Edited by Sarah Cornell, Tuesday, 28 Jul 2015, 08:30
It appears that being in a trial means getting picked up from home, taken to the hospital, laying around for a bit while blood is drawn, then being driven back home again. I'm fairly sure the taxi service is unusual for a study!
The baseline was in two parts. The first was on Friday 17th, which included signing the informed consent. This was set out in sections and I had to initial each bit and then sign/date at the bottom of each of the (two) pages. I was the only person in the 'endocrinology investigation unit' that afternoon, so it was all fairly straightforward - blood taken, pituitary-thyroid stimulating stuff given, blood taken again after 20 and 60 minutes. No fasting for this one, all went smoothly, nice friendly research nurse and so on.
The second part was this morning. This involved fasting from midnight (which was in fact from about 9.15pm), which is never fun even when you're having a single blood draw at 8am. This was several tubes of blood taken (for the specific tests, but also for a comprehensive set of 'standard' tests), then stuff given for pituitary-cortisol stimulation. Them more stuff given for growth hormone stimulation (it's still important even when you are a grown up) and more and more blood drawn. And on and on until the last tube was taken at 1.45pm.
At which point I was given lunch, which included a chocolate muffin:
The difference today was that there were four of us in for the morning. Two of us were on this VoxTox trial, another was having cortisol testing and the fourth growth hormone stuff. All fasting, all serial blood draws, and all on different schedules. Person 4 had tests a couple of hours apart, and no cannula, so he could (and did) just leave and come back as needed. A fifth person turned up at some point for some non-fasting timed tests (they got the bed person 3 had been on, person 3 went to person 4's chair, though by the time person 4 came back, person 3 was finished and gone!)
As it sounds, it was busy. As always at these times, there was a challenge getting the technology to cooperate - the printer would print the blood tube bar codes, just some time after the print button was clicked, by which time remembering which of the various tubes was which was fun. Especially when one tube was doing two tests, but one tube can't take two labels, so each got one label and then all the other labels were put in the bag with the samples with a note saying 'please test for both parameters at every time point'. At least the labels had names on, not just ID numbers!
I got to do a quality of life questionnaire, part of which was pituitary specific and the other part looked quite familiar to me as a standard form! More nostalgically, my demographic data, vital signs and such like went on to a paper CRF (case report form, for any non-clinical trial people who've got this far in reading this - the thing you record all the required information in). Just a single copy, no duplicate or triplicate stuff here. It had shocking things like a space for my name! There was also a box for my subject id but that hadn't been filled in yet...
All in all, interesting to see things from the other side - good to see that systems aren't always designed with reality in mind every step of the way! Easy to see how if you have lots of patients and protocols going on, it's not surprising things don't go entirely according to plan.
Study visit
It appears that being in a trial means getting picked up from home, taken to the hospital, laying around for a bit while blood is drawn, then being driven back home again. I'm fairly sure the taxi service is unusual for a study!
The baseline was in two parts. The first was on Friday 17th, which included signing the informed consent. This was set out in sections and I had to initial each bit and then sign/date at the bottom of each of the (two) pages. I was the only person in the 'endocrinology investigation unit' that afternoon, so it was all fairly straightforward - blood taken, pituitary-thyroid stimulating stuff given, blood taken again after 20 and 60 minutes. No fasting for this one, all went smoothly, nice friendly research nurse and so on.
The second part was this morning. This involved fasting from midnight (which was in fact from about 9.15pm), which is never fun even when you're having a single blood draw at 8am. This was several tubes of blood taken (for the specific tests, but also for a comprehensive set of 'standard' tests), then stuff given for pituitary-cortisol stimulation. Them more stuff given for growth hormone stimulation (it's still important even when you are a grown up) and more and more blood drawn. And on and on until the last tube was taken at 1.45pm.
At which point I was given lunch, which included a chocolate muffin:
The difference today was that there were four of us in for the morning. Two of us were on this VoxTox trial, another was having cortisol testing and the fourth growth hormone stuff. All fasting, all serial blood draws, and all on different schedules. Person 4 had tests a couple of hours apart, and no cannula, so he could (and did) just leave and come back as needed. A fifth person turned up at some point for some non-fasting timed tests (they got the bed person 3 had been on, person 3 went to person 4's chair, though by the time person 4 came back, person 3 was finished and gone!)
As it sounds, it was busy. As always at these times, there was a challenge getting the technology to cooperate - the printer would print the blood tube bar codes, just some time after the print button was clicked, by which time remembering which of the various tubes was which was fun. Especially when one tube was doing two tests, but one tube can't take two labels, so each got one label and then all the other labels were put in the bag with the samples with a note saying 'please test for both parameters at every time point'. At least the labels had names on, not just ID numbers!
I got to do a quality of life questionnaire, part of which was pituitary specific and the other part looked quite familiar to me as a standard form! More nostalgically, my demographic data, vital signs and such like went on to a paper CRF (case report form, for any non-clinical trial people who've got this far in reading this - the thing you record all the required information in). Just a single copy, no duplicate or triplicate stuff here. It had shocking things like a space for my name! There was also a box for my subject id but that hadn't been filled in yet...
All in all, interesting to see things from the other side - good to see that systems aren't always designed with reality in mind every step of the way! Easy to see how if you have lots of patients and protocols going on, it's not surprising things don't go entirely according to plan.