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These guidelines were initially formulated to provide a framework for a responsible stepwise evaluation of surgical innovations, but they also apply to complex interventions in the field of interventional radiology [ 10].
In line with MRC guidance on developing and evaluating complex interventions in health, we conducted a process evaluation alongside the trial.
It must also be recognised that the results of subgroup analyses and meta-regression performed in our study are subject to the challenges associated with interpreting complex interventions in such a manner.
discuss the challenges of carrying out randomised controlled trials (RCTs) to evaluate complex interventions in public health, and consider the role of realist evaluation in enhancing this design (Bonell, Fletcher, Morton, Lorenc, & Moore, 2012).
The development and evaluation of complex interventions in healthcare has obtained increased awareness.
These aspects of study design impact upon the evaluation of complex interventions in critical care.
The recognition of complex interventions in clinical care is another important consideration [ 14].
Moreover, difficulties have been reported when reproducing some complex interventions in different contexts.
Such analyses may be difficult to construct for complex interventions in complex settings.
Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs.
This approach has previously been used in trials of complex interventions in critical care [ 4, 6].
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