PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
LETTER OF INTENT (LOI) TEMPLATE: ADDRESSING DISPARITIES
Please provide the information requested below. Statements in gray italics denote how each response will be evaluated. Replace the italicized gray
text with your response. Please note that there is a three-page limit, which includes in-text citations. We recognize that you will not be able to
include many details.
NOTE: This LOI Template is for screening purposes only. If you are invited to submit an application, other criteria are required and will be reviewed.
TITLE OF PROPOSED STUDY:
Specific Aims*: State the specific aims of this study.
Specific aims should be clearly stated
Condition Burden and Impact: Briefly state the importance of the condition in terms of prevalence and/or clinical
impact.
High prevalence of condition and/or condition is associated with significant suffering for populations or significant
burden of disease for individuals is clearly stated
Gap Analysis: Quote the statement of the evidence gap and cite sources, including systematic review(s), guidelines, and
other evidence.
Clear documentation of high priority topic by research, clinical, and/or stakeholder community (such as the Institute of
Medicine and AHRQ). Explanation of why the particular comparison is important to a patient or other decision makers is
clearly stated
Description of Patients: Describe age and other demographic characteristics, source of patients, and main eligibility
criteria.
The patient population; inclusion of Addressing Disparities program target population(s) (i.e., racial/ethnic groups,
individuals with low socioeconomic status, individuals with limited English proficiency, lesbian, gay, bisexual, transgender
persons, residents of rural areas, and individuals with disabilities) is clearly described
Outcomes: Describe and justify outcome measures in terms of goals of strategies** (e.g., preventing stroke, improving
quality of life).
Patient-centeredness of outcomes is clearly defined and measurable; provide documented validations of the outcome
measure
Comparators: List options that are being compared.
Comparators should be clearly stated; applications studying usual care will be viewed skeptically unless its use is well
justified and well defined
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PCORI Letter of Intent Template: Addressing Disparities PFA
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
Estimate of Current Clinical Use of Strategies, If Appropriate: Provide an estimate of current use of clinical strategies
being compared in terms of proportion of patients or clinics, or absolute numbers.
If appropriate, provide evidence that the clinical strategies are currently accepted and used in practice
Established Efficacy or Effectiveness: Provide evidence of efficacy or effectiveness of comparator(s) or that comparator
is accepted practice despite inadequate evidence of efficacy.
Known efficacy, effectiveness, or established practice documented; lack of this information suggests that the proposal is
intended to establish efficacy, which is discouraged
Engagement: Briefly state how patients and stakeholders (e.g., insurers, employers, and clinical societies) are involved,
and list specific organizations involved.
Involvement throughout planning and conduct of the project is discussed
Study Design: Indicate whether the main comparative effectiveness research (CER) question is to be addressed as a
randomized trial (individual level or cluster); observational study (retrospective, prospective); quasi-experimental study;
or other (please specify).
Study design is clearly described and defended, including description of how selection bias and confounding will be
mitigated in non-randomized designs
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 viewed skeptically, unless the condition is rare
N (total)
N1
N2
N3
Hypothesized Effect Size for Intervention on Main Patient-Centered Outcome: State hypothesized effect size and cite
references to support that the effect size is (a) realistic and (b) clinically meaningful.
Effect size is documented to be realistic, based on published evidence, and meaningful to patients
Power Calculations: State the power of the proposed study to detect the hypothesized effect, including support for all
assumptions, including type-1 error level, standard deviation in outcome measure, underlying event rate, etc. Note
power for important subgroups, if applicable.
Assumptions are clearly stated and supported
Timing: State duration of intervention and length of follow-up.
Follow-up is realistic within three-year time frame and sufficient to produce meaningful outcomes
PCORI Letter of Intent Template: Addressing Disparities PFA
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
*Applicants should make sure that specific aims of their research do not include a formal cost-effectiveness analysis or
direct comparison of costs of care as the criterion for choosing the preferred alternative.
In addition, the Addressing Disparities program has funded a large number of projects that focus on self-management
techniques, community health workers/navigators, and cultural/language tailoring of interventions. Applications that
aim to study these types of interventions will undergo substantial scrutiny to ensure that the studies do not significantly
overlap with previously funded studies or concurrent proposals, or that they fill a gap within the program’s portfolio.
**Strategies are the specific preventive, screening, diagnostic, treatment, surveillance, or management options being
studied.
PCORI Letter of Intent Template: Addressing Disparities PFA
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