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At least 235 records · Page 13Linked to original sources

Practical applications of viral fitness in clinical practice.

PURPOSE OF REVIEW: To review recent clinical data regarding viral fitness and its potential utility in clinical practice. Therapeutic failure of antiretroviral regimens is often due to the development of drug resistance. The viral loads achieved by these drug-resistant variants frequently remain suppressed below pretreatment levels. Furthermore, many patients with virologic failure continue to maintain stable CD4 counts and remain clinically well. One possible explanation for these observations is that the resistant virus that emerges during failure of highly active antiretroviral therapy is less fit than its wild-type counterpart as a result of the requirement to maintain resistance mutations that allow it to replicate in the presence of antiretroviral drugs. Since there are many patients with limited treatment options due to extensive resistance or drug toxicities, or both, there is intense interest in exploring the possibility that viral fitness can be exploited for clinical benefit. This review describes the assays that are used to measure fitness and replication capacity, and investigations of their utility in clinical practice. RECENT FINDINGS: A number of methods have been developed to measure viral fitness. Replication kinetic and competitive culture assays are accurate, but labour and time intensive. The availability of a rapid, single-cycle recombinant assay that measures viral replication capacity presents the possibility that assessments of viral fitness could be incorporated into clinical management. The replication capacity assay appears to correlate with more standard measures of viral fitness, and recently accumulated data in both wild-type and drug resistant viral populations suggest that replication capacity describes an intrinsic characteristic of HIV-1. A number of investigations of the clinical utility of fitness and replication capacity assays have established correlations between these measurements and virologic and immunologic outcomes. SUMMARY: Much progress has been made in the past year in our understanding of viral fitness and replication capacity. Assays that measure these viral characteristics have the potential to expand the range of clinical strategies employed against HIV-1. Further investigations are needed to firmly establish the clinical utility of these assays.

Carbamates↗

Clinical practice guidelines in unstable angina improve clinical outcomes by assuring early intensive medical treatment.

OBJECTIVES: To determine the influence of clinical practice guidelines on treatment patterns and clinical outcomes in unstable angina and the effectiveness of guideline reminders on implementing practice guidelines, two groups of medium and high risk patients with unstable angina were compared. BACKGROUND: New guidelines have been published by the Agency for Health Care Policy and Research (AHCPR) for evaluating and managing patients with unstable angina. The impact of these guidelines to improve the quality of care has never been tested. METHODS: Group 1 included 338 consecutive medium or high risk patients admitted before publication of the AHCPR guidelines, and group 2 consisted of 181 consecutive similar risk patients admitted after institution of the AHCPR guideline reminders at this institution. Dissemination of clinical practice guidelines was ensured by a grand rounds lecture and by posting guideline reminders on all group 2 patients' charts within 24 h of admission. RESULTS: The two groups were similar in terms of most baseline characteristics, including hypercholesterolemia, diabetes, hypertension, smoking history, baseline ST segment depression and previous coronary artery bypass graft surgery. Group 1 patients were older (68+/-13 vs. 63+/-16 years, p = 0.001) and more frequently had a previous myocardial infarction (39% vs. 22%, p = 0.001). Group 2 patients more frequently required intravenous nitroglycerin to control the index episode of chest pain (43% vs. 34%, p = 0.003). Group 2 patients more frequently received aspirin (96% vs. 88%, p = 0.009) during admission and underwent coronary angiography (71% vs. 58%, p = 0.006). More importantly, group 2 patients received oral beta-blockers (p = 0.008), aspirin and coronary angiography (p = 0.001) earlier than group 1 patients and experienced recurrent angina (29% vs. 54%) and myocardial infarction or death less frequently (3% vs. 9%, p = 0.028). CONCLUSIONS: In unstable angina, clinical practice guidelines were associated with greater use of aspirin and coronary angiography and greater use and earlier administration of beta-blockers. Variation in drug use over time was also reduced. Objective improvement in clinical outcome was also noted. Thus, practice guidelines improve the quality of care of patients with unstable angina.

Adrenergic beta-Antagonists↗

The case for practical clinical trials in psychiatry.

OBJECTIVE: Clinical trials in psychiatry frequently fail to maximize clinical utility for practicing clinicians, or, stated differently, available evidence is not perceived by clinicians (and other decision makers) as sufficiently relevant to clinical practice, thereby diluting its impact. To attain maximum clinical relevance and acceptability, researchers must conduct clinical trials designed to meet the needs of clinicians and others who are making decisions about patients' care. The authors present the case for psychiatry's adoption of the practical clinical trials model, which is widely used in research in other areas of medicine. METHOD: The authors outline the characteristics and scope of practical clinical trials, give examples of practical clinical trials, and discuss the challenges of using the practical clinical trials model in psychiatry, including issues of funding. RESULTS: Practical clinical trials, which are intended to provide generalizable answers to important clinical questions without bias, are characterized by eight key features: a straightforward clinically relevant question, a representative sample of patients and practice settings, sufficient power to identify modest clinically relevant effects, randomization to protect against bias, clinical uncertainty regarding the outcome of treatment at the patient level, assessment and treatment protocols that enact best clinical practices, simple and clinically relevant outcomes, and limited subject and investigator burden. CONCLUSIONS: To implement the practical clinical trials model in psychiatry will require stable funding for network construction and maintenance plus methodological innovation in governance and trial selection, assessment, treatment, data management, site management, and data analytic procedures.

Adolescent↗

Development and use of evidence-based clinical practice guidelines for thyroid disease.

Clinical practice guidelines offer recommendations for optimizing health care. Guideline panels can rely on several methods for gathering information about current practice and synthesizing evidence that addresses specific questions. Clinical practice guidelines, including many that address thyroid disease, often rely on conventional narrative literature reviews and expert opinion rather than systematic evaluation of the published literature as the basis for their recommendations. This undermines the authority of practice guidelines and potentially results in disparate, invalid, or misleading recommendations. In contrast, incorporation of rigorous systematic reviews of literature and guidance by groups with multidisciplinary expertise decreases bias in evidence selection and increases precision of treatment effect estimates. Improved reliability and accuracy of evidence assessment, in turn, strengthens ultimate guideline recommendations. Cost-effective analyses further contribute to useful clinical practice guidelines and may encourage the explicit acknowledgment of values and preferences. Valid recommendations, however, prove futile in the absence of implementation. Adherence to guidelines may be improved with integration of user-friendly computer applications into clinical practice. By overcoming barriers to implementation and addressing the limitations of current guidelines, endocrinologists can play an essential role in improving the quality, efficiency, and cost-effectiveness of clinical practice related to thyroid disorders.

Endocrinology↗

Epilepsy--success in clinical practice: translating trials to practice.

Success in clinical practice results from the combination of a clinician's experience, an understanding of patient preferences and factors that influence patient perceptions, and careful interpretation of data from clinical trials. However, successful clinical trials fulfil rigid methodological requirements in order to provide a basis from which to evaluate the place of a drug within a therapeutic strategy. Their translation into practice is therefore complicated by an intrinsic tension between the requirements for scientific methods that minimize error, and the need for clinically relevant data. In practice, the clinician has the flexibility to individualize epilepsy management to maximize benefits and minimize adverse effects of antiepileptic drug (AED) therapy. AED adverse effects and psychiatric comorbidity, in particular depression, have a profound impact on subjective health status; systematic screening for these confounding variables can guide clinical management and optimize quality of life. In addition, patient preferences can be acknowledged in any management plan. To achieve success in clinical practice, we need to remember that the information gleaned from clinical trials provides only part of the picture and needs to be augmented by our clinical experience, patient assessment (including routine screening for adverse effects and depression) and patient preference.

Anticonvulsants↗

[Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use].

In Germany, Directive 2001/20/EC is implemented by articles 40 to 42a of the Federal Drug Act and by the Decree on Good Clinical Practice. Pivotal provisions have been included into the Federal Drug Act, such as those aiming at the clinical trial subject's protection and defining responsibilities for the evaluation of applications as well as for pharmacovigilance and surveillance. The Decree comprises: relevant definitions; requirements for manufacturing, importation and labelling of investigational medicinal products; the procedures to obtain the ethics committee's opinion and the authorization from the competent authority on the trial application and on amendments thereof; documentation and information tasks of the investigator, sponsor and competent authority; rules for inspection to verify compliance with good clinical and manufacturing practice. Finally, the decree lists infringements within the meaning of article 97, paragraph 2, no. 31 of the Federal Drug Act, and lays down the necessary provisions for a transitional period and the entering into force of the new provisions.

Adverse Drug Reaction Reporting Systems↗

Standards and practice guidelines as the foundation for clinical practice.

The structure and organization of health care delivery are in the midst of rapid change. Health care providers from a variety of disciplines are being challenged to define their practice and the expected patient outcomes resulting from their processes of care delivery. Standards and clinical practice guidelines are important tools for enhancing the quality of health care delivery and for documenting care. The article describes a process for developing standards and clinical practice guidelines and presents an organizational scheme for them. Based on recommendations from diverse national groups, a format for practice guidelines is presented, and a system for implementation and ongoing evaluation is recommended.

American Nurses' Association↗

Positioning advanced practice nurses for financial success in clinical practice.

Advanced practice nurses (APNs) are well prepared for patient care, but not for the financial aspects of clinical practice. A lack of reimbursement knowledge and skills limits the prospects for APNs to be key players in business and practice ventures. Faculty are challenged to strengthen the advanced practice reimbursement component of the financial management core to promote the reimbursement competency of APNs. The author discusses 4 primary content categories that are critical to financial success in clinical practice.

Current Procedural Terminology↗

A review of quantitative studies of adherence to mental health clinical practice guidelines.

Mental health clinical practice guidelines have proliferated, but there is little evidence regarding the degree to which they are actually implemented in clinical practice. The goal of this study was to locate and review all peer-reviewed reports published through 2000 that provide quantitative information on rates of adherence to specific mental health guidelines. A literature search yielded 41 pertinent studies. These studies were of three types: 26 were cross-sectional investigations performed after the release of guidelines, six were conducted before and after release of guidelines without any specific intervention (pre/post), and nine involved a controlled trial of a specific intervention. Only 37% were conducted in the mental health specialty sector. Adequate adherence was found in 27% of the cross-sectional and pre/post studies but in 67% of the controlled trials. Successful interventions tended to be complex, involving system redesign or additional resources. Only six of 13 investigations (46%) that also measured patient outcome found that better outcome was associated with greater guideline adherence. Several studies showed that after cessation of interventions, adherence rates returned to preintervention levels. Thus, evidence indicates that guideline adherence is not high without specific intervention, but that certain interventions (typically multifaceted and resource-intensive ones) improve adherence. However, the public health challenge is to design and implement interventions that are sustainable in general clinical practice.

Attitude of Health Personnel↗

Molecular pathology of solid tumours: some practical suggestions for translating research into clinical practice.

"Molecular pathology" can be broadly defined as the use of genetic data, in addition to the standard pathological parameters, to optimise diagnosis and to indicate treatment and prognosis. The benefit to be gained from the exploitation of molecular techniques to provide additional information to aid patient management is potentially vast. Currently, molecular pathology is rarely used in clinical practice, although it is anticipated that it will eventually become a part of routine practice. However, incorporating molecular techniques into routine practice will not be straightforward because there are several issues to be resolved. Following on from a symposium held at the Royal College of Pathologists to discuss some of these issues, the establishment of a committee of molecular pathology is proposed to plan and coordinate the introduction of molecular pathology into routine clinical practice.

Congresses as Topic↗

Evaluating a formal evidence-based clinical practice curriculum in a neurology residency program.

BACKGROUND: Since 1998, the University of Western Ontario Evidence-Based Neurology Programme has been fostering life-long self-teaching, self-evaluation, and promoting improvement of the care of neurological patients by teaching neurology residents to practice Evidence-Based Clinical Practice (EBCP). DESIGN/METHODS: Using a questionnaire/survey we evaluated participation during EBCP sessions and the applicability of EBCP to current and future clinical practice. Also, using a rating scale we investigated how likely our residents' and graduates' clinical practice has been influenced by the EBCP knowledge; and, if they were teaching these concepts to residents or medical students. The questionnaire was sent to all neurology residents and neurologists that graduated after implementation of the programme. RESULTS: All residents (100%) returned the survey/questionnaire, indicating that they attended the sessions consistently. Even though all respondents believed that the EBCP concepts were useful during their training, the concepts were infrequently utilized because of time constraints. On a scale of 1 to 10, they rated the influence to include EBCP concepts in their daily clinical practice as high (average: 6.8, S.D. 1.5). They all had frequent contact with medical students and non-neurology residents, but did not teach EBCP concepts to them on a consistent basis, because of time limitations. 10 (77%) out of 13 graduates returned the survey/questionnaire. They also believed the EBCP concepts were useful, but only used them when time allowed. They also rated the influence to include EBCP concepts in their daily clinical practice as high (mean 8.5, S.D. 1.2). Most graduates had frequent contact with trainees, but did not teach EBCP concepts to them on a consistent basis because of time constraints. Finally, all expressed the need to continue having this formal curriculum during residency. CONCLUSION/RELEVANCE: Although EBCP incorporated into the curriculum of a neurology residency programme increased neurologists and neurology trainees' confidence in knowledge of existing evidence, and reinforced the EBCP principles, these concepts were not used in daily clinical practice and were not taught to more junior trainees due to time constraints.

Academic Medical Centers↗

Clinical management protocols: the bedside answer to clinical practice guidelines.

TOPIC: Clinical Management Protocols for trauma patients. PURPOSE: The goals and process for developing and implementing Clinical Management Protocols are presented. Protocol development and the differences between clinical practice guidelines, critical pathways, and clinical management protocols are discussed. SOURCES: Published literature, experience, and clinical expertise. CONCLUSIONS: Utilizing annotated algorithms, the protocols are designed for and driven by patient care based on patient need and require the collaboration of experts and trauma team members.

Algorithms↗