B4.027 Prework Writing a Protocol

Question 1

purpose of a protocol

Answer 1

explain study rationale and study design

Question 2

sections of a paper

Answer 2

background
methods
results
conclusions

Question 3

key components of a protocol

Answer 3

title
project purpose
background
methods
implications of proposed project
dissemination of results
references

Question 4

what is the project purpose

Answer 4

brief statement: explains short term project objective

includes: method of investigation, population, setting, timeframe

Question 5

what is the function of the background section

Answer 5

using literature to frame your project rationale

what is the problem? extent of problem? causes and correlates of problem? what is known?

Question 6

what is included in a methods section?

Answer 6

research design
participants and setting
data collection
procedures
data analysis

Question 7

what are outcome variables

Answer 7

dependent variables

primary variables of interest that are the essence of the project

Question 8

what are predictor variables

Answer 8

independent variables
exposure of interest
predictor or correlates of outcome variables
variables that define subgroups

Question 9

clinically meaningful endpoints

Answer 9

directly measure how a patient feels, functions, or survives

Question 10

surrogate endpoints

Answer 10

laboratory measure of physical sign intended to be used as a substitute for a clinically meaningful endpoint

Question 11

clinically meaningful endpoint vs. surrogate endpoint

Answer 11

survival/complications vs. blood sugar

loss of vision vs. intraocular pressure