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[PMID]:29506509
[Au] Autor:Zhang Z; Zhou M; Liu K; Zhu B; Liu H; Sun X; Xu X
[Ad] Endereço:Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai, China.
[Ti] Título:Development of a new valid and reliable microsurgical skill assessment scale for ophthalmology residents.
[So] Source:BMC Ophthalmol;18(1):68, 2018 Mar 05.
[Is] ISSN:1471-2415
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: More and more concerns have been arisen about the ability of new medical graduates to meet the demands of today's practice environment. In this study, we wanted to develop a valid, reliable and standardized assessment tool for evaluating the basic microsurgical skills of residents in a microsurgery laboratory, to get them well prepared before entering the surgical realm of ophthalmology. METHODS: Twenty-three experts who have teaching experience reviewed the assessment scale. Constructive comments were incorporated to ensure face and content validity. Twenty-one attendings from different specialties then graded eight corneal rupture suturing videos with the scale to investigate interrater reliability. Fourteen of them graded the same videos 3 months later to investigate intrarater reliability (repeatability). RESULTS: A total of 280 assessment scales were completed. All the ICC values of interrater reliability were greater than 0.8 with 75% data greater than 0.9 (range 0.860-0.976). All the ICC values of intrarater reliability (repeatability) were also greater than 0.8 with 63% data greater than 0.9 (range 0.833-0.954). CONCLUSIONS: The assessment scale we developed is valid and reliable. This tool could be useful to ensure that junior residents achieve a certain level of microsurgical technique in a laboratory environment before training in the operation room. Hopefully, this tool will provide a structured template for other residency programs to assess their residents for basic microsurgical skills.
[Mh] Termos MeSH primário: Competência Clínica/normas
Avaliação Educacional/métodos
Internato e Residência
Microcirurgia/educação
Procedimentos Cirúrgicos Oftalmológicos/educação
Oftalmologia/educação
Técnicas de Sutura/educação
[Mh] Termos MeSH secundário: Lesões da Córnea/cirurgia
Seres Humanos
Reprodutibilidade dos Testes
Inquéritos e Questionários
[Pt] Tipo de publicação:JOURNAL ARTICLE; VALIDATION STUDIES
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180307
[St] Status:MEDLINE
[do] DOI:10.1186/s12886-018-0736-z


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[PMID]:29506498
[Au] Autor:Zhang Y; Chen YG
[Ad] Endereço:Department of Ophthalmology, Peking University Third Hospital, 49 North Huayuan Road, Haidian District, Beijing, 100191, China.
[Ti] Título:High incidence of rainbow glare after femtosecond laser assisted-LASIK using the upgraded FS200 femtosecond laser.
[So] Source:BMC Ophthalmol;18(1):71, 2018 Mar 05.
[Is] ISSN:1471-2415
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: To compare the incidence of rainbow glare (RG) after femtosecond laser assisted-LASIK (FS-LASIK) using the upgraded FS200 femtosecond laser with different flap cut parameter settings. METHODS: A consecutive series of 129 patients (255 eyes) who underwent FS-LASIK for correcting myopia and/or astigmatism using upgraded WaveLight FS200 femtosecond laser with the original settings was included in group A. Another consecutive series of 129 patients (255 eyes) who underwent FS-LASIK using upgraded WaveLight FS200 femtosecond laser with flap cut parameter settings changed (decreased pulse energy, spot and line separation) was included in group B. The incidence and fading time of RG, confocal microscopic image and postoperative clinical results were compared between the two groups. RESULTS: There were no differences between the two groups in age, baseline refraction, excimer laser ablation depth, postoperative uncorrected visual acuity and refraction. The incidence rate of RG in group A (35/255, 13.73%) was significantly higher than that in group B (4/255, 1.57%) (P < 0.05). The median fading time was 3 months in group A and 1 month in group B (P > 0.05).The confocal microscopic images showed wider laser spot spacing in group A than group B. The incidence of RG was significantly correlated with age and grouping (P < 0.05). CONCLUSIONS: The upgraded FS200 femtosecond laser with original flap cut parameter settings could increase the incidence of RG. The narrower grating size and lower pulse energy could ameliorate this side effect.
[Mh] Termos MeSH primário: Astigmatismo/cirurgia
Ofuscação
Ceratomileuse Assistida por Excimer Laser In Situ/métodos
Lasers de Excimer/efeitos adversos
Miopia/cirurgia
Transtornos da Visão/epidemiologia
[Mh] Termos MeSH secundário: Adulto
Seres Humanos
Incidência
Ceratomileuse Assistida por Excimer Laser In Situ/instrumentação
Microscopia Confocal
Refração Ocular/fisiologia
Estudos Retrospectivos
Retalhos Cirúrgicos
Tomografia de Coerência Óptica
Transtornos da Visão/fisiopatologia
Acuidade Visual/fisiologia
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180307
[St] Status:MEDLINE
[do] DOI:10.1186/s12886-018-0734-1


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[PMID]:29420981
[Au] Autor:Gaur S; Turkbey B
[Ad] Endereço:Molecular Imaging Program, National Cancer Institute, National Institutes of Health, 10 Center Drive, Building 10, Room B3B85, Bethesda, MD 20814, USA.
[Ti] Título:Prostate MR Imaging for Posttreatment Evaluation and Recurrence.
[So] Source:Radiol Clin North Am;56(2):263-275, 2018 Mar.
[Is] ISSN:1557-8275
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Prostate multiparametric MR imaging (mpMRI) plays an important role in local evaluation after treatment of prostate cancer. After radical prostatectomy, radiation therapy, and focal therapy, mpMRI can be used to visualize normal post-treatment changes and to diagnose locally recurrent disease. An understanding of the various treatments and expected changes is essential for complete and accurate post-treatment mpMRI interpretation.
[Mh] Termos MeSH primário: Imagem por Ressonância Magnética/métodos
Recidiva Local de Neoplasia/diagnóstico por imagem
Complicações Pós-Operatórias/diagnóstico por imagem
Próstata/diagnóstico por imagem
Neoplasias da Próstata/diagnóstico por imagem
Neoplasias da Próstata/cirurgia
[Mh] Termos MeSH secundário: Seres Humanos
Masculino
Recidiva Local de Neoplasia/patologia
Próstata/patologia
Neoplasias da Próstata/patologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180209
[St] Status:MEDLINE


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Registro de Ensaios Clínicos
Registro de Ensaios Clínicos
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[PMID]:29362795
[Au] Autor:Foa EB; McLean CP; Zang Y; Rosenfield D; Yadin E; Yarvis JS; Mintz J; Young-McCaughan S; Borah EV; Dondanville KA; Fina BA; Hall-Clark BN; Lichner T; Litz BT; Roache J; Wright EC; Peterson AL; STRONG STAR Consortium
[Ad] Endereço:Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia.
[Ti] Título:Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial.
[So] Source:JAMA;319(4):354-364, 2018 01 23.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Effective and efficient treatment is needed for posttraumatic stress disorder (PTSD) in active duty military personnel. Objective: To examine the effects of massed prolonged exposure therapy (massed therapy), spaced prolonged exposure therapy (spaced therapy), present-centered therapy (PCT), and a minimal-contact control (MCC) on PTSD severity. Design, Setting, and Participants: Randomized clinical trial conducted at Fort Hood, Texas, from January 2011 through July 2016 and enrolling 370 military personnel with PTSD who had returned from Iraq, Afghanistan, or both. Final follow-up was July 11, 2016. Interventions: Prolonged exposure therapy, cognitive behavioral therapy involving exposure to trauma memories/reminders, administered as massed therapy (n = 110; 10 sessions over 2 weeks) or spaced therapy (n = 109; 10 sessions over 8 weeks); PCT, a non-trauma-focused therapy involving identifying/discussing daily stressors (n = 107; 10 sessions over 8 weeks); or MCC, telephone calls from therapists (n = 40; once weekly for 4 weeks). Main Outcomes and Measures: Outcomes were assessed before and after treatment and at 2-week, 12-week, and 6-month follow-up. Primary outcome was interviewer-assessed PTSD symptom severity, measured by the PTSD Symptom Scale-Interview (PSS-I; range, 0-51; higher scores indicate greater PTSD severity; MCID, 3.18), used to assess efficacy of massed therapy at 2 weeks posttreatment vs MCC at week 4; noninferiority of massed therapy vs spaced therapy at 2 weeks and 12 weeks posttreatment (noninferiority margin, 50% [2.3 points on PSS-I, with 1-sided α = .05]); and efficacy of spaced therapy vs PCT at posttreatment. Results: Among 370 randomized participants, data were analyzed for 366 (mean age, 32.7 [SD, 7.3] years; 44 women [12.0%]; mean baseline PSS-I score, 25.49 [6.36]), and 216 (59.0%) completed the study. At 2 weeks posttreatment, mean PSS-I score was 17.62 (mean decrease from baseline, 7.13) for massed therapy and 21.41 (mean decrease, 3.43) for MCC (difference in decrease, 3.70 [95% CI,0.72 to 6.68]; P = .02). At 2 weeks posttreatment, mean PSS-I score was 18.03 for spaced therapy (decrease, 7.29; difference in means vs massed therapy, 0.79 [1-sided 95% CI, -∞ to 2.29; P = .049 for noninferiority]) and at 12 weeks posttreatment was 18.88 for massed therapy (decrease, 6.32) and 18.34 for spaced therapy (decrease, 6.97; difference, 0.55 [1-sided 95% CI, -∞ to 2.05; P = .03 for noninferiority]). At posttreatment, PSS-I scores for PCT were 18.65 (decrease, 7.31; difference in decrease vs spaced therapy, 0.10 [95% CI, -2.48 to 2.27]; P = .93). Conclusions and Relevance: Among active duty military personnel with PTSD, massed therapy (10 sessions over 2 weeks) reduced PTSD symptom severity more than MCC at 2-week follow-up and was noninferior to spaced therapy (10 sessions over 8 weeks), and there was no significant difference between spaced therapy and PCT. The reductions in PTSD symptom severity with all treatments were relatively modest, suggesting that further research is needed to determine the clinical importance of these findings. Trial Registration: clinicaltrials.gov Identifier: NCT01049516.
[Mh] Termos MeSH primário: Terapia Implosiva/métodos
Militares/psicologia
Psicoterapia/métodos
Transtornos de Estresse Pós-Traumáticos/terapia
[Mh] Termos MeSH secundário: Adulto
Campanha Afegã de 2001-
Feminino
Seres Humanos
Guerra do Iraque 2003-2011
Modelos Lineares
Masculino
Índice de Gravidade de Doença
Fatores de Tempo
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUPPORT, NON-U.S. GOV'T; RESEARCH SUPPORT, U.S. GOV'T, NON-P.H.S.
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180125
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.21242


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[PMID]:29362796
[Au] Autor:Bouillon K; Bertrand M; Bader G; Lucot JP; Dray-Spira R; Zureik M
[Ad] Endereço:Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France.
[Ti] Título:Association of Hysteroscopic vs Laparoscopic Sterilization With Procedural, Gynecological, and Medical Outcomes.
[So] Source:JAMA;319(4):375-387, 2018 01 23.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Safety of hysteroscopic sterilization has been recently questioned following reports of general symptoms such as allergy, tiredness, and depression in addition to associated gynecological results such as pelvic pain, perforation of fallopian tubes or uterus, and unwanted pregnancy. Objective: To compare the risk of reported adverse events between hysteroscopic and laparoscopic sterilization. Design, Setting, and Participants: French nationwide cohort study using the national hospital discharge database linked to the health insurance claims database. Women aged 30 to 54 years receiving a first hysteroscopic or laparoscopic sterilization between 2010 and 2014 were included and were followed up through December 2015. Exposures: Hysteroscopic sterilization vs laparoscopic sterilization. Main Outcomes and Measures: Risks of procedural complications (surgical and medical) and of gynecological (sterilization failure that includes salpingectomy, second sterilization procedure, or pregnancy; pregnancy; reoperation) and medical outcomes (all types of allergy; autoimmune diseases; thyroid disorder; use of analgesics, antimigraines, antidepressants, benzodiazepines; outpatient visits; sickness absence; suicide attempts; death) that occurred within 1 and 3 years after sterilization were compared using inverse probability of treatment-weighted Cox models. Results: Of the 105 357 women included (95.5% of eligible participants; mean age, 41.3 years [SD, 3.7 years]), 71 303 (67.7% ) underwent hysteroscopic sterilization, and 34 054 (32.3%) underwent laparoscopic sterilization. During the hospitalization for sterilization, risk of surgical complications for hysteroscopic sterilization was lower: 0.13% for hysteroscopic sterilization vs 0.78% for laparoscopic sterilization (adjusted risk difference [RD], -0.64; 95% CI, -0.67 to -0.60) and was lower for medical complications: 0.06% vs 0.11% (adjusted RD, -0.05; 95% CI, -0.08 to -0.01). During the first year after sterilization, 4.83% of women who underwent hysteroscopic sterilization had a higher risk of sterilization failure than the 0.69% who underwent laparoscopic sterilization (adjusted hazard ratio [HR], 7.11; 95% CI, 5.92 to 8.54; adjusted RD, 4.23 per 100 person-years; 95% CI, 3.40 to 5.22). Additionally, 5.65% of women who underwent hysteroscopic sterilization required gynecological reoperation vs 1.76% of women who underwent laparoscopic sterilization (adjusted HR, 3.26; 95% CI, 2.90 to 3.67; adjusted RD, 4.63 per 100 person-years; 95% CI, 3.38 to 4.75); these differences persisted after 3 years, although attenuated. Hysteroscopic sterilization was associated with a lower risk of pregnancy within the first year of the procedure but was not significantly associated with a difference in risk of pregnancy by the third year (adjusted HR, 1.04; 95% CI, 0.83-1.30; adjusted RD, 0.01 per 100 person-years; 95% CI, -0.04 to 0.07). Risks of medical outcomes were not significantly increased with hysteroscopic sterilization compared with laparoscopic sterilization. Conclusions and Relevance: Among women undergoing first sterilization, the use of hysteroscopic sterilization was significantly associated with higher risk of gynecological complications over 1 year and over 3 years than was laparoscopic sterilization. Risk of medical outcomes was not significantly increased over 1 year or over 3 years. These findings do not support increased medical risks associated with hysteroscopic sterilization.
[Mh] Termos MeSH primário: Histeroscopia/efeitos adversos
Laparoscopia/efeitos adversos
Complicações Pós-Operatórias/etiologia
Esterilização Tubária/métodos
[Mh] Termos MeSH secundário: Adulto
Estudos de Coortes
Feminino
França
Seres Humanos
Meia-Idade
Complicações Pós-Operatórias/epidemiologia
Gravidez
Gravidez não Planejada
Reoperação/estatística & dados numéricos
Esterilização Tubária/efeitos adversos
Falha de Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180125
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.21269


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[PMID]:29362794
[Au] Autor:Friedman DJ; Piccini JP; Wang T; Zheng J; Malaisrie SC; Holmes DR; Suri RM; Mack MJ; Badhwar V; Jacobs JP; Gaca JG; Chow SC; Peterson ED; Brennan JM
[Ad] Endereço:Duke Clinical Research Institute, Durham, North Carolina.
[Ti] Título:Association Between Left Atrial Appendage Occlusion and Readmission for Thromboembolism Among Patients With Atrial Fibrillation Undergoing Concomitant Cardiac Surgery.
[So] Source:JAMA;319(4):365-374, 2018 01 23.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: The left atrial appendage is a key site of thrombus formation in atrial fibrillation (AF) and can be occluded or removed at the time of cardiac surgery. There is limited evidence regarding the effectiveness of surgical left atrial appendage occlusion (S-LAAO) for reducing the risk of thromboembolism. Objective: To evaluate the association of S-LAAO vs no receipt of S-LAAO with the risk of thromboembolism among older patients undergoing cardiac surgery. Design, Setting, and Participants: Retrospective cohort study of a nationally representative Medicare-linked cohort from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2011-2012). Patients aged 65 years and older with AF undergoing cardiac surgery (coronary artery bypass grafting [CABG], mitral valve surgery with or without CABG, or aortic valve surgery with or without CABG) with and without concomitant S-LAAO were followed up until December 31, 2014. Exposures: S-LAAO vs no S-LAAO. Main Outcomes and Measures: The primary outcome was readmission for thromboembolism (stroke, transient ischemic attack, or systemic embolism) at up to 3 years of follow-up, as defined by Medicare claims data. Secondary end points included hemorrhagic stroke, all-cause mortality, and a composite end point (thromboembolism, hemorrhagic stroke, or all-cause mortality). Results: Among 10 524 patients undergoing surgery (median age, 76 years; 39% female; median CHA2DS2-VASc score, 4), 3892 (37%) underwent S-LAAO. Overall, at a mean follow-up of 2.6 years, thromboembolism occurred in 5.4%, hemorrhagic stroke in 0.9%, all-cause mortality in 21.5%, and the composite end point in 25.7%. S-LAAO, compared with no S-LAAO, was associated with lower unadjusted rates of thromboembolism (4.2% vs 6.2%), all-cause mortality (17.3% vs 23.9%), and the composite end point (20.5% vs 28.7%) but no significant difference in rates of hemorrhagic stroke (0.9% vs 0.9%). After inverse probability-weighted adjustment, S-LAAO was associated with a significantly lower rate of thromboembolism (subdistribution hazard ratio [HR], 0.67; 95% CI, 0.56-0.81; P < .001), all-cause mortality (HR, 0.88; 95% CI, 0.79-0.97; P = .001), and the composite end point (HR, 0.83; 95% CI, 0.76-0.91; P < .001) but not hemorrhagic stroke (subdistribution HR, 0.84; 95% CI, 0.53-1.32; P = .44). S-LAAO, compared with no S-LAAO, was associated with a lower risk of thromboembolism among patients discharged without anticoagulation (unadjusted rate, 4.2% vs 6.0%; adjusted subdistribution HR, 0.26; 95% CI, 0.17-0.40; P < .001), but not among patients discharged with anticoagulation (unadjusted rate, 4.1% vs 6.3%; adjusted subdistribution HR, 0.88; 95% CI, 0.56-1.39; P = .59). Conclusions and Relevance: Among older patients with AF undergoing concomitant cardiac surgery, S-LAAO, compared with no S-LAAO, was associated with a lower risk of readmission for thromboembolism over 3 years. These findings support the use of S-LAAO, but randomized trials are necessary to provide definitive evidence.
[Mh] Termos MeSH primário: Apêndice Atrial/cirurgia
Fibrilação Atrial
Procedimentos Cirúrgicos Cardíacos/efeitos adversos
Readmissão do Paciente/estatística & dados numéricos
Tromboembolia/prevenção & controle
[Mh] Termos MeSH secundário: Idoso
Valva Aórtica/cirurgia
Ponte de Artéria Coronária/efeitos adversos
Seguimentos
Seres Humanos
Estimativa de Kaplan-Meier
Valva Mitral/cirurgia
Modelos de Riscos Proporcionais
Estudos Retrospectivos
Dispositivo para Oclusão Septal
Tromboembolia/epidemiologia
Tromboembolia/etiologia
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; OBSERVATIONAL STUDY; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180125
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20125


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[PMID]:29362786
[Au] Autor:Woloshin S; Schwartz LM; Bagley PJ; Blunt HB; White B
[Ad] Endereço:Center for Medicine in the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire.
[Ti] Título:Characteristics of Interim Publications of Randomized Clinical Trials and Comparison With Final Publications.
[So] Source:JAMA;319(4):404-406, 2018 01 23.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Editoração
Ensaios Clínicos Controlados Aleatórios como Assunto
[Mh] Termos MeSH secundário: Seres Humanos
Publicações
Projetos de Pesquisa
Fatores de Tempo
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180125
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20653


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[PMID]:29340680
[Au] Autor:Jakobsen GS; Småstuen MC; Sandbu R; Nordstrand N; Hofsø D; Lindberg M; Hertel JK; Hjelmesæth J
[Ad] Endereço:Morbid Obesity Centre, Vestfold Hospital Trust, Tønsberg, Norway.
[Ti] Título:Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities.
[So] Source:JAMA;319(3):291-301, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: The association of bariatric surgery and specialized medical obesity treatment with beneficial and detrimental outcomes remains uncertain. Objective: To compare changes in obesity-related comorbidities in patients with severe obesity (body mass index ≥40 or ≥35 and at least 1 comorbidity) undergoing bariatric surgery or specialized medical treatment. Design, Setting, and Participants: Cohort study with baseline data of exposures from November 2005 through July 2010 and follow-up data from 2006 until death or through December 2015 at a tertiary care outpatient center, Vestfold Hospital Trust, Norway. Consecutive treatment-seeking adult patients (n = 2109) with severe obesity assessed (221 patients excluded and 1888 patients included). Exposures: Bariatric surgery (n = 932, 92% gastric bypass) or specialized medical treatment (n = 956) including individual or group-based lifestyle intervention programs. Main Outcomes and Measures: Primary outcomes included remission and new onset of hypertension based on drugs dispensed according to the Norwegian Prescription Database. Prespecified secondary outcomes included changes in comorbidities. Adverse events included complications retrieved from the Norwegian Patient Registry and a local laboratory database. Results: Among 1888 patients included in the study, the mean (SD) age was 43.5 (12.3) years (1249 women [66%]; mean [SD] baseline BMI, 44.2 [6.1]; 100% completed follow-up at a median of 6.5 years [range, 0.2-10.1]). Surgically treated patients had a greater likelihood of remission and lesser likelihood for new onset of hypertension (remission: absolute risk [AR], 31.9% vs 12.4%); risk difference [RD], 19.5% [95% CI, 15.8%-23.2%], relative risk [RR], 2.1 [95% CI, 2.0-2.2]; new onset: AR, 3.5% vs 12.2%, RD, 8.7% [95% CI, 6.7%-10.7%], RR, 0.4 [95% CI, 0.3-0.5]; greater likelihood of diabetes remission: AR, 57.5% vs 14.8%; RD, 42.7% [95% CI, 35.8%-49.7%], RR, 3.9 [95% CI, 2.8-5.4]; greater risk of new-onset depression: AR, 8.9% vs 6.5%; RD, 2.4% [95% CI, 1.3%-3.5%], RR, 1.5 [95% CI, 1.4-1.7]; and treatment with opioids: AR, 19.4% vs 15.8%, RD, 3.6% [95% CI, 2.3%-4.9%], RR, 1.3 [95% CI, 1.2-1.4]). Surgical patients had a greater risk for undergoing at least 1 additional gastrointestinal surgical procedure (AR, 31.3% vs 15.5%; RD, 15.8% [95% CI, 13.1%-18.5%]; RR, 2.0 [95% CI, 1.7-2.4]). The proportion of patients with low ferritin levels was significantly greater in the surgical group (26% vs 12%, P < .001). Conclusions and Relevance: Among patients with severe obesity followed up for a median of 6.5 years, bariatric surgery compared with medical treatment was associated with a clinically important increased risk for complications, as well as lower risks of obesity-related comorbidities. The risk for complications should be considered in the decision-making process.
[Mh] Termos MeSH primário: Cirurgia Bariátrica
Obesidade Mórbida/complicações
[Mh] Termos MeSH secundário: Adulto
Cirurgia Bariátrica/efeitos adversos
Índice de Massa Corporal
Estudos de Coortes
Comorbidade
Depressão/complicações
Diabetes Mellitus Tipo 2/complicações
Feminino
Ferritinas/sangue
Seres Humanos
Hipertensão/complicações
Masculino
Meia-Idade
Obesidade Mórbida/tratamento farmacológico
Obesidade Mórbida/cirurgia
Indução de Remissão
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
9007-73-2 (Ferritins)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180118
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.21055


  9 / 15283845 MEDLINE  
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[PMID]:29340679
[Au] Autor:Peterli R; Wölnerhanssen BK; Peters T; Vetter D; Kröll D; Borbély Y; Schultes B; Beglinger C; Drewe J; Schiesser M; Nett P; Bueter M
[Ad] Endereço:Department of Surgery, St Claraspital, Basel, Switzerland.
[Ti] Título:Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial.
[So] Source:JAMA;319(3):255-265, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Sleeve gastrectomy is increasingly used in the treatment of morbid obesity, but its long-term outcome vs the standard Roux-en-Y gastric bypass procedure is unknown. Objective: To determine whether there are differences between sleeve gastrectomy and Roux-en-Y gastric bypass in terms of weight loss, changes in comorbidities, increase in quality of life, and adverse events. Design, Setting, and Participants: The Swiss Multicenter Bypass or Sleeve Study (SM-BOSS), a 2-group randomized trial, was conducted from January 2007 until November 2011 (last follow-up in March 2017). Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers, 217 patients were enrolled and randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period. Interventions: Patients were randomly assigned to undergo laparoscopic sleeve gastrectomy (n = 107) or laparoscopic Roux-en-Y gastric bypass (n = 110). Main Outcomes and Measures: The primary end point was weight loss, expressed as percentage excess body mass index (BMI) loss. Exploratory end points were changes in comorbidities and adverse events. Results: Among the 217 patients (mean age, 45.5 years; 72% women; mean BMI, 43.9) 205 (94.5%) completed the trial. Excess BMI loss was not significantly different at 5 years: for sleeve gastrectomy, 61.1%, vs Roux-en-Y gastric bypass, 68.3% (absolute difference, -7.18%; 95% CI, -14.30% to -0.06%; P = .22 after adjustment for multiple comparisons). Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass (60.4%) than after sleeve gastrectomy (25.0%). Gastric reflux worsened (more symptoms or increase in therapy) more often after sleeve gastrectomy (31.8%) than after Roux-en-Y gastric bypass (6.3%). The number of patients with reoperations or interventions was 16/101 (15.8%) after sleeve gastrectomy and 23/104 (22.1%) after Roux-en-Y gastric bypass. Conclusions and Relevance: Among patients with morbid obesity, there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass at 5 years of follow-up after surgery. Trial Registration: clinicaltrials.gov Identifier: NCT00356213.
[Mh] Termos MeSH primário: Gastrectomia
Derivação Gástrica
Laparoscopia
Obesidade Mórbida/cirurgia
Perda de Peso
[Mh] Termos MeSH secundário: Adulto
Índice de Massa Corporal
Feminino
Seguimentos
Gastrectomia/efeitos adversos
Gastrectomia/métodos
Derivação Gástrica/efeitos adversos
Derivação Gástrica/métodos
Refluxo Gastroesofágico/etiologia
Seres Humanos
Masculino
Meia-Idade
Obesidade Mórbida/complicações
Obesidade Mórbida/fisiopatologia
Complicações Pós-Operatórias
Qualidade de Vida
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180118
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20897


  10 / 15283845 MEDLINE  
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[PMID]:29340678
[Au] Autor:Ikramuddin S; Korner J; Lee WJ; Thomas AJ; Connett JE; Bantle JP; Leslie DB; Wang Q; Inabnet WB; Jeffery RW; Chong K; Chuang LM; Jensen MD; Vella A; Ahmed L; Belani K; Billington CJ
[Ad] Endereço:Department of Surgery, University of Minnesota, Minneapolis.
[Ti] Título:Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study.
[So] Source:JAMA;319(3):266-278, 2018 01 16.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown. Objective: To compare durability of Roux-en-Y gastric bypass added to intensive lifestyle and medical management in achieving diabetes control targets. Design, Setting, and Participants: Observational follow-up of a randomized clinical trial at 4 sites in the United States and Taiwan, involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011) were followed up for 5 years, ending in November 2016. Interventions: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years, with and without (60 participants each) Roux-en-Y gastric bypass surgery followed by observation to year 5. Main Outcomes and Measures: The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years. Results: Of 120 participants who were initially randomized (mean age, 49 years [SD, 8 years], 72 women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristics were similar between groups: mean (SD) body mass index 34.4 (3.2) for the lifestyle-medical management group and 34.9 (3.0) for the gastric bypass group and had hemoglobin A1c levels of 9.6% (1.2) and 9.6% (1.0), respectively. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01). In the fifth year, 31 patients (55%) in the gastric bypass group vs 8 (14%) in the lifestyle-medical management group achieved an HbA1c level of less than 7.0% (difference, 41%; 95% CI, 19%-63%; P = .002). Gastric bypass had more serious adverse events than did the lifestyle-medical management intervention, 66 events vs 38 events, most frequently gastrointestinal events and surgical complications such as strictures, small bowel obstructions, and leaks. Gastric bypass had more parathyroid hormone elevation but no difference in B12 deficiency. Conclusions and Relevance: In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement. Trial Registration: clinicaltrials.gov Identifier: NCT00641251.
[Mh] Termos MeSH primário: Derivação Gástrica
Hemoglobina A Glicada/análise
[Mh] Termos MeSH secundário: LDL-Colesterol/sangue
Diabetes Mellitus Tipo 2/sangue
Feminino
Seres Humanos
Hipoglicemiantes
Estilo de Vida
Meia-Idade
Taiwan
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL; COMMENT
[Nm] Nome de substância:
0 (Cholesterol, LDL); 0 (Glycated Hemoglobin A); 0 (Hypoglycemic Agents)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180311
[Lr] Data última revisão:
180311
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180118
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.20813



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