Informed Consent In Trials and Using It As A Reference
Doctor patient relationships, informed consent in trails and finding solutions.
Ever have one of those days, where you feel like you are in a ultimate universe? I found myself in this situation a few weeks ago. It involved my recent experience in a clinical trial and dealing, with a medical issues there.
Those that may have read some of my other posts may know that I am very pro clinical trial participation. One of the essential items of a clinical trial is the ever popular informed consent. Informed consent is the mainstay of trial participation. Consider it the Holy Grail of trial life as participant.
I recently experienced an eye inflammation issue, while there is no clear correlation between the study drug and my eye inflammation. Since I had had eye inflammation issue before, there was a chance and a significant one that there was no relation. What this issue did start was a series of miscommunication and having to go back to basics.
To preface this story, I have had a couple of mixed doctor patient relationship moments with the study doctor. We have had some good times, some miscommunications and sometimes in which we really needed to figure out how to work with each other. This experience became a test of that relationship.
The best thing about being in a study is that you generally have an express helpline to the doctor. Trials are incredibly safe, like ridiculously, bubble wrapped safe. Everyone takes patient safety to a whole new level and every concern is taken seriously. Unfortunately, my eye issue seemed to trigger a whole different kind of response. The safe mode seemed to take over and it initially meant that I was not going be able to reduce my prednisone dosage (the study I am in examines the prednisone sparing abilities, in relation to the use of biologic). It is a double blind study, this means that I have no idea if I am getting the placebo or not. I was so disheartened that I thought I was not going to be able to reduce my prednisone that I considered withdrawing from the study. I was incredibly torn about this decision. I wasn't sure what to do. I spoke with a dear friend who works closely with trial participants and physicians and she encouraged me to have another read through my consent and to definitely book a discussion with my doctor the PI (not Magnum PI), but the Principal Investigator of the study. It was really helpful information. While my initial email exchange set me into a bit of dizzy, having a read through the consent was really helpful. In just about every study you can withdraw your consent and no longer participate, at any time and for any reason. It is my understanding that you don't even need to provide a reason for no longer wanting to participate, you can simply say that you are withdrawing. It is important to read the fine print, while you can withdraw participating, for your safety, you may need to still return to the study site for follow up appointment(s) and to monitor your health, so you are done but not exactly done.
I booked an appointment with my doc and we went through all the options about how my eye situation may or may not be factor. That my eye situation would need to be closely followed up by an Ophthalmologist, I already receive Ophthalmology care, there was no problem on that front. We discussed my options, if I were to leave the trial and re evaluated staying in the study. It is true that your care is NOT affected even if you decided to withdraw participation. This disclaimer is all over informed consent forms for trials, there is no need to be worried about your future care. I worked out a plan for next steps with the doc. The followup was easy and I needed to remind myself that having a conversation with your doc can make a world of difference and that the door is always open. This conversation really put me at ease for whatever decision would come next.
I hope you will consider participating in a study and supporting researchers.
Have you ever gotten "moon face" as a side effect of prednisone?