Indications of external radiotherapy for hepatocellular carcinoma from updated clinical guidelines: Diverse global viewpoints

The etiology and disease patterns of hepatocellular carcinoma(HCC)significantly vary among regions. Modern standard treatments commonly require multidisciplinary approaches, including applications of up-to date medicine and advanced procedures, and necessitate the support of socioeconomic systems. For these reasons, a number of clinical guidelines for HCC from different associations and regions have been presented. External beam radiation therapy was contraindicated for HCC until a few decades ago, but with the development of new technologies, its application has rapidly increased as selective irradiation for tumorous lesions became possible. Most of the guidelines had been opposed or indifferent to radiotherapy in the past, but several guidelines have introduced indications and recommendations for radiotherapy in their updated versions. This review will discuss the characteristics of important guidelines and their contents regarding radiotherapy and will also provide guidance to physicians who are considering applications of locoregional modalities that include radiotherapy.

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.

A review of 2022 Chinese clinical guidelines on the management of hepatocellular carcinoma: updates and insights

Significant improvements in the management of hepatocellular carcinoma(HCC)during the past three years have urged the timely update of clinical guidelines in China.In brief,aMAP score is newly recommended as an effective risk stratification tool to predict HCC occurrence especially for non-cirrhotic patients.Biomarker-based surveillance including 7 micro-RNA panel and GALAD score are advocated to assist early diagnosis.China liver cancer(CNLC)staging system proposed in the 2017 guideline continues to be the standard model for staging with modifications in the treatment allocations.Conversion therapies using multi-modal,high intensity strategies are advocated to facilitate subsequent resection for patients with technically unresectable CNLC stage Ia,Ib,IIa HCC,or technically resectable IIb,IIIa HCC.Super-selective transcatheter arterial chemoembolization(TACE)with the assistance of Cone-Beam CT if necessary is recommended to guarantee the efficacy of TACE.Hepatic arterial infusion chemotherapy(HAIC)using oxaliplatin,fluorouracil,and leucovorin(FOLFOX)regimen alone or in combination with systemic therapy is recommended for TACE-refractory patients or for patients with locally advanced HCC.The systemic treatments for HCC have evolved considerably since atezolizumab plus bevacizumab,and suntilimab plus bevacizumab analogue showing superior survival benefit to sorafenib,and donafenib with comparable efficacy with sorafenib are added to the first-line treatments.In addition to regorafenib,apatinib,camrelizumab and tislelizumab are added as the second-line systemic therapies for patients who progressed on sorafenib.Updates in the 2022 Barcelona Clinic Liver Cancer(BCLC)guidelines and Japanese Society of Hepatology(JSH)consensus statement are also introduced and compared with the 2022 Chinese guidelines.

2019 Chinese clinical guidelines for the management of hepatocellular carcinoma: updates and insights

Importance:Approximately half of newly-diagnosed hepatocellular carcinoma(HCC)cases in the world occur in China,with hepatitis B virus(HBV)infection being the predominant risk factor.Recently,the guidelines for the management of Chinese HCC patients were updated.Objective:The past decade has witnessed a great improvement in the management of hepatocellular carcinoma(HCC).This study reviews the recommendations in the 2019 Chinese guidelines and makes comparison with the practices from the Western world.Evidence Review:The updated recommendations on the surveillance,diagnosis,and treatment algorithm of HCC in the 2019 Chinese guidelines were summarized,and comparisons among the updated Chinese guidelines,the European Association for the Study of the Liver(EASL)and the American Association for the Study of Liver Diseases(AASLD)guidelines were made.Findings:Besides imaging and pathological diagnoses,novel biomarkers like the seven-micro-RNA panel are advocated for early diagnoses and therapeutic efficacy evaluation in the updated Chinese guidelines.The China liver cancer(CNLC)staging system,proposed in the 2017 guidelines,continues to be the standard model for patient classification,with subsequent modifications and updates being made in treatment allocations.Compared to the Barcelona Clinic Liver Cancer(BCLC)system,the CNLC staging system employs resection,transplantation,and transarterial chemoembolization(TACE)for more progressed HCC.TACE in combination with other regional therapies like ablation or with systemic therapies like sorafenib are also encouraged in select patients in China.The systemic treatments for HCC have evolved considerably since lenvatinib,regorafenib,carbozantinib,ramucirumab and immune checkpoint inhibitors(ICIs)were first prescribed as first-line or second-line agents.Conclusions and Relevances:Novel biomarkers,imaging and operative techniques are recommended in the updated Chinese guideline.More aggressive treatment modalities are suggested for more progressed HBV-related HCC in China.

Quality assessment of clinical guidelines in China： 1993-2010

Background Clinical practice guidelines （CPGs） play an important role in healthcare in China as well as in the world. However, the current status and trends of Chinese CPGs are unknown. The aim of this study was to systematically review the present situation and the quality of Chinese CPGs published in the peer-reviewed medical literature. Methods To identify Chinese CPGs, a systematic search of relevant literature databases （CBM, WANFANG, VIP, and CNKI） was performed for the period January 1978 to December 2010. We used the AGREE II instrument to assess the quality of the included guidelines. Results We evaluated 269 guidelines published in 115 medical journals from 1993 to 2010 and produced by 256 different developers. Only four guidelines （1%） described the systematic methods for searching and selecting the evidence, 14 （5%） guidelines indicated an explicit link between the supporting evidence and the recommendations, only one guideline used the Grading of Recommendations Assessment, Development and Evaluation （GRADE） system. Thirty-one guidelines （12%） mentioned updates and the average frequency of update was 5.5 years; none described a procedure for updating the guideline. From the assessment with the Appraisal of Guidelines for Research and Ecaluation II （AGREE II）, the mean scores were low for the domains ＂scope and purpose＂ （19%） and ＂clarity of presentation＂ （26%） and very low for the other domains （＂rigour of development＂ 7%, ＂stakeholder involvement＂ 8%, ＂applicability＂ 6% and ＂editorial independence＂ 2%）. Conclusions Compared with other studies on the quality of guidelines assessed with the AGREE instrument in other countries, Chinese CPGs received lower scores, which indicates a relatively poor quality of the guidelines. However, there was some increase over time.

Guidelines and standards for comprehensive clinical diagnosis and interventional treatment for diabetic foot in China(Issue 7.0)

Diabetic foot(DF)is one of the most common complications of diabetes and is associated with high morbidity,disability,lethality and low cure-rate.The clinical diagnosis and treatment of DF need to be standardized.The Chinese Diabetic Foot Cell and Interventional Therapy Technology Alliance has released six editions of guidelines and standards for clinical diagnosis and interventional treatment of DF,which filled the gap in the domestic DF treatment standard and played an important role in improving the level of diagnosis and treatment in China.In line with the latest developments in diagnosis and treatment,the Alliance,along with other 89 institutions,developed and issued the new edition based on the sixth edition to help standardize the clinical diagnosis and treatment of DF in China.

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.

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.

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.

Current guidelines for the management of celiac disease:A systematic review with comparative analysis

BACKGROUND Wheat and other gluten-containing grains are widely consumed,providing approximately 50%of the caloric intake in both industrialised and developing countries.The widespread diffusion of gluten-containing diets has rapidly led to a sharp increase in celiac disease prevalence.This condition was thought to be very rare outside Europe and relatively ignored by health professionals and the global media.However,in recent years,the discovery of important diagnostic and pathogenic milestones has led to the emergence of celiac disease(CD)from obscurity to global prominence.These modifications have prompted experts worldwide to identify effective strategies for the diagnosis and follow-up of CD.Different scientific societies,mainly from Europe and America,have proposed guidelines based on CD's most recent evidence.AIM To identify the most recent scientific guidelines on CD,aiming to find and critically analyse the main differences.METHODS We performed a database search on PubMed selecting papers published between January 2010 and January 2021 in the English language.PubMed was lastly accessed on 1 March 2021.RESULTS We distinguished guidelines from 7 different scientific societies whose reputation is worldwide recognized and representative of the clinical practice in different geographical regions.Differences were noted in the possibility of a no-biopsy diagnosis,HLA testing,follow-up protocols,and procedures.CONCLUSION We found a relatively high concordance between the guidelines for CD.Important modifications have occurred in the last years,especially about the possibility of a no-biopsy diagnosis in children.Other modifications are expected in the next future and will probably involve the extension of the non-invasive diagnosis to the adult population and the follow-up modalities.

Appraising the quality of clinical practice guidelines in Chinese patent medicine

Background:Chinese patent medicine(CPM)is a type of traditional Chinese medicine(TCM)that utilizes Chi-nese medicinal materials as its raw ingredients.Following the principles of TCM theory,it undergoes specific processing techniques to create various dosage forms for the prevention and treatment of diseases.The current CPM guidelines,both domestically and internationally,are constrained by limitations in methodological quality and reporting,which do not adequately address the requirements of the majority of clinicians and patients.Objective:To evaluate the methodological rigor and reporting quality of clinical practice guidelines(CPGs)in CPM,with aim to assess their current quality and to provide recommendations for improving guideline develop-ment.Methods:The study utilized the Appraisal of Guidelines for Research and Evaluation II(AGREE II)tool and the Reporting Items for Practice Guidelines in Healthcare for Traditional Chinese Medicine(RIGHT for TCM)checklist to evaluate the methodological rigor and reporting quality of CPM guidelines.After the training session,the four investigators were divided into two groups to evaluate the guidelines of patent Chinese medicine included in this study based on the aforementioned criteria.In case of any discrepancies,a secondary analysis was conducted by all four researchers under the guidance of two clinical experts,ensuring an impartial evaluation outcome.Average score or average reporting rate were calculated for each domain.Results:A total of 32 CPM guidelines that met the inclusion criteria were analyzed.The AGREE II yielded an average score of 67.2%.The domain scores were as follows:scope and purpose(93.3%),stakeholder involve-ment(50.1%),rigor of development(76.8%),clarity of presentation(79.4%),applicability(40.1%),and editorial independence(63.6%).The average reporting rate of the RIGHT for TCM checklist was 70.0%,with the report-ing rates for the seven domains as follows:basic information(94.2%),background(87.9%),evidence(97.5%),recommendation(57.5%),review and quality assurance(11.4%),funding and declaration and management of interests(26.6%),and other information(68.8%).Conclusions:The methodological and reporting quality of CPGs for CPM have been deemed acceptable since 2020.However,there is still room for improvement,particularly in enhancing the reporting quality to provide clinicians and patients with more effective and comprehensive guidance.Additionally,it may be beneficial to develop a comprehensive reporting checklist specifically tailored for CPM guideline development.

A Protocol for Developing Chinese Clinical Practice Guidelines of Hypertension

To improve the standard screening, diagnosis, and treatment of hypertension in patients in China;realize the standardization of clinical practice of hypertension;and improve the prevention and control level of hypertension in China, it is both important and necessary to develop a clinical practice guideline for hypertension according to a recognized methodology. Jointly sponsored by the National Center for Cardiovascular Diseases, Chinese Medical Doctor Association, Hypertension Committee of the Chinese Medical Doctor Association, Chinese Society of Cardiology, and Hypertension Committee of Cross-Straits Medicine Exchange Association, the “Chinese Clinical Practice Guidelines of Hypertension” was proposed. Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, Guideline and Standards Research Centre of Chinese Medical Association Publishing House, Lanzhou University Institute of Health Data Science, and Lanzhou University GRADE Center will provide methodological support for the guidelines.

Clinical practice guidelines for acute pancreatitis in the United States and Japan:similarities and differences

Acute pancreatitis(AP)is defined as sudden inflammation that occurs in the pancreas(1-4).Although most cases of AP are mild,approximately 20%of patients develop severe acute pancreatitis(SAP),which is potentially lethal(3,4).Because of the rapid expansion of knowledge regarding the pathogenesis,diagnosis,and treatment of AP,remaining apprised of the latest information regarding clinical practice can be challenging.Clinical practice guidelines are published statements proposed by a panel of experts and include recommendations regarding the optimal diagnosis and treatment of disease(5).Therefore,many clinicians rely on clinical practice guidelines for patient management.Recently,the American College of Gastroenterology(ACG)published clinical practice guidelines for AP management(1).However,in Japan,clinicians often rely on the 2021 Japanese clinical practice guidelines when managing AP(2).The ACG and Japanese clinical practice guidelines for AP share various recommendations regarding diagnosis,severity assessment,and management of this condition;however,these guidelines also have significant differences.Therefore,this editorial article discusses these similarities and differences.

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.

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.

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.