Keywords:
Hawthorne effect; diabetes technology; fear of hypoglycemia; randomized controlled trial
Abstract:
Scientific research needs a well-structured and robust study design and randomized controlled trials (RCTs) have been considered to be the gold standard to collect data that assess differing treatments. The impact of the Hawthorne effect on clinical research outcomes have been studied in RCTs with evidence that research participation may modify trial outcomes. The Hawthorne effect describes the awareness of being in a study, and the possible impact on behavior of the participant. The objective of this communication is to highlight the Hawthorne effect on psychobehavioral measures and the importance of a control group in clinical research, particularly for diabetes technologies.