Randomized Controlled Trials Questions
with Correct Answers A+
What is an RCT? - ✔✔RCTs are studies that *randomly* assign individuals to an intervention
group or control group, in order to measure the effects of the intervention.
Without randomization of assignment of interventions, you cannot conclude causality.
Why is randomization important? - ✔✔-To generate groups that are equal in known and
unknown prognostic factors.
-To eliminate selection bias
-Allows investigators to conclude that observed differences in the trial outcomes are due to the
intervention and not due to confounding factors
Selection Bias - ✔✔The ability of the investigator to choose which group the subject will be
placed
Ex) you assign the sickest patients to the intervention to see a positive result
What comes before the published RCT you're reading? - ✔✔Research question, protocol, getting
funding, approval by the Institutional Review Board (to make sure that it's ethical)
,What consists of the investigator's research question? - ✔✔Population, intervention, comparator,
outcome, timing, setting
Based on that research q, the researcher is going to make a very lengthy protocol, research what's
currently known/unknown about the topic, hypothesis, design an objective, step-by-step plan
Protocol - ✔✔Rationale for the idea and what's known/unknown about the topic, objectives,
hypothesis, aims, step-by-step plans for recruitment, enrollment, intervention, and follow up,
outcomes collection, analysis, etc.
Steps of Conducting the Trial - ✔✔1. Generate the random sequence for assigning interventions,
prepare the intervention & placebo
2. Recruit patients
3. Enroll patients that meet the inclusion criteria & obtain informed consent
4. Randomly assign subjects into the intervention or control groups and administer the
interventions
5. Ensure blinding to minimize bias
6. Follow the subjects for the pre-specified duration of time and collect pre-specified outcomes
7. Evaluate outcomes using pre-planned statistical analysis
8. Analyze & synthesize results
Organization of the manuscript - ✔✔1. Abstract
2. Intro
, 3. Methods
4. Results
5. Discussion
6. Conclusions
7. References
8. Supplements and appendices
Supplements and appendices - ✔✔Dont overlook these bc they have a lot of data. Journals have
word limits, so this section is where the author can further explain their data to supplement their
paper, and this could help you understand the big picture
Discussion - ✔✔This is where the *author* can explain themselves; their opinions. They can
discuss the limitations of their trial and data, how their conclusion can be used, why their data is
sound & credible.
How is randomization accomplished? - ✔✔Random sequence generators
This sequence should be completely random, should create an environment sot hat each patient
should have an equal chance of being assigned to any of the groups of the trial.
When you randomize, you balance all the factors. You're assigning purely by change - so you
balance all known and unknown factors.
with Correct Answers A+
What is an RCT? - ✔✔RCTs are studies that *randomly* assign individuals to an intervention
group or control group, in order to measure the effects of the intervention.
Without randomization of assignment of interventions, you cannot conclude causality.
Why is randomization important? - ✔✔-To generate groups that are equal in known and
unknown prognostic factors.
-To eliminate selection bias
-Allows investigators to conclude that observed differences in the trial outcomes are due to the
intervention and not due to confounding factors
Selection Bias - ✔✔The ability of the investigator to choose which group the subject will be
placed
Ex) you assign the sickest patients to the intervention to see a positive result
What comes before the published RCT you're reading? - ✔✔Research question, protocol, getting
funding, approval by the Institutional Review Board (to make sure that it's ethical)
,What consists of the investigator's research question? - ✔✔Population, intervention, comparator,
outcome, timing, setting
Based on that research q, the researcher is going to make a very lengthy protocol, research what's
currently known/unknown about the topic, hypothesis, design an objective, step-by-step plan
Protocol - ✔✔Rationale for the idea and what's known/unknown about the topic, objectives,
hypothesis, aims, step-by-step plans for recruitment, enrollment, intervention, and follow up,
outcomes collection, analysis, etc.
Steps of Conducting the Trial - ✔✔1. Generate the random sequence for assigning interventions,
prepare the intervention & placebo
2. Recruit patients
3. Enroll patients that meet the inclusion criteria & obtain informed consent
4. Randomly assign subjects into the intervention or control groups and administer the
interventions
5. Ensure blinding to minimize bias
6. Follow the subjects for the pre-specified duration of time and collect pre-specified outcomes
7. Evaluate outcomes using pre-planned statistical analysis
8. Analyze & synthesize results
Organization of the manuscript - ✔✔1. Abstract
2. Intro
, 3. Methods
4. Results
5. Discussion
6. Conclusions
7. References
8. Supplements and appendices
Supplements and appendices - ✔✔Dont overlook these bc they have a lot of data. Journals have
word limits, so this section is where the author can further explain their data to supplement their
paper, and this could help you understand the big picture
Discussion - ✔✔This is where the *author* can explain themselves; their opinions. They can
discuss the limitations of their trial and data, how their conclusion can be used, why their data is
sound & credible.
How is randomization accomplished? - ✔✔Random sequence generators
This sequence should be completely random, should create an environment sot hat each patient
should have an equal chance of being assigned to any of the groups of the trial.
When you randomize, you balance all the factors. You're assigning purely by change - so you
balance all known and unknown factors.
