The Oklahoma Lipid Research Clinic: research in cardiovascular disease through the Lipid Research Clinics Program.
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The authors describe their experience in carrying out clinical and psychobiological research in a therapeutic milieu setting. The clinical-research meeting, composed of clinical-care staff with secondary research responsibilities, researchers, and acutely psychotic patients, proved to be a useful mechanism for identifying and resolving inevitable problems at the clinical-research interface and enhanced the effectiveness of research implementation and patient care. The authors discuss three specific areas where covert issues threatened to undermine the work of the unit-the abrogation of research responsibility, the abrogation of clinical responsibility, and intergroup competition and envy.
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This paper presents a computerized data base management and information retrieval system for a heroin addiction research clinic, which has potential application for any type of clinical research. It describes data input checking programs, file structures, and output programs. The system contains several interesting features: built-in feedback error detection and correction; patient month matrix formatting and data compression; and a virtual blocking system to reduce the size of the files.
Cross-sectional age- and sex-specific plasma lipid distributions (means, medians and selected percentiles) are given for 48,431 white participants in visit 1 of the Lipid Research Clinics (LRC) Prevalence Study. This study consisted of two visits in which 10 LRCs screened participants selected from well-defined North American target populations that included a broad range of sociodemographic subgroups. These data confirm findings from earlier studies in developed countries, showing age-related differences in plasma lipid levels. However, for overall distributions, the LRC data showed slightly lower cholesterol and markedly higher triglyceride values than those previously reported for North America. Some variation in plasma lipid values was evident among the clinic populations. The large number of participants within most subgroups permitted a variety of analytic and comparative studies. For example, data from the large pediatric population revealed a drop in plasma cholesterol levels in adolescent males and females. Males aged 20--50 years had higher cholesterol levels than females in the same age group, and higher triglyceride levels between ages 20--70 years. Numbers were also sufficient for meaningful comparisons between lipid distributions of females who were taking sex hormones and those who were not: In females taking sex hormones, cholesterol and triglyceride levels were higher for subjects younger than 45 years, but slightly lower after age 45, than lipid levels in females not taking hormones.
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The place of clinical research in the veterinary profession is discussed against the author's personal experiences and in the context of how research workers, clinicians, teachers and veterinary students might be brought into a more cohesive unit through the development of a Faculty of clinical research and experimental medicine. It is argued that students should receive training in research and teaching and that efforts should be made to break down the attitude of "them" and "us" which tends to separate the clinicians and academics.
The Clinical Global Impression Scale (CGI) is a recognized rating scale for global clinical judgments comprising scores for disease severity, change of disease conditions, and a so-called "efficacy index." In this report, the authors subject the CGI to a methodological analysis. Thirty-seven physicians working in psychogeriatric wards were interviewed on 12 patients each with a DSM-III diagnosis of a dementia syndrome. After the physicians made global judgments on the patients with the CGI, "personal" assessment criteria were elicited. The CGI data were correlated in the statistical analysis with the physicians' assessments of the patients on their personal criteria and on "recognized" assessment criteria obtained from DSM-III-R diagnostic criteria for dementia syndrome. Interrater reliabilities between physicians and nursing staff as well as retest reliabilities for the CGI criteria were also measured. While the CGI-severity reflects primarily the cognitive aspects of dementia, the CGI global assessment of change of the disease condition was poorly correlated with the assessments based on "personal" or the recognized DSM-III-R criteria. This was also indicated by the result that the reliability scores for CGI-severity were high and did not vary greatly, whereas the reliability scores for CGI change showed wide confidence intervals.
This paper outlines an approach to studying productivity in clinical research programs that incorporates environmental, organizational, provider, and patient specific factors in the model of production process. We describe how this approach has been applied to the National Cancer Institute's (NCI) Community Clinical Oncology Programs (CCOPs). Next, a practical evaluative model of the productive process in CCOPs is outlined and its use in evaluation and monitoring performance in CCOPs is discussed. Each level of the model is described and a number of factors potentially affecting each level are explored. Finally, we discuss the strengths and weaknesses of this approach and show how management can use it to study and improve the productivity of clinical research programs.
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