PI name:
PCORI Application Checklist
Project title:
Consideration of Research Strategy (Background and Significance)
Yes
No
Included in Application:
1. Impact of the condition on the health of
individuals and populations clearly
stated
1a. Significance of burden on US population:
Prevalence? ___ Mortality? ___
Morbidity? ___
Individual suffering? __
Loss of productivity? ____
1b. Project addresses patients with chronic
conditions or multiple chronic conditions
2. Innovation and potential for
improvement is focused on patient
health, well-being, or quality of care
2a. Novelty in:
Methods/approach? __ Population? ___
Intervention? ___ Change to practice? ___
2b. Addresses a critical gap, evidenced by:
Systematic reviews? ___
Guidelines/development efforts?* ___
Published research priorities?* ___
2c. Significance recognized by stakeholders:
Patients? ___ Caregivers? ___
Clinicians? ___
2d. Preliminary studies cited or supplied
indicate significant potential for benefit over
current practice
2e. Clear dissemination plan articulated:
PI uses advocacy groups for rapid D&I? ___
Advocacy group support documented by
Established working relationship? ___
Letters of support? ____
3. Impact on health care performance
leads to improvements in care for the
individual or for a population of patients
3a. Is the proposal likely to lead to
improvements in convenience? ___
Elimination of wasted resources? ___
Are patient outcomes likely to be improved?
____
If lacking, method(s) to address in revision
Consideration of Research Strategy (Relevance to Patients – EXPANDED to include Caregivers, and Clinicians)
Yes
No
Included in Application:
Does the proposed research focus on
questions and outcomes of specific interest
to patients, and/or their caregivers?
Does the proposed research address one or
more of the key questions included in the
definition of PCOR as stated by PCORI?
Are these clearly articulated?
1a. Does the proposal demonstrate patient
involvement that is broad-based, rather
than statements from high profile
individual patients?
1b. Are patient surveys or responses
included in the project that map across the
entire spectrum or clinical care? If gaps are
observed, can they be addressed through
the proposal? What is the status of
development or implementation of patient
survey instruments?
2a. Does the proposal demonstrate
caregiver participation and involvement that
is broad-based, rather than limitations that
focus on high profile caregiver impact
statements?
2b. Are caregiver surveys or responses
included in the proposed research that map
across each phase of clinical care? How
effectively do these instruments sync with
the patient experience? Are gaps present?
What is the status of development or
implementation of caregiver response and
impact elements?
3a. Does the proposal demonstrate buy-in
and support of relevant advocacy groups
at each stage of the research plan?
Consider patient stakeholders, as well as
caregiver and clinical organizational
groups. Is documentation provided that
demonstrates real and functional
connections to such groups?
Are there alternative outcomes from the
study, and are these identified and
addressed?
If lacking, method(s) to address in revision
Consideration of Research Strategy (Approach)
Yes
No
Included in Application:
Are rigorous research methods included in
the approach?
Is the research strategy framed as
hypothesis-driven?
Are specific aims framed as patient-centric?
If not, can they be modified to demonstrate
shift towards patient and/or caregiver aligned
aims?
Is the study design carefully articulated?
Does the proposal describe the manner in
which qualitative or quantitative data will be
obtained and analyzed? Is any biostatistical
support needed to interpret the raw
information into generalizable findings?
Will the information, once obtained, be
sufficiently accurate and precise to be
beneficial and reliable for patients,
caregivers, and clinicians? Will this
information be unbiased?
Have potential gaps or pitfalls been
identified by the applicant? How have these
been examined and have alternative
methods been identified to cope with
potential obstacles?
Is the proposed study population relevant, or
are their identifiable limitations that interfere
with generalizations to provide the broadest
base for the results?
Is the available,or proposed sample size
adequate for the study? Are there
recruitment issues that should be addressed
up-front?
Are any of the specific aims in the proposal
supported by preliminary data, survey
documents, literature studies conducted or
analyzed by the applicant or team? Is the
preliminary information balanced across all
aims, or is the distribution lop-sided in a
specific area? Are any of the aims
exploratory or open-ended?
Has the applicant included a time line for the
specific aims of the project, when specific
deliverables are anticipated, or when data or
information analysis will be conducted? Does
this timeline include feedback and
information flow to and from patients,
caregivers, and clinicians, as well as
advocacy groups?
Does this proposal utilize ICTS cores in
either the design or implementation of the
project aims? Are there additional core
services or resources that would add value to
the project which should be considered?
If lacking, method(s) to address in revision
Consideration of Research Strategy (Inclusiveness of Different Populations)
Yes
No
Included in Application:
Does the study include a diverse population
with respect to age? ___ Gender? ___
Race? ___ Ethnicity ___ Geography? ___
Clinical stage/status? ____
Are institutional regulatory approvals in place
to support inclusiveness of patient
populations?
Does the proposal focus on and include a
previously understudied population where
effectiveness and outcomes information is
specifically needed?
Does the design of the study, with reference
to a patient’s unique biological, clinical, or
sociodemographic characteristics, and the
information gained provide insight into
enhanced and improved personalization of
decision-making?
If lacking, method(s) to address in revision
Consideration of People and Places (Research team and environment)
Yes
No
Included in Application:
Does the research team have the expertise
to implement the research program?
Does the skill set of the team exhibit
complementary and integrated research or
clinical expertise? Have any of the team
participants worked collaboratively together
at a previous time?
Will any members of the team (patients,
caregivers, clinicians, health system,
community members) require specific
training and have any such efforts been
described and developed in the approach?
Is training included in the timeline?
Are relevant patients and other key users of
the study results and information (caregivers,
clinicians, health system, community
members, or policy makers) included in the
team make-up?
What is the specific research environment?
Have important features, such as health
system, community involvement or
collaborative agreements, been described?
How will the environment, experience, or
expertise of the team contribute to project
success and demonstrate valuable outcomes
to patients, caregivers, and clinical
participants?
Has the institution or community
demonstrated investment in the project and
will this impact on enhanced and improved
personalization of decision-making? Has this
commitment (time, effort, resources) been
described?
If lacking, method(s) to address in revision
Consideration of Budget (Efficient use of research resources)
Yes
No
Included in Application:
Is the budget reasonable and does it request
funds commensurate with the potential
contribution of the research?
Is the time and effort of all participants
reasonable to meet the study aims? On
examination, are any team members
specifically overcommitted on other
tasks/responsibilities? If such individuals are
crucial to project success, then are
mechanisms in place to balance these
commitments?
Does the budget justification provided speak
to the efficiency with which PCORI resources
are utilized to deliver the scientific program?
Are there opportunities to make the study or
analysis more efficient?
Is there added value to the project through
the generation or creation of common data or
infrastructure that would be strategically
valuable to PCORI to support future
research?
If lacking, method(s) to address in revision
Use of ICTS Cores: Identify the ICTS Core(s) you consulted in preparation of this application and/or that you
anticipate using if this project receives funding from PCORI
P = Preparation, I = Implementation (check all that apply)
P
I
ICTS Core/ Service
P
I
ICTS Core/ Service
Research Design and Biostatistics Group
Clinical Research Unit (CARS, including LIRC)
Dissemination & Implementation Research Core
Pediatric Clinical Research Unit (CARS)
Center for Administrative Data Research
Clinical Trials Unit (CARS)
Center for Community Engaged Research
Human Imaging Unit
Center for Clinical Research Ethics
Translational Pathology and Tissue Banking
Regulatory Support Center(including Research Subject
Advocacy and Recruitment Enhancement)
Translational Cardiovascular Tissue Core
Center for Biomedical Informatics
Proteomics and Mass Spectrometry
Genomic Medicine Program
Brain, Behavior and Performance Unit
WU PAARC PBRN (Pediatric/Adolescent Ambulatory
Research Consortium)
WIHSC (Women and Infants’ Health Specimen Consortium)
10/30/13 EJK