Highly significant improvement in guideline adherence,relapse-free and overall survival in breast cancer patients when treated at certified breast cancer centres: An evaluation of 8323 patients

ObjectivesCertified multi-disciplinary breast cancer centres (CBCs) have been established worldwide. Development of CBCs, guideline-adherent systemic therapy and surgical management should now show an impact on outcomes. This analysis aimed to investigate whether guideline adherence (GA) rates, relapse-free survival (RFS) and overall survival (OS) have significantly improved at CBCs compared to the pre-certification period.Materials and methods8323 patients with primary breast cancer were treated in 17 German CBCs, which had been certified between 2003 and 2007 [2003 (n = 1), 2004 (n = 6), 2005 (n = 3), 2006 (n = 6) and 2007 (n = 1)]. 3544 patients (42.6%) were treated before certification and 4779 patients (57.4%) after certification.Results and conclusionA highly significant (p < 0.001) difference in 100%-GA was found between the various hospitals before certification (min 25.0%; max 54.6%). In 2008, when all participating hospitals were certified, the GA rate was 61.8% (min 39.5%, max 74.4%) and 69.2% (min 45.9%, max 86.4%) for patients <75 y (n = 6675). The difference between pre-certification 100%-GA (46.9%) and post-certification (57.2%) was highly significant (p < 0.001). RFS and OS were both significantly better after certification compared to the pre-certification period (RFS: HR = 0.79; 95% CI: 0.68–0.92; p = 0.003; OS: HR = 0.75; 95% CI: 0.65–0.85; p < 0.001). 5-year RFS (OS) of patients <75 y was 89.6% (85.4%) pre-certification and 91.4% (89.5%) post-certification.Since improvement in GA and outcomes correlated as well, GA remains a highly significant prognostic factor for RFS and OS regardless of NPI, intrinsic subtype and adjuvant systemic therapy. This suggests that the certification process is strongly associated with improvements in outcome.     

重视预防,规范管理——2007年版《中国2型糖尿病防治指南》

我国的2型糖尿病患病率正呈现迅猛增长的态势,已成为威胁国民健康的主要疾病之一.中华医学会糖尿病学分会为了更好地应对2型糖尿病防治工作的巨大挑战,组织全国专家,以循证医学为基础,借鉴近年来多个国际新指南,结合中国的糖尿病实践,制定了2007年版<中国2型糖尿病防治指南>.新指南明确了我国糖尿病的诊断标准,突出预防为主的方针,强调糖尿病的管理及多种心血管危险因素的综合防治.同时制定了更为严格的血糖控制目标以及符合中国2型糖尿病发病特点的治疗方案.该指南将推广"重视预防、规范管理"的糖尿病防治理念,培养更多合格的糖尿病防治骨干,提高我国的糖尿病防治水平.     

肝衰竭诊疗指南解读

2006年10月出台的《肝衰竭诊疗指南》（以下简称《指南》）是我国第一部有关肝衰竭的指南。国际上迄今为止仅见美国肝病联合会（AASLD）于2005年5月出台的有关《急性肝衰竭处理》的意见书,且范围局限。因此,可以说我国的《指南》最为全面和广泛地反映了肝衰竭的临床诊疗现状。该《指南》由中华医学会感染病学分会和中华医学会肝病学分会的肝衰竭与人工肝学组组织撰写,     

Report from the EPAA workshop: In vitro ADME in safety testing used by EPAA industry sectors

There are now numerous in vitro and in silico ADME alternatives to in vivo assays but how do different industries incorporate them into their decision tree approaches for risk assessment, bearing in mind that the chemicals tested are intended for widely varying purposes? The extent of the use of animal tests is mainly driven by regulations or by the lack of a suitable in vitro model. Therefore, what considerations are needed for alternative models and how can they be improved so that they can be used as part of the risk assessment process? To address these issues, the European Partnership for Alternative Approaches to Animal Testing (EPAA) working group on prioritisation, promotion and implementation of the 3Rs research held a workshop in November, 2008 in Duesseldorf, Germany. Participants included different industry sectors such as pharmaceuticals, cosmetics, industrial- and agro-chemicals. This report describes the outcome of the discussions and recommendations (a) to reduce the number of animals used for determining the ADME properties of chemicals and (b) for considerations and actions regarding in vitro and in silico assays. These included: standardisation and promotion of in vitro assays so that they may become accepted by regulators; increased availability of industry in vivo kinetic data for a central database to increase the power of in silico predictions; expansion of the applicability domains of in vitro and in silico tools (which are not necessarily more applicable or even exclusive to one particular sector) and continued collaborations between regulators, academia and industry. A recommended immediate course of action was to establish an expert panel of users, developers and regulators to define the testing scope of models for different chemical classes. It was agreed by all participants that improvement and harmonization of alternative approaches is needed for all sectors and this will most effectively be achieved by stakeholders from different sectors sharing data.     

东莞部分社区医生高血压防治知识现状与《中国高血压防治指南））（2009年基层版）差异性分析

目的了解东莞部分社区医生高血压防治知识现状以及与〈〈中国高血压防治指南〉〉（2009年基层版）差异性。方法东莞市部分社区医生现场答卷,以调查高血压相关知识。结果社区医生中,能够掌握心血管病和高血压危险因素的有58％,能够掌握患者高血压其临床评价的有61％,能够掌握患者高血压应用非药物手段进行治疗其内容的有42％,能够掌握关于高血压流行趋势与现状的有38％,能够掌握关于血压水平分类的有38％,能够掌握高血压降压药物其治疗原则的有35％,能够掌握患者高血压其危险分层的有31％,能够掌握降压药物其分类的有30．6％,能够合理的选择患者降压药物的有28％,能够熟悉高血压患者其监测与评估程序的有22％,能够掌握对特殊人群应用降压药物进行治疗的有9％,能够联合应用降压药物对患者进行治疗的有ll％,513％的社区医生知道中国高血压指南,23．8％医生接受过指南相关内容培训。结论社区医生高血压防治知识有待提高,社区高血压治疗需规范和优化。     

冠心病心绞痛口服给药临床研究申请存在问题分析及建议

统计近年来以冠心病心绞痛为主要适应证、申请临床研究的口服给药途径的中药新药申报情况,总结其类别分布、特点以及存在问题,结合该适应证临床研究指导原则的基本要求,提出建议,供临床研究人员与药物研发者参考.     

A parallel guideline development and formalization strategy to improve the quality of clinical practice guidelines

Purpose

Clinical practice guidelines often contain ambiguities, inconsistencies, and logical errors that hamper implementation of these guidelines in practice. As guideline formalization is useful to verify the logical structure, consistency, and completeness of guidelines, several authors have argued that the formalization of guidelines concurrent with their development may improve their quality. However, experiences with such a parallel guideline development and formalization approach have not yet been reported. The goal of this study was to develop such a strategy and evaluate its application in practice.

Methods

Existing methodologies for guideline development and guideline formalization were analyzed and used as a basis to develop a strategy in which guideline formalization is performed concurrently with guideline development. The developed strategy was applied in the development of a clinical practice guideline for cardiac rehabilitation.

Results

A parallel guideline development and formalization strategy was developed that intertwines the processes of guideline development and guideline formalization. Central assets are early involvement of guideline formalization specialists and formalization tools, cooperation between guideline authors and guideline formalization specialists in the development of clinical algorithms, access to domain knowledge when formalization identifies inconsistencies or omissions, and formal verification of the guideline model prior to guideline dissemination. This strategy was applied in the development of a guideline for cardiac rehabilitation and helped to identify several vague and inconsistent recommendations and impracticabilities in the narrative guidelines that could be resolved before publication. In addition, the strategy ensured consistency between the narrative and formalized guideline.

Conclusions

Based on our experience, formalizing a guideline concurrent with its development is feasible in practice and we recommend applying such a strategy as it can be beneficial to the quality of and consistency between the guideline's narrative and formalized version.     

Clinical practice guidelines for the treatment of schizophrenia: from theory to practice

INTRODUCTION: Based on the concept of evidence-based medicine (EBM), the clinical practice guidelines (CPG) occupy an increasingly important place in the field of the treatment of schizophrenia. Although CPGs have been elaborated in a rigorous way, few of them provide the readers with tools for their use in practice. The clinician must therefore create his own method of application. This problem was encountered within the framework of a retrospective study carried out in a rehabilitation unit, where we sought to answer the question concerning the use of the CPG approach in the pharmacological treatment of schizophrenia: "to what degree do doctors, with only indirect knowledge, respect these CPGs?" METHOD: The comparative study between CPG and practical current clinic implied: (1) the choice of a pertinent CPG for the clinical framework studied, (2) the selection of measuring instruments, which allow the quantification of obvious clinical problems approached in the CPG, and (3) the development of a standardized system of comparison to determine the degree of respect of the recommendations. The Expert Consensus Guideline for the treatment of schizophrenia (ECGTS) was selected as the reference. A method of application of the ECGTS is depicted: use of standardized clinical scales; translation of the results of the clinical examination in terms of clinical problems to which the recommendations of the guideline refers; and determination of the degree of respect of the recommendations. RESULTS: In the group of 20 patients included in this study, the recommendations of the ECGTS were totally respected in 65% of the patients, and partially respected in 10%, while in 25% of the patients, they were not respected. COMMENTS: These observations suggest that the clinical approach has to be improved, mainly with regard to the treatment of psychotic and depressive symptoms. This work also showed the limits of the CPG: for example, over half of the patients presented side effects on clinical evaluation, whereas the regulation of their medication respected the recommendations of the ECGTS. CONCLUSION: The future certainly belongs to CPG, which proposes, in addition to the clinical recommendations themselves, a method to check their application in clinical practice.     

Management issues for women with epilepsy—Focus on pregnancy (an evidence-based review): I. Obstetrical complications and change in seizure frequency

A committee assembled by the American Academy of Neurology (AAN) reassessed the evidence related to the care of women with epilepsy (WWE) during pregnancy, including the risk of pregnancy complications or other medical problems during pregnancy, change in seizure frequency, the risk of status epilepticus, and the rate of remaining seizure-free during pregnancy. The committee evaluated the available evidence according to a structured literature review and classification of relevant articles. For WWE who are taking antiepileptic drugs (AEDs), there is probably no substantially increased risk (>2 times expected) of cesarean delivery or late pregnancy bleeding, and probably no moderately increased risk (>1.5 times expected) of premature contractions or premature labor and delivery. There is possibly a substantially increased risk of premature contractions and premature labor and delivery during pregnancy for WWE who smoke. WWE should be counseled that seizure freedom for at least 9 months prior to pregnancy is probably associated with a high likelihood (84–92%) of remaining seizure-free during pregnancy. WWE who smoke should be counseled that they possibly have a substantially increased risk of premature contractions and premature labor and delivery.