2021 RD&E publications
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A summary list of all RD&E research outputs published or issued in 2021
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Item Updating estimates of the number of UK stroke patients eligible for endovascular thrombectomy: incorporating recent evidence to facilitate service planning(Sage, 2021-12-01) McMeekin, P.; Flynn, D.; James, M.; Price, C. I.; Ford, G. A.; White, P.INTRODUCTION: Endovascular thrombectomy (EVT) is a highly effective treatment for acute ischaemic stroke due to large arterial occlusion (LAO). To support decisions about service provision, we previously estimated the annual UK population eligible for EVT as ∼10% of stroke admissions. Since then, several trials have produced evidence that could alter these figures. We update our estimates considering information from studies and trials reporting 2018-2021 on incidence, presentation time and stroke severity and consider the possible impact of predicted demographic changes in the next 10-20 years. PATIENTS AND METHODS: We produce an updated decision tree describing the EVT eligible population for UK stroke admissions. One-way sensitivity analyses (using upper and lower confidence intervals for estimates at each branch of our decision tree) were used to identify where further research evidence is necessary to increase certainty around estimates for numbers of EVT eligible patients. RESULTS: The updated estimate for the number of UK stroke patients eligible for EVT annually was between 10,020 (no advanced imaging in early presenting patients) and 9,580 (advanced imaging in all early presenting patients), which compared with our estimates in 2017 is a minimal reduction. One-way sensitivity analyses established that enhanced evidence about eligibility for milder strokes, ASPECTS scores and pre-stroke disability are offset by evidence regarding a lower incidence of LAO. Importantly, predicted increases in life expectancy by 2040 may increase thrombectomy need by 40%. DISCUSSION: Information from additional randomised trials published during 2018-2020 with updated estimates of LAO prevalence had a minimal impact on overall estimates of stroke patients eligible for EVT in the UK. Ongoing research into the benefits of EVT for patients with mild stroke or European Stroke Journal For Peer Review lower ASPECTS scores has the potential to increase the estimates of the eligible population; future need for EVT will increase with the ageing population. CONCLUSION: Our updated analyses show overall numbers eligible little changed, but evidence from ongoing trials and demographic changes have the potential to increase the need for EVT significantly.Item Lissencephaly-pachygyria spectrum in a North Indian boy with Wolcott-Rallison syndrome due to homozygous deletion of exon 1 in the EIF2AK3 gene(Termedia, 2021-12-20) Gupta, A.; Reddy, C.; Saini, L.; Yadav, J.; Kumar, R.; Houghton, J.; Ellard, S.; Dayal, D.BACKGROUND: Wolcott-Rallison syndrome (WRS) is a rare autosomal recessive disorder characterized by neonatal diabetes mellitus (NDM), epiphyseal dysplasia, and hepatic and renal dysfunction. Although neuro-psychological features are common in patients with WRS, malformations of cortical development (MCDs) are rarely reported. CASE PRESENTATION: A 3-month-old boy, born to non-consanguineous parents, presented with right focal seizures since two months of age and recently detected diabetes mellitus. He also had a small head and lissencephaly-pachygyria spectrum on brain imaging. Genetic testing confirmed the diagnosis of WRS by identifying a biallelic homozygous deletion of exon 1 in the EIF2AK3 gene. The child achieved reasonable glycemic control on the basal-bolus insulin regimen. CONCLUSIONS: Presentation of WRS may occur with neurological manifestations such as lissencephaly-pachygyria spectrum. Early confirmation of the genetic diagnosis of WRS by screening for pathogenic variants in the EIF2AK3 gene is important in children with NDM and associated syndromic features. Establishing the diagnosis of WRS helps in predicting the development of subsequent clinical features, guides management, and may improve patient outcomes.Item Commentary on 'Academic Global Surgery Curricula: Current Status and a Call for a More Equitable Approach.'(Elsevier, 2021-12-09) Pasha, T.; Dickson, K.; Chin, Y. R.; Harrison, C. J.Item A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond(BioMed Central, 2021-12-11) Masoli, J. A. H.; Down, K.; Nestor, G.; Hudson, S.; O'Brien, J. T.; Williamson, J. D.; Young, C. A.; Carroll, C.BACKGROUND: Prior to the COVID-19 pandemic, the majority of clinical trial activity took place face to face within clinical or research units. The COVID-19 pandemic resulted in a significant shift towards trial delivery without in-person face-to-face contact or Remote Trial Delivery". The National Institute of Health Research (NIHR) assembled a Remote Trial Delivery Working Group to consider challenges and enablers to this major change in clinical trial delivery and to provide a toolkit for researchers to support the transition to remote delivery. METHODS: The NIHR Remote Trial Delivery Working Group evaluated five key domains of the trial delivery pathway: participant factors, recruitment, intervention delivery, outcome measurement and quality assurance. Independent surveys were disseminated to research professionals, and patients and carers, to ascertain benefits, challenges, pitfalls, enablers and examples of good practice in Remote Trial Delivery. A toolkit was constructed to support researchers, funders and governance structures in moving towards Remote Trial Delivery. The toolkit comprises a website encompassing the key principles of Remote Trial Delivery, and a repository of best practice examples and questions to guide research teams. RESULTS: The patient and carer survey received 47 respondents, 34 of whom were patients and 13 of whom were carers. The professional survey had 115 examples of remote trial delivery practice entered from across England. Key potential benefits included broader reach and inclusivity, the ability for standardisation and centralisation, and increased efficiency and patient/carer convenience. Challenges included the potential exclusion of participants lacking connectivity or digital skills, the lack of digitally skilled workforce and appropriate infrastructure, and validation requirements. Five key principles of Remote Trial Delivery were proposed: national research standards, inclusivity, validity, cost-effectiveness and evaluation of new methodologies. CONCLUSIONS: The rapid changes towards Remote Trial Delivery catalysed by the COVID-19 pandemic could lead to sustained change in clinical trial delivery. The NIHR Remote Trial Delivery Working Group provide a toolkit for researchers recommending five key principles of Remote Trial Delivery and providing examples of enablers."Item Refining Orthognathic Surgery Results by Synchronous Cheek Fat Compartment Augmentation with Fat Grafting in Adult Females with Class III Skeletal Profiles(Lippincott, Williams & Wilkins, 2021-12-01) Denadai, R.; Wallace, C. G.; Chou, P. Y.; Lo, L. J.; Chen, Y. R.; Chang, C. S.SUMMARY: Patients with maxillomandibular disharmony may present with a flat to concave midface. The effects of orthognathic surgery concomitant with midface fat grafting on facial appearance and midface volumetric and positional change have not formally been assessed to date. The authors' approach for synchronous orthognathic surgery and fat grafting is described and evaluated. Adult female patients (n = 20) who underwent synchronous two-jaw orthognathic surgery and cheek-specific fat grafting (1.9 ± 0.6 cm3 per side) for correction of skeletal class III deformity and anteromedial cheek deficiency were prospectively included. Preoperative and postoperative photographs were appraised by 42 blinded raters using facial appearance scales for beauty, attractiveness, and pleasantness parameters. The three-dimensional midface soft-tissue volume change and postoperative cheek mass position were computed. Facial imaging data from gender-, ethnic-, and facial pattern-matched adult patients (n = 20) who underwent isolated two-jaw orthognathic surgery (n = 20) were included for comparison. The three-dimensional facial norms database-derived cheek mass position information (2.19 ± 1.31mm) was also adopted for analysis. Patients treated with the synchronous procedure had significantly (p < 0.001) increased facial appearance-related perception change for beauty (2.9 ± 1.6), attractiveness (2.8 ± 1.8), and pleasantness (3.0 ± 1.5) parameters, three-dimensional midface volume change (1.8 ± 0.5 cm3), and postoperative cheek mass position (2.16 ± 0.47 mm) in comparison with those treated with the isolated procedure (2.0 ± 1.5, 1.9 ± 1.6, 2.3 ± 1.6, 0.6 ± 0.2 cm3, and 1.84 ± 0.43 mm, respectively). Healthy female individuals had similar and larger cheek mass position than patients treated with synchronous (p > 0.05) and isolated (p < 0.001) procedures, respectively. Synchronous orthognathic surgery and check-specific fat grafting resulted in superior enhancement of facial appearance and midface volume and position compared with isolated orthognathic surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.