中医临床研究优先领域/主题设置思路与方法
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摘要
为缓解中医临床研究数量激增与高质量临床证据不足间的矛盾,减少盲目研究与资源浪费,推进中医临床研究领域的良性发展,需要从宏观层面开展中医临床研究优先领域/主题设置的方法学研究。本文首先界定了中医临床研究的主要内容,介绍了优先领域设置方法学研究现状,并提出了中医临床研究优先领域设置的5个步骤:明确研究范围和研究计划、建立工作小组、了解研究领域全貌、确定优先研究主题次序、进行研究公布评价与更新。以期为相关中医药临床研究者、政策制定者及资助者进行决策提供证据支持。
In order to mediate the contradiction between the high quantity and low quality of Traditional Chinese Medicine(TCM) clinical research, to avoid blind research and waste of resources, and to promote the benign development of TCM clinical research, we proposed carrying out health research priority setting on the TCM clinical research. This paper defined the main content of TCM clinical research and briefly introduced the research status of priority setting methods. We described a five-step process of the TCM priority setting research: setting the research scope and plan,establishing the working group, mapping the research field, identifying priority research areas, reporting, evaluating and updating the research. It is expected that this area will receive the attention of relevant researchers, policy makers and research funders.
In order to mediate the contradiction between the high quantity and low quality of Traditional Chinese Medicine(TCM) clinical research, to avoid blind research and waste of resources, and to promote the benign development of TCM clinical research, we proposed carrying out health research priority setting on the TCM clinical research. This paper defined the main content of TCM clinical research and briefly introduced the research status of priority setting methods. We described a five-step process of the TCM priority setting research: setting the research scope and plan,establishing the working group, mapping the research field, identifying priority research areas, reporting, evaluating and updating the research. It is expected that this area will receive the attention of relevant researchers, policy makers and research funders.
引文
1张晓雨,商洪才.近十年国内中医药临床研究发展现状及存在的问题.中医杂志,2018, 59(21):1808-1811.
2赵一鸣,曾琳,李楠.临床研究的四个基本特征.中华医学杂志,2012, 92(36):2521-2523.
3 Food and Drug Administration. Clinical research versus medical treatment. Available at:https://www.fda.gov/ForPatients/ClinicalTrials/ClinicalvsMedical/ucm20041761.htm. 2018-3-22/2018-9-25.
4 “九五”以来中医药学科发展综合报告四、中医药学科优先领域与发展方向.“九五”以来中医药学科发展报告,2008.
5 Switzerland WGOPS. Priority setting for health research:lessons from developing countries. Health Policy Plan, 2000, 15(2):130-136.
6 Okello D, Chongtrakul P. A manual for research priority setting using the ENHR strategy. In Council on Health Research for Development(COHRED), 2000
7 Bryant J, Sanson-Fisher R, Walsh J, et al. Health research priority setting in selected high income countries:a narrative review of methods used and recommendations for future practice. Cost Eff Resour Alloc, 2014, 12:23.
8 Sibbald SL, Singer PA, Upshur R, et al. Priority setting:what constitutes success? A conceptual framework for successful prioritysetting. BMC Health Serv Res, 2009,9(1):1-12.
9 Viergever RF, Olifson S, Ghaffar A, et al. A checklist for health research priority setting:nine common themes of good practice.Health Res Policy Syst, 2010, 8(1):1-9.
10 Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase value and reduce waste when research priorities are set. Lancet,2014,383(9912):156-165.
11 Hollis C, Sampson S, Simons L, et al. Identifying research priorities for digital technology in mental health care:results of the James Lind Alliance priority setting partnership. Lancet Psychiatry, 2018,5(10):845-854.
12 Fernandez MA, Arnel L, Gould J, et al. Research priorities in fragility fractures of the lower limb and pelvis:a UK priority setting partnership with the James Lind Alliance. BMJ open, 2018, 8(10):e023301.
13 IOM(Institute of Medicine). Initial national priorities for comparative effectiveness research. Washington, DC:The National Academies Press, 2009.
14杨梦楠,赵琨,齐雪然,等.利用CHNRI方法确定中国卫生政策优先研究问题.中国卫生政策研究,2015, 8(1):74-79.
15康晓凤,吕蓉,张方圆,等.《成人急性心力衰竭护理实践指南》优先主题的确定.中国护理管理,2016,16(9):1191-1195.
16 Mitton C, Smith N, Peacock S, et al. Public participation in health care priority setting:A scoping review. Health Policy, 2009, 91(3):219-228.
17李伦,杨克虎,田金徽,等.一种新的证据总结方法一证据图简介.中国循证儿科杂志,2011,6(3):230-232.
18 Bragge P, Clavisi O, Turner T, et al. The global evidence mapping initiative:scoping research in broad topic areas. BMC Med Res Methodol, 2011,11(1):92.
2赵一鸣,曾琳,李楠.临床研究的四个基本特征.中华医学杂志,2012, 92(36):2521-2523.
3 Food and Drug Administration. Clinical research versus medical treatment. Available at:https://www.fda.gov/ForPatients/ClinicalTrials/ClinicalvsMedical/ucm20041761.htm. 2018-3-22/2018-9-25.
4 “九五”以来中医药学科发展综合报告四、中医药学科优先领域与发展方向.“九五”以来中医药学科发展报告,2008.
5 Switzerland WGOPS. Priority setting for health research:lessons from developing countries. Health Policy Plan, 2000, 15(2):130-136.
6 Okello D, Chongtrakul P. A manual for research priority setting using the ENHR strategy. In Council on Health Research for Development(COHRED), 2000
7 Bryant J, Sanson-Fisher R, Walsh J, et al. Health research priority setting in selected high income countries:a narrative review of methods used and recommendations for future practice. Cost Eff Resour Alloc, 2014, 12:23.
8 Sibbald SL, Singer PA, Upshur R, et al. Priority setting:what constitutes success? A conceptual framework for successful prioritysetting. BMC Health Serv Res, 2009,9(1):1-12.
9 Viergever RF, Olifson S, Ghaffar A, et al. A checklist for health research priority setting:nine common themes of good practice.Health Res Policy Syst, 2010, 8(1):1-9.
10 Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase value and reduce waste when research priorities are set. Lancet,2014,383(9912):156-165.
11 Hollis C, Sampson S, Simons L, et al. Identifying research priorities for digital technology in mental health care:results of the James Lind Alliance priority setting partnership. Lancet Psychiatry, 2018,5(10):845-854.
12 Fernandez MA, Arnel L, Gould J, et al. Research priorities in fragility fractures of the lower limb and pelvis:a UK priority setting partnership with the James Lind Alliance. BMJ open, 2018, 8(10):e023301.
13 IOM(Institute of Medicine). Initial national priorities for comparative effectiveness research. Washington, DC:The National Academies Press, 2009.
14杨梦楠,赵琨,齐雪然,等.利用CHNRI方法确定中国卫生政策优先研究问题.中国卫生政策研究,2015, 8(1):74-79.
15康晓凤,吕蓉,张方圆,等.《成人急性心力衰竭护理实践指南》优先主题的确定.中国护理管理,2016,16(9):1191-1195.
16 Mitton C, Smith N, Peacock S, et al. Public participation in health care priority setting:A scoping review. Health Policy, 2009, 91(3):219-228.
17李伦,杨克虎,田金徽,等.一种新的证据总结方法一证据图简介.中国循证儿科杂志,2011,6(3):230-232.
18 Bragge P, Clavisi O, Turner T, et al. The global evidence mapping initiative:scoping research in broad topic areas. BMC Med Res Methodol, 2011,11(1):92.