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[Results of a survey on the use of guidelines in neonatology].

To assess the use of guidelines in neonatology we conducted a survey on hyperbilirubinemia in 185 German pediatric hospitals from June to September 1999. Of these 136 hospitals (73%) treating infants with hyperbilirubinemia responded. Specific standards or guidelines were used by 99% of participating hospitals. 49% of those used a hospital-based guideline, 54% the recommendations of the Gesellschaft für Neonatologie und pädiatrische Intensivmedizin, 24% another not further specified guideline. In 98% of the hospitals paper copies were used. In 21% of the hospitals the implemented guidelines were also electronically available. A coordinator for their guidelines was available in 51% of the hospitals, whereas 49% did not coordinate locally the use of their guidelines. In conclusion, guidelines should be well maintained and regularly updated in order that they do not lose their impact and significance. In addition, the potential of these concise summaries of medical expertise do not seem to be fully exploited.

Germany↗

Which clinical practice guidelines for depression? An overview for busy practitioners.

BACKGROUND: Many policy and research documents on the treatment of depression in primary care suggest that general practitioners (GPs) should make use of clinical guidelines. AIM: To describe the content of peer-reviewed guidelines for the detection and treatment of depression in primary care and help GPs identify the one most useful to their own needs. METHOD: Guidelines were evaluated by an explicit method using the Institute of Medicine assessment instrument and according to six key clinical management questions identified as important by GPs and psychiatrists. RESULTS: Only five (30%) of the published guidelines identified met all the pre-defined inclusion criteria. Total scores for development process and content ranged from 54% to 82%. Validity scores ranged from 52% to 88%. No guideline answered all the key questions identified by clinicians. CONCLUSIONS: Only two guidelines conform to the quality standard of a clinical practice guideline. One covers all aspects of detection and management of depression in primary care but gives no advice on first-line choice of antidepressant, while the other focuses only on medication and fails to explore problems of case detection or to consider non-pharmacological treatments. However, taken together they do cover most of the key clinical issues in a reliable and valid manner. The identified guidelines vary considerably in both utility and clinical applicability.

Depressive Disorder↗

Case study of an inter-professional and inter-organisational programme to adapt, implement and evaluate clinical guidelines in secondary care.

This paper describes the implementation of a clinical guideline across three acute Trusts. A Clinical Effectiveness Steering Group identified prevention of venous thromboembolism as a health priority. A local guideline development group adapted the recommendations of an existing review and produced a local guideline. Then, a multidisciplinary implementation group developed the practical aspects of implementing guidelines into routine daily practice. They identified appropriate staff to carry out risk assessment and to administer appropriate prophylaxis, as necessary. They also produced a "guideline pack" containing a training resource manual and implementation aids. Following this a multiple strategy implementation programme was used to introduce the guidelines, and an evaluation was carried out eight to ten months after the introduction of the guidelines. The evaluation identified a number of areas for improving current practice. Guideline implementation is a complex, time-consuming process.

Antibiotic Prophylaxis↗

[Previous experiences with evaluation of practice guidelines].

Numerous expectations are associated with the development of guidelines. Referring to the experiences so far it can be stated that despite the large amount of guidelines that have been developed, little attention has been given to dissemination, implementation and evaluation of guidelines. The developed guidelines often do not follow international accepted quality criteria, for example many are not based on scientific evidence or they lack the involvement of all relevant parties. The main problems occur in the process from development to implementation of a guideline. Results from evaluation studies nevertheless show that guidelines can have positive effects on the process and outcome of medical care. More scientifically sound evaluation studies are needed to assess the effects of guidelines. Especially in Germany a lot more needs to be done to improve the quality of guidelines and the amount of evaluation studies.

Evidence-Based Medicine↗

Guidelines and algorithms: perceptions of why and when they are successful and how to improve them.

Medicine is increasingly complex, a reality created by the explosion of knowledge during the last 50 years. The cost of applying this knowledge creates a daunting economic challenge. As a result, there has been a profusion of guidelines intended to influence medical practice. This report explores the interrelated issues and concepts that impact the value and success of guidelines. These include medical quality and error, compliance, and the impact on outcomes in an evidence-based medicine context. Lessons learned from previous guidelines must be understood in relation to human behavior. Legal implications of the guidelines must be considered because both an increase and a decrease in liability can be anticipated. Many products have been labeled "advocacy guidelines" with a negative context. They are believed to express motivation rather than optimizing care. The ideal of professionalism is challenged, and there is potential for the growing use of guidelines in enforcing punitive actions. Constructive experience has emphasized the appropriate required elements for practice guidelines: a systematic review of the literature, an assessment of the volume and level of the evidence, and development of a review process by an appropriate multidisciplinary group for consistency, clinical impact, and resource implications leading to clearly stated and reasonable recommendations. The dissemination of guidelines, beyond conventional publication in a journal, will impact the success of the intended outcomes. The exploitation of electronic avenues, including the Internet and the evolving interactive electronic medical record, seems to be essential for future success in these endeavors.

Algorithms↗

Modeling data and knowledge in the EON guideline architecture.

Compared to guideline representation formalisms, data and knowledge modeling for clinical guidelines is a relatively neglected area. Yet it has enormous impact on the format and expressiveness of decision criteria that can be written, on the inferences that can be made from patient data, on the ease with which guidelines can be formalized, and on the method of integrating guideline-based decision-support services into implementation sites' information systems. We clarify the respective roles that data and knowledge modeling play in providing patient-specific decision support based on clinical guidelines. We show, in the context of the EON guideline architecture, how we use the Protégé-2000 knowledge-engineering environment to build (1) a patient-data information model, (2) a medical-specialty model, and (3) a guideline model that formalizes the knowledge needed to generate recommendations regarding clinical decisions and actions. We show how the use of such models allows development of alternative decision-criteria languages and allows systematic mapping of the data required for guideline execution from patient data contained in electronic medical record systems.

Artificial Intelligence↗

Practice guidelines for tumor marker use in the clinic.

BACKGROUND: Increasing interest in implementing the practice of evidence-based medicine in oncology has encouraged the development of clinical guidelines, many of which include recommendations about the appropriate use of serum tumor markers. METHODS: Recent national and international guidelines relating to the use of tumor markers in germ cell, colorectal, breast, ovarian, prostate, lung, neuroendocrine, and thyroid cancers were identified from the scientific literature and other sources and tabulated. RESULTS: Guideline recommendations developed by national and international groups and relating to the use of tumor markers for specific cancers are reviewed and compared, considering the recommendations made for their use in screening, diagnosis, prognosis, and monitoring of therapy. Potential advantages and disadvantages of clinical guidelines, how best to implement them, and means of auditing their effectiveness are also considered. CONCLUSIONS: Excellent clinical guidelines, including recommendations for the most appropriate use of tumor markers, are already available for many cancers. Many questions relating to optimal use of these important tests remain to be answered, but current guidelines already contain much valuable information and advice. Further dissemination and implementation of the guidelines should encourage better use of tumor markers in clinical practice. Careful audit studies are also required to establish the impact of these guidelines on the practice of evidence-based medicine.

Biomarkers, Tumor↗

[Discussion for gastric cancer treatment guidelines in Japan].

The Japan Gastric Cancer Association issued the first version of Gastric Cancer treatment guidelines in March 2001 and those for patients in December 2001. These guidelines aim to reduce differences in treatment selection by institutions and doctors by to provide standard indication for doctors and patients. This guidelines show treatment indications according to the clinical stages of disease. If doctors are planning to offer treatments different from those in the guidelines, they are expected to explain the reasons for this difference to patients. The advantages and disadvantages of the guidelines had been discussed in developing committee and symposium of Japanese gastric cancer association. In these guidelines for patients, [there is no evidence to prevent gastric cancer by Helicobacter pylori eradication.]. But, many studies have yielded a positive relationship between Helicobacter pylori and gastric cancer. These gastric cancer treatment guidelines are significant in every respect, especially medical care and informed consent. Treatment guidelines should be revised associated with developments in the treatment of gastric cancer.

Helicobacter Infections↗

[Comparison between the severity criteria of the Chinese guidelines for community acquired pneumonia and Fine's risk classes].

OBJECTIVE: To validate the Chinese guidelines for community-acquired pneumonia (CAP) in evaluating severe pneumonia and hospitalization criteria for the implementation of the Chinese guidelines accordingly. METHODS: The medical records of 137 inpatients with CAP in the hospital from September 1, 2001 to March 31, 2002 were retrospectively studied and analyzed with SPSS 10.0. Chi-square test and ANOVA were used to compare severity criteria of the Chinese guidelines with Fine's risk classes. Statistical differences in age, duration of hospitalization, cost, duration of intravenous therapy, number of risk factors, and the mortality of the three subgroups stratified by the severity criteria of the Chinese guidelines were also analyzed. RESULTS: (1) The correlation was significant between the severity criteria of the Chinese guidelines and Fine's risk classes (P < 0.001, Pearson coefficient 0.601); (2) The differences in age, duration of hospitalization, cost, duration of intravenous therapy, number of risk factors and mortality were statistically significant between patients who met the hospitalization criteria and patients who did not base on the severity criteria of the Chinese guidelines (P < 0.001). The number of risk factors and the mortality in patients with severe pneumonia were significantly higher than those in other groups (P < 0.01). CONCLUSIONS: The severity criteria of the Chinese CAP guidelines can differentiate patients with different risks. Fine's risk classification is useful for evaluating Chinese patients with CAP. The current Chinese guidelines for the management of CAP should be implemented.

Adolescent↗

A clinical practice guideline for treatment of septic arthritis in children: efficacy in improving process of care and effect on outcome of septic arthritis of the hip.

BACKGROUND: The development of clinical practice guidelines is a central precept of the evidence-based-medicine movement. The purposes of this study were to develop a guideline for the treatment of septic arthritis in children and to evaluate its efficacy with regard to improving the process of care and its effect on the outcome of septic arthritis of the hip in children. METHODS: A clinical practice guideline was developed by an interdisciplinary expert committee using evidence-based techniques. Efficacy was evaluated by comparing a historical control group of thirty consecutive children with septic arthritis of the hip managed before the utilization of the guideline with a prospective cohort group of thirty consecutive children treated with use of the guideline. Benchmark parameters of process and outcome were compared between groups. RESULTS: The patients treated with use of the guideline, compared with those treated without use of the guideline, had a significantly higher rate of performance of initial and follow-up C-reactive protein tests (93% compared with 13% and 70% compared with 7%), lower rate of initial bone-scanning (13% compared with 40%), lower rate of presumptive drainage (13% compared with 47%), greater compliance with recommended antibiotic therapy (93% compared with 7%), faster change to oral antibiotics (3.9 compared with 6.9 days), and shorter hospital stay (4.8 compared with 8.3 days). There were no significant differences between the groups with regard to other process variables, and there were no significant differences with regard to outcome variables, including readmission to the hospital, recurrent infection, recurrent drainage, development of osteomyelitis, septic osteonecrosis, or limitation of motion. CONCLUSIONS: Patients treated according to the septic arthritis clinical practice guideline had less variation in the process of care and improved efficiency of care without a significant difference in outcome.

Anti-Bacterial Agents↗

[Guidelines for the management of hypertension in Japan].

Hypertension is one of the most significant risk factors for cerebrovascular and heart diseases, which rank as the second and third most frequent causes of death in Japan. Two guidelines, Guidelines for the Management of Hypertension for General Practitioners(JSH2000) and Guideline for Treatment of Hypertension in the Elderly(2002 Revised Version), are currently available for treatment of hypertension in Japan. Both guidelines include indications for the treatment of hypertension, classification and evaluation of blood pressure(diagnosis), treatment strategy, modification of lifestyle and treatment with antihypertensive drugs. The guidelines are coming into clinical practice as useful references for the control and treatment of hypertension in Japan. They have advantages based on evidence from many recent studies in Japan and on consideration of the unique life style of Japanese, since the treatment guidelines for hypertension previously referenced are essentially guidelines for individuals in Western countries, primarily Caucasians. In Guideline for Treatment of Hypertension in the Elderly(2002 Revised Version), the opinions and criticisms of the Japanese hypertension experts are also incorporated. In future research, there is a need for further observational epidemiological studies and intervention trials in Japanese patients to provide direct evidence about the risks associated with blood pressure and other risk factors, as well as the antihypertensive drug effects.

Aged↗

[Guideline development in the Academic Medical Center, Amsterdam, the Netherlands, 1992-2001].

OBJECTIVE: To evaluate a program for the local development and implementation of evidence based guidelines in the Academic Medical Center in Amsterdam, the Netherlands. DESIGN: Retrospective evaluation study. METHOD: In the period 1992-2001, 50 guideline projects had received funding. Two questionnaires were developed to monitor aspects of development and implementation of guidelines. The first questionnaire was based on the 'Appraisal of Guidelines for Research & Evaluation' (AGREE) instrument. In total 39 projects of which the original application form as well as the final report was accessible, were scored by 3 researchers. A second questionnaire was developed on the basis of an implementation model by Grol and was filled out by 46 applicants. RESULTS: The primary motive for the development of a guideline were doubts about the effectiveness of a procedure. In 79% researchers (partly) collected their own data. The future users of the guideline were involved in an early stage of the development project in 72% of all cases. In 28% potential obstructing factors were identified. Introduction of the guideline was done through oral presentations in 42% without the use of an extensive implementation strategy. Of all subsidized projects, 24% was ongoing and 74% had been implemented successfully. CONCLUSION: In the AMC-program subsidized projects often led to successfully developed guidelines, which subsequently were introduced in practice.

Evidence-Based Medicine↗

[Asthma management in adult emergency departments in Israel in comparison to asthma guidelines].

BACKGROUND: Asthma management is in focus all over the world. It is constantly updated, including aspects of Emergency Department (ED) care, on the basis of global and national evidence-based clinical guidelines. Despite the existence of these guidelines, the management of asthma, including management in the ED, is lagging behind. AIM: This study strives to evaluate various aspects of asthma management in the EDs in Israel. METHOD: A questionnaire was sent to each Head or Deputy Head of all the adult EDs in Israel. The questionnaires were collected within 16 days in December 2000. Ninety-six percent of all adult EDs in Israel responded. The mean response of each ED to all the questions was 99.5%. RESULTS: Oximetry on admission is performed for every patient in a third of the EDs although an oximeter is available in every ED. Measurements of airway obstruction severity by PEFRm or FEV1 in more than 50% of patients before hospital admission or discharge is only conducted in 9% of the EDs and in 52% of them it is not measured at all. Inhalation of a short beta-agonist combined with anticholinergic is performed in 84% of EDs. Corticosteroids are given to more than 80% of the arriving patients in only 54% of EDs and on discharge it is continued in all or almost all patients in 63% of EDs. A written time interval for the next medical visit after discharge from ED is not specified in 50% of EDs. In contrast to these findings, there is almost complete accordance among EDs (88%) that asthma management in the ED should follow formal guidelines and that common guidelines for asthma management should be adopted by all EDs in Israel (71%). CONCLUSIONS: The discrepancies between the existing clinical guidelines for asthma management in the ED and its actual use on the one hand, and the agreement among EDs on the importance of the guidelines on the other hand, are raising the necessity for common guidelines for asthma management in the EDs in Israel. Perhaps, more importantly, it highlights the urgent need for new effective and creative ways to implement asthma guidelines into routine ED practice.

Adult↗

Nonsteroidal antiinflammatory drugs or acetaminophen for osteoarthritis of the hip or knee? A systematic review of evidence and guidelines.

OBJECTIVE: The interpretation of available evidence on the relative efficacy of nonsteroidal antiinflammatory drugs (NSAID) and acetaminophen in osteoarthritis (OA) has recently been debated. This systematic review summarizes the available evidence on the efficacy of NSAID compared to acetaminophen, and compares the quality and content of clinical guidelines regarding the pharmacological treatment of OA. METHODS: Published reports of randomized controlled trials (RCT) and clinical guidelines were identified by a systematic search of bibliographic databases and relevant websites. The quality of RCT was assessed by 2 reviewers independently using a standardized checklist. Data from these RCT were used to calculate pooled differences between groups for pain and disability. The methodology of identified guidelines was appraised using the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument. RESULTS: The search strategy resulted in the identification of 5 RCT. Statistical pooling of data from 3 trials with adequate methods and sufficient data presentation resulted in a pooled standardized mean difference for general pain of 0.33 (95% CI 0.15 to 0.51), indicating a small effect in favor of NSAID. Pooled estimates for other outcome measures were smaller. Three of the 9 identified guidelines satisfied more AGREE criteria than others, particularly regarding rigor of development. Stakeholder involvement, applicability, and editorial independence were poorly described in most guidelines. The content of recommendations regarding the use of NSAID or acetaminophen was fairly consistent. CONCLUSION: Acetaminophen is often effective in OA and is associated with fewer adverse reactions than NSAID. Available evidence supports the recommendations of recent guidelines to use acetaminophen as initial therapy for OA in addition to nonpharmacological interventions. Further research is needed to establish the efficacy of NSAID or acetaminophen in relevant subgroups of patients. We agree with guidelines that it is important that treatment is tailored to individual patients taking into account the severity of symptoms, previous use of acetaminophen, and the patient's knowledge, expectations, and preferences.

Acetaminophen↗

The Medical Society of Delaware's Uniform Clinical Guidelines for diabetes: did they have a positive impact on quality of diabetes care?

BACKGROUND: In 2001, the Diabetes Physician Committee of the Medical Society of Delaware developed Uniform Clinical Guidelines (UCGs) for diabetes mellitus. These guidelines were intended to provide a standard for the diabetes quality indicators that could be used by all providers and all major insurers in Delaware. The guidelines were sent to Delaware physicians in December 2001. This study examines whether implementation of the diabetes UCG had a positive impact on the quality of diabetes care in primary care offices. METHODS: A chart review was conducted for 258 diabetic patients of 28 primary care physicians in all three counties in Delaware. Quality of care was compared from the year prior to guideline implementation (2001) to the year after implementation (2002). Quality was determined by process measures, including receipt of recommended monitoring tests (glycosylated hemoglobin, blood pressure, lipids, microalbumin, foot exams, eye exams) and immunizations (influenza and pneumococcal), as well as by outcome measures, including adequate glycemic control, blood pressure control, and lipid control. RESULTS: There was no significant change in most quality indicators from the year before to the year after implementation of the UCG. The only improvements seen were in influenza immunizations and, to some extent, lipid and blood pressure control. However, none of these reached optimal levels, and for some process measures (microalbumin testing and eye exams) there was a decrease in adherence to guidelines. In a second analysis, physicians who used diabetes flow sheets had better quality of care for most measures, although these differences were relatively small and not consistent across all measures. CONCLUSIONS: The Medical Society of Delaware's Uniform Clinical Guidelines are intended to standardize care for diabetes and other conditions. While the guidelines may help to reduce unnecessary duplication and confusion caused by multiple guidelines, this study showed that they have not yet resulted in substantial improvements in quality of care for diabetes. Since the study does suggest that using flow sheets is associated with somewhat better care, it could be that quality will improve as more physicians incorporate these tools into their practices.

Adult↗

Methodological appraisal of guidelines. The AGREE instrument.

The increasingly important role of clinical practice guidelines as a support tool for clinical decision-making is shown by a growing number of publications in the literature. In fact, it is almost impossible to open a medical journal without coming across one or more guidelines on various subjects. Guidelines serve several objectives: 1) improvement in health care (increasing good and decreasing bad practices); 2) greater availability of and access to medical knowledge; and 3) promotion of cost-effective strategies. The recommended methodology for guideline design and development requires that the recommendations should be evidence-based, i.e., based on selected and critically appraised data, with the final inclusion of evidence that is valid, important and applicable, based on explicit pre-defined criteria. The methodological quality of guidelines varies substantially, raising credibility issues, with subsequent lack of results (in terms of changing medical practice). This has given rise to a series of recent publications on methodological rules for the design and writing of guidelines. This paper presents the first international instrument that can be used as a quality assurance tool for evidence-based clinical guidelines: the Appraisal of Guidelines Research and Evaluation (AGREE) instrument.

Cardiology↗

[Do clinical guidelines and economic restrictions on health care affect the criminal liability of health care professionals?].

Criminal liability in connection with clinical guidelines relates to several different aspects: (1) It refers to the guideline authors' liability under criminal law in the case of faulty guidelines. (2) Guidelines do not constitute legally binding rules. They can only contribute to determining the standard for medical specialists. (3) There can and must not be any reversal in the burden of proof with criminal proceedings. (4) In case of a deviation from guidelines and a related breach of duty, the subjective aspect of negligence (i.e. the recognizability of danger) can often be inferred from the knowledge of the respective guideline that we can reasonably expect of the physician. (5) No physician who has adhered to the guidelines can regularly be accused of (subjective) negligence. (6) Problems may be encountered in cases where the topic in question has not been covered, but only peripherally touched upon by guidelines. For the sake of uniformity in our legal system, the individual physician must not be held criminally responsible for the lack of economic means. Possible solutions include: (1) relating the standard to the practically instead of the theoretically feasible, (2) investigating to what extent criminal liability may be limited by acceptability and possibility. The complete refusal to provide medical care under inadequate conditions may increase the endangerment of legally protected rights and therefore be unacceptable. Attempts to improve structures towards the standard may be regarded as meeting the requirements under criminal law.

Costs and Cost Analysis↗

Vaidurya--a concept-based, context-sensitive search engine for clinical guidelines.

A major problem in the effective use of clinical guidelines is fast and accurate access at the point of care. Thus, we are developing a digital electronic guideline library (DeGeL) and a set of tools for incremental conversion of free-text guide-lines into increasingly machine-comprehensible representations, which support automated application. Even if guidelines are represented in electronic fashion, care providers need to be able to quickly retrieve the guidelines that best fit the clinical situation at hand. We describe Vaidurya, a search and retrieval engine that exploits the hybrid nature of guideline representation in the DeGeL architecture. Vaidurya can use not only free-text keywords, but also multiple semantic indices along which the guidelines are classified, and the mark up of guidelines in DeGeL, using the semantic roles of one or more guideline-representation languages. Preliminary evaluation of Vaidurya in a standard information task and a large guide-line repository is encouraging; formal evaluation is under way.

Algorithms↗