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 Q&A About Letter of Intent Part 2

What is the duration of follow-up for the women and children enrolled in this pilot?

Is there a standard template for the Letters of Intent? 

If funded, would the work proposed under the Letter of Intent be included in current contracts or would separate contracts be issued?

If work is funded and included in the current contract, would the financial reporting be done separately or would the work performed be included in the current financial reports for the contract?

If work is funded and included in our current contract, would the technical direct labor reports be done separately or would the work performed be included in the technical direct labor reports that we already are filing for the contract?

Are there plans to include a preconception cohort and if there are what proportion of enrolled women should be in this group?

Will strategies for recruitment include enrolling every eligible woman in all segments?

Are women in designated segments eligible for enrollment until and including the point of delivery?

Is the number of pregnant women enrolled of interest or is it the proportion they represent of all segment pregnancies.

In large Study Centers, the work of contacting/obtaining agreement from all providers serving segments will take more than just a few months (for the provider option) and starting up in June may be unrealistic, if a representative sample is needed.  Will the program office be open to an 18-month or longer pilot study if that is necessary?

What are the planned award dates for the three strategies?

What is the review process for Letters of Intent?

How will the possibility of “contamination” of study populations by forms of recruitment used in the pilot study be handled? For example, it may be that a Study Center would be disadvantaged if after extensive pilot work focused on provider-based recruitment, the intensive involvement with providers ceased and a new recruitment method is introduced. How can a center avoid losing support of providers in such a scenario?

In light of the many Letter of Intent questions from our center alone, and only 12 days until the submission deadline, we think it would be very helpful to have a conference call for Study investigators as soon as possible with Dr. Hirschfield and the program office to help answer questions. Can this be arranged? Our group is open to a weekend or evening teleconference.

Will door to door (household) recruitment be utilized in the High Intensity group for option 3?

In a situation where a High Intensity subject leaves or declines further participation, will the replacement from the Low Intensity pool be restricted to residence within the segment, or can they be enrolled from outside the segment boundaries to join the High Intensity Group?

Is it anticipated there will be any use of health care providers in options 2 and 3?

Please clarify the goals for the Low Intensity sample.

Will the Low Intensity sample need to be similar in terms of particular population characteristics to the segment in which we would conduct the High Intensity study.

The request for Letters of Intent mentioned the possibility of oversampling particular populations. Can you clarify the perceived needs for any oversampling?

What assumptions are to be made about the population representativeness in the High/Low model? Do the women in the Low Intensity group have to be followed by email, telephone, or mail, with no other options used? 

Is recruitment of the High Intensity women also part of this pilot study? 

 

What is the duration of follow-up for the women and children enrolled in this pilot?

For planning purposes assume that women enrolled in this pilot will be contacted until the birth of the subject child, early termination of pregnancy, or in the preconception group for 12 months following enrollment. All participants are considered to be part of the National Children’s Study and it is expected that all will be followed for the full duration of the Study. It is assumed that the duration of the recruitment phase for this pilot will be between 6-9 months. Specific protocols for data collections for children enrolled in this pilot cohort will be defined approximately 1 year prior to implementation of the data collection event.

 

Is there a standard template for the Letters of Intent?

Paper size should not exceed 8 ½ by 11 inches. Two-sided pages count as two pages. Margins should be at least 1 inch at the top and bottom and ½ inch for the right and left sides. The font size shall be no smaller than 11 point.

 

If funded, would the work proposed under the Letter of Intent be included in current contracts or would separate contracts be issued?

The work will be covered under the current contract.

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If work is funded and included in the current contract, would the financial reporting be done separately or would the work performed be included in the current financial reports for the contract?

The work would be included in current financial report or invoice.

 

If work is funded and included in our current contract, would the technical direct labor reports be done separately or would the work performed be included in the technical direct labor reports that we already are filing for the contract?

The work would be included in technical direct labor reports that are already being submitted.

 

Are there plans to include a preconception cohort and if there are what proportion of enrolled women should be in this group?

The initial target set for the Study was 20%. However, the final proportion will be determined empirically based on results of pilots. Please propose a percent that is feasible, up to 20%, for each strategy.

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Will strategies for recruitment include enrolling every eligible woman in all segments?

There are no changes to the first and second stage of sampling. However, it is anticipated that pilot activities will not be conducted in all segments as this large of a sample will not be required to meet the goals of this pilot.

 

Are women in designated segments eligible for enrollment until and including the point of delivery?

Women are eligible until the end of the hospital visit associated with the birth of the child.

 

Is the number of pregnant women enrolled of interest or is it the proportion they represent of all segment pregnancies.

Both endpoints are of interest as are others that relate to feasibility, acceptability and cost.

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In large Study Centers, the work of contacting/obtaining agreement from all providers serving segments will take more than just a few months (for the provider option) and starting up in June may be unrealistic, if a representative sample is needed.  Will the program office be open to an 18-month or longer pilot study if that is necessary?

In urban areas with high population density, it is anticipated that work associated with this pilot study will not be conducted in all segments. Additionally, work may be phased in and the implementation is part of the determination of feasibility. However, 18 months is outside the scope of acceptable.

 

What are the planned award dates for the three strategies?

See Q&A About Letter of Intent Part 1 posted on January 7.

 

What is the review process for Letters of Intent?

These will be tasks under existing contracts. Letters will be considered in development of these tasks by the Program and Contracts staff.

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How will the possibility of “contamination” of study populations by forms of recruitment used in the pilot study be handled? For example, it may be that a Study Center would be disadvantaged if after extensive pilot work focused on provider-based recruitment, the intensive involvement with providers ceased and a new recruitment method is introduced. How can a center avoid losing support of providers in such a scenario?

Study Centers are invited to consider this in their Letter of Intent if they believe it to be relevant to their approach. However, we believe cooperation of providers will be an important component of all recruitment strategies implemented in the main study.

 

In light of the many Letter of Intent questions from our center alone, and only 12 days until the submission deadline, we think it would be very helpful to have a conference call for Study investigators as soon as possible with Dr. Hirschfield and the program office to help answer questions. Can this be arranged? Our group is open to a weekend or evening teleconference.

A conference call has been scheduled for January 15, 2010 at 2:00 p.m. EST.

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Will door to door (household) recruitment be utilized in the High Intensity group for option 3? 

This is not planned, but if proposed in the Letter of Intent, the letter should include justification of need and cost-effectiveness for this approach.

 

In a situation where a High Intensity subject leaves or declines further participation, will the replacement from the Low Intensity pool be restricted to residence within the segment, or can they be enrolled from outside the segment boundaries to join the High Intensity Group?

As currently planned, all participants in the High Intensity Cohort must reside in the segment at the point of enrollment, regardless of when they join that cohort. Low Intensity participants can live either inside or outside of the segments.

 

Is it anticipated there will be any use of health care providers in options 2 and 3?

Yes. Study Centers are invited to explore and propose in their Letters of Intent cost-effective approaches that meet the goals of these pilot studies.

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Please clarify the goals for the Low Intensity sample.

The goals include identifying those who are eligible for the study and have shown interest without going door-to-door; to provide a large pool of participants to replace those who might drop out or refuse to participate in the high intensity sample; and to use a broader base for marketing strategies to reach a larger audience and generate more interest and general awareness of study. The Low Intensity group also provides a base for additional targeted data collections.

 

Will the Low Intensity sample need to be similar in terms of particular population characteristics to the segment in which we would conduct the High Intensity study.

There is currently no requirement for the Low Intensity group to be similar to the High Intensity group.

 

The request for Letters of Intent mentioned the possibility of oversampling particular populations. Can you clarify the perceived needs for any oversampling?

If Study Centers see a need for oversampling in their segments or PSU, submitted Letters of Intent should propose criteria relevant to their location. The Program Office is interested in understanding the feasibility of the approach.

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What assumptions are to be made about the population representativeness in the High/Low model? Do the women in the Low Intensity group have to be followed by email, telephone, or mail, with no other options used?

The High Intensity group would be representative of all births in the study segment. The Low Intensity group may be representative, depending on the specific method proposed. For the Low Intensity group, other options of contact and follow-up can be proposed, and all proposals should include information on feasibility.

 

Is recruitment of the High Intensity women also part of this pilot study?

Yes, the High Intensity National Children’s Study Cohort is a subset of participants in the Low Intensity Study. Women in the Low Intensity group who live in the predefined geographic segments will be invited to participate in the high intensity protocol.

  1/13/2010
  1/13/2010