1. Projects: Background, Design, Study Population, Exposure & Outcome Presentations start Continue on and

2. Presentations 11 groups in total
10 minutes max including questions 6 to 7 minute presentation
1 slide each
background – exposure
background - outcome
study question/hypothesis  what is unique
study design
study population
exposure and outcome

3. Research Proposal Research Question Hypothesis Null – no association
Alternative – an association, but no direction
Research/Operational – indicate direction
Cross-sectional surveys can have hypotheses

4. Research Proposal Background and Significance Exposure
Magnitude of the problem – why do we care
Prevalence in the US or SC
Outcome
Strengths – unique and novel aspects
Population available
Exposure measurement
Outcome measurement
Therefore, we propose to study X here

5. Research Proposal Overview Study design
Brief overview of components of the study
Flow chart of components and data collection points in the study

6. Research Proposal Study population Target population
Source/accessible population
Available n – need some estimate of this
Intended sample if sampling
Inclusion criteria
be specific: age, comorbidities
Trade off with generalizability
Exclusion criteria
Recruitment plan – how much time will it take
Remember inclusion criteria, exclusion criteria and drop-outs will affect your available n

7. Research Proposal Data collection Components of the study
Baseline – what, where, when and how
Follow-up – what, where, when and how
Questionnaire, interview, venipuncture, physical measurements

8. Research Proposal Data collection Main Exposure and Outcome Variables
Details on what will be collected for these variables
Questionnaires
Developed for this study?
Has it been validated?
Has it been validated in race/ethnic, age, gender?
Is a standard US food frequency questionnaire likely to work across different race-ethnic groups in the US
What language will be used?
If you are studying acculturation how will it impact your study if questionnaires are only available in English
Scale or a score, need to provide information on the range of values, how it is scored and interpreted, what type of variable is the output (continuous, discrete, ordinal, nominal)

9. Research Proposal Data collection Main Exposure and Outcome Variables
Details on what will be collected for these variables
Laboratory assays
Variation
How standardized are the measurements.
Are there different analytical techniques?
Does it matter which one you use?
Batch variation – is this a problem
Biologic variation – is this a problem
Reliability coefficient
same person different days
same sample different times
Where will the assays be completed. Will samples be stored and measured all at once or will they be sent as acquired.

10. Research Proposal Data collection Main Exposure and Outcome Variables
Details on what will be collected for these variables
Standardized measurements
Blood pressure, ultrasound, MRI
Need a standardized protocol for how you will measure it
Clinical protocol is not good enough
Good starting spot
Need a standardized protocol for how you will read it
Blinded
What is the final information that will be obtained
DXA – percent body fat
Carotid ultrasound – intima media thickness

11. Research Proposal Data collection Main Exposure and Outcome Variables
Details on what will be collected for these variables
Case definitions
Define exposure, outcome or study population
Clinical definition – not ideal
Standard criteria
What information are needed to make the diagnosis
How you will get that information
Abstract medical record
measure required variables to obtain information
Develop algorithm to define disease – missing data