TY  - JOUR
T1  - INclusion of training patients in us food and drug administration premarket approval cardiovascular device studies
AU  - Chen CE, Dhruva SS, Bero LA, Redberg RF
Y1  - 2011/03/28
N1  - 10.1001/archinternmed.2010.445
JO  - Archives of Internal Medicine
SP  - 534
EP  - 539
VL  - 171
IS  - 6
N2  - 
Training is essential for physicians inserting many new devices or conducting new procedures. Better outcomes for cardiovascular devices are positively associated with physician practice time and volume.1- 2 To allow for training, device studies may designate an initial stage for physicians to learn how to use an investigational device. This phase is intended so that “changes in physician proficiency with use of a new technology can be evaluated vis a vis their impact on clinical performance.”3(p70) Training patients (also called roll-in, learning, or run-in patients) are these first individuals in whom a physician uses an investigational device. Decisions on whether to use training patients, how many to permit, and whether to include their results in subsequent outcome analyses are highly variable and currently performed via clinical judgment in the absence of written guidelines.

SN  - 0003-9926
M3  - doi: 10.1001/archinternmed.2010.445
UR  - http://dx.doi.org/10.1001/archinternmed.2010.445
ER  -