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吉尔吉斯共和国基于证据的临床指南。

Evidence-based clinical guidelines in Kyrgyz Republic.

作者信息

Zurdinova A A

出版信息

Int J Risk Saf Med. 2015;27 Suppl 1:S45-6. doi: 10.3233/JRS-150683.

Abstract

BACKGROUND

Improving quality of care in many countries is one of the priorities of health systems. At the same time one of the most important methods of improving quality of care is the widespread use of methods and principles of evidence-based medicine (EBM) [1]. The implementation of EBM in public health practice provides for the optimization of quality of care in terms of safety, efficacy and cost, one way of which is the use of clinical guidelines. Clinical guidelines developed with the use of EBM, provide an opportunity to use the latest and accurate information to optimize or neutralize impact on physician decision-making of subjective factors such as intuition, expertise, opinion of respected colleagues, recommendations of popular manuals and handbooks, etc.

OBJECTIVE

To assess and analyze the developed clinical guidelines (CG) and protocols (CP) in the Kyrgyz Republic in the period from 2008 to 2014 and evaluate their implementation in practical healthcare.

METHODS

Retrospective analysis of the developed clinical guidelines and protocols according to the approved methodology, interviewing leaders, questioning doctors and patients for their implementation. All participants gave informed consent for voluntary participation in the study.

RESULTS

Within the framework of the National Program "Manas Taalimi" "Strategy for development of evidence-based medicine in the Kyrgyz Republic for 2006-2010" (MOH Order №490 from 09.04.06) was developed and approved for use. Its main purpose was to create a sustainable system of development, deployment and monitoring of the CG and CP and further promotion of EBM into practical health care, education and science. As a result, a number of documents ("Expert Council for assessing the quality of clinical guidelines/protocols", "AGREE instrument to assess the methodological content of clinical guidelines" [2], "The methodology of development and adaptation of clinical guidelines based on evidence-based medicine") were approved by the Order of the Ministry of Health from 31.12.2008 №704.This methodology was based on the international guideline SIGN-50 [3], as part of the strategy, it was decided to adapt clinical guidelines of the advanced countries of the world to the organizational characteristics of health care in the Kyrgyz Republic. According to the adopted methodology, the development of clinical guidelines should include the following steps: choose a theme, create a multidisciplinary group to conduct a search of existing clinical guidelines and assess their quality, if necessary, conduct an additional search of evidence, make recommendations and draw up the text of clinical guidelines, conduct peer review and consultations, approve clinical guidelines in the pilot, approve the clinical management of the Ministry of Health, publish and distribute, put into practice, monitor the effectiveness of implementation, provide for the revision and updating of clinical guidelines as new credible information appears. In the future, these CGs will be considered as a basis for the development of the CP in accordance with the possibilities of health care organizations of the country. Figuratively speaking, the CG answers the question - "What can be done in an ideal situation? ', And CP -" What should be done in a country?".The Ministry of Health over the period 2008-2014 years approved 41 CGs and 118 CPs for common diseases. It should be noted that only 31.7% of them were represented by the corresponding CGs. Among the approved CPs only 15.3% were based on the corresponding CGs. All of the CGs and CPs (100%) identified experts who prepared the documents and to whom they are addressed. The search strategy information was available only in 24.3% of cases, and only 18.1% used the criteria for selection of international guidelines, which were found in the CGs. 100% of the CGs and CPs indicated no conflict of interest of their developers, but it should be noted that 89% of the CG and CP were developed with the financial assistance of donor organizations supporting the Kyrgyz health reform. The degree of evidence of the recommendations was presented in 100% of the documents, but grading scales were different: in one CG manual grading was used with 3 levels of evidence (A, B, C), in the other - 4 levels (A, B, C, D ), and in the third - tier 5-6 (I, II, III, IV, V), which is not the approved methodology, which was based on gradation - A, B, C, D. In the process of approval of CGs and CPs, 100% did not specify points of methodological quality evaluation.To assess the implementation of approved CG in the practice (training, availability of the CG and CP for each doctor, informing patients about the CG and CP, monitoring use) we interviewed the leaders of health care organizations (20), surveyed 200 doctors and 100 patients. Only 10% of leaders said that they participated in the training on the CG and CP. 5% of them confirmed that every doctor had the corresponding copies of CGs and CPs, 100% of the leaders conduct internal audits on the use of the CG and CP, in 95% of cases the developed CGs and CPs do not take into account local health systems conditions (drugs, equipments etc.). 100% of respondents followed the CGs and CPs, as penalties were introduces by the Ministry of Health, Health Insurance Fund for violation of these recommendations. 25% of respondents reported improved clinical outcomes. To the question "How to improve the practice of medicine with the use of CGs and CPs?" 100% of the managers answered that they needed trainings: trainings for physicians, trainings for the developers of these documents. The survey of doctors showed that only 5% of them were trained in the use of CGs and CPs, 100% of them had the copies of CGs and CPs, 100% of doctors answered that the CGs and CPs not always were suitable for their practice. Questioning patients revealed the following: 100% of them never heard of the CGs and CPs, 2% of patients noted some improvement in healthcare delivery, and 20% of patients were referred to private laboratories for diagnostic tests, and 100% of the patients-respondents bought their drugs for their own pocket money.

CONCLUSIONS

It is very important to ensure equal opportunities in access to medical interventions designed accordingly to the CGs and CPs at all health facilities that will prevent discrimination, depending on territorial distribution, administrative subordination, and other factors in the provision of health care. Implementation of CG and CP recommendations depends not only on the level of health care, knowledge and judgment of a clinician, but also on affordability of a particular diagnostic or therapeutic technologies for a patient. Cases when effective services are not unaffordable for patients should be considered from ethical perspective.

摘要

背景

在许多国家,提高医疗服务质量是卫生系统的优先事项之一。与此同时,提高医疗服务质量的最重要方法之一是广泛应用循证医学(EBM)的方法和原则[1]。在公共卫生实践中实施循证医学可在安全性、有效性和成本方面优化医疗服务质量,其中一种方式是使用临床指南。通过循证医学制定的临床指南提供了利用最新、准确信息的机会,以优化或抵消直觉、专业知识、受尊敬同事的意见、流行手册和指南等主观因素对医生决策的影响。

目的

评估和分析2008年至2014年吉尔吉斯共和国制定的临床指南(CG)和协议(CP),并评估其在实际医疗保健中的实施情况。

方法

根据批准的方法对制定的临床指南和协议进行回顾性分析,采访负责人,询问医生和患者有关其实施情况。所有参与者均自愿签署知情同意书参与本研究。

结果

在国家计划“玛纳斯教育”(“吉尔吉斯共和国2006 - 2010年循证医学发展战略”,2006年4月9日卫生部第490号命令)框架内制定并批准使用。其主要目的是建立一个可持续的临床指南和协议开发、推广及监测系统,并进一步将循证医学推广到实际医疗保健、教育和科学领域。结果,一系列文件(“临床指南/协议质量评估专家委员会”、“评估临床指南方法学内容的AGREE工具”[2]、“基于循证医学的临床指南制定与改编方法”)于2008年12月31日经卫生部第704号命令批准。该方法基于国际指南SIGN - 50[3],作为战略的一部分,决定将世界发达国家的临床指南根据吉尔吉斯共和国医疗保健的组织特点进行改编。根据采用的方法,临床指南的制定应包括以下步骤:选择主题、组建多学科小组以检索现有临床指南并评估其质量、必要时进行额外证据检索、提出建议并起草临床指南文本、进行同行评审和咨询、在试点中批准临床指南、批准卫生部的临床管理、发布和分发、付诸实践、监测实施效果、随着新的可靠信息出现对临床指南进行修订和更新。未来,这些临床指南将根据该国医疗机构的情况被视为制定协议的基础。形象地说,临床指南回答了“在理想情况下可以做什么?”的问题,而协议回答了“在一个国家应该做什么?”的问题。卫生部在2008 - 2014年期间批准了41项常见疾病的临床指南和118项协议。需要注意的是,其中只有31.7%由相应的临床指南代表。在批准的协议中,只有15.3%基于相应的临床指南。所有临床指南和协议(100%)都确定了编写文件的专家以及文件的受众。搜索策略信息仅在24.3%的情况下可用,并且只有18.1%使用了临床指南中发现的国际指南选择标准。100%的临床指南和协议表明其开发者不存在利益冲突,但需要注意的是,89%的临床指南和协议是在支持吉尔吉斯卫生改革的捐助组织的财政援助下制定的。100%的文件中都给出了建议的证据程度,但分级量表不同:在一本临床指南手册中使用了3级证据分级(A、B、C),在另一本中是4级(A、B、C、D),在第三本中是5 - 6级(I、II\、III、IV、V),这与基于A、B、C、D分级的批准方法不同。在临床指南和协议的批准过程中,100%未指定方法学质量评估要点。为评估批准的临床指南在实践中的实施情况(培训、每位医生是否可获取临床指南和协议、向患者告知临床指南和协议、监测使用情况),我们采访了医疗机构负责人(20人),调查了200名医生和100名患者。只有10%的负责人表示他们参加了关于临床指南和协议的培训。其中5%确认每位医生都有临床指南和协议的相应副本,100%的负责人对临床指南和协议的使用进行内部审核,在95%的情况下,制定的临床指南和协议未考虑当地卫生系统状况(药品、设备等)。100%的受访者遵循临床指南和协议,因为卫生部、健康保险基金对违反这些建议实施了处罚。25%的受访者报告临床结果有所改善。对于“如何通过使用临床指南和协议来改善医疗实践?”这一问题,100%的管理人员回答他们需要培训:针对医生的培训、针对这些文件开发者的培训。对医生的调查显示,只有5%的医生接受过使用临床指南和协议的培训,100%的医生有临床指南和协议的副本,100%的医生回答临床指南和协议并非总是适用于他们的实践。对患者的询问结果如下:100%的患者从未听说过临床指南和协议,2%的患者指出医疗服务有一些改善,20%的患者被转至私立实验室进行诊断测试,100%的受访患者自掏腰包购买药品。

结论

确保所有医疗机构都能平等获得根据临床指南和协议设计的医疗干预措施非常重要,这将防止在提供医疗保健时因地域分布、行政隶属关系和其他因素而产生歧视。临床指南和协议建议的实施不仅取决于医疗保健水平、临床医生的知识和判断力,还取决于患者对特定诊断或治疗技术的可承受能力。对于有效服务患者无法承受的情况,应从伦理角度进行考量。

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