中国临床指南：解决利益冲突和吸纳患者参与

Clinicalguidelines in China: tackling conflict of interests and engaging patients

¹北京大学公共卫生学院流行病与卫生统计学系

²北京大学第三医院临床流行病学研究中心

³北京大学循证医学中心

⁴The BMJ

⁵香港中文大学公共卫生及基层医疗学院

循证医学强调基于当前最佳证据制定患者的诊疗决策，这种实践模式已经为世界各国广泛接受¹。临床实践指南是在“对医学证据的系统综述和对治疗利弊的评估”基础上给出的实践建议²，在指导临床治疗和改善临床结局中至关重要，对于中国这样人口众多的发展中国家更是如此。当然，其前提必须是高质量的指南。

Evidencebased medicine is widely accepted across the world and is used to make surethat decisions about patient care are informed by current best evidence.¹ Clinicalpractice guidelines, "informed by a systematic review of evidence andassessment of benefits and harms of alternative care options,” are important inguiding care and clinical outcomes, particularly for large developing countrieslike China.² However, they have to be of high quality.

截至2016年底，中国已经发表664个临床实践指南³。但利用指南研究与评价工具（Appraisal of Guidelines for Research and Evaluation，AGREE）对这些指南的评估显示，中国指南的质量与西方国家相比仍存在差距^4-7。一方面，现有临床实践指南的数量表明，循证医学在中国已被广泛接受，并且中国医学界积极参与了指南的制定。另一方面，低质量的临床实践指南可能起不到应有的作用，让人心忧。

China published 664 clinical practice guidelines by the end of 2016.³ Compared with those from Western countries, however, Chineseguidelines are generally of lower quality, according to the criteria of theAppraisal of Guidelines for Research and Evaluation (AGREE).^4-7 On one hand, the number of guidelines available shows that evidencebased medicine has been embraced widely in China and the Chinese medicalcommunity is active in guideline development. On the other hand, low qualityguidelines could do more harm than good.

中国需要少而精的、可靠的临床实践指南。但是，制定无偏、独立、透明且严谨的指南，我们面临着巨大挑战。这些挑战不仅有技术层面的，同时还有指南制定者对利益冲突缺乏足够认知和对指南制定过程监督和管理不足。

China needs fewer, but more high quality clinical guidelines. It ischallenging to develop unbiased, independent, transparent, and rigorousguidelines. Those challenges do not only exist in technical aspects, but canalso be the result of a lack of awareness of conflicts of interest andinsufficient and ineffective management in the guideline development process.

如何有效处理利益冲突和资金来源是持久且困难的议题。在AGREE要求的指南“编撰的独立性”方面，2017年中国出台的临床实践指南中只有26.4%说明了利益冲突，18.9%陈述了资金来源，这些比例远远低于西方发达国家⁸，似乎低估了实际情况。例如，西方发达国家中60%的临床实践指南在指南本身或者国家指南库（National Guideline Clearinghouse，NGC）中对此有相关说明，我们的情况可能并不会更好，而且西方指南中的利益冲突会在我们借鉴时会不知不觉地转移到中国的指南中⁹。大多数世界卫生组织的指南都在内容里报告了资金来源，公开了利益关系和外部捐助者的利益冲突¹⁰。值得一提的是，中国也并非停滞不前，近年来临床实践指南制定者开始采取措施，提高指南的透明度。例如，中国药理学会在其万古霉素的监测指南中提供了详细的利益冲突信息¹¹。

One big, ongoing challenge is the effective management of conflicts ofinterest and sources of funding. Among the six domains of AGREE, in the“editorial independence” domain, only 26.4% of Chinese clinical practiceguidelines published in 2017 disclosed a COI and 18.9% stated their sources offunding.⁸ In contrast, Western clinical practice guidelines scored much higherin this respect. For example, 60% of clinical guidelines reported disclosurestatements either in the guideline itself or in the National Guideline Clearinghousesummary.⁹ The majority of WHO guidelines reported funding sources,relationships of interest, and conflicts of interest of external contributorsin their guideline documents.¹⁰ It is worth noting, however, that some progress has been made inChina by guidelines developers to improve the transparency of authors in recentyears. For example, the Chinese Pharmacological Society provided detailedcompeting interest information in its guidelines for the monitoring ofvancomycin.¹¹

利益冲突包括财务和非财务方面的声明。在制定临床指南过程中陈述非财务方面的利益冲突并非易事¹²。2016年中华医学会发布的“制定中国临床指南的指南”，已经关注这个问题，并为中国指南制定者提供了利益冲突的说明政策¹³。虽然这个指南不是强制性的，但可以看出中国为了有效解决利益冲突而锐意变革的决心。另外，RIGHT声明作为临床实践指南的报告标准也在2017年出台¹⁴。我们希望中国医学期刊的编辑们要求所有指南制定者在提交出版指南时，依据RIGHT声明的相关要求将利益冲突说明作为附录一并提交。

Conflict of interest statements include both financial andnonfinancial declarations. Declaration of non-financial competing interests hasproven difficult in guideline development.¹² To tackle this problem, in 2016 the Chinese Medical Associationpublished their Guidelines for Developing Clinical Guidelines and proposedconflict of interest disclosure policies for Chinese guideline developers.¹³ Althoughthey are not mandatory, these guides showed the determination that exists inChina to make a change in order to effectively manage competing interests. Inaddition, the RIGHT Statement was issued as a reporting tool of clinicalguidelines in 2017.¹⁴ We urge the editors of Chinese medical journals to make it arequirement that all authors submit their conflict of interest statementsaccording to the RIGHT Statement at the time of submitting their guideline forpublication.

中国大多数指南是由医学专业委员会制定，但有些是在制药公司赞助下完成的⁸。西方发达国家已经有记录显示指南作者与制药行业之间有相当程度的“互动行为”¹⁵，只有准确说明这些互动的具体行为才能确保指南的透明度，消除潜在的偏倚。由此看来，减少甚至完全避免制药公司的赞助才是根本。为此，中国政府和非政府组织可以考虑建立公共基金，为指南制定直接提供支持。事实上中国已有非政府组织开始行动，比如中国健康促进基金会已经启动了一项计划，为制定抗血栓治疗和预防血栓形成指南提供资金¹⁶。

Although the majority of guidelines in China are developed bycommittees of medical professionals, some are financially supported bypharmaceutical companies.⁸ A considerable degree of interactions between authors and thepharmaceutical industry has been documented in western countries.¹⁵ It is important that all such interactions are explicitly disclosedin order to ensure transparency. Furthermore, simple disclosure may not beeffective in eliminating potential biases. It is important, therefore, toreduce or even totally avoid drug company sponsorship. In order to help reachthis ultimate goal, the Chinese government or non-government organisations couldconsider building a public foundation to finance the development of guidelines.Indeed, this has started to happen; the China Health Promotion Foundation, anon-governmental organisation, has initiated a programme to provide funding fordeveloping a Chinese guideline for antithrombotic therapy and prevention ofthrombosis.¹⁶

让患者参与指南制定是另一项重要议题。因为涉及方方面面的改变，让患者参与具有极大的挑战性。但如果我们牢记产生、搜集、综述、评估医学证据和制定临床指南的初心是为了患者，那么听取患者的意见就是十分必要的。国际上已经就促进患者和护理人员参与指南制定做出了努力，并鼓励他们分享各自的经验、价值观、偏好和观点¹⁷。目前中国的医患关系非常紧张，以及中国传统医患关系中医生父母式的地位，可能让医生和患者都担心他们如何在制定指南上有效合地作。另外，少有患者熟知指南的制定过程，患者也需要假以时日来认识他们的角色，掌握有关技能(包括制定指南以及与医生合作的技能)，并增加自信。中国临床实践指南制定者已经开启了破冰之旅，比如中国老年学与老年病学会（注册号：IPGRP-2017CN004，http：//www.guidelines-registry.cn）制定的膝关节骨性关节炎运动疗法临床实践指南已经邀请患者参与。

Another important matter is the engagement of patients in guidelinedevelopment. Initiating patient involvement is challenging as it is always hardto make a change in any field. We have made great efforts to generate, collect,review, and rate evidence, and develop guidelines. These are all for thebenefit of patients. Therefore, patients should have a say in decisions abouttheir treatment. Efforts have been made to involve patients and carers inguideline development and encourage them to share their experiences, values,preferences, and views.¹⁷ Doctor-patient relations are currently tense in China and traditionalviews about this relationship may make it difficult for patients and guidelinedevelopers work together effectively. Additionally, few patients are familiarwith guideline development and it takes time for them to understand their rolein their care and build up the skills and confidence to work with doctors. Somegroundbreaking work has been done by Chinese guideline developers. For example,efforts had been made to involve patients in developing the guidelines forexercise therapy for knee osteoarthritis developed by the China Association ofGerontology and Geriatrics.

我们需要更多的人来思考和讨论患者参与的必要性和参与方式。我们需要尝试各种参与方式，从中获取经验，为未来更大规模的病人参与提供依据。

We need more thinking, discussion, and debates about ways of involvingpatients. We need to experiment with various methods and accumulateexperiences. We need research to evaluate these methods and provide evidencefor further improvement. We need to share successful experiences and continueto improve.

为了将挑战转化为机遇，中国循证医学的推动者和临床实践指南的制定者应该通力合作，更有效地解决证据收集和解读、利益冲突、资金来源和患者参与的诸多问题。制定高质量的指南是促进患者健康和提高人民福祉的重要途径，同时也利于中国实现“健康中国2030”的目标。

To transfer challenges into opportunities, evidence based medicineadvocates and guideline developers should work together to manage moreeffectively conflicts of interest and funding sources, and engage patients.Generating high quality guidelines is important to promote patients’ health andthe populations wellbeing, which is important for China to achieve itsobjectives of Healthy China 2030.

周一帆  张靖雪  译

詹思延  唐金陵  校

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致谢：感谢BMJ、BMJ中国以及《The BMJ》《英国医学杂志中文版》对本公众号的信任和支持，以及对中国临床研究事业的持续关注与投入。