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PubMed2026

2025 Acute Coronary Syndrome Guideline: Missing the Boat on CYP2C19 Genotyping.

The 2025 American College of Cardiology/American Heart Association/American College of Emergency Physicians/National Association of Emergency Medical Services Physicians/Society for Cardiovascular Angiography & Interventions acute coronary syndrome guideline focuses on strategies to reduce bleeding risk with antiplatelet therapy yet lacks any recommendation related to CYP2C19 genotyping. The impact of CYP2C19 loss-of-function alleles on the effectiveness of clopidogrel is well documented, and although prasugrel and ticagrelor more effectively reduce the risk for atherothrombotic events compared with clopidogrel in patients with a CYP2C19 loss-of-function allele, clopidogrel reduces bleeding risk without an increase in atherothrombotic events compared with prasugrel or ticagrelor in those without a loss-of-function allele. Accordingly, an American Heart Association Scientific Statement supports CYP2C19 genetic testing before oral P2Y12 inhibitors are prescribed. This commentary summarizes the evidence in support of CYP2C19-guided P2Y12 inhibitor selection in the context of other 2025 acute coronary syndrome guideline recommendations and urges future guidelines to incorporate recommendations for CYP2C19 genotyping, especially for those at high bleeding risk.

Humans↗
PubMed1992

Clinical pathology for preclinical safety assessment: current global guidelines.

Regulatory guidelines for preclinical safety assessment studies of new drugs, chemicals, and food additives exist in many large industrial countries. Current guidelines include recommendations or requirements for clinical pathology testing. Many of the testing requirements are similar for every country, but others are not. The similarities and differences among several of the guidelines are discussed, and specific instances of ambiguous or inappropriate testing requirements are cited.

Animals↗
PubMed1992

Return to work after uncomplicated myocardial infarction: a trial of practice guidelines in the community.

OBJECTIVE: To evaluate the effectiveness of practice guidelines for return to work after acute myocardial infarction when disseminated from a university-based setting to a practice-based setting. DESIGN: Randomized clinical trial. PATIENTS: A total of 187 patients with uncomplicated acute myocardial infarction. INTERVENTION: Patients were randomly assigned to the intervention (n = 95) or to usual care (n = 92). The intervention consisted of a treadmill test, a counseling session based on the test results, and a consultation letter from a cardiologist to the primary care physician. Individualized recommendations for the timing of return to work, contained in the consultation letter, were based on the patient's risk for recurrent cardiac events. MEASUREMENTS: Questionnaire, chart review, and a phone interview documented the timing of return to work and the rates of cardiac death, coronary angioplasty, coronary artery surgery, and recurrent myocardial infarction. RESULTS: Median intervals between acute myocardial infarction and return to work were similar in both groups (intervention, 54 days; usual care, 67 days; P greater than 0.2). Among patients without myocardial ischemia, however, the interval was shorter in the intervention group than in the usual care group (38 days compared with 65 days, respectively, P = 0.008). Among patients with myocardial ischemia, intervals were similar in both groups (80 days compared with 76 days, respectively, P greater than 0.2). CONCLUSION: Practice guidelines developed in a university-based setting were not as successful in hastening return to work after uncomplicated acute myocardial infarction when tested in a practice-based setting. Physicians' reluctance to follow guidelines for patients with myocardial ischemia reflected their concern with prognosis even though medical outcome was good.

Adult↗
PubMed1992

Determination of reference intervals in the clinical laboratory using the proposed guideline National Committee for Clinical Laboratory Standards C28-P.

The Subcommittee on Reference Intervals of the National Committee for Clinical Laboratory Standards (NCCLS) has recently completed a proposed guideline, NCCLS Document C28-P, entitled "How to Define, Determine, and Utilize Reference Intervals in the Clinical Laboratory." This guideline document is an attempt to combine a concise set of procedures and recommendations, largely taken from the original literature, to form a standard, uniform, and reasonable protocol for determining population-based reference intervals. The intent of the guideline is to set forth the minimum requirements for the determination of a reliable and clinically useful reference interval. The subcommittee hopes the document will set a standard that upgrades the quality of reference intervals to a level worthy of their use in clinical medicine.

Female↗
PubMedDate not supplied

Utilization of medical services for the treatment of acute low back pain: conformance with clinical guidelines.

OBJECTIVE: To assess the utilization of diagnostic and therapeutic medical services for the management of acute low back pain in a primary care setting, and to determine whether such utilization conforms to suggested guidelines for the management of this condition. STUDY DESIGN: A retrospective chart audit of consecutive cases of acute low back pain. Specific elements of the diagnostic and therapeutic approach were judged appropriate or inappropriate based on comparison with published recommendations supported by the medical literature. SETTING: The primary care adult practice of a university-affiliated health maintenance organization. PATIENTS: One hundred eighty-three patients presenting with acute low back pain of musculoskeletal origin. MEASUREMENTS AND MAIN RESULTS: According to suggested guidelines for the care of acute low back pain, 26% of plain lumbar x-rays (10/38), 66% of computed tomography (CT) and magnetic resonance imaging (MRI) scans (12/18), and 82% (23/28) of subspecialty referrals were categorized as inappropriate. Among patients without indications for these services, 12% (10/85) had received lumbar x-rays, 7% (12/168) had received lumbar MRI or CT scans, and 14% (23/168) had received subspecialty referrals. Underutilization of these services had occurred in 71% (70/98) of patients with an indication for plain lumbar radiography, and 47% (7/15) of patients with potential indications for surgical referral or CT/MRI scanning. Neither overutilization nor underutilization had led to adverse outcomes or delays in diagnosis in this small sample. CONCLUSIONS: According to guidelines from the medical literature, the primary care physicians in this study both overutilized and underutilized diagnostic and referral services in cases of acute low back pain. It is necessary to determine whether underutilization of plain lumbar radiography adversely affects diagnostic accuracy and whether overutilization of other services improves important clinical outcomes, given the generally benign natural history of this condition.

Acute Disease↗
PubMed1979

Development of departmental promotion guidelines.

In making optimum use of its faculty, a medical school department should ensure that each faculty member has a clear understanding of what is expected of him and what will be evaluated when he is considered for reappointment or promotion. A set of departmental promotion guidelines which are available to all faculty can serve both these ends. In addition to defining the nature of the work which will be evaluated and stressing that performance quality is important, such guidelines should make explicit the various ways in which the work will benefit the department, the medical school, and the discipline. The guidelines can be used at the time of promotion, but they should also contribute to an ongoing evaluation of faculty work by the administration and by the faculty themselves.

Achievement↗
PubMed1975

Editorial: Guidelines for radioactive tracer studies of the heart and circulation. Report of the Inter-society Commission for Heart Disease Resources.

The Inter-Society Commission for Heart Disease Resources report concerning optimal resource guidelines for radioactive tracer studies of the heart and circulation is described. This report is an overview of the status of cardiovascular radionuclide diagnostic studies as well as a guideline to the hospital resources (physical and human) required for a high-quality nuclear medicine laboratory dealing with this area of study. These guidelines are directed to physicians and hospital administrators who are currently responsible for planning and organizing nuclear medicine programs or who anticipate a future need for such services in their community.

Cardiovascular Diseases↗
PubMed1979

Spinal metastasis: current status and recommended guidelines for management.

An overview of the current status of various aspects of spinal metastasis, including pathology, diagnosis, and management is presented. The cell type of the tumor, particularly with reference to its radiosensitivity, seems to be positively correlated with treatment outcome, regardless of the treatment modality. Because pretreatment neurological status also seems to influence prognosis, early identification of spinal involvement in patients at risk is important; therefore, a high index of suspicion in patients known to have cancer is necessary. The most useful warning of impending spinal cord or nerve root compression is spinal or radicular pain, which usually precedes neurological deficit by days to years. An aggressive diagnostic evaluation of pain symptoms is therefore warranted; this should include plain spine films and, in questionable cases, radioisotope bone scan. Myelography should also be considered in any cancer patient with persistent spinal or radicular pain, even in the absence of neurological deficit and certainly if there is any neurological impairment. Therapeutically, radiation and surgery continue as the mainstays of management, whereas steroids and chemotherapy serve as adjuvants. The guidelines for management recommended in this paper are to be viewed as tentative because the ideal treatment for spinal metastasis has not been established. The proposed guidelines are based on an analysis of retrospective studies that suggest that radiotherapy should be the primary mode of treatment and that surgery should be reserved for situations in which radiotherapy fails or where there is bony compression or spinal instability. Cases are presented to illustrate the application of these guidelines. (Neurosurgery, 5: 726--746, 1979).

Adolescent↗
PubMed1991

Development of guidelines for small scale genetic manipulation work.

The Genetic Manipulation Advisory Committee (GMAC) is the national body which reviews research and development work in Australia using genetic manipulation technologies. It supersedes and continues the work of the Recombinant DNA Monitoring Committee (RDMC). GMAC has recently drafted new guidelines for small scale laboratory work. The difference between these guidelines and the ones they have replaced is the broadening of the scope of work to be monitored, from recombinant DNA work to other genetic technologies which may also produce new combinations of inheritable genetic material. Experience from assessing proposals over the life of the RDMC and a previous Academy of Science committee enabled the GMAC Scientific Sub-committee to be more specific about the experiments it wanted to assess before they can begin, and those which could be safely exempted from the guidelines.

Animals↗
PubMed2026

Histoplasmosis in children: emerging insights and evolving guidelines.

PURPOSE OF REVIEW: This review provides an update on the epidemiology, risk factors, clinical presentation, diagnosis, and management recommendations incorporating recommendations from recent publications including the Infectious Disease Society of America guidelines for the management of pulmonary and disseminated histoplasmosis. RECENT FINDINGS: Updates to the epidemiology of histoplasmosis indicate a broader geographic range than historically defined. Updated guidelines do not recommend routine treatment for asymptomatic, mild and moderate pulmonary histoplasmosis although itraconazole can be offered for immunocompromised children or for prolonged or worsening symptoms. Liposomal amphotericin B is recommended as initial treatment for severe histoplasmosis syndromes (severe pulmonary and disseminated histoplasmosis). Fibrosing mediastinitis, a late complication of histoplasmosis is treated with stenting of vessels and bronchi. Recent studies demonstrate that rituximab (anti-CD20 monoclonal antibody) may stop progression or lead to regression of progressive fibrosis. SUMMARY: Histoplasmosis has manifold manifestations, many of which are self-limited and do not require treatment. Severe histoplasmosis and its complications should be treated with liposomal amphotericin B followed by itraconazole. Clinical trials are needed to assess the efficacy of rituximab for the treatment of fibrosing mediastinitis.

Humans↗
PubMed1992

National Asthma Education Program Expert Panel report: guidelines for the diagnosis and management of asthma.

1. Asthma, a chronic lung disease that affects 10 million Americans, is receiving increased attention as a public health problem due to increased occurrence and number of reported deaths. 2. This article presents an overview of the National Asthma Education Program Expert Panel guidelines, specifically addressing the definition and pathophysiology of asthma, effective management and control of asthma, and special considerations in asthma management. 3. Implications of the Expert Panel guidelines for occupational health nurses are addressed.

Asthma↗
PubMed1992

Cytogenetic guidelines for fragile X studies tested in routine practice.

Several organizations have proposed guidelines for fra(X) studies on peripheral blood lymphocytes. To evaluate these guidelines, we reviewed 1,033 consecutive specimens referred for fra(X) analysis. Each specimen was cultured with medium 199 and RPMI 1640 with 5-fluorodeoxyuridine or excess thymidine. The karyotype and expression of fra(X) were established from 20 GTL- or QFQ-banded cells and by screening of up to 130 more banded cells. We found anomalies other than fra(X) in 37 (3.6%) of the patients. We found 4% or more fra(X) cells in 38 (3.7%) cases from 36 unrelated families, including 33 (3.9%) of 850 males and 5 (2.7%) of 183 females. Another 4 females had 1 to 3% fra(X) cells. Six specimens were fra(X)-positive in only one stress system, and 32 were positive in 2 systems. To find the first 2 fra(X) cells in males, we needed to study up to 36 cells in 31 cases, 50 in one case, and 57 in another. To find the first 2 fra(X) cells in females, we needed to study up to 17 cells in 4 cases and 57 in another. A strong family history of fra(X) occurred in 5 patients, and each one was fra(X)-positive. Some manifestations of the fragile X syndrome occurred in 507 cases, 17 (3%) of which were fra(X)-positive. Abnormalities considered unlikely to be the fragile X syndrome occurred in 103 cases, 3 (3%) of which were fra(X)-positive. Use of chromosome breakage and fra(3)(p14) as quality control indicators of the fra(X) stress systems was found to be unreliable.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1992

Proposed guidelines for diagnosis of chromosome mosaicism in amniocytes based on data derived from chromosome mosaicism and pseudomosaicism studies.

Currently, accepted protocol which has been developed at the Prenatal Diagnosis Laboratory of New York City (PDL) requires that when a chromosome abnormality is found in one or more cells in one flask, another 20-40 cells must be examined from one or two additional flasks. Chromosome mosaicism is diagnosed only when an identical abnormality is detected in cells from two or more flasks. In a recent PDL series of 12,000 cases studied according to this protocol, we diagnosed 801 cases (6.68 per cent) of single-cell pseudomosaicism (SCPM), 126 cases (1.05 per cent) of multiple-cell pseudomosaicism (MCPM), and 24 cases (0.2 per cent) of true mosaicism. Pseudomosaicism (PM) involving a structural abnormality was a frequent finding (2/3 of SCPM and 3/5 of MCPM), with an unbalanced structural abnormality in 55 per cent of SCPM and 24 per cent of MCPM. We also reviewed all true mosaic cases (a total of 50) diagnosed in the first 22,000 PDL cases. Of these 50 cases, 23 were sex chromosome mosaics and 27 had autosomal mosaicism; 48 cases had numerical abnormalities and two had structural abnormalities. Twenty-five cases of mosaicism were diagnosed in the first 20 cells from two flasks, i.e., without additional work-up, whereas the other 25 cases required extensive work-up to establish a diagnosis (12 needed additional cell counts from the initial two culture flasks; 13 required harvesting a third flask for cell analysis). Our data plus review of other available data led us to conclude that rigorous efforts to diagnose true mosaicism have little impact in many instances, and therefore are not cost-effective. On the basis of all available data, a work-up for potential mosaicism involving a sex chromosome aneuploidy or structural abnormality should have less priority than a work-up for a common viable autosomal trisomy. We recommend revised guidelines for dealing with (1) a numerical versus a structural abnormality and (2) an autosomal versus a sex chromosome numerical aneuploidy. Emphasis should be placed on autosomes known to be associated with phenotypic abnormalities. These new guidelines, which cover both flask and in situ methods, should result in more effective prenatal cytogenetic diagnosis and reduced patient anxiety.

Amniocentesis↗
PubMed1992

An analysis of the U.S. Environmental Protection Agency neurotoxicity testing guidelines.

Few of the more than 65,000 chemicals listed in the Environmental Protection Agency (EPA) inventory have been tested for neurotoxicity. The nervous system may be especially vulnerable to toxicants because many compounds can cross the blood-brain barrier and induce irreversible damage. Additionally, the young, the elderly, and other sensitive populations may be particularly susceptible to neurotoxic injury. The EPA has developed guidelines including neurobehavioral, neuropathological, and neurochemical tests for the identification of possible neurotoxicants. In the present review, tests included in the current EPA guidelines for neurotoxicity testing are described and evaluated. The main benefit of the tests is that regulators are familiar with them, thus facilitating interpretation. Additionally, validation data on these tests are available for many known neurotoxicants. These factors make it difficult to introduce new methods that may include in vitro and other techniques. The current in vivo tests can be costly and prolonged and can involve the use of many laboratory animals, making them inappropriate for generalized use on existing chemicals. It is suggested that alternative tests be incorporated for screening of large numbers of chemicals and that testing priority be given to chemicals on the basis of structure/activity relationships, lipophilicity, bioaccumulation, and extent of exposure.

Animals↗
PubMed1992

Guidelines for safety evaluation of cosmetics ingredients in the EC countries.

The Scientific Committee on Cosmetology (SCC) of the Commission of the European Communities was established in 1978 to assist the Commission in the application of the 76/768 Directive, which regulates the production and marketing of cosmetics products. The Committee has been asked to update the general guidelines, defined in 1982, for testing cosmetics ingredients with the aim of ensuring consumers' safety. In the present paper the full document approved by the SCC in October 1990 is reported. This new document is based on the experience of the Committee over the last 10 years, during which more than 400 cosmetics ingredients have been evaluated. The document also highlights the need to proceed to define standard methods to be used to assess dermal absorption and phototoxicity--areas in which international guidelines have not yet been approved. The document also includes some comments made by the author in order to explain better the position of the Committee in relation to certain items.

Animals↗
PubMedDate not supplied

The ethics of resuscitation; differences between Europe and the USA--Europe should not adopt American guidelines without debate.

There are differences between Europe and the USA in the style of medical decision-making for patients who are critically ill or requiring CPR. These differences are both legal and philosophical. They concern principally the degree of influence the patient and next of kin should have on critical medical decisions. Currently American physicians transfer more of the decision-making to patients and relatives than do their European counterparts. The current state of the art in cardio-pulmonary resuscitation (CPR) from cardiac arrest occurring out-of-hospital requires public education programmes. These heighten public awareness of CPR-related questions. There has been a wide acceptance in Europe of the American guidelines for CPR. Cultural and legal differences, however, should encourage the acceptance of specific European guidelines. The author believes that it is important to introduce in the European CPR programmes discussions on the ethical dilemmas that may occur. This may help to conserve the relatively high level of public trust that facilitates the patient-doctor relationship in Europe, compared with the USA. Arguments are also put forward for a heightened sensitivity in the European medical profession concerning communication with the patients and their next of kin and with the mass media, in view of the increasing public sophistication and interest that the citizen CPR programmes are generating.

Cultural Diversity↗
PubMed1992

Presentation of drug prescribing guidelines and physician response.

Most Medicaid Drug Use Review (DUR) Programs disseminate prescribing practice guidelines by providing written reviews to physicians about specific prescribing practices that do not follow established criteria and inviting their comment. This study reviewed physicians' written responses to explore relationships between DUR communications and the degree to which these communications affect awareness of prescribing issues, increase knowledge, change erroneous beliefs, and generate intentions to apply the information appropriately. The form, content, and effective tone for all responses received in 1990 regarding five different drug therapy issues (N = 240) was recorded. Response rates, comprehension, counterarguments, and prescribing intentions varied by drug therapy issue. Attention to the communication process could improve the dissemination of prescribing practice guidelines by DUR Programs.

Attitude of Health Personnel↗