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WHI Extension Study Participants and Data

WHI Extension Study Participants and Data. Mary Pettinger 5/6/2009. Extension Study Objectives. Long term effects of the CT interventions Effect of original CT interventions on rarer clinical events Experience of HT women after stopping study pills Enhance WHI resource and its utilization.

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WHI Extension Study Participants and Data

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  1. WHI Extension StudyParticipants and Data Mary Pettinger 5/6/2009

  2. Extension Study Objectives Long term effects of the CT interventions Effect of original CT interventions on rarer clinical events Experience of HT women after stopping study pills Enhance WHI resource and its utilization

  3. Transition from WHI to the Extension Study CT: Consent obtained at closeout visit (Oct. 2004 – Mar. 2005) OS: Consent included in annual mailing (Apr. 2004 – Spring 2005)

  4. Consent Status by Study Component

  5. Characteristics of Extension Study Participants

  6. What data are collected during the Extension? Driven by study objectives

  7. Extension Study Frequency of Data Collection Key X = All Participants D = DM H = HT % = Percentage (subsample ) of participants

  8. Form 150 – Hormone use Update=> Collect detailed information on hormone use: type, frequency, duration, reason for use=> plus natural hormone use, and other medications for bone conditions

  9. Form 151 – Activities of Daily Living => Two-page form with aging related questions (QOL and functioning) => Majority of questions were also asked on Forms 37&38 – allows longitudinal analysis (includes Rand-36 PHYSFUN construct)

  10. Extension Study OutcomesChanges from WHI • During WHI, had local and central adjudication => Now central only • Some outcomes no longer adjudicated => Now self-report only => New self-reported outcomes added

  11. Important!!! Extension study outcomes are the first occurrence since WHI enrollment or randomization, NOT since consenting to the extension study.

  12. Cardiovascular

  13. Cancer and Fractures

  14. Other Age-related Diseases

  15. Other

  16. Implications for using the Extension Study Outcomes in Analyses Change in outcomes collection: Do you want to combine adjudicated and self-reported events? Are outcomes now compatible, i.e. inpatient requirement?

  17. Analysis of CT Interventions => No longer have the original, balanced treatment groups in the Extension Study

  18. Consent Status by Study Arm

  19. How to account for differences in participant characteristics? Potential for selection bias => May need to include adjustment variables in modeling

  20. How to account for differences in length of follow-up? Mean years of follow-up as of August 08: In Extension - 11.3 yrs Not in Extension - 6.9 yrs => In time-to-event analyses, taken into account by censoring

  21. When will Extension Study data be available on www.whiops.org? Includes: Updated outcomes data files Form 134, 150 and 151 data files

  22. What’s next ? • Medication inventory update • CMS (Medicare) data • SHARe

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