Interventional Study Flashcards

1
Q

What are the main types of intervention study designs?

A
  1. Before and after study 2. Non-randomized controlled trial 3. Randomized controlled trial (RCT) 4. Qualitative studies
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2
Q

What are the key steps in a before-and-after study design?

A
  1. Collect data before intervention (Point A) 2. Apply the intervention 3. Collect data after intervention (Point B)
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3
Q

What are the main challenges of interpreting results in before-and-after studies?

A
  1. Bias (results due to other systematic differences) 2. Confounding (other factors that changed) 3. Chance
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4
Q

What are the two groups involved in a non-randomized controlled trial?

A
  1. Intervention group (receives intervention) 2. Control group (does not receive intervention)
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5
Q

What are the challenges in interpreting results of non-randomized studies?

A
  1. Allocation bias 2. Measurement bias 3. Confounding 4. Chance
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6
Q

What is the main purpose of randomization in a randomized controlled trial (RCT)?

A

To reduce systematic allocation bias by evenly distributing known and unknown confounders.

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7
Q

What are the key features of a randomized controlled trial (RCT)?

A
  1. Participants are randomly assigned to groups 2. Each group receives different treatments/interventions 3. Outcomes are measured and compared
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8
Q

What are the steps in designing an RCT?

A
  1. Define outcome measures (clinical, patient experience, etc.) 2. Randomize participants 3. Administer intervention 4. Follow-up and measure outcomes
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9
Q

How can contamination in an RCT be minimized?

A

By using cluster randomization, where groups (e.g., schools or communities) are randomized instead of individuals.

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10
Q

What is allocation concealment, and why is it important?

A

Ensuring researchers and participants do not know group assignments beforehand; it prevents bias in participant selection and dropouts.

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11
Q

What is blinding in RCTs?

A

Blinding prevents knowledge of group assignments to minimize bias. It can be single (participants), double (participants and researchers), or triple (participants, researchers, and analysts).

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12
Q

What is the purpose of intention-to-treat analysis in RCTs?

A

To account for participants who drop out or do not adhere to the intervention, ensuring results reflect real-world scenarios.

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13
Q

What factors influence the required sample size in a study?

A
  1. Expected effect size 2. Level of significance (e.g., p < 0.05) 3. Study power (e.g., 80-90%)
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14
Q

What is the main advantage of an RCT over other study designs?

A

It minimizes bias and balances known and unknown confounders through randomization.

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15
Q

What does “chance” mean in interpreting study results?

A

Random variation or randomness that might explain observed results, rather than the intervention itself.

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16
Q

What statistical tools help account for chance in results?

A
  1. Confidence intervals 2. P-values
17
Q

What is the purpose of a control group in an RCT?

A

To provide a baseline for comparison, ensuring observed effects are due to the intervention.

18
Q

What are common types of bias in intervention studies?

A
  1. Allocation bias 2. Measurement bias 3. Attrition bias
19
Q

What are confounders in a study?

A

Factors other than the intervention that can influence outcomes (e.g., changes in environment or health policies).

20
Q

How can confounding be minimized in an RCT?

A

Through randomization, which distributes confounders evenly between groups.