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1.
Medicine (Baltimore) ; 99(46): e23110, 2020 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-33181678

RESUMO

Multilocular cystic renal neoplasm of low malignant potential (MCRNLMP) might be benefited from nephron-sparing surgery. Contrast-enhanced computed tomography is used for the diagnosis of MCRNLMP but contrast-enhanced ultrasound has lack of nephrotoxicity and several advantages over contrast-enhanced computed tomography and contrast-enhanced magnetic resonance. The purpose of the study was to compare diagnostic parameters of preoperative contrast-enhanced ultrasound against contrast-enhanced computed tomography for the detection of MCRNLMP in patients who faced curative surgery for complex cystic renal mass.Data regarding contrast-enhanced ultrasound, contrast-enhanced computed tomography, and clinicopathological results of 219 patients who underwent curative surgery for complex cystic renal mass (Bosniak classification III or IV) were retrospectively collected and analyzed. Bosniak classification for imaging modality and the 2016 WHO criteria for clinic pathology were used for detection of MCRNLMP.Contrast-enhanced ultrasound, contrast-enhanced computed tomography, and clinicopathology were detected 68, 66, and 67 as a MCRNLMP respectively. Contrast-enhanced ultrasound and contrast-enhanced computed tomography had 30.37% and 29.27% sensitivities for the detection of MCRNLMP. While 60% and 50% specificities respectively. Bosniak classification III (P = .045) and lower mean Hounsfield unit (P = .049) were associated with the prevalence of MCRNLMP. Contrast-enhanced computed tomography was detected 6 and 7, while contrast-enhanced ultrasound detected 3 and 2 complex cystic renal mass as false positive and false negative MCRNLMP respectively. A contrast-enhanced ultrasound had 0.011 to 1.0 diagnostic confidence and contrast-enhanced computed tomography had 0.045 to 0.983 diagnostic confidence for decision making of nephron-sparing surgeries.Contrast-enhanced ultrasound may have better visualization of MCRNLMP than contrast-enhanced computed tomography.Level of Evidence: III.


Assuntos
Carcinoma de Células Renais , Aumento da Imagem/métodos , Neoplasias Renais , Rim/diagnóstico por imagem , Compostos Organometálicos/farmacologia , Fosfolipídeos/farmacologia , Hexafluoreto de Enxofre/farmacologia , Tomografia Computadorizada por Raios X/métodos , Ultrassonografia/métodos , Carcinoma de Células Renais/diagnóstico , Carcinoma de Células Renais/cirurgia , Tomada de Decisão Clínica , Pesquisa Comparativa da Efetividade , Meios de Contraste/farmacologia , Precisão da Medição Dimensional , Feminino , Humanos , Neoplasias Renais/diagnóstico , Neoplasias Renais/cirurgia , Masculino , Pessoa de Meia-Idade , Nefrectomia/métodos , Tratamentos com Preservação do Órgão/métodos
3.
J Stroke Cerebrovasc Dis ; 29(10): 105143, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32912498

RESUMO

OBJECTIVE: The surgical procedure most appropriate for treating symptomatic Riles type 1A common carotid artery occlusion (CCAO) is unclear. This study compares the effects of ring-stripping retrograde endarterectomy (RSRE) and carotid artery crossover bypass (CACB) on cerebral perfusion improvement in patients with symptomatic Riles type 1A CCAO. METHODS: We conducted a retrospective analysis of symptomatic Riles type 1A CCAO patients treated at our centre. Postoperative improvements in the ipsilateral internal carotid artery (ICA) flow rate, ipsilateral cerebral blood perfusion (CBP) and the stroke recurrence rate were compared between patients who underwent RSRE and those who underwent CACB. RESULTS: A total of 20 CCAO patients were surgically treated at our centre from 2011 to 2018. Nine of these patients underwent RSRE, and eleven underwent CACB. No significant differences were identified between the groups in the ipsilateral blood flow rate of the ICA immediately after surgery and the ipsilateral-to-contralateral mean transit time ratios 1 day after surgery. However, the flow rate in the ICA was significantly higher in the RSRE group than in the CACB group 1 year after surgery (135.44 ± 19.22 ml/min vs. 116.36 ± 17.70 ml/min, p = 0.033). For CBP, the ipsilateral-to-contralateral mean transit time ratios were significantly lower in RSRE patients than in CACB patients 1 year after surgery (1.005 ± 0.052 vs. 1.064 ± 0.066, p = 0.044). In addition, the postoperative modified Rankin scale (mRS) score at the latest follow-up point (p = 0.884) and the stroke recurrence rate during the follow-up (88.9% vs. 90.9%, p > 0.999) were not significantly different between the two groups. CONCLUSIONS: Although the postoperative mRS score and the stroke recurrence rate were not significantly different between RSRE and CACB patients, compared to CACB, RSRE was better for improving the ipsilateral ICA flow rate and cerebral perfusion in symptomatic Riles type 1A CCAO patients.


Assuntos
Implante de Prótese Vascular , Artéria Carótida Primitiva/cirurgia , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas , Idoso , Velocidade do Fluxo Sanguíneo , Implante de Prótese Vascular/efeitos adversos , Artéria Carótida Primitiva/fisiopatologia , Artéria Carótida Interna/fisiopatologia , Estenose das Carótidas/complicações , Estenose das Carótidas/fisiopatologia , Circulação Cerebrovascular , Pesquisa Comparativa da Efetividade , Endarterectomia das Carótidas/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/fisiopatologia , Resultado do Tratamento
4.
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
6.
J Stroke Cerebrovasc Dis ; 29(8): 104894, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32689599

RESUMO

INTRODUCTION: Mobile Stroke Units (MSUs) deliver acute stroke treatment on-scene in coordination with Emergency Medical Services (EMS). One criticism of the MSU approach is the limited range of a single MSU. The Houston MSU is evaluating MSU implementation, and we developed a rendezvous approach as an innovative solution to expand the range and number of patients treated. METHODS: In addition to direct 911 dispatch of our MSU to the scene within our 7-mile catchment area, we empowered more distant EMS units to activate the MSU. We also monitored EMS radio communications to identify possible patients. For these distant patients, the MSU met the EMS unit en route to the stroke center and treated the patient at that intermediate location. The distribution of the distance from MSU base station to site of stroke and time from 911 alert to tissue plasminogen activator (tPA) bolus were compared between patients treated on-scene and by rendezvous using Wilcoxon rank sum test. RESULTS: Over 4 years, 338 acute ischemic stroke patients were treated with tPA on our MSU. Of these, 169 (50%) were treated on-scene after MSU dispatch at a median of 6.4 miles (IQR 6.4 miles) from MSU base station. 169 (50%) were treated by 'rendezvous' pathway with assessment and treatment of stroke a median of 12.4 miles from base (IQR 5.5 miles) (p< 0.0001). Time (min) from MSU alert to tPA bolus did not differ: 36.0 ± 10.0 for on-scene vs 37.0 ± 10.0 with rendezvous (p=0.65). 13% of patients alerted via direct 911 dispatch were treated vs 44% of rendezvous patients. CONCLUSION: Adding a rendezvous approach to an MSU dispatch pathway doubles the range of operations and the number of patients treated by an MSU in an urban area, without incurring delay.


Assuntos
Área Programática de Saúde , Prestação Integrada de Cuidados de Saúde , Despacho de Emergência Médica , Fibrinolíticos/administração & dosagem , Unidades Móveis de Saúde , Acidente Vascular Cerebral/tratamento farmacológico , Terapia Trombolítica , Tempo para o Tratamento , Ativador de Plasminogênio Tecidual/administração & dosagem , Transporte de Pacientes , Idoso , Idoso de 80 Anos ou mais , Pesquisa Comparativa da Efetividade , Feminino , Necessidades e Demandas de Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/fisiopatologia , Texas , Fatores de Tempo , Resultado do Tratamento , Serviços Urbanos de Saúde
7.
Surgery ; 168(4): 737-742, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32641277

RESUMO

BACKGROUND: We compared the clinical outcomes and cost-efficiency of surgical approaches (sternotomy-open, video assisted thoracoscopic surgery, and robotic assisted thoracic surgery) for thymectomy. METHODS: This is a retrospective review of 220 consecutive patients who underwent thymectomy between January 1, 2007, and January 31, 2017. Surgical approach was determined by the surgeon, but we only included cases that could be resected using any of the 3 approaches. RESULTS: Open approach was used in 69 patients, whereas minimally invasive technique was used in 151 (97, video assisted thoracoscopic surgery; 54, robotic assisted thoracic surgery). Open surgery was associated with greater total hospital cost ($22,847 ± $20,061 vs $14,504 ± $10,845, P < .001). Open group also revealed longer duration of intensive care unit (1.2 ± 2.8 vs 0.2 ± 1.3 days, P < .001) and hospital stay (4.3 ± 4.0 vs 2.0 ± 2.6 days, P < .001). There were no differences in major adverse clinical outcomes. Long-term recurrence-free survival after resection of thymoma was similar between the groups. CONCLUSION: Minimally invasive techniques were equally efficacious compared with the open approach in the resection of the thymus. Additionally, their use was associated with decreased hospital duration of stay and reduced cost. Hence the use of minimally invasive approaches should be encouraged in the resection of thymus.


Assuntos
Análise Custo-Benefício , Custos Hospitalares , Timectomia/economia , Timectomia/métodos , Adulto , Pesquisa Comparativa da Efetividade , Intervalo Livre de Doença , Feminino , Humanos , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/economia , Cirurgia Torácica Vídeoassistida/efeitos adversos , Cirurgia Torácica Vídeoassistida/economia , Timectomia/efeitos adversos , Timoma/cirurgia , Neoplasias do Timo/cirurgia , Resultado do Tratamento
8.
Value Health ; 23(6): 751-759, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32540233

RESUMO

OBJECTIVES: To assess the performance of unanchored matching-adjusted indirect comparison (MAIC) by matching on first moments or higher moments in a cross-study comparisons under a variety of conditions. A secondary objective was to gauge the performance of the method relative to propensity score weighting (PSW). METHODS: A simulation study was designed based on an oncology example, where MAIC was used to account for differences between a contemporary trial in which patients had more favorable characteristics and a historical control. A variety of scenarios were then tested varying the setup of the simulation study, including violating the implicit or explicit assumptions of MAIC. RESULTS: Under ideal conditions and under a variety of scenarios, MAIC performed well (shown by a low mean absolute error [MAE]) and was unbiased (shown by a mean error [ME] of about zero). The performance of the method deteriorated where the matched characteristics had low explanatory power or there was poor overlap between studies. Only when important characteristics are not included in the matching did the method become biased (nonzero ME). Where the method showed poor performance, this was exaggerated if matching was also performed on the variance (ie, higher moments). Relative to PSW, MAIC provided similar results in most circumstances, although it exhibited slightly higher MAE and a higher chance of exaggerating bias. CONCLUSIONS: MAIC appears well suited to adjust for cross-trial comparisons provided the assumptions underpinning the model are met, with relatively little efficiency loss compared with PSW.


Assuntos
Pesquisa Comparativa da Efetividade/métodos , Simulação por Computador , Modelos Teóricos , Neoplasias/terapia , Viés , Ensaios Clínicos como Assunto/métodos , Humanos , Pontuação de Propensão
9.
Stroke ; 51(7): 2076-2086, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32517580

RESUMO

BACKGROUND AND PURPOSE: Comparative effectiveness and safety of oral anticoagulants in patients with atrial fibrillation and high polypharmacy are unknown. METHODS: We used Medicare administrative data to evaluate patients with new atrial fibrillation diagnosis from 2015 to 2017, who initiated an oral anticoagulant within 90 days of diagnosis. Patients taking ≤3, 4 to 8, or ≥9 other prescription medications were categorized as having low, moderate, or high polypharmacy, respectively. Within polypharmacy categories, patients receiving apixaban 5 mg twice daily, rivaroxaban 20 mg once daily, or warfarin were matched using a 3-way propensity score matching. Study outcomes included ischemic stroke, bleeding, and all-cause mortality. RESULTS: The study cohort included 6985 patients using apixaban, 3838 using rivaroxaban, and 6639 using warfarin. In the propensity-matched cohorts there was no difference in risk of ischemic stroke between the 3 drugs in patients with low and moderate polypharmacy. However, among patients with high polypharmacy, the risk of ischemic stroke was higher with apixaban compared with warfarin (adjusted hazard ratio 2.34 [95% CI, 1.01-5.42]; P=0.05) and similar to rivaroxaban (adjusted hazard ratio, 1.38 [95% CI, 0.67-2.84]; P=0.4). There was no difference in risk of death between the 3 drugs in patients with low and moderate polypharmacy, but apixaban was associated with a higher risk of death compared with rivaroxaban (adjusted hazard ratio, 2.03 [95% CI, 1.01-4.08]; P=0.05) in the high polypharmacy group. Apixaban had lower bleeding risk compared with warfarin in the low polypharmacy group (adjusted hazard ratio, 0.54 [95% CI, 0.32-0.90]; P=0.02), but there was no difference in bleeding between the 3 drugs in the moderate and high polypharmacy groups. CONCLUSIONS: Our study suggests that among patients with significant polypharmacy (>8 drugs), there may be a higher stroke and mortality risk with apixaban compared with warfarin and rivaroxaban. However, differences were of borderline significance.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Polimedicação , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Rivaroxabana/uso terapêutico , Varfarina/uso terapêutico , Idoso , Fibrilação Atrial/mortalidade , Centers for Medicare and Medicaid Services, U.S. , Pesquisa Comparativa da Efetividade , Feminino , Hemorragia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Acidente Vascular Cerebral/epidemiologia , Estados Unidos
10.
Am Heart J ; 226: 94-113, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32526534

RESUMO

Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design. METHODS: RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, "Standard of Care Plus" (SCP), to a multi-level intervention, "Collaborative Care/Stepped Care" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months. DISCUSSION: This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities. TRIAL REGISTRATION: Clinicaltrials.govNCT02674464.


Assuntos
Pesquisa Comparativa da Efetividade/métodos , Assistência à Saúde/métodos , Disparidades em Assistência à Saúde , Hipertensão/prevenção & controle , Ensaios Clínicos Pragmáticos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Humanos , Resultado do Tratamento , Estados Unidos
11.
Jt Dis Relat Surg ; 31(2): 320-327, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32584732

RESUMO

OBJECTIVES: This study aims to compare the results of internal fixation with dynamic hip screw (DHS)/antirotation screw and conventional cannulated screw (CS) for femoral neck fracture. PATIENTS AND METHODS: This retrospective study included a total of 78 patients (57 males, 21 females) with collum femoris fractures treated with internal fixation between January 2015 and January 2019. Group 1 comprised 41 patients with a mean age of 45.7 years (range, 19 to 62 years) treated with DHSs/antirotation screws, while group 2 comprised 37 patients with a mean age of 41.9 years (range, 17 to 75 years) treated with CSs. The patients were evaluated for union, avascular necrosis (AVN), femoral neck shortness, operation time, duration of fluoroscopy exposure, and functional outcomes. RESULTS: Age, gender, and Garden classification stages were similar in both groups. No significant difference was found between the groups in respect of AVN and non-union rates. The non-union rate was 12.2% in group 1 and 21.6% in group 2 (p>0.05). The duration of fluoroscopy exposure was statistically significantly higher in group 2 (p=0.001) and the operation time was statistically significantly longer in group 1 (p=0.001). In group 2, femoral neck shortness stature was significantly higher (p=0.007). At the final follow-up examination, the Harris hip score was statistically significantly higher in group 1 (p=0.04). CONCLUSION: Dynamic hip screw/antirotation screw was a more relevant treatment method for transcervical femoral neck fractures compared to CS with more favorable functional outcomes and less fluoroscopy exposure.


Assuntos
Parafusos Ósseos , Fraturas do Colo Femoral/cirurgia , Fixação Interna de Fraturas/instrumentação , Osteonecrose , Complicações Pós-Operatórias , Adulto , Parafusos Ósseos/efeitos adversos , Parafusos Ósseos/classificação , Parafusos Ósseos/normas , Pesquisa Comparativa da Efetividade , Feminino , Fluoroscopia/estatística & dados numéricos , Fixação Interna de Fraturas/efeitos adversos , Fixação Interna de Fraturas/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Osteonecrose/etiologia , Osteonecrose/prevenção & controle , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Recuperação de Função Fisiológica , Estudos Retrospectivos
12.
Ann Rheum Dis ; 79(9): 1203-1209, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32581090

RESUMO

OBJECTIVE: To compare effectiveness of treatment with secukinumab (SEC) with that of alternative tumour necrosis factor inhibitors (TNFis) in patients with axial spondyloarthritis (axSpA) after withdrawal from one or more TNFis. METHODS: Patients diagnosed as having axSpA in the Swiss Clinical Quality Management cohort were included if they had initiated SEC (n=106) or an alternative TNFi (n=284) after experiencing TNFi failure. Drug retention was investigated with matching weights propensity score (PS) analyses and multiple adjusted Cox proportional hazards models. Matching weights PS-based analyses and multiple-adjusted logistic regression analyses were used to assess the proportion of patients reaching 50% reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50) at 1 year. RESULTS: SEC was more often used as third-line or later-line biological drug (76% vs 40% for TNFi). Patients starting SEC had higher BASDAI, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Metrology Index and C reactive protein levels. A comparable risk of drug discontinuation was found for SEC versus TNFi (HR 1.14, 95% CI 0.78 to 1.68 in the PS-based analysis and HR 1.16, 95% CI 0.79 to 1.71 in the multiple-adjusted analysis). No significant difference in BASDAI50 responses at 1 year was demonstrated between the two modes of biological drug action, with CI of estimates being, however, wide (OR for SEC vs TNFi 0.76, 95% CI 0.26 to 2.18 and 0.78, 95% CI 0.24 to 2.48 in the PS-based and the covariate-adjusted model, respectively). CONCLUSION: Our data suggest a comparable effectiveness of SEC versus an alternative TNFi after prior TNFi exposure.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Espondilartrite/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Adulto , Estudos de Coortes , Pesquisa Comparativa da Efetividade , Substituição de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Suíça , Resultado do Tratamento
13.
JAMA Netw Open ; 3(6): e205123, 2020 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-32515795

RESUMO

Importance: Few studies have described the longitudinal trajectories of serum levels of micronutrients whose deficiencies are associated with serious sequelae following bariatric procedures, such as anemia, osteoporotic fractures, and neuropathies. Furthermore, previous studies comparing laparoscopic sleeve gastrectomy (LSG) vs Roux-en-Y gastric bypass (LRYGB) or one-anastomosis gastric bypass (OAGB) procedures may have been limited by selection and confounding biases. Objective: To appraise the spectrum and temporal course of micronutrient deficiencies associated with bone metabolism and erythropoiesis after LSG vs OAGB or LRYGB procedures, using the propensity score as a balancing score. Design, Setting, and Participants: This prospective, longitudinal comparative effectiveness study was conducted at a high-volume bariatric unit in Singapore from September 1, 2008, to November 30, 2017, with a cutoff date for analysis of September 2018. Patients who underwent adjustable gastric banding, biliopancreatic diversion procedures, and intragastric balloon procedures were excluded. All other patients who underwent bariatric procedures were included. Data were analyzed from September 23 to 30, 2018. Main Outcomes and Measures: Serial assessment of 13 biochemical parameters at 12 time points for up to 5 years after bariatric procedure. Inverse probability-of-treatment weights were used to obtain estimates of the mean associations of variables assessed with the bariatric surgical interventions. Longitudinal trajectories were analyzed using mixed-effects generalized linear models to apportion the temporal variation of serum micronutrients into fixed-effects and random-effects components. Results: A total of 688 patients were included in this study, of whom 499 underwent LSG (mean [SD] age, 41.5 [11.3] years; 318 [63.7%] women) and 189 underwent OAGB or LRYGB (mean [SD] age, 48.6 [9.4] years; 112 [59.3%] women). There were no differences during follow-up among patients who underwent LSG vs those who underwent OAGB or LRYGB in intact parathyroid hormone levels (mean difference, 7.05 [95% CI, -28.67 to 42.77] pg/mL; P = .70), serum 25-hydroxyvitamin D levels (mean difference, -0.72 [95% CI, -1.56 to 0.12] ng/mL; P = .09), or phosphate levels (mean difference, 0.006 [95% CI, -0.052 to 0.064] mg/dL; P = .83). Hemoglobin levels were a mean 0.63 (95% CI, 0.41 to 0.85) g/dL higher among patients who underwent LSG compared with those who underwent OAGB or LRYGB (P < .001), despite no differences in iron concentration levels (mean difference, 1.50 [95% CI, -1.39 to 4.39] µg/dL; P = .31), total iron-binding capacity (mean difference, 4.36 [95% CI, -5.25 to 13.98] µg/dL; P = .37), or ferritin levels (mean difference, 3.0 [95% CI, -13.0 to 18.9] ng/mL; P = .71). Compared with patients who underwent LSG procedures, patients who underwent OAGB or LRYGB had higher folate levels (mean difference, 2.376 [95% CI, 1.716 to 3.036] ng/mL; P < .001) but lower serum magnesium levels (mean difference, -0.25 [95% CI, -0.35 to -0.16] mg/dL; P < .001) and zinc levels (mean difference, -7.58 [95% CI, -9.92 to -5.24] µg/dL; P < .001). Conclusions and Relevance: These findings suggest that LSG vs OAGB or LRYGB procedures have differential associations with various micronutrient and metabolic parameters. These differences should be recognized in guidelines for postbariatric nutritional surveillance and prevention.


Assuntos
Gastrectomia , Derivação Gástrica , Micronutrientes/sangue , Adulto , Anemia/etiologia , Osso e Ossos/metabolismo , Pesquisa Comparativa da Efetividade , Eritropoese , Feminino , Ferritinas/sangue , Ácido Fólico/sangue , Gastrectomia/efeitos adversos , Gastrectomia/métodos , Derivação Gástrica/efeitos adversos , Derivação Gástrica/métodos , Hemoglobinas/metabolismo , Humanos , Ferro/sangue , Estudos Longitudinais , Magnésio/sangue , Masculino , Pessoa de Meia-Idade , Estado Nutricional , Hormônio Paratireóideo/sangue , Fosfatos/sangue , Pontuação de Propensão , Estudos Prospectivos , Albumina Sérica/metabolismo , Fatores Sexuais , Vitamina D/análogos & derivados , Vitamina D/sangue , Zinco/sangue
14.
Ann Rheum Dis ; 79(7): 883-890, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32381560

RESUMO

OBJECTIVES: Target trial emulation is an intuitive design framework that encourages investigators to formulate their comparative effectiveness research (CER) question as a hypothetical randomised controlled trial (RCT). Our aim was to systematically review CER studies in rheumatoid arthritis (RA) to provide examples of design limitations that could be avoided using target trial emulation, and how these limitations might introduce bias. METHODS: We searched for head-to-head CER studies of biologic disease modifying anti-rheumatic drugs (DMARDs) in RA. Study designs were reviewed for seven components of the target trial emulation framework: eligibility criteria, treatment strategies, assignment procedures, follow-up period, outcome, causal contrasts of interest (ie, intention-to-treat (ITT) or per-protocol effect) and analysis plan. Hypothetical trials corresponding to the reported methods were assessed to identify design limitations that would have been avoided with an explicit target trial protocol. Analysis of the primary effectiveness outcome was chosen where multiple analyses were performed. RESULTS: We found 31 CER studies, of which 29 (94%) had at least one design limitation belonging to seven components. The most common limitations related to: (1) eligibility criteria: 19/31 (61%) studies used post-baseline information to define baseline eligibility; (2) causal contrasts: 25 (81%) did not define whether ITT or per-protocol effects were estimated and (3) assignment procedures: 13 (42%) studies did not account for confounding by indication or relied solely on statistical confounder selection. CONCLUSIONS: Design limitations were found in 94% of observational CER studies in RA. Target trial emulation is a structured approach for designing observational CER studies that helps to avoid potential sources of bias.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Pesquisa Comparativa da Efetividade/estatística & dados numéricos , Estudos Observacionais como Assunto/estatística & dados numéricos , Projetos de Pesquisa , Pesquisa Comparativa da Efetividade/métodos , Humanos , Estudos Observacionais como Assunto/métodos
15.
Respir Med ; 170: 106036, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32469732

RESUMO

OBJECTIVES: To evaluate the imaging features of routine admission chest X-ray in patients referred for novel Coronavirus 2019 infection. METHODS: All patients referred to the emergency departments, RT-PCR positive for SARS-CoV-2 infection were evaluated. Demographic and clinical data were recorded. Two radiologists (8 and 15 years of experience) reviewed all the X-ray images and evaluated the following findings: interstitial opacities, alveolar opacities (AO), AO associated with consolidation, consolidation and/or pleural effusion. We stratified patients in groups according to the time interval between symptoms onset (cut-off 5 days) and X-ray imaging and according to age (cut-off 60 years old). Computed tomography was performed in case of a discrepancy between clinical symptoms, laboratory and X-ray findings, and/or suspicion of complications. RESULTS: A total of 468 patients were tested positive for SARS-CoV-2. Lung lesions primarily manifested as interstitial opacities (71.7%) and AO opacities (60.5%), more frequently bilateral (64.5%) and with a peripheral predominance (62.5%). Patients admitted to the emergency radiology department after 5 days from symptoms onset, more frequently had interstitial and AO opacities, in comparison to those admitted within 5 days, and lung lesions were more frequently bilateral and peripheral. Older patients more frequently presented interstitial and AO opacities in comparison to younger ones. Sixty-eight patients underwent CT that principally showed the presence of ground-glass opacities and consolidations. CONCLUSIONS: The most common X-ray pattern is multifocal and peripheral, associated with interstitial and alveolar opacities. Chest X-ray, compared to CT, can be considered a reliable diagnostic tool, especially in the Emergency setting.


Assuntos
Infecções por Coronavirus , Pandemias , Derrame Pleural , Pneumonia Viral , Radiografia Torácica , Tomografia Computadorizada por Raios X , Betacoronavirus/isolamento & purificação , Técnicas de Laboratório Clínico/métodos , Pesquisa Comparativa da Efetividade , Infecções por Coronavirus/complicações , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Derrame Pleural/diagnóstico por imagem , Derrame Pleural/etiologia , Pneumonia Viral/complicações , Pneumonia Viral/diagnóstico , Pneumonia Viral/diagnóstico por imagem , Pneumonia Viral/epidemiologia , Pneumonia Viral/etiologia , Radiografia Torácica/métodos , Radiografia Torácica/estatística & dados numéricos , Reprodutibilidade dos Testes , Tomografia Computadorizada por Raios X/métodos , Tomografia Computadorizada por Raios X/estatística & dados numéricos
16.
Acta Orthop Traumatol Turc ; 54(3): 337-343, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32442123

RESUMO

OBJECTIVE: Internal fixation with cannulated screws for nondisplaced femoral neck fractures in the elderly has substantial reoperation and mortality rates. The selection of either internal fixation or arthroplasty for nondisplaced femoral neck fracture is debatable. METHODS: We performed a systematic review of the literature regarding complications in the internal fixation of nondisplaced femoral neck fractures in elderly (>60 years old) patients. We searched in multiple databases (PubMed, Web of Science, Embase, and Cochrane Library) for articles in this area; there was no limitation over the publication year. RESULTS: A total of 1971 patients were identified from 16 published studies. All these patients were over 60 years old. The minimum follow-up after the surgical procedure was 11 months (range: 11-183 months). A total of 329 fractures (16.7%) with radiographic and clinical failures after fixation were identified with regard to stable femoral neck fractures. The single most common complication after surgery was nonunion (129/329), with a pooled percentage of 39.2%. Osteonecrosis was found to be the second most common cause of revision surgery (31.9%). The overall reoperation rate attributable to surgical complications was 15.2% (300/1971 patients). Conversion to hip arthroplasty was performed in 244 patients (12.4%) after primary fixation. CONCLUSION: Our study elucidated further the complication rate of nondisplaced femoral neck fractures treated with internal screw fixation. Since the failure rate of screw fixation for stable femoral neck fractures in elderly patients is not low, we believe that hemiarthroplasty is a reasonable treatment option in select patients. LEVEL OF EVIDENCE: Level III, Therapeutic study.


Assuntos
Fraturas do Colo Femoral/cirurgia , Fixação Interna de Fraturas , Hemiartroplastia , Complicações Pós-Operatórias , Idoso , Parafusos Ósseos , Pesquisa Comparativa da Efetividade , Fixação Interna de Fraturas/efeitos adversos , Fixação Interna de Fraturas/instrumentação , Fixação Interna de Fraturas/métodos , Hemiartroplastia/efeitos adversos , Hemiartroplastia/métodos , Humanos , Seleção de Pacientes , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle
17.
Crit Care Resusc ; 22(2): 110-118, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32389103

RESUMO

Comparative effectiveness research can help guide the use of common, routine medical practices. However, to be safe and informative, such trials must include at least one treatment arm that accurately portrays current practices. While comparative effectiveness research is widely perceived as safe and to involve no or only minimal risks, these assumptions may not hold true if unrecognised deviations from usual care exist in one or more study arms. For critically ill subjects in particular, such practice deviations may increase the risk of death or injury and undermine safety monitoring. Furthermore, unrecognised unusual care seems likely to corrupt informed consent documents, with underappreciated risks shrouded under the reassuring "comparative effectiveness" research label. At present, oversight measures are inadequate to ensure that research subjects enrolled in comparative effectiveness trials are actually receiving usual and not unusual care. Oversight by governmental and non-governmental entities with appropriate expertise, empowered to ensure that current clinical practice has been properly represented, could help prevent occurrences in clinical trials of unusual care masquerading as usual care.


Assuntos
Pesquisa Comparativa da Efetividade , Estado Terminal , Sujeitos da Pesquisa , Ética em Pesquisa , Humanos , Projetos de Pesquisa
19.
Medicine (Baltimore) ; 99(14): e19679, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32243404

RESUMO

BACKGROUND: There has been a significant improvement in both our understanding and therapeutic choices available to clinicians for the management of cancer associated thrombosis (CAT). Even with the recent publication of a systematic review and landmark trials demonstrating the non-inferiority of DOACS-based anticoagulation strategy compared to the standard of care in patients with CAT, there is unresolved uncertainty regarding the exact hierarchy of risks and effectiveness of various DOAC analogues in these cohorts of patients. METHOD: We will carry out a network meta-analyses, utilizing a novel generalized pairwise methodology to generate direct and indirect comparisons between the various DOAC analogues. We will search the following databases for studies that satisfies pre-specified inclusions criteria; these include PubMed, EMBASE, Cochrane library, Clinicaltrials.gov, conference abstracts among other sources. The primary efficacy and safety outcomes are recurrent VTE and major hemorrhagic events, respectively. Two reviewers will Search the databases independently with the view to identify studies that meet eligibility criteria. The methodological quality of the included studies will be determined using a recently validated risk of bias assessment tool. RESULTS: We expect that the result of this review will ascertain the hierarchy of risks and effectiveness of various DOAC analogues in patients with CAT. CONCLUSION: Results of this review will assist in informed decisions making regarding therapeutic guidelines of DOAC in CAT.


Assuntos
Inibidores do Fator Xa/uso terapêutico , Neoplasias/complicações , Prevenção Secundária/métodos , Tromboembolia Venosa/tratamento farmacológico , Adulto , Idoso , Pesquisa Comparativa da Efetividade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Metanálise em Rede , Recidiva , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Resultado do Tratamento , Tromboembolia Venosa/etiologia
20.
Acta Orthop Traumatol Turc ; 54(2): 178-185, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32254034

RESUMO

OBJECTIVE: This study compared the clinical and radiological results of the arthroscopic transosseous (ATO) and transosseous-equivalent (TOE) double-row rotator cuff repair techniques. METHODS: Prospective data collected from patients treated with ATO (32 women and 7 men, mean age: 57.03±6.39 years) and TOE (36 women and 8 men; mean age: 57.86±7.81 years) techniques were retrospectively evaluated. The visual analog scale score, Constant score, and Oxford shoulder score were used to assess the clinical results. Anchor pullout on standard anteroposterior shoulder radiographs and rotator cuff re-tear on magnetic resonance images were examined at the final follow-up to evaluate the radiological results. Rotator cuff re-tears were graded as per the classification system described by Sugaya et al. Results: The mean follow-up duration was 33.3±11.8 months. No difference was observed in the demographic data of the two groups. Significant improvement was observed in the postoperative shoulder scores of the groups; however, no difference was observed between the groups. Re-tear was detected in 10 patients of the TOE group and 9 patients of the ATO group. Age, tear size, and retraction level could cause re-tear. CONCLUSION: In the treatment of rotator cuff tears, the ATO and TOE techniques may achieve considerable improvements in shoulder functions in the short term. LEVEL OF EVIDENCE: Level III, Therapeutic study.


Assuntos
Artroplastia , Artroscopia , Lesões do Manguito Rotador/cirurgia , Ombro , Artroplastia/efeitos adversos , Artroplastia/métodos , Artroscopia/efeitos adversos , Artroscopia/métodos , Pesquisa Comparativa da Efetividade , Feminino , Humanos , Imagem por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , Radiografia/métodos , Estudos Retrospectivos , Manguito Rotador/cirurgia , Ombro/diagnóstico por imagem , Ombro/fisiopatologia , Resultado do Tratamento
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