Community based interventions (e.g. to reduce obesity and increase physical activity) can play an important role in reducing the risk and overall mortality and morbidity of diseases such as coronary heart disease and cancer. They are especially important for African Americans, who are disproportionately at risk for a wide range of negative health conditions, including cancer of the breast, colon, esophagus, prostate, pancreas, ant stomach; mortality from cardiovascular disease; hypertension; and elevated serum cholesterol. This project will develop more efficient and cost-effective methods for analysis of longitudinal studies using quasi-least squares (QLS), with special emphasis on studies in diverse populations.
Our aims are: (1) To develop more efficient and informative methods for analysis in longitudinal studies and community-based interventions, by applying QLS for a wide range of correlation models not currently implemented for generalized estimating equations (GEE) and constructing confidence intervals and tests of hypotheses for the parameters of the new structures, for data with one or more levels of within-cluster associations (e.g. both within families and within subjects over time). (2) To develop methods for planning more powerful studies and taking advantage of re-computing interim power, by (i) assessing loss in efficiency in estimation for different study designs and correlation models and (ii) providing explicit formulas for sample size and power calculations for several correlation structures, including the structures implemented in Aim 1.
This aim will consider both the regression and the correlation parameters. (3) To apply our methods in analyses of several studies in female, pediatric, and African-American Populations at the University of Pennsylvania, to further refine and tailor their development to the characteristics of data for diverse populations and to answer new questions that our methods make possible. (4) To compare and contrast our approaches with alternative methods, including methods based on random effects models and recent extensions of GEE, via simulations to assess small sample efficiency and bias and data analyses to compare results of the different approaches. (5) To implement the methods for analysis (Aim 1) and planning (Aim 2) in Stata programs, for use by other statisticians. Further, to widely disseminate the programs, and their documentation, on a web site developed for this project.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA096885-02
Application #
6909016
Study Section
Biostatistical Methods and Research Design Study Section (BMRD)
Program Officer
Feuer, Eric J
Project Start
2004-07-01
Project End
2007-06-30
Budget Start
2005-07-20
Budget End
2006-06-30
Support Year
2
Fiscal Year
2005
Total Cost
$178,313
Indirect Cost
Name
University of Pennsylvania
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Amsterdam, Jay D; Shults, Justine; Soeller, Irene et al. (2012) Chamomile (Matricaria recutita) may provide antidepressant activity in anxious, depressed humans: an exploratory study. Altern Ther Health Med 18:44-9
Amsterdam, Jay D; Shults, Justine (2010) Efficacy and safety of long-term fluoxetine versus lithium monotherapy of bipolar II disorder: a randomized, double-blind, placebo-substitution study. Am J Psychiatry 167:792-800
Amsterdam, Jay D; Yao, Yubing; Mao, Jun James et al. (2009) Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause. J Clin Psychopharmacol 29:478-83
Amsterdam, Jay D; Wang, Chia-Hao; Shwarz, Michelle et al. (2009) Venlafaxine versus lithium monotherapy of rapid and non-rapid cycling patients with bipolar II major depressive episode: a randomized, parallel group, open-label trial. J Affect Disord 112:219-30
Sun, Wenguang; Shults, Justine; Leonard, Mary (2009) A note on the use of unbiased estimating equations to estimate correlation in analysis of longitudinal trials. Biom J 51:5-18
Amsterdam, Jay D; Li, Yimei; Soeller, Irene et al. (2009) A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder. J Clin Psychopharmacol 29:378-82
Amsterdam, Jay D; Shults, Justine; Rutherford, Nancy (2008) Open-label study of s-citalopram therapy of chronic fatigue syndrome and co-morbid major depressive disorder. Prog Neuropsychopharmacol Biol Psychiatry 32:100-6
Tu, X M; Zhang, J; Kowalski, J et al. (2007) Power analyses for longitudinal study designs with missing data. Stat Med 26:2958-81
Shults, Justine; Mazurick, Carissa A; Richard Landis, J (2006) Analysis of repeated bouts of measurements in the framework of generalized estimating equations. Stat Med 25:4114-28
Amsterdam, Jay D; Shults, Justine; Rutherford, Nancy et al. (2006) Safety and efficacy of s-citalopram in patients with co-morbid major depression and diabetes mellitus. Neuropsychobiology 54:208-14