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In separate experiments, we fed 30 male and 25 female baboons a diet enriched in cholesterol and saturated fat for periods of 3.3 and 2.6 years. Using operant conditioning with water rewards, we trained the animals to puff on smoking machines in a human-like manner. Half of the animals smoked more than 40 cigarettes per day, while the remaining animals (controls) puffed air. Initially, the diet produced twofold (males) and threefold (females) elevations from baseline levels in serum cholesterol concentrations, but over the course of the experiments, the serum cholesterol decreased to 1.5 (males) and 2.0 (females) times baseline levels in both cigarette smokers and controls. Blood carbon monoxide concentration, plasma thiocyanate concentration, and urine cotinine concentration were significantly greater in smokers than in controls. Responses to smoking in males included lymphocytosis, elevated fasting blood glucose concentration, and decreased seminal vesicle weight. In females, hemoglobin and mean corpuscular hemoglobin concentrations were elevated. The extent of atherosclerosis was examined after 2.8 (males) and 1.6 (females) years of smoking. Among males, the extent of lesions in carotid arteries was significantly greater in smokers than in controls, but there were no significant differences in atherosclerosis in the aorta or the brachial, iliac-femoral, or coronary arteries. Among females, there were no significant differences in atherosclerosis between smokers and controls in any artery. These experiments show little effect of 2 to 3 years of cigarette smoke inhalation and concurrent modest elevation of blood carboxyhemoglobin on experimental atherosclerosis in the presence of moderate hyperlipidemia.

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An effective data management system ensures high quality research data by making certain of the proper execution of the study design. This paper presents the components of a data management system and describes procedures for use in each component of the system to obtain high quality data. We discuss the interrelationship among the components of the data management system and the relationship of the data management system to other parts of the research project. We identify underlying principles in design and implementation of a data management system to ensure high quality data.

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The Institutional Review Board is a committee of the institution responsible for carrying out the institution's responsibilities for the protection of human research subjects. Since it is a local committee, most of the complaints about the IRB can be resolved locally provided it is borne in mind that the IRB is the champion not only of the human research subject but also of the investigator. National or regional cooperative research protocols present problems that are not insurmountable.

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The accuracy and reliability of noninvasive measurement of blood pressure in the forearms of baboons by means of an automated oscillometric method were evaluated. Comparisons of 255 oscillometric determinations of systolic, diastolic and mean arterial pressure in eight anesthetized animals with simultaneously taken direct radial artery pressure measurements revealed average differences and standard deviations of +0.14 (+/- 9.05), +4.34 (+/- 6.75), and -1.01 (+/- 5.84) Torr, respectively. Computation of statistical error bounds indicated that any single oscillometric reading could be expected to fall within 9.6%, 11.0% nd 7.4% of directly measured systolic, diastolic, and mean blood pressure with a probability of 0.90. The oscillometric determinations accurately tracked rapid changes in pressure caused by intravenous infusion of pressor and depressor drugs. The method provided fast, reliable readings of arterial pressure without the use of microphones or other transducers that require precise placement and low-noise environments.

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One hundred twenty-six adult female baboons (Papio cynocephalus) were hysterectomized and all except 18 were ovariectomized. The animals were fed a moderately atherogenic diet (40% calories form hydrogenated vegetable oil, 1.5 gm cholesterol/kcal) for two years. Ovariectomized-hysterectomized animals received estrone sulfate, ethynyl estradiol, or diethylstilbestrol orally in daily doses similar to those given humans. An ovariectomized-hysterectomized group and a hysterectomized group received no drug. The average total serum cholesterol concentration rose from 136 mg/dl to 223 mg/dl and declined to 186 mg/dl. Concentrations of cholesterol, triglyceride, and phospholipid in whole serum, low density lipoproteins and high density lipoproteins showed no consistent statistically significant differences among the groups. Triglyceride and phospholipid concentrations were higher in the estrogen-treated and intact-ovary groups than in the ovariectomized nonestrogen treated group, but not all pairwise comparisons were statistically significant. There were no consistent statistically significant differences in atherosclerotic lesions among the groups. Neither ovariectomy nor estrogen replacement influence diet-induced experimental atherosclerosis in the baboon within two years.

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Male and female infant baboons were reared from birth to 112 days of age on infant formulas containing concentrations of carrageenan varying from none to 5 times the concentration in commercially available formulas for human infants. Carrageenan content of the formula did not affect weight, characteristics of urine and feces, findinds on physical examination, hematological variables, blood chemical analyses, organ system weights, or the macroscopic and microscopic appearance of the gastrointestinal tract.

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Male and female weight percentiles for 24 nursery reared infant baboons (Papio cynocephalus) were developed from weight measurements made from birth to 15 weeks of age. True birth weights could not be obtained and weights at the time of removal from the mother (18-24 hours after parturition) were used as initial weights. The difference in initial weights for males compared to females was found to be statistically significant with males having greater initial weights.

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The accuracy and precision of indirect blood pressure measurements in baboons were studied by comparing the results of indirect measurements with simultaneous direct measurements. The indirect measurements were made by four observers using a Doppler ultrasound instrument. A statistically significant difference between the two methods was found for systolic blood pressure but not for diastolic blood pressure. The indirect systolic averaged 13.8 mmHg higher than direct systolic and was found to be more precise than the indirect diastolic. The difference in blood pressure obtained by the two methods varied over animals and observers with an interaction between animals and observers. The effect of arm was examined by performing direct blood pressure measurements in both arms. No statistically significant arm effect was found.

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