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, medical record review Develop a figure that depicts data collection for each participant.

Research Proposal Enroll 600 women Prenatal Examination GCRC Figure 3. Study Components Enrollment (n=50) Bariatric Patients Pre-surgery Full Exam GCRC Surgery Liver Biopsy OR 3,6,9-month Post-OP Brief Exam GCRC 12-month Post-OP 4-week Post-OP Figure 5.1. Components of the proposed study Prenatal Examination GCRC Medical Record Abstraction Enroll 600 women Telephone Interview 2 week 3 month 6 month 9 month Delivery Cord Blood 6-week Examination GCRC Mother and Child Components 1-year Examination GCRC

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? 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 Upper and lower bounds 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 May need repeatability studies for scanning/reading Blinded

Research Proposal Data collection What is the final information that will be obtained DXA – percent body fat MRI – visceral adiposity, amount of fat in kg Carotid ultrasound – intima media thickness The focus of your study – may be a lot of information available but what is central to your study.

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 will you get that information: Abstract medical record or measure required variables to obtain all required information Develop algorithm to define disease - missing data

Research Proposal Data collection Confounders -- covariates Identify potential confounders Comorbidities Age, sex, race, SES Observational study – these can make or break Less information on measurement of these variables

Research Proposal Data analysis For each hypothesis write out your exposure and outcome. Indicate variable to be used in analysis for both the exposure and outcome. Continuous, categorical, nominal or ordinal Power calculation for that hypothesis

Research Proposal Theoretical model Exposure  Outcome Covariates – where do they enter in

Research Proposal Diet/ Physical Activity Obesity ↕ Visceral Adiposity Hepatocyte Metabolism Microbiome Hepatic Steatosis Diabetes Incretin/Satiety Insulin Resistance Impaired Insulin Secretion Figure 4. Aim 1 Conceptual Framework; Proposed etiology of diabetes and hepatic steatosis in morbidly obese patients prior to gastric bypass surgery.

Research Proposal Problems, Pitfalls and limitations Keep a running list of problems with your study