Anyone has a sample statistical analysis plan for this type of study design to share?
There is one control arm and two intervention arms. The researchers not only wants the end point, which is new disease incidence rate, be studied at cluster level, but also want to study the new disease incidence rate by age group, gender, etc within an arm.
I just get the project and it's due by tomorrow morning.
Many thanks!
Haiyan
This is a three-arm RCT, without the pairing. Perhaps it can serve as a template for your analysis plan:
Scharf, Hanns-Peter, et al. "Acupuncture and knee osteoarthritis: a three-armed randomized trial." Annals of internal medicine 145.1 (2006): 12-20.
Ariel
Thank you, Ariel.
It was due 2/4. I used 2 references as the followings:
Ref1:
Chuang J-H, Hripcsak G, Heitjan DF. Design and Analysis of Controlled Trials in Naturally Clustered Environments: Implications for Medical Informatics.Journal of the American Medical Informatics Association : JAMIA2002;9(3):230-238. doi:10.1197/jamia.M0997.
Ref2:
Bick DE, Kettle C, Macdonald S, Thomas PW, Hills RK, Ismail KM. PErineal Assessment and Repair Longitudinal Study (PEARLS): protocol for a matched pair cluster trial. BMC Pregnancy and Childbirth 2010;10:10. doi:10.1186/1471-2393-10-10.
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