Study protocol for a multicentre comparative diagnostic accuracy study of tools to establish the presence and severity of peripheral arterial disease in people with diabetes mellitus: the DM PAD study.

INTRODUCTION: Peripheral arterial disease (PAD) is a key risk factor for cardiovascular disease, foot ulceration and lower limb amputation in people with diabetes. Early diagnosis of PAD can enable optimisation of therapies to manage these risks. Its diagnosis is fundamental, though challenging in the context of diabetes. Although a variety of diagnostic bedside tests are available, there is no agreement as to which is the most accurate in routine clinical practice.The aim of this study is to determine the diagnostic performance of a variety of tests (audible waveform assessment, visual waveform assessment, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in people with diabetes as determined by a reference test (CT angiography (CTA) or magnetic resonance angiography (MRA)). In selected centres, we also aim to evaluate the performance of a new point-of-care duplex ultrasound scan (PAD-scan). METHODS AND ANALYSIS: A prospective multicentre diagnostic accuracy study (ClinicalTrials.gov Identifier NCT05009602). We aim to recruit 730 people with diabetes from 18 centres across the UK, covering primary and secondary healthcare. Consenting participants will undergo the tests under investigation. Reference tests (CTA or MRA) will be performed within 6 weeks of the index tests. Imaging will be reported by blinded consultant radiologists at a core imaging lab, using a validated scoring system, which will also be used to categorise PAD severity. The presence of one or more arterial lesions of ≥50% stenosis, or tandem lesions with a combined value of ≥50%, will be used as the threshold for the diagnosis of PAD. The primary outcome measure of diagnostic performance will be test sensitivity. ETHICS AND DISSEMINATION: The study has received approval from the National Research Ethics Service (NRES) (REC reference 21/PR/1221). Results will be disseminated through research presentations and papers. TRIAL REGISTRATION NUMBER: NCT05009602.

Evaluating the medical direct costs associated with prematurity during the initial hospitalization in Rwanda: a prevalence based cost of illness study.

BACKGROUND: Prematurity is still the leading cause of global neonatal mortality, Rwanda included, even though advanced medical technology has improved survival. Initial hospitalization of premature babies (PBs) is associated with high costs which have an impact on Rwanda's health budget. In Rwanda, these costs are not known, while knowing them would allow better planning, hence the purpose and motivation for this research. METHODS: This was a prospective cost of illness study using a prevalence approach conducted in 5 hospitals (University Teaching Hospital of Butare, Gisenyi, Masaka, Muhima, and Ruhengeri). It included PBs admitted from June to July 2021 followed up prospectively to determine the medical direct costs (MDC) by enumerating the cost of all inputs. Descriptive analyses and ordinary least squares regression were used to illustrate factors associated with and predictive of mean cost. The significance level was set at p < 0.05. RESULTS: A total of 123 PBs were included. Very preterm and moderate PBs were 36.6% and 23.6% respectively and the average birth weight (BW) was 1724 g (SD: 408.1 g). The overall mean MDC was $237.7 per PB (SD: $294.9) representing 28% of Gross Domestic Product (GDP) per capita per year. Costs per PB varied with weight category, prematurity degree, hospital level, and length of stay (LoS) among other variables. MDC was dominated by drugs and supplies (65%) with oxygen being an influential driver of MDC accounting for 38.4% of total MDC. Birth weight, oxygen therapy, and hospital level were significant MDC predictive factors. CONCLUSION: This study provides an in-depth understanding of MDC of initial hospitalization of PBs in Rwanda. It also indicates predictive factors, including birth weight, which can be managed through measures to prevent or delay preterm birth. IMPLICATION FOR PREMATURITY PREVENTION AND MANAGEMENT: The results suggest a need to revise the benefits and entitlements of insured people to include drugs and interventions not covered that are essential and where there are no alternatives. Having oxygen plants in hospitals may reduce oxygen-related costs. Furthermore, interventions to reduce prematurity should be evaluated using cost-effectiveness analysis since its overall burden is high.

Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS²ACE): trial protocol for a randomised controlled multicentre trial.

INTRODUCTION: Spinal cord injury (SCI) including permanent paraplegia constitutes a common complication after repair of thoracoabdominal aortic aneurysms. The staged-repair concept promises to provide protection by inducing arteriogenesis so that the collateral network can provide a robust blood supply to the spinal cord after intervention. Minimally invasive staged segmental artery coil embolisation (MIS2ACE) has been proved recently to be a feasible enhanced approach to staged repair. METHODS AND ANALYSIS: This randomised controlled trial uses a multicentre, multinational, parallel group design, where 500 patients will be randomised in a 1:1 ratio to standard aneurysm repair or to MIS2ACE in 1-3 sessions followed by repair. Before randomisation, physicians document whether open or endovascular repair is planned. The primary endpoint is successful aneurysm repair without substantial SCI 30 days after aneurysm repair. Secondary endpoints include any form of SCI, mortality (up to 1 year), length of stay in the intensive care unit, costs and quality-adjusted life years. A generalised linear mixed model will be used with the logit link function and randomisation arm, mode of repair (open or endovascular repair), the Crawford type and the European System for Cardiac Operative Risk Evaluation (euroSCORE) II as fixed effects and the centre as a random effect. Safety endpoints include kidney failure, respiratory failure and embolic events (also from debris). A qualitative study will explore patient perceptions. ETHICS AND DISSEMINATION: This trial has been approved by the lead Ethics Committee from the University of Leipzig (435/17-ek) and will be reviewed by each of the Ethics Committees at the trial sites. A dedicated project is coordinating communication and dissemination of the trial. TRIAL REGISTRATION NUMBER: NCT03434314.