Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Hematology/American Society of Clinical Oncology clinical practice guideline update

Purpose: To update the American Society of Clinical Oncology/American Society of Hematology (ASCO/ASH) recommendations for the use of epoetin. The guideline was expanded to address use of darbepoetin and thromboembolic risk associated with these agents. Method: An Update Committee ("Committee") reviewed and analyzed data published since 2002 through July 2007. MEDLINE and the Cochrane Collaboration Library databases were searched. Recommendations: For patients with chemotherapy-associated anemia, the Committee continues to recommend initiating an erythropoiesis-stimulating agent (ESA) as hemoglobin (Hb) approaches, or falls below, 10 g/dL, to increase Hb and decrease transfusions. ESA treatment continues to be recommended for patients with low-risk myelodysplasia for similar reasons. There is no evidence showing increased survival as a result of ESA treatment. Conclusive evidence is lacking that, absent clinical circumstances necessitating earlier treatment, initiating ESAs at Hb levels greater than 10 g/dL either spares more patients from transfusion or substantially improves their quality of life. Starting doses and dose modifications based on response or lack thereof should follow the package insert. Continuing ESAs beyond 6 to 8 weeks in the absence of response, assuming appropriate dose increase has been attempted in nonresponders as per US Food and Drug Administration–approved label, does not seem to be beneficial, and ESA therapy should be discontinued. The Committee recommends monitoring iron stores and supplementing iron intake for ESA-treated patients. ESAs should be used cautiously with chemotherapy, or in clinical states, associated with elevated risk for thromoembolic complications. The Committee also cautions against ESA use for patients with cancer who are not receiving chemotherapy, since recent trials report increased thromboembolic risks and decreased survival under these circumstances.      

American Society of Hematology/American Society of Clinical Oncology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer

Purpose: To update American Society of Hematology/American Society of Clinical Oncology recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer. Methods: An Update Committee reviewed data published between January 2007 and January 2010. MEDLINE and the Cochrane Library were searched. Results: The literature search yielded one new individual patient data analysis and four literature-based meta-analyses, two systematic reviews, and 13 publications reporting new results from randomized controlled trials not included in prior or new reviews. Recommendations: For patients undergoing myelosuppressive chemotherapy who have a hemoglobin (Hb) level less than 10 g/dL, the Update Committee recommends that clinicians discuss potential harms (eg, thromboembolism, shorter survival) and benefits (eg, decreased transfusions) of ESAs and compare these with potential harms (eg, serious infections, immune-mediated adverse reactions) and benefits (eg, rapid Hb improvement) of RBC transfusions. Individual preferences for assumed risk should contribute to shared decisions on managing chemotherapy-induced anemia. The Committee cautions against ESA use under other circumstances. If used, ESAs should be administered at the lowest dose possible and should increase Hb to the lowest concentration possible to avoid transfusions. Available evidence does not identify Hb levels ≥ 10 g/dL either as thresholds for initiating treatment or as targets for ESA therapy. Starting doses and dose modifications after response or nonresponse should follow US Food and Drug Administration-approved labeling. ESAs should be discontinued after 6 to 8 weeks in nonresponders. ESAs should be avoided in patients with cancer not receiving concurrent chemotherapy, except for those with lower risk myelodysplastic syndromes. Caution should be exercised when using ESAs with chemotherapeutic agents in diseases associated with increased risk of thromboembolic complications. Table 1 lists detailed recommendations.     

The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia

Immune thrombocytopenia (ITP) is commonly encountered in clinical practice. In 1996 the American Society of Hematology published a landmark guidance paper designed to assist clinicians in the management of this disorder. Since 1996 there have been numerous advances in the management of both adult and pediatric ITP. These changes mandated an update in the guidelines. This guideline uses a rigorous, evidence-based approach to the location, interpretation, and presentation of the available evidence. We have endeavored to identify, abstract, and present all available methodologically rigorous data informing the treatment of ITP. We provide evidence-based treatment recommendations using the GRADE system in those areas in which such evidence exists. We do not provide evidence in those areas in which evidence is lacking, or is of lower quality--interested readers are referred to a number of recent, consensus-based recommendations for expert opinion in these clinical areas. Our review identified the need for additional studies in many key areas of the therapy of ITP such as comparative studies of "front-line" therapy for ITP, the management of serious bleeding in patients with ITP, and studies that will provide guidance about which therapy should be used as salvage therapy for patients after failure of a first-line intervention.     

《2015年日本胃肠病学会慢性胰腺炎循证临床实践指南》摘译

日本第1版慢性胰腺炎(chronic pancreatitis,CP)临床实践指南在2009年提出,主要基于2001年日本胰腺协会慢性胰腺炎临床诊断标准.2015年参考CP早期病变的诊断重新修订了CP临床实践指南;此外,引入了高滴度脂肪酶制剂及伴有疼痛患者低脂要素饮食.指南中还包括了体外冲击波碎石(extracorporeal shock wave lithotripsy,ESWL)、新型抗糖尿病药物(如肠促胰素相关药物),以及根据2013亚特兰大分类修订的胰腺假性囊肿的概念和治疗.指南中增加了胰管支架治疗伴有胰源性胸腹水的胰腺内瘘,以及胆道支架治疗CP并发的胆管狭窄.此外,在观点描述和推荐等级中应用了GRADE系统(推荐、评估、发展和评价等级).本指南包括4章(诊断、分期、治疗和预后)和65个临床问题.     

Investment analysts and the American Society of Hematology

Investment analysts are a growing presence at the Annual Meeting of the American Society of Hematology (ASH), and financial professionals frequently contact ASH members for information and perspective on drugs, devices, and scientific developments. Recent incidents have raised concerns about consulting relationships between physicians and the investment industry; the appropriate role of medical societies in influencing these relationships is unclear. In this essay, I summarize the current situation, discuss potential risks and benefits from interactions between physicians and investment analysts, and outline issues that all individuals involved in investment industry consulting should consider. I also propose changes in ASH policy that may help safeguard public trust as well as preserve the access of clinicians and scientists to clinically relevant data presented at the Annual Meeting.     

《2015年日本胃肠病学会肝硬化循证医学临床实践指南》摘译

本指南是日本胃肠病学会根据2015年肝硬化循证医学临床实践指南修订的更新版本,主要是为肝硬化及其并发症在临床实践中提供最佳的治疗方案和干预措施.美国或欧洲肝硬化临床实践指南将肝硬化分为乙型肝炎、丙型肝炎、酒精性肝病、门静脉高压、腹水/肝肾综合征和肝性脑病等不同部分分别进行阐述.而本指南首次将肝硬化作为一个整体,对肝硬化及其并发症的管理进行综合性概述.其主要包括6部分:概念、诊断、治疗、并发症、预后和肝移植.现将文中的推荐意见及相关内容进行摘译,以供相关专业人士参考.本指南根据GRADE系统进行推荐强度及证据质量分级.证据质量分为A(高)、B(中)、C(低)及D(极低)等级;推荐强度分为1(强烈推荐)和2(较弱推荐)等级.     

Clinical guidelines and the practice of scientific evidence-based cardiology. Part I]

Scientific medical information presents special characteristics, particularly its huge quantity as well as the speed with which it evolves as a result of cardiological research. These facts create difficulties in transferring research results into practice, thereby delaying the benefits of medical advances to patients. One of the possible solutions to this problem is the development, dissemination and implementation of clinical practice guidelines, as a clinical decision support system as well as a quality assurance methodology. The process of developing clinical practice guidelines involves a needs assessment, individual formulations, implementation and evaluation, as well as periodic revisions. It constitutes a complex activity, requiring technical and scientific resources for a good design and an efficacious practical implementation. In this article--as well as the next--we will present and discuss the methodology of creation, structure, evaluation and implementation of clinical practice guidelines, as a clinical decision support system as well as a quality assurance methodology in cardiology.     

Development and use of evidence-based clinical practice guidelines for thyroid disease.

Clinical practice guidelines offer recommendations for optimizing health care. Guideline panels can rely on several methods for gathering information about current practice and synthesizing evidence that addresses specific questions. Clinical practice guidelines, including many that address thyroid disease, often rely on conventional narrative literature reviews and expert opinion rather than systematic evaluation of the published literature as the basis for their recommendations. This undermines the authority of practice guidelines and potentially results in disparate, invalid, or misleading recommendations. In contrast, incorporation of rigorous systematic reviews of literature and guidance by groups with multidisciplinary expertise decreases bias in evidence selection and increases precision of treatment effect estimates. Improved reliability and accuracy of evidence assessment, in turn, strengthens ultimate guideline recommendations. Cost-effective analyses further contribute to useful clinical practice guidelines and may encourage the explicit acknowledgment of values and preferences. Valid recommendations, however, prove futile in the absence of implementation. Adherence to guidelines may be improved with integration of user-friendly computer applications into clinical practice. By overcoming barriers to implementation and addressing the limitations of current guidelines, endocrinologists can play an essential role in improving the quality, efficiency, and cost-effectiveness of clinical practice related to thyroid disorders.     

Italian Society of Hematology practice guidelines for the management of iron overload in thalassemia major and related disorders

New measures of iron accumulation in liver and heart (superconducting quantum inference device and magnetic resonance imaging), and oral iron chelators (deferiprone and deferasirox) are available for managing iron overload in thalassemia major. To assure appropriate use of these new health technologies, the Italian Society of Hematology appointed a panel of experts to produce clinical practice-guidelines for the management of iron overload in thalassemia major and related disorders. The analytical hierarchy process, a technique for multicriteria decision analysis, was applied to relevant key questions in order to identify the alternative strategies, generate explicit criteria for their evaluation, and check how well the alternatives fulfilled the criteria. The result of a comprehensive systematic review of articles released from 1990 to 2007 was used as a source of scientific evidence to compare the decisional options pairwise, and select the final recommendation. Every step in the model was developed from questionnaires and group discussion. The resulting recommendations advise about which examination to carry out in order to plan iron chelation therapy, when to start iron chelation, which iron chelator to choose in regularly transfused patients, how to monitor iron chelation therapy, and when and how to switch standard therapy.     

Medical therapy for pulmonary arterial hypertension: updated ACCP evidence-based clinical practice guidelines

A consensus panel convened by the American College of Chest Physicians developed guidelines for the treatment of pulmonary arterial hypertension (PAH) that were published in 2004. Subsequently, several important clinical trials have been published, and new treatments have received regulatory approval. In addition, add-on and combination therapy are being explored, which promise to open new therapeutic avenues. This article, taking into consideration studies published prior to September 1, 2006, provides an update to the previously published guidelines. The original guidelines have been summarized, a discussion of new studies has been added, and the treatment algorithm has been revised to take into account recent developments in therapy. This update provides evidence-based treatment recommendations for physicians involved in the care of patients with PAH. Due to the complexity of the diagnostic evaluation required and the treatment options available, referral of patients with PAH to a specialized center continues to be strongly recommended.     

Management of sepsis in neutropenic patients: 2014 updated guidelines from the Infectious Diseases Working Party of the German Society of Hematology and Medical Oncology (AGIHO)

Sepsis is a major cause of mortality during the neutropenic phase after intensive cytotoxic therapies for malignancies. Improved management of sepsis during neutropenia may reduce the mortality of cancer therapies. Clinical guidelines on sepsis treatment have been published by others. However, optimal management may differ between neutropenic and non-neutropenic patients. Our aim is to give evidence-based recommendations for haematologist, oncologists and intensive care physicians on how to manage adult patients with neutropenia and sepsis.