An Orthotics and Prosthetics Company Conducts a Single-Blind, Randomized, Parallel

An orthotics and prosthetics company conducts a single-blind, randomized, parallel group trial to investigate the effects of custom foot orthoses with motion control shoes versus the effects of motion control shoes alone in individuals with patellofemoral joint osteoarthritis.  Eligible subjects are randomized to receive either custom foot orthoses with motion control shoes or motion control shoes alone, to be worn for 4 months.  A significant number of patients are lost to follow-up or are noncompliant to the assigned intervention during the study.  However, results for the patients who completed the protocol are encouraging.  Which of the following techniques is most appropriate to estimate the real effect of custom foot orthoses in the population?

A) As-treated analysis
B) Intention-to-treat analysis
C) Noninferiority analysis
D) Per-protocol analysis
E) Stratified analysis

Correct Answer:

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