美国临床生化科学院检验医学实践指南：睾丸、前列腺、结直肠、乳腺及卵巢癌肿瘤标志物的应用

经美国临床生化科学院(NCAB)授权,由鄢盛恺教授组织学者、专家翻译审定2009年NCAB检验医学实践指南:睾丸、前列腺、结直肠、乳腺及卵巢癌中肿瘤标志物的应用单行本(Catharine M.Sturgeon教授和Eleftherios P.Diaman-dis教授编辑)。该指南包含第1至6章共6部分内容,参加指南制订的专家阵容强大,分别从临床及检验角度对睾丸、前列腺、结直肠、乳腺及卵巢癌中肿瘤标志物的检测与临床应用方面的问题进行了详细阐述与说明,是目前国内外在肿瘤实验诊断方面的纲领性应用文件。不仅适合广大检验人员、临床医护人员学习使用,也非常适合相关仪器试剂生产厂商研发应用。本指南由刘洋、薛丽、林文涛、李江、梁红艳、顾兵、潘世扬、郑磊等翻译,姜晓峰、沈文梅、田亚平、鄢盛恺审校,最后由鄢盛恺统稿审定。本指南的翻译出版,不仅有助于我国检验人员和医护人员合理的检测和应用睾丸、前列腺、结直肠、乳腺及卵巢癌肿瘤标志物,对我国检验医学指南的编写与应用也有一定的借鉴作用。本刊特在本期刊发,以飨广大读者。     

用循证医学指导临床组合检验项目的应用

按照循证医学的理念对检验项目临床应用进行评价，包括技术性能、诊断性能、患者结果、经济性能等严格评价，根据不同的诊断目的和不同的疾病，制定检验项目组合的临床应用指南，为临床医生提供最佳临床实验室诊断服务，以保证患者得到最大受益。     

医学实验室认可在临床微生物学检验领域的实践

临床微生物学检验作为医学实验室的认可领域之一,其认可在我国目前主要根据CNAS-CL02：2008《医学实验室质量和能力认可准则》和CNAS-GL23：2008《医学实验室质量和能力认可准则在临床微生物学检验领域的指南》来进行的。本文根据临床微生物检验领域医学实验室认可不同阶段,针对学习认可文件、编写标准化作业指导书、现场评审、分析前质量控制、建立危急结果回报制度、持续改进质量和管理体系以及存在的问题等进行论述与讨论,以促进我国临床微生物检验领域医学实验室认可的发展与进步。     

医学实验室认可在临床微生物学检验领域的实践

临床微生物学检验作为医学实验室的认可领域之一,其认可在我国目前主要根据CNAS-CL02:2008《医学实验室质量和能力认可准则》和CNAS-GL23:2008《医学实验室质量和能力认可准则在临床微生物学检验领域的指南》来进行的。本文根据临床微生物检验领域医学实验室认可不同阶段,针对学习认可文件、编写标准化作业指导书、现场评审、分析前质量控制、建立危急结果回报制度、持续改进质量和管理体系以及存在的问题等进行论述与讨论,以促进我国临床微生物检验领域医学实验室认可的发展与进步。     

美国临床生化科学院检验医学实践指南:心血管疾病和卒中一级预防中新的生物标志物 第1章 前言

本文件编写的目的是提供美国临床生化科学院(NACB)关于心血管疾病(CVD)和卒中一级预防中新生物标志物的检验医学实践指南。NACB是美国临床化学协会(AACC)的学术委员会,一项重要职能是制定检验医学实践指南以帮助临床和实验室对患者特定疾病危险增高时进行实际判定。背景     

美国临床生化科学院检验医学实践指南：心血管疾病和卒中一级预防中新的生物标志物

编者按:经美国临床化学协会(American Association for Clinical Chemistry,AACC)下设的美国临床生化科学院(National Academy of Clinical Biochemistry,NACB)授权,由鄢盛恺研究员组织学者、专家翻译审定了2009年NACB检验医学实践指南:心血管疾病和卒中一级预防中的新生物标志物单行本(Garg L.Myers编辑)。该指南包含第1～10章共10部分内容。参加指南制订的专家阵容强大,分别从临床及医学检验     

甲状腺疾病诊断治疗中实验室检测项目的应用建议

为了在甲状腺疾病的诊断和治疗中科学、合理地应用实验室检测项目,中华医学会检验分会、卫生部临床检验中心和中华检验医学杂志编辑委员会共同决定制定甲状腺疾病诊断治疗中实验室检测项目的应用建议,并委托中华医学会检验分会的临床疾病实验室检测项目应用建议编写组负责起草制定.本建议编写时参考了美国临床生化学会的甲状腺疾病实验室诊断指南(Laboratory Support for theDiagnosis and Monitoring of Thyroid Disease).本建议在制定过程中,通过多种方式广泛征求临床甲状腺疾病学专家和检验医学工作者的意见,作为修改的一个重要参考依据.本建议最后经中华医学会检验分会和卫生部临床检验中心组织专家进行讨论修改后,由中华医学会检验分会、卫生部临床检验中心和中华检验医学杂志编辑委员会共同发布.     

4年制本科医学检验技术专业实践教学体系的构建

为适应医学检验技术4年制理学学士培养方案改革,制订4年制医学检验技术毕业实习指导手册,构建新的4年制本科医学检验技术专业实践教学体系。本文从4年制本科医学检验技术专业实践教学体系的构建、创新及临床实践教学应用中尚存在的问题进行分析,提出改进策略,建立一个医学检验技术专业规范化实习管理的框架和指南。     

临床微生物检验自动化流水线应用专家共识

全自动微生物自动化流水线在我国的应用尚处于起步阶段, 缺乏临床微生物检验自动化流水线应用的相关标准。为推进自动化技术的发展, 中华医学会检验医学分会和中国医学装备协会检验医学分会组织制定了《临床微生物检验自动化流水线应用专家共识》。共识围绕自动化流水线的临床应用问题, 讨论了应用前期需要考虑的实际要素, 评价了应用过程中流水线的技术特点, 特别指出应用后实验室面临的检验流程再造等问题, 最后提出实施微生物自动化流水线的挑战和展望。该共识为推动医学检验自动化仪器的应用, 临床微生物检验由传统手工操作转向自动化检测的变革提供指导。     

基于临床案例的设计性实验在临床检验基础实验教学中的应用

探讨基于临床案例的设计性实验在医学检验专业临床检验基础实验教学中的应用。在临床检验基础实验教学中,选择有代表性的临床案例,由学生设计实验方案并完成实验过程,2012级和2013级医学检验本科生实践表明,应用基于临床案例的设计性实验能激发学生学习的积极性、主动性和创造性,培养学生的临床思维能力;不仅能提高实验教学质量,培养学生的科研创新能力,同时也有利于教师综合水平的提高,有助于应用型医学检验人才的培养。     

Evidence-based guidelines in laboratory medicine: principles and methods

BACKGROUND: Guidelines are commonly used tools for supporting medical decisions. Formulating evidence-based recommendations has become a leading principle in guideline development. AIM: This narrative review integrates the most recent methods of evidence-based guideline development and adapts those to the field of laboratory medicine. SUMMARY: We present a 10-step process and a list of criteria for the development of laboratory guidelines. Laboratory guidelines should be outcome oriented, be developed by a multidisciplinary team, and begin with a clear statement of the clinical question(s) that the use of the test(s) is addressing. The clinical questions define the type of study designs that offer the best evidence to answer those questions. Guidelines should be based on the critical appraisal and systematic review of literature and explicitly state the strength of evidence supporting each recommendation. Pragmatic considerations dictate that priority is given to topics with the highest clinical or economic impact. Scientific evidence is necessary but insufficient for recommendations, as considered judgment is required about benefits, harms, costs, and local applicability of recommendations. Formal consensus methods are needed when the evidence base is lacking or controversial. Guidelines should be disseminated widely and their impact monitored regularly. Regular reviewing is needed because the lack of timely updates is a major cause of nonadherence to guidelines. CONCLUSIONS: Guidelines should be developed in a transparent process by a multidisciplinary team, with graded recommendations based on critically appraised scientific studies. Systematic, standardized, and explicit methodology, adapted to laboratory medicine, should be followed when developing recommendations involving the use of laboratory tests.     

Guidelines for immunoassay data processing

These guidelines outline the minimum requirements for a data-processing package to be used in the immunoassay laboratory. They include recommendations on hardware, software, and program design. We outline the statistical analyses that should be performed to obtain the analyte concentrations of unknown specimens and to ensure adequate monitoring of within- and between-assay errors of measurement.     

Clinical guidelines

Clinical guidelines are likely to be an important part of medical practice for the foreseeable future. Guidelines at their best are tools for consistency and effectiveness in patient care. Guideline methodology has evolved such that there are internationally agreed standards with which to develop and assess guidelines. Guideline development groups should ideally be multidisciplinary in composition and if possible have patient representation. Key to the process is the rigour of the systematic review in order to assess the best evidence on which to base recommendations. Guideline recommendations should be explicitly linked to the evidence. In order to safeguard trust, guideline development groups must have editorial independence of government, industry and special interest groups, while at the same time having regard to the implications of their recommendations. Implementation of guidelines by passive dissemination is largely ineffective; effective dissemination requires an imaginative approach tailored to the intended audience.     

Antiemetic guidelines: creating a more practical treatment approach

Antiemetic guidelines from a variety of professional organizations have been available for several years. It is unclear just how often these guidelines have been used, however; data indicate that some practitioners still do not treat their patients according to the recommendations. Some of those involved in the creation of the original guidelines convened to try to create a simpler, more practical approach to the use of antiemetics in preventing chemotherapy-induced nausea and vomiting. The group's intention was to clarify available guidelines and produce a practical document, based on evidence, that could be used in everyday practice. The group created four consensus statements that would serve as a basis for their recommendations. One primary strategy used was to have chemotherapy-induced nausea and vomiting viewed as a single process that can occur throughout a treatment cycle, and not so much as an acute and a delayed process, as is usual in clinical trials. Patients' management should be considered over a 4- to 5-day period, rather than primarily dealing with the day of treatment only. The group created three tables: emetic risk of chemotherapy; treatment options based on emetic category; and antiemetic dosing recommendations. Use of these tables should make appropriate antiemetic selection more straightforward and easier for the practitioner in an everyday setting. Although this document alone may not solve all the challenges with appropriate antiemetic management, it will hopefully prove to be a step in the right direction.     

Hospital-acquired pneumonia guidelines in Europe: a review of their status and future development

Hospital-acquired pneumonia (HAP) is the most common healthcare-acquired infection contributing to death. Effective management requires accurate diagnosis, administration of a suitable antibiotic regimen early in infection and implementation of prevention strategies. In recent years, there has been a rapid increase in the number of country-specific HAP guidelines in Europe, which vary in their formulation, coverage of different disease aspects and overall recommendations. Development of comprehensive pan-European HAP guidelines would rationalize the conflicting proposals, provide a useful resource and limit guideline proliferation. However, careful consideration needs to be given to the principles of guideline development to ensure that the output is rigorous, broadly applicable and facilitates update as new data becomes available. The use of an evidence-based approach to HAP guideline development is optimal, but is compromised by limitations in the supporting data. The implementation of a formalized evidence grading system is key to introducing consistency into the guideline development process. Pan-European guidelines should provide recommendations on core aspects of HAP common to all treatment settings and locations, and reflect the differing perspectives of the countries involved. Given the different antibiotic susceptibility profiles across Europe, such guidelines should provide general treatment recommendations suitable for local adaptation. The development of such guidelines represents an ideal time to identify priorities for European research, by addressing controversies and identifying previously unconsidered aspects of HAP. Establishing a pan-European consensus on core processes of care should be viewed as an impetus for change to improve clinical practices and should include a suitable implementation strategy.     

Dutch Physiotherapy Guidelines for Low Back Pain

Many guidelines for the management of low back pain in primary care have been published during recent years, but guidelines for physiotherapy do not yet exist. Therefore, physiotherapy guidelines have been developed, reflecting the consequences of the current state of knowledge of effective and appropriate physiotherapy for low back pain. They aim to improve the efficiency and effectiveness of physiotherapeutic care for patients with low back pain.The guidelines were constructed on the basis of the phases of the physiotherapy process, using the Dutch method of developing physiotherapy guidelines. Scientific evidence of systematic reviews was used as the basis for the recommendations. A computerised literature search of Medline, Cinahl, the Cochrane Database of Systematic Reviews and the Database of the Dutch National Institute of Allied Health Professions was conducted to identify relevant systematic reviews. If no evidence was available, consensus between experts was obtained.The guidelines were pilot tested among one hundred physiotherapists and reviewed by an external multi-disciplinary panel.The guidelines recommend that the diagnostic process should focus on disability and participation problems resulting from back pain. The treatment should consist of an active approach, in which the patients learn to take control over their back pain. For patients with a normal course, where activities and participation gradually increase, reassurance, adequate information and advice to stay active are the most important recommendations. For patients with an abnormal course, where activities and participation do not increase, exercise therapy should also be provided, with a behavioural approach if necessary.These are the first national physiotherapy guidelines for low back pain. The recommendations are largely in line with other primary care guidelines for low back pain. Implementation will be a major challenge for the near future.     

Update of guidelines for the prevention and treatment of infection in patients with an absent or dysfunctional spleen

Guidelines for the prevention and treatment of infection in patients with an absent or dysfunctional spleen were first published by the British Committee for Standards in Haematology in 1996. Key aspects of these guidelines related to anti-infective prophylaxis, immunisation schedules and treatment of proven or suspected infection. A recent review of the guidelines was undertaken, with a view to updating the recommendations where necessary The guideline review process did not reveal any major change in patient groups considered at risk. Occupational exposure to certain pathogens may, however, be a new risk factor for some infections. The recommendations for anti-infective prophylaxis remain unchanged. New recommendations for vaccination include the use of meningococcal group C vaccine in previously non-immunised hyposplenic patients and a need to consider the use of seven-valent pneumococcal vaccine. Recommendations for treatment of suspected or proven infection have not been significantly amended, but a local protocol should take into account relevant resistance patterns. There is an identified urgent need for further research into the effectiveness of varying vaccination strategies in the hyposplenic patient, and audit of infective episodes in this patient group should continue long term. Key guidelines are summarised below, together with grades of recommendation.     

Conflict between guideline methodologic quality and recommendation validity: a potential problem for practitioners

BACKGROUND: It is not clear if good methodologic quality in current practice guidelines necessarily leads to more valid recommendations, i.e., those that are supported with consistent research evidence or, when evidence is conflicting or lacking, with sufficient consensus among the guideline development team. To help clarify this issue, we assessed whether there is a link between methodologic quality and recommendation validity in practice guidelines for the use of laboratory tests in the management of patients with non-small cell lung cancer (NSCLC). METHODS: We conducted a systematic review of data on laboratory tests in NSCLC published in English or in French within the last 10 years and retrieved 11 practice guidelines for the use of these tests. The guidelines were critically appraised and scored for methodologic quality and recommendation validity based on the Appraisal of Guidelines Research and Evaluation (AGREE) criteria and on the systematic review. RESULTS: Overall, these 11 guidelines had considerable shortcomings in methodologic quality and, to a lesser extent, in recommendation validity. Practice guidelines with the best methodologic quality were not necessarily the most valid in their recommendations, and conversely. CONCLUSIONS: Poor methodologic quality and lack of recommendation validity in laboratory medicine call for methodologic standards of guideline development and for international collaboration of guideline development agencies. We advise readers of guidelines to critically evaluate the methods used as well as the content of the recommendations before adopting them for use in practice.     

LITHIUM FOLLOW-UP IN GENERAL PRACTICE

Lithium salts have been used in medicine for over a century and are a widely accepted treatment. Clinical practice in the London borough of Barnet led us to suspect that agreed guidelines were not being followed. We checked them against published guidelines and followed up their implementation. A list of patients on lithium was obtained from the local biochemistry laboratory and a representative sample extracted. We looked at the frequency of laboratory testing and compared it with the guidelines. We found that the standards for lithium therapy follow-up were not being met and that while we awaited the outcome of our consultant psychiatrists' committee deliberations, the recommendations were not being implemented. A lithium register or clinic needs to be established in the area, and there is also a need for more reliable and effective implementation of clinical audit recommendations.     

Guidelines for the laboratory diagnosis and susceptibility testing of methicillin-resistant Staphylococcus aureus (MRSA)

These evidence-based guidelines have been produced after a literature review of the laboratory diagnosis and susceptibility testing of methicillin-resistant Staphylococcus aureus (MRSA). We have considered the detection of MRSA in screening samples and the detection of reduced susceptibility to glycopeptides in S. aureus. Recommendations are given for the identification of S. aureus and for suitable methods of susceptibility testing and screening for MRSA and for S. aureus with reduced susceptibility to glycopeptides. These guidelines indicate what tests should be used but not when the tests are applicable, as aspects of this are dealt with in guidelines on control of MRSA. There are currently several developments in screening media and molecular methods. It is likely that some of our recommendations will require modification as the new methods become available.