Background: Practical studies in real-world settings may be particularly vulnerable to unintended effects on intervention outcomes, including what is commonly known as the Hawthorne Effect. This phenomenon suggests that study subjects' behavior or study results are altered by the subjects' awareness that they are being studied or that they received additional attention. This is especially a concern when subjects are not blinded to randomization or when they participate in studies with observational components. As part of a larger practical intervention designed to improve the clinical management of skin and soft tissue infections (SSTIs), we specifically examined the potential for a Hawthorne Effect from the extra attention some clinicians received when completing follow-up case reviews.
Methods: De-identified, electronic data from a larger practical intervention allowed for the comparison of the clinical management of SSTIs among 14 randomly selected clinicians who participated in follow-up case reviews versus 77 clinicians who did not.
Results: There were no differences in the management of SSTIs between the 2 groups of clinicians. No evidence of a Hawthorne Effect was observed in this quality-improvement intervention.
Conclusion: More extensive contact with the research team did not seem to have unintended effects on the outcomes of interest for the management of SSTIs. Further study in practice-based research settings could help to establish whether different types of studies and outcomes are more or less susceptible to the Hawthorne Effect.