GRADE system

等级制度
  • 文章类型: Journal Article
    中国乳腺外科学会(CSBrS)2021年实践指南发布近一年前。根据先前出版物的综合反馈对新指南进行了修订。旨在为中国乳腺外科医师提供更好的参考。
    参考等级(建议评估等级,开发和评估)系统,准则接受的证据分为四类:I,II,III和IV,定量地反映了证据的可靠性。该指南还综合考虑了指南在中国临床实践中的可及性,并给出了不同优势的建议。
    该指南强调了治愈性手术方法属于根治性肿瘤手术的基本思想。六章,包括“浸润性乳腺癌患者的诊断和治疗”,“早期乳腺癌患者的前哨淋巴结活检”,“早期乳腺癌患者的保乳手术”,“乳腺癌改良根治术”,“乳腺癌全身治疗的中心静脉通路”,和“妊娠期乳腺癌和产后乳腺癌”进行了修订。
    与2021版相比,根据最新的研究证据和临床需求,新指南已分为六章进行了修订。
    UNASSIGNED: The Chinese Society of Breast Surgery (CSBrS) Practice Guideline 2021 was published nearly one year ago. The new guideline was revised based on comprehensive feedback of the previous publication. The aim is to provide a better reference suitable for Chinese breast surgeons.
    UNASSIGNED: Referred to GRADE (Grading of Recommendations Assessment, Development and Evaluation) system, evidences accepted by the Guideline were classified into four categories: I, II, III and IV, which reflected the reliability of the evidences quantitatively. The guideline also comprehensively considered the accessibility of the guideline in clinical practice in China and gave recommendations with different strengths.
    UNASSIGNED: The guideline emphasized the basic idea that a curative surgical approach falls under the category of radical tumor surgery. Six chapters, including \"Diagnosis and treatment of patients with invasive breast cancer\", \"Sentinel lymph node biopsy in patients with early-stage breast cancer\", \"Breast-conserving surgery in patients with early-stage breast cancer\", \"Modified radical mastectomy of breast cancer\", \"Central venous access for the systemic treatment of breast cancer\", and \"Breast cancer in pregnancy and postpartum breast cancer\" were revised.
    UNASSIGNED: Compared with the 2021 edition, the new guideline has been revised in six chapters based on the latest research evidence and clinical needs.
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  • 文章类型: Journal Article
    目的:更新证据基础,以告知2024年JCR临床实践指南(CPGs)用于治疗老年人类风湿性关节炎(RA)。
    方法:评估了关于药物治疗的有效性和安全性的四个临床问题(CQs)。用CQ1寻址甲氨蝶呤(MTX),CQ2生物疾病缓解抗风湿药(bDMARDs),CCD3Janus激酶(JAK)抑制剂,和CQ4糖皮质激素(GC)。使用建议分级评估来评估证据的质量,发展,和评价体系。
    结果:观察性研究证实了MTX在老年RA患者治疗中的关键作用。荟萃分析显示,肿瘤坏死因子抑制剂和JAK抑制剂在老年RA患者中明确有效。没有数据表明bDMARDs对老年患者不安全。没有老年患者使用JAK抑制剂的安全性数据。一项随机对照试验表明,低剂量GC的长期治疗会增加GC相关不良事件的风险。对于所有CQ,总体证据的确定性非常低。
    结论:本系统综述为开发2024个JCRCPGs治疗老年RA患者提供了必要的证据。需要继续更新JAK抑制剂和GC的证据。
    OBJECTIVE: To update an evidence base informing the 2024 JCR clinical practice guidelines (CPGs) for the management of rheumatoid arthritis (RA) in older adults.
    METHODS: Four clinical questions (CQs) regarding efficacy and safety of drug treatment were evaluated, with CQ1 addressing methotrexate (MTX), CQ2 biological disease-modifying antirheumatic drugs (bDMARDs), CQ3 Janus kinase (JAK) inhibitors, and CQ4 glucocorticoids (GCs). Quality of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system.
    RESULTS: Observational studies confirmed a pivotal role of MTX in the treatment of older RA patients. The meta-analysis showed that tumor necrosis factor inhibitors and JAK inhibitors were unequivocally effective in older RA patients. No data indicated that bDMARDs were unsafe for older patients. No safety data for JAK inhibitor use in older patients were available. One randomized controlled trial demonstrated that long-term treatment with low-dose GCs increased risks of GC-associated adverse events. The certainty of overall evidence was very low for all CQs.
    CONCLUSIONS: This systematic review provides the necessary evidence for developing 2024 JCR CPGs for managing older patients with RA. Continued updates on the evidence of JAK inhibitors and GC are desired.
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  • 文章类型: Journal Article
    总结目前皮肤癌的治疗方法,日本皮肤癌协会发布了第一个皮肤癌指南,包括黑色素瘤,鳞状细胞癌,基底细胞癌(BCC),和Paget的乳房外疾病,2007年。这些准则于2015年修订。在这里,我们介绍2021版日本BCC临床指南的英文版.在最新版本中,所有程序均根据建议分级进行,评估,开发和评估系统。选择无法回答的临床问题进行进一步分析。全面的文献检索,系统审查,每个临床问题的建议由皮肤科医生组成的多学科专家小组确定,整形和重建外科医生,还有病理学家.手术切除是治疗BCC的金标准。放射治疗或局部治疗,除了手术切除,已在某些情况下使用。不可切除或转移性BCC患者需要全身治疗。新型特工,如免疫应答调节剂或刺猬通路抑制剂,正在世界范围内出现BCC的治疗方法。基于这些观点,四个相关的临床问题,手术切除,放射治疗,局部治疗,和全身治疗,本报告旨在帮助临床医生为患者选择合适的治疗方法。
    To summarize the current therapies for skin cancers, the Japanese Skin Cancer Society issued the first guidelines for skin cancers, including melanoma, squamous cell carcinoma, basal cell carcinoma (BCC), and extramammary Paget\'s disease, in 2007. These guidelines were revised in 2015. Herein, we present the English version of the 2021 edition of the Japanese clinical guidelines for BCC. In the latest edition, all procedures were performed according to the Grading of Recommendations, Assessment, Development and Evaluation systems. The clinical questions that could not be answered were selected for further analysis. A comprehensive literature search, systematic review, and recommendations for each clinical question were determined by a multidisciplinary expert panel comprising dermatologists, a plastic and reconstructive surgeon, and a pathologist. Surgical resection is the gold-standard therapy of BCC. Radiotherapy or topical treatments, other than surgical resection, have been used in some cases. Patients with unresectable or metastatic BCC require systemic therapy. Novel agents, such as immune response modifiers or hedgehog pathway inhibitors, are emerging worldwide for the treatment of BCC. Based on these viewpoints, four relevant clinical questions regarding, surgical resection, radiotherapy, topical treatment, and systemic therapy, were raised in this report that aims to help clinicians select suitable therapies for their patients.
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  • 文章类型: Journal Article
    目的:胰腺癌临床实践指南于2006年由日本胰腺学会首次发布,并于2009年、2013年、2016年和2019年进行了修订。2022年7月,日本新修订了胰腺癌临床实践指南。
    方法:对于此修订版,我们根据《2020年准则发展思想手册》制定了一个全新的准则,其中包括等级-分级建议评估的概念,发展,和评估,以便更好地理解当前的指导方针。患者和公众积极参与了指南的制定和实施。
    结果:指南包括诊断算法,治疗,化疗,和胰腺癌的精准医学,并涉及7个主题:诊断,手术治疗,辅助治疗,放射治疗,化疗,支架治疗,以及支持性和姑息性医疗。它包括73个临床问题和112个陈述。这些陈述对应于临床问题,证据水平,推荐优势,和协议率。
    结论:本指南代表了迄今为止日本最标准的临床和实用管理指南。这是日本2022年胰腺癌临床实践指南的英文摘要,并尝试在全球范围内传播日本指南,以引入日本方法来治疗胰腺癌。
    OBJECTIVE: Clinical Practice Guidelines for Pancreatic Cancer was first published in 2006 by the Japan Pancreas Society, and revised in 2009, 2013, 2016, and 2019. In July 2022, Clinical Practice Guidelines for Pancreatic Cancer was newly revised in Japanese.
    METHODS: For this revision, we developed an entirely new guideline according to the Minds Manual for Guideline Development 2020, which includes the concepts of GRADE-Grading Recommendations Assessment, Development, and Evaluation, to enable a better understanding of the current guidelines. Patients and the public were actively involved in both the development and implementation of the guideline.
    RESULTS: The guideline includes algorithms for diagnosis, treatment, chemotherapy, and precision medicine of pancreatic cancer, and addresses 7 subjects: diagnosis, surgical therapy, adjuvant therapy, radiation therapy, chemotherapy, stent therapy, and supportive & palliative medical care. It includes 73 clinical questions and 112 statements. The statements correspond to the clinical questions, evidence levels, recommendation strengths, and agreement rates.
    CONCLUSIONS: This guideline represents the most standard clinical and practical management guideline available until date in Japan. This is the English synopsis of the Clinical Practice Guidelines for Pancreatic Cancer 2022 in Japanese, and is an attempt to disseminate the Japanese guideline worldwide to introduce the Japanese approach to the clinical management of pancreatic cancer.
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  • 文章类型: Meta-Analysis
    目的:为日本难治性血管炎研究委员会修订抗中性粒细胞胞浆抗体(ANCA)相关性血管炎的临床实践指南提供依据。
    方法:PubMed,中部,和日本医学文摘学会数据库搜索2015年至2020年发表的文章,以更新现有临床问题的系统评价,而PubMed,中部,EMBASE,和日本医学文摘社检索了2000年至2020年之间发表的文章,以对新开发的临床问题进行系统评价。用等级方法评估证据的确定性。
    结果:对于缓解诱导,与环磷酰胺或利妥昔单抗联合使用时,与标准剂量糖皮质激素相比,减少剂量糖皮质激素可降低严重不良事件的风险.与高剂量糖皮质激素相比,在12个月时,阿伐托班可改善持续缓解。在缓解诱导治疗中添加血浆置换并不能降低死亡风险,终末期肾病,或复发。为了缓解,与硫唑嘌呤相比,利妥昔单抗降低了复发风险。与短期利妥昔单抗或硫唑嘌呤相比,长期利妥昔单抗或硫唑嘌呤可降低复发风险,分别。
    结论:本系统综述提供了制定2023年ANCA相关性血管炎临床实践指南所需的证据。
    OBJECTIVE: The objective of this study is to provide evidence for the revision of clinical practice guidelines for the management of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis by the Japan Research Committee for Intractable Vasculitis.
    METHODS: PubMed, CENTRAL, and the Japan Medical Abstracts Society databases were searched for articles published between 2015 and 2020 to update the systematic review for existing clinical questions, while PubMed, CENTRAL, EMBASE, and the Japan Medical Abstracts Society were searched for articles published between 2000 and 2020 to conduct a systematic review for newly developed clinical questions. The certainty of evidence was assessed with the GRADE approach.
    RESULTS: For remission induction, when used in conjunction with cyclophosphamide or rituximab, reduced-dose glucocorticoid lowered the risk of serious adverse events compared to standard-dose glucocorticoid. Avacopan improved sustained remission at 12 months compared to high-dose glucocorticoid. Addition of plasma exchange to remission induction therapy did not reduce the risk of death, end-stage kidney disease, or relapse. For remission maintenance, rituximab reduced the risk of relapse compared to azathioprine. Long-term rituximab or azathioprine reduced the risk of relapse compared to short-term rituximab or azathioprine, respectively.
    CONCLUSIONS: This systematic review provided evidence required to develop the 2023 clinical practice guideline for the management of ANCA-associated vasculitis.
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  • 文章类型: Journal Article
    未经评估:应广泛评估临床实践指南(CPG)的质量。这项研究旨在评估包括针灸建议的日本CPG。
    未经评估:在文献检索中,寻求CPG,包括在2021年10月之前在日本发布的针灸建议。我们评估(1)CPG是否根据分级建议评估制定,开发和评估(等级)系统,(2)使用《研究与评价指南》(AGREE)II评估的CPG质量,(3)针灸推荐的强度是否与每个CPG的预定义程序一致。
    UNASSIGNED:确定并评估了17项CPG,包括总共23项建议。(1)三个CPG符合等级制度。(2)在7分Likert量表上,使用AGREEII进行总体评估的平均得分为4.5。域1的平均域得分为77%(范围和目的),54%的领域2(利益相关者参与),领域3的48%(发展的严谨性),领域4的78%(呈现清晰度),领域5(适用性)的20%,域6(编辑独立性)为51%。(3)在两个CPG中提出的针灸建议的强度被认为被低估了。某些CPG包含AGREEII中未考虑的基本问题。
    UASSIGNED:日本CPG的方法学质量,包括针灸的建议,不一定很高。由于每个治疗领域都存在技术问题,各自的专家应参与制定和审查CPG,以传播准确的健康信息。
    UNASSIGNED: The quality of clinical practice guidelines (CPGs) should be extensively evaluated. This study aimed to evaluate Japanese CPGs that include recommendations for acupuncture.
    UNASSIGNED: In a literature search, CPGs including recommendations for acupuncture published in Japan until October 2021 were sought. We assessed (1) whether the CPGs were developed in accordance with the Grading Recommendations Assessment, Development and Evaluation (GRADE) system, (2) the quality of the CPGs using the Appraisal of Guidelines for Research and Evaluation (AGREE) II, and (3) whether the strength of the recommendations for acupuncture was consistent with each CPG\'s predefined procedure.
    UNASSIGNED: Seventeen CPGs including 23 recommendations in total were identified and assessed. (1) Three CPGs were in accordance with the GRADE system. (2) The mean score of overall assessment using AGREE II was 4.5 on a 7-point Likert scale. The mean domain scores were 77% for domain 1 (scope and purpose), 54% for domain 2 (stakeholder involvement), 48% for domain 3 (rigor of development), 78% for domain 4 (clarity of presentation), 20% for domain 5 (applicability), and 51% for domain 6 (editorial independence). (3) The strength of the recommendations for acupuncture in two CPGs was judged to be underestimated. Some of the CPGs contained elementary problems that were not considered in AGREE II.
    UNASSIGNED: The methodological quality of Japanese CPGs including recommendations for acupuncture was not necessarily high. Since technical issues exist in each field of therapy, the respective experts should be involved in developing and reviewing CPGs to disseminate accurate health information.
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  • 文章类型: Journal Article
    对催眠应用功效的研究持续增长,但是科学和临床实践之间仍然存在重大差距。一个挑战是缺乏共识,根据研究证据,催眠的应用是有效的。2018年,6个主要催眠组织合作成立了建立临床催眠功效标准工作组。本文介绍了工作组制定的临床催眠应用功效评估指南,提出了十项具体建议。该指南旨在成为那些想要评估任何特定适应症的临床催眠疗效的现有证据质量的工具。本文还讨论了解释和实施这些准则的方法问题。未来的论文将报告催眠功效工作组的其他产品,例如对催眠结果研究的最佳实践建议,以及对研究人员和临床医生关于催眠的当前实践和态度的国际调查。
    Research on the efficacy of hypnosis applications continues to grow, but there remain major gaps between the science and clinical practice. One challenge has been a lack of consensus on which applications of hypnosis are efficacious based on research evidence. In 2018, 6 major hypnosis organizations collaborated to form the Task Force for Establishing Efficacy Standards for Clinical Hypnosis. This paper describes a Guideline for the Assessment of Efficacy of Clinical Hypnosis Applications developed by the Task Force, which makes 10 specific recommendations. The guideline is intended to be a tool for those who want to assess the quality of existing evidence on the efficacy of clinical hypnosis for any particular indication. The paper also discusses methodological issues in the interpretation and implementation of these guidelines. Future papers will report on the other products of the Hypnosis Efficacy Task Force, such as best practice recommendations for outcomes research in hypnosis and an international survey of researchers and clinicians on current practice and attitudes about hypnosis.
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  • 文章类型: Journal Article
    目的:本研究的目的是根据日本医疗环境的最新变化,更新日本风湿病学会(JCR)治疗类风湿性关节炎(RA;JCRCPG)的临床实践指南(CPG)。本文是指南的摘要版本。
    方法:我们使用了建议分级,评估,发展,和评估方法更新2014年RAJCRCPG。CPG小组成员达成了共识。
    结果:我们确定了36个关于药物治疗的重要临床问题,并提出了针对RA的相应建议。建议包括以下RA药物:非甾体抗炎药,皮质类固醇,常规合成抗风湿药,生物疾病缓解抗风湿药,核因子-κB配体抗体的抗受体激活剂,和Janus激酶抑制剂,以及这些药物的逐渐减少和停药。还制定了有关老年人和合并症患者治疗疗效和安全性的建议。最后,我们使用这些建议创建了基于治疗目标方法的RA药物治疗的原始算法.
    结论:2020年RAJCRCPG为风湿病学家提供了有用的工具,卫生保健专业人员,和RA患者,在各种临床情况下实现共同决策。
    OBJECTIVE: The aim of this study was to update the Japan College of Rheumatology (JCR) clinical practice guidelines (CPG) for the management of rheumatoid arthritis (RA; JCR CPG for RA) according to recent changes in the medical environment in Japan. This article is a digest version of the guidance.
    METHODS: We used the Grading of Recommendations, Assessment, Development, and Evaluation method to update the 2014 JCR CPG for RA. A consensus was formed by CPG panel members.
    RESULTS: We identified 36 important clinical questions regarding drug treatment and developed corresponding recommendations for RA. The recommendations included the following RA medications: non-steroidal anti-inflammatory drugs, corticosteroids, conventional synthetic disease-modifying antirheumatic drugs, biological disease-modifying antirheumatic drugs, anti-receptor activator for nuclear factor-κB ligand antibodies, and Janus kinase inhibitors, as well as the tapering and discontinuation of these medications. Recommendations regarding the efficacy and safety of treatments in the elderly and patients with comorbidities were also developed. Finally, we used these recommendations to create an original algorithm for drug treatment for RA based on the Treat-to-Target approach.
    CONCLUSIONS: The 2020 JCR CPG for RA provides a useful tool for rheumatologists, health care professionals, and patients with RA, enabling shared decision-making in a variety of clinical situations.
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  • 文章类型: Journal Article
    In the last decade, the development of clinical practice guidelines in China has grown rapidly. However, with regards to the guidelines that have been established in the past, few were of high quality and in line with international standards. The main reason for this was that many clinical experts were not familiar with the procedures and rules of clinical guidelines before established, which lowered the quality seriously. Clinical practice guidelines are based on a clinical problem that is distilled into populations, interventions, comparison and outcome (PICO). After comprehensive systematic review, recommendations are made through evidence grading and strength of recommendation system. In addition, other issues should be noted such as pros and cons of the recommendation for specific population, preferences and values of the population, cost-effectiveness, and the health care system. A high-quality guideline requires multidimensional thinking (from clinicians, patients and policy makers), the implementation of a standard procedure (to ensure guidelines scientifically sound, honest and transparent), as well as the collaboration of multiple organizations (including experts, methodologists and policy makers).
    近10年,我国临床实践指南的制定迅速增长。然而,纵观既往制定的临床实践指南,能与国际接轨的高质量指南为数不多,主要原因是许多临床专家在制定指南之前并不熟悉其相关流程和规则,严重影响了指南的质量。临床实践指南需从临床问题出发,通过凝练化解为目标人群、方案或干预措施、其他备选措施以及可能的结局指标(即PICO问题),利用全面的系统评价、证据分级及推荐强度系统,对评价的措施给予确切的推荐意见。制定过程当中,需要同时考量推荐意见对适用人群的利弊,包括权衡适用人群的偏好和价值观、成本效益、医疗保健系统等。由此,一部高质量临床实践指南的制定需要多维度思考(从临床医生、患者、政策制定者思考)、实施标准流程(确保指南的科学性、真实性与透明性)以及依赖于多方协作(包括本专业领域专家、方法学家和政策制定者)。.
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  • 文章类型: Journal Article
    目的:为老年人类风湿性关节炎(RA)的临床治疗指南提供依据。
    方法:PubMed,科克伦图书馆,并在日本CentraRevuoMedicina数据库中搜索了1990年至2019年之间发表的文章。使用建议分级评估来评估证据的质量,开发和评估系统,有一些修改。
    结果:在702篇确定的文章中,有5项随机对照试验和10项观察性研究的事后分析.前者的荟萃分析得出,使用肿瘤坏死因子抑制剂治疗的vanderHeijde改良的Sharp总评分的平均差为-2.79(95%置信区间[CI]-3.74至-1.84)。美国风湿病学会50%反应率的风险比(RR),严重不良事件为2.83(95CI1.90-4.21)和1.32(95CI0.53-3.31),分别,用于Janus激酶抑制剂。观察性研究的荟萃分析得出,对于接受生物疾病缓解抗风湿药物的老年患者和年轻患者,疾病活动评分-28缓解和严重感染的RR为0.76(95CI0.64-0.91)和1.92(95CI1.31-2.81)。分别。
    结论:本系统综述为发展CPG治疗老年人RA提供了必要的证据。
    OBJECTIVE: To provide an evidence base for clinical practice guidelines (CPG) for the management of rheumatoid arthritis (RA) in older adults.
    METHODS: PubMed, Cochrane library, and Japan Centra Revuo Medicina databases were searched for articles published between 1990 and 2019. Quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation system, with some modifications.
    RESULTS: Among 702 identified articles, there were 5 post-hoc analyses of randomized controlled trials and 10 observational studies. Meta-analysis of the former yielded a mean difference of the van der Heijde-modified total Sharp score of -2.79 (95% confidence interval [CI] - 3.74 to -1.84) for treatment with tumor necrosis factor inhibitors. The risk ratio (RR) for the American College of Rheumatology 50% response rate, and for serious adverse events was 2.83 (95%CI 1.90-4.21) and 1.32 (95%CI 0.53-3.31), respectively, for Janus kinase inhibitors. Meta-analysis of the observational studies yielded an RR for disease activity score-28 remission and serious infections of 0.76 (95%CI 0.64-0.91) and 1.92 (95%CI 1.31-2.81) for older-versus-younger patients receiving biological disease-modifying antirheumatic drugs, respectively.
    CONCLUSIONS: This systematic review provides the necessary evidence for developing CPG for the management of RA in older adults.
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