BME100 f2014:Group15 L1
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Geriatric Clinical Trials of Lipopolysaccharide and the Effect on Amount of Inflammotin in Subjects
Independent and Dependent Variables
In this experiment there are a total of three groups. Each group is broken up by age and will receive increasing dosages of LPS. However, before the experiment begins, each subject will be tested in order to establish baseline levels of inflammotin in the body. This is to ensure the experiment has controlled data to compare in the analysis of the data produced.
The first group has people ranging from ages 60 - 69. The second group has people ranging from ages 70 - 79 and the third group has people 80 years and older.
Number of subjects per group
In each group there are ten subjects. Ten was determined to be the best number of subjects to get data from so that there could potentially be a person of every age receiving dosages of LPS. This would also ensure diversity of people within each group.
The voluntary subjects selected for this experiment are people who have responded to advertisements in newspapers, nursing homes, golf courses, and senior centers all over the state of Arizona. The various areas chosen allow for diversity in lifestyles and health conditions to determine the effects the different variables have on the efficiency of the lipopolysaccharide. The subjects must meet an age requirement of 60 years or older to be a part of this experiment.
Sources of Error and Bias
We are looking for an increase in the amount of inflammotin from the lowest amount of LPS possible, thus we need to make sure we are objective if results vary from prediction. Our experiment is to be administered by another group of scientists who do not know the effects of the medication, to subjects who also do not know the effects of the pills. This ensures a double blind study.
Because these are clinical trials, we are unable to control all aspects of the subject's lives. A particular diet, or lifestyle, could vary the results from subject to subject, sometimes greatly, which is why the baseline control group is necessary. A lifestyle where the subject is active each day, such as daily walks/runs/bike rides would effect the amount of inflammotin in the subject. To control the potential diet issue, they will be meeting with a nutritionist every week (including the week before testing begins) to monitor their diet and change it if necessary. For lifestyle, exercise will be monitored by a in the same method as their diet by a physical therapist, to ensure that they are not over exerting themselves and causing injury. The body’s physical refusal of the drug is also another potential error that can affect the experiment and considering the age of our subjects, another concern is injury in their daily lives, or even if the subject passes away.
A fall could negatively affect our results. Death would remove an entire aspect of data from our trials (however, the subjects chosen are healthy, and thus death would occur by outside causes i.e. car crash). A consent form would be signed, stating that we are not liable for any illness or injury that occurs during trial period outside of experimental parameters. If illness, injury, or death occurs their results will be removed from the data.
Geriatric subjects are often on a variety of medication, some of which is life saving. Certain kinds of medication, such as anti-inflammatory, could affect our results further. To eliminate this source of error, our subjects must be relatively healthy and not on lifesaving medications, and could go the trial time of 10 weeks without medication that could potentially affect our results (Subjects with arthritis, for example, could not be tested due to their medication).
An unsuitable environment for the drugs is also another critical factor. For example, if the LPS is not kept at the proper room temperature then it can affect the outcome of the experiment variably. To control for this, all of the drugs will be kept in a closely monitored facility. Furthermore, the ELISA test that will be used for measurement can be affected by user error, so it will be important for the people conducting the test to be properly trained.