Stepped wedge design
6 important questions on Stepped wedge design
Explain short the goal of the PREPARATION study.
Anaesthesiologist needs to decide about the risks.
A multidiciplinary meeting can be helpfull in making a good risk-benefit analysis.
Risks? Benefits? Alternatives? Wishes of patient?
=> optimized patient outcome
What is a disadvantage of stepped wedge study?
- Confounder of time
- It is really needed that all clusters get the intervention?
Why is justified to cluster in the PREPARATION study? What are cons of using clusters? (3)
- If one patient gets a meeting => the doctors are aware of the possibility and will also use it, maybe unconciously, in other patients.
- Not ethical to give one patient the intervention and the other not in the same hospital
Con:
- Small numbers of clusters
- Increases false positive significant treatment effect
- Confounding by specific characteristics of one hospital => like how doctor normally care
- Higher grades + faster learning
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Why is a stepped wedge design in addition to cluster randomisation justified in the PREPARATION study?
- It gives more statistical power; when you have a limited number of clusters => you also make a comparison within a cluster.
- Logistics more feasible => introduce the new meeting in the different hospitals
- Social appeal (ethical) => everyone will get the intervention.
What are logistical challenges for a stepped wedge design?
- Recruitment can not take too long => because there is a fix period. => everyone needs to be ready because everyone gets the time of the treatment randomized. You don't know when.
- You can not just extend the period.
What is a big disadvantage of the stepped wedge trial?
=> how long should the transition period be?
The question on the page originate from the summary of the following study material:
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