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PubMedDate not supplied

Public information about clinical trials and research.

Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

Clinical Trials as Topic↗
PubMed1997

Position statement: single-dose activated charcoal. American Academy of Clinical Toxicology; European Association of Poisons Centres and Clinical Toxicologists.

In preparing this Position Statement, all relevant scientific literature was identified and reviewed critically by acknowledged experts using agreed criteria. Well-conducted clinical and experimental studies were given precedence over anecdotal case reports and abstracts were not usually considered. A draft Position Statement was then produced and subjected to detailed peer review by an international group of clinical toxicologists chosen by the American Academy of Clinical Toxicology and the European Association of Poisons Centres and Clinical Toxicologists. The Position Statement went through multiple drafts before being approved by the boards of the two societies and being endorsed by other societies. The Position Statement includes a summary statement for ease of use and is supported by detailed documentation which describes the scientific evidence on which the Statement is based. Single-dose activated charcoal should not be administered routinely in the management of poisoned patients. Based on volunteer studies, the effectiveness of activated charcoal decreases with time; the greatest benefit is within 1 hour of ingestion. The administration of activated charcoal may be considered if a patient has ingested a potentially toxic amount of a poison (which is known to be adsorbed to charcoal) up to 1 hour previously; there are insufficient data to support or exclude its use after 1 hour of ingestion. There is no evidence that the administration of activated charcoal improves clinical outcome. Unless a patient has an intact or protected airway, the administration of charcoal is contraindicated.

Administration, Oral↗
PubMedDate not supplied

Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature.

A large number of taxonomies are used to rate the quality of an individual study and the strength of a recommendation based on a body of evidence. We have developed a new grading scale that will be used by several family medicine and primary care journals (required or optional), with the goal of allowing readers to learn one taxonomy that will apply to many sources of evidence. Our scale is called the Strength of Recommendation Taxonomy. It addresses the quality, quantity, and consistency of evidence and allows authors to rate individual studies or bodies of evidence. The taxonomy is built around the information mastery framework, which emphasizes the use of patient-oriented outcomes that measure changes in morbidity or mortality. An A-level recommendation is based on consistent and good quality patient-oriented evidence; a B-level recommendation is based on inconsistent or limited quality patient-oriented evidence; and a C-level recommendation is based on consensus, usual practice, opinion, disease-oriented evidence, or case series for studies of diagnosis, treatment, prevention, or screening. Levels of evidence from 1 to 3 for individual studies also are defined. We hope that consistent use of this taxonomy will improve the ability of authors and readers to communicate about the translation of research into practice.

Algorithms↗
PubMedDate not supplied

BI-RADS classification for management of abnormal mammograms.

The Breast Imaging Reporting and Data System (BI-RADS), developed by the American College of Radiology, provides a standardized classification for mammographic studies. This system demonstrates good correlation with the likelihood of breast malignancy. The BI-RADS system can inform family physicians about key findings, identify appropriate follow-up and management and encourage the provision of educational and emotional support to patients.

Breast Diseases↗
PubMed2005

War-related mental health problems of today's veterans: new clinical awareness.

1. Veterans of the military conflicts in Iraq and Afghanistan may have been exposed to significant psychological stressors, resulting in mental and emotional disorders. 2. Posttraumatic stress disorder (PTSD) is characterized by symptoms in three domains: reexperiencing the trauma, avoiding stimuli associated with the trauma, and symptoms of increased autonomic arousal. 3. Treatment of PTSD often requires both psychological and pharmacological interventions. 4. In addition to PTSD, other mental disorders may be precipitated or worsened by exposure to combat, including depression, anxiety, psychosis, and substance abuse.

Adaptation, Psychological↗
PubMed2001

Heart failure disease management: a team approach.

Patients with heart failure do better if they are treated in a formal heart failure disease-management program than if they receive standard care: their hospitalization rates and costs of treatment are lower, and their functional status is higher. The programs feature close coordination between primary care givers, subspecialty consultants, and nurses with specialty training in the nuances of heart failure management. Aggressive medical therapy must be coupled with patient education and rapid response to early identified problems. This article reviews the principles of heart failure disease-management programs and cites evidence that they are beneficial.

Adrenergic beta-Antagonists↗
PubMed2004

Impact of an electronic antibiotic advice and approval system on antibiotic prescribing in an Australian teaching hospital.

The impact of a computer-based infectious diseases electronic antibiotic advice and approval system ("IDEA(3)S") was assessed as an alternative to a labour-intensive, phone-based approval system. IDEA(3)S-based approvals replaced 48% of all approvals for the most frequently requested antimicrobial agents (ceftriaxone/cefotaxime, vancomycin) and were associated with stable overall rates of antimicrobial use. Antibiotic prescribing for community-acquired pneumonia was 76% concordant with IDEA(3)S recommendations, and clinical acceptance of IDEA(3)S was excellent. Successful implementation required a coordinated, evidence-based approach between clinicians, pharmacists and hospital administration, together with ongoing staff education and feedback of results. IDEA(3)S is a useful new adjunct to routine clinician consultation to support appropriate antibiotic prescribing for a number of common indications in hospitals.

Anti-Bacterial Agents↗
PubMed2003

Informatics training in pathology residency programs: proposed learning objectives and skill sets for the new millennium.

CONTEXT: To be successful in tomorrow's health care environment, to make the most appropriate decisions for their laboratories, to optimize training and continuing medical education opportunities, and to advance pathology as a professional specialty, pathologists must possess basic informatics knowledge and proficiency. Traditional areas of anatomic and clinical pathology residency training employ learning objectives, knowledge expectations, and skill sets, but such items have not been as well developed or widely implemented for pathology informatics training. OBJECTIVE: We present a proposal that defines a standard and specific set of learning (knowledge) objectives and skill set (proficiency) expectations for resident training in pathology informatics. DESIGN: The proposal includes a comprehensive and detailed set of knowledge applications and proficiencies that will assist residency programs in developing basic pathology informatics training for residents. The content of the proposal is based on and compiled from existing successful pathology informatics training programs. Learning objectives include those related to general and enterprise computing as well as objectives related specifically to pathology informatics. Skill set expectations include the ability to use software that facilitates and adds value to the work of pathologists, including the use of a laboratory information system and of productivity software and other tools. Other topics include guidelines for evaluating residents' informatics competency, suggestions regarding curriculum structure and implementation, and recommendations for residents' computing infrastructure. CONCLUSION: This proposal provides a foundation for building effective and standard curricula for residency training in pathology informatics. These curricula will be able to meet increasing expectations and needs for pathologists to contribute to clinical information management.

Clinical Competence↗
PubMed1996

Forum One: Current recommendations about intensification of metabolic control in non-insulin-dependent diabetes mellitus.

PURPOSE: To review issues about intensive management of non-insulin-dependent diabetes mellitus (NIDDM) and to formulate recommendations for goals and general approaches to implementation of intensive management. METHOD: A panel of clinical scientists and practitioners specializing in diabetes initially used a formal nominal process to identify the points of agreement on major issues. These points were further refined in a general conference discussion. CONCLUSIONS: 1) On the basis of data from intervention trials in IDDM that prove that intensive glycemic control reduces microvascular and neuropathic complications, coupled with epidemiologic and basic scientific data that support the strong likelihood of a similar benefit in NIDDM, the goal of treatment in NIDDM should be near-normal glycemia (glycohemoglobin level no higher than 1.0% above the upper normal limit); 2) glycemic targets should be adjusted individually according to clinical factors such as increased risk for hypoglycemia, advanced age, or reduced life expectancy from comorbid conditions; 3) some degree of comprehensive and repetitive instruction about diet and exercise and the use of blood glucose self-monitoring for all patients is essential to achieve the chosen targets; 4) intensive management of hyperglycemia should be instituted early and should initially emphasize diet and exercise therapy; staged introduction of oral hypoglycemic agents and finally insulin regimens of increasing complexity are recommended as needed to achieve glycemic targets; 5) comprehensive care must also include aggressive attempts to reduce cardiovascular risk factors (particularly hypertension, smoking, dyslipidemia, and obesity) as well as prevention of nephropathy and neuropathy; 6) the complex interaction among treatment regimens for hyperglycemia, dyslipidemia, obesity, and hypertension ideally requires a team approach, using a physician, diabetes educator, nurse, dietitian, and other health professionals; health insurers should make these resources available to generalists who currently care for most diabetic patients.

Blood Glucose↗
PubMed1996

Cholesterol screening in asymptomatic adults, revisited. Part 2.

OBJECTIVE: To assess the role of serum lipid levels as screening tests in adults. DESIGN: Pooled analysis of clinical trials, supplemented by analysis of data from the Framingham Heart Study, to estimate the effect of cholesterol reduction in patient groups stratified by cardiac risk. STUDY SELECTION: Published randomized controlled trials of cholesterol reduction, meta-analyses of such trials, prospective cohort studies of the association between cholesterol levels and morbidity and death related to coronary heart disease, and cost-effectiveness analyses of cholesterol reduction. DATA ANALYSIS: Two-stage logistic regression on cardiac risk factors and outcomes in the Framingham Heart Study. The first stage predicted the risk for death from coronary heart disease using standard risk factors but not cholesterol; the second stage predicted the risk for death from coronary heart disease and all causes as functions of age and cholesterol level, stratified by the risk predicted from the first stage. RESULTS: Randomized clinical trials show that cholesterol reduction confers survival benefits in patients with symptomatic coronary disease. In asymptomatic middle-aged men, who are at lower risk for death from coronary disease, cholesterol reduction prevents coronary disease but has not been shown to prolong life. The risk model based on analysis of the data from the Framingham Heart Study is consistent with the randomized trial data and shows that in the demographic groups excluded from trials, the hypothetical benefits of cholesterol reduction are greatest when the underlying risk for coronary disease is greatest. CONCLUSIONS: Screening with total cholesterol levels is most likely to be useful when done in populations at high short-term risk for dying of coronary heart disease, such as survivors of myocardial infarction and middle-aged men with multiple cardiac risk factors. In these populations, cholesterol reduction appears to be both effective and cost-effective. In other populations, the benefits of reduction are much smaller or are uncertain.

Adult↗
PubMed1997

Collaborative management of chronic illness.

In chronic illness, day-to-day care responsibilities fall most heavily on patients and their families. Effective collaborative relationships with health care providers can help patients and families better handle self-care tasks. Collaborative management is care that strengthens and supports self-care in chronic illness while assuring that effective medical, preventive, and health maintenance interventions take place. In this paper, the following essential elements of collaborative management developed in light of behavioral principles and empirical evidence about effective care in chronic illness are discussed: 1) collaborative definition of problems, in which patient-defined problems are identified along with medical problems diagnosed by physicians; 2) targeting, goal setting, and planning, in which patients and providers focus on a specific problem, set realistic objectives, and develop an action plan for attaining those objectives in the context of patient preferences and readiness; 3) creation of a continuum of self-management training and support services, in which patients have access to services that teach skills needed to carry out medical regimens, guide health behavior changes, and provide emotional support; and 4) active and sustained follow-up, in which patients are contacted at specified intervals to monitor health status, identify potential complications, and check and reinforce progress in implementing the care plan. These elements make up a common core of services for chronic illness care that need not be reinvented for each disease.

Chronic Disease↗
PubMed2000

Cultural and economic factors that (mis)shape antibiotic use: the nonpharmacologic basis of therapeutics.

The use of antibiotics in both ambulatory and inpatient settings is heavily shaped by cultural and economic factors as well as by microbiological considerations. These nonpharmacologic factors are relevant to clinicians and policymakers because of the clinical and fiscal toll of inappropriate antibiotic prescribing, including excessive use, preventable adverse effects, and the increasing prevalence of resistant organisms. An understanding of the determinants of antibiotic consumption is critical to explain current patterns of use and to devise programs to reduce inappropriate use. Patient motivations include the desire for a tangible product of the clinical encounter coupled with incorrect perceptions of the effectiveness of antibiotics, particularly in viral infections. Physician behavior can be explained by such factors as lack of information, a desire to satisfy patient demand, and pressure from managed care organizations to speed throughput. Marketing campaigns directed at both physicians and patients further serve to increase demand, especially for newer, costlier products. Studies of antibiotic use patterns in inpatient and outpatient care consistently demonstrate considerable inappropriate prescribing, which is likely to exacerbate the emergence of resistant organisms. Several approaches have been shown to improve the rationality of antibiotic use. Computer-based algorithms or reminders can prompt physicians to improve antibiotic choices at the time of prescribing; paper-based order entry forms can achieve the same goal. Interactive educational outreach ("academic detailing") is a practical implementation of social marketing principles to improve antibiotic use. Public education programs directed at consumers can help to reduce the inappropriate patient demand that helps to drive much improper antibiotic prescribing.

Anti-Bacterial Agents↗