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Problem Solving Exercise - Randomized Trials

A randomized trial is a study design where participants are randomly allocated into experimental and control groups to test if a treatment causes an effect. Randomization helps reduce bias by distributing participant characteristics evenly between groups. Researchers should select eligible participants without bias and randomly assign them to groups using a random number table or computer program. Data collection should account for treatment received versus assigned, objective outcome measures, and masking to reduce bias. Researchers must also address issues like noncompliance and retention of participants. Results should be reported by intention-to-treat analysis and can be generalized cautiously to populations similar to those in the study based on internal and external validity. Randomized trials inform treatment but individual patients may differ. Ethics require informed consent and oversight.

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67 views1 page

Problem Solving Exercise - Randomized Trials

A randomized trial is a study design where participants are randomly allocated into experimental and control groups to test if a treatment causes an effect. Randomization helps reduce bias by distributing participant characteristics evenly between groups. Researchers should select eligible participants without bias and randomly assign them to groups using a random number table or computer program. Data collection should account for treatment received versus assigned, objective outcome measures, and masking to reduce bias. Researchers must also address issues like noncompliance and retention of participants. Results should be reported by intention-to-treat analysis and can be generalized cautiously to populations similar to those in the study based on internal and external validity. Randomized trials inform treatment but individual patients may differ. Ethics require informed consent and oversight.

Uploaded by

theodore_estrada
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Saint Louis University

SCHOOL OF MEDICINE

METHODS OF RESEARCH I

PROBLEM SOLVING

SCENARIO: You want to conduct a randomized trial for your research study

1. What is a randomized trial? (Describe the basic design of a randomized trial. Cite a
specific example aside from the one mentioned in the reference.)

2. How should participants for a randomized trial be selected?

3. How should participants in randomized trial be allocated to the different groups in the
study? (Discuss the process of randomization. Illustrate this with an example.)

4. When collecting data from the participants, how should the following issues be addressed?

a) Assigned treatment versus received treatment

b) Measurement of the outcome

c) Prognostic profile at entry

d) Masking (Blinding)

e) Noncompliance

5. What problems may be encountered in the recruitment and retention of study participants
and how can these problems be addressed?

6. How could the results of randomized trials be reported?

7. How can the results of a randomized trial be generalized beyond the study population?
(Please include the difference between external and internal validity.)

8. What are the implications of the results of a randomized trials for physicians treating
individual patients?

9. What ethical considerations should be observed when conducting randomized trials?

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