I. Introduction

Summary of Program

The Patient-Centered Outcomes Research Institute (PCORI) is launching this PCORI Funding Announcement (PFA) to support investigator-initiated projects to implement patient-centered, comparative clinical effectiveness research (CER) findings obtained from PCORI-funded studies. This PFA promotes the targeted implementation and systematic uptake of shared decision making (SDM) in healthcare settings, in line with PCORI’s goal of supporting patients in making informed decisions about their care. 

This PFA will support projects that propose active, multi-component approaches to implementing effective SDM strategies that address existing barriers and obstacles to uptake and maintenance, with the goal of effectively and sustainably integrating these interventions into practice.

For this PFA, PCORI defines an SDM strategy as an intervention or approach that draws on and presents available evidence to inform patients of available treatment options and their risks and benefits, and either engages patients in a decision-making process with their clinician that reflects their values, or promotes their ability to engage in such a process.

PCORI seeks to fund multiple SDM implementation projects with all of the following requisite features:

• Proposes to implement an SDM strategy that is consistent with the above definition
• Demonstrates that the proposed SDM strategy has been developed and tested in alignment with existing quality standards (as appropriate). (Please see the Shared Decision Making Approach Template under Applicant Resources for more detail.)
• Documents that the proposed SDM strategy has demonstrated effectiveness on patient, caregiver, or healthcare provider decision making using well-accepted metrics 
  1. At a minimum, the intervention should have demonstrated efficacy or effectiveness with respect to patient-centered decisional outcomes (e.g., decision conflict, decision confidence, decision congruence with preferences). PCORI will not consider as sufficient interventions for which testing has been limited to tool validation, usability, or satisfaction.
  2. Note that although this initiative does not support developing new SDM strategies, those with demonstrated effectiveness may be adapted for broader implementation audiences and contexts with appropriate justification.
  3. This initiative does not support research to establish efficacy or effectiveness of SDM strategies, or to study the comparative clinical effectiveness of multiple SDM strategies. Projects proposing to compare the effectiveness of two or more SDM strategies should consider applying to PCORI’s Communication and Dissemination Research Program PFA.
• Proposes to implement an SDM strategy informing a preference-sensitive decision
• Proposes a multi-component implementation strategy that comprehensively addresses barriers and obstacles to SDM uptake, integration into practice, and maintenance of the intervention. The strategy should be guided by an established conceptual model or framework and, where possible, by evidence regarding the implementation of evidence-based practices and interventions.
• Conducts a rigorous evaluation that assesses the fidelity of the SDM approach as implemented; the effectiveness of the implementation approach; and the impact of the SDM strategy on relevant decisional, clinical, and healthcare utilization outcomes  
  1. Evaluation plans should include an appropriate balance of process measures, proximal healthcare utilization outcomes and more distal utilization and health outcomes as appropriate within the project scope. 
• Proposes a project team that draws on expertise in SDM and implementation science sufficient to guide these central aspects of the proposed project
• Proposes an implementation strategy that incorporates the perspectives and experiences of patients and stakeholders, including individuals living with the disease or condition of interest. Also, describes how front-line staff, care providers, and leadership of host delivery settings have been included, and demonstrates the commitment and involvement of those required to accomplish the project successfully.

In addition, PCORI will consider the following elements of the proposed implementation strategy:

• Sites: Proposes implementation sites that have a demonstrable commitment to improving healthcare quality and a willingness to invest in SDM, such that they provide a supportive context and culture for undertaking the proposed project
• Setting: PCORI is interested in implementing SDM in diverse geographical and practice settings including but not limited to networks of primary care, specialty care, acute care, and community-based care settings
• Generalizability: Proposes an SDM strategy and corresponding implementation approach with potential for use and scalability beyond the targeted implementation settings
• Sustainability: PCORI is interested in implementing SDM strategies in the context of sustainable payment models in both fee-for-service and non-fee-for-service environments

Background

Even with CER evidence, many important healthcare decisions are not clear-cut; often, several reasonable alternatives exist among the available treatment options. In these instances, patients and their clinicians need to consider the available options, using the best existing evidence to support patients in making choices that reflect their values and preferences. SDM is widely recognized as a key component of patient-centered health care and an important decision-making model in the context of uncertainty. Decades of research demonstrate the positive impact of SDM interventions on patient decision-making processes and care outcomes. [1]

Recent commentary and research have emphasized the potential of SDM as an integral component of patient-centered, value-based care. [2],[3],[4] The policy context surrounding SDM has also shifted in favor of SDM implementation and uptake. Washington State has passed legislation incentivizing SDM as an alternative to traditional informed consent procedures for preference-based treatment decisions; the National Quality Forum recently published certification standards for patient decision aids; the Centers for Medicare and Medicaid have started requiring SDM as a precondition of payment for two preference-sensitive treatment choices; and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) includes SDM as one of four performance categories used for determining clinicians’ reimbursement under its Merit-Based Incentive Program. ² Yet despite research demonstrating the effectiveness of SDM, mounting policy momentum, and a wealth of available SDM interventions, [1],[5] uptake of SDM in clinical practice remains slow, and most clinicians and care settings have little or no experience with SDM. Some of the systemic barriers to the use and practice of SDM include perceived time constraints associated with SDM; perceptions that SDM does not work well with certain patient groups; lack of training to equip clinicians with requisite education and skills necessary to facilitate SDM; and the perception among providers that they already do SDM with their patients, despite evidence to the contrary. [6] Systematic reviews [7] [8] ^,underscore the need for multi-component implementation strategies that consider and target interventions to both the patient and the healthcare provider when incorporating SDM into routine clinical practice.

Multi-Component Implementation Approaches

Multi-component implementation approaches that reflect a comprehensive view of the barriers and facilitators to using SDM in the proposed setting(s) will generally be required to ensure a proposed project’s success. Using combinations of different implementation strategies to drive change among different stakeholders (e.g., patients and providers) at different levels (e.g., individual, clinical setting, or community) enhances the likelihood of implementation success. [9] The implementation science literature has identified dozens of implementation strategies that fall into six main domains of strategic focus: (1) planning, (2) education, (3) financial, (4) restructuring, (5) quality management, and (6) attention to policy context. [9] For the purposes of this PFA, PCORI is open to diverse, well-considered approaches to sustainable implementation of SDM. Proposed multi-component implementation approaches should reflect the selected SDM approach, target settings, and other contextual factors.

Funds Available

PCORI has allotted up to $6.5 million in total costs under this PFA. The total amount awarded and the number of awards made will depend upon the quality and costs of the applications received. Total direct costs may not exceed $1.5 million for any individual project. The maximum project period is up to three years.

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II. Guidance for Preparing Applications

In developing an implementation strategy and PCORI application, applicants should pay attention to four fundamental concepts: (1) Evidence Context, (2) Setting, (3) Engagement, and (4) Evaluation. [10]^,[11]^,[12]^,[13]^,[14]

• Evidence Context refers to the body of existing evidence relevant to the PCORI research finding. It is rare that a single finding warrants implementation independent of other research findings. Applicants should explain how the current finding supports, augments, or differs from related evidence and how the proposed SDM strategy and its implementation take account of the full body of related information.
• Setting The proposed project should consider carefully the setting in which the implementation will take place (e.g., primary care network, hospital, or community). Applicants should demonstrate that implementation sites have a commitment to improving healthcare quality and a willingness to invest in SDM, such that they provide a supportive context and culture for undertaking the proposed project. At a minimum, the project should move findings out of a controlled research setting to a more general setting, demonstrating the ability of the proposed strategy to bring PCORI findings to targeted end-users in ways that promote uptake. [6] Project design should reflect relationships among the stakeholders within the setting because these will be critical to the project’s success.
• Engagement involves meaningful involvement of interested patients and stakeholders in the project’s design, execution, and evaluation. The project should involve stakeholders who can contribute to the implementation strategy’s sustainability in the target setting and to broader implementation, if warranted, in the future. Proposed engagement approaches should ensure that the perspectives and experiences of interested patients and stakeholders, including individuals living with the disease or condition of interest and representatives from all levels within the host delivery setting, are included. Engagement should ensure that evidence and strategies are tailored appropriately to the target end-users and the setting. Plans for engaging stakeholders should reflect a spirit of partnership, trust, and reciprocity.
• Evaluation is essential to understanding how and why implementation activities are or are not successful, as a basis for adjustment, reconsideration, or future replication of strategies. Applicants should propose a rigorous evaluation of the proposed implementation effort’s effectiveness, to include assessment of the implementation approach; fidelity of the SDM approach as implemented; and the impact of the SDM strategy on relevant decisional, clinical, and utilization outcomes. Evaluation plans should include an appropriate balance of measurable process outcomes and proximal and distal utilization and health outcomes. PCORI will not consider as sufficient proposed evaluation plans that are limited to measures of dissemination. The following resources may be helpful for identifying an appropriate evaluation strategy. [10], [15]

PCORI encourages applicants to review recently published standards for reporting implementation studies (STaRI), which provide helpful guidance related to project planning, execution, evaluation, and reporting. [16]^,[17]^,[18] These standards promote using a dual-strands approach to describing (a) the strategies used to promote implementation and (b) the intervention being implemented. This approach is particularly relevant to this funding opportunity.

Non-responsiveness

PCORI may administratively withdraw as nonresponsive to this PFA any Letters of Intent (LOIs) and applications where the proposed project:

• Proposes to establish efficacy or effectiveness of SDM strategies or to study the comparative clinical effectiveness of multiple SDM strategies.
  • Applicants interested in conducting CER should consider applying to PCORI’s Communication and Dissemination Research Program using the appropriate application materials. PCORI will not refer projects proposing to perform CER under this PFA and will withdraw them as nonresponsive.
• Proposes to implement evidence that does not include a PCORI-funded CER or methods study result.
• Proposes to translate or adapt an SDM approach without actively implementing it.
• Proposes to develop or validate a new tool or system for patients or clinicians without the primary purpose of actively implementing evidence.
  • Modification or adaptation of tools and systems previously found to be effective and proposed as the primary mechanism for actively disseminating and implementing evidence will be considered, as long as their development is not the primary activity proposed.
• Proposes to use contract funds to pay the cost of the interventions being disseminated in the project.
  • In general, PCORI does not pay the cost of the interventions being disseminated in the projects it funds. These are direct patient care costs and PCORI expects health delivery organizations or other payers to cover these expenses. Intervention costs PCORI does not cover include, but are not limited to, compensation for personnel that are delivering the intervention and equipment and materials costs associated with delivery of the intervention. PCORI encourages all applicants to find support from sites, payers, or other stakeholders for these expenses. Only under special circumstances will PCORI consider an exception for coverage of patient care intervention costs.
  • If you are requesting the use of PCORI funds for any portion of these costs, your application must include a detailed justification in the Budget Justification Template, outlining the importance of the request to the project’s overall success. Your justification must also explain how you will cover these costs in the future, post-PCORI funding—not only in the sites participating in the study but also in other communities and healthcare settings that undertake the proposed strategies. Applicants should develop contingency plans in the event that PCORI does not approve the request.

Protection of Human Subjects

If applicable, applicants should describe the protection of human subjects involved in their proposed research. If human subject protection is not applicable, applicants should justify why it is not necessary for their project. PCORI follows the Federal Policy for the Protection of Human Subjects (45 CFR part 46), including the Common Rule. For more detailed information, please see Section 5 titled “Human Subjects Research Policy” in the Supplemental Grant Application Instructions for All Competing Applications and Progress Reports, issued by the U.S. Department of Health and Human Services. PCORI does not require that applicants comply with sections of this policy referring to requirements for federal-wide assurance or to standards for including women, minorities, and children. Awardees must also comply with appropriate state, local, and institutional regulations and guidelines pertaining to the use of human subjects in research.

PCORI merit reviewers will examine plans for protection of human subjects in all applications and may provide comments regarding the plans (see How To Evaluate Human Subjects Protections). The overall application score does not reflect reviewers’ comments on human subject research, but PCORI staff may use them during potential funding negotiations. Final determinations about adequacy of human subject protections rest with the Institutional Review Board (IRB) or IRBs that have jurisdiction for the study.

The Awardee Institution or organization, whether domestic or foreign, bears ultimate responsibility for safeguarding the rights and welfare of human subjects in PCORI-supported activities.

Required Education of Key Personnel on the Protection of Human Subject Participants

For those projects requiring human subject protection, PCORI requires that all applicants adhere to the National Institutes of Health (NIH) policy on education in the protection of human subject participants in the conduct of research. This applies to all individuals listed as key personnel in the application. The policy and FAQs are on the NIH website.

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III. How To Submit an Application

Letter of Intent

Applicants should download the LOI Template for the Shared Decision Making (SDM) PFA from the PCORI Funding Opportunities. The LOI has a three-page limit. You should number references in the text and provide full citations on a separate page following the LOI. PCORI suggests including all references as in-text citations using American Medical Association citation style, but other citation styles are acceptable. Complete the document and convert it to a PDF file. Do not upload additional documents as part of your LOI, including Letters of Endorsement or Support, because they are not requested at this stage. Inclusion of additional documents will result in LOI rejection without review. Please visit the PCORI Funding Opportunities for additional applicant resources, including the PFA and required templates. LOIs are a mandatory prerequisite to submit a full application. Applicants who fail to submit an LOI cannot submit a full application to the corresponding award cycle.

The LOI for the proposed project should contain the following information:

• Title of proposed project
• Original PCORI research award number, original research project title, and name of original Principal Investigator (PI)
• Clear indication of whether you are:
  1. Proposing to implement an SDM strategy that was formally tested and demonstrated to be effective in a PCORI research award, or
  2. Proposing an implementation project that will incorporate new PCORI CER evidence into an existing and tested SDM strategy, and then implementing the updated strategy.
• Objective and specific aims of the proposed implementation project
• Identification of the preference-sensitive decision the proposed SDM strategy addresses and clear indication how this new PCORI evidence contributes to patient or provider decision making
• Description of the implementation problem (e.g., use of the evidence or gaps in informed decision making) that motivate the proposed project
• Description of the PCORI research findings and related evidence most relevant to your proposed implementation project
  1. If your PCORI project tested an SDM approach, describe the results of the PCORI study, including effectiveness on patient-centered decisional outcomes. Describe the body of evidence associated with the SDM approach and how your study findings contributed to this evidence base.
     Further, describe the evidence that was summarized and presented within this SDM approach in your PCORI research study and how it relates to the body of evidence related to this health decision. If the evidence will be updated for the proposed project, describe and explain the revised presentation of evidence.
  2. If your PCORI project produced new evidence that will be incorporated into an existing effective SDM approach, describe the most relevant results of your PCORI study, the evidence base surrounding those findings, and the evidence base relevant to the chosen SDM approach.
• Indication and description of the setting(s) in which implementation will take place, the immediate target of the implementation activity, and a logic pathway describing how affecting change in the proposed target audience and setting will ultimately change healthcare outcomes and delivery 
• Description of the multi-component approach being proposed for implementing the SDM strategy
• Description of the evaluation plan that assess the effectiveness of the proposed implementation approach as well as the continued effectiveness of the SDM strategy on relevant decisional, clinical, and utilization outcomes. The evaluation plan should include an appropriate balance of measurable process, proximal, and distal outcomes.
• Description of how patients and other relevant stakeholder groups are involved in the planning and implementation of this effort

Please address all categories in the LOI Template and then upload the document into PCORI Online. The deadline for LOI submission is October 2, 2017, by 5 p.m. (ET).

Letter of Intent Review

An LOI is required to submit a full application. PCORI screens LOIs for responsiveness to this PFA and to ensure compliance with administrative guidelines. PCORI invites only applicants whose LOIs are most responsive to this PFA to submit a full application. Nonresponsive LOIs and those not adhering to Application Guidelines will not be invited to submit a full application. Notification of denial or approval to submit an application will occur no later than October 30, 2017. Please refer to the Application Guidelines for information on how to submit your LOI via PCORI Online.

Submission Dates

You must submit LOIs and applications in accordance with the published dates and times listed in the Overview section of this document and in the PCORI Funding Opportunities.

PCORI Online

To submit an application properly, you must register with PCORI Online and submit both an LOI and an application for each cycle to which you are applying. Please ensure that you are applying to the PFA titled “PCORI Funding Announcement: Implementation of Effective Shared Decision-Making (SDM) Approaches in Practice Settings.”

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IV. Applicant Resources

• Implementation of Shared Decision Making Approaches PFA (Cycle 2 2017)
• Implementation of Shared Decision Making Approaches PFA Application Guidelines (Cycle 2 2017)
• Implementation of Shared Decision Making Approaches PFA FAQs for Applicants

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IV. Merit Review

PCORI’s merit review process is designed to support the following goals:

• Identify applications that have the strongest potential to help patients, caregivers, clinicians, policy makers, and other healthcare system stakeholders make informed decisions to improve patient outcomes.
• Implement a transparent, fair, objective, and consistent process to identify these applications.
• Elicit high-quality feedback that reflects a diversity of perspectives to ensure that the PCORI-funded research reflects the interests and views of patients and other stakeholders and those who care for them, and that it meets the criteria for scientific rigor.
• Fund projects that fill important evidence gaps and have strong implementation potential.
• Regularly evaluate and continually improve the merit review process and policies in support of PCORI’s mission.

PCORI merit review is a multiphase process that includes staff evaluation of LOIs; preliminary review of full applications by review panels; in-person panel review of a subset of full applications (identified based on preliminary review and program priorities); final programmatic review; recommendation for approval of funding; and final PCORI approval.

Preliminary Review

PCORI conducts a rigorous merit review of the full applications it receives. Note that PCORI may eliminate applications from the review process for scientific reasons (e.g., non-responsiveness) or for administrative reasons. PCORI may administratively withdraw an application if it is incomplete; is submitted past the stated due date and time; or does not meet the formatting criteria outlined in the Application Guidelines, in the PCORI templates, and in PCORI Online.

PCORI Merit Review Officers (MROs) recruit each merit review panel based on the number and type of topic areas represented by invited LOIs. MROs recruit the Panel Chair; scientist reviewers who are subject matter experts; patient representatives; and representatives of other stakeholder groups. All panel members receive training during the review cycle to ensure that they understand the programmatic and organizational goals of review.

Application Review Criteria

The following are PCORI’s merit review criteria for this PFA. PCORI’s review panels use these criteria during the preliminary and in-person phases to score and evaluate all submitted applications. Please note that the merit review criteria for this PFA are different from those used when reviewing PCORI research applications.

Criterion 1. Importance of research results in the context of the existing body of evidence

• If the application proposes to implement an SDM approach that was previously tested in a PCORI-funded study:

  • Are the study results clearly described (with appropriate citations), including the effectiveness on patient‐centered decisional outcomes?
  • Will understanding and broader use of these results lead to a meaningful change in practice and improved outcomes that matter to patients?
  • Does the application clearly describe the body of evidence associated with the proposed SDM approach and, where applicable, how the PCORI study findings on that approach contribute to the evidence base?
  • Does the application clearly and sufficiently describe (with appropriate citations) the evidence related to the choice among treatment or other healthcare choices being summarized and presented within the proposed SDM approach?
  • If the applicant is proposing to update the evidence being presented in the proposed SDM approach as part of the project, does the applicant provide a rationale and sufficient detail about their process for updating and incorporating the revised evidence into their SDM approach?

—OR—

• If the application proposes to incorporate new PCORI-funded CER evidence into an existing SDM approach:

  • Does the application clearly and sufficiently describe (with appropriate citations) the CER results, including their strength in terms of clinical and statistical significance?
  • Will understanding and broader use of these results lead to a meaningful change in practice and improved outcomes that matter to patients?
  • ​Is the evidence associated with the proposed SDM approach clearly and sufficiently described (with appropriate citations), including how the incorporated CER findings contribute to the SDM evidence base and whether this evidence includes impact on patient-centered outcomes?
  • Does the application clearly and sufficiently describe (with appropriate citations) the evidence related to the choice among treatment or other healthcare choices summarized and presented within the proposed SDM approach?
  • If the applicant is proposing to update the evidence presented in the proposed SDM approach as part of the project, does the applicant provide a rationale and sufficient detail about their process for updating and incorporating the revised evidence into their SDM approach?

Criterion 2. Readiness of the research results for dissemination

• Does the application demonstrate that the proposed SDM approach has been developed and tested with rigor and transparency per existing quality standards, as appropriate? Does the application describe efforts undertaken to eliminate bias in the presentation of evidence?
• Given the description of the PCORI results provided (see Criterion 1), are these results clinically meaningful in the context of the existing evidence base to warrant implementation as proposed in the application? Similarly, is the evidence associated with the proposed SDM approach sufficiently strong to warrant implementation as proposed in the application? 
• Does the application sufficiently address the generalizability of the PCORI research results to populations beyond the immediate study sample?
• Does the application identify the decision-making context in which the PCORI results are most relevant beyond the initial study setting?

Criterion 3. Technical merit of the proposed dissemination or implementation project (project design, outcomes, and evaluation)

• Does the application use a dissemination and implementation (D&I) framework or model to anchor and inform the project design, outcomes, and evaluation plan?
  • Does the applicant provide a clear logic pathway linking the implementation approach and SDM strategy to meaningful improvements in relevant healthcare and patient-centered outcomes?

• Does the application provide a well-described, comprehensive, and appropriate multi-component strategy for implementing the proposed SDM approach into real-world clinical practice?

• ​Is the proposed implementation approach supported by existing evidence, best practices, or case examples of effective implementation approaches?

• Does the application sufficiently describe the group(s) that will be the immediate targets of the implementation activity and the end-users of the SDM strategy? Does it sufficiently describe the setting(s) in which the implementation will take place? Are these targeted groups and settings generalizable?

• Does the application describe and consider the existing barriers and obstacles to SDM uptake in the proposed implementation setting(s)? Does the proposed implementation plan effectively address those barriers and include plans to address new barriers as they arise?

• How will the proposed implementation plan lead to continued use of the SDM approach beyond the PCORI project period?

• Does the application propose an appropriate evaluation strategy that includes plans for:

  • Evaluating the effectiveness of the proposed implementation approach as well as the continued effectiveness of the SDM strategy?

  • Measuring fidelity of the SDM approach as delivered, as well as its impact on relevant decisional, clinical, and healthcare utilization outcomes?

• Is the proposed timeline realistic, including specific project milestones?

Criterion 4. Project personnel and environment

This criterion should assess the appropriateness (e.g., qualifications and experience) of the project personnel/team and capacity of the environment (e.g., resources, facilities, and equipment) to support the proposed project. It should not be an assessment of the institution’s quality.

• How well qualified is the project team (e.g., PIs, collaborators, and other stakeholders) to conduct the proposed activities? Does the project team include individuals with sufficient expertise in SDM, implementation science, and other relevant areas?
• Does the investigator (or co-investigator) have demonstrated experience conducting projects of similar size, scope, and complexity?
• If the project is collaborative or dual-PI, do the investigators have complementary and integrated expertise? Are the leadership, governance, and organizational structures appropriate for the project?
  • (Dual-PI Option Only) Does the Leadership Plan adequately describe and justify roles and areas of responsibility of the PIs? 
• Is the level of effort for each team member appropriate for successful conduct of the proposed work?
• Does the application describe adequate availability of and access to facilities and resources (e.g., collaborative or partnering arrangements) to carry out the proposed project?
• Is the institutional support appropriate for the proposed project?

Criterion 5. Patient-centeredness

• Is the proposed SDM approach to be implemented in this project of interest to patients, and is it likely to increase their involvement in their healthcare decisions? If so, how? 
• Is the SDM approach proposed for implementation likely to provide useful information to patients or their caregivers facing health-related decisions?

Criterion 6. Patient and stakeholder engagement

• Does the application demonstrate that stakeholders central to the proposed project, including targeted end-users or their representatives, are engaged with the project planning and execution?
• Does the application demonstrate that stakeholders central to the proposed project are engaged in planning for the sustainability of the proposed SDM approach?
• Does the application demonstrate clear interest and support of personnel responsible for implementing SDM at target settings? In what ways is the application convincing that these personnel will participate as active partners in the project?
• Has the application demonstrated a sufficient willingness and readiness of the healthcare settings in which implementation will occur to provide a supportive context and culture for undertaking the proposed project?
• Does the application demonstrate the principles of reciprocal relationships, co-learning, partnership, trust, transparency, and honesty?

In-Person Review

During preliminary review, all administratively compliant applications are evaluated and scored based on PCORI’s merit review criteria. After the preliminary review is completed, PCORI program staff members evaluate panel scores and critiques to identify a subset of applications for merit reviewers to discuss at the in-person review meeting. Not all submitted applications move on to in-person review.

During the in-person review, merit reviewers meet to discuss applications, clarify further the merits of the proposed Project Plan, and identify areas for improvement. In addition, each application is re-scored based on the content of discussion. The Panel Chair and PCORI MRO lead the in-person panel meeting and ensure that all applications receive a fair and thorough review according to the standards outlined in the PFA.

Post-Panel Review

After the in-person meeting, PCORI program staff evaluate final merit review panel scores and comments, identify duplication or synergy among funded projects, and consider the fit of applications within the programmatic vision. Engagement/Dissemination Program staff members then recommend projects for funding approval. The D&I Program, including its funded projects portfolio, is governed by the Engagement, Dissemination, and Implementation Committee—a subcommittee of PCORI’s Board of Governors.

In addition, PCORI evaluates applicant risk before issuing a PCORI award. Factors considered include financial stability, quality of management systems, audit findings, and past performance on PCORI awards (e.g., compliance with PCORI reporting requirements, conformance to PCORI terms and conditions on previous awards, and timely achievement of milestones). Based on the risk assessment, PCORI may impose special terms and conditions on awardees or withhold contract issuance until such business risks are mitigated. PCORI will not award new contracts to current awardees with overdue reports (progress, interim, final, etc.) until PCORI receives the overdue reports.

Summary Statements and Funding Recommendations

Applicants receive summary statements approximately two weeks before funding decisions are announced. If an application progresses to in-person discussion, the applicant will receive a summary statement that includes:

• In-person panel discussion notes
• Final average overall score
• Preliminary reviewer critiques

Summary statements for applications that do not progress to in-person discussion include only the preliminary reviewer critiques.

Funding recommendations are made by identifying meritorious applications that fit the programmatic needs and that satisfactorily address the merit review criteria. Program teams also consider the funds allotted for the current PFA when deciding which applications to recommend for approval. Applicants to this current cycle’s PFA will receive summary statements and notification of the funding status of their application no later than August 2018.