I was just recently asked to review a paper for Infection Control and Hospital Epidemiology. This got me thinking again about methodology.The epidemiology gold standard study remains the cluster randomized, prospective trial. But not all clinical questions can be answered this way. Of note, to assess the effectiveness of hand hygiene it would not be ethical to perform a randomized, prospective trial of hand hygiene versus no hand hygiene across a health system.
There is another limitation of clinical trials: they frequently do not represent real life conditions.
Clinical trials are overseen by a dedicated team, have motivated participants and have structured oversight to ensure protocol fidelity. I have seen several prospective, clinical trials fail to "take root" after the conclusion of the protocol, even if the results were beneficial.
Pragmatic studies, although not as methodologically sound, can test the implementation of an intervention in real life situations. It may not be as robust, but it does give a sense of both feasibility and impact. This is practical and applicable. It is also reproducible.
If more robust protocols cannot be implemented in the real world, then what is their real value?
