Data Collection

Data were collected from WHI participants via self-administered forms, in-person interviews, and clinical measurements. The Frequency of Data Collection table outlines the contacts at which these procedures were conducted, specified by WHI study component. The Participant Characteristics over Time document provides additional details about the data collection schedule during the WHI study and extension periods. Detailed procedures for collecting data from WHI participants are documented in Study Manuals.

Biospecimen Collection

Specimens collected from WHI participants are maintained in a biorepository in Rockville, MD. The sample inventory is tracked via a WHI Specimen Tracking database, which includes variables associated with the specimens, such as number of fasting hours before blood draw, extraction and quantitation method, and number of freeze/thaw cycles. All biospecimens collected from WHI participants are available for use by Ancillary Studies (ASs) based on scientific merit. To access WHI biospecimens, investigators must have an approved and funded ancillary study. See our Propose an Ancillary Study page for details.

To explore existing specimen results that are available in the WHI datafiles, see the Specimen Results page.

For more details about biospecimen collection and availability, see the Biospecimen page.

Outcomes

All WHI clinical outcomes were identified by self-report on the routine Form 33 - Medical History Update, which was administered semi-annually to Clinical Trial (CT) participants and annually to Observational Study (OS) participants during the main study period. During Extension Studies 1 and 2, Form 33 was collected annually for all participants. More specific information on newly diagnosed health conditions or recent procedures is collected from participants who report a potential WHI-defined outcome.

Investigation of potential WHI clinical outcomes depended on the type of outcome, the participant’s study component, and whether or not the outcome was a first versus a recurrent event.

To explore the outcomes collected in WHI, see our Outcome Collection page.

Related Publications:

Curb D, McTiernan A, Heckbert S, Kooperberg C, Stanford J, Nevitt M, Johnson K, Proulx-Burns L, Pastore L, Criqui M, Daugherty S. Outcomes Ascertainment and Adjudication Methods in the WHI. Ann Epidemiol 2003;13:S122-S128.