The Herts and Minds study: feasibility of a randomised controlled trial of Mentalizationbased Treatment versus usual care to support the wellbeing of children in foster care

© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.Background: There is a lack of well-designed randomized controlled trials (RCTs) to investigate the efficacy of psychological therapies for children in foster care with emotional and behavioural difficulties. Mentalization-based therapy (MBT) focuses on supporting the carer-child relationship by promoting reflective capacity. This study examined the feasibility and acceptability of an RCT of MBT, delivered in a family-format, for children who are in foster care in the UK. Method: Herts and Minds was a phase II, blinded feasibility RCT with follow-up of at 12 and 24 weeks post-randomisation. Participants were children (age 5-16) in foster care referred to a targeted mental health service, who had some level of difficulty as identified by the Strengths and Difficulties Questionnaire (SDQ). Aims were to assess: the feasibility of recruitment processes and study uptake; capacity to train mental health practitioners to deliver MBT to an acceptable level of treatment integrity; establish acceptability and credibility of MBT as an intervention for children in foster care; establish feasibility and acceptability to participants of conducting an RCT; and estimate the likely treatment efficacy effect size. Participants were randomly allocated to either MBT (n = 15) or Usual Clinical Care (UCC) (n = 21) individually or in sibling groups. A range of qualitative and quantitative data was gathered to assess feasibility. Results: Feasibility was established with regard to: capacity to recruit participants to a study; capacity to train mental health practitioners to deliver MBT to an acceptable level of treatment integrity; acceptability and credibility of MBT; and feasibility and acceptability to participants of conducting an RCT. A number of issues made it difficult to estimate a likely treatment efficacy effect size. Conclusion: With modifications, it is feasible to run an RCT of MBT for children in foster care. Both the therapy and research design were acceptable to participants, but modifications may be needed regarding both the timing of assessments and the identification of appropriate primary outcome measures. Given the lack of evidenced based therapies for this population, such a trial would be a significant contribution to the field. Findings may be useful for other groups planning clinical trials of psychological therapies for children in foster care. Trial registration: ISRCTN 90349442. The trial was retrospectively registered on 6 May 2016.Peer reviewedFinal Published versio

Pathways to "opportunity and excellence": collaborative curriculum innovation in South Yorkshire

This paper reports on two aspects of a large-scale curriculum project currently taking place in four LEAs in South Yorkshire. The first of these is concerned with the positive and negative influences on effective curriculum innovation and is addressed from the perspective of the LEA project managers who are managing the delivery of the project in the region's schools. The second aspect considers what the pupils (Year 10, age 14-15) think about the new learning opportunities. The project is set in the context of regional regeneration. The paper concludes that the extremely positive responses from the sample of pupils in all three strands of the programme indicate that the greater emphasis on vocational work and work experience in schools is having a strong motivational effect on pupils who are responding with improved attendance, behaviour and achievement.</p

Evaluation of the cost-effectiveness of services for Schizophrenia in the UK across the entire care pathway in a single whole-disease model

Importance The existing economic models for schizophrenia often have 3 limitations; namely, they do not cover nonpharmacologic interventions, they report inconsistent conclusions for antipsychotics, and they have poor methodologic quality. Objectives To develop a whole-disease model for schizophrenia and use it to inform resource allocation decisions across the entire care pathway for schizophrenia in the UK. Design, Setting, and Participants This decision analytical model used a whole-disease model to simulate the entire disease and treatment pathway among a simulated cohort of 200 000 individuals at clinical high risk of psychoses or with a diagnosis of psychosis or schizophrenia being treated in primary, secondary, and tertiary care in the UK. Data were collected March 2016 to December 2018 and analyzed December 2018 to April 2019. Exposures The whole-disease model used discrete event simulation; its structure and input data were informed by published literature and expert opinion. Analyses were conducted from the perspective of the National Health Service and Personal Social Services over a lifetime horizon. Key interventions assessed included cognitive behavioral therapy, antipsychotic medication, family intervention, inpatient care, and crisis resolution and home treatment team. Main Outcomes and Measures Life-time costs and quality-adjusted life-years. Results In the simulated cohort of 200 000 individuals (mean [SD] age, 23.5 [5.1] years; 120 800 [60.4%] men), 66 400 (33.2%) were not at risk of psychosis, 69 800 (34.9%) were at clinical high risk of psychosis, and 63 800 (31.9%) had psychosis. The results of the whole-disease model suggest the following interventions are likely to be cost-effective at a willingness-to-pay threshold of £20 000 ($25 552) per quality-adjusted life-year: practice as usual plus cognitive behavioral therapy for individuals at clinical high risk of psychosis (probability vs practice as usual alone, 0.96); a mix of hospital admission and crisis resolution and home treatment team for individuals with acute psychosis (probability vs hospital admission alone, 0.99); amisulpride (probability vs all other antipsychotics, 0.39), risperidone (probability vs all other antipsychotics, 0.30), or olanzapine (probability vs all other antipsychotics, 0.17) combined with family intervention for individuals with first-episode psychosis (probability vs family intervention or medication alone, 0.58); and clozapine for individuals with treatment-resistant schizophrenia (probability vs other medications, 0.81). Conclusions and Relevance The results of this study suggest that the current schizophrenia service configuration is not optimal. Cost savings and/or additional quality-adjusted life-years may be gained by replacing current interventions with more cost-effective interventions

Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study

BACKGROUND: The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced real-time surveillance of seasonal influenza vaccination. The EMA has specified a list of adverse events of interest to be monitored. The EMA sets out 3 different ways to conduct such surveillance: (1) active surveillance, (2) enhanced passive surveillance, or (3) electronic health record data mining (EHR-DM). English general practice (GP) is a suitable setting to implement enhanced passive surveillance and EHR-DM. OBJECTIVE: This study aimed to test the feasibility of conducting enhanced passive surveillance in GP using the yellow card scheme (adverse events of interest reporting cards) to determine if it has any advantages over EHR-DM alone. METHODS: A total of 9 GPs in England participated, of which 3 tested the feasibility of enhanced passive surveillance and the other 6 EHR-DM alone. The 3 that tested EPS provided patients with yellow (adverse events) cards for patients to report any adverse events. Data were extracted from all 9 GPs' EHRs between weeks 35 and 49 (08/24/2015 to 12/06/2015), the main period of influenza vaccination. We conducted weekly analysis and end-of-study analyses. RESULTS: Our GPs were largely distributed across England with a registered population of 81,040. In the week 49 report, 15,863/81,040 people (19.57% of the registered practice population) were vaccinated. In the EPS practices, staff managed to hand out the cards to 61.25% (4150/6776) of the vaccinees, and of these cards, 1.98% (82/4150) were returned to the GP offices. Adverse events of interests were reported by 113 /7223 people (1.56%) in the enhanced passive surveillance practices, compared with 322/8640 people (3.73%) in the EHR-DM practices. CONCLUSIONS: Overall, we demonstrated that GPs EHR-DM was an appropriate method of enhanced surveillance. However, the use of yellow cards, in enhanced passive surveillance practices, did not enhance the collection of adverse events of interests as demonstrated in this study. Their return rate was poor, data entry from them was not straightforward, and there were issues with data reconciliation. We concluded that customized cards prespecifying the EMA's adverse events of interests, combined with EHR-DM, were needed to maximize data collection. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2016-015469

Systematic review of the methods of health economic models assessing antipsychotic medication for schizophrenia

Background Numerous economic models have assessed the cost-effectiveness of antipsychotic medications in schizophrenia. It is important to understand what key impacts of antipsychotic medications were considered in the existing models and limitations of existing models in order to inform the development of future models. Objectives This systematic review aims to identify which clinical benefits, clinical harms, costs and cost savings of antipsychotic medication have been considered by existing models, to assess quality of existing models and to suggest good practice recommendations for future economic models of antipsychotic medications. Methods An electronic search was performed on multiple databases (MEDLINE, EMBASE, PsycInfo, Cochrane database of systematic reviews, The NHS Economic Evaluation Database and Health Technology Assessment database) to identify economic models of schizophrenia published between 2005–2020. Two independent reviewers selected studies for inclusion. Study quality was assessed using the National Institute for Health and Care Excellence (NICE) checklist and the Cooper hierarchy. Key impacts of antipsychotic medications considered by exiting models were descriptively summarised. Results Sixty models were included. Existing models varied greatly in key impacts of antipsychotic medication included in the model, especially in clinical outcomes used for assessing reduction in psychotic symptoms and types of adverse events considered in the model. Quality of existing models was generally low due to failure to capture the health and cost impact of adverse events of antipsychotic medications and input data not obtained from best available source. Good practices for modelling antipsychotic medications are suggested. Discussions This review highlights inconsistency in key impacts considered by different models, and limitations of the existing models. Recommendations on future research are provided

Psychometric properties of the five-level EuroQoL-5 dimension and Short Form-6 dimension measures of health-related quality of life in a population of pregnant women with depression

BACKGROUND: Although evidence suggests that the EuroQoL-5 dimension (EQ-5D) and Short Form-6 dimension (SF-6D) have equivalent psychometric properties in people with depression, there is some evidence that the EQ-5D may lack responsiveness in certain populations with depression. AIMS: To examine the psychometric properties of the five-level EQ-5D (EQ-5D-5L) and SF-6D measures of health-related quality of life in a representative sample of pregnant women with depression. METHOD: Data were taken from a cohort of pregnant women identified at or soon after the first antenatal care contact and followed-up at 3 months postpartum. Health-related quality of life was measured using both the EQ-5D-5L and the SF-6D at baseline and follow-up. We examined acceptability and conducted psychometric validation in the aspects of concurrent validity, convergent validity, known-group validity and responsiveness in 421 women with available data. RESULTS: The EQ-5D-5L and SF-6D have similarly high levels of acceptability. However, concurrent validation shows a lack of concordance between the EQ-5D-5L and SF-6D. The EQ-5D-5L tends to be higher than the SF-6D in individuals with better health states. The SF-6D tends to be higher than EQ-5D-5L in individuals with poorer health states. Convergent and known-group validity are comparable between the two utility measures. Longitudinally, women who recovered show larger increase in SF-6D utilities than those who did not recover at follow-up. With the EQ-5D-5L, this is not the case. Additionally, the ceiling effects were more apparent in the EQ-5D-5L. CONCLUSIONS: The effectiveness of perinatal mental health interventions may be better captured by the SF-6D than the EQ-5D-5L but this needs to be cross-validated in more studies. DECLARATION OF INTEREST: L.M.H. chaired the National Institute for Health and Care Excellence CG192 guidelines development group on antenatal and postnatal mental health in 2012-2014. L.M.H. reports grants from NIHR, MRC, Nuffield and the Stefanou Foundation, UK. K.T., M.H. and S.B. report funding by NIHR and the Stefanou Foundation, UK

Permission to exist *

Abstract We provide a new model that generates persistent performance differences amongst seemingly similar enterprises. Our model provides a mechanism whereby efficient incumbent rivals can give permission for an inefficient firm to exist in the presence of efficient entrants. We demonstrate that, in a repeated game, an efficient incumbent has a unilateral incentive to establish a relational contract that softens price competition to either strengthen the inefficient firm in a war of attrition that emerges post-entry or reduce the value to the inefficient firm of selling its position to entrants. The paper provides conditions under which that equilibrium exists and derives a number of empirical predictions as implications of the model. It is demonstrated that performance differences are likely to be associated with stability in the identity of firms in the market