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

INTRODUCTION: 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. AIM: 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. RESULTS: 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. CONCLUSIONS: 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.