国家主导、多方参与,共同促进中医临床研究整体水平提高

自20世纪末循证医学和系统评价的方法引入我国,有关中医药系统评价常见的结论多为：尚无证据证明某种药物或疗法的疗效,原始研究的方法学存在缺陷,建议规范开展多中心、大规模临床研究[1]。这种严峻的现实刺激和激励了我国中医药临床研究的深刻反思和奋起直追。     

我国中医药临床研究的现状和评价

中医药现代化与国际化是我们面临的重大课题。中医药临床研究必须依赖方法学的突破和思路的创新，重视以国际评估标准进行科研设计的评价方法并在实践中规范应用。对中医类期刊及其所载临床研究献的质量评价结果显示，我国中医类期刊随机对照试验献不超过30％，所载临床研究献的Jadad评分低于3分。但是，随着循证医学的引入与推广，中医临床研究质量在不断提高。近年来，我国有关中医药防治疾病的系统评价数量快速增长，截至2004年已达43个，且纳入献质量及系统评价质量均有提高。一些系统评价已初步显示出中医药在疾病防治的有效性和安全性方面具有一定优势。随着循证医学的发展，中医药界已逐渐意识到如何运用国际科研设计和评价方法以提高中医药临床研究质量是中医药现代化的关键。     

卫生研究中证据的定义与循证规范

近20年随着循证医学的发展及其方法学的不断完善，证据概念和循证原则不仅在医学各领域广泛应用，且逐渐渗透于非医学领域。我们调查了不同组织对卫生研究中证据的定义，结合实际工作提出对证据的新定义：“证据是系统评价后的信息”；同时论述循证规范的形成，为其服务于其他学科和行业提供借鉴和参考。     

循证医学在康复临床中的应用

在康复医学领域如何开展循证医学？循证医学证据的分级，实践循证医学的步骤，以及怎样才能够通过临床医师参与和利用Cochrane协作网、阅读和应用循证医学文献来寻找到目前最好的证据，以解决患者的实际问题；循证医学应用于心肺疾患、神经系统疾患、骨关节疾患等已取得较好的经济效益和社会效益；而目前的部分系统评价所收集的原始文献尚不充分，大部分缺乏大型、多中心随机对照试验的支持，有的系统评价无法得出对临床有帮助的结论。文章综述了康复科主要相关疾病的循证医学研究概况，为临床康复医师如何实践循证医学和进行康复医学科研提供参考。     

中医药多元证据整合方法学MERGE框架

在循证医学时代下,依托规范的技术方法和标准化的操作规程发掘中医药独特优势,是实现中医药现代化、国际化发展并惠泽人类的必由之路。中医理论、人用经验和研究证据三结合证据体系的提出标志着中医药特色评价体系思维方法取得了重要进步,经过恰当方法整合后的多元证据体是中医药临床指南推荐意见和循证卫生决策的有力支撑。本文基于当前国际证据合成与分级方法学前沿进展,初步提出中医药多元证据整合的方法学框架——MERGE(Merge Evidence-based Research and artificial intelliGence to support smart dEcision)框架,以期为中医药循证医学方法学体系的完善和发展提供借鉴和参考。     

循证医学与临床实践

目前循证医学方法学已广泛应用于临床医疗实践，指导、制定临床各科疾病的治疗方案，评价药物、治疗方案的有效性、适应性，以及为政府部门制定卫生政策、新药的研究、开发评价提供证据，并已形成了许多相关学科。介绍循证医学对临床医疗、中医药发展和药学研究的影响及其临床指导作用，提倡在临床医疗实践中，充分应用循证医学的原则与方法，为临床、科研、卫生决策、医学教育提供最佳证据，并应用最佳证据指导临床决策。     

论循证医学对中医学发展的贡献

循证医学作为一种系统评价体系和方法学，已被政府机关、保险机构、研究领域、医疗卫生等单位与个人作为决策或决定的依据。在中医现代化的进程中，如何应用循证医学的思维和理念进行中医的科研，使未来的研究成果符合客观化的要求，加快中医药国际化步伐是急待解决的问题。循证医学方法在中医药领域的研究可从以下几方面入手。(1)用循证医学方法评价现有中成药的疗效，使中成药的疗效更具有客观依据。利用已有的研究结果对中成药进行系统疗效评价，可以客观地指导临床实践，避免滥用。(2)用多中心、大样本、随机双盲的方法，用最新的疗效标准评价具有人类长期使用证据的药物，使其应用更具科学性和合理性。(3)在中药新药开发过程中，药物安全性和疗效的现代化标准是评价的主流。建立和应用现代最先进的系统评价体系，使开发出的新药具有较强的生命力。     

中国的循证医学研究和培训中心

为在中国开展和普及循证医学，华西医科大学附属第一医院于 1997年 7月经卫生部正式批准建立中国循证医学中心，也称中国 Cochrane中心。于 1999年 3月被国际 Cochrane协作网正式批准注册为全世界 13个 Cochrane中心之一。该中心是亚洲和中国的第一个循证医学 /Cochrane中心。目前正在建立中文临床研究资料库 (包括神经疾病 )，进行系统评价和卫生技术评价，开展高质量临床研究，为中国临床实践和政府卫生决策提供可靠的临床研究依据；并举办循证医学培训班，普及和推广循证医学知识，培养高质量临床研究证据的提供者和应用者 (中国循证医…     

不同类型循证问题的构成

目的循证实践是以采用科学证据、解决临床问题为目的的活动,包括证据整合、证据传播和证据应用三个环节。提出明确的、结构化的循证问题是循证护理实践的第一步。根据目的不同,循证问题可分为两类:创证的循证问题和用证的循证问题。对于护理学科领域而言,诸多研究问题往往不能简单地采用PICO模型将研究问题转化为结构化的循证问题。近年来,澳大利亚JBI循证卫生保健中心基于多元化证据观的理念,在系统评价方法学上不断在发展,已形成一系列包括有效性评价、质性研究评价、成本/经济评价、发生率和流行趋势评价、诊断性试验评价、病因和风险评价、文本和专家意见评价、混合性研究评价、系统评价再评价和文献范畴综述共10种不同类型的系统评价的方法学。本文将详细介绍不同类型系统评价问题构成,并介绍证据应用阶段如何提出合适的循证问题,为之后开展制定纳入、排除标准和系统性检索提供重要依据。     

循证医学与临床实践

目前循证医学方法学已广泛应用于临床医疗实践,指导、制定临床各科疾病的治疗方案,评价药物、治疗方案的有效性、适用性,以及为政府部门制定卫生政策、新药的研究、开发评价提供证据,并已形成了许多相关学科。介绍循证医学对临床医疗、中医药发展和药学研究的影响及其临床指导作用,提倡在临床医疗实践中,充分应用循证医学的原则与方法,为临床、科研、卫生决策、医学教育提供最佳证据,并应用最佳证据指导临床决策。     

中医药大规模临床研究的数据核查

当前我国中医药临床研究质量普遍偏低,其提供的有关中医药有效性和安全性的证据强度较弱。研究过程中缺乏科学管理,尤其在数据管理环节存在较多问题,是导致中医药研究水平较低的原因之一。因此,加强临床研究过程中的数据管理,对提高中医药临床研究质量十分必要。本文结合国家科技攻关计划项目的具体实践,介绍了数据管理中的核查环节,以供参考。     

Evidence-based medicine: revisiting the pyramid of priorities

Evidence-based medicine (EBM) is beset with numerous problems. In addition to the fact that varied audiences have each customarily sought differing types of evidence, EBM traditionally incorporated a hierarchy of clinical research designs, placing systematic reviews and meta-analyses at the pinnacle. Yet the canonical pyramid of EBM excludes numerous sources of research information, such as basic research, epidemiology, and health services research. Models of EBM commonly used by third party payers have ignored clinical judgment and patient values and expectations, which together form a tripartite and more realistic guideline to effective clinical care. Added to this is the problem in which enhanced placebo treatments in experimentation may obscure verum effects seen commonly in practice. Compounding the issue is that poor systematic reviews which comprise a significant portion of EBM are prone to subjective bias in their inclusion criteria and methodological scoring, shown to skew outcomes. Finally, the blinding concept of randomized controlled trials is particularly problematic in applications of physical medicine. Examples from the research literature in physical medicine highlight conclusions which are open to debate. More progressive components of EBM are recommended, together with greater recognition of the varying audiences employing EBM.     

Corroborating evidence‐based medicine

Proponents of evidence‐based medicine (EBM) have argued convincingly for applying this scientific method to medicine. However, the current methodological framework of the EBM movement has recently been called into question, especially in epidemiology and the philosophy of science. The debate has focused on whether the methodology of randomized controlled trials provides the best evidence available. This paper attempts to shift the focus of the debate by arguing that clinical reasoning involves a patchwork of evidential approaches and that the emphasis on evidence hierarchies of methodology fails to lend credence to the common practice of corroboration in medicine. I argue that the strength of evidence lies in the evidence itself, and not the methodology used to obtain that evidence. Ultimately, when it comes to evaluating the effectiveness of medical interventions, it is the evidence obtained from the methodology rather than the methodology that should establish the strength of the evidence.     

Application of the principles of evidence-based medicine to patient care

Evidence-based medicine (EBM) is the conscientious and judicious use of the best evidence available collected from clinical trials, guidelines, and consensus statements. This article provides simple ways to practice EBM using five steps (assess the patient, ask a clearly focused clinical question, acquire the best evidence available from the medical literature, appraise the evidence, and apply the evidence to patient care) and how to execute each step properly, multiple examples of how to apply EBM to patient care, and examples of how to apply the PICO mnemonic (patient, intervention, comparison, and outcome) to the process of EBM.     

Traditional chinese medicine for the treatment of chronic prostatitis in China: a systematic review and meta-analysis

OBJECTIVE: To systematically evaluate the effectiveness of Chinese herbal medicine for treating chronic prostatitis (CPT) in China. DESIGN: Electronic medical database from China National Knowledge Infrastructure (CNKI) was searched, language is Chinese; date is from January 1, 1994 to December 31, 2003. A total of 108 trials were found, and all studies with words like "randomization" or "quasi-randomization" in their abstracts were included, whether they used blinding or not. Nineteen theses that met the entry criteria were downloaded and fully printed. Four groups were divided: Chinese herbs orally treated group (based on syndrome differentiation), Chinese herbs externally treated group, Chinese herbs orally and externally treated group, and integrated Western with Chinese herbs treated group. RESULTS: All 19 articles that met the entry criteria were clinical trial studies with low quality (Jadad Score <3). The results showed that Traditional Chinese Medicine (TCM) may benefit the patients who had CPT. However, from the results of the funnel plots analysis of all four groups of clinical trials that met the inclusion criteria in this systematic review are distant asymmetrical and irregular plots, which indicate that a positive publication bias may exist. There was no obvious evidence indicating that the efficacy of the therapy in the treated groups using TCM was superior to that of the control group (Western medicine treatment group). CONCLUSIONS: All of the four groups in the clinical trials have not provided evidence of evidence-based medicine (EBM) A class (including 1a, 1b, 1c level), failed to prove that the TCM may have beneficial effects for patients with CPT, because of low quality in all the trials and a positive publication bias. Therefore, in light of some positive outcomes, a good design of multicentered, randomized, parallel-controlled and blinding trials is needed in order to make further studies, and deserve further examination for the treatment of CPT with TCM.     

Evidence-based laboratory medicine

Evidence-based medicine (EBM) is a method for solving problems concerning the assessment of laboratory testing in patient care. Practising EBM involves the use of the available evidence to make health care decisions. The best way to practice EBM is the development, validation and implementation of guidelines. Guidelines are considered as the process by which healthcare research and experience are translated into improved patient care. In laboratory diagnostics EBM can be best demonstrated in high-prevalence conditions. Because of the number of patients encountered, high-prevalence conditions have a greater impact on patient morbidity and health care expenditure. In evidence-based laboratory medicine the best evidence comes from systematic reviewing studies of diagnostic tests. The reviewing of diagnostic trials and the development of good practice guidelines on the basis of these studies must be an important task of the scientific associations of clinical chemistry and laboratory medicine.     

Ethical and Epistemological Problems When Applying Evidence-Based Medicine to Pain Management

Abstract:   Epistemology, or the theory of knowledge, is a branch in philosophy concerned with the definitions of knowledge and evidence. Although evidence-based medicine (EBM) has a strong ethical imperative behind it, rooted in the concern to do no harm, to do one's best for one's patients, and by doing so—eliminating waste, it still harbors within it serious epistemological limits. These include methodological and ethical limits to perform randomized controlled trials, the idea of "hierarchy of evidence" which may provide conclusions well short of medical knowledge, and the unique use of a single particular theory of statistical inference which is far from consensual. In this article, we review these difficulties and suggest that EBM is at best a methodological solution to some clinical phenomena, but remains blind to mechanisms of explanation and causation needed, in order to advance our knowledge. Further research in the theory of evidence and inference, causation and correlation, clinical judgment and collective knowledge, the structure of medical theory, and the nature of clinical effectiveness are needed.     

Evidentiary challenges to evidence-based medicine

The evidence-based medicine (EBM) movement has exerted a strong influence on contemporary medicine. It has been used to define the hierarchy of knowledge in clinical medicine by classifying clinical findings according to the perceived relevance and validity of the respective methodologies of studies from which evidence was collected. In the spectrum of theories of knowledge, EBM predominantly relies on findings obtained from population-derived clinical research. This reliance on knowledge obtained from population studies sharply contrasts with a physiologic model of clinical knowledge advocated by basic science researchers and many clinicians. An apparent schism between proponents of physiologic and population models in the approach to the practice of medicine has been created. This dichotomy between practising physicians and EBM physicians in the approach to clinical knowledge should not be irreconcilable. We advocate a consilient approach to the interpretation of evidence and the integration of medical knowledge. This approach relies on 'linking of facts and fact-based theory across various disciplines to create a common groundwork of explanation'.     

Evidence-based practice of transfusion medicine: is it possible and what do the words mean?

Evidence-based medicine (EBM) optimizes clinical decision making by dictating that clinical decisions be based on the best available research evidence and by integrating best research evidence with clinical expertise and patient values. Several rankings of the strength of the evidence generated from different types of clinical research designs have been presented, and, in addressing a particular problem, clinicians can base their decision making on the types of clinical reports that have been published, along with an assessment of the strengths and weaknesses of each study. At a policy level, the concept of EBM would dictate that policy decisions also be made based on the best available research evidence. In transfusion medicine, however, decisions are based on a broader range of inputs, and the criteria for evaluating the efficacy and/or cost-effectiveness of proposed interventions differ from those used in other areas. Reasons why policy decisions are often based on considerations other than the best research evidence include public expectations about transfusion safety and proposals for applying the precautionary principle to transfusion medicine. Using the debate over the appropriateness of introducing universal white-cell reduction as an example, this review describes 2 perspectives for assessing evidence and/or making clinical or policy decisions: the evidence-based approach and the precautionary-principle approach; and also considers whether decisions in transfusion medicine can be truly evidence based.