Specimen Results Available

Tests performed by WHI and WHI Core studies

WHI Clinic CBC Results

CBC tests were performed on the blood collected at a screening visit (and, for the OS participants, Annual Visit 3) and analyzed at each Clinical Center’s (CC) local laboratory. Values were reported for the following tests: white blood cell (WBC) count (Kcell/ul), platelet count (Kcell/ul), and hematocrit (%), and, when available, hemoglobin (gm/dl).

Broad range checks have been applied to the CBC results to exclude biologically implausible values. Extreme values and inconsistencies between results may still exist, careful inspection of the CBC result data is recommended before using these results in analyses. Note that Data are missing if the lab was unable to process the sample and WBC differential data are not available. While individual clinics may have assessed WBC differential, the results were not entered into the WHI database.

Core Analyte Results (CT Subsample)*

Performed on the CT 6% subsample (W1) at baseline, Years 1, 3, and 6, and on the OS Measurement Precision Study participants (W2 - 1% of OS participants) at baseline and Month 3. The 20 core analytes include:

• Coagulation Factors (citrate plasma): Factor VII Ag (antigen), Factor VIIC (activity), Fibrinogen
• Lipids (EDTA plasma): HDL, HDL-2, HDL-3, LDL, Lp(a), total cholesterol, triglyceride
• Micronutrients (serum): Alpha carotene, beta-carotene, alpha-tocopherol, gamma tocopherol, beta-cryptoxanthine, lycopene, lutein + zeaxanthin, retinol
• Metabolic (serum): glucose, insulin

Observational Study Measurement Precision Study (OS-MPS)*

The OS-MPS blood was drawn within 6 months after the baseline blood draw and includes approximately 1% of the OS.

*Because the sub-sampling incorporated oversampling of minorities, it is recommended that all analyses using these data either weight the reporting of means by the overall CT race/ethnicity distribution, or include race/ethnicity as a covariate in any modeling.

Baseline CVD Biomarkers

A subset of WHI participants have CVD biomarkers at baseline through a core set of WHI studies (additional participants have had CVD biomarkers measured through smaller ancillary studies, but those are not described here). It is important to note that CVD Biomarkers were measured at two different labs using different methods.

• ~5,600 participants had baseline CVD biomarkers (plasma: lipids, serum: glucose and insulin) measured at MRL/PPD as a subset of the WHI core analytes measured in studies W1 (6% CT subsample) and W2 (1% OS measurement Precision Study).

• ~24,500 participants had baseline CVD biomarkers (Laboratory Methods: serum: lipids, glucose, insulin, creatinine, and CRP) measured at UMMC in studies W54 (African Americans and Hispanics), W58 (European Americans in the HT), W66 (LLS eligibility pool expansion), and AS422 (Native Americans). W54 and W58 together are often referred to as the "CVD Biomarker Cohort", but W66 and AS422 also contribute to the baseline CVD biomarker resource.

	MRL/PPD Labs		University of Minnesota (UMMC)
	W1: 6% CT subsample	W2: 1% OS Measurement Precision study	W54: African American and Hispanic	W58: European American HT	W66: LLS eligibility pool expansion{" "}	AS422: Native American
	N=~4,546	N=~1,082	N=~12,157	N=~10,306	N=~1,502	N=~594	Total ~N
A. Original CVD Biomarker Cohort (selected to be a representative subsample of WHI, tested at UMMC)			X	X			22,463
B. All CVD biomarkers tested at UMMC			X	X	X	X	24,558
C. Core analyte subcohort (tested at MRL/PPD)	X	X					5,628
D. All (tested at MRL/PPD and/or UMMC)	X	X	X	X	X	X	27,544
	Serum: glucose and insulin EDTA plasma: lipids subset of WHI core analytes Creatinine and CRP were NOT measured		Serum: glucose, insulin, lipids, creatinine and CRP

Note:

• Counts are of the participants selected for a study, not the number with specimen results. A small number of participants selected for a study may not have results for one or more assays due to insufficient sample or assay failure.
• 2,642 participants overlap between options B and C.

Related Publications

Baseline blood analyses for the CT and OS have been published in the following documents.

Baseline monographs

• Hays J, Hunt J, Hubbell A, Anderson G, Limacher M, Allen C, Rossouw J. The WHI Recruitment Methods and Results. Ann Epidemiol 2003;13:S18-S77 PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/14575939
• Langer R, White E, Lewis C, Kotchen J, Hendrix S, Trevisan M. The WHI OS: Baseline Characteristics of Participants and Reliability of Baseline Measures. Ann Epidemiol 2003;13:S107. PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/14575943

See also the blood analytes tables under Baseline summary tables

Additional Documents

• Calculation of estimated glomerular filtration rate (eGFR): calculating eGFR with known serum creatinine values
• Standardization of Assays from Multiple Labs for a Given Analyte: this document describes a method that uses linear regression to account for gross systematic differences in location (e.g., mean) and/or scale (e.g., standard deviation) of measurements between labs.

Tests performed by ancillary studies

Data from ancillary studies are generally made available 1 year after the end of the study funding period. Specimen data from ancillary studies may be requested earlier by contacting the BAA or AS PI for permission to use it. Note that any of transfer of associated WHI covariate data would require WHI approval and a signed data use agreement for the use of the data. Questions about the BAA and AS data sets should be addressed with the BAA or AS PIs.

Test Results Available for the Long Life Study blood collection (W64)

Between 2012 and 2013, 7,875 MRC participants completed an LLS visit with a blood draw (~14-19 years post baseline). The LLS blood draw was scheduled to be a fasting draw, but in some cases participants were not fasting. Fasting status is indicated in the WHI database.

Test results available for the LLS blood draw include:

CVD Biomarkers in serum at UMMC: glucose, insulin, creatinine, CRP, lipids Complete blood count (CBC) with 26 variables including WBC, RBC, hemoglobin, hematocrit, platelet count, WBC differential (automated), and numerous indices. Note that participants selected for LLS phase I and II recruitment all had samples sent for baseline CVD biomarkers and GWAS. When the eligibility pool needed to be expanded due to low enrollment (Phase III of recruitment), the LLS phase III eligible participants had baseline CVD biomarkers and/or GWAS measured (W66).

See the Long Life Study page for more information.