2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
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DOI：
10.1161/cir.0000000000000471
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发表时间：
2017-03-21
期刊：
影响因子：
37.8
通讯作者：
Walsh ME
中科院分区：
文献类型：
--
作者：
Gerhard-Herman MD;Gornik HL;Barrett C;Barshes NR;Corriere MA;Drachman DE;Fleisher LA;Fowkes FG;Hamburg NM;Kinlay S;Lookstein R;Misra S;Mureebe L;Olin JW;Patel RA;Regensteiner JG;Schanzer A;Shishehbor MH;Stewart KJ;Treat-Jacobson D;Walsh ME
自 1980 年以来，美国心脏病学会 (ACC) 和美国心脏协会 (AHA) 已将科学证据转化为临床实践指南，并提供改善心血管健康的建议。这些指南基于评估和分类证据的系统方法，为优质心血管护理奠定了基石。为了响应医学研究所的报告以及评估新知识并保持护理点相关性的任务，ACC/AHA 临床实践指南工作组（工作组）修改了其方法。指南、数据标准、适当使用标准和绩效衡量标准之间的关系在别处讨论。实践指南提供适用于患有或有患心血管疾病风险的患者的建议。重点是美国的医疗实践，但与其他组织合作制定的指南可能有更广泛的目标。尽管指南可用于告知监管或付款人决策，但其目的是提高护理质量并符合患者的利益。指南旨在定义满足大多数（但不是全部）情况下患者需求的实践，并且不应取代临床判断。工作组每年对指南进行审查，并且该指南是 ACC 和 AHA 的官方政策。每项指南均被视为最新指南，直至其被更新、修订或被已发布的附录、澄清声明、重点更新或修订后的全文指南取代。为了确保指南保持最新状态，每半年审查一次新数据，以确定是否应修改建议。一般来说，完整修订版以 5 年为一个周期发布。流程已经发展到支持指南作为可以动态更新的“活动文档”的演变。该过程描述了解决特定临床问题的建议，随后是简洁的文本（最好<250字）和支持性证据的超链接。这种方法可以满足忙碌的临床医生的时间限制，并有助于通过电子搜索引擎和其他不断发展的技术更轻松地获取建议。写作委员会成员审查文献；权衡支持或反对特定测试、治疗或程序的证据质量；并估计预期的健康结果。在制定建议时，写作委员会使用基于所有可用数据的循证方法。文献检索侧重于随机对照试验 (RCT)，但也包括登记、非随机比较和描述性研究、病例系列、队列研究、系统评价和专家意见。仅引用选定的参考文献。工作组认识到需要建立客观、独立的证据审查委员会 (ERC)，其中包括方法学家、流行病学家、临床医生和生物统计学家，他们系统地调查、抽象和评估证据，以解决 PICOTS 格式中提出的系统审查问题（P=总体、I=干预、C=比较者、O=结果、T=时间、S=设置）。实际考虑因素，包括时间和资源限制，将 ERC 限制为与关键临床问题相关的证据，并有助于进行可能影响相应建议强度的系统审查和分析。术语“指南指导的管理和治疗”(GDMT) 是指主要由 ACC/AHA I 类建议定义的护理。对于这些和所有推荐的药物治疗方案，读者应使用产品说明书材料确认剂量，并仔细评估禁忌症和相互作用。建议仅限于在美国批准用于临床的治疗、药物和设备。建议类别（COR；即建议的强度）包括与风险成比例的预期收益大小和确定性。证据水平 (LOE) 根据临床试验和其他报告数据的类型、质量、数量和一致性对支持干预效果的证据进行评级（表 1）。除非另有说明，否则建议按 COR 排序，然后按 LOE 排序。如果存在比较数据，则首选策略优先。当同一 COR 和 LOE 中存在 > 1 种药物、策略或疗法并且没有可用的比较数据时，选项按字母顺序列出。 ACC 和 AHA 在没有商业支持的情况下赞助了该指南，成员自愿贡献时间。工作组积极避免因与行业或其他实体 (RWI) 的关系而可能出现的实际、潜在或感知的利益冲突。所有写作委员会成员和审稿人都必须从开始写作工作前 12 个月起披露当前的行业关系或个人兴趣。 RWI 的管理包括选择一个平衡的写作委员会，并确保主席和大多数委员会成员没有相关的 RWI（附录 1）。会员在其 RWI 适用的部分撰写或投票时受到限制。为了提高透明度，会员的综合披露信息可在线获取。工作组的综合披露信息也可在线获取。工作组力求避免偏见，方法是从代表不同地理区域、性别、种族、知识观点/偏见和临床实践范围的广泛背景中选择专家，并邀请具有相关兴趣和专业知识的组织和专业协会作为合作伙伴或合作者参与。管理患有多种疾病的患者可能很复杂，特别是当适用于共存疾病的建议不一致或相互作用时。该指南旨在定义在大多数（但不是所有）情况下满足患者需求的实践。这些建议不应取代临床判断。只有遵循指南建议的管理才有效。通过临床医生和患者之间的共同决策，以及患者根据个人价值观、偏好以及相关条件和合并症选择干预措施，可以增强对建议的遵守。因此，可能会出现适当偏离这些准则的情况。
Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines with recommendations to improve cardiovascular health. These guidelines, based on systematic methods to evaluate and classify evidence, provide a cornerstone of quality cardiovascular care. In response to reports from the Institute of Medicine and a mandate to evaluate new knowledge and maintain relevance at the point of care, the ACC/AHA Task Force on Clinical Practice Guidelines (Task Force) modified its methodology. The relationships among guidelines, data standards, appropriate use criteria, and performance measures are addressed elsewhere. Practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The focus is on medical practice in the United States, but guidelines developed in collaboration with other organizations may have a broader target. Although guidelines may be used to inform regulatory or payer decisions, the intent is to improve quality of care and align with patients' interests. Guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances, and should not replace clinical judgment. Guidelines are reviewed annually by the Task Force and are official policy of the ACC and AHA. Each guideline is considered current until it is updated, revised, or superseded by published addenda, statements of clarification, focused updates, or revised full-text guidelines. To ensure that guidelines remain current, new data are reviewed biannually to determine whether recommendations should be modified. In general, full revisions are posted in 5-year cycles. Processes have evolved to support the evolution of guidelines as “living documents” that can be dynamically updated. This process delineates a recommendation to address a specific clinical question, followed by concise text (ideally <250 words) and hyperlinked to supportive evidence. This approach accommodates time constraints on busy clinicians and facilitates easier access to recommendations via electronic search engines and other evolving technology. Writing committee members review the literature; weigh the quality of evidence for or against particular tests, treatments, or procedures; and estimate expected health outcomes. In developing recommendations, the writing committee uses evidence-based methodologies that are based on all available data. Literature searches focus on randomized controlled trials (RCTs) but also include registries, nonrandomized comparative and descriptive studies, case series, cohort studies, systematic reviews, and expert opinion. Only selected references are cited. The Task Force recognizes the need for objective, independent Evidence Review Committees (ERCs) that include methodologists, epidemiologists, clinicians, and biostatisticians who systematically survey, abstract, and assess the evidence to address systematic review questions posed in the PICOTS format (P=population, I=intervention, C=comparator, O=outcome, T=timing, S=setting). Practical considerations, including time and resource constraints, limit the ERCs to evidence that is relevant to key clinical questions and lends itself to systematic review and analysis that could affect the strength of corresponding recommendations. The term “guideline-directed management and therapy” (GDMT) refers to care defined mainly by ACC/AHA Class I recommendations. For these and all recommended drug treatment regimens, the reader should confirm dosage with product insert material and carefully evaluate for contraindications and interactions. Recommendations are limited to treatments, drugs, and devices approved for clinical use in the United States. The Class of Recommendation (COR; ie, the strength of the recommendation) encompasses the anticipated magnitude and certainty of benefit in proportion to risk. The Level of Evidence (LOE) rates evidence supporting the effect of the intervention on the basis of the type, quality, quantity, and consistency of data from clinical trials and other reports (Table 1). Unless otherwise stated, recommendations are sequenced by COR and then by LOE. Where comparative data exist, preferred strategies take precedence. When >1 drug, strategy, or therapy exists within the same COR and LOE and no comparative data are available, options are listed alphabetically. The ACC and AHA sponsor the guidelines without commercial support, and members volunteer their time. The Task Force zealously avoids actual, potential, or perceived conflicts of interest that might arise through relationships with industry or other entities (RWI). All writing committee members and reviewers are required to disclose current industry relationships or personal interests, from 12 months before initiation of the writing effort. Management of RWI involves selecting a balanced writing committee and assuring that the chair and a majority of committee members have no relevant RWI (Appendix 1). Members are restricted with regard to writing or voting on sections to which their RWI apply. For transparency, members' comprehensive disclosure information is available online. Comprehensive disclosure information for the Task Force is also available online. The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds representing different geographic regions, sexes, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators. Managing patients with multiple conditions can be complex, especially when recommendations applicable to coexisting illnesses are discordant or interacting. The guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances. The recommendations should not replace clinical judgment. Management in accordance with guideline recommendations is effective only when followed. Adherence to recommendations can be enhanced by shared decision making between clinicians and patients, with patient engagement in selecting interventions on the basis of individual values, preferences, and associated conditions and comorbidities. Consequently, circumstances may arise in which deviations from these guidelines are appropriate.