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PubMed2002

Clinical practice guidelines. Managing oral anticoagulant therapy.

Clinical practice guidelines (CPG) provide recommendations based on the summary of large volumes of literature and expert opinion. They are not absolute care directives, but are intended to facilitate individualized decision making related to patient care situations. Each month this column reviews a CPG of direct relevance to clinical practice. Readers are urged to contact the author, Mary Jo Goolsby (mjgoolsby@aanp.org) with requests for reviews of specific clinical guidelines or submissions of manuscripts addressing major guidelines that readers have found helpful in their practice. The Clinical Practice Guideline column is designed to inform practitioners of the wide range of accessible and current recommendations on a myriad of clinical topics. The guideline reviewed this month is actually one part of a large report stemming from the Sixth American College of Chest Physicians (ACCP) Consensus Conference on Antithrombotic Therapy. The management of oral anticoagulant therapy is but one portion of the overall report, complemented and supported by other components, including a preceding chapter that summarizes the mechanisms of action, clinical effectiveness, and therapeutic range of oral agents. This CPG focuses on following issues: (a) initiating and maintaining dosage, (b) managing non-therapeutic dosages, (c) managing the agents during invasive procedures, and (d) recognizing and responding to adverse events. Special situations are discussed, including management of patients who are elderly or pregnant, and comparisons of the management in different models of care. There is in-depth discussion of the literature, accompanied by a summary of recommendations.

Anticoagulants↗
PubMedDate not supplied

Guidelines for the evaluation of instructional software by hospital nursing departments.

Hospital nursing departments are becoming more receptive to the use of computer assisted instruction to facilitate and augment educational requisites for both staff and client. Numerous guidelines exist for software assessment, but none has been devised specifically for the often inexperienced hospital nursing committee charged with software review. This paper introduces the Hospital Oriented Instructional Software Evaluation, guidelines developed specifically for hospital use.

Computer-Assisted Instruction↗
PubMed1997

How to write a scientific paper.

The essential requirements of a scientific paper are described although each journal publishes its own specific 'Guidelines for Contributors' which may differ to some extent from those required by other journals. It is essential to follow such guidelines and to check and recheck your paper.

Abstracting and Indexing↗
PubMed1996

The NIH Consensus Development Program. The evolution of guidelines.

The U.S. National Institutes of Health (NIH) Consensus Development Program (CDP) Guidelines have undergone some modifications over the program's 18-year history. They have never been published in archival form. This article reviews the evolution of the NIH CDP Guidelines and then presents the complete 1995 version.

Consensus Development Conferences, NIH as Topic↗
PubMed1998

Use of guidelines in primary care--practitioners' perspectives.

BACKGROUND AND OBJECTIVES: Concern about the inadequate take-up of guidelines in general practice has concentrated on problems arising from the process of their development and implementation. However, these perspectives fail to take account of the needs, attitudes and problems of GPs themselves. In this study we aimed to identify barriers to the use of guidelines and opportunities for tackling them, from the point of view of the GP, so that future guideline development and policy could be more sensitive to the needs of GPs in the environment in which they work. METHOD: Twenty in-depth semi-structured interviews were audiotaped with GPs from within the Avon Health Authority area, representing GPs with different backgrounds and working environments. The transcribed data collected were analysed using a grounded theory approach. RESULTS: Utilization of guideline information is complex. GPs' appraisals of the value of guidelines interact with prior knowledge and beliefs, practicalities of existing information storage and retrieval systems, and individual working practices. Conditions where guidelines are most likely to be referred to may be those either very rarely or very commonly presenting in general practice. Key issues for the uptake of guidelines in the consultation are: general preference for certain formats of presentation; reputability and ownership; use of guidelines in shared decision-making; scope for computer-based systems; and GPs' attitudes to time pressures on information-seeking in relation to tolerance of uncertainty. CONCLUSION: Local initiatives might usefully explore the possibilities of supporting development of guideline-retrieval systems customized for individual GPs or practices. Novel means of stimulating 'ownership' and demonstrating reputability should be sought. The analysis provides a framework for understanding the complexities of the processes of GPs' use of guidelines in practice which can be useful in explaining the results of trials of guideline effectiveness. Guideline implementation occurs in the context of conflicting pressures for clinical autonomy and professional standardization and quality improvement.

Attitude of Health Personnel↗
PubMed2000

Bioethics. Helsinki's new clinical rules: fewer placebos, more disclosure.

After 3 years of intense debate, medical researchers and ethicists have agreed on international standards that would dramatically tighten the rules for clinical research and put new limitations on the risks to which patients may be exposed. Meeting in Edinburgh, U.K., on 7 October, the general assembly of the World Medical Association voted to approve a revised version of the 1964 Declaration of Helsinki, the cornerstone of clinical research ethics, that reduces ambiguity in existing guidelines and could force changes in the design of future drug trials.

Bioethics↗
PubMed1998

Management of antiretroviral therapy.

In a very short period of time, availability of antiretroviral drugs has increased from one drug with very modest activity to 12 approved drugs with remarkable potency, particularly when used in combination. The additional availability of absolutely quantitative assays with a broad dynamic range to measure plasma HIV-1 RNA has dramatically changed the evaluation of these new antivirals and the management of patients infected with the human immunodeficiency virus (HIV). The approved antiretroviral drugs represent three novel classes including nucleoside analog reverse transcriptase inhibitors, non-nucleoside analog reverse transcriptase inhibitors as well as protease inhibitors. Clinical trials evaluating different combinations of these drugs have resulted in the generation of some basic guidelines for their appropriate use. These guidelines focus on using these drugs in complex, multidrug regimens with the ultimate goal to keep the viral burden, as measured by plasma viral RNA levels, as low as possible and for as long as possible on a drug regimen that is compatible with long-term tolerance and compliance. To maximize the potential of these new drugs and to avoid significant associated toxicities and drug interactions, the treating physician must be completely aware of the pharmacokinetics and unique antiviral properties of these drugs. This review focuses on these unique properties as well as provides general guidelines for their appropriate use.

Anti-HIV Agents↗
PubMedDate not supplied

United States pharmacopeia development of the Medicare model formulary guidelines.

Prescription drug formularies are a key element in prescription drug benefit management. The use of formularies can both increase the quality of prescribing and reduce the costs of prescription drug therapy. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 specified that an external agency, the United States Pharmacopeial Convention, Inc. (USP) through the Secretary of the United States Department of Health and Human Services develop model formulary guidelines for prescription drug plans. The model formulary guidelines are to assist individual drug plans in developing formularies that would qualify for participation in the Medicare Part D prescription program. The guidelines were developed through a Model Guidelines Expert Committee assisted by USP staff and following input from patient advocate groups, health care organizations, and pharmaceutical organizations over a period of 8 months (April 2004 to December 2004). The USP Model Formulary Guidelines organize prescription medications into 41 therapeutic categories (32 with associated pharmacologic classes and nine with no associated pharmacologic classes), 137 pharmacologic classes, and 146 unique therapeutic categories and pharmacologic classes.

Aged↗
PubMed2006

Quality assessment of sedation in intensive care.

BACKGROUND: In the intensive care unit (ICU), analgesia and sedation are used to improve the comfort and safety of patients undergoing intensive care therapies. However, continuous administration of sedatives prolongs the time on mechanical ventilation and ICU stay. These adverse effects can be reduced by clear definition of the goals of sedation combined with a sedation protocol. METHODS: The adherence to the local sedation guideline of a university affiliated ICU was monitored prospectively before and after intervention: reinforcement of the guideline. The primary endpoints of the study were the occurrence of daily interruption or tapering of sedation and achievement of the target Ramsay scale level (days: 2-3, nights: 3-4) according to the guideline. RESULTS: Comparing sedation before and after the intervention (166 and 170 ICU days), no significant differences were observed in the occurrence of daily interruption or tapering of sedatives, 94/129 (73%) vs. 109/139 (78%) of sedation days, nor in the Ramsay scale level during the day, 4 (3-5) vs. 4 (3-5), or in the night, 5 (4-5) vs. 5 (4-5), respectively. After the intervention, Ramsay scale recordings were made more frequently, 280/398 (70%) vs. 234/380 (62%) of the nurses' shifts (P < 0.01). CONCLUSION: Adherence to the local sedation guideline was not high, and no significant change was seen after this simple intervention. Continuous education and discussion on the desirable and undesirable effects of sedation, followed by multidisciplinary re-evaluation of the current guideline, are due in our unit.

Aged↗
PubMed1993

A critique of the AHCPR's "Preventing pressure ulcers--a patient's guide" as a written instructional tool.

Preventing Pressure Ulcers--A patient's guide was released by the Agency for Health Care Policy and Research (AHCPR) in May 1992. Using criteria suggested by Falvo (1985), Redman (1988), Ruzicki (1989), and others, the guide was critiqued to determine how it compared to existing criteria for evaluating written tools. The AHCPR guidelines does not meet all the criteria; suggestions for improvement are provided.

Educational Status↗
PubMed2000

[Guidelines Clearing House Statement "Hypertension". Summary and recommendations for a rational hypertension guideline in Germany].

BACKGROUND: In order to promote quality of hypertension management in Germany, a national hypertension guidelines clearing project was initiated in 1999 by the German Guidelines Clearinghouse. OBJECTIVES: To identify and review published German- and English language hypertension guidelines. To establish criteria for future guideline development and implementation. To familiarize stakeholders in Germany with state-of-the-art hypertension guidelines. To identify key topics for a future national evidence-based guideline. METHODS: Search procedure, formal appraisal: Systematic search using literature databases and English-/German-language databases, published between 1990 and 1999. Abstract screening of the search results according to the inclusion criteria (n = 132 of a total of 548 hits). Systematic guideline evaluation using checklist with predefined criteria. APPRAISAL OF GUIDELINES' CONTENTS: Peer review of guidelines with the following inclusion criteria: hypertension--general, German and English language, published later than 1994, original or primary guideline or update, issued for nationwide use. Peer review was performed by a multidisciplinary focus group of EBM experts (primary and secondary care physicians, clinical pharmacologist, clinical epidemiologist). None of these was involved in hypertension guideline development during the review period. DOCUMENTATION OF CRITICAL APPRAISAL RESULTS: Systematic documentation of methodological appraisal and peer review results using a structured abstract form. The focus group wrote a final report (clearing report) including methodological abstracts for each guideline, essential topics for a future German hypertension guideline based on examples from the appraised guidelines, comments and recommendations for health care policy markers in Germany. RESULTS: 11 out of 132 guidelines were in accordance with the formal minimal standard with a wide range range within the following domains: "description of the development process", "declaration of authors' independence", "explicit link between recommendations and the supporting evidence", "management options", "tools for implementation". None of the guidelines identified all the key identified by the focus group, such as: (1) definition of hypertension--epidemiology--health care problems--intended guideline users/goals, (2) blood pressure measurement, (3) medical history and physical examination, (4) case-finding/screening, (5) indications for referral, (6) risk-stratification, (7) diagnostic procedures, (8) therapeutic goals/indications for therapy, (9) nonpharmacological measures, (10), pharmacotherapy, (11) follow-up/patient education/motivation/compliance, (12) comorbidity, hypertension in childhood/elderly, pregnancy, (13) primary prevention, (14) quality assurance/quality management, (15) dissemination/implementation, (16) open questions/challenges for the future. SUMMARY POINTS: To improve the quality of hypertension management in Germany, the expert panel suggested to develop a national evidence-based guideline. This should follow internationally agreed criteria and procedures. The experts identified and reviewed 11 out of 132 hypertension, which might make useful contributions for a future German Hypertension guideline. The expert group identified 16 key topics for a national hypertension guideline.

Comorbidity↗
PubMed2002

The role of the UKEMS in the development of testing guidelines.

Twenty years ago UKEMS established a sub-committee to determine the minimal professional criteria that should be achieved to comply with mutagenicity testing requirements in the UK. Recommendations on the conduct of basic and supplementary tests were published in 1983 and 1984, respectively. Despite their local distribution, these recommendations had an impact around the world. Further guidelines for statistical evaluation of mutagenicity test data and revisions to the first two volumes followed. By the early 1990s the mood was for international harmonization rather than national or regional isolation. The processes by which UKEMS had achieved its testing recommendations in the 1980s and early 1990s were successfully employed in the International Workshops for Genotoxicity Testing, of which three have now been held, and made a significant impact on OECD guidelines and ICH guidance. Summary outcomes from the latest meeting (2002 Plymouth Workshop) are given.

Animals↗
PubMed1996

Duration of antibiotic treatment in surgical infections of the abdomen. Introduction--the different ways to reach consensus.

The many interrelated issues concerning administration of antibiotics following operations for abdominal contamination and infection were a powerful impetus to create this Discussion Forum in The European Journal of Surgery, which focuses on the duration of administration-a previously neglected topic. The guidelines presented herein are not based on previous randomised trials alone, nor are they prescribed by dictatorship of one person. Instead, they are proposed by a steering committee in the form of a table and are confirmed by consensus of many experts. The science of consensus has to be recognized in surgery. The Discussion Forum offers written judgements that provide more details than the usual Consensus Development Conference statements. It can be used for a nominal group process organized by sepsis trial groups and may be of value for a consensus-based treatment of individual patients.

Abdomen↗