Management of hepatitis C; Report of the Consensus Meeting at the 45th Annual Meeting of the Japan Society of Hepatology (2009)

The consensus meeting for the diagnosis, management and treatment for hepatitis C was held in 45^th annual meeting for the Japan Society of Hepatology (JSH) in June 2009 where the recommendations and informative statements were discussed including organizers and presenters. The Several important informative statements and recommendations have been shown. This was the fourth JSH consensus meeting of hepatitis C, however, the recommendations have not been published in English previously. Thus, this is the first report of JSH consensus of hepatitis C. The rate of development of hepatocellular carcinoma (HCC) in HCV‐infected patients in Japan is higher than in the USA, because the average age of the HCV‐infected patients is greater and there are more patients with severe fibrosis of the liver than in the USA. In Japan, more than 60% of HCV‐infected patients are genotype 1b infection, and they show lower response to perinterferon and ribavirin combination treatment. To improve the response rate is also an important issue in our country. To establish the original recommendations and informative statements to prevent the development of HCC is a very important issue in Japan.     

Management of hepatocellular carcinoma in Japan: Consensus-Based Clinical Practice Guidelines proposed by the Japan Society of Hepatology (JSH) 2010 updated version

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer death not only in Japan but also worldwide. Clinical practice guidelines for HCC were first published in 2001 by the European Society of Study of the Liver (EASL) followed by the American Association for the Study of Liver Disease (AASLD) published in 2005 and updated in 2010. However, these guidelines have proven to be somewhat unsuitable for Japanese patients. In 2005, supported by the Japanese Ministry of Health, Labour and Welfare, evidence-based clinical practice guidelines for HCC were compiled in Japan. In 2009, a revised version of evidence-based guidelines was published. Based on both 'evidence-based' guidelines and the consensus of an expert panel on HCC, the Japan Society of Hepatology (JSH) published the Consensus-Based Clinical Practice Manual in 2007 and updated in 2010. In this article, the 2010 updated version of this manual, especially issues on prevention, surveillance, pathology, diagnosis, staging, and treatment algorithm are summarized.     

Developing multidisciplinary guidelines for the management of early rheumatoid arthritis

Objective: To develop an evidence based guideline, for the multidisciplinary management of early rheumatoid arthritis (RA). Methods: Recommendations were developed using both an evidence‐based approach and expert opinion. The scientific committee, composed of key members of the rheumatology multidisciplinary team used a Delphi approach to evaluate topics and standard statements, which formed the basis for developing recommendations for management of RA in the first 2 years of disease. Evidence taken from literature was used to support these recommendations. Results: 24 evidence based recommendations for the management of early RA, with a grade of recommendation from A to C, were developed. In addition an algorithm of care was designed to promote a clear multidisciplinary management pathway. A mechanism for audit was also identified. Conclusion: Involvement of the multidisciplinary rheumatology team has enabled a holistic guideline to be developed for the management of patients presenting with early RA. This guideline is based around best practice that is supported by published literature. Whilst most statements in the guideline are based on strong evidence, others have been formulated by expert consensus in the absence of data and should serve as an opportunity to improve current practice through future research and audit. The development and implementation of such a guideline should improve the care of patients with early RA. Copyright © 2007 John Wiley & Sons, Ltd.     

Management of hepatitis B: Consensus of the Japan Society of Hepatology 2009

Recently, much progress has been made in the field of hepatitis B, such as natural history of the disease in relation to the amount of hepatitis B virus (HBV) DNA, genotypes of HBV influencing the natural course and treatment effects, mutations of HBV influencing the severity of the disease and development of hepatocellular carcinoma, and antiviral treatment such as nucleos(t)ide analogues and pegylated interferon. To make the consensus for the diagnosis, management and treatment of hepatitis B, a meeting was held during 45th annual meeting of Japan Society of Hepatology (JSH) in June 2009. In the meeting, recommendations and informative statements were discussed on the following subjects: (i) natural history of HBV infection; (ii) clinical implication of HBV genotypes; (iii) HBV mutations and their potential impact on pathogenesis of HBV infection; (iv) indications for antiviral treatment of chronic hepatitis B; (v) nucleos(t)ide analogues for chronic hepatitis B; and (vi) interferon therapy for chronic hepatitis B. The presenters reviewed the data on these subjects and proposed the consensus statements and recommendations. These statements were discussed among the organizers and presenters, and were approved by the participants of the meeting. In the current report, the relevant data were reviewed and the 12 consensus statements and nine recommendations on chronic hepatitis B were described.     

Guidelines for the diagnosis and treatment of Helicobacter pylori infection in Korea, 2013 revised edition

The Korean College of Helicobacter and Upper Gastrointestinal Research first developed guidelines for the diagnosis and treatment of Helicobacter pylori (H. pylori) infection in 1998, and revised guidelines were proposed in 2009 by the same group. Although the revised guidelines were based on a comprehensive review of published articles and the consensus of expert opinions, the revised guidelines were not developed using an evidence‐based process. The new guidelines presented in this study include specific changes regarding indication and treatment of H. pylori infection in Korea, and were developed through the adaptation process using an evidence‐based approach. After systematic review of the literature, six guidelines were selected using the Appraisal of Guidelines for Research and Evaluation (AGREE) II process. A total of 21 statements were proposed with the grading system and revised using the modified Delphi method. After the guideline revisions, 11 statements about indication of test and treatment, four statements about diagnosis, and four statements about treatment of H. pylori infection were developed. The revised guidelines were reviewed by external experts before receiving official endorsement from the Korean College of Helicobacter and Upper Gastrointestinal Research, and disseminated to physicians and other medical professionals for use in clinical practice in Korea. The guidelines will continue to be updated and revised periodically.     

Hepatocellular carcinoma: Consensus,controversies and future directions: A report from the Canadian Association for the Study of the Liver Hepatocellular Carcinoma Meeting

Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality worldwide and its incidence has rapidly increased in North America in recent years. Although there are many published guidelines to assist the clinician, there remain gaps in knowledge and areas of controversy surrounding the diagnosis and management of HCC. In February 2014, the Canadian Association for the Study of the Liver organized a one-day single-topic consensus conference on HCC. Herein, the authors present a summary of the topics covered and the result of voting on consensus statements presented at this meeting.     

Australian infection control in endoscopy consensus statements on carbapenemase‐producing Enterobacteriaceae

Outbreaks of carbapenemase‐producing Enterobacteriaceae clinical infections related to endoscopic transmission are well documented. The high morbidity and mortality associated with these infections emphasizes the need to reassess endoscopic reprocessing protocols. The Gastroenterological Society of Australia established a multi‐society committee to formulate evidence‐based consensus statements on the prevention and management of endoscopic transmission of carbapenemase‐producing Enterobacteriaceae. A literature search was undertaken utilizing the MEDLINE database. Further references were sourced from published paper bibliographies. Nine statements were formulated. Using the Delphi methodology, the statements were initially reviewed electronically by the committee members and subsequently at a face‐to‐face meeting in Melbourne, Australia. After further discussion, four additional sub‐statements were added resulting in a total of 13 statements. Each statement was assessed for level of evidence, recommendation grade and the voting on recommendation was recorded. For a statement to be accepted, five out of six committee members had to “accept completely” or “accept with some reservation.” All 13 statements achieved consensus agreement. Eleven statements achieved 100% “accepted completely.” Two statements were 83% “accepted completely” and 17% “accepted with some reservation.” Of particular significance, automated flexible endoscope reprocessors were mandated for high‐level disinfection, and the use of forced‐air drying cabinets was mandated for endoscope storage. These evidence‐based statements encourage preventative strategies with the aim of ensuring the highest possible standards in flexible endoscope reprocessing thereby optimizing patient safety. They must be considered in addition to the broader published guidelines on infection control in endoscopy.     

Management of early hepatocellular carcinoma: results of the Delphi consensus process of the Americas Hepato-Pancreato-Biliary Association

BackgroundThere are many potential treatment options for patients with early stage hepatocellular carcinoma (HCC) and practice patterns vary widely. This project aimed to use a Delphi conference to generate consensus regarding the management of small resectable HCC.MethodsA base case was established with review by members of AHPBA Research Committee. The Delphi panel of experts reviewed the literature and scored clinical case statements to identify areas of agreement and disagreement. Following initial scoring, discussion was undertaken, questions were amended, and scoring was repeated. This cycle was repeated until no further likelihood of reaching consensus existed.ResultsThe panel achieved agreement or disagreement consensus regarding 27 statements. The overarching themes included that resection, ablation, transplantation, or any locoregional therapy as a bridge to transplant were all appropriate modalities for early or recurrent HCC. For larger lesions, consensus was reached that radiofrequency ablation and microwave ablation were not appropriate treatments.ConclusionUsing a validated system for identifying consensus, an expert panel agreed that multiple treatment modalities are appropriate for early stage HCC. These consensus guidelines are intended to help guide physicians through treatment modalities for early HCC; however, clinical decisions should continue to be made on a patient-specific basis.     

Clinical practice update on heart failure 2019: pharmacotherapy,procedures, devices and patient management. An expert consensus meeting report of the Heart Failure Association of the European Society of Cardiology

The European Society of Cardiology (ESC) has published a series of guidelines on heart failure (HF) over the last 25 years, most recently in 2016. Given the amount of new information that has become available since then, the Heart Failure Association (HFA) of the ESC recognized the need to review and summarise recent developments in a consensus document. Here we report from the HFA workshop that was held in January 2019 in Frankfurt, Germany. This expert consensus report is neither a guideline update nor a position statement, but rather a summary and consensus view in the form of consensus recommendations. The report describes how these guidance statements are supported by evidence, it makes some practical comments, and it highlights new research areas and how progress might change the clinical management of HF. We have avoided re‐interpretation of information already considered in the 2016 ESC/HFA guidelines. Specific new recommendations have been made based on the evidence from major trials published since 2016, including sodium–glucose co‐transporter 2 inhibitors in type 2 diabetes mellitus, MitraClip for functional mitral regurgitation, atrial fibrillation ablation in HF, tafamidis in cardiac transthyretin amyloidosis, rivaroxaban in HF, implantable cardioverter‐defibrillators in non‐ischaemic HF, and telemedicine for HF. In addition, new trial evidence from smaller trials and updated meta‐analyses have given us the chance to provide refined recommendations in selected other areas. Further, new trial evidence is due in many of these areas and others over the next 2 years, in time for the planned 2021 ESC guidelines on the diagnosis and treatment of acute and chronic heart failure.     

Guidelines in pulmonary medicine: a 25-year profile.

OBJECTIVE: We attempted to identify clinical practice guideline and pathway articles in the area of pulmonary medicine published in peer-reviewed journals since 1974. DESIGN: Review. DATA SOURCES: MEDLINE, the Cochrane Database, Best Evidence, and Abstracts of Clinical Care Guidelines from January 1974 to December 1998. STUDY SELECTION: All articles contained relevant search terms for pulmonary topics and were included irrespective of setting (primary or specialty, inpatient or outpatient). Controlled and uncontrolled trials as well as observational studies and consensus opinion/statements were all identified. The articles were stratified by design as well as by pulmonary topic. DATA EXTRACTION: Limited data on study type, study focus, year of publication, and results of study were abstracted. RESULTS: Our criteria yielded 271 articles, including 115 consensus statements and expert opinion guidelines; 30 controlled studies, meta-analyses, or systematic reviews; and 126 uncontrolled trials and observational studies. Of these, 82 articles (30.3%) related to asthma, 46 articles (17.0%) related to COPD, and 36 articles (13.3%) related to pneumonia. In addition, we tracked the increasing publication of all guideline-related pulmonary articles; randomized, controlled trials (RCTs); systematic reviews; and consensus statements by year for the past 25 years. CONCLUSION: Pulmonary guidelines are increasingly published in peer-reviewed journals, but few are tested clinically in RCTs. There is continued reliance on consensus statements and expert opinion. Pulmonary guideline publications have continued to dramatically increase in number and in importance since 1974, both on the local level and internationally.     

Practice guidelines, a new reality in medicine. II. Methods of developing guidelines.

Current methods for developing practice guidelines include informal consensus development, formal consensus development, evidence-based guideline development, and explicit guideline development. Informal consensus development is the oldest and most common approach, but guidelines produced in this manner are often of poor quality and lack adequate documentation of methods. Formal consensus development uses a systematic approach to assess expert opinion and to reach agreement on recommendations. Evidence-based guideline development links recommendations directly to scientific evidence of effectiveness; rules of evidence are emphasized over expert opinion in making recommendations. Explicit guideline development clarifies the rationale by specifying the potential benefits, harms, and costs of available interventions; estimating the possibility of the outcomes; and comparing the desirability of the outcomes based on patient preferences. Steps in the development of practice guidelines include introductory decisions (selection of topic and panel members, clarification of purpose); assessments of clinical appropriateness (review of scientific evidence and expert opinion); assessment of public policy issues (resource limitations, feasibility issues); and guideline document development and evaluation (drafting of document, peer review, and pretesting).     

The 2nd edition of consensus statements for the diagnosis and management of intestinal Behçet’s disease: indication of anti-TNFα monoclonal antibodies

Background

Clinical evidence regarding intestinal Behçet’s disease (BD) management is lacking and intestinal lesions are a poor prognostic factor. In 2007, the Japan consensus statement for diagnosis and management of intestinal BD was developed. Recently, the efficacy of anti-tumor necrosis factor (TNF)α monoclonal antibodies (mAbs), and infliximab (IFX) was reported and adalimumab (ADA) was approved for intestinal BD in Japan. This study renewed consensus-based practice guidelines for diagnosis and treatment of intestinal BD focusing on the indication of anti-TNFα mAbs.

Methods

An expert panel of Japanese gastroenterology and rheumatology specialists was involved. Clinical statements for ratings were extracted from the literature, a professional group survey, and by an expert panel discussion, which rated clinical statements on a nine-point scale. After the first round of ratings, a panelist meeting discussed areas of disagreement and clarified areas of uncertainty. The list of clinical statements was revised after the panelist meeting and a second round of ratings was conducted.

Results

Fifteen relevant articles were selected. Based on the first edition consensus statement, improved clinical statements regarding indications for anti-TNFα mAbs use were developed. After a two-round modified Delphi approach, the second edition of consensus statements was finalized.

Conclusions

In addition to standard therapies in the first edition, anti-TNFα mAbs (ADA and IFX) should be considered as a standard therapy for intestinal BD. Colchicines, thalidomide, other pharmacological therapy, endoscopic therapy, and leukocytapheresis were deemed experimental therapies.     

Consensus statements on the clinical usage and characteristics of aripiprazole for Hong Kong

Aripiprazole, a dopamine partial agonist, is a second‐generation anti‐psychotic that is widely used for the treatment of schizophrenia and other psychotic disorders. A group of psychiatric experts in Hong Kong developed a set of consensus statements, aiming to facilitate the understanding of clinical properties and usages of aripiprazole among local physicians. Of note, because aripiprazole long‐acting injectable has been available locally not long before the establishment of the consensus panel, which limited the discussion on its use in the local context, the consensus statements were focused primarily on oral aripiprazole. To draft the consensus statements, the panellists discussed the published evidence and their clinical experience regarding aripiprazole in a series of meetings based on several areas. At the final meeting, each drafted statement was voted on anonymously by all panellists based on its practicability of recommendation in Hong Kong. A set of consensus statements on the characteristics and clinical use of aripiprazole was established and accepted by the panel. These statements serve to provide a practical reference for physicians in Hong Kong, and possibly other parts of the Asia‐Pacific region, on the use of aripiprazole in people with schizophrenia spectrum disorders and other psychotic problems.     

Re‐evaluating transarterial chemoembolization for the treatment of Hepatocellular Carcinoma: Consensus recommendations and review by an International Expert Panel

Patients with unresectable hepatocellular carcinoma (HCC) usually receive transarterial chemoembolization (TACE) or systemic therapies with intermediate and advanced‐stage disease. However, intermediate‐stage HCC patients often have unsatisfactory clinical outcomes with repeated TACE and there is considerable uncertainty surrounding the criteria for repeating or stopping TACE treatment. In July 2012, an Expert Panel Opinion on Interventions in Hepatocellular Carcinoma (EPOIHCC) was re‐convened in Shanghai in an attempt to provide a consensus on the practice of TACE, particularly in regard to evaluating TACE ‘failure’. To that end, current clinical practice throughout Asia was reviewed in detail including safety and efficacy data on TACE alone as well as in combination with targeted systemic therapies for intermediate HCC. This review summarizes the evidence discussed at the meeting and provides expert recommendations regarding the use of TACE for unresectable intermediate‐stage HCC. A key consensus of the Expert Panel was that the current definitions of TACE failure are not useful in differentiating between situations where TACE is no longer effective in controlling disease locally vs. systemically. By redefining these concepts, it may be possible to provide a clearer indication of when TACE should be repeated and more importantly, when TACE should be discontinued.     

Do the national survey results reflect the state of drug‐induced liver injury in a single local city in which there is no hospital having Members of the Board of Councilors of the Japan Society of Hepatology? Results of a questionnaire survey conducted in a local city

Aim: This survey aims at clarifying if there are common features of drug‐induced liver injury (DILI) in local areas and in the national surveys, and the degree of dissemination of the new diagnostic criteria (JDDW scale) proposed during the Japan Digestive Disease Week (JDDW) in 2004 and Manual for Serious Side‐Effects of DILI (Manual) published in April 2008. Methods: An anonymous questionnaire for DILI was conducted for 6 weeks starting on 20 October 2008. The participants were 179 medical doctors. One hundred and fifty‐seven of them belonged to the Medical Association of Nakatsu City (population: 86 000 persons), which is located in northern Kyushu, and 22 physicians working in a core hospital, Nakatsu Municipal Hospital. Results: Seventy‐four percent of the responding doctors with 13 various specialties had experienced DILI cases. The three most frequent causative drugs were antibiotics, folk medicines and drugs for the circulatory system. DILI associated with folk medicines was encountered mostly after 2000. The doctors' recognition of the JDDW scale and Manual were as low as 17% and 29%, respectively. Conclusion: This survey revealed that the results of the national investigations conducted by the Japan Society of Hepatology (JSH) reflect the current state of DILI in local areas in which there is no hospital with Members of the Board of Councilors of the JSH. Widespread utilization of the Manual and JDDW scale by local doctors must be facilitated for early diagnosis of DILI and the prevention of severe conditions.     

胃肠间质瘤外科诊治的中国专家共识与NCCN指南解读

2010年,中国临床肿瘤协作组成立胃肠间质瘤专家委员会,订立了我国的GIST诊治共识。以后每年均进行更新1次。而美国国家癌症综合网络发布的NCCN指南是目前全球应用最为广泛的癌症治疗指南。笔者就GIST的最新国内共识和新版NCCN指南的外科诊治部分作以解读。     

Asian Pacific Association for the Study of the Liver consensus recommendations on hepatocellular carcinoma

Introduction

The Asian Pacific Association for the Study of the Liver (APASL) convened an international working party on the management of hepatocellular carcinoma (HCC) in December 2008 to develop consensus recommendations.

Methods

The working party consisted of expert hepatologist, hepatobiliary surgeon, radiologist, and oncologist from Asian-Pacific region, who were requested to make drafts prior to the consensus meeting held at Bali, Indonesia on 4 December 2008. The quality of existing evidence and strength of recommendations were ranked from 1 (highest) to 5 (lowest) and from A (strongest) to D (weakest), respectively, according to the Oxford system of evidence-based approach for developing the consensus statements.

Results

Participants of the consensus meeting assessed the quality of cited studies and assigned grades to the recommendation statements. Finalized recommendations were presented at the fourth APASL single topic conference on viral-related HCC at Bali, Indonesia and approved by the participants of the conference.     

Evaluation of current treatment recommendations for chronic hepatitis B: a 2011 update

Background and Aim: Guidelines for the treatment of chronic hepatitis B have been recently updated in the 2009 European Association for the Study of the Liver consensus statement, the 2008 US Panel, the 2008 Asian–Pacific consensus statement, and the 2009 American Association for the Study of Liver Disease practice guidelines. We sought to determine whether these guidelines identified patients who developed hepatocellular carcinoma (HCC) or who died of non‐HCC liver‐related deaths for antiviral therapy. Methods: The criteria described in the new treatment guidelines were matched to the database of 369 hepatitis B surface antigen‐positive patients, in whom 30 developed HCC and 37 died of non‐HCC liver‐related deaths during a mean follow up of 84 months. Results: Using criteria for antiviral therapy as stated by the four current guidelines, 19–30% of patients who died of non‐HCC liver‐related complications, and 23–53% of patients who developed HCC, would have been excluded for antiviral therapy. If baseline serum albumin levels of ≤ 3.5 g/dL or platelet counts of ≤ 130 000 mm³ were included into the treatment criteria, then 85–94% of patients who developed liver‐related complications would have been recommended for antiviral therapy. Also, the addition of precore A1896 mutants and basal core promoter T1762/A1764 mutants would have identified 98.5–100% of these patients. Conclusion: The updated treatment guidelines for hepatitis B still excluded patients who developed serious liver‐related complications. The inclusion of baseline serum albumin and platelet counts to current criteria would have identified a majority of these patients for antiviral therapy. These tests should be included into hepatitis B treatment strategies.     

Clinical practice guidelines for IgG4‐related sclerosing cholangitis

IgG4‐related sclerosing cholangitis (IgG4‐SC) is a distinct type of cholangitis frequently associated with autoimmune pancreatitis and currently recognized as a biliary manifestation of IgG4‐related disease. Although clinical diagnostic criteria of IgG4‐SC were established in 2012, differential diagnosis from primary sclerosing cholangitis and cholangiocarcinoma is sometimes difficult. Furthermore, no practical guidelines for IgG4‐SC are available. Because the evidence level of most articles retrieved through searching the PubMed, Cochrane Library, and Igaku Chuo Zasshi databases was below C based on the systematic review evaluation system of clinical practice guidelines MINDS 2014, we developed consensus guidelines using the modified Delphi approach. Three committees (a guideline creating committee, an expert panelist committee for rating statements according to the modified Delphi method, and an evaluating committee) were organized. Eighteen clinical questions (CQs) with clinical statements were developed regarding diagnosis (14 CQs) and treatment (4 CQs). Recommendation levels for clinical statements were set using the modified Delphi approach. The guidelines explain methods for accurate diagnosis, and safe and appropriate treatment of IgG4‐SC.