Independent Variable: Dosage (mg) of an inflammation inducing agent (lipopolysaccharide)
Rationale: The independent variable is the lipopolysaccharide because this is the variable that we are changing in order to produce measure the effect it has on another. The doses of lipopolysaccharide will vary and its effect to the dependent variable will be measured. This variable is not itself changed or affected in any way; therefore, it is the independent variable.
Dependent Variable:Inflammotin Protien level in blood
Rationale: This is the dependent variable because it is the variable that is being tested and measured due to manipulations of the independent variable. The independent variable causes changes in the dependent variable- the dependent variable is dependent on it. Since the experiment tests the levels of a specific protein due to varying doses of lipopolysaccharide, the protein levels become the dependent variable.
Experimental Design
Groups
5 test groups (10 People per group)
Group 1: 1 mg Pill
Group 2: 5 mg Pill
Group 3: 10 mg Pill
Group 4: 15 mg Pill
Group 5: Control 10 mg (Sugar Pills: Placebo)
The experiment will be composed of five test groups which will contain ten people each. By having ten people, there is a higher population in which results are more reliable due to various subject being tested. Although the experiment would be more accurate with an even greater population, the lab is limited on money; therefore, volunteers will be taken for the experiment. One of the groups will serve as the control group. The control group will receive 10 mg of a sugar pill. This pill will serve as the placebo in order for the control group to remain the unchanged source. The other four groups will be given 1 mg, 5 mg, 10 mg, and 15 mg of the pill lipopolysaccharide respectively. Since we are seeking the lowest possible dose of an inflammation inducing agent, we are testing doses less than and greater than 10 mg of lipopolysaccharide which prior work recommends. Therefore, there will be five different groups: control and four different doses of lipopolysaccharide.
Age
Since the investigation is supposed to be on the elderly the age of test subjects should be 65 or older.
Number of subjects per group
Each group, including the control group, should have ten people for a total of 50 people in this experiment. This allows a big enough group to show conclusive and reliable results due to the various subjects being tested. Although the experiment would be more accurate with an even greater population, the lab is limited on money; therefore, volunteers will be taken for the experiment.
Subject Selection
Who is Included?
Include human volunteers who are 65+ in age, because 65 is the average age in the nursing home for seniors.
To ensure that the efficiency and effectiveness of the experiment, the test subjects must meet the following criteria. Subjects must be 65+ years of age, male or female, and willing to participate in the study voluntarily. These first two constraints will account for compiling a group of test subject that is the equivalent of the people that the drug will be intended to for once it is on the market.
Who is Excluded?
Exclude subjects with a history of inflammatory problems, because the levels of inflammatory protein already present in their body would affect the outcome and measurement due to the pill. These patients will not be allowed to participate in the study, because the data obtained from these participants would not accurately represent the effect of the pill.
The selection of the the subjects that will participate in the study will be randomized to the point of having volunteers that meet the previously stated criteria, and biases will be prevented by equally giving anyone the opportunity to participate in the study that meets the criteria.
All of the participants that are selected by this process to participate in the study will be pooled together and the control group and the test groups will be randomly selected from the pool.
Sources of Error and Bias
While testing it is important to keep in mind any sources of error or biases.
Error can be connected to:
Device issues
Differing Diets of Patients
Differing Allergies/Medication
Level of Physical Activity
For the sake of the experiment and to avoid bias and errors in the data it is important to randomize the subjects as well as display all data collected. Possible subjects will be recruited through numerous doctors to insure randomization. To control and limit error 1, the experimenter must use the same device for all patients to insure reliability. To test reliability, the device will always be first tested with the control group. In order to control and limit error 2 and 3, is to ask the subjects to maintain a range of avergae lifestyle in what they eat, and physical activity. And in order to control adn limit error 4, the in finding subjects for the study, potential subjects will be excluded from the study for the sake that only the inflammation inducing agent is affecting the change in Inflammotin levels in the blood.
Through this process it’s possible to generate the most accurate feedback for results.
BME 100 Spring 2016
