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Guideline development process for the design, implementation, and reporting of control interventions in efficacy and mechanistic clinical trials of physical, psychological, and self-management interventions.
- David J Hohenschurz-Schmidt
- Andrew SC Rice
- Jerry Draper-Rodi
- Lene Vase
- Whitney Scott
- Oliver Thomson
- Donna Kennedy
- Jan Vollert
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Description: The primary purpose of this guideline development process was to derive a set of fundamental considerations for the design and implementation of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management interventions. Informed by a preliminary systematic review of methods, the panellists’ experiences and an external patient and stakeholder engagement exercise, the aim was to enhance and standardise control intervention design in the field and find solutions to the particular challenges of placebo controlling clinical trials of complex participatory interventions.
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