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Women’s Health Initiative: Participant Survey Supplement Opportunity

Request for Questions (RFQ)

September 19, 2013

Due:

October 31, 2013

Decision Date:

November 30, 2013

Overview:

The WHI remains a major and unique resource in advancing our understanding of important risk factors associated with morbidity and mortality, as well as factors associated with successful aging and longevity, among a diverse population of older women. The likelihood of ever re-creating a comparable cohort is extremely low. The extensive characterization of this cohort is without parallel. However, several key “gaps” in the data have been identified, as well as emerging new areas of science and discovery as new research is published and WHI investigators develop papers and ancillary studies. This RFQ solicits inputon critical missing data and specific questions that will advance science and enhance the value of the WHI resources. Although we will review any items that follow the criteria and proposal process provided below, we are especially interested in questions that address the following themes:

Factors that contribute to or are predictive of exceptional longevity

Living well – while living longer

  • Impediments to functioning optimally
  • Strategies and resources to prevent or overcome current & anticipated future impediments

Aging in place – strategies women use to maintain their independent status in their preferred living setting

Family history of major health outcomes tracked in WHI

In considering new items, please be certain the question has not already been asked or if already asked, document the need for repeated measure. Also, focus on whether the items you propose promise to significantly advance the overall science on older women’s health and why WHI is an optimal study in which to address this area.

We expect to receive more items than can be included in the form. Please submit the briefest assessment of the content you are recommending. That way more investigators’ suggestions can be considered for inclusion.

Depending on the time needed to format and print the supplemental questionnaire, and available resources, our goal is to have the next supplement – Form 157 – in place by spring/summer of 2014 or no later than October 1, 2014.

Competitive responses to this RFQ must include the elements listed below and must be submitted on the attached template:

Scientific Rationale

Provide a brief discussion of the area in which there is a critical absence of key informationwithin the WHI resources. This could include items used in the past that have been dropped and/or for which a repeated measure of a specific topic could have dramatically changed between assessments and measuring the change will enhance science. Also, we welcome items or scales never used in WHI to date. Include a review of the relevance of the proposed area(s) to be addressed and theirscientific value. Proposals should focus on how this additional information will significantly advance the science on women and aging, and represent a significant addition to the existing resources available within WHI. If proposed items have been used before, a strong rationale must be provided for repeating them and the formatting must be consistent with the original. Also, in the submitted proposals, investigators must address the limitations associated with the fact that these items will be added to the surviving cohort of WHI participants. Thus, it is critical that proposals demonstrate knowledge of WHI resources and the current, active cohort of participants. Detailed information on the WHI and scientific resources that are available to investigators can be found at Special consideration will be given to ideas/concepts that are synergistic with multiple research questions (as opposed to a single focus).

Competitive proposals must include the specific proposed items or scales, their source, and proprietary considerations as well as data on validity/reliability for proposed scales. If a single item or a list of items that do not represent a validated scale is proposed, information on prior use in existing studies, the acceptability/performance of these items, and the populations on which they’ve been used, must be provided. Special consideration will be given to items that would provide comparative data to other cohorts w/the same items.

Eligible Individuals:

At least one of the PIs/Co-Is on the RFQ must be formally associated with the WHI as either a named investigator or consultant on one of the Regional Centers or the Clinical Coordinating Center contracts. Although not required, a WHI Senior Investigator sponsor is strongly encouraged, as s/he is familiar with the WHI resources/data and able to assist you in developing a competitive proposal. If you have any questions about who would qualify as a senior WHI investigator, send an email query to the WHI Help Desk () with the subject line, Survey Supplement RFQ.

Data Collection & Availability

The items selected from this RFQ will be included as a supplement to Form 33. Note that Form 33 is distributed to all WHI participants on an annual basis. However, the supplemental data will be collected on a single occasion. The supplement will be limited to two pages (printed on both sides). This limitation should be kept in mind when proposing items/scales, recognizing that competition for space will be tight.

It is critical to note that items selected through this mechanism are open to all WHI investigators for use in papers and ancillary study proposals. Proposing successful items does not indicate proprietary “ownership” of the items.That said, it is anticipated that those submitting competitive proposals in response to this RFQ will be well-poised to submit manuscript and ancillary study proposals using these data.

Budget

We anticipate that the inclusion of a two page supplement to Form 33, with scannable questions printed on both sides, will cost approximately $80K. Thus, for example, each quarter page addition will cost approximately $20K.

Responses to this proposal should include an estimate of the cost of the items based on the above estimates and space required for the proposed questions/scales. Although not required, a discussion of potential funding sources is welcomed. These might include support from local institutions, consortia, etc.

Application and Submission Information:

See attached template which is required for all proposals.

Review Process and Timeline:

Proposals are due: October31, 2013 – no items will be considered after that date

Review Process:

  • Proposals will be reviewed bya committee of WHI investigators
  • Recommendations from the committee will be presented to the WHI SC for final review/approval.
  • Investigators will be notified of the decisions by December 1, 2013.

Once a final set of items are approved, the SC will convene a task force to oversee the process and make certain the supplementary form moves forward in a timely fashion.

Submit Proposals via email to: Helen Penor ()

WHI Survey Supplement: RFQ Template

Title:

Date Submitted:

Investigator(s):

(Please indicate with an asterisk all investigators who areformally associated with the WHI as either a named investigator or consultant on one of the Regional Centers or the Clinical Coordinating Center contracts.)

PI

Co-investigators

Contact Information for Principal Investigator:

If Relevant, the Scientific Interest Group involved with the Proposal:

WHI Senior Investigator Sponsor*:

Scientific Rational& Specific Hypotheses (not to exceed 1-single-spaced page of text).

Proposed Item(s)/Scale(s)

Provide the specific items/scales proposed, the sources for these items/scales, data on validity/reliability and populations in which these scales were normed/tested. In addition, provide information on which data derived from WHI can be compared to other cohorts. Further, please discuss issues related to participant burden or risks associated with inclusion of these items in Form 33.

As an attachment, provide a proposed lay-out for the items using 14.0 font. Be certain to include both the wording of the items and all response categories.

Please note if a proposed scale is proprietary and, if it is, the costs associated with its inclusion in the Form 33 supplement.

Budget

  1. Cost for proposed items/scale: Based on formatting and proprietary issues, provide an estimated cost for the inclusion of the items/scales in the Form 33 supplement – assuming a cost of $20K/quarter page.
  2. Do you have access to available resources to fund the proposed questions/items?
  3. ____ No
  4. ____ Yes; if yes:
  5. What amount are you able to cover?
  6. What is (are) the proposed sources?

References:

List references associated with the scientific rationale and the proposed items/scales.

Biosketches:

Please attach biosketches in NIH format for lead investigator

Attach Letter of Support from Senior Investigator Sponsor*

*A WHI Senior Investigator sponsor is not required. However, we strongly encourage you to work with a senior WHI scientist as s/he will be familiar with the WHI resources/data and able to assist you in developing a competitive proposal. If you have any questions about who would qualify as a senior WHI investigator, send an email query to the WHI Help Desk () with the subject line, Survey Supplement RFQ.