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1.
Ann Vasc Surg ; 71: 411-418, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32891744

RESUMO

INTRODUCTION: An important step to reach a favorable outcome of abdominal endovascular aneurysm repair (EVAR) is preoperative sizing of the stent graft using computed tomography angiography (CTA) images of the abdominal aorta. A variety of costly image processing software options is available to obtain the necessary aortic measurements. A package that can be used for EVAR sizing is OsiriX Lite®-an open source, freely downloadable image processing option. This study assesses the concurrent validity of OsiriX Lite® when compared with commercially available 3Mensio Vascular® and Siemens Syngo.via®. METHODS: CTA scans of 20 patients that underwent EVAR for abdominal aneurysm were selected, 10 elective and 10 ruptured. For each scan, 6 observers determined 20 parameters needed for proper stent graft sizing, 2 using Osirix Lite®, 3 using 3Mensio Vascular®, and 1 using Siemens Syngo.via®. For each parameter, an intraclass correlation coefficient (ICC) and a P-value were calculated. Interrater agreement was interpreted using the Koo and Li Guidelines. Time needed to perform EVAR planning was compared. RESULTS: Overall interrater agreement between the 3 sizing options was found to be either "good" or "moderate" for 16 out of 20 parameters (80%). Time needed to perform EVAR planning was not significantly different for Osirix Lite® (568 sec) when compared with 3Mensio Vascular® (603 sec) or Siemens Syngo.via® (659 sec) with a P-value of 0.88. CONCLUSIONS: The authors conclude that Osirix Lite® is an accurate and time-effective image processing option for preoperative sizing of an EVAR stent graft when matched to 3Mensio Vascular® and Siemens Syngo.via®.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Ruptura Aórtica/cirurgia , Aortografia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Angiografia por Tomografia Computadorizada , Procedimentos Endovasculares/instrumentação , Interpretação de Imagem Radiográfica Assistida por Computador , Software , Stents , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Ruptura Aórtica/diagnóstico por imagem , Implante de Prótese Vascular/efeitos adversos , Tomada de Decisão Clínica , Procedimentos Endovasculares/efeitos adversos , Humanos , Variações Dependentes do Observador , Valor Preditivo dos Testes , Desenho de Prótese , Reprodutibilidade dos Testes , Estudos Retrospectivos , Resultado do Tratamento
2.
Trials ; 25(1): 482, 2024 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-39014498

RESUMO

BACKGROUND: Narrowband ultraviolet B (NB-UVB) phototherapy is commonly prescribed for patients with moderate-to-severe atopic eczema (AE). The efficacy of NB-UVB, however, has not yet properly been established, as current evidence is of low certainty. Our aim is to assess the short-term and long-term (cost-)effectiveness and safety of NB-UVB in adult AE patients by performing a pragmatic, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial. This protocol outlines its methodology. METHODS: A pragmatic, multicenter, PROBE trial will be performed with 1:1 randomization of 316 adult patients with moderate-to-severe AE who have inadequate disease control with topical therapy and who are eligible for optimal topical therapy (OTT) or NB-UVB in combination with OTT as a next step. Participants in the interventional arm will receive a minimum of 3 months of OTT combined with 8 to 16 weeks of NB-UVB. The control group receives 3 months of OTT. Following the interventional phase, follow-up will continue for 9 months. Physician-reported and patient-reported outcomes (according to the Harmonising Outcome Measures for Eczema (HOME) Core Outcome Set) and adverse events are assessed at 4 weeks, 3, 6, 9, and 12 months. DISCUSSION: The UPDATE trial aims to provide high-quality evidence regarding the (cost-)effectiveness and safety of NB-UVB phototherapy in moderate-to-severe AE patients. Challenges that are addressed in the protocol include the possible bias arising from applying open-label treatment and the necessity of introducing OTT into the study design to prevent a high dropout rate. TRIAL REGISTRATION: ClinicalTrials.gov NCT05704205. Registered on December 8, 2022.


Assuntos
Dermatite Atópica , Estudos Multicêntricos como Assunto , Ensaios Clínicos Pragmáticos como Assunto , Terapia Ultravioleta , Humanos , Terapia Ultravioleta/economia , Terapia Ultravioleta/efeitos adversos , Terapia Ultravioleta/métodos , Dermatite Atópica/terapia , Dermatite Atópica/economia , Dermatite Atópica/diagnóstico , Estudos Prospectivos , Resultado do Tratamento , Análise Custo-Benefício , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/economia , Fármacos Dermatológicos/efeitos adversos , Fármacos Dermatológicos/uso terapêutico , Adulto , Fatores de Tempo , Administração Cutânea , Ensaios Clínicos Controlados Aleatórios como Assunto , Terapia Combinada , Índice de Gravidade de Doença , Feminino
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