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Biomedical subjects

Rickey E Carter

Publications and source records attributed to Rickey E Carter.

11 recordsLinked to original sources
PubMed2006

Characteristics of cocaine- and marijuana-dependent subjects presenting for medication treatment trials.

Evaluation of the characteristics of individuals presenting for substance abuse treatment can provide important information to help focus treatment services. In this study, demographic and clinical characteristics of individuals presenting for medication trials for the treatment of cocaine or marijuana dependence were compared. Marijuana-dependent subjects were generally younger than cocaine-dependent subjects, more likely to be Caucasian, and completed more years of education. Marijuana-dependent subjects also reported significantly more days using than cocaine-dependent subjects, as well as higher levels of craving. Some differences in psychiatric symptomatology were also noted, with cocaine-dependent subjects more likely to report anxiety symptoms and marijuana-dependent subjects reporting more past depressive episodes. Past and current other drug use was similar between the two groups. These results highlight the significant impairments associated with marijuana and cocaine dependence.

Adult↗
PubMed2006

Factors associated with physical activity among African-American men and women.

BACKGROUND: African Americans have lower rates of physical activity (PA) than Caucasians. Although correlates of PA have been studied in many populations, little is known about the influences on physical activity for African Americans, particularly African-American men. METHODS: Individuals were randomly selected from 20 church rosters and participated in a telephone survey (165 men, 407 women) in May to September 2003. Participants were classified according to whether they were meeting recommendations for moderate to vigorous physical activity, walking, and strength training. Sociodemographic, health, psychosocial, and physical environment correlates were also assessed. Mixed-model logistic regression analyses were conducted. RESULTS: For men, explained variance ranged from 20.8% to 33.3%. For women, the independent variables explained 10.8% to 23.2% of the variance in physical activity behavior. Significant positive correlates among men were employment, income, self-rating of health, PA self-efficacy, and PA enjoyment, and fruit and vegetable intake, with age as a negative correlate. Significant positive correlates among women were employment, education, income, self-rating of health, PA self-efficacy, PA enjoyment, fruit and vegetable intake, reporting PA programs at their church, and attempting weight loss. Negative correlates included age, number of chronic health conditions, and body mass index. CONCLUSIONS: Various factors influenced PA in men and women, suggesting a need for gender targeting in addition to cultural adaptations in PA interventions for African Americans.

Black or African American↗
PubMed2006

Sertraline treatment for generalized anxiety disorder: a randomized, double-blind, placebo-controlled study.

OBJECTIVE: This study assessed the efficacy and safety of sertraline in the treatment of generalized anxiety disorder (GAD). METHOD: The study was conducted from April 2000 to May 2002. Outpatients with DSM-IV GAD (N = 326) who satisfied inclusion/exclusion criteria and completed a 1-week screening phase were randomly assigned to 10-week double-blind treatment with flexible dosing of sertraline (50-200 mg/day) or placebo. The primary efficacy measure was change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) total score. Response was defined as a 50% or greater decrease in HAM-A total score at endpoint. RESULTS: Sertraline produced a statistically significant reduction in anxiety symptoms, as measured by HAM-A total change scores (p = .032), HAM-A psychic anxiety subscale (p = .011), and Hospital Anxiety and Depression Scale-anxiety subscale (p = .001). Response rates were significantly higher (p = .05) for the sertraline group (59.2%) compared to the placebo group (48.2%). Sertraline was well tolerated, with only sexual side effects reported significantly more often by subjects receiving sertraline than those receiving placebo. CONCLUSION: Despite the relatively small between-group differences, study findings suggest a role for sertraline in the acute treatment of GAD.

Adult↗
PubMed2005

Practical considerations for estimating clinical trial accrual periods: application to a multi-center effectiveness study.

BACKGROUND: Adequate participant recruitment is vital to the conduct of a clinical trial. Projected recruitment rates are often over-estimated, and the time to recruit the target population (accrual period) is often under-estimated. METHODS: This report illustrates three approaches to estimating the accrual period and applies the methods to a multi-center, randomized, placebo controlled trial undergoing development. RESULTS: Incorporating known sources of accrual variation can yield a more justified estimate of the accrual period. Simulation studies can be incorporated into a clinical trial's planning phase to provide estimates for key accrual summaries including the mean and standard deviation of the accrual period. CONCLUSION: The accrual period of a clinical trial should be carefully considered, and the allocation of sufficient time for participant recruitment is a fundamental aspect of planning a clinical trial.

Humans↗
PubMed2005

Systems validation: application to statistical programs.

BACKGROUND: In 2003, the United States Food and Drug Administration (FDA) released a guidance document on the scope of "Part 11" enforcement. In this guidance document, the FDA indicates an expectation of a risk-based approach to determining which systems should undergo validation. Since statistical programs manage and manipulate raw data, their implementation should be critically reviewed to determine whether or not they should undergo validation. However, the concepts of validation are not often discussed in biostatistics curriculum. DISCUSSION: This paper summarizes a "Plan, Do, Say" approach to validation that can be incorporated into statistical training so that biostatisticians can understand and implement validation principles in their research. SUMMARY: Validation is a process that requires dedicated attention. The process of validation can be easily understood in the context of the scientific method.

Clinical Trials as Topic↗
PubMed2005

Quasi-likelihood estimation for relative risk regression models.

For a prospective randomized clinical trial with two groups, the relative risk can be used as a measure of treatment effect and is directly interpretable as the ratio of success probabilities in the new treatment group versus the placebo group. For a prospective study with many covariates and a binary outcome (success or failure), relative risk regression may be of interest. If we model the log of the success probability as a linear function of covariates, the regression coefficients are log-relative risks. However, using such a log-linear model with a Bernoulli likelihood can lead to convergence problems in the Newton-Raphson algorithm. This is likely to occur when the success probabilities are close to one. A constrained likelihood method proposed by Wacholder (1986, American Journal of Epidemiology 123, 174-184), also has convergence problems. We propose a quasi-likelihood method of moments technique in which we naively assume the Bernoulli outcome is Poisson, with the mean (success probability) following a log-linear model. We use the Poisson maximum likelihood equations to estimate the regression coefficients without constraints. Using method of moment ideas, one can show that the estimates using the Poisson likelihood will be consistent and asymptotically normal. We apply these methods to a double-blinded randomized trial in primary biliary cirrhosis of the liver (Markus et al., 1989, New England Journal of Medicine 320, 1709-1713).

Antibiotics, Antineoplastic↗
PubMed2005

Health service use among persons with comorbid bipolar and substance use disorders.

OBJECTIVE: This study tested the hypothesis that patients with comorbid bipolar and substance use disorders use health services to a greater extent than patients with either bipolar or substance use disorder alone. METHODS: A retrospective chart review was conducted among patients who used health services at the Ralph H. Johnson Department of Veterans Affairs medical center in Charleston, South Carolina, and had bipolar disorder alone, substance use disorder alone, and comorbid bipolar and substance use disorders. Patients with a psychiatric admission between 1999 and 2003 were included in the study. Information was collected on the use of health services one year before and including the index admission. RESULTS: The records of 106 eligible patients were examined for this study: 18 had bipolar disorder alone, 39 had substance use disorder alone, and 49 had both bipolar and substance use disorders. Compared with the other two groups, the group with comorbid bipolar and substance use disorders was significantly more likely to be suicidal. Compared with the group with bipolar disorder alone, the group with comorbid disorders had significantly fewer outpatient psychiatric visits and tended to have shorter psychiatric hospitalizations. Among patients with an alcohol use disorder, those who also had bipolar disorder were significantly less likely than those with an alcohol use disorder alone to have had an alcohol-related seizure. Patients with comorbid bipolar and substance use disorders were significantly less likely than those with substance use disorder alone to be referred for intensive substance abuse treatment, even though both groups were equally likely to enter and complete treatment when they were referred. CONCLUSIONS: Despite significant functional impairment among patients with comorbid bipolar and substance use disorders, they had significantly fewer psychiatric outpatient visits than those with bipolar disorder alone and were referred for intensive substance abuse treatment significantly less often than those with substance use disorder alone.

Bipolar Disorder↗
PubMed2004

Statistical design considerations for pilot studies transitioning therapies from the bench to the bedside.

Pilot studies are often used to transition therapies developed using animal models to a clinical setting. Frequently, the focus of such trials is on estimating the safety in terms of the occurrence of certain adverse events. With relatively small sample sizes, the probability of observing even relatively common events is low; however, inference on the true underlying event rate is still necessary even when no events of interest are observed. The exact upper limit to the event rate is derived and illustrated graphically. In addition, the simple algebraic expression for the confidence bound is seen to be useful in the context of planning studies.

Editorial↗
PubMed2004

Alzheimer's Disease in the Family Practice Setting: Assessment of a Screening Tool.

BACKGROUND: The prevalence of Alzheimer's disease (AD) is approximately 4.5 million people in the United States, and it is projected that by 2050, the prevalence could be as high as 16 million. As one step to minimize this health care burden, we investigated the practices of primary care physicians (PCPs) to determine barriers to and incentives in diagnosing AD and assessed the feasibility of utilizing a caregiver-based phone interview for dementia in the primary care setting. METHOD: This feasibility study was conducted in 2 phases. Phase I included PCP focus groups conducted to identify barriers and incentives to diagnosis of Alzheimer's disease, knowledge of available screening instruments, and current diagnostic procedures and patterns. A survey of a random sample of PCPs was also conducted to reassess the data obtained via the focus groups. Phase II assessed the feasibility of implementing a brief, caregiver-based dementia screening tool in the primary care setting. A participant's score on the screening tool was compared with the PCP's clinical impression using the kappa statistic. RESULTS: A general willingness exists among PCPs to improve the level of care for patients with AD; however, time constraints are a sizeable barrier in the PCP setting. The incorporation of a telephone-based (or caregiver-based) assessment is feasible. The agreement between the caregiver ratings and the PCPs' clinical impressions was kappa = 0.64 (95% CI = 0.19 to 1.0). CONCLUSION: The caregiver-based telephone assessment has indications of good agreement with the PCP's general assessment of dementia or possible AD. The limited number of patients with positive screens hinders generalization of this phase of the study, but the results confirm the potential value of caregiver-based assessment and the desirability of a larger study to address the scientific properties of a telephone-based screening instrument.

Journal Article↗
PubMedDate not supplied

End-of-life communication and hospital nurses: an educational pilot.

Heart failure is a high prevalence, high burden disease with an unpredictable trajectory. Given that approximately 50% of persons with the diagnosis die within 5 years, the implications for communication about advance planning and end of life, although simultaneously providing hope and treatment, are extremely challenging. This article reports on a feasibility trial of a modest continuing education seminar to increase awareness and communication skills of inpatient nurses. Curriculum design details, including objectives and methods, are described. Needs assessment and evaluation data are reported. At the 2-month posttest, a summary communications skill score showed significant improvement. Data also illustrated that the challenge of facing issues about dying are complicated by a work force of relatively young staff and low exposure to few actual deaths during relatively short lengths of stay.

Attitude to Death↗