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Using WHI Outcomes Data

Using WHI Outcomes Data. Rebecca Rodabough May 6, 2009. Focus on:. What has been collected in WHI Which outcomes are adjudicated What data is available on the website - Format - How to use. Clinical Outcomes in the CT. Defined as: primary or secondary

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Using WHI Outcomes Data

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  1. Using WHI Outcomes Data Rebecca Rodabough May 6, 2009

  2. Focus on: • What has been collected in WHI • Which outcomes are adjudicated • What data is available on the website - Format - How to use

  3. Clinical Outcomes in the CT • Defined as: primary or secondary • Each study component (HT, DM, CaD) has 1 or 2 primary, and multiple secondary

  4. Clinical Outcomes in the OS • Same outcomes collection process as in the CT • No primary/secondary designation • Fewer outcomes are adjudicated

  5. Adjudication and Confirmation • Most outcomes start as a self-report on Form 33 •  Form 33D used to collect more information •  Defined set of medical records obtained for selected outcomes • Adjudication process confirms or denies the self-report (two levels: local and central)

  6. Cardiovascular Outcomes

  7. Subsequent Condition Rule • Angina occurring on or after the same date as an MI is CENSORED (i.e. not counted) • Carotid artery disease on or after the same date as a stroke is CENSORED (i.e. not counted)

  8. Cancer Outcomes

  9. Subsequent Condition Rule • In situ breast cancer occurring on or after the same date as an invasive breast cancer is CENSORED (i.e. not counted)

  10. Fracture Outcomes * Only for participants at the 3 BMD clinical centers

  11. Other Outcomes • 1º - Primary outcome • 2º - Secondary outcome • C – Centrally adjudicated • L – Locally adjudicated • S – Self-report

  12. Self-reported Outcomes • Source: Form 33, question 8 • “Since the date given on the front of this form, has a doctor told you for the first time that you have any of the following specific conditions?” • Glaucoma, osteoporosis, osteoarthritis, rheumatoid arthritis, intestine or colon polyps or adenomas, gallbladder disease or gallstones, lupus, kidney or bladder stones, cataracts

  13. Self-reported Outcomes (cont.) • Source: Form 33, question 9 • “Since the date given on the front of this form, has a doctor prescribed for the first time any of the following pills or treatments? • Pills for diabetes, insulin shots for diabetes, pills for high blood pressure

  14. Other Sources of Outcomes Data • ECG results (CT only) • BMD results from DEXA (subset of CT & OS at 3 clinical centers) • Form 33, question 3 (falls), question 10 (exams, tests, and procedures) • OS follow-up questionnaires (Form 48, Forms 143-149) – 19 conditions

  15. Outcomes Data on WHIOPS • Clinical outcomes data files: Not ‘Form’ level data One record per participant • Outc_adj_ctos_inv.dat • Outc_self_ctos_inv.dat • Outc_adj_cad_inv.dat • Outc_self_cad_inv.dat • (Corresponding ‘.sas’, and ‘.pdf’ files)

  16. CaD Trial Outcomes • 91% of CaD participants were randomized at year 1 of the CT • 8% at year 2 of the CT • 1 % at other visits Timing of events in CaD participants uses CaD randomization date as the starting point

  17. Format of data for each outcome • Two variables: • Indicator that outcome occurred (yes/no) • Days from randomization to date of outcome * Some outcomes have a third variable that tells type of adjudication IMPORTANT: Outcomes are first occurrence only Outcome from ‘best’ adjudication only

  18. Actual Data

  19. Uses of Outcomes Variables • Get counts of outcomes (may want to include COD only events) • Compare timing of events using ‘days’ variables • In ‘time-to-event’ analyses (survival)

  20. EXAMPLE #1: Creating a time-to-event variable Outcome of interest: MI => had event (MI=1), misurvtm=MIDY => no event (MI=0), censored (follow-up ends because of death or last contact) if death=1 then misurvtm=DEATHDY else misurvtm=LAST33DY

  21. EXAMPLE #2: Creating time-to-event variables for a composite outcome Outcome of interest: MI or CABG micabg=Max(MI, CABG) => had event (MI=1 or CABG=1) micabgtm=Min(MIDY, CABGDY) => no event (MI=0 and CABG=0) if death=1 then micabgtm=DEATHDY else micabgtm=LAST33DY

  22. Additional Information • Detailed information on specific outcomes to be added (aiming for Fall) includes data from Forms 121, 122, 123, 124, 126, 130, 131, 132 • Documentation available on outcomes definitions, and entire adjudication process • Useful source of information: Outcomes chapter in the baseline monograph

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