Healthcare professionals' experiences in identifying and supporting mental health problems in adults living with type 1 diabetes mellitus: A qualitative study.

AIMS: To explore perspectives and experiences of healthcare professionals in the identification and support provision of mental health problems in adults living with type 1 diabetes. METHODS: Using a qualitative research design, 15 healthcare professionals working in the United Kingdom were individually interviewed using a semi-structured interview schedule. Data were analysed using reflexive inductive thematic analysis. RESULTS: Four themes were identified relating to barriers: time, knowledge, relationship between services and stigma. Three themes were identified relating to facilitators: education, communication and appropriate tools and services. CONCLUSIONS: This research emphasises the need for educational tools to improve the skills and competency of healthcare professionals in identifying mental health problems in people with type 1 diabetes, highlighting practical and theoretical implications for healthcare improvements and the necessity for additional research to design care pathways that better support this population, in which all healthcare professionals are aware of.

Home monitoring of haemoglobin A1c in diabetes: A systematic review and narrative synthesis on accuracy, reliability and patient acceptability.

AIM: In the UK people with diabetes who do not attend annual review appointments often have higher haemoglobin A1c (HbA1c ) levels. We aim to determine the acceptability of self-collected posted capillary blood samples, and if they produce accurate and reliable HbA1c results. METHODS: We include adult studies comparing capillary blood to venous blood for measuring HbA1c . We exclude methods not suitable for postage. Electronic databases of MEDLINE, Embase, CINAHL, Web of Science, Google Scholar and OpenGrey were searched from inception to September 2021, as well as relevant conference abstracts. Two reviewers performed study selection, data extraction and risk of bias assessment independently. Narrative synthesis was performed. RESULTS: Our search retrieved 3747 records. Following de-duplication and screening 30 articles were included. The mean difference (MD) and limits of agreement (LoA) between capillary and venous HbA1c were smaller and narrower respectively when micro/capillary tubes (micro/cap) were used for capillary blood storage compared to dried blood spots (capDBS) (micro/cap MD range -0.4 to 1.4 mmol/mol vs. capDBS MD range -4.3 to 7.2 mmol/mol, micro/cap LoA width 2.4 to 6 mmol/mol vs. capDBS LoA width 11.7 to 16.8 mmol/mol). After using self-collection kits, 83%-96% of participants reported satisfaction, 87%-99% found it easy and 69%-94% reported they would use it again. CONCLUSION: Microtubes/capillary tubes look promising as a method of self-collecting and posting capillary blood samples for the measurement of HbA1c based on the accuracy and reliability findings presented. DBS samples demonstrated comparatively poorer accuracy. Data on acceptability were limited and further research is needed.

Population stratification in type 2 diabetes mellitus: A systematic review.

AIMS: There is increasing interest in using stratification in type 2 diabetes to target resources, individualise care and improve outcomes. We aim to systematically review and collate literature that has utilised population stratification methods in the study of adults with type 2 diabetes; and to describe and compare stratification methodologies, population characteristics, variables used to stratify and outcome variables. METHODS: The MEDLINE, EMBASE, CINAHL and Cochrane databases were searched from inception to July 2020. Studies included adults with type 2 diabetes using population stratification methods. The review protocol was registered on PROSPERO (ID: CRD42020206604) and conducted in line with PRISMA guidance. Extracted data included study aims; study setting (primary or secondary care); population characteristics; stratification variables and outcomes; and methodological approach to stratification. RESULTS: Across 348 included studies, there were a total of 10,776,009 participants with a mean age of 61.0 years (SD 5.94). 6.7% of studies used data-driven methods and the rest employed expert-driven approaches using pre-defined stratification criteria. The commonest variable used to stratify populations was HbA1c (n = 57, 16.4%); few studies stratified using clinically important non-traditional variables such as health behaviours and beliefs. CONCLUSIONS: Most studies performing population stratification in type 2 diabetes used expert-driven approaches with the aim of predicting outcomes in glycaemic control, mortality and cardiovascular complications. We identified relatively few studies using data-driven approaches, which offer opportunities generate hypotheses beyond current expert knowledge. We describe important research gaps including stratification with regard to disease remission.

The WISDOM self-management intervention: A cost-effectiveness analysis to support the transformation of type 2 diabetes care in England.

OBJECTIVES: To assess the cost-effectiveness of the WISDOM self-management intervention for type 2 diabetes compared with care as usual. DESIGN: We performed a difference-in-differences analysis to estimate differences in risk factors for diabetes complications between people in the WISDOM group (n = 25, 276) and a control group (n = 15, 272) using GP records. A decision analytic model was then used to extrapolate differences in risk factors into costs and outcomes in the long term. SETTING: Participating GP practices in West Hampshire and Southampton, UK. PARTICIPANTS: All people diagnosed with type 2 diabetes between January 1990 and March 2020 (n = 40,548). OUTCOMES: Diabetes-related complications, quality-adjusted life years (QALYs) and costs to the English National Health Service at 5 years and lifetime. INTERVENTIONS: The WISDOM intervention included risk stratification, self-management education programme to professionals and people with type 2 diabetes, and monitoring of key treatment targets. RESULTS: WISDOM was associated with less atrial fibrillation [p = 0.001], albuminuria [p = 0.002] and blood pressure [p = 0.098]. Among all people in the intervention group, WISDOM led to 51 [95%CI: 25; 76] QALYs gained and saved £278,036 [95%CI: -631,900; 176,392] in the first 5 years after its implementation compared with care as usual. During those people' lifetime, WISDOM led to 253 [95%CI: 75; 404] QALYs gained and cost saving of £126,380 [95%CI: -1,466,008; 1,339,628]. The gains in QALYs were a result of reduced diabetes-related complications through improved management of the associated risk factors. CONCLUSIONS: The WISDOM risk-stratification and education intervention for type 2 diabetes appear to be cost-effective compared to usual care by reducing diabetes complications.

Liraglutide and the management of overweight and obesity in people with severe mental illness: qualitative sub-study.

BACKGROUND: People with severe mental illness are two to three times more likely to be overweight or have obesity than the general population and this is associated with significant morbidity and premature mortality. Liraglutide 3 mg is a once daily injectable GLP-1 receptor agonist that is licensed for the treatment of obesity in the general population and has the potential to be used in people with severe mental illness. AIMS: To record the expectations and experiences of people with schizophrenia, schizoaffective disorders or first episode psychosis taking daily liraglutide 3 mg injections in a clinical trial for the treatment of obesity. To seek the views of healthcare professionals about the feasibility of delivering the intervention in routine care. METHODS: Qualitative interviews were undertaken with a purposive sub-sample of people with schizophrenia, schizoaffective disorders or first episode psychosis with overweight or obesity who were treated with a daily injection of liraglutide 3 mg in a double-blinded, randomised controlled pilot study evaluating the use of liraglutide for the treatment of obesity. Interviews were also conducted with healthcare professionals. RESULTS: Seventeen patient participants were interviewed. Sixteen took part in the baseline interview, eight completed both baseline and follow-up interviews, and one took part in follow-up interview only. Mean interview duration was thirteen minutes (range 5-37 min). Despite reservations by some participants about the injections before the study, most of those who completed the trial reported no challenges in the timing of or administering the injections. Key themes included despondency regarding prior medication associated weight gain, quality of life impact of weight loss, practical aspects of participation including materials received and clinic attendance. Healthcare professionals reported challenges with recruitment, however, overall it was a positive experience for them and for participants. CONCLUSION: Liraglutide appears to be an acceptable therapy for obesity in this population with limited side effects. The quality of life benefits realised by several intervention participants reinforce the biomedical benefits of achieved weight loss.

Introduction to the development of complex interventions.

Healthcare interventions are complex, but have the potential to deliver more efficient, cost-effective care and improved health outcomes. Careful attention must be paid to their early planning and development to minimise research waste or interventions that fail to deliver what they set out to achieve. The Medical Research Council provides guidance to help intervention developers, encouraging an explicit and iterative approach. This article describes the Medical Research Council's guidance and introduces two frequently used tools that further support the process of intervention design.

The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: Results of a pilot randomized, double-blind, placebo-controlled trial.

AIM: To investigate the feasibility and acceptability of using liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis. MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled pilot trial took place in mental health centres and primary care within Southern Health NHS Foundation Trust. The participants were adults with schizophrenia, schizoaffective or first-episode psychosis prescribed antipsychotic medication who were overweight or obese. The intervention was once-daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. The primary outcomes were recruitment, consent, retention and adherence. The secondary exploratory outcomes were weight, HbA1c and Brief Psychiatric Rating Scale. RESULTS: Seven hundred and ninety-nine individuals were screened for eligibility. The most common reasons for exclusion were ineligibility (44%) and inability to make contact (28%). The acceptance rate, as a proportion of all eligible participants, was 12.2%. The most commonly stated reason why eligible candidates declined to participate related to the study-specific medication and protocol (n = 50). Forty-seven participants were randomized, with 79% completing the trial. Participants in the liraglutide arm lost a mean 5.7 ± 7.9 kg compared with no significant weight change in the placebo group (treatment difference -6.0 kg, p = .015). Body mass index, waist circumference and HbA1c were reduced in the intervention group. CONCLUSIONS: This study supports the need for a larger randomized controlled trial to evaluate the use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness.

Completion of annual diabetes care processes and mortality: A cohort study using the National Diabetes Audit for England and Wales.

AIM: To conduct an analysis to assess whether the completion of recommended diabetes care processes (glycated haemoglobin [HbA1c], creatinine, cholesterol, blood pressure, body mass index [BMI], smoking habit, urinary albumin, retinal and foot examinations) at least annually is associated with mortality. MATERIALS AND METHODS: A cohort from the National Diabetes Audit of England and Wales comprising 179 105 people with type 1 and 1 397 790 people with type 2 diabetes, aged 17 to 99 years on January 1, 2009, diagnosed before January 1, 2009 and alive on April 1, 2013 was followed to December 31, 2019. Cox proportional hazards models adjusting for demographic characteristics, smoking, HbA1c, blood pressure, serum cholesterol, BMI, duration of diagnosis, estimated glomerular filtration rate, prior myocardial infarction, stroke, heart failure, respiratory disease and cancer, were used to investigate whether care processes recorded January 1, 2009 to March 31, 2010 were associated with subsequent mortality. RESULTS: Over a mean follow-up of 7.5 and 7.0 years there were 26 915 and 388 093 deaths in people with type 1 and type 2 diabetes, respectively. Completion of five or fewer, compared to eight, care processes (retinal screening not included as data were not reliable) had a mortality hazard ratio (HR) of 1.37 (95% confidence interval [CI] 1.28-1.46) in people with type 1 and 1.32 (95% CI 1.30-1.35) in people with type 2 diabetes. The HR was higher for respiratory disease deaths and lower in South Asian ethnic groups. CONCLUSIONS: People with diabetes who have fewer routine care processes have higher mortality. Further research is required into whether different approaches to care might improve outcomes for this high-risk group.

The role of community pharmacists and their position in the delivery of diabetes care: an update for medical professionals.

Pharmacists are the third largest group of healthcare professionals worldwide, but are underused in the delivery of diabetes care. The aim of this narrative was to describe how integration of community pharmacy services into existing healthcare models may improve diabetes care. Relevant literature exploring pharmacy-led interventions for diabetes were identified from a search of Medline, Embase and Cinahl online databases. This review highlights that community pharmacists are accessible, experts in medicine management, trusted by the public and able to achieve financial savings. They are poorly integrated into existing healthcare models, and commissioning arrangements can be poorly perceived by the public and those working in primary care. Community pharmacy interventions in type 2 diabetes have similar, if not greater effects compared to those delivered by other healthcare professionals. It was concluded that community pharmacy interventions in diabetes are feasible, acceptable and deliver improved health outcomes. Future work should build public recognition of pharmacists and improve communication between them and other healthcare professionals.

Evaluating the long-term cost-effectiveness of fixed-ratio combination insulin degludec/liraglutide (IDegLira) for type 2 diabetes in Spain based on real-world clinical evidence.

AIM: To evaluate the long-term cost-effectiveness of fixed-ratio combination insulin degludec/liraglutide (IDegLira) versus comparator regimens for type 2 diabetes in Spain, based on real-world evidence. MATERIALS AND METHODS: Clinical data were taken from the European Xultophy Treatment Retrospective Audit (EXTRA) real-world evidence study in which patients failing to meet glycaemic targets were switched to IDegLira. Baseline regimens (prior to IDegLira treatment) were categorized as: multiple daily insulin injections (MDI; 28%); glucagon-like peptide-1 (GLP-1) receptor agonists in combination with insulin (24%); basal insulin (19%); GLP-1 receptor agonists (10%); and non-injectable medications (19%). The IQVIA CORE Diabetes Model was used to project long-term outcomes for patients switching to IDegLira or continuing their baseline regimens (excluding non-injectable regimens). Costs were accounted from a Spanish National Health System perspective. Future costs and clinical benefits were discounted at 3% annually and sensitivity analyses were performed. RESULTS: IDegLira was projected to reduce the incidence of diabetes-related complications and improve quality-adjusted life expectancy versus all four comparators. IDegLira reduced direct medical costs versus GLP-1 receptor agonists in combination with insulin, and versus GLP-1 receptor agonist therapy, and was therefore considered dominant (cost saving while improving outcomes). IDegLira was found to be cost-effective versus MDI and basal insulin with incremental cost-effectiveness ratios of EUR 3013 per quality-adjusted life-year (QALY) gained and EUR 6890 per QALY gained, respectively. CONCLUSIONS: Long-term projections based on real-world evidence indicated that IDegLira is likely to improve clinical outcomes and reduce costs or be cost-effective compared with other injectable regimens in people with type 2 diabetes in Spain.

Use and effectiveness of a fixed-ratio combination of insulin degludec/liraglutide (IDegLira) in a real-world population with type 2 diabetes: Results from a European, multicentre, retrospective chart review study.

AIMS: To describe the real-world use and effectiveness of IDegLira, a fixed-ratio combination of the basal insulin degludec, and the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide. MATERIALS AND METHODS: This European, multicentre, retrospective chart review comprised adults (n = 611) with type 2 diabetes, who started IDegLira ≥6 months before data collection. Clinical characteristics were assessed at baseline (defined as the most recent recording during the 6 months before the first IDegLira prescription) and 3, 6, 9 and 12 months (± 45 days for each time point) after commencing IDegLira, where data were available. RESULTS: Baseline regimens included non-injectable medications (19%), basal insulin (19%), GLP-1RA (10%), free combination therapy (insulin/GLP-1RA, 24%) and multiple daily-dose insulin injections (MDI, 28%), all ± oral antidiabetic drugs. After 6 months, significant glycated haemoglobin (HbA1c) reductions were observed in patients overall and in all subgroups (-10 mmol/mol [-0.9%] overall; P < .0001), and a significant reduction in mean body weight (-0.7 kg; P < .05) was observed in patients overall and in patients receiving MDI (-2.4 kg; P < .0001). The mean IDegLira dose was 22, 30 and 32 dose steps at initiation, and at 6 and 12 months follow-up, respectively. In total, only 67 patients reached the maximum 50 dose steps, with most coming from the free combination therapy (n = 31) or MDI (n = 15) baseline regimen groups. Hypoglycaemia rates were reduced by 82% (rate ratio 0.18; P < .0001) in the 6-month period after vs before IDegLira initiation. Overall, a total of 12 patients experienced 15 events in the 6 months after IDegLira initiation. CONCLUSION: In real-world practice, after 6 months and at a moderate dose, IDegLira resulted in substantial reductions in HbA1c and body weight, with a reduced risk of hypoglycaemia.

Differences in level of confidence in diabetes care between different groups of trainees: the TOPDOC diabetes study.

BACKGROUND: There is an increasing prevalence of diabetes. Doctors in training, irrespective of specialty, will have patients with diabetes under their care. The aim of this further evaluation of the TOPDOC Diabetes Study data was to identify if there was any variation in confidence in managing diabetes depending on the geographical location of trainees and career aspirations. METHODS: An online national survey using a pre-validated questionnaire was administered to trainee doctors. A 4-point confidence rating scale was used to rate confidence in managing aspects of diabetes care and a 6-point scale used to quantify how often trainees would contribute to the management of patients with diabetes. Responses were grouped depending on which UK country trainees were based and their intended career choice. RESULTS: Trainees in Northern Ireland reported being less confident in IGT diagnosis, use of IV insulin and peri-operative management and were less likely to adjust oral treatment, contact specialist, educate lifestyle, and optimise treatment. Trainees in Scotland were less likely to contact a specialist, but more likely to educate on lifestyle, change insulin, and offer follow-up advice. In Northern Ireland, Undergraduate (UG) and Postgraduate (PG) training in diagnosis was felt less adequate, PG training in emergencies less adequate, and reporting of need for further training higher. Trainees in Wales felt UG training to be inadequate. In Scotland more trainees felt UG training in diagnosis and optimising treatment was inadequate. Physicians were more likely to report confidence in managing patients with diabetes and to engage in different aspects of diabetes care. Aspiring physicians were less likely to feel the need for more training in diabetes care; however a clear majority still felt they needed more training in all aspects of care. CONCLUSIONS: Doctors in training have poor confidence levels dealing with diabetes related care issues. Although there is variability between different groups of trainees according to geographical location and career aspirations, this is a UK wide issue. There should be a UK wide standardised approach to improving training for junior doctors in diabetes care with local training guided by specific needs.

Prevalence of mental disorders in people living with type 1 diabetes: A systematic literature review and meta-analysis.

OBJECTIVE: Type 1 diabetes is associated with increased prevalence of individual categories of mental disorders. We aimed to systematically synthesise the prevalence of all the different categories of mental disorders to estimate the overall burden of psychiatric morbidity in the type 1 diabetes population. METHOD: The electronic database of OVID was searched, and retrieved papers were screened for eligibility by two independent reviewers. Data were extracted using a standardised data extraction form and the quality of included papers was assessed. Where possible, comparisons with control groups without type 1 diabetes were made. Prevalence data were synthesised into Diagnostic and Statistical Manual of Mental Disorders version 5 categories, a narrative data-synthesis, and a subsequent meta-analysis where possible was conducted for mental disorder categories. RESULTS: Thirty-eight articles were included. Depressive, anxiety, and feeding and eating disorders were the most examined mental disorders. Studies utilising diagnostic interviews reported higher prevalence of mental disorders than in studies utilising clinical registers, with an up to 24-fold difference respectively. In studies with a control group, the prevalence for nearly every mental disorder were increased for the type 1 diabetes samples. CONCLUSIONS: There appears to be a high prevalence of mental disorders and associated need among people with type 1 diabetes, although the quality of research needs to improve. SYSTEMATIC REVIEW REGISTRATION: This protocol was submitted for registration with the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42020221530).

Delivering Biopsychosocial Health Care Within Routine Care: Spotlight-AQ Pivotal Multicenter Randomized Controlled Trial Results.

BACKGROUND: Annual national diabetes audit data consistently shows most people with diabetes do not consistently achieve blood glucose targets for optimal health, despite the large range of treatment options available. AIM: To explore the efficacy of a novel clinical intervention to address physical and mental health needs within routine diabetes consultations across health care settings. METHODS: A multicenter, parallel group, individually randomized trial comparing consultation duration in adults diagnosed with T1D or T2D for ≥6 months using the Spotlight-AQ platform versus usual care. Secondary outcomes were HbA1c, depression, diabetes distress, anxiety, functional health status, and healthcare professional burnout. Machine learning models were utilized to analyze the data collected from the Spotlight-AQ platform to validate the reliability of question-concern association; as well as to identify key features that distinguish people with type 1 and type 2 diabetes, as well as important features that distinguish different levels of HbA1c. RESULTS: n = 98 adults with T1D or T2D; any HbA1c and receiving any diabetes treatment participated (n = 49 intervention). Consultation duration for intervention participants was reduced in intervention consultations by 0.5 to 4.1 minutes (3%-14%) versus no change in the control group (-0.9 to +1.28 minutes). HbA1c improved in the intervention group by 6 mmol/mol (range 0-30) versus control group 3 mmol/mol (range 0-8). Moderate improvements in psychosocial outcomes were seen in the intervention group for functional health status; reduced anxiety, depression, and diabetes distress and improved well-being. None were statistically significant. HCPs reported improved communication and greater focus on patient priorities in consultations. Artificial Intelligence examination highlighted therapy and psychological burden were most important in predicting HbA1c levels. The Natural Language Processing semantic analysis confirmed the mapping relationship between questions and their corresponding concerns. Machine learning model revealed type 1 and type 2 patients have different concerns regarding psychological burden and knowledge. Moreover, the machine learning model emphasized that individuals with varying levels of HbA1c exhibit diverse levels of psychological burden and therapy-related concerns. CONCLUSION: Spotlight-AQ was associated with shorter, more useful consultations; with improved HbA1c and moderate benefits on psychosocial outcomes. Results reflect the importance of a biopsychosocial approach to routine care visits. Spotlight-AQ is viable across health care settings for improved outcomes.

One-third of doctors completing specialist training in diabetes fail to secure a substantive consultant post: young Diabetologists' Forum Survey 2010.

Reports have highlighted a shortage of consultant diabetologist posts in the UK. The number of doctors completing specialist training in diabetes has increased in recent years, but little is known about their employment after they receive their certificate of completion of training. An online survey was sent to all doctors who completed specialist diabetes training from January 2008 to September 2010. Of the 95 eligible respondents, 69 (73%) completed the survey (61% men; median age 36 years). Forty-three (62%) respondents secured substantive NHS consultant posts, and of those who gave their job breakdown, 48/51 (94%) were contributing to specialist diabetes care. Five (7%) respondents held substantive academic positions, while 11 (16%) were locum consultants. Seven (9%) respondents worked abroad, with half of these attributing their emigration to lack of opportunities in the UK. When asked about alternative choices, 39% of respondents were likely to seek 'general physician' roles, which equalled the number who would consider emigrating. Overall, only two-thirds of doctors who complete specialist training in diabetes secure substantive NHS consultant positions, which suggests a failure in workforce planning and a lack of expansion of the number of consultant posts despite progression of the diabetes epidemic.

Postal methods for monitoring HbA1c in diabetes mellitus: a protocol for systematic review.

BACKGROUND: Worldwide there are an estimated 463 million people with diabetes. In the UK people with diabetes are offered annual review, which includes monitoring of haemoglobin A1c (HbA1c). This can identify people with diabetes who are not meeting their glycaemic targets, enabling early intervention. Those who do not attend these reviews often have poorer health outcomes. During the COVID-19 pandemic, there was a 77% reduction in monitoring of HbA1c in the UK. AIM: It is hypothesised that people with diabetes could take finger-prick samples at home for measurement of HbA1c. This study will examine the agreement and correlation of capillary HbA1c values compared with a venous reference standard. It will explore reliability and repeatability of capillary HbA1c testing methods, as well as the direction of effect of storage variables. The study will also explore patient acceptability and safety. It will look at capillary blood methods that would be suitable for posting. DESIGN & SETTING: A systematic review will be undertaken. METHOD: The core terms of 'Diabetes', 'HbA1c' and 'Capillary sampling' will be used to search MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science Core Collection, Google Scholar, OpenGrey, and other grey literature, from database inception until 2021. Risk of bias will be assessed using the 'COSMIN Risk of Bias tool to assess the quality of studies on reliability and measurement error'. CONCLUSION: A narrative synthesis will be produced to explore whether there are viable postal alternatives to venous sampling, as well as exploring acceptability and safety of patient self-collection.

Protocol paper: multi-Centre randomised controlled trial evaluating a pre-clinic diabetes assessment and mapped care planning intervention amongst adults with type 1, type 2 or pre-diabetes.

BACKGROUND: Existing therapeutic interventions to treat diabetes are well known, yet the majority of people with diabetes do not consistently achieve blood glucose targets (even individual therapy targets) for optimal health, despite the large range of treatment options available. Such outcomes have remained stubbornly poor for decades with <25% adults with diabetes achieving glycaemic targets. Patient behaviour, individually supported in routine clinical care, is an important missing component to improved outcomes, in a medical healthcare model not ideally suited to supporting successful diabetes management. METHODS: A multi-centre, parallel group, individually randomised trial comparing consultation duration in adults with type 1, type 2 or pre-diabetes using the Spotlight Consultations pre-clinic assessment compared to usual care in the Spotlight-AQ study. Two hundred adults with type 1, type 2 or pre-diabetes attending routine care outpatient appointments across up to ten participating sites will be invited to participate. INTERVENTION: An outpatient pre-clinic intervention delivered within 1 week prior to scheduled routine outpatient appointment. PRIMARY OUTCOME MEASURE: Duration of routine outpatient consultation. SECONDARY OUTCOME MEASURES: Functional health status Diabetes distress Depression Treatment satisfaction Impact on self-care behaviours HCP burnout HCP treatment satisfaction and burden Hypoglycaemia (time less than 70mg/dL) Hyperglycaemia (time above 180 mg/dL) Change in weight Change in HbA1c Cost effectiveness of intervention DISCUSSION: Results from the study will provide valuable insights into patient-professional communication practices within routine care and recommendations will be made, as necessary, for improvements to that. If the intervention is shown to be clinically and cost-effective, the feedback from participants and healthcare professionals will be used to make any improvements prior to its deployment to support improved communication and associated health outcomes. ETHICS AND DISSEMINATION: The trial was approved by the Wales REC7 Research Ethics Committee (21/WA/0020). Results will be disseminated through national and international conferences, scientific journals, newsletters, magazines and social media. Target audiences include consultants and other clinicians in diabetes, and medical professionals or scientists overall. TRIAL REGISTRATION: ISRCTN15511689 . Registered on 10 November 2021.

Protocol for a national audit on self-reported confidence levels, training requirements and current practice among trainee doctors in the UK: the Trainees Own Perception of Delivery of Care in Diabetes (TOPDOC) Study.

BACKGROUND: As the incidence and prevalence of diabetes increases across the world, resource pressures require doctors without specialist training to provide care for people with diabetes. In the UK, national standards have been set to ensure quality diabetes care from diagnosis to the management of complications. In a multi-centre pilot study, we have demonstrated a lack of confidence among UK trainee doctors in managing diabetes. Suboptimal confidence was identified in a number of areas, including the management of diabetes emergencies. A national survey would clarify whether the results of our pilot study are representative and reproducible. METHODS/DESIGN: Target cohort: All postgraduate trainee doctors in the UK. DOMAINS STUDIED: The self reported online survey questionnaire has 5 domains: (1) confidence levels in the diagnosis and management of diabetes, (2) working with diabetes specialists, (3) perceived adequacy of training in diabetes (4) current practice in optimising glycaemic control and (5) perceived barriers to seeking euglycaemia.Assessment tools: Self-reported confidence is assessed using the 'Confidence Rating' (CR) scale for trainee doctors developed by the Royal College of Physicians. This scale has four points--('not confident' (CR1), 'satisfactory but lacking confidence' (CR2), 'confident in some cases (CR3) and 'fully confident in most cases' (CR4).Frequency of aspects of day-to-day practice is assessed using a six-point scale. Respondents have a choice of 'always' (100%), 'almost always' (80-99%), 'often' (50-79%), 'not very often' (20-49%) and 'rarely' (5-19%) or never (less than 5%). DISCUSSION: It is anticipated that the results of this national study will clarify confidence levels and current practice among trainee doctors in the provision of care for people with diabetes. The responses will inform efforts to enhance postgraduate training in diabetes, potentially improving the quality of care for people with diabetes.

The upper limit of the reference range for thyroid-stimulating hormone should not be confused with a cut-off to define subclinical hypothyroidism.

The upper limit of the reference range for serum thyroid-stimulating hormone (TSH) is used to assist in identifying individuals with hypothyroidism. Improvements in TSH assays have led to better definition of the lower limit of the reference range, but the upper limit of the range for a healthy population is currently a topic of some debate. Population studies have improved our understanding of the clinical implications of elevated serum TSH concentrations in terms of future progression to hypothyroidism, but have not yet fully elucidated the correlation of modestly elevated TSH levels with long-term morbidity. This paper will review the current debate including the arguments for and against reducing the upper limit of the TSH range, whether such a level should be based on evidence from epidemiological studies, and the implications of categorizing large numbers of people with subclinical hypothyroidism. The impact of using different methodologies for the measurement of TSH and the inherent variability of results on reference ranges is also discussed. We argue that the reference range for TSH should be assay-specific and be determined by standard techniques in normal populations as recommended by the National Academy of Clinical Biochemistry. In contrast, we suggest that a decision level be determined separately from epidemiological studies to identify a population with subclinical hypothyroidism. Serial monitoring of TSH in this population deserves further study as a means of identifying those at risk of progressing to frank hypothyroidism and meriting treatment.