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

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          Abstract

          Randomised controlled trials (RCTs) of social interventions are often criticised as failing to open the 'black box' whereby they only address 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. Realist RCTs are proposed as an approach to evaluation science that addresses these gaps while preserving the strengths of RCTs in providing evidence with strong internal validity in estimating effects.

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          Social Theory and Social Structure

          Robert K. Merton, RK Merton, RK MERTON … (1968)
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            Realist RCTs of complex interventions - an oxymoron.

            Bruno Marchal, Gill Westhorp, Geoff Wong … (2013)
            Bonell et al. 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). They argue for a "synergistic, rather than oppositional relationship between realist and randomised evaluation" and that "it is possible to benefit from the insights provided by realist evaluation without relinquishing the RCT as the best means of examining intervention causality." We present counter-arguments to their analysis of realist evaluation and their recommendations for realist RCTs. Bonell et al. are right to question whether and how (quasi-)experimental designs can be improved to better evaluate complex public health interventions. However, the paper does not explain how a research design that is fundamentally built upon a positivist ontological and epistemological position can be meaningfully adapted to allow it to be used from within a realist paradigm. The recommendations for "realist RCTs" do not sufficiently take into account important elements of complexity that pose major challenges for the RCT design. They also ignore key tenets of the realist evaluation approach. We propose that the adjective 'realist' should continue to be used only for studies based on a realist philosophy and whose analytic approach follows the established principles of realist analysis. It seems more correct to call the approach proposed by Bonell and colleagues 'theory informed RCT', which indeed can help in enhancing RCTs. Copyright © 2013 Elsevier Ltd. All rights reserved.
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              Time to rethink the systematic review catechism? Moving from ‘what works’ to ‘what happens’

              Mark Petticrew (2015)
              Systematic review methods are developing rapidly, and most researchers would recognise their key methodological aspects, such as a closely focussed question, a comprehensive search, and a focus on synthesising ‘stronger’ rather than ‘weaker’ evidence. However, it may be helpful to question some of these underlying principles, because while they work well for simpler review questions, they may result in overly narrow approaches to more complex questions and interventions. This commentary discusses some core principles of systematic reviews, and how they may require further rethinking, particularly as reviewers turn their attention to increasingly complex issues, where a Bayesian perspective on evidence synthesis, which would aim to assemble evidence - of different types, if necessary - in order to inform decisions’, may be more productive than the ‘traditional’ systematic review model. Among areas identified for future research are the examination of publication bias in qualitative research; research on the efficiency and potential biases of comprehensive searches in different disciplines; and the use of Bayesian methods in evidence synthesis. The incorporation of a systems perspective into systematic reviews is also an area which needs rapid development.
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                Author and article information

                Journal
                Journal ID (iso-abbrev): Trials
                Title: Trials
                Publisher: Springer Nature
                ISSN (Electronic): 1745-6215
                ISSN (Print): 1745-6215
                Publication date (Electronic): Oct 15 2015
                Volume: 16
                Affiliations
                [1 ] Department of Social Science, UCL Institute of Education, 18 Woburn Square, London, WC1H 0NR, UK. F.Jamal@ioe.ac.uk.
                [2 ] School of Social Sciences, Cardiff University, 1-3 Museum Place, Cardiff, CF10 3BD, UK. FletcherA@cardiff.ac.uk.
                [3 ] UCL Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK. Nicholashackleton@hotmail.com.
                [4 ] Medical Statistics Department, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Diana.Elbourne@lshtm.ac.uk.
                [5 ] UCL Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK. R.viner@ucl.ac.uk.
                [6 ] Department of Social Science, UCL Institute of Education, 18 Woburn Square, London, WC1H 0NR, UK. C.bonell@ioe.ac.uk.
                Article
                Publisher Item ID: 10.1186/s13063-015-0980-y
                DOI: 10.1186/s13063-015-0980-y
                PMC ID: 4608279
                PubMed ID: 26470794
                SO-VID: 12be6c2b-3a17-45a5-9ec6-fa0b4e7822a2
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