Interventional Study Flashcards
What are the main types of intervention study designs?
- Before and after study 2. Non-randomized controlled trial 3. Randomized controlled trial (RCT) 4. Qualitative studies
What are the key steps in a before-and-after study design?
- Collect data before intervention (Point A) 2. Apply the intervention 3. Collect data after intervention (Point B)
What are the main challenges of interpreting results in before-and-after studies?
- Bias (results due to other systematic differences) 2. Confounding (other factors that changed) 3. Chance
What are the two groups involved in a non-randomized controlled trial?
- Intervention group (receives intervention) 2. Control group (does not receive intervention)
What are the challenges in interpreting results of non-randomized studies?
- Allocation bias 2. Measurement bias 3. Confounding 4. Chance
What is the main purpose of randomization in a randomized controlled trial (RCT)?
To reduce systematic allocation bias by evenly distributing known and unknown confounders.
What are the key features of a randomized controlled trial (RCT)?
- Participants are randomly assigned to groups 2. Each group receives different treatments/interventions 3. Outcomes are measured and compared
What are the steps in designing an RCT?
- Define outcome measures (clinical, patient experience, etc.) 2. Randomize participants 3. Administer intervention 4. Follow-up and measure outcomes
How can contamination in an RCT be minimized?
By using cluster randomization, where groups (e.g., schools or communities) are randomized instead of individuals.
What is allocation concealment, and why is it important?
Ensuring researchers and participants do not know group assignments beforehand; it prevents bias in participant selection and dropouts.
What is blinding in RCTs?
Blinding prevents knowledge of group assignments to minimize bias. It can be single (participants), double (participants and researchers), or triple (participants, researchers, and analysts).
What is the purpose of intention-to-treat analysis in RCTs?
To account for participants who drop out or do not adhere to the intervention, ensuring results reflect real-world scenarios.
What factors influence the required sample size in a study?
- Expected effect size 2. Level of significance (e.g., p < 0.05) 3. Study power (e.g., 80-90%)
What is the main advantage of an RCT over other study designs?
It minimizes bias and balances known and unknown confounders through randomization.
What does “chance” mean in interpreting study results?
Random variation or randomness that might explain observed results, rather than the intervention itself.