《第十届中国卫生技术评估论坛》资料下载.pdf

Evidence-Based Medicine: Practice and Challenges Boheng Zhang MD PhD Center for EvidenceBased Medicine Fudan University Evidence-Based Medicine up-to-date evidence BEST possible outcomes. clinician’s individual expertise patient’s own preferences & expectations EBM and clinical practice Not only EVIDENCE  Integrate with clinician’s individual expertise and patient’s own preferences, expectations, values  –  And the inconvenience, availability, and costs. Bedside EBM: NNT/NNH Evidence A particular clinical question • Original research • Systematic review • • • Treatment availability Costs Ethical considerations Guidelines Challenges  developing better means of integrating different types of evidence from a range of sources to improve decisions about individual patients, and embedding guidelines in personal and stimulating clinical practice. 国内外EBM现况  国外：EBM已从理论构建过渡到实际应用阶段  国内：EBM停留在“循证医学专业人员”的学 习和研究阶段，临床实践的推广阶段 A major challenge to current EBM is how to evaluate and integrate different types of research from a range of conceptual and methodological backgrounds into frontline clinical care and shared decision-making with patients. Guideline Debate 1: Experience- or evidence- BM  EBM vs EBM – Guideline: experts consensus  Mixture of scientific research and clinical practice and observation  Expert opinion  Many studies now focus on developing and evaluating optimal strategies for guideline implementation in the real world of practice. Peter Croft, et al. The pros and cons of evidence-based medicine. Spine Publish Ahead of Print DOI: 10.1097/BRS.0b013e318223ae4c Debate 2: Strong focus on RCTs Overemphasized on RCT  RCT gold standard for intervention  GRADE (5-/3+)  Study Limitations – Deficiencies in validity or precision – Inconsistencies in outcomes – Indirectness of evidence – Publication bias. – Large magnitude of effect – Plausible confounding(negative) – Dose-response gradient – Clinical practice is more complex than trials Research evidence, clinical guidelines, clinical practice  Complexity  – – – implementation: too many, contradiction Combinations: multimorbidity, evidence? Clinical guidelines concerns therapeutic interventions, more than prognosis and diagnosis No time, no competence   EBM has been defined as the conscientious, explicit, and judicious use of current best evidence, to integrate evidence with clinical expertise, to apply the evidence for each individual patient. Evidence usually from SRs and clinical guidelines. Too many to keep up. Little evidence of what works guidelines often provide what you should not do instead of recommending what you should.  Studies suggesting “no effect” of a treatment are often not enough sample size.  The number of guideline recommendations for cardiologists had increased, so also had the proportion based on lower levels of evidence or on clinical opinion [Tricoci P, JAMA 2009].  Small effects only Everything works, but the effect is small.  placebo effect”, “context effect”  Lack of generalisability average results from populations versus individualized treatment. [heterogeneity]  EBM emphasizes evidence for application to individuals but there will always be uncertainty in doing this.  RCTs often in well-controlled experimental circumstances, versus health care in routine circumstances.  Other aspects besides evidence Evidence alone is never sufficient to make a clinical decision.  Decision: benefits and harms, clinicians’ and patients´ values, preferences and expectations, and the inconvenience, availability, and costs.  Conflicts of interest Profession group  Health insurance  Industries  Promoting the industry  You Suning: kidnapped by pharmaceutical industry –  Approximately 80% of all trials are industry funded litigation related to EBM and guideline use Hampers innovation  Sufficient evidence may take decades. – – allowing the use of new, innovative interventions at an early stage within the setting of RCTs, audit studies. The alternative: exception to EBM Guidelines and routine work Guidelines be used only in situations where they do not immediately know what clinical decision to make. Not in routine cases.  SR and clinical guidelines is a growing and serious problem.   Developing implementation strategies is a major challenge for the future.