Publications
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Adisa A, Bahrami-Hessari M, Bhangu A, et al., 2023, Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries, British Journal of Surgery, Vol: 110, Pages: 804-817, ISSN: 0007-1323
BackgroundHealthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres.MethodsThis study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries.ResultsIn phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia.ConclusionThis is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries.
Singh H, Agarwal L, Jani C, et al., 2023, Pulmonary hypertension associated mortality in the United States from 2003 to 2020: an observational analysis of time trends and disparities, Journal of Thoracic Disease, Vol: 15, Pages: 1-18, ISSN: 2072-1439
Background: Pulmonary hypertension (PH) is an independent risk factor for morbidity and mortality. In the last two decades, significant advances have been made in management of World Health Organization (WHO) group 1 PH. However, there are no approved targeted pharmacotherapies for PH secondary to left-sided heart diseases or chronic hypoxic lung diseases which are thought to account for more than 70–80% of the disease burden. No recent investigation has analyzed and compared the mortality burden related to WHO group 1 PH with the mortality burden with WHO groups 2–5 PH at the national level in the United States (US). We hypothesize that WHO group 1 PH-related mortality has improved over the last two decades in comparison to WHO groups 2–5 PH.Methods: In this study, we used data from the Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research (CDC WONDER) the underlying cause of death database to study age-standardized mortality rates related to PH in the US from 2003 to 2020.Results: A total of 126,526 deaths were recorded from PH in the US between 2003 and 2020. Across the study period, PH-related ASMR increased from 17.81 per million population in 2003 to 23.89 in 2020 with a percentage change (PC) of +34%. However, there are contrasting mortality trends in WHO group 1 PH when compared to WHO groups 2–5 PH. Data demonstrated a decline in mortality from group 1 PH regardless of gender. In contrast, an increase in mortality from WHO groups 2–5 PH was observed, accounting for the major proportion of the overall PH mortality burden in recent years.Conclusions: PH-related mortality continues to an increase primarily due to increase in mortality attributed to WHO groups 2–5 PH. These findings have notable public health implications. Screening and risk assessment tools for secondary PH, risk factor modification, and novel management strategies are vital to improve outcomes.
Punjwani S, Jaroenlapnopparat A, Jani C, et al., 2023, An estimate of the burden of pancreatic cancer globally and its comparison with different WHO regions using Global Burden of Disease Database: A retrospective population-based analysis, Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Publisher: LIPPINCOTT WILLIAMS & WILKINS, ISSN: 0732-183X
Singh H, Rupal A, Al Omari O, et al., 2023, Trends in pulmonary tuberculosis mortality between 1985 and 2018: an observational analysis, BMC Pulmonary Medicine, Vol: 23, Pages: 1-12, ISSN: 1471-2466
BackgroundPulmonary tuberculosis (TB) is a major source of global morbidity and mortality. Latent infection has enabled it to spread to a quarter of the world's population. The late 1980s and early 1990s saw an increase in the number of TB cases related to the HIV epidemic, and the spread of multidrug-resistant TB. Few studies have reported pulmonary TB mortality trends. Our study reports and compares trends in pulmonary TB mortality.MethodsWe utilized the World Health Organization (WHO) mortality database from 1985 through 2018 to analyze TB mortality using the International Classification of Diseases-10 codes. Based on the availability and quality of data, we investigated 33 countries including two countries from the Americas; 28 countries from Europe; and 3 countries from the Western Pacific region. Mortality rates were dichotomized by sex. We computed age-standardized death rates per 100,000 population using the world standard population. Time trends were investigated using joinpoint regression analysis.ResultsWe observed a uniform decrease in mortality in all countries across the study period except the Republic of Moldova, which showed an increase in female mortality (+ 0.12 per 100,000 population). Among all countries, Lithuania had the greatest reduction in male mortality (-12) between 1993–2018, and Hungary had the greatest reduction in female mortality (-1.57) between 1985–2017. For males, Slovenia had the most rapid recent declining trend with an estimated annual percentage change (EAPC) of -47% (2003–2016), whereas Croatia showed the fastest increase (EAPC, + 25.0% [2015–2017]). For females, New Zealand had the most rapid declining trend (EAPC, -47.2% [1985–2015]), whereas Croatia showed a rapid increase (EAPC, + 24.9% [2014–2017]).ConclusionsPulmonary TB mortality is disproportionately higher among Central and Eastern European countries. This communicable disease cannot be eliminated
Bhatt PS, Singh H, Jani C, et al., 2023, Trends in Carbon Monoxide Morbidity and Mortality in the United States From 1990 to 2019-an Observational Analysis Using the Global Burden of Disease (GBD) Database, International Conference of the American-Thoracic-Society (ATS), Publisher: AMER THORACIC SOC, ISSN: 1073-449X
Hagroo A, Ali R, Goodall R, et al., 2023, Pelvic fracture incidence in EU15+countries: trends over a 30-year period, Publisher: OXFORD UNIV PRESS, ISSN: 0007-1323
Proctor DW, Goodall R, Borsky K, et al., 2023, Trends in the mortality, incidence and disability-adjusted life-years relating to appendicitis in EU15+countries: an observational study of the Global Burden of Disease database, 1990-2019, Publisher: OXFORD UNIV PRESS, Pages: III28-III28, ISSN: 0007-1323
Javed A, Machin M, Gwozdz A, et al., 2023, Meta-analysis of lytic catheter-based intervention for acute proximal deep vein thrombosis in the reduction of post-thrombotic syndrome, Journal of Vascular Surgery: Venous and Lymphatic Disorders, ISSN: 2213-333X
Al Omari O, Jani C, Ahmed A, et al., 2023, Lung Cancer Mortality in the United States between 1999 and 2019: An Observational Analysis of Disparities by Sex and Race, International Conference of the American-Thoracic-Society, Publisher: AMER THORACIC SOC, Pages: 612-616, ISSN: 1546-3222
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Picciochi M, Glasbey JC, Li E, et al., 2023, Elective surgical services need to start planning for summer pressures, British Journal of Surgery, Vol: 110, Pages: 508-510, ISSN: 0007-1323
Bergner R, Onida S, Velineni R, et al., 2023, Metabolic profiling reveals changes in serum predictive of venous ulcer healing, Annals of Surgery, Vol: 277, Pages: e467-e474, ISSN: 0003-4932
Objective: The aim of this study was to identify potential biomarkers predictive of healing or failure to heal in a population with venous leg ulceration.Summary Background Data: Venous leg ulceration presents important physical, psychological, social and financial burdens. Compression therapy is the main treatment, but it can be painful and time-consuming, with significant recurrence rates. The identification of a reliable biochemical signature with the ability to identify nonhealing ulcers has important translational applications for disease prognostication, personalized health care and the development of novel therapies.Methods: Twenty-eight patients were assessed at baseline and at 20 weeks. Untargeted metabolic profiling was performed on urine, serum, and ulcer fluid, using mass spectrometry and nuclear magnetic resonance spectroscopy.Results: A differential metabolic phenotype was identified in healing (n = 15) compared to nonhealing (n = 13) venous leg ulcer patients. Analysis of the assigned metabolites found ceramide and carnitine metabolism to be relevant pathways. In this pilot study, only serum biofluids could differentiate between healing and nonhealing patients. The ratio of carnitine to ceramide was able to differentiate between healing phenotypes with 100% sensitivity, 79% specificity, and 91% accuracy.Conclusions: This study reports a metabolic signature predictive of healing in venous leg ulceration and presents potential translational applications for disease prognostication and development of targeted therapies.
Bhatt P, Salciccioli I, Singh H, et al., 2023, Asthma Mortality Trends Across EU15+Countries with a Focus on Age Disparities, Annual Meeting of the American-Academy-of-Allergy-Asthma-and-Immunology (AAAAI), Publisher: MOSBY-ELSEVIER, Pages: AB160-AB160, ISSN: 0091-6749
Salciccioli I, Bhatt P, Shalhoub J, et al., 2023, Persistent sex and race disparities in anaphylaxis mortality in the US, 1999 to 2020: an analysis of the CDC Multiple Cause of Death database, Annual Meeting of the American-Academy-of-Allergy-Asthma-and-Immunology (AAAAI), Publisher: MOSBY-ELSEVIER, Pages: AB222-AB222, ISSN: 0091-6749
Machin M, Peerbux S, Whittley S, et al., 2023, Examining the benefit of graduated compression stockings in the prevention of hospital-associated venous thromboembolism in low-risk surgical patients: a multicentre cluster randomised controlled trial (PETS Trial), BMJ Open, Vol: 13, Pages: 1-7, ISSN: 2044-6055
Introduction Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor.Methods and analysis A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18–59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression.Ethics and dissemination Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration number ISRCT
The Vascular and Endovascular Research Network VERN Executive Committee, Hitchman L, Birmpili P, et al., 2023, The DEFINITE Audit: a prospective audit of diabetic foot debridement in theatre, Journal of Vascular Societies Great Britain and Ireland
Hammond-Haley M, Hartley A, Al-Khayatt BM, et al., 2023, Trends in the incidence and mortality of infective endocarditis in high-income countries between 1990 and 2019, INTERNATIONAL JOURNAL OF CARDIOLOGY, Vol: 371, Pages: 441-451, ISSN: 0167-5273
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Turner B, Jasionowska S, Machin M, et al., 2023, Systematic review and meta-analysis of exercise therapy for venous leg ulcer healing and recurrence, Journal of vascular surgery. Venous and lymphatic disorders, Vol: 11, Pages: 219-226, ISSN: 2213-3348
Objective:National guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer healing and recurrence are sparse. In the present study, we aimed to quantify the evidence for exercise regarding venous ulcer healing with respect to the primary outcomes of the proportion of healed ulcers and rate of ulcer recurrence. The secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and adverse events reported.Methods:The review followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines using a registered protocol (CRD42021220925). The MEDLINE and Embase databases and Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial Number registries were searched up to April 6, 2022 and included studies comparing exercise therapy and compression vs compression alone. Data for the proportion of healed ulcers were pooled using a fixed effects meta-analysis.Results:After screening 1046 reports, 7 were included, with 121 participants allocated to exercise therapy and 125 to compression alone. All the reports were of randomized controlled trials and had reported ulcer healing at 12 weeks, with a pooled relative risk of ulcer healing of 1.38 for exercise vs compression (95% confidence interval, 1.11-1.71). Only one study had reported on recurrence; thus, data pooling was not performed. No differences between exercise and usual care were demonstrated. Compliance with exercise ranged from 33% to 81%. The included studies demonstrated low enrollment and a high risk of bias. Also, most of the trials had failed to demonstrate any differences in activity completed between the intervention and control arms.Conclusions:A paucity of studies has examined leg ulcer recurrence after exercise programs, with no evidence to s
Jani C, Abdallah N, Mouchati C, et al., 2022, Trends of kidney cancer burden from 1990 to 2019 in European Union 15+ countries and World Health Organization regions, Scientific Reports, Vol: 12, ISSN: 2045-2322
In recent decades, variability in the incidence and mortality of kidney cancer (KC) has been reported. This study aimed to compare trends in incidence, mortality, and disability-adjusted life years (DALY) of KC between the European Union (EU) 15 + countries and 6 World Health Organization (WHO) regions. The data of KC Age-standardized incidence rates (ASIRs), age-standardized mortality rates (ASMRs), and age-standardized DALYs were extracted from the Global Burden of Disease database. Joinpoint regression was employed to examine trends. From 1990 to 2019, the ASIR increased in most countries except for Luxembourg (males), the USA (females) and Austria and Sweden (both sexes). ASIR increased across all 6 WHO regions for both sexes except for females in Americas. The ASMR increased in 10/19 countries for males and 9/19 for females as well across most WHO regions. The mortality-to-incidence ratio (MIR) decreased in all countries and WHO regions. Trends in DALYs were variable across countries and WHO regions. While the incidence and mortality from KC rose in most EU15 + countries and WHO regions from 1990 to 2019, the universal drop in MIR suggests an overall improvement in KC outcomes. This is likely multifactorial, including earlier detection of KC and improved treatments.
Jani C, Mouchati C, Abdallah N, et al., 2022, Trends in Prostate Cancer Mortality in the United States of America, by State and Race, from 1999 to 2019: estimates from the Centers for Disease Control WONDER Database, Prostate Cancer and Prostatic Diseases
Ghajar A, Essa M, DeLago A, et al., 2022, Atrial fibrillation/atrial flutter related mortality trends in the US population 2010–2020: regional, racial, sex variations, Pacing and Clinical Electrophysiology, ISSN: 0147-8389
Al Omari O, Jani C, Ahmed A, et al., 2022, Lung cancer mortality in the United States between 1999 and 2019: an observational analysis of disparities by sex and race, Annals of the American Thoracic Society, ISSN: 1546-3222
Panhelleux B, Shalhoub J, Silverman A, et al., 2022, A review of through-knee amputation, Vascular, Vol: 30, Pages: 1149-1159, ISSN: 0967-2109
Objectives: Through knee amputation (TKA) is an umbrella term for several different surgical techniques, which may affect clinical and functional outcomes. This makes it hard to evaluate the benefits and need for a TKA approach. This paper seeks to: (1) Determine the number of TKAs performed compared with other major lower limb amputations (MLLA) in England over the past decade; (2) identify the theoretical concepts behind TKA surgical approaches and their potential effect on functional and clinical outcomes; and (3) provide a platform for discussion and research on TKA and surgical outcomes.Methods: National Health Service Hospital Episodes Statistics were used to obtain recent numbers of MLLAs in England. EMBASE and MEDLINE were searched using a systematic approach with predefined criteria for relevant literature on TKA surgery.Results: In the past decade, 4.6% of MLLA in England were TKAs. Twenty-six articles presenting TKA surgical techniques met our criteria. These articles detailed three TKA surgical techniques; the classical approach, which keeps the femur intact and retains the patella; the Mazet technique, which shaves the femoral condyles into a box shape; and the Gritti-Stokes technique, which divides the femur proximal to the level of the condyles and attaches the patella at the distal cut femur.Conclusions: TKA has persisted as a surgical approach over the past decade, with three core approaches identified. Studies reporting clinical, functional, and biomechanical outcomes of TKA frequently fail to distinguish between the 3 distinct and differing approaches, making direct comparisons difficult. Future studies that compare TKA approaches to one another and to other amputation levels are needed.
Jasionowska S, Turner B, Machin M, et al., 2022, Systematic review of exercise therapy in the management of post-thrombotic syndrome, Phlebology, Vol: 37, Pages: 695-700, ISSN: 0268-3555
ObjectivesExercise improves haemodynamic parameters in patients with chronic venous disease. There is a paucity of evidence on its effect in post-thrombotic syndrome (PTS). The aim of this systematic review is to assess the impact of exercise in PTS.MethodsAdhering to PRISMA guidelines and following PROSPERO registration (CRD42021220924), MEDLINE, Cochrane Library, EMBASE database, and trial registries were searched on 19th May 2022.ResultsOne article met the inclusion criteria and a narrative synthesis was carried out. The included randomised controlled trial reported a between-group mean difference of 4.6 points (p = .027) in the VEINES-QOL score and −2.0 points (p = .14) in the Villalta score, in favour of exercise therapy. The statistical significance threshold was not reached.ConclusionData on exercise in PTS remains sparse but exercise appears to be a safe intervention. In the context of this literature, a potential future trial and outcome reporting measures are suggested.
Hanna L, Sounderajah V, Abdullah AA, et al., 2022, Trends in Thoracic Aortic Aneurysm Hospital Admissions, Interventions, and Mortality in England between 1998 and 2020: An Observational Study, Journal of Vascular Surgery, Vol: 76, Pages: 1755-1755, ISSN: 0741-5214
Otunla AA, Shanmugarajah K, Salciccioli JD, et al., 2022, Symptomatic atherosclerotic vascular disease and graft survival in primary kidney transplant recipients - Observational analysis of the united network of organ sharing database, TRANSPLANT IMMUNOLOGY, Vol: 75, ISSN: 0966-3274
Houdmont J, Daliya P, Adiamah A, et al., 2022, Identification of surgeon burnout via a single-item measure, Occupational Medicine, Vol: 72, Pages: 641-643, ISSN: 0962-7480
BackgroundBurnout is endemic in surgeons in the UK and linked with poor patient safety and quality of care, mental health problems, and workforce sustainability. Mechanisms are required to facilitate the efficient identification of burnout in this population. Multi-item measures of burnout may be unsuitable for this purpose owing to assessment burden, expertise required for analysis, and cost.AimsTo determine whether surgeons in the UK reporting burnout on the 22-item Maslach Burnout Inventory (MBI) can be reliably identified by a single-item measure of burnout.MethodsConsultant (n = 333) and trainee (n = 217) surgeons completed the MBI and a single-item measure of burnout. We applied tests of discriminatory power to assess whether a report of high burnout on the single-item measure correctly classified MBI cases and non-cases.ResultsThe single-item measure demonstrated high discriminatory power on the emotional exhaustion burnout domain: the area under the curve was excellent for consultants and trainees (0.86 and 0.80), indicating high sensitivity and specificity. On the depersonalisation domain, discrimination was acceptable for consultants (0.76) and poor for trainees (0.69). In contrast, discrimination was acceptable for trainees (0.71) and poor for consultants (0.62) on the personal accomplishment domain.ConclusionsA single-item measure of burnout is suitable for the efficient assessment of emotional exhaustion in consultant and trainee surgeons in the UK. Administered regularly, such a measure would facilitate the early identification of at-risk surgeons and swift intervention, as well as the monitoring of group-level temporal trends to inform resource allocation to coincide with peak periods.
Gwilym BL, Pallmann P, Waldron C-A, et al., 2022, Short-term risk prediction after major lower limb amputation: PERCEIVE study., Br J Surg, Vol: 109, Pages: 1300-1311
BACKGROUND: The accuracy with which healthcare professionals (HCPs) and risk prediction tools predict outcomes after major lower limb amputation (MLLA) is uncertain. The aim of this study was to evaluate the accuracy of predicting short-term (30 days after MLLA) mortality, morbidity, and revisional surgery. METHODS: The PERCEIVE (PrEdiction of Risk and Communication of outcomE following major lower limb amputation: a collaboratIVE) study was launched on 1 October 2020. It was an international multicentre study, including adults undergoing MLLA for complications of peripheral arterial disease and/or diabetes. Preoperative predictions of 30-day mortality, morbidity, and MLLA revision by surgeons and anaesthetists were recorded. Probabilities from relevant risk prediction tools were calculated. Evaluation of accuracy included measures of discrimination, calibration, and overall performance. RESULTS: Some 537 patients were included. HCPs had acceptable discrimination in predicting mortality (931 predictions; C-statistic 0.758) and MLLA revision (565 predictions; C-statistic 0.756), but were poor at predicting morbidity (980 predictions; C-statistic 0.616). They overpredicted the risk of all outcomes. All except three risk prediction tools had worse discrimination than HCPs for predicting mortality (C-statistics 0.789, 0.774, and 0.773); two of these significantly overestimated the risk compared with HCPs. SORT version 2 (the only tool incorporating HCP predictions) demonstrated better calibration and overall performance (Brier score 0.082) than HCPs. Tools predicting morbidity and MLLA revision had poor discrimination (C-statistics 0.520 and 0.679). CONCLUSION: Clinicians predicted mortality and MLLA revision well, but predicted morbidity poorly. They overestimated the risk of mortality, morbidity, and MLLA revision. Most short-term risk prediction tools had poorer discrimination or calibration than HCPs. The best method of predicting mortality was a statistical tool th
Sugand K, Ali R, Goodall R, et al., 2022, Trends in Neck of Femur Fracture Incidence in EU15+ Countries from 1990-2017, Injury
NIHR Global Health Unit on Global Surgery, COVIDSurg Collaborative, 2022, Elective surgery system strengthening: development, measurement, and validation of the surgical preparedness index across 1632 hospitals in 119 countries., The Lancet, Vol: 400, Pages: 1607-1617, ISSN: 0140-6736
BACKGROUND: The 2015 Lancet Commission on global surgery identified surgery and anaesthesia as indispensable parts of holistic health-care systems. However, COVID-19 exposed the fragility of planned surgical services around the world, which have also been neglected in pandemic recovery planning. This study aimed to develop and validate a novel index to support local elective surgical system strengthening and address growing backlogs. METHODS: First, we performed an international consultation through a four-stage consensus process to develop a multidomain index for hospital-level assessment (surgical preparedness index; SPI). Second, we measured surgical preparedness across a global network of hospitals in high-income countries (HICs), middle-income countries (MICs), and low-income countries (LICs) to explore the distribution of the SPI at national, subnational, and hospital levels. Finally, using COVID-19 as an example of an external system shock, we compared hospitals' SPI to their planned surgical volume ratio (SVR; ie, operations for which the decision for surgery was made before hospital admission), calculated as the ratio of the observed surgical volume over a 1-month assessment period between June 6 and Aug 5, 2021, against the expected surgical volume based on hospital administrative data from the same period in 2019 (ie, a pre-pandemic baseline). A linear mixed-effects regression model was used to determine the effect of increasing SPI score. FINDINGS: In the first phase, from a longlist of 103 candidate indicators, 23 were prioritised as core indicators of elective surgical system preparedness by 69 clinicians (23 [33%] women; 46 [67%] men; 41 from HICs, 22 from MICs, and six from LICs) from 32 countries. The multidomain SPI included 11 indicators on facilities and consumables, two on staffing, two on prioritisation, and eight on systems. Hospitals were scored from 23 (least prepared) to 115 points (most prepared). In the second phase, surgical preparedness
Normahani P, Burgess L, Norrie J, et al., 2022, 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, BMJ Open, Vol: 12, Pages: 1-9, ISSN: 2044-6055
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 (computed tomography 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 United Kingdom (UK), covering primary and secondary healthcare. Consenting participants will undergo the tests under investigation. Reference tests (CTA or MRA) will be performed within six 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 presentatio
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