RTA: Specific Aims Faheem Guirgis, MD Center for Research Training Slides from Rosemarie Fernandez, MD
Objectives • The review process (why SA page is so important) • What reviewers are looking for: Grantsmanship and the Review Process • Aims Do’s and Don’ts
What you need to know: • Your study section is comprised of 20 – 30 people with very different areas of expertise
What you need to know: • Your grant is reviewed by 3 people • They are NOT all experts in your field!
What you need to know: • If your 3 reviewers give you a high enough score, your grant is discussed by the whole group
What you need to know: • What is high enough?
What you need to know: • What is high enough?
What you need to know: • What is high enough? Depends on the study section study section
What you need to know: • What is high enough? Depends on the study section • At least 50% of submissions must be reviewed • All resubmissions must be reviewed
What you need to know: • What is high enough? Triaged out Reviewed by committee
What you need to know: • If you are reviewed by the committee . . . Reviewer 1
What you need to know: • If you are reviewed by the committee . . . Reviewer 1
What you need to know: • If you are reviewed by the committee . . . Reviewers 2 &3
What you need to know: • Then the committee discusses your application • Each application is 100 – 150 pages long
What you need to know:
What you need to know: • Members of the section will flip through to find key info KEY INFO = SPECIFIC AIMS
Hard Truths • Study section members are not experts in your field • Abbreviations make it hard to follow your work, especially when scanning your grant • MVA (motor vehicle accident, manual vacuum aspiration, multivariate analysis) • Consistency in language is your friend • Dense language and writing is scary
WHAT YOU CAN DO
General Grantsmanship • Use the same terminology for the same concept throughout your grant
General Grantsmanship • Use the same terminology for the same concept throughout your grant X
General Grantsmanship • AVOID: • Jargon • Abbreviations • Acronyms *if you use these, do so sparingly and not in your Specific Aims or Abstract • Make it easy to read • Parallel structure in Aims can help
Specific Aims Content • State why your problem so important Sepsis is a common, costly and deadly condition. Sepsis incidence is estimated at 1.7 million annual cases in the United States with a mortality of approximately 20% and a cost of 20 billion dollars.
Specific Aims Content • Clearly state the knowledge gap you will address Novel investigations of sepsis pathobiology are critical to understanding clinical trajectories, developing precision medicine, and improving long-term outcomes. A large gap in our knowledge of lipid and lipoprotein dysregulation in sepsis exists that prevents complete understanding of previously observed lipid changes.
Specific Aims Content • Clearly state your hypothesis: We hypothesize that inflammatory, lipidomic, and genomic changes in early sepsis result in dysregulated lipid and lipoprotein metabolism & altered lipid function, oxidation and reduced levels that play a central role in sepsis pathobiology.
Specific Aims Content • State the overall goal of your project or your research The overall goal of this application is to identify lipid and lipoprotein differences in sepsis that indicate metabolic pathways as targets for novel therapies.
Specific Aims Content • Point to the request for proposals if appropriate This project directly addresses the NIGMS mission of researching biological mechanisms that underlay the foundation for advances in treatment of diseases such as sepsis.
Specific Aims Content • This can lead into your Aims This work is organized into 3 independent Aims described briefly below.
Specific Aims Content • Sample Aim: SA1: Determine the association of persistent Dys-HDL elevation with early sepsis-associated organ dysfunction, incidence of CCI and morbid outcomes after sepsis. In a prospective design, serial measures of Dys-HDL will be taken in 160 patients with sepsis who will be assessed for early cumulative organ dysfunction via Sequential Organ Failure Assessment score and followed for the development of CCI, and a composite morbid outcome (full functional dependence or death at 1 year). [H1] We hypothesize that persistently elevated Dys-HDL levels will be associated with early organ dysfunction as well as increased incidence of CCI and morbid outcomes.
Specific Aims Content • Consider briefly stating why your team is well-positioned to do the work The work proposed builds upon a solid foundation of preliminary data as well as considerable expertise in simulation- based training, evaluation methods, and resuscitation outcomes. • Could also state: The research team has a history of successful collaboration and includes expertise in team science, simulation science, trauma outcomes, and clinical trial design. As such, this team is uniquely positioned to execute the proposed work.
Major Issues with Specific Aims • Aims are interdependent • If the success of one aim depends on the success of another, this is a HUGE problem and you are probably dead in the water
Major Issues with Specific Aims • Aims are completely unrelated • If one of your aims seems out of left field, it will raise a red flag • Outcomes are not well-specified • Clearly state your primary and secondary outcomes.
Major Issues with Specific Aims • Overall goal doesn’t pass the “so what” test Contribution to science should be clear and important
Reviewing Your Aims • Does your first paragraph make people say “This is a huge problem!” Unlike other age groups, older adult rates of opioid use disorders (OUD) and opioid-related hospitalizations are rising. Older adults develop opioid use disorders 10 times greater than the general population, leading to a 25% increase in related hospitalizations over the past year. (numbers made up)
Reviewing Your Aims • Does every single sentence in your Aims add something Tools that can assess an individual patient’s risk for OUD and opioid - related injury (ORI) prior to opioid prescribing in the ED are lacking, particularly in patients with acute pain. Existing OUD screening tools were designed for non-ED populations with persistent pain.
Reviewing Your Aims • Are your Aims statements as specific as they can be • When appropriate, do you give testable hypotheses
Reviewing Your Aims • In the end, does your reviewer think that not doing your study would be a crime against humanity?
QUESTIONS?
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