复旦大学：《循证医学》课程教学资源（教材教案）循证医学各章教案及相关文献.pdf

】Comment Evidence-based medicine in China Inrecent decades,evidence-based medicine has been Medical associations in every discipline have built clinical guidelines for common diseases according to Evid inf making an Joumal of Evidence-Based Pediatrics were launched in traditional chinese medicine have been established and 2001-06.Several organisations developed programmes the rigour of traditional medicine has been gradually to strengthen a national culture of evidence-based raised.The Chinese clinical trial registry was established ng th in 2007 and the number of clinical trials registered in of the a isincreasing (figure). of the in China First access to scientific evidence is not equal in all regions. Cochrane Centre (which became the 14th centre of Doctors from developed areas and large cities.such as the Internationa Cochrane Collaboration in 1999), Shanghai and Beijing,can search the literature for free Ministry of Ed cation's virtual research centre o t their university via databa es such as Me dline.Bu 4,and e areas might no be ar h nanised in 2003 mited kn nt use of the The board members of these organisations are located best evidence in their practice all around China,and have sought to disseminate Second.most of the world's dinical evidence does knowledge of evidence-based medicine throughout the ot come from China.Few results from China hav Usually 1-3 mont been indu uing educati epidemi in The New England oumal of Medicine The lance medicine have become compulsory curricula fot medical and lAMA How ever,only 0-21%of these were from students and dinical postgraduates in all universities. mainland China. Wu and colleaques'analysec randomised trials on 20 common diseases p n China's natural know ure 450 19 that only eview criteria)fre ical analy are also found in Chinese medical journals,which reduces the credibility of the evidence Third,becaus of a lack of fu nding for ir estigator-lec mo good ese clinic are ph y to ha 100- outcomes that favour the nonsor's product which could result in publication bias.>Finally.although the 2000 200 2005 2006 3007 2008 Chinese Government has made research into traditiona medicine a prionty area and randomised trals hav e 第10页第2页

Comment 532 www.thelancet.com Vol 375 February 13, 2010 Evidence-based medicine in China In recent decades, evidence-based medicine has been propagated rapidly in China, not only to doctors but also to nurses and other health-care professionals. The Chinese Journal of Evidence-Based Medicine, the Journal of Evidence-Based Medicine, and the Chinese Journal of Evidence-Based Pediatrics were launched in 2001–06. Several organisations developed programmes to strengthen a national culture of evidence-based medicine, including the clinical epidemiology committee of the Chinese Medical Association (established in 1993) working with the Chinese Clinical Epidemiology Network (ChinaCLEN; registered as part of the International Clinical Epidemiology Network in 1989),1 the Chinese Cochrane Centre (which became the 14th centre of the International Cochrane Collaboration in 1999),2 the Ministry of Education’s virtual research centre of evidence-based medicine founded in 2004, and the China Medical Doctor Association’s evidence-based medicine committee organised in 2003.3 The board members of these organisations are located all around China, and have sought to disseminate knowledge of evidence-based medicine throughout the country. Programmes (usually 1–3 months) organised by the Ministry of Education, continuing education programmes, and online education programmes are available. Clinical epidemiology and evidence-based medicine have become compulsory curricula for medical students and clinical postgraduates in all universities. Medical associations in every discipline have built clinical guidelines for common diseases according to the evidence to inform clinical decision making and teaching. Evidence-based medicine has also engaged with traditional Chinese medicine. Research teams in traditional Chinese medicine have been established and the rigour of traditional medicine has been gradually raised. The Chinese clinical trial registry4 was established in 2007 and the number of clinical trials registered in China is increasing (fi gure).5 There are, however, several concerns about the develop ment of evidence-based medicine in China. First, access to scientifi c evidence is not equal in all regions. Doctors from developed areas and large cities, such as Shanghai and Beijing, can search the literature for free at their university via databases such as Medline. But doctors in remote areas might not be able to access the best information resources, which, together with a limited knowledge of English, could prevent use of the best evidence in their practice. Second, most of the world’s clinical evidence does not come from China. Few results from China have been included in systematic reviews6 or clinical practice guidelines. I calculated that from 1999 to 2008, 1880 clinical research articles were published in The New England Journal of Medicine, The Lancet, and JAMA. However, only 0·21% of these were from mainland China.7 Wu and colleagues8 analysed randomised trials on 20 common diseases published in China’s natural knowledge infrastructure database from 1994 to 2005, and found that only 7% of them met methodological criteria (according to Cochrane review criteria). Frequent errors in statistical analyses are also found in Chinese medical journals,9 which reduces the credibility of the evidence. Third, because of a lack of funding for investigator-led randomised trials, most good-quality Chinese clinical trials are pharmaceutical premarketing trials sponsored by drug companies. Such research is more likely to have outcomes that favour the sponsor’s product, which could result in publication bias.10 Finally, although the Chinese Government has made research into traditional medicine a priority area and randomised trials have shown effi cacy for some traditional therapies, because of the low methodological quality of trials and selective 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 Year 50 100 150 200 250 Numbers 300 350 400 450 500 Phase 1/2 Phase 3 Phase 4 Randomised trials Observational studies Total Figure: Growth in clinical trials in China We searched ClinicalTrials.gov5 on June 15, 2009, with the term “lead principal investigator/sponsor=China”. ㄀义第 2 页

Comment www.thelancet.com Vol 375 February 13, 2010 533 Fomenting a prevention revolution for HIV 2010 heralds the year set by the UN to achieve universal access to HIV prevention, treatment, care, and support.1 Despite major achievements and heroic eff orts over the past decades by people living with HIV to assert their rights for treatment equity, to end stigma and discrimination, and to ensure more inclusive approaches to governing the response, much remains to be done. 80 countries still criminalise homosexuality.2 People living with HIV face restrictions on entry, stay, and residence in some 57 countries.3,4 About 10 million people are currently denied access to lifesaving treatment. Despite, or perhaps because of, its success, the AIDS response has itself come under attack.5,6 Coalitions of social conservatives have orchestrated a global campaign against condom promotion and supported legislation criminalising same-sex relations.7 Such actions increase stigma and isolate people most at risk of HIV at a publication of positive results, the effi cacy of most traditional therapies is uncertain.11 Several factors might contribute to this situation. Most active clinical researchers and physicians have little formal training in research methods.12 Even the editors and peer reviewers of Chinese medical journals do not know or ignore reporting criteria, such as CONSORT, STROBE, STARD, and PRISMA.13 Preclinical trial registration has not been essential for publication, even though registration results in trials that are more rigorous, effi ciently conducted, and ethically sound.14 To counter these problems, I have several suggestions. Clinical researchers in China should be formally trained and accredited in clinical trial methodology. Reporting guidelines have been translated into Chinese and published partly in Chinese,15 and are now available online.1,7 Researchers need to improve study design by adopting the advice in relevant reporting guidelines to reduce bias. National level platforms need to be established for consultation and administration of multicentre clinical trials. Journal editors must require documentation of ethics approval and clinical trial registration before manuscript acceptance. Journals in China that are members of the ICMJE16 should obey international criteria for publication. Finally, the Chinese Government should increase its support of clinical research, in the form of clinical research grants for physicians, the creation of national repositories of clinical cases and samples of serum and tissues, and fi nancial support for universities in remote areas to buy literature databases. There is a long way to go before the words of a Lancet Editorial—“China has the opportunity to lead the world not only in research quantity, but also in quality”17—are fulfi lled. Jiyao Wang Department of Internal Medicine, Zhongshan Hospital, Fudan University, Shanghai 200032, China wang.jiyao@zs-hospital.sh.cn I am: president of ChinaCLEN; chair of the Clinical Epidemiology Committee of the Chinese Medical Association; vice chair of the Society of Evidence-Based Medicine, Chinese Medical Doctor Association; a board member of the Ministry of Education’s virtual research centre of evidence-based medicine; and a member of the Board of Trustees, INCLEN. I thank Xue-juan Jin for collecting information to make the fi gure. 1 China Clinical Epidemiology Network. http://www.chinaclen.org.cn (accessed Dec 13, 2009). 2 Chinese Cochrane Centre. http://www.hxyx.com/cochrane_new (accessed Oct 12, 2009) (in Chinese). 3 Chinese Medical Doctor Association. http://www.cmda.gov.cn (accessed Oct 12, 2009) (in Chinese). 4 The Chinese Clinical Trial Register. http://www.chictr.org (accessed Dec 14, 2009). 5 ClinicalTrials.gov. http://www.clinicalTrials.gov (accessed June 15, 2009). 6 Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-based medicine: therapy, 3rd edn. London, UK: Elsevier, 2005. 7 Wang JY. Follow international reporting guidelines to raise the quality of articles about clinical research in China (Commentary). Chung Hua Hsiao Hua Tsa Chih 2010; 30: 1 (in Chinese). 8 Wu T, Li Y, Bian Z, Liu G, Moher D. Randomized trials published in some Chinese journals: how many are randomized? Trials 2009; 10: 46. 9 He J, Jin Z, Yu D. Statistical reporting in Chinese biomedical journals. Lancet 2009; 373: 2091–93. 10 Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003; 326: 1167–70. 11 Tang J-L, Liu B-Y, Ma K-W. Traditional Chinese medicine. Lancet 2008; 372: 1938–40. 12 Schulz KF, Grimes DA. The Lancet handbook of essential concepts in clinical research. Philadelphia, PA, USA: Elsevier, 2006. 13 EQUATOR Network. Enhancing the quality and transparency of health research. http://www.equator-network.org (accessed Dec 13, 2009). 14 Yu H, Liu JP. A review of international clinical trial registration. Zhong Xi Yi Jie He Xue Bao 2007; 5: 234–42 (in Chinese). 15 Wang J, Gluud C, eds. Evidence based medicine and clinical practice, 2nd edn. Appendix 3 and 5. Beijing, China: Science Publisher, 2006: 383–87. 16 International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. http://www.icmje.org (accessed Dec 13, 2009). 17 The Lancet. Reforming research in China. Lancet 2007; 369: 880. ㄀义第 3 页

JAMA CLASSICS CELEBRATING 125 YEARS Progress in Evidence-Based Medicine SUMMARY OF THE ORIGINAL ARTICLE Evidence-Based Medicine: A New Approach to Teaching the Practice of Medicine Evidence-Based Medicine Working Group JAMA. 1992;268(17):2420-2425. A new paradigm for medical practice is emerging. Evidencebased medicine de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research. Evidencebased medicine requires new skills of the physician, including efficient literature searching and the application of formal rules of evidence evaluating the clinical literature. See www.jama.com for full text of the original JAMA article. Commentary by Victor M. Montori, MD, MSc, and Gordon H. Guyatt, MD, MSc I N 1992 JAMA PUBLISHED AN ARTICLE BY THE EVIDENCEBased Medicine Working Group focusing on the role of evidence-based medicine (EBM) in medical education.1 Although the term evidence-based medicine first appeared in the published literature the prior year,2 the JAMA publication brought both the label and the underlying philosophy to the attention of a wider medical community. The article was audacious in suggesting that EBM represented a new paradigm in the teaching and practice of medicine by deemphasizing unsystematic clinical observations, pathophysiological inference, and authority. The article honored traditional skills (eg, understanding biology, demonstrating empathy), but emphasized new skills thatlearnersmust acquire and use: question formulation, search and retrieval of the best available evidence, and critical appraisal of the study methods to ascertain the validity of results. The article aggressively presented EBM as a fundamentally new approach. The Rapid Development and Uptake of EBM The Users’ Guides to the Medical Literature series in JAMA3 that quickly followed the article1 provided tools for learners and teachers to hone their skills in appraising and applying results of studies focused on questions of therapy, diagnosis, prognosis, and harm. Subsequent articles in this series, which eventually addressed 25 separate topics, helped readers understand the value of systematic reviews, decision and economic analyses, and practice guidelines. Courses on how to teach EBM, popular books on the subject (including one based on the Users’ Guides series4 ); related series in medical and surgical specialties; and enthusiastic uptake by junior faculty (mostly in general medicine), students, and trainees followed. The term EBM proved extraordinarily popular and is now widely used in related health fields (eg, evidence-based health policy, evidence-based nursing). The influence of EBM has been widely recognized both in lay publications (eg, the New York Times listed EBM as one of its ideas of the year in 2001) and in the academic press (eg, BMJ listed EBM as one of the 15 greatest medical milestones since 1840). Key developments since the recognition of EBM have included enormous advances in ease of accessing and understanding information, the development of preprocessed evidence-based information, and the increasing emphasis on patients’ values and preferences in clinical decision making. Evolution of EBM: Knowledge Access and Dissemination The development of the Internet has made finding and retrieving original articles much easier. Emblematic of this effort is the pioneering work of the National Library of Medicine in developing and maintaining the MEDLINE database. Users often access this database from its own interface, Author Affiliations: Knowledge and Encounter Research Unit, Department of Medicine and Department of Health Sciences Research, College of Medicine, Mayo Clinic, Rochester, Minnesota (Dr Montori); and Clinical Advances Through Research and Information Translation (CLARITY) Research Group, Department of Clinical Epidemiology and Biostatistics, and Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada (Dr Guyatt). Corresponding Author: Gordon H. Guyatt, MD, MSc, Department of Clinical Epidemiology and Biostatistics, Health Sciences Centre, Room 2C12, McMaster University, Hamilton, ON, Canada L8N 3Z5 (guyatt@mcmaster.ca). 1814 JAMA, October 15, 2008—Vol 300, No. 15 (Reprinted) ©2008 American Medical Association. All rights reserved. Downloaded from www.jama.com by guest on August 17, 2010 第 4 页

PubMed, but also from Internet search engines (eg, Google), and from commercial MEDLINE interfaces (eg, OVID). These search and retrieval interfaces have improved with the development of “hedges,” search strategies that retrieve articles with optimal sensitivity and precision,5 and by linking the title and abstract to the full-text publications and related documents. Clinicians and other learners benefit not only from these “pull” services, but alsofrom services that electronically “push” selected evidence screened for quality, newsworthiness, and relevance to the user (eg, services produced by the McMaster Premium Literature Service [PLUS] such as the ACP Journal Club Plus). A key benefit of some of these push services is the rigorous preappraisal of evidence. For instance, the ACP Journal Club not only highlights selected articles with high methodological quality and potential relevance but also offers structured abstracts that document methodological quality criteria, which allows readers to evaluate the validity of the results. In addition, these services present pertinent results transparently and offer independent commentary. The dissemination of systematic reviews of primary studies, which was gaining credibility at the time of the EBM publication1 has also helped clinicians integrate all of the best available evidence addressing a particular clinical problem.6 Systematic reviews have demonstrated the limitations of basing practice on the most salient, most recent, or most popular study. The Cochrane database now includes more than 3000 systematic reviews and the Cochrane Collaboration has played a crucial role in advancing the science of knowledge synthesis. Relative to traditional medical texts, a number of electronic textbooks represent a revolutionary change in gathering and summarizing evidence and making recommendations—a change driven largely by EBM. These resources (eg, PIER, BMJClinical Evidence, UpToDate), which make use of the preappraised resources detailed in the previous paragraphs, increasingly bring evidence explicitly and practically to the point of care. Decision support systems that embed such summaries in the medical record and the clinical workflow are still evolving. Evolution of EBM: Values and Preferences Identifying, critically appraising, and summarizing the evidence were initial areas of focus for EBM. As the 1992 article1 had hinted, however, evidence alone is not sufficient to make clinical decisions. In 2000, the Evidence-Based MedicineWorking Group presented the second fundamental principle of EBM (the hierarchy of evidence being the first): whatever the evidence, value and preference judgments are implicit in every clinical decision.7 A key implication of this second principle is that clinical decisions, recommendations, and practice guidelines must not only attend to the best available evidence, but also to the values and preferences of the informed patient. Values and preferences refer not only the patients’ perspectives, beliefs, expectations, and goals for life and health, but also the processes individuals use to consider the available options and their relative benefits, harms, costs, and inconveniences. Since 1992, much work in the fields of shared decision making and of patient decision support technologies (ie, decision aids), the evolution of the patient rights movement, and the Internet-enabled democratization of technical information have changed the landscape substantially. Recently, the first National Health Service Constitution in Great Britain suggests that patient participation in decision making is a patient’s right8 ; in the United States, the Institute of Medicine designated evidence-based patientcentered health care delivery as a key feature of highquality medical care.9 Evolution of EBM: GRADE The pioneering work of Eddy10 in strengthening the evidence base of clinical practice guidelines preceded the EBM article.1 The Evidence-Based Medicine Working Group initially focused on the relationship between individual clinicians and the application of the original literature to clinical care. Recognition of the importance of preappraised resources and guidelines has led the EBM movement to a greater focus on the methodology of applying EBM principles to management recommendations. The Grades of Recommendation Assessment, Development and Evaluation Working Group (GRADE) has developed a framework for the formulation of treatment recommendations that is based on the contemporary principles of EBM.11 The GRADE process highlights the importance of clear specification of the question with identification of all patient-important outcomes and the necessity for systematic summaries of all the best evidence to guide recommendations. The GRADE process includes an important evolution in EBM: the definition of quality of evidence and the components that determine quality (including study design and study limitations, consistency, precision, and the extent to which the evidence directly applies to the patients, interventions, and outcomes of interest). The GRADE framework requires the specification of values and preferences in making recommendations and demands attention to circumstances (and resources for competing priorities) in deciding how confident one is that following a recommendation will do more good than harm. This system produces either strong recommendations (ideal targets for quality improvement efforts) or weak ones (ideal targets for careful incorporation of patient preferences [eg, using decision aids in practice]). EBM and the Current Health Care Context: Misuses of EBM An analogy can be made between EBM and nuclear fission: it can be very powerful when used appropriately and dangerous when used inappropriately. The term evidencebased precedes many recommendations, guidelines, and alJAMA CLASSICS ©2008 American Medical Association. All rights reserved. (Reprinted) JAMA, October 15, 2008—Vol 300, No. 15 1815 Downloaded from www.jama.com by guest on August 17, 2010 第 5 页