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Medical outcomes and antimicrobial costs with the use of the American Thoracic Society guidelines for outpatients with community-acquired pneumonia.

CONTEXT: The American Thoracic Society (ATS) published guidelines based on expert opinion and published data--but not clinically derived or validated--for treating adult outpatients with community-acquired pneumonia. OBJECTIVE: To compare medical outcomes and antimicrobial costs for patients whose antimicrobial therapy was consistent or inconsistent with ATS guidelines. DESIGN: Multicenter, prospective cohort study. SETTING: Emergency departments, medical clinics, and practitioner offices affiliated with 3 university hospitals, 1 community teaching hospital, and 1 health maintenance organization. PARTICIPANTS: A total of 864 immunocompetent, adult outpatients with community-acquired pneumonia: 546 aged 60 years or younger with no comorbidity and 318 older than 60 years or with 1 comorbidity or more. MAIN OUTCOME MEASURES: Patients' antimicrobial therapy was classified as being consistent or inconsistent with the ATS guidelines. Mortality, subsequent hospitalization, medical complications, symptom resolution, return to work and usual activities, health-related quality of life, and antimicrobial costs were compared among those treated consistently or inconsistently with the guidelines. RESULTS: Outpatients aged 60 years or younger with no comorbidity who were prescribed therapy consistent with ATS guidelines (ie, erythromycin with some exceptions) had 3-fold lower antimicrobial costs ($5.43 vs $18.51; P<.001) and no significant differences in medical outcomes. Outpatients older than 60 years or with 1 comorbidity or more who were prescribed therapy consistent with ATS guidelines (ie, second-generation cephalosporin, sulfamethoxazole-trimethoprim, or beta-lactam and beta-lactamase inhibitor with or without a macrolide) had 10-fold higher antimicrobial costs ($73.50 vs $7.50; P<.001); despite trends toward higher mortality and subsequent hospitalization, no significant differences in medical outcomes were observed. CONCLUSION: Our findings support the use of erythromycin as recommended by the ATS guidelines for outpatients aged 60 years or younger with no comorbidity. Although the antimicrobial therapy recommended in outpatients older than 60 years or with 1 comorbidity or more is more costly, this observational study provides no evidence of improved medical outcomes in the small subgroup who received ATS guideline-recommended therapy.

Adult↗

Review of Canadian low-risk drinking guidelines and their effectiveness.

This study compared 18 low-risk drinking guidelines that were gathered from Canadian government agencies, non-government agencies, medical bodies, and public and private agencies involved in the treatment of addictions. The results show that two sets of guidelines are predominantly used in Ontario. The formulation of these guidelines was entirely independent and their intended audiences are also different. However, a direct comparison of the two guidelines shows that differences are more apparent than real. This study also examines the literature evaluating low-risk drinking guidelines Very little literature exists on evaluating low-risk drinking guidelines as vehicles for primary prevention and it is not known to what extent such guidelines influence knowledge and drinking behaviour. Future low-risk drinking recommendations should be evaluated for knowledge about standard drink units, awareness of the guidelines, use of materials and aids included in the dissemination program, and changes in behaviour from campaign exposure.

Adult↗

Guidelines for education and training of medical physicists in radiotherapy. Recommendations from an ESTRO/EFOMP working group.

PURPOSE: To provide a guideline curriculum covering theoretical and practical aspects of education and training for medical physicists in radiotherapy within Europe. MATERIAL AND METHODS: Guidelines have been developed for the specialist theoretical knowledge and practical experience required to practice as a medical physicist in radiotherapy. It is assumed that the typical entrant into training will have a good initial degree in the physical sciences, therefore these guidelines also require that and are additional to it. National training programmes of medical physics, radiation physics and radiotherapy physics from a range of European countries and from North America were reviewed by an expert panel set up by the European Society of Therapeutic Radiology and Oncology (ESTRO) and the European Federation of Organisations for Medical Physics (EFOMP). A draft document prepared by this group was circulated, via the EFOMP infrastructure, among national professional medical physics societies in Europe for review and comment and was also discussed in an education session in the May 2003 EFOMP scientific meeting in Eindhoven. RESULTS: The resulting guideline curriculum for education and training of medical physicists in radiotherapy within Europe discusses the EFOMP terms, qualified medical physicist (QMP) and specialist medical physicist (SMP), and the group's view of the links to the EU (Directive 97/43) term, medical physics expert (MPE). The minimum level expected in each topic in the theoretical knowledge and practical experience sections is intended to bring trainees up to the requirements of a QMP. The responses from the circulation of the document to national societies and its discussion were either to agree its content, with no changes required, or to suggest changes, which were taken into account after consideration by the expert group. Following this the guidelines have been endorsed by the parent organisations. CONCLUSIONS: This new joint ESTRO/EFOMP European guideline curriculum is a first step to harmonise specialist training of medical physicists in radiotherapy within Europe. It provides a common framework for national medical physics societies to develop or benchmark their own curricula, but is also flexible enough to suit different situations of initial physics qualifications, medical physics training programmes, accreditation structures, etc. The responsibility for the implementation of these standards and guidelines will lie with the national training bodies and authorities.

Curriculum↗

Effectiveness of a nationally implemented smoking cessation guideline on provider and patient practices.

BACKGROUND: The Agency for Health Care Policy and Research (AHCPR) smoking cessation guideline outlines a set of recommendations for physicians to follow in daily practice. However, the effectiveness of this guideline has not been reported. The goal of this project was to evaluate the effect of the AHCPR smoking cessation guideline on provider practices with smokers and on patient smoking rates. METHODS: Patient survey and chart review data from 138 Veterans Administration (VA) acute care medical centers with outpatient facilities were examined. Data were available from both sources in 1996, 1997, and 1998. At the midpoint of this period (1997), the VA recommended the AHCPR smoking cessation clinical practice guideline for implementation throughout the VA healthcare system. RESULTS: From 1996 to 1998, both the chart audit and the patient survey showed a significant increase in the percentage of patients in the VA who were counseled about smoking and a significant decrease in the percentage of patients who smoke. CONCLUSIONS: Because the VA tied the guideline implementation to report cards and other performance-enhancing measures, guideline adherence may have been maximized in this setting. These findings suggest that healthcare systems should take an integrated approach to guideline implementation.

Adult↗

World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, part 2: long-term treatment of schizophrenia.

These guidelines for the biological treatment of schizophrenia were developed by an international Task Force of the World Federation of Societies of Biological Psychiatry (WFSBP). The goal during the development of these guidelines was to review systematically all available evidence pertaining to the treatment of schizophrenia, and to reach a consensus on a series of practice recommendations that are clinically and scientifically meaningful based on the available evidence. These guidelines are intended for use by all physicians seeing and treating people with schizophrenia. The data used for developing these guidelines have been extracted primarily from various national treatment guidelines and panels for schizophrenia, as well as from meta-analyses, reviews and randomised clinical trials on the efficacy of pharmacological and other biological treatment interventions identified by a search of the MEDLINE database and Cochrane Library. The identified literature was evaluated with respect to the strength of evidence for its efficacy and then categorised into four levels of evidence (A-D). This second part of the guidelines covers the long-term treatment as well as the management of relevant side effects. These guidelines are primarily concerned with the biological treatment (including antipsychotic medication, other pharmacological treatment options, electroconvulsive therapy, adjunctive and novel therapeutic strategies) of adults suffering from schizophrenia.

Antipsychotic Agents↗

Clinical practice guideline for the physiotherapy of patients with whiplash-associated disorders.

STUDY DESIGN: A clinical practice guideline. OBJECTIVES: To assist physiotherapists in decision making and to improve the efficacy and uniformity of care for patients with whiplash-associated disorders Grades I and II. SUMMARY OF BACKGROUND DATA: Whiplash constitutes a considerable problem in health care. Many interventions are used in physiotherapy practice, despite increasing evidence for the use of active interventions. There is still no clinical practice guideline for the management of patients with whiplash-associated disorders. METHOD OF DEVELOPMENT: A computerized literature search of Medline, Cinahl, Cochrane Controlled Trial Register, Cochrane Database of Systematic Reviews, and the Database of the Dutch National Institute of Allied Health Professions was performed to search for information about the diagnostic process and the therapeutic process in whiplash patients. When no evidence was available, consensus between experts was achieved to develop the guideline. Practicing physiotherapists reviewed the clinical applicability and feasibility of the guideline, and their comments were used to improve it. RECOMMENDATIONS: The diagnostic process consists of systematic history taking and a physical examination supported by reliable and valid assessment tools to document symptoms and functional disabilities. The primary goals of treatment are a quick return to normal activities and the prevention of chronicity. Active interventions such as education, exercise therapy, training of functions, and activities are recommended according to the length of time since the accident and the rate of recovery. The biopsychosocial model is used to address the consequences of whiplash trauma. CONCLUSIONS: Scientific evidence for the diagnosis and physiotherapeutic management of whiplash is sparse; therefore, consensus is used in different parts of the guideline. The guideline reflects the current state of knowledge of the effective and appropriate physiotherapy in whiplash patients. More and better research is necessary to validate this guideline in the future.

Acceleration↗

Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients.

OBJECTIVE: This study was conducted to develop evidence-based clinical practice guidelines for nutrition support (ie, enteral and parenteral nutrition) in mechanically ventilated critically ill adults. OPTIONS: The following interventions were systematically reviewed for inclusion in the guidelines: enteral nutrition (EN) versus parenteral nutrition (PN), early versus late EN, dose of EN, composition of EN (protein, carbohydrates, lipids, immune-enhancing additives), strategies to optimize delivery of EN and minimize risks (ie, rate of advancement, checking residuals, use of bedside algorithms, motility agents, small bowel versus gastric feedings, elevation of the head of the bed, closed delivery systems, probiotics, bolus administration), enteral nutrition in combination with supplemental PN, use of PN versus standard care in patients with an intact gastrointestinal tract, dose of PN and composition of PN (protein, carbohydrates, IV lipids, additives, vitamins, trace elements, immune enhancing substances), and the use of intensive insulin therapy. OUTCOMES: The outcomes considered were mortality (intensive care unit [ICU], hospital, and long-term), length of stay (ICU and hospital), quality of life, and specific complications. EVIDENCE: We systematically searched MEDLINE and CINAHL (cumulative index to nursing and allied health), EMBASE, and the Cochrane Library for randomized controlled trials and meta-analyses of randomized controlled trials that evaluated any form of nutrition support in critically ill adults. We also searched reference lists and personal files, considering all articles published or unpublished available by August 2002. Each included study was critically appraised in duplicate using a standard scoring system. VALUES: For each intervention, we considered the validity of the randomized trials or meta-analyses, the effect size and its associated confidence intervals, the homogeneity of trial results, safety, feasibility, and the economic consequences. The context for discussion was mechanically ventilated patients in Canadian ICUs. BENEFITS, HARMS, AND COSTS: The major potential benefit from implementing these guidelines is improved clinical outcomes of critically ill patients (reduced mortality and ICU stay). Potential harms of implementing these guidelines include increased complications and costs related to the suggested interventions. SUMMARIES OF EVIDENCE AND RECOMMENDATIONS: When considering nutrition support in critically ill patients, we strongly recommend that EN be used in preference to PN. We recommend the use of a standard, polymeric enteral formula that is initiated within 24 to 48 hours after admission to ICU, that patients be cared for in the semirecumbent position, and that arginine-containing enteral products not be used. Strategies to optimize delivery of EN (starting at the target rate, use of a feeding protocol using a higher threshold of gastric residuals volumes, use of motility agents, and use of small bowel feeding) and minimize the risks of EN (elevation of the head of the bed) should be considered. Use of products with fish oils, borage oils, and antioxidants should be considered for patients with acute respiratory distress syndrome. A glutamine-enriched formula should be considered for patients with severe burns and trauma. When initiating EN, we strongly recommend that PN not be used in combination with EN. When PN is used, we recommend that it be supplemented with glutamine, where available. Strategies that maximize the benefit and minimize the risks of PN (hypocaloric dose, withholding lipids, and the use of intensive insulin therapy to achieve tight glycemic control) should be considered. There are insufficient data to generate recommendations in the following areas: use of indirect calorimetry; optimal pH of EN; supplementation with trace elements, antioxidants, or fiber; optimal mix of fats and carbohydrates; use of closed feeding systems; continuous versus bolus feedings; use of probiotics; type of lipids; and mode of lipid delivery. VALIDATION: This guideline was peer-reviewed and endorsed by official representatives of the Canadian Critical Care Society, Canadian Critical Care Trials Group, Dietitians of Canada, Canadian Association of Critical Care Nurses, and the Canadian Society for Clinical Nutrition. SPONSORS: This guideline is a joint venture of the Canadian Critical Care Society, the Canadian Critical Trials Group, the Canadian Society for Clinical Nutrition, and Dietitians of Canada. The Canadian Critical Care Society and the Institute of Nutrition, Metabolism, and Diabetes of the Canadian Institutes of Health Research provided funding for development of this guideline.

Canada↗

Practice guidelines and standards: an overview.

Organized medicine, insurance companies, regulators, and the peer review organizations are all interested in practice guidelines. Recently, the U.S. Congress established the Agency for Health Care Policy and Research, which is charged with overseeing the development of practice guidelines. If properly developed, disseminated, and used, practice guidelines should reduce the incidence of inappropriate care and help control costs. Although guidelines have been used by physicians for years, guidelines now being developed should be more comprehensive, specific, exhaustive, and--on the basis of the best scientific evidence of effectiveness and expert opinion--more effectively discriminate between useful and useless care. Practice guidelines can improve the quality of care when used voluntarily by physicians in practice, when used as standards for quality monitoring and assurance programs, and when used as the basis for reimbursement for services. All interested parties should share responsibilities for the research, development, and production of appropriateness criteria, their translation into guidelines and standards, and the dissemination and maintenance of the guidelines, including evaluation, revision, and updating.

Clinical Protocols↗

Do practice guidelines guide practice? The effect of a consensus statement on the practice of physicians.

Guidelines for medical practice can contribute to improved care only if they succeed in moving actual practice closer to the behaviors the guidelines recommend. To assess the effect of such guidelines, we surveyed hospitals and obstetricians in Ontario before and after the release of a widely distributed and nationally endorsed consensus statement recommending decreases in the use of cesarean sections. These surveys, along with discharge data from hospitals reflecting actual practice, revealed that most obstetricians (87 to 94 percent) were aware of the guidelines and that most (82.5 to 85 percent) agreed with them. Attitudes toward the use of cesarean section were congruent with the recommendations even before their release. One third of the hospitals and obstetricians reported changing their practice as a consequence of the guidelines, and obstetricians reported rates of cesarean section in women with a previous cesarean section that were significantly reduced, in keeping with the recommendations (from 72.2 percent to 61.1 percent; P less than 0.01). The surveys also showed, however, that knowledge of the content of the recommendations was poor (67 percent correct responses). Furthermore, data on actual practice after the publication of the guidelines showed that the rates of cesarean section were 15 to 49 percent higher than the rates reported by obstetricians, and they showed only a slight change from the previous upward trend. We conclude that guidelines for practice may predispose physicians to consider changing their behavior, but that unless there are other incentives or the removal of disincentives, guidelines may be unlikely to effect rapid change in actual practice. We believe that incentives should operate at the local level, although they may include system-wide economic changes.

Cesarean Section↗

An evaluation of the Dietary Guidelines for Americans in relation to cancer occurrence.

BACKGROUND: Although scientific knowledge regarding the influence of nutritional factors on health and disease serves as the basis for specific recommendations included in the Dietary Guidelines for Americans, limited empirical epidemiologic data are available to verify that adherence to the cluster of nutrition-related behaviors included in the Dietary Guidelines will reduce the incidence of disease. OBJECTIVE: We examined the association of compliance with the Dietary Guidelines and incident cancers. DESIGN: Data from a population-based cohort of postmenopausal women (n = 34 708) were examined. A dietary guidelines index was derived as a summary measure of compliance with the Dietary Guidelines, and the association of this index and cancer incidence was examined for all cancers combined and for site-specific cancers with > 100 events. RESULTS: For all cancers combined, the relative risks associated with the upper 4 quintiles of the dietary guidelines index in reference to the bottom quintile were 0.95 (95% CI: 0.87, 1.05) for quintile 2, 0.88 (95% CI: 0.80, 0.97) for quintile 3, 0.88 (95% CI: 0.80, 0.96) for quintile 4, and 0.85 (95% CI: 0.77, 0.93) for quintile 5 (P for trend < 0.01). Similar patterns in relative risks were found for cancers of the colon, bronchus and lung, breast, and uterus. In contrast, ovarian cancer incidence was positively associated with the dietary guidelines index. CONCLUSION: Our findings suggest that adherence to the cluster of nutrition-related behaviors included in the Dietary Guidelines for Americans may be associated with a lower risk of cancer.

Age Factors↗

Impact of local evidence-based clinical guidelines--a Danish intervention study.

OBJECTIVE: We aimed to evaluate whether a cheap and less labour-intensive regional implementation strategy for guidelines was sufficient to change knowledge and behaviour among GPs. The model studied was the implementation of anticoagulant therapy to prevent stroke in atrial fibrillation. METHOD: The intervention took place in the county of Viborg (149 GPs), Denmark, with the county of Ringkøbing (166 GPs) as control. A local interdisciplinary steering group modified national college-based guidelines, followed by a regional dissemination and implementation strategy. The effect of the intervention was evaluated during a follow-up period by a repeated questionnaire and by monitoring prescriptions for oral anticoagulants in 1993 and 1995 in the Danish National Health Service. RESULTS: Adherence to the guidelines was higher after the intervention but, considering secular trends and baseline differences, the guidelines had no significant effect. The use of oral anticoagulants increased substantially in both counties during the 2-year follow-up period, but the difference in relative change between the counties was negligible. Adherence to the guidelines could not be predicted by any of the reported practice characteristics or attitudes to guidelines. CONCLUSION: Despite solid scientific documentation and regional modification to establish ownership of nationally agreed guidelines, the impact of guidelines on GPs' knowledge and behaviour was disappointing.

Anticoagulants↗

The impact of patient management guidelines on the care of breast, colorectal, and ovarian cancer patients in Italy.

The impact of a national education program based on the dissemination of written guidelines for the treatment of breast, colorectal, and ovarian cancer was investigated in Italy. Through a survey of 770 physicians exploring their knowledge and attitudes and a review of medical records of 1,483 patients assessing current clinical practice, this study examined whether 1) the guidelines reached the target population of physicians, 2) they were effective in shaping doctors' opinions, and 3) care patterns conformed with the guidelines. Overall, the net effect of the intervention appeared to be limited in terms of actual diffusion, attributable influence, and impact. As for diffusion, only 60%, 47%, and 44% of doctors were aware of breast, colorectal, and ovarian cancer guidelines, respectively. Although doctors who were aware of the guidelines had more appropriate opinions than those who were not, overall agreement with recommendations was often unsatisfactory. With reference to guidelines recommendations, quality of care was far from optimal, especially in relation to diagnosis and staging. Marked variations in compliance with recommendations emerged with values ranging from 37% to 89%, from 48% to 82%, and from 10% to 97% for breast, colorectal, and ovarian cancer, respectively, and this held true even in hospitals where the larger awareness of the guidelines might have been expected to result in better quality care. It was concluded that any thorough assessment of the impact of educational interventions should include a careful analysis of the strategy and process of dissemination. The availability of clinically relevant messages must also be realistically considered before deciding whether the "guidelines approach" is the strategy most likely to succeed.

Adult↗

Use of venous thromboprophylaxis and adherence to guideline recommendations: a cross-sectional study.

BACKGROUND: Consensus Conferences and Guidelines for deep vein thrombosis prophylaxis have been published, which recommend the use of prophylactic heparins in patients with risk of venous thromboembolism (VTE). The aim of this study was the assessment of the prophylaxis of VTE and the adherence to accepted guideline recommendations throughout the hospital. METHODS: A cross-sectional study was carried out in a teaching hospital after guidelines were implemented. Patients' risk factors of deep vein thrombosis, risk categories of patients, and prophylaxis used in different wards were recorded. Appropriate adherence to the guidelines was analysed. RESULTS: Of 397 patients, prophylaxis was used in 231 patients (58%), and low-molecular-weight heparins (LMWH) were used in 224 of them (97%). Patients with prophylaxis had a higher mean number of risk factors (SD) than those without prophylaxis [3.1 (1.4) vs 1.9 (1.4); p < 0.05)]. Prophylaxis was used in 72% and 90% of moderate and high-risk patients respectively. Appropriate adherence to all guideline recommendations was observed in 42% of patients. Adherence to guidelines was high as regards the use of prophylaxis according to patients' risk factors (78%) and the use of appropriate types of prophylaxis (99%), but was low regarding appropriate heparin dosage (47%) and preoperative dosage (37%). Appropriate prophylaxis use was higher in critical care and surgical wards than in medical wards. CONCLUSION: Prophylaxis of VTE is generally used in risk patients, but appropriate adherence to guidelines is less frequent and variable among different wards. Continuing medical education, discussion and dissemination of guidelines, and regular clinical audit are necessary to improve prophylaxis of VTE in clinical practice.

Journal Article↗

Medical practice guidelines: current activities and future directions.

OBJECTIVE: To examine the state of the art in the field of medical practice guidelines, to identify limitations, and to suggest future directions. DESIGN: Informal descriptive survey using a questionnaire administered by telephone, supplemented by comments, by opinions, and by examples solicited from the participating organizations. PARTICIPANTS: Eight prominent organizations representing prototypic approaches to guideline development; these organizations included three medical societies, two health care organizations, two insurers, and one private health benefits management company. RESULTS: Improving the quality of medical care was a stated goal of all eight surveyed organizations. However, their objectives have not been stated in operational terms, reflecting the lesser emphasis placed on methods and means for both implementing guidelines and evaluating their impact on health practices and outcomes. In contrast, several systematic methods for developing guidelines exist. They differ in the stress placed on formal literature reviews, reliance on local as opposed to national experts, and formal methods of group judgment, but no evidence exists on which approaches produce sounder and more usable guidelines. CONCLUSIONS: Guidelines are being vigorously promoted as a means to improve the effectiveness of the health care system. Current initiatives show both strengths and weaknesses. In particular, the attention now paid to the development of guidelines needs to be matched by attention to implementation strategies and to the scientific evaluation of their effectiveness in real clinical settings. Also, more agreement is needed on acceptable methods for developing guidelines, assessing their content, and evaluating their impact on professional behavior, patient outcomes, and health care costs. Fortunately, several initiatives to bring greater order and quality to this field are under way.

Goals↗

Ethics committee develops supportive care guidelines.

In response to widespread physician noncompliance with "do not resuscitate" (DNR) guidelines in 1983, the ethics committee at St. Joseph's Hospital, St. Paul, MN, set out to clarify the confusion over "supportive care only" (SCO) and DNR orders. A task force of nurses and physicians developed tentative supportive care guidelines and a subcommittee related ethical principles to the supportive care concept. The completed draft, "Principles and Guidelines in Deciding to Forego Life-Sustaining Treatment," was reviewed by the medical executive board and hospital attorney. St. Joseph's medical staff and board of trustees approved it in May 1985, and the document became hospital policy. The policy addresses patient autonomy, the burden/benefit principle, informed consent, and patient competency. It lists six guidelines for making supportive care plans. St. Joseph's has implemented the policy in several ways. Committee members make "ethics rounds" to discuss patient cases and the guidelines with hospital personnel. A brochure acquaints patients and their families as well as community groups with the guidelines. Nurses have introduced the guidelines to physicians in critical care units. When necessary, new insights will be incorporated into the guidelines.

Catholicism↗

Evidence synthesis and development of guidelines in interventional pain management.

BACKGROUND: The past decade has been marked by unprecedented interest in evidence-based medicine and various types of avenues that can provide valid and reliable information about healthcare, including clinical practice guidelines. Thus, healthcare decisions are purportedly and increasingly being made on research-based evidence rather than on expert opinion or clinical experience alone. The methods describing evidence synthesis or development of guidelines in interventional pain management are scarce. OBJECTIVE: To describe the methods of evidence synthesis and development of guidelines in interventional pain management in practical terms. DESCRIPTION: This review sought to provide an understanding of evidence-based medicine, the importance and synthesis of clinical practice guidelines, and the variety of issues related to rating the quality of individual articles, understanding narrative and systematic reviews, grading the strength of the body of evidence, searching for evidence, and finally, the analytical preparation of guidelines, with a focus on interventional pain management. CONCLUSION: Evidence synthesis and development of guidelines in interventional pain management is a complex and difficult task. It is emphasized that practice guidelines are not intended as standards or absolute requirements. Consequently, practice guidelines may be adapted, modified, or rejected, according to the clinical needs and constraints of each practitioner and patient.

Journal Article↗

[Guidelines and practice of evidence based medicine].

This is a review paper with pedagogic goals in essence. The concept of guidelines is defined and the function and types of guidelines described. Different types of guidelines, such as normative, methodological and practice-motivated, are considered. The most common methods for the drafting of guidelines are presented. The difference between evidence-based guidelines and consensus-based guidelines is established and the importance of grading the strength of recommendations in guidelines, on basis of the validity of the evidence, is stressed. Finally, an update of the role of guidelines in the practice of EBM is put forward.

Evidence-Based Medicine↗

Use of anti-tumour necrosis factor agents in inflammatory bowel disease. European guidelines for 2001-2003.

The introduction of novel anti-tumor necrosis factor (TNF) agents has not only led to impressive new therapeutic opportunities but also resulted in uncertainty regarding their optimal use and possible side effects. Guidelines are presented here for the use of anti-TNF agents in gastrointestinal disorders. Experts were chosen from different European countries by an algorithm to avoid bias. An expert consensus on guidelines was established using a two-stage procedure of systematic Medline and abstract search for evidence and a qualifying meeting to derive recommendations. Detailed guidelines were developed for the use and the future clinical development of anti-TNF agents in inflammatory bowel disease. Grading of available evidence and grading of recommendations were performed according to AHCPR guidelines. At present infliximab is the only registered agent for Crohn's disease. Infliximab should be always used at a dose of 5 mg/kg. The guidelines define the indications both in refractory and in fistulating disease for the readministration and before surgery. Guidelines for safety and for concomitant treatments are given. Prospects, potential clinical use, and future directions for the clinical development of other anti-TNF agents are detailed. Clinical use of anti-TNF agents will be influenced by a large number of clinical trials being concluded in 2001 and 2002. It is likely that anti-TNF therapies will become an important long-term therapy for a proportion of patients with Crohn's disease. Biological agents will be followed by smaller and more stable, orally available compounds. These guidelines will be succeeded by a formal public consensus in 2002/2003.

Crohn Disease↗