EXPIRED
October 26, 2020
NOT-HL-22-061 - Notice to Clarify Expiration Date for NOT-HL-20-815 "Notice of Special Interest (NOSI): Use of Predictive Analytics to Accelerate Late-Stage Implementation Research to Address Heart, Lung, Blood, and Sleep Disorders"
PAR-19-274 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)
PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
NOT-OD-16-025 - Clarifying NIH Priorities for Health Economics Research
NOT-OD-19-122 - Fast Healthcare Interoperability Resources (FHIR ) Standard
National Heart, Lung, and Blood Institute (NHLBI)
Purpose
NHLBI is issuing this Notice of Special Interest (NOSI) to leverage existing data resources using Predictive Analytics Implementation Research (PAIR) that utilizes complex and innovative methodologies and modeling techniques to rely on integration of existing data to inform the designs (and often test) implementation strategies for heart, lung, blood, and sleep (HLBS) conditions. NHLBI also encourages applications which focus on the development of advance modeling techniques and data reporting, which would be publicly available and could be used to inform subsequent implementation strategies to address HLBS conditions.
Scope
PAIR modeling will be supported to identify the critical details, parameters, or factors for more efficient evidence-based practices (EBP) and guidelines to improve HLBS health and disease outcomes. Repetitive findings across multiple data resources can reveal robust insights from existing information which can be applied to the context-specific design of implementation strategies of EBP as compared to traditional clinical site-specific data which often use de novo data collection for that given site. Intermittent use of predictive analytical methods can refine an on-going EBP implementation strategy to achieve sustainable, adaptive implementation strategies. Using data across communities, PAIR provides unique solutions for preventive strategies and health policy for HLBS.
Data integrated from multiple types of communities (e.g., school, primary care, and clinic) can use complex forecast models and predictive analytics to propose implementation strategies for scale-up. NHLBI encourages applicants to define each community clearly and describe how findings would inform similar communities for this NOSI. The NLM Common Data Definition for the term community is a set of people with some shared elements. That shared element varies widely, from geography to situations to interests to lives and values. For example, a community may be defined by geospatial location, by the type of health practice, by people with a specific set of characteristics, e.g., common diagnoses, genetic traits, risk profiles, etc. There may be multiple types of communities within a particular study depending on the complexity of the predictive analytical methodology and outcomes desired, and the source data used for data integration, analyses, and forecasting.
Collaborations among multiple disciplines are encouraged for this NOSI, including implementation scientists, health system analysts, methodologists, and data repository administrators. The community-based stakeholders and other end-users (e.g., clinicians, public health analysts, patients, parents, clinicians, public health analysts, patients, patient representatives) are welcome along the research continuum, from initial study conception to dissemination and implementation.
We encourage the development and dissemination of the implementation strategy plan, which includes re-usable infrastructure such as national standards for data extraction and interoperability, e.g., NOT-OD-19-122, (i.e., use of Fast Healthcare Interoperability Resources (FHIR), principles of findability, accessibility, interoperability, and reusability (FAIR) data, Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM), so that the approach may be replicated longitudinally and allow others to adapt the implementation strategies. Applicants are encouraged to become familiar with the most-recent NIH Strategic Plan for Data Science (November 2020, https://datascience.nih.gov/sites/default/files/NIH_Strategic_Plan_for_Data_Science_Final_508.pdf)).
Applicants considering health economic analyses are encouraged to review NOT-OD-16-025 for the NIH policy related to funding health economics research. PAIR applications defined as clinical trials, according to NOT-OD-15-015, should be submitted in response to PAR-19-274, or its successor. NHLBI is also interested in studies that focus on developing predictive analytical modeling methodologies and PAIR-generated data not defined as a clinical trial. Applicants considering PAIR that are not defined as NIH clinical trials should be submitted in response to PA-20-185 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed).
Prospective applicants are encouraged to contact the most appropriate NLHBI scientific research contact(s) listed below to ensure that the proposed aims are consistent with NHLBI's mission. Scientific research contacts may advise on the criteria for defining an NIH clinical trial and selecting the appropriate Funding Opportunity Announcement (FOA) for this NOSI.
Research projects that could be addressed in response to this NOSI include, but are not limited to, the following:
Note: NHLBI will only accept PAIR clinical trial applications as defined by NIH (NOT-OD-15-015) in response to PAR-19-274 Dissemination and Implementation Research in Health. NHLBI will only accept PAIR applications that are not clinical trials defined by NIH, which are submitted in response to PA-20-185 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed).
Non-clinical trial PAIR applications may focus on methodological development and proof of concept methodologies, including the use of secondary data analyses that do not meet NIH's definition of a clinical trial.
Application and Submission Information
This notice applies to due dates on or after February 5, 2021 and subsequent receipt dates through January 7, 2024.
Submit applications for this NOSI using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Scientific/Research Contact(s)
For Clinical Trial PAIR Applications (that target PAR-19-274 Dissemination and Implementation Research in Health (R01 Clinical Trial Optional))
Keith Mintzer, PhD
Center for Translation Research and Implementation Science
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-827-7949
Email:mintzerk@nhlbi.nih.gov
Marishka K. Brown, PhD
Division of Lung Diseases
National Heart, Lung and Blood Institute (NHLBI)
Phone: 301-435-0199
Email: marishka.brown@nih.gov
George Papanicolaou, PhD
Division of Cardiovascular Sciences
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0453
Email:gjp@nhlbi.nih.gov
For Non-Clinical Trial PAIR applications (that target PA-20-185 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed))
Lucy Hsu, MS
Division of Cardiovascular Sciences
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-402-3276
Email:Lucy.Hsu@nih.gov
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)
Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0186
Email: agrestia@nhlbi.nih.gov