Asking women with diabetes about sexual problems: An exploratory study of NHS professionals' attitudes and practice: A survey of healthcare professionals regarding communication and silences about sexual problems during the routine care of women with diabetes.

AIMS: To explore UK healthcare professionals' practice and attitudes towards asking women with diabetes about sexual health problems, including symptoms of female sexual dysfunction (FSD). METHODS: An online questionnaire to address the study aims was developed, piloted by ten healthcare professionals (HCPs) and completed by 111 eligible HCPs, recruited via professional networks and social media. Free text data were analysed and reported thematically. Two questions were analysed to test the hypothesis of differences between men's and women's responses. RESULTS: The majority of respondents did not ask women with diabetes about sexual problems. Multiple barriers to inquiry were reported, including inadequate training, time constraints, competing priorities, the perceived likelihood that questions will cause surprise or distress (especially for certain groups of women), the belief that sexual problems are to be expected as women age, and the belief that FSD is complex or untreatable, with unclear management pathways. Exploratory findings indicated significant differences in men and women's responses (men disagreed more strongly with prioritisation, and fewer reported routine inquiry about sexual problems in their usual practice). CONCLUSIONS: HCPs reported not asking women with diabetes about sexual problems during routine care. They described multiple factors reinforcing the silence about sexual health, including inadequate education and perceived social risk for individual HCPs who deviate from the patterns of topics usually discussed in diabetes consultations.

Sustaining the benefits of structured education: Participants' experiences of receiving structured individual support during a programme (DAFNEplus) informed by behavioural science.

AIMS: The DAFNEplus programme seeks to promote sustained improvements in glycaemic management by incorporating techniques from behavioural science. It includes five sessions of structured individual support delivered over 12 months following group education. As part of a broader evaluation, and to inform decision-making about roll-out in routine care, we explored participants' experiences of, and engagement with, that individual support. METHODS: We interviewed DAFNEplus participants (n = 28) about their experiences of receiving individual support and the impact they perceived it as having on their self management practices. We analysed data thematically. RESULTS: Participants described several important ways individual support had helped strengthen their self management, including: consolidating and expanding their understandings of flexible intensive insulin therapy; promoting ongoing review and refinement of behaviour; encouraging continued and effective use of data; and facilitating access to help from healthcare professionals to pre-empt or resolve emergent difficulties. Participants characterised themselves as moving towards independence in self management over the time they received individual support, with their accounts suggesting three key stages in that journey: 'Working with healthcare professionals'; 'Growing sense of responsibility'; and, 'Taking control'. Whilst all portrayed themselves as changed, participants' progress through those stages varied; a few continued to depend heavily on DAFNEplus facilitators for advice and/or direction at 12 months. CONCLUSIONS: While all participants benefited from individual support, our findings suggest that some may need, or gain further benefit from, longer-term, tailored support. This has important implications for decision-making about roll-out of DAFNEplus post-trial and for the development of future programmes seeking to bring about sustainable changes in self management practices.

PRIORITY Trial: Results from a feasibility randomised controlled trial of a psychoeducational intervention for parents to prevent disordered eating in children and young people with type 1 diabetes.

AIMS: Children and young people (CYP) with type 1 diabetes (T1D) are at increased risk of disordered eating. This study aimed to determine the feasibility and acceptability of a novel, theoretically informed, two-session psychoeducational intervention for parents to prevent disordered eating in CYP with T1D. METHODS: Parents of CYP aged 11-14 years with T1D were randomly allocated to the intervention or wait-list control group. Self-reported measures including the Diabetes Eating Problem Survey-Revised (DEPS-R), Problem Areas in Diabetes Parent Revised (PAID-PR), Child Eating Behaviour Questionnaire subscales (CEBQ), Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), clinical outcomes (e.g. HbA1c, BMI, medication and healthcare utilisation) and process variables, were collected at baseline, 1-and 3-month assessments. Acceptability data were collected from intervention participants via questionnaire. RESULTS: Eighty-nine parents were recruited, which exceeded recruitment targets, with high intervention engagement and acceptability (<80% across domains). A signal of efficacy was observed across outcome measures with moderate improvements in the CEBQ subscale satiety responsiveness (d = 0.55, 95% CI 0.01, 1.08) and child's BMI (d = -0.56, 95% CI -1.09, 0.00) at 3 months compared with controls. Trends in the anticipated direction were also observed with reductions in disordered eating (DEPS-R) and diabetes distress (PAID-PR) and improvements in wellbeing (WEMWBS). CONCLUSIONS: This is the first study to have co-designed and evaluated a novel parenting intervention to prevent disordered eating in CYP with T1D. The intervention proved feasible and acceptable with encouraging effects. Preparatory work is required prior to definitive trial to ensure the most relevant primary outcome measure and ensure strategies for optimum outcome completion.

PaRent InterventiOn to pRevent dIsordered eating in children with TYpe 1 diabetes (PRIORITY): Study protocol for a feasibility randomised controlled trial.

AIMS: Increasing evidence suggests that children and young people with type 1 diabetes (T1D) are at greater risk of disordered eating compared to children without T1D. Disordered eating in T1D has been linked to impaired wellbeing, increased health service use and early mortality. To address this problem, we will co-develop a psycho-education intervention for parents of children and young people with T1D, informed by the Information Motivation Behavioural Skills model. METHODS: The objective of this study is to assess the feasibility and acceptability of the intervention compared to a waitlist control group using a feasibility randomised controlled trial (RCT) design. We aim to recruit 70 parents of children and young people with T1D (11-14 years), 35 in each arm. Those assigned to the intervention will be invited to participate in two workshops of 2 h each. Parents will be asked to complete outcome measures regarding eating habits, diabetes management, as well as a questionnaire based on the Information Motivation Behavioural Skills model which provides a theoretical foundation for the intervention. These will be completed at baseline, 1- and 3-month post-intervention. Children and young people will be asked to complete questionnaires on their eating behaviours at the same time intervals. Parents randomised to receive the intervention will be invited to take part in interviews to feedback on the intervention and research protocol acceptability. CONCLUSION: It is anticipated that the psycho-education intervention aimed at parents will help prevent the development of disordered eating in children and young people with T1D and improve parental wellbeing. The results of this feasibility trial will determine whether this intervention approach is acceptable to families living with T1D, and whether a definitive RCT of intervention effectiveness is justified. Qualitative findings will be used to refine the intervention and study protocols. TRIAL REGISTRATION: This protocol has been registered with ClinicalTrials.gov [Identifier: NCT04741568].

A comparison of the acceptability and psychometric properties of scales assessing the impact of type 1 diabetes on quality of life-Results of 'YourSAY: Quality of Life'.

AIMS: To compare the acceptability, reliability and validity of five contemporary diabetes-specific quality of life (QoL) scales among adults with type 1 diabetes in the United Kingdom and Australia. METHODS: Adults with type 1 diabetes (UK = 1139, Australia = 439) completed a cross-sectional, online survey including ADDQoL-19, DCP, DIDP, DSQOLS and Diabetes QoL-Q, presented in randomised order. After completing each scale, participants rated it for clarity, relevance, ease of completion, length and comprehensiveness. We examined scale acceptability (scale completion and user ratings), response patterns, structure (exploratory and confirmatory factor analyses) and validity (convergent, concurrent, divergent and known groups). To assess cross-country reproducibility, analyses conducted on the UK dataset were replicated in the Australian dataset. RESULTS: Findings were largely consistent between countries. All scales were acceptable to participants: ≥90% completing all items, and ≥80% positive user ratings, except for DSQOLS' length. Scale structure was not supported for the DCP. Overall, in terms of acceptability and psychometric evaluation, the DIDP was the strongest performing scale while the ADDQoL-19 and Diabetes QoL-Q scales also performed well. CONCLUSIONS: These findings suggest that the recently developed brief (7 items), neutrally worded DIDP scale is acceptable to adults with type 1 diabetes and has the strongest psychometric performance. However, questionnaire selection should always be considered in the context of the research aims, study design and population, as well as the wider published evidence regarding both the development and responsiveness of the scales.

The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel.

AIMS: Self-management programmes for type 1 diabetes, such as the UK's Dose Adjustment for Normal Eating (DAFNE), improve short-term clinical outcomes but difficulties maintaining behavioural changes attenuate long-term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change. METHODS: A four-step method was based on the BCW intervention development approach: (1) Identifying self-management behaviours and barriers/enablers to maintain them via stakeholder consultation and evidence synthesis, and mapping barriers/enablers to the Capability, Opportunity, Motivation-Behaviour (COM-B) model. (2) Specifying behaviour change techniques (BCTs) in the existing DAFNE intervention using the Behaviour Change Techniques Taxonomy (BCTTv1). (3) Identifying additional BCTs to target the barriers/enablers using the BCW and BCTTv1. (4) Parallel stakeholder consultation to generate recommendations for intervention revision. Revised materials were co-designed by stakeholders (diabetologists, psychologists, specialist nurses and dieticians). RESULTS: In all, 34 barriers and 5 enablers to sustaining self-management post-DAFNE were identified. The existing DAFNE intervention contained 24 BCTs, which partially addressed the enablers. In all, 27 BCTs were added, including 'Habit formation', 'Credible source' and 'Conserving mental resources'. In total, 15 stakeholder-agreed recommendations for content and delivery were incorporated into the final DAFNEplus intervention, comprising three co-designed components: (1) face-to-face group learning course, (2) individual structured follow-up sessions and (3) technological support, including blood glucose data management. CONCLUSIONS: This method provided a systematic approach to specifying and revising a behaviour change intervention incorporating stakeholder input. The revised DAFNEplus intervention aims to support the maintenance of behavioural changes by targeting barriers and enablers to sustaining self-management behaviours.

Value-based recruitment in midwifery: do the values align with what women say is important to them?

AIM: The aim of this study was to discuss theoretical conceptualization and definition of values and value-based recruitment in the context of women's views about what they would like from their midwife. BACKGROUND: Value-based recruitment received headline status in the UK government's response to pervasive deficiencies in compassionate care identified in the health service. Core values which aim to inform service user's experience are defined in the National Health Service Constitution but clarity about whether these encompass all that women say is important to them is needed. DESIGN: Discussion paper. DATA SOURCES: A literature search included published papers written in English relating to values, VBR and women's views of a 'good' midwife with no date limiters. DISCUSSION: Definitions of values and value-based recruitment are examined. Congruence is explored between what women say is important to them and key government and professional regulatory documentation. The importance of a 'sustainable emotional' dimension in the midwife-mother relationship is suggested. CONCLUSION: Inconsistencies are identified between women's views, government, professional documentation and what women say they want. An omission of any reference to emotions or emotionality in value-based recruitment policy, professional recruitment and selection guidance documentation is identified. IMPLICATIONS: A review of key professional documentation, in relation to selection for 'values', is proposed. We argue for clarity and revision so that values embedded in value-based recruitment are consistent with health service users' views. An enhancement of the 'values' in the value-based recruitment framework is recommended to include the emotionality that women state is a fundamental part of their relationship with their midwife.

Modeling predictors of changes in glycemic control and diabetes-specific quality of life amongst adults with type 1 diabetes 1 year after structured education in flexible, intensive insulin therapy.

Few studies have identified determinants of glycemic control (HbA1c) and diabetes-specific quality of life (DSQoL) in adults with type 1 diabetes. To identify factors predicting outcomes following structured diabetes education. 262 participants completed biomedical and questionnaire assessments before, and throughout 1 year of follow-up. The proportion of variance explained ranged from 28 to 62 % (DSQoLS) and 14-20 % (HbA1c). When change in psychosocial variables were examined, reduced hypoglycemia fear, lower 'perceived diabetes seriousness', greater self-efficacy and well-being predicted QoL improvements from baseline to 3-months. Increased frequency of blood glucose testing predicted improvements in HbA1c from baseline to 6-months. Greater benefits may be achieved if programs focus explicitly on psychosocial factors. Self-care behaviours did not predict HbA1c suggesting existing assessment tools need refinement. Evaluation of treatment mechanisms in self-management programs is recommended.

Type 1 diabetes patients' experiences of, and need for, social support after attending a structured education programme: a qualitative longitudinal investigation.

AIMS AND OBJECTIVES: To explore patients' experiences of, views about and need for, social support after attending a structured education programme for type 1 diabetes. BACKGROUND: Patients who attend structured education programmes attain short-term improvements in biomedical and quality-of-life measures but require support to sustain self-management principles over the longer term. Social support can influence patients' self-management practices; however, little is known about how programme graduates use other people's help. DESIGN: This study was informed by the principles of grounded theory and involved concurrent data collection and analysis. Data were analysed using an inductive, thematic approach. METHODS: In-depth interviews were undertaken postcourse, six and 12 months later, with 30 adult patients with type 1 diabetes recruited from Dose Adjustment for Normal Eating courses in the United Kingdom. RESULTS: Patients' preferences for social support from other people ranged from wanting minimal involvement, to benefiting from auxiliary forms of assistance, to regular monitoring and policing. New self-management skills learnt on their courses prompted and facilitated patients to seek and obtain more social support. Support received/expected from parents varied according to when patients were diagnosed, but parents' use of outdated knowledge could act as a barrier to effective support. Support sought from others, including friends/colleagues, was informed by patients' domestic/employment circumstances. CONCLUSION: This study responds to calls for deeper understanding of the social context in which chronic illness self-management occurs. It highlights how patients can solicit and receive more social support from family members and friends after implementing self-care practices taught on education programmes. RELEVANCE TO CLINICAL PRACTICE: Health professionals including diabetes specialist nurses and dietitians should explore: patients' access to and preferences for social support; how patients might be encouraged to capitalise on social support postcourse; and new ways to inform/educate people within patients' social networks.

The views, opinions and decision-making of UK-based paramedics on the use of pre-hospital 12-lead electrocardiograms in acute stroke patients: a qualitative interview study.

Introduction: A qualitative exploration into the views, opinions and decision-making of paramedics involved in undertaking pre-hospital 12-lead electrocardiograms (PHECGs) for stroke patients was undertaken, in order to gain a deeper understanding of the clinical and occupational context that the paramedics work within, the acceptability of the paramedics in using PHECGs for stroke patients and the consequences and influences of their decision-making. Methods: Data were collected via semi-structured interviews and analysed using the framework method, with the underpinning theoretical framework of cognitive continuum theory. A purposive sample of 14 paramedics was recruited and interviewed. Results: Five themes were generated from the analysis of the interviews: (1) 'time is brain': minimising delays and rapid transport to definitive care; (2) barriers and facilitators to undertaking PHECGs for stroke patients; (3) recognising and gaining cues; (4) maintaining patient dignity, self-protection and fully informed consent; and (5) education, experience and engagement with evidence. Conclusion: The study showed mixed views on the usefulness of PHECGs, but all participants agreed that PHECGs should not cause additional delays. Paramedic decision-making on recording PHECGs relies on intuitive and quasi-rational cognitive modes, and requires a number of clinical, logistical and ethical considerations. The findings suggest careful consideration is needed of the benefits and potential drawbacks of incorporating PHECGs into pre-hospital stroke care.

Supporting self-management after attending a structured education programme: a qualitative longitudinal investigation of type 1 diabetes patients' experiences and views.

BACKGROUND: Structured education programmes for patients with diabetes and other chronic conditions are being widely adopted. However, follow-up studies suggest that course graduates may struggle to sustain the self-care practices taught on their courses over time. This study explored the support needs of patients with type 1 diabetes after attending a structured education programme promoting an empowerment approach and training in use of flexible intensive insulin therapy, a regimen now widely advocated and used to manage this condition. The objective was to inform future support offered to course graduates. METHODS: Repeat, in-depth interviews with 30 type 1 diabetes patients after attending Dose Adjustment for Normal Eating (DAFNE) courses in the UK, and six and 12 months later. Data were analysed using an inductive, thematic approach. RESULTS: While the flexible intensive insulin treatment approach taught on DAFNE courses was seen as a logical and effective way of managing one's diabetes, it was also considered more technically complex than other insulin regimens. To sustain effective disease self-management using flexible intensive insulin treatment over time, patients often expected, and needed, on-going input and support from health care professionals trained in the approach. This included: help determining insulin dose adjustments; reassurance; and, opportunities to trouble-shoot issues of concern. While some benefits were identified to receiving follow-up support in a group setting, most patients stated a preference or need for tailored and individualised support from appropriately-trained clinicians, accessible on an 'as and when needed' basis. CONCLUSIONS: Our findings highlight potential limitations to group-based forms of follow-up support for sustaining diabetes self-management. To maintain the clinical benefits of structured education for patients with type 1 diabetes over time, course graduates may benefit from and prefer ongoing, one-to-one support from health care professionals trained in the programme's practices and principles. This support should be tailored and personalised to reflect patients' specific and unique experiences of applying their education and training in the context of their everyday lives, and could be the subject of future research.

Development and Theoretical Underpinnings of the PRIORITY Intervention: A Parenting Intervention to Prevent Disordered Eating in Children and Young People With Type 1 Diabetes.

Children and young people (CYP) with type 1 diabetes (T1D) are twice as likely to develop disordered eating (T1DE) and clinical eating disorders than those without. This has significant implications for physical and mental health, with some eating disorders associated with repeated diabetic ketoacidosis and higher HbA1c levels, both of which are life threatening. There is currently limited psychological support for CYP and families with T1D but increasingly, policy and practice are suggesting disordered eating in T1D may be effectively prevented through psychological intervention. We describe the development and theoretical underpinnings of a preventative psychological intervention for parents of CYP aged 11-14, with T1D. The intervention was informed by psychological theory, notably the Information Motivation Behaviour Skills model and Behaviour Change Technique Taxonomy. The intervention was co-developed with an expert advisory group of clinicians, and families with T1D. The manualised intervention includes two online group workshops, and supplementary online materials. The intervention continues to evolve, and feasibility findings will inform how best to align the intervention with routine care in NHS diabetes teams. Early detection and intervention are crucial in preventing T1DE, and it is hoped that the current intervention can contribute to improving the psychological and physical wellbeing of young people and families managing T1D.

The pre-hospital 12-lead electrocardiogram is associated with longer delay and worse outcomes in patients presenting to emergency medical services with acute stroke: a linked cohort study.

Objectives: To investigate the association between pre-hospital 12-lead electrocardiogram (PHECG) use in patients presenting to emergency medical services (EMS) with acute stroke, and clinical outcomes and system delays. Methods: Multi-centre linked cohort study. Patients with verified acute stroke admitted to hospital via EMS were identified through routinely collected hospital data and linked to EMS clinical records via EMS unique identifiers. Ordinal and logistic regression analyses were undertaken to analyse the relationship between having a PHECG and modified Rankin Scale (mRS); hospital mortality; pre-hospital time intervals; door-to-scan and door-to-needle times; and rates of thrombolysis. Results: Of 1161 eligible patients admitted between 29 December 2013 and 30 January 2017, PHECG was performed in 558 (48%). PHECG was associated with an increase in mRS (adjusted odds ratio [aOR] 1.30, 95% confidence interval [CI] 1.01-1.66, p = 0.04) and hospital mortality (aOR 1.83, 95% CI 1.26-2.67, p = 0.002). There was no association between PHECG and administration of thrombolytic treatment (aOR 1.06, 95% CI 0.75-1.52, p = 0.73). Patients who had PHECG recorded spent longer under the care of EMS (median 49 vs 43 minutes, p = 0.006). No difference in times to receiving brain scan (median 28 with PHECG vs 29 minutes no PHECG, p = 0.32) or thrombolysis (median 46 vs 48 minutes, p = 0.37) were observed. Conclusion: The PHECG was associated with worse outcomes and longer delays in patients with acute ischaemic stroke.

Cocoa flavanol consumption improves lower extremity endothelial function in healthy individuals and people with type 2 diabetes.

Background: diabetes and age are major risk factors for the development of lower extremity peripheral artery disease (PAD). Cocoa flavanol (CF) consumption is associated with lower risk for PAD and improves brachial artery (BA) endothelial function. Objectives: to assess if femoral artery (FA) endothelial function and dermal microcirculation are impaired in individuals with type 2 diabetes mellitus (T2DM) and evaluate the acute effect of CF consumption on FA endothelial function. Methods: in a randomised, controlled, double-blind, cross-over study, 22 individuals (n = 11 healthy, n = 11 T2DM) without cardiovascular disease were recruited. Participants received either 1350 mg CF or placebo capsules on 2 separate days in random order. Endothelial function was measured as flow-mediated dilation (FMD) using ultrasound of the common FA and the BA before and 2 hours after interventions. The cutaneous microvasculature was assessed using optical coherence tomography angiography. Results: baseline FA-FMD and BA-FMD were significantly lower in T2DM (FA: 3.2 ± 1.1% [SD], BA: 4.8 ± 0.8%) compared to healthy (FA: 5.5 ± 0.7%, BA: 6.0 ± 0.8%); each p < 0.001. Whereas in healthy individuals FA-FMD did not significantly differ from BA-FMD (p = 0.144), FA-FMD was significantly lower than BA-FMD in T2DM (p = 0.003) indicating pronounced and additional endothelial dysfunction of lower limb arteries (FA-FMD/BA-FMD: 94 ± 14% [healthy] vs. 68 ± 22% [T2DM], p = 0.007). The baseline FA blood flow rate (0.42 ± 0.23 vs. 0.73 ± 0.35 l min-1, p = 0.037) and microvascular dilation in response to occlusion in hands and feet were significantly lower in T2DM subjects than in healthy ones. CF increased both FA- and BA-FMD at 2 hours, compared to placebo, in both healthy and T2DM subgroups (FA-FMD effect: 2.9 ± 1.4%, BA-FMD effect 3.0 ± 3.5%, each pintervention< 0.001). In parallel, baseline FA blood flow and microvascular diameter significantly increased in feet (3.5 ± 3.5 µm, pintervention< 0.001) but not hands. Systolic blood pressure and pulse wave velocity significantly decreased after CF in both subgroups (-7.2 ± 9.6 mmHg, pintervention = 0.004; -1.3 ± 1.3 m s-1, pintervention = 0.002). Conclusions: individuals with T2DM exhibit decreased endothelial function that is more pronounced in the femoral than in the brachial artery. CFs increase endothelial function not only in the BA but also the FA both in healthy individuals and in those with T2DM who are at increased risk of developing lower extremity PAD and foot ulcers.

Optimisation of the tuberculin skin test for detection of Mycobacterium bovis in African buffaloes (Syncerus caffer).

Effective screening methods are critical for preventing the spread of bovine tuberculosis (bTB) among livestock and wildlife species. The tuberculin skin test (TST) remains the primary test for bTB globally, although performance is suboptimal. African buffaloes (Syncerus caffer) are a maintenance host of Mycobacterium bovis in South Africa, tested using the single intradermal tuberculin test (SITT) or comparative test (SICTT). The interpretation of these tests has been based on cattle thresholds due to the lack of species-specific cut-off values for African buffaloes. Therefore, the aims of this study were to calculate buffalo-specific thresholds for different TST criteria (SITT, SICTT, and SICTT72h that calculates the differential change at 72 h only) and compare performance using these cut-off values. The results confirm that 3 mm best discriminates M. bovis-infected from unexposed control buffaloes with sensitivities of 69 % (95 % CI 60-78; SITT and SICTT) and 76 % (95 % CI 65-83; SICTT72h), and specificities of 86 % (95 % CI 80-90; SITT), 96 % (95 % CI 92-98; SICTT72h) and 97 % (95 % CI 93-99; SICTT), respectively. A comparison between TST criteria using buffalo-specific thresholds demonstrates that the comparative TST performs better than the SITT, although sensitivity remains suboptimal. Therefore, further research and the addition of ancillary tests, such as cytokine release assays, are necessary to improve M. bovis detection in African buffaloes.

Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes.

INTRODUCTION: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs). METHODS AND ANALYSIS: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation. ETHICS AND DISSEMINATION: Ethics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals. TRIAL REGISTRATION NUMBER: ISRCTN42908016.

A critical review of self-management and educational interventions in inflammatory bowel disease.

The purpose of this study was to examine self-management and educational interventions developed to support people with inflammatory bowel disease (IBD) and to identify which type of intervention seems to be most effective. The search was deliberately overinclusive to capture studies that evaluated educational and self-management interventions. The following databases were searched: MEDLINE, Embase, CINAHL, PsycINFO, the National Research Register, and Cochrane. Twenty-three studies were included. Thirteen of these were randomized controlled trials. The content of the interventions reviewed varied widely. As expected, it is the three studies that have explicitly labeled themselves as self-management interventions that have incorporated the greatest number of self-management techniques. Two of these studies reported the greatest number of improved outcomes in relation to symptom reporting, psychological well-being, and healthcare resource use. There is clearly a role for information in IBD, but this review supports research in other conditions that shows that education cannot be assumed to lead to improvements in health and well-being. Much of the research in this area focuses on education rather than self-management. Where self-management techniques have been applied, the findings tend to be more promising. Gastroenterology nurses (or in the United Kingdom, IBD specialist nurses) may be best placed to facilitate self-management in this group.

Diabetes-related distress and daily cortisol output in people with Type 2 diabetes.

AIMS: Diabetes-related distress is common in Type 2 Diabetes and is linked with poor diabetes control. However, mechanisms underlying this association are unclear. One pathway that could be involved is neuroendocrine dysfunction, as Type 2 Diabetes is associated with altered diurnal cortisol output. This study investigated the link between diabetes-related distress and diurnal cortisol output. METHODS: 134 people with Type 2 Diabetes provided 5 cortisol samples over the course of a day. Multivariate linear regression models were used to assess whether overall and sub-domains of diabetes-related distress measured by the Diabetes Distress Scale, predicted cortisol parameters (waking cortisol, cortisol awakening response, cortisol slope and evening cortisol). RESULTS: Physician-related distress was associated with greater waking (B = 2.747, p = .015) and evening cortisol (B = 1.375, p = .014), and a blunted cortisol awakening response (B = -3.472, p = .038) adjusting for age, sex, income, body mass index, smoking and time of awakening. No associations were detected for overall distress, emotional, interpersonal or regimen distress. CONCLUSION: Physician-related distress was associated with alterations in daily cortisol output. Longitudinal research is required to understand how physician-related distress is associated with diurnal cortisol patterning over time.

Mixed methods in pre-hospital research: understanding complex clinical problems.

Healthcare is becoming increasingly complex. The pre-hospital setting is no exception, especially when considering the unpredictable environment. To address complex clinical problems and improve quality of care for patients, researchers need to use innovative methods to create the necessary depth and breadth of knowledge. Quantitative approaches such as randomised controlled trials and observational (e.g. cross-sectional, case control, cohort) methods, along with qualitative approaches including interviews, focus groups and ethnography, have traditionally been used independently to gain understanding of clinical problems and how to address these. Both approaches, however, have drawbacks: quantitative methods focus on objective, numerical data and provide limited understanding of context, whereas qualitative methods explore more subjective aspects and provide perspective, but can be harder to demonstrate rigour. We argue that mixed methods research, where quantitative and qualitative methods are integrated, is an ideal solution to comprehensively understand complex clinical problems in the pre-hospital setting. The aim of this article is to discuss mixed methods in the field of pre-hospital research, highlight its strengths and limitations and provide examples. This article is tailored to clinicians and early career researchers and covers the basic aspects of mixed methods research. We conclude that mixed methods is a useful research design to help develop our understanding of complex clinical problems in the pre-hospital setting.

PAID-11: A brief measure of diabetes distress validated in adults with type 1 diabetes.

OBJECTIVE: The Problem Areas In Diabetes (PAID) questionnaire is widely used to assess emotional distress related to living with diabetes, although it is lengthy for routine clinical use. Our aim was to determine whether the original 20-item PAID questionnaire can be abbreviated, whilst maintaining its reliability, validity and utility. METHODS: We analysed data from the UK DAFNE (Dose Adjustment For Normal Eating) education programme for adults with Type 1 diabetes. Data were analysed at baseline (n = 1547) and 1-year post intervention (n = 846). Exploratory factor analysis (EFA) with principal axis factoring method was used to examine PAID responses within a random half of the baseline data (n = 746). Then, two confirmatory factor analyses (CFA) were conducted using the remaining baseline (n = 801) and 1-year data. Reliability, predictive validity, convergent validity and responsiveness were also examined. RESULTS: Based on the EFA results, which were corroborated by CFA, an 11-item PAID questionnaire was identified with a cut-off score of 18 indicating severe diabetes distress. In the current sample, this brief version had high internal consistency (Cronbach's α = 0.93). Predictive validity was demonstrated with the PAID-11 identifying severe diabetes distress from the original 20-item measure, with 95% sensitivity and 96% specificity. Convergent validity was demonstrated by strong positive correlations with HADS anxiety and depressive symptoms (average r = 0.65 and r = 0.55, respectively), while divergent validity was shown with weaker correlations with EQ5D health status (average r = 0.37). CONCLUSIONS: Based on present results, PAID-11 appears to be a valid and reliable measure, which seems suitable for use as a brief tool for the detection of diabetes distress in adults with type 1 diabetes. Importantly, this tool may reduce participant burden in multi-measure studies. However, further studies are urgently needed to determine the validity and utility of PAID-11 beyond the UK DAFNE population.