Abstract
There is currently no consensus on how to define, diagnose and treat vitamin B12 deficiency. This is partly due to insufficient and non‐uniform study design. It is essential to come to a harmonization of rational study designs. In order to evaluate new tests for the diagnosis of vitamin B12 deficiency, it is important that independent and unequivocal criteria for a clear‐cut definition of the disease are used. Furthermore, it is crucial to have a mutual understanding on the progression of the disease, how fast the different symptoms may develop and on the expected time frame of treatment and evaluation of response. The kind and intensity of treatment must also be agreed upon. The present article overviews the potential strategies of how to define and diagnose vitamin B12 deficiency and on follow‐up of treatment response. Finally, based on these considerations, the prerequisites of a cost‐utility analysis of guidelines for diagnosing vitamin B12 deficiency are discussed.