期刊
JOURNAL OF EVALUATION IN CLINICAL PRACTICE
卷 28, 期 4, 页码 607-614出版社
WILEY
DOI: 10.1111/jep.13653
关键词
aggression; lessons learned; multisite; nutritional supplements; trial
资金
- ZonMw (The Netherlands Organisation for Health Research and Development) [836031016]
- Healthcare Insurance Fund, The Netherlands (Het Innovatiefonds Zorgverzekeraars) [3326]
This paper describes the challenges and practical lessons learned from two RCTs conducted in care settings. It highlights five main difficulties encountered and how they were overcome. By sharing these experiences, the aim is to assist other researchers in designing optimal trials and facilitate their implementation.
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 trials were registered in the Clinical Trials Register (RCT A: NCT02498106; RCT B: NCT03212092).
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