Match the following study types to their definition below: case control study, randomized controlled trial, registry, Investigational Device Exemptions (IDE)

A.

B.

C.

D.

 

Prospectively comparing the outcomes of patients randomly assigned to be treated with a new device or procedure relative to a control group that may receive no treatment or standard treatment

A.

 

Case control study

A.

B.

C.

D.

Monitoring outcomes through a collection of cases performed in a real world, which may be accumulated either prospectively or retrospectively after a number of cases have been performed

B.

Registry

A.

B.

C.

D.

 

Retrospectively comparing the outcomes of a group of patients treated with a new device or procedure to a matched group receiving no treatment or a standard treatment

C.

 

Investigational Device Exemptions (IDE)

A.

B.

C.

D.

 

Allows a device to be used in a clinical study in order to collect safety and effectiveness data.

D.

Randomized controlled trial

In a small study, 12 women with cervical cancer (cancer of the cervix) and 12 women with no apparent cervical cancer were contacted and asked whether they had ever used the hormone estrogen as a drug. Each woman with cancer was matched by age, race, and weight with a woman without the disease. This is an example of:

a) A randomized controlled trial

b)A prospective cohort study

c) A case-control study

d) A retrospective cohort study

Randomized controlled trials (RCTs) are the strongest research design for establishing cause and effect. Which of the following is the main limitation of RCTs?

a) RCTs may not be ethical for some studies.

b) RCT design cannot control for confounders.

c) Randomized controlled trials may have a disproportionate number of people exposed to the risk factor.

d) Randomized controlled trials are, by their very design, likely to be very biased towards an expected outcome.

In a randomized controlled trial, patients with meningitis who were treated with corticosteroids had lower rates of death, hearing loss, and long-term neurological effects. Which of the following is a randomized comparison?

a) Patients who remained for the duration of the trial versus those who dropped out after randomization.

b) Patients who responded to the disease versus those who did not.

c) The sample of patients who took the drug before being randomized and developed the disease.

d) The sample of patients who, at the time of randomization, were severely affected by the disease