Don’t Crash on Approach

Getting the approach – the methods section of your grant – fine-tuned is literally the heart of it all. You must land your science smoothly. Study section members know, and recent evidence confirms, your grant’s score is not an equal weighting of component scores. NIH criterion scores are for significance, innovation, approach, investigators, and environment.

No surprises here, approach has the highest weight. Reviewers care most if the scientific methods in are sound. For studies with human participants from case-cohort studies to clinical trials you must implement this flight checklist:

Brief overview of the study design/population (repeated as necessary if this changes across aims).
Summary/figure detailing the timing and sequence of data collection including biological specimens, interview data, exposure measures, and outcomes.
Succinct summary of inclusion and exclusion criteria for participants (and if needed the larger study from which participants are identified).
Flow diagram indicating how many individuals were, or are estimated to be, excluded. Provide reasons if you have an extant cohort.
Clear estimates or exact numbers (better) of how many individuals will be available or recruited for analysis in each aim.
Operational definitions for: 1) Main exposure/intervention; 2) Primary and secondary outcomes; and 3) Key candidate confounders
Text introducing measures in a logical order (e.g., order that data is collected or order of relevance to aims).
Summary of general data quality assessment (e.g., logic checks) and data cleaning steps.*
Information about how missing or incomplete data will be handled.*
Details of quality control approach for any measures (labs, surveys, etc.).*
Description of analytic approach including data preparation, models to be used, and how choices will be made for any analysis of effect modification and confounding for each aim, if applicable.*
Methods for how you will check for and handle any violations of model assumptions.
Specific delineation between primary analyses and secondary analyses.
Power calculations supplemented with a table or figure.
Summary of potential challenges and solutions if they are encountered.
Timeline for completion of the work.
Conclusion/summary of the strength of the approach with a final pitch covering why the science is innovative.

Work the checklist. The glidepath provided by crisp and clear operational details will bring you in. A sound approach is required for a smooth landing.