Methodology Of Clinical Trials In Hyperbaric Medicine

The conventional methodology of randomized therapeutic trials can be applied to hyperbaric medicine as long as the following requirements are met:

- ethics / feasibility and legal requirements such as pertaining to emergency situations.

- choice of trial population. It must be precisely defined and trial results must be applied to this population only. Extrapolating is always dicey.

- modalities of random sampling, one of the essential elements of organizing therapeutic trials, since the whole point is to select comparable populations. So no bias must be allowed. Some predictable difficulties are specific to hyperbaric medicine: decisions must imperatively be made at a place and time where all forms of therapy are available. Lastly, the person performing the random sampling must not know results in advance.

- choice of judgement criteria and associated therapies, also an essential element of therapeutic trials. Since the pathophysiological justification is no longer considered sufficient, a clinical criterion must be selected (i.e., quality of healing at a given time, decrease in mortality, morbidity, etc.) In some situations double-blind studies can be considered, although they are more complicated. Obviously, hyperbaric chambers must already be provided with the necessary equipment for delivering various gas mixtures. In any controlled study, but particularly in multi-centre research, HBO therapy should be standardized to avoid centre-related effects. Variables in the way a therapy is provided may have significant impact on the results, not only whether or not it was given.

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