Key Dates

Related Announcements

PAR-20-179 - Advancing Research to Develop Improved Measures and Methods for Understanding Multimorbidity (R01 Clinical Trial Optional)

Issued by

Office of Research on Women's Health (ORWH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The purpose of this notice is to inform potential applicants that the Office of Research on Women's Health (ORWH) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will participate, effective immediately, in PAR-20-179, "Advancing Research to Develop Improved Measures and Methods for Understanding Multimorbidity (R01 Clinical Trial Optional)".

The following text has been added to reflect ORWH's and NICHD's participation in this FOA.
 

Part 1. Overview Information

Components of Participating Organizations

Office of Research on Women’s Health (ORWH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 

Catalog of Federal Domestic Assistance (CFDA) Numbers

93.313, 93.865
 

Part 2. Section I. Funding Opportunity Description

Priority Areas:

Office of Research on Women's Health (ORWH)

ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH and throughout the scientific community.

The 2019-2023 Trans-NIH Strategic Plan for Women's Health Research includes goals and objectives that aim to increase and improve women's health research supported by NIH. Goal two of the strategic plan is to "develop methods and leverage data sources to consider sex and gender influences that enhance research for women's health." To achieve this goal, in part, the ORWH is interested in supporting research that could have a significant impact on understanding and addressing the multimorbidity or multiple chronic conditions (MCCs) among women. Research topics of interest include but are not limited to:

• Interventions to reduce multiple morbidities among understudied, underrepresented, and underreported women such as racial and ethnic minority populations of women, women with complex health needs such as the co-occurrence of cardiovascular disease, gynecologic pain syndromes, diabetes mellitus, chronic lung disease, or obesity; women of low socioeconomic status (SES), women residing in rural or underserved urban areas, women in migrant and immigrant populations, women are experiencing homelessness or living in overcrowded congregate housing, or women involved with the criminal system (incarcerated or under community supervision).
• Descriptive studies using quantitative and qualitative methods to expand understanding of differences in chronic comorbidity by sex and gender, race, and ethnicity.
• Secondary data analyses aimed at the discovery of new phenotypes or new mechanisms to assess known phenotypic characteristics in females/males, and its relationship to disease etiology and impact on overall morbidity.
• Development and validation of instruments that assess the development of MCCs among women and girls.
   

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NICHD invites applications that respond to the priority areas articulated in the NICHD Strategic Plan 2020. In particular, NICHD welcomes applications through this funding opportunity that directly address the following areas of interest:

• Development and validation of measures of MCCs specific to NICHD’s priority populations, including:
   

• Infants, children and adolescents
• Individuals with intellectual and developmental disabilities
• Individuals with specific learning disorders
• Individuals with physical disabilities
• Pregnant, lactating and postpartum women
   

NICHD is particularly interested in measures that draw from multiple sources (e.g. medical records, biomarkers, school/work, self-reported health/quality of life/risk behaviors, neurodevelopmental assessments) and multiple respondents (self, parents/caregivers, teachers). This includes development of risk assessment tools that draw from multiple sources (e.g. medical records from preconception to postpartum, biomarkers, laboratory data, etc.) for pregnant and postpartum women with MCCs to assess maternal morbidity and mortality.

NICHD is also interested in studies that better delineate the similarities and differences between self-report, parent/caregiver report, and parent/caregiver-proxy report (in which the parent/caregiver attempts to report from the viewpoint of the individual in question, rather than from their own perspective) among individuals with MCCs.

Applications focused on measure development must demonstrate validity across members of the target population, including individuals who are also members of racially/ethnically diverse, sexual minority, and underserved/low-resource communities. Measures should be applicable to a range of conditions and diagnoses; NICHD will not accept proposals for measures that are applicable only to a single group of related conditions or a single organ system. Measures should also demonstrate sensitivity to change over time and developmental stages, as evidence of their potential utility as outcome measures in future longitudinal studies or clinical trials.

NICHD also has a specific interest in the development and validation of measures that can be used to better understand the transition of adolescents with MCCs to adulthood. Again, such measures must be applicable to a range of conditions and diagnoses: NICHD will not accept measures of transition that are applicable only to a single group of related conditions or a single organ system.

• Development and validation of analytic methods to better understand the impact of MCCs in NICHD’s priority populations, as listed above.
   

As with measure development, NICHD is particularly interested in methods that can accommodate data drawn from multiple sources (e.g. medical records, biomarkers, school/work, self-reported health/quality of life) and multiple respondents (self, parents/caregivers, teachers, health service providers).

NICHD also has interest in methods for a capturing the impact of MCCs on others whose health status is closely intertwined with the person experiencing MCCs; specifically:

• Effects of MCCs in pregnant women on their offspring
• Effects of MCCs in parents on their children’s health and developmental outcomes
• Effects of MCCs in children on health and developmental outcomes of their parents/caregivers/siblings. (Note: Applications looking solely at stress and/or mental health outcomes of parents/caregivers/siblings will not be accepted.)
   

Finally, NICHD has a specific interest in the development and validation of methods that can lend insight into the longitudinal impact of MCCs in infancy, childhood and adolescence on health, development and well-being. This includes:

• Methods to assess young adult and midlife (up to age 50) outcomes of MCCs in childhood.
• Methods to assess longitudinal health and developmental outcomes of infants, children and adolescents with MCCs emanating from the multiple organ dysfunction syndrome (MODS), independent of the etiology.
   

NICHD will not fund research proposing efficacy or effectiveness clinical trials through this FOA. Investigators are strongly encouraged to discuss their research plans with NICHD program staff prior to submitting an application.

All other aspects of PAR-20-179 remain unchanged.

Inquiries

Please direct all inquiries to:

Rajasri Roy, Ph.D., M.P.H.
Office of Research on Women’s Health (ORWH)
Telephone: 301-451-0993
Email: [email protected]
 

Tracy King, M.D., M.P.H.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-1822
Email: [email protected]