SEARCH · PubMed Health
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
BACKGROUND: In Chicago October 15, 1998, the American Medical Association (AMA) Department of Clinical Quality Improvement introduced a broadened scope for its Practice Parameters Forum, now retitled the Clinical Quality Improvement Forum. The Forum will now focus on integrating all the components of what the AMA has identified as the quality continuum-clinical practice guidelines, performance measurement, and process and outcomes analysis. KEYNOTE ADDRESS: The address "The Quality Continuum" heralded the ushering in of a third stage known as "clinical integration," which will become medicine's "industrial revolution." Unexplained clinical variation remains the major roadblock to lowering costs, improving quality, and establishing accountability. But several tools, from guidelines to case management, will help us work through our industrial revolution and integrate clinically. PANEL I: GUIDELINES AND EVIDENCE-BASED REPORTS: The international Cochrane Collaboration, through its Collaborative Review Groups and systematic reviews, and the Agency for Health Care Policy and Research, through its Evidence-Based Practice Centers and other programs, are providing the evidence for other groups to use in developing their own guidelines, performance measures, and other tools. But measuring the effectiveness of implementing clinical preventive services remains a difficult challenge. PANEL II: CLINICAL PROCESS MEASUREMENT: Presentations on the relationship between guidelines and performance measures, translating guidelines into review criteria/process measures, reasons for non-compliance with guideline recommendations, patient-reported process measurement, and specific process measurement experiences together reflected federal, national medical specialty society, state medical society/peer review organization, and university/health plan perspectives. PANEL III: CLINICAL OUTCOMES MEASUREMENT: If outcomes can be associated with specific processes of care, clinical practice guidelines can be refined. However, outcomes are dependent on factors outside physicians' behavior and control, such as patient compliance, comorbidities, and other risk factors, and consequently consideration of these variables is essential to appropriately interpreting the data.
Clinicians ignore lengthy guidelines and prefer pocket cards and concise pamphlets. However, brevity in guidelines may lead to deficiency in quality. Our objective, therefore, was to examine the quality of brief guidelines produced by professional bodies, using those produced by the UK Royal College of Obstetricians and Gynaecologists (RCOG) as an example. We assessed all 22 'green-top' guidelines, produced by September 2002, for quality using a validated 37-item appraisal instrument. This instrument evaluated the guidelines on three dimensions, namely rigour of development, context and content and applicability. Ten (45%), 18 (82%) and five (23%) of the 22 guidelines met at least half the quality criteria for rigour of development, context and content and applicability, respectively. We conclude that the brief guidelines were deficient in several specific quality items, particularly those in the applicability dimension. Guideline developers need to achieve the higher quality standards expected of professional bodies.
BACKGROUND: Valid clinical guidelines can be effective in improving patient care. Genital Chlamydia trachomatis infection is the commonest curable sexually transmitted disease (STD) in England and Wales and is an important cause of pelvic inflammatory disease (PID), tubal infertility and ectopic pregnancy. No published guidelines exist on managing genital chlamydial infection in British general practice. OBJECTIVE: We aimed to develop valid guidelines for the management of genital chlamydial infection for use in British general practice. METHODS: A district-wide postal questionnaire survey was used to document current clinical practice. A critical review of the evidence concerning the management of genital chlamydial infection as it relates to British general practice was performed. The information gained from the critical review and survey was used to develop evidence-based guidelines within a multidisciplinary guideline recommendation group. RESULTS: The guidelines covered the diagnosis, investigation, drug treatment and referral of adult male and female patients with genital chlamydial infection in general practice. CONCLUSION: Valid guidelines for the management of genital chlamydial infection have been developed for use in British general practice. Appropriate dissemination and implementation of the guidelines should lead to earlier detection and treatment of men and women with chlamydial infection and thereby reduce the incidence of PID, tubal infertility and ectopic pregnancy in women.
BACKGROUND: Clinical practice guidelines (CPG) are thought to be an effective tool in improving efficiency and outcomes of clinical practice. Physicians' adherence to guidelines is reported to be poor. We evaluated the relationship between generalizability of guidelines on hypertension and physicians' adherence to guidelines' recommendations for pharmacological treatment. METHODS: We used the Sixth Joint National Committee's (JNC VI) guidelines on hypertension to evaluate our hypothesis. We evaluated the evidence from controlled clinical trials on which the JNC VI bases its recommendation, and compared the population enrolled in those trials with the American hypertensive population. Data on this population came from the National Health and Nutritional Examination Survey III. RESULTS: Twenty-three percent of the NHANES population had a diagnosis of hypertension, 11% had hypertension requiring drug treatment according to the JNC VI. Only half of the population requiring treatment would have been enrolled in at least two trials. Rate of adherence to CPG was 69%. We found a weak association between generalizability and physicians' adherence to guidelines. Baseline risk was the major determinant of the decision to treat. CONCLUSION: JNC VI guidelines may not be generalizable to their target population. We found a relatively poor adherence rate to these guidelines. Failing of completely taking into account the clinical characteristics of the patients may be partly responsible for this lack of adherence.
OBJECTIVE: To measure the impact of a computerized guideline for glucose regulation in an ICU. DESIGN: A randomized, controlled trial with an off-on-off design. METHODS: We implemented a glucose regulation guideline in an intensive care unit in paper form during the first study period. During the second period, the guideline was randomly applied in either paper or computerized form. In the third period, the guideline was available only in paper form. MEASUREMENTS AND RESULTS: We analyzed data for 484 patients. During the intervention period, the control group included 54 patients and the computerized intervention group included 66 patients. The two guideline-related outcome measures consisted of compliance with: (a) glucose measurement timing recommendations and (b) insulin dose advice. We measured clinical impact as the proportion of time that glucose levels fell within target range. In the first (paper-based) study period, 29.0% of samples occurred with optimal timing; during the second period, this increased to 35.5% for paper-based and to 40.2% for computerized protocols. The third study period timeliness scores reverted to the first period rates. Late (suboptimal) sampling occurred for 66% of glucose measurements in the first study period, for 42% of paper-based and 28% of computer-based protocol samples in the second period, and for 50.0% of samples in the third study period. In the first study period, insulin-dosing guideline compliance was 56.3%; in the second period, it was 64.2% for paper-based and 77.3% for computer-based protocols, and it fell to 42.4% in the third period. For the second study period, the time that a patient's glucose values fell within target range improved for both the control (52.9%) and the computerized groups (54.2%) compared with the first study period (44.3%) and the third period (42.3%). CONCLUSION: Implementing a computerized version of a guideline significantly improved timeliness of measurements and glucose level regulation for critically ill patients compared with implementing a paper-based version of the guideline.
The Children's Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers are risk-based, exposure-related clinical practice guidelines intended to promote earlier detection of and intervention for complications that may potentially arise as a result of treatment for pediatric malignancies. Developed through the collaborative efforts of the Children's Oncology Group Late Effects Committee, Nursing Discipline, and Patient Advocacy Committee, these guidelines represent a statement of consensus from a multidisciplinary panel of experts in the late effects of pediatric cancer treatment. The guidelines are both evidence-based (utilizing established associations between therapeutic exposures and late effects to identify high-risk categories) and grounded in the collective clinical experience of experts (matching the magnitude of risk with the intensity of screening recommendations). They are intended for use beginning 2 or more years following the completion of cancer therapy; however, they are not intended to provide guidance for follow-up of the survivor's primary disease. A complementary set of patient education materials ("Health Links") was developed to enhance follow-up care and broaden the application of the guidelines. The information provided in these guidelines is important for health care providers in the fields of pediatrics, oncology, internal medicine, family practice, and gynecology, as well as subspecialists in many fields. Implementation of these guidelines is intended to increase awareness of potential late effects and to standardize and enhance follow-up care provided to survivors of pediatric cancer throughout the lifespan. The Guidelines, and related Health Links, can be downloaded in their entirety at www.survivorshipguidelines.org.
In order to promote the care of patients with COPD in Germany a national guideline clearing project was initiated jointly by autonomous corporate bodies of the German health care system. Following a systematic search of literature data bases between 1992 and 2002, 20 guidelines were identified that met the inclusion criteria and were evaluated with the German Checklist for Methodological Guideline Appraisal. Following this, a multidisciplinary expert group appointed by the German Guideline Clearinghouse (Leitlinien-Clearingstelle im Arztlichen Zentrum fur Qualitat in der Medizin, AZQ) reviewed the suitability of these guidelines for the use in the German health care system. Referring to methodological aspects, criteria were best met by the guideline of the Veteran's Health Administration/Department of Defense (US), followed by the one of the Deutsche Atemwegsliga and the Deutsche Gesellschaft fur Pneumologie. Aiming at the production respectivly a revision of a German national guideline for COPD the expert group agreed on recommendations organized in 19 chapters. Among others these strengthened the role of a precise definition of COPD based primarily on the pathogenesis, of a subtle description of all diagnostic and therapeutic tools and of a detailed description of quality assurance and quality management. The feasability of recommendations were demonstrated by examples chosen from the evaluated guidelines. Additionally the presented findings may be used as steering tools in the German Health care system.
BACKGROUND: The 2003 European Society of Hypertension/European Society of Cardiology (ESH-ESC) guidelines have recently proposed a new risk stratification scheme for estimating absolute risk for cardiovascular disease. At variance from the previous 1999 World Health Organization-International Society of Hypertension (WHO/ISH) guidelines, the new criteria include some additional risk factors such as obesity, abnormal high-density (HDL) or low-density lipoprotein (LDL) cholesterol levels and define a slight increase in creatinine and microalbuminuria as signs of target organ damage (TOD). OBJECTIVE: The aim of the study was to assess overall cardiovascular risk in uncomplicated hypertensives according to the 2003 ESH-ESC guidelines comparing this approach with the stratification scheme of the 1999 WHO/ISH guidelines. METHODS: Four hundred and twenty-five never-treated grade 1 and 2 essential hypertensive patients, referred for the first time to our outpatient clinic without diabetes mellitus, were included in the study. They underwent the following procedures: (i) repeated clinical blood pressure measurements; (ii) routine blood chemistry and urine analysis; (iii) electrocardiogram; (iv) 24-h urine collection for microalbuminuria; (v) echocardiogram; and (vi) carotid ultrasonogram. Risk was assessed according to both stratification schemes suggested by the 2003 ESH-ESC and 1999 WHO/ISH guidelines. RESULTS: According to the 2003 ESH-ESC guidelines, 15.5% of the 425 patients were considered at low added risk, 47.8% at medium added risk and 36.7% at high added risk; 146 patients (34.3%) were classified in the high-risk stratum because of at least one manifestation of TOD and 5.6% having three or more risk factors. The accuracy in detecting TOD of the combined approach with ultrasound procedures and microalbuminuria was approximately 10-fold higher than that provided by routine investigation. As a result of the 1999 WHO/ISH stratification scheme, 34.5% were low-risk, 34.4% medium-risk and 31.1% high-risk patients. CONCLUSIONS: Our findings show that: (i) more than one-third of uncomplicated grade 1 and 2 hypertensives seen in a outpatient hypertension hospital clinic have a high added risk according to the ESH-ESC scheme; (ii) classification of the patients in the high stratum is mainly influenced by the presence of TOD; (iii) the routine diagnostic work-up is a highly insensitive approach for the detection of TOD; (iv) the 2003 ESH-ESC guidelines stratify a higher proportion of hypertensive patients in the medium and high-risk groups than do the 1999 WHO/ISH guidelines.
In Finland, guidelines have been used in primary care since the late 1980s to bridge the gap between research evidence and practice. From the very beginning, the electronic format has been the primary source for EBM Guidelines (EBMG). Although also published on CD and in print, the guidelines are currently mostly used via the Internet. Keeping more than 1000 guidelines up to date is a great challenge to the editorial group, and several methods are used to guarantee the quality. The Cochrane Library has become the most important source of information for the guideline producers and all Cochrane reviews relevant to GPs are summarized and linked to the guidelines. In this article we present our experience of producing the electronic guidelines for GPs, the methodology used, and data on the clinical use of these guidelines and their Cochrane links. We also discuss the barriers and facilitators to our process and present ideas for future development.
Clinical guidelines can be effective in achieving health gain when they are validly developed, disseminated and implemented appropriately. There is, however, a potential conflict between the need for validity through use of expert resources available at a national level, and implementation, which is undertaken at local level and depends on the local relevance of the guideline. This paper presents a model by which valid guidelines for the management of a given disease (genital chlamydial infection) by general practitioners can be developed at local level using the resources available to a district health authority department of public health. The model has three elements. First, a district-wide postal questionnaire survey was used to document current clinical practice. Secondly, a critical review of the evidence relating to the management of genital chlamydial infection as it relates to British general practice was performed. Thirdly, the information gained from the critical review and survey was used by a multidisciplinary group to develop evidence-based guideline recommendations. It is argued that the Leicestershire Genital Chlamydia Guidelines compare favourably with other recently published national guidelines in terms of their development and content. Local guideline development of guidelines for selected topics can be practical and appropriate.
OBJECTIVE: To allow exchange of clinical practice guidelines among institutions and computer-based applications. DESIGN: The GuideLine Interchange Format (GLIF) specification consists of GLIF model and the GLIF syntax. The GLIF model is an object-oriented representation that consists of a set of classes for guideline entities, attributes for those classes, and data types for the attribute values. The GLIF syntax specifies the format of the test file that contains the encoding. METHODS: Researchers from the InterMed Collaboratory at Columbia University, Harvard University (Brigham and Women's Hospital and Massachusetts General Hospital), and Stanford University analyzed four existing guideline systems to derive a set of requirements for guideline representation. The GLIF specification is a consensus representation developed through a brainstorming process. Four clinical guidelines were encoded in GLIF to assess its expressivity and to study the variability that occurs when two people from different sites encode the same guideline. RESULTS: The encoders reported that GLIF was adequately expressive. A comparison of the encodings revealed substantial variability. CONCLUSION: GLIF was sufficient to model the guidelines for the four conditions that were examined. GLIF needs improvement in standard representation of medical concepts, criterion logic, temporal information, and uncertainty.
We propose to present a poster (and potentially also a demonstration of the implemented system) summarizing the current state of our work on a hybrid, multiple-format representation of clinical guidelines that facilitates conversion of guidelines from free text to a formal representation. We describe a distributed Web-based architecture (DeGeL) and a set of tools using the hybrid representation. The tools enable performing tasks such as guideline specification, semantic markup, search, retrieval, visualization, eligibility determination, runtime application and retrospective quality assessment. The representation includes four parallel formats: Free text (one or more original sources); semistructured text (labeled by the target guideline-ontology semantic labels); semiformal text (which includes some control specification); and a formal, machine-executable representation. The specification, indexing, search, retrieval, and browsing tools are essentially independent of the ontology chosen for guideline representation, but editing the semi-formal and formal formats requires ontology-specific tools, which we have developed in the case of the Asbru guideline-specification language. The four formats support increasingly sophisticated computational tasks. The hybrid guidelines are stored in a Web-based library. All tools, such as for runtime guideline application or retrospective quality assessment, are designed to operate on all representations. We demonstrate the hybrid framework by providing examples from the semantic markup and search tools.
BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the 14th of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on reporting guidelines and recommendations. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: There is little empirical evidence that addresses these questions. Our answers are based on logical arguments and standards put forward by other groups. What standard types of recommendations or reports should WHO use? WHO should develop standard formats for reporting recommendations to facilitate recognition and use by decision makers for whom the recommendations are intended, and to ensure that all the information needed to judge the quality of a guideline, determine its applicability and, if needed, adapt it, is reported. WHO should develop standard formats for full systematically developed guidelines that are sponsored by WHO, rapid assessments, and guidelines that are endorsed by WHO. All three formats should include the same information as full guidelines, indicating explicitly what the group preparing the guideline did not do, as well as the methods that were used. These formats should be used across clinical, public health and health systems recommendations. How should recommendations be formulated and reported? Reports should be structured, using headings that correspond to those suggested by the Conference on Guideline Standardization or similar headings. The quality of evidence and strength of recommendations should be reported explicitly using a standard approach. The way in which recommendations are formulated should be adapted to the specific characteristics of a specific guideline. Urgent attention should be given to developing a template that provides decision makers with the relevant global evidence that is needed to inform a decision and offers practical methods for incorporating the context specific evidence and judgements that are needed.
Current methods for developing practice guidelines include informal consensus development, formal consensus development, evidence-based guideline development, and explicit guideline development. Informal consensus development is the oldest and most common approach, but guidelines produced in this manner are often of poor quality and lack adequate documentation of methods. Formal consensus development uses a systematic approach to assess expert opinion and to reach agreement on recommendations. Evidence-based guideline development links recommendations directly to scientific evidence of effectiveness; rules of evidence are emphasized over expert opinion in making recommendations. Explicit guideline development clarifies the rationale by specifying the potential benefits, harms, and costs of available interventions; estimating the possibility of the outcomes; and comparing the desirability of the outcomes based on patient preferences. Steps in the development of practice guidelines include introductory decisions (selection of topic and panel members, clarification of purpose); assessments of clinical appropriateness (review of scientific evidence and expert opinion); assessment of public policy issues (resource limitations, feasibility issues); and guideline document development and evaluation (drafting of document, peer review, and pretesting).
OBJECTIVE: To determine which attributes of clinical practice guidelines influence the use of guidelines in decision making in clinical practice. DESIGN: Observational study relating the use of 47 different recommendations from 10 national clinical guidelines to 12 different attributes of clinical guidelines-for example, evidence based, controversial, concrete. SETTING: General practice in the Netherlands. SUBJECTS: 61 general practitioners who made 12 880 decisions in their contacts with patients. MAIN OUTCOME MEASURES: Compliance of decisions with clinical guidelines according to the attribute of the guideline. RESULTS: Recommendations were followed in, on average, 61% (7915/12 880) of the decisions. Controversial recommendations were followed in 35% (886/2497) of decisions and non-controversial recommendations in 68% (7029/10 383) of decisions. Vague and non-specific recommendations were followed in 36% (826/2280) of decisions and clear recommendations in 67% (7089/10 600) of decisions. Recommendations that demanded a change in existing practice routines were followed in 44% (1278/2912) of decisions and those that did not in 67% (6637/9968) of decisions. Evidence based recommendations were used more than recommendations for practice that were not based on research evidence (71% (2745/3841) v 57% (5170/9039)). CONCLUSIONS: People and organisations setting evidence based clinical practice guidelines should take into account some of the other important attributes of effective recommendations for clinical practice.