Poster Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2017

The Hawthorne effect unveiled in a randomised controlled trial (#362)

Jennifer Nicholas 1 2 , Mary Abraham 1 2 3 , Michael Crone 4 , Tim Jones 1 2 3 , Liz Davis 1 2 3
  1. The University of Western Australia, Telethon Kids Institute, Perth, Western Australia, Australia
  2. Princess Margaret Hospital, Subiaco, WA, Australia
  3. School of Paediatrics and Child Health, The University of Western Australia, Perth, Western Australia, Australia
  4. University of New South Wales, Sydney, New South Wales, Australia

Introduction

The Hawthorne effect describes the potential impact on participant behaviours, resulting from research participation, which has been studied in randomised controlled trials.

Objective

To acknowledge the potential impact of the Hawthorne effect and significance of a control group in diabetes technology trials.

Methods

Adolescents and young adults with type 1 diabetes on insulin pump therapy with impaired hypoglycaemia awareness were evaluated for fear of hypoglycaemia (FOH) as part of a larger randomised single-centre clinical trial. Participants in the control arm had standard insulin pump therapy while participants in the intervention arm had sensor-augmented pump with low-glucose suspension. All participants had research visits at similar time points and review by the same health care professional. The FOH was evaluated by the Hypoglycaemia Fear Survey, at baseline and end of study at six months.

Results

At the end of study at 6 months, there was no difference in the FOH scores in parents (n=57) and participants (adolescents n=30, adults n=24) in both control and intervention groups. However, in parents, there was a decline in the FOH scores from baseline in both control (p=0.001) and intervention groups (p=0.003), with no difference between the two groups at the end of the study (p=0.486). A similar decline from baseline was noted in adults in the intervention group (p=0.006).

Conclusions

A decline in FOH scores was observed in both control and intervention groups, possibly demonstrating the Hawthorne effect in a research setting. In the absence of a control group, it could be inferred that significant reduction in FOH in parents and adult participants was due to the intervention. The decline in FOH scores in the control group is important to acknowledge, demonstrating the possibility of the Hawthorne effect in a research setting and highlighting the importance of a control group in scientific research.