The updated clinical guideline development process in Estonia is an efficient method for developing evidence-based guidelines

Clinical practice guidelines are one of the tools available to improve the quality of health care. However, it may be difficult for countries to develop their own national guidelines “from scratch” because of limitations in time, expertise, and financial resources. The Estonian Health Insurance Fund (EHIF), in collaboration with other stakeholders, has launched a national effort to develop and implement evidence-based clinical practice guidelines aimed at improving the quality of care. Although the first EHIF handbook for preparing guidelines was published in 2004, there has been wide variation in the format and quality of guidelines prepared by medical specialty societies, EHIF, and other organizations in Estonia. An additional challenge to guideline development in Estonia is that it is a country with limited human resources. Therefore, revision of the Estonian guideline process was aimed at developing an efficient method for adapting current high-quality guidelines to the Estonian setting without compromising their quality. In 2010, a comprehensive assessment of guideline development in Estonia was made by the World Health Organization, EHIF, the Medical Faculty at the University of Tartu, and selected national and international experts in an effort to streamline and harmonize the principles and processes of guideline development in Estonia. This study summarizes the evaluation of and revisions to the process. Estonia has made substantial changes in its processes of clinical practice guideline development and implementation as part of an overall program aiming for systematic quality improvement in health care. This experience may be relevant to other small or resource-limited countries.     

The practice guideline 'Dementia' (second revision) from the Dutch College of General Practitioners; a response from the perspective of neurology

The revised version of the practice guideline 'Dementia' from the Dutch College of General Practitioners provides a sound and comprehensive overview, and a practical guideline especially for the period following the diagnostic evaluation. The advice on the issues of whether to refer patients and whether to start symptomatic drug treatment is stated in rather general terms. Therefore, for most general practitioners it will still be difficult to decide how best to act on these issues. The fact that the cognitive examination is treated as part of the history taking will, most probably, negatively affect the quality of the diagnostic evaluation.     

A national agenda for public health informatics.

The American Medical Informatics Association 2001 Spring Congress brought together the public health and informatics communities to develop a national agenda for public health informatics. Discussions on funding and governance; architecture and infrastructure; standards and vocabulary; research, evaluation, and best practices; privacy, confidentiality, and security; and training and workforce resulted in 74 recommendations with two key themes: (1) all stakeholders need to be engaged in coordinated activities related to public health information architecture, standards, confidentiality, best practices, and research and (2) informatics training is needed throughout the public health workforce. Implementation of this consensus agenda will help promote progress in the application of information technology to improve public health.     

Current assessment of the effects of environmental chemicals on the mammary gland in guideline rodent studies by the U.S. Environmental Protection Agency (U.S. EPA), Organisation for Economic Co-operation and Development (OECD), and National Toxicology Program (NTP)

Background: Evaluation of the structural and/or functional integrity of the mammary gland (MG) across life stages is integral to the assessment of developmental, reproductive, and carcinogenic risk for environmental chemicals.Objectives: In this commentary I characterize MG assessment recommended in U.S. Environmental Protection Agency, Organisation for Economic Co-operation and Development, and National Toxicology Program guideline toxicology study protocols and identify any information gaps for the evaluation of MG development, structure, and function.Discussion: Several data gaps, issues, and challenges were identified. Current guidelines that include a lactation phase do not provide specific recommendations to record observations on maternal or offspring lactation or nursing behavior. In guideline studies, the assessment of MG toxicity often relies upon indirect, nonspecific, or surrogate end points, and information that could be useful in the interpretation of these data (e.g., mode of action or toxicokinetics) is often unavailable. Most guideline studies designed to assess general organ toxicity do not expose test animals during sensitive stages of MG development; histopathological evaluation of the developing MG is not routinely conducted; and evaluation of MG tissue for both sexes is inconsistently recommended.Conclusions: I propose the following general recommendations to enhance MG assessment in guideline toxicology studies: a) inclusion of more specific criteria for the evaluation of MG end points in guideline language, b) inclusion of histopathological evaluation of MG development (using whole-mount techniques) in existing or new guideline protocols that include offspring with perinatal and/or pubertal treatment, c) incorporation of perinatal exposures into rodent subchronic and carcinogenicity assays, and d) expansion of the histopathological evaluation of male MG tissue.     

Nursing on the Web: the creation and validation process of a web site on coronary artery disease

The World Wide Web is an important health information research source. A challenge for the Brazilian Nursing Informatics area is to use its potential to promote health education. This paper aims to present a developing and validating model used in an educational Web site, named CardioSite, which subject is Coronary Heart Disease. In its creation it was adopted a method with phases of conceptual modeling, development, implementation, and evaluation. In the evaluation phase, the validation was performed through an online informatics and health experts panel. The results demonstrated that information was reliable and valid. Considering that national official systems are not available to that approach, this model demonstrated effectiveness in assessing the quality of the Web site content.     

Evaluation of animal and public health surveillance systems: a systematic review

Disease surveillance programmes ought to be evaluated regularly to ensure they provide valuable information in an efficient manner. Evaluation of human and animal health surveillance programmes around the world is currently not standardized and therefore inconsistent. The aim of this systematic review was to review surveillance system attributes and the methods used for their assessment, together with the strengths and weaknesses of existing frameworks for evaluating surveillance in animal health, public health and allied disciplines. Information from 99 articles describing the evaluation of 101 surveillance systems was examined. A wide range of approaches for assessing 23 different system attributes was identified although most evaluations addressed only one or two attributes and comprehensive evaluations were uncommon. Surveillance objectives were often not stated in the articles reviewed and so the reasons for choosing certain attributes for assessment were not always apparent. This has the potential to introduce misleading results in surveillance evaluation. Due to the wide range of system attributes that may be assessed, methods should be explored which collapse these down into a small number of grouped characteristics by focusing on the relationships between attributes and their links to the objectives of the surveillance system and the evaluation. A generic and comprehensive evaluation framework could then be developed consisting of a limited number of common attributes together with several sets of secondary attributes which could be selected depending on the disease or range of diseases under surveillance and the purpose of the surveillance. Economic evaluation should be an integral part of the surveillance evaluation process. This would provide a significant benefit to decision-makers who often need to make choices based on limited or diminishing resources.     

COSMIN guideline for systematic reviews of patient-reported outcome measures

Purpose

Systematic reviews of patient-reported outcome measures (PROMs) differ from reviews of interventions and diagnostic test accuracy studies and are complex. In fact, conducting a review of one or more PROMs comprises of multiple reviews (i.e., one review for each measurement property of each PROM). In the absence of guidance specifically designed for reviews on measurement properties, our aim was to develop a guideline for conducting systematic reviews of PROMs.

Methods

Based on literature reviews and expert opinions, and in concordance with existing guidelines, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) steering committee developed a guideline for systematic reviews of PROMs.

Results

A consecutive ten-step procedure for conducting a systematic review of PROMs is proposed. Steps 1–4 concern preparing and performing the literature search, and selecting relevant studies. Steps 5–8 concern the evaluation of the quality of the eligible studies, the measurement properties, and the interpretability and feasibility aspects. Steps 9 and 10 concern formulating recommendations and reporting the systematic review.

Conclusions

The COSMIN guideline for systematic reviews of PROMs includes methodology to combine the methodological quality of studies on measurement properties with the quality of the PROM itself (i.e., its measurement properties). This enables reviewers to draw transparent conclusions and making evidence-based recommendations on the quality of PROMs, and supports the evidence-based selection of PROMs for use in research and in clinical practice.

     

A comparison of clinical practice guideline appraisal instruments

OBJECTIVE: To identify and compare clinical practice guideline appraisal instruments. METHODS: Appraisal instruments, defined as instruments intended to be used for guideline evaluation, were identified by searching MEDLINE (1966-99) using the Medical Subject Heading (MeSH) practice guidelines, reviewing bibliographies of the retrieved articles, and contacting authors of guideline appraisal instruments. Two reviewers independently examined the questions/statements from all the instruments and thematically grouped them. The 44 groupings were collapsed into 10 guideline attributes. Using the items, two reviewers independently undertook a content analysis of the instruments. RESULTS: Fifteen instruments were identified, and two were excluded because they were not focused on evaluation. All instruments were developed after 1992 and contained 8 to 142 questions/statements. Of the 44 items used for the content analysis, the number of items covered by each instrument ranged from 6 to 34. Only the instrument by Cluzeau and colleagues included at least one item for each of the 10 attributes, and it addressed 28 of the 44 items. This instrument and that of Shaneyfelt et al. are the only instruments that have so far been validated. CONCLUSIONS: A comprehensive, concise, and valid instrument could help users systematically judge the quality and utility of clinical practice guidelines. The current instruments vary widely in length and comprehensiveness. There is insufficient evidence to support the exclusive use of any one instrument, although the Cluzeau instrument has received the greatest evaluation. More research is required on the reliability and validity of existing guideline appraisal instruments before any one instrument can become widely adopted.     

Leitlinien als Instrument der Qualitätssicherung in der Medizin Das Leitlinienprogramm der Arbeitsgemeinschaft Wissenschaftlicher Medizinischer Fachgesellschaften (AWMF)

The Association of the Scientific Medical Societies in Germany (AWMF) established a national guideline-programme respecting the specific conditions of the German health-care system as well as fulfilling the demands of clinical research. It consists of a three-level concept for guideline development and an implementation system. The three-level concept assumes a continuous process of development and quality improvement of guidelines. At level three, guidelines have to fulfill five criteria of systematic development: consensus (presupposed application of formal techniques and participation of all relevant stakeholders), logical analysis (clinical algorithms), evidence (based on best available evidence derived from comprehensive, systematic reviews and linking all recommendations explicitly to the evidence), decision analysis and outcome analysis (using epidemiologic, effectiveness, pharmacologic, psychometric, economic studies and qualitative methods for identifying the true endpoint). The implementation system is based on four components: definite guideline groups within the scientific societies, conceptualised quality improvement of guidelines, continuous medical education and systematic evaluation. The establishment of this system has induced a change: the process of developing top-level guidelines has become uniform and there is a strong trend towards quality improvement. 75 evidence- and consensus- based guidelines (level two and three) have already been published. The scientific medical societies have indicated their motivation to continue the program by formulating 75 prior conditions for which top-level guidelines shall be developed in the near future.     

Economic evaluations of leukemia: a review of the literature

Objectives: Leukemia, together with lymphoma and multiple myeloma, are hematological malignancies, malignancies of the blood-forming organs. There are four major types of leukemia: acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). There is a growing amount of literature of the health economic aspects of leukemia. However, no comprehensive review is yet performed on the health economic evidence for the disease. Hence, our aim was to review and analyze the existing literature on economic evaluations of the different types of leukemia.Methods: A systematic literature search used electronic databases to identify published cost analyses and economic evaluations of leukemia treatments. After reviewing all identified studies, sixty studies were considered relevant for the purpose of the review.Results: The identified studies were published after 1990, with a few exceptions. Many of the identified economic evaluations in leukemia, particularly for ALL and AML, may be defined as cost-minimization analyses, where only the costs of different treatment strategies are compared. In CML, a new treatment, imatinib, was introduced in 2001 and several cost-effectiveness analyses have since then been conducted comparing imatinib with previous first line treatments.Conclusions: This review indicates that there is a shortage of cost-effectiveness information in leukemia. The introduction of new therapies will stress the need for new economic evaluations in this group of diseases. More information about the total costs, that is, including indirect costs, and quality of life effects would be valuable in future evaluations in leukemia.     

The role of 'confounding by indication' in assessing the effect of quality of care on disease outcomes in general practice: results of a case-control study

Background  

In quality of care research, limited information is found on the relationship between quality of care and disease outcomes. This case-control study was conducted with the aim to assess the effect of guideline adherence for stroke prevention on the occurrence of stroke in general practice. We report on the problems related to a variant of confounding by indication, that may be common in quality of care studies.     

The Methodological Quality of Economic Evaluations of Guideline Implementation into Clinical Practice: A Systematic Review of Empiric Studies

OBJECTIVES: Despite the emphasis on efficiency of health-care services delivery, there is an imperfect evidence base to inform decisions about whether and how to develop and implement guidelines into clinical practice. In general, studies evaluating the economics of guideline implementation lack methodological rigor. We conducted a systematic review of empiric studies to assess advances in the economic evaluations of guideline implementation. METHODS: The Cochrane Effective Professional and Organisational Change Group specialized register and the MEDLINE database were searched for English publications between January 1998 and July 2004 that reported objective effect measures and implementation costs. We extracted data on study characteristics, quality of study design, and economic methodology. It was assessed whether the economic evaluations followed methodological guidance. RESULTS: We included 24 economic evaluations, involving 21 controlled trials and three interrupted time series designs. The studies involved varying settings, targeted professionals, targeted behaviors, clinical guidelines, and implementation strategies. Overall, it was difficult to determine the quality of study designs owing to poor reporting. In addition, most economic evaluations were methodologically flawed: studies did not follow guidelines for evaluation design, data collection, and data analysis. CONCLUSIONS: The increasing importance of the value for money of providing health care seems to be reflected by an increase in empiric economic evaluations of guideline implementation. Because of the heterogeneity and poor methodological quality of these studies, however, the resulting evidence is still of limited use in decision-making. There seems to be a need for more methodological guidance, especially in terms of data collection and data synthesis, to appropriately evaluate the economics of developing and implementing guidelines into clinical practice.     

Systematic review of economic evaluations and cost analyses of guideline implementation strategies

To appraise the quality of economic studies undertaken as part of evaluations of guideline implementation strategies, we conducted a systematic review of such studies published between 1966 and 1998. Studies were assessed against BMJ economic evaluations guidelines for each stage (guideline development, implementation and treatment). Of 235 studies identified, 63 reported some information on cost. Only 3 studies provided evidence that their guideline was effective and efficient, 38 reported treatment costs only, 12 implementation and treatment costs, 11 implementation costs alone, and 2 guideline development, implementation and treatment costs. No study gave reasonably complete information on costs. Thus, very few satisfactory economic evaluations of guideline implementation strategies have been performed. Current evaluations have numerous methodological defects and rarely consider all relevant costs and benefits. Future evaluations should focus on evaluating the implementation of evidence-based guidelines. Additional data for tables are available on request from the authors.     

Effect of clinical guidelines in nursing, midwifery, and the therapies: a systematic review of evaluations.

BACKGROUND: Although nursing, midwifery, and professions allied to medicine are increasingly using clinical guidelines to reduce inappropriate variations in practice and ensure higher quality care, there have been no rigorous overviews of their effectiveness, 18 evaluations of guidelines were identified that meet Cochrane criteria for scientific rigor. METHODS: Guideline evaluations conducted since 1975 which used a randomised controlled trial, controlled before and after, or interrupted time series design were identified through a combination of database and hand searching. RESULTS: 18 studies met the inclusion criteria. Three studies evaluated guideline dissemination or implementation strategies, nine compared use of a guideline with a no guideline state; six studies examined skill substitution: performance of nurses operating according to a guideline were compared with standard care, generally provided by a physician. Significant changes in the process of care were found in six out of eight studies measuring process and in which guidelines were expected to have a positive impact on performance. In seven of the nine studies measuring outcomes of care, significant differences in favour of the intervention group were found. Skill substitution studies generally supported the hypothesis of no difference between protocol driven by nurses and care by a physician. Only one study included a formal economic evaluation, with equivocal findings. CONCLUSIONS: Findings from the review provide some evidence that care driven by a guideline can be effective in changing the process and outcome of care. However, many studies fell short of the criteria of the Cochrane Effective Practice and Organisation of Care Group (EPOC) for methodological quality.     

STATISTICAL CONCEPTS IN THE PLANNING AND EVALUATION OF DRUG SAFETY FROM CLINICAL TRIALS IN DRUG DEVELOPMENT: ISSUES OF INTERNATIONAL HARMONIZATION

The assessment of the safety of new drugs during pre-marketing clinical studies is an important and integral part of the drug development and regulatory evaluation process. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory decision-makers of Europe, Japan and the United States of America and the experts from the pharmaceutical industry in the three regions to seek ways to eliminate redundant and duplicative technical requirements among the developed countries for registering new medicinal substances and products. The ICH is developing guidelines or position papers to achieve the goal of harmonizing technical standards in three broad areas, namely, drug efficacy, safety and quality. Within the area of drug safety, this paper will discuss three of the safety topics because of their relevant statistical framework, and because these topics have not, to date, received any attention by the statistical community. The three issues under consideration by the International Conference on Harmonization (ICH), are. 1. Dose–response information to support drug registration (especially dose/toxicity relationship). 2. Studies in support of special populations; Geriatrics, A Draft Guideline. 3. ICH Draft Guideline 3 on The extent of population exposure required to assess clinical safety for drug intended for long-term-treatment of non-life-threatening conditions'. The ICH special population guideline concerning studies in geriatric patients is closely related to a recent Food and Drug Administration ‘Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs’,⁴ which is another example of a ‘subgroup’ for whom specific interest exists to evaluate drug safety and efficacy.     

Guidelines for economic evaluation of pharmaceuticals in Korea]

An economic evaluation is required in order to apply to the Health Insurance Review and Assessment Service (HIRA) for a listing in the national drug formulary. To assist companies in preparing the necessary documents, HIRA published guidelines for the economic evaluation of pharmaceuticals in 2006. The guidelines are composed of two parts: guidance an explanatory notes. Each guideline reflects the best practice which meets both the theoretical consensus within the academic community and local situations, like data availability. To enhance the transparency of evaluation, guidelines emphasize the reproducibility of data and analysis result. That is, all evaluation processes are required to be described in enough detail to be replicated by reviewers. With growing experience and theoretical development in this area, HIRA guidelines will be revised periodically.     

疾病预防控制中心实验室质量管理探讨

目的本文从质量管理体系的构成和建立为起点,阐述建立疾病预防控制中心实验室质量管理体系的具体工作。论述了实验室质量方针的制定,实验室内部及实验室之间的质量控制,疾控机构内部管理评审,国家计量认证及实验室认可评审的重要性。提出了在实验室运行过程中信息管理、交流时的信息数据安全问题的解决方法。     

Development and evaluation of public health informatics at University of Washington.

Public Health Informatics (PHI) education began at the University of Washington (UW) with a Summer Institute in 1995. The Biomedical and Health Informatics graduate program, which is housed in the School of Medicine, is an interdisciplinary, multi-school program. It demonstrates the UW's cooperative efforts in advancing informatics, encompassing the schools of public health, medicine, nursing, dentistry, pharmacy, information and graduate schools in computer science. This article provides an overview of the developmental milestones related to activities in PHI and describes the evaluation strategy and assessment plan for PHI training at the UW (http://phig.washington.edu).     

Linking evaluation and program development. The case of AHCPR-supported clinical practice guidelines

Within a research organization such as the Agency for Health Care Policy and Research (AHCPR), the process of evaluating program performance must often be integrated with a larger research and development agenda. The blending of evaluation and program development (research and development activities undertaken to build expertise and knowledge in a specific programmatic area) can both strengthen the quality of a program and enhance the science of evaluation research. This article describes AHCPR's evaluation strategy and highlights evaluation activities for the agency's clinical practice guideline program. A case study is presented to illustrate the unique methodological challenges in guideline evaluation, the creation of new tools and approaches for evaluating clinical quality, and the benefits of linking evaluation research with program development.     

我国护理质量评价研究的文献计量学分析

目的探索我国护理质量评价研究现状,为进一步完善我国护理质量评价体系、提升临床护理质量提供参考。方法采用文献计量学方法,检索1995年-2015年收录在中国期刊全文数据库（CNKI）、万方数据库等与护理质量评价有关的文献,对文献数量年度变化、文献类型、研究主题等进行分析。结果检索出符合标准的文献160篇,文献数量呈逐年递增趋势,文献类型以论著和综述为主,研究内容主要为综合性医院的护理质量评价。结论我国护理质量评价广泛开展,研究方法趋于规范,专科特色不断深化,建议构建一套规范、全面、统一的护理质量评价指标体系,以提升医疗机构整体护理质量。