The Research On Quality Assessment Of Chinese Clinical Practice Guidelines

Backgrounds Clinical practice guidelines(CPG)play an important role in clinical diagnosis and treatment,guiding clinical decisions,promoting the quality of healthcare,improving patient safety and saving medical costs.The quality evaluation of CPG could help health workers learn whether the guidelines were developed rigorously and transparently,and whether the recommendations were based on available best evidence.There were many evaluation tools for guidelines developed by international or national organizations.AGREE(Appraisal of Guidelines for Research and Evaluation)?published in 2009 was gradually adopted and used by more and more international organizations.However,some studies on the quality evaluation of CPGs in China showed that AGREE? might have some limitations to be applied to Chinese guidelines.Objectives 1)To analyze the status quo of literature on the quality assessment of Chinese CPGs;2)To compare the quality appraisal tools for clinical practice guidelines;3)To evaluate the quality of Chinese clinical practice guidelines published in journals in 2015 using the AGREE?.Methods Two methods were mainly adopted,including the bibliometrics analyses and systematic reviews of studies on the quality assessment of Chinese CPGs,quality appraisal tools for CPGs and Chinese CPGs published in journals in 2015.We also assessed the quality of Chinese CPGs published in journals in 2015 using AGREE?.Results 1)We included 61 articles on the quality assessment of Chinese practice clinical guidelines,which were published in 38 journals from 2005 to 2016 and were mostly conducted by hospitals and universities.In terms of assessed guidelines,the average amount was 33 and they ranged from 1 to 270 that covered all the disciplines.As for the assessment tool,58(95%)of included studies applied AGREE/AGREE?,32(53%)complained about the limitations of AGREE/AGREE?in evaluating Chinese guidelines,6(10%)suggested that there was an urgent need for a new tool designed for the quality assessment of Chinese guidelines.2)We included 23 quality appraisal tools for CPGs published from 1992 to 2013.Most were developed by American and European countries and only one was developed by Chinese researchers.Sixteen tools had the quality appraisal domains that ranged 2 to 21 and all toold reported the appraisal items that ranged 3 to 51.In terms of contents of appraisal items,twenty-two(96%)tools foused on the evidence assessment and the presentation of guideline,21(91%)reported the guideline development group,18(91%)addressed the evidence summary and benefits and risks,17(74%)reported the evidence retrieval,16(70%)reported the formulation of recommendations and patient population,14(61%)reported updating plan,13(57%)reported independent review and cost consideration,11(48%)reported patient's views,10(43%)reported guideline implementation and questions and outcomes,7(30%)reported guideline evaluation and pilot test.Among these tools,AGREE?covered the largest number of items.3)We included 73 Chinese clinical guidelines on Western Medicine and Integrated Medicine,which were published in 46 journals in 2015.Fifty-five(75%)guidelines were developed by medical societies or associations but no guideline reported the involvement of methodologists.Nine(12)guidelines reported the information on evidence retrieval but no guideline mentioned the inclusion criteria,28(38%)reported the methods of assessing the quality of evidence and 27(37%)mentioned the methods of grading the strength of recommendations.Two(3%)of guidelines treported he information on external review,12(16%)indicated the funding resources,no one guideline mentioned the statement on conflicts of interests.Based on the results of quality assessment using AGREE?,we found that 73 guidelines got an overall score of 36.9%,10 guidelines(14%)were less than 20% in Scope and Purpose,46(63%)were less than 20% in Stakeholder Involvement,49(67%)were less than 20% in Rigour of Development,6(8%)were less than 40% in Clarity of Presentation,60(82%)were less than 20% in Applicability,73(99%)were less than 20% in Editorial Independence.Conclusions 1)Based on the analysis of literature on the quality assessment of Chinese CPGs,we found that the assessed guidelines were related to the development and implementation in different disciplines in China.The most widely used quality assessment tool was the AGREE or AGREE?.Nearly half of the literature presented the potential limitations of AGREE or AGREE?in quality assessment of Chinese guidelines.And some studies suggested that it is necessary to develop a new quality assessment tool for Chinese guidelines.2)The analysis of quality appraisal tools for CPGs showed the increasing items and became more comprehensive year by year.Most tools were issued by some developed countries.Although Chinese researchers developed a quality appraisal tools for CPGs,it was similar with AGREE.Many quality appraisal tools focused on evidence retrieval,assessment and synthesis,the presentation of recommendations,guideline updating and external review,however,the guideline questions and outcomes,patient values and preferences,cost,funding,conflicts of interest,guideline dissemination,implementation and evaluation.AGREE? developed by international multidisciplinary team is still current comprehensive,validated and updated quality appraisal tools for CPGs.Greater focus should be placed on reliability of guideline methodology and trustworthiness of clinical contents in the further development of guideline appraisal tools.3)Based on the quality assessment of Chinese clinical practice guidelines on Western Medicine and Integrated Medicine published in journals in 2015,we found that the quality of Chinese CPGs was improved year by year,but still need to be improved in the following domains such as Stakeholder Involvement,Rigour of Development,Applicability and Editorial Independence.Also,we need to strength the implementation and reporting of some key development steps and methods,such as the grading of quality of evidence and the strength of recommendations,the consideration of patient's values and preferences,the consideration of economic factors,the reporting of implementation strategies and the management of conflicts of interests.AGREE?could help identify the problems of Chinese guidelines and promote the quality improvement of Chinese guidelines.However,it was hard to assess whether key development methods were implemented correctly.Also,AGREE?failed to consider some key steps in the development,such as the registration of a guideline,the protocol for a guideline and the collection or identification of clinical questions.For Chinese CPGs,AGREE?cannot help assess the applicability of foreign evidence and the characteristics of recommendations on Traditional Chinese Medicine.Therefore,it is necessary to consider to develop Chinese guideline evaluation tool to help the development and implementation of high-quality guidelines in China.