​​​​​Using the WHI Participation Page

 

​WHI participation.png

1. The Venn diagram visually displays which WHI study components are represented in the group of selected participants. See WHI Study Participation below for more details.

2. WHI Study Participation: Select which study components you would like to allow, require, or exclude.

  • See About WHI - Design and Protocol for details about the Observational Study (OS) and Clinical Trials (CT).

  • Participants in the OS do not overlap with the participants in the CT.

  • The three Clinical Trials include the (1) Hormone Therapy (HT) Trial, (2) Diet Modification (DM) Trial and (3) the Calcium/Vitamin D (CaD) trial. Participants may be in one, two or all three of the Clinical Trials. Participants could only be in the CaD Trial if they were already enrolled in the HT and/or the DM Trials. By using the allow/require/exclude buttons you can limit the overlap combinations to only those you want.  The Venn diagram at the top of the page will changed based on your selection.

  • Example: To select HT participants that were not enrolled in CaD you would require HT participation, but exclude CaD (see picture below). As the Venn diagram below illustrates, all of the selected participants were in the HT. Some will overlap with the DM, but the HT participants that were also part of the CaD trial are excluded. OS participants are excluded in this example because there is no overlap between the OS and the CT.

WHI participation example 1.png 

​​​3. Clinical Trial Arms: You can limit the Clinical Trial participants based on trial arm (active vs. control). ​This feature is not available for all levels of Query Builder access. Please contact the Help Desk​ if you have questions.

  • Note that there were two Hormone Trials: (1) Estrogen alone (E alone) for women with a prior hysterectomy, and (2) Estrogen + Progestin (E+P) for women with an intact uterus. Please see the Hormone Trials page for more information.
  • Example: You want to include participants that were in the OS or DM as controls, but exclude all other CT participants (including participants in the active DM arm). In order to do this, you would "exclude" HT and CaD trial participants, but "allow" DM and OS participants. Then, de-select the active arm of the DM trial (see picture below).

 

WHI participation example 2.png ​​

4. Extension Participation: You have the option of limiting the query to specific extension participation. If you do not wish to make this limitation, leave this section blank.

WHI participation - extension participation.png 

  • Core WHI Study (1993-2005) - covered by the initial WHI consent.  Subsequent WHI extensions required separate consent (from existing WHI participants - no new participants were recruited). Make this selection if you want participants that were in the Core WHI study, but NOT in the following extensions.
  • WHI Extension 1 Study 2005-2010.
  • WHI Extension 2 Study 2010-2015​ (see also for a description of the Extension 2 Medical Records and Self Report Cohorts)

5. Cohort/Subsample: You have the option of limiting the query to specific WHI cohorts or subsamples. If you do not wish to make this limitation, leave this section blank.

WHi participation - cohort participation.png 

  • WHI Long Life Study: 7, 875 Medical Records Cohort participants had a home visit (blood collection + clinical and functional assessment) between March 2012 and May 2013. See the Long Life Study page for information.
  • Bone Mineral Density (Osteoporosis sub-study​): See WHI protocol Volume 1, section 1.8 for a description of the Osteoporosis sub-study. Briefly, there were three participating WHI clinics. The OS and CT participants at these clinics had bone densitometry measured and urine collected at the 1st and 3rd clinic visits, and every 3 years thereafter.
  • 6% CT Blood Subsample: All CT participants provided a blood sample at baseline and Year 1. A 6% subsample of CT participants was randomly selected to provide additional blood samples at Year 3, 6, and 9. See the W1 study page for more information.
  • dbGap Eligible: Participants who either (1) consented to the Supplemental Use Consent, (2) did not return the Supplemental Use Consent form, or (3) were deceased at the time it was distributed can have their genetic data submitted to dbGaP. If a participant refused the Supplemental Use Consent, their genetic data cannot be posted to dbGaP.
  • dbGap Commercial Use Eligible: Only those participants who consented to the Supplemental Use Consent may have their genetic information on dbGap used for commercial purposes.


 6. Negate: Press this button if you want to make the criteria you have selected NOT true. The Negate button is available on all ​criteria screens. To undo, simply click the "Undo Negation" button.

WHI participation - negation.png

If you have additional questions that are not answered here, please contact the WHI help desk.