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Exploring the continuum: medical information to effective clinical practice. Paper I: the translation of knowledge into clinical practice.

This paper investigates the translation of medical information into clinical practice and the role of thoughtful dissent by exploring the influence of sociological factors on change, the impact of evidence-based medicine (EBM), and the role of industry. Changing practice related to hormone therapy for menopausal and post-menopausal women provides context for this discussion. Medical change involves diffusion of ideas to potential users and ongoing reconciliation of new information with old ideas; this process is influenced by sociological factors including values and experiences, interpersonal relationships and local context. While EBM has alerted doctors to the importance of high quality research and theoretically provides a tool for translating research into practice, there are important problems with its application: (1) it has resulted in a reductionist approach to research and illness; (2) there is a considerable gap between research findings and the complex environment of clinical practice; and (3) EBM has been appropriated by experts, thus corporately developed 'standard-of-care' documents have become instruments of external regulation, and EBM has ceased to be a tool in the hand of individual clinicians. In addition, industry impacts the translation of knowledge by significantly influencing academia, researchers, medical publications, consensus conferences, and practising doctors. While questioning doctrinaire practices or directives is a daunting prospect for individual clinicians, the translation of knowledge into practice and evolution of medical thought is dependent on the progressive role of thoughtful dissent.

Biomedical Research↗

Finding and evaluating clinical practice guidelines.

Clinical practice guidelines are valuable, clinical decision-making aids for preventive, diagnostic, therapeutic, and palliative patient care. This article identifies ways to access clinical practice guidelines and discusses evaluative criteria for identifying gold-standard evidence-based practice guidelines. Finally, clinicians are reminded of crucial questions to ask before applying any guidelines to patient care.

Databases, Factual↗

Variation in clinical practice in genitourinary medicine clinics in the United Kingdom.

OBJECTIVES: This study was conducted to examine the variation in clinical practice in genitourinary medicine clinics in the United Kingdom in early 2002. METHODS: Questionnaires were sent to all 234 consultants in charge of genitourinary medicine clinics in the United Kingdom in March-May 2002. The questions concerned clinical practice in respect of asymptomatic patients presenting for an infection screen, and practice in respect of some specific sexually transmitted and other genitourinary infections. RESULTS: The test for infection least likely to be offered to heterosexuals is an HIV test (71% and 70% of clinics routinely offer this to male and female heterosexuals respectively). The practice of permitting "low risk" patients to telephone for their HIV results now extends to 24% of clinics. 34% of clinics do not require patients with non-specific urethritis to attend for follow up. 41% of clinics routinely ask patients treated for Chlamydia trachomatis to return for a follow up chlamydia detection test. 25% of clinics routinely offer two tests of cure to all patients with gonorrhoea. 6% of clinics do not routinely offer syphilis serology to heterosexuals. Other significant variations in clinical practice were documented. CONCLUSIONS: Overall, our findings indicate the need for further evidence to guide clinical practice and a wider knowledge and debate of national guidelines.

Ambulatory Care↗

Legal and practical impact of clinical practice guidelines on nursing and medical practice.

The Agency for Health Care Policy and Research's clinical practice guidelines on pressure ulcers establish the most effective and appropriate standard of care, based on current research. But the guidelines may not fit all patients in all circumstances. Practitioners should use the guidelines as a recommendation only, to avoid having the guidelines used against them in a malpractice case. Other ways practitioners can defend themselves include thorough documentation and close supervision when delegating tasks to other health care personnel.

Evidence-Based Medicine↗

Legal and practical impact of clinical practice guidelines on nursing and medical practice.

The Agency for Health Care Policy and Research's clinical practice guidelines establish the most effective and appropriate standard of care, based on current research. But the guidelines may not fit all patients in all circumstances. Two guidelines (on pressure ulcer prevention and treatment) are referred to in demonstrating potential legal risks. Practitioners should use the guidelines as a recommendation only, to avoid having the guidelines used against them in a malpractice case. Other ways practitioners can defend themselves include thorough documentation and close supervision when delegating tasks to other health care personnel.

Humans↗

Good clinical practice (GCP) standards: clinical trials in India. An interview with Dr. Urmila Thatte, Head of Clinical Pharmacology, TN Medical College & BYL Nair Hospital. Interview by Viveka Roychowdhury.

Dr. Urmila Thatte, Head of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai serves on several medical ethics committees. Viveka Roychowdhury interviews Dr. Thatte to get her views on the importance of ethics and adherence to Good Clinical Practice (GCP) standards.

Clinical Trials as Topic↗

[Good clinical practice. Requirements for clinical documentation on the introduction of new drugs].

Good clinical practice (GCP) includes protection of the involved patients/volunteers and quality of the clinical documentation which forms the basis for registration of a preparation. During recent years, guidelines for GCP have been presented from various quarters. These describe the requirements which must be fulfilled to document the effect and safety of a new preparation. The requirements comprise involvement of the investigator and also of the monitor and sponsor and ethical committees. In this article, the contents of the guidelines are reviewed and the significance these obtain of the involved parts in the clinical development of medicinal preparations.

Clinical Trials as Topic↗

Application of NKF-K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease: changes of clinical practices and their effects on outcomes and quality standards in three haemodialysis units.

BACKGROUND: The K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease was published in October 2003. The objective of this study was to analyse the effect of the application of those guidelines on clinical practices and on the achievement of bone disease targets and quality standards. METHODS: We included in the study 342 patients dialysed in our three HD units during 2003 and 2004. Starting October 2003, the K-DOQI recommendations were introduced into practice. Parathyroid hormone (PTH) was measured every 3 months and the serum Ca and P levels, monthly. In patients whose medications were modified, PTH was measured monthly and Ca and P levels, weekly or biweekly. RESULTS: The following are the main findings for 2004 (post-K/DOQI): an increased use of dialysates with a Ca concentration of 2.5 mEq/l (27.2-50.9%, P<0.001) and a reduced use of a dialysate calcium of 3.0 mEq/l (44.6-39.6%, P: NS) and 3.5 mEq/l (28-9.4%, P<0.001); a reduced use of calcium-based phosphate binders (891.9-565.5 mg Ca/day, P<0.001) and increased use of sevelamer hydrochloride (800 mg) (from 4.86 to 7.51 mg, tablets/day, P<0.001) lower serum Ca levels (9.7-9.4 mg/dl, P<0.01), and higher intact PTH levels (201.4-311.8 pg/ml, P<0.001), without changes in serum P levels; an increased proportion of patients with serum Ca levels within the K/DOQI target range (38.7-46.6%, P<0.01), resulting mainly from the reduced percentage of patients with hypercalcaemia (55-44.4%, P<0.01); a decreased proportion of patients with PTH<150 pg/ml (53.8-31.4%, P<0.001) but an increased proportion of patients with PTH>300 pg/ml, with no change in the proportion of patients with PTHs within the K/DOQI target range. Phosphorus levels and targets did not show significant differences between 2003 and 2004 (56.9-56.2%, P: NS). CONCLUSIONS: The only way to ensure that K/DOQI guidelines actually improve medical outcomes is to emphasize implementation strategies and also the scientific evaluation of their effectiveness in clinical settings. In spite of the application of the K-DOQI recommendations, a large proportion of our patients stayed outside the proposed targets, which points to the need for more effective therapeutic options.

Aged↗

The nurse lecturer role in clinical practice conceptualized: helping clinical teachers provide optimal student learning.

Despite the fairly wide reporting in the literature of the many roles of clinical supervision by the nursing teacher, little attention has been given to conceptualizing the relative priorities these roles take during the process of supervising nursing students in clinical practice. The purpose of this paper is to consider the manifestations and implications of conflicting roles when nurse lecturers undertake clinical supervision. Previously published research will provide working examples of issues in a conceptual framework for clinical teaching.

Clinical Competence↗

The impact of clinical practice guidelines and clinical trials on treatment decisions.

With increasing numbers of clinical practice guidelines (CPGs) becoming available to guide physicians, it is important to understand how guidelines are developed. Of importance, is evaluation of the scientific evidence on which guidelines are based, indeed whether the guideline is evidence based or based on expert opinion alone. This report will review in general, guideline development. The impact of CPGs, including expected outcomes, as well as potential harms is discussed. Clinical trials, meta analyses and CPGs relevant to the treatment of lung cancer are reviewed.

Antineoplastic Protocols↗

Principles of good clinical practice (GCP) in clinical research.

Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained.

Clinical Trials as Topic↗

[The Cologne Guidelines Conference: computer-assisted clinical practice guidelines in clinical diagnosis].

Eighteen clinical practice guidelines on interdisciplinary diagnostic issues were developed at the University Hospital of Cologne, Germany. The guideline committee is organized and directed by the quality control program, which also includes the local Cochrane initiative and a wide range of organizational topics. During guideline development, questions of differential diagnosis were addressed to the same extent as the organizational and financial realization. Broad consideration was given to medicolegal implications, but need for interspecialty cooperation was judged to be more critical and even more relevant in this regard. Guidelines were primarily developed as algorithms and translated to text versions secondarily. Critical steps in the decision tree were supported by rated literature and recommendations weighte by criteria as used in evidence-based medicine. For implementation, guidelines were presented to colleagues in a series of short lectures, as print versions containing all literature used in the developing process, and in hypertext format, which is accessible via intranet. Three levels of presentation were chosen in the html-version: algorithm, decision, and information. The former is due to orientation in the guideline, the second displays the binary question, and the latter makes the scientific background available, together with literature and links for more information. Efforts to check effectiveness are currently been made, questions of efficiency will be addressed in future.

Algorithms↗

Consumer contributions in developing clinical practice guidelines.

Clinical practice guidelines are designed for use with consumers. However, consumers are rarely consulted about their development. This paper describes a research project to develop clinical practice guidelines for a community meeting to prevent and intervene with assaultive behavior. The research included consumer input from psychiatric inpatients. The two-phase approach with the consumers included a focus group, followed by survey research. Results, problems, and recommendations are presented.

Boston↗

The development of evidence-based clinical practice guidelines. Integrating medical science and practice.

Practice guidelines are rapidly becoming preferred decision-making resources in medicine, as advances in technology and pharmaceutics continue to expand. An evidence-based approach to the development of practice guidelines serves to anchor healthcare policy to scientific documentation, and in conjunction with practitioner opinion can provide a powerful and practical clinical tool. Three sources of information are essential to an evidence-based approach: a) an exhaustive literature synthesis; b) meta-analysis; and c) consensus opinion. The systematic merging of evidence from these sources offers healthcare providers a scientifically supportable document that is flexible enough to deal with clinically complex problems. Evidence-based practice guidelines, in conjunction with practice standards and practice advisories, are invaluable resources for clinical decision making. The judicious use of these documents by practitioners will serve to improve the efficiency and safety of health care well.

Anesthesiology↗

[Good clinical practice].

Good clinical practice is the pattern of international standards to assure ethical and scientific quality in the design, conduction and report of studies that involve human beings. These standards are applied in pharmaceutical research, since they came out as regulations to register new medications. Nowadays, they are accepted as standard procedures in clinical research. They are enforced in developed countries since more than a decade and are currently being implemented in Latin America, thanks to an initiative of the pharmaceutical industries. The saturation and high costs of clinical research in Europe and United States, render Latin America as a potential region to conduct clinical studies. FDA, Europe and Japan accept data from abroad, if the studies are conducted following the norms of good clinical practice. It is therefore important that Chilean research centers and researchers become familiar with these norms and be prepared for their implementation.

Clinical Protocols↗

[Immunosuppressive therapy in clinical practice].

In clinical practice immunosuppressive therapy is performed by means of glucocorticoids in most patients. In addition, some patients are given alkylating agents (cytoxan, chlorambucil) or purine analogues (azathioprine). Recently a new immunosuppressive drug, cyclosporine A, has been developed. The mechanisms of action of these four compounds are discussed, for which purpose a simple model of the immunological network is presented. The present indications for the use of cyclosporine A in clinical practice are discussed.

Alkylating Agents↗