Canadian Thoracic Society: Presenting a new process for clinical practice guideline production

A key mandate of the Canadian Thoracic Society (CTS) is to promote evidence-based respiratory care through clinical practice guidelines (CPGs). To improve the quality and validity of the production, dissemination and implementation of its CPGs, the CTS has revised its guideline process and has created the Canadian Respiratory Guidelines Committee to oversee this process. The present document outlines the basic methodological tools and principles of the new CTS guideline production process. Important features include standard methods for choosing and formulating optimal questions and for finding, appraising, and summarizing the evidence; use of the Grading of Recommendations Assessment, Development and Evaluation system for rating the quality of evidence and strength of recommendations; use of the Appraisal of Guidelines for Research and Evaluation instrument for quality control during and after guideline development and for appraisal of other guidelines; use of the ADAPTE process for adaptation of existing guidelines to the local context; and use of the GuideLine Implementability Appraisal tool to augment implementability of guidelines. The CTS has also committed to develop guidelines in new areas, an annual guideline review cycle, and a new formal process for dissemination and implementation. Ultimately, it is anticipated that these changes will have a significant impact on the quality of care and clinical outcomes of individuals suffering from respiratory diseases across Canada.     

中国2型糖尿病防治指南（2013年版）更新要点的解读

近日,由中华医学会糖尿病学分会制定的《中国2型糖尿病防治指南（2013年版）》（下称“新版指南”）正式发布.该指南是继2010年版指南之后的新版指南,其内容强调需符合我国国情和疾病变迁特征,反映了我国糖尿病相关研究和防治策略的进展.新版指南在汇集国内证据和参考国外证据的基础上编撰而成,并对前一版指南的内容进行了丰富,更加关注T2DM防治的临床和应用.本文着重从T2DM的更新要点进行解读,并与国外指南及循证证据进行对比.     

Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline from the American College of Physicians

DESCRIPTION: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the comparative effectiveness and safety of type 2 diabetes medications. METHODS: This guideline is based on a systematic evidence review evaluating literature published on this topic from 1966 through April 2010 that was identified by using MEDLINE (updated through December 2010), EMBASE, and the Cochrane Central Register of Controlled Trials. Searches were limited to English-language publications. The clinical outcomes evaluated for this guideline included all-cause mortality, cardiovascular morbidity and mortality, cerebrovascular morbidity, neuropathy, nephropathy, and retinopathy. This guideline grades the evidence and recommendations by using the American College of Physicians clinical practice guidelines grading system. RECOMMENDATION 1: ACP recommends that clinicians add oral pharmacologic therapy in patients diagnosed with type 2 diabetes when lifestyle modifications, including diet, exercise, and weight loss, have failed to adequately improve hyperglycemia (Grade: strong recommendation; high-quality evidence). RECOMMENDATION 2: ACP recommends that clinicians prescribe monotherapy with metformin for initial pharmacologic therapy to treat most patients with type 2 diabetes (Grade: strong recommendation; high-quality evidence). RECOMMENDATION 3: ACP recommends that clinicians add a second agent to metformin to treat patients with persistent hyperglycemia when lifestyle modifications and monotherapy with metformin fail to control hyperglycemia (Grade: strong recommendation; high-quality evidence).     

胰岛素注射指南有循证依据吗?各国胰岛素注射指南的系统评价

目的系统评价各国胰岛素注射指南关于针头是否重复使用、轮换注射部位的方法、不同胰岛素注射不同部位以及注射针头长度的循证依据。方法计算机检索PubMed、Medline、Embase、中国知网、维普数据库、万方数据库(1946年1月至2016年12月),搜索美国、澳大利亚、加拿大、丹麦、中国香港、荷兰、英国糖尿病教育学会官网(至2016年12月),按纳入和排除标准纳入胰岛素注射指南。两名研究人员根据指南研究和评价标准独立筛选并评价纳入指南的质量,提取相关数据进行评价。结果初检出相关文献967100篇,最终纳入10项指南,均发表于2007至2016年之间。系统评价发现,就各指南引用的证据而言,一针一用、在不同区域轮换注射(即大轮换,区别于同一部位轮换)以及不同胰岛素(如短效、中效等)应注射不同区域的建议所引用的依据缺乏准确性。结论现有胰岛素注射指南的部分建议证据引用不充分,将来需要开展更多与胰岛素注射相关的临床随机对照试验,为胰岛素注射指南的制定提供科学依据。     

Executive summary of the 2020 clinical practice guidelines for the management of hypertension in the Philippines

Hypertension is the most common cause of death and disability worldwide with its prevalence rising in low to middle income countries. It remains to be an important cause of morbidity and mortality in the Philippines with poor BP control as one of the main causes. Different societies and groups worked and collaborated together to develop the 2020 Philippine Clinical Practice Guidelines of hypertension arising for the need to come up with a comprehensive local practice guideline for the diagnosis, treatment, and follow up of persons with hypertension. A technical working group was organized into six clusters that analyzed the 30 clinical questions commonly asked in practice, looking into the definition of hypertension, treatment thresholds, blood pressure targets, and appropriate medications to reach targets. This guideline also includes recommendations for the specific management of hypertension among individuals with uncomplicated hypertension, hypertension among those with diabetes, stroke, chronic kidney disease, as well as hypertension among pregnant women and pediatric populations. It also looked into the appropriate screening and monitoring of patients when managing hypertension, and identification of groups who are at high risk for cardiovascular (CV) events. The ADAPTE process was used in developing the statements and recommendations which were then presented to a panel of experts for discussion and approval to come up with the final statements. This guideline aims to aid Filipino healthcare professionals to provide evidence‐based care for persons with hypertension and help those with hypertension adequately control their blood pressure and reduce their CV risk     

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.     

Moxibustion therapy on lumbar disc herniation: An evidence-based clinical practice guideline

Background:Lumbar disc herniation (LDH), as a disease with great disturbance to life and work, is known as the origin of the severe and disabling forms of nerve root pain. Recognized as an increasingly widely accepted treatment, the efficacy of moxibustion on LDH has been affirmed. However, clinical practice guidelines (CPG) for the treatment of LDH with moxibustion have not been developed. Therefore, we will carry out this work following the accepted methodological quality standards.Methods:The new CPG will be developed according to the Institute of Medicine (IOM), the Appraisal of Guidelines for Research & Evaluation II (AGREE II) and WHO guideline handbook. And then determine recommendations based on high-level evidence. We will set up a Guideline Working Group and define clinical issues according to the PICO principles (Population, Intervention, Comparison, Outcomes). After evidence syntheses and several rounds of Delphi process, we will reach the consensus. In making the guideline, Patient values or preferences, results of peer review, and interest statements are all within the bounds of what we must consider.Results:As the study is not yet complete, no results can be reported.Conclusion:So far, we will develop the first CPG for moxibustion of LDH strictly based on systematic methodologies in China. This CPG will establish the standard of LDH in moxibustion therapy.Registration number:IPGRP-2020CN034.     

Consensus statements on osteoporosis diagnosis, prevention, and management in the Philippines

Objective: The consensus statements were developed to assist healthcare practitioners in providing optimal care to postmenopausal individuals at risk for osteoporosis and fragility fractures in the local setting. Methodology: The Technical Review Committee formed by the Osteoporosis Society of the Philippines Foundation Inc. in cooperation with the Philippine Orthopedic Association drafted, retrieved available published evidence, and appraised important issues on osteoporosis and fragility fractures. The Appraisal of Guidelines Research and Evaluation instrument was used to appraise published guidelines while a systematic way of validating the quality of evidence and the level of recommendation was done using the GRADE system. A multidisciplinary panel of experts and stakeholders in an en banc meeting conferred and approved the recommendations. Results and conclusion: There were five key issues on preventive, seven on diagnostic, nine on therapeutic aspects of osteoporosis with four other surgical concerns on fragility fractures. All were approved by a panel of stakeholders through a majority vote. These statements will best inform the clinicians and the specialists including orthopedic surgeons and general care practitioners on issues of postmenopausal Filipino women at risk for osteoporosis and fragility fractures.     

Insulin glargine in type 2 diabetes in everyday clinical practice: 7 years experience

Insulin therapy is often essential in people with type 2 diabetes mellitus (T2DM) but is typically not initiated early enough or aggressive enough, leading to worsening of glycaemic control and the majority of people staying above recommended haemoglobin A_1c (HbA_1c) targets of <7%. The extensive clinical experience gained with insulin glargine, in particular, the low risk of hypoglycaemia and consistent improvements in HbA_1c, suggests that insulin glargine can be initiated aggressively to help patients reach such HbA_1c targets. However, many clinicians may be unaware of how easy it is to initiate insulin glargine. Indeed, the once-daily injection of insulin glargine plus once-daily measurement of blood glucose should provide little difficulty for patients. In the current review, the options for the initiation of insulin glargine in T2DM and how the patient can become more involved in management of their diabetes are discussed. The advantages of insulin glargine in randomized controlled trials and how these have translated into everyday clinical practice are also discussed.     

Major Global Coronary Artery Calcium Guidelines

This review summarizes the framework behind global guidelines of coronary artery calcium (CAC) in atherosclerotic cardiovascular disease risk assessment, for applications in both the clinical setting and preventive therapy. By comparing similarities and differences in recommendations, this review identifies most notable common features for the application of CAC presented by different cardiovascular societies across the world. Guidelines included from North America are as follows: 1) the 2019 American College of Cardiology/American Heart Association Guideline on the Primary Prevention of Cardiovascular Disease; and 2) the 2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for Prevention of Adult Cardiovascular Disease. The authors also included European guidelines: 1) the 2019 European Society for Cardiology/European Atherosclerosis Society Guidelines for the Management of Dyslipidemias; and 2) the 2016 National Institute for Health and Care Excellence Clinical Guidelines. In this comparison, the authors also discuss: 1) the Cardiac Society of Australia and New Zealand Guidelines on CAC; 2) the Chinese Society of Cardiology Guidelines; and 3) the Japanese Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases. Last, they include statements made by specialty societies including the National Lipid Association, Society of Cardiovascular Computed Tomography, and U.S. Preventive Services Task Force. Utilizing an in-depth review of clinical evidence, these guidelines emphasize the importance of CAC in the primary and secondary prevention of atherosclerotic cardiovascular disease. International guidelines all empower a dynamic clinician-patient relationship and advocate for individualized discussions regarding disease management and pharmacotherapy treatment. Some differences in precise coronary artery calcium score intervals, risk cut points, treatment thresholds, and stratifiers of specific patient subgroups do exist. However, international guidelines employ more similarities than differences from both a clinical and functional perspective. Understanding the parallels among international coronary artery calcium guidelines is essential for clinicians to correctly adjudicate personalized statin and aspirin therapy and further medical management.     

From authority recommendations to fact-sheets—a future for guidelines

ADA/EASD recommendations and diabetes expert consensus statements are not evidence-based. Reform of guideline development is urgently needed. Overriding governance and composition of the guideline committee is a key problem. Methodologists without important conflicts of interest should lead the development process and have primary responsibility. The rating of the quality of evidence should be separated from making the recommendations, transparency has to be increased and conflicts of interest must be tackled. Patient needs are not yet met in guidelines. Patients increasingly demand concise, easy-to-read summaries of the benefits and risks of medicines together with more comprehensive scientific data. However, patient participation in individual decision making is not considered in guidelines. Guidelines do not provide the information necessary for informed or shared decision making. Study fact-sheets and drug facts boxes should be included in practice guidelines. It is timely to consider patient needs from the outset of the development of future guidelines.     

Evidence summaries and recommendations from the international evidence‐based guideline for the assessment and management of polycystic ovary syndrome: Lifestyle management

Lifestyle is fundamental in chronic disease prevention and management, and it has been recommended as a first‐line treatment in the Australian polycystic ovary syndrome (PCOS) guideline 2011. The first international evidence‐based guideline on PCOS was developed in 2018, which expanded the scope and evidence in the Australian guideline. This paper summarizes the lifestyle recommendations and evidence summaries from the guideline. International multidisciplinary guideline development groups delivered the International Evidence‐based Guideline for the Assessment and Management of Polycystic Ovary Syndrome 2018. The process followed the Appraisal of Guidelines for Research and Evaluation II and The Grading of Recommendations, Assessment, Development and Evaluation framework. Extensive communication and meetings addressed six prioritized clinical questions through five reviews. Evidence‐based recommendations were formulated before consensus voting within the panel. Evidence shows the benefits of multicomponent lifestyle intervention, efficacy of exercise and weight gain prevention with no specific diet recommended. Lifestyle management is the first‐line management in the intervention hierarchy in PCOS. Multicomponent lifestyle intervention including diet, exercise and behavioural strategies is central to PCOS management with a focus on weight and healthy lifestyle behaviours. The translation programme optimizes reach and dissemination for health professionals and consumers.     

Guidelines for antimicrobial treatment of uncomplicated acute bacterial cystitis and acute pyelonephritis in women. Infectious Diseases Society of America (IDSA).

This is part of the series of practice guidelines commissioned by the Infectious Diseases Society of America (IDSA) through its Practice Guidelines Committee. The purpose of this guideline is to provide assistance to clinicians in the diagnosis and treatment of two specific types of urinary tract infections (UTIs): uncomplicated, acute, symptomatic bacterial cystitis and acute pyelonephritis in women. The guideline does not contain recommendations for asymptomatic bacteriuria, complicated UTIs, Foley catheter-associated infections, UTIs in men or children, or prostatitis. The targeted providers are internists and family practitioners. The targeted groups are immunocompetent women. Criteria are specified for determining whether the inpatient or outpatient setting is appropriate for treatment. Differences from other guidelines written on this topic include use of laboratory criteria for diagnosis and approach to antimicrobial therapy. Panel members represented experts in adult infectious diseases and urology. The guidelines are evidence-based. A standard ranking system is used for the strength of the recommendation and the quality of the evidence cited in the literature reviewed. The document has been subjected to external review by peer reviewers as well as by the Practice Guidelines Committee and was approved by the IDSA Council, the sponsor and supporter of the guideline. The American Urologic Association and the European Society of Clinical Microbiology and Infectious Diseases have endorsed it. An executive summary and tables highlight the major recommendations. Performance measures are described to aid in monitoring compliance with the guideline. The guideline will be listed on the IDSA home page at http://www.idsociety.org It will be evaluated for updating in 2 years.     

A Framework for Crafting Clinical Practice Guidelines that are Relevant to the Care and Management of People with Multimorbidity

Many patients of all ages have multiple conditions, yet clinicians often lack explicit guidance on how to approach clinical decision-making for such people. Most recommendations from clinical practice guidelines (CPGs) focus on the management of single diseases, and may be harmful or impractical for patients with multimorbidity. A major barrier to the development of guidance for people with multimorbidity stems from the fact that the evidence underlying CPGs derives from studies predominantly focused on the management of a single disease. In this paper, the investigators from the Improving Guidelines for Multimorbid Patients Study Group present consensus-based recommendations for guideline developers to make guidelines more useful for the care of people with multimorbidity. In an iterative process informed by review of key literature and experience, we drafted a list of issues and possible approaches for addressing important coexisting conditions in each step of the guideline development process, with a focus on considering relevant interactions between the conditions, their treatments and their outcomes. The recommended approaches address consideration of coexisting conditions at all major steps in CPG development, from nominating and scoping the topic, commissioning the work group, refining key questions, ranking importance of outcomes, conducting systematic reviews, assessing quality of evidence and applicability, summarizing benefits and harms, to formulating recommendations and grading their strength. The list of issues and recommendations was reviewed and refined iteratively by stakeholders. This framework acknowledges the challenges faced by CPG developers who must make complex judgments in the absence of high-quality or direct evidence. These recommendations require validation through implementation, evaluation and refinement.     

Das GRADE-System

Clinical practice guidelines have become an important source of information to support clinicians in the management of individual patients. However, current guideline methods have limitations that include the lack of separating the quality of evidence from the strength of recommendations. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) working group, an international collaboration of guideline developers, methodologists, and clinicians have developed a system that addresses these shortcomings. Core elements include transparent methodology for grading the quality of evidence, the distinction between quality of the evidence and strength of a recommendation, an explicit balancing of benefits and harms of health care interventions, an explicit recognition of the values and preferences that underlie recommendations. The GRADE system has been piloted in various practice settings to ensure that it captures the complexity involved in evidence assessment and grading recommendations while maintaining simplicity and practicality. Many guideline organizations and medical societies have endorsed the system and adopted it for their guideline processes.     

Adherence of published diabetes mellitus practice guidelines to methodologic standards of guideline development.

There are multiple practice guidelines published pertaining to diabetes care. Experts have formulated methodologic standards of guideline formulation. To determine whether practice guidelines pertaining to diabetes and published in peer-reviewed publications and the Internet adhered to established methodologic standards of guideline development. We identified all guidelines pertaining to diabetes care published between 1980 and 2000 using a computerized search of Medline, the Practice Guidelines Clearinghouse, the Institute for Clinical Systems Improvement Web site, and a global internet search engine. We used a previously validated 25-item assessment tool to determine guideline adherence to methodologic standards in three categories: guideline development and format, identification and summary of evidence, and formulation of recommendations. We conducted a multivariable regression analysis to determine the influence of guideline author, publishing medium, year of publication, and guidelines length on adherence to methodologic standards of guideline development. We evaluated 43 guidelines: 33% published on the Internet, 66% in peer-reviewed journals; 51% published by organizations, and 49% by individual experts. Of a maximum of 25 methodologic standards, the number of standards adhered by a guideline was 9 (range, 2 to 19). Mean proportion (SD) of guidelines that adhered to methodologic standards on guideline development and format was 48% (28); on identification and summary of evidence, 21% (22); and on the formulation of recommendations, 36% (27). Longer guidelines had greater adherence to methodologic standards (P < 0.0001). Guidelines pertaining to diabetes care published on the internet and in peer-reviewed publications do not meet most methodologic standards of guideline development.     

Methods of granting hospital privileges to perform gastrointestinal endoscopy

This is one of a series of statements discussing the utilization of gastrointestinal endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy prepared this text. In preparing this guideline, a MEDLINE literature search was performed, and additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When little or no data exist from well-designed prospective trials, emphasis is given to results from large series and reports from recognized experts. Guidelines for appropriate utilization of endoscopy are based on a critical review of the available data and expert consensus. Further controlled clinical studies are needed to clarify aspects of this statement, and revision may be necessary as new data appear. Clinical consideration may justify a course of action at variance to these recommendations.     

ASGE guideline: the management of low-molecular-weight heparin and nonaspirin antiplatelet agents for endoscopic procedures

This is one of a series of statements discussing the utilization of GI endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy prepared this text. In preparing this guideline, a MEDLINE literature search was performed, and additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When little or no data exist from well-designed prospective trials, emphasis is given to results from large series and reports from recognized experts. Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus. Further controlled clinical studies are needed to clarify aspects of this statement, and revision may be necessary as new data appear. Clinical consideration may justify a course of action at variance to these recommendations.     

The role of endoscopy in the evaluation and treatment of patients with pancreaticobiliary malignancy

This is one of a series of statements discussing the utilization of GI endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy prepared this text. In preparing this guideline, a MEDLINE literature search was performed, and additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When little or no data exist from well-designed prospective trials, emphasis is given to results from large series and reports from recognized experts. Guidelines for appropriate utilization of endoscopy are based on a critical review of the available data and expert consensus. Further controlled clinical studies are needed to clarify aspects of this statement, and revision may be necessary as new data appear. Clinical consideration may justify a course of action at variance to these recommendations.