PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
LETTER OF INTENT (LOI) TEMPLATE: SYMPTOM MANAGEMENT
Instructions:
An LOI is required for new and resubmitted applications. Provide the information requested on the attached template. You must answer all questions listed in the template. Statements in gray italics denote how each response will be evaluated. Replace the gray italics and any instructional text with your responses, but retain the bold headings and question numbers. No other modifications may be made to this template; any modifications will result in administrative withdrawal of the LOI. Applicants are required to follow the rules and guidelines listed below.
1. Replace the gray italics 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. References will not be included within the three-page limit.
4. Do not upload this cover page.
5. Do not include supplemental materials (e.g., supporting journal articles and Letters of Support) or additional information not requested on the template. Their inclusion will result in LOI rejection without review.
Any additional template modifications will result in disqualification of your LOI. The LOI must be submitted as a PDF in PCORI Online.
Formatting Guidelines:
· Header: Include the Principal Investigator’s (PI’s) full name on every page in the top-left corner
· Font: Calibri size 11; figures, tables, and captions may have size 8 font
· Spacing: Single
· Margins: Half-inch (The header may fall within the top margin, but the body text may not begin closer than a half-inch from the edge of the page.)
· Page numbers: Consecutive
· Page limit: Three pages (excluding references)
· File name format: PI Last Name_(last four digits of LOI number)_LOI.pdf. An LOI number will be generated automatically and visible at the top of the web page in PCORI Online once the LOI has been saved.
· References: PCORI suggests including all references as in-text citations using American Medical Association citation style, but other citation styles are accepted.
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. Focus on including critical information because space is limited. Provide a description that allows the scientific community to understand the project—including the aims and study design—without reviewing the full application. If you have any additional questions, contact PCORI at or 202-627-1885 for administrative inquiries and or 202-627-1884 for programmatic inquiries.
LETTER OF INTENT (LOI) TEMPLATE: SYMPTOM MANAGEMENT
TITLE OF PROPOSED STUDY:
Specific Aims:
· State the goals of the proposed research, the interventions, and the expected outcomes.
Background:
· State the evidence gap that underlies the uncertainty faced by patients, clinicians, and other decision makers by referencing systematic review(s), guidelines, and other evidence.
Significance:
· Describe the potential for the study to improve the quality of the evidence available to help patients and relevant stakeholders make informed health decisions and improve health care and outcomes.
· Describe how the research is focused on questions that affect outcomes of interest to patients and their caregivers.
Approach: Describe the overall strategy, interventions, methodology, and analyses to be used to accomplish the specific aims.
1. Study Design: Briefly describe the study design (e.g., individual or cluster randomized controlled trial, nonrandomized [prospective or retrospective] study, or other design [please specify]).
2. Engagement Approach: Briefly mention the plan to engage patients and stakeholders meaningfully in the various phases of research.
3. Study Population and Setting: Specify the study population and the settings.
4. Interventions: List the options or clinical strategies being compared, and provide evidence of efficacy or wide use for these interventions. Note that all options must be in current clinical use.
5. Outcomes: Describe the outcomes that people representing the population of interest notice and care about, including your use of patient-reported outcomes when patients or people at risk of a condition are the best source of information.
6. Analytic Plan: Describe a priori specific plans for data analysis that correspond to major aims.
7. Sample Size and Power: Provide the total sample size for the main comparative clinical effectiveness research analysis and the number per arm (N1, 2, 3, 4 . . .), as applicable. Include justification of the proposed study size, citing published estimates, including effect sizes, and standard deviations.
Prior Relevant Experience
8. What is your previous experience with recruiting and retaining study participants in trials of similar size, study design, and target population(s)?
Duration and Total Direct Costs
9. What are the estimated total direct costs and project duration of the proposed study?
a) Provide a brief justification indicating how the funds will be used and why the level of funding and duration requested are appropriate. Answers such as “will not exceed $2 million” are not adequate and will be deemed nonresponsive.
10. Are you requesting a budget with total direct costs greater than $2 million? (Note that these costs will be taken into account when evaluating your LOI in terms of the value of the research.)
Answer: Yes/No_____
a) If your proposed budget exceeds a total direct cost of $2 million, provide a brief description of how any additional funds will be used, documenting the budget requirements with respect to the scope of the proposed research and the data collection and analysis efforts.
b) If the proposed level of funding cannot be provided, explain the feasibility of conducting the research with no more than $2 million in direct costs.
References:
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PCORI Cycle 2 2017: Letter of Intent Template: Symptom Management