LETTER OF INTENT (LOI) TEMPLATE: IMPROVING HEALTHCARE SYSTEMS
Instructions:
Please provide the information requested on the attached template. Statements in gray italics denote how each
response will be evaluated. Applicants are required to follow the rules and guidelines listed below:
1. Replace the italicized gray and any instructional text on the next page with your response, but retain the bold
headings and question numbers.
2. Figures and general tables are allowed and will be included in the page count.
3. All references should be included in American Medical Association (AMA) citation style within the three-page
limit. You may submit additional pages of references that will not be included in the page count.
4. Do not include supplemental materials (e.g., supporting journal articles, Letters of Support) or additional
information not requested on the template (e.g., responses to reviewer comments, Resubmission Letter).
Any additional modifications to the template will result in your LOI being disqualified. This cover page should be deleted
before submitting the LOI in PCORI Online.
Formatting Guidelines:
 Font: Calibri size 11, figures and captions may have size 8 font
 Spacing: Single
 Margins: Half-inch (The header may fall within the top margin, but the body text should not begin closer than a
half-inch from the edge of the page.)
 Page limit: Three pages
 File name format: PI Last Name__(last five digits of Request ID)_ LOI.pdf. A request ID number will be
automatically generated once the LOI has been saved. When you select the “Save and Review” button, the new
request ID number will be visible at the top of the webpage in PCORI Online.
LOIs are competitive and will be screened by PCORI staff. The information included in this template will be used as the
primary source of information for the screening process. Please focus on including critical information, as space is
limited. If you have any additional questions, please contact PCORI at pfa@pcori.org or 202-627-1885 for
administrative inquiries and sciencequestions@pcori.org or 202-627-1884 for programmatic inquiries.
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
LETTER OF INTENT (LOI) TEMPLATE: IMPROVING HEALTHCARE SYSTEMS
TITLE OF PROPOSED STUDY:
Specific Aims: State the specific aims of this study.
Please propose comparative effectiveness research (CER) with a focus on health systems issues. Projects to develop new
or novel interventions, without evidence of efficacy or effectiveness, or those that include formal cost-effectiveness
analysis or direct comparison of costs of care, are out of scope and will be rejected. Out-of-pocket costs to patients and
overall cost of the intervention to the health system are acceptable.
Condition Burden and Impact: Briefly describe the prevalence and/or impact of the condition.
High prevalence and/or association with significant patient suffering. Rare diseases (conditions affecting fewer than
200,000 people in the United States) are also of interest.
Gap Analysis: Describe the evidence gap; be sure to include references, such as systematic review(s), guidelines, and
other evidence.
Documentation that the proposed topic is considered a high priority by research, clinical, patient advocacy, and/or
stakeholder groups (e.g., the Institute of Medicine [IOM] and the Agency for Healthcare Research and Quality [AHRQ]);
stating that the gap is one of the priority topics (e.g., IOM 100 CER or PCORI topics) without further documentation is not
adequate.
Study Design: Describe the study design: randomized trial (individual level or cluster), observational study (retrospective,
prospective), quasi-experimental study, or other (please specify). Include a brief description of theoretical or conceptual
framework(s) and the way in which this informs the selection of the design and the variables being tested. If your
proposed study builds on prior pilot work, briefly describe the prior study or studies in terms of setting, patient
population, design, sample size, and key findings.
Clearly describe and defend the study design, including a description of how selection bias and confounding will be
mitigated in a nonrandomized design; reference PCORI’s Methodology Standards.
Description of Participants and Participating Study Site(s): Describe the source of recruitment of participants,
demographic characteristics of the participants targeted by the intervention and their representativeness of the target
population, and inclusion and exclusion criteria. In cases where the unit of randomization is the study site, rather than
the participant, describe the representativeness of proposed participating site(s).
Provide evidence of availability of patients and ability of the sites to conduct the proposed study successfully.
PCORI Cycle 3 2015: Letter of Intent Template: Improving Healthcare Systems
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
Outcomes: Describe the study outcomes and the validated measures used to assess them. Explain why the selected
outcomes are important to patients and relevant to health systems and how the study results may be used to influence
practice change.
Outcomes should be clearly defined, patient-centered, measurable, and measured with instruments of documented
validity.
Power Calculations: State the power of the proposed study to detect the hypothesized effect, including support for all
assumptions (e.g., type-1 error level, standard deviation in outcome measure, underlying event rate). Note power for
important subgroups, if applicable.
Clearly state and support all assumptions.
Hypothesized Effect Size for Intervention on Main Patient-Centered Outcome: State the hypothesized effect size and
cite references to support the assertion that the effect size is both realistic and clinically meaningful.
Document that the effect size is realistic, based on published evidence, and meaningful to patients.
Sample Size: Provide the total sample size for the main CER analysis and the number per arm (N1, 2, 3, 4 . . .), as applicable.
As a general guide, <50 per arm may be considered underpowered, unless the condition is rare.
N (total)
N1
N2
N3
Comparators: List the interventions being compared.
1.
2.
3.
Description of Comparators: Describe each intervention listed above under “Comparators,” including:
a. Evidence of the efficacy or effectiveness of each, or statements about its acceptance in widespread practice
despite its having limited evidence of efficacy or effectiveness
b. An estimate of frequency of use in clinical practice
c. If usual care is a comparator, provide justification of its inclusion and a proposal to describe and document its
components clearly
Document efficacy/effectiveness or established practice documented. (Note that lack of either suggests that the proposal
is intended to establish efficacy, which is out of scope for this PCORI Funding Announcement [PFA]–and the LOI will be
rejected.) Provide evidence that the clinical strategies are currently accepted and used in practice. If a comparator is
usual care, it must be well-defined.
PCORI Cycle 3 2015: Letter of Intent Template: Improving Healthcare Systems
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
Engagement: Briefly state how patients and stakeholders are involved in all aspects of the research and list specific
organizations involved.
Clearly describe how patients, family members, caregivers, and the organizations that represent them, as well as any
other relevant stakeholders, will be involved in planning the study, conducting the study, and potentially disseminating
study results/findings.
Duration of Study: State duration of intervention and length of follow-up as they fit into a three- or five-year project.
Follow-up is realistic within a three-year or five-year time frame and sufficient to produce meaningful outcomes.
Cost of Study: State whether the study is small (up to $1.5 million in total direct costs for up to three years) or large (up
to $5 million in total direct cost for up to five years).
State the study size (small or large), estimated budget, and time frame. Include justification for the size.
“Real-Life” Applicability of Strategies: State how the intervention will be delivered and received in real-life clinical
settings. Explain how the study results will provide practical information that supports patients and other stakeholders
in making informed decisions about their health care and health outcomes.
Provide a description of how the strategies will be delivered in actual care strategies.
NOTE: This LOI Template is for screening purposes only. If you are invited to submit an application, your application must
be consistent with what is provided in this LOI.
PCORI Cycle 3 2015: Letter of Intent Template: Improving Healthcare Systems
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
References:
PCORI Cycle 3 2015: Letter of Intent Template: Improving Healthcare Systems
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