Realist RCTs of complex interventions - an oxymoron

Area of Science:

• Public Health Research
• Methodology in Health Sciences
• Complex Intervention Evaluation

Background:

• Randomized controlled trials (RCTs) face challenges evaluating complex public health interventions.
• Bonell et al. proposed integrating realist evaluation with RCTs to enhance causality examination.
• This integration aims for a synergistic relationship, leveraging realist insights without abandoning RCTs.

Purpose of the Study:

• To present counter-arguments to the analysis of realist evaluation by Bonell et al.
• To critique the recommendations for "realist RCTs" concerning complex interventions.
• To clarify the appropriate application of the term "realist" in research methodology.

Main Methods:

• Critique of existing literature on realist evaluation and RCTs.
• Analysis of ontological and epistemological compatibility between positivist and realist paradigms.
• Examination of challenges posed by complexity in public health interventions for RCT design.

Main Results:

• The proposed "realist RCTs" inadequately address the complexities of public health interventions.
• The fundamental positivist underpinnings of RCTs are difficult to reconcile with a realist paradigm.
• Key tenets of realist evaluation are overlooked in the proposed integrated design.

Conclusions:

• The term "realist" should be reserved for studies adhering strictly to realist philosophy and analysis.
• The approach suggested by Bonell et al. is better described as "theory-informed RCTs".
• "Theory-informed RCTs" can enhance the design and evaluation of complex public health interventions.