PubMed Health⌕ Search

Biomedical subjects

J Grizzle

Publications and source records attributed to J Grizzle.

10 recordsLinked to original sources

A comparison of statistical methods for clustered data analysis with Gaussian error.

We investigate by simulation the properties of four different estimation procedures under a linear model for correlated data with Gaussian error: maximum likelihood based on the normal mixed linear model; generalized estimating equations; a four-stage method, and a bootstrap method that resamples clusters rather than individuals. We pay special attention to the group randomized trials where the number of independent clusters is small, cluster sizes are big, and the correlation within the cluster is weak. We show that for balanced and near balanced data when the number of independent clusters is small (< or = 10), the bootstrap is superior if analysts do not want to impose strong distribution and covariance structure assumptions. Otherwise, ML and four-stage methods are slightly better. All four methods perform well when the number of independent clusters reaches 50.

Bias↗

The beta-carotene and retinol efficacy trial (CARET) for chemoprevention of lung cancer in high risk populations: smokers and asbestos-exposed workers.

CARET is a multicenter, two-armed, double-masked randomized chemoprevention trial in Seattle, Portland, San Francisco, Baltimore, Connecticut, and Irvine, to test whether oral administration of beta-carotene (30 mg/day) plus retinyl palmitate (25,000 IU/day) can decrease the incidence of lung cancer in high risk populations, namely, heavy smokers and asbestos-exposed workers. The intervention combines the antioxidant action of beta-carotene and the tumor suppressor mechanism of vitamin A. As of April 30, 1993, CARET had randomized 1,845 participants in the 1985-1988 pilot phase plus 13,260 "efficacy" participants since 1989; of these, 4,000 are asbestos-exposed males and 11,105 are smokers and former smokers (44% female). Accrual is complete everywhere except Irvine, which was the last center added (1991), and the safety profile of the regimen to date has been excellent. With 14,420 smokers, 4,010 asbestos-exposed participants, and 114,100 person-years through February 1998, we expect CARET to be capable of detecting a 23% reduction in lung cancer incidence in the two populations combined and 27, 49, 32, and 35% reductions in the smokers, female smokers, male smokers, and asbestos-exposed subgroups, respectively. CARET is highly complementary to the alpha-tocopherol-beta-carotene study in Finland and the Harvard Physicians Health Study (beta-carotene alone) in the National Cancer Institute portfolio of major cancer chemoprevention trials.

Aged↗

Cancer control at the workplace: the Working Well Trial.

BACKGROUND. Few research studies have been conducted on cancer prevention and control at the workplace. This article presents an overview of the largest worksite cancer control trial in the United States--The Working Well Trial--conducted in 114 worksites by four study centers, a coordinating center, and the National Cancer Institute. The trial's organizational structure, research design, dependent measures, and theoretical model for intervention are described. Special features of the trial include using the worksite as the unit of randomization, intervention, and evaluation and a theory-driven conceptual model of intervention that places emphasis on individual and organizational targets for change, uses the transtheoretical stage of change model to guide a sustained 2-year multiple risk factor intervention, and makes use of volunteer resources within the worksite to reduce cost, increase participation, and improve tailoring to individual needs. The trial will have a potential impact on over 25,000 workers. CONCLUSION. The issues raised in this overview have implications for the evaluation and dissemination of cancer prevention and control programs to defined populations.

Health Promotion↗

Relationships among concentrations of steroids, insulin-like growth factor-I, and insulin-like growth factor binding proteins in ovarian follicular fluid of beef cattle.

The relationship between ovarian follicular steroidogenesis and insulin-like growth factor binding protein (IGFBP) activity was evaluated during the follicular phase of the bovine estrous cycle. In experiment 1, follicles were collected from cyclic cows (n = 11) slaughtered at 48 h after administration of prostaglandin F2 alpha (PGF; 35 mg i.m.). In experiment 2, cows were injected twice daily with saline (control) or FSH (FSH cows; total dosage = 42 mg) from Day 2 to Day 6 (estrus = Day 0) and with PGF (35 mg i.m.) on Day 7; follicles were collected from control cows (n = 20) slaughtered at 0, 24, 48, or 72 h and from FSH cows (n = 8) at 0 and 48 h after PGF. Follicular fluid was assayed for estradiol (E2), androstenedione (A4), progesterone (P4), and insulin-like growth factor-I (IGF-I) by RIA and for IGFBP activity by ligand blotting and densitometry. Intensities of the 34-kDa (IGFBP-2), 29-27-kDa, and 22-kDa IGFBP bands in follicular fluid were nondetectable or were lower (p < 0.01) in the fluid of large (> or = 8 mm) E-active (E-A; E2 > 50 ng/ml and > P4) follicles than in large E-inactive (E-I), medium (5-7 mm), or small (< 5 mm) follicles. IGFBP-3 (44-40-kDa doublet) was unaffected by follicle stage in experiment 1, but IGFBP-3 was lower (p < 0.01) in follicular fluid of E-A vs. E-I large follicles in experiment 2. Profiles of IGFBP activity were similar in follicular fluid of small, medium, and E-I large follicles. In experiment 2, E2 concentrations in large E-A follicles increased (p < 0.01) from 0 to 48 h after the PGF injection for control cows but decreased (p < 0.01) for FSH cows, whereas follicular fluid IGFBP-2 binding activity decreased from 0 to 48 h after PGF in controls and increased in FSH cows (treatment x time, p < 0.05). IGFBP-3 binding was unaffected by FSH treatment or time after administration of PGF. Profiles of IGFBP activity in homogenates of granulosa or theca cells were similar to follicular fluid profiles except for the absence of IGFBP-3 binding activity. The disappearance of binding activities for IGFBP-2 and smaller-molecular-mass IGFBPs in E-A follicles suggests a possible regulatory role for IGFBPs in follicular maturation and on aromatase activity.(ABSTRACT TRUNCATED AT 400 WORDS)

Androstenedione↗

Nutritional and environmental factors involved in egg shell quality of laying hens.

1. Two experiments were conducted to assess the effects of lighting regime, dietary calcium source and sodium bicarbonate on production variables and egg shell quality of White Leghorn hens. In both experiments, hens were assigned to one of three lighting programmes that provided evening, morning or intermittent (midnight) lighting supplements in addition to natural daylight. Experimental diets used in the first study were formulated to contain (1) ground oyster shell flour, (2) limestone flour, or (3) and (4) the same +2/3 of the calcium source as hen-size oyster shell grit. The same 4 diets plus those containing hen-size limestone or hen-size limestone and oyster shells were used in experiment II. Additionally, diets in the first experiment contained either 0 or 10 g/kg sodium bicarbonate. 2. Hen-day egg production and food consumption were not affected by any of the experimental treatments. Hens fed on oyster shell diets or exposed to intermittent lighting regimes laid eggs of the highest specific gravity. Shell quality, as measured by specific gravity, was not affected by the addition of dietary sodium bicarbonate. 3. As expected, elevated temperatures (greater than 32 degrees C) significantly reduced egg shell quality. However, this effect was variable particularly in experiment II which used younger hens. 4. The shell quality of eggs from hens exposed to intermittent lighting in experiment II was significantly higher in each of the 4 sampling periods: morning (08.00-12.00), afternoon (12.00-16.00), evening (16.00-20.00) and night (20.00-08.00). 5. It is suggested that midnight lighting programmes provide a means of supporting egg shell quality of older laying hens during the summer months without a significant reduction in egg production.

Animal Nutritional Physiological Phenomena↗

Comparison of multicenter study designs for investigation of carotid endarterectomy efficacy.

BACKGROUND: Our report summarizes and compares the characteristics of six prospective, multicenter, randomized clinical trials of carotid endarterectomy underway in North America and Europe. SUMMARY OF REVIEW: Three trials are designed to evaluate the safety and efficacy of endarterectomy in patients with asymptomatic carotid artery stenosis. The other three trials enroll patients who have had transient ischemic attacks or a minor cerebral infarction in the distribution of the randomized artery. Considered together, these six clinical trials span the range of candidates for carotid endarterectomy. The inclusion and exclusion criteria, methodology, and statistical considerations of each study are detailed in tables. CONCLUSIONS: The results from these trials will be helpful in resolving some of the questions surrounding endarterectomy, provided the similarities and differences in the study designs are considered when interpreting the results.

Carotid Arteries↗

CARET, the beta-carotene and retinol efficacy trial to prevent lung cancer in asbestos-exposed workers and in smokers.

CARET is a two-armed, double-blind, randomized chemo-prevention trial to test the hypothesis that oral administration of beta-carotene 30 mg/day plus retinyl palmitate 25,000 IU/day will decrease the incidence of lung cancer in high-risk populations: heavy smokers and asbestos-exposed workers who have smoked. The agents combine anti-oxidant and nuclear tumor suppressor mechanisms. Fastidious monitoring for possible side effects is facilitated by inclusion of a Vanguard population. As of 31 December 1990, 6,105 participants of the 18,000 needed have been randomized in the trial. Efficacy results are expected in 1999.

Aged↗

Pooling 12 nomifensine studies for efficacy generalizability.

Twelve parallel group, randomized, double-blind studies of nomifensine's safety and efficacy in the treatment of depressed patients were combined into three pools according to common protocols. This approach permitted evaluation of 1) efficacy results for studies with moderate-sized pools of patients, 2) the degree to which efficacy was generalizable to depressed patients in the general population, and 3) the conditions under which pooled active vs. active (imipramine vs. nomifensine) studies could be regarded as pivotal in support of efficacy. Results showed that nomifensine's superiority over placebo was generalizable to patients with a wide range of characteristics, including age 60 years or older. An appropriate statistical profile of more pronounced nomifensine responders would include patients with a duration of present episode less than 4 months who are acutely depressed, exhibit more severe symptoms, and have been previously hospitalized or treated with other psychotropic medications. A comprehensive assessment and power analysis of the pooled active vs. active studies provided strong evidence for comparability of nomifensine and imipramine.

Adolescent↗