preview

Cohort Study Paper

Decent Essays

Trial Design and Sample Size
The main outcome of this Prospective Cohort Study is incidence of dementia in subjects with Parkinson’s disease.
An estimated sample size of 235 study subjects across two centers in Hawaii and Massachusetts is foreseen. This sample size was selected based on the literature, and standard statistics charts showing an effect size, E/S = 0.30, α = 0.050, and β = 0.100, and at a power = 0.900. It is envisaged that there will be a total of 117 study subjects at the center in Hawaii and 118 study subjects at the center in Massachusetts. An effect size > 0.10 was chosen in order to detect a meaningful magnitude of the association of coffee consumption with the incidence of PDD in the population. A large enough sample …show more content…

It is expected that those who will not be exposed to dementia will be more than 50% greater than those subjects who will have dementia. To detect the presence or absence of dementia in study subjects, MMSE scores will be used. Study subjects will be evaluated for signs/no signs of dementia every six months for five years. In the interim, consideration will be given to those study subjects who either die during the study or opted out of the study for personal reasons. For events of these types happening, the statistical analyses will be adjusted accordingly to accommodate them. The final statistical analysis will be performed after a five- year continuous observation or after a significant and measurable effect in cognition is …show more content…

•By making sure that the participation is based on voluntary and fully informed consent.

•The interviewer will secure the written Informed Consent, and Boston University IRB will review it.

•The Protocol will be reviewed by Boston University IRB.

• Subjects who are dependent on others, they can be affected by coercion of undue influence.

EXPECTED PROJECT CHALLENGES:
Long time of study is a challenge.
Follow-up with all participants and ensuring minimum loss to follow- up is challenging, especially when considering age and mortality rate of Parkinson disease population.

Participants may move from one group to other( exposed vs. unexposed) during the study period.

Participants who have a long history of chronic conditions like diabetes, high cholesterol and who develop strokes during study cannot be diagnosed with dementia due to Parkinson disease with certainty. It may well be that they have underlying multi-infarct dementia, and neither can be diagnosed with certainty.
During study follow-up some participants are likely to deteriorate which will require assesment of their

Get Access