This PCORI Funding Announcement will open on Thursday, January 3, 2019. Preliminary details are provided below. More information will be posted here as the open date approaches.

Notice of Upcoming PCORI Funding Announcement 

This notice provides information about an upcoming Patient-Centered Outcomes Research Institute (PCORI) funding announcement (PFA), which will be released by PCORI on January 3, 2019. PCORI seeks to fund projects that address important methodological gaps and lead to improvements in the strength and quality of evidence generated by PCOR/CER studies. For the Cycle 1 2019 Methods PFA, PCORI has identified the following Research Areas of Interest (RAIs) as programmatic priorities:

• Methods Related to Ethical and Human Subjects Protections (HSP) Issues in PCOR/CER
• Methods to Improve Study Design
• Methods to Support Data Research Networks
• Methods to Improve the Use of Natural Language Processing

Proposed research should be justified with respect to published scientific literature and designed to advance methods for PCOR/CER. Projects that simply apply methods or approaches to a particular domain, seek to disseminate an approach, or focus on infrastructure development will not align with program priorities. 

Methods Related to Ethical and Human Subjects Protections (HSP) Issues in PCOR/CER

PCORI is interested in funding projects to address important ethical and HSP issues related to the conduct of PCOR/CER. Applications responding to this RAI must include an empirical component. PCORI will consider purely conceptual and theoretical work to be nonresponsive. Moreover, PCORI will give preference to proposals that seek to develop or test new approaches rather than those that conduct primarily descriptive work.

The following topics are considered priorities for this RAI:

1. Methods to improve consent processes for participation in clinical research in the context of conventional randomized controlled trials (RCTs), observational studies conducted in learning healthcare system settings, cluster randomized trials, pragmatic trials, or adaptive trials. Note: PCORI will consider projects focusing on informed decision making and consent in the context of clinical care to be nonresponsive.
2. Methods to assess the concept of minimal risk in clinical research (including clinical trials)
3. Methods to improve review and monitoring of PCOR/CER, including protocol adherence and adjudication of study outcomes

Methods to Improve Study Design

PCORI is interested in funding projects that foster improvements in the use of specific study designs to address PCOR/CER questions. Preference will be given to proposals that seek to evaluate the proposed methods using both simulations and data from real-world studies.

The following topics are considered priorities for this RAI:

1. Methods to improve the design and conduct of cluster randomized trials, including methods to account for the dependence of observations within clusters
2. Methods to support the inclusion of patient preferences for allocation of interventions in randomized designs, while minimizing threats to internal validity
3. Methods to manage adaptation of treatment strategies, while minimizing threats to internal validity in studies of complex interventions
4. Methods to improve the design and conduct of PCOR/CER studies in circumstances limiting the use of RCTs

Methods to Support Data Research Networks

PCORI is interested in funding projects that improve the quality of data and analyses for multi-site PCOR/CER using data research networks. PCORI will consider that focus on infrastructure development and/or capacity-building for specific platforms to be nonresponsive.

The following topics are considered priorities for this RAI:

1. ​Methods to improve distributed analyses in data research networks
   • Methods to evaluate optimal network designs and analytical approaches (e.g., distributed regression, meta-analysis)
2. Methods to improve data quality in data research networks
   • Methods to assess dimensions of data quality (e.g., completeness, accuracy, or consistency)
   • Methods to prevent, mitigate, or impute missing or inaccurate data and improve understanding of mechanisms of missingness and implausibilities in electronic health records (EHRs) and distributed data settings
   • Methods to determine optimal linkage of multiple data sources, such as EHRs, claims, and national registry data
   • Methods to conduct patient-level disambiguation for de-identified linkage of data across networks

Methods to Improve the Use of Natural Language Processing

PCORI is interested in funding projects that develop and evaluate natural language processing (NLP) and other related methods for leveraging free-text clinical information contained in electronic health records (EHRs) for PCOR/CER. PCORI will consider proposals that simply seek to apply NLP to a particular clinical context to be nonresponsive.

The following topics are considered priorities for this RAI:

1. Methods to improve concept parsing in the extraction of valid medical information from EHRs
2. Methods to develop more effective and efficient approaches to the use of annotation when extracting data from unstructured text in EHRs
3. Methods to address issues associated with negation in the extraction of data from EHRs