9/17/2015 1 Access WHI: Proposing Analyses and Ancillary Studies Andrea Z. LaCroix, PhD Professor of...

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Access WHI:Access WHI:Proposing Analyses and Ancillary Proposing Analyses and Ancillary

StudiesStudies

Andrea Z. LaCroix, PhDAndrea Z. LaCroix, PhDProfessor of Epidemiology and Co-PIProfessor of Epidemiology and Co-PI

WHI Clinical Coordinating CenterWHI Clinical Coordinating CenterFred Hutchinson Cancer Research CenterFred Hutchinson Cancer Research Center

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7 Simple Steps for Getting Started7 Simple Steps for Getting Started

1.1. Envision your research question, read Envision your research question, read existing literatureexisting literature

2.2. Assess whether WHI data resources can Assess whether WHI data resources can contribute to answering this questioncontribute to answering this question

3.3. Develop a paper proposalDevelop a paper proposal

4.4. Find a collaborator/sponsorFind a collaborator/sponsor

5.5. Submit your proposal to P&PSubmit your proposal to P&P

6.6. Establish your writing groupEstablish your writing group

7.7. Analyze the data and write your paper!Analyze the data and write your paper!

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Envision Your Research Question

Example:

Does coffee consumption increase risk of coronary heart disease in postmenopausal women?

5

Background Meta-analysisBackground Meta-analysis

J. Wu et al. / International Journal of Cardiology 137 (2009) 216–225

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Check WHI Publications for OverlapCheck WHI Publications for Overlap

All publicationsAll publications

www.whi.org/bibliography/SitePages/Publications and Paper Proposals (Excel).aspx

Presented as an Excel-style worksheetPresented as an Excel-style worksheet Search by using CTRL-FSearch by using CTRL-F Approved papers in progress will not Approved papers in progress will not

appear here; these must be checked by a appear here; these must be checked by a WHI investigator on the internal websiteWHI investigator on the internal website

Joshua Loomis

Both approved proposals and existing manuscripts are listed here. Only WHI investigators with appropriate rights can download and view the documents, however.

Joshua Loomis

Just a bit more description, since it looks different than it had before.

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Evaluating WHI Data ResourcesEvaluating WHI Data Resources

Understand the different WHI Program Understand the different WHI Program components (Clinical Trial, Observational components (Clinical Trial, Observational Study)Study)

Check the data collection schedule for the Check the data collection schedule for the timing of form administrationtiming of form administration

Determine whether the outcome of Determine whether the outcome of interest is measured in WHI by self-report interest is measured in WHI by self-report and/or medical record adjudicationand/or medical record adjudication

Determine whether and how the exposure Determine whether and how the exposure of interest is measured in WHIof interest is measured in WHI

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www.whi.org is your friend

Program components:Program components:

www.whi.org/about

Data collection scheduleData collection schedule

www.whi.org/data/Documents/collection_frequency_grid.pdf

OutcomesOutcomes

www.whi.org/about/SitePages/Outcomes.aspx

Exposures and covariatesExposures and covariates

www.whi.org/data/Documents/Data variables by form.pdf

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WHI Paper ProposalsWHI Paper Proposals

Step-by-step process is described in this Step-by-step process is described in this document:document:

www.whi.org/researchers/Documents Write www.whi.org/researchers/Documents Write a Paper/pp_schematic.pdfa Paper/pp_schematic.pdf

It is useful to be working with a WHI It is useful to be working with a WHI investigator during proposal development.investigator during proposal development.

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WHI Paper ProposalsWHI Paper Proposals

Paper proposals should include:Paper proposals should include: BackgroundBackground

Assessment of any overlapsAssessment of any overlaps ObjectivesObjectives

Hypotheses, if appropriateHypotheses, if appropriate Pertinent variablesPertinent variables Analysis planAnalysis plan Interpretation issuesInterpretation issues Table and figure shellsTable and figure shells

Follow the detailed template:Follow the detailed template:www.whi.org/researchers/Documents Write a Paper/proposal_template.pdfwww.whi.org/researchers/Documents Write a Paper/proposal_template.pdf

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Find a WHI Collaborator/SponsorFind a WHI Collaborator/Sponsor

Call a WHI Principal Investigator who…Call a WHI Principal Investigator who… Has published in your area of interestHas published in your area of interest Is affiliated with your institutionIs affiliated with your institution Leads a regional center in your areaLeads a regional center in your area Leads a focus group in your area of Leads a focus group in your area of

interestinterest

Check this part of the WHI website:Check this part of the WHI website:www.whi.org/researchers/SitePages/WHI Investigators.aspxwww.whi.org/researchers/SitePages/WHI Investigators.aspx

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Submitting your WHI Manuscript Proposal

E-mail document to [email protected] 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

Joshua Loomis

I believe these might go to Annie Brandjord now, [email protected].

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.

How to Propose a WHI Ancillary Study

Read about the process online: www.whi.org/researchers/SitePages/Ancillary Studies

Overview.aspx

Check ongoing and completed research: www.whi.org/researchers/SitePages/Current and

Completed Studies.aspx

Find a WHI collaborator/sponsor

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.

Conclusions

The WHI Data Resource is vast; many topics have yet to be explored.

Follow the directions on 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)

9/17/2015 1 Access WHI: Proposing Analyses and Ancillary Studies Andrea Z. LaCroix, PhD Professor of...

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