We're piloting a novel exposure-based treatment for PTSD nightmares and anticipate a fair proportion of dropouts. Because it's a pilot, we'd like to ask participants their reasons for dropping out and assess suicidality, nightmare, insomnia, PTSD symptom levels at drop-out both to determine participant safety and to gather information about the treatment tolerability.
I think it's fine to ask them their reasons. I was on a study recently where we included a statement in the consent form that said you may choose to drop out at anytime, but we may ask your reasons for dropping out so we can better understand the needs of patients like yourself and improve the quality of the study.
It's an important bit of information, especially in a pilot phase. I might suggest this phrase, "What could we do differently to improve the study?" as opposed to this phrase, "Why did you drop out?" You will get better quality answers with the first question. The "Why did you drop out" might just get you answers like - it was too time consuming, or I didn't want to do it. But I would definitely ask. Good luck!
Loretta Anderson's response makes a whole lot of sense since we are dealing with subjects in a Pilot Study. However, I am uncomfortable because of its impact on the ethical concept of "Voluntariness" in obtaining subjects consent. Except this is explicitly explained to the subject before obtaining his/her consent, getting drop out subjects back for this exercise will be unethical.
Thanks, Alexander. We're including the explanation of the early termination visit in the informed consent. Thanks for addressing our ethical concerns.
Yes, Alexander and Patricia, this is a very important point about maintaining the integrity of our studies by keeping within ethical standards. I think this can be addressed in 2 ways: First, the idea of including it in the informed consent, and second, the way the follow up question is phrased. In my previous answer, I suggest asking for feedback about the study, rather than asking for personal feedback about the study participant. Didn't want to complicate the answer at the time, but I'm glad Alexander pointed that out. Indeed, we need to maintain our ethical standards at all times. Keep us posted Patricia!
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