The Methodology Quality Of Clinical Practice Guidelines For Traditional Chinese Medicine

Backgrounds Practice guidelines(hereafter referred to guidelines) are guidance documents mostly used in current clinical practice. Guidelines, which largely lower the medical cost and patients’ burden and effectively change the maldistribution of medical resources, are critical tools to improve the whole level of medical service and backbones for healthcare system reform. Since 1980 s, more and more attention was put on Traditional Chinese Medicine(TCM) in China, and a growing number of TCM guidelines have been published, which played an increasingly important role in TCM clinical practice. However, no study examined the methodology quality of TCM guidelines and their recommendations systematically.Objectives To collect TCM guidelines published on journals or monographs comprehensively and use AGREEⅡto evaluate the quality of included guidelines. And then, to investigate the clarity and evidence sources of the recommendations based on quality evaluation.Method We systematically searched Wan Fang, VIP, CNKI, and CBM for TCM guidelines published on journals; and Google, Amazon(http://www.amazon.cn/) and Dangdang(http://www.dangdang.com/) for guidelines published as monographs. We also searched the reference lists of relevant articles as complementary. AGREE Ⅱ was applied to evaluate the methodology quality of the included guidelines, and systematic review and bibliometrics were employed to analyze the clarity and evidence sources of recommendations in guidelines.Results 1) Quality of TCM guidelines: 115 TCM guidelines were included, among which 164(56%) scored <50% in scope and purpose; 2 73(63.4%) scored <25% in stakeholder involvement; 387(76%) scored <25% in rigour of development; 477(70%) scored <25% in clarity of presentation; 5 all guidelines scored <25% in applicability; and 6107(97%) scored <25% in editorial independence. From the evaluation findings, we can see that the quality of TCM guidelines was far behind the mean level of international guidelines. 2) For clarity of recommendations: among the 115 included TCM guidelines, no one was classified as A –presenting recommendations as a specific section in guidelines, 56(49%) were classified as B – some symbolic statements or grade symbols indicated the strength of recommendation and the quality of evidence, 59(51%) were classified as C – a typical word like “recommend”, “recommendation”, “suggest”, “advice” could be found. 3) Source of evidence: there were 1041 recommendations from 62 guidelines, in which 1238 references were collected. For the research type of references: 65(5%) were guidelines, 101(8%) were systematic reviews/ meta-analysis, 214(17%) were randomized controlled trials, 346(28%) were cohort studies/ case-control studies, 70(6%) were case series/ case reports, and 432(35%) were others including animal studies and cross-sectional studies.Conclusions 1) while the quality of TCM guidelines have been improved, a wide gap still existed when compared with the international guidelines, especially in editorial independence, rigour of development and stakeholder involvement(lack multidisciplinary team). TCM guideline developers have already tried to use international standards to develop guidelines, but there were many problematic details demanding effective measures. For example, TCM guideline developers could structure questions(PICO), then conduct systematic search, evaluation and synthesis. More importantly, the cost, environment to implement and value and preference of patient should be taken into consideration, then achieve better transparency and independence of guideline development. 2) Recommendations of most guidelines could be distinguished just by finding some typical vocabularies, and some were too unclear to be identified. Also, the standards for strength of recommendation and quality of evidence should be unified. 3) Only half of the TCM guidelines provided the reference of evidence, from which animal studies, cross-sectional studies and expert opinions were the main sources. We can see that though investing a large amount of human, material and financial resources, most of the TCM evidence are still of less social benefit, which to some degree, lead to resources waste. In the future, TCM guideline developers should be aware of systematically search all the evidence of interest, then include studies of high quality if multiple types of evidence to the same question.