Leiden University Scholarly Publications

Persistent URL of this record https://hdl.handle.net/1887/3563663

In Collections

This item can be found in the following collections:

Bles, N.J.; Gast, D.A.A.; Slot, A.J.C. van der; Didden, R.; Hemert, A.M.; Rius Ottenheim, N.; Giltay, E.J. (2022)

Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour

Article / Letter to editor
Background: Setting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs. Approach: In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disabilities. We describe five main difficulties and how these were overcome: (1) multisite setting, (2) inclusion of vulnerable participants, (3) nutritional supplements and placebos, (4) assessment of behavioural outcomes, and (5) collecting bio samples. Conclusions: By sharing these practical experiences, we hope to inform other researchers how to optimally design their trials, while avoiding and minimising the difficulties that we encountered, and to facilitate the implementation of a trial. Both...Show moreBackground: Setting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs. Approach: In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disabilities. We describe five main difficulties and how these were overcome: (1) multisite setting, (2) inclusion of vulnerable participants, (3) nutritional supplements and placebos, (4) assessment of behavioural outcomes, and (5) collecting bio samples. Conclusions: By sharing these practical experiences, we hope to inform other researchers how to optimally design their trials, while avoiding and minimising the difficulties that we encountered, and to facilitate the implementation of a trial. Both trials were registered in the Clinical Trials Register (RCT A: NCT02498106; RCT B: NCT03212092).Show less
aggression
lessons learned
multisite
nutritional supplements
trial
All authors
Bles, N.J.; Gast, D.A.A.; Slot, A.J.C. van der; Didden, R.; Hemert, A.M.; Rius Ottenheim, N.; Giltay, E.J.
Date
2022-01-17
Journal
Journal of Evaluation in Clinical Practice
Volume
28
Issue
4
Pages
607 - 614
DOI
doi:10.1111/jep.13653