Interventions Tested in Randomised Controlled Trials Can and Should Adapt to Context: Here’s How

Aligning the planning, development, and implementation of complex interventions to local contexts with an equity focus: application of the PRISM/RE-AIM Framework

“…We propose the use of two concepts from the complex systems literature to align intervention's core functions and forms to contextual characteristics. An intervention's core functions refer to "what the intervention was intended to do" [46], the structural or procedural goals designed to meet system and/or patients' needs [7]. Using PRISM to align an intervention's core functions to local contexts is critical to preserving the integrity and fidelity of the intervention and the change process [7,46].…”

“…An intervention's core functions refer to "what the intervention was intended to do" [46], the structural or procedural goals designed to meet system and/or patients' needs [7]. Using PRISM to align an intervention's core functions to local contexts is critical to preserving the integrity and fidelity of the intervention and the change process [7,46]. For example, for a clinical intervention where families are screened in primary care for psychosocial needs, a core function of that intervention is of increasing caregiver awareness and knowledge of the impact of toxic stress and trauma on children's development.…”

“…They are also dependent on the level of function from a particular intervention (e.g., broad/macro-level public health function versus a specific health prevention education function). Forms then can change to adapt to the dynamic and diverse nature of local contexts, while preserving fidelity to the intervention's core functions [7,46]. Thus, Functions and forms are "ways to conceptualize an intervention's change process (or mechanism) and specify its components…consistent with theory. "…”