Study Design Midterm Review - Erica's Notes

Study Design Midterm Review - Erica's Notes - Study Design...

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Study Design Midterm Review SPPS 208-Study Design By Erica Lee Week #1 Part 1 (Designing Your Own Study) Objectives: Understand elements and requirements of the graduation research project. List proposal writing elements required by the NIH grants proposal. Demonstrate ability to design a clinical research study. 1. Outline of Study Protocol: Table 1.1 on pg. 4 of textbook 1
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Element Purpose Research questions What questions will the study address? Background and significance Why are these questions important? Design Time frame Epidemiologic approach How is the study structured? Subjects Selection criteria Sampling design Who are the subjects and how will they be selected? Variables Predictor variables Confounding variables Outcome variables What measurements will be made? Statistical issues Hypotheses Sample size Analytic approach How large is the study and how will it be analyzed? 2. Main Elements of a Proposal (based on the NIH model) Title Abstract Administrative (budget, biosketch, resource) Specific aim Background & significance Preliminary studies Methods o Study design 2
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o Subjects o Measurements o Statistical issues o Quality control & data management o Timetable o Limitations & issues Ethical consideration Reference Appendices 3. Overview of NIH: Figure 19.2 on pg. 311 of textbook. 3
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Approach of the NIH Typical Approach of Foundation US Government Congressional appropriation NIH funds allocated to each institute Wealthy Donor Gift of donor Foundation funds 4. Graduation Research Project Identify topic Need creativity, tenacity, judgment Review of graduation research proposal guidelines 4 Grant applications Requests for grant applications Investigator- initiated Foundation- initiated Decision by Board of Directors K-awards (career development ) RFA Requests for Applications (for a grant) R-awards (individual research grant applications) RFP Request for Proposals (for a contract) Investigator- initiated Institute- initiated Priorities established by advisory committees
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Part 2 (Study Design Overview) Objectives: List common clinical research study designs. Understand differences between inclusion and exclusion criteria of research subjects/participants. List different sampling strategies and compare the advantages and disadvantages of the different sampling strategies. List different types of variables and their roles in clinical research. Know the inferences drawn from different types of clinical studies. List and give examples of errors in clinical research. 1. Common Clinical Research Study Designs: Table 1.2 on pg. 6 from textbook Study Design Key Features Observational Designs Cohort study A group followed over time Cross-sectional study A group examined at one point in time Case-control study Two groups selected based on the presence or absence of an outcome Clinical Trial Design Randomized blinded trial Two groups created by a random process, and a blinded intervention
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Study Design Midterm Review - Erica's Notes - Study Design...

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