Appraisal of the Quality and Contents of Clinical Practice Guidelines for Hypertension Management in Chinese Medicine: A Systematic Review

Objective: To evaluate the quality and consistency of recommendations in the clinical practice guidelines(CPGs) for hypertension in Chinese medicine(CM). Methods: CM CPGs were identified from 5 electronic databases and hand searches through related handbooks published from January 1990 to December 2013. Three reviewers independently appraised the CPGs based on the Appraisal of Guidelines for Research and Evaluation(AGREE Ⅱ) instrument, and compared the CPGs' recommendations on CM syndrome pattern classification and treatment. Results: Five CM CPGs for hypertension were included. The quality score of the evidence-based(EB) guideline was higher than those of the consensus-based with no explicit consideration of evidence-based(CB-EB) and the consensus-based(CB) guidelines. Three out of five patterns in the CPGs were recommended by the EB guideline. Tianma Gouteng Formula(天麻钩藤复方) in the EB guideline was recommended mostly for hypertension patients with pattern of ascendant hyperactivity of Gan(Liver)-yang and pattern of yin deficiency with yang hyperactivity in the CPGs. Acupuncture and massage were recommended for Grade Ⅰ and Grade Ⅱ hypertension with severe symptoms weakening the quality of life in the EB guideline. For Grade Ⅰ and Grade Ⅱ hypertension, CM could be used alone, while for Grade Ⅲ hypertension, they should be used in combination with Western medicines. Conclusion: The quality of EB guideline was higher than those of CB and CB-EB CPGs in CM for hypertension and CM should be prescribed alone or combined with Western medicines based on the grade of hypertension.     

慢性鼻窦炎指南的评价与内容分析

背景　慢性鼻窦炎是耳鼻喉科高发疾病，对患者造成严重的影响和经济负担，但目前国内外慢性鼻窦炎诊疗指南推荐意见存在差异。目的　对慢性鼻窦炎诊疗指南进行质量评价并分析其治疗意见，为指南制定和推荐意见的采纳提供建议。方法　于2019年2月检索中英文数据库和各专业指南网站获取相关文献，同时追踪参考文献，筛选适用于青少年及成年人的推荐意见中包含对慢性鼻窦炎的治疗意见的指南。检索时间为建库至检索日期。使用临床指南研究与评估系统Ⅱ（AGREE Ⅱ）和卫生保健实践指南报告清单（RIGHT）对纳入指南的方法学质量和报告质量进行评价，并绘制气泡图和思维导图，对比分析关于慢性鼻窦炎治疗的推荐意见。结果　最终纳入8部指南，AGREE Ⅱ评价总分平均为48.76%（30.90%~73.09%），仅2部指南强烈推荐使用（得分>60%），其余6部需修订后推荐。RIGHT条目总体报告率为34.29%~65.71%，其中评审和质量控制方面报告率均为0。指南推荐一致的治疗方法包括皮质类固醇、鼻腔盐水冲洗和手术治疗，以及过敏者口服抗组胺药，可选用的措施包括细菌溶解物、黏痰溶解药、质子泵抑制剂、植物疗法、辣椒素、亮氨酸拮抗剂、鼻用呋塞米、木糖醇盐水冲洗液、次氯酸钠盐水冲洗液、含婴儿香波的盐水冲洗液，尚无统一观点的治疗措施包括抗生素、减充血剂、白三烯受体拮抗剂、IgE拮抗剂及阿司匹林加重呼吸系统疾病患者阿司匹林脱敏治疗。结论　现有慢性鼻窦炎诊疗指南制定方法及其报告质量需提高，建议纳入患者的偏好、使用统一的评价工具和考虑运用性。推荐意见有冲突时，建议参考制定方法更为严谨的指南。     

Quality Assessment of Clinical Practice Guidelines for Integrative Medicine in China: A Systematic Review

Objective: To assess the quality of integrative medicine clinical practice guidelines(CPGs) published before 2014. Methods: A systematic search of the scientific literature published before 2014 was conducted to select integrative medicine CPGs. Four major Chinese integrated databases and one guideline database were searched: the Chinese Biomedical Literature Database(CBM), the China National Knowledge Infrastructure(CNKI), China Science and Technology Journal Database(VIP), Wanfang Data, and the China Guideline Clearinghouse(CGC). Four reviewers independently assessed the quality of the included guidelines using the Appraisal of Guidelines for Research and Evaluation(AGREE) Ⅱ Instrument. Overall consensus among the reviewers was assessed using the intra-class correlation coefficient(ICC). Results: A total of 41 guidelines published from 2003 to 2014 were included. The overall consensus among the reviewers was good [ICC: 0.928; 95% confidence interval(CI): 0.920 to 0.935]. The scores on the 6 AGREE domains were: 17% for scope and purpose(range: 6% to 32%), 11% for stakeholder involvement(range: 0 to 24%), 10% for rigor of development(range: 3% to 22%), 39% for clarity and presentation(range: 25% to 64%), 11% for applicability(range: 4% to 24%), and 1% for editorial independence(range: 0 to 15%). Conclusions: The quality of integrative medicine CPGs was low, the development of integrative medicine CPGs should be guided by systematic methodology. More emphasis should be placed on multi-disciplinary guideline development groups, quality of evidence, management of funding and conflicts of interest, and guideline updates in the process of developing integrative medicine CPGs in China.     

中医临床实践指南评价的思路和方法

指南制定的目的在于应用,没有应用,任何指南都是废纸一张。质量评价和适用性评价是保证指南作用发挥的前提。中医共识临床实践指南和中医循证临床实践指南是中医临床实践指南的主体。中医循证临床实践指南宜在指南发布前,采用AGREEⅡ进行质量评价,为指南使用者提供参考。中医共识临床实践指南应在指南推广应用中,采用《中医临床诊疗指南适用性调查问卷》评价,为指南进一步制修订提供依据。     

《临床指南研究与评价系统Ⅱ》简介

临床指南在医患临床决策和卫生政策制定时起着重要作用。在指南制定过程中由于方法学和制定策略的不足,导致指南的质量良莠不齐,因此,对指南进行研究和评价具有重要意义。2003年发表的第1版《临床指南研究与评价系统》（Appraisal of Guidelines for Research and Evaluation,AGREE）对指南的质量保证和成功实施产生了重要作用,目前已得到广泛支持和认同。2009年,AGREE国际协作组织对2003版AGREE修正后制定出新的AGREE即AGREEII。目前,AGREE1I已取代2003版AGREE,但国内尚没有AGREEⅡ的相关介绍。本文作者对AGREEⅡ作一介绍,以期其利于指南的研究和评价。     

Study on the Methodology of Developing Evidence-Based Clinical Practice Guidelines of Chinese Medicine

At present,evidence-based clinical practice guideline(EBCPG) is the main mode of developing clinical practice guidelines(CPGs) in the world,but in China,most of CPGs of Chinese medicine(CM) are still guidelines based on expert consensus.The objective of this study is to construct initially the methodology of developing EBCPGs of CM and to promote the development of standardization of CM.Based on the development of "Guideline for Diagnosis and Treatment of Common Pediatric Diseases in CM",the methodology of developing EBCPG of CM was explored by analyzing the pertinent literature and considering the characteristics of CM.In this study,the key problem was to put forward the suggestion and strategies.However,due to the methodology study of developing EBCPG of CM is still in the initial stage,there are still some problems which need further study.     

Assessing the Quality of the First Batch of Evidence-Based Clinical Practice Guidelines in Traditional Chinese Medicine

Objective: To assess the quality of the first batch of Chinese evidence-based clinical practice guidelines (CPGs) in Traditional Chinese Medicine (TCM) using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. Methods: Evidence-based CPGs in TCM supported by the World Health Organization Western Pacific Regional Office (WHO/WPRO) and whose development was organized by the China Academy of Chinese Medical Sciences were identified and manually retrieved. CPGs were assessed using the AGREE instrument, and the data in each CPG were analyzed in terms of the six domains in the AGREE instrument: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and editorial independence. Results: Twenty-eight CPGs were identified, of which 26 were included in the study. The AGREE instrument rated the 26 CPGs in terms of the six domains. The assessment results showed the following average scores: for editorial independence, 84.16%; for rigor of development, 80.95%; for scope and purpose, 79.96%; for clarity and presentation, 70.88%; for stakeholder involvement, 61.28%; for applicability, the average score was only 27.09%. In summary, nine CPGs were rated as "strongly recommended", six as "recommended with provision or alternation", and 11 as "unsure". Conclusion: Most of the first batch of Chinese evidence-based CPGs in TCM had significant shortcomings in applicability. It is suggested that special attention be paid to enhancing the quality of applicability when developing evidence-based CPGs in TCM.     

Towards evidence-based clinical practice guidelines in Saudi Arabia

The objective of this review is to provide a brief background on clinical practice guidelines CPGs and tools to assess and locally adapt CPGs. Over the last 2 decades, CPGs have become an increasingly popular tool for synthesis of clinical information, so as to change clinical practice and improve quality of health care. Such a quantitative growth in the number of guidelines available in different specialties is a source of concern since there is evidence that recommendations produced by different groups can be conflicting, invalid, unreliable, and even harmful. Various critical appraisal instruments were designed and tested to assess whether developers have minimized the biases inherent in creating guidelines and addressed the requirements for effective implementation. We recommend using the AGREE instrument which was developed by the Appraisal of Guideline Research and Evaluation AGREE collaboration. It is the most well-developed guideline appraisal instrument available, and it has been shown to have good reliability and validity. There is a growing recognition that it is not possible for national guidelines to be produced on every clinical problem of concern. The cost is huge and few practices have the resources or skills to develop their own valid evidence-based guidelines. Several developed countries encourage local adaptation of international good quality guidelines to avoid duplication of work and cost involved in guidelines development. Therefore wherever possible, Saudi guidelines should be based on existing good quality guidelines. The methodology for local adaptation of CPGs to meet the local needs and resources are explained in this review.     

中医和中西医结合临床指南制定的现状与问题

随着临床循证指南的广泛应用及中医药规范化工作的开展,各类中医或中西医临床指南也在逐渐增多。借助指南质量评估工具对2008年10月前公开发表的11个中医和中西医结合临床指南进行初步评价,大部分指南未描述证据收集和综合证据的方法,仅1篇说明推荐意见的证据分级标准,存在指南制作不够规范,编写人员专业背景单一,缺乏高级别的证据等问题。建议成立多学科组成的指南制定小组,注重证据并严格遵循循证指南制订的原则和流程,建立符合中医文献自身特点的证据评价和分级方法,注重中医指南的适用性与指导性,并加强对指南质量的评估。     

Proceedings of the 1994 Canadian Clinical Practice Guidelines Network Workshop

A workshop on the Clinical Practice Guidelines (CPG) Network was held in Ottawa on Oct. 31 and Nov. 1, 1994. Five plenary sessions focused on CPGs and the roles of organizations, priority setting, dissemination and implementation, evaluation, and establishment of a network of individuals and organizations active in the CPG field. In general, the participants identified consumers as important stakeholders in CPG processes and agreed that there was a role for national coordination and information gathering, however, local and regional bodies have a role in CPG development, dissemination and implementation. Burden of illness and likeliness that the guidelines would affect the burden were key criteria for setting priorities. Eighteen high-priority topics were identified for CPG development and dissemination. Methods to enhance the effectiveness of dissemination and implementation were identified: improved funding, enhanced research and decreased duplication of effort. Barriers to CPG evaluation were lack of funding and inadequate data sources. Voluntary self-audit was the preferred evaluation method. The participants agreed on three important functions of the network: facilitation, cooperation and communication, operation of a central CPG information centre, and provision of expertise in CPG processes. They also agreed to the use of an existing organization as a secretariat for the network, with a voluntary, informal membership of all those interested.     

Report on activities and attitudes of organizations active in the clinical practice guidelines field.

The organizing committee of a workshop on clinical practice guidelines (CPGs) surveyed invited organizations on their attitudes and activities related to five topics to be covered during the workshop sessions: organizational roles, priority setting, guidelines implementation, guidelines evaluation and development of a network of those active in the CPG field. Organizational roles: The national specialty societies were felt to have the largest role to play; the smallest roles were assigned to consumers, who were seen to have a role mainly in priority setting, and to industry and government, both of which were seen to have primarily a funding role. Many barriers to collaboration were identified, the solutions to all of which appeared to be better communication, establishment of common principles and clear role definitions. Priority setting: There was considerable agreement on the criteria that should be used to set priorities for CPG activities: the burden of disease on population health, the state of scientific knowledge, the cost of treatment and the economic burden of disease on society were seen as important factors, whereas the costs of guidelines development and practitioner interest in guidelines development were seen as less important. Organizations were unable to give much information on how they set priorities. Guidelines implementation: Most of the organizations surveyed did not actively try to ensure the implementation of guidelines, although a considerable minority devoted resources to implementation. The 38% of organizations that implemented guidelines actively listed a wide variety of activities, including training, use of local opinion leaders, information technology, local consensus processes and counter detailing. Guidelines evaluation: Formal evaluation of guidelines was undertaken by fewer than 13% of the responding organizations. All the evaluations incorporated assessments before and after guideline implementation, and some used primary patient data. Barriers to evaluation included lack of money, time, data or expertise. CPG Network: Most of the respondents felt that all organizations and individuals interested or involved in guidelines should form the membership of the network. The three most important functions of such a network were deemed to be (a) to facilitate collaboration among those involved in the CPG process, (b) to maintain an information centre on CPGs and (c) to provide expertise to the CPG process. It was felt that the network should have some formal structure and communicate through e-mail and print media.     

难治性胃食管反流病临床指南的系统评价

背景　当前,难治性胃食管反流病的发病率呈现逐年上升趋势,而难治性胃食管反流病的诊疗规范尚未形成统一的共识意见,这使得临床上对难治性胃食管反流病患者的管理变得复杂,并且不同指南对于我国患者的适用性尚有待明确。目的　系统评价难治性胃食管反流病临床指南,以期为临床使用提供参考。方法　计算机检索PubMed、EMBase、Guidelines International Network（GIN）、National Guideline Clearinghouse（NGC）、National Institute for Health and Care Excellence（NICE）、American Gastroenterology Association（AGA）和World Health Organization（WHO）官网,以及中国知网、万方数据知识服务平台、维普网及医脉通,检索时限均为2004年1月—2018年1月。由2位研究者按照纳入与排除标准独立筛选文献、提取资料。采用AGREE Ⅱ系统评价纳入指南的证据质量和推荐强度,AGREE Ⅱ评估系统包括范围和目的、参与人员、严谨性、清晰性、应用性和编辑独立性。使用组内相关系数（ICC）进行研究者间一致性检验。结果　最终纳入5篇指南,发表时间跨度为2009—2016年。其中美国2篇,日本、中国和亚太地区各1篇。5篇指南AGREE Ⅱ评价平均得分依次为“范围和目的”88.33%、“清晰性”86.66%、“严谨性”72.08%、“参与人员”69.99%、“应用性”68.33%和“编辑独立性”20.00%,指南总体推荐级别均为B级。各指南推荐意见较为一致。结论　目前世界难治性胃食管反流病指南质量一般,尤其在“编辑独立性”领域还需特别加强。我国尚未见独立的难治性胃食管反流病指南,仅有难治性胃食管反流病专家共识,且质量还有待进一步提高。应尽快制定符合我国国情的难治性胃食管反流病循证指南,以期为临床实践提供更好的诊疗措施。     

Clinical Practice Guideline of Integrative Chinese and Western Medicine for Acute Myocardial Infarction

With increasing morbidity and mortality, acute myocardial infarction (AMI) has become one of the major causes of human death, leading to heavy burdens to individuals, families and society. Previous researches have found that though large amount of resources and great effort were devoted, no significant improvements were achieved in reducing the in-hospital mortality of AMI patients. Meanwhile, extensive studies about Chinese medicine (CM) have found that CM has special advantages in treating AMI patients. However, there is no standardized and unified clinical practice guideline (CPG) of CM for AMI. Therefore, a CPG with strict standard and generally acknowledgement is urgent to be established. This guideline was developed following the methodological process established by the World Health Organization Handbook for Guideline Development. Extensive search on clinical evidences including systematic review (SR), randomized controlled trial (RCT), observational study and case reports was launched, covering evidence of CM for AMI on several aspects, such as diagnosis, CM patterns, CM interventions on AMI and complications, cardiac rehabilitation and clinical pathway management. Besides, the application of Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach enabled the evaluation of evidence and formulation of grade of recommendation (GOR) and level of evidence (LOE). With the help of GOR and LOE, this CPG recommends the integrative CM and WM treatment method in AMI patients and provides useful information on medical decision for clinical physicians.     

国内临床指南发展现状及国内外指南比较分析

目的了解国内临床指南发展概况。方法电子检索结合人工检索方法收集题名为“临床指南”、“临床实践指南”、“防治指南”的临床书籍310本,分析其中的111本指南;使用AGREE工具对8本指南进行质量评分。结果(1)111本指南中,6．31％的指南编写成员来自多个相关专业领域,2．70％的指南涉及有关循证医学知识、支持证据方面的信息,27．03％的临床指南附有参考文献,指南中没有对潜在费用影响进行讨论,没有指南给出出版前是否进行试用的信息;(2)对8本指南的评分显示：3本国内指南可以推荐使用,但与国外3本指南(积极推荐使用)相比存在差距;2本国内指南不推荐使用。结论国内出版的指南数量较少、多数指南的质量较差、权威性较低,具有真正意义上的临床指南寥寥无几,很有必要在这方面给予更多的关注与努力。     

Recommendations for Acupuncture in Clinical Practice Guidelines of the National Guideline Clearinghouse

Objective: To organize the clinical practice guidelines(CPGs) related to acupuncture included in the National Guideline Clearinghouse(NGC) to systematically summarize the diseases and disorders most commonly treated with acupuncture, the strength of recommendations for acupuncture and the quality of evidence. Methods: The NGC database was systematically searched for guidelines that included acupuncture as an intervention. Two independent reviewers studied the summaries and the full texts of the guidelines and included guidelines based on the inclusion and exclusion criteria. Thirty-nine guidelines were collected with 80 recommendations. The Appraisal of Guidelines for Research and Evaluation(AGREE) Ⅱ instrument was used to assess the quality of these guidelines. Results: Of the 80 recommendations on acupuncture, 49 recommendations were clearly for acupuncture, 25 recommendations were against acupuncture and 6 recommendations did not indicate any clear recommendations, 37 recommendations were for painful diseases/disorders, and 12 recommendations were for non-painful diseases/disorders. Locomotor system disorders were the most common in the painful diseases/disorders category. Out of all the recommendations for acupuncture, most recommendations(87.76%) were weak in strength, and most of the evidence(40.84%) was of low quality. Conclusion: In the National Guideline Clearinghouse, the recommendations for acupuncture focus on painful diseases/disorders. The recommendations in the guidelines are not high in strength, and most of the evidence is moderate or low in quality.     

Guidelines for the use of carotid endarterectomy: current recommendations from the Canadian Neurosurgical Society

OBJECTIVE: To develop guidelines on the suitability of patients for carotid endarterectomy (CEA). OPTIONS: For atherosclerotic carotid stenosis that has resulted in retinal or cerebral ischemia: antiplatelet drugs or CEA. For asymptomatic carotid stenosis: CEA or no surgery. OUTCOMES: Risk of stroke and death. EVIDENCE: Trials comparing CEA with nonsurgical management of carotid stenosis. VALUES: Greatest weight was given to findings that were highly significant both statistically and clinically. BENEFITS, HARMS AND COSTS: Benefit: reduction in the risk of stroke. Major harms: iatrogenic stroke, cardiac complications and death secondary to surgical manipulations of the artery or the systemic stress of surgery. Costs were not considered. RECOMMENDATIONS: CEA is clearly recommended for patients with surgically accessible internal carotid artery (ICA) stenoses equal to or greater than 70% of the more distal, normal ICA lumen diameter, providing: (1) the stenosis is symptomatic, causing transient ischemic attacks or nondisabling stroke (including retinal infarction); (2) there is no worse distal, ipsilateral, carotid distribution arterial disease; (3) the patient is in stable medical condition; and (4) the rates of major surgical complications (stroke and death) among patients of the treating surgeon are less than 6%. Surgery is not recommended for asymptomatic stenoses of less than 60%. Symptomatic stenoses of less than 70% and asymptomatic stenoses of greater than 60% are uncertain indications. For these indications, consideration should be given to (1) patient presentation, age and medical condition; (2) plaque characteristics such as degree of narrowing, the presence of ulceration and any documented worsening of the plaque over time; (3) other cerebral arterial stenoses or occlusions, or cerebral infarcts identified through neuroimaging; and (4) surgical complication rates at the institution. CEA should not be considered for asymptomatic stenoses unless the combined stroke and death rate among patients of the surgeon is less than 3%. VALIDATION: These guidelines generally agree with position statements prepared by other organizations in recent years, and with a January 1995 consensus statement by a group of experts assembled by the American Heart Association.     

Guidelines for cochlear implantation in Saudi Arabia

This study aim to establish unified clinical practice guidelines (CPGs) for adults and pediatric cochlear implantation (CI) for the Ministry of Health specialist hospitals in the Kingdom of Saudi Arabia. A comprehensive literature review was carried out by a task force group. Guidelines were based on evidence-based medicine including institutions and individuals’ experiences. Bilateral CI is recommended for adults and pediatrics with bilateral severe/profound hearing loss. The minimum age of implantation for children is recommended at 9 months. This study provides a safe framework for the multidisciplinary team to select appropriate CI candidates. It is important to establish a comprehensive multidisciplinary team covering different aspects of health care providers.     

Exploration of Stratified Evidence Scoring Method of Acupuncture Clinical Practice Guidelines

Due to its own internal laws of development,Chinese medicine(CM)seems more inclined to empirical medicine in a relatively long historical period.It is considered to be lacking objective and unified clinical practice guidelines(CPGs),and the difficulties in diagnosis and therapeutic effect evaluation comes with it,have restricted its further inheritance,development and international communication.Over the years,our research group has been committed to improving the standardization theory and methodology of CM,also perfecting relative techniques for further application,which are all based on the stratified evidence scoring method.We have already applied this method to 45 issued guidelines,including 5 national guidelines,3 industrial guidelines,and 37 formulation/revision social organization guidelines.The stratified evidence scoring method has been recognized and used widely.It helps scholars and applicators to study,formulate,publish and popularize the acupuncture therapy clinical practice guidelines better,thus further promotes the development of acupuncture therapy.