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PubMed1999

Clinical economics in clinical trials: the measurement of cost and outcomes in the assessment of clinical services through clinical trials.

As the population ages and more expensive high-technology services become available, health care costs continue to spiral upward. Because the financial resources for health care are limited, economic analysis can help to evaluate expenditures and set priorities. Economic analysis of medical technology or medical care evaluates a medical service by comparing its dollar cost with its dollar benefit (cost-benefit), by measuring its dollar cost in relation to its outcomes (cost-effectiveness) as well as in relation to its utility or quality-adjusted outcomes (cost-utility), or simply by tabulating the costs involved (cost-identification). Direct costs are generated as services are provided. In addition, patients' productivity is affected, and these costs can be considered, especially in determining the benefit of a service that decreases morbidity or mortality. Intangible costs are those of pain, suffering, and grief. The point of view, or perspective, of the study determines the costs and benefits that will be measured in the analysis. Sensitivity analysis, which can evaluate the stability of the conclusions to the data used, is an important assessment within economic analysis. Economic analysis of new pharmaceutical therapies is increasingly being incorporated into clinical trials. Although there are some limitations of pharmacoeconomic information in clinical studies of drug safety and efficacy, these trials are often the only opportunity for economic data collection before adoption and reimbursement decisions are made. Validation after the drug has been introduced should complement economic information developed from clinical trials.

Clinical Trials as Topic↗

PubMed1993

Effects of time-in-clinic, clinic setting, and faculty supervision on the continuity clinic experience.

STUDY OBJECTIVE: To evaluate the effects of setting, type of supervision, and time in clinic on the resident continuity clinic experience. DESIGN: Prospective cohort with preintervention and postintervention measures. SETTINGS: Pediatric residents selected one of three clinic settings for their continuity clinic experience. These included a traditional, university-based clinic, private practice offices, and publicly funded community-based clinics. SUBJECTS: All pediatric residents at the University of Utah Health Sciences Center, July 1985 through June 1991. INTERVENTIONS: Using varied clinic sites, matching residents one or two to one with preceptors for their continuity clinic, increasing continuity clinic from 1 to 2 half-days per week. MEASUREMENTS AND MAIN RESULTS: Residents in private offices had the most varied experience, seeing more patients, more acute care, and a broader age range of patients than residents at other sites. They were more likely both to be observed by their preceptors during patient visits and to observe their preceptors delivering care. Because the number of patients seen per session rose, increasing continuity clinic time from one to two half-days per week more than doubled the number of patients seen per week. Increased time away from hospital did not affect scores on the Pediatric In-Training Examination. While test scores were similar for incoming residents, those in private offices scored higher on the final Behavioral Pediatrics Examination (P < .05). CONCLUSIONS: Clinic setting, time in clinic, and faculty supervision affect the quality of the continuity clinic experience. Increased time in clinic resulted in a broader exposure to patients. Residents placed in private offices had a more varied patient mix, were more closely supervised, and seemed to gain primary care skills more rapidly than residents at other sites.

Clinical Competence↗

PubMed2000

Benefiting from clinical experience: the influence of learning style and clinical experience on performance in an undergraduate objective structured clinical examination.

OBJECTIVE: To assess the relationship between clinical experience, learning style and performance in an objective structured clinical examination (OSCE) in medical students at the end of their first clinical year. DESIGN: Prospective study of undergraduate students taking an OSCE examination at the end of their first clinical year. SUBJECTS: 194 undergraduate medical students (95 male). MAIN OUTCOME MEASURES: Performance in the OSCE examination, the Entwhistle Learning Style Inventory1 and a composite self-reported score of clinical activity during the students first clinical year. RESULTS: Performance in the OSCE examination was related to well-organized study methods but not to clinical experience. A significant relationship between clinical experience and organized deep-learning styles suggests that knowledge gained from clinical experience is related to learning style. CONCLUSIONS: The relationship between clinical experience and student performance is complex. Well-organized and strategic learning styles appear to influence the benefits of increased clinical exposure. Further work is required to elucidate the most beneficial aspects of clinical teaching.

Adult↗

PubMed1999

[Need to establish academic research organization for cancer clinical trial and clinical research system having clinical investigators and study coordinators, with special reference to promotion of medical and life science research policy].

There are two types of cancer clinical trials in Japan. One is the therapeutic trial sponsored by a pharmaceutical company for approval of clinical use of new anticancer agent, and another is the clinical trial sponsored by an investigator for establishment of standard state-of-the-art therapy. Advances in cancer chemotherapy can not be achieved without active use of both types of cancer clinical trial. However, the infrastructure, such as academic research organization for cancer clinical trials and clinical research systems having clinical investigators and study coordinators, has not been sufficiently established. New GCP and the Drugs, Cosmetics and Medical Instruments Act are applied only to the therapeutic trials sponsored by pharmaceutical companies, but not to clinical trials sponsored by investigators. There is no National Research Act to cover both types of clinical trial. In this paper, the problems mentioned above are summarized, and a proposal to solve these problems is presented. The Medical and Life Science Research Policy of the Japanese Government should be improved to promote both basic and clinical research. The promotion of clinical research is essential for improvement in the quality of medical practice, appropriate changes in the medical security system, and activation of pharmaceutical science.

Biological Science Disciplines↗

PubMed1989

International Federation of Clinical Chemistry Education Division and International Union of Pure and Applied Chemistry Clinical Chemistry Division Commission on Teaching of Clinical Chemistry. Guidelines (1988) for training in clinical laboratory management.

Trainees in laboratory medicine must develop skills in laboratory management. Guidelines are detailed for laboratory staff in training, directors responsible for staff development and professional bodies wishing to generate material appropriate to their needs. The syllabus delineates the knowledge base required and includes laboratory planning and organisation, control of operations, methodology and instrumentation, data management and statistics, financial management, clinical use of tests, communication, personnel management and training, and research and development. Methods for achievement of the skills required are suggested. A bibliography of IFCC publications and other material is provided to assist in training in laboratory management.

Chemistry, Clinical↗

PubMed1991

[Clinical continuing education of younger physicians. A pedagogic trial with postgraduate clinical training using the clinical decision process].

The aim of this study was to improve the clinical training of the staff of a department of internal medicine. A total of 16 clinical pathological conferences with patient demonstrations were given. The doctor in charge of the conference motivated his choice of patient and made a critical review of the clinical decision process according to a 16 item check list. The median time used for planning of the presentation was five hours, range 2.5-8 hours. Sixteen of the participants (94%) found the training programme of very high or high quality while 1 (6%) found it less good. Fifteen (88%) of the doctors indicated higher clinical skill after than before the conferences (p less than 0.01). The registrars revealed a significantly better improvement of their clinical skills than did the senior registrars and consultants (p less than 0.05). The median educational value of the items of the check list was stated to be 1.3 (0-2). Statement of the probability of the final diagnosis of the patient, value judgement in clinical decisions and costs of diagnostic examinations were considered of highest educational value, 1.5-1.6. Postgraduate clinical pathological conferences with patient demonstrations including systematic reviews of the clinical decision process are valuable in the clinical training of doctors.

Clinical Competence↗

PubMed1997

Adherence in AIDS clinical trials: a framework for clinical research and clinical care.

Assessment of adherence within AIDS clinical trials is a critical component of the successful evaluation of therapeutic outcomes. Poor medication adherence can result in the misinterpretation of clinical trial data. Research on factors affecting adherence in AIDS clinical trials has been scarce, and few investigations have evaluated strategies for enhancing patient participation. One reason may be the absence of a conceptual framework to guide research. Consistent with previous research on medical adherence, we propose a framework whereby factors affecting adherence in AIDS clinical trials can be categorized as characteristics of the: (a) individual, (b) treatment regimen, (c) patient-provider relationship, (d) clinical setting, and (e) disease. This framework is used as a heuristic for reviewing studies that examine factors affecting adherence in AIDS clinical trials. Suggestions for future research and clinical intervention are provided. These efforts are timely because adherence is now the center of attention in discourse about the efficacy of the new class of protease inhibitor drugs; non-adherence has been linked to viral resistance and drug failure. Efforts to identify factors that influence adherence to AIDS clinical trials can inform future attempts to improve adherence and retention. Better adherence protects the scientific integrity of AIDS clinical trials, promoting more efficient and accurate evaluations of therapeutic value. Accelerated access to new treatments may follow, ultimately enhancing patient care.

Acquired Immunodeficiency Syndrome↗

PubMed2002

Clinical anatomy as the basis for clinical examination: development and evaluation of an Introduction to Clinical Examination in a problem-oriented medical curriculum.

Clinical anatomy is usually defined as anatomy applied to patient care. The question is asked whether students of a new horizontally and vertically integrated medical curriculum recognize the subject as the basis for clinical examination. A clinical anatomy practicum was developed in the special activity, "Introduction to Clinical Medicine," held in the second year of the Pretoria medical curriculum. The practicum was conducted on a station basis to anatomically prepare the student for the inspection, palpation, percussion, and auscultation of the cardiovascular, respiratory, abdominal, and urogenital systems. A total of 23 stations consisting of eight cardiovascular, seven respiratory, and eight abdominal/urogenital stations were designed. Standardized patients, cadavers, skeletons, prosected specimens, x-rays, computed tomography (CT) scans, magnetic resonance imaging (MRI), multimedia programs, and clinical case studies were used as resources. A Likert-type questionnaire was used for student evaluation of the practicum. Most students realized the importance of surface anatomy for a family physician. More than two-thirds thought the practicum improved their understanding of the anatomical basis for clinical examination. The minority of students were stimulated to do further reading on clinical examination. The students' response to their ability to integrate the clinical examination with the radiological anatomy was average. Most students were continuously aware of the appropriateness of the practicum for their future career. We conclude that medical students recognize the importance of anatomy as the basis for clinical examination when exposed to an appropriate integrated presentation format.

Anatomy↗

PubMed2002

Predictive validity and estimated cut score of an objective structured clinical examination (OSCE) used as an assessment of clinical skills at the end of the first clinical year.

BACKGROUND: Assessment plays a key role in the learning process. The validity of any given assessment tool should ideally be established. If an assessment is to act as a guide to future teaching and learning then its predictive validity must be established. AIM: To assess the ability of an objective structured clinical examination (OSCE) taken at the end of the first clinical year of an undergraduate medical degree to predict later performance in clinical examinations. METHODS: Performance of two consecutive cohorts of year 3 medical undergraduates (n=138 and n=128) in a 23 station OSCE were compared with their performance in 5 subsequent clinical examinations in years 4 and 5 of the course. RESULTS: Poor performance in the OSCE was strongly associated with later poor performance in other clinical examinations. Students in the lowest three deciles of OSCE performance were 6 times more likely to fail another clinical examination. Receiver operating characteristic curves were constructed as a method to criterion reference the cut point for future examinations. CONCLUSION: Performance in an OSCE taken early in the clinical course strongly predicts later clinical performance. Assessing subsequent student performance is a powerful tool for assessing examination validity. The use of ROC curves represents a novel method for determining future criterion referenced examination cut points.

Clinical Competence↗

PubMed1996

Relationships between students' clinical experiences in introductory clinical courses and their performances on an objective structured clinical examination (OSCE).

PURPOSE: To elucidate the link between the quantity and quality of clinical exposure gained by first-year clinical students in hospital settings and their performance on a subsequent comprehensive assessment of clinical skills (the objective structured clinical examination, or OSCE). METHOD: Data relating to educational activities and workload were collected for the second introductory clinical attachment undertaken by 152 (of 246) students in two British medical colleges prior to a joint comprehensive 22-station OSCE administered in May 1994. Pearson correlation coefficients were used as the main analytical tool to study the relationships between measures of clinical activity and total OSCE scores. RESULTS: In general, of 43 indices of the amount, nature, and quality of bedside, ward-based, or outpatient experience, only six correlated with OSCE scores. The strongest links were for whether students examined out-patients on their own (r = .2), whether the objectives had been made clear (r = .19) and the number of clinics attended (r = .18). Variables meeting the criteria were entered into a backwards stepwise regression analysis to predict total OSCE scores, but they explained only 23% of the variance. CONCLUSION: The association between clinical experience and educational outcomes remains poorly understood.

Clinical Competence↗

PubMed1989

Guidelines (1988) for training in clinical laboratory management. International Federation of Clinical Chemistry (IFCC) Education Division and International Union of Pure and Applied Chemistry (IUPAC) Clinical Chemistry Division Commission on Teaching of Clinical Chemistry.

Administrative Personnel↗

PubMed1999

[Clinical guidelines as part of total quality management. Analysis of heterogenous treatment concepts of sepsis in various clinics with computer assisted generation, logical testing and complexity assessment of clinical algorithms].

Generation, local tailoring, implementation and evaluation of clinical guidelines is an integral part of quality management. Clinical guidelines are intimately related to the independency of physicians' decisions. By this the physicians should be responsible for guideline development and guarantee the use of adequate methods of total quality management and outcome assessment. Formal consensus finding and transparency of evidence are necessary to guarantee the use of guidelines. Clinical algorithms are highly formalized and they are well suited for generation and analysis by the software ALGO. Determination of complexity and comparison of the clinical contents of algorithms is done by the scores CASA (Clinical Algorithm Structural Analysis) and CAPA (Clinical Algorithm Patient Abstraction). In a study of 22 clinical departments on treatment management concepts in sepsis following anastomotic insufFiciency in colorectal carcinoma a considerable heterogeneity was shown using this program.

Algorithms↗

PubMed1994

[History of professionalization of modern clinical pharmacist (3). The birth of clinical medicine and clinical pharmacy].

At the end of eighteenth century and the beginning of the nineteenth century clinical medical and clinical pharmaceutical teaching was organized according to the reformation of the medical system in French Republic. Michel Foucault said in the book "Naissance de la clinique." -- "To all appearance, it was simply reviving, as the only possible way of salvation, the clinical trandition that had been developed in the 18-century. But it was fundamental experience, because, unlike the 18-century clinic, it is not a question of an encounter, after the event, of a previously formed experience and an ignorance to be dissipated. It is a question, in the absence of any previous structure, of a domain in which truth teaches itself, and, in exactly the same way, offers itself to the gaze of both the experienced observer and the naïve apprentice; for both, there is only one language: the hospital, in which the series of patients examined is itself a school."--(M. Foucault, 1963) Clinical pharmaceutical teaching started in the central pharmacy and in the hospital pharmacies in Paris with the rule of 4. ventose in year X. This was the birth of Clinical Pharmacy Practice as a new fundamental experience in France.

Clinical Medicine↗

PubMed1985

Definition of clinical pharmacy as a specialty in clinical practice. Committee on Clinical Pharmacy as a Specialty. American Pharmacy Association.

Specialty credentialing has been discussed extensively and debated within pharmacy for more than ten years. Within the profession, there now appears to be a consensus on the need for and appropriateness of acknowledging professional practice areas as unique, defined entities. However, there remain substantive differences on how the definition of specialty practice should be constructed. One approach is to identify practice areas by functional activity (e.g., nuclear pharmacy, drug information) and/or therapeutic focus (e.g., psychopharmacy, clinical pharmacokinetics). A second approach is to define clinical pharmacy as a specialty practice that would, at least initially, coalesce clinical practitioners with the common denominator of an active role in the therapeutic decision-making process. The following document was developed by the Committee on Clinical Pharmacy as a Specialty (CCPS). The CCPS is independent of any formal organizational affiliations. It will serve as the preface to a petition that will be submitted to the Board of Pharmaceutical Specialties requesting recognition of clinical pharmacy as a specialty. The intention of the committee is to resolve the question of specialty status for clinical pharmacy through the Board of Pharmaceutical Specialties' review process. It is then hoped that pharmacy can move forward on the important issue of specialty credentialing.

Certification↗

PubMed1979