2019年期刊公开发表的中国临床实践指南文献调查与评价——证据质量和推荐强度

目的调查2019年期刊公开发表的中国临床实践指南证据质量和/或推荐强度分级现状,以期为指南制订者合理应用证据质量和推荐强度分级方法提供参考。方法系统检索并筛选2019年期刊公开发表的中国临床实践指南,纳入对推荐意见进行证据质量和/或推荐强度分级的指南。提取证据质量和推荐强度的分级方法、分级描述和表述内容等信息。结果 2019年期刊公开发表的中国临床实践指南共226篇,其中106篇(46.9%)(中文87篇,英文19篇)纳入本研究。采用的分级方法共18种,其中推荐意见分级评价、制订与评估(Grading of Recommendations Assessment, Development and Evaluation, GRADE)分级系统应用最多(35.8%,38/106);采用的分级描述共6种,证据质量分级描述多采用字母(39.6%,42/106),推荐强度分级描述多采用文字(34.9%,37/106)。采用文字描述推荐强度的指南中,最常使用的词语是"可以"。38篇指南采用GRADE分级,仅15篇按照GRADE工作组要求规范呈现分级标准及内容,共包含250条分级明确的推荐意见,60.4%(151/250)为强推荐,44.8%(112/250)的推荐意见引用低或极低质量证据,38.4%(96/250)的推荐意见采用系统评价作为证据支持。结论 2019年期刊公开发表的中国指南分级系统使用率较低,且分级方法使用仍不完整、不统一、不规范。GRADE分级系统使用率低,仅极少数指南按照GRADE工作组要求规范呈现分级标准及内容。推荐使用GRADE分级系统,促进指南推荐意见的科学、透明与合理制订。     

脑卒中康复临床实践指南推荐意见研究

目的 分析国内外脑卒中康复临床实践指南的推荐意见内容,为脑卒中康复临床实践指南的制订和使用人员提供参考和建议。方法 系统检索PubMed、EMBASE、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方数据库及指南相关网站,时间为从建库之日起至2020年1月,搜集国内外脑卒中康复临床实践指南,参照世界卫生组织指南制订手册(第二版)的流程,对国内外脑卒中康复临床实践指南主要关注的康复内容、推荐意见是否基于证据、基于证据的类型及证据分级范围进行分析。结果 共纳入12篇脑卒中康复临床实践指南,其中中文1篇,英文11篇。制订国家包括美国(3篇)、英国(3篇)、加拿大(3篇)、澳大利亚(2篇)和中国(1篇),发表时间为2005年9月至2019年2月。脑卒中康复临床实践指南中质量评价采用指南研究与评价(AGREE)的有3篇(25.0%),分级系统采用GRADE的有2篇(16.7%)。指南推荐意见内容涉及领域有:认知功能障碍4个维度,推荐最多为认知功能的评估(7篇,66.7%);言语及吞咽功能障碍5个维度,推荐最多为吞咽相关并发症(10篇,83.3%);运动功能障碍6个维度,推荐最多为对痉挛的治疗(10篇,83.3%);心理及行为功能障碍4个维度,推荐最多为评估(6篇,50.0%)。4个领域推荐意见中基于的证据类型不一,多为观察性研究和/或随机对照试验。结论 推荐意见基于的证据类型和推荐强度分级不尽相同。建议脑卒中康复临床实践指南制订应该参照世界卫生组织指南制订手册的方法和流程规范推荐意见的撰写,提高康复指南的整体质量和可实施性,并进一步提高康复的质量和安全性。     

2019年期刊公开发表的中国临床实践指南文献调查与评价——引文分析

  目的  调查2019年期刊公开发表的中国临床实践指南推荐意见的证据引用现状,为合理利用研究证据支撑指南推荐意见提供参考。  方法  系统检索并筛选2019年期刊公开发表的中国临床实践指南,纳入有明确推荐意见、证据质量分级和相应分级说明的指南,提取指南推荐意见的引文信息并对其进行分析。  结果  共纳入指南31篇(中文29篇,英文2篇),包含568条推荐意见(平均每篇指南包含18条推荐意见)和3126篇引文,其中2541条引文作为证据在指南推荐意见说明中呈现(此类引文,下文简称“证据”)。平均每篇指南引用82篇证据,平均每条推荐意见引用4篇证据。证据来源位居前3位的国家依次为中国(28.8%)、美国(25.9%)和英国(7.0%)。发表于近5年的证据仅占比39.2%(995/2541)。证据文献类型主要为随机对照试验(26.9%),系统评价仅占比12.0%。  结论  2019年期刊公开发表的中国指南,存在未明确列出推荐意见及对支撑推荐意见的证据引用不全面、实效性差等问题。指南制订者应合理利用当前可得的研究证据,进一步提高我国临床实践指南的制订质量。     

2019年期刊公开发表的中国临床实践指南文献调查与评价——证据质量和推荐强度

目的 调查2019年期刊公开发表的中国临床实践指南证据质量和/或推荐强度分级现状,以期为指南制订者合理应用证据质量和推荐强度分级方法提供参考.方法 系统检索并筛选2019年期刊公开发表的中国临床实践指南,纳入对推荐意见进行证据质量和/或推荐强度分级的指南.提取证据质量和推荐强度的分级方法、分级描述和表述内容等信息.结果...     

康复临床实践指南:发展现状研究

目的 分析康复临床实践指南的发展现状和存在的问题,为制订康复临床实践指南提供参考和借鉴。方法 检索PubMed、EMBASE、中国生物医学文献数据库(CBM)、中国知网(CNKI)、万方数据库、医脉通、英国国家卫生与临床优化研究所(NICE)、美国国立指南文库(NGC)、苏格兰校际指南协作网(SIGN)、世界卫生组织(WHO)、国际指南协作网(GIN)等数据库和指南相关网站,搜索国内外已发布的康复临床实践指南,检索时限均从建库至2020年1月11日。根据纳入和排除标准筛选文献,提取纳入指南的发表年代、国家、期刊、发布机构、涉及的健康问题和制订方法等数据,并做描述性统计分析。结果 共纳入康复临床实践指南84篇,其中中文17篇,英文67篇。康复临床实践指南发表量位于前4位的国家是美国(19篇)、中国(17篇)、英国(12篇)和加拿大(11篇),制订指南的机构主要是各医学专业学会和协会(49篇)。康复临床实践指南发表量位于前5位的疾病为脑卒中(12篇)、心血管疾病(9篇)、肩关节损伤(5篇)、肺部疾病(5篇)和脊髓损伤(5篇)。35篇(42%)指南的推荐意见有证据分级和推荐强度;22篇(26%)指南指出会定期更新推荐意见。结论 康复临床实践指南数量较少,纳入指南聚焦的健康问题主要为神经、肌肉骨骼系统疾病,以及心肺功能障碍康复。多数指南的推荐意见以文献综述或专家意见为主,少数指南基于循证方法系统制订,康复指南的制订需要进一步规范化。     

腹膜透析患者运动管理方案的最佳证据总结

目的 总结了腹膜透析患者运动管理方案的最佳证据,为腹膜透析患者运动管理临床实践提供参考。方法 检索国内外中英文相关指南和专家共识库、循证资源数据库、原始研究数据库、护理学专业数据库中关于腹膜透析患者运动管理方案的文献,包括临床决策、临床实践指南、最佳临床实践、证据汇总、专家共识、系统评价以及随机对照试验。然后,基于文献质量评价系统和证据分级系统进行文献质量分析、证据汇总和制定推荐意见。结果 最终共纳入20篇文献,包括1篇临床指南、1篇专家共识、6篇系统评价以及12篇随机对照试验,并从6个方面总结了11条最佳证据。结论 医护人员应在安全性原则下根据腹膜透析患者的意愿、临床实践情况制定个体化运动处方,提高患者远期存活率。     

埃博拉病毒病个人防护装备使用的证据总结

目的:系统检索并提取埃博拉病毒病个人防护装备最新、最佳使用证据,并形成证据总结。方法:计算机检索Cochrane Library、Pub Med、EMbase、Joanna Briggs(JBI)循证图书馆、加拿大临床实践指南数据库、世界卫生组织(WHO)、美国疾病预防控制中心(CDC)、美国指南网(NGC)、中国生物医学文献数据库(CBMdisc)、万方数据库、中国国家卫生计生委和中国疾病预防控制中心网站内所有埃博拉病毒病个人防护装备相关证据,包括指南、证据总结、最佳实践信息册、推荐实践、系统评价、组织经验、专家意见、RCT以及经验总结等,由2名研究者对文献质量进行评价和证据提取。结果:共检索到原始研究24篇、指南类文献23篇,其中最佳实践指南5篇,以专家共识为基础的指南(暂时或快速指南)3篇,专家推荐实践2篇,专家意见1篇,组织经验4篇,最佳实践信息册4篇。提取证据共159条,再次采用JBI证据预分级及证据推荐级别系统(2014版)对证据的质量等级和推荐级别分别进行描述。结论:国外指南并不适宜直接翻译过来使用,需要进行修订或者证据提取,使之在实用性和可操作性方面更适于国人习惯。提取埃博拉病毒病个人防护装备使用的最新最佳证据或推荐,形成证据总结手册,经过专家评价后可直接应用于临床实践。     

低质量证据强推荐意见在中国护理实践指南中的现状分析

目的 分析中国护理实践指南中对低质量证据给予强推荐的现状。方法 计算机检索中国生物医学文献数据库（CMB）、中国期刊全文数据库（CNKI）、万方数据库（Wan Fang）、维普中文科技期刊数据库（VIP）以及复旦大学护理中心循证实践资源中的护理实践指南,并对纳入文献的参考文献进行手动补充检索。检索时限为2010年7月28日—2020年7月28日。由2位评价员按照研究纳排标准独立筛选指南及资料提取。结果 本研究共纳入指南15篇,总形成推荐意见778条,其中低/极低证据质量强推荐的条目达256（32.9%）条,40.0%（6/15）的指南低/极低质量强推荐条目超过总推荐意见条目的50%。结论 虽然目前国内临床护理实践指南的制订质量已有长足进步,但指南制订过程中推荐意见质量及推荐强度的确定仍需进一步规范。     

2015年欧洲肝病学会丙型肝炎治疗指南推荐意见

<正>欧洲肝脏学会(European Association for the Study of the Liver,EASL)新近发布了2015年丙型肝炎病毒(HCV)感染治疗指南,并在线发表于《Journal of Hepatology》杂志。本文对指南的推荐意见介绍如下。指南中提及的证据和推荐意见按照GRADE系统进行分级,证据强度分为高(A)、中(B)、低(C)3种水平,推荐意见分为强(1)、弱(2)两个级别。     

GRADE指南:Ⅰ.导论——GRADE证据概要表和结果总结表

本文是GRADE(Grading of Recommendations Assessment,Development,and Evaluation)系列文章的导论。该系列文章为使用GRADE系统提供指导,介绍如何将该系统用于系统评价、卫生技术评估(HTAs)及临床实践指南中备选方案的证据质量评价和推荐强度评级。GRADE方法始于提出一个明晰的问题,包括对所有重要结果的详细说明。证据被收集和汇总后,GRADE提供了明确的标准来评价其质量,包括研究设计、偏倚风险、不精确性、不一致性、间接性及效应量大小。根据支撑证据质量及备选方案带来的预期和非预期结果间的平衡情况,推荐强度以强/弱(或表述为"有条件的"/"任意的")作为特征。GRADE建议用简洁、透明、信息量丰富的结果总结表来汇总证据(以显示证据质量及每一重要结果的相对效应量和绝对效应量),和(或)以证据概要表形式额外提供证据质量评价理由的详细信息。本系列的后续文章涉及如何采用GRADE方法明确构建问题、评价证据质量及形成推荐意见。     

Evidence-based guidelines for blood transfusion

The AABB has initiated a process to develop evidence-based guidelines for blood transfusion to assist clinicians, other health professionals, and patients in their transfusion decisions. In this article, the author discusses the process of developing the recently published guidelines for plasma transfusion using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology.     

From MARS to MAGIC: The remarkable journey through time and space of the Grading of Recommendations Assessment,Development and Evaluation initiative

For over 30 years, “evidence‐based” clinical guidelines remained entrenched in an oversimplified, design‐based, framework for rating the strength of evidence supporting clinical recommendations. The approach frequently equated the rating of evidence with that of the recommendations themselves. “Grading Recommendations Assessment, Development and Evaluation (GRADE)” has emerged as a proposed antidote to obsolete guideline methodology. GRADE sponsors and collaborators are in the process of attempting to amplify and extend the framework to encompass implementation and adaptation of guidelines, above and beyond the evaluation and rating of clinical research. Alternative schemes and models for such extensions are beginning to appear. This commentary reviews the strengths and weaknesses of GRADE with reference to other recent critiques. It considers the GRADE Working Group's “evidence‐to‐decision” extension of the evidence rating framework, together with proposed alternatives. It identifies pitfalls of the GRADE system's cooptation of relational processes necessary to the interpretation and uptake of recommendations that properly belong to end‐users. It also identifies dangers inherent in blurring important boundaries between clinical and policy applications of guidelines. Finally, it addresses criticisms regarding the lack of a theoretical framework supporting the different facets of the GRADE approach and proposes a social constructivist orientation to clinical guideline development and use. Recommendations are offered to potential guideline developers and users regarding how to draw upon the strengths of the GRADE framework without succumbing to its pitfalls.     

中国全膝关节置换术围手术期疼痛管理指南(2022)

全膝关节置换术(total knee arthroplasty, TKA)是目前治疗终末期膝关节疾病的主要方法。TKA术后常伴有中度至重度的疼痛,严重影响患者术后康复、患者满意度和总体疗效。多模式镇痛被认为是缓解TKA术后疼痛的理想方案。目前尚无TKA围手术期疼痛管理指南。经中华医学会骨科学分会关节外科学组、北京医学会骨科专业委员会关节外科学组批准及专家讨论,采用推荐意见的分级评估、制定及评价方法及国际实践指南报告规范,遴选出最为关注的20个临床问题,通过证据检索、证据质量评价及确立推荐意见和强度,采用德尔菲法进行4轮函询,最终形成20条推荐意见。本指南的制定旨在提高TKA围手术期疼痛管理的规范化和标准化。     

Cross-sectional Analysis of Recommendations for the Treatment of Hip and Knee Osteoarthritis in Clinical Guidelines

ObjectiveTo compare guideline recommendations for hip and knee osteoarthritis (OA) and their level of evidence.Data SourcesMEDLINE, Embase, the Cochrane Library, and websites of professional societies were searched in June 2020 using keywords such as knee or hip osteoarthritis, degenerative arthritis, guideline, and practice guideline.Study SelectionGeneral treatment guidelines for OA of the hip or knee published in English. After 461 abstracts were screened, 31 publications (17 guidelines from 10 professional societies) were included for analysis.Data ExtractionThree reviewers assessed the quality of the guidelines according to the Appraisal of Guidelines for Research and Evaluation II tool. The rating of evidence and strength of recommendation was extracted and standardized into the Grading of Recommendations Assessment, Development, and Evaluation criteria.Data SynthesisOf the 17 guidelines included, 6 (35%) were of high quality, 10 (59%) of moderate quality, and 1 (6%) of low quality. Guidelines published after 2017 were of good quality. Although guidelines generally agreed on a nonsurgical multimodal concept, including patient education, exercise, and weight loss in obese, some recommendations remained vague and the level of evidence varied widely. In pharmacologic treatment, oral nonsteroidal anti-inflammatory drugs were the mainstay for pain management. Guidelines published after 2017 were more cautious in their recommendation for the use of paracetamol and strong opioids. Disagreement was observed for chondroitin sulfate, glucosamine, and intra-articular hyaluronic acid injections. Recommendations were conflicting for the use of insoles, braces, and transcutaneous electrical stimulation. The main indications for hip/knee arthroplasty were severe, persisting pain and loss of function despite nonsurgical treatment. No guideline defined a minimum time of conservative treatment before surgery.ConclusionsWe found a wide variation in evidence and strength of recommendations for OA treatment. Recommendations on when to refer patients for surgery remained unclear.     

Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2)

Acute kidney injury (AKI) is a common and serious problem affecting millions and causing death and disability for many. In 2012, Kidney Disease: Improving Global Outcomes completed the first ever international multidisciplinary clinical practice guideline for AKI. The guideline is based on evidence review and appraisal, and covers AKI definition, risk assessment, evaluation, prevention, and treatment. Two topics, contrast-induced AKI and management of renal replacement therapy, deserve special attention because of the frequency in which they are encountered and the availability of evidence. Recommendations are based on systematic reviews of relevant trials. Appraisal of the quality of the evidence and the strength of recommendations followed the Grading of Recommendations Assessment, Development and Evaluation approach. Limitations of the evidence are discussed and a detailed rationale for each recommendation is provided. This review is an abridged version of the guideline and provides additional rationale and commentary for those recommendation statements that most directly impact the practice of critical care.     

Systematic reviews and meta-analyses for more profitable strategies in peripheral artery disease

Abstract

Clearly defined processes exist for developing evidence-based guidelines in clinical medicine. Approaches such as the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) where recommendations are made on the basis of quality of evidence gathered in a systematic literature review are also appropriate for recommendations relating to nutritional management of disease. Strong recommendations are based on high-quality evidence derived from randomized controlled trials (RCTs). In nutritional studies, RCTs often examine risk factors and occasionally other surrogates of disease rather than clinical end-points. Criteria are suggested as to when such surrogates may be used. GRADE and similar approaches are less appropriate when considering recommendations regarding chronic disease prevention. Cancer develops over many years, and RCTs exploring nutritional measures to reduce risk are inappropriate. The World Cancer Research Fund (WCRF) has developed an approach in which recommendations are based on clearly defined ‘convincing’ or ‘probable’ relationships between nutritional variables and disease outcomes.

The WCRF criteria have been adapted for developing a wide range of policy recommendations which provide opportunities for those responsible for implementing policy to select options best suited to their purpose. Recommendations related to nutrition policy tend to evolve as a delicate balance between political wisdom and judgement of the scientific evidence. However, policy recommendations are important since they have the potential to create environments which are conducive to the behavioural changes required for improved nutrition.     

Going from evidence to recommendations: Can GRADE get us there?

The evidence based medicine movement has championed the need for objective and transparent methods of clinical guideline development. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was developed for that purpose. Central to this framework is criteria for assessing the quality of evidence from clinical studies and the impact that body of evidence should have on our confidence in the clinical effectiveness of a therapy under examination. Grades of Recommendation, Assessment, Development, and Evaluation has been adopted by a number of professional medical societies and organizations as a means for orienting the development of clinical guidelines. As a result, the method of GRADE has implications on how health care is delivered and patient outcomes. In this paper, we reveal several issues with the underlying logic of GRADE that warrant further discussion. First, the definitions of the “grades of evidence” provided by GRADE, while explicit, are functionally vague. Second, the “criteria for assigning grade of evidence” is seemingly arbitrary and arguably logically incoherent. Finally, the GRADE method is unclear on how to integrate evidence grades with other important factors, such as patient preferences, and trade‐offs between costs, benefits, and harms when proposing a clinical practice recommendation. Much of the GRADE method requires judgement on the part of the user, making it unclear as to how the framework reduces bias in recommendations or makes them more transparent—both goals of the programme. It is our view that the issues presented in this paper undermine GRADE's justificatory scheme, thereby limiting the usefulness of GRADE as a tool for developing clinical recommendations.