Outcomes
Overview
Clinical outcomes in the WHI are identified in the table below as 1° (primary outcomes with sufficient power for detection in a specific Clinical Trial component) or 2° (secondary outcomes of interest or a composite of primary and secondary outcomes). All clinical outcomes were monitored in all WHI components and, as indicated in the table, were adjudicated (either locally only (L) or locally and centrally(C)), except diabetes mellitus requiring medication, which was obtained by self report. Other clinical events were also ascertained by self-report (see Form 33 - Medical History Update).
WHI Clinical Outcomes
| Outcome |
HT |
DM |
CaD |
OS |
Form |
|---|
| CARDIOVASCULAR: |
|---|
| Coronary heart disease |
1° - C |
2° - L |
L |
L |
121 |
| Stroke |
2° - C |
2° - L |
L |
C |
121/132 |
| Congestive heart failure |
2° - C |
2° - L |
L |
L |
121 |
| Angina |
2° - C |
2° - L |
L |
L |
121 |
| Peripheral vascular disease |
2° - L |
2° - L |
L |
L |
121 |
| Carotid artery disease |
L |
L |
L |
L |
121 |
| Coronary revascularization |
2° - C |
2° - L |
L |
L |
121 |
| Total cardiovascular |
2° |
2° |
|
|
|
CANCER: |
|---|
| Breast cancer |
2° - C |
1° - C |
2° - C |
C |
122/130 |
| Endometrial cancer |
2° - C |
2° - C |
C |
C |
122/130 |
| Colorectal cancer |
C |
1° - C |
2° - C |
C |
122/130 |
| Ovarian cancer |
2° - C |
2° - C |
C |
C |
122/130 |
| Other cancers |
L |
L |
L |
L |
122 |
| Total cancers |
2° |
2° |
2° |
|
|
FRACTURES: |
|---|
| Hip |
2° - C |
C |
1° - C |
C |
123 |
| Other fractures |
2° - L |
L |
2° - L |
L |
123 |
| Total fractures |
2° |
|
2° |
|
|
OTHER: |
|---|
| Pulmonary embolism |
2° - C |
|
|
|
126 |
| Deep vein thrombosis |
2° - C |
|
|
|
126 |
| Diabetes mellitus requiring therapy |
S |
2° - S |
S |
S |
33 |
| Death from any cause |
2° - C |
2° - C |
2° - C |
L |
124 |
- 1° - Primary outcome
- 2° - Secondary outcome
- C - Centrally adjudicated
- L - Locally adjudicated
- S - Self-report
Ascertainment
All WHI clinical outcomes were identified by self-report on the routine Form 33 - Medical History Update administered semi-annually to Clinical Trial (CT) participants and annually to Observational Study (OS) participants. Those participants who reported a potential WHI-defined outcome were then contacted by mail or phone and a Form 33D – Medical History Update (Detail) was completed to obtain more specific information on newly diagnosed health conditions or recent procedures.
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. A documentation set was defined for each type of WHI clinical outcome, and these medical records were used for adjudication (see Related Documents, below).
Adjudication:
Local Adjudication
Based on specific adjudication criteria (see WHI Manuals, below), a physician adjudicator at the local Clinical Center either confirmed or denied a potential clinical outcome. Data on confirmed WHI outcomes were entered on outcomes-specific forms for cardiovascular disease, cancer, fracture, hysterectomy, venous thromboembolic disease, as well as hospitalizations and deaths. Central Adjudication
WHI Clinical Centers were asked to send selected locally adjudicated case packets to the Clinical Coordinating Center for central adjudication, depending on the type of outcome and the participant’s study component. Centrally-trained cardiovascular physician adjudicators (and neurologists, in the case of stroke outcomes) reviewed and adjudicated cardiovascular and death outcomes. The five primary cancers (breast, colon, rectum, endometrium, and ovary) were coded centrally by tumor registry coders. All hip fractures were centrally adjudicated at the WHI Bone Density Center.
Related publications
Baseline monograph
- 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.
See also
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