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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. 7 Simple Steps for Getting Started. Envision your research question, read existing literature

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access whi proposing analyses and ancillary studies

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

7 simple steps for getting started
7 Simple Steps for Getting Started
  • Envision your research question, read existing literature
  • Assess whether WHI data resources can contribute to answering this question
  • Develop a paper proposal
  • Find a collaborator/sponsor
  • Submit your proposal to P&P
  • Establish your writing group
  • Analyze the data and write your paper!
7 simple steps for getting started1
7 Simple Steps for Getting Started

Envision your research question, read existing literature

Assess whether WHI data resources can contribute to answering this question

Develop a paper proposal

Find a collaborator/sponsor

Submit your proposal to P&P

Establish your writing group

Analyze the data and write your paper!

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envision your research question
Envision Your Research Question

Example:

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

background meta analysis
Background Meta-analysis

5

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

check whi publications for overlap
Check WHI Publications for Overlap

All publications

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

Presented as an Excel-style worksheet

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

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7 simple steps for getting started2
7 Simple Steps for Getting Started

Envision your research question, read existing literature

Assess whether WHI data resources can contribute to answering this question

Develop a paper proposal

Find a collaborator/sponsor

Submit your proposal to P&P

Establish your writing group

Analyze the data and write your paper!

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evaluating whi data resources
Evaluating WHI Data Resources

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

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 and how the exposure of interest is measured in WHI

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www whi org is your friend
www.whi.org is your friend

Program components:

www.whi.org/about

Data collection schedule

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

Outcomes

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

Exposures and covariates

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

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7 simple steps for getting started3
7 Simple Steps for Getting Started

Envision your research question, read existing literature

Assess whether WHI data resources can contribute to answering this question

Develop a paper proposal

Find a collaborator/sponsor

Submit your proposal to P&P

Establish your writing group

Analyze the data and write your paper!

10

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whi paper proposals
WHI Paper Proposals

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

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

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

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whi paper proposals1
WHI Paper Proposals

Paper proposals should include:

Background

Assessment of any overlaps

Objectives

Hypotheses, if appropriate

Pertinent variables

Analysis plan

Interpretation issues

Table and figure shells

Follow the detailed template:

www.whi.org/researchers/Documents Write a Paper/proposal_template.pdf

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7 simple steps for getting started4
7 Simple Steps for Getting Started

Envision your research question, read existing literature

Assess whether WHI data resources can contribute to answering this question

Develop a paper proposal

Find a collaborator/sponsor

Submit your proposal to P&P

Establish your writing group

Analyze the data and write your paper!

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find a whi collaborator sponsor
Find a WHI Collaborator/Sponsor

Call a WHI Principal Investigator who…

Has published in your area of interest

Is affiliated with your institution

Leads a regional center in your area

Leads a focus group in your area of interest

Check this part of the WHI website:

www.whi.org/researchers/SitePages/WHI Investigators.aspx

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7 simple steps for getting started5
7 Simple Steps for Getting Started

Envision your research question, read existing literature

Assess whether WHI data resources can contribute to answering this question

Develop a paper proposal

Find a collaborator/sponsor

Submit your proposal to P&P

Establish your writing group

Analyze the data and write your paper!

15

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submitting your whi manuscript proposal
Submitting your WHI Manuscript Proposal
  • E-mail document to abrandjo@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
whi ancillary studies
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
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
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
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)