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Leptomeningeal metastases are increasingly becoming recognized as a treatable, yet generally incurable, complication of advanced cancer. As modern cancer therapeutics have prolonged the lives of patients with metastatic cancer, specifically in patients with parenchymal brain metastases, treatment options and clinical research protocols for patients with leptomeningeal metastases from solid tumors have similarly evolved to improve survival within specific populations. Recent expansion in clinical investigation, early diagnosis, and drug development have given rise to new unanswered questions. These include leptomeningeal metastasis biology and preferred animal modeling, epidemiology in the modern cancer population, ensuring validation and accessibility of newer leptomeningeal metastasis diagnostics, best clinical practices with multi-modality treatment options, clinical trial design and standardization of response assessments, and avenues worthy of further research. An international group of multi-disciplinary experts in the research and management of leptomeningeal metastases, supported by the Society for Neuro-Oncology and American Society of Clinical Oncology, were assembled to reach a consensus opinion on these pressing topics and provide a roadmap for future directions. Our hope is that these recommendations will accelerate collaboration and progress in the field of leptomeningeal metastases and serve as a platform for further discussion and patient advocacy.
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Anxiety disorders are very prevalent and often persistent mental disorders, with a considerable rate of treatment resistance which requires regulatory clinical trials of innovative therapeutic interventions. However, an explicit definition of treatment-resistant anxiety disorders (TR-AD) informing such trials is currently lacking. We used a Delphi method-based consensus approach to provide internationally agreed, consistent and clinically useful operational criteria for TR-AD in adults. Following a summary of the current state of knowledge based on international guidelines and an available systematic review, a survey of free-text responses to a 29-item questionnaire on relevant aspects of TR-AD, and an online consensus meeting, a panel of 36 multidisciplinary international experts and stakeholders voted anonymously on written statements in three survey rounds. Consensus was defined as ≥75% of the panel agreeing with a statement. The panel agreed on a set of 14 recommendations for the definition of TR-AD, providing detailed operational criteria for resistance to pharmacological and/or psychotherapeutic treatment, as well as a potential staging model. The panel also evaluated further aspects regarding epidemiological subgroups, comorbidities and biographical factors, the terminology of TR-AD vs. "difficult-to-treat" anxiety disorders, preferences and attitudes of persons with these disorders, and future research directions. This Delphi method-based consensus on operational criteria for TR-AD is expected to serve as a systematic, consistent and practical clinical guideline to aid in designing future mechanistic studies and facilitate clinical trials for regulatory purposes. This effort could ultimately lead to the development of more effective evidence-based stepped-care treatment algorithms for patients with anxiety disorders.
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Background: Pharmacotherapy with biologics and small molecules, as the more effective therapies for moderate to severe ulcerative colitis (UC) and Crohn's disease (CD), is complex. Choosing the best methods for their utilization in order to induce and maintain remission are critical for practicing gastroenterologists. We aimed to develop an Iranian consensus on the management of inflammatory bowel disease (IBD) patients with biologics and small molecules. Methods: A Delphi consensus was undertaken by experts who performed a literature summary and voting process. Quality of evidence was assessed using the Grading and Recommendations Assessment, Development, and Evaluation; and an additional risk of bias-protocol. Results: Following an extensive search of the literature, 219 studies were used to determine the quality of the evidence. After three rounds of voting, consensus (defined as≥80% agreement) was reached for 87 statements. Conclusion: We considered different aspects of pharmacotherapy in this consensus. This guideline, along with clinical judgment, can be used to optimize management of IBD patients.
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Despite the unexpectedly high tumor responses and limited treatment-related toxicities observed with SFRT, prospective multi-institutional clinical trials of SFRT are still lacking. High variability of SFRT technologies and methods, unfamiliar complex dose and prescription concepts for heterogeneous dose and uncertainty regarding systemic therapies present major obstacles towards clinical trial development. To address these challenges, the consensus guideline reported here aimed at facilitating trial development and feasibility through a priori harmonization of treatment approach and the full range of clinical trial design parameters for SFRT trials in gynecologic cancer. Gynecologic cancers were evaluated for the status of SFRT pilot experience. A multi-disciplinary SFRT expert panel for gynecologic cancer was established to develop the consensus through formal panel review/discussions, appropriateness rank voting and public comment solicitation/review. The trial design parameters included eligibility/exclusions, endpoints, SFRT technology/technique, dose/dosimetric parameters, systemic therapies, patient evaluations, and embedded translational science. Cervical cancer was determined as the most suitable gynecologic tumor for an SFRT trial. Consensus emphasized standardization of SFRT dosimetry/physics parameters, biologic dose modeling, and specimen collection for translational/biological endpoints, which may be uniquely feasible in cervical cancer. Incorporation of brachytherapy into the SFRT regimen requires additional pre-trial pilot investigations. Specific consensus recommendations are presented and discussed.
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BACKGROUND: Because the etiologies of bronchiectasis and related diseases vary significantly among different regions and ethnicities, this study aimed to develop a diagnostic bundle for bronchiectasis in South Korea. METHODS: A modified Delphi method was used to develop expert consensus statements on a diagnostic bundle for bronchiectasis in South Korea. Initial statements proposed by a core panel, based on international bronchiectasis guidelines, were discussed in an online meeting and two email surveys by a panel of experts (≥70% agreement). RESULTS: The study involved 21 expert participants, and 30 statements regarding a diagnostic bundle for bronchiectasis were classified as recommended, conditional, or not recommended. The consensus statements of the expert panel were as follows: A standardized diagnostic bundle is useful in clinical practice; diagnostic tests for specific diseases, including immunodeficiency and allergic bronchopulmonary aspergillosis, are necessary when clinically suspected; initial diagnostic tests, including sputum microbiology and spirometry, are essential in all patients with bronchiectasis, and patients suspected with rare causes such as primary ciliary dyskinesia should be referred to specialized centers. CONCLUSION: Based on this Delphi survey, expert consensus statements were generated including specific diagnostic, laboratory, microbiological, and pulmonary function tests required to manage patients with bronchiectasis in South Korea.
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This consensus paper is derived from a meeting of an international group of 19 neurological rehabilitation specialists with a combined experience of more than 250 years (range 4-25 years; mean 14.1 years) in treating post-stroke spasticity with botulinum toxin A. The group undertook critical assessments of some recurring practical challenges, not yet addressed in guidelines, through an exten-sive literature search. They then discussed the results in the light of their individual clinical experience and developed consensus statements to present to the wider community who treat such patients. The analysis provides a comprehensive overview of treatment with botulinum toxin A, including the use of adjunctive therapies, within a multidisciplinary context, and is aimed at practicing clinicians who treat patients with post-stroke spasticity and require further practical guidance on the use of botulinum toxin A. This paper does not replicate information published elsewhere, but instead aims to provide practical advice to help optimize the use of botulinum toxin A and maximize clinical outcomes. The recommendations for each topic are summarized in a series of statements. Where published high-quality evidence exists, the recommendations reflect this. However, where evidence is not yet conclusive, the group members issued statements and, in some cas-es, made recommendations based on their clinical experience.
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Toxinas Botulínicas Tipo A/uso terapêutico , Espasticidade Muscular/tratamento farmacológico , Acidente Vascular Cerebral/complicações , Consenso , Humanos , Fármacos Neuromusculares/uso terapêuticoRESUMO
The guidelines for metastatic colorectal cancer crudely state that the best local treatment should be selected from a 'toolbox' of techniques according to patient- and treatment-related factors. We created an interdisciplinary, consensus-based algorithm with specific resectability and ablatability criteria for the treatment of colorectal liver metastases (CRLM). To pursue consensus, members of the multidisciplinary COLLISION and COLDFIRE trial expert panel employed the RAND appropriateness method (RAM). Statements regarding patient, disease, tumor and treatment characteristics were categorized as appropriate, equipoise or inappropriate. Patients with ECOG≤2, ASA≤3 and Charlson comorbidity index ≤8 should be considered fit for curative-intent local therapy. When easily resectable and/or ablatable (stage IVa), (neo)adjuvant systemic therapy is not indicated. When requiring major hepatectomy (stage IVb), neo-adjuvant systemic therapy is appropriate for early metachronous disease and to reduce procedural risk. To downstage patients (stage IVc), downsizing induction systemic therapy and/or future remnant augmentation is advised. Disease can only be deemed permanently unsuitable for local therapy if downstaging failed (stage IVd). Liver resection remains the gold standard. Thermal ablation is reserved for unresectable CRLM, deep-seated resectable CRLM and can be considered when patients are in poor health. Irreversible electroporation and stereotactic body radiotherapy can be considered for unresectable perihilar and perivascular CRLM 0-5cm. This consensus document provides per-patient and per-tumor resectability and ablatability criteria for the treatment of CRLM. These criteria are intended to aid tumor board discussions, improve consistency when designing prospective trials and advance intersociety communications. Areas where consensus is lacking warrant future comparative studies.
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Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Guias de Prática Clínica como Assunto , Infecções Estafilocócicas/tratamento farmacológico , Vancomicina/farmacologia , Vancomicina/uso terapêutico , Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/prevenção & controle , Antibacterianos/efeitos adversos , Antibacterianos/farmacocinética , Área Sob a Curva , Monitoramento de Medicamentos , Humanos , Testes de Sensibilidade Microbiana , Estados Unidos , Vancomicina/efeitos adversos , Vancomicina/farmacocinéticaRESUMO
BACKGROUND: Clinically relevant issues in the real-world treatment of depression have not always been captured by conventional treatment guidelines. METHODS: Certified psychiatrists of the Japanese Society of Clinical Neuropsychopharmacology were asked to evaluate treatment options regarding 23 clinical situations in the treatment of depression using a 9-point Likert scale (1="disagree" and 9="agree"). According to the responses of 114 experts, the options were categorized into first-, second-, and third-line treatments. RESULTS: First-line antidepressants varied depending on predominant symptoms: escitalopram (mean ± standard deviation score, 7.8 ± 1.7) and sertraline (7.3 ± 1.7) were likely selected for anxiety; duloxetine (7.6 ± 1.9) and venlafaxine (7.2 ± 2.1) for loss of interest; mirtazapine for insomnia (8.2 ± 1.6), loss of appetite (7.9 ± 1.9), agitation and severe irritation (7.4 ± 2.0), and suicidal ideation (7.5 ± 1.9). While first-line treatment was switched to either an SNRI (7.7 ± 1.9) or mirtazapine (7.4 ± 2.0) in the case of non-response to an SSRI, switching to mirtazapine (7.1 ± 2.2) was recommended in the case of non-response to an SNRI, and vice versa (switching to an SNRI (7.0 ± 2.0) in the case of non-response to mirtazapine). Augmentation with aripiprazole was considered the first-line treatment for partial response to an SSRI (7.1 ± 2.3) or SNRI (7.0 ± 2.5). LIMITATIONS: The evidence level of expert consensus is considered low. All included experts were Japanese. CONCLUSIONS: Recommendations made by experts in the field are useful and can supplement guidelines and informed decision making in real-world clinical practice. We suggest that pharmacological strategies for depression be flexible and that each patient's situational needs as well as the pharmacotherapeutic profile of medications be considered.
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Antidepressivos , Depressão , Antidepressivos/uso terapêutico , Consenso , Humanos , Japão , Cloridrato de VenlafaxinaRESUMO
INTRODUCTION: During the last 20 years, multiple sclerosis (MS) disease has seen major changes with new diagnostic criteria, a better identification of disease phenotypes, individualization of disease prognosis and the appearance of new therapeutic options in relapsing remitting as well as progressive MS. As a result, the management of MS patients has become more complex and challenging. The objective of these consensus recommendations was to review how the disease should be managed in Argentina to improve long-term outcomes in MS patients. METHODS: A panel of 36 experts in neurology from Argentina, dedicated to the diagnosis and care of MS patients, gathered both virtually and in person during 2018 and 2019 to carry out a consensus recommendation on the management of MS patients in Argentina. To achieve consensus, the methodology of "formal consensus-RAND/UCLA method" was used. RESULTS: Recommendations focused on diagnosis, disease prognosis, tailored treatment, treatment failure identification and pharmacovigilance process. CONCLUSIONS: The recommendations of these consensus guidelines attempt to optimize the health care and management of patients with MS in Argentina.
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Consenso , Gerenciamento Clínico , Esclerose Múltipla/epidemiologia , Esclerose Múltipla/terapia , Neurologistas/normas , Guias de Prática Clínica como Assunto/normas , Argentina/epidemiologia , Humanos , Imageamento por Ressonância Magnética/métodos , Imageamento por Ressonância Magnética/normas , Esclerose Múltipla/diagnóstico por imagem , Neurologia/métodos , Neurologia/normasRESUMO
Use of image-guided radiation therapy (IGRT) helps to account for daily prostate position changes during radiation therapy for prostate cancer. However, guidelines for the use of IGRT are scarce. An ESTRO panel consisting of leading radiation oncologists and medical physicists was assembled to review the literature and formulate a consensus guideline of methods and procedure for IGRT in prostate cases. Advanced methods and procedures are also described which the committee judged relevant to further improve clinical practice. Moreover, ranges for margins for the three most popular IGRT scenarios have been suggested as examples.
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Neoplasias da Próstata/radioterapia , Radioterapia Guiada por Imagem/métodos , Consenso , Campos Eletromagnéticos , Humanos , Imageamento por Ressonância Magnética/métodos , Masculino , Movimento , Próstata/diagnóstico por imagem , Próstata/fisiopatologia , Neoplasias da Próstata/diagnóstico por imagem , Radiografia/métodos , Radioterapia Guiada por Imagem/normas , Glândulas Seminais/diagnóstico por imagem , Glândulas Seminais/fisiopatologia , Tomografia Computadorizada por Raios X/métodos , Ultrassonografia/métodosRESUMO
Tyrosine kinase inhibitors (TKIs) have improved the overall survival of patients with gastrointestinal stromal tumors (GISTs), but their side effects can impact dose intensity and, consequently, the clinical benefit. To date, no guideline or consensus has been published on the TKI-associated adverse reactions. Therefore, the Chinese Society of Surgeons for Gastrointestinal Stromal Tumor of the Chinese Medical Doctor Association organized an expert panel discussion involving representatives from gastrointestinal surgery, medical oncology, cardiology, dermatology, nephrology, endocrinology, and ophthalmology to consider the systemic clinical symptoms, molecular and cellular mechanisms, and treatment recommendations of GISTs. Here, we present the resultant evidence- and experience-based consensus to guide the management of TKI-associated side events in clinical practice.
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Antineoplásicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Tumores do Estroma Gastrointestinal/tratamento farmacológico , Inibidores de Proteínas Quinases/efeitos adversos , Proteínas Tirosina Quinases/antagonistas & inibidores , China , Consenso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Humanos , Médicos/normas , Sociedades Médicas/normasRESUMO
BACKGROUND AND PURPOSE: Delineation of clinical target volumes (CTVs) remains a weak link in radiation therapy (RT), and large inter-observer variation is seen. Guidelines for target and organs at risk delineation for prostate cancer in the primary setting are scarce. The aim was to develop a delineation guideline obtained by consensus between a broad European group of radiation oncologists. MATERIAL AND METHODS: An ESTRO contouring consensus panel consisting of leading radiation oncologists and one radiologist with known subspecialty expertise in prostate cancer was asked to delineate the prostate, seminal vesicles and rectum on co-registered CT and MRI scans. After evaluation of the different contours, literature review and multiple informal discussions by electronic mail a CTV definition was defined and a guide for contouring the CTV of the prostate and the rectum was developed. RESULTS: The panel achieved consensus CTV contouring definitions to be used as guideline for primary RT of localized prostate cancer. CONCLUSION: The ESTRO consensus on CT/MRI based CTV delineation for primary RT of localized prostate cancer, endorsed by a broad base of the radiation oncology community, is presented to improve consistency and reliability.
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Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/radioterapia , Planejamento da Radioterapia Assistida por Computador/normas , Radioterapia Guiada por Imagem/normas , Consenso , Humanos , Imageamento por Ressonância Magnética/métodos , Imageamento por Ressonância Magnética/normas , Masculino , Variações Dependentes do Observador , Órgãos em Risco/diagnóstico por imagem , Planejamento da Radioterapia Assistida por Computador/métodos , Radioterapia Guiada por Imagem/métodos , Reto/diagnóstico por imagem , Reprodutibilidade dos Testes , Glândulas Seminais/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Tomografia Computadorizada por Raios X/normasRESUMO
One of the biggest challenges in multiple sclerosis (MS) is the definition of treatment response/failure in order to optimize treatment decisions in affected patients. The objective of this consensus was to review how disease activity should be assessed and to propose recommendations on the identification of treatment failure in RRMS patients in Argentina. METHODS: A panel of experts in neurology from Argentina, dedicated to the diagnosis and care of MS patients, gathered both virtually and in person during 2016 and 2017 to carry out a consensus recommendation on the identification of treatment failure in RRMS patients. To achieve consensus, the methodology of "formal consensus-RAND/UCLA method" was used. RESULTS: Recommendations were established based on published evidence and the expert opinion. Recommendations focused on disease management, disease activity markers and treatment failure identification were determined. Main consensus were: ≥2 relapses during the first year of treatment and/or ≥3 new or enlarged T2 or T1 GAD+ lesions and/or sustained increase of ≥2 points in EDSS or ≥100% in T25FW defines treatment failure in RRMS patients. CONCLUSIONS: The recommendations of this consensus guidelines attempts to optimize the health care and management of patients with MS in Argentina.
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Consenso , Esclerose Múltipla Recidivante-Remitente , Falha de Tratamento , Argentina/epidemiologia , Avaliação da Deficiência , Humanos , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Esclerose Múltipla Recidivante-Remitente/terapiaRESUMO
Alemtuzumab is a humanized monoclonal antibody indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis with active disease. Multiple sclerosis (MS) patients treated with alemtuzumab are at increased risk for autoimmune adverse events (thyroid disorders, immune thrombocytopenia, and renal disease). The use of alemtuzumab has been associated with the development of renal immune-mediated adverse events in 0.3% of patients in clinical trials in MS, which generally occurred within 39 months of the last administration. Both anti-GBM disease and membranous nephropathy have been associated with the use of alemtuzumab. Early detection is necessary to allow for early diagnosis and prevent adverse renal and patient outcomes. Through the implementation of the risk minimization measures, patients can be diagnosed, and treated if needed, early allowing for generally favorable outcomes. This important goal can be reached through health care professional and patient education, careful analysis of the monthly lab tests, and close collaboration between the patient, neurologist, and the nephrologist. This article presents the consensus of Belgian MS specialists and nephrologists on the practicalities of diagnosis, management, and treatment of alemtuzumab-associated renal adverse events based on good clinical practice.
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Alemtuzumab/efeitos adversos , Antineoplásicos Imunológicos/efeitos adversos , Consenso , Gerenciamento Clínico , Nefropatias , Esclerose Múltipla/tratamento farmacológico , Bélgica/epidemiologia , Diagnóstico Precoce , Feminino , Humanos , Nefropatias/induzido quimicamente , Nefropatias/diagnóstico , Nefropatias/terapia , Masculino , Esclerose Múltipla/epidemiologiaRESUMO
Major depression represents among the most frequent psychiatric disorders in the general population with an estimated lifetime prevalence of 16-17%. It is characterized by high levels of comorbidities with other psychiatric conditions or somatic diseases as well as a recurrent or chronic course in 50 to 80% of the cases leading to negative repercussions on the daily functioning, with an impaired quality of life, and to severe direct/indirect costs. Large cohort studies have supported that failure of a first-line antidepressant treatment is observed in more than 60% of patients. In this case, several treatment strategies have been proposed by classical evidence-based guidelines from internationally recognized scientific societies, referring primarily on: I) the switch to another antidepressant of the same or different class; II) the combination with another antidepressant of complementary pharmacological profile; III) the addition of a wide range of pharmacological agents intending to potentiate the therapeutic effects of the ongoing antidepressant medication; IV) the association with appropriate psychological therapies; and, V) the use of non-invasive brain stimulation techniques. However, although based on the most recently available data and rigorous methodology, standard guidelines have the significant disadvantage of not covering a large variety of clinical conditions, while currently observed in everyday clinical practice. From these considerations, formalized recommendations by a large panel of French experts in the management of depressed patients have been developed under the shared sponsorship of the French Association of Biological Psychiatry and Neuropsychopharmacology (AFPBN) and the Fondation FondaMental. These French recommendations are presented in this special issue in order to provide relevant information about the treatment choices to make, depending particularly on the clinical response to previous treatment lines or the complexity of clinical situations (clinical features, specific populations, psychiatric comorbidities, etc.). Thus, the present approach will be especially helpful for the clinicians enabling to substantially facilitate and guide their clinical decision when confronted to difficult-to-treat forms of major depression in the daily clinical practice. This will be expected to significantly improve the poor prognosis of the treatment-resistant depression thereby lowering the clinical, functional and costly impact owing directly to the disease.
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Antidepressivos/uso terapêutico , Psiquiatria Biológica/normas , Transtorno Depressivo Resistente a Tratamento/terapia , Neuropsicologia/normas , Comitês Consultivos/organização & administração , Comitês Consultivos/normas , Antipsicóticos/uso terapêutico , Psiquiatria Biológica/organização & administração , Comorbidade , Consenso , Transtorno Depressivo Resistente a Tratamento/classificação , Transtorno Depressivo Resistente a Tratamento/diagnóstico , Transtorno Depressivo Resistente a Tratamento/epidemiologia , Quimioterapia Combinada , Prova Pericial , França/epidemiologia , Humanos , Neuropsicologia/organização & administração , Qualidade de Vida , Sociedades Médicas/normasRESUMO
BACKGROUND: The frequency of metabolic and bariatric surgery (MBS) is increasing worldwide, with over 500,000 cases performed every year. Obstructive sleep apnea (OSA) is present in 35%-94% of MBS patients. Nevertheless, consensus regarding the perioperative management of OSA in MBS patients is not established. OBJECTIVES: To provide consensus based guidelines utilizing current literature and, when in the absence of supporting clinical data, expert opinion by organizing a consensus meeting of experts from relevant specialties. SETTING: The meeting was held in Amsterdam, the Netherlands. METHODS: A panel of 15 international experts identified 75 questions covering preoperative screening, treatment, postoperative monitoring, anesthetic care and follow-up. Six researchers reviewed the literature systematically. During this meeting, the "Amsterdam Delphi Method" was utilized including controlled acquisition of feedback, aggregation of responses and iteration. RESULTS: Recommendations or statements were provided for 58 questions. In the judgment of the experts, 17 questions provided no additional useful information and it was agreed to exclude them. With the exception of 3 recommendations (64%, 66%, and 66% respectively), consensus (>70%) was reached for 55 statements and recommendations. Several highlights: polysomnography is the gold standard for diagnosing OSA; continuous positive airway pressure is recommended for all patients with moderate and severe OSA; OSA patients should be continuously monitored with pulse oximetry in the early postoperative period; perioperative usage of sedatives and opioids should be minimized. CONCLUSION: This first international expert meeting provided 58 statements and recommendations for a clinical consensus guideline regarding the perioperative management of OSA patients undergoing MBS.
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Cirurgia Bariátrica/métodos , Obesidade Mórbida/cirurgia , Assistência Perioperatória/métodos , Apneia Obstrutiva do Sono/terapia , Assistência ao Convalescente/métodos , Anestesia/métodos , Pressão Positiva Contínua nas Vias Aéreas/métodos , Humanos , Obesidade Mórbida/complicações , Medição de Risco/métodos , Apneia Obstrutiva do Sono/complicaçõesRESUMO
BACKGROUND: We tested the hypothesis that moxifloxacin monotherapy is equally effective and safe as a betalactam antibiotic based combination therapy in patients with acute respiratory distress syndrome (ARDS) evoked by severe community acquired pneumonia (CAP). METHODS: In a retrospective chart review study of 229 patients with adult respiratory distress syndrome (ARDS) admitted to our intensive care unit between 2001 and 2011, 169 well-characterized patients were identified to suffer from severe CAP. Patients were treated with moxifloxacin alone, moxifloxacin in combination with ß-lactam antibiotics, or with another antibiotic regimen based on ß-lactam antibiotics, at the discretion of the admitting attending physician. The primary endpoint was 30-day survival. To assess potential drug-induced liver injury, we also analyzed biomarkers of liver cell integrity. RESULTS: 30-day survival (69% overall) did not differ (p = 0.89) between moxifloxacin monotherapy (n = 42), moxifloxacin combination therapy (n = 44), and other antibiotic treatments (n = 83). We found significantly greater maximum activity of aspartate transaminase (p = 0.048), alanine aminotransferase (p = 0.003), and direct bilirubin concentration (p = 0.01) in the moxifloxacin treated groups over the first 10-20 days. However, these in-between group differences faded over time, and no differences remained during the last 10 days of observation. CONCLUSIONS: In CAP evoked ARDS, moxifloxacin monotherapy and moxifloxacin combination therapy was not different to a betalactam based antibiotic regimen with respect to 30-day mortality, and temporarily increased markers of liver cell integrity had no apparent clinical impact. Thus, in contrast to the current S3 guidelines, moxifloxacin may also be safe and effective even in patients with severe CAP evoked ARDS while providing coverage of an extended spectrum of severe CAP evoking bacteria. However, further prospective studies are needed for definite recommendations.
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Antibacterianos/uso terapêutico , Fluoroquinolonas/uso terapêutico , Pneumonia Bacteriana/tratamento farmacológico , Síndrome do Desconforto Respiratório/tratamento farmacológico , Adulto , Alanina Transaminase/análise , Aspartato Aminotransferases/análise , Bilirrubina/análise , Infecções Comunitárias Adquiridas/complicações , Infecções Comunitárias Adquiridas/tratamento farmacológico , Quimioterapia Combinada , Feminino , Humanos , Unidades de Terapia Intensiva , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Moxifloxacina , Pneumonia Bacteriana/complicações , Síndrome do Desconforto Respiratório/etiologia , Estudos Retrospectivos , beta-LactamasRESUMO
BACKGROUND AND PURPOSE: To internally and externally validate an atlas based automated segmentation (ABAS) in loco-regional radiation therapy of breast cancer. MATERIALS AND METHODS: Structures of 60 patients delineated according to the ESTRO consensus guideline were included in four categorized multi-atlas libraries using MIM Maestro™ software. These libraries were used for auto-segmentation in two different patient groups (50 patients from the local institution and 40 patients from other institutions). Dice Similarity Coefficient, Average Hausdorff Distance, difference in volume and time were computed to compare ABAS before and after correction against a gold standard manual segmentation (MS). RESULTS: ABAS reduced the time of MS before and after correction by 93% and 32%, respectively. ABAS showed high agreement for lung, heart, breast and humeral head, moderate agreement for chest wall and axillary nodal levels and poor agreement for interpectoral, internal mammary nodal regions and LADCA. Correcting ABAS significantly improved all the results. External validation of ABAS showed comparable results. CONCLUSIONS: ABAS is a clinically useful tool for segmenting structures in breast cancer loco-regional radiation therapy in a multi-institutional setting. However, manual correction of some structures is important before clinical use. The ABAS is now available for routine clinical use in Danish patients.
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Neoplasias da Mama/radioterapia , Planejamento da Radioterapia Assistida por Computador/métodos , Atlas como Assunto , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/cirurgia , Feminino , Humanos , Mastectomia/métodos , Órgãos em Risco/diagnóstico por imagem , Guias de Prática Clínica como Assunto , Radioterapia Adjuvante , Radioterapia de Intensidade Modulada/métodos , Reprodutibilidade dos Testes , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: Patients presenting to the healthcare system with rotator cuff pathology do not always receive high quality care. High quality care occurs when a patient receives care that is accessible, appropriate, acceptable, effective, efficient, and safe. The aim of this study was twofold: 1) to develop a clinical pathway algorithm that sets forth a stepwise process for making decisions about the diagnosis and treatment of rotator cuff pathology presenting to primary, secondary, and tertiary healthcare settings; and 2) to establish clinical practice guidelines for the diagnosis and treatment of rotator cuff pathology to inform decision-making processes within the algorithm. METHODS: A three-step modified Delphi method was used to establish consensus. Fourteen experts representing athletic therapy, physiotherapy, sport medicine, and orthopaedic surgery were invited to participate as the expert panel. In round 1, 123 best practice statements were distributed to the panel. Panel members were asked to mark "agree" or "disagree" beside each statement, and provide comments. The same voting method was again used for round 2. Round 3 consisted of a final face-to-face meeting. RESULTS: In round 1, statements were grouped and reduced to 44 statements that met consensus. In round 2, five statements reached consensus. In round 3, ten statements reached consensus. Consensus was reached for 59 statements representing five domains: screening, diagnosis, physical examination, investigations, and treatment. The final face-to-face meeting was also used to develop clinical pathway algorithms (i.e., clinical care pathways) for three types of rotator cuff pathology: acute, chronic, and acute-on-chronic. CONCLUSION: This consensus guideline will help to standardize care, provide guidance on the diagnosis and treatment of rotator cuff pathology, and assist in clinical decision-making for all healthcare professionals.