Are trials of psychological and psychosocial interventions for schizophrenia and psychosis included in the NICE guidelines pragmatic? A systematic review

Autoři: Chiara Gastaldon aff001;  Franziska Mosler aff002;  Sarah Toner aff002;  Federico Tedeschi aff001;  Victoria Jane Bird aff002;  Corrado Barbui aff001;  Stefan Priebe aff002
Působiště autorů: WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy aff001;  Unit for Social and Community Psychiatry, WHO Collaborating Centre for Mental Health Services Development Queen Mary University of London, London, England, United Kingdom aff002
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0222891



The NICE clinical guidelines on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on the results of randomized controlled trials (RCTs), which may not be studies with a pragmatic design, leading to uncertainty on applicability or recommendations to everyday clinical practice.


To assess the level of pragmatism of the evidence used to develop the NICE guideline for psychosocial interventions in psychoses.

Material and methods

We conducted a systematic and critical appraisal of RCTs used to develop the ‘psychological therapy and psychosocial interventions’ section of the NICE guideline on the treatment and management of psychosis and schizophrenia in adults, published in 2014. For each study we assessed pragmatism using the pragmatic–explanatory continuum indicator summary-2 (PRECIS-2) and the Cochrane risk of bias tool. The mean score of PRECIS-2, averaging across nine domains, was calculated to describe the level of pragmatism of each individual study.


A total of 143 studies were included in the analysis. Based on the PRECIS-2 tool, 16.8% were explanatory, 33.6% pragmatic, and 49.7% were rated in an intermediate category. Compared to explanatory studies, pragmatic studies showed a lower risk of bias. Additionally, pragmatism did not significantly improve over time, and no associations were found between pragmatism and a number of trial characteristics. However, studies with a UK leading investigator had the highest mean score of pragmatism. Cognitive behavioural therapy (CBT), art therapy, family intervention, psychoeducation, and adherence therapy, showed the higher average pragmatism scores.


Two third of studies used to produce NICE recommendations on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on studies that did not employ a pragmatic design.

Klíčová slova:

Diagnostic medicine – Mental health and psychiatry – Psychological and psychosocial issues – Psychoses – Schizophrenia – Treatment guidelines – Mental health therapies – Psychotherapy


1. World Health Organization. Evaluation of methods for the treatment of mental disorders. Report of a WHO Scientific Group on the Treatment of Psychiatric Disorders. World Health Organization technical report series. 1991;812:1–75. 1746165

2. Hotopf M, Churchill R, Lewis G. Pragmatic randomised controlled trials in psychiatry. The British journal of psychiatry: the journal of mental science. 1999;175:217–23.

3. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147. doi: 10.1136/bmj.h2147 25956159

4. Salmoirago-Blotcher E, Ockene IS. Methodological limitations of psychosocial interventions in patients with an implantable cardioverter-defibrillator (ICD) A systematic review. BMC cardiovascular disorders. 2009;9:56. doi: 10.1186/1471-2261-9-56 20040100

5. Slade M, Priebe S. Are randomised controlled trials the only gold that glitters? The British journal of psychiatry: the journal of mental science. 2001;179:286–7.

6. Ford I, Norrie J. Pragmatic Trials. N Engl J Med. 2016;375(5):454–63. doi: 10.1056/NEJMra1510059 27518663

7. Purgato M, Barbui C, Stroup S, Adams C. Pragmatic design in randomized controlled trials. Psychol Med. 2015;45(2):225–30. doi: 10.1017/S0033291714001275 25065958

8. National Collaborating Centre for Mental Health (Great Britain), National Institute for Health and Care Excellence (Great Britain). Psychosis and schizophrenia in adults: treatment and management. Updated edition 2014. ed. 1 online resource (PDF file (684 pages)) p.

9. Haddock G, Eisner E, Boone C, Davies G, Coogan C, Barrowclough C. An investigation of the implementation of NICE-recommended CBT interventions for people with schizophrenia. Journal of Mental Health. 2014;23(4):162–5. doi: 10.3109/09638237.2013.869571 24433132

10. Ruggeri M, Lora A, Semisa D, Group S-DS. The SIEP-DIRECT'S Project on the discrepancy between routine practice and evidence. An outline of main findings and practical implications for the future of community based mental health services. Epidemiol Psichiatr Soc. 2008;17(4):358–68. 19024723

11. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 2009;180(10):E47–57. doi: 10.1503/cmaj.090523 19372436

12. Loudon K, Zwarenstein M, Sullivan FM, Donnan PT, Gagyor I, Hobbelen H, et al. The PRECIS-2 tool has good interrater reliability and modest discriminant validity. J Clin Epidemiol. 2017;88:113–21. doi: 10.1016/j.jclinepi.2017.06.001 28603007

13. Hu GP, Zhan SY. [The PRECIS-2 tool: designing trials that are fit for purpose]. Zhonghua Liu Xing Bing Xue Za Zhi. 2018;39(2):222–6. doi: 10.3760/cma.j.issn.0254-6450.2018.02.017 29495210

14. Dal-Re R, Janiaud P, Ioannidis JPA. Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic? BMC medicine. 2018;16(1):49. doi: 10.1186/s12916-018-1038-2 29615035

15. Palese A, Bevilacqua MG, Dante A. Do randomized controlled nursing trials have a pragmatic or explanatory attitude? Findings from the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool exercise. The journal of nursing research: JNR. 2014;22(3):216–20. doi: 10.1097/jnr.0000000000000045 25111115

16. Mansouri A, Cooper B, Shin SM, Kondziolka D. Randomized controlled trials and neurosurgery: the ideal fit or should alternative methodologies be considered? J Neurosurg. 2016;124(2):558–68. doi: 10.3171/2014.12.JNS142465 26315006

17. Higgins JP GS. Cochrane Handbook for Systematic Reviews of Interventions: Chichester: John Wiley & Sons, Ltd; 2011.

18. Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, et al. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016;17:32. doi: 10.1186/s13063-016-1158-y 26772801

19. Sox HC, Lewis RJ. Pragmatic Trials: Practical Answers to "Real World" Questions. Jama. 2016;316(11):1205–6. doi: 10.1001/jama.2016.11409 27654606

20. Witt CM, Manheimer E, Hammerschlag R, Ludtke R, Lao L, Tunis SR, et al. How well do randomized trials inform decision making: systematic review using comparative effectiveness research measures on acupuncture for back pain. PloS one. 2012;7(2):e32399. doi: 10.1371/journal.pone.0032399 22389699

21. Taylor M, Perera U. NICE CG178 Psychosis and Schizophrenia in Adults: Treatment and Management—an evidence-based guideline? The British journal of psychiatry: the journal of mental science. 2015;206(5):357–9.

22. Coghill D. Are NICE guidelines losing their impartiality? The British journal of psychiatry: the journal of mental science. 2015;207(3):271.

23. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390 19001484

24. Zwarenstein M. 'Pragmatic' and 'explanatory' attitudes to randomised trials. J R Soc Med. 2017;110(5):208–18. doi: 10.1177/0141076817706303 28504072

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