Table 2 Interventions in surgical randomised controlled trials (RCTs): suggested terminology and definitions
From: Interventions in randomised controlled trials in surgery: issues to consider during trial design
Term | Definition |
|---|---|
Complex intervention | An intervention with multiple components that act inter-dependently or independently to influence outcomes [6]. |
Surgical intervention | An intervention that cuts or physically alters a patient’s tissues (whether using a scalpel, stapler, laser or another instrument or device) and involves the use of a sterile environment, anaesthesia, antiseptic conditions and suturing or stapling [10]. |
Concomitant intervention (or co-intervention) | Interventions that naturally accompany or are associated with the intervention itself [22]. Concomitant interventions can occur before, during or after the main intervention. |
Context | The distinctive features of an intervention’s setting, participants and delivery [23]. |
Expertise | The ability to integrate technical and non-technical skills to complete challenging tasks. |
Fidelity | How far those responsible for delivering an intervention actually adhere to the intervention as it is outlined by its designers [24]. Fidelity is also referred to as compliance or adherence. |
Pragmatic trial | A trial which is designed to answer the question ‘How well does the intervention work in comparison to the control when delivered under usual conditions?’ [25] (that is, effectiveness focused, usually aiming to influence health policy) |
Explanatory trial | A trial that is designed to answer the question ‘How well does the intervention work in comparison to the control when delivered under ideal conditions?’ [25] (that is, efficacy focused, usually aiming to investigate the causal relationship between an intervention and physiological processes) |