[Validity studies in laparoscopic simulation. Methodology and design considerations.]

To describe a roadmap of the most representative milestones and considerations in the validation of surgical simulators, especially those of laparoscopic surgery. And additionally, help determine when in this process a simulator can be considered as validated.

A non-systematic review was carried out searching terms like simulation, validation, training, assessment, skills and learning curve, as well as providing the experience accumulated by our center.

An ideal classical validation process should consist of the following steps: fidelity, verification/calibration/ reliability, subjective and objective strategies. Baseline tests of fidelity and verification/calibration/ technological reliability are not always detailed in the simulation literature. A simulator can be considered validated if, at least, satisfactorily completed any of the two main objective strategies, that is, constructive and/or criterion validity.

The methodologies to validate simulators as useful and reliable for the improvement of psychomotor/ technical skills are widely analyzed, although there is a variety of approaches depending on the scientific reference consulted, not being implemented equally in all works. This apparent arbitrariness should be considered in advance because it can lead the researcher to misunderstandings, especially when the simulator will be regarded as valid.