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Biomedical subjects

C R Klimt

Publications and source records attributed to C R Klimt.

At least 19 recordsLinked to original sources

Emergency department duty: a training model for the future.

Air National Guard (ANG) medical units perform 2 weeks of active duty training each year to develop and maintain essential medical skills. Providing meaningful training is, however, a great challenge to both the Guard unit and its active duty counterpart. Too often, annual training is not a relevant learning experience and so the ability of some Guard medical units to respond to actual medical taskings is compromised. The 135th Tactical Clinic, an ANG medical unit, devised and implemented a unique plan--a plan particularly relevant to the medical support requirements of Operation Desert Shield.

Education, Medical, Continuing↗

Varied acceptance of clinical trial results.

The subject of varied acceptance of clinical trial results is discussed in the context of review of trials with which I have been involved and my subjective evaluation of their impact on the practice of clinical medicine. My experience goes back to 1949 and a World Health Organization trial of hyperimmune gamma globulin against rabies. This was followed by a large trial of secondary prevention of poliomyelitis. I participated in the planning and initiation of the first chronic disease trial, the University Group Diabetes Program (UGDP). The latter lasted for 15 years and its ramifications continue to this day. My next trial was the Coronary Drug Project (CDP), a complex trial with more than 8,000 patients. The trials of aspirin and aspirin combined with persantine (the CDPA, AMIS, PARIS I, and PARIS II) followed. My last three trials were a trial of photocoagulation in diabetic retinopathy (DRS), a six-country trial of the antiarrhythmic drug mexiletine (IMPACT), and a study involving two diagnostic procedures for pulmonary embolism (PIOPED). When one considers, in retrospect, the plethora of trials one is struck by the uniform absence of a priori considerations of the impact on medical practice, or likely lack thereof, of possible outcomes.

Anecdotes as Topic↗

Persantine-Aspirin Reinfarction Study. Part II. Secondary coronary prevention with persantine and aspirin.

In the Persantine-Aspirin Reinfarction Study, Part II (PARIS II), 3,128 persons who had recovered from myocardial infarction, suffered from 4 weeks to 4 months previously, were randomized into two groups: dipyridamole (Persantine) plus aspirin (n = 1,563) and placebo (n = 1,565). The average length of follow-up was 23.4 months. Prespecified primary end points were coronary incidence (definite nonfatal myocardial infarction plus death due to recent or acute cardiac event), coronary mortality (death due to recent or acute cardiac event) and total mortality, each at 1 year of patient follow-up and at the end of the study. Coronary incidence in the Persantine plus aspirin group was significantly lower than in the placebo group, both at 1 year (30% reduction) and at the end of the study (24% reduction). The statistically significant differences in coronary incidence, at 1 year and at the end of the study, in favor of the combination treatment remained after adjustment for multiple baseline variables and adjustment for multiple testing (three end points for two time periods). Although there were reductions for other end points, these differences were not statistically significant. Coronary mortality was 20% lower in the Persantine plus aspirin group compared with the placebo group at 1 year, and 6% lower overall. Total mortality in the treated group compared with the placebo group was 11% lower at 1 year and 3% lower overall. The reduced rates of coronary incidence largely reflected lower rates of definite nonfatal myocardial infarction in the Persantine plus aspirin group. Several subgroups were defined a priori and at the end of the study. The beneficial effect of Persantine plus aspirin compared with placebo for coronary incidence tended to be greater for the following groups of patients: those who had a non-Q wave infarct; those who were not taking digitalis; those who were receiving beta-receptor blocking drugs at baseline; those who were in New York Heart Association functional class I; those who had had only one myocardial infarction; or those who were enrolled in the study early, that is within 85 days of the qualifying myocardial infarction.

Actuarial Analysis↗

A transcribed emergency record at minimum cost.

We have developed a new method of implementing a transcribed emergency record at minimum cost. Dictated emergency records are typed immediately by a transcriber located in the emergency department. This member of the medical record transcriber pool is given other non-urgent medical record material to type when there are no emergency records to type. The costs are reduced to the same level as routine medical records transcription. In 1982, 19,892 of the total 28,000 emergency records were transcribed by adding only 1.35 full-time equivalents (FTEs) to the transcriber pool. The remaining charts were handwritten because insufficient funds had been allocated to type all emergency records. The transcriber is capable of typing a maximum of 64 charts, averaging 13 lines (156 words) each, per 8-hour shift. The service can be phased in gradually as funds for transcribing the emergency record are allocated to the central transcriber pool.

Cost Control↗

Secondary prevention of myocardial infarction with drugs.

Clinical trials in the field of secondary prevention of myocardial infarctions are reviewed, with emphasis on those studies that were randomized and included at least 100 patients. Standardized total mortality data, when available, are provided. Five groups of drugs are reviewed: 1) antiarrhythmic drugs, including studies of phenytoin, tocainide, mexiletine and aprindine. Important, commonly used drugs in this group, which apparently have not been submitted to clinical trials, include procainamide and lidocaine; 2) lipid-lowering drugs, including estradiol, conjugated equine estrogen, dextrothyroxine, clofibrate and nicotinic acid; 3) anticoagulant drugs, the oldest and most controversial preventive drug measure. In this group, only the oral drug derivatives of indandione or coumarin have been tested, and no appropriate studies of parenteral heparin were found; 4) platelet-active drugs--six studies dealing with aspirin alone, one combining aspirin and dipyridamole, and one study of sulfinpyrazone are reviewed; and 5) beta-adrenergic blocking drugs, including practolol and timolol.

Adrenergic beta-Antagonists↗

The conduct and principles of randomized clinical trials.

Some of the guiding principles as well as the pitfall of long-term randomized clinical trials are presented. Examples have been chosen from trials in the cardiovascular field. A typical long-term clinical trial is divided into five phases: planning, preparation, recruitment, clinical follow-up and termination, and finally analysis. Administrative, legal, and ethical aspects of a trial are discussed, as well as the cost of clinical trials. Organization patterns are described and some prevalent ones are criticized. Further, practical matters such as recruitment techniques, obtaining informed consent from the patients, determining drug dosage and formulation as well as the problem of interaction with nonstudy drugs are referred to. Adherence testing remains a problem, because of our inability to test for placebo adherence.

Clinical Trials as Topic↗

Terminating a long-term clinical trial.

Long-term clinical trials often include more than one active treatment group. These may be discontinued independently if found to be ineffective or possibly harmful. Certain subgroups of patients may be discovered, in the course of a clinical trial, who do not respond satisfactorily and are, therefore, excluded during the course of a trial. Yet another kind of termination comes when we have a therapeutic breakthrough or when hope has to be abandoned for demonstrating beneficial effects for one, several, or all treatments included in a trial. Examples from the authors' experience are presented, as are successful and unsuccessful techniques in managing terminations of various types.

Clinical Trials as Topic↗

Terminating a long-term clinical trial.

Long-term trials often include more than one active treatment group. These may be discontinued independently if found ineffective or possibly harmful. Certain subgroups of patients may be discovered, in the course of a clinical trial, who do not respond satisfactorily and are, therefore, excluded during the course of a trial. Yet anouther kind of termination comes when we have a therapeutic breakthrough or when hope has to be abandoned for demonstrating beneficial effects for one, several, or all treatments included in a trial. Examples from the authors' experience are presented, as are successful and unsuccessful techniques in managing terminations of various types.

Clinical Trials as Topic↗

Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. VII. Mortality and selected nonfatal events with insulin treatment.

The University Group Diabetes Program is a long-term prospective clinical trial designed to evaluate the effects of various hypoglycemic agents on vascular complications in patients with asymptomatic adult-onset diabetes. Mortality and blood glucose levels were determined as well as certain nonfatal events for patients assigned to diet alone or to either of two insulin treatment regimens. Lower levels of blood glucose with mean values close to normoglycemia were achieved in the treatment group in which the insulin dosage was adjusted to achieve normoglycemia compared with the levels achieved in patients treated with diet alone or with a fixed dose of insulin. In spite of differences in blood glucose levels among the treatment groups, there were only minor differences in the occurrence of fatal or nonfatal events.

Blood Glucose↗

Clinical trials in thrombosis: secondary prevention of myocardial infarction.

Numerous in vivo and in vitro experiments, investigating the inhibition of platelet aggregation and the prevention of experimentally-induced thrombosis, suggest that anti-platelet drugs, such as aspirin or the combination of aspirin, and dipyridamole or sulfinpyrazone, may be effective anti-thrombotic agents in man. Since 1971, seven randomized prospective trials and two case-control studies have been referenced in the literature or are currently being conducted, which evaluate the effects of aspirin, sulfinpyrazone, or dipyridamole in combination with aspirin in the secondary prevention of myocardial infarction. A critical review of these trials indicates a range of evidence from no difference to a favorable trend that anti-platelet drugs may serve as anti-thrombotic agents in man. To date, a definitive answer concerning the therapeutic effects of these drugs in the secondary prevention of coronary heart disease is not available.

Aspirin↗