Strength of Recommendation Taxonomy (SORT):
A Patient-Centered Approach to Grading Evidence
in the Medical Literature
英文原文
A large number of taxonomies are used to rate the quality of an individual study and the strength of a recommendation based on a body of evidence. We have developed a new grading scale that will be used by several family medicine and primary care journals (required or optional), with the goal of allowing readers to learn one taxonomy that will apply to many sources of evidence. Our scale is called the Strength of Recommendation Taxonomy. It addresses the quality, quantity, and consistency of evidence and allows authors to rate individual studies or bodies of evidence. The taxonomy is built around the information mastery framework, which emphasizes the use of patient-oriented outcomes that measure changes in morbidity or mortality. An A-level recommendation is based on consistent and good-quality patient-oriented evidence; a B-level recommendation is based on inconsistent or limited-quality patient-oriented evidence; and a C-level recommendation is based on consensus, usual practice, opinion, diseaseoriented evidence, or case series for studies of diagnosis, treatment, prevention, or screening. Levels of evidence from 1 to 3 for individual studies also are defined. We hope that consistent use of this taxonomy will improve the ability of authors and readers to communicate about the translation of research into practice.
对应中文
现在有很多不同分类法用在依据大量证据对单个研究的质量和建议的强度进行评级上。我们开发了一个新的分级量表，将被几家家庭医学和初级保健杂志（必选或可选）采用，目的是让读者学习一种适用于多种证据来源的分类法。我们的评价法名为“证据强度分类(SORT)”，它涉及证据的质量、数量和一致性，并允许作者对单个研究或证据体进行评级。该分类法是围绕信息证据力度框架构建的，强调使用以患者为导向的结果来衡量发病率或死亡率的变化。A级证据基于一致且优质的以患者为导向的证据；B级证据基于质量不一致或有限的以患者为导向的证据；C级证据基于共识、惯例、意见、疾病导向证据或诊断、治疗、预防或筛查研究的病例系列。另外，我们还定义了单个研究的1到3级证据。我们希望这种证据强度分类法的持续使用能够加强作者和读者的交流，提升将研究转化为实践的能力。
英文原文
Review articles (or overviews) are highly valued by physicians as a way to keep upto-date with the medical literature. Sometimes, though, these articles are based more on the authors’ personal experience, anecdotes, or incomplete surveys of the literature than on a comprehensive collection of the best available evidence. As a result, there is an ongoing effort in the medical publishing field to improve the quality of review articles through the use of more explicit grading of the strength of evidence on which recommendations are based.
对应中文
综述文章(或综述)是医生高度重视的跟上最新医学知识的学习方式。然而，有时这些文章更多地是基于作者的个人经历、轶事或对文献的不完整调查，而不是基于对可获得的最佳证据的综合收集和分析。因此，医学出版领域正在不断努力，通过对推荐所依据的证据强度进行更明确的分级，提高评论文章的质量。
英文原文
Therefore, the editors of the U.S. family medicine and primary care journals (i.e., American Family Physician, Family Medicine, The Journal of Family Practice, Journal of the American Board of Family Practice, and BMJ-USA) and the Family Practice Inquiries Network (FPIN) came together to develop a unified taxonomy for the strength of recommendations based on a body of evidence. The new taxonomy should: (1) be uniform in most family medicine journals and electronic databases; (2) allow authors to evaluate the strength of recommendation of a body of evidence; (3) allow authors to rate the level of evidence for an individual study; (4) be comprehensive and allow authors to evaluate studies of screening, diagnosis, therapy, prevention, and prognosis; (5) be easy to use and not too time-consuming for authors, reviewers, and editors who may be content experts but not experts in critical appraisal or clinical epidemiology; and (6) be straightforward enough that primary care physicians can readily integrate the recommendations into daily practice.
对应中文
因此，美国家庭医学和初级保健期刊 (即《美国家庭医生》、《家庭医学》、《家庭实践杂志》、《美国家庭实践委员会杂志》和《BMJ-USA》)的编辑和家庭实践查询网络(FPIN)联合起来，为基于证据的推荐力度制定了统一的证据力度分类法。新的分类法应该满足以下要求：（1）在大多数医学期刊和电子数据库中保持统一；（2） 允许作者评估证据主体推荐的强度；（3） 允许作者对单个研究的证据水平进行评分；（4） 覆盖全面，允许作者评估筛查、诊断、治疗、预防和预后的研究；（5） 对于可能是内容专家但不是批判性评估或临床流行病学专家的作者、评论员和编辑来说，易于使用且不太耗时；（6）足够简单，初级保健医师可以很容易地将建议整合到日常实践中。
Definitions
定义
英文原文
Disease-Oriented Outcomes. These outcomes include intermediate, histopathologic, physiologic, or surrogate results (e.g., blood sugar, blood pressure, flow rate, coronary plaque thickness) that may or may not reflect improvement in patient outcomes.
对应中文
以疾病为导向的结果：
这些结果包括中间结果、组织病理学、生理学或替代结果（例如，血糖、血压、流速、冠状动脉斑块厚度），这些结果可能反映或可能不反映患者预后的改善。
英文原文
Patient-Oriented Outcomes. These are outcomes that matter to patients and help them live longer or better lives, including reduced morbidity, reduced mortality, symptom improvement, improved quality of life, or lower cost.
对应中文
以患者为导向的结果：
这些结果对患者很重要，帮助他们活得更长或更好，包括降低发病率、降低死亡率、改善症状、提高生活质量或降低成本。
英文原文
Level of Evidence. The validity of an individual study is based on an assessment of its study design. According to some methodologies,6 levels of evidence can refer not only to individual studies but also to the quality of evidence from multiple studies about a specific question or the quality of evidence supporting a clinical intervention. For purposes of maintaining simplicity and consistency in this proposal, we use the term “level of evidence” to refer to individual studies.
对应中文
证据水平：
个体研究的有效性基于对其研究设计的评估。根据一些方法，6等级别的证据不仅可以指个体研究，还可以指关于特定问题的多个研究的证据质量或支持临床干预的证据质量。为了保持本提案的简单性和一致性，我们使用“证据水平”一词来指某一个研究的证据力度程度。
英文原文
Strength of Recommendation. The strength (or grade) of a recommendation for clinical practice is based on a body of evidence (typi- cally more than one study). This approach takes into account the level of evidence of individual studies; the type of outcomes measured by these studies (patient-oriented or diseaseoriented); the number, consistency, and coherence of the evidence as a whole; and the relationship between benefits, harms, and costs.
对应中文
推荐力度：
临床实践建议的强度（或等级）基于一系列证据（通常不止一项研究）。该方法考虑了个体研究的证据水平；这些研究衡量的结果类型(以病人为导向或以疾病为导向)；整个证据的数量、一致性和连贯性；以及利益、伤害和成本之间的关系。
英文原文
Practice Guideline (Evidence-Based). These guidelines are recommendations for practice that involve a comprehensive search of the literature, an evaluation of the quality of individual studies, and recommendations that are graded to reflect the quality of the supporting evidence. All search, critical appraisal, and grading methods should be described explicitly and be replicable by similarly skilled authors.
对应中文
实践指南 (循证)：
这些指南是针对实践的建议，涉及对文献的全面搜索、对单个研究的质量进行评估、并对证据力度进行分级以反映支持证据的质量。所有搜索、批判性评估和评分方法都应明确描述，并可由具有类似技能的作者复制。
英文原文
Practice Guideline (Consensus). Consensus guidelines are recommendations for practice based on expert opinions that typically do not include a systematic search, an assessment of the quality of individual studies, or a system to label the strength of recommendations explicitly.
对应中文
实践指南（共识）：
共识指南是基于专家意见的实践建议，通常不包括系统搜索、单个研究质量评估、或明确标记建议强度的系统。
英文原文
Research Evidence. This evidence is presented in publications of original research, involving collection of original data or the systematic review of other original research publications. It does not include editorials, opinion pieces, or review articles (other than systematic reviews or meta-analyses). UV such.
对应中文
研究证据：
这一证据在原始研究出版物中有所体现，包括收集原始数据或对其他原始研究出版物进行系统审查。它不包括社论、观点文章或评论文章（系统评论或荟萃分析除外）。
英文原文
Review Article. A nonsystematic overview of a topic is a review article. In most cases, it is not based on an exhaustive, structured review of the literature and does not evaluate the quality of included studies systematically. UV such.
对应中文
评论文章：
一个主题的非系统性概述是一篇评论文章。在大多数情况下，它不是基于对文献的详尽、结构化审查，也没有系统地评估纳入研究的质量。
英文原文
Systematic Reviews and Meta-Analyses. A systematic review is a critical assessment of existing evidence that addresses a focused clinical question, includes a comprehensive literature search, appraises the quality of studies, and reports results in a systematic manner. If the studies report comparable quantitative data and have a low degree of variation in their findings, a meta-analysis can be performed to derive a summary estimate of effect.
对应中文
系统评价和荟萃分析：
系统评价是对现有证据的批判性评估，旨在解决一个重点临床问题，包括全面的文献检索、全面地评估研究质量，并以系统的方式报告结果。如果其所包含研究中含有可比的定量数据，且其结果的变异程度较低，则可以执行荟萃分析来得出效果的概要估计。
Existing Strength-of-Evidence Scales
现有证据强度量表
英文原文
In March 2002, the Agency for Healthcare Research and Quality (AHRQ) published a report that summarized the state-of-the-art in methods of rating the strength of evidence.The report identified a large number of systems for rating the quality of individual studies: 20 for systematic reviews, 49 for randomized controlled trials, 19 for observational studies, and 18 for diagnostic test studies. It also identified 40 scales that graded the strength of a body of evidence consisting of one or more studies.
对应中文
2002年3月，医疗研究和质量机构(AHRQ)发表了一份报告，总结了证据强度评级方法的最新进展。报告中涵盖了大量用于评价个体研究质量的系统：20个用于系统评价的，49个用于随机对照试验的，19项用于观察研究的，18项用于诊断试验研究的。报告还确定了40个等级，用以对一个或多个研究组成的证据体的强度进行分级。
英文原文
The authors of the AHRQ report proposed that any system for grading the strength of evidence should consider three key elements: quality, quantity, and consistency. Quality is the extent to which the identified studies minimize the opportunity for bias and is synonymous with the concept of validity. Quantity is the number of studies and subjects included in those studies. Consistency is the extent to which findings are similar between different studies on the same topic. Only seven of the 40 systems identified and addressed all three of these key elements.
对应中文
AHRQ报告的作者提出，任何证据强度分级系统都应该考虑三个关键要素：质量、数量和一致性。质量是指确定的研究在多大程度上减少了产生偏差的机会，并且与有效性概念一致。数量是指这些研究中包括的研究和受试者的数量；一致性是指同一主题的不同研究结果之间的相似程度。40个系统中只有7个覆盖且解决了所有这三个关键要素。
Strength of Recommendation Taxonomy (SORT)
证据强度分类 (SORT)
英文原文
In general, only key recommendations for readers require a grade of the “Strength of Recommendation.” Recommendations should be based on the highest quality evidence available. For example, vitamin E was found in some cohort studies (level 2 study quality) to have a benefit for cardiovascular protection, but good-quality randomized trials (level 1) have not confirmed this effect. Therefore, it is preferable to base clinical recommendations in a manuscript on the level 1 studies.
对应中文
一般来说，只有面向读者的关键推荐才需要“证据强度”的等级。推荐证据应基于最高质量的可用事实数据。例如，在一些队列研究（2级研究质量）中发现维生素E有利于心血管保护，但高质量随机试验（1级）尚未证实这一效果。因此，最好将临床建议建立在1级研究的基础上。
Strength of recommendation Definition
推荐证据强度的定义
英文原文
A Recommendation based on consistent and good-quality patient-oriented evidence.*
B Recommendation based on inconsistent or limited-quality patient-oriented evidence.*
C Recommendation based on consensus, usual practice, opinion, disease-oriented evidence,* or case series for studies of diagnosis, treatment, prevention, or screening. UV such.
对应中文
A 基于一致且高质量的以患者为导向的证据的建议。
B 基于不一致或质量有限的以患者为导向的证据的建议。
C 基于共识、惯常做法、意见、以疾病为导向的证据的建议或用于诊断、治疗、预防或筛查研究的病例系列。
英文原文
Patient-oriented evidence measures outcomes that matter to patients: morbidity, mortality, symptom improvement, cost reduction, and quality of life. Disease-oriented evidence measures intermediate, physiologic, or surrogate end points that may or may not reflect improvements in patient outcomes (e.g., blood pressure, blood chemistry, physiologic function, pathologic findings).
High-quality diagnostic cohort study: cohort design, adequate size, adequate spectrum of patients, blinding, and a consistent, welldefined reference standard.
High-quality RCT: allocation concealed, blinding if possible, intention-to-treat analysis, adequate statistical power, adequate follow-up (greater than 80 percent).
In an all-or-none study, the treatment causes a dramatic change in outcomes, such as antibiotics for meningitis or surgery for appendicitis, which precludes study in a controlled trial.
对应中文
以患者为导向的证据衡量对患者重要的结果：发病率、死亡率、症状改善、成本降低和生活质量。以疾病为导向的证据衡量中间、生理或替代终点，这些终点可能反映或可能不反映患者结果的改善（例如，血压、血液化学、生理功能、病理结果）。
高质量诊断队列研究：队列设计、足够的规模、足够的患者谱系、正确使用盲法，以及一致的、定义明确的参考标准。
高质量的随机对照试验 (RCT)：隐蔽分配、（如果可能）盲法、治疗意向分析、足够的统计能力、足够的随访（大于80%）。
但在一项全有或全无研究中，治疗会导致结果的显著变化，例如用于脑膜炎的抗生素或用于阑尾炎的外科手术，这排除了在对照试验中进行研究的可能性。
英文原文
We believe there are several advantages to our proposed taxonomy. It is straightforward and comprehensive, is easily applied by authors and physicians, and explicitly addresses the issue of patient-oriented versus disease-ori-ented evidence. The latter attribute distinguishes SORT from most other evidence-grading scales. These strengths also create some limitations. Some clinicians may be concerned that the taxonomy is not as detailed in its assessment of study designs as others, such as that of the Centre for Evidence-Based Medicine (CEBM).However, the primary difference between the two taxonomies is that the CEBM version distinguishes between good and poor observational studies while the SORT version does not. We concluded that the advantages of a system that provides the physician with a clear recommendation that is strong (A), moderate (B), or weak (C) in its support of a particular intervention outweighs the theoretic benefit of distinguishing between lower quality and higher quality observational studies, particularly because there is no objective evidence that the latter distinction carries important differences in clinical recommendations.
对应中文
我们相信我们提出的分类法有几个优点。它是直截了当和全面的，很容易被作者和医生应用，并明确地解决了以患者为中心的证据与以疾病为中心的证据的问题。后一个属性使SORT从大多数其他证据等级评价体系脱颖而出。当然，这些优势也造成了一些局限性。一些临床医生可能担心，在对研究设计的评估中，分类学没有其他分类学详细，例如循证医学中心（CEBM）。然而，两种分类法之间的主要区别在于CEBM版本区分了良好和较差的观察研究，而SORT版本则没有。我们的结论是，为医生提供支持特定干预的明确建议(A)、中等(B)或弱(C)的系统的优势超过了区分低质量和高质量观察性研究的理论好处，特别是因为没有客观证据表明后者在临床建议中具有重要的差异。
英文原文
Any publication applying SORT (or any other evidence-based taxonomy) should describe carefully the search process that preceded the assignment of a SORT rating. For example, authors could perform a comprehensive search of MEDLINE and the gray literature, a comprehensive search of MEDLINE alone, or a more focused search of MEDLINE plus secondary evidence-based sources of information.
对应中文
任何应用SORT (或任何其他基于证据的分类法) 的出版物都应该仔细描述SORT之前的文献搜索过程。例如，作者可以对MEDLINE和灰色文献进行全面搜索，单独对MEDLINE进行全面搜索，或者对MEDLINE加上二级循证信息源进行更有针对性的搜索。
Final CommentProte****ction Sunglasses
最终建议
英文原文
The SORT is a comprehensive taxonomy for evaluating the strength of a recommendation based on a body of evidence and the quality of an individual study. If applied consistently by authors and editors in the family medicine literature, it has the potential to make it easier for physicians to apply the results of research in their practice through the information mastery approach and to incorporate evidence- based medicine into their patient care.
对应中文
SORT是一种综合分类法，用于根据大量证据和单个研究的质量评估建议的强度。如果医学文献中的作者和编辑一致应用，它有可能使医生更容易通过信息掌握方法将研究结果应用于实践，并将循证医学纳入患者护理。
英文原文
Like any such grading scale, it is a work in progress. As we learn more about biases in study design, and as the authors and read- ers who use the taxonomy become more sophisticated about principles of information mastery, evidence-based medicine, and critical appraisal, it is likely to evolve. We remain open to suggestions from the primary care community for refining and improving SORT.
对应中文
就像任何类似评分标准一样，这是一项持续进行的工作。随着我们更多地了解研究设计中的偏见，以及使用分类法的作者和读者对信息掌握、循证医学和批判性评估的原则变得更加成熟，它很可能会演变。我们仍然愿意听取医疗保健团体的建议，以完善和改进分类。
REFERENCES
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Ebell MH, Siwek J, Weiss BD, Woolf SH, Susman J, Ewigman B, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician. 2004;69(3):548-56.