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A cohort study is the next most rigorous approach to answer cause and effect questions, sharing with an RCT the advantage of prospective follow-up.
Recent literature [1,2] suggests that differences between the results seen in an RCT and in an observational study can be larger than expected not because of confounding, but because of differences between their respective patient populations.
The prospective cohort study is an alternative to the RCT design to answer the question of need for radiotherapy.
If a randomised controlled trial (RCT) is not feasible, an observational design such as a cohort or a case-control study should be considered.
By extending existing RCT infrastructure, efforts to evaluate such patients in parallel cohort arms would provide an efficient means of generating multi-center prospective data on natural history, which would facilitate the development of future RCTs involving these subgroups of interest.
This RCT in cohort study provides important data on the prevention of hypertension, especially in patients with a high risk for hypertension development.
Conversely, having patients enrolled in a RCT after data has proved superiority of an arm of the study postpones beneficial therapy for patients and society.
Owing to these differences, findings from RCT are not necessarily more reliable than those from well-designed prospective cohort studies.
So, a RCT must have only one primary outcome, which should be decided at the outset of the study.
Cohort study designs should be considered when RCT are not possible or practical for ethical, logistical, or financial reasons.
An RCT is less susceptible to bias than other study designs for assessing therapeutic interventions.