1. 9/17/2015 1 Access WHI: Proposing Analyses and Ancillary Studies Andrea Z. LaCroix, PhD Professor of Epidemiology and Co-PI WHI Clinical Coordinating Center Fred Hutchinson Cancer Research Center

2. 9/17/2015 2 7 Simple Steps for Getting Started 1. Envision your research question, read existing literature 2. Assess whether WHI data resources can contribute to answering this question 3. Develop a paper proposal 4. Find a collaborator/sponsor 5. Submit your proposal to P&P 6. Establish your writing group 7. Analyze the data and write your paper!

3. 9/17/2015 3 7 Simple Steps for Getting Started 1. Envision your research question, read existing literature 2. Assess whether WHI data resources can contribute to answering this question 3. Develop a paper proposal 4. Find a collaborator/sponsor 5. Submit your proposal to P&P 6. Establish your writing group 7. Analyze the data and write your paper!

4. Envision Your Research Question Example: Does coffee consumption increase risk of coronary heart disease in postmenopausal women?

5. 5 Background Meta-analysis J. Wu et al. / International Journal of Cardiology 137 (2009) 216–225

6. 9/17/2015 6 Check WHI Publications for Overlap All publications All publications www.whi.org/bibliography/SitePages/Publications and Paper Proposals (Excel).aspx www.whi.org/bibliography/SitePages/Publications and Paper Proposals (Excel).aspx Presented as an Excel-style worksheet Presented as an Excel-style worksheet Search by using CTRL-F Search by using CTRL-F Approved papers in progress will not appear here; these must be checked by a WHI investigator on the internal website Approved papers in progress will not appear here; these must be checked by a WHI investigator on the internal website

7. 9/17/2015 7 7 Simple Steps for Getting Started 1. Envision your research question, read existing literature 2. Assess whether WHI data resources can contribute to answering this question 3. Develop a paper proposal 4. Find a collaborator/sponsor 5. Submit your proposal to P&P 6. Establish your writing group 7. Analyze the data and write your paper!

8. 9/17/2015 8 Evaluating WHI Data Resources Understand the different WHI Program components (Clinical Trial, Observational Study) Understand the different WHI Program components (Clinical Trial, Observational Study) Check the data collection schedule for the timing of form administration Check the data collection schedule for the timing of form administration Determine whether the outcome of interest is measured in WHI by self-report and/or medical record adjudication Determine whether the outcome of interest is measured in WHI by self-report and/or medical record adjudication Determine whether and how the exposure of interest is measured in WHI Determine whether and how the exposure of interest is measured in WHI

9. 9/17/2015 9 www.whi.orgwww.whi.org is your friend www.whi.org Program components: Program components: www.whi.org/about Data collection schedule Data collection schedule www.whi.org/data/Documents/collection_frequency_grid.pdf Outcomes Outcomes www.whi.org/about/SitePages/Outcomes.aspx Exposures and covariates Exposures and covariates www.whi.org/data/Documents/Data variables by form.pdf www.whi.org/data/Documents/Data variables by form.pdf

10. 9/17/2015 10 7 Simple Steps for Getting Started 1. Envision your research question, read existing literature 2. Assess whether WHI data resources can contribute to answering this question 3. Develop a paper proposal 4. Find a collaborator/sponsor 5. Submit your proposal to P&P 6. Establish your writing group 7. Analyze the data and write your paper!

11. 9/17/2015 11 WHI Paper Proposals Step-by-step process is described in this document: www.whi.org/researchers/Documents Write a Paper/pp_schematic.pdf www.whi.org/researchers/Documents Write a Paper/pp_schematic.pdf It is useful to be working with a WHI investigator during proposal development.

12. 9/17/2015 12 WHI Paper Proposals Paper proposals should include: Background Background Assessment of any overlaps Assessment of any overlaps Objectives Objectives Hypotheses, if appropriate Hypotheses, if appropriate Pertinent variables Pertinent variables Analysis plan Analysis plan Interpretation issues Interpretation issues Table and figure shells Table and figure shells Follow the detailed template: www.whi.org/researchers/Documents Write a Paper/proposal_template.pdf www.whi.org/researchers/Documents Write a Paper/proposal_template.pdf

13. 9/17/2015 13 7 Simple Steps for Getting Started 1. Envision your research question, read existing literature 2. Assess whether WHI data resources can contribute to answering this question 3. Develop a paper proposal 4. Find a collaborator/sponsor 5. Submit your proposal to P&P 6. Establish your writing group 7. Analyze the data and write your paper!

14. 9/17/2015 14 Find a WHI Collaborator/Sponsor Call a WHI Principal Investigator who… Has published in your area of interest Has published in your area of interest Is affiliated with your institution Is affiliated with your institution Leads a regional center in your area Leads a regional center in your area Leads a focus group in your area of interest Leads a focus group in your area of interest Check this part of the WHI website: www.whi.org/researchers/SitePages/WHI Investigators.aspx www.whi.org/researchers/SitePages/WHI Investigators.aspx

15. 9/17/2015 15 7 Simple Steps for Getting Started 1. Envision your research question, read existing literature 2. Assess whether WHI data resources can contribute to answering this question 3. Develop a paper proposal 4. Find a collaborator/sponsor 5. Submit your proposal to P&P 6. Establish your writing group 7. Analyze the data and write your paper!

16. Submitting your WHI Manuscript Proposal E-mail document to abrandjo@WHI.org@WHI.org WHI P&P Committee review calls occur twice monthly Once approved, writing group members will be solicited from the WHI community of investigators (plus selected co-authors of your choice) Analysis can proceed at CCC, regionally, or locally; data is accessed via secure website

17. WHI Ancillary Studies Definition: A WHI ancillary study (AS) is any study that requires the collection of additional data from participants enrolled in any WHI component, including data obtained from the analysis of existing biological specimens.

18. How to Propose a WHI Ancillary Study Read about the process online: www.whi.org/researchers/SitePages/Ancillary Studies Overview.aspxwww.whi.org/researchers/SitePages/Ancillary Studies Overview.aspx Check ongoing and completed research: www.whi.org/researchers/SitePages/Current and Completed Studies.aspxwww.whi.org/researchers/SitePages/Current and Completed Studies.aspx Find a WHI collaborator/sponsor

19. Ancillary Study Considerations Biospecimen resources (blood, urine, DNA) are limited. Consider how to reduce specimen requests. Additional data collection from participants requires OSMB approval and usually additional participant consent. Both types of studies require CCC effort to support study activities and coordination.

20. Conclusions The WHI Data Resource is vast; many topics have yet to be explored. Follow the directions on www.whi.org.www.whi.org The WHI Investigator group stands ready to collaborate with prepared investigators. Forthcoming data will expand opportunities greatly (CMS data, in-person visit)