Medical Research Council Guideline for complex interventions Flemming Bro

Complex interventions are : ”interventions that contain several interacting components” (First generation statement) 2 ▪

Dimensions of complexity in complex interventions :  Number of and interactions between components  Number and difficulty of behaviours required by those delivering or receiving the intervention  Number of groups or organisational levels targeted by the intervention  Number and variability of outcomes  Degree of flexibility or tailoring of the intervention permitted (Second generation statement) 3 ▪

Afdeling for Almen Medicin Phase III: RCT. Defined target group – control Phase II: Efficacy Selected patients,- effects/ side effects Phase I: Volonteers Pharmacokinetics, effect, safety Preclinical phase Molecular studies, animal models Phase IV: Effectiveness, rutine situation Developing drugs

Afdeling for Almen Medicin Phase I: Modelling Testing and remodelling Preclinical Model based on theory and empirical evidence Phase II: Exploration Test and evaluate in selected practices Phase III: RCT Target group Control Monitoring Phase VI: Effectiveness Rutine control Developing complex interventions i general practice

Afdeling for Almen Medicin Phase VI: Effectiveness Rutine control Preclinical Model based on theory and empirical evidence Phase I: Modelling Testing and re modelling Phase II: Exploration Test and evaluate in selected practices Phase III: RCT Target group Control Monitoring Developing complex interventions i general practice