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In this unit you will learn about experimental studies. You will learn about when they are used, how they are designed and conducted, and how they relate to other study design (e.g. observational studies). Time to complete: 2 hoursACTION ITEMSAnswer these questions as you work through this module:How do RCTs differ from observational studies? How are they the same?What is the difference between efficacy and effectiveness?Why is randomization important?Why is blinding important? What are the different types of blinding?What are the 2 approaches to analyzing RCTs? What are the pros/cons of each?Read/Review the readings/videos Required (read)LectureFletcher Chapter 9Fletcher Chapter 1 pages 8-10 (section on confounding) Required (review)Video: Why randomization is important (5:02)Video: Controlling confounding during the design phase of a study (6:23)Video: Intention-to-treat analysis (4:43)Video: Blinding (7:14)Optional (Other materials that may be of interest or to supplement) Boston Univ. School of Public Health module on clinical trialsAt the end of this unit you should be able to define these terms:EfficacyEffectivenessRandomizationEquipoisePlaceboBlindingPhase 1 trialPhase 2 trialPhase 3 trialPhase 4 trialIntention to treat analysisPer protocol analysisSampling Inclusion criteriaExclusion criteriaCross overAllocation concealmentConfounding ................
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