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

ABSTRACT: 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.

SUBMITTER: Gastaldon C

PROVIDER: S-EPMC6759154 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Gastaldon Chiara C Mosler Franziska F Toner Sarah S Tedeschi Federico F Bird Victoria Jane VJ Barbui Corrado C Priebe Stefan S

PloS one 20190924 9

<h4>Introduction</h4>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.<h4>Aim</h4>To assess the level of pragmatism of the evidence used to develop the NICE guideline for psychosocial interventions in psychoses.<h4>Material and ...[more]

PMID: 31550279

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Project description:BackgroundInformation on cost-effectiveness of interventions to treat schizophrenia can assist health policy decision making, particularly given the lack of health resources in developing countries like Thailand. This study aims to determine the optimal treatment package, including drug and non-drug interventions, for schizophrenia in Thailand.MethodsA Markov model was used to evaluate the cost-effectiveness of typical antipsychotics, generic risperidone, olanzapine, clozapine and family interventions. Health outcomes were measured in disability adjusted life years. We evaluated intervention benefit by estimating a change in disease severity, taking into account potential side effects. Intervention costs included outpatient treatment costs, hospitalization costs as well as time and travel costs of patients and families. Uncertainty was evaluated using Monte Carlo simulation. A sensitivity analysis of the expected range cost of generic risperidone was undertaken.ResultsGeneric risperidone is more cost-effective than typicals if it can be produced for less than 10 baht per 2 mg tablet. Risperidone was the cheapest treatment with higher drug costs offset by lower hospital costs in comparison to typicals. The most cost-effective combination of treatments was a combination of risperidone (dominant intervention). Adding family intervention has an incremental cost-effectiveness ratio of 1,900 baht/DALY with a 100% probability of a result less than a threshold for very cost-effective interventions of one times GDP or 110,000 baht per DALY. Treating the most severe one third of patients with clozapine instead of risperidone had an incremental cost-effectiveness ratio of 320,000 baht/DALY with just over 50% probability of a result below three times GDP per capita.ConclusionsThere are good economic arguments to recommend generic risperidone as first line treatment in combination with family intervention. As the uncertainty interval indicates the addition of clozapine may be dominated and there are serious side effects, treating severe patients with clozapine is advisable only for patients who do not respond to risperidone and only in the presence of a stricter side effect monitoring system than currently exists.

Project description:INTRODUCTION:There is rising awareness that we need multidisciplinary approaches integrating psychological treatments for schizophrenia, but a comprehensive evidence based on their relative efficacy is lacking. We will conduct a network meta-analysis (NMA), integrating direct and indirect comparisons from randomised controlled trials (RCTs) to rank psychological treatments for schizophrenia according to their efficacy, acceptability and tolerability. METHODS AND ANALYSIS:We will include all RCTs comparing a psychological treatment aimed at positive symptoms of schizophrenia with another psychological intervention or with a no treatment condition (waiting-list and treatment as usual). We will include studies on adult patients with schizophrenia, excluding specific subpopulations (eg, first-episode patients or patients with psychiatric comorbidities). Primary outcome will be the change in positive symptoms on a published rating scale. Secondary outcomes will be acceptability (dropout), change in overall and negative symptoms of schizophrenia, response, relapse, adherence, depression, quality of life, functioning and adverse events. Published and unpublished studies will be sought through database searches, trial registries and websites. Study selection and data extraction will be conducted by at least two independent reviewers. We will conduct random-effects NMA to synthesise all evidences for each outcome and obtain a comprehensive ranking of all treatments. NMA will be conducted in Stata and R within a frequentist framework. The risk of bias in studies will be evaluated using the Cochrane Risk of Bias tool and the credibility of the evidence will be evaluated using an adaptation of the Grading of Recommendations Assessment, Development and Evaluation framework to NMA, recommended by the Cochrane guidance. Subgroup and sensitivity analyses will be conducted to assess the robustness of the findings. ETHICS AND DISSEMINATION:No ethical issues are foreseen. Results from this study will be published in peer-reviewed journals and presented at relevant conferences. PROSPERO REGISTRATION NUMBER:CRD42017067795.

Project description:ObjectiveTo examine the evidence for the use of psychological and psychosocial interventions offered to forensic mental health inpatients.DesignCINAHL, MEDLINE, PsycINFO, ScienceDirect and Web of Science databases were searched for research published in English between 1 January 1990 and 31 May 2018.Outcome measuresDisturbance, mental well-being, quality of life, recovery, violence/risk, satisfaction, seclusion, symptoms, therapeutic relationship and ward environment. There were no limits on the length of follow-up.Eligibility criteriaWe included randomised controlled trial (RCT) studies of any psychological or psychosocial intervention in an inpatient forensic setting. Pilot or feasibility studies were included if an RCT design was used.We restricted our search criteria to inpatients in low, medium and high secure units aged over 18. We focused on interventions considered applicable to most patients residing in forensic mental health settings.Data extraction and synthesisTwo independent reviewers extracted data and assessed risk of bias.Results17 232 citations were identified with 195 full manuscripts examined in detail. Nine papers were included in the review. The heterogeneity of the identified studies meant that meta-analysis was inappropriate. The results were presented in table form together with a narrative synthesis. Only 7 out of 91 comparisons revealed statistically significant results with no consistent significant findings. The most frequently reported outcomes were violence/risk and symptoms. 61% of the violence/risk comparisons and 79% of the symptom comparisons reported improvements in the intervention groups compared with the control groups.ConclusionsCurrent practice is based on limited evidence with no consistent significant findings. This review suggests psychoeducational and psychosocial interventions did not reduce violence/risk, but there is tentative support they may improve symptoms. More RCTs are required with: larger sample sizes, representative populations, standardised outcomes and control group interventions similar in treatment intensity to the intervention.Prospero registration numberCRD42017067099.

Project description:BackgroundUpdating is important to ensure clinical guideline (CG) recommendations remain valid. However, little research has been undertaken in this field. We assessed CGs produced by the National Institute for Health and Care Excellence (NICE) to identify and describe updated recommendations and to investigate potential factors associated with updating. Also, we evaluated the reporting and presentation of recommendation changes.MethodsWe performed a descriptive analysis of original and updated CGs and recommendations, and an assessment of presentation formats and methods for recording information. We conducted a case-control study, defining cases as original recommendations that were updated ('new-replaced' recommendations), and controls as original recommendations that were considered to remain valid ('not changed' recommendations). We performed a comparison of main characteristics between cases and controls, and we planned a multiple regression analysis to identify potential predictive factors for updating.ResultsWe included nine updated CGs (1,306 recommendations) and their corresponding original versions (1,106 recommendations). Updated CGs included 812 (62%) recommendations 'not reviewed', 368 (28.1%) 'new' recommendations, 104 (7.9%) 'amended' recommendations, and 25 (1.9%) recommendations reviewed but unchanged. The presentation formats used to indicate the changes in recommendations varied widely across CGs. Changes in 'amended', 'deleted', and 'new-replaced' recommendations (n?=?296) were reported infrequently, mostly in appendices. These changes were recorded in 167 (56.4%) recommendations; and were explained in 81 (27.4%) recommendations. We retrieved a total of 7.1% (n?=?78) case recommendations ('new-replaced') and 2.4% (n?=?27) control recommendations ('not changed') in original CGs. The updates were mainly from 'Fertility CG', about 'gynaecology, pregnancy and birth' topic, and 'treatment' or 'prevention' purposes. We did not perform the multiple regression analysis as originally planned due to the small sample of recommendations retrieved.ConclusionOur study is the first to describe and assess updated CGs and recommendations from a national guideline program. Our results highlight the pressing need to standardise the reporting and presentation of updated recommendations and the research gap about the optimal way to present updates to guideline users. Furthermore, there is a need to investigate updating predictive factors.

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

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

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