Five Directions for Evidence-based Medicine
家
Gordon H. Guyatt
Department of Clinical Epidemiology & Biostatistics, McMaster University, 1200 Main Street West, Hamilton, Ontario, Canada, L8N 3Z5
Evidence-based medicine continues to evolve.
This exposition will briefly describe five ongoing
developments.
Evidence-based medical texts
For those with access to key electronic data bases,
the biggest challenge to the practice of evidence-
based medicine involves dealing with time pressure.
Clinicians worldwide experience intense pressure to
see many patients in a short period of time. As a result,
they need pre-processed evidence-based resources to
facilitate efficient evidence-based practice.
One metaphor for the ideal resource is an onion, that
is because of an onion’s layers. Sometimes, clinicians
require only evidence-based recommendations for
action. At other times, they need the next layer –
knowledge of whether those recommendations are
strong or weak. Particularly if recommendations
are weak, they may need a third layer of succinct
summaries of the relevant evidence, ideally in the form
of systematic reviews. On occasion, they may wish to
look at the final layer, individual studies summarized
in the reviews.
The last five years has seen the rapid evolution
of resources that are moving toward this model.
The most efficient resource would be electronic –
a mouse-click would move the clinician from one
layer to the next. UpToDate©, an extremely clinician-
friendly text, is rapidly becoming very evidence-
based in its approach (conflict of interest). Barriers to
UpToDate for lower-GDP countries include expense,
and recommendations tailored to western resource
availability, and western practice.
Clinical Evidence (http://www.clinicalevidence.
com), published by the BMJ Publishing Group
is less oriented to making recommendations, and
less comprehensive, but makes an effort to keep a
worldwide audience in mind. Resources such as
UpToDate and Clinical Evidence represent huge steps
forward in making evidence-based practice achievable
for most clinicians.
Biography
Gordon H. Guyatt, MD, Prof. of Medicine & Clinical Epidemiology
& Biostatistics in McMaster University, involve in Evidence-based
clinical research and practicing EBM for 20 years. First developing
the term of "evidence-based medicine" in JAMA in 1992. This article
is specially for the Chinese readers.
中国循证医学杂志 2006年第6卷第3期
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专
论
坛
Development of Evidence-based
Guidelines
Tr a d i t i o n a l l y, c l i n i c i a n s r e l y o n e x p e r t
recommendations to guide their practice. While
evidence-based medicine provides clinicians with
a heretofore unavailable autonomy in interpreting
and applying evidence, clinicians will continue (if
only because of time limitations) to rely on expert
recommendations.
Because of clinicians’ continued reliance on expert
recommendations, EBM leaders are spending much
of their time trying to influence the two important
directions in which expert recommendations have
evolved. The first direction I’ve already discussed:
innovative, evidence-based texts. Their importance has
dictated one of my own priorities, helping UpToDate
become optimally evidence-based.
The second direction is the increasing proliferation
of clinical guidelines. If experts understand how to
produce evidence-based guidelines, and develop a
commitment to so doing, the result will be a huge step
forward for evidence-based practice. My own work
with guideline groups has focused on the American
College of Chest Physicians (ACCP) antithrombotic
guidelines which, through a series of seven iterations,
have become increasingly evidence-based. Their
evolution has included explicit articulation of
clinical questions (including identifying the relevant
patients, interventions, comparators, and outcomes);
using those question elements, and specification
of methodology (restrict to randomized trials or
include observational studies) to define explicit
eligibility criteria for literature searches; conducting
comprehensive searches; using explict criteria to judge
the methodologic quality of the relevant studies; and
adoption of increasingly more sophisticated grades
of recommendation. Currently, the antithrombotic
recommendations represent a standard for producing
evidence-based guidelines.
Fortunately, the understanding and commitment
reflected in ACCP antithrombotic guidelines is
developing rapidly among many guideline producers.
An international group of guideline developers,
systematic reviewers, and clinical epidemiologists
is facilitating this process through the development
and dissemination of a system of grading quality
of evidence and grades of recommendations. The
GRADE group’s system is simple to use and applicable
to a wide variety of clinical recommendations that
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 span the full spectrum of medical specialties and
clinical care[1, 2]. It provides a structure for decision-
making that, if followed rigorously, ensures that
Expert Forum
recommendations will be evidence-based.
When optimally applied, GRADE relies on
an explicit summary of the evidence linking the
alternative management strategies and their impact on
all patient-important outcomes. For each outcome,
guideline developers rate the quality of the evidence.
Randomized trials start at high quality, but can be
rated down because of poor design or implementation,
inconsistency, imprecision of evidence, indirectness
of evidence, or high likelihood of reporting bias.
Observational studies begin at low quality, but can
be rated up if they demonstrate very large treatment
effects.
Recommendations can be strong or weak. Weak
recommendations result from low quality evidence,
or from closely balance benefits and risks. Guideline
panels offer strong recommendations when they
believe that almost all fully informed patients
would choose the same management option, weak
recommendations when patients with different values
and preferences would make different choices.
Another way clinicians can think about strong
recommendations is that they represent advice to
“just do it”. Weak recommendations suggest they
think about the issues, and make a determined effort
to ensure that the final decision is consistent with the
patient’s values and preferences.
There is a real prospect that the GRADE group
will achieve its goal of a uniform international
system of grading quality of evidence and strength
of recommendations[3]. The Cochrane Collaboration
is moving to adopt the GRADE approach to rating
of methodological quality, and the revised Quality
of Reporting of Systematic Reviews (QUOROM)
statement is likely to endorse the approach. The
World Health Organization has endorsed GRADE, and
the Endocrine Society was the first North American
organization to adopt GRADE for its recommendations
while another important organization, the American
College of Chest Physicians (ACCP), has adopted a
slightly modified version of GRADE which UpToDate
will soon put to good use. Other organizations
that have or will soon endorse GRADE include the
American Thoracic Society and the American College
of Physicians.
Ensuring Evidence-based Practice
While evidence-based guidelines hold tremendous
promise, they will not in themselves ensure evidence-
based practice. Indeed, there is good evidence that
isolated publication of guidelines does nothing to
change clinicians’ behavior. Randomized trials provide
some evidence (unfortunately, not always consistent)
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that strategies such as computer reminders, audit and
feedback and participatory small-group educational
sessions can alter behavior [4]. Further research is
required to deepen our understanding of how to
ensure that the highest quality evidence guides clinical
practice. Furthermore, optimal strategies may differ
across cultures and medical systems. What works best
in North America may not necessarily work best in
China.
Exploring the best ways of ensuring
clinical decisions are consistent with
patients’ values and preferences
There are two fundamental principles of evidence-
based medicine. Most clinicians with even a passing
familiarity with EBM are more or less aware of
one: a hierarchy of evidence that suggests that, for
instance, high quality randomized trials summarized
in a rigorous systematic review provide much stronger
inferences than a single observational study. The
second principle, that evidence never by itself can
guide action, and that patients’ values and preferences
always play an important role, is less widely
appreciated.
Faced with the same decision – whether, for instance
to use warfarin or aspirin to prevent a stroke that
may be consequent on chronic atrial fibrillation –
patients with different values and preference will make
different choices. In the atrial fibrillation example,
patients who are more stroke averse will be inclined to
choose warfarin; those who are more bleeding averse
will be more likely to choose aspirin.
Emerging evidence suggests, not surprisingly, that
values and preferences vary widely across physicians,
and across patients. In at least some situations,
patient and physician values may vary systematically.
When faced with the atrial fibrillation scenario, for
instance, patients tend to be more stroke averse than do
physicians[5].
These considerations suggest that clinicians should
devote considerable effort to ensuring that important
decisions reflect patient values and preferences.
Achieving this goal is made challenging by the absence
of this skill as an objective of medical training, the
limited research evidence bearing on how best to
achieve the goal, and the time constraints of medical
practice. Structured scripts, decision board, booklets,
and videos – as a group called “decision aids” –
is one promising way of ensuring fully informed
patients[6]. Ensuring decisions reflect patient values
and preferences remains a frontier of evidence-based
practice that investigators should be addressing in the
coming years.
Bringing evidence-based principles to
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the world of health policy
Public policy, including health policy, is often
driven by ideology. When evidence plays a role, the
hierarchy suggested by EBM may be unknown or not
respected. Even health policy researchers are may
not be fully cognizant of EBM principles, or skilled in
their application. This situation is inimical to optimal
public decision-making.
Some politicians and policy-makers are beginning
to realize the potential power of evidence-based
principles. In 2002, a former premier of the Canadian
province of Saskatchewan produced a pivotal blueprint
for health care in Canada [7]. The Romanow report
explicitly acknowledged evidence-based principles,
and observed these principles scrupulously in
formulating recommendations.
Our own group has applied principles of systematic
reviews and meta-analysis to health policy issues. We
have found that for-profit hospitals are associated with
higher mortality and greater costs[8] than not-for-profit
hospitals, and for-profit dialysis facilities are associate
with higher mortality than not-for-profit hospitals[9].
The next decade should see increasing application of
evidence-based medicine principles to areas of health
policy.
Conclusion
I have identified five areas in which the future
of evidence-based medicine appears to me both
challenging and promising. If investigators, clinicians
and policy-makers effectively address these issues, the
impact will be enormous.
Conflict of interest
I would like to acknowledge a conflict of interest. Our research
group has worked with UpToDate to help them become more
循证医学的五个发展方向
Gordon H. Guyatt
Department of Clinical Epidemiology & Biostatistics, McMaster University, 1200 Main Street West, Hamilton, Ontario, Canada, L8N 3Z5
循证医学在不断发展，本文简要阐述当前其五个发展
方向。
作者简介
Gordon H. Guyatt, 医学博士，加拿大医学与临床流行病学和生物
医学系教授，从事循证临床研究与实践20年。1992年以第一作
者身份在JAMA上撰文，首次提出“循证医学”一词，本文是作者
应本刊要求，特别为中国同行撰写的。
中国循证医学杂志 2006年第6卷第3期
www.cjebm.org.cn
evidence-based, and we have received over $50,000 over a
number of years, money that has contributed to our ongoing
research and educational endeavours. 专
家
References 论
Atkins D, Best D, Briss PA, et al. Grading
1 ���������������������������� ��������������������������������
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2 Guyatt G, Gutterman D, Baumann MH, et al. ��������������������
������������������������������������� Grading strength of
recommendations and quality of evidence in clinical guidelines:
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Chest, 2006; 129(1): 174-181.
3 Guyatt G, Vist G, Falck-Ytter Y, et al. An emerging consensus on
grading recommendations. ACP J Club, 2006; 144(1): A8-9.
4 Grimshaw J, Eccles M, Tetroe J. Implementing clinical guidelines:
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5 Devereaux PJ, Anderson DR, Gardner MJ, et al. Differences
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Canada at URL: http://www.hc-sc.gc.ca/english/pdf/romanow/pdfs/
HCC_Final_Report.pdf
8 Devereaux PJ, Heels-Ansdell D, Lacchetti C, et al. ���������
���������������������������������������������� Payments
for care at private for-profit and private not-for-profit hospitals:
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1817-1824.
9 Devereaux PJ, Schunemann HJ, Ravindran N, et al. �����������
�������������������������������������������� Comparison
of mortality between private for-profit and private not-for-profit
hemodialysis centers: a systematic review and meta-analysis. JAMA,
2002. 288(19): 2449-2457.
1 循证医学资源
对有条件使用主要电子数据库的人而言，实践循证医
学最大的挑战在于如何应付时间压力。全世界的临床医生
都面临在短时间内处理大量患者的巨大压力。这就要求他
们事先获取足够的循证资源以保证有效地循证实践。
理想的资源就象洋葱一样有层次。有时，临床医生仅
159
 需要循证的推荐意见以指导诊治。有时，还需要进一层信 荐意见的制定[1,2]。若能严格按照该系统提供的决策模式执
息用于判断推荐意见强弱。尤其当推荐强度很低时，他们 行，将确保推荐意见符合循证理念。
Expert Forum

可能需要第三层信息——相关证据的简要总结（最好是系 最理想的情况是，清楚总结可选处理方案及各自对患
统评价）。有时，他们也可能希望看到最后一层——综述 者重要结局指标影响的相关证据，并据此评级。对每个结
（系统评价）中单个研究的具体情况。 局指标，由指南制定者对证据质量评分。随机试验起评分
最近5年医学信息资源正朝着这个模式飞速发展。最高 高，但也可能因设计或实施差、前后矛盾、证据不准确、
效的资源应该是电子资源——点击一次鼠标即可将临床医 非直接证据或存在高发表偏倚可能等而得低分。观察性研
©
生带向不同的层次。UpToDate （http://www.uptodate.com） 究起评分低，但若其能证实疗效显著，也可能得到高分。
是一个非常适合临床医生使用的电子数据库，其制作也正 推荐意见强度不同。低强度推荐意见源于低质量证据
快速地向严格循证转型。人均GDP低的国家使用UpToDate 或利弊相近的证据。当指南小组确认所有知情患者都可能
的障碍包括费用、根据西方国家可用资源量身定制的推 作出同一选择时，给予强力推荐；而当患者因价值观和喜
荐意见及针对西方国家的医疗实践。BMJ出版集团出版的 好不同而选择各异时，则给予低强度推荐。换言之，临床
Clinical Evidence (http://www.clinicalevidence.com) 则力求照 医生在看待推荐意见时可以认为，强力推荐即代表“直接
顾到全世界的读者，但较少提供推荐意见、内容也不够全 采纳”（“Just do it”）；而低强度推荐则表示仅供参考，
面。UpToDate和Clinical Evidence这类资源的出现使多数临 在决策时应保证最终处理方案符合患者的价值观和喜好。
床医生实施循证实践的可能性取得了长足进步。 GRADE工作组完全有望实现国际统一的证据质量和推
荐强度评级系统这一目标 [3]。Cochrane协作网已开始采用
2 制定循证指南 GRADE的方法来评价方法学质量，系统评价报告质量标准
（QUOROM）修订版很可能采用GRADE标准；世界卫生
临床医生历来依靠专家意见指导实践。循证医学赋予 组织（WHO）已经采用GRADE；内分泌学会（Endocrine
了临床医生在理解和应用证据时前所未有的自主性。临床 Society）是第一家采用GRADE制定其推荐意见的北美组
医生仍可继续（仅当时间有限时）根据专家意见决策。 织；另一家北美机构ACCP也已采用经少量修改的GRADE
正因为临床医生习惯于依赖专家意见，循证医学倡 （UpToDate即将广泛采用该修改版）；其他一些机构也
导者正花费大量时间力图从两个重要的方向去改善这种状 已或很快将采用GRADE，如美国胸肺学会（American
况，并赋予 “专家意见”新的内涵。第一个方向前面已 Thoracic Society）和美国内科医师学会（American College of
讨论：创新的循证资源。其重要性决定了我的研究重点 Physicians）。
之一，即帮助UpToDate更符合循证理念，臻至完美。第二
个方向针对不断增加的临床指南。如果专家们知道怎样制 3 确保循证实践
定循证指南，并成立委员会来做，将推进循证实践向前迈
进一大步。我参与指南制定组的工作主要集中在制定美国 尽管“循证指南”前景光明，但指南自身并不能确保
胸科医师协会（ACCP）抗血栓指南。经过连续7次反复修 循证临床实践。事实上已有充分证据证明单纯发表指南丝
订，该系列指南已变得越来越符合循证理念。其制定过程 毫不能改变临床医生的行为。一些随机试验（遗憾的是结
包括清楚表述临床问题（包括确定相关患者、干预措施、 果并非完全一致）发现，诸如计算机提醒、监督和反馈及
对照及结局指标）；根据临床问题所包含的元素和指定的 参与小组专题培训可能会有作用 [4]。下一步研究应着重于
方法学（仅限随机试验或纳入观察性研究）为文献检索明 怎样确保以最高质量的证据来指导临床实践。此外，最佳
确定义纳入标准；进行全面检索；使用严格的标准来评价 策略可能会因文化和医疗系统差异而不同，北美最好的方
相关研究的方法学质量；采用久经考验的推荐意见分级标 案拿到中国就不一定是最好的。
准。现在，该抗血栓推荐意见已成为制定循证指南的一个
标准。 4 探索最佳途径，确保临床决策符合患者价值观
所幸ACCP抗血栓指南中体现的思路和形式已在指南 和喜好
制定者中广为传播。一个由指南制定者、系统评价员和临
床流行病学家组成的国际工作组（GRADE working group） 循证医学有两个基本原则，多数临床医生，哪怕是
正致力于制定和传播一套证据质量和推荐意见评级系统以 偶然耳闻过循证医学者都或多或少知道第一个原则：证据
推动指南的循证化。GRADE工作组制定的评级系统简明易 分级，如制作严谨的高质量随机试验的系统评价得出的结
用、适用范围广，可用于各医学专业和临床护理的临床推 论说服力较单个观察性研究的结论强得多。而第二个原

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则——证据自身并不能指导行动，患者的价值观和喜好起
着重要作用——却远未被广泛接受。
在面临同一决策时，不同价值观和喜好的患者可能会
作出不同的选择。如使用华法令或阿司匹林预防卒中可能
继发慢性心房纤颤。发生过慢性心房纤颤的患者中，担心
发生卒中的患者偏向于选择华法令，而更担心出血的患者
很可能选择阿司匹林。
不同医生及病人间价值观和喜好历来大相径庭，不足
为奇。至少在某些情况下，医生和病人的价值观可能大不
相同。比如前述关于心房纤颤的问题中，患者比医生更担
心发生卒中[5]。
综上所述，临床医生应尽量保证重要的临床决策能反
映病人的价值观和喜好。而要达此目的将面临多方挑战，
包括现有医学教育未将尊重患者意愿和选择纳入培训目
标；缺少如何最好达此目标的研究证据；医疗实践中医生
时间不够等。利用“决策辅助工具”（decision aids）（包
括整理后的医师手稿、决策宣传栏、宣传册及影音资料）
[6]
来帮助患者充分知情是一种颇有前景的选择 。确保临床
一些政治家和政策制定者已开始意识到循证原则的潜
力。2002年，加拿大Saskatchewan省前省长Romanow撰写了
专
一份重要的卫生保健蓝皮书 [7]。报告采纳了循证原理和方
家
法，并明确体现在其谨慎的推荐意见中。
论
我们的工作组已将系统评价和Meta分析原理用于卫生
坛
政策领域。我们发现，赢利性医院的病死率和医疗费用较
非赢利性医院高 [8]；与透析设备相关的病死率，赢利性医
院也较非赢利性医院高 [9]。未来十年，循证医学原理在卫
生政策领域的应用将持续增长。
6 结论
我为循证医学描绘的五个未来发展方向于我本人既是
挑战也是期盼。如果研究者、临床医生及政策制定者能更
多地关注这些问题，必将福泽深远。
利益冲突
我的工作组已与UpToDate合作以帮助他们更加科学、循证。

决策符合患者价值观和喜好，在未来几年内仍将是循证实 迄今已收到UpToDate赞助的经费5万余美元，用于在研的课题和教

践领域研究的焦点。 育。

5 在卫生政策领域引入循证原则 （姚 巡，杜 亮 译；李幼平 审校）

收稿日期：2006-02-05 修回日期：2006-03-15
公共政策，包括卫生政策通常受意识形态驱使。当证 本文编辑：蔡羽嘉
据日益得到重视的时候，循证医学倡导的证据分级却可能
尚未为人所知，或并未受到重视。甚至卫生政策研究者并
不完全清楚循证医学原理更谈不上熟练运用。这种情况不
利于最佳公共决策。

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