Question

For each question below (2- 12), describe one feasible, ethical approach to exploring the relationship
using a case-control study, a cohort study, or a randomized trial. Be specific about the study population,
the primary research question, how you would allocate patients to cases/cohorts/treatments, and what outcomes you would observe.

1. Whether a new cholesterol drug is better than the current standard statin prescribed to lower
cholesterol
2. The relationship between high-stress jobs and death from heart disease
3. The effect of nutritional deficiencies due to poverty on brain development in children
4. The relationship between a new caffeine alternative and alertness (compared to caffeine)

Answer 1

Note:

Hey there! Thank you for your question. Since you have posted several different questions, according to our policy, we have solved the first one for you.

1.

The existing drug for treating cholesterol is statin. It is not a placebo, but a standard drug that helps to treat cholesterol. While trying to test a new drug for treating cholesterol and compare it with statin, a randomized trial may be conducted. The trial can be conducted by allocating some patients to be treated by statin, and the others to be treated by the new drug.

The new drug can be considered to have satisfied all the necessary, prescribed criteria of a cholesterol drug. As a result, it is ethical to treat patients with it.

If it is feasible to conduct a randomized trial, it should always be used to explore the relationship of interest, above most other methods, as the researcher has the freedom to manipulate all variables with potential effect on the relationship.

Since high cholesterol levels are not exactly rare, it should not be a problem to find enough number of patients to randomly allocate to the two treatments. Hence, it is feasible to use a randomized trial.

Study population:

The study population relevant to the study is, “persons with high cholesterol levels”.

Primary research question:

The primary research question is, “whether the new cholesterol drug is better than statin in lowering cholesterol”.

Allocation of patients to treatments:

Consider a list of patients.

For each patient, use a random method (such as, tossing a coin, rolling a die, selecting random numbers from a random number table or a software random number generator) to determine whether they should be allocated to be treated by the new drug, or by statin.

Outcomes to be observed:

For each patient, check the cholesterol level before applying any of the two suggested treatments.

Then, apply the treatment. The patients allocated to the new drug should be treated by it, and those allocated to statin must be treated by statin, following a method suggested by the doctors.

After the treatments are applied, at the suitable time (also, preferably suggested by doctors), measure the cholesterol levels again.

Find the difference: D = Cholesterol level (after) – Cholesterol level (before), for each patient.

If, after suitable hypothesis testing procedures, it is observed that the difference is more for patients allocated to the new drug than those allocated to statin, it can be said that there is evidence to support the claim that the new cholesterol drug is better than statin in lowering cholesterol.