Projects: Background, Design, Study Population, Exposure & Outcome Presentations start 10-23-2018 Continue on 10-30-2018 and 11-01-2018

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

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

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

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

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

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

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)

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.

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

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