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

Abstract

IntroductionThe 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.AimTo assess the level of pragmatism of the evidence used to develop the NICE guideline for psychosocial interventions in psychoses.Material and methodsWe 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.ResultsA 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.ConclusionsTwo 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.

Appraisal of patient-level health economic models of severe mental illness: systematic review

“…34,35 Studies available to inform NICE guidelines for psychosis are largely characterised by short follow-up periods (up to 6 months) and small samples (an average of 79 participants per study). 36 NICE explicitly identifies this as a key limitation in their psychosis guidanceas data for several parameters, including relapse and treatment discontinuation probabilities, require extrapolation to a lifetime horizon to capture the long-term impact of treatment on patient outcomes and costs. 31 Psychosis is a severe and often enduring mental health problem, with most patients experiencing multiple episodes or persistent symptoms.…”

Schizophrenia: A Narrative Review of Etiopathogenetic, Diagnostic and Treatment Aspects

“…Therefore, researchers have recently directed their research interest towards new neurochemical targets, such as the glutamatergic system [ 194 , 197 , 198 ]. While, on the other hand, from a non-pharmacological perspective, despite the demonstrated evidence-based efficacy of cognitive–behavioral approach [ 199 , 200 , 201 , 202 ], its use is still poor in routine clinical practice for schizophrenic individuals [ 24 , 203 ]. In patients with treatment-resistant schizophrenia (TRS), researchers have explored the utility of brain stimulation procedures [ 204 ], such as electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), and deep brain stimulation (DBS).…”

“…Finally, psychosocial interventions and recovery-oriented rehabilitative interventions (e.g., cognitive remediation and metacognitive reflection and insight therapy (MERIT) etc.) have been rapidly developed in order to target cognitive and/or metacognitive deficits that can hamper the functional recovery of schizophrenic patients and in subjects at ultra-high risk of psychosis [ 203 , 207 , 208 , 209 , 210 ], even though they do not seem to be adequately integrated in the mental health services [ 24 , 203 ]. Similarly, family-based interventions and supported employment programs are seldom implemented in routine clinical practice [ 24 , 203 , 211 ].…”

Pragmatic trials of pain therapies: a systematic review of methods

“… 25 , 31 , 112 , 120 Even so, the time horizon of a patient's decision is rarely encapsulated by common RCT follow-up periods that are usually 6 months or less. 32 Despite this lack of generalizability, RCTs still form the basis of most health policies, medicines regulatory approval, and treatment guidelines 43 , 45 , 57 , 89 because they allow for controlling most factors apart from the intervention as well as realistically possible.…”