338x Filetype PPTX File size 0.06 MB Source: www.bumc.bu.edu
What to do:
1) Connect the experimental plan / study design to
the study question(s) / aims
2) Justify your choice of study design. Why is your
study the best way to address your study question?
3) Use correct study design terminology.
Observational, cohort, case-control, pilot,
prospective, retrospective, matched, etc… Clinical
trial ? (parallel, cross-over, factorial, randomized,
blinded, controlled, etc…)
4) Justify your sample size. This may be a power
analysis or based on practical considerations
(depends on the study)
5) Make sure your “unit of observation” / sample
size is clear. How many samples, animals,
subjects, experiments? Number of
measurements per animal or subject?
6) Explain how (if) you have access to all relevant
data needed to answer your study question(s).
Explain what information will be collected. If any
important data isn’t available explain why and
discuss how your results could still be valid.
7) Consider sources of bias. Explain how you
will control for these sources or explain why
you will still get useful results in spite of them
8) Consider possible “effect modification”.
Could results differ for subgroups of
individuals? Possibly make this part of your
plan
9) Address loss to follow-up in a prospective
study. Explain how you will minimize loss to
follow-up and missing data
10) Make a picture!
– Study design illustration
– Study flow chart
– Study evaluation chart
Pet Peeves
1) Obviously trying to sound “smart”. We know
you are smart. Focus on being clear.
2) A list of study procedures over time in the
text, instead of using a chart. “At baseline we
will collect A,B,C and D. At Week 1 we will
collect A,B and C. At Week 2 we will collect
A,B and C. At week 3 we will collect A,B,C
and D.” (and so on…)
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