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Women’s Health Initiative: Participant Supplemental Questionnaire 2018
Updated Request for Questions (RFQ) Distributed 5/30/17
Special Emphasis: Resilience & Aging Well
Due:
Monday, June 12, 2017 (extended due date)
Submit proposals and supporting material via email to: Helen Penor ().
Decisions made and responders notified:
July-August 2017
Implementation:
January 2018-December 2018, mailed with Form 33 – Medical History Update
Data available:
Summer/Fall 2019
RFQ: Supplemental Questionnaire 2018
This RFQ solicits input on critical missing data and specific questions that will advance science and enhance the value of the WHI resources. Although the special emphasis of this solicitation is on resilience, aging well, well-being, and what works in the lives of our WHI participants, compelling scientific arguments for questions that do not specifically align with this theme will be considered. Special consideration may be given to proposed items that could be used in the development of a randomized controlled trial (RCT) or Observational ancillary study.
This will be the fourth supplemental questionnaire during the WHI Extensions, Form 159 Supplemental Questionnaire 2018. Copies of the previous questionnaires, Form 156 Supplemental Questionnaire, Form 157 Supplemental Questionnaire 2014-2015 and Form 158 Supplemental Questionnaire 2017 can be linked directly from this document or found on the WHI website under the Researchers tab, WHI Forms. The Supplemental Questionnaires are distributed to WHI participants with their annual mailings. Supplemental Questionnaire data for Forms 156 and 157 are currently available to investigators with approved paper proposals. Form 158 is currently in the field through 2017 with data becoming available summer or fall 2018. Data from the supplemental questionnaires have been used as preliminary data for grant proposals and as topics for manuscripts. Data for Form 159 will become available in summer or fall 2018.
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 information within 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 their scientific 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 (n=77,203; WHI 2016 Progress Report, pages 1-8, WHI website, for age, race/ethnicity distributions). 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 www.whi.org.
Competitive proposals must include the specific proposed items or scales, their source, and proprietary considerations, such as permissions or cost for use that may be needed, 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.
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, Supplemental Questionnaire 2018 RFQ.
Data Collection, Participant Burden and Data Availability
The items selected from this RFQ will be included as a supplemental questionnaire with Form 33. Note that Form 33 is distributed to all WHI participants on an annual basis. The supplement will be limited to two pages (single piece of paper printed on both sides), respecting participant burden. The page limitation should be kept in mind when proposing items/scales, recognizing that competition for space will be tight. Additionally, as with all WHI forms, this supplement will be a scannable form, and items with defined categorical responses are preferable; manually data-entered items may add costs to the form that would be the responsibility of the investigator.
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. With 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.
Space Estimates and Budget
OMB review is no longer required for WHI and thus WHI contract funds can be used. There are no costs to the investigators for a 2 page (single piece of paper printed on both sides) scannable supplemental form in 14-point font to be added to the Form 33 annual mailing. Costs related to fee-associated proprietary questions and non-categorical manual or non-scannable data entry are the responsibility of the investigator.
Responses to this proposal should include an estimate of the space required for the proposed questions/scales. If there are fee-associated costs for proprietary questions or non-categorical manual or non-scannable data entry costs, cost should be also included with the investigator response.
Application and Submission Information
See attached template which is required for all proposals.
Review Process and Timeline
Ø Proposals are due: June 12, 2017
Ø Review Process:
o Proposals will be reviewed by a committee of WHI investigators.
o Recommendations from the committee will be presented to the WHI SC for final review/approval.
o Investigators to be notified of decisions July/August 2017.
Ø Mailing will occur with Form 33-Medical History Update; begins January 2018 and continues through 2018.
Ø Data will be posted to the WHI investigator datasets in summer/fall 2018.
Submit proposals and supporting material no later than June 12, 2017 via email to:
Helen Penor ()
WHI RFQ Template for Form 159 Supplemental Questionnaire 2018: RFQ Template
Title:
Date submitted:
Investigator(s):
(Please indicate with an asterisk all investigators who are formally 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 layout for the items using 14.0 pt. 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, permissions and/or the costs associated with its inclusion in the Form 33 supplement.
Space and Budget:
1. Space requested, e.g., 1/8 page, ¼ page, ½ page, etc.
2. Cost for any proposed fee-associated proprietary items/scale or manual non-categorical non-scannable data entry.
3. Do you have access to available resources to fund the proposed fee-associated proprietary questions/items or manual non-categorical non-scannable data entry?
a. ____ No
b. ____ Yes; if yes:
i. What amount are you able to cover?
ii. What is (are) the proposed funding sources?
References:
List references associated with the scientific rationale and the proposed items/scales.
Biosketches:
Please attach biosketches in NIH format for lead investigator(s).
Attach Letter of Support from WHI 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, Supplemental Questionnaire 2018 RFQ.