A web-based self-management programme for people with type 2 diabetes : the HeLP-Diabetes research programme including RCT

Background: In the UK, 6% of the UK population have diabetes mellitus, 90% of whom have type 2 diabetes mellitus (T2DM). Diabetes mellitus accounts for 10% of NHS expenditure (£14B annually). Good self-management may improve health outcomes. NHS policy is to refer all people with T2DM to structured education, on diagnosis, to improve their self-management skills, with annual reinforcement thereafter. However, uptake remains low (5.6% in 2014–15). Almost all structured education is group based, which may not suit people who work, who have family or other caring commitments or who simply do not like group-based formats. Moreover, patient needs vary with time and a single education session at diagnosis is unlikely to meet these evolving needs. A web-based programme may increase uptake. / Objectives: Our aim was to develop, evaluate and implement a web-based self-management programme for people with T2DM at any stage of their illness journey, with the goal of improving access to, and uptake of, self-management support, thereby improving health outcomes in a cost-effective manner. Specific objectives were to (1) develop an evidence-based theoretically informed programme that was acceptable to patients and health-care professionals (HCPs) and that could be readily implemented within routine NHS care, (2) determine the clinical effectiveness and cost-effectiveness of the programme compared with usual care and (3) determine how best to integrate the programme into routine care. / Design: There were five linked work packages (WPs). WP A determined patient requirements and WP B determined HCP requirements for the self-management programme. WP C developed and user-tested the Healthy Living for People with type 2 Diabetes (HeLP-Diabetes) programme. WP D was an individually randomised controlled trial in primary care with a health economic analysis. WP E used a mixed-methods and case-study design to study the potential for implementing the HeLP-Diabetes programme within routine NHS practice. / Setting: English primary care. / Participants: People with T2DM (WPs A, D and E) or HCPs caring for people with T2DM (WPs B, C and E). / Intervention: The HeLP-Diabetes programme; an evidence-based theoretically informed web-based self-management programme for people with T2DM at all stages of their illness journey, developed using participatory design principles. / Main outcome measures: WPs A and B provided data on user ‘wants and needs’, including factors that would improve the uptake and accessibility of the HeLP-Diabetes programme. The outcome for WP C was the HeLP-Diabetes programme itself. The trial (WP D) had two outcomes measures: glycated haemoglobin (HbA1c) level and diabetes mellitus-related distress, as measured with the Problem Areas in Diabetes (PAID) scale. The implementation outcomes (WP E) were the adoption and uptake at clinical commissioning group, general practice and patient levels and the identification of key barriers and facilitators. / Results: Data from WPs A and B supported our holistic approach and addressed all areas of self-management (medical, emotional and role management). HCPs voiced concerns about linkage with the electronic medical records (EMRs) and supporting patients to use the programme. The HeLP-Diabetes programme was developed and user-tested in WP C. The trial (WP D) recruited to target (n = 374), achieved follow-up rates of over 80% and the intention-to-treat analysis showed that there was an additional improvement in HbA1c levels at 12 months in the intervention group [mean difference –0.24%, 95% confidence interval (CI) –0.44% to –0.049%]. There was no difference in overall PAID score levels (mean difference –1.5 points, 95% CI –3.9 to 0.9 points). The within-trial health economic analysis found that incremental costs were lower in the intervention group than in the control group (mean difference –£111, 95% CI –£384 to £136) and the quality-adjusted life-years (QALYs) were higher (mean difference 0.02 QALYs, 95% CI 0.000 to 0.044 QALYs), meaning that the HeLP-Diabetes programme group dominated the control group. In WP E, we found that the HeLP-Diabetes programme could be successfully implemented in primary care. General practices that supported people in registering for the HeLP-Diabetes programme had better uptake and registered patients from a wider demographic than those relying on patient self-registration. Some HCPs were reluctant to do this, as they did not see it as part of their professional role. / Limitations: We were unable to link the HeLP-Diabetes programme with the EMRs or to determine the effects of the HeLP-Diabetes programme on users in the implementation study. / Conclusions: The HeLP-Diabetes programme is an effective self-management support programme that is implementable in primary care. / Future work: The HeLP-Diabetes research team will explore the following in future work: research to determine how to improve patient uptake of self-management support; develop and evaluate a structured digital educational pathway for newly diagnosed people; develop and evaluate a digital T2DM prevention programme; and the national implementation of the HeLP-Diabetes programme. / Trial registration: Research Ethics Committee reference number 10/H0722/86 for WPs A–C; Research Ethics Committee reference number 12/LO/1571 and UK Clinical Research Network/National Institute for Health Research (NIHR) Portfolio 13563 for WP D; and Research Ethics Committee 13/EM/0033 for WP E. In addition, for WP D, the study was registered with the International Standard Randomised Controlled Trial Register as reference number ISRCTN02123133. / Funding details: This project was funded by the NIHR Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 6, No. 5. See the NIHR Journals Library website for further project information

The importance of infrarenal sealing zone assessment in endovascular aneurysm repair

An abdominal aortic aneurysm (AAA) is a dilatation of the abdominal aorta and occurs in 2-8% of the population. AAAs carry a high risk of rupture, often resulting in fatalities. Therefore, patients undergo preventive treatment with endovascular aneurysm repair (EVAR). During EVAR, an endograft is inserted to exclude the aneurysm from blood flow. Ensuring adequate contact surface (sealing zone) between the endograft and the aortic wall below the renal arteries (infrarenal) is crucial to prevent complications, such as proximal leakage of blood into the aneurysm (type 1a endoleak). Currently, annual CT-scans are performed to detect complications post-EVAR. However, the assessment of the infrarenal sealing zone is often overlooked, and complications are missed. This is why the primary goal of this thesis was to advocate for structured sealing zone assessment following EVAR. Our approach began with defining the preoperative and postoperative sealing zones, and we developed a decision algorithm to determine the most appropriate follow-up strategy. Additionally, we demonstrated that the length of the postoperative sealing zone is a predictor for the development of type 1a endoleaks. A diminishing sealing zone length may indicate the onset of a type 1a endoleak as well. Furthermore, we explored the performance of a novel endograft for EVAR in patients with challenging aortic anatomy. The sealing zone length serves as a crucial quality outcome measure that should be routinely evaluated. While there are still challenges to overcome, the time is ripe to incorporate structured sealing zone assessment into clinical EVAR practice to proactively prevent complications

Single-center results of the Gore Excluder Conformable Endoprosthesis with active control system in endovascular aneurysm repair

BACKGROUND: The GORE EXCLUDER Conformable Endoprosthesis with active control (CEXC) was developed to treat challenging aortic neck anatomy. This study investigated the clinical results and changes in endograft (ap)position during follow-up. METHODS: Patients treated with the CEXC between 2018 and 2022 were included in this prospective single-center study. Computed tomography angiography (CTA) follow-up was grouped into three categories: 0 to 6 (FU1), 7 to 18 (FU2), and 19 to 30 (FU3) months. Clinical end points were endograft-associated complications and reinterventions. CTA analysis included the shortest apposition length (SAL) between the endograft fabric and the first slice where circumferential apposition was lost, shortest fabric distance (SFD) between both renal arteries and the endograft fabric, and maximum infrarenal and suprarenal aortic curvature. FU2 and FU3 were compared with FU1 to establish changes. RESULTS: Included were 46 patients, of whom 36 (78%) had at least one hostile neck feature and 13 (28%) were treated outside instructions for use. Technical success was 100%. Median CTA follow-up was 10 months (2-20 months); 39 patients had a CTA available at FU1, 22 at FU2, and 12 at FU3. At FU1, the median SAL was 21.4 mm (13.2-27.4 mm), which did not significantly change during follow-up. No type I endoleaks, and one type III endoleak at an IBD occurred during follow-up. Two cases of endograft migration (SFD increase &gt;10 mm) were seen during follow-up (one treated outside the instructions for use). Maximum infrarenal and suprarenal aortic curvature did not significantly change during follow-up. CONCLUSIONS: The use of the CEXC in challenging aortic necks enables stable apposition without significant changes in aortic morphology at short-term follow-up.</p