Background: Patient and Public Involvement (PPI) is an important component of healthcare research. Conducting PPI within paediatric palliative care research requires specific ethical and practical considerations. Regular reviews of PPI activity are important.Aim: To evaluate a paediatric palliative care research centre's PPI activity to determine what went well, or less well; and how future activities can be improved.Design: Two stage evaluation: first a review of PPI study logs; second a qualitative exploration using a survey, structured interviews and a focus group. Data were analysed thematically.Settings/participants: Parents of children with life-limiting conditions, bereaved parents and researchers, all engaged in PPI activity within a paediatric palliative care research centre.Findings: The review of PPI logs for 15 studies highlighted the crucial role of funding in enabling PPI throughout the research. Eight parents completed the survey, 4 parents were interviewed and 12 researchers participated in a focus group. Three themes were developed: Clarity of processes and purpose; balanced relationships created a safe space; and mutual respect and value for PPI. These themes highlight what is working well within the Centre's approach to PPI and the opportunities to improve.Conclusions: To undertake meaningful PPI in paediatric palliative care research, adequate time and resources are required. Roles, processes and expectations must be explicitly agreed. Establishing relationships ensures trust and enables authenticity and vulnerability. In addition to improving research, PPI has personal benefits for researchers and parents. The evaluation led to the development of a 'route map' for establishing an impactful PPI group for paediatric palliative care research.

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.

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.

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.

Introduction Involving people with lived experience is an important component in health research. Conducting public and patient involvement (PPI) within paediatric palliative care (PPC) research requires sensitivity and has specific ethical and practical considerations. As a research group, it was important to reflect on how we have worked with parents of children with life-liming conditions and bereaved parents, referred to herein as PPI-partners. We needed to understand what has worked well, what could be improved and what lessons can be learnt. Aims To increase understanding about the research group's PPI activities. Methods A qualitative evaluation of PPI-partner and researchers' experiences of PPI activities. An anonymous survey was distributed to all those involved in PPI work with the research group, including members of our Family Advisory Board (FAB). Members of the FAB were also invited to be interviewed and a focus group was held with researchers. The data were analysed thematically. Results Twelve researchers participated in a focus group, four PPI-partners were interviewed and 8 completed the survey. Gaps in communication of processes and the purpose of the PPI group were found. Balanced and open relationships between researchers and PPI-partners created a safe space and enabled the discussion of sensitive topics. PPI partners valued when their contributions, and the impact of their PPI work, was recognised and acknowledged. Conclusion For successful PPI in PPC research, roles, processes, and expectations must be explicitly agreed. Investment of time and resources in establishing relationships creates a sense of safety and enables authenticity and vulnerability from all involved. PPI has positive personal benefits for both researchers and PPI-partners, in addition to improving the research. Impact The evaluation of experiences of those involved in PPI, led to the development of a 'route map' for establishing an impactful PPI group for paediatric palliative care research.

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.

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.

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.

BackgroundClinical 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.AimIdentify and synthesise studies assessing the outcomes of hormones for masculinisation/feminisation in adolescents experiencing gender dysphoria/incongruence.MethodsSystematic 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.Results12 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.ConclusionsThere 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.

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.

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.

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.

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. 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). 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). 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.

BACKGROUND:An estimated 21 million children worldwide would benefit from palliative care input and over 7 million die each year. For parents of these children this is an intensely emotional and painful time through which they will need support. There is a lack of synthesised research about how parents experience the care delivered to their child at the end of life. AIM:To systematically identify and synthesise qualitative research on parents' experiences of end-of-life care of their child. DESIGN:A qualitative evidence synthesis was conducted. The review protocol was registered in PROSPERO (CRD42021242946). DATA SOURCES:MEDLINE, EMBASE, CINAHL, PsycINFO and Web of Science databases were searched for qualitative studies published post-2000 to April 2020. Studies were appraised for methodological quality and data richness. Confidence in findings was assessed by GRADE-CERQual. RESULTS:About 95 studies met the eligibility criteria. A purposive sample of 25 studies was taken, of good-quality papers with rich data describing the experience of over 470 parents. There were two overarching themes: parents of children receiving end-of-life care experienced a profound need to fulfil the parental role; and care of the parent. Subthemes included establishing their role, maintaining identity, ultimate responsibility, reconstructing the parental role, and continuing parenting after death. CONCLUSIONS:Services delivering end-of-life care for children need to recognise the importance for parents of being able to fulfil their parental role and consider how they enable this. What the parental role consists of, and how it's expressed, differs for individuals. Guidance should acknowledge the need to enable parents to parent at their child's end of life.

Background: Worldwide, around 21 million children would benefit from palliative care and over 7 million babies and children die each year. Whilst provision of paediatric palliative care is advancing, there major gaps between what should be done, and what is being done, in clinical practice. In 2017, the National Institute for Health and Care Excellence (NICE) introduced a quality standard, to standardise and improve children's palliative care in England. However, there is little evidence about what good experiences of palliative care for children are, and how they relate to the quality standard for end-of-life care. Aim: This study explored how the NICE quality standard featured in parental experiences of palliative care for children to understand what 'good' palliative care is. Design: Qualitative study, employing in-depth, telephone and video-call, semi-structured interviews. Data were analysed using thematic analysis, informed by Appreciative Inquiry. Setting/participants: Participants were parents of children and young people (aged 0-17 years) in England, who were receiving palliative care, and parents whose child had died. Results: Fourteen mothers and three fathers were interviewed. Seven were bereaved. Parents were recruited via four children's hospices, one hospital, and via social media. Good palliative care is co-led and co-planned with trusted professionals; is integrated, responsive and flexible; encompasses the whole family; and enables parents to not only care for, but also to parent their child to end of life. Conclusions: Findings have implications for informing evidence based practice and clinical guidelines, overall improving experiences of care.

BACKGROUND:Trials of hospital deprescribing interventions have demonstrated limited changes in practitioner behaviour. Our previous research characterised four barriers and one enabler to geriatricians and pharmacists deprescribing in hospital that require addressing by a behaviour change intervention. Six behaviour change techniques (BCTs) have also been selected by the target audience using the hospital Deprescribing Implementation Framework (hDIF). This research aimed to co-design and operationalise the content, mode of delivery and duration/intensity of the six selected BCTs to develop the CompreHensive geriAtRician-led MEdication Review (CHARMER) deprescribing intervention.METHODS:We established co-design panels at three hospitals representing contextual factors likely to influence CHARMER implementation. Panels comprised geriatricians, pharmacists and other hospital staff likely to be involved in implementation. We convened two rounds of co-design workshops with each hospital to design a prototype for each BCT, which went for feedback at a final workshop attended by all three hospital panels.RESULTS:The six BCTs were co-designed into an intervention comprising:(1&2) Pharmacists' workshop with pros and cons of deprescribing activities, and videos of salient patient cases3 Regular geriatrician and pharmacist deprescribing briefings4 Videos of geriatricians navigating challenging deprescribing consultations5 Hospital deprescribing action plan6 Dashboard to benchmark deprescribing activitiesAutomated prompts to flag high-risk patients for deprescribing and a primary and secondary care deprescribing forum were proposed as additional BCTs by stakeholders. These were later excluded as they were not fidelitous to the theoretical determinants of geriatricians' and pharmacists' deprescribing behaviours.CONCLUSIONS:This study illustrates the integration of theory and co-design methodology with the target audience and staff likely to be involved in implementation of a hospital deprescribing behaviour change intervention. The development of an intervention that remains faithful to the underpinning mechanisms of action of behaviour change is a strength of this approach.

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.

Background Half of older people are prescribed unnecessary/inappropriate medications that are not routinely deprescribed in hospital hence there is a need for deprescribing trials. We aimed to develop a Core Outcome Set (COS) for deprescribing trials for older people under the care of a geriatrician during hospital admission. Methods We developed a list of potentially relevant outcomes from the literature. Using a two-round Delphi survey of stakeholder groups representing older people and carers, hospital clinicians, hospital managers, and ageing/deprescribing researchers, each outcome was scored according to Grading of Recommendations Assessment, Development and Evaluation, followed by two consensus workshops to finalise the COS. Results Two hundred people completed Round 1 and 114 completed Round 2. Representing all stakeholder groups, 10 people participated in workshop 1 and 10 in workshop 2. Six outcomes were identified as most important, feasible and acceptable to collect in a trial: number of prescribed medicines stopped; number of prescribed medicines with dosage reduced; quality of life; mortality; adverse drug events and number of hospital stays. Three other outcomes were identified as important, but currently too burdensome to collect: number of potentially inappropriate medicines prescribed; burden from medication routine; and medication-related admissions to hospital. Conclusions A COS represents the minimum outcomes that should be collected and reported. Whilst uncommon practice for COS development, the value of considering outcome collection feasibility is demonstrated by the removal of three potential outcomes that, if included, may have compromised COS uptake due to challenges with collecting the data.

Background Approximately 60 000 people in England have coexisting type 2 diabetes mellitus (T2DM) and severe mental illness (SMI). They are more likely to have poorer health outcomes and require more complex care pathways compared with those with T2DM alone. Despite increasing prevalence, little is known about the healthcare resource use and costs for people with both conditions. Aims To assess the impact of SMI on healthcare resource use and service costs for adults with T2DM, and explore the predictors of healthcare costs and lifetime costs for people with both conditions. Method This was a matched-cohort study using data from the Clinical Practice Research Datalink linked to Hospital Episode Statistics for 1620 people with comorbid SMI and T2DM and 4763 people with T2DM alone. Generalised linear models and the Bang and Tsiatis method were used to explore cost predictors and mean lifetime costs respectively. Results There were higher average annual costs for people with T2DM and SMI (£1930 higher) than people with T2DM alone, driven primarily by mental health and non-mental health-related hospital admissions. Key predictors of higher total costs were older age, comorbid hypertension, use of antidepressants, use of first-generation antipsychotics, and increased duration of living with both conditions. Expected lifetime costs were approximately £35 000 per person with both SMI and T2DM. Extrapolating nationally, this would generate total annual costs to the National Health Service of around £250 m per year. Conclusions Our estimates of resource use and costs for people with both T2DM and SMI will aid policymakers and commissioners in service planning and resource allocation.