Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese medicine and Western medicine

Integrated traditional Chinese medicine(TCM)and Western medicine(WM)is a new medical science grounded in the knowledge bases of both TCM and WM,which then forms a unique modern medical system in China.Integrated TCM and WM has a long history in China,and has made important achievements in the process of clinical diagnosis and treatment.However,the methodological defects in currently published clinical practice guidelines(CPGs)limit its development.The organic integration of TCM and WM is a deeper integration of TCM and WM.To realize the progression of"integration"to"organic integration",a targeted and standardized guideline development methodology is needed.Therefore,the purpose of this study is to establish a standardized development procedure for clinical practice guidelines for the organic integration of TCM and WM to promote the systematic integration of TCM and WM research results into clinical practice guidelines in order to achieve optimal results as the whole is greater than the sum of the parts.

Levels of evidence and grades of recommendation supporting European society for medical oncology clinical practice guidelines

Background:The European Society for Medical Oncology(ESMO)guidelines are among the most comprehensive and widely used clinical practice guidelines(CPGs)globally.However,the level of scientific evidence supporting ESMO CPG recommendations has not been systematically investigated.This study assessed ESMO CPG levels of evidence(LOE)and grades of recommendations(GOR),as well as their trends over time across various cancer settings.Methods:We manually extracted every recommendation with the Infectious Diseases Society of America(IDSA)classification from each CPG.We examined the distribution of LOE and GOR in all available ESMO CPG guidelines across different topics and cancer types.Results:Among the 1,823 recommendations in the current CPG,30%were classified as LOEⅠ,and 43%were classified as GOR A.Overall,there was a slight decrease in LOEⅠ(−2%)and an increase in the proportion of GOR A(+1%)in the current CPG compared to previous versions.The proportion of GOR A recommendations based on higher levels of evidence such as randomized trials(LOEⅠ–Ⅱ)shows a decrease(71%vs.63%,p=0.009)while recommendations based on lower levels of evidence(LOEⅢ–Ⅴ)show an increase(29%vs.37%,p=0.01)between previous and current version.In the current versions,the highest proportion of LOEⅠ(42%)was found in recommendations related to pharmacotherapy,while the highest proportion of GOR A recommendations was found in the areas of pathology(50%)and diagnostic(50%)recommendations.Significant variability in LOEⅠand GOR A recommendations and their changes over time was observed across different cancer types.Conclusion:One-third of the current ESMO CPG recommendations are supported by the highest level of evidence.More well-designed randomized clinical trials are needed to increase the proportion of LOEⅠand GOR A recommendations,ultimately leading to improved outcomes for cancer patients.

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.

China Association of Acupuncture–Moxibustion Evidence-based clinical practice guideline of acupuncture and moxibustion: Primary dysmenorrhea

Dysmenorrhea refers to periodic abdominal pain,or radiating to lumbosacral region.For the severe case,it is intolerable,combined with nausea and vomiting sometimes.This disease is commonly seen in unmarried young women.Epidemiological studies have shown that dysmenorrhea is the most common gynecological disease,especially in young women[1].Acupuncture and moxibustion have a long history in the treatm ent of primary dysmenorrhea(hereinafter referred to as PD),and compared with medication,the advantages are presented in the treatment.Entrusted by the Standardization Working Committee of China Association for Acupuncture and Moxibustion(CAAM),Department of Acupuncture and Moxibustion,Dongzhimen Hospital,Beijing University of Traditional Chinese Medicine has undertaken the drafting of Evidence-Based Clinical Practice Guideline of Acupuncture and Moxibustion:Primary Dysmenorrhea(hereinafter referred to as the Guideline).The Guideline was issued in 2014 by CAAM.It summarizes the research achievements in acupuncture-moxibustion treatm ent for dysmenorrhea in recent decades and is intended to standardize the clinical regimen of treatm ent with acupuncture and moxibustion so as to improve the clinical effect.

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.

On Treatment Patterns for Modeling Medical Treatment Processes in Clinical Practice Guidelines

Clinical practice guidelines(CPGs)contain evidence-based and economically reasonable medical treatment processes.Executable medical treatment processes in healthcare information systems can assist the treatment processes.To this end,business process modeling technologies have been exploited to model medical treatment processes.However,medical treatment processes are usually flexible and knowledge-intensive.To reduce the effort in modeling,we summarize several treatment patterns(i.e.,frequent behaviors in medical treatment processes in CPGs),and represent them by three process modeling languages(i.e.,BPMN,DMN,and CMMN).Based on the summarized treatment patterns,we propose a pattern-based integrated framework for modeling medical treatment processes.A modeling platform is implemented to support the use of treatment patterns,by which the feasibility of our approach is validated.An empirical analysis is discussed based on the coverage rates of treatment patterns.Feedback from interviewed physicians in a Chinese hospital shows that executable medical treatment processes of CPGs provide a convenient way to obtain guidance,thus assisting daily work for medical workers.

Chinese version of NCCN Clinical Practice Guidelines in Oncology officially authorized by NCCN

The publishing conference of the Chinese version of National Comprehensive Cancer Network （NCCN） Clinical Practice Guidelines in Oncology （hereinafter referred to as NCCN Guidelines） and the inaugural peer reviewer meeting of NCCN Clinical Practice Guidelines in Oncology： Digestive System Cancers （hereinafter referred to as NCCN Guidelines on Digestive System Cancers） were held in People＇s Medical Publishing House in January 28^th, 2016 （Figure 1）.

An Analysis of the Application of the Suggestions of Clinical Practice Guideline for Ostomy Care in China:A Cross-Sectional Investigation

Background:Clinical practice guidelines refer to the guidance provided by the expert system to help medical staff and patients decide on appropriate treatments for a specific clinical situation,mainly including guidelines based on expert consensus and evidence-based guidelines.Since there is no research and clinical application of a specific stoma guidance in China.It is of great significance to understand the application status of the recommended guidelines and the influencing factors in promoting the development of stoma care.Purpose:To investigate the application status of recommended clinical practice guidelines for stoma nursing in China,and to analyse the reasons for the knowledge and application of recommendations.Methods:The Questionnaire on the Application of Recommendations in Clinical Practice Guidelines for Ostomy Nursing was adopted.Results:We collected 195 questionnaires and 183 valid questionnaires were available.(1)The average knowledge rate of a total of 31 recommendations was 73.65%.The main reasons for unknown were insufficient dissemination and lack of training.(2)The average application rate of the 31 recommendations was 58.08%.The overall satisfaction rate of people who used them was high.The main reasons for not applying recommendations were complex.Conclusions:Different levels of recommendations awareness and application are different.There is a lack of evidence-based guidelines for clinical practice in ostomy nursing in the field of stoma care in China,which limits the scientific development of stoma care to a certain extent.However,this study provides reference for the future construction of a guidebook adapted to our country’s localization.

Clinical practice guidelines for the interventional treatment of advanced pancreatic cancer(5^(th)edition)

Pancreatic cancer has become a major disease affecting people’s health because of its insidiousness,rapid progression and poor prognosis.Based on the practical needs of clinical work,combined with domestic multi-center research and experience,this guideline provides constructive suggestions for the interventional treatment of pancreatic cancer.

Colorectal surgeon consensus with diverticulitis clinical practice guidelines

AIM To determine the application of clinical practice guidelines for the current management of diverticulitis and colorectal surgeon specialist consensus in Australia and New Zealand.METHODS A survey was distributed to 205 colorectal surgeons in Australia and New Zealand, using 22 hypothetical clinical scenarios.RESULTS The response rate was 102(50%). For 19 guidelinebased scenarios, only 11(58%) reached consensus(defined as > 70% majority opinion) and agreed with guidelines; while 3(16%) reached consensus and did not agree with guidelines. The remaining 5(26%) scenarios showed community equipoise(defined as less than/equal to 70% majority opinion). These included diagnostic imaging where CT scan was contraindicated, management options in the failureof conservative therapy for complicated diverticulitis, surgical management of Hinchey grade 3, proximal extent of resection in sigmoid diverticulitis and use of oral mechanical bowel preparation and antibiotics for an elective colectomy. The consensus areas not agreeing with guidelines were management of simple diverticulitis, management following the failure of conservative therapy in uncomplicated diverticulitis and follow-up after an episode of complicated diverticulitis. Fifty-percent of rural/regional based surgeons would perform an urgent sigmoid colectomy in failed conservative therapy of diverticulitis compared to only 8% of surgeons city-based(Fisher's exact test P = 0.016). In right-sided complicated diverticulitis, a greater number of those in practice for more than ten years would perform an ileocecal resection and ileocolic anastomosis(79% vs 41%, P < 0.0001).CONCLUSION While there are areas of consensus in diverticulitis management, there are areas of community equipoise for future research, potentially in the form of RCTs.

Obstacles in employing evidence-based practice by nurses in their clinical settings: a descriptive study

Objective: The challenge of employing evidence-based practice (EBP) is multifarious and varied. Nursing interventions supported by research evidence have been exposed to progress positive patient outcomes, while its implementation is faced with various obstacles. This study aimed to identify obstacles in employing EBP by nurses in their clinical settings. Methods: This descriptive design study was conducted at Benha University Hospital with a convenient sample of 154 nurses. Two tools were utilized: (Ⅰ) sociodemographic data sheet, which included sociodemographic characteristics of the participants, and (Ⅱ) interview scale, which contained two parts: (1) obstacles scale, which contained obstacles that impede nurses from the utilization of EBP, and (2) questions to rank the three greatest obstacles in employing EBP by nurses. Results: The greatest EBP obstacle ranked by nurses was the organizational limitations (90.9%), followed by research quality (86.9%) and research accessibility (51.0%), while individual characteristics (35.9%) were ranked as the least obstacle. There was a significant statistical correlation between organizational limitations, research quality as well accessibility-related obstacles and nurses' age, level of education, as well their years of work experience (P<0.05). Conclusions: Findings of this study showed series of obstacles in employing EBP by nurses in their clinical settings, stressing the call for expansion of nurses' capabilities related to EBP utilization in patients' care.

Adherence to Clinical Practice Guidelines during Antenatal Management of Gestational Diabetes Mellitus: An Integrative Review

The number of pregnant women affected by gestational Diabetes (GDM) is increasing globally with an estimated prevalence as high as 15%. Gestational Diabetes Miletus is associated with birth complications for women and newborn, includes development of type II diabetes, preeclampsia during pregnancy, increasing the risk of fetal loss, stillbirth and perinatal death. An integrative literature review applied, systematic search from different data base obtained from international and middle east countries to assess adherence level of guidelines. Clinical guidelines are set to ensure and assure homogeneity as well as the quality of provision of care. National and international consensus has yet to be achieved in the management of diabetes in pregnancy, adherence of recommended antenatal care content to a minimum level appears to be unmet. Complete provider adherence to first antenatal guidelines was 48.1%, Guideline dissemination alone does not change practice;assessment of barriers/enablers and implementation is important. Guidelines are useless when they are not used or adhered to. Each guideline needs an Appendix on how adherence has to be measured, there is a need for some uniformity across guidelines to measure adherence. Diabetes management is an essential constituent to prevent prognosis of diabetes complications.

An Exploration of Perceived Barriers to Evidence-Based Practice among Physiotherapy Students during Clinical Placement—A Descriptive Cross-Sectional Study

Introduction: Teaching evidence-based practice (EBP) has become part of the standard curriculum for health care students and professionals. Teaching EBP skills should be emphasized in entry level physiotherapy education as physiotherapists are expected to practice in an evidence-based way. Identifying barriers to the application of EBP in clinical placement plays an important role in developing physiotherapy programs. The present study aimed to explore physiotherapy students’ perceived barriers toward the use of EBP during their clinical placements. Methods: A cross-sectional study was conducted among third-year physiotherapy students at the Faculty of Health Sciences University of Ljubljana, Slovenia. Participants were asked to complete a self-reported questionnaire that was developed by the researcher based on previously developed surveys. The analyses applied included descriptive statistics and calculation of frequencies, percentages, means and standard deviations of the participating students’ scores. Results: Fifty final-year undergraduate students with a mean age of 23.7 (±4.3, range 23 - 27) years participated in the study. Majority of participants reported lack of formal training, poor ability to critically appraise research evidence, insufficient time, their clinical supervisors, or other therapists not using EBP when treating patients as barriers towards practicing EBP. Conclusions: Physiotherapy students face many challenges in terms of training, organizational, and personal barriers toward the use of EBP during clinical placement. Lack of formal training, lack of research skills, insufficient time and their clinical supervisors or other therapists not using EBP when treating patients, emerged as top barriers. This fact underlines the importance of teaching students EBP skills, which would enable them to use EBP when working with patients.

Organic Integration of Traditional Chinese and Western Medicines—Future of Clinical Practice Guidelines of Integrated Traditional Chinese and Western Medicines

The transformation and implementation of clinical practice guidelines for integrated traditional Chinese medicine(TCM)and Western medicine(WM)is crucial to the adoption of medical science and technological findings and is an important way for TCM to be made available to the world.First,clinical practice guidelines(CPGs)of TCM and WM integration in recent years was analyzed to clarify the current situation and problems in the existing guidelines according to the following four perspectives:(1)perspective of TCM and WM integration in guidelines,(2)diagnosis Using integrated TCM and WM,(3)integration of TCM and WM treatment,(4)promoting TCM and WM integration.Secondly,the information and quality evaluation of CPGs for integrated Chinese and Western medicine in 2020–2022 were analyzed to explore the degree and methods of integration of Chinese and Western medicine guidelines.And last this study aimed to lay a foundation for the further establishment of Chinese characteristic,repeatable,and calculable clinical practice guidelines of TCM and WM integration.

Clinical practice guideline for acupuncture and moxibustion:Allergic rhinitis

Acupuncture is one of the most effective complementary therapies for allergic rhinitis(AR)and has been recommended by several clinical practice guidelines(CPGs)for AR.However,these CPGs mentioned acupuncture without making recommendations for clinical implementation and therapeutic protocols,therefore limiting the applicability of acupuncture therapies for AR.Hence,for the benefit of acupuncture practitioners around the world,the World Federation of Acupuncture-moxibustion Societies have initiated a project to develop the CPG for the use of acupuncture and moxibustion to treat AR.This CPG was developed according to the Grading of Recommendations Assessment,Development,and Evaluation(GRADE)methodology,referring to the principles of the World Health Organization Handbook for Guideline Development.During the development of the CPG,the guideline development group(GDG)played an important role.The clinical questions,recommendations and therapeutic protocols were all formulated by the GDG using the modified Delphi method.The CPG contains recommendations for 15 clinical questions about the use of acupuncture and moxibustion interventions.These include one strong recommendation for the intervention based on high-quality evidence,three conditional recommendations for either the intervention or standard care,and 11 conditional recommendations for the intervention based on very low quality of evidence.The CPG also provides one filiform needle acupuncture protocol and five moxibustion protocols extracted based on the protocols presented in randomized controlled trials reviewed by the GDG.

Clinical practice guideline for acupuncture and moxibustion: Female urinary incontinence

Urinary incontinence (UI) is a common problem worldwide.It has a major impact on physical and social activities and interpersonal relationships.UI is common in women,but is under-reported and undertreated.It affects the quality of life of female patients severely.Acupuncture and moxibustion have been proposed as potentially effective interventions for female UI.Hence,for the benefit of acupuncture practitioners around the world,the World Federation of Acupuncture-moxibustion Societies initiated a project to develop a clinical practice guideline (CPG) for the use of acupuncture and moxibustion to treat female UI.This CPG was developed according to the Grading of Recommendations Assessment,Development,and Evaluation (GRADE) methodology,referring to the principles of the World Health Organization Handbook for Guideline Development.During the development of the CPG,the guideline development group (GDG) played an important role.The clinical questions,recommendations and therapeutic protocols were all formulated by GDG using the modified Delphi method.This CPG contains ten recommendations about the use of acupuncture and moxibustion interventions for ten clinical questions,which include nine conditional recommendations for the intervention and one conditional recommendation for either the intervention or the comparison.This CPG also provides one protocol for conventional filiform needle therapy,two therapy protocols for deep needling stimulation on lumbosacral acupoints,and four moxibustion therapy protocols,based on the protocols presented in randomized controlled trials reviewed by the GDG.

Development of rapid advice guideline and standard and continuous updating guideline:experiences and practice

We published rapid advice guidelines and updated guidelines for coronavirus disease 2019(COVID-19)management on February 6,2020,and September 4,2020,respectively.These two guidelines vary widely in their developmental background,type of evidence,grade of recommendation and so on.We shared our experience for the development of these two guidelines to help clinical practitioners better understand and implement guidelines and to help guideline developers facilitate communication and discussion for guideline development during the pandemic.

Appraisal of Five Clinical Guidelines for the Management of Hypertension in Andean Countries and Europe

There is global concern on the methodological limitations, transferability and effectiveness of clinical practice guidelines (CPGs) for chronic non-communicable diseases, particularly for hypertension. Bolivia, Ecuador and Peru have regularly produced CPGs;however no formal assessment has been done on their contents, transferability and effectiveness. The past decade saw significant migration from Andean countries to Europe. Knowing how European CPGs compare with those produced in Andean countries is necessary to recommend future changes targeted to the migrant population. A systematic search of CPGs was done on indexed databases and non-indexed publications. Recognized and approved CPGs were identified by technical officers in the Ministries of Health of the respective countries. The guidelines of the European Society of hypertension and four selected CPGs from the Andean countries were assessed by two independent evaluators using the “Agree II instrument for assessing clinical practice guidelines, AGREE II Consortium, May 2009”. Comparison of the CPGs is based on the six domain scores provided by the Agree II instrument. The overall score of CPGs ranged from 1.85 to 2.94 of 6 maximum possible. The European CPG scored highest in 3 of 6 domains compared, most notably in rigor of development. Average domain scores for clarity of presentation (0.84) and scope and purpose (0.64) were highest scores for applicability (0.30). Stakeholder involvement (0.28) and rigor of development (0.17) were the lowest. The CPGs assessed appear to fail meeting the standards of quality and pertinence. They show a progressive worsening from domains declaring good intentions of being clear, to those which measure their hard aspects and implications.

Development of the Scientific,Transparent and Applicable Rankings (STAR) tool for clinical practice guidelines

Background:This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines,named Scientific,Transparent and Applicable Rankings tool(STAR),and test its reliability,validity,and usability.Methods:This study set up a multidisciplinary working group including guideline methodologists,statisticians,journal editors,clinicians,and other experts.Scoping review,Delphi methods,and hierarchical analysis were used to develop the STAR tool.We evaluated the instrument’s intrinsic and interrater reliability,content and criterion validity,and usability.Results:STAR contained 39 items grouped into 11 domains.The mean intrinsic reliability of the domains,indicated by Cronbach’sαcoefficient,was 0.588(95%confidence interval[CI]:0.414,0.762).Interrater reliability as assessed with Cohen’s kappa coefficient was 0.774(95%CI:0.740,0.807)for methodological evaluators and 0.618(95%CI:0.587,0.648)for clinical evaluators.The overall content validity index was 0.905.Pearson’s r correlation for criterion validity was 0.885(95%CI:0.804,0.932).The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min.Conclusion:The instrument performed well in terms of reliability,validity,and efficiency,and can be used for comprehensively evaluating and ranking guidelines.