【社会人文】《柳叶刀》——临床研究在中国
发布于 2011-01-08 · 浏览 3123 · IP 浙江浙江
这个帖子发布于 14 年零 150 天前，其中的信息可能已发生改变或有所发展。
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60017-2/fulltext?rss=yes
In western countries since the 19th century, clinical research has contributed greatly to the accumulation of knowledge regarding prevention, diagnosis, and treatment of disease and disability.1 However, in general, it has been assumed that there has been a lower level of academic achievement in clinical research in China than that in the west. There are only very few Chinese publications in the first-class western journals, such as The Lancet and New England Journal of Medicine, and rarely are these Chinese reports influential.2 Since only a few studies have examined the clinical research situation in China, our aim was to address the issue, and to offer advice for policy reform in clinical research and medical education.
We did a study in one comprehensive and national key university in China to investigate three aspects: the extent to which Chinese work is published in western journals; the extent of research activity and knowledge in practising hospital doctors; and the amount of research training received by medical students.
First, we did a computer literature search with PubMed for clinical research articles (2000—09) both in China and worldwide. Publications on clinical research, basic medical science, and randomised controlled trial (RCT) research were extracted. These were indexed under the “MESH” or “Publication type” fields using one or more specific headings.
We then did a cross-sectional survey in six affiliated hospitals of Peking University, Beijing, in 2007, to ascertain the extent of doctors' experience and involvement in research. Information was obtained from a self-completed questionnaire, which consisted of three main parts and a total of 43 questions. The first part was for demographic characteristics. The second was about practices and attitudes towards clinical research. The third comprised seven items (translated into Chinese) abstracted from the Fresno test—a simple, valid tool for assessing knowledge and skill in all the usual domains of evidence-based medicine.3
Further, we collected training information on undergraduate andgraduate courses for medical students. Three aspects were included: teaching content, credit hours, and assessment patterns, and information was obtained from the Department of Education in the University.
The literature search found that published articles related to basic medical science and clinical research from China increased on average by 31·2% and 22·0%, respectively, each year between 2000 and 2009 (figure). The basic medical science to clinical research ratio was on average 1·3:1 (range from 0·7:1 to 1·5:1). The number of RCTs done in China increased from 85 in 2000 to 743 in 2009, and constituted nearly a third of the total clinical research publications in China (3321 [31·9%]). China accounted for 1·5% and 1·7% of the total of the worldwide clinical research and RCT publications, respectively.
[float=left]
Figure Full-size image (44K) Download to PowerPoint
Number and ratio of Chinese publications on basic science and clinical research, 2000—09
In total, 2005 doctors who were registered employees of the six hospitals were involved in the survey on doctors' experience and involvement in research. About 20% of the participants had led clinical research in the past 5 years, and 43% reported that they had done research under a leading researcher. The mean time spent on clinical treatment of patients was 8·4 units (half day/person/week), and 1·5 units for clinical research. Most responders (96·5%) believed that it was necessary to do clinical research and 97·1% of them had the intention of doing clinical research. However, only 54·8% put the ideas into action. The reasons for inaction included: insufficient research funding (67·6%), no available time (66·5%), and an unsupportive research environment (35·7%).
Only 28 respondents (1·4%) achieved the top score on the Fresno test. Participants who did well on the Fresno test, had the intention of doing clinical research, and were willing to take part in symposiums or seminars on clinical research, were most likely to have led or done clinical research in the past 5 years. The top three influential factors that had had an effect on the improvement of clinical research capabilities were: awareness of hospital administrators (60·8%), resources input (60·0%), and learning of scientific thinking methods (54·2%).
The survey of courses offered to medical students at this university suggested a deficient clinical research teaching programme. The survey indicated that the number of research-related courses was not sufficient at both undergraduate and graduate levels. Further, formal expository teaching has been the main teaching approach, which might not be helpful in promoting students' critical thinking and creativity in clinical research.
The data we have collected offer a picture of clinical research on three aspects in China: relevant publications, doctors' capabilities, and training courses. In some respects, our report indicates that there are deficiencies, and, since Peking University is the nation's leading medical education institution, it probably represents the top level of clinical research in China. The importance of clinical research has been recognised in most countries, and, in 2003, the Chinese Institute of Medicine's Clinical Research Roundtable brought together the leaders of medical specialty and clinical research societies to address the challenges facing clinical research and to define and formulate solutions.4 China still needs to step up efforts in many aspects to promote the development of clinical research.
The study was funded by the China Medical Board. We declare that we have no conflicts of interest.
[float=left]References1 Beaufort Id, Englert Y. Ethical aspects of clinical research in developing countries: the European Group on Ethics in Science and New Technologies. http://ec.europa.eu/european_group_ethics/docs/avis17_en.pdf. (accessed Oct 10, 2009).
2 BA D. Enhance the clinical research to further improve the level of clinical research level. Natl Med J China 2003; 83: 1-2.[url= http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Search&term=Natl%20Med%20J%20China [Jour]+AND+83[Volume]+AND+1[page]]PubMed[/url]
3 Ramos KD, Schafer S, Tracz SM. Validation of the Fresno test of competence in evidence based medicine. BMJ 2003; 326: 319-321. CrossRef | [url= http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Search&term=BMJ [Jour]+AND+326[Volume]+AND+319[page]]PubMed[/url]
4 Murillo H, Reece EA, Snyderman R, Sung NS. Meeting the challenges facing clinical research: solutions proposed by leaders of medical specialty and clinical research societies. Acad Med 2006; 81: 107-112. CrossRef | [url= http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Search&term=Acad%20Med [Jour]+AND+81[Volume]+AND+107[page]]PubMed[/url]
[/float]
a Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China
b Institute of Mental Health, Peking University, Beijing, China
c Department of Pediatrics, Peking University First Hospital, Beijing, China
d Department of Gastroenterology, Peking University People's Hospital, Beijing, China
e Department of Neurology, Peking University Third Hospital, Beijing, China
f Department of Oral Pathology, Peking University School of Stomatology, Beijing, China
g Beijing Institute for Cancer Research, Peking University School of Oncology, Beijing, China
h Office of Scientific Research, Peking University Health Science Center, Beijing, China
i Office of Education, Peking University Health Science Center, Beijing, China
j Office of International Cooperation, Peking University Health Science Center, Beijing, China
k Office of President, Peking University Health Science Center, Beijing, China
l Beijing Institute for Cancer Research, School of Oncology, Peking University, Beijing 100034, China
In western countries since the 19th century, clinical research has contributed greatly to the accumulation of knowledge regarding prevention, diagnosis, and treatment of disease and disability.1 However, in general, it has been assumed that there has been a lower level of academic achievement in clinical research in China than that in the west. There are only very few Chinese publications in the first-class western journals, such as The Lancet and New England Journal of Medicine, and rarely are these Chinese reports influential.2 Since only a few studies have examined the clinical research situation in China, our aim was to address the issue, and to offer advice for policy reform in clinical research and medical education.
We did a study in one comprehensive and national key university in China to investigate three aspects: the extent to which Chinese work is published in western journals; the extent of research activity and knowledge in practising hospital doctors; and the amount of research training received by medical students.
First, we did a computer literature search with PubMed for clinical research articles (2000—09) both in China and worldwide. Publications on clinical research, basic medical science, and randomised controlled trial (RCT) research were extracted. These were indexed under the “MESH” or “Publication type” fields using one or more specific headings.
We then did a cross-sectional survey in six affiliated hospitals of Peking University, Beijing, in 2007, to ascertain the extent of doctors' experience and involvement in research. Information was obtained from a self-completed questionnaire, which consisted of three main parts and a total of 43 questions. The first part was for demographic characteristics. The second was about practices and attitudes towards clinical research. The third comprised seven items (translated into Chinese) abstracted from the Fresno test—a simple, valid tool for assessing knowledge and skill in all the usual domains of evidence-based medicine.3
Further, we collected training information on undergraduate andgraduate courses for medical students. Three aspects were included: teaching content, credit hours, and assessment patterns, and information was obtained from the Department of Education in the University.
The literature search found that published articles related to basic medical science and clinical research from China increased on average by 31·2% and 22·0%, respectively, each year between 2000 and 2009 (figure). The basic medical science to clinical research ratio was on average 1·3:1 (range from 0·7:1 to 1·5:1). The number of RCTs done in China increased from 85 in 2000 to 743 in 2009, and constituted nearly a third of the total clinical research publications in China (3321 [31·9%]). China accounted for 1·5% and 1·7% of the total of the worldwide clinical research and RCT publications, respectively.
[float=left]
Figure Full-size image (44K) Download to PowerPoint
Number and ratio of Chinese publications on basic science and clinical research, 2000—09
In total, 2005 doctors who were registered employees of the six hospitals were involved in the survey on doctors' experience and involvement in research. About 20% of the participants had led clinical research in the past 5 years, and 43% reported that they had done research under a leading researcher. The mean time spent on clinical treatment of patients was 8·4 units (half day/person/week), and 1·5 units for clinical research. Most responders (96·5%) believed that it was necessary to do clinical research and 97·1% of them had the intention of doing clinical research. However, only 54·8% put the ideas into action. The reasons for inaction included: insufficient research funding (67·6%), no available time (66·5%), and an unsupportive research environment (35·7%).
Only 28 respondents (1·4%) achieved the top score on the Fresno test. Participants who did well on the Fresno test, had the intention of doing clinical research, and were willing to take part in symposiums or seminars on clinical research, were most likely to have led or done clinical research in the past 5 years. The top three influential factors that had had an effect on the improvement of clinical research capabilities were: awareness of hospital administrators (60·8%), resources input (60·0%), and learning of scientific thinking methods (54·2%).
The survey of courses offered to medical students at this university suggested a deficient clinical research teaching programme. The survey indicated that the number of research-related courses was not sufficient at both undergraduate and graduate levels. Further, formal expository teaching has been the main teaching approach, which might not be helpful in promoting students' critical thinking and creativity in clinical research.
The data we have collected offer a picture of clinical research on three aspects in China: relevant publications, doctors' capabilities, and training courses. In some respects, our report indicates that there are deficiencies, and, since Peking University is the nation's leading medical education institution, it probably represents the top level of clinical research in China. The importance of clinical research has been recognised in most countries, and, in 2003, the Chinese Institute of Medicine's Clinical Research Roundtable brought together the leaders of medical specialty and clinical research societies to address the challenges facing clinical research and to define and formulate solutions.4 China still needs to step up efforts in many aspects to promote the development of clinical research.
The study was funded by the China Medical Board. We declare that we have no conflicts of interest.
[float=left]References1 Beaufort Id, Englert Y. Ethical aspects of clinical research in developing countries: the European Group on Ethics in Science and New Technologies. http://ec.europa.eu/european_group_ethics/docs/avis17_en.pdf. (accessed Oct 10, 2009).
2 BA D. Enhance the clinical research to further improve the level of clinical research level. Natl Med J China 2003; 83: 1-2.[url= http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Search&term=Natl%20Med%20J%20China [Jour]+AND+83[Volume]+AND+1[page]]PubMed[/url]
3 Ramos KD, Schafer S, Tracz SM. Validation of the Fresno test of competence in evidence based medicine. BMJ 2003; 326: 319-321. CrossRef | [url= http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Search&term=BMJ [Jour]+AND+326[Volume]+AND+319[page]]PubMed[/url]
4 Murillo H, Reece EA, Snyderman R, Sung NS. Meeting the challenges facing clinical research: solutions proposed by leaders of medical specialty and clinical research societies. Acad Med 2006; 81: 107-112. CrossRef | [url= http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Search&term=Acad%20Med [Jour]+AND+81[Volume]+AND+107[page]]PubMed[/url]
[/float]
a Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China
b Institute of Mental Health, Peking University, Beijing, China
c Department of Pediatrics, Peking University First Hospital, Beijing, China
d Department of Gastroenterology, Peking University People's Hospital, Beijing, China
e Department of Neurology, Peking University Third Hospital, Beijing, China
f Department of Oral Pathology, Peking University School of Stomatology, Beijing, China
g Beijing Institute for Cancer Research, Peking University School of Oncology, Beijing, China
h Office of Scientific Research, Peking University Health Science Center, Beijing, China
i Office of Education, Peking University Health Science Center, Beijing, China
j Office of International Cooperation, Peking University Health Science Center, Beijing, China
k Office of President, Peking University Health Science Center, Beijing, China
l Beijing Institute for Cancer Research, School of Oncology, Peking University, Beijing 100034, China
最后编辑于 2011-01-13 · 浏览 3123
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