Clinical Scenario
You are a medical student participating in a summer research project with a Cardiologist as your supervisor. The study you are currently working on is investigating a new hypertension (high blood pressure) medication, Brackenolol (an up and coming beta-blocker).
In this study, patients are randomized into treatment and control groups. The treatment group received a 5 mg pill Brackenolol daily. The control group in the study received a daily pill that was identical (e.g. shape and color) to the brackenolol pill that has no active ingredients (a placebo).The primary outcome in this study is the patient’s blood pressure, which is measured weekly on Friday afternoons. You are interested in the difference between patients’ systolic blood pressure readings before taking the pill (either placebo or treatment) and after taking the pill. Your supervisor has assigned you to do the statistics for this project. Where do you start?
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Investigation Definitions to Remember Randomization: A process by which extraneous variables are balanced between groups in studies, so that each patient has an equal chance of falling into the exposed or unexposed group. Randomization balances variables known to affect prognosis, but also balances variables whose effect on prognosis is unknown. Treatment Group: The group of patients in a study who receive an intervention that is believed to be better than current alternatives. The treatment groups in this study will receive Brackenolol. Control Group: The group of patients in a study who do not receive the experimental intervention. The control group and treatment group are treated in the same ways other than the intervention they are exposed to. The control group in this study received a placebo. Placebo: An intervention intended to be indistinguishable from the active treatment, but which does not have a specific known mechanism of action. Sugar pills and saline injections are common examples of placebos. Primary Outcome: Is the main measurement in the trial that is used to determine the effectiveness of the intervention. In this case a significant decrease in blood pressure would be the primary outcome. Secondary Outcomes: Other measurements tracked during the trial which are also important to the patients and researchers. Side effects of the medication are a common secondary outcome. |