Atrial fibrillation (AF) is a rapid and unorganized beating of the upper chamber
ID: 3523257 • Letter: A
Question
Atrial fibrillation (AF) is a rapid and unorganized beating of the upper chambers of the heart. It is generally not life-threatening in the short term, but it dramatically impacts how a patient feels. Suppose you are designing a study of an implantable medical device that detects AF episodes and attempts to terminate them with electrical pulses. The device can store analyzable information on number of AF episodes, duration of AF episodes, whether each episode was successfully terminated by the device, as well as dates and times of all AF episodes. Your study will implant devices into 100 subjects.
Via remote control, you have the ability to turn ON or OFF the electrical pulses that are designed to stop AF. Your study will follow each patient for 1 year. You are most interested in the device’s effectiveness at terminating AF, but of course you will also collect information about adverse events and about implant procedure (duration of implant procedure, blood loss, etc.) for all subjects.
(1) Select an endpoint that you would like to study. Some possible endpoints of your study include: number of AF episodes/month, percentage of time spent in AF, time until first AF episode that lasts at least 24 hours. (You are welcome to think of others.)
(2) Decide how you will implement the intervention: turning ON and/or OFF the electrical pulses. (There are many ways to do this.)
(3) Based on your answers to (1) and (2), is your study: (a) a randomized crossover trial, (b) a randomized parallel groups trial, or (c) an uncontrolled study?
Explanation / Answer
1. End point selected: number of atrial fibrillation episodes per month.
2.Intervention for AF episode can be implemented by using an electric stimulation device which can be used to switch on/off electric impulse and regulate hypertension which is a cause of atrial fibrillation.
3.Based on options (1) and (2), the study is an uncontrolled study since there is no comparison used with any control group for the data .
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