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Technical standards and guidelines: venous thromboembolism (Factor V Leiden and prothrombin 20210G >A testing): a disease-specific supplement to the standards and guidelines for clinical genetics laboratories.

These standards and guidelines are designed primarily as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to this statement does not necessarily ensure a successful medical outcome. These standards and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the clinical molecular geneticist should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the laboratory record the rationale for any significant deviation from these standards and guidelines.

Factor V↗

CT brain scans after acute stroke: how far are we from meeting the Scottish intercollegiate guidelines network (SIGN) recommendations? Results from the year prior to guideline publication.

OBJECTIVE: To determine what proportion of patients admitted to Ninewells Hospital & Medical School in 1996 with acute stroke underwent CT brain scans and in what time frame. To decide if the targets set by the SIGN guidelines can be met, and if not, the reasons for this. DESIGN: Data from the Dundee Ninewells Stroke Register and the Computerised Radiology Information System were used to determine the timing of CT scanning in relation to stroke and admission. Notes were also reviewed to determine why CT scans had not been done in some patients. SETTING: Departments of Medicine and Radiology, Ninewells Hospital & Medical School Dundee. SUBJECTS: All patients admitted with acute stroke in the calendar year 1996. RESULTS: Two hundred and eighty six patients presented with acute stroke in 1996. Of these patients, 250 patients (87%) had a CT brain scan. Eighty three (29%) underwent CT brain scanning within 48 hours of the acute event. A total of 163 (57%) were scanned within a week. Two hundred and thirty three (81%) were scanned within three weeks. Thirty six patients were not scanned after their acute event and the reasons recorded are reviewed. CONCLUSIONS: Less than two-thirds of patients were scanned within the time interval of seven days recommended in the SIGN Guidelines for stroke management. Implementation of the current SIGN Guidelines will therefore, require reorganisation of the service to ensure that all patients receive scans within seven and preferably within two days and may have resource implication.

Adult↗

Optimisation of the antibiotic guidelines in The Netherlands. VII. SWAB guidelines for antimicrobial therapy in adult patients with infectious endocarditis.

The Working Party on Antibiotic Policy (Dutch acronym is SWAB) is a Dutch organisation that develops guidelines for in-hospital antimicrobial therapy of bacterial infectious diseases. This present guideline describes the antimicrobial treatment for adult patients with infective endocarditis. The choice and duration of antimicrobial therapy is determined by the infecting micro-organism, sensitivity of this micro-organism for antimicrobial therapy, location of the endocarditis, left-sided or right-sided, and presence of intracardial prosthetic material. In this guideline, the empirical therapy for endocarditis is discussed as well as the therapy for the most frequent causative organisms: streptococci, enterococci, staphylococci and HACEK micro-organisms.

Adult↗

API consensus guidelines for use of antiretroviral therapy in adults (API-ART guidelines). Endorsed by the AIDS Society of India.

With rational use of antiretroviral therapy (ART), human immunodeficiency virus (HIV) infection has been transformed into a chronic manageable illness like diabetes and hypertension. These guidelines provide information on state of art, evidence based approach for use of ART in Indian context. When to initiate ART? Antiretroviral therapy is indicated for all symptomatic HIV infected persons regardless of CD4 counts and plasma viral load (PVL) levels. In asymptomatic patients, ART should be offered when the CD4 counts < 200/mm3 and should be considered in patients with CD4 counts between 200-250/mm3. Therapy is not recommended for patients with CD4 count more than 350/ mm3. Involvement of patient in all treatment decisions and assessing readiness is critical before initiating ART. What to start with? A non-nucleoside reverse transcriptase inhibitor (NNRTI) based regimen is recommended for antiretroviral naïve patients. The choice between nevirapine and efavirenz is based on differences in adverse events profiles; cost and availability of convenient fixed dose combinations and need for concomitant use of rifampicin. A backbone of 2-nucleoside reverse transcriptase inhibitors (NRTIs) is combined with the NNRTI. Various combinations and ART strategies not to be used in clinical practice has been enlisted. How to follow up? Recommendations have been made for baseline evaluation and monitoring of patients on ART. These include guidelines on laboratory and clinical evaluation. A plasma viral load at 6 months after initiation of first-line ART is strongly recommended. Yearly estimation of lipid profile has been recommended. How to identify and manage ART failure? The guidelines recognize the issue of identifying ART failure late if only CD4 counts are used for monitoring. In the absence of resistance testing various second-line regimens have been enlisted. A boosted protease inhibitor based regimen is recommended in this situation to be combined with 2-NRTIs. Special situations Recommendations have been made for use of ART in HIV-TB, HIV-HBV, and HIV-HCV co-infected patients. In patients with active TB and a CD4 count < 200/mm3, initiation of ART is recommended as soon as the anti-TB treatment is tolerated. Efavirenz is the only ARV drug, which can be safely used with rifampicin. In pregnancy use of single dose nevirapine for reducing risk of mother to child transmission of HIV is not recommended, because of the risk of development of resistance. For post-exposure prophylaxis taking ART treatment history of the source patient is crucial in designing an effective regimen.

Acquired Immunodeficiency Syndrome↗

Development of sexually transmitted diseases treatment guidelines, 1993. New methods, recommendations, and research priorities. STD Treatment Guidelines Project Team and Consultants.

To develop the 1993 Sexually Transmitted Diseases Treatment Guidelines, experts from the Centers for Disease Control and Prevention reviewed the literature on sexually transmitted disease treatment, assembled tables of evidence, and listed key questions on therapeutic outcome: microbiologic cure, alleviation of symptoms, and prevention of sequelae and transmission. At a meeting with external experts, evidence was systematically assessed and guidelines developed. Quality of evidence for microbiologic cure was generally good for gonorrhea and chlamydia, poor for syphilis, and fair for most other diseases. Evidence on preventing sequelae and transmission was limited. The Guidelines include new recommendations for single-dose oral therapy of gonorrhea (cefixime, ciprofloxacin, and ofloxacin), chlamydia (azithromycin), and chancroid (azithromycin); outpatient therapy of pelvic inflammatory disease (ofloxacin and either clindamycin or metronidazole); and patient-applied therapy of genital warts (podofilox). Syphilis therapy did not change substantially. Several global issues that emerged during the development of the World Health Organization Recommendations for the Management of Sexually Transmitted Diseases also are discussed. This evidence-based approach clarified important treatment issues and the rationale for recommendations, and identified research priorities.

Anti-Infective Agents↗

Derivation of a clinical guideline for the assessment of nonspecific abdominal pain: the Guideline for Abdominal Pain in the ED Setting (GAPEDS) Phase 1 Study.

OBJECTIVE: The purpose of this study was to identify a clinical guideline for the evaluation of nonspecific abdominal pain (NSAP) using history, physical examination, laboratory analysis, acute abdominal series (AAS) radiographs, and nonenhanced helical computed tomography (NHCT) clinical predictor variables (CPVs). SETTING: The setting of this study was at an urban emergency department (ED) with 70,000 yearly visits. METHODS: This is an institutional review board-approved, prospective, observational study. The primary outcome variable was urgent intervention (UI), defined as a diagnosis requiring surgical or medical treatment to prevent death or major morbidity. Subjects underwent prompted history, physical, laboratory studies, AAS, and NHCT and were followed up to 6 months for ultimate diagnosis and outcome. CPVs were subjected to classification and regression tree analysis. RESULTS: One hundred sixty-five subjects were analyzed. Thirteen percent of subjects required UI within 24 hours of presentation; an additional 34% underwent elective interventions that mitigated morbidity or mortality. Four guideline models were generated. Model 1 consisted of history and physical, with a sensitivity of 25%, a specificity of 92%, a positive likelihood ratio of 3.17, and a negative likelihood ratio of 0.81. Model 2 consisted of model 1 with laboratory, with a sensitivity of 39%, a specificity of 88%, a positive likelihood ratio of 3.25, and a negative likelihood ratio of 0.69. Model 3 consisted of model 2 with AAS, with a sensitivity of 56%, a specificity of 81%, a positive likelihood ratio of 2.94, and a negative likelihood ratio of 0.54. Model 4 comprised all inputs, including NHCT, with a sensitivity of 92%, a specificity of 90%, a positive likelihood ratio of 9.2, and a negative likelihood ratio of 0.089. NHCT was the single most accurate CPV for UI. CONCLUSIONS: No clinical guideline was identified exclusive of NHCT that possessed adequate sensitivity for exclusion of UI. NHCT is a rational choice for decision support in the evaluation of NSAP and is likely the single most useful diagnostic adjunct available to augment the clinical evaluation.

Abdomen, Acute↗

The price of guidelines: revising the national guidelines for managing Australian women with abnormal pap smears.

Australia utilises nationally approved guidelines for managing women with abnormal Pap smears. The guidelines were recently revised using the process designated by the National Health and Medical Research Council. Revising the guidelines was protracted and controversial. This paper explores the reasons for the difficulties encountered and queries the cost of undertaking such work.

Australia↗

National curricular guidelines for third-year family medicine clerkships. The Society of Teachers of Family Medicine (STFM) Working Committee to Develop Curricular Guidelines for a Third-Year Family Medicine Clerkship.

In most U.S. medical schools, required clerkships in internal medicine, pediatrics, surgery, obstetrics and gynecology, and psychiatry are considered the core components of a student's clinical education. Because the specialty of family practice is not as well established in the medical school curriculum, the federal government is interested in promoting the specialty as part of its continuing efforts to increase the number of primary care physicians. Therefore, in August 1989 the Division of Medicine, Bureau of Health Professions, United States Department of Health and Human Services, awarded a purchase order to the Society of Teachers of Family Medicine to develop curricular guidelines for third-year family medicine clerkships. The authors represent the working committee that developed these guidelines. This paper describes the process used to develop the core curricular guidelines, presents the product of the curriculum development activities, and discusses dissemination, implementation, and further development activities.

Clinical Clerkship↗

The French clinical guidelines and medical references programme: development of 48 guidelines for private practice over a period of 18 months.

The French medical profession and health insurance organizations have jointly committed themselves to a concept termed the 'medical regulation' of care. They decided to promote the quality of health care, judging that an approach based on quality was the best option for reducing the increase in health costs. The Clinical Guidelines and Medical References programme was entrusted to ANDEM (Agence Nationale pour le Développement de L'Evaluation Médicale). Fifty working groups (669 experts) and 50 reading groups (1643 experts) met from June 1994 to November 1995 to produce guidelines. Learned societies were involved to propose experts. Hospital practitioners, doctors who specialized in the topic in question and those who did not had equal representation in the groups. The method consisted of a review of the literature to determine the level of scientific evidence. ANDEM's Scientific Council suggested modifications to the groups and agreed to disseminate 48 of the 50 texts. Careful observation of the operation of the groups identified factors that can positively influence the nature of the discussions and help avoid conflict: an abundance of high-quality literature, an understanding of clinical research methodology, the existence of guidelines from different institutions or different countries tending towards the same conclusions, good initial work carried out by the chairperson and the project manager, a limit to the number of questions asked of the group, the chairperson having good people skills and meeting-management skills, and an absence of professional and financial consequences for the participants. Good management of working groups is an additional factor in ensuring success. The regulatory medical references programme has led to changes of behaviour within the medical profession.

Consensus Statements as Topic↗

Revision and establishment of Japanese drinking water quality guidelines for di(2-ethylhexyl) phthalate, toluene and vinyl chloride -- differences from the latest WHO guideline drafts.

The revision of the Japanese drinking water quality guidelines was established in May 2003. The WHO drinking water quality guidelines for the 3(rd) edition were also revised and the draft has been open to the public since last year. Most guideline values of each chemical in both Japan and WHO were quite similar; however, there are different overt values for three chemicals. In this short communication, we describe them and discuss the reason for taking the different toxicity endpoints and derivation method for these three chemicals, di(2-ethylhexyl) phthalate, toluene and vinyl chloride.

Diethylhexyl Phthalate↗

Practice guidelines for cancer pain therapy. Issues pertinent to the revision of national guidelines.

The high prevalence of pain in cancer patients has been appreciated for a long time. However, despite release of cancer pain management guidelines by the Agency for Health Care Policy and Research (AHCPR) in 1994, pain is still undertreated. Recent reports in the literature have identified multiple factors that influence analgesic response and pain management, such as the ethnicity, gender, and age of the patient. Recognition of these factors, and the availability of new drugs, alternative delivery methods, and an enhanced understanding of pain mechanisms and receptor pharmacology compel a revision of the existing cancer pain management guidelines. Assessment and management of pain and other symptoms in cancer patients that influence the quality of survival are increasingly being incorporated into randomized-controlled clinical trials. Strategies should be developed by the National Comprehensive Cancer Network (NCCN) to develop and implement extant and revised pain management guidelines into clinical practice and test new hypotheses regarding pain management treatments in clinical trials.

Analgesics↗

Americans with Disabilities Act (ADA) accessibility guidelines for buildings and facilities. Architectural and Transportation Barriers Compliance Board. Final guidelines.

The Architectural and Transportation Barriers Compliance Board is issuing final guidelines to assist the Department of Justice to establish accessibility standards for new construction and alterations in places of public accommodation and commercial facilities, as required by title III the Americans with Disabilities Act (ADA) of 1990. The guidelines will ensure that newly constructed and altered portions of buildings and facilities covered by title III of the ADA are readily accessible to and usable by individuals with disabilities in terms of architecture and design, and communication. The Department of Justice has proposed to adopt the guidelines as the accessibility standards for new construction and alterations in places of public accommodation and commercial facilities for purposes of title III of the ADA.

Architectural Accessibility↗

Guidelines for the microbiological quality of treated wastewater used in agriculture: recommendations for revising WHO guidelines.

Three different approaches for establishing guidelines for the microbiological quality of treated wastewater that is reused for agriculture are reviewed. These approaches have different objectives as their outcomes: the absence of faecal indicator organisms in the wastewater, the absence of a measurable excess of cases of enteric disease in the exposed population and a model-generated estimated risk below a defined acceptable risk. If the second approach (using empirical epidemiological studies supplemented by microbiological studies of the transmission of pathogens) is used in conjunction with the third approach (using a model-based quantitative risk assessment for selected pathogens) a powerful tool is produced that aids the development of regulations. This combined approach is more cost-effective than the first approach and adequately protects public health. The guideline limit for faecal coliform bacteria in unrestricted irrigation (< or = 1000 faecal coliform bacteria/ 100 ml) is valid, but for restricted irrigation < or = 10(5) faecal coliform bacteria/100 ml is recommended when adult farmworkers are exposed to spray irrigation. A limit of < or = 10(3) faecal coliform bacteria/100 ml is recommended if flood irrigation is used or children are exposed. The guideline limit for nematode eggs for both types of irrigation is adequate except when conditions favour the survival of nematode eggs and where children are exposed; in these cases it should be reduced from < or = 1 egg/l to < or = 0.1 egg/l.

Adult↗

[Guidelines in the management of Helicobacter pylori infection in Japan--in comparison with the guidelines published in other countries].

Helicobacter pylori(H. pylori) is a causative agent for chronic gastritis and is an important risk factor for peptic ulcers, gastric carcinomas, and gastric MALT lymphomas. In 2000, the Japanese Society for Helicobacter Research published a guideline on the diagnosis and treatment of H. pylori infection for physicians in routine medical practice. In this guideline, H. pylori eradication therapy is recommended in gastric or duodenal ulcer patients. H. pylori eradication is also recommended in gastric MALT lymphoma patients but the guideline says it should be done at specialist institutions. Considering the high prevalence of gastric carcinomas in Japan. H. pylori eradication for the prevention of gastric carcinomas should be discussed urgently.

Europe↗

[Marked similarity between the Dutch Institute for Health Care Improvement guideline 'Aspecific low back pain complaints' and the Dutch College of General Practitioners guideline 'Low back pain'].

The Dutch Institute for Healthcare Improvement's (CBO) guideline on the diagnosis and treatment of aspecific, acute and chronic, low back complaints corresponds in general to the Dutch College of General Practitioners' guideline with regard to the following topics: time-contingent treatment, restricted use of X-ray examination, and the options for non-medical treatment. A noteworthy exception in the CBO-guideline is the suggestion of manipulation of the spine as a possible treatment although there is no mention of proof of effectiveness.

Acute Disease↗

Clinical guidelines and the management of hypertension: a between-practice and guideline comparison.

It has previously been demonstrated that individual general practitioners (GPs) diagnose and treat at different levels of blood pressure and according to different risk factor profiles. This study sought to examine the variation in the achievement of control of hypertension in a sample of 20 treated hypertensive patients in 18 UK general practices. There was a marked between-practice variation in the percentage of patients with controlled hypertension. Practices appear to apply different hypertension guidelines to patients consistently, with significant correlations across practices in seven out of ten possible guideline combinations. There remains marked variation in the management of hypertension between different general practices in the UK. Factors other than recommendations in guidelines appear to be responsible for this variation.

England↗

Guideline-based standardized care is associated with substantially lower mortality in medicare patients with acute myocardial infarction: the American College of Cardiology's Guidelines Applied in Practice (GAP) Projects in Michigan.

OBJECTIVES: We sought to assess the impact of the American College of Cardiology's Guidelines Applied in Practice (GAP) project for acute myocardial infarction (AMI) care, encompassing 33 acute-care hospitals in southeastern Michigan, on rates of mortality in Medicare patients treated in Michigan. BACKGROUND: The GAP project increases the use of evidence-based therapies in patients with AMI. It is unknown whether GAP also can reduce the rate of mortality in patients with AMI. METHODS: Using a before (n = 1,368) and after GAP implementation (n = 1,489) cohort study, 2,857 Medicare patients with AMI were studied to assess the influence of the GAP program on mortality. Multivariate models tested the independent impact of GAP after controlling for other conditions on in-hospital, 30-day, and one-year mortality. RESULTS: Average patient age was 76 years, 48% were women, and 16% represented non-white minorities. The rate of mortality decreased after GAP for each interval studied: hospital, 10.4% versus 13.6%; 30-day, 16.7% versus 21.6%; and one-year, 33.2% versus 38.3%; all p < 0.02. After multivariate adjustment, GAP correlated with a 21% to 26% reduction in mortality, particularly at 30 days (odds ratio of GAP to baseline 0.74; 95% confidence interval [CI] 0.59 to 0.94; p = 0.012) and one year (odds ratio 0.78; 95% CI 0.64 to 0.95; p = 0.013), particularly in the patients for whom a standard discharge tool was used (1-year mortality, odds ratio 0.53; 95% CI 0.36 to 0.76; p = 0.0006). CONCLUSIONS: Embedding AMI guidelines into practice was associated with improved 30-day and one-year mortality. This benefit is most marked when patients are cared for using standardized, evidence-based clinical care tools.

Aged↗

Project of Polish guidelines for conducting pharmacoeconomic evaluations in comparison to international health economic guidelines.

We present the project of Polish guidelines for conducting economic evaluation and compare them with international health economic guidelines, highlighting areas of agreement and dissent. The Polish guidelines are very similar to those in Australia, Canada, and some European Union countries. Nevertheless a number of implementation and attitude problems seem to have delayed the introduction of pharmacoeconomic evaluation as a prerequisite for reimbursement of new pharmaceutical products. A transitional phase is required for collecting reliable cost data and familiarizing and training personnel both in public authorities and private industry.

Journal Article↗