• D De Amici, C Klersy, F Ramajoli, L Brustia, and P Politi.
• Department of Epidemiology and Clinical Biometry-Scientific Direction, IRCCS Policlinico San Matteo, Pavia, Italy. ddeamici@smatteo.pv.it
• Control Clin Trials. 2000 Apr 1; 21 (2): 103-14.

AbstractClinical research can be influenced by many factors that are capable of invalidating results, and one of these factors is known as the Hawthorne effect: the mere awareness of being under observation can alter the way in which a person behaves. In experimental research this effect can be the undesired effect of the experiments themselves, and the stronger its presence, the greater it can influence the results. In anesthesia practice, owing to the particular emotional condition of a patient facing a surgical operation, the Hawthorne effect could be especially strong. The aim of our study was to show the impact that the knowledge of being included in a study has (Hawthorne effect), by comparing the postoperative changes in psychological well-being in two groups of patients undergoing knee arthroscopy and receiving different information about the study from the anesthetist during the preoperative interview. Other signs and symptoms such as postoperative knee pain, nausea, vomiting (the most feared occurrences), headache, return of spontaneous diuresis, analgesic request, anesthesia complications, as well as the intensity of anxiety were also assessed as secondary endpoints. Our results show that subjects who were aware that they were part of a study scored significantly better on postoperative measures of psychological well-being and postoperative knee pain, compared to subjects who were unaware. The size of the effect, as measured by the odds ratio, remains unchanged when controlling for potential confounding factors. The study has enabled us to demonstrate the presence of the Hawthorne effect in clinical research. Therefore, the Hawthorne effect should be acknowledged and accounted for in the design of a study and in the interpretation of results.

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