Introduction And Study Design

Question 1

What is biostatistics?

Answer 1

Is the application of statistical principles in medicine, public health, or biology. Statistical principles are based in applied mathematics and include tools and techniques for collecting information or data and then summarizing, analyzing, and interpreting those results.

Question 2

What is epidemiology?

Answer 2

Field of study focused on the study of health and illness in human populations, patterns of health or disease, and the factors that influence these patterns.

Question 3

What is “study design”?

Answer 3

The Methodology that is used to collect the information to address the research question.

Question 4

What is bias?

Answer 4

A systematic error that introduces uncertainty in estimates of effect or association

Question 5

What is “blind/ double blind”?

Answer 5

The state whereby a participant is unaware of his or her treatment status.( experience,ents, drug or placebo). A study is said to be double blind when both the participant and the outcome assessor are unaware of the treatment status.

Question 6

What is another term used to describe blind or double blind?

Answer 6

Masking

Question 7

What is a clinical trial?

Answer 7

A specific type of study involving human participants and randomization to the comparison groups

Question 8

What is a cohort?

Answer 8

A group of participants who usually share some common characteristics and who are monitored or followed over time

Question 9

What is concurrent?

Answer 9

At the same time; optimally, comparison treatments are evaluated concurrently or in parallel

Question 10

What is cross-sectional?

Answer 10

At a single point in time

Question 11

What is incidence ( of disease)?

Answer 11

The number of new cases ( of disease) over a period of time.

Question 12

What is prevalence (of disease)?

Answer 12

The proportion of individuals with the condition (disease) at a single point in time

Question 13

What is a placebo?

Answer 13

An inert substance designed to look, feel and taste like the active or experimental treatment. (Saline solution would be a suitable placebo for a clear, tasteless liquid medication)

Question 14

What is matching?

Answer 14

A process of organizing comparison groups by similar characteristics

Question 15

What is protocol?

Answer 15

A step by step plan for a study that details every aspect of the study design and data collection plan

Question 16

What is a quasi-experimental design?

Answer 16

A design in which subjects are not randomly assigned to treatments

Question 17

What is “ prospective”?

Answer 17

A study in which information is collected looking forward in time

Question 18

What is “randomization” ?

Answer 18

A process by which participants are assigned to receive different treatments ( this is usually based on a probability scheme)

Question 19

What is prognostic fear?

Answer 19

A characteristic that is strongly associated with an outcome (Disease) such that it could be used to reasonably predict whether a person is likely to develop a disease or not

Question 20

What is “per protocol “?

Answer 20

An analytic strategy whereby only participants who adhered to the study protocol ( the specific procedures or treatments given to them) are analyzed (in other words, an analysis of only those assigned to a particular group who followed all procedures for that group)

Question 21

What is “intention to treat”?

Answer 21

An analytic strategy whereby participants are analyzed in the treatment group they were assigned regardless of whether they followed they study procedures completely ( regardless of whether they took all of the assigned medication)

Question 22

What is “retrospective”?

Answer 22

A study in which information is collected looking backward in time

Question 23

What is an observational design?

Answer 23

We generally observe a phenomenon

Question 24

What is stratification?

Answer 24

A process whereby participants are partitioned or separated into mutually exclusive or non overlapping groups

Question 25

What are examples of observation studies? (5)

Answer 25

The case report/ case series, the cohort study, cross-sectional survey, the case-control study, the nested case-control study

Question 26

What does randomized studies show?

Answer 26

They are used to test specific hypothesis or to evaluate the effect of an intervention

Question 27

What are examples of randomized studies? (2)

Answer 27

The crossover trial and the randomized controlled trial or clinical trial

Question 28

A study is designed to evaluate the impact of a daily multivitamin on students academic performance. 160 students are randomly assigned to receive either the multivitamin or a placebo and are instructed to take the assigned drug daily for 20 days. On day 20 each student takes a standardized exam and the mean exam scores are compared between groups. This study is an example of?

Answer 28

Randomized controlled trial

Question 29

What is a crossover trial?

Answer 29

A clinical trial where each participant is assigned to two or more treatments sequentially. When there are two treatments (experimental and control), each participant receives both treatments.

Question 30

What is a wash out period?

Answer 30

Used in a cross over trial, when there is not treatment given. It is included so that that any therapeutic effects of the first treatment are removed prior to the administration of the second treatment.

Question 31

What is the difference between random and fixed assignment in a cross over trial?

Answer 31

Random: participants are randomly assigned to the experimental treatment or the control treatment in period one. Participants are then assigned the other treatment in period two.
Fixed: all participants are assigned the same treatment SEQUENCE