PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
LETTER OF INTENT TEMPLATE: ASSESSMENT OF OPTIONS
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 the total word count may not exceed 1,900 words, including the template, which
is 689 words. References are not included in the word count. We recognize that you will not be able to include many details. NOTE: This Letter of
Intent (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.
Clearly stated; lacking a formal cost-effectiveness analysis or direct comparison of costs of care as the criterion for
choosing the preferred alternative; no decision aids
Condition Burden and Impact: Briefly state the importance of the condition in terms of prevalence and/or clinical
impact.
High prevalence and/or associated with significant suffering
Gap Analysis: Quote the statement of the evidence gap and cite sources, including systematic review(s), guidelines, and
other evidence.
Documentation of high-priority topic by research, clinical, and/or stakeholder community (such as the Institute of
Medicine and AHRQ), including quotes from recommendations [e.g., “randomized trials to compare the effects of
(specific) interventions for depression on patient-centered outcomes are needed . . .,”] and citing source(s)
Description of Patients: Describe age and other demographic characteristics, source of patients, and main eligibility
criteria.
Clear description; representative of community practice; inclusion of PCORI priority populations
Outcomes: Describe and justify outcome measures in terms of goals of strategies* (e.g., preventing stroke, improving
walking speed).
Patient-centeredness of outcomes, clearly defined, measurable; documented validations of the outcome measure
Comparators: List options that are being compared.
Reflecting clinical options (not traits of individuals); clearly stated; if usual care is a comparator, it is justified and stated
how usual care will be described
1.
2.
3.
PCORI Letter of Intent Template: Assessment of Options PFA
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
Estimate of Current Clinical Use of Strategies: Provide an estimate of current use of clinical strategies being compared
in terms of proportion of patients or clinics, or absolute numbers.
Evidence that the clinical strategies are currently accepted and used in practice
Established Efficacy: Provide evidence of efficacy of comparator(s) or that comparator is accepted practice despite
inadequate evidence of efficacy.
Known efficacy or established practice documented; lack of either suggests that the proposal is intended to establish
efficacy, which is discouraged
Engagement: Briefly state how patients and stakeholders are involved, and list specific organizations involved.
Involvement throughout planning and conduct of the project discussed
Study Design: Indicate whether the main comparative effectiveness research (CER) question in study 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 clearly described and defended, including description of how selection bias and confounding will be
mitigated in nonrandomized 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 a three-year time frame and sufficient to produce meaningful outcomes
*Strategies are the specific preventive, screening, diagnostic, treatment, surveillance, or management options being
studied.
PCORI Letter of Intent Template: Assessment of Options PFA
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
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.
WORD COUNT: ____ (Must be <1,900 words in total; note that the template is 689 words.)
References:
PCORI Letter of Intent Template: Assessment of Options PFA
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