No Brasil, os avanços nas pesquisas nacionais e internacionais não têm sido traduzidos na construção de diretrizes para nortear o tratamento tópico da úlcera venosa. Ainda persistem muitas dúvidas a respeito dos melhores tratamentos, o que gera uma diversidade de condutas. Este estudo foi desenvolvido em três etapas, com o objetivo de construir uma proposta de diretriz para tratamento tópico de úlcera venosa, a partir de evidências da literatura, e avaliar a concordância de especialistas das áreas de enfermagem e medicina antes e após duas intervenções. Na primeira etapa, buscaram-se as evidências pelo levantamento bibliográfico de publicações indexadas em diversas bases de dados. Para serem elegíveis, as publicações tinham que avaliar a terapia de compressão ou tópica no tratamento de úlcera venosa e relatar uma medida objetiva de redução de edema ou cicatrização de ferida. Na segunda etapa foi construída a proposta de diretriz, amparada nas evidências da literatura e diretrizes internacionais. Na terceira etapa, de delineamento quase-experimental, utilizou-se a técnica Delphi (Delfos) para identificar a opinião dos especialistas a respeito das recomendações e a influência das evidências e da opinião dos pares para a busca de concordância. Pela revisão sistemática de 33 estudos primários, 2 metanálises e 4 diretrizes, concluiu-se que o uso de terapia compressiva por bandagens ou meias aumenta as taxas de cicatrização e o não uso está associado com a recorrência da úlcera. O tratamento com compressão resulta em cicatrização confiável na maioria dos pacientes, mas deve ser associado a coberturas. Ao final da revisão sistemática, extraíram-se 82 recomendações que constituíram a proposta de diretriz, composta de 8 domínios: 1 avaliação do paciente e de sua ferida; 2 documentação dos achados clínicos; 3 cuidado com a ferida e pele ao redor; 4 indicação da cobertura; 5 uso de antibiótico; 6 melhoria do retorno venoso e prevenção de recidiva; 7 encaminhamentos dos pacientes; 8 capacitação profissional. O estudo quase-experimental foi desenvolvido com 42 médicos dermatologistas, angiologistas e cirurgiões vasculares e 31 enfermeiros membros da Sociedade Brasileira de Enfermagem em Dermatologia ou estomaterapeutas de várias cidades do Brasil. Durante a pesquisa, houve perda de 15 participantes. No primeiro momento, quando os participantes receberam as recomendações para a prática baseada em evidências, as melhores concordâncias ocorreram em quatro domínios. Após a primeira intervenção, quando os participantes receberam a proposta de diretriz com os estudos que as embasavam e o nível de evidência, houve aumento dos participantes na posição concordante em todos os domínios, sendo que o domínio 2 manteve-se como o melhor aceito e o 4 como o menos aceito. Após a segunda intervenção, quando os participantes tomaram conhecimento da opinião dos seus pares, houve aumento de participantes na posição concordante na maioria dos domínios, com exceção do domínio 4. O melhor aceito passou a ser o domínio 8 e o menos aceito manteve-se o domínio 4. Observou-se que as intervenções resultaram em mudanças estatisticamente significativas nos domínios 1, 3, 6 e 7. Pode-se afirmar que ambas intervenções foram capazes de modificar a posição dos participantes, levando-os para a posição de concordância quanto às recomendações baseadas em evidências para o tratamento de úlceras venosas. / In Brazil, advances in national and international research have not been translated in the construction of topic treatment guidelines for venous ulcers. Many doubts remain about what the best treatments are, which gives rise to a variety of behaviors. This three-phase study aimed to elaborate a guideline proposal for topic treatment of venous ulcers, based on evidence from literature, as well as to evaluate nursing and medical specialists’ agreements before and after two interventions. In the first phase, evidences were collected through a bibliographic survey of publications that were indexed in different databases. Publications were included if they evaluated compression or topic therapy in venous ulcer treatment and reported on an objective edema reduction or wound healing measure. In the second phase, a guideline proposal was elaborated on the basis of the evidence collected in literature and international guidelines. In the third phase, a quasi-experimental design was adopted, using the Delphi technique to identify specialists’ opinion on the recommendations and how the evidence and peer opinions influenced the search for an agreement. The systematic review of 33 primary studies, 2 meta-analyses and 4 guidelines revealed that using compression therapy by means of bandages or stockings increases healing rates and that non-use is associated with ulcer recurrence. In most patients, compression treatment results in a reliable result, although it should be associated with dressings. The systematic review resulted in 82 recommendations, which constituted the guideline proposal, covering 8 domains: 1 patient and wound assessment, 2 documentation of clinical findings, 3 wound and surrounding skin care, 4 dressing indication, 5 use of antibiotics, 6 venous return improvement and relapse prevention, 7 patient referrals, 8 professional training. The quasi-experimental study involved 42 dermatologists, angiologists and vascular surgeons and 31 nurses who were members of the Brazilian Society of Dermatology Nursing or stomal therapists from different Brazilian cities. 15 participants left the study while in course. At the beginning, when the participants received evidence-based practice recommendations, the highest agreement levels were concentrated in four domains. After the first intervention, when the participants received the guideline proposal, including the studies it was based on and the level of evidence, agreement levels increased across all domains. Domain 2 continued as the most accepted and 4 as the least accepted domain. After the second intervention, when the participants got to know their peers’ opinions, agreement levels increased in most domains, except for domain 4. Domain 8 became the most accepted, while 4 continued as the least accepted domain. The interventions brought about statistically significant changes in domains 1, 3, 6 and 7. Both interventions were capable of changing the participants’ position towards agreement on evidence-based recommendations for venous ulcer treatment.

O uso do cateter venoso central é apontado como um importante fator de risco para infecção da corrente sanguínea, acarretando no prolongamento da internação, aumento da morbimortalidade, e elevação dos custos de hospitalização. Frente ao exposto objetivou-se avaliar as evidências científicas sobre o controle de infecção relacionada ao cateter venoso central utilizado em pacientes adultos hospitalizados. A prática baseada em evidências representou o referencial teórico-metodológico. E, como recurso para obtenção das evidências de Níveis I e II realizou-se a revisão integrativa da literatura nas bases de dados LILACS, CINAHL e MEDLINE. Totalizou-se 17 publicações nos últimos dez anos. A análise dos estudos culminou em 03 categorias temáticas: cateteres impregnados com anti-sépticos, dispositivos seguros e manutenção do cateter. Como resultado obteve-se o apontamento de diversos aspectos no controle da infecção relacionada a cateter, dentre eles: uso de cateter de lúmen único, inserção por via subclávia com técnica estéril e aplicação de anti-séptico a base de clorexidine. Acresce-se que a indicação de cateteres impregnados com anti-sépticos, bem como de sistemas valvulados sem agulha, ainda é controversa. Em geral, os estudiosos sobre a temática alertaram que a qualidade da assistência à pacientes com cateter venoso central está diretamente relacionada com o risco de infecção. Assim, esforços têm sido recomendados a fim de viabilizar a aplicação das evidências advindas das pesquisas e conseqüentemente nortear o poder de decisão na prática clínica, contribuindo para a melhoria da qualidade da assistência. / The use of central venous catheter is pointed as a factor of risk to the infection of the blood stream, which increases the hospitalization period, the morbidity and mortality, and also the hospitalization costs. Therefore, this study aimed to evaluate scientific evidences about the control of infection related to the central venous catheter used in hospitalized adult patients. The evidence based practice is the theoretical-methodological reference. To obtain evidences Level I and II, an integrative literature review was performed on the databases LILACS, CINAHL e MEDLINE. In the last ten years was found a total of 17 publications. From the analysis of these studies emerged three thematic categories: catheters impregnated with antiseptics, safe devices and maintenance of the catheter. As a result, several aspects of the control of infection related to the catheter were pointed, such as: the use of the single lumen catheter, insertion through the subclavian with sterile technique and application of clorexidine based antiseptic. It is important to mention that the indication of catheters impregnated with antiseptics, as the use of needleless valve systems are still controversy. In general, researchers alerted that the quality of assistance to patients with venous catheter is directly related to the risk of infection. Therefore, efforts are recommended in order to facilitate the implementation of evidences found in research, and consequently, guide the decision making process in the clinical practice, contributing to the improvement of the quality of assistance.

The guidelines for the curative treatment of prostate cancer presented by the German Society of Urology are discussed. They are based on the current knowledge of the outcomes of surgical and radiotherapeutic treatment for prostate cancer. Radical prostatectomy is recommended as the first-line treatment for organ-confined prostate cancer in patients with an individual life expectancy of at least 10 years. Radiotherapy can be considered as an alternative treatment modality, although current knowledge does not allow a definite assessment of the relative value of radiotherapy compared to radical prostatectomy. Locally advanced cT3 prostate cancer is overstaged in about 20% and curative treatment is possible in selected cases. Guidelines represent rules based on the available evidence. This implies that exceptions must be made whenever appropriate and that guidelines have to be reviewed regularly as new information becomes available. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

Evidence-based guidelines are important sources of knowledge in everyday clinical practice. In 2005, the German Society for Urology decided to develop a highquality evidence-based guideline for the early detection, diagnosis and treatment of the different clinical manifestations of prostate cancer. The guideline project started in 2005 and involved 75 experts from 10 different medical societies or medical organizations including a patient organization. The guideline was issued in September 2009 and consists of 8 chapters, 170 recommendations, and 42 statements. Due to the broad spectrum of clinical questions covered by the guideline and the high number of participating organizations and authors, the organizers faced several methodological and organizational challenges. This article describes the methods used in the development of the guideline and highlights critical points and challenges in the development process. Strategies to overcome these problems are suggested which might be beneficial in the development of new evidence-based guidelines in the future. / Evidenzbasierte Leitlinien sind wichtige Quellen komprimierten Wissens für die tägliche klinische Praxis. Die Deutsche Gesellschaft für Urologie beschloss im Jahr 2005, eine qualitativ hochwertige evidenzbasierte Leitlinie zur Früherkennung, Diagnose und Behandlung der verschiedenen klinischen Manifestationen des Prostatakarzinoms zu erstellen. Das Leitlinienprojekt begann im Jahr 2005 unter Mitwirkung von 75 Experten und Patientenvertretern aus 10 verschiedenen Fachgesellschaften und Organisationen. Die Leitlinie wurde im September 2009 veröffentlicht und besteht aus 8 Kapiteln mit insgesamt 170 Empfehlungen und 42 Statements. Das breite thematische Spektrum der Leitlinie und die hohe Zahl teilnehmender Autoren und Organisationen stellten die Organisatoren vor verschiedene methodische und logistische Herausforderungen. Dieser Beitrag stellt die angewendete Methodik bei der Leitlinienerstellung dar und betont kritische Punkte und Probleme der Erstellung. Die beschriebenen Lösungsansätze können bei der Planung und Durchführung künftiger evidenzbasierter Leitlinienprojekte hilfreich sein. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

The thesis consists of an introduction and two papers. In the introduction a brief historical survey of empirical investigations into the effectiveness of medicinal interventions is given. Also, the main ideas of the EBM (evidence-based medicine) movement are presented. Both included papers can be viewed as investigations into the reasonableness of EBM and its hierarchies of evidence. Paper I: Typically, in a clinical trial patients with specified symptoms are given either of two or more predetermined treatments. Health endpoints in these groups are then compared using statistical methods. Concerns have been raised, not least from adherents of so-called alternative medicine, that clinical trials do not offer reliable evidence for some types of treatment, in particular for highly individualized treatments, for example traditional homeopathy. It is argued that such concerns are unfounded. There are two minimal conditions related to the nature of the treatments that must be fulfilled for evaluability in a clinical trial, namely (1) the proper distinction of the two treatment groups and (2) the elimination of confounding variables or variations. These are delineated, and a few misunderstandings are corrected. It is concluded that the conditions do not preclude the testing of alternative medicine, whether individualized or not. Paper II: Traditionally, mechanistic reasoning has been assigned a negligible role in standard EBM literature, although some recent authors have argued for an upgrading. Even so, mechanistic reasoning that has received attention has almost exclusively been positive -- both in an epistemic sense of claiming that there is a mechanistic chain and in a health-related sense of there being claimed benefits for the patient. Negative mechanistic reasoning has been neglected, both in the epistemic and in the health-related sense. I distinguish three main types of negative mechanistic reasoning and subsume them under a new definition of mechanistic reasoning in the context of assessing medical interventions. Although this definition is wider than a previous suggestion in the literature, there are still other instances of reasoning that concern mechanisms but do not (and should not) count as mechanistic reasoning. One of the three distinguished types, which is negative only in the health-related sense, has a corresponding positive counterpart, whereas the other two, which are epistemically negative, do not have such counterparts, at least not that are particularly interesting as evidence. Accounting for negative mechanistic reasoning in EBM is therefore partly different from accounting for positive mechanistic reasoning. Each negative type corresponds to a range of evidential strengths, and it is argued that there are differences with respect to the typical strengths. The variety of negative mechanistic reasoning should be acknowledged in EBM, and presents a serious challenge to proponents of so-called medical hierarchies of evidence. / <p>QC 20150413</p>

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Indiana University-Purdue University Indianapolis (IUPUI) / Healthcare workers are responsible for providing evidence-based care to patients; however, many patients receive unnecessary or harmful care. Successful implementation of evidence-based guidelines can improve patient outcomes, particularly among vulnerable neuroscience patients. Focused efforts to improve nursing knowledge of and adherence to these guidelines are warranted. The purpose of this dissertation was to determine the most effective strategies for implementing evidence-based guidelines into nursing practice. First, an integrative review of the literature was conducted to explore studies addressing implementation of evidence-based guidelines in nursing. Implications from the review suggested further research to better understand which strategies should be utilized to best implement evidence-based nursing practices. Two pre- and posttest studies were then designed to identify a bundle of implementation strategies to improve neurocritical care nurses' knowledge of and adherence to stroke and spinal cord injury guidelines. The tailored, multi-faceted strategies consisted of local opinion leaders, printed educational materials, and educational outreach. Improvements in nursing knowledge of and adherence to these guidelines were noted. Lastly, program evaluations were conducted using a mixed-methods study to understand neurocritical care nurses' perceptions of the usefulness of the strategies employed during the two studies. Findings from this research provided support for the most effective implementation strategies to enhance knowledge development and guideline adherence among neurocritical care nurses for implementation of stroke and spinal cord guidelines.

Clinical practice guidelines (CPGs) are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options. CPGs’ recommendations have traditionally focused on informing clinicians and patients on the best options, i.e., supporting decisions that occur at the clinical encounter level. Considering all their advantages (a systematic and comprehensive review of the evidence, a multidisciplinary team assessing the evidence and balancing benefits and harms, and the additional considerations such as patients’ preferences, implementability and feasibility of interventions and their costs) CPGs have also become powerful tools to inform decisions and activities outside the clinical encounter. This, because the clinical encounter cannot be completely separated from other decisions that indirectly affect that level, such as those related to quality improvement activities and economic decisions in healthcare. Moreover, activities that are not directly related to the clinical encounter can benefit from CPGs, like education and licensing activities and research prioritization processes, or judicial decisions. The role of CPGs in all these activities has been neglected in the literature. In this study, I performed a critical interpretive synthesis of the literature to summarize the different roles CPGs play outside the clinical encounter and to understand how, and under what conditions CPGs are used in these roles. I also conducted an international survey to describe how frequent these roles exist, from the CPGs developers' perspectives. Lastly, I conducted a multiple case study to understand how and under what conditions CPGs play one of the main roles outside the clinical encounter (drug funding decisions), in two different settings (Colombia and Canada/Ontario). Based on the results, I developed a framework to describe and categorize the roles of CPGs outside the clinical encounter and to determine how and under what conditions CPGs are used in these roles. I highlighted the key areas that require additional methodological research and categorize the roles in main, secondary and unanticipated roles. I also described how international developers reported that CPGs play these roles and how these roles are part of their CPGs final aims in the second study. Lastly, in the case study, I revealed that CPGs were instrumentally used to inform one of the main roles, drug funding decisions, in the Colombian case, and they had a minor conceptual use in the case of Canada/Ontario. / Thesis / Doctor of Philosophy (PhD)

Purpose of Review: To review the clinical evidence on the use of percutaneous coronary intervention (PCI) revascularization options in left main (LM) disease in comparison with coronary artery bypass graft (CABG). Coronary artery disease (CAD) involving the LM is associated with high morbidity and mortality. Though CABG remains the gold standard for complex CAD involving the LM artery, recent trials have shown a trend towards non-inferiority of the LM PCI when compared with CABG in certain subset of patients. Recent Findings: Two recent major randomized trials compared the outcomes of PCI versus CABG in the LM and multi-vessel disease with LM involvement. The NOBLE trial included patients with all range of Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) scores and utilized biolimus drug-eluting stent (DES). The trial concluded that MACCE (major adverse cardiac and cerebrovascular event) was significantly higher with PCI (28%) when compared with CABG (18%) but overall stroke and motility were not different. EXCEL trial evaluated the same treatment option in low to intermediate SYNTAX score population with third-generation everolimus DES platform as PCI option. Results showed no significant differences in the composite primary endpoints of death, stroke, and myocardial infarction (MI) at the end of 30 days (22% versus 19.2%, p = 0.13), although repeat revascularization was higher in PCI group (16.9% versus 10%). Summary: Recent evidence suggests that PCI is an acceptable alternative to treat symptomatic LM stenosis in select group of patients. In low to medium SYNTAX score, particularly in patients without diabetes mellitus, PCI remains a viable option. Future trials focusing on evaluating subset of patients who would benefit from one particular revascularization option in comparison with other is warranted.