Glossary

This glossary offers definitions for terms used across PCORI.org—and in our funding process—as we apply PCORI’s unique approach to healthcare research.

A

Administrative Official (AO)

The individual within the recipient organization who is responsible for the proper administration of the contract, including, but not limited to, overseeing the submission of the contract activation, contract renewals, and additional materials required by PCORI’s policies and procedures.

Advisory Panel

Advisory panels provide recommendations to PCORI’s Board of Governors, Methodology Committee, and staff to help plan, develop, implement, improve, and refine our research agenda. While the panels do not hold decision-making authority, they are critical to PCORI’s ongoing effort to ensure that patients and stakeholders provide substantive input into the refinement of the institute’s research portfolio and other activities.

Allowable Costs

A cost that is approved within the budget and is not otherwise unallowable under the PCORI Funded Research Policies. A direct cost is allocable to the project if the goods or services involved are chargeable or assignable to the project in accordance with relative benefits received or other equitable relationship. As a result, a cost is allocable to the funded project if (1) it is incurred solely to advance the work under the project, or (2) it benefits both the funded project and other work of the recipient organization, in proportions that can be approximated through use of reasonable methods.

Award Page Title

A less-technical, often abbreviated version of the researchers’ project title.

Awarded - Contract Pending

The project has been approved by PCORI’s Board of Governors, and it is receiving a PCORI business and programmatic review or the final research contract is being executed.

Awardee

An organization that has received a PCORI award.

B

Biosketch

A profile of the experience and accomplishments of the key personnel in an application. A biosketch also satisfies the requirements of the PCORI professional profile.

Board Approval Date

The date of approval to fund by the PCORI Board of Governors. The actual project start dates vary as the negotiation of project milestones must be completed before the contract can be fully executed.

Board of Governors

PCORI is governed by a 21-member Board of Governors. The Board represents a broad range of perspectives and collective expertise in clinical health sciences research. The Comptroller General of the United States appoints members of the Board, including its Chairperson and Vice Chairperson, in accordance with PCORI’s authorizing law.

Broad PCORI Funding Announcements (PFA)

These announcements seek investigator-initiated applications for patient-centered comparative clinical effectiveness research (CER) projects aligned with our five priority areas for research. An announcement in each area is posted twice a year.

Burden

The frequency of the condition, the expected mortality and morbidity, and/or the degree of suffering associated with symptoms, complications, or other consequences of the condition. Additionally, it may include the costs to the US population of healthcare services used, the individual patient’s out-of-pocket expenses, as well as intangible costs to the patient, such as time away from paid or unpaid occupations.

C

Care Transitions

The movement patients make between different clinicians or settings—such as from a hospital to home or a nursing facility—during the course of their illness.

Clinical Data Research Networks (CDRN)

CDRNs are networks that originate in healthcare systems, such as hospitals, health plans, or practice-based networks, and securely collect health information during the routine course of patient care.

Clinical Practice Guidelines

Systematically developed statements or recommendations to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. They present indications for performing a test, procedure, or intervention, or the proper management for specific clinical problems. Guidelines may be developed by government agencies, institutions, organizations such as professional societies or governing boards, or by convening expert panels.

Closeout

The process by which PCORI determines that all applicable administrative actions and all required work of the contract have been completed and officially closes the contract.

Co-Investigator (Co-I)

An individual recognized by the prime institution and the principal investigator (PI) as someone making a significant contribution to a project. The Co-I is an individual who the PI relies on to assume responsibilities related to the execution of the project and to commit a specified percentage of time to the project. A Co-I is considered “key personnel” and may be employed by or formally affiliated (through written agreement) with the prime institution or a collaborating institution. The patient and/or stakeholder partner may be listed as a Co-I. The designation of a Co-I does not affect the PI’s roles and responsibilities nor does it imply a Dual PI Award.

Co-Principal Investigator (Co-PI)

An individual recognized by the prime institution and the principal investigator (PI) as someone who shares scientific and administrative leadership responsibilities for a project with the PI. The Co-PI is an individual who the PI relies on to contribute substantively to the scientific development and direction of the project in addition to the execution of the project. The Co-PI shares responsibility with the PI for ensuring that milestones are achieved and contracted deliverables are completed on time. The Co-PI is considered “key personnel” and may be employed by or formally affiliated (through a written agreement) with the prime institution or a collaborating institution. The patient and/or stakeholder partner may be listed as a Co-PI. The designation of a Co-PI does not affect the PI’s roles and responsibilities nor does it imply a Dual PI Award.

Collaborative Research Groups (CRG)

These groups are composed of content experts from within PCORnet focused on generating high-priority, engaging research questions to leverage PCORnet’s unique infrastructure. The CRGs collaborate with stakeholders including patients, caregivers, advocacy groups, providers, and funders early on to move research forward more quickly and more efficiently.

Comparative Effectiveness Research (CER)

The direct comparison of two or more existing healthcare interventions to determine which interventions work best for which patients and which interventions pose the greatest benefits and harms. The core question of CER is which treatment works best, for whom, and under what circumstances.

Comparators

Two or more options for diagnosis, prevention, treatment, or healthcare delivery that would be available to the patients, caregivers, providers, and/or health systems facing the actual healthcare decision. For PCORI studies, usual care should not be used as a comparator unless it represents a legitimate and coherent clinical option (e.g., a clinical alternative based on guidelines).

Conditions

These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. But you can use the keyword search box to find any PCORI-funded study.

Conflict of Interest

As defined by PCORI’s authorizing legislation, a Conflict of Interest is any “association, including a financial or personal association, that has the potential to bias or has the appearance of biasing an individual’s decisions in matters related to the Institute or the conduct of activities” [Patient Protection and Affordable Care Act, Pub L No. 111-148, 124 Stat 727, §6301(a)(3)]. Conflicts of Interest will be considered and managed throughout every step of the review and selection process, including, but not limited to, the technical and programmatic reviews, the selection and assignment of scientific and stakeholder reviewers, Board of Governors deliberations, and post-award negotiations and monitoring.

Consultant

Typically an individual who is not involved with the management of the project, but instead provides general services or subject matter expertise for an hourly fee. Applicants must include a letter of support from the consultant detailing their work and rate of compensation per hour. The patient and/or stakeholder partner may be listed as a consultant.

Contact Principal Investigator (PI)

If electing to submit a Dual PI Award application with two PIs, the prime institution must designate one PI as the Contact Principal Investigator. The Contact PI is the PI responsible for submitting the application and all contracted deliverables to PCORI and will serve as PCORI's primary point of contact for all communication. The Contact PI must be employed by or formally affiliated (through written agreement) with the prime institution and is named in the award contract.

Contract

The legally binding document that PCORI uses to make awards for research projects.

D

Data and Safety Monitoring Board

An independent committee of experts responsible for reviewing research study data on an ongoing basis to ensure the safety of study subjects and validity and integrity of the data.

Data Universal Numbering System (DUNS)

A unique identifier assigned to a single business entity. You may apply for a DUNS number online.

Decisional Dilemma

Challenging clinical choices faced by patients, caregivers, clinicians, or health systems about what works best for whom, and under what circumstances. PCORI studies should be designed to support better-informed decisions by generating evidence that improves understanding of the risks and benefits of the available options.

Dissemination (active)

The intentional, active process of identifying target audiences and tailoring communication strategies to increase awareness and understanding of evidence, and to motivate its use in policy, practice, and individual choices. The purpose of dissemination is to spread and sustain knowledge and the associated evidence-based interventions.

Dissemination (passive)

Sometimes called research diffusion, is an untargeted dissemination process whereby new evidence is absorbed and acted upon by a small body of highly motivated recipients.

Dissemination and Implementation Award

Funding to promote dissemination and implementation of evidence through two award opportunities: Eugene Washington PCORI Engagement Awards Program and PCORI Limited Competition Awards for Disseminating and Implementing Research Findings. See also Eugene Washington PCORI Engagement Award.

Draft Final Research Report

The draft final research report documents all of the work completed in the PCORI-funded study. This report must include a detailed description of the study’s background, methods, results, and conclusions, consistent with PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings. The draft final research report goes through external peer review and may be revised by the awardee before it is accepted by PCORI as the final research report.

Dual Principal Investigator (PI) Award

An award in which the prime institution has designated two individuals as PIs who share equally the authority and responsibility for leading and directing the project, intellectually and logistically. The presence of two PIs on an application or award diminishes neither the responsibility nor the accountability of any individual PI.

E

Electronic Health Record (EHR)/Electronic Medical Record (EMR)

An electronic health record is a repository of electronic information about an individual’s health status and health care. EHRs contain much of the same information that is found in a patient’s (paper) medical chart, but because the records are digitized, the data can be viewed, and providers (eg, primary care physicians and specialists) can capture far more extensive information. EHRs may contain administrative and billing data, patient demographics, progress notes, vital signs, medical histories, diagnoses, medications, immunization records, allergies, radiology images, laboratory and other test results, and much more.

Employer Identification Number (EIN)

The Federal Tax Identification Number used to identify a business entity. You may apply for an EIN in various ways, including online.

Engagement Award Initiative Notice (EAIN)

A targeted funding notice within the Engagement Awards Program. The purpose is to provide guidelines for available funding support for meetings and conferences that align with PCORI’s mission and strategic plan, and to also facilitate expansion of PCOR and CER.

Engagement in Research

The meaningful involvement of patients, caregivers, clinicians, and other healthcare stakeholders throughout the research process—from topic selection through design and conduct of research to dissemination of results.

Engagement Plan

A defined strategy to effectively involve patients, caregivers, clinicians, and relevant healthcare stakeholders throughout the research process. Applicants should reference the Engagement Rubric while developing this plan.

Engagement Program Awards

These awards include our Eugene Washington PCORI Engagement Awards and our Pipeline to Proposal Awards, which endeavor to increase patient and other stakeholder engagement in healthcare research. This program does not support research studies. Our focus is on funding innovative approaches to increase the capacity for non-researcher engagement in PCOR and CER.

Engagement Rubric

A resource intended to provide guidance regarding engagement in the conduct of research to those planning or conducting research, merit reviewers, awardees, engagement/program officers (for creating milestones and monitoring projects), and interested patients, caregivers, patient/caregiver organizations, and other stakeholders.

Eugene Washington PCORI Engagement Award

These awards are designed to help build a national community of patients, caregivers, clinicians, researchers, and other healthcare stakeholders who will advance patient-centered CER.

Evidence Updates

These materials present information from recent PCORI studies or from systematic reviews that summarize evidence.  Created in collaboration with patient organizations, clinicians, and others with an interest in the findings, these materials bring timely and relevant information to audiences who can benefit from knowing and using the information.

F

Financial Official (FO)

The individual designated by the recipient organization who is responsible for the proper accounting of contract funds and the submission of payment details. The FO is responsible for completing and certifying the required yearly expenditure reports.

Fringe Benefits

A form of pay for the performance of services. Fringe benefits commonly include health insurance, group term life coverage, and nonwage compensation.

Funding Announcement

See Broad PCORI Funding Announcements (PFA), Targeted PCORI Funding Announcements, Pragmatic Clinical Studies PCORI Funding Announcements, and Engagement Program Awards.

G

Greater-Than Request

A request for budget and/or time that exceeds the total award amount and/or maximum project period specified in the funding announcement.

I

Implementation

The deliberate, iterative process of integrating evidence into policy and practice through adapting evidence to different contexts and facilitating behavior change and decision making based on evidence across individuals, communities, and healthcare systems.

Indirect Costs

Costs not directly accountable to the project. Indirect costs include taxes, administration, personnel (not directly related to the project), and security costs.

Inpatient Costs

Costs incurred for patient study participants who are formally admitted to a hospital on doctor’s orders.

Institutional Review Board (IRB)

A group that follows federal regulations, state laws, and institutional policy to review, monitor, and approve research in order to protect the ethical rights and privacy of the subjects involved.

K

Key Personnel

Individuals who contribute to the scientific development or execution of the project in a substantive and measurable way. The contribution is independent of financial compensation.

L

Letter of Intent or Letter of Inquiry (LOI)

A notification to PCORI that an organization intends to apply. Submission of an LOI is a prerequisite to submitting an application. The Letter of Intent or Letter of Inquiry also includes information describing the proposed project.

Letters of Collaboration

Signed letters from each collaborating individual or organization that will demonstrate that the PI has the support or resources necessary for the proposed work. Letters of support from patient and stakeholder partners should clearly describe the origin of the study topic and the role of the patient partners in defining the question, outcomes, comparators, goals and outcomes, etc. Letters from the partners or partnering organizations affirming support to disseminate and implement research findings that are germane and warranted for implementation are also highly encouraged.

Letters of Organizational Support

Letters of support signed by the Department Chair or appropriate organizational official, confirming the institutional support of the proposed project, space to conduct the research, equipment, and other resources available for the project, including staff. A letter from the leadership of your department or organization affirming support to disseminate research findings that are appropriate and warranted for implementation may also be included.

Limited Competition

The process by which only certain groups may apply for an award, such as only PCORnet networks or teams that have a completed PCORI project.

M

Merit Review

A review of the scientific and technical merit of applications for funding. Merit review consists of both online and in-person reviews by qualified reviewers who read, score, and provide feedback on the applications.

Merit Review Officer (MRO)

A scientist who presides over a merit review panel and is responsible for coordinating and reporting the discussion of each application assigned to it. The MRO serves as an intermediary between the applicant and reviewers and prepares summary statements for all applications reviewed.

Methodology Committee

Per PCORI’s authorizing legislation, the 17-member group working to develop and advance scientific methods in patient-centered outcomes research. The Methodology Committee is a sub-tending committee that supports the PCORI Board of Governors.

O

Organization

The institution/organization in which the project originates, or the primary institution or organization that received funding for the project.

Other Principal Investigator

An additional lead investigator. This investigator may be affiliated with a different institution or organization from the Principal Investigator.

Outpatient Costs

Costs incurred for patient care when the patient is not formally admitted to a hospital.

P

Patient Engagement

Involvement of patients and other stakeholders throughout the planning, conduct, and dissemination of the proposed projects.

Patient Investigator

Patients or other stakeholders involved in the investigation of PCORI research who have a role in guiding the aims of the study.

Patient Partners

Patients who are representative of the population of interest in a study, as well as their family members, caregivers, and the organizations that represent them. Patient partners are not to be confused with patient subjects; patient partners are members of the research team and involved in the planning, conduct, and dissemination of the research, whereas patient subjects are those individuals enrolled in the study as participants.

Patient-Centered Outcomes Research (PCOR)

Research that helps people and their caregivers communicate and make informed healthcare decisions, while allowing their voices to be heard in assessing the value of healthcare options. This research answers patient-centered questions. A full definition can be found on our website.

Patient-Powered Research Networks (PPRN)

PPRNs are operated and governed by patient groups and their partners, and are focused on particular conditions or populations.

Patients

Individuals who have or have had the condition under study; it may include patient surrogates or caregivers as well. It does not necessarily mean, but does not exclude, patient advocates or patient navigators.

Payers

Those who function as financial intermediaries in the health system, including private insurers and public insurers, and organizations representing insurers, such as America’s Health Insurance Plans.

PCORI Funding Announcement (PFA)

PCORI's notice of a funding opportunity and request for applications. A PFA describes our intent to fund research in specific areas. Each PFA has a summary of the opportunity and guidance for proposing research for funding. It is accompanied by Application Guidelines and templates or forms for submission through PCORI Online.

PCORI Funding Center

The central location on PCORI’s website where applicants can access all templates, guidelines, information, and training needed to prepare and submit an application. Available at in our funding center.

PCORI Information Request

During the application phase, the process by which PCORI program staff or contract staff request additional information from an applicant by a defined deadline, usually to address questions or concerns.

PCORI Online System

PCORI’s online application and award management system, designed to facilitate the applicant’s submission of materials, and the activation of a contract through completion and closeout. Available in the PCORI Online System.

PCORnet

PCORnet is a network of networks that brings together patients, clinicians, researchers, and healthcare systems to share information and participate in research. PCORnet’s Clinical Data Research Networks (CDRNs) include hospitals, doctors’ offices, health centers, or other facilities that provide services to patients. The Patient-Powered Research Networks (PPRNs) are made up of patients and their families, caregivers, researchers, and other people or organizations focused on specific medical conditions or populations of interest.

Peer Review

The goal of peer review is to ensure that the primary research studies funded by PCORI are held to the highest standards of scientific integrity, methodological rigor, and relevance and usefulness to patients, caregivers, clinicians, and other healthcare stakeholders. Our process includes review of study findings by content experts, methodologists, patients, and other healthcare stakeholders with experience related to the study.

Pilot Project

PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community.

Pipeline to Proposal Award

The Pipeline to Proposal Awards program provides seed money to individuals and groups who have healthcare research ideas and an interest in patient-centered CER. The awards will be used to build capacity and engage community around a healthcare research interest. These awards focus on building the community of patients, stakeholders, and researchers who can participate in patient-centered outcomes research.

Pragmatic Clinical Study (PCS) PCORI Funding Announcements

These announcements seek applications for pragmatic clinical trials, large simple trials, or large-scale observational studies that compare two or more alternatives for prevention, diagnosis, treatment, or management of a disease or symptom; improving healthcare system-level approaches to managing care; or eliminating health or healthcare disparities.

Principal Investigator

The lead researcher and primary contact for the project.

Professional Profile

A profile of the experience and accomplishments of a person who will play a significant role on a PCORI-funded research project. Also see Biosketch.

Program Director

The individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as Program Directors/Principal Investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the applicant organization, or as appropriate, to a collaborating organization for the proper conduct of the project or program including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI.

Programmatic Review

A review of the scientific portion(s) of the application to ensure that it meets PCORI’s programmatic requirements. These may include but are not limited to: presence of a CER question; absence of a cost effectiveness question; and, when applicable, addressing the specific research question in a targeted funding announcement.

Project End Date

Includes the research project period and may be subject to modification to allow other research-related activities such as peer review.

Project Status

View definitions of the life cycle of an awarded project

Project Title

The original title of the project supplied by the project lead or team.

Project Type

Research projects are designed to improve patient outcomes by comparing two or more care approaches and enhance the methods and infrastructure needed to support such research. Research support projects are not research studies but designed to encourage better integration of patients and other stakeholders into the research process.

Public Abstract

A summary of the research plan that is written for, and will be accessible to, a general, lay audience.

Public Abstract

A summary of the research plan or research findings that is written for, and will be accessible to, a general (lay) audience.

Purchasers

Those who purchase health benefits for employees and their dependents, including individual businesses as well as local, state, regional, and national business groups, coalitions that represent businesses, and health coalitions.

R

Randomized Controlled Trial (RCT)

An experiment in which participants are randomly allocated to receive one of two (or more) diagnostic, preventive, therapeutic, or palliative interventions and are then followed to determine the effects of the intervention.

Reasonable Costs

A cost may be considered reasonable if the nature of the goods or services acquired or applied is appropriate and justifiable. The amount involved reflects the action that a prudent person would have taken under the circumstances prevailing at the time the decision to incur the cost was made.

Renewed Support

Approval of an additional funding period for the same project within the approved project period. The original agreement will remain in place and additional funds obligated near the end of each funding period. Any funds remaining on the contract prior to the new obligation will remain available for the recipient’s use.

Research Team

A group of people organized to function cooperatively to design and conduct research. For PCORI, teams should be interdisciplinary, and include patients and other stakeholders as key contributors to the research process.

Resubmission

An application that was submitted and received a summary statement, but was not funded and is being resubmitted to the same PFA for new consideration. An application that was withdrawn before merit review, or an LOI that was not invited to provide a full application, would not be considered a resubmission.

S

Shared Decision Making

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 or promotes their ability to engage in such a process.

Stakeholder Partner

Members of constituencies based on professional, rather than personal, experience. These can include clinicians, healthcare purchasers, payers, industry, hospitals and other health systems, policy makers, training institutions, and researchers. Some individuals may fit into several categories.

Stakeholders

Stakeholder partners may include members of constituencies based on professional, rather than personal, experience. For example, these constituencies can include: clinicians, purchasers, payers, industry, hospitals and health systems, policy makers, and training institutions. Some individuals may fit into several categories. Find more information on how PCORI defines stakeholders here.

State

The state where the project originates, or where the primary institution or organization is located.

Study Advisory Committee

For Targeted PFAs and Pragmatic Clinical Studies (PCS), the SAC described in the PFA is to ensure that a broad spectrum of patients and other stakeholders advise and assist the research team with refining the study questions, outcomes, and protocols. These patients and other stakeholders must include national or regional organizations that represent, at a minimum, patients, caregivers, clinicians, policy makers, and other healthcare system stakeholders.

Study Registration

PCORI-funded studies are required to register in ClinicalTrials.gov (NCT) or the National Library of Medicine’s Health Services Research Projects in Progress (HSRP) database. Study registration information includes study aims, patient population eligibility, interventions and comparators, outcomes measures, and, as required, participant recruitment status.

Subcontractor

An individual or group who takes a portion of a contract from the prime contractor (awardee) or from another subcontractor.

Summary Statement

For applications that are discussed at the in-person merit review meeting, the summary statement includes a final overall average application score, a summary of the application discussion at the in-person merit review meeting, and preliminary online reviewer critiques. For applications that are not discussed at the in-person merit review meeting, the summary statement includes only the preliminary online reviewer critiques. Summary statements no longer include any preliminary review scores.

Systematic Review

A synthesis and critique of existing literature, which can identify evidence gaps and inform decisions regarding how to address these gaps.

T

Targeted PCORI Funding Announcements

These announcements seek applications on specific, high-impact topics selected in response to input from patients and other stakeholders through our advisory panels and public workshops. These are one-time opportunities.

Targeted PFAs

Announcements that seek applications on specific, high-impact topics selected in response to input from patients and other stakeholders through our advisory panels and public workshops. These are one-time opportunities.

Technical Abstract

A summary of the research plan that is written for scientists and researchers.

Timeframe

Length of follow-up for collecting data on primary outcomes.

Transitional Care

A range of services designed to ensure continuity and promote safe and coordinated transitions between settings and clinicians.

Transitional Care Evidence to Action Network

A network of PCORI-funded awardee teams and stakeholders collaborating around the topic of transitional care.

Y

Year Awarded

The year the PCORI Board of Governors approved funding for the project or the year the proposal received a notice of award.