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2021年中国发布临床实践指南利益冲突与经济学证据的调查分析

发表时间:2023年02月25日阅读量:1112次下载量:456次下载手机版

作者: 王彦博 1 赵明娟 2 王强 3 许慧中 4 陶华 5 郭家平 6 黄修森 7 任学群 8 曾宪涛 2, 9

作者单位: 1. 中国人民武装警察部队北京市总队医院(北京 100027) 2. 武汉大学中南医院循证与转化医学中心(武汉 430071) 3. 中华人民共和国国家卫生健康委员会医疗管理服务指导中心标准管理处(北京 100044) 4. 东台市人民医院神经外科(江苏东台 224200) 5. 郑州市第二人民医院药学部(郑州 450015) 6. 赣南医学院第一附属医院感染管理科(江西赣州 341000) 7. 广西钦州市第一人民医院医务科(广西钦州 535000) 8. 河南大学循证医学与临床转化研究院(河南开封 475000) 9. 武汉大学中南医院中南医学期刊社(武汉 430071)

关键词: 临床实践指南 利益冲突 经济学 经费来源 循证医学

DOI: 10.12173/j.issn.1004-5511.202210053

基金项目: 基金项目: 国家重点研发计划“科技助力经济2020”重点专项;国家重点研发计划“数字诊疗装备研发”重点专项(2016YFC0106300);国家卫健委医管中心委托课题([2019]099号)

引用格式:王彦博, 赵明娟, 王强, 许慧中, 陶华, 郭家平, 黄修森, 任学群, 曾宪涛. 2021 年中国发布临床实践指南利益冲突与经济学证据的调查分析[J]. 医学新知, 2023, 33(1): 8-49. DOI: 10.12173/j.issn.1004-5511.202210053.

Wang YB, Zhao MJ, Wang Q, Xu HZ, Tao H, Guo JP, Huang XS, Ren XQ, Zeng XT. Conflict of interest and economic evidence in Chinese clinical practice guidelines published in 2021: a survey[J]. Yixue Xinzhi Zazhi, 2023, 33(1): 8-49. DOI: 10.12173/j.issn.1004-5511.202210053.[Article in Chinese]

摘要|Abstract

目的  评价2021年中国发布的临床实践指南中利益冲突和经济学证据的情况,并与2017年和2018年发布的临床实践指南进行对比,充分了解中国指南制订变化情况,为进一步完善我国临床实践指南的制订提供参考。

方法  系统检索中国知网(CNKI)、中国生物医学文献数据库(CBM)和万方数据库(WanFang Data),搜索2021年1月1日至2021年12月31日我国发布的临床实践指南。由2名研究者独立进行文献筛选、提取纳入指南的利益冲突和是否考虑经济学证据等相关信息后,使用Microsoft Excel 2019软件进行统计分析。

结果  共纳入临床实践指南164部,其中112部(68.29%)声明了利益冲突,70部(42.68%)报告了资金来源,在临床实践指南推荐意见形成及治疗中考虑经济学证据的只有30部(18.29%),三方面同时报道的指南仅有16部(9.76%)。相较于2017年与2018年,2021年我国发布的临床实践指南在利益冲突声明和资金投入力度方面均有改善,但经济学证据关注仍然很低。

结论  建议进一步完善我国临床实践指南对利益冲突的声明和管理及对经济学证据的关注,使指南制订更加客观、透明和科学。

全文|Full-text

临床实践指南是指针对特定的临床问题,系统制订出一套能帮助临床医生和患者做出恰当处理的指导意见。高质量的临床实践指南可直接为医药卫生提供决策依据,提高卫生保健质量,节约医疗成本及改善患者结局。我国临床实践指南数量近年来不断增加,2014至2018年间已发表指南573部,运用指南研究与评价工具(Appraisal of Guidelines for Research and Evaluation Ⅱ, AGREE Ⅱ)进行方法学评价,只有12.8%报道编辑独立性(即利益冲突);使用指南报告清单(Reporting Items for Practice Guidelines in Healthcare,RIGHT)评价同样仅有12.6%报道资助与利益冲突声明和管理[1]。国外调查研究发现在临床实践指南中平均至少有一半的指南制订委员会成员存在财务冲突[2-3],而利益冲突的存在可直接影响临床实践指南制订的独立性,从而影响整个指南的质量与可信度。目前,随着医疗成本的增加,临床实践指南制订需要将医疗成本考虑至指南推荐中。当前,我国临床实践指南推荐考虑经济学证据仍不足,本研究团队分别于2017年和2018年调查了我国发布临床实践指南经济学证据的情况,发现仅为11.32%与23.01%[4-5],而国外约有一半以上临床实践指南在指南推荐中考虑到成本问题[6-7]。本研究将进一步更新我国2021年发布的临床实践指南利益冲突与经济学证据情况,并与2017年和2018年发布的临床实践指南进行对比分析,为进一步完善我国临床实践指南制订提供依据。

1 资料与方法

1.1 纳入与排除标准

纳入标准:2021年1月1日至2021年12月31日发布的所有中国医药卫生领域的临床实践指南,仅限中文。排除标准 :①地方性及区域性指南 ;②不同刊物同步发表的同一部指南,选择其中最详细的版本纳入;③指南的解读与摘译;④专家共识及计划书或草案;⑤无法获取全文。

1.2 文献检索策略

计算机检索中国知网(CNKI)、中国生物医学文献数据库(CBM)和万方数据库(WanFang Data),搜索2021年我国发布的有关医药卫生领域的临床实践指南,检索时间为2021年1月1日至2021年12月31日。采用“主题词+自由词”方式检索,中文检索词包括:临床实践指南、指南、诊疗常规、共识,限定在“医药卫生科技”或“医药、卫生”领域。以CNKI为例,具体检索策略见框1。

  • 框图1 CNKI检索策略
    Box1.CNKI retrieval strategy

1.3 文献筛选与资料提取

由2名研究者独立进行文献筛选、资料提取并交叉核对,若遇分歧,则讨论解决或交由第三名研究者解决;缺乏相关资料时尽量与原作者联系并予以补充。文献筛选时首先通过阅读标题进行初筛,排除明确不相关的文献后,再进一步阅读摘要与全文,最终确定是否纳入。预先设计好资料提取表,提取资料内容主要包括:临床实践指南的标题、制订组织、版本、涉及专业、关注领域、是否基于循证医学、资金来源、是否考虑经济学及利益冲突的声明。

1.4 统计学分析

使用Microsoft Excel 2019软件进行资料整理和数据分析。以描述性分析为主,比较分析2021年我国发布的临床实践指南与2017—2018年发布指南在资金来源、经济学证据及利益冲突声明三个方面的情况,并通过柱状图展示。

2 结果

2.1 文献筛选流程及结果

通过系统检索初步获取8 196部相关临床实践指南,按照纳入与排除标准严格筛选后,最终纳入164部[8-171]指南。文献筛选的流程及结果详见图1。

  • 图1 2021年中国发布临床实践指南筛选的流程及结果
    Figure1.The process and results of screening clinical practice guidelines published in China in 2021

2.2 纳入研究的基本信息及利益冲突声明与经济学证据分析结果

本次研究共纳入164部临床实践指南,其中声明利益冲突的有112部(68.29%)[11-16,19-21,23-30,32-33,36-37,39,42,44-70,75,78-79,82-83,85-92,95,100,102-112,114-116,118,124-143,145,148,151, 153,155,158,162-167],78部(69.64%)[14-16,20,24-25,28-30,32-33,36-37,42,44-55,57-60,62-70,75,78-79,82-83,85-90,95,100,102,105-106,114,116,124-125,127-129,134,137-140,143,145,151,153,155,162-167]指南仅简单声明所有作者均不存在利益冲突,仅有5部(4.46%)[23,27,56,104,115]指南报告利益冲突的收集,但对于如何获取该信息未报道。1篇指南[18]披露指南制订过程得到非盈利组织的资金赞助,但并未明确说明是否存在利益冲突。纳入的临床实践指南中报告资金来源的有70部(42.68%)[11,14-15,17,19-20,27-28,37,39-40,43-44,46-49,52-53,56-57,59,61,71-73,76,80-81,90-91,94,98,100-101,103-104,106-107,108-121,124-125,127,130-136,138-139, 148,154,156,166,168],在资助来源方面,46部(65.71%)[14,17,27-28,37,39,46-49,52,71-73, 76, 80-81,90-91,98,103-104,106-112,114-115,118-120,125,130-136,148,154,156,168]指南来源于国家级项目基金,其中有12部指南[108-111,114,130-136]资金均来自同一个项目(国家中医药管理局标准化项目)支持。只有30部(18.29%)在临床实践指南推荐意见形成及治疗中考虑经济学证据[11,13,18,27,34,39,44,46,52,60-65,72,81,103-104,109-110,114,118,122,132, 134,157,161,166,168]。临床实践指南中同时报告利益冲突、资金来源及经济学证据的仅有16部[11,27,39,44,46,52,61,103-104,109-110,114,118,132,134,166]。相较于2017年与2018年中国发布的临床实践指南,在资金资助力度和利益冲突声明方面均有明显改善,但在经济学方面关注度仍然不足,详见图2。此外,2021年中国发布的指南制订基于循证医学方法的有54部(32.93%)[11-15,18,20,23,27,30,39-44,47,49,53,56,58-59,61,65,68-69,79,84,90-91,102,104-105,107-116,118,122,124-125,130-136],其中88.89%的指南声明利益冲突,70.37%指南报告资金来源,29.63%指南关注经济学证据。临床实践指南的制订内容主要聚焦在疾病的诊疗(83部,50.61%)[8,10,12,14,18,20-25,28,30,32-37,41-43,47,50,52,57-58,62,65-71,74,77-78,80-84,91,93-97,99,101,104-105,115,119-129,140,144,146-147, 150,152-153,156-157,159,163-166,168-171],其次是治疗(60部,36.59%)[9,11,13,26-27,31, 40, 44, 46, 48, 51,54-56,59,61,64,72-73,76,79,85-90,98,100,102-103,107-114,117-118,130-139,145,149,151,154-155,159-162,167]。临床实践指南学科涵盖19个专业领域,主要分布在肿瘤科(21.34%)与中医科(18.90%),但每个学科在投入的资金、声明的利益冲突与关注经济学的证据方面均有差异,详细内容见表1。

  • 图2 2021年与2017—2018年中国发布临床实践指南有关利益冲突声明及经济学证据的对比结果
    Figure2.Comparison results of disclosed conflicts of interest and economic in China's clinical practice guidelines issued in 2021 and 2017—2018

  • 表格1 2021年中国发布的临床实践指南有关利益冲突及经济学证据的基本信息
    Table1.The characteristic of conflict of interest and economic evidence in the clinical practice guidelines issued by China in 2021

3 讨论

对2021年我国发布的164部临床实践指南中的利益冲突、资金来源及经济学证据情况调查分析后发现,相较于2017年和2018年,我国发布的临床实践指南利益冲突声明和资金来源报告均有所提高,但经济学证据关注度仍然不足,三者同时报告的指南比例更低。在声明利益冲突方面中仍有一半以上的指南仅简单描述不存在利益冲突,未提供可判断的证明材料,亦无法获取相关信息的公开途径。

以循证为基础的临床实践指南是目前国际指南制订的趋势[172-173]。针对特定的问题和特定人群,由特定的组织和人员按照规范化的流程,结合当前最佳的证据,根据证据的等级和推荐制订,它比非循证的临床实践指南更加清晰、规范、科学及实用。2021年我国发布的临床实践指南中只有54部(32.93%)是基于循证医学方法制订的,但它们在利益冲突声明、资金来源报告及经济学证据方面均高于非循证医学制订的指南。不同学科领域的临床实践指南在这三方面声明情况存在差异[4-5],基于循证医学方法制订的54部指南中占比较大的学科是中医科(22部,40.74%)。考虑到每个学科临床实践指南发布不均衡,因此建议制订指南时不能生搬硬套,需充分结合各学科领域实际情况,提倡和推广基于循证方法制订指南,从而提高我国临床实践指南制订的规范性和合理性。

美国医学研究所发布的报告指出指南制订应遵循6条基本原则,其中制订过程要透明、避免利益冲突被重点强调[174]。利益冲突的存在可直接影响临床实践指南制订的独立性。一般情况下,利益冲突按照经济和非经济来划分[175]。目前,我国大部分指南对利益冲突的描述较为简单和模糊,如仅以“无或均不存在利益冲突”表示,未对利益冲突的具体类型加以细化和区别,由于缺乏具体的细节,指南使用者和评价者很难判断其利益冲突的真实情况[176-177]。本研究发现69.64%的指南仅简单声明所有作者均不存在利益冲突,只有1部指南报告披露指南制订过程得到非盈利组织的资金赞助,但并未明确说明是否存在利益冲突及对推荐意见形成的影响,其他声明无利益冲突的指南亦未提供材料进行考证,因此还待加强制定并细化中国临床实践指南制订组织有关利益冲突声明和管理的方案,尽可能减少利益冲突,从而促进我国指南更加客观、公正和透明化。值得提及的是,相较于2017年与2018年,2021年发布的指南利益冲突声明数量明显提高,这可能与国家加强经费支持有关,资助由原来的18.87%提高至42.68%。

临床实践指南最终是为了服务患者,因此指南制订一定要考虑患者意愿和价值观,这就要求临床医生在指导患者治疗时,综合考虑药物治疗的效果和患者经济承受能力。卫生经济学强调通过对医药卫生领域资源的配置和有效利用,以有限的资源实现健康的最大改善。临床实践指南作为指导性文件,在证据向推荐意见转化过程中要考虑经济学证据,来实现患者享受最具临床和成本效果的治疗。NICE制订的指南对卫生技术评估报告会基于经济与临床两个方面综合做出推荐意见[178],但我国发布的指南中没有明确的经济学证据支持,故无法形成具有卫生经济学价值的推荐意见。为了制订科学化的临床决策以更好服务患者,建议在指南制订过程中重视多学科成员的参与,尤其是患者、方法学家和卫生经济学专家。卫生经济学家可确保经济学证据是基于当前最可信的假设和最佳临床证据。此外,仍然需要提高我国有关卫生经济学的原始研究的产出。

综上所述,我国发布的临床实践指南在利益冲突声明和资金来源报告方面均有所改善,但指南中经济学证据关注仍然不足。其中,利益冲突声明的内容不充分且无法公开获取详细的信息,这些将影响指南制订的科学性、客观性与透明性。因此,未来指南制订机构仍需要加强对利益冲突的声明和管理,以及对经济学证据的关注和生产落实。

利益冲突声明 所有作者均不存在利益冲突。

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72. 中华医学会神经病学分会帕金森病及运动障碍学组, 中国医师协会神经内科医师分会帕金森病及运动障碍学组. 中国帕金森病早期运动症状治疗循证医学指南[J]. 中国神经免疫学和神经病学杂志, 2021, 28(4): 267-279. [Parkinson's Disease and Motor Disorders Group, Neurological Branch, Chinese Medical Association; Parkinson's Disease and Motor Disorders Group, Neurophysicians Branch, Chinese Medical Association. Evidence based medicine guidelines for the treatment of early motor symptoms of Parkinson's disease in China[J]. Chinese Journal of Neuroimmunology and Neurology, 2021, 28(4): 267-279.] DOI: 10.3969/j.issn.10062963.2021.04.001.

73. 中国医师协会神经内科医师分会, 中华医学会神经病学分会帕金森病及运动障碍学组. 中国帕金森病重复经颅磁刺激治疗指南[J]. 中国神经精神疾病杂志, 2021, 47(10): 577-585. [Neurophysicians Branch of Chinese Medical Association, Parkinson's Disease and Motor Disorders Group of Neurological Branch of Chinese Medical Association. Guidelines for repeated transcranial magnetic stimulation treatment of Parkinson's disease in China[J]. Chinese Journal of Nervous and Mental Diseases, 2021, 47(10): 577-585] DOI: 10.3969/j.issn.1002-0152.2021.010.001.

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75. 中华医学会神经病学分会脑电图与癫痫学组. 中国围妊娠期女性癫痫患者管理指南[J]. 中华神经科杂志, 2021, 54(6): 539-544. [Chinese Society of EEG and Epilepsy. Chinese guidelines for the management of women with epilepsy during periconceptional period[J]. Chinese Journal of Neurology, 2021, 54(6): 539-544.] DOI: 10.3760/cma.j.cn113694-20201116-00879.

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78. 中华医学会神经外科学分会, 中国医师协会急诊医师分会, 国家卫生健康委员会脑卒中筛查与防治工程委员会. 出凝血功能障碍相关性脑出血中国多学科诊治指南[J]. 中华神经外科杂志, 2021, 37(7): 649-662. [Chinese Society of Neurosurgery, Chinese Society of Emergency Physicians, Stroke Screening and Prevention Engineering Committee of the National Health Commission. Chinese multidisciplinary guidelines for the diagnosis and treatment of cerebral hemorrhage related to haemorrhagic and coagulative dysfunction[J]. Chinese Journal of Neurosurgery, 2021, 37(7): 649-662.] DOI: 10.3760/cma.j.cn112050-20210218-00087.

79. 中华医学会神经外科学分会, 国家卫健委脑卒中筛查与防治工程委员会, 海峡两岸医药卫生交流协会神经外科分会缺血性脑血管病学组. 大面积脑梗死外科治疗指南[J]. 中华医学杂志, 2021, 101(45): 3700-3711. [Chinese Society of Neurosurgery, the Stroke Screening and Prevention Engineering Committee of the National Health Commission; the Ischemic Cerebrovascular Disease Group of the Neurosurgery Branch of the Cross Strait Medical and Health Exchange Association. Guidelines for surgical treatment of massive cerebral infarction[J]. Chinese Medical Journal, 2021, 101(45): 3700-3711.] DOI: 10.3760/cma.j.cn112137-20210729-01687.

80. 中国医师协会神经介入专业委员会, 中国颅内动脉瘤计划研究组. 中国颅内破裂动脉瘤诊疗指南2021[J]. 中国脑血管病杂志, 2021, 18(8): 546-574. [Chinese Federation of Interventional Clinical Nerosciences, China Intracranial Aneursm Project Study Group. Chinese guidelines for diagnosis and treatment of ruptured intracranial aneurysm 2021[J]. Chinese Journal of Cerebrovascular Diseases, 2021, 18(8): 546-574.] DOI: 10.3969/j.issn.1672-5921.2021.08.007.

81. 中国医师协会神经介入专业委员会, 中国颅内动脉瘤计划研究组. 中国颅内未破裂动脉瘤诊疗指南2021[J]. 中国脑血管病杂志, 2021, 18(9): 634-664. [Chinese Federation of Interventional clinical Nerosciences, China Intracranial Aneursm Project Study Group. Chinese guidelines for the diagnosis and treatment of unruptured intracranial aneurysm 2021[J]. Chinese Journal of Cerebrovascular Diseases, 2021, 18(9): 634-664.] DOI: 10.3969/j.issn.1672-5921.2021.09.008.

82. 中华医学会肾脏病学分会专家组. 抗中性粒细胞胞质抗体相关肾炎诊断和治疗中国指南[J]. 中华肾脏病杂志, 2021, 37(7): 603-620. [Chinese Society of Nephrology. Chinese guidelines for the diagnosis and treatment of anti-neutrophil cytoplasmic antibody-associated glomerulonephritis[J]. Chinese Journal of Nephrology, 2021, 37(7): 603-620.] DOI: 10.3760/cma.j.cn441217-20210107-00092.

83. 中华医学会肾脏病学分会专家组. 糖尿病肾脏疾病临床诊疗中国指南[J]. 中华肾脏病杂志, 2021, 37(3): 255-304. [Expert Group of Chinese Society of Nephrology. Chinese guidelines for clinical diagnosis and treatment of diabetes kidney disease[J]. Chinese Journal of Nephrology, 2021, 37(3): 255-304] DOI: 10.3760/cma.j.cn441217-20201125-00041.

84. 中华医学会外科学分会, 中华医学会麻醉学分会. 中国加速康复外科临床实践指南(2021版)[J]. 中国实用外科杂志, 2021, 41(9): 961-992. [Chinese Society of Surgery, Chinese Medical Association, Chinese Society of Anesthesiology, Chinese Medical Association. Clinical practice guidelines for enhanced recovery after surgery in China (2021 edition)[J]. Chinese Journal of Practical Surgery, 2021, 41(9): 961-992.] DOI: 10.19538/j.cjps.issn1005-2208.2021.09.01.

85. 中华医学会外科学分会, 中华医学会麻醉学分会. 中国加速康复外科临床实践指南(2021版) (一)[J]. 中华麻醉学杂志, 2021, 41(9): 1028-1034. [Chinese Society of Surgery, Chinese Society of Anesthesiology. Clinical practice guidelines for ERAS in China (2021 edition) (I)[J]. Chinese Journal of Anesthesiology, 2021, 41(9): 1028-1034.] DOI: 10.3760/cma.j.cn131073.20210719.00902.

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《医学新知》由国家新闻出版总署批准,中国农工民主党湖北省委主管,武汉大学中南医院和中国农工民主党湖北省委医药卫生工作委员会主办的综合性医学学术期刊,国内外公开发行。

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