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.

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）.

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.

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.

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.

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.

Differences in Contents and Formation Methods of Clinical Questions in Chinese and Korean Clinical Practice Guidelines of Acupuncture-Moxibustion:Scoping Review

Objective:To analyze the differences in the needs of users and the value orientation of clinical practice guidelines(CPGs)by comparing the contents and formation methods of clinical questions in Chinese and Korean CPGs of acupuncture-moxibustion(Acup-Mox).Methods:The full text of CPGs was systematically searched from the official websites of Chinese and Korean traditional medicine societies and Acup-Mox associations,with the topic"Acup-Mox for treating diseases"and the retrieval time up to September 28,2022.Two researchers screened the CPGs independently,and extracted the guidelines'topics,content,quantity and formation methods of clinical questions.The quantitative data were collected by counting the frequency,and the qualitative data were classified and described by thematic analysis.Results:A total of 29 guidelines were included in this study,including 20 Chinese guidelines(305 questions)and 9 Korean guidelines(223 questions).The differences lie in the aspects of content and diversity,and formation method.As for content and diversity,Chinese guidelines focused mainly on the questions related to treatment such as the operation of specific intervention(86,28.2%),efficacy of intervention(78,25.6%),and also involving questions in diagnosis,prevention,and prognosis.While the clinical questions in Korean guidelines were concentrated to efficacy of intervention(218,97.8%).As for formation method,in Chinese guidelines,questions were usually collected directly from clinicians,and then determined and optimized by experts.In Korean guidelines,frequently used clinical Acup-Mox interventions would be screened first.Then the expert group would set up corresponding intervention control measures so as to form clinical questions related to treatment efficacy.Conclusions:The differences reflect the different needs of clinical practitioners,and the different aims or concepts in developing Acup-Mox guidelines between China and South Korea.Chinese guidelines emphasized promoting operation protocols and techniques of Acup-Mox for practical use,while Korean guidelines emphasized promoting the frequently used clinical intervention therapies.It is speculated that the guidelines from these two countries would play different roles in guiding clinical operation and supporting medical decision.In terms of formation methods of clinical questions,it is suggested to attach importance to optimizing process in formatting clinical questions to improve the clinical applicability of CPGs of Acup-Mox.

Clinical Practice Guideline of Traditional Medicine for Primary Osteoporosis

BACKGROUND Primary osteoporosis is a disease characterized by low bone mass and microarchitectural deterioration of bone tissue,leading to enhanced bone fragility and a consequent increase in fracture risk. Primary osteoporosis is particularly common in senile persons and in postmenopausal women.It ranks the fifth of diseases in the modern society.

A systematic review of clinical practice guidelines and best practice statements for the diagnosis and management of varicocele in children and adolescents

A systematic review was conducted to identify and qualitatively analyze the methods as well as recommendations of Clinical Practice Guidelines （CPG） and Best Practice Statements （BPS） concerning varicocele in the pediatric and adolescent population. An electronic search was performed with the MEDLINE, EMBASE, Science Direct, and Scielo databases, as well as guidelines＇ Web sites until September 2015. Four guidelines were included in the qualitative synthesis. In general, the recommendations provided by the CPG/BPS were consistent despite the existence of some gaps across the studies. The guidelines issued by the American Urological Association （AUA） and American Society for Reproductive Medicine （ASRM） did not provide evidence-based levels for the recommendations given. Most of the recommendations given by the European Association of Urology （EAU） and European Society of Pediatric Urology （ESPU） were derived from nonrandomized clinical trials, retrospective studies, and expert opinion. Among all CPG/BPS, only one was specifically designed for the pediatric population. The studied guidelines did not undertake independent cost-effectiveness and risk-benefit analysis. The main objectives of these guidelines were to translate the best evidence into practice and provide a framework of standardized care while maintaining clinical autonomy and physician judgment. However, the limitations identified in the CPG/BPS for the diagnosis and management of varicocele in children and adolescents indicate ample opportunities for research and future incorporation of higher quality standards in patient care.

Development of Clinical Practice Guidelines in 11 Common Diseases with Chinese Medicine Interventions in China

Objective： To analyze the clinical practice guideline （CPG） development on 11 common diseases with Chinese medicine （CM） interventions in China. Methods： The CPGs of 11 common diseases which could be treated effectively with CM had been published between 1980 and 2010 in China. The 11 diseases include coronary heart disease （angina pectoris）, hypertension, chronic gastritis, rheumatoid arthritis, cerebral infarction, migraine, diabetes, primary osteoporosis, insomnia, common cold, and IgA nephropathy. The issuing organization, date of publication, development methods, and citation rate of the CPGs were analyzed. According to the development method, each guideline was categorized as consensus-based （CB）, evidence-based （EB）, or consensus based with no explicit consideration of evidence-based （CB-EB）. Results： Thirty-three CPGs on the 11 common diseases were found： 20 guidelines were classified as CB, 13 as CB-EB and none as EB. Fifteen CPGs were issued by the China Association of Chinese Medicine, 8 by professional working groups, and 4 by the State Administration of Traditional Chinese Medicine. Six guidelines were published between 1980 and 1990, 9 between 1991 and 2000, and 18 between 2001 and 2010. Fifty-eight percent of these guidelines have not been amended timely. Only 54.5% （18/33） of the 33 guidelines were cited by other researchers and 45.5% （15/33） percent had never been cited. Conclusions： Most CPGs developed for 11 common diseases with CM approaches in China are consensus, and their citation rates are relatively low. The results suggest that more EB CPG or CPG strictly based on expert consensus could be developed, and great efforts should be made for future CM CPG application.

Appraisal of Clinical Practice Guidelines for Ischemic Stroke Management in Chinese Medicine with Appraisal of Guidelines for Research and Evaluation Instrument:A Systematic Review

Objective： To systematically review the clinical practice guidelines （CPGs） for ischemic stroke in Chinese medicine （CM） with the Appraisal of Guidelines for Research and Evaluation （AGREE II） instrument. Methods： CM CPGs for ischemic stroke were searched in 5 online databases and hand-searches in CPG- related handbooks published from January 1990 to December 2012. The CPGs were categorized into evidence based （EB） guideline, consensus based with no explicit consideration of evidence based （CB-EB） guideline and consensus based （CB） guideline according to the development method. Three reviewers independently appraised the CPGs based on AGREE II instrument, and compared the CPGs＇ recommendations on CM pattern classification and treatment. Results： Five CM CPGs for ischemic stroke were identified and included. Among them, one CPG was EB guideline, two were CB guidelines and two were CB-EB guidelines. The quality score of the EB guideline was higher than those of the CB-EB and CB guidelines. Five CM patterns in the CPGs were recommended in the EB CPG. The comprehensive protocol of integrative Chinese and Western medicine recommended in the EB CPG was mostly recommended for ischemic stroke in the CPGs. The recommendations varied based on the CM patterns. Conclusion： The quality of EB CPG was higher than those of CB and CB-EB CPGs in CM for ischemic stroke and integrative approaches were included in CPGs as major interventions.

Appraisal of the Quality and Contents of Clinical Practice Guidelines for Hypertension Management in Chinese Medicine: A Systematic Review

Objective： To evaluate the quality and consistency of recommendations in the clinical practice guidelines（CPGs） for hypertension in Chinese medicine（CM）. Methods： CM CPGs were identified from 5 electronic databases and hand searches through related handbooks published from January 1990 to December 2013. Three reviewers independently appraised the CPGs based on the Appraisal of Guidelines for Research and Evaluation（AGREE Ⅱ） instrument, and compared the CPGs＇ recommendations on CM syndrome pattern classification and treatment. Results： Five CM CPGs for hypertension were included. The quality score of the evidence-based（EB） guideline was higher than those of the consensus-based with no explicit consideration of evidence-based（CB-EB） and the consensus-based（CB） guidelines. Three out of five patterns in the CPGs were recommended by the EB guideline. Tianma Gouteng Formula（天麻钩藤复方） in the EB guideline was recommended mostly for hypertension patients with pattern of ascendant hyperactivity of Gan（Liver）-yang and pattern of yin deficiency with yang hyperactivity in the CPGs. Acupuncture and massage were recommended for Grade Ⅰ and Grade Ⅱ hypertension with severe symptoms weakening the quality of life in the EB guideline. For Grade Ⅰ and Grade Ⅱ hypertension, CM could be used alone, while for Grade Ⅲ hypertension, they should be used in combination with Western medicines. Conclusion： The quality of EB guideline was higher than those of CB and CB-EB CPGs in CM for hypertension and CM should be prescribed alone or combined with Western medicines based on the grade of hypertension.

Clinical Practice Guideline of Chinese Medicine for Chronic Gastritis

Chronic gastritis （CG） is an inflammatory condition of the gastric mucosa, induced by various causes. A commonly-seen disease in clinical practice, it is found in about 80%-90% of patients undergoing gastroscopic examination. The prevalence rate in the general population remains unclear. It is generally considered that its incidence rate accords with Helicobacter. pylori infection rate and the prevalence of CG is 30%-80% in China. Possible etiological factors include H. pylori infection, smoking, drinking alcohol, food allergies, duodenal juice reflux, drug-induced injuries, heredity, immunity, and radiation.^[1-8].

Exploration of Stratified Evidence Scoring Method of Acupuncture Clinical Practice Guidelines

Due to its own internal laws of development,Chinese medicine(CM)seems more inclined to empirical medicine in a relatively long historical period.It is considered to be lacking objective and unified clinical practice guidelines(CPGs),and the difficulties in diagnosis and therapeutic effect evaluation comes with it,have restricted its further inheritance,development and international communication.Over the years,our research group has been committed to improving the standardization theory and methodology of CM,also perfecting relative techniques for further application,which are all based on the stratified evidence scoring method.We have already applied this method to 45 issued guidelines,including 5 national guidelines,3 industrial guidelines,and 37 formulation/revision social organization guidelines.The stratified evidence scoring method has been recognized and used widely.It helps scholars and applicators to study,formulate,publish and popularize the acupuncture therapy clinical practice guidelines better,thus further promotes the development of acupuncture therapy.

Clinical Practice Guideline of Integrative Chinese and Western Medicine for Acute Myocardial Infarction

With increasing morbidity and mortality,acute myocardial infarction(AMI)has become one of the major causes of human death,leading to heavy burdens to individuals,families and society.Previous researches have found that though large amount of resources and great effort were devoted,no significant improvements were achieved in reducing the in-hospital mortality of AMI patients.Meanwhile,extensive studies about Chinese medicine(CM)have found that CM has special advantages in treating AMI patients.However,there is no standardized and unified clinical practice guideline(CPG)of CM for AMI.Therefore,a CPG with strict standard and generally acknowledgement is urgent to be established.This guideline was developed following the methodological process established by the World Health Organization Handbook for Guideline Development.Extensive search on clinical evidences including systematic review(SR),randomized controlled trial(RCT),observational study and case reports was launched,covering evidence of CM for AMI on several aspects,such as diagnosis,CM patterns,CM interventions on AMI and complications,cardiac rehabilitation and clinical pathway management.Besides,the application of Grading of Recommendations Assessment,Development and Evaluation(GRADE)approach enabled the evaluation of evidence and formulation of grade of recommendation(GOR)and level of evidence(LOE).With the help of GOR and LOE,this CPG recommends the integrative CM and WM treatment method in AMI patients and provides useful information on medical decision for clinical physicians.

Clinical Practice Guidelines and Experts’Consensuses for Treatment of Coronavirus Disease 2019(COVID-19)Patients with Chinese Herbal Medicine:A Systematic Review

Objective:To systematically review the clinical practice guidelines for the treatment of coronavirus disease 2019(COVID-19)patients with Chinese herbal medicine(CHM),summarize their recommendations and evaluate their qualities.Methods:Electronic databases,websites of governments,academic associations or organizations for eligible guidelines were searched up to April 2020.Information were extracted to summarize recommendations for the use of Chinese herbal formulae and Chinese patent medicine(CPM)for COVID-19 patients.The methodological quality and reporting quality of the included guidelines were independently evaluated,using the Appraisal of Guidelines for REsearch and Evaluation(AGREE)Ⅱtool and Reporting Items for Practice Guidelines in healthcare(RIGHT)statement,respectively.Results:Totally 45 guidelines were identififi ed:42(93%)suggested specific CM formulae for treating COVID-19 patients;and 35(78%)assigned patients diagnosed with COVID-19 to 4 stages(early,development,critical and recovery).The recommended formulae and CPMs for each stage with diverse syndrome types have been summarized.Most of the included guidelines were of low methodological quality,with only one achieving moderate quality of AGREEⅡ.The frequency with which the 35 items in the Reporting Items for Practice Guidelines in Healthcare(RIGHT)checklist were reported averaged 36.5%across the 45 guidelines.Conclusions:This systematic review has summarized current recommendations for treating COVID-19 patients with CHM and shows that the general quality of present guidelines is quite low.The development of future guidelines should include increased awareness of the features of good quality guidelines.

2019 Chinese Clinical Practice Guidelines for the Prevention of Mother-to-child Transmission of Hepatitis B Virus

To develop the evidence-based guidelines for managing mother-to-child transmission of hepatitis B virus in China, a multidisciplinary guideline development group was estab-lished. Clinical questions were identified from two rounds of surveys on the concerns of first-line clinicians. We conducted a comprehensive search and review of the literature. A grading of recommendations' assessment, development, and evaluation system was adopted to rate the quality of evidence and the strength of recommendations. Recommen-dations were formulated based on the evidence, overall balance of benefits and harms (at individual and population levels), patient/health worker values and preferences, re-sources available, cost-effectiveness, and feasibility. Even-tually, recommendations related to 13 main clinical concerns were developed, covering diagnostic criteria, treatment in-dications, antiviral therapy choice, timing to initiate and discontinue treatment, immunoprophylaxis strategy at birth, and how to deal with special situations, such as unintended pregnancy, assisted reproduction, and breastfeeding. The guidelines are intended to serve as guidance for clinicians and patients, to optimize the management of majority of pregnant women who are positive for hepatitis B surface antigen. Guideline registration: International Practice Guide Registration Platform (IPGRP-2018CN040).