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1.
Klin Padiatr ; 227(6-7): 339-49, 2015 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-26600177

RESUMO

BACKGROUND: Several therapy optimization studies (TOSs) for the treatment of hematologic and oncologic disorders in children and adolescents have been conducted in Germany. The publication of research results is necessary to ensure that future studies are well designed and based on relevant and unanswered questions. This retrospective cohort study was conducted to analyze the study- and publication practice in this field. METHODS: All study protocols in the field of the pediatric oncology and hematology in Germany were collected. Relevant data from study protocols were extracted, beginning with 1) general information about the study protocol, and 2) information about each methodological trial. In a second step, the publication practice was characterized by searching in electronic databases and by contacting principal investigators. Relevant Data of each publication was extracted. RESULTS: The research activity has increased significantly in the past few years. The found publication rate of 85% represents an outstanding publication practice. Additionally, German, as being the main publication language a few decades ago, has been almost completely replaced with English. An acceptable methodological conduct was observed in the analyzed study protocols. DISCUSSION AND CONCLUSION: Studies have been principally based on the concept of TOS, without considering a detailed breakdown into each methodological trial. A markedly subdivision of studies into methodologically identifiable trials would allow a clear definition of their parameters, while increasing transparency of the study conduct and its results.


Assuntos
Antineoplásicos/efeitos adversos , Saúde da Criança/estatística & dados numéricos , Filho de Pais com Deficiência/estatística & dados numéricos , Inquéritos Epidemiológicos , Neoplasias/tratamento farmacológico , Sobreviventes , Adolescente , Antineoplásicos/uso terapêutico , Criança , Serviços de Saúde da Criança/estatística & dados numéricos , Pré-Escolar , Europa (Continente) , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Lactente , Recém-Nascido , Masculino , Neoplasias/psicologia , Projetos Piloto , Qualidade de Vida/psicologia , Estudos Retrospectivos
2.
Artigo em Alemão | MEDLINE | ID: mdl-25380968

RESUMO

BACKGROUND: Practicing physicians are faced with many medical decisions daily. These are mainly influenced by personal experience but should also consider patient preferences and the scientific evidence reflected by a constantly increasing number of medical publications and guidelines. With the objective of optimal medical treatment, the concept of evidence-based medicine is founded on these three aspects. It should be considered that there is a high risk of misinterpreting evidence, leading to medical errors and adverse effects without knowledge of the methodological background. OBJECTIVES: This article explains the concept of systematic error (bias) and its importance. Causes and effects as well as methods to minimize bias are discussed. This information should impart a deeper understanding, leading to a better assessment of studies and implementation of its recommendations in daily medical practice. CONCLUSION: Developed by the Cochrane Collaboration, the risk of bias (RoB) tool is an assessment instrument for the potential of bias in controlled trials. Good handling, short processing time, high transparency of judgements and a graphical presentation of findings that is easily comprehensible are among its strengths. Attached to this article the German translation of the RoB tool is published. This should facilitate the applicability for non-experts and moreover, support evidence-based medical decision-making.


Assuntos
Algoritmos , Viés , Ensaios Clínicos Controlados como Assunto , Interpretação Estatística de Dados , Avaliação de Resultados em Cuidados de Saúde/métodos , Medição de Risco/métodos , Software , Biometria/métodos , Alemanha , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Tradução
3.
Artigo em Alemão | MEDLINE | ID: mdl-23978984

RESUMO

BACKGROUND: Evidence mapping is an increasingly popular approach to systematically evaluate published research. While there are methodological standards for systematic reviews, discrepancies exist between the terminology and methods used within evidence mapping. AIM: The aim of this systematic review is to describe the methodology and terminology used in evidence mapping and to demonstrate the continuum between evidence mapping and traditional systematic reviews. METHODS: A systematic literature search was conducted in 10 databases in order to obtain a comprehensive picture of the state of the research standards for evidence mapping. In addition, websites of institutions which are already conducting evidence mapping were searched. RESULTS: The included study pool (n = 12) shows that the terms 'evidence map' and 'scoping review' are widely used within evidence mapping. Evidence maps are an approach to depict both the number and characteristics of studies in tabular form that exist as well as evidence gaps based on primary studies and systematic reviews of broad clinical questions. Scoping reviews also summarize the literature in a tabular form but also give a descriptive narrative summary of the results. A quality assessment of the studies is generally not included. CONCLUSION: Evidence mapping allows the identification of research gaps. This aspect is particularly important for interventions which are used without sufficient evidence. In contrast, systematic reviews are mainly used to estimate effects for interventions and evaluate whether the included studies are reliable.


Assuntos
Pesquisa Biomédica/métodos , Medicina Baseada em Evidências/métodos , Publicações Periódicas como Assunto , Projetos de Pesquisa , Literatura de Revisão como Assunto , Terminologia como Assunto
4.
Artigo em Alemão | MEDLINE | ID: mdl-21161479

RESUMO

The influenza pandemic (H1N1) 2009 showed that many decision and policy makers do not trust citizens to effectively cope with uncertainty. We discuss three fundamental problems with the information management at the time: (1) knowledge of available and missing evidence was not communicated transparently and completely, (2) rather than informing citizens, officials often treated them paternalistically, and (3) public trust in vaccinations and institutions was damaged as a result of (1) and (2). We suggest the following measures to policy and decision makers in order to avoid similar problems in the future: transparent description of the situation instead of buzzwords such as "pandemic;" transparent communication of existing and missing evidence instead of dramatic estimates of death rates; disclosure of political decision processes and conflicts of interest.


Assuntos
Planejamento em Desastres/organização & administração , Vírus da Influenza A Subtipo H1N1 , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , Pandemias/prevenção & controle , Competência Profissional , Administração em Saúde Pública , Alemanha/epidemiologia , Humanos , Vacinas contra Influenza/provisão & distribuição , Disseminação de Informação/métodos , Pandemias/estatística & dados numéricos , Vigilância da População/métodos , Medição de Risco , Gestão de Riscos/métodos
5.
Artigo em Alemão | MEDLINE | ID: mdl-19343283

RESUMO

It is a moral responsibility of those performing clinical studies towards patients, funding organizations, the scientific community and towards the general public to publish the results of clinical trials. Under-reporting of clinical trials with null or even negative results as well as over-reporting of trials with positive results can lead to a biased assessment of (new) treatments, which leads to overestimation of potential benefits and underestimation of potential risks. Comprehensive, publicly accessible clinical trial registries are now widely accepted as an essential tool to fill the information gap. Here, the background for implementing a clinical trials register in Germany is described, whereby publication bias, in particular, is addressed.


Assuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , Editoração/legislação & jurisprudência , Sistema de Registros , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/estatística & dados numéricos , Difusão de Inovações , Ética em Pesquisa , Medicina Baseada em Evidências/ética , Medicina Baseada em Evidências/legislação & jurisprudência , Alemanha , Humanos , Viés de Publicação/legislação & jurisprudência , Viés de Publicação/estatística & dados numéricos , Editoração/ética , Sistema de Registros/ética , Sistema de Registros/estatística & dados numéricos
6.
Artigo em Alemão | MEDLINE | ID: mdl-19308331

RESUMO

In order to provide a central portal for information on clinical research in Germany and thus to facilitate the search of planned, ongoing and completed clinical trials, the German Clinical Trials Register (GermanCTR) was implemented in cooperation with the WHO's registries network. It is an open access online register of clinical trials conducted in Germany, which allows all users to search for, register and share information on clinical trials. The project is funded by the Federal Ministry of Education and Research and is implemented at the Institute for Medical Biometry and Medical Informatics of the University Medical Center Freiburg as a joint project of the Clinical Trials Center Freiburg and the German Cochrane Center. Since October 2008 the GermanCTR is an approved WHO Primary Registry and allows clinical trial registration in Germany according to the requirements of the International Committee of Medical Journal Editors (ICMJE). Reasons for a national trials register, general and technical aspects of implementing the GermanCTR as well as the national and international integration are described here.


Assuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , Cooperação Internacional/legislação & jurisprudência , Sistema de Registros , Comitês de Monitoramento de Dados de Ensaios Clínicos/ética , Comitês de Monitoramento de Dados de Ensaios Clínicos/legislação & jurisprudência , Comitês de Monitoramento de Dados de Ensaios Clínicos/organização & administração , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Comissão de Ética , Alemanha , Humanos , Editoração/ética , Editoração/legislação & jurisprudência , Sistema de Registros/ética , Sistema de Registros/normas , Apoio à Pesquisa como Assunto/ética , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Apoio à Pesquisa como Assunto/organização & administração , Organização Mundial da Saúde
7.
Cochrane Database Syst Rev ; (2): CD006053, 2008 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-18425935

RESUMO

BACKGROUND: Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple operation or a pylorus-preserving pancreaticoduodenectomy but it is still unclear which of the two procedures is more favourable in terms of survival, mortality, complications, perioperative factors and quality of life. OBJECTIVES: Several publications pointed out both advantages and disadvantages of both techniques and the current basis of evidence remains unclear. The objective of this systematic review is to compare the effectiveness of each technique. SEARCH STRATEGY: A search was conducted to identify all published and unpublished randomised controlled trials. Trials were identified by searching the following electronic databases - The Cochrane Library, MEDLINE, EMBASE and Current Contents. Reference lists from trials selected by electronic searching were hand-searched to identify further relevant trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing the classical Whipple (CW) with the pylorus-preserving pancreaticoduodenectomy (PPW) were considered eligible if patients with periampullary or pancreatic carcinoma were included. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data for included studies. A random-effects model was used for pooling data from the different trials. Binary outcomes were compared using odds ratios, continuous outcomes were pooled using weighted mean differences and hazard ratios were used to for the meta-analysis of survival data. The methodological quality of included studies was evaluated independently by two authors according to quality standards and by using a questionnaire that covers different aspects of quality. MAIN RESULTS: 1235 abstracts were retrieved and checked for eligibility and seven RCTs were finally included. The critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. The comparison of overall in-hospital mortality (odds ratio 0.49; 95% CI 0.17 to 1.40; P=0.18), overall survival (hazard ratio 0.84; 95% CI 0.61 to 1.16; P=0.29) and morbidity showed no significant difference. However, operating time (weighted mean difference -68.26 min; 95% CI -105.70 to -30.83; P=0.0004) and intra-operative blood loss (weighted mean difference -0.76 ml; 95% CI -0.96 to -0.56; P<0.00001) were significantly reduced in the PPW group. AUTHORS' CONCLUSIONS: There is no evidence of relevant differences in mortality, morbidity and survival between the PPW and the CW. Given obvious clinical and methodological inter-study heterogeneity, future efforts have to be undertaken to perform high quality RCTs of complex surgical interventions on the basis of well defined outcome parameters.


Assuntos
Ampola Hepatopancreática/cirurgia , Neoplasias do Ducto Colédoco/cirurgia , Neoplasias Pancreáticas/cirurgia , Pancreaticoduodenectomia/métodos , Neoplasias do Ducto Colédoco/mortalidade , Esvaziamento Gástrico , Humanos , Neoplasias Pancreáticas/mortalidade , Pancreaticoduodenectomia/mortalidade , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
8.
J Med Ethics ; 34(9): e20, 2008 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-18757621

RESUMO

BACKGROUND: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied. METHODS: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg (Germany) in 2000 were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications. RESULTS: 299 study protocols were included. The most frequent study design was randomised controlled trial (141; 47%), followed by uncontrolled studies (61; 20%), laboratory studies (30; 10%) and non-randomised studies (29; 10%). 182 (61%) were multicentre studies including 97 (53%) international collaborations. 152 of 299 (51%) had commercial (co-)funding and 46 (15%) non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication (total 210 articles); the publication rate was 48%. 168 of 210 identified publications (80%) were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication (range 0-1151). CONCLUSIONS: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research.


Assuntos
Ensaios Clínicos como Assunto/ética , Comitês de Ética em Pesquisa/ética , Disseminação de Informação/ética , Editoração/ética , Projetos de Pesquisa/normas , Protocolos Clínicos/normas , Ensaios Clínicos como Assunto/normas , Comitês de Ética em Pesquisa/normas , Alemanha , Humanos , Viés de Publicação , Editoração/normas , Editoração/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos
9.
Ophthalmologe ; 105(3): 255-61, 2008 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-17899115

RESUMO

BACKGROUND: The medical database MEDLINE contains only a part of all published randomized controlled (RCTs) and controlled clinical (CCTs) trials. The validity of a systematic review depends on the complete consideration of all studies pertaining to a clinical question. Therefore, a manual systematic search in medical journals is mandatory. METHODS: The last 30 years of the three peer-reviewed German-language ophthalmological journals Der Ophthalmologe, Klinische Monatsblätter für Augenheilkunde, and Spektrum der Augenheilkunde were retrospectively searched for controlled trials. All identified RCTs and CCTs were classified according to their ophthalmological subspecialty. The quality of the studies was evaluated using the CONSORT Statement. Moreover, a comparison was made of how many of the studies identified by hand searching are registered in MEDLINE and correctly classified as RCTs/CCTs. RESULTS: In total 984 RCTs and CCTs were identified; 62% of the trials were from the subspecialty anterior eye segment, 14% belonged to the subspecialty posterior eye segment, and 18% belonged to glaucoma. A sample size calculation was reported in less than 2% of the full-text publications and 34% reported a blinded study design. A randomization process was described in 23% of the RCTs. Most controlled trials were published in the 1990s in all three journals. From 1998 onward, there was a decrease in the number of published controlled trials in the reviewed German literature. About 63% of the studies registered in MEDLINE are correctly classified. CONCLUSION: In the specialty of ophthalmology there are many important studies which provide basic information for compilation of systematic reviews and clinical guidelines. However, many of the identified clinical trials in German-language journals show deficiencies in the study quality. Only a part of the identified controlled trials are correctly classified in MEDLINE. Therefore, a retrospective registration is essential to complete the electronic database in ophthalmology.


Assuntos
Pesquisa Biomédica , Ensaios Clínicos Controlados como Assunto , Oftalmologia , Publicações Periódicas como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Bases de Dados como Assunto , Alemanha , Humanos , MEDLINE , Fatores de Tempo
10.
Chirurg ; 78(11): 1052-7, 2007 Nov.
Artigo em Alemão | MEDLINE | ID: mdl-17622501

RESUMO

BACKGROUND: The identification of all available and relevant study reports is mandatory for a comprehensive assessment of randomised (RCTs) and controlled clinical trials (CCTs) in systematic reviews. Incomplete compilation of health care journals in electronic databases and incorrect indexing of the studies impair the result of a systematic literature search. An additional search in medical journals that are not listed in electronic databases can obtain higher search precision. METHODS: In the hand searching project of the Cochrane Collaboration, in Germany 14 surgical journals were searched manually for RCTs and CCTs. The identified study reports were compared with Medline records, and the publication frequency was analysed. The study reports were published in the Cochrane Library and are henceforth available for inclusion in systematic reviews. RESULTS: Four hundred (77%) of the 519 published volumes in the 14 surgical journals were searched for RCTs and CCTs. Of the 1152 controlled trials (670 RCTs and 482 CCTs) identified, 674 (58%) were not included in Medline. CONCLUSIONS: The gap between the number of hand search results and the number of Medline indexed RCTs and CCTs is also reflected in other special medical fields. To ensure completeness of the literature compilation, the hand searching project should be continued.


Assuntos
Ensaios Clínicos Controlados como Assunto/estatística & dados numéricos , Bases de Dados Bibliográficas/estatística & dados numéricos , Medicina Baseada em Evidências , Cirurgia Geral/estatística & dados numéricos , Armazenamento e Recuperação da Informação/estatística & dados numéricos , MEDLINE/estatística & dados numéricos , Publicações Periódicas como Assunto/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Indexação e Redação de Resumos/normas , Indexação e Redação de Resumos/estatística & dados numéricos , Viés , Bases de Dados Bibliográficas/normas , Alemanha , Humanos , Armazenamento e Recuperação da Informação/normas , MEDLINE/normas , Estados Unidos
11.
Chirurg ; 78(10): 938-44, 2007 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-17805496

RESUMO

The enormous number of medical publications available online and in print media makes it difficult for surgeons to keep abreast of new scientific developments. In addition to information overload and lack of time, studies of questionable quality and expertise when performing systematic literature searches jeopardize proper surgical decision making. The concept of systematic reviews (SR) and meta-analyses (MA) is based on a critically appraised synthesis of individual trials addressing comparable medical problems. This qualitative evaluation and quantitative aggregation of research findings offer valid decision making tools for the clinician, scientist, and health care authorities. Systematic reviews employ comprehensive methods to control for potential bias when synthesizing individual trials. Thus the clinical question and methodological aspects should be defined a priori in a protocol. In the following step the relevant literature must be identified through systematic searches in databases. After critical assessment of the methodological quality and heterogeneity of individual studies, the results can be presented qualitatively. They also can be quantitatively summarized in MA if appropriate. Compared to single trials, properly conducted SR and MA facilitate more precise estimation of the treatment effect of surgical interventions. Hence they represent an ideal basis for future research endeavors. In conclusion, SR and MA implemented in clinical guidelines, evidence-based consumer information, or health technology assessment, enable the necessary bridging between research and clinical practice.


Assuntos
Cirurgia Geral , Metanálise como Assunto , Literatura de Revisão como Assunto , Ensaios Clínicos Controlados como Assunto , Técnicas de Apoio para a Decisão , Difusão de Inovações , Medicina Baseada em Evidências , Humanos , Sistemas de Informação , Avaliação de Resultados em Cuidados de Saúde
12.
Chirurg ; 77(9): 837-43, 2006 Sep.
Artigo em Alemão | MEDLINE | ID: mdl-16850289

RESUMO

BACKGROUND: Comprehensive identification of relevant literature is mandatory for valid assessment of the effectiveness of surgical interventions. Thus, electronic database searches are often complemented by handsearching of relevant surgical journals. The aim of this study was to assess the quantity and quality of randomized controlled (RCTs) and controlled clinical trials (CCTs) in the German surgical journal Der Chirurg. METHODS: Quantitative and qualitative assessment was made after handsearching of studies published from 1948 to 2005 in Der Chirurg. Systematic database search (MEDLINE) was used for comparison of RCTs published in Der Chirurg and international surgical journals. RESULTS: Overall, 112 controlled clinical trials (90 RCTs, 22 CCTs) were identified by handsearching. The implementation of sample size calculation was reported in 12 of 90 (13%) RCTs. Forty-six (51%) did not specify the randomization process, and five (6%) incorporated the "intention to treat" principle in their analyses. After 2000, RCTs were published in declining frequency in Der Chirurg, whereas international surgical journals printed stable quantities of these studies. CONCLUSION: Improving the prerequisites of patient-centered clinical research in surgery, rigorous implementation of principles of the CONSORT statement, and modified publication strategies may improve the quality and quantity of reports on clinical studies in Germany.


Assuntos
Ensaios Clínicos Controlados como Assunto/estatística & dados numéricos , Cirurgia Geral/estatística & dados numéricos , Publicações Periódicas como Assunto/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Comparação Transcultural , Interpretação Estatística de Dados , Bases de Dados Bibliográficas/estatística & dados numéricos , Europa (Continente) , Alemanha , Humanos , MEDLINE/estatística & dados numéricos , Editoração/estatística & dados numéricos , Resultado do Tratamento
13.
Infect Control Hosp Epidemiol ; 25(1): 21-5, 2004 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-14756214

RESUMO

OBJECTIVE: To review the evidence regarding the effects of interventions to improve hospital design and construction on the occurrence of nosocomial infections. METHODS: Systematic review of experimental and non-experimental, architectural intervention studies in intensive care units (ICUs), surgical departments, isolation units, and hospitals in general. The studies dated from 1975, and were in English, French, German, Italian, and Spanish. Regardless of format, the studies were identified through seven medical databases, reference lists, and expert consultation. RESULTS: One hundred seventy-eight scientific articles were identified; however, none of these described a meta-analysis, systematic review, or randomized, controlled trial. Most of the articles were categorized at the lowest level of evidence (expert judgment or consensus statements). Only 17 described completed concurrent or historical cohort studies matching the inclusion criteria (ICUs, 9; surgical departments, 4; isolation units, 2; hospitals in general, 2). The interventions generally included a move to other premises or renovation. However, in many studies, the staff-to-patient ratio was also improved. Some studies showed lower infection rates after intervention, but this finding cannot be generalized because of confounding and frequently small study populations. CONCLUSIONS: The lack of stringent evidence linking hospital design and construction with the prevention of nosocomial infection is partly attributable to the multifactorial nature of these infections, and some improvement will be seen if basic conditions such as the availability of sufficient space, isolation capacity, and facilities for handwashing are met. However, to our knowledge, other factors, especially the improper hand hygiene of medical staff, have greater impact.


Assuntos
Arquitetura , Infecção Hospitalar/epidemiologia , Infecção Hospitalar/prevenção & controle , Arquitetura Hospitalar , Controle de Infecções/métodos , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Isolamento de Pacientes , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/prevenção & controle
14.
Eur J Radiol ; 2(3): 238-41, 1982 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-6181996

RESUMO

The radiologic findings on small bowel enema examination using barium and methylcellulose (SBE + Ba + MC) in a patient with Whipple's disease before and after treatment are described. The changes on SBE + Ba + MC corresponded well to the clinical and morphologic picture. The advantages of this double contrast technique compared to the enteroclysis with barium alone are demonstrated. The SBE + Ba + MC is a good method to demonstrate the manifestations of Whipple's disease involving the small bowel and the mesentery.


Assuntos
Sulfato de Bário , Metilcelulose , Doença de Whipple/diagnóstico por imagem , Enema , Humanos , Masculino , Pessoa de Meia-Idade , Radiografia , Tecnologia Radiológica
15.
Cochrane Database Syst Rev ; (2): CD003046, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-15106188

RESUMO

BACKGROUND: Hepatocellular carcinoma is one of the most common malignant diseases worldwide. A potential curative option is surgical resection. Due to impaired liver function and/or anatomical reasons only few patients can be treated surgically. For the majority of patients, several interventions have been developed. Among these, local radiofrequency inducing heat production has been used to coagulate the cancer. OBJECTIVES: To evaluate the effects of radiofrequency thermal ablation in hepatocellular carcinoma patients with respect to clinically relevant outcomes (mortality, rate of recurrences, adverse events, quality of life, and duration of hospital stay) versus sham intervention, no intervention, or other interventions. SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library, MEDLINE, EMBASE, CancerLit, and Current Contents until October 2003. Handsearches were also conducted. Reference lists of the identified articles were checked for further trials. SELECTION CRITERIA: All randomised trials investigating radiofrequency thermal ablation versus placebo, no intervention, or any other therapeutic approach were considered for inclusion, regardless of blinding, language, and publication status. DATA COLLECTION AND ANALYSIS: Trial inclusion, quality assessment, and data extraction were performed independently by two reviewers. Principal investigators were contacted for further information. MAIN RESULTS: Only two randomised clinical trials were identified. One trial including 102 patients compared radiofrequency thermal ablation versus percutaneous ethanol injection for small hepatocellular carcinoma. Radiofrequency thermal ablation significantly increased recurrence-free survival (hazard ratio 0.48, 95% confidence interval (CI) 0.27 to 0.85) but did not significantly influence overall survival (hazard ratio 0.20, 95% CI 0.02 to 1.69). The rate of complications and side effects did not differ significantly between the two groups. Another trial with methodological flaws compared radiofrequency thermal ablation versus percutaneous microwave coagulation for 72 patients with 94 hepatocellular carcinoma lesions. The main outcome criterion was the rate of recurrences in both groups; no significant difference was detected. The rate of side effects did not differ significantly, but significantly more treatment sessions were needed with percutaneous microwave coagulation to achieve complete tumour ablation. REVIEWERS' CONCLUSIONS: Radiofrequency thermal ablation seems a potentially promising technique for the treatment of small hepatocellular carcinoma. However, more randomised clinical trials are needed.


Assuntos
Carcinoma Hepatocelular/cirurgia , Ablação por Cateter , Neoplasias Hepáticas/cirurgia , Carcinoma Hepatocelular/terapia , Etanol/administração & dosagem , Humanos , Neoplasias Hepáticas/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
16.
Cochrane Database Syst Rev ; (3): CD003046, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-12137670

RESUMO

BACKGROUND: Hepatocellular carcinoma (HCC) is one of the most common malignant diseases worldwide. The only possibly curative therapeutic option is surgical resection. Due to impaired liver function and/or anatomical reasons only a low percentage of patients can be treated surgically. For the remainder, several non-surgical treatment approaches have been developed. In addition to percutaneous ethanol injection, transarterial interventions, and several medical interventions, radiofrequency thermal ablation has been investigated in coagulating HCC lesions. OBJECTIVES: To evaluate the effects of radiofrequency thermal ablation in HCC patients with respect to clinically relevant outcomes (mortality, rate of recurrences, adverse events, quality of life, and duration of hospital stay). SEARCH STRATEGY: We searched The Cochrane Hepato-Biliary Group Trials Register, The Cochrane Controlled Trials Register on The Cochrane Library, MEDLINE, Current Contents, EMBASE, and CancerLit until June 2001 and further handsearch was conducted. Reference lists of the identified articles were checked for further trials. SELECTION CRITERIA: All randomised or quasi-randomised clinical trials investigating radiofrequency thermal ablation versus placebo, no intervention, or any other therapeutic approach were considered for inclusion, regardless of blinding, language, and publication status. DATA COLLECTION AND ANALYSIS: Trial inclusion, quality assessment, and data extraction were performed independently by two reviewers. Principal investigators were contacted for further information. MAIN RESULTS: One randomised trial which is still ongoing and only published as an interim analysis was identified. This trial compared radiofrequency thermal ablation versus percutaneous ethanol injection in 102 patients with small HCC. With respect to mortality the trial showed no significant difference between the two treatments (relative risk = 0.19, 95% confidence interval 0.02 to 1.59). Concerning the recurrence free survival the trial demonstrated no significant superiority of radiofrequency thermal ablation versus percutaneous ethanol injection (relative risk = 0.70, 95% confidence interval 0.46 -1.04). REVIEWER'S CONCLUSIONS: At present, radiofrequency thermal ablation is an insufficiently studied intervention for HCC.


Assuntos
Carcinoma Hepatocelular/cirurgia , Ablação por Cateter , Neoplasias Hepáticas/cirurgia , Carcinoma Hepatocelular/terapia , Etanol/administração & dosagem , Humanos , Neoplasias Hepáticas/terapia , Resultado do Tratamento
17.
Rofo ; 134(1): 10-5, 1981 Jan.
Artigo em Alemão | MEDLINE | ID: mdl-6452324

RESUMO

A modified technique of the small bowel enema is described. Diluted barium followed by an aqueous suspension of 0.5% methylcellulose is injected through a duodenal tube. Pathologic findings can be better recognized by the resulting double-contrast images than by other techniques. A detailed description of this method, and of our own experience, is given.


Assuntos
Sulfato de Bário , Enteropatias/diagnóstico por imagem , Metilcelulose , Feminino , Humanos , Intestino Delgado/diagnóstico por imagem , Masculino , Radiografia
18.
Rofo ; 174(4): 480-4, 2002 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-11960412

RESUMO

PURPOSE: Assessment of long-term results of CT-guided lumbar sympathicolysis (LSL) in advanced peripheral arterial vascular disease (pavd). Establishment of a suitable patient selection. PATIENTS AND METHODS: LSL was performed in 138 cases with Fontaine stages III (13 %) and IV (87 %). 250 consecutive patients were examined with a radionuclide perfusion study of the feet prior to and during peridural anaesthesia (PDA) in order to select suitable patients for LSL. LSL was not performed in patients with impaired perfusion under PDA (n = 112). Early and long-term results after one to five years were evaluated. RESULTS: In 79 % an initial improvement was found after LSL. After more than one year success was established in 38 %. 49 % of the cases had a progression of the disease. This is significantly better compared to a control group with conservative treatment and an initial improvement of 36 %. After more than one year only12 % revealed an improvement. In 82 % the disease was progressive. Diabetics showed also a positive response to LSL. CONCLUSION: LSL has a positive influence on the course of pvad in patients selected by radionuclide perfusion studies. Diabetes and angiographic findings do not play any first role in patient selection for LSL.


Assuntos
Arteriopatias Oclusivas/terapia , Perna (Membro)/irrigação sanguínea , Doenças Vasculares Periféricas/terapia , Simpatectomia Química , Tomografia Computadorizada por Raios X , Adulto , Idoso , Idoso de 80 Anos ou mais , Anestesia Epidural , Anestésicos Locais , Arteriopatias Oclusivas/diagnóstico , Arteriopatias Oclusivas/diagnóstico por imagem , Etanol , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Doenças Vasculares Periféricas/diagnóstico , Doenças Vasculares Periféricas/diagnóstico por imagem , Cintilografia , Fatores de Tempo , Resultado do Tratamento
19.
Rofo ; 135(6): 691-4, 1981 Dec.
Artigo em Alemão | MEDLINE | ID: mdl-6212387

RESUMO

Seven patients had a percutaneous transluminal removal of catheter fragments using a Dormier stone-basket within the last 14 months. An immediate intervention should be performed because serious complications are expected from catheter embolization. The percutaneous transluminal catheter retrieval as a method of low risk and of little discomfort to the patient should always precede surgical procedures. The Dormier-basket proved to be a successful and easy handling catheter instrument in all our cases.


Assuntos
Cateterismo/métodos , Cateteres de Demora/efeitos adversos , Embolia/terapia , Adulto , Idoso , Cateterismo/instrumentação , Embolia/etiologia , Humanos , Pessoa de Meia-Idade
20.
Rofo ; 134(6): 649-52, 1981 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-6454625

RESUMO

It has been shown in an animal experiment that alterations of the renal vasculature and parenchyma after hemostasis performed by Infrared-Contact-Coagulation are best shown by intravital magnification angiography (magnification factor 2.22). Following pole resection and hemostasis the final morphologic state is reached 6 weeks postoperatively. The resulting scar penetrates into the parenchyma up to 1 cm. The loss of function corresponds to the parenchymal defect. There was no additional loss of renal function or damage to the parenchyma on nuclear medicine or histologic examinations.


Assuntos
Embolização Terapêutica/instrumentação , Hemorragia/cirurgia , Raios Infravermelhos/uso terapêutico , Nefropatias/cirurgia , Nefrectomia , Animais , Cães , Hemostasia Cirúrgica/instrumentação , Radiografia , Renografia por Radioisótopo , Artéria Renal/diagnóstico por imagem , Cicatrização
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