The three stages of building and testing mid-level theories in a realist RCT: a theoretical and methodological case-example

Jamal, Farah; Fletcher, Adam; Shackleton, Nichola; Elbourne, Diana; Viner, Russell; Bonell, Chris

doi:10.1186/s13063-015-0980-y

Cited by 65 publications

(78 citation statements)

References 41 publications

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“…In October 2015, Jamal and colleagues [1] published a paper on realist randomised controlled trials (RCT), in which they present a detailed overview and guidance of how realist RCTs can be designed. Jamal et al argue convincingly that RCTs “examine quite crude questions about ‘what works’ without explaining the underlying processes of implementation and mechanisms of action, and how these vary by contextual characteristics of person and place” (p. 1).…”

Section: Introductionmentioning

confidence: 99%

Can “realist” randomised controlled trials be genuinely realist?

Belle

Wong

Westhorp³

et al. 2016

Trials

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In this paper, we respond to a paper by Jamal and colleagues published in Trials in October 2015 and take an opportunity to continue the much-needed debate about what applied scientific realism is. The paper by Jamal et al. is useful because it exposes the challenges of combining a realist evaluation approach (as developed by Pawson and Tilley) with the randomised controlled trial (RCT) design.We identified three fundamental differences that are related to paradigmatic differences in the treatment of causation between post-positivist and realist logic: (1) the construct of mechanism, (2) the relation between mediators and moderators on one hand and mechanisms and contexts on the other hand, and (3) the variable-oriented approach to analysis of causation versus the configurational approach.We show how Jamal et al. consider mechanisms as observable, external treatments and how their approach reduces complex causal processes to variables. We argue that their proposed RCT design cannot provide a truly realist understanding. Not only does the proposed realist RCT design not deal with the RCT’s inherent inability to “unpack” complex interventions, it also does not enable the identification of the dynamic interplay among the intervention, actors, context, mechanisms and outcomes, which is at the core of realist research. As a result, the proposed realist RCT design is not, as we understand it, genuinely realist in nature.

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Section: Introductionmentioning

confidence: 99%

Can “realist” randomised controlled trials be genuinely realist?

Belle

Wong

Westhorp³

et al. 2016

Trials

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“…This paper is a further contribution to the debate in Trials [1, 2] about the possibility of conducting ‘genuinely realist’ [2] randomised controlled trials (RCTs). However, before engaging in the debate, we should clarify what we mean when we talk about realism, and explain why we believe that it can make a worthwhile contribution to evaluation science.…”

Section: Introductionmentioning

confidence: 99%

“…Our central contention in this paper is that realist RCTs designed to evaluate the effectiveness of behaviour-changing interventions are possible, but only if they are founded upon a different type of realist philosophy to that currently adopted by both Jamal et al [1] in their commendation of realist RCTs and Van Belle et al [2] in their critique of them. The common ground they share is the version of realism that is found in the philosophical underpinnings of Pawson and Tilley’s [20] realist evaluation.…”

Section: Introductionmentioning

confidence: 99%

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The possibility of critical realist randomised controlled trials

Porter

McConnell

Reid

2017

Trials

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BackgroundSome realists have criticised randomised controlled trials for their inability to explain the causal relations that they identify; to take into account the influence of the social context of the interventions they evaluate; and to account for individual difference. However, among realists, there is controversy over whether it is possible to improve trials by making them realist, or whether realism and the philosophical assumptions underlying trials are incompatible. This paper contributes to the debate in Trials on this issue. The debate thus far has concentrated on the possibility of combining trial methodology with that of realist evaluation.Main bodyWe concur with the contention that it is not feasible to combine randomised controlled trial design with the realist evaluation approach. However, we argue that a different variant of realism, critical realism, provides a more appropriate theoretical grounding for realist trials.In contrast to realist evaluation, which regards social mechanisms as an amalgam of social resources and people’s reasoning, critical realism insists on their distinction. It does so on the basis of its assertion of the need to distinguish between social structures (in which resources lie) and human agency (which is at least partly guided by reasoning). From this perspective, conceiving of social mechanisms as external to participants can be seen as a valid methodological strategy for supplementing the exclusive concentration of trials on outcomes.While accepting realist evaluation’s insistence that causality in open systems involves a configuration of multiple generative mechanisms, we adopt the critical realist interpretation of the experimental method, which sees it as creating artificial closure in order to identify the effects of specific causal mechanisms. If randomised controlled trials can be regarded as epidemiological proxies that substitute probabilistic controls over extraneous factors for closed experiments, their examination of the powers of discrete mechanisms through observation of the variation of outcomes is appropriate.ConclusionWhile there are still issues to be resolved, critical realist randomised controlled trials are possible and have the potential to overcome some of the difficulties faced by traditional trial designs in accounting for the influence of social context and individual interpretation.

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“…Farah's work on evaluation methods also included the elaboration of a systematic method by which so-called ‘realist trials’ might examine what works for whom and under what conditions 7. She was refining and testing this method within the INCLUSIVE trial of an intervention to reduce aggression and bullying in schools at the time of her death 5 8.…”

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confidence: 99%