. The results of large, randomized, clinical trials have established the benefit of surgical revascularization in patients with symptomatic or asymptomatic carotid stenosis. The introduction of balloon angioplasty and stenting of the extracranial carotid artery as a potential alternative to surgery has been received with enthusiasm by patients and physicians. Whether or not this enthusiasm is justified fully has yet to be determined. This article reviews established and emerging data from clinical trials evaluating the safety and efficacy of carotid endarterectomy, carotid angioplasty, and stenting.

19.
Ann Thorac Surg ; 85(5): 1556-62; discussion 1562-3, 2008 May.
Artigo em Inglês | MEDLINE | ID: mdl-18442537

RESUMO

BACKGROUND: Stroke is an important complication of cardiopulmonary bypass (CPB). This study determined if the timing of stroke events after CPB predicted stroke-related mortality or rehabilitation needs at hospital discharge. METHODS: We performed a retrospective review of 7201 consecutive cardiac surgical patients during a 10-year period and identified 202 strokes. Postoperative stroke after CPB was classified as early (< or = 24 hours) or late (> 24 hours). Data were collected on patient characteristics, intraoperative variables and outcomes, postoperative course, stroke severity, and discharge status, including death from stroke. Logistic regression analysis was used to assess the relationship between the timing of stroke and discharge status after adjusting for clinically relevant factors. RESULTS: The stroke incidence was 2.8%. Postoperative strokes occurred within 24 hours in 22.8% (46 of 202) and after 24 hours in 77.2% (156 of 202). Factors found in logistic regression analysis to be independently associated with stroke-related death included stroke within 24 hours postoperatively (odds ratio [OR], 9.16; p < 0.0001), preoperative chronic renal insufficiency (OR, 4.46; p = 0.01), and National Institute of Health Stroke Scale (NIHSS) score (OR, 1.16 per NIHSS point increase; p < 0.0001). Among survivors, early stroke was associated with greater rehabilitation needs (p < 0.001). CONCLUSIONS: Early stroke after CPB is independently associated with higher stroke-related death and is associated with increased need for skilled rehabilitation at discharge. Neuroprotective strategies aimed at reducing early postoperative stroke may positively impact death and neurologic disability after CPB.


Assuntos
Ponte Cardiopulmonar/mortalidade , Doenças Cardiovasculares/cirurgia , Ponte de Artéria Coronária , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca , Complicações Pós-Operatórias/mortalidade , Acidente Vascular Cerebral/mortalidade , Idoso , Idoso de 80 Anos ou mais , Causas de Morte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/reabilitação , Período Pós-Operatório , Fatores de Risco , Reabilitação do Acidente Vascular Cerebral
20.
J Stroke Cerebrovasc Dis ; 16(1): 34-9, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17689390

RESUMO

OBJECTIVE: The purpose of the study was to assess whether there were sex differences in stroke severity, infarct characteristics, symptoms, or the symptoms-deficit relationship at the time of acute stroke presentation. METHODS: In a prospective study of 505 patients with first-ever ischemic stroke (the Ischemic Stroke Genetics Study), stroke subtype was centrally adjudicated and infarcts were characterized by imaging. Deficits were assessed by National Institutes of Health Stroke Scale (NIHSS) and stroke symptoms were assessed using a structured interview. Kappa statistics were generated to assess agreement between the NIHSS and the structured interview, and a Chi square test was used to assess agreement between the NIHSS and the structured interview by sex. RESULTS: In all, 276 patients (55%) were men and 229 (45%) were women. Ages ranged from 19 to 94 years (median, 65 years). The mean (+/-SD) NIHSS score of 3.8 (+/-4.5) for men and 4.3 (+/-5.2) for women was similar (P = .15). No sex difference was observed for the symptoms of numbness, visual deficits, or language. Weakness occurred in a greater proportion of women (69%) than men (59%) (P = .03). Stroke subtype did not differ significantly between sexes (P = .79). Infarct size and location were similar for each sex. The association between symptoms and neurologic deficits did not differ by sex. CONCLUSIONS: We found no sex difference in stroke severity, stroke subtype, or infarct size and location in patients with incident ischemic stroke. A greater proportion of women presented with weakness; however, similar proportions of men and women presented with other traditional stroke symptoms.


Assuntos
Isquemia Encefálica/epidemiologia , Fatores Sexuais , Adulto , Idoso , Idoso de 80 Anos ou mais , Consumo de Bebidas Alcoólicas/epidemiologia , Isquemia Encefálica/classificação , Isquemia Encefálica/complicações , Infarto Cerebral/complicações , Infarto Cerebral/epidemiologia , Infarto Cerebral/patologia , Diabetes Mellitus/epidemiologia , Feminino , Humanos , Hiperlipidemias/epidemiologia , Hipertensão/epidemiologia , Hipestesia/etiologia , Transtornos da Linguagem/etiologia , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/epidemiologia , Debilidade Muscular/etiologia , Infarto do Miocárdio/epidemiologia , Estudos Prospectivos , Fatores de Risco , Índice de Gravidade de Doença , Fumar/epidemiologia , Transtornos da Visão/etiologia
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