Thoughts from a Lab Rat

Repeats are routine but what are they and how do they work? Well, a repeat is called by the study doctor when a lab value, ECG, blood-pressure or other screening factor is outside of the protocol range. Each study has a range that every lab result must be within. Depending on how out of range the result is will determine whether a repeat will be allowed. Typically, things like blood pressure, body temperature and pulse rate will have an automatic repeat and depending on the study, may allow a manual repeat by a paramedic. Values related to drugs, cotinine and alcohol are not repeated and typically will result in automatic disqualification. For street drugs and sometimes alcohol, you may be banned from the clinic permanently. For most urine and blood values, if your results are slightly out of range, you will typically be called in for a repeat. If the study doctor feels that your results are “clinically significant” or abnormally out of range, you may not get a repeat and will be disqualified from the study. Sometimes the study doctor will refer you to your own physician for a follow-up before you are allowed to screen again.
A repeat can happen at any stage of the study. You can have a repeat from your screening, check-in, anytime during the study, your exit labs and or any outpatient visits. It is important to note that if you have a repeat for your screening, you are not considered screened until you complete the repeat. If you are finishing a study and have a repeat, you are not considered finished with the study until you complete the repeat. Any delays in doing a repeat can affect your inclusion into a study and your payment after a study. If you are asked for a repeat, you should try to get it done as fast as possible.
The reason repeats are done is to ensure your safety before, during and after a study. The study doctor wants to make sure that your screening labs are all within normal or sponsor required ranges to see if there are any changes once you start dosing in the study. Comparisons are done throughout the study to detect any problems. It’s best to think of repeats as being “better safe than sorry”.

Well, you all have probably heard about this flu that is going around and the fatal effects it can have. As a precaution, if you have travelled to Mexico within the last 2 weeks or you have been experiencing the flu or flu-like symptoms, then it is highly recommended that you do not attempt to screen or check-in to a study. The consequences of exposing a large number of study volunteers and clinic staff to this potentially fatal virus can be devastating and irresponsible. While earning some extra cash by participating in a research study is great, killing a bunch of people is not. Okay, that sounded really bad but it is true. I have that worst case scenario mentality. Hopefully this threat will subside in the near future and it will be a distant memory but for now, take extra precautions to protect yourself. Simple things like washing your hands and avoiding crowded and cramped conditions.

Major updates coming the middle of May. I am getting ready to do my bi-annual update and verification of my site. While I do update clinic pages as new or changed information comes in, I check all of the travel information twice a year. I am working on some other ideas but am not sure when I will implement them. I am seeing how twitter works and have been told this could be a simple yet effective tool.

One of the most common problems people get disqualified for seems to be ‘out of range’ blood pressure. More than likely, it’s just nervousness and or anxiety. For many people, getting into a study means the difference between paying your rent and living on the streets. It shouldn’t be that way. But it’s stress like that than can cause your blood pressure to go up. Most of the time it is a psychological problem. If you stare at the machine or the clock or the technician and your waiting for the test to start, then your body is going to tense up. Try just staring at a fixed object. Let your body relax. Don’t anticipate the test starting. Think about something you like to do or something relaxing. Sounds retarded but it works for me most of the time. When I screen and check-in to a study, my blood pressure us usually in the upper limits but once I’m in the study, my blood pressure returns to normal. Again, it’s mostly psycological. Just don’t think about it. Some other minor factors include wearing tight clothes, tight shoes, the cuff is too tight or too small and talking. You should not talk or laugh during the test. Lastly, try to breathe as normally as possible. Don’t try to regulate your breathing because your just using more energy which can drive up your bp.

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It happens a lot. Even I get disqualified occasionally. But a good 20% of disqualifications are for out-of-range blood pressure. Every study has certain ranges that everything must fall into. The blood pressure ranges are usually 90/50 to 140/90. The first number is systolic and the second number is diastolic. The pulse is usually 40 to 50 over 90. For a detailed explanation of blood pressure, click here for the wikipedia entry. Certain studies may have lower or higher cut-offs depending on the sponsor requirements.

There is a lot of talk about the machines that some clinics use, being poorly calibrated because the only time they have out-of-range blood pressure is when they use that machine. While it is true that machine measurement is not the most accurate method, it is considered clinically reliable, hence why they are used. However, most people who get disqualified are are only a few points over or under which is not clinically significant. I have a problem with getting stressed out. I mean hey, I trying to get into a study so my stress level is high. Once I get into a study and my mind knows this, my blood pressure is normal, middle range. It’s only at screenings and check-in.

There are a few tips to help improve your blood pressure. First of all, make sure you use your bare arm. Sleeves can give abnormal results. Breath deeply. Don’t look at the machine or the clock. If your body knows when it’s going to run, it’s going to tense. Keep your feet flat on the floor. Wear loose fitting clothes. Don’t wear anything that will constrict your waist. Rest the arm that you use as high as possible. The lower your arm is from your heart, the harder it has to pump to circulate blood. Don’t think about it. That’s kinda hard, but think about something else. If you have to get a repeat, breathe deeper and don’t stress out.

If you are disqualified for out-of-range blood pressure, unless it was very high, you can still screen for another study at a later date. Occasionally, they may suggest that you see your physician to follow up. While it is unfortunate to get disqualified, there is not much you can do. Sometimes your body is stressed out, sometimes you get a bad reading. But once the clinic runs the tests, the results are final. Just relax and don’t panic.

Well, it’s been quite a rough year so far. Just not having a lot of luck as far as getting into studies is concerned. Just little things getting out of whack like too much potassium (strange as I don’t eat bananas) or my blood pressure is too high. Unfortunately, that is part of the game. You will have times when you don’t get into studies and it always seems to be at a time when you want the money the most. If you are excluded from a study for a laboratory result, it doesn’t necessarily mean you are unhealthy. It just means that your results were out of the range the sponsor was looking for. Your lab values change from day to day and I’ve said it a millions times that it’s amazing that all the things they check for are ever all within range at one time. You just gotta make sure you eat healthy, don’t do any heavy exercise and keep trying. And by way, a lot of people like me, get nervous and overexcited during vitals. So your results are artificially high. As soon as I dose and know I’m in the study, my BP is rock solid in the mid range. So, a few tips, don’t look at the machine or the clock, keep your feet flat on the ground, wear loose clothes, breathe deeply and just relax. Your friend in time, Paul