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A realist approach to the evaluation of complex mental health interventions

  • Craig Duncan (a1), Scott Weich (a2), Sarah-Jane Fenton (a3), Liz Twigg (a4), Graham Moon (a5), Jason Madan (a6), Swaran P. Singh (a7), David Crepaz-Keay (a8), Helen Parsons (a9) and Kamaldeep Bhui (a10)...
Summary

Conventional approaches to evidence that prioritise randomised controlled trials appear increasingly inadequate for the evaluation of complex mental health interventions. By focusing on causal mechanisms and understanding the complex interactions between interventions, patients and contexts, realist approaches offer a productive alternative. Although the approaches might be combined, substantial barriers remain.

Declaration of interest

All authors had financial support from the National Institute for Health Research Health Services and Delivery Research Programme while completing this work. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the National Health Service, the National Institute for Health Research, the Medical Research Council, Central Commissioning Facility, National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, the Health Services and Delivery Research Programme or the Department of Health. S.P.S. is part funded by Collaboration for Leadership in Applied Health Research and Care West Midlands. K.B. is editor of the British Journal of Psychiatry.

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Corresponding author
Correspondence: Craig Duncan, PhD, Department of Geography, Buckingham Building, Lion Terrace, University of Portsmouth, Portsmouth PO1 3HE, UK. Email: craig.duncan@port.ac.uk
References
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1Deaton, A, Cartwright, N. Understanding and misunderstanding randomized controlled trials. Soc Sci Med 2017, in press.
2Priebe, S, Slade, M. Evidence in Mental Health Care. Brunner-Routledge, 2002.
3Carey, TA, Stiles, WB. Some problems with randomized controlled trials and some viable alternatives. Clin Psychol Psychother 2016; 23(1): 8795.
4Pawson, R, Tilley, N. Realistic Evaluation. Sage, 1997.
5Pawson, R. The Science of Evaluation. Sage, 2013.
6Greenhalgh, T, Wong, G, Westhorp, G, Pawson, R. Protocol-realist and meta-narrative evidence synthesis: evolving standards (RAMESES). BMC Med Res Methodol 2011; 11(1): 115.
7Byng, R, Norman, I, Redfern, S, Jones, R. Exposing the key functions of a complex intervention for shared care in mental health: case study of a process evaluation. BMC Health Serv Res 2008; 8(1): 274.
8Bonell, C, Fletcher, A, Morton, M, Lorenc, T, Moore, L. Realist randomised controlled trials: a new approach to evaluating complex public health interventions. Soc Sci Med 2012; 75(12): 2299–306.
9Murphy, SM, Edwards, RT, Williams, N, Raisanen, L, Moore, G, Linck, P, et al. An evaluation of the effectiveness and cost effectiveness of the National Exercise Referral Scheme in Wales, UK: a randomised controlled trial of a public health policy initiative. J Epidemiol Community Health 2012; 66(8): 745–53.
10Van Belle, S, Wong, G, Westhorp, G, Pearson, M, Emmel, N, Manzano, A, et al. Can ‘realist’ randomised controlled trials be genuinely realist? Trials 2016; 17(1): 313.
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The British Journal of Psychiatry
  • ISSN: 0007-1250
  • EISSN: 1472-1465
  • URL: /core/journals/the-british-journal-of-psychiatry
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A realist approach to the evaluation of complex mental health interventions

  • Craig Duncan (a1), Scott Weich (a2), Sarah-Jane Fenton (a3), Liz Twigg (a4), Graham Moon (a5), Jason Madan (a6), Swaran P. Singh (a7), David Crepaz-Keay (a8), Helen Parsons (a9) and Kamaldeep Bhui (a10)...
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eLetters

Psychiatry does need more RCTs

tom burns, professor of social psychiatry emeritus, oxford university
15 August 2018

Duncan et al (ref BJPsych 2018, 451-453) claim that ‘Conventional approaches to evidence that prioritise randomised controlled trials appear increasingly inadequate for the evaluation of complex mental health interventions.’ Nothing could be further from the truth. The exaggerated distinctions presented between research in psychiatry and that in the rest of medicine are in a long tradition of special pleading that does our discipline no favours.

RCTs seek to identify what works for whom – careful identification of the target population and appropriate outcome measures are key to all successful trials. Their findings do, indeed, ‘apply to groups …not equally to everyone’ – clinicians are still needed to interpret and apply their findings. RCTs do not seek to substitute for the exploration of mechanisms, nor the creative development of alternative approaches to treatment. Their purpose is to reduce persisting doubts about the effectiveness or otherwise of an intervention. If there are no doubts they are not needed. But where there is doubt about treatment effects (highly likely in the long-term relapsing-remitting disorders in psychiatry with their probabilistic outcomes over extended periods) their superiority has proved itself time and time again. One simply needs to observe the staggering improvements in evidence-based medicine over the last fifty years.

The authors’ implication that in general medicine trials are so much simpler, interventions less complex, or treatments less ‘personalised’ would receive a dusty response from our colleagues in oncology or cardiology. Where interventions are complex they need to be carefully dissected to determine what is potentially effective and what is potentially redundant. Such hard-nosed examination is sorely needed in psychiatry and it can be highly productive in its own right, even without RCTs to test core components.

Psychiatry is not handicapped by the dominance of ‘positivistic’ research favouring RCTs and systematic reviews. On the contrary it is handicapped by there not being anywhere near enough of them, and not enough weight being given to their results. In their contrast between ‘realist’ and ‘positivist’ research the authors omit to acknowledge what Karl Popper considered scientific method’s cardinal virtue – its ability to falsify hypotheses (ref The Logic of Scientific Discovery 1935, first in English 1959).

Rigorously designed and conducted RCTs have an almost unique power to reverse strongly held clinical convictions. It was Acker and Osner’s 1957 RCT that ended Insulin Coma’s two decades of dominance in schizophrenia treatment (1). Twice I have been forced, painfully, to abandon cherished beliefs when confronted by RCT evidence. Assertive Community Treatment teams did not, despite my enthusiasm and commitment to it, deliver superior care to CMHTs (2, 3), nor do CTOs stabilise severe psychosis in the community (4, 5). Would the proposed realism studies achieve this?

Our current demand is for parity of esteem. We are more likely to get equal respect and funding if our practice matches that of our medical colleagues. Holding psychiatry’s practice to the same rigorous standards in research will go a long way to establishing society’s trust and, through that, genuine parity of esteem for our profession and patients.



1. The Logic of Scientific Discovery. Karl Popper. Routledge, UK. 1959

1. Ackner B, Harris A, Oldham A. Insulin treatment of schizophrenia; a controlled study. Lancet. 1957; 272(6969): 607.

2. Burns T, Creed F, Fahy T, Thompson S, Tyrer P, White I. Intensive versus standard case management for severe psychotic illness: a randomised trial. The Lancet. 1999; 353(9171): 2185-9.

3. Burns T, Catty J, Dash M, Roberts C, Lockwood A, Marshall M. Use of intensive case management to reduce time in hospital in people with severe mental illness: systematic review and meta-regression. BMJ. 2007; 335(7615): 336.

4. Burns T, Rugkåsa J, Molodynski A, Dawson J, Yeeles K, Vazquez-Montes M, et al. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. The Lancet. 2013; 381(9878): 1627-33.

5. Kisely S, Hall K. An updated meta-analysis of randomized controlled evidence for the effectiveness of community treatment orders. Canadian journal of psychiatry. 2014; 59(10): 561-4.

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Conflict of interest: None declared

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