Question

For the following health issues, please identify and briefly describe the most appropriate study design that you have learned about in this course to study the issue. Provide a clear and accurate justification for each choice of study design (suggested length for each response, 3-4 sentences maximum). 1) Breast cancer and lifetime use of oral contraceptives 2) Health effects related to a high fat diet. 3) Vitamin D intake and risks for multiple sclerosis 4) The impacts of poverty among refugee children on academic outcomes 5) Health promotion educational campaign aimed at cessation from vaping in teenagers

Answer 1

1) Breast cancer and lifetime use of oral contraceptives: I did a CohortStudy design when I was learning about Breast Cancer and lifetime use of oral contraceptives. You can also go through a study which was done regarding this , i.e, The Royal College of General Practitioner's Oral Contraception Study.

This study is justified to learn the lifetime use of oral contraceptives and the risks of cancer in women. Most of the women who choose to use oral contraceptives do not expose themselves to long-term cancer problem, instead, with some cancers, many women benefit from important reductions of risk that continues for many years after stopping. Thus, cohort studies can also be hypothesis testing studies and can infer and interpret a causal relationship between an exposure and a proposed outcome, but cannot establish it .

2) Health effects related to a high fat diet: The Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-003) . This study was learned by me and it is an Open-label study design. I too did a study design which was open-label.

It is a type of study in which patients and heath providers were aware of the drugs given. This study design is significant because open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this can only occur if the open-label extension study is designed, executed, analysed and reported competently.

3) Vitamin D intake and risks for multiple sclerosis: I did a study design of Randomized Clinical Trial.

This study design is very useful while examining the patients because it involves randomizing subjects with similar characteristics to two groups (or multiple groups): the group that receives the intervention/experimental therapy and the other group that receives the placebo (or standard of care). While doing study for this it becomes easier  investigating variations in sunlight exposure, latitude and diet have supported the correlation between a high serum concentration of vitamin D and reduced severity of the disease course in established MS.

4)The impacts of poverty among refugee children on academic outcomes :Community Trial Design can be done in this case.

This study design is most suitable because community trials are also known as cluster‐randomized trials, involve groups of individuals with and without disease who are assigned to different intervention/experiment groups. Hence, groups of individuals from a certain area, such as a town or city, or a certain group such as school or college, will undergo the same intervention/experiment and thus it becomes easier to find the impact of Poverty among refugee children on academic outcomes.

5) Health promotion educational campaign aimed at cessation from vaping in teenagers : Clinical Trial Design is the most appropriate study design for this concern.

I chosed this study design because Clinical trials are also known as therapeutic trials, which involve subjects with disease and are placed in different treatment groups. It is considered a gold standard approach for epidemiological research. So, it can be effective in studying cessation from vaping in teenagers by health promotion educational campaign. While designing a clinical trial, it is important to select the population that is best representative of the general population. Therefore, the results obtained from the study can be generalized to the population from which the sample population was selected. It is also as important to select appropriate endpoints while designing a trial. Endpoints need to be well‐defined, reproducible, clinically relevant and achievable.