Development and validation of a patient reported experience measure for experimental cancer medicines (PREM-ECM) and their carers (PREM-ECM-Carer).

BACKGROUND: Our aim was to develop a validated Patient Reported Experience Measure (PREM) to capture patient and carer experience during participation in experimental cancer medicine trials (ECM): called PREM-ECM. METHODS: Mixed method design, consisting of four stages. Questionnaire items were produced for both patients and carers using interviews, focus groups, and cognitive interviews with patients and carers separately. For both patient and carer PREMs, a cross-sectional questionnaire study was conducted to identify final items for inclusion using hierarchical item reduction and Rasch analysis. Questionnaire validity and reliability were assessed, including administration feasibility. RESULTS: Initial interview participants suggested the need for three PREMs, two specific to patients: (i) a 'prior' questionnaire that captured experiences of trial introduction, screening, consenting, and early trial experience (< 6 weeks post consent); and (ii) 'on-trial' that captured experiences of ongoing consent and trial participation; and (iii) a PREM specific for carers. The draft 25-item 'prior' questionnaire was completed by 162 patients and 162 patients completed the draft 35-item 'on-trial' questionnaire. Hierarchical and Rasch analysis produced a 14-item 'prior' list and a 15-item list for 'on-trial'. Both patient PREM's demonstrated a good fit to the Rasch model following Bonferroni correction (X2p = 0.008). The carer 34-draft item questionnaire was completed by 102 participants. Hierarchical and Rasch analysis produced a 13-item list for PREM-ECM-Carer, with good fit to the Rasch model ( X2p = 0.62). The pilot testing demonstrated the feasibility of all the PREMs in capturing patient and caregiver experiences in routine clinical settings. CONCLUSIONS: The three PREM-ECM questionnaires will be the first validated experience measures for ECM trial patients and their carers. These questionnaires may be used to assess patients' and their carers' experiences of ECM and enable robust comparisons across cancer trial units highlighting areas for service improvement.

Psychosocial support interventions for children and adolescents experiencing gender dysphoria or incongruence: a systematic review.

BACKGROUND: National and international guidelines recommend that psychosocial support should be a key component of the care offered to children and adolescents experiencing gender dysphoria/incongruence. However, specific approaches or interventions are not recommended. AIM: To identify and summarise evidence on the outcomes of psychosocial support interventions for children and adolescents (age 0-18) experiencing gender dysphoria/incongruence. METHODS: Systematic review and narrative synthesis. Database searches (MEDLINE; EMBASE; CINAHL; PsycINFO; Web of Science) were performed in April 2022, with results assessed independently by two reviewers. Peer-reviewed articles reporting the results of studies measuring outcomes of psychosocial support interventions were included. Quality was assessed using the Mixed Methods Appraisal Tool. RESULTS: Ten studies were included. Half were conducted in the US, with others from Australia, Canada, New Zealand and the UK. Six were pre-post analyses or cohort studies, three were mixed methods, and one was a secondary analysis of intervention data from four trials. Most studies were of low quality. Most analyses of mental health and psychosocial outcomes showed either benefit or no change, with none indicating negative or adverse effects. CONCLUSIONS: The small number of low-quality studies limits conclusions about the effectiveness of psychosocial interventions for children/adolescents experiencing gender dysphoria/incongruence. Clarity on the intervention approach as well as the core outcomes would support the future aggregation of evidence. More robust methodology and reporting is required. PROSPERO REGISTRATION NUMBER: CRD42021289659.

Characteristics of children and adolescents referred to specialist gender services: a systematic review.

BACKGROUND: Increasing numbers of children/adolescents experiencing gender dysphoria/incongruence are being referred to specialist gender services. Services and practice guidelines are responding to these changes. AIM: This systematic review examines the numbers and characteristics of children/adolescents (under 18) referred to specialist gender or endocrinology services. METHODS: Database searches were performed (April 2022), with results assessed independently by two reviewers. Peer-reviewed articles providing at least birth-registered sex or age at referral were included. Demographic, gender-related, mental health, neurodevelopmental conditions and adverse childhood experience data were extracted. A narrative approach to synthesis was used and where appropriate proportions were combined in a meta-analysis. RESULTS: 143 studies from 131 articles across 17 countries were included. There was a twofold to threefold increase in the number of referrals and a steady increase in birth-registered females being referred. There is inconsistent collection and reporting of key data across many of the studies. Approximately 60% of children/adolescents referred to services had made steps to present themselves in their preferred gender. Just under 50% of studies reported data on depression and/or anxiety and under 20% reported data on other mental health issues and neurodevelopmental conditions. Changes in the characteristics of referrals over time were generally not reported. CONCLUSIONS: Services need to capture, assess and respond to the potentially co-occurring complexities of children/adolescents being referred to specialist gender and endocrine services. Agreement on the core characteristics for collection at referral/assessment would help to ensure services are capturing data as well as developing pathways to meet the needs of these children.PROSPERO registration number CRD42021289659.

Interventions to suppress puberty in adolescents experiencing gender dysphoria or incongruence: a systematic review.

BACKGROUND: Treatment to suppress or lessen effects of puberty are outlined in clinical guidelines for adolescents experiencing gender dysphoria/incongruence. Robust evidence concerning risks and benefits is lacking and there is a need to aggregate evidence as new studies are published. AIM: To identify and synthesise studies assessing the outcomes of puberty suppression in adolescents experiencing gender dysphoria/incongruence. METHODS: A systematic review and narrative synthesis. Database searches (Medline, Embase, CINAHL, PsycINFO, Web of Science) were performed in April 2022, with results assessed independently by two reviewers. An adapted version of the Newcastle-Ottawa Scale for cohort studies was used to appraise study quality. Only moderate-quality and high-quality studies were synthesised. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines were used. RESULTS: 11 cohort, 8 cross-sectional and 31 pre-post studies were included (n=50). One cross-sectional study was high quality, 25 studies were moderate quality (including 5 cohort studies) and 24 were low quality. Synthesis of moderate-quality and high-quality studies showed consistent evidence demonstrating efficacy for suppressing puberty. Height increased in multiple studies, although not in line with expected growth. Multiple studies reported reductions in bone density during treatment. Limited and/or inconsistent evidence was found in relation to gender dysphoria, psychological and psychosocial health, body satisfaction, cardiometabolic risk, cognitive development and fertility. CONCLUSIONS: There is a lack of high-quality research assessing puberty suppression in adolescents experiencing gender dysphoria/incongruence. No conclusions can be drawn about the impact on gender dysphoria, mental and psychosocial health or cognitive development. Bone health and height may be compromised during treatment. More recent studies published since April 2022 until January 2024 also support the conclusions of this review. PROSPERO REGISTRATION NUMBER: CRD42021289659.

Clinical guidelines for children and adolescents experiencing gender dysphoria or incongruence: a systematic review of guideline quality (part 1).

BACKGROUND: Increasing numbers of children and adolescents experiencing gender dysphoria/incongruence are being referred to specialist gender services. There are various guidelines outlining approaches to the clinical care of these children and adolescents. AIM: To examine the quality and development of published guidelines or clinical guidance containing recommendations for managing gender dysphoria/incongruence in children and/or adolescents (age 0-18). A separate paper reports the synthesis of guideline recommendations. METHODS: A systematic review and narrative synthesis. Databases (Medline, Embase, CINAHL, PsycINFO, Web of Science) were searched to April 2022 and web-based searches and contact with international experts continued to December 2022, with results assessed independently by two reviewers. The Appraisal of Guidelines for Research and Evaluation tool was used to examine guideline quality. RESULTS: Twenty-three guidelines/clinical guidance publications (1998-2022) were identified (4 international, 3 regional and 16 national). The quality and methods reporting in these varied considerably. Few guidelines systematically reviewed empirical evidence, and links between evidence and recommendations were often unclear. Although most consulted with relevant stakeholders, including 10 which involved service users or user representatives, it was often unclear how this influenced recommendations and only two reported including children/adolescents and/or parents. Guidelines also lacked clarity about implementation. Two international guidelines (World Professional Association for Transgender Health and Endocrine Society) formed the basis for most other guidance, influencing their development and recommendations. CONCLUSIONS: Most clinical guidance for managing children/adolescents experiencing gender dysphoria/incongruence lacks an independent and evidence-based approach and information about how recommendations were developed. This should be considered when using these to inform service development and clinical practice. PROSPERO REGISTRATION NUMBER: CRD42021289659.

Gender services for children and adolescents across the EU-15+ countries: an online survey.

BACKGROUND: Over the last 10-15 years, there has been an increase in the number of children and adolescents referred to gender services, particularly among adolescent birth-registered females. This population shows a higher prevalence of co-occurring mental health difficulties and neurodevelopmental conditions. Some countries have recently restricted access to medical treatments in recognition of the uncertain evidence base. AIM: To understand the current provision of gender services for children and adolescents across the EU-15+ countries that have comparable high-income healthcare systems, to inform service development in the UK. METHODS: An e-survey of paediatric gender services was conducted between September 2022 and April 2023. It covered service structure, care pathways, interventions and data collection. Data were described and compared to identify similarities and differences among participating services. RESULTS: 15 services in eight countries (Australia, Belgium, Denmark, Norway, Northern Ireland, The Netherlands, Spain and Finland) responded. While a multidisciplinary team was present in all services, its composition and organisation varied. Clinical practice was informed by international guidelines, with four countries following their own national guidelines. Differences were observed in referral criteria, care pathways for prepubertal children and those with co-occurring conditions. Eligibility criteria for medical interventions also varied. Psychosocial support and interventions were limited, and outcome data collection was scarce. CONCLUSIONS: This survey revealed both similarities and key variations in the clinical practice of paediatric gender services across eight different countries. The study emphasises the need for service development that both considers the management of co-occurring conditions and embeds routine data collection in practice.

Care pathways of children and adolescents referred to specialist gender services: a systematic review.

BACKGROUND: Increasing numbers of children and adolescents experiencing gender dysphoria/incongruence are being referred to specialist gender services. However, little is currently known about the proportions accessing different types of care and treatment following referral. AIM: This systematic review examines the range of care pathways of children/adolescents (under 18) referred to specialist gender or endocrinology services. METHODS: Database searches were performed (April 2022), with results assessed independently by two reviewers. Peer-reviewed articles providing data for numbers of children and/or adolescents at referral/assessment and their treatment pathways were included. A narrative approach to synthesis was used and where appropriate proportions were combined in a random-effects meta-analysis. RESULTS: 23 studies across nine countries were included, representing 6133 children and/or adolescents with a median age at assessment of 14-16 and overall a higher percentage of birth-registered females. Of those assessed, 36% (95% CI 27% to 45%) received puberty suppression, 51% (95% CI 40% to 62%) received masculinising or feminising hormones, 68% (95% CI 57% to 77%) received puberty suppression and/or hormones and 16% (95% CI 10% to 24%) received surgery. No study systematically reported information about the full pathway or psychological care received by children/adolescents. Follow-up in many studies was insufficient or unclear. Reasons for discontinuation were rarely provided. CONCLUSIONS: Prospective studies with long-term follow-up reporting information about the full range of pathways are needed to understand what happens to children and adolescents referred to specialist gender services. Information about provision of psychological care is needed considering high rates of psychosocial difficulties in this population.PROSPERO registration number CRD42021289659.

Clinical guidelines for children and adolescents experiencing gender dysphoria or incongruence: a systematic review of recommendations (part 2).

BACKGROUND: Increasing numbers of children and adolescents experiencing gender dysphoria/incongruence are being referred to specialist gender services and there are various published guidelines outlining approaches to clinical care. AIM: To examine the recommendations about the management of children and/or adolescents (age 0-18) experiencing gender dysphoria/incongruence in published guidelines or clinical guidance. A separate paper examines the quality and development of guidelines. METHODS: A systematic review and narrative synthesis. Databases (Medline, Embase, CINAHL, PsycINFO, Web of Science) were searched to April 2022 and web-based searches and contact with international experts continued to December 2022, with results assessed independently by two reviewers. The Appraisal of Guidelines for Research and Evaluation tool was used to examine guideline quality. RESULTS: 23 guidelines/clinical guidance publications (1998-2022) were identified (4 international, 3 regional, 16 national). Guidelines describe a similar care pathway starting with psychosocial care for prepubertal children, puberty suppressants followed by hormones for eligible adolescents and surgical interventions as these adolescents enter adulthood. In general, there is consensus that adolescents should receive a multidisciplinary assessment, although clear guidance about the purpose or approach is lacking. There are differing recommendations about when and on what basis psychological and medical interventions should be offered. There is limited guidance about what psychological care should be provided, about the management of prepubertal children or those with a non-binary gender identity, nor about pathways between specialist gender services and other providers. CONCLUSIONS: Published guidance describes a similar care pathway; however, there is no current consensus about the purpose and process of assessment for children or adolescents with gender dysphoria/incongruence, or about when psychological or hormonal interventions should be offered and on what basis. PROSPERO REGISTRATION NUMBER: CRD42021289659.

Masculinising and feminising hormone interventions for adolescents experiencing gender dysphoria or incongruence: a systematic review.

BACKGROUND: Clinical guidelines outline the use of hormones for masculinisation/feminisation in adolescents experiencing gender dysphoria or incongruence. Robust evidence concerning risks and benefits is lacking. There is a need to aggregate evidence as research becomes available. AIM: Identify and synthesise studies assessing the outcomes of hormones for masculinisation/feminisation in adolescents experiencing gender dysphoria/incongruence. METHODS: Systematic review and narrative synthesis. Database searches (MEDLINE, Embase, CINAHL, PsycINFO, Web of Science) were performed in April 2022, with results assessed independently by two reviewers. An adapted version of the Newcastle-Ottawa Scale for Cohort Studies was used to assess study quality. Moderate- and high-quality studies were synthesised. RESULTS: 12 cohort, 9 cross-sectional and 32 pre-post studies were included (n=53). One cohort study was high-quality. Other studies were moderate (n=33) and low-quality (n=19). Synthesis of high and moderate-quality studies showed consistent evidence demonstrating induction of puberty, although with varying feminising/masculinising effects. There was limited evidence regarding gender dysphoria, body satisfaction, psychosocial and cognitive outcomes, and fertility. Evidence from mainly pre-post studies with 12-month follow-up showed improvements in psychological outcomes. Inconsistent results were observed for height/growth, bone health and cardiometabolic effects. Most studies included adolescents who received puberty suppression, making it difficult to determine the effects of hormones alone. CONCLUSIONS: There is a lack of high-quality research assessing the use of hormones in adolescents experiencing gender dysphoria/incongruence. Moderate-quality evidence suggests mental health may be improved during treatment, but robust study is still required. For other outcomes, no conclusions can be drawn. More recent studies published since April 2022 until January 2024 also support the conclusions of this review.PROSPERO registration number: CRD42021289659.

Impact of social transition in relation to gender for children and adolescents: a systematic review.

BACKGROUND: Increasing numbers of children and adolescents experiencing gender dysphoria or incongruence are being referred to specialist gender services. Historically, social transitioning prior to assessment was rare but it is becoming more common. AIM: To identify and synthesise studies assessing the outcomes of social transition for children and adolescents (under 18) experiencing gender dysphoria/incongruence. METHODS: A systematic review and narrative sythesis. Database searches (Medline, Embase, CINAHL, PsycINFO, Web of Science) were perfomed in April 2022. Studies reporting any outcome of social transition (full or partial) for children and adolescents experiencing gender dysphoria/incongruence were included. An adapted version of the Newcastle-Ottawa Scale for cohort studies was used to appraise study quality. RESULTS: Eleven studies were included (children (n=8) and adolescents (n=3)) and most were of low quality. The majority were from the US, featured community samples and cross-sectional analyses. Different comparator groups were used, and outcomes related to mental health and gender identity reported. Overall studies consistently reported no difference in mental health outcomes for children who socially transitioned across all comparators. Studies found mixed evidence for adolescents who socially transitioned. CONCLUSIONS: It is difficult to assess the impact of social transition on children/adolescents due to the small volume and low quality of research in this area. Importantly, there are no prospective longitudinal studies with appropriate comparator groups assessing the impact of social transition on mental health or gender-related outcomes for children/adolescents. Professionals working in the area of gender identity and those seeking support should be aware of the absence of robust evidence of the benefits or harms of social transition for children and adolescents. PROSPERO REGISTRATION NUMBER: CRD42021289659.

Economic evaluation of a trial exploring the effects of a web-based support tool for parents of children with juvenile idiopathic arthritis.

OBJECTIVE: To explore the cost-effectiveness of a web-based support tool for parents of children with Juvenile Idiopathic Arthritis. METHODS: A multi-centred randomised controlled trial was conducted in paediatric rheumatology centres in England. The WebParC intervention consisted of online information about JIA and its treatment and a toolkit using cognitive-behavioural therapy principles to support parents manage their child's JIA. An economic evaluation was performed alongside the trial involving 220 parents. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress, with two dimensions; difficulty and frequency. These measures along with costs were assessed post intervention at 4 months and 12 months. Costs were calculated for healthcare usage using a UK NHS economic perspective. Data was collected and analysed on the impact of caring costs on families. Uncertainty around cost effectiveness was explored using bootstrapping and cost-effectiveness acceptability curves. RESULTS: The intervention arm showed improved average Pediatric Inventory for Parents scores for the dimensions of frequency and difficulty, of 1.5 and 3.6 respectively at 4 months and. 0.35 and 0.39 at 12 months, representing improved PIP scores for the intervention arm. At both 4 and 12 month follow up the average total cost per case was higher in the control group when compared with the intervention arm with mean differences of £360 (95% CI £29.6 to £691) at 4 months and £203 (95% CI £16 to £390) at 12 months. The probability of the intervention being cost effective ranged between 49% and 54%. CONCLUSION: The WebParC intervention led to reductions in primary and secondary healthcare resource use and costs at 4 and 12 months. The intervention demonstrated particular savings for rheumatology services at both follow ups. Future economies of scale could be realised by health providers with increased opportunities for cost effectiveness over time. TRIAL REGISTRATION: ISRCTN, ISRCTN13159730.

Are custodial-based mothers and children's units evaluated, effective and aligned with a human rights-based approach? - A systematic review of the evidence.

Background: Special considerations are warranted for incarcerated mothers and their children, as both experience substantial health and social disadvantage. Children residing in custodial settings are at risk of not having access to the equivalence of education, healthcare and socialisation commensurate to that of children living in the community. This systematic review describes the existing evidence regarding underpinning theories, accessibility, and the effectiveness of custody-based Mothers and children's units (M&Cs) globally. Methods: A systematic database search was conducted on May 1, 2023, of PsycINFO, Scopus, Sociology Ultimate and Web of Science (January 1, 2010, and May 1, 2023). Findings: Our systematic synthesis reveals evidence gaps related to best practice guidelines that align with a human right-based approach, and evaluations of the impact of the prison environment on mothers and their children. Interpretation: These findings support re-design of M&Cs using co-design to develop units that are evidence-based, robustly evaluated, and underpinned by the 'best interest of the child'. Funding: This systematic review was conducted as part of a broader review into M&C programs commissioned and funded by Corrective Services NSW, Australia (CSNSW), a division of the Department of Communities and Justice, as part of the NSW Premier's Priority to Reduce Recidivism within the Women as Parents workstream. No funding was received for this review.

A core outcome set for trials evaluating self-management interventions in people with severe mental illness and coexisting type 2 diabetes.

BACKGROUND: People with severe mental illness (SMI), such as schizophrenia, have higher rates of type 2 diabetes and worse outcomes, compared to those without SMI and it is not known whether diabetes self-management interventions are effective for people who have both conditions. Research in this area has been impeded by a lack of consensus on which outcomes to prioritise in people with co-existing SMI and diabetes. AIMS: To develop a core outcome set (COS) for use in effectiveness trials of diabetes self-management interventions in adults with both type 2 diabetes and SMI. METHODS: The COS was developed in three stages: (i) identification of outcomes from systematic literature review of intervention studies, followed by multi-stakeholder and service user workshops; (ii) rating of outcomes in a two-round online Delphi survey; (iii) agreement of final 'core' outcomes through a stakeholder consensus workshop. RESULTS: Seven outcomes were selected: glucose control, blood pressure, body composition (body weight, BMI, body fat), health-related quality of life, diabetes self-management, diabetes-related distress and medication adherence. CONCLUSIONS: This COS is recommended for future trials of effectiveness of diabetes self-management interventions for people with SMI and type 2 diabetes. Its use will ensure trials capture important outcomes and reduce heterogeneity so findings can be readily synthesised to inform practice and policy.

Safety, resource use and nutritional content of home-blended diets in children who are gastrostomy fed: findings from 'YourTube' - a prospective cohort study.

OBJECTIVE: To assess the risks, benefits and resource implications of using home-blended food in children with gastrostomy tubes compared with currently recommended formula feeds. DESIGN: This is a cohort study. Data were collected at months 0, 12 and 18 from parents and clinicians using standardised measures. SETTING: 32 sites across England: 28 National Health Service trusts and 4 children's hospices. PATIENTS: Children aged 6 months-18 years who were gastrostomy fed. MAIN OUTCOME MEASURE: The main outcome measure was the PedsQL Gastrointestinal Symptoms Scales score. Secondary outcomes included quality of life, sleep (child, parent), dietary intake, anthropometry, healthcare usage, safety outcomes and resource use. RESULTS: 180 children and families completed the baseline data collection, with 134 (74%) and 105 (58%) providing follow-up data at 12 and 18 months. There were fewer gastrointestinal (GI) symptoms at all time points in the home-blended diet group, but there was no difference in change over time within or between the groups. The nutritional intake of those on a home-blended diet had higher calories per kilogram and fibre, and both home-blended and formula-fed children have values above the dietary reference values for most micronutrients. Safety outcomes were similar between groups and over time. The total costs to the statutory sector were higher among children who were formula fed, but the costs of purchasing special equipment for home-blended food and the total time spent on childcare were higher for families with home-blended diet. CONCLUSIONS: Children who are gastrostomy fed a home-blended diet have similar safety profile, adequate nutritional intake and lower burden of GI symptoms than formula-fed children.Trial registration number ISRCTN13977361.

EXPRESS: Contextual diversity and anchoring: Null effects on learning word forms and opposing effects on learning word meanings.

Words that appear in many contexts/topics are recognised faster than those occurring in fewer contexts (Nation, 2017). However, contextual diversity benefits are less clear in word learning studies. Mak et al. (2021) proposed that diversity benefits might be enhanced if new word meanings are anchored before introducing diversity. In our study, adults (N = 288) learned meanings for eight pseudowords, four experienced in six topics (high diversity) and four in one topic (low diversity). All items were first experienced five times in one topic (anchoring phase), and results were compared to Norman et al. (2022) which used a similar paradigm without an anchoring phase. An old-new decision post-test (did you learn this word?) showed null effects of contextual diversity on written form recognition accuracy and response time, mirroring Norman et al.. A cloze task involved choosing which pseudoword completed a sentence. For sentences situated in a previously experienced context, accuracy was significantly higher for pseudowords learned in the low diversity condition, whereas for sentences situated in a new context, accuracy was non-significantly higher for pseudowords learned in the high diversity condition. Anchoring modulated these effects. Low diversity item accuracy was unaffected by anchoring. However, for high diversity items, accuracy in familiar contexts was better in the current experiment (anchoring) than in Norman et al. (non-anchoring), but accuracy in new contexts did not differ between the two experiments. These results suggest that anchoring facilitates meaning use in familiar contexts, but not generalisation to new contexts, nor word recognition in isolation.

Work-related resources and demands predicting the psychological well-being of staff in children's hospices.

OBJECTIVES: This study assessed the work-related resources and demands experienced by children's hospice staff to help identify staff support systems and organizational practices that offer the most potential to prevent staff burnout and enhance well-being at work. METHODS: The relationships between individual and organizational characteristics, work-related resources and demands, and burnout and work engagement outcomes experienced by children's hospice staff were explored using two surveys: the Children's Hospice Staff survey, completed by UK children's hospice staff, and the Children's Hospice Organisation and Management survey, completed by the Heads of Care. We used structural equation modeling to assess the relationships between the variables derived from the survey measures and to test a model underpinned by the Job Demands-Resource (JD-R) theory. RESULTS: There were 583 staff responses from 32 hospices, and 414 participants provided valid data for burnout and work engagement outcome measures. Most participants were females (95.4%), aged 51-65 years old (31.3%), and had more than 15 years of experience in life-limiting conditions (29.7%). The average score for burnout was 32.5 (SD: 13.1), and the average score for work engagement was 7.5 (SD: 1.5). The structural model validity showed good fit. Demands significantly predicted burnout (b = 4.65, p ≤ 0.001), and resources predicted work engagement (b = 3.09, p ≤ 0.001). The interaction between resources and demands only predicted work engagement (b = -0.31, p = 0.115). Burnout did not predict work engagement (b = -0.09, p = 0.194). SIGNIFICANCE OF RESULTS: The results partly supported the JD-R model, with a clear association between resources and work engagement, even when the demands were considered. Demands were only directly associated with burnout. The findings also identified a set of the most relevant aspects related to resources and demands, which can be used to assess and improve staff psychological well-being in children's hospices in the UK.

A new scale assessing the stressors and rewards of children's hospice work.

BACKGROUND: There is a workforce shortage in the children's hospice sector, but there has been little research on the specific challenges of working in this setting and on how these challenges might be alleviated. To identify appropriate interventions to improve staff wellbeing, the drivers of wellbeing in children's hospices need to be known and measured. This paper reports on the development of two measures, one for work-related rewards and one for work-related stressors, for use in children's hospice care teams. METHODS: A mixed-methods, four-stage study; the first three phases focused on the development of the scales, and the last stage focused on the validation of the scales. Participants of all stages were children's hospice care team staff members in the UK. Stage 1: survey assessing the relevance and comprehensiveness of the original scale items (N = 60); Stages 2 (focus groups; N = 16) and 3 (cognitive interviews; N = 14) to assess content validity; Stage 4: UK-wide survey (N = 414) to validate the final version of the new, children's hospice-specific scales using Rasch Analysis (RA) and Confirmatory Factor Analysis (CFA). RESULTS: Due to poor fitting indices shown in the results from the RA, five items (out of 36) were removed from the new rewards scale used in the UK-wide survey and 20 (out of 62) were removed from the new stressors scale. CFA also supported the removal of the items and showed a one-factor structure for the rewards scale and a three-factor structure for the stressors scale were adequate-the sub-scales for the stressors scale related to caring for an ill or dying child ("Child" sub-scale), working with parents and families ("Parent" sub-scale), and stressors related to organisational factors, such as team conflict and workload ("Organisation" sub-scale). CONCLUSIONS: Both of the new scales showed good psychometric properties and can be useful in clinical settings and research to assess the perceived intensity of the work-related rewards and stressors for children's hospice staff.

Safety, Effectiveness, and Treatment Persistence of Subcutaneous Vedolizumab in IBD: A Multicenter Study From the United Kingdom.

BACKGROUND AND AIMS: Despite intravenous (IV) vedolizumab being established for treatment of inflammatory bowel disease (IBD), the novel subcutaneous (SC) route of administration may provide numerous incentives to switch. However, large-scale real-world data regarding the long-term safety and effectiveness of this strategy are lacking. METHODS: IBD patients on IV vedolizumab across 11 UK sites agreed to transition to SC injections or otherwise continued IV treatment. Data regarding clinical disease activity (Simple Clinical Colitis Activity Index, partial Mayo score, and modified Harvey-Bradshaw Index), biochemical markers (C-reactive protein and calprotectin), quality of life (IBD control), adverse events, treatment persistence, and disease-related outcomes (namely corticosteroid use, IBD-related hospitalization, and IBD-related surgery) were retrospectively collected from prospectively maintained clinical records at baseline and weeks 8, 24, and 52. RESULTS: Data from 563 patients (187 [33.2%] Crohn's disease, 376 [66.8%] ulcerative colitis; 410 [72.8%] SC, 153 [27.2%] IV) demonstrated no differences in disease activity, remission rates, and quality of life between the SC and IV groups at all time points. Drug persistence at week 52 was similar (81.1% vs 81.2%; P = .98), as were rates of treatment alteration due to either active disease (12.2% vs 8.9%; P = .38) or adverse events (3.3% vs 6.3%; P = .41). At week 52, there were equivalent rates of adverse events (9.8% vs 7.8%; P = .572) and disease-related outcomes. IBD control scores were equivalent in both IV-IV and IV-SC groups. CONCLUSIONS: Switching to SC vedolizumab appears as effective, safe, and well tolerated as continued IV treatment and maintains comparable disease control and quality of life as IV treatment at 52 weeks.

Developing best practice principles for the provision of programs and services to people transitioning from custody to the community: study protocol for a modified Delphi consensus exercise.

INTRODUCTION: There is a lack of standard nomenclature and a limited understanding of programmes and services delivered to people in prisons as they transition into the community to support their integration and reduce reoffending related risk factors. The aim of this paper is to outline the protocol for a modified Delphi study designed to develop expert consensus on the nomenclature and best-practice principles of programmes and services for people transitioning from prison into the community. METHODS AND ANALYSIS: An online, two-phase modified Delphi process will be conducted to develop an expert consensus on nomenclature and the best-practice principles for these programmes. In the preparatory phase, a questionnaire was developed comprising a list of potential best-practice statements identified from a systematic literature search. Subsequently, a heterogeneous sample of experts including service providers, Community and Justice Services, Not for Profits, First Nations stakeholders, those with lived experience, researchers and healthcare providers will participate in the consensus building phase (online survey rounds and online meeting) to achieve consensus on nomenclature and best-practice principles. Participants will indicate, via Likert scale, to what extent they agree with nomenclature and best-practice statements. If at least 80% of the experts agree to a term or statement (indicated via Likert scale), it will be included in a final list of nomenclature and best-practice statements. Statements will be excluded if 80% experts disagree. Nomenclature and statements not meeting positive or negative consensus will be explored in a facilitated online meeting. Approval from experts will be sought on the final list of nomenclature and best-practice statements. ETHICS AND DISSEMINATION: Ethical approval has been received from the Justice Health and Forensic Mental Health Network Human Research Ethics Committee, the Aboriginal Health and Medical Research Council Human Research Ethics Committee, the Corrective Services New South Wales Ethics Committee and the University of Newcastle Human Research Ethics Committee. The results will be disseminated via peer-reviewed publication.

Acceptability and feasibility of using contingency management for cannabis reduction in specialist mental health services for psychosis: A qualitative study of staff views.

AIM: There is increasing evidence linking cannabis use to onset, continuation, and relapse of psychosis. Contingency Management (CM) is discussed as a candidate intervention to reduce cannabis use. Our study aimed to explore staff views on the feasibility and acceptability of using CM for cannabis reduction in early intervention services for psychosis (EIS), in order to inform wider learning about implementation of such approaches in mental health services. SETTING: EIS teams in England. METHOD: Semi-structured interviews and focus groups analysed thematically. PARTICIPANTS: Forty managers and staff members working in mental health services where a CM intervention was delivered as part of a trial, four staff who delivered CM in these settings, and three key informants (academic experts in relevant fields). INTERVENTION: A complex intervention comprising CM with incremental financial incentives (vouchers) for reducing or stopping cannabis use, and psychoeducation about the risks of cannabis use. FINDINGS: Acceptability appeared to depend on how well the intervention was seen to fit with the service setting and ethos. Concerns included who should deliver CM; potential impacts on the therapeutic relationship; the ethics of using incentives to reduce socially objectionable behaviours; and how CM fits with the work of mental health practitioners. Feasibility concerns centred on resource limitations including time, cost, training, and national guidance and commissioning. CONCLUSIONS: Staff attitudes are likely to be a crucial influence on successful implementation of contingency management for cannabis reduction in specialist mental health settings. Several contextual barriers would need to be overcome to increase the acceptability of the intervention for use in early intervention services for psychosis.