一个中国化医学临床指南评价工具的研发

目的:开发一个适合我国医疗实践实际的本土化临床指南评价工具。方法:在比较国外各种医学临床指南评价工具的基础上,根据AGREE工具并采用Delphi法进行了专家咨询和分析。结果:开发出一个适合我国情况的本土化临床指南评价工具。结论:开发出的首个临床指南评价工具,对于今后我国临床指南的开发制定具有一定指导意义。     

A comparison of clinical practice guideline appraisal instruments

OBJECTIVE: To identify and compare clinical practice guideline appraisal instruments. METHODS: Appraisal instruments, defined as instruments intended to be used for guideline evaluation, were identified by searching MEDLINE (1966-99) using the Medical Subject Heading (MeSH) practice guidelines, reviewing bibliographies of the retrieved articles, and contacting authors of guideline appraisal instruments. Two reviewers independently examined the questions/statements from all the instruments and thematically grouped them. The 44 groupings were collapsed into 10 guideline attributes. Using the items, two reviewers independently undertook a content analysis of the instruments. RESULTS: Fifteen instruments were identified, and two were excluded because they were not focused on evaluation. All instruments were developed after 1992 and contained 8 to 142 questions/statements. Of the 44 items used for the content analysis, the number of items covered by each instrument ranged from 6 to 34. Only the instrument by Cluzeau and colleagues included at least one item for each of the 10 attributes, and it addressed 28 of the 44 items. This instrument and that of Shaneyfelt et al. are the only instruments that have so far been validated. CONCLUSIONS: A comprehensive, concise, and valid instrument could help users systematically judge the quality and utility of clinical practice guidelines. The current instruments vary widely in length and comprehensiveness. There is insufficient evidence to support the exclusive use of any one instrument, although the Cluzeau instrument has received the greatest evaluation. More research is required on the reliability and validity of existing guideline appraisal instruments before any one instrument can become widely adopted.     

Guidelines in cardiac clinical practice: evaluation of their methodological quality using the AGREE II instrument

Although clinical guidelines have an influential role in healthcare practice, their development process and the evidence they cite has been subject to criticism. This study evaluates the quality of guidelines in cardiac clinical practice by examining how they adhere to validated methodological standards in guideline development. A structured review of cardiac clinical practice guidelines published in seven cardiovascular journals between January 2001 and May 2011 was performed. The AGREE II assessment tool was used by two researchers to evaluate guideline quality. A total of 101 guidelines were identified. Assessment of guidelines using AGREE II found methodological quality to be highly variable (median score, 58.70%; range, 45.34–76.40%). ‘Scope and purpose’ (median score, 86.1%) and ‘clarity of development’ (median score, 83.3 %) were the two domains within AGREE II that received the highest scores. Applicability (median score, 20.80%; range, 4.20–54.20%) and editorial independence (median score, 33.30%; range, 0–62.50%) had the lowest scores. There is considerable variability in the quality of cardiac clinical practice guidelines and this has not improved over the last 10 years. Incorporating validated guideline assessment tools, such as AGREE II, may improve the quality of guidelines.     

全球前列腺癌筛查指南质量评价

目的系统评价现有前列腺癌筛查指南的方法学质量和报告质量,为今后同类指南的制定和更新提供参考。方法以前列腺癌、前列腺肿瘤、筛查、筛检、指南、共识、规范、标准、prostate cancer、prostate carcinoma、prostate tumor、screening、early detection、guideline、recommendation等为关键词系统检索中国知网、万方数据知识服务平台、中国生物医学文献服务系统、PubMed、Embase、Cochrane Library,并同时检索机构官网发布的指南作为补充。采用开发指南研究和评估工具Ⅱ(AGREEⅡ)和国际实践指南报告标准(RIGHT)对纳入指南的方法学质量和报告质量进行比较和评价。结果经过筛选后共纳入13部指南。AGREEⅡ评价结果显示,推荐等级为A级的有10部、B级的有2部、C级的有1部;13部指南在参与人员、应用性领域得分均较低,平均得分分别为52.1%和34.0%。RIGHT评价结果显示,13部指南的报告质量一般,报告质量较差的条目主要集中在证据(64.6%)、资金资助和利益冲突(44.2%)、其他方面(46.2%)3个领域。结论我国目前尚无前列腺癌筛查指南。本研究纳入的前列腺癌筛查指南方法学质量整体良好,可为我国指南制定提供参考,但报告质量一般,规范性有待进一步加强。     

Guideline development in the Academic Medical Center, Amsterdam, the Netherlands, 1992-2001

OBJECTIVE: To evaluate a program for the local development and implementation of evidence based guidelines in the Academic Medical Center in Amsterdam, the Netherlands. DESIGN: Retrospective evaluation study. METHOD: In the period 1992-2001, 50 guideline projects had received funding. Two questionnaires were developed to monitor aspects of development and implementation of guidelines. The first questionnaire was based on the 'Appraisal of Guidelines for Research & Evaluation' (AGREE) instrument. In total 39 projects of which the original application form as well as the final report was accessible, were scored by 3 researchers. A second questionnaire was developed on the basis of an implementation model by Grol and was filled out by 46 applicants. RESULTS: The primary motive for the development of a guideline were doubts about the effectiveness of a procedure. In 79% researchers (partly) collected their own data. The future users of the guideline were involved in an early stage of the development project in 72% of all cases. In 28% potential obstructing factors were identified. Introduction of the guideline was done through oral presentations in 42% without the use of an extensive implementation strategy. Of all subsidized projects, 24% was ongoing and 74% had been implemented successfully. CONCLUSION: In the AMC-program subsidized projects often led to successfully developed guidelines, which subsequently were introduced in practice.     

Predictors of high quality clinical practice guidelines: examples in oncology.

OBJECTIVE: Clinical practice guidelines are widely used as effective tools for improving the management of patients with cancer. However, there is increasing concern about variation in guideline quality. In this study we identified predictors for high-quality guidelines in oncology. DESIGN: The quality scores for 32 oncology guidelines from 13 countries were determined by four independent appraisers using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. MAIN MEASURE: : The contribution to the quality score of six characteristics of guidelines and three of guideline developing organizations was then assessed using analysis of variance and stepwise linear regression analysis. RESULTS: Some guideline and organizational characteristics were shown to be responsible for a large part of the variations in quality scores. The availability of background information was the strongest predictor of quality with an explained variance ranging from 17% ("Applicability") to 67% ("Rigour of development"). High-quality guidelines were more often produced by government-supported organizations and/or within a structured, coordinated programme. The other characteristics (publication year, type of guideline, format, level of care, and scope) were not independent predictors of quality. CONCLUSIONS: Guidelines should provide more explicit information about the context of their development and methods used in order to improve their quality and thus encourage their use in clinical practice.     

Analysis of the Status of Chinese clinical practice guidelines development

ABSTRACT: BACKGROUND: The work of developing clinical practice guidelines began just a little more than ten years ago in China. Up to now, there have been few studies about them. Objectives To review and analyze the status of Chinese clinical practice guidelines in 1997-2007. METHODS: All Chinese guidelines from 1997-2007 were collected, and made a regression analysis, and a citation analysis for evaluating the impact of guidelines. To analyze the developing quality, the most influential guidelines were evaluated with AGREE instrument, and each guideline was evaluated to check for any updating. In order to analyze the objective and target population, all guidelines were classified and counted separately according to disease/symptom center, and whether towards specialists or general practitioners. RESULTS: 143 guidelines were collected. An exponential function equation was established for the trend in the number of guidelines. The immediacy index in every year was very low while the average citation rate was not. Both the percentages of highly cited and never cited were high. For the evaluation with AGREE, only the average score of clarity and presentation was high (89.9%); the remaining were much lower. Editorial independence scored 0. Only 27 (18.9%) of 143 guidelines, were found to be evidence-based. Only a few had ever been updated, with an average updating interval of 5.2 years. Only 2.1% were symptom-centered, and only 4.2% were aimed at general practitioners. CONCLUSION: Much progress has been obtained for Chinese guidelines development. However, there were still defects, and greater efforts should be made in the future.     

Methodology of Clinical Nutrition Guidelines for Adult Cancer Patients

Background: Malnutrition delays recovery from cancer treatment and can lead to additional serious complications. Clinical guidelines for the management of malnutrition in cancer patients are essential tools for optimizing nutritional care; therefore, their methodological quality is of great importance. This review assesses the methodological quality of international clinical guidelines for the management of malnutrition in adult cancer patients. Methods: Guidelines were identified through searches in multiple electronic databases; afterward, they were systematically reviewed with the AGREE instrument, which is one method of evaluating the methodological quality of guidelines. Results: The methodological quality of the guidelines reviewed varied greatly. The highest scores were observed in the domains “scope and purpose” and “clarity and presentation,” while the lowest scores were awarded in the domains “editorial independence,” “stakeholder involvement,” and “applicability.” Furthermore, there was consensus on the indication for parenteral nutrition and nutrition screening. However, there was a lack of consensus on how nutritional therapy should be provided. No improvement was observed in methodological quality of the more recent guidelines compared to the older ones. Conclusions: The methodological quality of clinical guidelines on malnutrition for cancer patients and the way they are reported need to be improved. To achieve this, developers should utilize available guideline assessment tools, such as the AGREE instrument, when writing or updating guidelines on this topic.     

Characteristics of high-quality guidelines: evaluation of 86 clinical guidelines developed in ten European countries and Canada

OBJECTIVES: To identify predictors of high-quality clinical practice guidelines. METHODS: A total of 86 guidelines from 11 countries were assessed by four independent appraisers per guideline using the AGREE instrument (23 items). Six aspects of guideline development were considered to explain the variation in quality scores: care level (primary/secondary care), scope (diagnosis/treatment), type of guideline (new/update), year of publication, type of agency (governmental/professional), and whether the guideline was produced within a structured and coordinated program. RESULTS: Guidelines produced within a guideline program and by governmental agencies had higher scores than their counterparts. Differences in the applicability of the guidelines could not be explained by the variables studied. CONCLUSION: To ensure high quality, clinical guidelines should be produced within a structured and coordinated program. Professional organizations or specialist societies that aim to develop guidelines may adopt quality criteria from leading guideline agencies.     

Development and application of a generic methodology to assess the quality of clinical guidelines.

BACKGROUND: Despite clinical guidelines penetrating every aspect of clinical practice and health policy, doubts persist over their ability to improve patient care. We have designed and tested a generic critical appraisal instrument, that assesses whether developers have minimized the biases inherent in creating guidelines, and addressed the requirements for effective implementation. DESIGN: Thirty-seven items describing suggested predictors of guideline quality were grouped into three dimensions covering the rigour of development, clarity of presentation (including the context and content) and implementation issues. The ease of use, reliability and validity of the instrument was tested on a national sample of guidelines for the management of asthma, breast cancer, depression and coronary heart disease, with 120 appraisers. A numerical score was derived to allow comparison of guidelines within and between diseases. RESULTS: The instrument has acceptable reliability (Cronbach's alpha coefficient, 0.68-0.84; intra-class correlation coefficient, (0.82-0.90)). The results provided some evidence of validity (Pearson's correlation coefficient between appraisers' dimension scores and their global assessment was 0.49 for dimension one, 0.63 for dimension two and 0.40 for dimension three). The instrument could differentiate between national and local guidelines and was easy to apply. There was variation in the performance of guidelines with most not achieving a majority of criteria in each dimension. CONCLUSIONS: Use of this instrument should encourage developers to create guidelines that reflect relevant research evidence more accurately. Potential users or groups adapting guidelines for local use could apply the instrument to help decide which one to follow. The National Health Service Executive is using the instrument to assist in deciding which guidelines to recommend to the UK National Health Service. This methodology forms the basis of a common approach to assessing guideline quality in Europe.