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At least 199 records · Page 11Linked to original sources
PubMed1997

Is good clinical research practice for clinical trials good clinical practice?

This article presents results of monitoring of the recruitment process for a phase III study of a new antidepressant drug in elderly patients with depressive disorders, focusing on the peculiarities of recruitment posed by the presence of comorbidity and coadministration of medications. Data are derived from screening of 188 patients, the majority of whom lived at home, referred for trial inclusion. One hundred and seventy-one (91%) had Hamilton Rating Scale score in excess of 18 and met inclusion criteria. Only eight (4.2%) elderly depressed subjects could be recruited, after application of exclusion criteria. The trial data so obtained may be scientifically credible, but the conclusions reached by trials with very stringent exclusion criteria do not reflect the practice environment in which the product will be prescribed by clinicians. This raises questions of the relevance of good clinical research practice and good clinical practice guidelines to the reality of good clinical practice beyond the trial situation.

Aged↗
PubMed2000

Ethical aspects of clinical practice.

HYPOTHESIS: Clinical ethics is grounded in the belief that medicine is an inherently moral enterprise. Sick persons ask physicians to help them get better and physicians profess to be morally committed and technically competent to help the sick. DATA SOURCES: MEDLINE literature search and review of published works on medical ethics, and the references cited therein. STUDY SELECTION: Critical studies containing supporting evidence were selected. DATA SYNTHESIS: The central ethical aspects of modern medical practice are clinical competence, respect for patients and their health care decisions, and maintaining the primacy of patient's need in the face of external pressure in a changing social, economic, and political climate. There is a need to teach both the cognitive and behavioral aspects of ethics. Development of these skills, in turn, depends on the character of the physician who will be applying these skills. CONCLUSIONS: The outcome of patient care can be improved by efforts made to secure informed consent of the patient. This also helps avoid ethical conflicts, confusion, and misunderstanding between patients and physicians. Clinical ethics should be an integral part of medical education at all levels in medical school, in the residency, and in continuing education.

Clinical Competence↗
PubMed2001

Defining benefits and risks for SERMs in clinical trials and clinical practice.

Differences between clinical trials and clinical practice with respect to defining benefits and benefit/risk ratios for SERMs are discussed. These differences stem from the perception that there is discordance between the statistical significance and the "clinical meaningfulness" of research data in the minds of the practitioner and patient. One way that we can obtain data that are more clinically meaningful is to solicit input in the planning stages of clinical trials from practicing community clinicians and their patients. However, there are drawbacks to community input, such as potentially unrealistic expectations. A further issue is the need to characterize clinically meaningful drug benefits and acceptable benefit/risk ratios for a drug. Individual patients have differences regarding their views of optimal benefits and acceptable risks, so a method or tool for determining what is clinically meaningful would be helpful in presenting comprehensive information to the patient. To present useful information to clinicians, head-to-head comparisons of a new drug with a standard agent should be undertaken. NIH's support in this area of comparator trials is critical to their implementation. Estrogen has been considered the standard for comparison of agents for conditions associated with menopause in clinical trials. Estrogen has been the "gold standard" in clinical practice as well. In fact, challenging the position of estrogen, even where scientifically supported, has proven to be an uphill battle. In the practice setting, we elaborate the challenges of keeping up with the scientific literature and of then communicating this information in a fashion that is relevant to the individual patient.

Clinical Trials as Topic↗
PubMed2006

Clinical benefit of enoxaparin in patients with high-risk acute coronary syndromes without ST elevations in clinical practice.

In randomized clinical trials, low-molecular-weight heparin enoxaparin has been shown to decrease ischemic complications in patients with acute coronary syndromes (ACSs) without ST elevations who are treated conservatively. Enoxaparin has been shown to be equally effective as unfractionated heparin in high-risk patients with an early invasive approach. Little is known about the use and efficacy of enoxaparin in unselected patients with non-ST-elevation ACSs in clinical practice. In a retrospective analysis of the prospective ACOS registry, we compared the outcome of patients who were >60 years of age with non-ST-elevation myocardial infarction or unstable angina with ST-segment changes who were treated with enoxaparin or unfractionated heparin. In total, 4,806 patients (55%) with non-ST-elevation ACS fulfilled our inclusion criteria for this analysis; 1,178 (25%) were treated with enoxaparin and 3,628 (75%) with unfractionated heparin. There were no differences between groups in baseline characteristics. We observed a significant decrease in the combined end point of death or nonfatal reinfarction with enoxaparin in the entire study group (odds ratio 0.51, 95% confidence interval 0.37 to 0.70) and in subgroups treated with early percutaneous coronary intervention (n = 1,333, odds ratio 0.36, 95% confidence interval 0.17 to 0.80), coronary artery bypass grafting during the index hospitalization (n = 270, odds ratio 0.31, 95% confidence interval 0.04 to 2.42), or conservatively (n = 3,203, odds ratio 0.57, 95% confidence interval 0.40 to 0.81). There was no significant increase in severe bleeding complications with enoxaparin (5.2% vs 4.5%). In conclusion, in clinical practice, in unselected high-risk patients with non-ST-elevation ACSs who are treated conservatively or with early percutaneous coronary intervention, early treatment with enoxaparin is associated with a significant decrease in the combined end point of in-hospital death and reinfarction, without a significant increase in severe bleeding complications.

Aged↗
PubMed2006

Will screening colonoscopy disappear and transform gastroenterology practice? Threats to clinical practice and recommendations to reduce their impact: report of a consensus conference conducted by the AGA Institute Future Trends Committee.

The AGA Institute Future Trends Committee (FTC) developed this report based on a consensus conference it convened on April 1-2, 2006, in Washington, DC. The report was prepared for the FTC by Carol Regueiro, MD, a medical writer under contract to the AGA Institute, and Michael Stolar, PhD, staff liaison to the FTC. It was approved by the FTC on July 12, 2006, and accepted by the AGA Institute Governing Board on July 22, 2006. This report reflects the panel's assessment of information available at the time of the conference. Readers should view this report in the context of data that will continue to accumulate and facts that may change after its creation.

Colonoscopy↗
PubMed2002

The current status of home care nursing practice: part 1: clinical practice under PPS.

As part of our celebration of home care nursing and 's 20th year of publication, I considered how I could present a "snapshot" of current nursing practice since the prospective payment system (PPS) began October 1, 2000. Over the past year, I have asked many people what they've done to successfully respond to PPS. Although many have told me they have developed new programs, reinvented some approaches, and thoroughly transformed their agencies, NO ONE would agree to author an article on this subject. So, what's an editor to do? Become a Roving Reporter!

Home Care Services↗