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[The Ottawa ankle guidelines: analysis of their validity as clinical decision guidelines in the indication of X-rays for ankle and/or middle-foot injuries].

OBJECTIVE: To analyse the validity of the Ottawa ankle guidelines (OAG) as clinical decision guidelines in the indications of X-rays for ankle and/or middle-foot traumas in primary care. DESIGN: Observational, with application of the OAG and prospective measurement of the results.Setting. Hospital casualty. PATIENTS: Adults who attended casualty for ankle or middle-foot traumas between 1st June 1999 and 31th March 2000. Criteria for exclusion were: under 18, pregnancy, grave sensory and/or awareness disturbances, multi-trauma or multi-contusion patients, traumas over a week old, skin lesions as side-effects of the trauma, X-ray in other department, high inflammation or oedema hindering palpation of bone protuberances. MEASUREMENTS: Application of the OAG and X-ray on all patients, regardless of the result of the OAG. Calculation of sensitivity, negative predictive value, specificity and positive predictive value. RESULTS: 56 of a sample of 494 patients had a fracture (11.34%), 34 in the malleolus area (6.9%) and 22 in the middle-foot area (4.44%). OAG sensitivity was 96.43% (95% CI, 94.8-98). Negative predictive value was 97.22% (95.77-98.67). Specificity was 15.98% (12.75-19.21), and positive predictive value was 12.8% (9.86-15.74). CONCLUSIONS: The OAG are valid in primary care as guidelines to decide whether to request X-rays for patients with ankle or middle-foot traumas.

Adolescent↗

Prescription drugs; revocation of final guideline patient package inserts and withdrawal of draft guideline patient package inserts--Food and Drug Administration. Notice.

The Food and Drug Administration (FDA) is revoking the final guideline patient package inserts for 5 classes of drugs and is withdrawing the draft guideline patient package inserts for 5 other classes of drugs. Elsewhere in this issue of the Federal Register, the agency is revoking the regulations that established general requirements for the preparation and distribution of patient package inserts for prescription drug products. Those regulations had established a pilot program that would have been applied to 10 classes of drugs for 3 years. This notice revokes the draft and final guidelines which described how manufactures might comply with the regulations with respect to affected classes of drug.

Drug Labeling↗

Nephrolithiasis Clinical Guidelines Panel summary report on the management of staghorn calculi. The American Urological Association Nephrolithiasis Clinical Guidelines Panel.

The American Urological Association Nephrolithiasis Clinical Guidelines Panel recommendations for managing struvite staghorn calculi are based on a comprehensive review of the treatment literature and meta-analysis of outcome data from the 110 pertinent articles containing viable, unduplicated data. The panel concluded that the 3 most significant outcome probabilities are those of being stone-free, undergoing secondary unplanned procedures and having associated complications. Panel guideline recommendations for most standard patients are that neither shock wave lithotripsy monotherapy nor open surgery should be a first-line treatment choice but that a combination of percutaneous stone removal and shock wave lithotripsy should be used.

Humans↗

Diagnosis and management of osteoporosis in postmenopausal women: clinical guidelines. International Committee for Osteoporosis Clinical Guidelines.

The authors, all physicians involved in clinical research on bone and practicing clinicians, propose practical guidelines for identifying persons with osteoporosis or those at high risk of developing the disease and for managing patients who may benefit from therapy. These guidelines are based on an analysis of peer-reviewed articles published before November 1998. A flowchart of women who might benefit from treatment is provided, including clinical presentation (recent fracture of the spine, hip, or other bone or no fracture; risk factors for osteoporosis); relevant investigations (bone mineral density measurement and laboratory tests required for the differential diagnosis); and therapeutic management (general measures such as calcium and vitamin D supplementation and specific pharmacologic interventions such as estrogen, bisphosphonates, intranasal calcitonin, raloxifene, fluoride salts, and other compounds that have been assessed in randomized clinical trials). The strongest evidence for antifracture efficacy (reduction of vertebral and nonvertebral fracture risk) was observed with alendronate.

Adult↗

The impact of provider knowledge and attitudes toward national asthma guidelines on self-reported implementation of guidelines.

This study determines the impact of provider knowledge and attitude on implementation of guidelines: spirometry, peak flows, patient assessments, action plans, severity assessment, and anti-inflammatories. A self-administered survey conducted in academic family practice sites in Buffalo, NY assessed knowledge, self-reported use, and perceived usefulness. Knowledge was associated with regular use of peak flows (p = 0.048) and anti-inflammatories (p = 0.01). Positive attitude was associated with regular use of spirometry (p = 0.03), peak flows (p < or = 0.001), patient assessments (p = 0.02), action plans (p = 0.046), anti-inflammatories (p < or = 0.001), and severity assessment (p < or = 0.001). Perceived usefulness is critical to implementing asthma guidelines. Interventions to improve provider adherence must address attitude.

Adult↗

Towards more effective use of decision support in clinical practice: what the guidelines for guidelines don't tell you.

The Brisbane Cardiac Consortium Clinical Support Systems Program used multiple strategies in optimising quality of care of patients with either of two cardiac conditions. One of these strategies was the development and active implementation of decision support systems centred on evidence-based, locally agreed clinical practice guidelines. Our experience in undertaking this task highlighted numerous operational challenges for which solutions were difficult to extract from existing published literature. In the present article we provide a methodology grounded in both theory and real-world experience that may assist others in developing and implementing systems of guideline-based decision support.

Clinical Trials as Topic↗

Application of A.S.P.E.N. clinical guidelines: parenteral nutrition use at a university hospital and development of a practice guideline algorithm.

Few studies have attempted to implement the 1993 A.S.P.E.N. Guidelines into clinical practice. We retrospectively studied parenteral nutrition (PN) use over a 3-month period in 148 patients. Forty-three percent of PN starts lasted < or = 5 days. This short-term use of PN was more likely to occur when peripheral access for PN was used. Overall, short-term use of PN was found over a wide variety of diagnoses for a large number of reasons given in the medical record. Next, an algorithm was developed for the decision to initiate PN based on the 1993 A.S.P.E.N. Guidelines and was used to evaluate the use of PN. Several potential means for reducing overuse of PN were identified: using established criteria for malnutrition, restricting PN to known conditions in which the gastrointestinal (GI) tract cannot be used, and recognizing the transitory nature of many GI disorders.

Algorithms↗

Scientific application of sports medicine principles for acute low back problems. The Agency for Health Care Policy and Research Low Back Guideline Panel (AHCPR, Guideline #14)

The Agency for Health Care Policy and Research Low Back Guideline Panel (AHCPR, Guideline #14) truly brought to life sports medicine principles in the care of the most common and expensive musculoskeletal problem by focusing on the basic activity paradigm of musculoskeletal limitations. Twenty-three experts and seven international consultants led a review of over 10,000 abstracts and evaluation of over 4,600 articles. This effort was to establish scientifically how any clinician can: 1) safely be sure that the patient only has a back problem, 2) offer safe options for comfort, and 3) concentrate on the real treatment for an activity intolerance with sports medicine principles: activity, not rest, begets activity tolerance. Evidence tables and their subsequent derivation as "Finding and Recommendation Statements" provide an understanding of what medical science can and cannot presently support as predictable.

Clinical Trials as Topic↗

Practice guidelines for the clinical assessment and care management of Alzheimer's disease and other dementias among adults with intellectual disability. AAMR-IASSID Workgroup on Practice Guidelines for Care Management of Alzheimer's Disease among Adults with Intellectual Disability.

The AAMR/IASSID practice guidelines, developed by an international workgroup, provide guidance for stage-related care management of Alzheimer's disease, and suggestions for the training and education of carers, peers, clinicians and programme staff. The guidelines suggest a three-step intervention activity process, that includes: (1) recognizing changes; (2) conducting assessments and evaluations; and (3) instituting medical and care management. They also provide guidance for public policies that reflect a commitment for aggressive care of people with Alzheimers's disease and intellectual disability, and avoidance of institutionalization solely because of a diagnosis of dementia.

Activities of Daily Living↗

Food and Drug Administration proposed testing guidelines for reproduction studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration.

In the United States, the Food and Drug Administration (FDA) is the agency responsible for ensuring that the direct food additives and color additives used in food are safe for all consumers. In order to determine the safety of these additives for consumption, appropriate information and results from a series of tests must be made available to the agency. In 1982, in an effort to provide guidance to the food industry concerning the appropriate tests for the determination of safety, the FDA issued the Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Foods, commonly referred to as the Redbook. In 1993, based on the expansion of technology and the use of food additives, as well as the refinement of the scientific criteria for establishing safety, the FDA updated its guidelines and issued the draft Redbook II. Since Redbook II was issued, additional refinements have been made in the procedures for the multigeneration reproduction study and for the assessment of effects on male reproduction. The latest proposed guidelines for multigeneration studies are provided here.

Animals↗

Food and Drug Administration proposed testing guidelines for developmental toxicity studies. Revision Committee. FDA Guidelines for Developmental Toxicity and Reproduction, Food and Drug Administration.

The Food and Drug Administration (FDA) is the agency responsible for ensuring that the direct food additives and color additives used in food in the United States are safe for all consumers. In 1982, in an effort to provide guidance concerning appropriate tests, the FDA issued Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, commonly known as the Redbook. The Redbook included detailed guidelines for testing the effects of direct and indirect food and color additives on mothers and their developing fetuses. Based on refinements in safety assessment and risk evaluation as well as expansion of knowledge concerning the metabolism and pharmacokinetics of food and color additives, the need to revise and update the 1982 document became apparent. In 1993, Redbook II in draft form was made available for public comment. Since then, test end points and developmental landmarks have been refined. The latest proposed guidelines for developmental toxicity studies are provided here.

Animals↗

Use of personal digital assistant devices in order to access, consult and apply a corpus of clinical guidelines and decision-based support documentation like the Italian SPREAD Guidelines on stroke disease.

During the past few years, personal digital assistants (PDAs) have become widespread commodities, like computers and mobile phones. Many health-care providers, particularly physicians, routinely use PDAs in their everyday work. Accessing guidelines and clinical decision-based support tools, such as the downloadable version of the Italian SPREAD Guidelines represents one of the most important and common clinical applications. The current experience suggests that the need for best evidence models at the time of decision making is strong and that portable accessibility is critical: including just-in-time information systems that allow physicians to retrieve the best evidence at the point of care, and a standardized electronic health record (EHR) easily integrating into daily practice and is affordable to most family physicians.

Computers, Handheld↗

Teaching the theory behind guidelines: the Royal College of General Practitioners Guidelines Skills Course.

In the face of a perceived lack of widespread understanding of the theoretical issues underlying the development, dissemination and implementation of clinical guidelines, the Royal College of General Practitioners Guidelines Group developed a 2-day course aimed at teaching the theory in these areas. The course was targeted at potential opinion formers and ran on six occasions. Postal questionnaire assessment of the course revealed high levels of satisfaction with all aspects of the course and high levels of reported use of the knowledge gained. Further developments of the course are discussed.

Clinical Competence↗

Guidelines for assessing postnatal problems: introducing evidence-based guidelines in Australian general practice.

BACKGROUND: Postnatal morbidity is high, and many GPs lack the confidence and knowledge to deal with common postnatal problems. There is a high consultation rate, but few women disclose common health problems. OBJECTIVE: The aim of the present study was to increase the knowledge and skills of GPs to enable them to identify and manage common health problems experienced by women in the year following childbirth. METHODS: An educational programme [Guidelines for Assessing Postnatal Problems (GAPP)] embedded within a large randomized community intervention trial [Program of Resources, Information and Support for Mothers (PRISM)] with a before/after evaluation was undergone by Australian GPs working in four metropolitan and four rural communities. The programme comprised audit, interactive workshops, role-play and evidence-based guidelines, and was evaluated at baseline and 6 months through written questionnaires and a surgery consultation with a trained simulated patient evaluator. RESULTS: A total of 68 (86%) GPs took part in the full GAPP programme. The odds of a GP improving on the knowledge items ranged from 1.0 to 16, with the greatest change occurring in knowledge about the effectiveness of cognitive behavioural therapy for maternal depression. Of the GPs with an incorrect response at baseline, the percentage demonstrating improved knowledge at follow-up ranged from 22 to 100%. Around half of the GPs demonstrated excellent communication skills at baseline. Of the remaining GPs, more than half demonstrated greatly improved skills to detect common postnatal problems at follow-up. At baseline simulated patient visit, 70% of GPs inquired about sexual problems yet none inquired about the possibility of abuse, whereas at follow-up 94% inquired about sexual problems and 51.5% facilitated the disclosure of physical and emotional abuse. Anonymous feedback on the programme by participating GPs showed that 89% believed the programme positively influenced their actual practice. Interestingly, GPs demonstrated greater knowledge and skills in the simulated setting than on the written questionnaire. CONCLUSIONS: This relatively brief multifaceted educational programme assisted many participants in improving their knowledge and the skills required to improve both physical and emotional health after birth. Despite being experienced clinicians and participating actively in a programme on interviewing skills, half of the GPs did not facilitate disclosure of the underlying sensitive issue (abuse) during the follow-up consultation and could benefit from further in-depth training in effective communication skills.

Australia↗

Guidelines for the clinical use of electronic mail with patients. The AMIA Internet Working Group, Task Force on Guidelines for the Use of Clinic-Patient Electronic Mail.

Guidelines regarding patient-provider electronic mail are presented. The intent is to provide guidance concerning computer-based communications between clinicians and patients within a contractual relationship in which the health-care provider has taken on an explicit measure of responsibility for the client's care. The guidelines address two interrelated aspects: effective interaction between the clinician and patient, and observance of medicolegal prudence. Recommendations for site-specific policy formulation are included.

Communication↗

A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627].

BACKGROUND: A significant proportion of the health care administered to women in Latin American maternity hospitals during labor and delivery has been demonstrated to be ineffective or harmful, whereas effective interventions remain underutilized. The routine use of episiotomies and the failure to use active management of the third stage of labor are good examples. METHODS/DESIGN: The aim of this trial is to evaluate the effect of a multifaceted behavioral intervention on the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection of 10 International Units of oxytocin). The intervention is based on behavioral and organizational change theories and was based on formative research. Twenty-four hospitals in three urban districts of Argentina and Uruguay will be randomized. Opinion leaders in the 12 intervention hospitals will be identified and trained to develop and implement evidence-based guidelines. They will then disseminate the guidelines using a multifaceted approach including academic detailing, reminders, and feedback on utilization rates. The 12 hospitals in the control group will continue with their standard in-service training activities. The main outcomes to be assessed are the rates of episiotomy and oxytocin use during the third stage of labor. Secondary outcomes will be perineal sutures, postpartum hemorrhages, and birth attendants' opinions.

Journal Article↗

[Mapping the scientific evidence for bedside care to unstable angina. A preliminary step to develop clinical guidelines. The name of the study group CAMBIE Change in the Medical services based on the clinical practice guidelines].

BACKGROUND: The uncertainty in clinical practice arise from the need of physicians to make decisions on a limited ground of knowledges. Guidelines are supposed to facilitate clinical decisions in such circumstances. Sharing knowledges on natural history of diseases and clinical expertise allow to define and array of steps structured on a formal flow-chart. The node of algorithms identifies decisions to analyze. This paper presents a taxonomy of specific questions related to each decision nodes for management of unstable angina and assesses the level of evidence available for each question. MATERIAL AND METHOD: A flow chart diagram display the conceptualized key nodes for clinical management of unstable angina. A set of specific question related to clinical exclusive circumstances, diagnostic approach, utility of diagnostic procedures, definition of prognosis and outcomes was raised for each decision node. From a systematic literature review the best available evidence was gathered. Each recommendation was linked to a level (A-C) of evidence, and to a body of consensus expert panel decisions. RESULTS: 34 decision nodes were identified, related with at least 1 question for appraisal of the best evidence. The solution to these questions yielded 40 recommendations scored by the strength of the evidence available. Five recommendations of diagnostic, 20 at prognostic and 15 at therapeutic step. The strength of evidence was A for 73% of recommendations at therapeutic step versus 40% at the two other steps. CONCLUSIONS: A clinical complex problem can be displayed in a continuous process, to allow identification and appraisal of decisions at different clinical nodes. The work-up to achieve a conceptualization of a clinical problem is the preliminary step to develop clinical practice guidelines. Identification of decision nodes allows to manage uncertainty in a explicit way and make policy statement more acceptable by managers and physicians.

Algorithms↗

Guideline for the management of heart failure caused by systolic dysfunction: Part I. Guideline development, etiology and diagnosis.

Over the past decade, the conceptual understanding of heart failure has changed significantly. Several large clinical trials have demonstrated that pharmacologic interventions can dramatically reduce the morbidity and mortality associated with heart failure. These trials have extended the therapeutic paradigm for treating heart failure beyond the goal of limiting congestive symptoms of volume overload. This two-part article presents an evidence-based guideline to assist primary care physicians in evaluating and treating patients with heart failure. Part I describes the new paradigm of heart failure and offers guidance for diagnostic testing. Part II presents a treatment guideline.

Evidence-Based Medicine↗