Guidelines for medical practice: 1. The reasons why.

Various external special interest groups are promoting attempts to better measure and control the performance of the medical profession, primarily to restrain costs. We can neither afford to ignore the rising costs nor reject efforts by provincial licensing authorities to improve supervision of the quality of care. Furthermore, there is increasing public interest in the outcome of medical treatment and a suspicion that some care may be unnecessary or inappropriate. Much of what physicians do is not based on impeccable or complete scientific evidence, and we have not established a method whereby science can consistently be translated into practice. Optimal practice patterns must be defined to improve the quality of care and to maximize the efficiency with which scarce resources are used. Careful scientific evaluation of data is particularly necessary with the arrival of new drugs and technology. Sensible, flexible guidelines produced by appropriate panels will help promote improved practice. Rigid standards must be avoided to allow for individual consideration and scientific innovation. The recognized difficulties of influencing clinical practice by precept or education and the problems imposed by rapidly changing scientific knowledge are two hurdles to be overcome. Licensing bodies must identify and enforce minimal standards, but optimal practice patterns are better devised by a broader segment of the profession. Intervention by third-party payers, as is prevalent in the United States, intrudes upon physician autonomy and reduces access to care. Physicians must support the development of guidelines for optimal medical practice based on the best existing data and focused on improving the quality of care.     

Brazil and the development of international scientific biosafety testing guidelines for transgenic crops

Under the umbrella of the International Organisation of Biological Control (IOBC), an international working group of public sector scientists entitled on "Transgenic Organisms in Integrated Pest Management and Biological Control" has been organized. The group will develop scientific principles and detailed scientific guidelines for biosafety testing of transgenic crops. The key elements of this project are: (1) An international initiative including expert scientists from leading research institutions in developed and developing countries; (2) coordination of the development and implementation of the guidelines as a dynamic process, which will include scientific and technical capacity building and communication among scientists and between scientists and policy makers; (3) rapid serial publication of sections of the guidelines as they are completed; and (4) rapid and timely revision of previously published sections. The guidelines will be constructed on a case-by-case basis and will have no regulatory legitimacy themselves.     

生态系统质量评估方法——理想参照系和关键指标

良好的生态系统质量是社会可持续发展的重要基础,也是国家生态文明建设的重要目标之一。目前,我国在生态系统质量评估体系建设方面取得了很好的进展,但由于缺乏科学的评估标准和统一的指标体系,不同区域间评估结果的可比性差或同一区域不同时期间评估结果难以比较,难以开展区域和国家尺度的集成研究,同时也难以满足快速评估关键区域或国家尺度生态系统质量的需求。为了有效克服上述困难与挑战,迫切需要构建一套科学的、经济可行的、简单快速的、且适用于区域或国家尺度的生态系统质量评估体系。以国内生态系统质量评估现状为基础,通过梳理现有的评估体系,提出了"理想参照系"的概念体系,旨在进一步完善评估体系的基本框架;同时,较详细地阐述了理想参照系中阈值的确定方法。此外,从科学、直观、快速、经济可行等角度出发,建议重新思考生态系统质量评估的关键指标(如生产力、土壤有机质、植物多样性和景观破碎度)。新构建的"理想参照系+关键指标"的新型生态系统质量评估体系,理论上可满足新时期区域或国家生态系统质量快速评估的需求,但许多技术细节仍待于进一步完善;由于新评估体系能量化生态系统质量的恢复潜力与发展阶段,它可为更合理配置资源、提高保护成效等提供科学依据。     

From autonomy to accountability: the role of clinical practice guidelines in professional power

Evidence-based medicine (EBM) aims to address the persistent problem of clinical practice variation with the help of various tools, including standardized practice guidelines. Based on a systematic evaluation of the available scientific evidence, these guidelines offer recommendations for clinicians about details of patient care and clinical decision making. Because clinical practice guidelines specify how health care should be performed, they could be considered a threat to clinical and professional autonomy. Inspired by the theory of countervailing powers, this article explores how clinical practice guidelines have shifted the focus of professional power from autonomy to accountability. Professional organizations develop clinical practice guidelines as a service to their members but do not require strict adherence to the guidelines. Indeed, implementation studies show at best a modest change in clinical behavior. Such non-adherence might render a profession vulnerable, however, when third parties seize upon guidelines and offer financial incentives to keep clinicians accountable for delivering optimal patient care.     

Guidelines on anticoagulant treatment in atrial fibrillation in Great Britain: variation in content and implications for treatment.

OBJECTIVE: To describe the content of guidelines on the use of anticoagulant treatment in patients with atrial fibrillation and the impact of variations in guidelines on treatment. DESIGN: Postal survey of guidelines, semistructured interview with lead developers of guidelines, and application of guidelines to patient sample. SUBJECTS: 15 lead developers of the 20 guidelines identified in the postal survey were interviewed. 100 patients over 65 with atrial fibrillation to whom the guidelines were applied. MAIN OUTCOME MEASURES: Evaluation of guidelines and the methods of dissemination, implementation, review, and evaluation; proportion of patients recommended for anticoagulant treatment by each guideline; and level of agreement between guidelines. RESULTS: There was considerable variation in whether anticoagulant treatment was recommended for subjects (range 13% to 100%, kappa = 0.12). Guidelines varied greatly in advice on treatment by age, the use of echocardiography, and the target value or range of the international normalised ratio (8 of the 20 guidelines included values unlikely to be effective). Development was unsystematic; evidence based approaches were rarely used, 9 of the 15 lead developers had developed the guidelines themselves, and the 6 guidelines developed by groups relied on informal consensus. Methods to support effective dissemination, implementation, and evaluation were limited. CONCLUSION: The widespread non-systematic production of guidelines has led to considerable variation with implications for the quality of care and clinical decision making. There is a need for a central, well funded programme of guideline development to ensure that valid guidelines are produced and disseminated.     

Ethics and biomedical research

Ethics in biomedical research took off from the 1947 Nuremberg Code to its own right in the wake of the Declaration of Helsinki in 1964. Since then, (inter)national regulations and guidelines providing a framework for clinical studies and protection for study participants have been drafted and implemented, while ethics committees and drug evaluation agencies have sprung up throughout the world. These two developments were crucial in bringing about the protection of rights and safety of the participants and harmonization of the conduct of biomedical research. Ethics committees and drug evaluation agencies deliver ethical and scientific assessments on the quality and safety of the projects submitted to them and issue respectively approvals and authorizations to carry out clinical trials, while ensuring that they comply with regulatory requirements, ethical principles, and scientific guidelines. The advent of biomedical ethics, together with the responsible commitment of clinical investigators and of the pharmaceutical industry, has guaranteed respect for the patient, for whom and with whom research is conducted. Just as importantly, it has also ensured that patients reap the benefit of what is the primary objective of biomedical research: greater life expectancy, well-being, and quality of life.     

Guidelines for medical practice: 2. A possible strategy.

The recognition that much current medical practice is based on incomplete scientific evidence has led to calls for the generation of guidelines for optimal patterns of practice. These guidelines must be developed from a synthesis of existing scientific data ideally obtained from randomized clinical trials. However, at present we may have to rely on less satisfactory data and the views of experts in the field. The primary purpose of these initiatives must be to improve patient care. The Ontario Medical Association has made recommendations on how such guidelines should be produced, and in a recent survey a substantial majority of family physicians supported them. There is general agreement that the coordinating body should be independent of government and other interested parties. In addition, the medical profession must have the primary role, and a number of medical organizations should also be represented. We propose a possible structure for a group charged with developing guidelines for medical practice at a provincial level and on an experimental basis. Recommendations are made on its membership, function and relationship with other organizations. The identification and diffusion of justifiable, scientific practice patterns will help reduce waste of scarce resources, maintain the role of the profession as guardian of the quality of care and ultimately benefit the patient.     

Machinery Risk Assessment for Risk Reduction

New avenues are reviewed and discussed for preventing industrial machine-related injury by means of realistic risk evaluation and reduction processes at the design and application stages of machinery development and use. U.S. guidelines and European standards on machinery risk assessment procedures are described. Applications of risk assessment for machine-related injury risk management and teaching machine-risk control are discussed.     

Quality, safety and efficacy of follow-on biologics in Japan

Recently, WHO, EU, Japan and Canada have published guidelines on biosimilar/follow-on biologics. While there seems to be no significant difference in the general concept in these guidelines, the data to be submitted for product approval are partially different. Differences have been noted in the requirements for comparability studies on stability, prerequisites for reference product, or for the need of comparability exercise for determination of process-related impurities. In Japan, there have been many discussions about the amount and extent of data for approval of follow-on biologics. We try to clarify the scientific background and rational for regulatory pathway of biosimilar/follow-on biologics in Japan in comparison with the guidelines available from WHO, EU and Canada. In this article, we address and discuss the scientific background underlying these differences to facilitate the harmonization of follow-on biologic principles in the guidelines in future.     

Guidelines for reading literature reviews.

One strategy for dealing with the burgeoning medical literature is to rely on reviews of the literature. Although this strategy is efficient, readers may be misled if the review does not meet scientific standards. Therefore, guidelines that will help readers assess the scientific quality of the review are proposed. The guidelines focus on the definition of the question, the comprehensiveness of the search strategy, the methods of choosing and assessing the primary studies, and the methods of combining the results and reaching appropriate conclusions. Application of the guidelines will allow clinicians to spend their valuable reading time on high-quality material and to judge the validity of an author''s conclusions.     

The success (or not) of HUGO nomenclature

Current usage of gene nomenclature is ambiguous and impairs the efficient handling of scientific information. Therefore it is important to propose guidelines to deal with this problem. This study attempts to evaluate the success of HUGO nomenclature for human genes. The results indicate that HUGO guidelines are not supported by the scientific community.     

Medicine, methodology, and values: trade-offs in clinical science and practice

The current guidelines of evidence-based medicine (EBM) presuppose that clinical research and clinical practice should advance from rigorous scientific tests as they generate reliable, value-free knowledge. Under this presupposition, hypotheses postulated by doctors and patients in the process of their decision making are preferably tested in randomized clinical trials (RCTs), and in systematic reviews and meta-analyses summarizing outcomes from multiple RCTs. Since testing under this scheme is predominantly focused on the criteria of generality and precision achieved through methodological rigor, at the cost of the criterion of realism, translating test results to clinical practice is often problematic. Choices concerning which methodological criteria should have priority are inevitable, however, as clinical trials, and scientific research in general, cannot meet all relevant criteria at the same time. Since these choices may be informed by considerations external to science, we must acknowledge that science cannot be value-free in a strict sense, and this invites a more prominent role for value-laden considerations in evaluating clinical research. The urgency for this becomes even more apparent when we consider the important yet implicit role of scientific theories in EBM, which may also be subjected to methodological evaluation and for which selectiveness in methodological focus is likewise inevitable.     

Strategies for evaluating indicators based on guidelines from the Environmental Protection Agency’s Office of Research and Development

The Environmental Protection Agency’s Office of Research and Development (ORD) has prepared technical guidelines to evaluate the suitability of ecological indicators for monitoring programs. The guidelines were adopted by ORD to provide a consistent framework for indicator review, comparison and selection, and to provide direction for research on indicator development. The guidelines were organized within four evaluation phases: (1) conceptual relevance; (2) feasibility of implementation; (3) response variability; (4) interpretation and utility. Three example indicators were analyzed to illustrate the use of the guidelines in an evaluation. The examples included a direct chemical measurement (dissolved oxygen concentration), an estuarine benthic community index, and a stream fish community index of biotic integrity. Comparison of the three examples revealed differences in approach, style and types of information used to address each guideline. The Evaluation Guidelines were intended to be flexible within a consistent framework and the various strategies used in the examples demonstrate that the process can be useful for a wide variety of indicators and program objectives.     

Assisted Knowledge Discovery for the Maintenance of Clinical Guidelines

Background

Improving antibiotic prescribing practices is an important public-health priority given the widespread antimicrobial resistance. Establishing clinical practice guidelines is crucial to this effort, but their development is a complex task and their quality is directly related to the methodology and source of knowledge used.

Objective

We present the design and the evaluation of a tool (KART) that aims to facilitate the creation and maintenance of clinical practice guidelines based on information retrieval techniques.

Methods

KART consists of three main modules 1) a literature-based medical knowledge extraction module, which is built upon a specialized question-answering engine; 2) a module to normalize clinical recommendations based on automatic text categorizers; and 3) a module to manage clinical knowledge, which formalizes and stores clinical recommendations for further use. The evaluation of the usability and utility of KART followed the methodology of the cognitive walkthrough.

Results

KART was designed and implemented as a standalone web application. The quantitative evaluation of the medical knowledge extraction module showed that 53% of the clinical recommendations generated by KART are consistent with existing clinical guidelines. The user-based evaluation confirmed this result by showing that KART was able to find a relevant antibiotic for half of the clinical scenarios tested. The automatic normalization of the recommendation produced mixed results among end-users.

Conclusions

We have developed an innovative approach for the process of clinical guidelines development and maintenance in a context where available knowledge is increasing at a rate that cannot be sustained by humans. In contrast to existing knowledge authoring tools, KART not only provides assistance to normalize, formalize and store clinical recommendations, but also aims to facilitate knowledge building.     

Stability testing of vaccines: Developing Countries Vaccine Manufacturers' Network (DCVMN) perspective

Stability testing is an integral part of the vaccine manufacturing process and is crucial for the success of immunization programs. WHO (World Health Organization) has recently published guidelines on the stability testing of vaccines. These guidelines enlist scientific basis and principles for stability testing at various stages like development, pre-clinical, clinical, licensing, lot release and post-licensure monitoring. DCVMN (Developing Countries Vaccine Manufacturers' Network) is an international body of developing countries vaccine manufacturers and has viewpoints on technical and administrative issues in stability testing of vaccines. We here highlight viewpoints, possible roles and global expectations of DCVMN in the area of stability testing of vaccines.     

United States Army Research Institute of Environmental Medicine: Warfighter research focusing on the past 25 years

The United States Army Research Institute of Environmental Medicine (USARIEM) celebrated its 50th anniversary on July 1, 2011. This article reviews its history, evolution, and transition of its research programs as well as its scientific and military accomplishments, emphasizing the past 25 yr. During the 1990s, USARIEM published a series of pocket guides providing guidance for sustaining Warfighter health and performance in Southwest Asia, Somalia, the former Republic of Yugoslavia, Rwanda, and Haiti. Issues identified during Operation Desert Storm elicited research that improved nutritional guidelines for protracted desert operations; safer use of nuclear, chemical, and biological protective clothing; equipment, development, and fielding of efficient microclimate cooling systems; and effective evaluation of pharmaceuticals to protect soldiers from chemical and biological threats. During the first decade of the 21st century, USARIEM and the Department of the Army published official medical/performance doctrines for operations in the heat and cold and at high altitude. The current Global War on Terrorism focused research to improve doctrines for hot, cold, and high-altitude operations, reduce musculoskeletal training injuries, provide improved field nutrition, more efficient planning for operational water requirements, and improve both military clothing and materiel. This article also describes the critically important interactions and communications between USARIEM and deployed units and the benefits to Warfighters from this association. This report presents USARIEM's unique and world-class facilities, organizational changes, scientific and support personnel, and major research accomplishments, including the publication of 2,200 scientific papers over the past 25 yr.     

景感评价方法研究

通过与生态系统服务和可持续发展的有效结合,在景感生态学的内涵与外延得到扩展的同时,景感营造与评价的概念也进一步明确。景感评价是基于一定的目的和相应的评价标准,针对特定的景感（现状或营造过程）进行评价与预测,可为认识与理解景感、营造与改善景感,以及基于景感的生态规划与建设提供科学依据。景感评价除了遵从广义景感生态学的原理与目标外,其主要理论基础来自生态系统服务理论、可持续发展理论、复合生态系统理论以及生态文明理论。景感评价应遵循景感的协调性、可持续性与评价的系统性、针对性等主要原则。具体的景感评价方法可分为基于特定评价目标的单因子评价与考虑多要素的综合性评价;前者一般限于针对某个评价目标或者考虑某个限制因子时使用,后者则主要包括层次分析法、数据包络法和重要性-绩效分析法。不同的评价方法有其优缺点和适用范围,景感评价应根据不同情景和目的来灵活使用不同方法,还需充分考虑人的感知或愿景与自然环境要素的统一,以及景感营造与生态系统服务及可持续发展意识的统一。景感评价的研究与应用处于初始阶段,在发展过程中存在一些困难和问题,未来应重视若干内容的研究。随着学科的交叉与融合、技术的进步与发展以及相关学者的共同努力,景感评价将会有效地指导人类对自然资源进行合理利用与科学管理。     

International Commission on Trichinellosis: recommendations on the use of serological tests for the detection of Trichinella infection in animals and man

The use of serological tests to detect Trichinella infection in domestic and wild animals and in humans has not been standardised yet. This review provides an uniform set of recommendations for the development and use of serological tests to detect circulating antibodies in serum samples. The recommendations are based on the best scientific published information and on the unpublished data from laboratories with a great expertise in this field and represent the official position of the International Commission on Trichinellosis regarding acceptable methods and the evaluation of the sensitivity and specificity. These recommendations are subject to change as new scientific information becomes available.