Primum et super omnium: nihil nocere Operationsindikation im Wandel bei Divertikulitis

Diverticulitis is a common disease in western countries and its incidence is increasing especially among young patients. Colonic diverticulosis, incidentally diagnosed by endoscopy or CT-scanning, has no immediate clinical consequences. Progression to diverticulitis develops in only 4 % of cases. In the last decades management of diverticular disease evolved and expectative treatment and less invasive techniques have gained importance. Elective resection has traditionally been advised after a second episode of diverticulitis or after a first episode if the patient was less than 50 years of age or complicated disease occurred. Recent changes in understanding the natural history of diverticular disease have substantially modified treatment paradigms. Elective resection in case of recurrent diverticular disease should be performed on a individual basis and in cases with complications like intestinal obstruction or fistulas. Primary anastomosis is an option even in emergency surgery due to colonic perforation, while diverting operations are indicated for selected patient groups with a high risk profile. Several prospective studies showed good results for laparoscopic drainage and lavage in the setting of perforated diverticulitis with generalized peritonitis, though this concept needs to be controlled with randomized clinical trials before application into the daily practice. This article should provide a short overview of trends in the surgical treatment of diverticulitis, help to understand the natural history of the disease and thereby explain the currently lower frequency of surgical interventions for diverticulitis.

Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.

The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

Mechanical endovascular thrombectomy for acute ischemic stroke: a retrospective multicenter study in Belgium.

Clinical trials have shown a beneficial effect of mechanical thrombectomy in acute ischemic stroke patients treated within six up to even 12 h after symptom onset. This treatment was already performed in selected hospitals in Belgium before completion of the randomized controlled trials. Outcome data on these procedures in Belgium have not been published. We performed a retrospective multicenter study of all patients with acute ischemic stroke treated with mechanical endovascular therapy in four hospitals in Belgium. Clinical outcomes, as measured by the modified Rankin Scale (mRS), site of arterial occlusion, reperfusion and the association between these variables were studied. The study included 80 patients: 65 patients with an occlusion in the anterior circulation and 15 with an occlusion in the posterior circulation. Good functional outcome (GFO) rates, defined as mRS 0-2 at 90 days, were 42 % in all patients, 44 % in anterior circulation stroke and 34 % in posterior circulation stroke. Reperfusion was achieved in 78 % of patients; more (100 %) in patients with posterior compared to patients with anterior circulation stroke (72 %; p = 0.02). The rate of GFO was greater in patients with reperfusion versus patients in whom reperfusion was not achieved (adjusted OR 8.2, 95 % CI 2.0-34.2). Symptomatic intracerebral hemorrhage was documented in 5 % of all patients. Endovascular treatment with mechanical devices for acute ischemic stroke in Belgium results in GFO and reperfusion rates similar to recently published results in the endovascular-treated arms of randomized clinical trials. Rates of symptomatic intracranial hemorrhage are low and comparable to other cohort studies and clinical trials.

The Importance of Patency in Patients with Critical Limb Ischemia Undergoing Endovascular Revascularization for Infrapopliteal Arterial Disease.

Critical limb ischemia (CLI) represents the most severe form of peripheral arterial disease (PAD) and frequently occurs in medically frail patients. CLI patients frequently exhibit multi-segmental PAD commonly including the tibial arterial segment. Endovascular therapy has been established as first-line revascularization strategy for most CLI patients. Restenosis was reported to occur in up to more than two-thirds of CLI patients undergoing angioplasty of complex tibial arterial obstructions. Nevertheless, favorable clinical outcomes were observed for infrapopliteal angioplasty when compared with bypass surgery, despite higher patency rates for the latter. Based on these observations, infrapopliteal patency was considered to be only of secondary importance upon clinical outcomes in CLI patients. In contrast to these earlier observations, however, recent findings from two randomized clinical trials indicate that infrapopliteal patency does impact on clinical outcomes in CLI patients. The purpose of the present manuscript is to provide a critical reappraisal of the present literature on the clinical importance of tibial arterial patency in CLI patients undergoing endovascular revascularization and to discuss utility and limitations of currently available anti-restenosis technologies.

Perspectives on the 2014 ESC/EACTS Guidelines on Myocardial Revascularization: Fifty Years of Revascularization: Where Are We and Where Are We Heading?

The joint European Society of Cardiology and European Association of Cardio-Thoracic Surgery (ESC/EACTS) guidelines on myocardial revascularization collect and summarize the evidence regarding decision-making, diagnostics, and therapeutics in various clinical scenarios of coronary artery disease, including elective, urgent, and emergency settings. The 2014 document updates and extends the effort started in 2010, year of the first edition of these guidelines. Importantly, this latest edition provides a systematic review of all randomized clinical trials performed since 1980, comparing different strategies of myocardial revascularization, including coronary artery bypass graft (CABG), balloon angioplasty, percutaneous coronary intervention (PCI) with bare-metal stents (BMS) and first- and second-generation drug-eluting stents (DES). This review aims to highlight the most relevant novelties introduced by the 2014 edition of the ESC/EACTS myocardial revascularization guidelines as compared with the previous edition and to describe similarities and differences with the American societies' guidelines.

Efficacy, Acceptability, and Tolerability of Antipsychotics in Treatment-Resistant Schizophrenia: A Network Meta-analysis.

Importance In treatment-resistant schizophrenia, clozapine is considered the standard treatment. However, clozapine use has restrictions owing to its many adverse effects. Moreover, an increasing number of randomized clinical trials (RCTs) of other antipsychotics have been published. Objective To integrate all the randomized evidence from the available antipsychotics used for treatment-resistant schizophrenia by performing a network meta-analysis. Data Sources MEDLINE, EMBASE, Biosis, PsycINFO, PubMed, Cochrane Central Register of Controlled Trials, World Health Organization International Trial Registry, and clinicaltrials.gov were searched up to June 30, 2014. Study Selection At least 2 independent reviewers selected published and unpublished single- and double-blind RCTs in treatment-resistant schizophrenia (any study-defined criterion) that compared any antipsychotic (at any dose and in any form of administration) with another antipsychotic or placebo. Data Extraction and Synthesis At least 2 independent reviewers extracted all data into standard forms and assessed the quality of all included trials with the Cochrane Collaboration's risk-of-bias tool. Data were pooled using a random-effects model in a Bayesian setting. Main Outcomes and Measures The primary outcome was efficacy as measured by overall change in symptoms of schizophrenia. Secondary outcomes included change in positive and negative symptoms of schizophrenia, categorical response to treatment, dropouts for any reason and for inefficacy of treatment, and important adverse events. Results Forty blinded RCTs with 5172 unique participants (71.5% men; mean [SD] age, 38.8 [3.7] years) were included in the analysis. Few significant differences were found in all outcomes. In the primary outcome (reported as standardized mean difference; 95% credible interval), olanzapine was more effective than quetiapine (-0.29; -0.56 to -0.02), haloperidol (-0. 29; -0.44 to -0.13), and sertindole (-0.46; -0.80 to -0.06); clozapine was more effective than haloperidol (-0.22; -0.38 to -0.07) and sertindole (-0.40; -0.74 to -0.04); and risperidone was more effective than sertindole (-0.32; -0.63 to -0.01). A pattern of superiority for olanzapine, clozapine, and risperidone was seen in other efficacy outcomes, but results were not consistent and effect sizes were usually small. In addition, relatively few RCTs were available for antipsychotics other than clozapine, haloperidol, olanzapine, and risperidone. The most surprising finding was that clozapine was not significantly better than most other drugs. Conclusions and Relevance Insufficient evidence exists on which antipsychotic is more efficacious for patients with treatment-resistant schizophrenia, and blinded RCTs-in contrast to unblinded, randomized effectiveness studies-provide little evidence of the superiority of clozapine compared with other second-generation antipsychotics. Future clozapine studies with high doses and patients with extremely treatment-refractory schizophrenia might be most promising to change the current evidence.

The enduring effects of psychodynamic treatments vis-à-vis alternative treatments: A multilevel longitudinal meta-analysis

Although evidence suggests that the benefits of psychodynamic treatments are sustained over time, presently it is unclear whether these sustained benefits are superior to non-psychodynamic treatments. Additionally, the extant literature comparing the sustained benefits of psychodynamic treatments compared to alternative treatments is limited with methodological shortcomings. The purpose of the current study was to conduct a rigorous test of the growth of the benefits of psychodynamic treatments relative to alternative treatments across distinct domains of change (i.e., all outcome measures, targeted outcome measures, non-targeted outcome measures, and personality outcome measures). To do so, the study employed strict inclusion criteria to identify randomized clinical trials that directly compared at least one bona fide psychodynamic treatment and one bona fide non-psychodynamic treatment. Hierarchical linear modeling (Raudenbush, Bryk, Cheong, Congdon, & du Toit, 2011) was used to longitudinally model the impact of psychodynamic treatments compared to non-psychodynamic treatments at post-treatment and to compare the growth (i.e., slope) of effects beyond treatment completion. Findings from the present meta-analysis indicated that psychodynamic treatments and non-psychodynamic treatments were equally efficacious at post-treatment and at follow-up for combined outcomes (k=20), targeted outcomes (k=19), non-targeted outcomes (k=17), and personality outcomes (k=6). Clinical implications, directions for future research, and limitations are discussed.

The Role of Platelets in Venous Thromboembolism

Multiple factors contribute to the risk of venous thromboembolism (VTE). Platelets have attracted much interest in arterial cardiovascular disease, whereas their role in VTE has received much less attention. Recent evidence suggests that platelets may play a more important role in VTE than previously anticipated. This review discusses the mechanisms that link platelets with venous thrombotic disease and their potential applications as novel risk factors for VTE. In addition, animal studies and randomized clinical trials that highlight the potential effect of antiplatelet therapy in venous thrombosis are evaluated to assess the role of platelets in VTE. The clinical significance of platelets for VTE risk assessment in specific patient cohorts and their role as a suitable therapeutic target for VTE prevention is acknowledged. The role of platelets in VTE is a promising field for future research.

Determinants of adherence to highly active antiretroviral therapy for HIV-infected children: A research synthesis

Highly active antiretroviral therapy (HAART) has taken HIV-infection from a rapidly terminal illness to one that is a slowly progressive, chronic illness. HIV-infected children can now live long, normal lives. Today, four classes of antiretroviral medications are widely used and several antiretrovirals are available in each class, but resistance and cross-resistance to these medications can occur very quickly if the patient does not adhere to strict medication dosing guidelines. One method to improve pediatric adherence to antiretrovirals is to focus on identified determinants of adherence at clinical visits, but very few studies have been conducted to identify determinants of adherence to antiretrovirals and the best methods to measure adherence in the pediatric population. This research synthesis found adherence factors related to children can be divided into child-identified factors and caregiver-identified factors. Child identified factors include medication-related, demographic-related, cognitive-related, psychosocial-related, and biological marker-related barriers to adherence. Caregiver identified factors include medication-related, cognitive-related, relationship-related, and psychosocial-related barriers to adherence. More randomized clinical trials are needed to identify determinants to adherence, identify methods to best measure adherence, and to identify the best interventions to improve adherence in HIV-infected children and adolescents. ^

Probiotics and the prevention of necrotizing enterocolitis in preterm infants: A systematic review of the literature

Necrotizing enterocolitis is a common gastrointestinal disease associated with high mortality and morbidity among preterm infants. This was a systematic literature review that evaluated whether the administration of probiotic supplements is of benefit in the prevention of NEC. The search was narrowed to randomized clinical trials identified through The Cochrane Central Register of Controlled Trials, U.S. National Institute of Health clinical trials registry database, Pub Med and OVID MEDLINE databases. Inclusion criteria were: prospective, randomized clinical trials that administered probiotics as a preventive measure against NEC for infants of early gestational age (<35 wks) and/or low birth weight (<1500g), maintained NEC as the primary measured outcome, used Bell’s classification for NEC diagnosis with reports of stage 2 NEC or higher, and began probiotic administration within 10 days of life. Trials were excluded if participant enrollment was fewer than 100 infants, published before the year 2000, or probiotic supplementation was discontinued after less than seven consecutive days. Based on specific study characteristics, each resulting article was then judged by two authors for study quality. The search was further narrowed to studies of either high or moderate quality, which were then summarized in a set of tables based on study characteristics and results. From an initial set of 20 identified studies, five clinical trials met all criteria; each was discussed thoroughly based on trial limitations, strengths and comparisons to other included publications. Based on this review, the weight of evidence appears to support the use of probiotic supplementation in preterm infants as a preventive measure against NEC. Recommendations for future research were also provided.^

Comparação entre prótese plástica e metálica na paliação endoscópica da obstrução maligna da via biliar: revisão sistemática e metanálise baseadas em estudos randomizados

INTRODUÇÃO: A prótese biliar endoscópica é aceita em todo o mundo como a primeira escolha de tratamento paliativo na obstrução biliar maligna. Atualmente ainda persistem dois tipos de materiais utilizados em sua confecção: plástico e metal. Consequentemente, muitas dúvidas surgem quanto a qual deles é o mais benéfico para o paciente. Esta revisão reúne as informações disponíveis da mais alta qualidade sobre estes dois tipos de prótese, fornecendo informações em relação à disfunção, complicação, taxas de reintervenção, custos, sobrevida e tempo de permeabilidade; e pretende ajudar a lidar com a prática clínica nos dias de hoje. OBJETIVO: Analisar, através de metanálise, os benefícios de dois tipos de próteses na obstrução biliar maligna inoperável. MÉTODOS: Uma revisão sistemática de ensaios clínicos randomizados (RCT) foi conduzida, com a última atualização em março de 2015, utilizando EMBASE, CINAHL (EBSCO), Medline, Lilacs / Centro (BVS), Scopus, o CAPES (Brasil), e literatura cinzenta. As informações dos estudos selecionados foram extraídas tendo em vista seis desfechos: primariamente disfunção, taxas de reintervenção e complicações; e, secundariamente, custos, sobrevivência e tempo de permeabilidade. Os dados sobre as características dos participantes do RCT, critérios de inclusão e exclusão e tipos de próteses também foram extraídos. Os vieses foram avaliados principalmente através da escala de Jadad. Esta metanálise foi registrada no banco de dados PROSPERO pelo número CRD42014015078. A análise do risco absoluto dos resultados foi realizada utilizando o software RevMan 5, calculando as diferenças de risco (RD) de variáveis dicotômicas e média das diferenças (MD) de variáveis contínuas. Os dados sobre a RD e MD para cada desfecho primário foram calculados utilizando o teste de Mantel-Haenszel e a inconsistência foi avaliada com o teste Qui-quadrado (Chi2) e o método de Higgins (I2). A análise de sensibilidade foi realizada com a retirada de estudos discrepantes e a utilização do efeito aleatório. O teste t de Student foi utilizado para a comparação das médias aritméticas ponderadas, em relação aos desfechos secundários. RESULTADOS: Inicialmente foram identificados 3660 estudos; 3539 foram excluídos por título ou resumo, enquanto 121 estudos foram totalmente avaliados e foram excluídos, principalmente por não comparar próteses metálicas (SEMS) e próteses plásticas (PS), levando a treze RCT selecionados e 1133 indivíduos metanálise. A média de idade foi de 69,5 anos, e o câncer mais comum foi de via biliar (proximal) e pancreático (distal). O diâmetro de SEMS mais utilizado foi de 10 mm (30 Fr) e o diâmetro de PS mais utilizado foi de 10 Fr. Na metanálise, SEMS tiveram menor disfunção global em comparação com PS (21,6% versus 46,8% p < 0,00001) e menos reintervenções (21,6% versus 56,6% p < 0,00001), sem diferença nas complicações (13,7% versus 15,9% p = 0,16). Na análise secundária, a taxa média de sobrevida foi maior no grupo SEMS (182 contra 150 dias - p < 0,0001), com um período maior de permeabilidade (250 contra 124 dias - p < 0,0001) e um custo semelhante por paciente, embora menor no grupo SEMS (4.193,98 contra 4.728,65 Euros - p < 0,0985). CONCLUSÃO: SEMS estão associados com menor disfunção, menores taxas de reintervenção, melhor sobrevida e maior tempo de permeabilidade. Complicações e custos não apresentaram diferença

Os inibidores orais do fator Xa na prevenção de eventos cerebrovasculares em doentes com fibrilhação auricular não-reumática

Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2014

Decúbito ventral em doentes com ARDS

Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2014

Adaptive designs in the time to event setting: The potential for benefit and risk

Thesis (Ph.D.)--University of Washington, 2016-06

Representações sociais de familiares sobre o atendimento das emergências psiquiátricas

The reformist movements in the field of mental health have pointed battle flags, among which the prioritization of production of mental health care out of the asylum environment should be highlighted, aiming the reduction of psychiatric beds, greater control over the hospitalization, family co-participation and the rescue of the citizenship of the social players involved. With the progressive reduction of asylum beds, associated with a lot of structural problems in the health services, the occurrence of crises outside the hospital environment has been increasingly frequent, thus giving the family an important therapeutic role. In face of this scenario, there is an urgent need to understand the social construction of the care for psychiatric emergencies, identifying the meanings assigned by family members to their constituent aspects. This study seeks to answer the following research question: what are the social representations of family members about the care of psychiatric emergencies in the city of Mossoró, Rio Grande do Norte? Therefore, the aim is to analyze the social representations of family members about the care of psychiatric emergencies in the city of Mossoró, Rio Grande do Norte. This is an exploratory and descriptive study, with a mixed approach, making use of multimethods: for collection, the semi-structured interview and the Technique of Free Association of Words; for data analysis, the Thematic Analysis of Bardin and its steps was used, with the informational support of the softwares ALCESTE (Analyse Lexicale par Contexte d'un Ensemble de Segments de Texte) and Iramuteq (Interface de R pour les Analyses Multidimensionnelles de Textes et de Questionnaires); and the theoretical support of social representations. The study participants totaled 72, and they were selected from the following criteria: older than18 years, with degree of kinship with users suffering from some mental and behavioral disorder, and who have already witnessed a situation of crisis, rescued by the SAMU or other means and taken to the psychiatric hospital or general emergency room. Preliminary results point out: 1.Previous note of the research project with the aim to disseminate it in the scientific community and ensure the intellectual property of the work; 2.The contextual analysis of the care for emergencies in the study place. Reflection about the phenomenon provide a name to the care for the psychiatric emergencies, which is called immediate context; the technical and operational aspects that influence the care, as a specific/ general context; and mental health policies in Brazil are identified as metacontext; 3. The systematic review from randomized clinical trials in the databases PubMed, COCHRANE, LILACS, SciELO and SCIRUS, with the use of the descriptors: ‘Physical restraint’, ‘Psychiatric emergency services’, ‘Restraint’, ‘Physical and Emergency Services’, ‘Psychiatric’. Only one work met the search protocol criteria: a short-term essay that records limited results about the proportion of people who are in restraint and seclusion. It does not show statistically significant results in relation to indications, contraindications and risks of the use of physical restraint; 4. The social representations of the care for psychiatric emergencies. The study results point to the presence of five thematic categories: 1. feeling in the face of the crisis/care; 2. thoughts and perspectives about the crisis/care; 3. centrality of care in the medical- medication-hospitalization triad; 4. the thinking/acting in the face of the use of physical restraint and police force; 5. periodicity of crises. The central core of the representation is in the first category, whilst the peripheral elements are in the third and fifth categories. The contrast zone is in the second and fourth categories. The sadness is the most prominent element of the structure. The social representations about the care for psychiatric crises are at a time of transition between the hegemonic and reformist models, with the traditional aspects being predominant, but already showing peripheral and contrast elements that point to a possible change in the representational field.