A cognitive behavioural model of the bidirectional relationship between disordered eating and diabetes self care in adult men with Type 1 diabetes mellitus.

AIMS: This qualitative study aimed to develop the first cognitive behavioural (CBT) model outlining the development and maintenance of disordered eating in adult men living with Type 1 diabetes to improve on previous theoretical models of Type 1 diabetes and disordered eating and to draw comparisons to women with Type 1 diabetes and disordered eating. METHODS: Twenty-seven men (n = 16 with Type 1 diabetes and disordered eating, n = 11 with Type 1 diabetes without disordered eating) participated in semi-structured interviews. Data were analysed using thematic analysis and individual CBT formulations were developed for each participant to inform the model. RESULTS: Men with Type 1 diabetes and disordered eating experience negative thoughts about food, insulin, weight/shape and diabetes itself, which cause negative emotions such as fear and vulnerability and difficulties with diabetes self care such as problems with hyper and hypoglycaemia and problems accessing structured education and technology result in men feeling more dissatisfied about their body weight/shape. CONCLUSIONS: This CBT model of disordered eating in men with Type 1 diabetes can guide new interventions.

Developing a novel intervention for type 1 diabetes and disordered eating using a participatory action design process: Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY).

AIMS: To develop a cognitive behavioural therapy-based intervention for people with type 1 diabetes and disordered eating using Experience-Based Co-Design as part of the Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY). METHODS: Fifteen people with type 1 diabetes and experience of disordered eating (33 ± 11 years old, 22 ± 12 years diabetes duration) and 25 healthcare professionals working in type 1 diabetes or eating disorders (44 ± 9 years old; 14 ± 10 years of professional experience) attended six Experience-Based Co-Design workshops from July 2019 to March 2020 to collaboratively develop intervention content. RESULTS: We developed a cognitive behaviour therapy intervention 'toolkit' that can be tailored for individual patient needs. Participants designed and revised toolkit materials to ensure acceptability and relevance for people with diabetes and disordered eating by engaging in guided discussion, brainstorming, and rapid testing to review toolkit prototypes in an iterative process. Workshop themes were 'Insulin titration'; 'Hypoglycaemia'; 'Coming to terms with diabetes'; 'Fear of weight gain'; 'Toolkit revision'; and 'Practical elements of STEADY therapy'. The intervention is focussed on improving diabetes self-care and embedded in a multidisciplinary healthcare approach. The intervention will be delivered in 12 sessions by a diabetes specialist nurse trained in cognitive behavioural therapy. CONCLUSIONS: Through an iterative co-design process, people with type 1 diabetes and healthcare professionals collaboratively developed a novel intervention toolkit that can be used with a wide range of disordered eating presentations. The intervention will be tested in the STEADY feasibility randomised controlled trial.

Valproate prescription to women of childbearing age in English primary care: repeated cross-sectional analyses and retrospective cohort study.

BACKGROUND: Valproate is a teratogenic drug that should be avoided during the preconception period and pregnancy. The aim was to explore general practitioners' (GPs) prescription patterns over time, describe trends, and explore inter-practice variation within primary care. METHODS: We identified women of childbearing age (12-46 years old) in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network. We performed repeated cross-sectional analyses from 2004 to 2018 to determine rates of prescription and a retrospective cohort estimated the prevalence of use of valproate during pregnancy. RESULTS: In 2004, 0.31% (95% Confidence Interval (95%CI):0.18 to 0.44%) women were prescribed valproate, decreasing to 0.16% (95%CI:0.07 to 0.24%) by 2018. Among women with epilepsy, the rate fell from 15.2% (95%CI:14.4 to 16.0%) to 8.8% (95% CI:8.2 to 9.7%) over the same period. In 2018, almost two thirds (62.2%) of women who were prescribed valproate had epilepsy only, whereas bipolar disorder and migraine accounted for 15.8% and 7.4% respectively. Contraceptive prescriptions did not increase over time, and only in 2018 was there greater odds of being prescribed contraception (OR 1.41, 95%CI:1.08 to 1.45). Just under a fifth (19.7%) of women were prescribed valproate during their pregnancy; two out of three of these pregnancies were preceded by folic acid prescription (5 mg). While some practices reduced their rate of valproate prescription, others did not. CONCLUSIONS: Regulatory guidelines have changed GPs' prescription patterns in women of childbearing potential for valproate but not for contraception. Further research is needed to identify the barriers of GPs and women of childbearing potential to undertaking contraception.

A cognitive behavioural model of the bidirectional relationship between disordered eating and diabetes self care in people with type 1 diabetes mellitus.

AIMS: This qualitative study aimed to develop the first cognitive behavioural therapy model outlining the development and maintenance of disordered eating in type 1 diabetes and report on recovery strategies and resilience factors to improve previous theoretical models of type 1 diabetes and disordered eating. METHODS: Twenty-three women (n = 9 with type 1 diabetes and disordered eating, n = 5 with type 1 diabetes recovering from disordered eating, and n = 9 with type 1 diabetes without disordered eating) participated in semi-structured interviews. Data were analysed using grounded theory and individual cognitive-behavioural formulations were developed for each participant to inform the development/maintenance and resilience models. RESULTS: The development/maintenance model summarises commonly experienced vicious cycles of thoughts, feelings and behaviours in type 1 diabetes and disordered eating. The resilience model summarises strategies and knowledge acquired by those with type 1 diabetes in recovery from disordered eating and individuals with type 1 diabetes who did not develop disordered eating. Early adverse life events, past psychiatric history, perfectionist personality traits, difficult experiences around type 1 diabetes diagnosis and its relentless daily management sensitise individuals to eating, weight and shape cues. Alongside physical symptoms/complications, unhelpful interpersonal reactions and inadequate healthcare, vicious cycles of thoughts, feelings and behaviours develop. 'Good enough' psychological adaptation to type 1 diabetes, integrating type 1 diabetes into one's identity, self care and compassion around eating, weight and shape were key protective/post-traumatic resilience factors. CONCLUSIONS: This first cognitive behavioural therapy model of type 1 diabetes and disordered eating informed by personal experience will inform an intervention for type 1 diabetes and disordered eating.

Intensification to injectable therapy in type 2 diabetes: mixed methods study (protocol).

BACKGROUND: In the UK, type 2 diabetes mellitus (T2D) is largely managed in primary care. Delay in the intensification to injectable therapy, a form of clinical inertia, is associated with worse glycaemic control. UK general practice is highly computerised, with care being recorded on computerised medical record systems; this allows for quantitative analysis of clinical care but not of the underpinning decision-making process. The aim of this study is to investigate perceptions of patients and clinicians in primary care on the initiation of injectable therapies in T2D, and the context within which those decisions are made. METHODS: This is a mixed methods study, taking a "realist evaluation" approach. The qualitative components comprise focus groups, interviews, and video recordings of simulated surgeries; the quantitative analysis: an overview of participating practices, elements of the video recording, and an online survey. We will recruit primary care clinicians (general practitioners and nurses) and patients from a representative sample of practices within the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. Participants will be patients with T2D, and primary care clinicians. Focus groups and semi-structured interviews will be recorded, transcribed verbatim and analysed using Framework Analysis. The simulated surgeries will include cases that might be escalated to injectable therapy. The consultation will be reviewed using the Calgary-Cambridge model to assess communication and determination of adherence to national prescribing guidelines. We will conduct multi-channel video recording including screen capture, clinician and patient facial expressions, wide angle view of the consultation, and the computerised medical record screen. This allows annotation and qualitative analysis of the video recordings, and statistical analyses for the quantitative data. We will also conduct an online survey of primary care clinicians' attitudes to, and perceptions of, initiation of injectable therapies, which will be analysed using summary statistics. DISCUSSION: Results aim to provide a detailed insight into the dynamic two-way decision-making process underpinning use of injectable therapy for T2D. The study will provide insights into clinical practice and enable the development of training, interventions and guidelines that may facilitate, where appropriate, the intensification to injectable therapy.

Barriers and Facilitators to the Initiation of Injectable Therapies for Type 2 Diabetes Mellitus: A Mixed Methods Study.

INTRODUCTION: Initiation of injectable therapies in type 2 diabetes (T2D) is often delayed, however the reasons why are not fully understood. METHODS: A mixed methods study performed in sequential phases. Phase 1: focus groups with people with T2D (injectable naïve [n = 12] and experienced [n = 5]) and healthcare professionals (HCPs; nurses [n = 5] and general practitioners (GPs) [n = 7]) to understand their perceptions of factors affecting initiation of injectables. Phase 2: video-captured GP consultations (n = 18) with actor-portrayed patient scenarios requiring T2D treatment escalation to observe the initiation in the clinical setting. Phase 3: HCP surveys (n = 87) to explore external validity of the themes identified in a larger sample. RESULTS: Focus groups identified patients' barriers to initiation; fear, lack of knowledge and misconceptions about diabetes and treatment aims, concerns regarding lifestyle restrictions and social stigma, and feelings of failure. Facilitators included education, good communication, clinician support and competence. HCP barriers included concerns about weight gain and hypoglycaemia, and limited consultation time. In simulated consultations, GPs performed high-quality consultations and recognised the need for injectable initiation in 9/12 consultations where this was the expert recommended option but did not provide support for initiation themselves. Survey results demonstrated HCPs believe injectable initiation should be performed in primary care, although many practitioners reported inability to do so or difficulty in maintaining skills. CONCLUSION: People with T2D have varied concerns and educational needs regarding injectables. GPs recognise the need to initiate injectables but lack practical skills and time to address patient concerns and provide education. Primary care nurses also report difficulties in maintaining these skills. Primary care HCPs initiating injectables require additional training to provide practical demonstrations, patient education and how to identify and address concerns. These skills should be concentrated in the hands of a small number of primary care providers to ensure they can maintain their skills.

The multidisciplinary, theory-based co-design of a new digital health intervention supporting the care of oesophageal cancer patients.

OBJECTIVE: Oesophageal cancer patients have complex care needs. Cancer clinical nurse specialists play a key role in coordinating their care but often have heavy workloads. Digital health interventions can improve patient care but there are few examples for oesophageal cancer. This paper aims to describe the multidisciplinary co-design process of a digital health intervention to improve the experience of care and reduce unmet needs among patients with oesophageal cancer. METHODS: A theory-based, multi-disciplinary, co-design approach was used to inform the developmental process of the digital health intervention. Key user needs were elicited using mixed methodology from systematic reviews, focus groups and interviews and holistic need assessments. Overarching decisions were discussed among a core team of patients, carers, health care professionals including oncologists and cancer clinical nurse specialists, researchers and digital health providers. A series of workshops incorporating a summary of findings of key user needs resulted in the development of a minimum viable product. This was further refined after a pilot study based on feedback from end users. RESULTS: The final digital health intervention consists of a mobile app feature for patients and carers connected to a dashboard with supporting additional features for clinical nurse specialist. It contains a one-way messaging function for clinical nurse specialists to communicate with patients, functions for patients to record weight and holistic need assessment results which could be viewed by their clinical nurse specialists as well as a library of informative articles. CONCLUSIONS: The multidisciplinary co-design of a digital health intervention providing support for oesophageal cancer patients and health care professionals has been described. Future studies to establish its impact on patient outcomes are planned.

Benefit-risk of Patients' Online Access to their Medical Records: Consensus Exercise of an International Expert Group.

BACKGROUND: Patients' access to their computerised medical records (CMRs) is a legal right in many countries. However, little is reported about the benefit-risk associated with patients' online access to their CMRs. OBJECTIVE: To conduct a consensus exercise to assess the impact of patients' online access to their CMRs on the quality of care as defined in six domains by the Institute of Medicine (IoM), now the National Academy of Medicine (NAM). METHOD: A five-round Delphi study was conducted. Round One explored experts' (n = 37) viewpoints on providing patients with access to their CMRs. Round Two rated the appropriateness of statements arising from Round One (n = 16). The third round was an online panel discussion of findings (n = 13) with the members of both the International Medical Informatics Association and the European Federation of Medical Informatics Primary Health Care Informatics Working Groups. Two additional rounds, a survey of the revised consensus statements and an online workshop, were carried out to further refine consensus statements. RESULTS: Thirty-seven responses from Round One were used as a basis to initially develop 15 statements which were categorised using IoM's domains of care quality. The experts agreed that providing patients online access to their CMRs for bookings, results, and prescriptions increased efficiency and improved the quality of medical records. Experts also anticipated that patients would proactively use their online access to share data with different health care providers, including emergencies. However, experts differed on whether access to limited or summary data was more useful to patients than accessing their complete records. They thought online access would change recording practice, but they were unclear about the benefit-risk of high and onerous levels of security. The 5-round process, finally, produced 16 consensus statements. CONCLUSION: Patients' online access to their CMRs should be part of all CMR systems. It improves the process of health care, but further evidence is required about outcomes. Online access improves efficiency of bookings and other services. However, there is scope to improve many of the processes of care it purports to support, particularly the provision of a more effective interface and the protection of the vulnerable.

Incidence of household transmission of acute gastroenteritis (AGE) in a primary care sentinel network (1992-2017): cross-sectional and retrospective cohort study protocol.

INTRODUCTION: Acute gastroenteritis (AGE) is a highly transmissible condition. Determining characteristics of household transmission will facilitate development of prevention strategies and reduce the burden of this disease.We are carrying out this study to describe household transmission of medically attended AGE, and explore whether there is an increased incidence in households with young children. METHODS AND ANALYSIS: This study used the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) primary care sentinel network, comprising data from 1 750 167 registered patients (August 2017 database). We conducted a novel analysis using a 'household key', to identify patients within the same household (n=811 027, mean 2.16 people). A 25-year repeated cross-sectional study will explore the incidence of medically attended AGE overall and then a 5-year retrospective cohort study will describe household transmission of AGE. The cross-sectional study will include clinical data for a 25-year period-1 January 1992 until the 31 December 2017. We will describe the incidence of AGE by age-band and gender, and trends in incidence. The 5-year study will use Poisson and quasi-Poisson regression to identify characteristics of individuals and households to predict medically attended AGE transmitted in the household. This will include whether the household contained a child under 5 years and the age category of the first index case (whether adult or child under 5 years). If there is overdispersion and zero-inflation we will compare results with negative binomial to handle these issues. ETHICS AND DISSEMINATION: All RCGP RSC data are pseudonymised at the point of data extraction. No personally identifiable data are required for this investigation. The protocol follows STrengthening the Reporting of OBservational studies in Epidemiology guidelines (STROBE). The study results will be published in a peer-review journal, the dataset will be available to other researchers.

A systematic review of the effectiveness of self-management interventions in people with multiple sclerosis at improving depression, anxiety and quality of life.

BACKGROUND: Self-management interventions have become increasingly popular in the management of long-term health conditions; however, little is known about their impact on psychological well-being in people with Multiple Sclerosis (MS). PURPOSE: To examine the effectiveness of self-management interventions on improving depression, anxiety and health related quality of life in people with MS. METHOD: A structured literature search was conducted for the years 2000 to 2016. The review process followed the PRISMA guidelines, and is registered with PROSPERO (no. CRD42016033925). RESULTS: The review identified 10 RCT trials that fulfilled selection criteria and quality appraisal. Self-management interventions improved health-related quality of life in 6 out of 7 studies, with some evidence of improvement in depression and anxiety symptoms. CONCLUSION: Although the results are promising more robust evaluation is required in order to determine the effectiveness of self-management interventions on depression, anxiety and quality of life in people with MS. Evaluation of the data was impeded by a number of methodological issues including incomplete content and delivery information for the intervention and the exclusion of participants representing the disease spectrum. Recommendations are made for service development and research quality improvement.

Balancing professional tension and deciding upon the status of death: Making end-of-life decisions in intensive care units.

This study investigated how intensivists make decisions regarding withholding and withdrawing treatment for patients at the end of their lives. This involved completing in-depth interviews from two sites of the South of England, United Kingdom by twelve intensivists. The data collected by these intensivists were analysed using thematic analysis. This resulted in the identification of three themes: intensivists' role, treatment effectiveness, and patients' best interest. Transcending these were two overarching themes relating to the balance between quantity and quality of life, and the intensivists' sense of responsibility versus burden. The results are considered in terms of making sense of death and the role of beliefs in the decision-making process.