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At least 595 records · Page 33Linked to original sources
PubMed1995

Problems with the report of the Expert Panel on blood cholesterol levels in children and adolescents.

An Expert Panel convened by the National Cholesterol Education Program has recommended selective screening and treatment of children for high blood cholesterol levels, based on family history of cardiovascular disease or high blood cholesterol. This recommendation is problematic for several reasons. First, the recommended diets are likely to cause only a slight decrease in low-density lipoprotein cholesterol levels, the projected benefits of which will be offset by a similar decrease in high-density lipoprotein cholesterol levels. Lack of efficacy of the recommended diets could lead to use of more restrictive diets or to cholesterol lowering drugs. Second, even under optimistic assumptions, beneficial effects of cholesterol intervention will be small and delayed for many decades. As a result, childhood cholesterol-lowering efforts will not be cost-effective. Third, the Expert Panel's recommendations do not address important gender differences. Girls have higher average cholesterol levels than boys. They will therefore qualify for more dietary and drug treatment despite their lower age-adjusted risk of heart disease and the lack of association between cholesterol levels and cardiovascular mortality in women. Finally, recent evidence from randomized trials, cohort studies, and animal experiments suggests that cholesterol lowering may have serious adverse effects. This evidence was not discussed in the Expert Panel's report. Given current evidence, any screening and treatment of children for high blood cholesterol levels is, at best, premature.

Adolescent↗
PubMed1999

The importance of randomized clinical trials and evidence-based medicine: a clinician's perspective.

Clinical evaluation of therapies for patient care has evolved during the twentieth century from a variety of scientific methods. As a result of medical, political, and economic changes that occurred in the 1990s, randomized clinical trials and evidence-based methods are presently in the forefront of the physician's thinking in the decision-making process for therapeutic interventions. A new standard of patient care has emerged during this process. This report provides a clinician's viewpoint of the importance and interpretation of evidence-based methods and suggests a strategy when such evidence does not exist.

Cardiovascular Diseases↗
PubMed1993

Monitoring clinical trials: experience of, and proposals under consideration by, the Cancer Therapy Committee of the British Medical Research Council.

The accumulating data from all randomized trials conducted by the Cancer Therapy Committee (CTC) of the British Medical Research Council are monitored on a regular basis. However, for important practical reasons the form of this data monitoring may vary from trial to trial. Thus a trial addressing what is considered a major question in the treatment of cancer patients, (a 'pivotal' or 'high profile' trial), has a formal data monitoring committee (DMC). This is usually made up of two clinicians and one statistician who are completely independent of the trial organization and do not enter patients into the trial. Other trials, which constitute the majority, are monitored by a less formal trial progress group made up of the clinical co-ordinator and trial statistician, sometimes supplemented by a trial participant. Experience with this dual system has led to a new proposal: if the trial progress group wish to modify or stop a trial then they are required to set up and consult an ad hoc DMC for independent advice. This proposal has many advantages, including maximizing the use of resources available, while achieving the degree of objectivity in decision-making required for the many different types of cancer trials conducted by the CTC.

Clinical Trials as Topic↗
PubMed1992

Issues of concern in the standardization and harmonization of drug trials in Europe: health-related quality of life, ESCT meeting, Strasbourg, 23-24 May 1991.

Overviews of the development of the concept of quality of life from a medical viewpoint, and the need for new models and methods to assess health-related quality of life were presented, along with WHO, FDA and European regulatory viewpoints and a discussion on the measurement and valuation of health by social judgement, at the health-related quality of life session at an ESCT meeting on issues of concern in the standardization and harmonization of drug trials in Europe. It was concluded that, for the present, all three types of measurements of quality of life--individual, disease-specific, and generic scales--should be used in research to look for convergent versus divergent validity.

Clinical Trials as Topic↗
PubMedDate not supplied

Blueprint for a research career in general internal medicine.

An academic career in general internal medicine is a challenging but rewarding endeavor. The strategies for success require flexibility as the ground rules may change. Nevertheless, attention to the aforementioned principles will help the academic generalist to swim with sharks and survive, and simultaneously to promote the entire field of academic general internal medicine.

Employment↗
PubMed2002

Outstanding problems with response evaluation criteria in solid tumors (RECIST) in breast cancer.

BACKGROUND: In 1999 European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States and National Cancer Institute of Canada published Response Evaluation Criteria in Solid Tumors (RECIST) as a revision of the WHO criteria to achieve a unified, objective set of criteria for assessing antitumor activity. The present paper discusses breast cancer assessment using RECIST and discusses various outstanding problems in breast cancer therapy. METHODS: The subjects were 50 advanced/recurrent breast cancer patients who were eligible/completed cases and were registered in various clinical trials at Gunma Cancer Center from 1995-2000. The subjects were investigated with regard to the application of RECIST to evaluate the appropriateness and efficacy of the criteria for these patients, in comparison with General Rules for Clinical and Pathological Recording of Breast Cancer formulated by the Japanese Breast Cancer Society (JBCS). In addition, a study was conducted of the survival rate as a function of the initial site of metastasis in 258 recurrent cases. RESULTS: Of the 50 cases judged to be eligible by the JBCS General Rules, 16 cases (32%) were judged to be ineligible by RECIST. The results using the two sets of criteria were the same for CR and PD, while there were some differences in PR and SD/NC. CONCLUSION: To fully adopt RECIST for breast cancer, the following should be discussed further: (1) the exclusion of bone lesions (2) assessment of long NC (3) difference in survival by metastatic lesion site (4) eligible cases are reduced due to the exclusion of target lesions having a diameter of less than 2.0 cm.

Breast Neoplasms↗