Adjudicated and Self Reported Outcomes
Self reported outcomes are collected on Form 33. For many of these events medical records were collected and Adjudicated.
The adjudication process, set of outcomes adjudicated, self-reported outcomes, and information on screening procedures collected on Form 33 changed at the start of Extension Study 1, and again at the start of Extension Study 2. The following tables describe the changes.
Tabulations of WHI outcomes by study component and demographic characteristics are available by reviewing our Annual Progress Reports.
C - Centrally adjudicated, L - Locally adjudicated, S - Self-reported
| WHI 1993-2005 | Extension 1 2005-2010 | Extension 2 2010-2020 | Form | |||||
|---|---|---|---|---|---|---|---|---|
| Outcome | HT | DM | CaD | OS | CT/OS | MRC | SRC | |
| CARDIOVASCULAR | ||||||||
| MI | C | L | L | L | C | C | S | 121 |
| Stroke | C | L1 | L1 | C1 | C | C | C2 | 121/132 |
| WHI congestive heart failure | C | L | L | L | S | S | 121 | |
| UNC heart failure | C3 | C3 | C3 | C3 | C3 | C3 | 135/136 | |
| Angina | C | L | L | L | S | S | S | 121 |
| Peripheral artery disease | L | L | L | L | C | C | S | 121 |
| Carotid artery disease | L | L | L | L | C | C | S | 121/132 |
| Coronary revascularization | L | L | L | L | C | C | S | 121 |
| TIA | C | L | L | L | S | S | S | 121/132 |
| Heart valve disease | C | S | 121 | |||||
| Aortic aneurysm/dissection | C | S | 121 | |||||
| CANCER | ||||||||
| Breast cancer | C | C | C | C | C | C4 | C4 | 122/130 |
| Endometrial cancer | C | C | C | C | C | C4 | C4 | 122/130 |
| Colorectal cancer | C | C | C | C | C | C4 | C4 | 122/130 |
| Ovarian cancer | C | C | C | C | C | C4 | C4 | 122/130 |
| All other cancers | C | C | C | C | C | C4 | C4 | 122/130 |
| FRACTURES | ||||||||
| Hip | C | C | C | C | C | C | S | 123 |
| Non-hip fractures | L | L | L | L5 | S | S | S | 123 |
| OTHER | ||||||||
| Pulmonary embolism | C6 | C6 | C6 | C6 | C6 | C | S | 126 |
| Deep vein thrombosis | C6 | C6 | C6 | C6 | C6 | C | S | 126 |
| Hysterectomy | C | S | S | S | C (HT) | S | S | 131 |
| Death from any cause | C | C | C | L | C | C | S | 124 |
- Used central adjudication data when available, and local adjudication data otherwise
- Strokes among SRC participants during the Extension Study 2 were retroactively adjudicated for cases between October 2010 and January 2021. Stroke is now adjudicated across the full WHI cohort through all WHI follow-up.
- Adjudication by UNC is only done for the HT and Black/Hispanic participants.
- Initially all cancers were centrally adjudicated on all Extension Study 2 participants. WHI is currently shifting to use of the NCI Virtual Pooled Registry (VPR) for cancer data. As of June 15, 2023, WHI has stopped adjudicating cancers for the SRC participants that are included in the registry. The published cancer data currently only includes those adjudications that WHI has performed. VPR cancer data compilation and QA is currently underway and access to this data will be at a future date.
- Done only at the BMD centers
- Adjudication of DVT and PE is only done for the HT and Black/Hispanic participants
Self Reported Outcomes not adjudicated by WHI
| Outcome | WHI 1993-2005 | Extension 1 2005-2010 | Extension 2 2010-2020 |
|---|---|---|---|
| Condition | |||
| Atrial fibrillation | - | - | X |
| Cataracts* | X | - | - |
| Colorectal polyps/adenomas | X | X | X |
| COPD | - | - | X |
| Dementia, Alzheimer's | - | X | X |
| Diabetes diagnosis, ever | - | X | - |
| Fainted/blacked out | X | - | - |
| Falls | X | - | X |
| Fractures (non-hip) | X | X | X |
| Gallbladder disease/stones | X | - | - |
| Glaucoma | X | - | - |
| Kidney/bladder stones* | X | - | - |
| Macular degeneration | - | X | X |
| Osteoarthritis* | X | X | X |
| Osteoporosis | X | - | - |
| Parkinson's disease | - | X | X |
| Rheumatoid arthritis | X | - | - |
| SLE | X | X | X |
| Exams/Procedures | |||
| Barium enema X-ray* | X | X | - |
| Blood in stool | X | X | X |
| Blood pressure* | X | - | - |
| Bone density scan | - | X | X |
| Breast biopsy/aspiration | X | X | X |
| Breast exam | X | X | X |
| Breast exam, other (MRI/ ultrasound) | - | X | X |
| Cholesterol | X | - | - |
| D&C | X | X | - |
| ECG | X | - | - |
| Endometrial biopsy | X | X | X |
| Eye exam* | X | - | - |
| Flex sig/colonoscopy | X | X | X |
| Hysterectomy | X (non HT) | X (non HT) | X |
| Mammogram | X | X | X |
| PAP smear | X | - | - |
| Physical exam* | X | - | - |
| Rectal exam | X | X | - |
| Medication/treatments | |||
| Anxiety pills | - | X | - |
| Depression pills/therapy | - | X | - |
| Diabetes, diet/exercise | - | X | X |
| Diabetes, insulin | X | X | X |
| Diabetes, pills* | X | X | X |
| Estrogen pills | - | X | - |
| High blood pressure pills* | X | X | X |
| High cholesterol pills | - | X | - |
| Shots for DVT* | X | - | - |
| Osteoporosis calcium pills | - | X | - |
| Osteoporosis non-calcium pills | - | X | - |
Outcome adjudication Forms
Adjudication Forms |
|---|
| Adjudication Forms120 - Initial Notification of Death |
| Adjudication Forms120H - Hospitalization Supplement |
| Adjudication Forms121 - Report of Cardiovascular Outcome |
| Adjudication Forms122 - Report of Cancer Outcome |
| Adjudication Forms123 - Report of Fracture Outcome |
| Adjudication Forms124 - Final Report of Death |
| Adjudication Forms126 - Report of Venous Thromboembolic Disease (HRT) |
| Adjudication Forms130 - Cancer Surveillance Form |
| Adjudication Forms132 - Central Report of Stroke Outcome |
| Adjudication Forms135 - UNC Heart Failure |
| Adjudication Forms136 - UNC Heart Failure Abstract |
