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.

Cardiac evaluation of renal transplant candidates with heart failure

Patients with advanced kidney disease are at elevated risk of developing heart failure and appropriate risk stratification is important to permit them to receive kidney transplantation.The American Heart Association and American College of Cardiology joint statement provides guidance on risk stratification for the major cause of heart failure for these patients in its recommendations for coronary heart disease.Herein we provide an overview of the available literature on risk strati-fication for nonischemic heart failure and functional heart disease states such as pulmonary hypertension.Many of these options for optimizing these patients be-fore transplant include optimizing their volume status,often with more agg-ressive ultrafiltration.Kidney transplantation remains the treatment of choice for patients with advanced kidney disease and cardiac disease,the correction of the azotemic substances with kidney transplantation has been associated with imp-roved survival than remaining on dialysis long-term.The findings in the studies reviewed here are expected to help clinicians refine current strategies for evalua-ting potential kidney transplant recipients.

A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus(2019-nCoV) infected pneumonia(standard version)

In December 2019, a new type viral pneumonia cases occurred in Wuhan, Hubei Province;and then named "2019 novel coronavirus(2019-nCoV)" by the World Health Organization(WHO) on 12 January 2020. For it is a never been experienced respiratory disease before and with infection ability widely and quickly, it attracted the world’s attention but without treatment and control manual. For the request from frontline clinicians and public health professionals of 2019-nCoV infected pneumonia management, an evidence-based guideline urgently needs to be developed. Therefore, we drafted this guideline according to the rapid advice guidelines methodology and general rules of WHO guideline development;we also added the first-hand management data of Zhongnan Hospital of Wuhan University. This guideline includes the guideline methodology, epidemiological characteristics, disease screening and population prevention, diagnosis, treatment and control(including traditional Chinese Medicine), nosocomial infection prevention and control, and disease nursing of the 2019-nCoV. Moreover, we also provide a whole process of a successful treatment case of the severe 2019-nCoV infected pneumonia and experience and lessons of hospital rescue for 2019-nCoV infections. This rapid advice guideline is suitable for the first frontline doctors and nurses, managers of hospitals and healthcare sections, community residents, public health persons, relevant researchers, and all person who are interested in the 2019-nCoV.

Practice guidelines for the pathological diagnosis of primary liver cancer: 2015 update

In 2010, a panel of Chinese pathologists reported the first expert consensus for the pathological diagnosis of primary liver cancers to address the many contradictions and inconsistencies in the pathological characteristics and diagnostic criteria for PLC. Since then considerable clinicopathological studies have been conducted globally, prompting us to update the practice guidelines for the pathological diagnosis of PLC. In April 18, 2014, a Guideline Committee consisting of 40 specialists from seven Chinese Societies(including Chinese Society of Liver Cancer, Chinese Anti-Cancer Association; Liver Cancer Study Group, Chinese Society of Hepatology, Chinese Medical Association; Chinese Society of Pathology, Chinese Anti-Cancer Association; Digestive Disease Group, Chinese Society of Pathology, Chinese Medical Association; Chinese Society of Surgery, Chinese Medical Association; Chinese Society of Clinical Oncology, Chinese Anti-Cancer Association; Pathological Group of Hepatobiliary Tumor and Liver Transplantation, Chinese Society of Pathology, Chinese Medical Association) was created for the formulation of the first guidelines for the standardization of the pathological diagnosis of PLC, mainly focusing on the following topics: gross specimen sampling, concepts and diagnostic criteria of small hepatocellular carcinoma(SHCC), microvascular invasion(MVI), satellite nodules,and immunohistochemical and molecular diagnosis. The present updated guidelines are reflective of current clinicopathological studies, and include a novel 7-point baseline sampling protocol, which stipulate that at least four tissue specimens should be sampled at the junction of the tumor and adjacent liver tissues in a 1:1 ratio at the 12, 3, 6 and 9 o'clock reference positions. For the purposes of molecular pathological examination, at least one specimen should be sampled at the intratumoral zone, but more specimens should be sampled for tumors harboring different textures or colors. Specimens should be sampled at both adjacent and distant peritumoral liver tissues or the tumor margin in order to observe MVI, satellite nodules and dysplastic foci/nodules distributed throughout the background liver tissues. Complete sampling of whole SHCC ≤ 3 cm should be performed to assess its biological behavior, and in clinical practice, therapeutic borders should be also preserved, even in SHCC. The diagnostic criteria of MVI and satellite nodules, immunohistochemical panels, as well as molecular diagnostic principles, such as clonal typing, for recurrent HCC and multinodule HCC were also proposed and recommended. The standardized process of pathological examination is aimed at ensuring the accuracy of pathological PLC diagnoses as well as providing a valuable frame of reference for the clinical assessment of tumor invasive potential, the risk of postoperative recurrence, long-term survival, and the development of individualized treatment regimens. The updated guidelines could ensure the accuracy of pathological diagnoses of PLC, and provide a valuable frame of reference for its clinical assessment.

Distress management in cancer patients:Guideline adaption based on CAN-IMPLEMENT

Objective This study aimed to adapt relevant clinical practice guidelines for distress management in cancer patients based on A Guideline Adaptation and Implementation Planning Resource(CAN-IMPLEMENT),and develop Cancer-related Distress Management Guidelines in the context of the research site.Methods According to CAN-IMPLEMENT,the symptoms of cancer patients in Shanghai were investigated,and a work plan was formulated to adapt cancer-related distress management guidelines.The relevant clinical practice guidelines for distress management in cancer patients were searched,screened and assessed,the contents of the included clinical practice guidelines were screened,extracted and integrated,and the Cancer-related Distress Management Guidelines was developed.After peer review,the Cancer-related Distress Management Guidelines was finally formed.Results The physical symptom distress score was higher than the psychological symptom distress score among cancer patients in Shanghai.Two clinical practice guidelines related to distress management in cancer patients were included after searching,screening,assessment and selection systematically.The domain scores of the draft Cancer-related Distress Management Guidelines on Appraisal of Guidelines for Research and Evaluation II(AGREE II)were 73.75%–87.50%,respectively.The scores of most recommendations on feasibility,appropriateness,meaningfulness and effectiveness were at least 90%.The final guidelines included 13 recommendations.Conclusions The quality of the draft Cancer-related Distress Management Guidelines based on two included guidelines was well-accepted.The final Cancer-related Distress Management Guidelines needs to be further verified in clinical practice for feasibility,suitability and effectiveness.

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.

Distress management in cancer patients:Guideline implementation based on CAN-IMPLEMENT

Objective:To standardize the distress management of gastric cancer patients receiving chemotherapy,the adapted Cancer-related Distress Management Guidelines were implemented in nursing practice among gastric cancer patients receiving chemotherapy based on A Guideline Adaptation and Implementation Planning Resource(CAN-IMPLEMENT).Methods:Based on the theoretical framework of CAN-IMPLEMENT,A multidisciplinary team was established,barriers and facilitators obstacles of guidelines implementation in medical oncology units were assessed,corresponding solutions were formulated,the guidelines implementation process was monitored,and implementation results were evaluated.Results:The multidisciplinary team developed review criteria,standardized work paths,assessment tools,training manuals for healthcare professionals,education manuals for patients and their caregivers.After guidelines implementation,the completion rate of the distress management record came up to 97.9%(189/193).From September 2017 to December 2018,the compliance of medical staff on most items in the audit checklist was improved,ranging from 57.1%(100/175)to 100.0%(193/193).The positive distress rate of gastric cancer patients receiving chemotherapy was decreased from 22.7%(32/141)to 9.3%(18/193)(P<0.05),and the Median(range)of the distress score declined from 2(0e9)to 0(0e7)(P<0.001).Conclusions:The implementation of guidelines based on CAN-IMPLEMENT promotes the establishment of a distress management system in the medical oncology units.The review standards,standardized work paths,and evaluation tools for distress in cancer patients formulated by the multidisciplinary team had clinical applicability and effectiveness.Quality control in the practice of distress management was effective.The compliance of healthcare professionals with distress management was improved.The distress of gastric cancer patients receiving chemotherapy was alleviated effectively.

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.

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.

Artificial intelligence for the development and implementation guidelines for traditional Chinese medicine and integrated traditional Chinese and western medicine

The translation and implementation of clinical practice guidelines(CPGs)for Traditional Chinese Medicine(TCM)and Integrated Traditional Chinese and Western medicine is crucial to the adoption of medical science and technology,but the low operability and slow update of integrated traditional Chinese and Western Medicine guidelines,and the lack of integration between guidelines and clinical practice,result in the guidelines not having the desired clinical effects in practice.The application of Artificial Intelligence(AI)to the field of CPGs development aims to shorten the development time,optimize and accelerate the whole process of CPG’s development.This article summarized the current research and application status of AI in development and implementation CPGs for TCM and Integrated Traditional Chinese and Western medicine and proposed the method of Combining real world data and AI technology to enrich for TCM and Integrated Traditional Chinese and Western medicine.

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.

Clinical practice guideline dissemination and a new approach using Haddon matrix as a conceptual framework of evidence-based implementation strategies

To err is human. Clinical practice guidelines （CPGs） are often not followed and lead to adverse outcomes. The issue on implementation of CPG is complex. A review of CPG implementation is done to identify the barriers and enablers. For the first time, a fishbone diagram is used to delineate the root-causes. And Haddon matrix is applied to help understand the complexity of evidence-based implementation （EBI） strategies.

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.

Risk factors in cardiovascular patients:Challenges and opportunities to improve secondary prevention

BACKGROUND Effective management of major cardiovascular risk factors is of great importance to reduce mortality from cardiovascular disease(CVD).The Survey of Risk Factors in Coronary Heart Disease(SURF CHD)II study is a clinical audit of the recording and management of CHD risk factors.It was developed in collaboration with the European Association of Preventive Cardiology and the European Society of Cardiology(ESC).Previous studies have shown that control of major cardiovascular risk factors in patients with established atherosclerotic CVD is generally inadequate.Azerbaijan is a country in the South Caucasus,a region at a very high risk for CVD.AIM To assess adherence to ESC recommendations for secondary prevention of CVD based on the measurement of both modifiable major risk factors and their therapeutic management in patients with confirmed CHD at different hospitals in Baku(Azerbaijan).METHODS Six tertiary health care centers participated in the SURF CHD II study between 2019 and 2021.Information on demographics,risk factors,physical and laboratory data,and medications was collected using a standard questionnaire in consecutive patients aged≥18 years with established CHD during outpatient visits.Data from 687 patients(mean age 59.6±9.58 years;24.9%female)were included in the study.RESULTS Only 15.1%of participants were involved in cardiac rehabilitation programs.The rate of uncontrolled risk factors was high:Systolic blood pressure(BP)(SBP)(54.6%),low-density lipoprotein cholesterol(LDL-C)(86.8%),diabetes mellitus(DM)(60.6%),as well as overweight(66.6%)and obesity(25%).In addition,significant differences in the prevalence and control of some risk factors[smoking,body mass index(BMI),waist circumference,blood glucose(BG),and SBP]between female and male participants were found.The cardiovascular health index score(CHIS)was calculated from the six risk factors:Non-or ex-smoker,BMI<25 kg/m2,moderate/vigorous physical activity,controlled BP(<140/90 mmHg;140/80 mmHg for patients with DM),controlled LDL-C(<70 mg/dL),and controlled BG(glycohemoglobin<7%or BG<126 mg/dL).Good,intermediate,and poor categories of CHIS were identified in 6%,58.3%,and 35.7%of patients,respectively(without statistical differences between female and male patients).CONCLUSION Implementation of the current ESC recommendations for CHD secondary prevention and,in particular,the control rate of BP,are insufficient.Given the fact that patients with different comorbid pathologies are at a very high risk,this is of great importance in the management of such patients.This should be taken into account by healthcare organizers when planning secondary prevention activities and public health protection measures,especially in the regions at a high risk for CVD.A wide range of educational products based on the Clinical Practice Guidelines should be used to improve the adherence of healthcare professionals and patients to the management of CVD risk factors.

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.