University of Southern California Patient Crossover Discussion & Replies

**Discussion: ** When conducting a study, patients occasionally “crossover” to other portions of the study. List one intervention that may impact the patient after this crossover, how it might affect the results of the study, and which (if any) precautions need to be considered when finding crossover data. Additionally, explain what a cohort study is and which types of disease are best to study using a cohort.  (250-300 words) **Peer# 1** Crossover study on Oncology This study intervention on oncology trials crossover, which allows patients to crossover from the control group to switch to the intervention arm and receive the investigational product after a pre-established study occurrence, for example, either after disease progression or after demonstration of clinical superiority of the investigational medicine, Nonetheless, implementing crossover in a trial will reduce the treatment differences between the randomized arms for long-term trial endpoints, such as overall survival (OS). Results from a simulation study indicate that a crossover rate of more than 50% dramatically decreases the probability of detecting differences in OS by up to 90% (Barrett, D,2019).  Cohort studies are a type of longitudinal study—an approach that follows research participants over a period of time (often many years). Specifically, cohort studies recruit and follow participants who share a common characteristic, such as a particular occupation or demographic similarity. Some of the cohorts will be exposed to a specific risk factor or characteristic; by measuring outcomes over a period of time, it is then possible to explore the impact of this variable (eg, identifying the association between smoking and lung cancer (Barrett, D,2019). Cohort studies are, vital in some ways in public health and epidemiology, helping to build an understanding of what factors increase or decrease the probability of developing the disease. A cohort study can also be utilized to measure the level to which a particular risk factor, such as obesity, increases the risk of disease. **(200-250 words)** **Peer# 2** During crossover studies, patients are randomly assigned to either the experimental or control group and will be switched off to the other group meaning, both groups will be given the treatment/intervention. An intervention that can impact the patient after the crossover and can affect the results of the study is surgical interventions. For example, if a crossover study aims to determine if a surgical procedure produces better results in individuals with coronary artery disease than medication (such as beta blockers). The experimental group will first receive the surgical procedure while the control group will receive the beta blockers. After the crossover, they will receive the opposite intervention. Since the experimental group already received surgery (which cannot be undone), it affects the results for this group because the surgery is now a factor that can impact the effectiveness of the beta blockers whereas the control group has reported their results of the beta blockers first before receiving an intervention that cannot be undone (the surgical procedure. When finding cross over data, it is important to take into consideration the possible effects the intervention may bring to both groups. In this case, since the surgery can not be undone, the group to receive the surgery first will generate different results than the other group. A cohort study is considered a longitudinal study where participants are followed over time. Cohort studies can either be retrospective or prospective. In prospective cohort studies, exposed groups are chosen in the present whereas retrospective, they are chosen in the past. Diseases that are best to study using cohort are cardiovascular disease, diabetes, obesity, etc. These diseases have many risk factors that can be observed and followed over time making them perfect for cohort studies. (200-250 words)

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