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How does the PRO Core relate to the ECHO Program as a whole?

• The PRO Core is responsible for maintaining and providing PROs, assisting with the incorporation of PROs into study design, coordinating the mode of administration, and updating existing and validating emerging child PROs.
• The PD(s)/PI(s) of the PRO Core will report to and obtain input from the ECHO Steering Committee (including the Executive Committee), the External Scientific Board, the ECHO Coordinating Center PD/PI, the ECHO Data Analysis Center PD/PI, the ECHO Genetics Core PD/PI, the ECHO CHEAR Core PD/PI, the ECHO Pediatric Cohort site PDs/PIs, and the IDeA States Pediatric Clinical Trials Network Data Coordinating and Operations Center (DCOC) PD/PI.
• The PRO Core will have representation on the Executive Committee of the Steering Committee, the broader Steering Committee, and several Steering Committee subcommittees, including the Data Measurement and Sharing, Biostatistics and Design, and Publications subcommittees.

How does the PRO Core relate to the PEPR Program?

• Investigators interested in responding to this FOA are encouraged to review the description and scope of the Pediatric Patient-Reported Outcomes in Chronic Diseases (PEPR) Consortium and address in their applications any areas of potential leverage of resources, collaborations, and synergies. 

Can a multiple Principal Director/Principal Investigator (PD/PI) option be used for this application/award?

• Yes, multi-PD/PI (MPI) applications may be used for this award. Please refer to the NIH website for more information on applying with MPIs. Owing to the complexity, diversity, and goals of the ECHO Consortium, the successful PRO Core applicant(s) will need to be a nationally-recognized expert(s) with experience in complex research networks and broad-based pediatric clinical research and care. Also needed will be skills in modern measurement theory and state-of-the-art techniques for the initial development and validation of self (or proxy) assessment instruments for all ages of pediatrics. Regarding ECHO, this will mean experience with very young-aged children, including to birth. The PD/PI, if a single individual, should have documented expertise in the evaluation, development and validation of cPROs (or proxy measures) in child health care and disease.

Is the development and validation of new outcome measures allowed?

• Depending on the needs of the ECHO Consortium, the PRO Core team will be expected to have the required experience and expertise that enable the development and validation of new pediatric self, or proxy, patient-reported outcome (cPRO) instruments. Such efforts are anticipated to be substantially interactive and harmonized with those of the recently funded Pediatric Patient-Reported Outcomes in Chronic Diseases (PEPR) Consortium: .    

Are observer-reported outcomes (ObsROs) allowed in the ECHO PRO Core?

• Yes, ObsROs may be proposed as within the scope of the ECHO PRO Core. ObsROs differ from child Patient-Reported Outcomes (CPROs) and proxy-reported outcomes, as described in the RFA . Capturing these observational measures may help to better understand the impact of the wide variety of environmental stressors that could potentially impact the health of the pediatric cohorts to be studied in ECHO. Applicants should clearly define these proposed outcomes and how they will be included as assessments in this Core.

To whom should the letter of intent be sent and by when?

• James Witter, M.D., Ph.D.
  Telephone: 301-594-5032
  Email:witterj@mail.nih.gov
• Letters of intent are due by March 15, 2016