复旦大学：《循证医学》课程教学资源（文献资料）王吉耀教授在Lancet发表评述（Wang Jiyao Comment in Lancet 2010）

Comment Evidence-based medicine in China In recent decades, evidence-based medicine has been Medical associations in every discipline have built propagated rapidly in China, not only to doctors but clinical guidelines for common diseases according to to nurses and other health-care professionals. the evidence to inform clinical decision making and Chinese Journal of Evidence-Based Medicine, the teaching. Evidence-based medicine has also engaged Journal of Evidence-Based Medicine, and the Chinese with traditional Chinese medicine. Research teams in Journal 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 medicine, including the clinical epidemiology committee in 2007 and the number of clinical trials registered in of the Chinese Medical Association(established in 1993) China is increasing(figure) working with the Chinese Clinical Epidemiology Network There are, however, several concerns about the devel (ChinaCLEN; registered as part of the International opment of evidence- based medicine in China. First, Clinical Epidemiology Network in 1989),the Chinese 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 International Cochrane Collaboration in 1999), Shanghai and Beijing, can search the literature for free the Ministry of Educations virtual research centre of at their university via databases such as Medline. But evidence-based medicine founded in 2004, and the doctors in remote areas might not be able to access China Medical Doctor Association,'s evidence-based the best information resources, which, together with a medicine committee organised in 2003.3 limited knowledge of English, could prevent use of the The board members of these organisations are located best evidence in their practice seminate Second most of the world 's clinical evidence does knowledge of evidence-based medicine throughout the not come from China. Few results from China have country Programmes(usually 1-3 months)organised been included in systematic reviews or clinical by the Ministry of Education, continuing education practice guidelines. I calculated that from 1999 to programmes, and online education programmes are 2008, 1880 clinical research articles were published available. Clinical epidemiology and evidence-based in The New England Journal of Medicine, The Lancet, medicine have become compulsory curricula for medical and JAMA. However, only 0-21% of these were from students and clinical postgraduates in all universities. mainland China. Wu and colleagues analysed randomised trials on 20 common diseases published in Chinas 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, which reduces the credibility of the evidence Third, because of a lack of funding for investigator-led trials are pharmaceutical premarketing trials sponsored by drug companies. Such research is more likely to have could result in publication bias. Finally, although the Chinese government has made research into traditional 2006 0072008 shown effcacy for some nal therapies, because We searched clinical Trials. go on June 15, 2009, with the term "lead principal investigator/sponsor=China ity of trials and selective www.thelancet.comVol375February13,2010

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 devel￾op 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

Comment publication of positive results, the effcacy of most Jiyao Wang traditional therapies is uncertain. Department of Internal Medicine, Zhongshan He Several factors might contribute to this situation. University, Shanghai200032, China Most active clinical researchers and physicians have wang jiyao@zs-hospitalshcn little formal training in research methods. "Even the the chinese Medical Association; vice chair of the Society of Evidence-Based do not know or ignore reporting criteria, such as of Education's virtual research centre of evidence-based medicine; anda try editors and peer reviewers of Chinese medical journals Medicine, Chinese Medical Doctor Association a board member of the Mini he Board of Trustees, INCLEN. I thank Xue-juan Jin for collecting CONSORT STROBE. STARD and PRISMA 13 Preclinical information to make the figure. trial registration has not been essential for publication, 1ChinadinicalEpidemiologyNetwork.httpc//www.chinaclen.org.cn ccessed Dec 13, 2009) eventhoughregistrationresultsintrialsthataremore2chineseCochraneCentrehttp:/www.hxyx.com/cochrane_new(accessed rigoroUs, effciently conducted, and ethically sound Oct 12, 2009)(in Chinese) 3ChineseMedicalDoctorAssociationhttp://www.cmdagov.cn(accessed To counter these problems, I have several suggestion Oct 12, 2009)(in Chinese). Clinical researchers in China should be formally trained andaccreditedinclinicaltrialmethodologyReporting5clinicaLtrialsgov.http://www.clinicaltrials.gow(accesSedJune15,2009). guidelines have been translated into Chinese and pub- Straus SE, Richardson WS, Glasziou P, Haynes RB Evidence-based medicine. lished partly in Chinese, 5 and are now available online. 77 Wang )Y Follow international reporina(Commentary ) e the quality of searchers need to improve study design by adopting the advice in relevant reporting guidelines to reduce 8 WuT, LiY, Bian Z, Liu G, Moher D Randomized trials published in some how many are randomized? Trials 2009: 10: bias. National level platforms need to be established for 9 He, jinz, Yu D Statistical reporting in Chinese biomedical joumal consultation and administration of multicentre clinical trials. journal editors must require documentation of f 10 Lexchin Bero JA, Djubegovic B, Clark. Pharmaceutical industry ethics approval and clinical trial registration before BM20x261670 Journals in China that are 372:1938-40. members of the ICMJE should obey international criteria 12 Schulz KF, Grimes DA. The Lancet handbook of essential concepts in dinical for publication. Finally, the Chinese Government should 13 EQUATOR Network Enhancin increaseitssupportofclinicalresearchintheformofresearchhttp://www.equator-networkorg(accessedDec13,2009) clinical research grants for physicians, the creation of YiJie He Xue Bao 2007: 5: 234-42(in Chinese) national repositories of clinical cases and samples of 15 Gluud C, eds Evidence based medicine and clinical practice, endix 3 and 5. Beijing, China: Science Publishe serum and tissues, and financial support for universities in remote areas to buy literature databases There is a long way to go before the words of a Lancet Dec13,2009) Editorial-"China has the opportunity to lead the world The Lancet. Reforming research in China. Lancet 2007: 369: 880. not only in research quantity, but also in quality"are fulfilled Fomenting a prevention revolution for Hiv 2010 heralds the year set by the UN to achieve universal stay, and residence in some 57 countries. M About access to HIV prevention, treatment, care, and support 10 million people are currently denied access Despite major achievements and heroic efforts over saving treatment the past decades by people living with HIv to assert Despite or perhaps because of, its success, the AIDS their rights for treatment equity, to end stigma and response has itself come under attack. Coalitions of discrimination, and to ensure more inclusive approaches social conservatives have orchestrated a global campaign to governing the response, much remains to be against condom promotion and supported legislation done. 80 countries still criminalise homosexuality? criminalising same-sex relations. Such actions increase People living with Hiv face restrictions on stigma and isolate people most at risk of HIv at a www.thelancet.comVol375February13,2010

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 life￾saving 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 pub￾lished 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