Letter of Intent Template: Assessment of Options

LETTER OF INTENT TEMPLATE: ASSESSMENT OF OPTIONS

Please provide the information requested below.Statements ingray italicsdenote how each response will be evaluated.Replacethe italicized graytext with your response.Please note that the total word count maynot exceed1,900 words,including the template, which is689words.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.

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.

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 1,900words in total; note that the template is 689words.)

References:

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