Dataset Information

VESPA: Vanderbilt Electronic Systems for Pharmacogenomic Assessment

ABSTRACT:

The Vanderbilt Electronic Systems for Pharmacogenomic Assessment (VESPA) Project is a large electronic medical record (EMR)- and biobank-based initiative for translational pharmacogenomics discoveries. Key research resources utilized in this effort include the BioVU DNA databank and associated Synthetic Derivative database of clinical information, and software tools developed to identify drugs and clinical events using EHR-derived structured and unstructured ("free text") data. Cohorts include subjects with primarily drug-response phenotypes, and most cases and controls identified include three data types: ICD-9 codes, medication regimens, and medical test results. Advanced informatics methods, such as natural language processing, were also used for some phenotypes. Algorithms used event-sequence analyses to establish temporal relationships between drugs and phenotypes. Both cases and control algorithms excluded records that contained specific comorbidities and were refined to achieve positive predictive value (PPV) > 90%. For automated algorithms failing to meet this threshold, manual review was coupled with algorithms to validate that the included cases were true positives.

A total of 11,639 subjects met phenotyping criteria for a least one of the 28 phenotypes investigated. Across all phenotypes cases and controls, 90% were reused as either a case or control for a least one other phenotype. Data are deposited for individual phenotypes in the VESPA substudies.

Substudies:

VESPA: Genome Wide Association Study of Serum Creatinine during Vancomycin Therapy and Vancomycin Pharmacokinetics - phs000894

VESPA: Genome Wide Study of Clinically Diagnosed Ace Inhibitor Cough - phs000992

PROVIDER: phs000991 | dbGaP |

SECONDARY ACCESSION(S): PRJNA296728PRJNA296729

REPOSITORIES: dbGaP

ACCESS DATA

Dataset's files

Source:

			Action	DRS
	GapExchange_phs000991.v1.p1.xml	Xml
	dbGaPEx2.1.5.xsd	Other
	Study_Report.phs000991.VESPA_Cohort.v1.p1.MULTI.pdf	Pdf
	manifest_phs000991.VESPA_Cohort.v1.p1.c1.HMB.pdf	Pdf
	datadict_v2.xsl	Other

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Project description:The Women's Health Initiative (WHI) is a long-term national health study that has focused on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. The original WHI study included 161,808 postmenopausal women enrolled between 1993 and 1998. The Fred Hutchinson Cancer Research Center in Seattle, WA serves as the WHI Clinical Coordinating Center for data collection, management, and analysis of the WHI. The WHI has two major parts: a partial factorial randomized Clinical Trial (CT) and an Observational Study (OS); both were conducted at 40 Clinical Centers nationwide. The CT enrolled 68,132 postmenopausal women between the ages of 50-79 into trials testing three prevention strategies. If eligible, women could choose to enroll in one, two, or all three of the trial components. The components are: <ul> <li>Hormone Therapy Trials (HT): This double-blind component examined the effects of combined hormones or estrogen alone on the prevention of coronary heart disease and osteoporotic fractures, and associated risk for breast cancer. Women participating in this component with an intact uterus were randomized to estrogen plus progestin (conjugated equine estrogens [CEE], 0.625 mg/d plus medroxyprogesterone acetate [MPA] 2.5 mg/d] or a matching placebo. Women with prior hysterectomy were randomized to CEE or placebo. Both trials were stopped early, in July 2002 and March 2004, respectively, based on adverse effects. All HT participants continued to be followed without intervention until close-out.</li> <li>Dietary Modification Trial (DM): The Dietary Modification component evaluated the effect of a low-fat and high fruit, vegetable and grain diet on the prevention of breast and colorectal cancers and coronary heart disease. Study participants were randomized to either their usual eating pattern or a low-fat dietary pattern.</li> <li>Calcium/Vitamin D Trial (CaD): This double-blind component began 1 to 2 years after a woman joined one or both of the other clinical trial components. It evaluated the effect of calcium and vitamin D supplementation on the prevention of osteoporotic fractures and colorectal cancer. Women in this component were randomized to calcium (1000 mg/d) and vitamin D (400 IU/d) supplements or a matching placebo.</li> </ul> The Observational Study (OS) examines the relationship between lifestyle, environmental, medical and molecular risk factors and specific measures of health or disease outcomes. This component involves tracking the medical history and health habits of 93,676 women not participating in the CT. Recruitment for the observational study was completed in 1998 and participants were followed annually for 8 to 12 years. The original protocol allowed for follow-up until March 2005, after which participants were invited to enroll in the first WHI Extension Study for follow-up through 2010. Participants were invited again to participate in the second WHI Extension Study with continued follow up from 2010 to 2015. As of March 31, 2011 there were 93,122 women enrolled in the second extension. As part of the second Extension, 80+ year old women were asked to consent to an In Person Visit at their homes during which additional blood samples were collected and various measurements were taken (such as blood pressure, height, weight, waist circumference, grip strength, etc). The WHI Cohort is utilized in the following dbGaP substudies. To view genotypes, analysis, expression data, other molecular data, and derived variables collected in these substudies, please click on the following substudies below or in the "Substudies" box located on the right hand side of this top-level study page phs000200 WHI Cohort. <ul> <li><a href="./study.cgi?study_id=phs000386">phs000386</a> WHI SHARe</li> <li><a href="./study.cgi?study_id=phs000281">phs000281</a> GO-ESP WHISP</li> <li><a href="./study.cgi?study_id=phs000315">phs000315</a> WHI GARNET</li> <li><a href="./study.cgi?study_id=phs000503">phs000503</a> WHISE</li> </ul>

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Project description:Objectives The Cardiovascular Health Study (CHS) is a study of risk factors for development and progression of CHD and stroke in people aged 65 years and older. The objectives of the Cardiovascular Health Study are to: 1) quantify associations of conventional and hypothesized risk factors with CHD and stroke; 2) assess the associations of non-invasive measures of subclinical disease with the incidence of CHD and stroke; 3) quantify the associations of risk factors with subclinical disease; 4) characterize the natural history of CHD and stroke, and identify factors associated with clinical course; and 5) describe the prevalence and distributions of risk factors, non-invasive measures of subclinical disease, and clinical CHD and stroke. Background The study originated in 1988 from the recommendations of an NHLBI workshop on the management of CHD in the elderly. This is the most extensive study undertaken by the NHLBI to study CVD exclusively in an elderly population. Initially funded for six years, it was renewed for a second six year period in 1994 and recently was renewed with limited support for the Coordinating Center, the Laboratory and the Steering Committee. Grant funding from several sources has supported an additional clinic visit in 2005-2006 and continued morbidity and mortality follow-up. Subjects The 5,888 study participants were recruited from four U.S. communities and have undergone extensive clinic examinations for evaluation of markers of subclinical cardiovascular disease. The original cohort totaled 5,201 participants. A new cohort was recruited in 1992. The 687 participants in the new cohort are predominately African-American and were recruited at three of the four field centers. Design The 2,962 women and 2,239 men were examined yearly from 1989 through 1999. The added minority cohort of 256 men and 431 women was examined from 1992 to 1999. Examination components have included medical history questionnaires, measurement of ankle-brachial index, abdominal and carotid ultrasound studies, echocardiograms, ambulatory electrocardiograms, cerebral magnetic resonance imaging, spirometry and retinal photographs over the past decade. The most extensive evaluations were at study entry (baseline) and again in 1992-1993 to assess change in subclinical disease measures. CHS has undertaken extensive follow-up for ascertainment of cardiovascular events including incident claudication, myocardial infarction, congestive heart failure, stroke and death. Genetic Research The Cardiovascular Health Study has expanded its research mission into the study of genetic factors underlying CVD and other disorders using DNA that was collected from blood samples from most participants. Subsets of CHS participants have been genotyped in large-scale genotyping projects, including thousands of SNP genotypes for candidate gene regions as part of the NHLBI Candidate gene Association Resource (CARe) and genome-wide genotyping as part of the NHLBI SNP Typing for Association with Multiple Phenotypes from Existing Epidemiologic Data (STAMPEED). Whole exome sequencing of an overlapping subset of CHS participants was performed through the NHLBI "Grand Opportunity" Exome Sequencing Project (GO-ESP). The Cardiovascular Health Study Cohort is utilized in the following dbGaP substudies. To view genotypes, analysis, expression data, other molecular data, and derived variables collected in these substudies, please click on the following substudies below or in the "Substudies" box located on the right hand side of this top-level study page phs000287 Cardiovascular Health Study Cohort. <li><a href="./study.cgi?study_id=phs000226">phs000226</a> STAMPEED: Cardiovascular Health Study (CHS)</li> <li><a href="./study.cgi?study_id=phs000301">phs000301</a> PAGE: CaLiCo: Cardiovascular Health Study</li> <li><a href="./study.cgi?study_id=phs000377">phs000377</a> CARe Cardiovascular Health Study</li> <li><a href="./study.cgi?study_id=phs000400">phs000400</a> GO-ESP-CHS: Cardiovascular Health Study Component of the Exome Sequencing Project</li> <li><a href="./study.cgi?study_id=phs000667">phs000667</a> CHARGE-S: Cardiovascular Health Study (CHS)</li>

Dataset Information

VESPA: Vanderbilt Electronic Systems for Pharmacogenomic Assessment

Dataset's files

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