Co-creation: a collaborative odyssey in dental education with students at the helm.

Co-creation may be described as collaborative innovation towards a shared goal. It is increasingly being applied in education to develop interventions to support the development of various aspects of educational programmes, including dental education. Students are valuable partners in the process and their unique perspective allows for relevant and novel curricular developments. Other stakeholders within an institution, such as educators, subject experts and programme leads, are also frequently involved. The co-creation process has been reported to be mutually beneficial for all parties.Benefits of co-creation for students include the development of personal and professional skills that are not conventionally taught within a curriculum. Staff can feel more inspired and engaged. The process can lead to more inclusive and socially relevant curricula. There are also associated challenges, such as gaining adequate support and buy-in from stakeholders to ensure success. This paper explores the concept of co-creation and its application in education, providing recommendations on how it may be successfully applied within the context of dental education.

A scoping review of guidelines on caries management for children and young people to inform UK undergraduate core curriculum development.

BACKGROUND: Current evidence in cariology teaching is not consistently reflected in paediatric dentistry in the United Kingdom (UK). Many dental schools are not consistently teaching biological approaches to caries management, with outdated or complex methods being taught outwith the purview of general dental practitioners. This scoping review aimed to map current guidelines on the management of caries in children and young people. This is part of a work package to inform the consensus and development of a UK-wide caries management curriculum for paediatric dentistry. METHODS: A search of electronic databases for peer reviewed literature was performed using Cochrane Library, MEDLINE via PubMed, TRIP Medical Database and Web of Science. Hand searching was undertaken for grey literature (citations of sources of evidence, websites of global organisations and Google Web Search™ (Google LLC, California, USA). Results from databases were screened independently, concurrently by two reviewers. Full texts were obtained, and reviewers met to discuss any disagreement for both database and hand searching. RESULTS: This review identified 16 guidelines suitable for inclusion. After quality appraisal, eight were selected for synthesis and interpretation. Key themes included the shift towards selective caries removal and avoidance of complete caries removal unless in specific circumstances in anterior teeth. For "early lesions" in primary and permanent teeth with and without cavitation, several guidelines recommend biological management including site specific prevention and fissure sealants. CONCLUSIONS: This review mapping current cariology guidelines for children and young people found gaps in the literature including classification of early carious lesions and management of early cavitated lesions. Areas identified for further exploration include integration of biological caries management into treatment planning, selective caries removal and whether pulpotomy is specialist-level treatment, requiring referral. These results will inform consensus recommendations in the UK, using Delphi methods.

Mitigating Severe Hypoglycemia in Users of Advanced Diabetes Technologies: Impaired Awareness of Hypoglycemia and Unhelpful Hypoglycemia Beliefs as Targets for Interventions.

Objective: A subgroup analysis of the Hypoglycemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycemia persisting despite optimized care (HARPdoc) trial was conducted to explore the impact of Blood Glucose Awareness Training (BGAT, a hypoglycemia awareness training program) and the HARPdoc (a psychoeducation addressing unhelpful hypoglycemia beliefs) in reducing severe hypoglycemia (SH) in individuals using advanced diabetes technologies (ADTs). Methods: Data from trial participants who utilized ADTs, including continuous glucose monitors or automated insulin delivery systems, were extracted. Generalized linear mixed-effects models with Poisson distribution or linear mixed-effects models were used to evaluate SH incidence, and Gold questionnaire, Attitudes to Awareness of Hypoglycemia (A2A), Problem Areas in Diabetes (PAID), Hospital Anxiety and Depress Scale (HADS)-anxiety, and HADS-depression scores as measures of hypoglycemia awareness, unhelpful hypoglycemia beliefs, diabetes distress, and anxiety and depression symptoms, respectively. Results: In the 45 participants using ADTs, the BGAT and HARPdoc interventions both reduced SH incidence by more than 50% (P < 0.0001) and yielded improvements in hypoglycemia awareness (P < 0.05). HARPdoc outperformed BGAT in reducing SH at month 24 (P = 0.01). HARPdoc also mitigated unhelpful hypoglycemia beliefs (P < 0.0001), diabetes distress (P < 0.05), and anxiety symptoms (P < 0.05); BGAT demonstrated no significant impacts in these respects. Neither HARPdoc nor BGAT had significant effects on depression symptoms. Conclusion: Psychoeducation (BGAT and HARPdoc) was effective in reducing SH in people using ADTs. HARPdoc may also provide greater long-term SH reduction and improves psychological well-being in this patient group.

Are we practising what we preach and are we all singing from the same hymn sheet? An exploration of teaching in paediatric caries management across UK dental schools.

BACKGROUND: The evidence underpinning caries management for children has progressed dramatically over the past 20 years. Anecdotally, this is not reflected in the teaching provided to undergraduate dental students, with the ongoing teaching of outdated methods within some dental schools. AIM: To capture the current undergraduate teaching provision and clinical treatment experience requirement relative to caries management in paediatric dentistry in UK dental schools. DESIGN: Cross-sectional analysis of current teaching methods on paediatric caries management was obtained using a piloted online data collection form. Question content included current caries teaching methods, assessment of student exposure and competence. The results were analysed descriptively. RESULTS: Of the 16 UK dental schools, 14 participated. Discrepancy in teaching content was apparent. Many schools (n = 9) taught biological caries management through therapeutic fissure sealants, yet this was not reflected in assessment and clinical requirements. Some schools (n = 4) taught amalgam placement in children, and most (n = 12) operatively taught treatments that would no longer be routinely provided in general dental practice in the UK, including primary tooth pulpotomy. CONCLUSION: There is substantial variation in the paediatric caries management techniques that are taught across UK dental schools, demonstrating a need for a national consensus to address these disparities.

Clinical utility of point-of-care glucose testing in the assessment of gestational diabetes: Prospective cohort study.

OBJECTIVE: To assess the clinical utility of point-of-care (POC) capillary blood glucose (CBG) testing in the assessment of gestational diabetes mellitus (GDM) during oral glucose tolerance test (OGTT). DESIGN: Prospective cohort study. SETTING: Antenatal clinics at King's College Hospital. POPULATION: Women screened for GDM between March and June 2020. METHODS: The CBG was measured using the POC StatStrip® test and the venous plasma glucose (VPG) was measured by Roche analyser (Cobas 8000 c702). GDM was diagnosed based on the 2015 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline criteria. The two methods were compared statistically using Analyse-It 5.40.2. MAIN OUTCOME MEASURES: Diagnostic sensitivity, specificity, positive and negative predictive values (PPV and NPV) for the POC StatStrip® test, compared with VPG measured by reference laboratory method. RESULTS: A total of 230 women were included. The number and percentage of women with glucose concentrations above the GDM threshold using the POC StatStrip® test versus laboratory VPG measurement was 15 (6.5%) versus eight (3.4%) at fasting and 105 (45.6%) versus 72 (31.1%) at 2 h, respectively. The sensitivity and specificity values (and 95% CIs) for the POC StatStrip® test were 88% (52%-99%) and 97% (93%-98%) at fasting and 97% (91%-99%) and 79% (71%-84%) at 2 h, respectively. However, the specificity and the NPV for the POC StatStrip® test for concentrations of ≤5.0 mmol/L at fasting or <7.5 mmol/L at 2 h were 100%, and the sensitivity and the PPV for concentrations of >9.5 mmol/L at 2 h were 100%. CONCLUSIONS: In our cohort the POC measurement of CBG cannot entirely replace the laboratory method for the OGTT; however, it can be used to rule out/rule in GDM for glucose concentrations of ≤5.0 mmol/L at fasting or <7.5/>9.5 mmol/L at 2 h.

Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

Proliferative verrucous leukoplakia: a general dental practitioner-focused clinical review.

Proliferative verrucous leukoplakia (PVL) is a distinct type of oral leukoplakia which has the potential to enlarge or develop into new areas of leukoplakia coupled with areas of a warty surface texture. PVL is usually diagnosed from the fifth decade onwards and is more common in female patients. The most frequent sites involved tend to be gingivae, followed by buccal mucosa and lateral border of tongue. It is one of the oral potentially malignant conditions with a high risk of malignant transformation. It is important for general dental practitioners (GDPs) to identify such lesions to facilitate referral for further investigation and diagnosis. Management is challenging with long-term monitoring and surgical excision when appropriate; however, PVL tends to recur following surgical excision. This article provides an up-to-date review tailored for GDPs on the present knowledge of PVL and illustrates the management challenges with clinical cases.

Perspectives of women and partners from migrant and refugee backgrounds accessing the Cross Cultural Worker Service in maternity and early childhood services-a survey study.

BACKGROUND: Women from migrant and refugee backgrounds living in high-income countries have increased risk of adverse perinatal outcomes and report lower satisfaction with perinatal healthcare. In Sydney, Australia, a new service known as the Cross Cultural Workers (CCWs) in Maternity and Child and Family Health Service (the CCW Service) was implemented to support such women and families from pregnancy to the early parenting period. This study aimed to ascertain the experiences of women and their partners engaging with the CCW Service. METHODS: A survey study was undertaken. Women accessing the CCW Service were recruited during pregnancy and were asked to complete surveys at three time points: in the third trimester of pregnancy, at 6 and 12 months postpartum. Their partners were invited to complete a survey at 6 months postpartum. Survey data were analysed to compare satisfaction, usefulness, number of CCW interactions, cultural sensitivity, and service improvement recommendations across all three survey timepoints. RESULTS: A total of 231 surveys were received: 113 during pregnancy, 50 at 6-months postpartum, 44 at 12-months postpartum, and 24 partner surveys. Participants in all surveys reported the CCW Service to be useful (84-94%), stating that it increased their understanding of pregnancy, birth and parenting (95-100%), and that they would recommend the CCW Service (92-98%). Participants experienced a high level of satisfaction (88-95%) irrespective of the number of CCW interactions (p = 0.42). Thoughts on becoming a mother or parent were more positive after meeting the CCW than before for both women (p = 0.01) and partners (p = 0.12). Suggestions for CCW Service improvement were to 1) increase the provision of information, specifically financial entitlements, postnatal depression, and support services, 2) increase involvement of partners in care, 3) increase the CCW workforce/or number of CCWs. CONCLUSION: The CCW Service was associated with positive experiences and high rates of satisfaction at all timepoints. This service has the potential to inform the implementation of similar models of care that improve accessibility, the perinatal experience, and respond to the unique needs of women and families from migrant and refugee backgrounds.

Are we Getting It Right First Time? An exploration of clinical coding practices within a UK paediatric dental hospital department.

Introduction Issues arising from the current coding system in dentistry have been highlighted. Available codes are considered to lack clarity and fail to reflect all dental specialties. There are no paediatric-specific codes, which means codes from other specialties are used, which may not accurately reflect the work carried out.Aim This paper aims to explore the range of codes and the consistency and accuracy of current coding practices within the paediatric dentistry department at Newcastle Dental Hospital, and explore the potential impact of introducing new speciality-specific codes for the aforementioned procedures.Method Data were retrospectively collected to determine whether the following treatments had been undertaken, and if so, which procedure code had been used for the treatment: inhalation sedation; dietary advice; acclimatisation; preformed metal crowns, silver diamine fluoride application; and apexification. All codes used within the department for a six-month period were also reviewed retrospectively and the frequency in which procedures relating to the potential new codes would be undertaken within the department was estimated to facilitate consideration of potential financial impact of the introduction of new codes.Results Codes utilised for the aforementioned procedures did not accurately reflect work carried out despite being relatively consistent. The potential new codes corresponded to procedures that were commonly undertaken within the department.Discussion This study highlights shortcomings in the coding system relating to a lack of applicable codes for paediatric dentistry procedures. Introduction of new speciality-specific codes should help to address this deficit to ensure a more accurate representation of the needs of the community to help commissioning and workforce planning.

A multi-site service evaluation of silver diamine fluoride use for children.

Introduction The use of silver diamine fluoride (SDF) is relatively new to the UK. It is unknown how it is being used and for what indications in UK paediatric dental services.Aim To: 1) establish how SDF is being used across different paediatric dental settings in the UK; and 2) consider parental and patient views on the treatment experience and side effect of discolouration.Method A multi-site service evaluation was carried out across six paediatric dentistry units covering hospital and community services. Data were collected prospectively from 17/02/2020 to 02/03/2022. Simple descriptive statistics were used to analyse the data.Results Data were collected for 54 patients. The included patients had an age range of 2-13 years, with a mean of 4.9 years. The reason SDF was chosen was reported as: to avoid general anaesthetic (n = 25); to avoid extractions (n = 8); stabilisation (n = 25); acclimatisation (n = 24); and insufficient cooperation for other treatment (n = 17). In total, 42 cases had SDF applied to the primary dentition. This was in the anterior dentition for 18 patients and the posterior dentition for 15, with nine patients having SDF applied both anteriorly and posteriorly. The majority of children and parents were accepting of the technique and immediate aesthetic outcome.Conclusion In the services involved in this multi-site service evaluation, SDF is used for young patients in the primary dentition for the purpose of caries arrest. The technique was viewed positively by the majority of parents and children.

Interventions to enhance pre-pregnancy care for women with type 2 diabetes: A systematic review of the literature.

AIMS: The aim of the study was to examine the content and impact of interventions that have been used to increase the uptake of pre-pregnancy care for women with type 2 diabetes, and their impact on maternal and fetal outcomes. METHODS: A systematic search of multiple databases was conducted in November 2021, and updated July 2022, to identify studies assessing interventions to enhance pre-pregnancy care for women with type 2 diabetes. Over 10% of articles were screened by two reviewers at title and abstract phase, after which all selected full-text articles were screened by two reviewers. Quality assessment was conducted using the Critical Appraisal Skills Programme checklist for cohort studies. Meta-analysis was not possible due to study heterogeneity; therefore, narrative synthesis was conducted. RESULTS: Four eligible cohort studies were identified. The conclusions able to be drawn by this review were limited as women with type 2 diabetes (n = 800) were in the minority in all four studies (35%-40%) and none of the interventions were exclusively tailored for them. The uptake of pre-pregnancy care was lower in women with type 2 diabetes (8%-10%) compared with other participant groups in the studies. Pregnancy preparation indicators generally improved among all groups exposed to pre-pregnancy care, with varying impact on pregnancy outcomes. CONCLUSIONS: This review demonstrates that previous interventions have had a limited impact on pre-pregnancy care uptake in women with type 2 diabetes. Future studies should focus on tailored interventions for improving pre-pregnancy care for women with type 2 diabetes, particularly those from ethnic minorities and living in poorer communities.

Co-creation to Develop Interventions to Facilitate Deep Reflection for Dental Students.

Background: Deep reflective practice is important in healthcare education to allow students to explore emotions associated with the learning experience, access deeper learning and develop their personal and professional identity. Previous research demonstrated that the current methods of reflective practice using logbooks at the end of a clinical session to facilitate reflection within this setting were viewed as suboptimal by staff and student users. To address this problem co-creation, or a 'students as partners' approach, was used to develop and implement a comprehensive intervention to facilitate deep reflection for undergraduate dental students. This included the production of educational resources, and development of an online safe space to reflect. Approach: In this paper we discuss the process of using co-creation with undergraduate dental students as a research methodology to successfully produce curricular change with respect to reflective practice by involving the voice and experience of student partners. These student partners were part of a team that included researchers and teaching staff and worked with other stakeholders within the institution within a wider team. Evaluation: This paper demonstrates the positive benefits of using co-creation with undergraduate dental students for students such as increased confidence, developing professional and personal skills and impacting meaningful change. Reflection: For researchers and educators, the process gave motivation and enjoyment in curricular development to address pedagogical problems and ensured that the developed intervention was sustainable and appropriate. The paper discusses benefits and challenges of co-creation to develop curricular change. This co-creation approach is recommended for solving similar problems in healthcare education.

The gestational diabetes future diabetes prevention study (GODDESS): A partially randomised feasibility controlled trial.

OBJECTIVES: To assess the feasibility of an ante- and post-natal lifestyle intervention for women with gestational diabetes mellitus (GDM) to reduce type 2 diabetes risk. DESIGN: A partially randomised patient preference feasibility trial. SETTING: Diabetes antenatal clinics in two inner-London hospitals, UK. PARTICIPANTS: Pregnant women ≥18 years with a GDM diagnosis and pre-pregnancy body mass index of ≥25kg/m2. INTERVENTION: Participants in the intervention group were offered four motivational interview-based sessions (two antenatally and two postnatally, at 3 and 6 months postpartum), a WhatsApp support group, a FitBit and electronic self-help resources. OUTCOME MEASURES: Recruitment; retention; intervention dose received; data completion; adaptions; proportion achieving ≥5% weight loss; weight change, blood glucose; blood pressure; diet, physical activity, breastfeeding and depression. Clinical outcomes were measured at baseline and 6 months postpartum. RESULTS: 50 participants were recruited from 155 eligible women (32% recruitment rate). Thirty-four were recruited to the intervention group (23 following randomisation (RI-group) and 11 based on preference (PI-group)); and 16 to the control group (13 randomised (RC-group) and 3 preference (PC-group)). Attrition was 44% (n = 22/50). Forty-six percent (n = 6) of the intervention group (25% (n = 2) of the RI-group and 80% (n = 4) of the PI-group) achieved ≥5% weight loss compared to 8% (n = 1) in the control group (95% confidence interval (CI) -0.69 to 0.07). Mean weight change was -2.1kg±9.0 in the intervention group (0kg±5.4 in the RI-group and -5.4kg±13.0 in the PI-group) compared to +4.4kg±4.9 in the control group (RC +4.4kg ±5.3 and PC +4.7kg ±3.1, 95% CI -12.4 to 0.2). CONCLUSIONS: Recruitment was feasible, but strategies to improve retention are needed. The findings suggest the intervention can support women with GDM to lose weight. The observed weight loss was primarily in women who preferred the intervention. Therefore, future trials may need to adopt a preference design and consider factors associated with preference. TRIAL REGISTRATION: Trial registration: ISRCTN52675820 https://www.isrctn.com/ISRCTN52675820?q=ISRCTN52675820&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search.

Study protocol for a real-world evaluation of an integrated child and family health hub for migrant and refugee women.

INTRODUCTION: Continuity of child and family healthcare is vital for optimal child health and development for developmentally vulnerable children. Migrant and refugee communities are often at-risk of poor health outcomes, facing barriers to health service attendance including cultural, language, limited health literacy, discrimination and unmet psychosocial needs. 'Integrated health-social care hubs' are physical hubs where health and social services are co-located, with shared referral pathways and care navigation. AIM: Our study will evaluate the impact, implementation and cost-benefit of the First 2000 Days Care Connect (FDCC) integrated hub model for pregnant migrant and refugee women and their infants. MATERIALS AND METHODS: This study has three components. Component 1 is a non-randomised controlled trial to compare the FDCC model of care with usual care. This trial will allocate eligible women to intervention and control groups based on their proximity to the Hub sites. Outcome measures include: the proportion of children attending child and family health (CFH) nurse services and completing their CFH checks to 12 months of age; improved surveillance of growth and development in children up to 12 months, post partum; improved breastfeeding rates; reduced emergency department presentations; and improved maternal well-being. These will be measured using linked medical record data and surveys. Component 2 will involve a mixed-method implementation evaluation to clarify how and why FDCC was implemented within the sites to inform future roll-out. Component 3 is a within-trial economic evaluation from a healthcare perspective to assess the cost-effectiveness of the Hubs relative to usual care and the implementation costs if Hubs were scaled and replicated. ETHICS AND DISSEMINATION: Ethical approval was granted by the South Eastern Sydney Local Health District Human Research Ethics Committee in July 2021 (Project ID: 020/ETH03295). Results will be submitted for publication in peer-reviewed journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001088831.

Through the looking glass: a review of the literature surrounding reflective practice in dentistry.

Reflection is an essential component of the learning process that helps to elicit deeper learning. In healthcare, this uses experiential activities to produce knowledge that compels the clinician to change their practice. Deep reflection allows one to explore emotions associated with challenging learning experiences, empowering reinterpretation of these experiences and removing barriers to further learning. Reflection is a key requirement of dental education at all stages. This paper aims to explore the existing literature on reflective practice in dentistry and identify areas for further research to improve reflective practice within dentistry.Traditional methods of reflecting through written means are not facilitating the deep reflection which is desired. A systematic overhaul of reflective practice is suggested, involving a shift away from structured written reflections. There is little evidence to inform the most appropriate format for reflective practice in dental education. There is a need for further research to determine the effectiveness of reflective practice in dental education, particularly as a move away from structured written reflection to more creative reflective opportunities are encouraged. Greater exploration of barriers to reflection in dentistry is indicated, with consideration to how these may be overcome and a need to engage regulatory bodies in system-wide changes.

An integrated primary care-based programme of PRE-Pregnancy cARE to improve pregnancy outcomes in women with type 2 Diabetes (The PREPARED study): protocol for a multi-method study of implementation, system adaptation and performance.

BACKGROUND: The number of women of childbearing age with Type 2 diabetes(T2DM) is increasing, and they now account for > 50% of pregnancies in women with pre-existing diabetes. Diabetes pregnancies without adequate pre-pregnancy care have higher risk for poor outcomes (miscarriages, birth-defects, stillbirths) and are associated with increased complications (caesarean deliveries, macrosomic babies, neonatal intensive-care admissions). The risks and costs of these pregnancies can be reduced with pregnancy preparation (HbA1c, ≤ 6.5%, 5 mg folic acid and stopping potentially harmful medicines). However, 90% of women with T2DM, most of whom are based in primary care, are not adequately prepared for pregnancy. This study will evaluate a programme of primary care-based interventions (decision-support systems; pre-pregnancy care-pathways; pregnancy-awareness resources; professional training; and performance monitoring) to improve pregnancy preparation in women with T2DM. METHODS: The study aims to optimise the programme interventions and estimate their impact on pregnancy preparation, pre-pregnancy care uptake and pregnancy outcomes. To evaluate this multimodal intervention, we will use a multi-method research design following Complex Adaptive Systems (CAS) theory, refining the interventions iteratively during the study. Thirty GP practices with ≥ 25 women with T2DM of reproductive age (18-45 years) from two South London boroughs will be exposed to the intervention. This will provide > 750 women with an estimated pregnancy incidence of 80-100 to study. The research involves: a clinical audit of processes and outcomes; a process evaluation informing intervention feasibility, implementation, and behaviour change; and a cost-consequences analysis informing future economic evaluation. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes. Following CAS theory, we will use repeated measurements to monitor intervention impact on pregnancy preparation markers at 4-monthly intervals over 18-months. We will use performance and feasibility data to optimise intervention effects iteratively. The target performance for the intervention is a 30% increase in the proportion of women meeting pre-pregnancy care criteria. DISCUSSION: The primary output will be development of an integrated programme of interventions to improve pregnancy preparation, pre-pregnancy care uptake, and reduce adverse pregnancy outcomes in women with T2DM. We will also develop an implementation plan to support the introduction of the interventions across the NHS. TRIAL REGISTRATION: ISRCTN47576591 ; February 8, 2022.

A parallel randomised controlled trial of the Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised self-care (HARPdoc).

Impaired awareness of hypoglycaemia (IAH) is a major risk for severe hypoglycaemia in insulin treatment of type 1 diabetes (T1D). To explore the hypothesis that unhelpful health beliefs create barriers to regaining awareness, we conducted a multi-centre, randomised, parallel, two-arm trial (ClinicalTrials.gov NCT02940873) in adults with T1D and treatment-resistant IAH and severe hypoglycaemia, with blinded analysis of 12-month recall of severe hypoglycaemia at 12 and/or 24 months the primary outcome. Secondary outcomes included cognitive and emotional measures. Adults with T1D, IAH and severe hypoglycaemia despite structured education in insulin adjustment, +/- diabetes technologies, were randomised to the "Hypoglycaemia Awareness Restoration Programme despite optimised self-care" (HARPdoc, n = 49), a psychoeducation programme uniquely focussing on changing cognitive barriers to avoiding hypoglycaemia, or the evidence-based "Blood Glucose Awareness Training" (BGAT, n = 50), both delivered over six weeks. Median [IQR] severe hypoglycaemia at baseline was 5[2-12] per patient/year, 1[0-5] at 12 months and 0[0-2] at 24 months, with no superiority for HARPdoc (HARPdoc vs BGAT incident rate ratios [95% CI] 1.25[0.51, 3.09], p = 0.62 and 1.26[0.48, 3.35], p = 0.64 respectively), nor for changes in hypoglycaemia awareness scores or fear. Compared to BGAT, HARPdoc significantly reduced endorsement of unhelpful cognitions (Estimated Mean Difference for Attitudes to Awareness scores at 24 months, -2.07 [-3.37,-0.560], p = 0.01) and reduced scores for diabetes distress (-6.70[-12.50,-0.89], p = 0.02); depression (-1.86[-3.30, -0.43], p = 0.01) and anxiety (-1.89[-3.32, -0.47], p = 0.01). Despite positive impact on cognitive barriers around hypoglycaemia avoidance and on diabetes-related and general emotional distress scores, HARPdoc was not more effective than BGAT at reducing severe hypoglycaemia.

Characteristics of adults with type 1 diabetes and treatment-resistant problematic hypoglycaemia: a baseline analysis from the HARPdoc RCT.

AIMS/HYPOTHESIS: Problematic hypoglycaemia still complicates insulin therapy for some with type 1 diabetes. This study describes baseline emotional, cognitive and behavioural characteristics in participants in the HARPdoc trial, which evaluates a novel intervention for treatment-resistant problematic hypoglycaemia. METHODS: We documented a cross-sectional baseline description of 99 adults with type 1 diabetes and problematic hypoglycaemia despite structured education in flexible insulin therapy. The following measures were included: Hypoglycaemia Fear Survey II (HFS-II); Attitudes to Awareness of Hypoglycaemia questionnaire (A2A); Hospital Anxiety and Depression Index; and Problem Areas In Diabetes. k-mean cluster analysis was applied to HFS-II and A2A factors. Data were compared with a peer group without problematic hypoglycaemia, propensity-matched for age, sex and diabetes duration (n = 81). RESULTS: The HARPdoc cohort had long-duration diabetes (mean ± SD 35.8 ± 15.4 years), mean ± SD Gold score 5.3 ± 1.2 and a median (IQR) of 5.0 (2.0-12.0) severe hypoglycaemia episodes in the previous year. Most individuals had been offered technology and 49.5% screened positive for anxiety (35.0% for depression and 31.3% for high diabetes distress). The cohort segregated into two clusters: in one (n = 68), people endorsed A2A cognitive barriers to hypoglycaemia avoidance, with low fear on HFS-II factors; in the other (n = 29), A2A factor scores were low and HFS-II high. Anxiety and depression scores were significantly lower in the comparator group. CONCLUSIONS/INTERPRETATION: The HARPdoc protocol successfully recruited people with treatment-resistant problematic hypoglycaemia. The participants had high anxiety and depression. Most of the cohort endorsed unhelpful health beliefs around hypoglycaemia, with low fear of hypoglycaemia, a combination that may contribute to persistence of problematic hypoglycaemia and may be a target for adjunctive psychological therapies.