Publications by authors named "Gerard Stansby"

101 Publications

Reliability of the Edinburgh Claudication Questionnaire for Identifying Symptomatic PAD in General Practice.

Angiology 2021 May 5;72(5):474-479. Epub 2021 Jan 5.

Northern Vascular Centre, Freeman Hospital, 5983The Newcastle upon Tyne NHS Hospitals Foundation Trust, Newcastle upon Tyne, United Kingdom.

The Edinburgh Claudication Questionnaire (ECQ) was developed to help identify peripheral arterial disease (PAD) in the general population but has not been validated against diagnostic arterial imaging methods such as Duplex Vascular Ultrasound Scanning (DUS). In the present study, we assessed the accuracy of the ECQ for diagnosis using DUS. As part of a National Institute of Health Research funded project looking at novel diagnostic methods, 250 patients were studied from 15 general practices across North East England from May 2015 and November 2016. Practices identified those with a PAD diagnosis from their registers as well as age- and sex-matched controls. All the ECQs were recorded by a vascular specialist nurse. Duplex vascular ultrasound scanning was used as a reference standard for the diagnosis of occlusive PAD. The ECQ had a sensitivity of 52.5% (95% CI: 42.3%-62.5%), specificity of 87.1% (95% CI: 80.6%-92.0%), positive likelihood ratio of 4.06 (95% CI: 2.57-6.42), and negative likelihood ratio of 0.55 (95% CI: 0.44-0.68) compared with reference standard DUS. The ECQ has relatively poor overall diagnostic test accuracy in isolation. It may be helpful in ruling out PAD or as a supplementary test to improve diagnosis of symptomatic disease in General Practice.
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http://dx.doi.org/10.1177/0003319720984882DOI Listing
May 2021

Compression stockings in addition to low-molecular-weight heparin to prevent venous thromboembolism in surgical inpatients requiring pharmacoprophylaxis: the GAPS non-inferiority RCT.

Health Technol Assess 2020 12;24(69):1-80

Department of Surgery and Cancer, Imperial College London, London, UK.

Background: Patients admitted to hospital for surgery are at an increased risk of venous thromboembolism. Pharmaco-thromboprophylaxis and mechanical prophylaxis (usually graduated compression stockings or intermittent pneumatic compression) have been shown to reduce the incidence of venous thromboembolism. The evidence base supporting the National Institute for Health and Care Excellence's recommendation for the use of graduated compression stockings for venous thromboembolism prevention in the UK has recently been challenged. It is unclear if the risks and costs associated with graduated compression stockings are justified for deep-vein thrombosis prevention in moderate- and high-risk elective surgical inpatients receiving low-dose low-molecular-weight heparin pharmaco-thromboprophylaxis.

Objectives: The primary objective was to compare the venous thromboembolism rate in elective surgical inpatients at moderate or high risk of venous thromboembolism who were receiving either graduated compression stockings and low-dose low-molecular-weight heparin (standard care) or low-dose low-molecular-weight heparin alone (intervention).

Design: This was a pragmatic, multicentre, prospective, non-inferiority, randomised controlled trial.

Setting: This took place in secondary care NHS hospitals in the UK.

Participants: Patients aged ≥ 18 years who were assessed to be at moderate or high risk of venous thromboembolism according to the NHS England venous thromboembolism risk assessment tool (or the trust equivalent based on this form) and who were not contraindicated to low-molecular-weight heparin or graduated compression stockings were deemed eligible to take part.

Interventions: Participants were randomised 1 : 1 to either low-molecular-weight heparin or low-molecular-weight heparin and graduated compression stockings.

Main Outcome Measures: The primary outcome measure was venous thromboembolism up to 90 days after surgery. A combined end point of duplex ultrasound-proven new lower-limb deep-vein thrombosis (symptomatic or asymptomatic) plus imaging-confirmed symptomatic pulmonary embolism. Secondary outcomes included quality of life, compliance with graduated compression stockings and low-molecular-weight heparin during admission, and all-cause mortality.

Results: A total of 1905 participants were randomised and 1858 were included in the intention-to-treat analysis. A primary outcome event occurred in 16 out of 937 (1.7%) patients in the low-molecular-weight heparin-alone arm compared with 13 out of 921 (1.4%) patients in the low-molecular-weight heparin plus graduated compression stockings arm. The risk difference between low-molecular-weight heparin and low-molecular-weight heparin plus graduated compression stockings was 0.30% (95% confidence interval -0.65% to 1.26%). As the 95% confidence interval did not cross the non-inferiority margin of 3.5% ( < 0.001 for non-inferiority), the results indicate that non-inferiority of low-molecular-weight heparin alone was shown.

Limitations: In total, 13% of patients did not receive a duplex ultrasound scan that could have detected further asymptomatic deep-vein thrombosis. However, missing scans were balanced between both trial arms. The subpopulation of those aged ≥ 65 years assessed as being at a moderate risk of venous thromboembolism was under-represented in the study; however, this reflects that this group is under-represented in the general population.

Conclusions: For elective surgical patients at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and graduated compression stockings. These findings indicate that graduated compression stockings may be unnecessary for most elective surgical patients.

Future Work: Further studies are required to evaluate whether or not adjuvant graduated compression stockings have a role in patients receiving extended thromboprophylaxis, beyond the period of hospital admission, following elective surgery or in patients undergoing emergency surgical procedures.

Trial Registration: Current Controlled Trials ISRCTN13911492.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 69. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24690DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7750868PMC
December 2020

Age-related changes in pulse risetime measured by multi-site photoplethysmography.

Physiol Meas 2020 08 11;41(7):074001. Epub 2020 Aug 11.

Centre for Intelligent Healthcare, Coventry University, Coventry, CV1 5FB, United Kingdom. Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, NE2 4HH, United Kingdom.

Objective: It is accepted that changes in the peripheral pulse waveform characteristics occur with ageing. Pulse risetime is one important feature which has clinical value. However, it is unclear how it varies across the full age spectrum from child to senior and for different peripheral measurement sites. The objectives of this study were to determine the association between age and pulse risetime characteristics over an 8-decade age range at the ears, fingers, and toes, and to consider effects arising from differences in systolic blood pressure (SBP), height and heart rate.

Approach: Multi-site photoplethysmography (MPPG) pulse waveforms were recorded non-invasively from the right and left ears, fingers, and toes of 304 normal healthy human subjects (range 6-87 years; 156 male and 148 female). SBP, height, and heart rate were also measured. Multi-site PPG pulse risetimes, and their site differences, were determined.

Main Results: Univariate regression analysis showed positive correlations with risetime for age (ears, fingers and toes: + 0.8, + 1.9, and + 1.1 ms/year, respectively), SBP (+0.5, + 1.3, and + 0.9 ms/mmHg) and height (+0.5, + 1.2, and + 1.0 ms/cm), but with a clear inverse association with heart rate (-1.8, - 2.5, and - 1.6 ms min) (P < 0.0001). No significant differences between male and female subjects were found for pulse risetime.

Significance: Normative multi-site PPG risetime characteristics have been defined in over 300 subjects and are shown to increase with age linearly up to the 8th decade. In contrast, we have shown that heart rate has a clear inverse relationship with risetime for all measurement sites.
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http://dx.doi.org/10.1088/1361-6579/ab9b67DOI Listing
August 2020

Improving the safety of resuscitative endovascular balloon occlusion of the aorta - Compliant versus semi-compliant balloon systems.

Vascular 2020 Oct 1;28(5):612-618. Epub 2020 May 1.

R Adams Cowley Shock Trauma Center, University of Maryland Medical Center, Baltimore, MD, USA.

Objectives: Resuscitative endovascular balloon occlusion of the aorta is an alternative to resuscitative thoracotomy in non-compressible torso haemorrhage. Low-profile, compliant balloon catheter systems have been developed, which can be deployed without the need for fluoroscopy. However, concern exists for over inflation and aortic injury, especially as compliant balloon material can stretch reducing syringe feedback and limiting the effectiveness of a safety valve. An alternative material would be a semi-compliant balloon material, but its performance is unknown. The aim of this study was to compare the inflation characteristics of compliant versus semi-compliant balloon systems and to determine whether a pressure relief safety valve can be practically applied to a semi-compliant balloon catheter as a safety device.

Methods: This was an ex vivo study using porcine segments of thoracic aorta. The study consisted of two phases. The first phase involved intermittent inflation of six compliant balloon and six semi-compliant balloon balloons until balloon or aortic rupture. In the second phase, six semi-compliant balloons with the pressure-relief valve set at 0.45 atmospheres were inflated in the aortas until the valve release, followed by injection with additional 30 mL. Data including pressure, volume, balloon working length, diameter and circumferential stretch ratio were collected.

Results: At failure, mean balloon volume was almost double in compliant balloon group vs semi-compliant balloon group - 49.83 mL (±23.25) and 25.16 mL (±8.93), respectively ( = 0.004), with 36% increase in working length in the compliant balloon group - 81.17 mm (±19.11) vs 59.49 (±4.86) for semi-compliant balloon ( = 0.023). When plotted, the relationship pattern between volume and pressure fit a linear model for the compliant balloon, and a quadratic model for the semi-compliant balloon. Following attempted over inflation with the pressure valve, there was no change in parameters before and after attempted over inflation.

Conclusions: The inflation profile differs between balloon designs. In contrast to semi-compliant balloons, compliant balloons will accommodate more volume to mitigate increase in pressure. This does not completely eliminate the risk of over inflation. The inflation characteristics of the semi-compliant balloon permit pairing it with a safety valve, which could lead to a development of a safer balloon technology in the future.
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http://dx.doi.org/10.1177/1708538120922106DOI Listing
October 2020

Perceived Anxiety is Negligible in Medical Students Receiving Video Feedback During Simulated Core Practical Skills Teaching: A Randomised Trial Comparing Two Feedback Modalities.

Cureus 2020 Mar 31;12(3):e7486. Epub 2020 Mar 31.

Northern Oesophagogastric Unit, Royal Victoria Infirmary, Newcastle upon Tyne, GBR.

Introduction The ability to undertake simple practical procedures is essential for graduating medical students and is typically assessed using simulated models. Feedback is a key component of the learning process in developing proficiency in these key skills. Video feedback (VF) has previously shown promise, however, negative effects of VF-related anxiety on performance have been previously reported. Our aim was to investigate for a difference in participant anxiety between supervised individualised video feedback (SIVF) and unsupervised generic video feedback (UGVF) when undertaking simulated basic practical procedures. Methods Undergraduate medical students participating in a clinical skills study to compare UGVF and SIVF completed a Likert scale questionnaire detailing perceived anxiety. During the study, students were recorded performing three basic surgical skills (simple interrupted suturing, intravenous cannulation, urinary catheterisation). Feedback was then provided by one of two methods: (1) SIVF - participant video footage reviewed together with a tutor providing targeted feedback, and (2) UGVF - participant video footage reviewed alone with concurrent access to a generic pre-recorded 'expert tips' video clip for comparison. Each participant received SIVF and UGVF at least once. Results The majority of participants did not find either SIVF (81.7%) or UGVF (78.8%) stressful. Students had a strong preference for SIVF (77.5%) and disagreed that similar 'face-to-face' feedback had impaired learning in the past (80.3%). Conclusion Medical student-perceived anxiety is negligible when video feedback is employed during simulated core practical skill training.
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http://dx.doi.org/10.7759/cureus.7486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7188453PMC
March 2020

Nurses' and patients' experiences and preferences of the ankle-brachial pressure index and multi-site photoplethysmography for the diagnosis of peripheral arterial disease: A qualitative study.

PLoS One 2019 7;14(11):e0224546. Epub 2019 Nov 7.

Northern Medical Physics and Clinical Engineering Department, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.

Peripheral arterial disease is a global health problem, affecting around 20% of people aged over 60 years. Whilst ankle-brachial pressure index (ABPI) is regularly used for diagnosis, it has a number of limitations, which have presented a need for alternative methods of diagnosis. Multi-site photoplethysmography (MPPG) is one such method, but evidence of acceptability of both methods is lacking. This study aims to describe and compare preferences and experiences amongst nurses and patients of ABPI and MPPG use in primary care. We used qualitative research methods in the context of a clinical diagnostic study comparing ABPI with MPPG. Use of ABPI and MPPG by 13 nurses were observed with 51 patients across general practice surgeries in North-East England in 2015/16. Follow-up semi-structured interviews were conducted with 12 nurses and 27 patients. Data were thematically analysed. Two major themes were identified: (1) device preferences; (2) test discomfort and anxiety. There was a compelling preference for MPPG due to ease of use, speed of the test, patient comfort, and perceived device accuracy/objectivity. However some patients struggled to identify a preference, describing ambivalence to medical testing. ABPI was deemed uncomfortable and painful, particularly when the blood pressure cuff was inflated at the lower limbs. There was also evidence of anxiety amongst patients when their foot pulses were not identified using ABPI. Whilst ABPI is a non-invasive and routine procedure it was associated with a number of drawbacks in clinical practice. Nurses required considerable dexterity to employ the test, and it resulted in anxiety amongst some patients. Conversely, MPPG was deemed to be easier and quicker to use, and perceived to be less subjective. Should diagnostic accuracy and cost be comparable to ABPI, then the findings of this study suggest MPPG would be preferable to ABPI for patients as well as nurses.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224546PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6837749PMC
March 2020

Peripheral arterial disease diagnosis and management in primary care: a qualitative study.

BJGP Open 2019 Oct 29;3(3). Epub 2019 Oct 29.

Lead Clinical Scientist in Microvascular Diagnostics, Northern Medical Physics and Clinical Engineering, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.

Background: Patients diagnosed with peripheral arterial disease (PAD) are at an increased risk of coronary heart disease, stroke, heart attack, and PAD progression. If diagnosed early, cardiovascular risk factors can be treated and the risk of other cardiovascular diseases can be reduced. There are clear guidelines on PAD diagnosis and management, but little is known about the issues faced in primary care with regards adherence to these, and about the impact of these issues on patients.

Aim: To identify the issues for primary care health professionals (HPs) and patients in PAD diagnosis and management, and to explore the impact of these on HPs and PAD patients.

Design & Setting: Qualitative study conducted in a primary care setting in the North East of England. Data was collected between December 2014 and July 2017.

Method: Semi-structured interviews and focus groups were conducted with PAD register patients ( = 17), practice nurses ([PNs], = 17), district nurses (DNs], = 20), tissue viability nurses ( = 21), and GPs ( = 21).

Results: HPs' attitudes to PAD, difficulty accessing tests, and patient delays impacted upon diagnosis. Some HPs had a reactive approach to PAD identification. Patients lacked understanding about PAD and some reported a delay consulting their GP after the onset of PAD symptoms. After diagnosis, few were attending for regular GP follow-up.

Conclusion: Patient education about PAD symptoms and risks, and questioning about exercise tolerance, could address the problem of under-reporting. Annual reviews could provide an opportunity to probe for PAD symptoms and highlight those requiring further investigation. Improved information when PAD is diagnosed and, considering the propensity for patients to tolerate worsening symptoms, the introduction of annual follow-up (at minimum) is warranted.
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http://dx.doi.org/10.3399/bjgpopen19X101659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6970582PMC
October 2019

Educational Impact of a Pulsatile Human Cadaver Circulation Model for Endovascular Training.

Eur J Vasc Endovasc Surg 2019 Oct 5;58(4):602-608. Epub 2019 Sep 5.

Department of Vascular Surgery, Northern Vascular Centre, Freeman Hospital, Newcastle Upon Tyne, UK.

Objectives: The face and construct validity of a novel pulsatile human cadaver model (PHCM) was recently demonstrated for endovascular training. This study aimed to assess the model's educational impact.

Methods: Twenty-four endovascular novices were recruited and split into two equal training groups: PHCM and virtual reality simulator (VRS). Each candidate performed eight consecutive training attempts of endovascular renal artery catheterisation on their designated model, and a final crossover attempt on the alternate model. Performances were video recorded and scored using a validated scoring tool by two independent endovascular experts, blinded to the candidate's identity and attempt number. Each participant was given a task specific checklist score (TSC), global rating score (GRS), and overall procedure score (OPS).

Results: In the PHCM group average OPS improved gradually from 19.42 (TSC 8.58, GRS 10.83) to 39.50 (TSC 15.00, GRS 24.5) over eight attempts (p < .0005). In the VRS group OPS improved from 20.54 (TSC 10.29, GRS 10.25) to 36.04 (TSC 14.21, GRS 21.88) between the first and eighth attempts (p < .0005), with limited improvement after the second attempt. PHCM training significantly improved OPS on their VRS crossover attempt (p ≤ .0001), achieving a similar OPS to candidates who had completed VRS training (p = .398). VRS training significantly improved OPS on PHCM (p < 0.05); however, OPS was significantly worse than candidates who had completed PHCM training (p ≤ .001).

Conclusions: PHCM training has a longer learning curve, with gradual improvement, reflecting the enhanced difficulty of a more realistic model. These results support the use of PHCM preceded by VRS training, prior to performing endovascular surgery on patients.
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http://dx.doi.org/10.1016/j.ejvs.2019.03.026DOI Listing
October 2019

Venous thromboembolism prophylaxis strategies for people undergoing elective total knee replacement: a systematic review and network meta-analysis.

Lancet Haematol 2019 Oct 20;6(10):e530-e539. Epub 2019 Aug 20.

University Hospitals of Leicester NHS Trust, Leicester, UK.

Background: Hospital-associated venous thromboembolism is a major patient safety concern. Provision of prophylaxis to patients admitted for elective total knee replacement surgery has been proposed as an effective strategy to reduce the incidence of venous thromboembolism. We aimed to assess the relative efficacy and safety of all available prophylaxis strategies in this setting.

Methods: We did a systematic review and Bayesian network meta-analyses of randomised controlled trials to assess the relative efficacy and safety of venous thromboembolism prophylaxis strategies and to populate an economic model that assessed the cost-effectiveness of these strategies and informed the updated National Institute for Health and Care Excellence (NICE) guideline recommendations for patients undergoing elective total knee replacement surgery. The Cochrane Library (CENTRAL), Embase, and Medline were last searched on June 19, 2017, with key terms relating to the population (venous thromboembolism and total knee replacement) and the interventions compared, including available pharmacological and mechanical interventions. Outcomes of interest were deep vein thrombosis (symptomatic and asymptomatic), pulmonary embolism, and major bleeding. Risk of bias was assessed, and relevant data extracted from the included randomised controlled trials for the network meta-analyses. Relative risks (RR; with 95% credible intervals [95% CrI]) compared to no prophylaxis, median ranks (with 95% CrI), and the probability of being the best intervention were calculated. The study was done in accordance with PRISMA guidelines.

Findings: 25 randomised controlled trials were included in the network meta-analyses. 23 trials (19 interventions; n=15 028) were included in the deep vein thrombosis network, 12 in the pulmonary embolism network (13 interventions; n=15 555), and 19 in the major bleeding network (11 interventions; n=19 797). Risk of bias ranged from very low to high. Rivaroxaban ranked first for prevention of deep vein thrombosis (RR 0·12 [95% CrI 0·06-0·22]). Low molecular weight heparin (LMWH; standard prophylactic dose, 28-35 days) ranked first in the pulmonary embolism network (RR 0·02 [95% CrI 0·00-3·86]) and LMWH (low prophylactic dose, 10-14 days) ranked first in the major bleeding network (odds ratio 0·08 [95% CrI 0·00-1·76]), but the results for pulmonary embolism and major bleeding are highly uncertain.

Interpretation: Single prophylaxis strategies are more effective in prevention of deep vein thrombosis in the elective total knee replacement population than combination strategies, with rivaroxaban being the most effective. The results of the pulmonary embolism and major bleeding meta-analyses are uncertain and no clear conclusion can be made other than what is biologically plausible (eg, that no prophylaxis and mechanical prophylaxis strategies should have the lowest risk of major bleeding).

Funding: National Institute for Health and Care Excellence.
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http://dx.doi.org/10.1016/S2352-3026(19)30155-3DOI Listing
October 2019

Venous Thromboembolism Prophylaxis Strategies for People Undergoing Elective Total Hip Replacement: A Systematic Review and Network Meta-Analysis.

Value Health 2019 08 17;22(8):953-969. Epub 2019 May 17.

University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK.

Objectives: To assess the efficacy and safety of venous thromboembolism prophylaxis in people undergoing elective total hip replacement.

Methods: Systematic review and Bayesian network meta-analyses of randomized controlled trials were conducted for 3 outcomes: deep vein thrombosis (DVT), pulmonary embolism (PE), and major bleeding (MB). MEDLINE, EMBASE, and Cochrane Library (CENTRAL) databases were searched. Study quality was assessed using the Cochrane risk-of-bias checklist. Fixed- and random-effects models were fitted and compared. The median relative risk (RR) and odds ratio (OR) compared with no prophylaxis, with their 95% credible intervals (CrIs), rank, and probability of being the best, were calculated.

Results: Forty-two (n = 24 374, 26 interventions), 30 (n = 28 842, 23 interventions), and 24 (n = 31 792, 15 interventions) randomized controlled trials were included in the DVT, PE, and MB networks, respectively. Rivaroxaban had the highest probability of being the most effective intervention for DVT (RR 0.06 [95% CrI 0.01-0.29]). Strategy of low-molecular-weight heparin followed by aspirin had the highest probability of reducing the risk of PE and MB (RR 0.0011 [95% CrI 0.00-0.096] and OR 0.37 [95% CrI 0.00-26.96], respectively). The ranking of efficacy estimates across the 3 networks, particularly PE and MB, had very wide CrIs, indicating high degree of uncertainty.

Conclusions: A strategy of low-molecular-weight heparin given for 10 days followed by aspirin for 28 days had the best benefit-risk balance, with the highest probability of being the best on the basis of the results of the PE and MB network meta-analyses. Nevertheless, there is considerable uncertainty around the median ranks of the interventions.
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http://dx.doi.org/10.1016/j.jval.2019.02.013DOI Listing
August 2019

Aspirin versus placebo for the treatment of venous leg ulcers-a phase II, pilot, randomised trial (AVURT).

Trials 2019 Jul 26;20(1):459. Epub 2019 Jul 26.

Bristol Centre for Surgical Research, Bristol NIHR Biomedical Research Centre, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.

Background: Venous leg ulcers (VLUs) can take many months to heal and 25% fail to heal. The main treatment for venous leg ulcers is compression therapy and few additional therapies exist. Two previous trials indicated that low-dose aspirin may improve healing time, but these trials were insufficiently robust.

Methods: A multi-centred, pilot, phase II, randomised, double blind, parallel-group, placebo-controlled, efficacy trial (RCT) was conducted to determine: if aspirin improves VLU healing time; the safety of aspirin in this population; treatment compliance; and the feasibility of recruitment to a phase III trial. We recruited patients from secondary care who were aged ≥ 18 years, had a chronic VLU and not regularly taking aspirin. Participants were randomly assigned (1:1) to receive 300 mg of daily aspirin or placebo in addition to standard care, which consisted of multi component compression therapy aiming to deliver 40 mmHg at the ankle where possible. The randomisation list was stratified by ulcer size (≤ 5 cm or > 5 cm). The primary endpoint was time to ulcer healing, which was defined as 'complete epithelial healing in the absence of scab (eschar) with no dressing required'. Safety outcomes were assessed in all participants who received at least one dose of the study drug.

Results: Twenty-seven patients were recruited from eight sites (target 100 patients). A short time-frame to recruit and a large number of patients failing to meet the eligibility criteria were the main barriers to recruitment. There was no evidence of a difference in time to healing of the reference ulcer following adjustment for log ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85; p = 0.357). One expected serious adverse event related to aspirin was recorded. A number of options to improve recruitment were explored.

Conclusions: There was no evidence that aspirin was effective in expediting the healing of chronic VLUs. However, the analysis was underpowered due to the low number of participants recruited. The trial design would require substantial amendment in order to progress to a phase III (effectiveness) trial.

Trial Registration: Clinicaltrials.gov, NCT02333123. Registered on 5 November 2014.
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http://dx.doi.org/10.1186/s13063-019-3480-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6660698PMC
July 2019

Reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism in medical inpatients.

Clin Med (Lond) 2019 03;19(2):100-103

Elderly Care Unit, Gloucestershire Royal NHS Trust, Gloucester, UK.

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http://dx.doi.org/10.7861/clinmedicine.19-2-100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6454363PMC
March 2019

A multicenter randomized controlled study to evaluate whether neuromuscular electrical stimulation improves the absolute walking distance in patients with intermittent claudication compared with best available treatment.

J Vasc Surg 2019 05 18;69(5):1567-1573. Epub 2019 Feb 18.

Academic Section of Vascular Surgery, Department of Surgery & Cancer, Imperial College London, London, United Kingdom; Therapies Outpatients Department, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom. Electronic address:

Objective: To assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device to improve the absolute walking distance in patients with intermittent claudication as an adjunct to the local standard care available at the study sites compared with local standard care alone.

Methods: This open, multicenter, randomized controlled trial included eight participating centers in England. Sites are equally distributed between those that provide supervised exercise therapy programs and those that do not. Patients with intermittent claudication meeting the eligibility criteria and providing consent will be randomized, depending on the center type, to either NMES and locally available standard care or standard care alone. The primary end point is change in absolute walking distance at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life, compliance with the interventions, economic evaluation of the NMES device, and lower limb hemodynamic measures to further the understanding of underlying mechanisms. Recruitment commenced in March 2018 and will continue for a total of 15 months. The Neuromuscular Electrical Stimulation Improves the Absolute Walking Distance in Patients with Intermittent Claudication trial is funded by the UK Efficacy and Mechanism Evaluation Programme, Medical Research Council, and National Institute for Health Research partnership.
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http://dx.doi.org/10.1016/j.jvs.2018.10.046DOI Listing
May 2019

Acute Leg Ischaemia in a Child due to a Thrombosed Popliteal Aneurysm.

EJVES Short Rep 2019 22;42:1-3. Epub 2018 Nov 22.

Northern Vascular Centre, Freeman Hospital, Newcastle upon Tyne, UK.

Introduction: The case of an idiopathic thrombosed popliteal aneurysm is described in an otherwise healthy 6 year old child. This is the fourth reported case and the second youngest patient to present with an idiopathic isolated popliteal aneurysm.

Report: A 6 year old boy presented with an acutely ischaemic right foot. Computed tomography angiography confirmed a thrombosed popliteal aneurysm. A femoropopliteal bypass was performed with reversed long saphenous vein and ligation of the aneurysm. Yearly follow up is ongoing with ultrasound surveillance; the child's growth and development is unaffected, and the graft is patent. There was a readmission over six years later with claudication on the right side. There was evidence of thrombus in the graft with associated distal embolisation, which was managed conservatively with anticoagulation.

Discussion: Given the rarity of such presentations in the paediatric population, there is minimal good quality data to guide treatment. There have been three previous cases of idiopathic popliteal aneurysms all managed with a reversed long saphenous vein femoropopliteal bypass with resection of the aneurysm. Management should be guided based on the clinical picture and should be undertaken in specialised tertiary centres if possible. Surgical intervention is the treatment of choice in patients with an ischaemic limb.
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http://dx.doi.org/10.1016/j.ejvssr.2018.10.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6293015PMC
November 2018

Cost-Utility Analysis of Venous Thromboembolism Prophylaxis Strategies for People Undergoing Elective Total Hip and Total Knee Replacement Surgeries in the English National Health Service.

Front Pharmacol 2018 27;9:1370. Epub 2018 Nov 27.

University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.

Major orthopedic surgery, such as elective total hip replacement (eTHR) and elective total knee replacement (eTKR), are associated with a higher risk of venous thromboembolism (VTE) than other surgical procedures. Little is known, however, about the cost-effectiveness of VTE prophylaxis strategies in people undergoing these procedures. The aim of this work was to assess the cost-effectiveness of these strategies from the English National Health Service perspective to inform NICE guideline (NG89) recommendations. Cost-utility analysis, using decision modeling, was undertaken to compare 15 VTE prophylaxis strategies for eTHR and 12 for eTKR, in addition to "no prophylaxis" strategy. The analysis complied with the NICE Reference Case. Structure and assumptions were agreed with the guideline committee. Incremental net monetary benefit (INMB) was calculated, vs. the model comparator (LMWH+ antiembolism stockings), at a threshold of £20,000/quality-adjusted life-year (QALY) gained. The model was run probabilistically. Deterministic sensitivity analyses (SAs) were undertaken to assess the robustness of the results. The most cost-effective strategies were LMWH for 10 days followed by aspirin for 28 days (INMB = £530 [95% CI: -£784 to £1,103], probability of being most cost-effective = 72%) for eTHR, and foot pump (INMB = £353 [95% CI: -£101 to £665]; probability of being most cost-effective = 18%) for eTKR. There was considerable uncertainty regarding the cost-effectiveness ranking in the eTKR analysis. The results were robust to change in all SAs. For eTHR, LMWH (standard dose) for 10 days followed by aspirin for 28 days is the most cost-effective VTE prophylaxis strategy. For eTKR, the results are highly uncertain but foot pump appeared to be the most cost-effective strategy, followed closely by aspirin (low dose). Future research should focus on assessing cost-effectiveness of VTE prophylaxis in the eTKR population.
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http://dx.doi.org/10.3389/fphar.2018.01370DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6289021PMC
November 2018

Effect of testing for cancer on cancer- or venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE.

Cochrane Database Syst Rev 2018 11 8;11:CD010837. Epub 2018 Nov 8.

Cochrane Common Mental Disorders Group, Centre for Reviews and Dissemination, University of York, Heslington, York, UK, YO10 5DD.

Background: Venous thromboembolism (VTE) is a collective term for two conditions: deep vein thrombosis (DVT) and pulmonary embolism (PE). A proportion of people with VTE have no underlying or immediately predisposing risk factors and the VTE is referred to as unprovoked. Unprovoked VTE can often be the first clinical manifestation of an underlying malignancy. This has raised the question of whether people with an unprovoked VTE should be investigated for an underlying cancer. Treatment for VTE is different in cancer and non-cancer patients and a correct diagnosis would ensure that people received the optimal treatment for VTE to prevent recurrence and further morbidity. Furthermore, an appropriate cancer diagnosis at an earlier stage could avoid the risk of cancer progression and lead to improvements in cancer-related mortality and morbidity. This is an update of a review first published in 2015.

Objectives: To determine whether testing for undiagnosed cancer in people with a first episode of unprovoked VTE (DVT of the lower limb or PE) is effective in reducing cancer or VTE-related mortality and morbidity and to determine which tests for cancer are best at identifying treatable cancers early.

Search Methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 11 July 2018. We also undertook reference checking to identify additional studies.

Selection Criteria: Randomised and quasi-randomised trials in which people with an unprovoked VTE were allocated to receive specific tests for identifying cancer or clinically indicated tests only were eligible for inclusion. Primary outcomes included all-cause mortality, cancer-related mortality and VTE-related mortality.

Data Collection And Analysis: Two review authors independently selected studies, assessed risk of bias and extracted data. We resolved any disagreements by discussion.

Main Results: No new studies were identified for this 2018 update. In total, four studies with 1644 participants are included. Two studies assessed the effect of extensive tests including computed tomography (CT) scanning versus tests at the physician's discretion, while the other two studies assessed the effect of standard testing plus positron emission tomography (PET)/CT scanning versus standard testing alone. For extensive tests including CT versus tests at the physician's discretion, the quality of the evidence, as assessed according to GRADE, was low due to risk of bias (early termination of the studies). When comparing standard testing plus PET/CT scanning versus standard testing alone, the quality of evidence was moderate due to a risk of detection bias. The quality of the evidence was downgraded further as detection bias was present in one study with a low number of events.When comparing extensive tests including CT versus tests at the physician's discretion, pooled analysis on two studies showed that testing for cancer was consistent with either benefit or no benefit on cancer-related mortality (odds ratio (OR) 0.49, 95% confidence interval (CI) 0.15 to 1.67; 396 participants; 2 studies; P = 0.26; low-quality evidence). One study (201 participants) showed that, overall, malignancies were less advanced at diagnosis in extensively tested participants than in participants in the control group. In total, 9/13 participants diagnosed with cancer in the extensively tested group had a T1 or T2 stage malignancy compared to 2/10 participants diagnosed with cancer in the control group (OR 5.00, 95% CI 1.05 to 23.76; P = 0.04; low-quality evidence). There was no clear difference in detection of advanced stages between extensive tests versus tests at the physician's discretion: one participant in the extensively tested group had stage T3 compared with four participants in the control group (OR 0.25, 95% CI 0.03 to 2.28; P = 0.22; low-quality evidence). In addition, extensively tested participants were diagnosed earlier than control group (mean: 1 month with extensive tests versus 11.6 months with tests at physician's discretion to cancer diagnosis from the time of diagnosis of VTE). Extensive testing did not increase the frequency of an underlying cancer diagnosis (OR 1.32, 95% CI 0.59 to 2.93; 396 participants; 2 studies; P = 0.50; low-quality evidence). Neither study measured all-cause mortality, VTE-related morbidity and mortality, complications of anticoagulation, adverse effects of cancer tests, participant satisfaction or quality of life.When comparing standard testing plus PET/CT screening versus standard testing alone, standard testing plus PET/CT screening was consistent with either benefit or no benefit on all-cause mortality (OR 1.22, 95% CI 0.49 to 3.04; 1248 participants; 2 studies; P = 0.66; moderate-quality evidence), cancer-related mortality (OR 0.55, 95% CI 0.20 to 1.52; 1248 participants; 2 studies; P = 0.25; moderate-quality evidence) or VTE-related morbidity (OR 1.02, 95% CI 0.48 to 2.17; 854 participants; 1 study; P = 0.96; moderate-quality evidence). Regarding stage of cancer, there was no clear difference for detection of early (OR 1.78, 95% 0.51 to 6.17; 394 participants; 1 study; P = 0.37; low-quality evidence) or advanced (OR 1.00, 95% CI 0.14 to 7.17; 394 participants; 1 study; P = 1.00; low-quality evidence) stages of cancer. There was also no clear difference in the frequency of an underlying cancer diagnosis (OR 1.71, 95% CI 0.91 to 3.20; 1248 participants; 2 studies; P = 0.09; moderate-quality evidence). Time to cancer diagnosis was 4.2 months in the standard testing group and 4.0 months in the standard testing plus PET/CT group (P = 0.88). Neither study measured VTE-related mortality, complications of anticoagulation, adverse effects of cancer tests, participant satisfaction or quality of life.

Authors' Conclusions: Specific testing for cancer in people with unprovoked VTE may lead to earlier diagnosis of cancer at an earlier stage of the disease. However, there is currently insufficient evidence to draw definitive conclusions concerning the effectiveness of testing for undiagnosed cancer in people with a first episode of unprovoked VTE (DVT or PE) in reducing cancer- or VTE-related morbidity and mortality. The results could be consistent with either benefit or no benefit. Further good-quality large-scale randomised controlled trials are required before firm conclusions can be made.
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http://dx.doi.org/10.1002/14651858.CD010837.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517248PMC
November 2018

Gene therapy for peripheral arterial disease.

Cochrane Database Syst Rev 2018 10 31;10:CD012058. Epub 2018 Oct 31.

Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK, EH8 9AG.

Background: Peripheral arterial disease (PAD), caused by narrowing of the arteries in the limbs, is increasing in incidence and prevalence as our population is ageing and as diabetes is becoming more prevalent. PAD can cause pain in the limbs while walking, known as intermittent claudication, or can be more severe and cause pain while at rest, ulceration, and ultimately gangrene and limb loss. This more severe stage of PAD is known as 'critical limb ischaemia'. Treatments for PAD include medications that help to reduce the increased risk of cardiovascular events and help improve blood flow, as well as endovascular or surgical repair or bypass of the blocked arteries. However, many people are unresponsive to medications and are not suited to surgical or endovascular treatment, leaving amputation as the last option. Gene therapy is a novel approach in which genetic material encoding for proteins that may help increase revascularisation is injected into the affected limbs of patients. This type of treatment has been shown to be safe, but its efficacy, especially regarding ulcer healing, effects on quality of life, and other symptomatic outcomes remain unknown.

Objectives: To assess the effects of gene therapy for symptomatic peripheral arterial disease.

Search Methods: The Cochrane Vascular Information Specialist searched Cochrane CENTRAL, the Cochrane Vascular Specialised Register, MEDLINE Ovid, Embase Ovid, CINAHL, and AMED, along with trials registries (all searched 27 November 2017). We also checked reference lists of included studies and systematic reviews for further studies.

Selection Criteria: We included randomised and quasi-randomised studies that evaluated gene therapy versus no gene therapy in people with PAD. We excluded studies that evaluated direct growth hormone treatment or cell-based treatments.

Data Collection And Analysis: Two review authors independently selected studies, performed quality assessment, and extracted data from the included studies. We collected pertinent information on each study, as well as data for the outcomes of amputation-free survival, ulcer healing, quality of life, amputation, all-cause mortality, ankle brachial index, symptom scores, and claudication distance.

Main Results: We included in this review a total of 17 studies with 1988 participants (evidence current until November 2017). Three studies limited their inclusion to people with intermittent claudication, 12 limited inclusion to people with varying levels of critical limb ischaemia, and two included people with either condition. Study investigators evaluated many different types of gene therapies, using different protocols. Most studies evaluated growth factor-encoding gene therapy, with six studies using vascular endothelial growth factor (VEGF)-encoding genes, four using hepatocyte growth factor (HGF)-encoding genes, and three using fibroblast growth factor (FGF)-encoded genes. Two studies evaluated hypoxia-inducible factor 1-alpha (HIF-1α) gene therapy, one study used a developmental endothelial locus-1 gene therapy, and the final study evaluated a stromal cell-derived factor-1 (SDF-1) gene therapy. Most studies reported outcomes after 12 months of follow-up, but follow-up ranged from three months to two years.Overall risk of bias varied between studies, with many studies not providing sufficient detail for adequate determination of low risk of bias for many domains. Two studies did not utilise a placebo control, leading to risk of performance bias. Several studies reported in previous protocols or in their Methods sections that they would report on certain outcomes for which no data were then reported, increasing risk of reporting bias. All included studies reported sponsorships from corporate entities that led to unclear risk of other bias. The overall quality of evidence ranged from moderate to very low, generally as the result of heterogeneity and imprecision, with few or no studies reporting on outcomes.Evidence suggests no clear differences for the outcomes of amputation-free survival, major amputation, and all-cause mortality between those treated with gene therapy and those not receiving this treatment (all moderate-quality evidence). Low-quality evidence suggests improvement in complete ulcer healing with gene therapy (odds ratio (OR) 2.16, 95% confidence interval (CI) 1.02 to 4.59; P = 0.04). We could not combine data on quality of life and can draw no conclusions at this time regarding this outcome (very low-quality evidence). We included one study in the meta-analysis for ankle brachial index, which showed no clear differences between treatments, but we can draw no overall association (low-quality evidence). We combined in a meta-analysis pain symptom scores as assessed by visual analogue scales from two studies and found no clear differences between treatment groups (very low-quality evidence). We carried out extensive subgroup analyses by PAD classification, dosage schedule, vector type, and gene used but identified no substantial differences.

Authors' Conclusions: Moderate-quality evidence shows no clear differences in amputation-free survival, major amputation, and all-cause mortality between those treated with gene therapy and those not receiving gene therapy. Some evidence suggests that gene therapy may lead to improved complete ulcer healing, but this outcome needs to be explored with improved reporting of the measure, such as decreased ulcer area in cm², and better description of ulcer types and healing. Further standardised data that are amenable to meta-analysis are needed to evaluate other outcomes such as quality of life, ankle brachial index, symptom scores, and claudication distance.
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http://dx.doi.org/10.1002/14651858.CD012058.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517203PMC
October 2018

AVURT: aspirin versus placebo for the treatment of venous leg ulcers - a Phase II pilot randomised controlled trial.

Health Technol Assess 2018 10;22(55):1-138

Bristol Centre for Surgical Research, National Institute for Health Research (NIHR) Biomedical Research Centre, University of Bristol, Bristol, UK.

Background: Venous leg ulcers (VLUs) are the most common cause of leg ulceration, affecting 1 in 100 adults. VLUs may take many months to heal (25% fail to heal). Estimated prevalence is between 1% and 3% of the elderly population. Compression is the mainstay of treatment and few additional therapies exist to improve healing. Two previous trials have indicated that low-dose aspirin, as an adjunct to standard care, may improve healing time, but these trials were insufficiently robust. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established.

Objectives: Primary objective - to assess the effects of 300 mg of aspirin (daily) versus placebo on the time to healing of the reference VLU. Secondary objectives - to assess the feasibility of leading into a larger pragmatic Phase III trial and the safety of aspirin in this population.

Design: A multicentred, pilot, Phase II randomised double-blind, parallel-group, placebo-controlled efficacy trial.

Setting: Community leg ulcer clinics or services, hospital outpatient clinics, leg ulcer clinics, tissue viability clinics and wound clinics in England, Wales and Scotland.

Participants: Patients aged ≥ 18 years with a chronic VLU (i.e. the VLU is > 6 weeks in duration or the patient has a history of VLU) and who are not regularly taking aspirin.

Interventions: 300 mg of daily oral aspirin versus placebo. All patients were offered care in accordance with Scottish Intercollegiate Guidelines Network (SIGN) guidance with multicomponent compression therapy aiming to deliver 40 mmHg at the ankle when possible.

Randomisation: Participants were allocated in a 1 : 1 (aspirin : placebo) ratio by the Research Pharmacy, St George's University Hospitals NHS Foundation Trust, using a randomisation schedule generated in advance by the investigational medicinal product manufacturer. Randomisation was stratified according to ulcer size (≤ 5cm or > 5cm).

Main Outcome Measure: The primary outcome was time to healing of the largest eligible ulcer (reference ulcer).

Feasibility Results – Recruitment: 27 patients were recruited from eight sites over a period of 8 months. The target of 100 patients was not achieved and two sites did not recruit. Barriers to recruitment included a short recruitment window and a large proportion of participants failing to meet the eligibility criteria.

Results: The average age of the 27 randomised participants (placebo,  = 13; aspirin,  = 14) was 62 years (standard deviation 13 years), and two-thirds were male ( = 18). Participants had their reference ulcer for a median of 15 months, and the median size of ulcer was 17.1 cm. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis for log-ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85;  = 0.357). One expected, related serious adverse event was recorded for a participant in the aspirin group.

Limitations: The trial under-recruited because many patients did not meet the eligibility criteria.

Conclusions: There was no evidence that aspirin was efficacious in hastening the healing of chronic VLUs. It can be concluded that a larger Phase III (effectiveness) trial would not be feasible.

Trial Registration: Clinical Trials.gov NCT02333123; European Clinical Trials Database (EudraCT) 2014-003979-39.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 55. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta22550DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6204573PMC
October 2018

Innovative Multi-Site Photoplethysmography Analysis for Quantifying Pulse Amplitude and Timing Variability Characteristics in Peripheral Arterial Disease.

Diseases 2018 Sep 17;6(3). Epub 2018 Sep 17.

Northern Medical Physics and Clinical Engineering, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE7 7DN, UK.

Photoplethysmography (PPG) is a simple-to-perform vascular optics measurement technique that can detect blood volume changes in the microvascular bed of tissue. Beat-to-beat analysis of the PPG waveform enables the study of the variability of pulse features, such as the amplitude and the pulse arrival time (PAT), and when quantified in the time and frequency domains, has considerable potential to shed light on perfusion changes associated with peripheral arterial disease (PAD). In this pilot study, innovative multi-site bilateral finger and toe PPG recordings from 43 healthy control subjects and 31 PAD subjects were compared (recordings each at least five minutes, collected in a warm temperature-controlled room). Beat-to-beat normalized amplitude variability and PAT variability were then quantified in the time-domain using two simple statistical measures and in the frequency-domain bilaterally using magnitude squared coherence (MSC). Significantly reduced normalized amplitude variability (healthy control 0.0384 (interquartile range 0.0217⁻0.0744) vs. PAD 0.0160 (0.0080⁻0.0338) ( < 0.0001)) and significantly increased PAT variability (healthy control 0.0063 (0.0052⁻0.0086) vs. PAD 0.0093 (0.0078⁻0.0144) ( < 0.0001)) was demonstrated for the toe site in PAD using the time-domain analysis. Frequency-domain analysis demonstrated significantly lower MSC values across a range of frequency bands for PAD patients. These changes suggest a loss of right-to-left body side coherence and cardiovascular control in PAD. This study has also demonstrated the feasibility of using these measurement and analysis methods in studies investigating multi-site PPG variability for a wide range of cardiac and vascular patient groups.
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http://dx.doi.org/10.3390/diseases6030081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6165367PMC
September 2018

Evaluating the Construct Validity of a Pulsatile Fresh Frozen Human Cadaver Circulation Model for Endovascular Training.

Ann Vasc Surg 2018 Oct 19;52:237-243. Epub 2018 May 19.

Professor of Vascular Surgery, Northern Vascular Centre, Department of Vascular Surgery, Freeman Hospital, Newcastle Upon Tyne, UK.

Background: We recently described a pulsatile fresh frozen human cadaver model (PHCM) for training endovascular practitioners. This present study aims to assess the construct validity of PHCM; its ability to differentiate between participants of varying expertise.

Methods: Twenty-three participants with varying endovascular experience (12 novice, 4 intermediate, and 7 expert) were recruited. Each attempted catheterization of the left renal artery on PHCM within 10 min under exam conditions. Performances were video recorded and scored using a validated scoring tool by 2 independent endovascular experts, blinded to performer status. Each participant was given a task-specific checklist score (TSC), global rating score (GRS), and overall procedure score (OPS). Finally, examiners were asked whether they would be happy to supervise the participant in theater, with each participant graded as "fail", "borderline," or "pass".

Results: All expert and intermediate participants completed the index procedure within the allotted 10 min; however, only one of the 12 novice participants achieved this (P < 0.0005). Endovascular novices had significantly lower TSC, GRS, and OPS than both intermediate participants and endovascular experts. There were no significant differences in TSC, GRS, or OPS between intermediate participants and endovascular experts. When participants were graded as "fail", "borderline," or "pass," there were significant differences between groups (P = 0.001). All of the intermediate and expert participants received a pass. Out of the 12 novice participants, 2 received a pass, 6 received a borderline, and 4 were failed.

Conclusions: The PHCM demonstrates construct validity. Further work is required to determine its educational impact in endovascular training.
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http://dx.doi.org/10.1016/j.avsg.2018.03.041DOI Listing
October 2018

Asynchronous Unsupervised Video-Enhanced Feedback As Effective As Direct Expert Feedback in the Long-Term Retention of Practical Clinical Skills: Randomised Trial Comparing 2 Feedback Methods in a Cohort of Novice Medical Students.

J Surg Educ 2018 Nov 7;75(6):1463-1470. Epub 2018 May 7.

Newcastle Upon Tyne Hospitals NHS foundation Trust, Newcastle, United Kingdom.

Objectives: To determine the degree of practical clinical skills' retention over a 7-week period after receiving either video-enhanced direct expert feedback (DEF) or asynchronous unsupervised video-enhanced feedback (UVF).

Design: A prospective single-blinded randomized trial was conducted over a 7-week period with novice medical students. Following a generic introduction, PowerPoint presentation and live demonstration of intravenous cannulation was given by an expert, and candidates performed the same task in isolation while being recorded and were randomized to receive either DEF or UVF. Further, 20 students were randomized to receive UVF and 22 to receive DEF. Candidates returned to repeat the video-recorded task at week 1, 4, and 7, with no further feedback provision on these occasions. Performances were fully anonymized and independently marked by 2 expert assessors.

Setting: Newcastle University, Medical School, England, United Kingdom.

Participants: A total of 42 novice medical students from the preclinical years were selected, with no prior experience of intravenous cannulation.

Results: No significant difference existed between demographics of either cohort. Good between-assessor score correlation was noted, with an intraclass correlation coefficient (ICC) of 0.89. The DEF arm significantly improved from their prefeedback performance at Day 1 on repeating the skill a week later (p < 0.0001); this improved score was maintained throughout the duration of the study. The UVF arm showed a nonsignificant improvement; however, there was no significant difference in the scores between the UVF and the DEF groups at any point in the trial.

Conclusions: Video-technology may play a significant role in the provision of feedback for practical skills. The ability for experts to provide remotely delivered but individualized feedback can be an efficient use of valuable resources, while students being able to self-assess their own performance alongside an expert video have the potential to provide students with an excellent opportunity to learn clinical skills without requiring intensive educator involvement.
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http://dx.doi.org/10.1016/j.jsurg.2018.03.013DOI Listing
November 2018

Systematic Review of Economic Models Used to Compare Techniques for Detecting Peripheral Arterial Disease.

Pharmacoecon Open 2019 Mar;3(1):21-30

Northern Medical Physics and Clinical Engineering, Newcastle Upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.

Background And Objective: Peripheral arterial disease (PAD) is a common condition, in which atherosclerotic narrowing in the arteries restricts blood supply to the leg muscles. In order to support future model-based economic evaluations comparing methods of diagnosis in this area, a systematic review of economic modelling studies was conducted.

Methods: A systematic literature review was performed in June 2017 to identify model-based economic evaluations of diagnostic tests to detect PAD, with six individual databases searched. The review was conducted in accordance with the methods outlined in the Centre for Reviews and Dissemination's guidance for undertaking reviews in healthcare, and appropriate inclusion criteria were applied. Relevant data were extracted, and studies were quality assessed.

Results: Seven studies were included in the final review, all of which were published between 1995 and 2014. There was wide variation in the types of diagnostic test compared. The majority of the studies (six of seven) referenced the sources used to develop their model, and all studies stated and justified the structural assumptions. Reporting of the data within the included studies could have been improved. Only one identified study focused on the cost-effectiveness of a test typically used in primary care.

Conclusions: This review brings together all applied modelling methods for tests used in the diagnosis of PAD, which could be used to support future model-based economic evaluations in this field. The limited modelling work available on tests typically used for the detection of PAD in primary care, in particular, highlights the importance of future work in this area.
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http://dx.doi.org/10.1007/s41669-018-0076-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6393284PMC
March 2019

Interventions for hyperhidrosis in secondary care: a systematic review and value-of-information analysis.

Health Technol Assess 2017 12;21(80):1-280

Centre for Reviews and Dissemination, University of York, York, UK.

Background: Hyperhidrosis is uncontrollable excessive sweating that occurs at rest, regardless of temperature. The symptoms of hyperhidrosis can significantly affect quality of life. The management of hyperhidrosis is uncertain and variable.

Objective: To establish the expected value of undertaking additional research to determine the most effective interventions for the management of refractory primary hyperhidrosis in secondary care.

Methods: A systematic review and economic model, including a value-of-information (VOI) analysis. Treatments to be prescribed by dermatologists and minor surgical treatments for hyperhidrosis of the hands, feet and axillae were reviewed; as endoscopic thoracic sympathectomy (ETS) is incontestably an end-of-line treatment, it was not reviewed further. Fifteen databases (e.g. CENTRAL, PubMed and PsycINFO), conference proceedings and trial registers were searched from inception to July 2016. Systematic review methods were followed. Pairwise meta-analyses were conducted for comparisons between botulinum toxin (BTX) injections and placebo for axillary hyperhidrosis, but otherwise, owing to evidence limitations, data were synthesised narratively. A decision-analytic model assessed the cost-effectiveness and VOI of five treatments (iontophoresis, medication, BTX, curettage, ETS) in 64 different sequences for axillary hyperhidrosis only.

Results And Conclusions: Fifty studies were included in the effectiveness review: 32 randomised controlled trials (RCTs), 17 non-RCTs and one large prospective case series. Most studies were small, rated as having a high risk of bias and poorly reported. The interventions assessed in the review were iontophoresis, BTX, anticholinergic medications, curettage and newer energy-based technologies that damage the sweat gland (e.g. laser, microwave). There is moderate-quality evidence of a large statistically significant effect of BTX on axillary hyperhidrosis symptoms, compared with placebo. There was weak but consistent evidence for iontophoresis for palmar hyperhidrosis. Evidence for other interventions was of low or very low quality. For axillary hyperhidrosis cost-effectiveness results indicated that iontophoresis, BTX, medication, curettage and ETS was the most cost-effective sequence (probability 0.8), with an incremental cost-effectiveness ratio of £9304 per quality-adjusted life-year. Uncertainty associated with study bias was not reflected in the economic results. Patients and clinicians attending an end-of-project workshop were satisfied with the sequence of treatments for axillary hyperhidrosis identified as being cost-effective. All patient advisors considered that the Hyperhidrosis Quality of Life Index was superior to other tools commonly used in hyperhidrosis research for assessing quality of life.

Limitations: The evidence for the clinical effectiveness and safety of second-line treatments for primary hyperhidrosis is limited. This meant that there was insufficient evidence to draw conclusions for most interventions assessed and the cost-effectiveness analysis was restricted to hyperhidrosis of the axilla.

Future Work: Based on anecdotal evidence and inference from evidence for the axillae, participants agreed that a trial of BTX (with anaesthesia) compared with iontophoresis for palmar hyperhidrosis would be most useful. The VOI analysis indicates that further research into the effectiveness of existing medications might be worthwhile, but it is unclear that such trials are of clinical importance. Research that established a robust estimate of the annual incidence of axillary hyperhidrosis in the UK population would reduce the uncertainty in future VOI analyses.

Study Registration: This study is registered as PROSPERO CRD42015027803.

Funding: The National Institute for Health Research Health Technology Assessment programme.
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http://dx.doi.org/10.3310/hta21800DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5757187PMC
December 2017

A Pulsatile Fresh Frozen Human Cadaver Circulation Model for Endovascular Training: A Trial of Face Validity.

Ann Vasc Surg 2018 Jan 6;46:345-350. Epub 2017 Sep 6.

Department of Vascular Surgery, Northern Vascular Centre, Freeman Hospital, Newcastle Upon Tyne, UK.

Background: The authors have published their design of a pulsatile fresh frozen human cadaver circulation model (PHCM) for endovascular training the face validity of the PHCM for training endovascular practitioners was subsequently assessed.

Methods: Twelve endovascular clinicians performed the same 2 procedures (catheterization of the left renal artery and left subclavian artery) on PHCM and Simbionix angiomentor virtual reality simulator (SVR). They were randomized to begin on either the PHCM or SVR. A pretrial questionnaire determined participants' endovascular experience. After training, participants rated statements relating to their experience on a numerical scale from 1 to 5, with 1 representing the strongest agreement with the statement.

Results: When participants were asked to compare the realism of training modalities with live patients, PHCM scored significantly higher than SVR on statements regarding "realism of vascular access" (P = 0.002), "guide-wire manipulation" (P = 0.001), and "vessel catheterization" (P = 0.004). Candidates again favored PHCM as "a valuable learning exercise" (P = 0.016) and strongly favored PHCM as a "useful training model" compared to SVR (P = 0.004).

Conclusions: This is the first published trial in world literature to assess the validity of a PHCM for training endovascular practitioners. The PHCM demonstrates good face validity when compared to both real patients and the SVR model and holds exciting potential.
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http://dx.doi.org/10.1016/j.avsg.2017.07.030DOI Listing
January 2018

Effect of testing for cancer on cancer- and venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE.

Cochrane Database Syst Rev 2017 08 23;8:CD010837. Epub 2017 Aug 23.

Department of Vascular Surgery, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, High Heaton, Newcastle upon Tyne, UK, NE7 7DN.

Background: Venous thromboembolism (VTE) is a collective term for two conditions: deep vein thrombosis (DVT) and pulmonary embolism (PE). A proportion of people with VTE have no underlying or immediately predisposing risk factors and the VTE is referred to as unprovoked. Unprovoked VTE can often be the first clinical manifestation of an underlying malignancy. This has raised the question of whether people with an unprovoked VTE should be investigated for an underlying cancer. Treatment for VTE is different in cancer and non-cancer patients and a correct diagnosis would ensure that people received the optimal treatment for VTE to prevent recurrence and further morbidity. Furthermore, an appropriate cancer diagnosis at an earlier, potentially curative stage could avoid the risk of cancer progression and thus lead to improvements in cancer-related mortality and morbidity. This is an update of a review first published in 2015.

Objectives: To determine whether testing for undiagnosed cancer in people with a first episode of unprovoked VTE (DVT of the lower limb or PE) is effective in reducing cancer and VTE-related mortality and morbidity and to determine which tests for cancer are best at identifying treatable cancers early.

Search Methods: For this update, the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (16 February 2017). In addition, the CIS searched the Cochrane Register of Studies CENTRAL (2017, Issue 1). We searched trials registries (February 2017) and checked the reference lists of relevant articles.

Selection Criteria: Randomised and quasi-randomised trials in which people with an unprovoked VTE were allocated to receive specific tests for cancer or clinically indicated tests only were eligible for inclusion in this review. Primary outcomes included all-cause mortality, cancer-related mortality and VTE-related mortality.

Data Collection And Analysis: Two review authors independently selected studies, assessed quality and extracted data. We resolved any disagreements by discussion.

Main Results: Four studies with 1644 participants met the inclusion criteria (two studies in the original review and two in this update). Two studies assessed the effect of extensive tests versus tests at the physician's discretion) while the other two studies assessed the effect of standard testing plus positron emission tomography (PET)/computed tomography (CT) scanning versus standard testing alone. For extensive tests versus tests at the physician's discretion, the quality of the evidence was low due to risk of bias (early termination of the studies). When comparing standard testing plus PET/CT scanning versus standard testing alone, the quality of evidence was moderate due to a risk of detection bias. The quality of the evidence was downgraded further when detection bias was present in one study with a low number of events.When comparing extensive tests versus tests at the physician's discretion, pooled analysis on two studies showed that testing for cancer was consistent with either a benefit or no benefit on cancer-related mortality (odds ratio (OR) 0.49, 95% confidence interval (CI) 0.15 to 1.67; 396 participants; 2 studies; P = 0.26; low quality evidence). One study (201 participants) showed that, overall, malignancies were less advanced in extensively tested participants than in participants in the control group. In total, 9/13 participants diagnosed with cancer in the extensively tested group had a T1 or T2 stage malignancy compared to 2/10 participants diagnosed with cancer in the control group (OR 5.00, 95% CI 1.05 to 23.76; P = 0.04; low quality evidence). There was no clear difference in detection of advanced stages between extensive tests versus tests at the physician's discretion: one participant in the extensively tested group had stage T3 compared with four participants in the control group (OR 0.25, 95% CI 0.03 to 2.28; P = 0.22; low quality evidence). In addition, extensively tested participants were diagnosed earlier than control group (mean: 1 month with extensive tests versus 11.6 months with tests at physician's discretion to cancer diagnosis from the time of diagnosis of VTE). Extensive testing did not increase the frequency of an underlying cancer diagnosis (OR 1.32, 95% CI 0.59 to 2.93; 396 participants; 2 studies; P = 0.50; low quality evidence). Neither study measured all-cause mortality, VTE-related morbidity and mortality, complications of anticoagulation, adverse effects of cancer tests, participant satisfaction or quality of life.When comparing standard testing plus PET/CT screening versus standard testing alone, standard testing plus PET/CT screening was consistent with either a benefit or no benefit on all-cause mortality (OR 1.22, 95% CI 0.49 to 3.04; 1248 participants; 2 studies; P = 0.66; moderate quality evidence), cancer-related mortality (OR 0.55, 95% CI 0.20 to 1.52; 1248 participants; 2 studies; P = 0.25; moderate quality evidence) or VTE-related morbidity (OR 1.02, 95% CI 0.48 to 2.17; 854 participants; 1 study; P = 0.96; moderate quality evidence). With regards to stage of cancer, there was no clear difference for detection of early (OR 1.78, 95% 0.51 to 6.17; 394 participants; 1 study; P = 0.37; low quality evidence) or advanced (OR 1.00, 95% CI 0.14 to 7.17; 394 participants; 1 study; P = 1.00; low quality evidence) stages of cancer. There was also no clear difference in the frequency of an underlying cancer diagnosis (OR 1.71, 95% CI 0.91 to 3.20; 1248 participants; 2 studies; P = 0.09; moderate quality evidence). Time to cancer diagnosis was 4.2 months in the standard testing group and 4.0 months in the standard testing plus PET/CT group (P = 0.88). Neither study measured VTE-related mortality, complications of anticoagulation, adverse effects of cancer tests, participant satisfaction or quality of life.

Authors' Conclusions: Testing for cancer in people with unprovoked VTE may lead to earlier diagnosis of cancer at an earlier stage of the disease. However, there is currently insufficient evidence to draw definitive conclusions concerning the effectiveness of testing for undiagnosed cancer in people with a first episode of unprovoked VTE (DVT or PE) in reducing cancer and VTE-related morbidity and mortality. The results could be consistent with either benefit or no benefit. Further good-quality large-scale randomised controlled trials are required before firm conclusions can be made.
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http://dx.doi.org/10.1002/14651858.CD010837.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6483606PMC
August 2017

A Prospective, Randomized, Multicenter Clinical Trial on the Safety and Efficacy of a Ready-to-Use Fibrin Sealant as an Adjunct to Hemostasis during Vascular Surgery.

Ann Vasc Surg 2017 Nov 21;45:127-137. Epub 2017 Jun 21.

Clinical Department, Instituto Grifols S.A., Barcelona, Spain.

Background: Anastomotic or "stitch hole" bleeding is common during vascular surgery with synthetic material such as Dacron or polytetrafluoroethylene. Hemostatic adjuncts such as fibrin sealant (FS) may reduce blood loss and operating time in such circumstances. We evaluated the safety and the hemostatic effectiveness of a ready-to-use human plasma-derived FS in vascular surgery.

Methods: Patients with mild/moderate suture line bleeding during elective, open, vascular surgery using synthetic grafts or patches were studied. In an initial Exploratory Study, all patients were treated with FS Grifols, and in a subsequent Primary Study were randomized in a 2:1 ratio to FS Grifols or manual compression (MC). The primary efficacy end point was time to hemostasis (TTH), assessed at defined intervals from the start of treatment application, during a 10-min observational period. Safety end points (in Exploratory + Primary Studies) included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests (coagulation, complete blood count, serum clinical chemistry parameters, microscopic urinalysis), viral markers, and immunogenicity.

Results: In the Primary Study, the proportion of patients who achieved hemostasis at the 3-min time point was higher in the FS Grifols group (46.4%, n = 51/110) than in the MC group (26.3%, n = 15/57) (P < 0.05). The benefit was maintained at successive time intervals: 69 FS Grifols patients (62.7%) and 18 MC patients (31.6%) at 4 min; 82 FS Grifols patients (74.5%) and 28 MC patients (49.1%) at 5 min. The differences between the groups persisted for TTH ≤ 7 min and TTH ≤ 10 min. Treatment failure was reported for 13 FS Grifols patients (11.8%) and 16 MC patients (28.1%). TTH was shorter after FS Grifols application than after MC application. Differences were statistically significant in favor of FS Grifols for each TTH category and for the overall comparison (P < 0.001) as well as for each TTH category (cumulative) and for treatment failure (P = 0.016). Overall, AE experience and types of AEs reported were those expected in this patient population and were similar between the 2 treatment groups. The most frequently reported AEs were procedural pain (59.9% and 69.2% of patients in the FS Grifols [n = 72 + 111] and MC [n = 57] groups, respectively) and nausea (23.5% and 19.2% of patients, respectively).

Conclusions: FS Grifols was efficacious and safe as an adjunct to anastomotic hemostasis in patients undergoing arterial surgery using prosthetic material with mild to moderate bleeding.
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http://dx.doi.org/10.1016/j.avsg.2017.06.043DOI Listing
November 2017

Design of a Pulsatile Fresh Frozen Human Cadaver Circulation Model for Endovascular Training.

Ann Vasc Surg 2017 Oct 4;44:425-430. Epub 2017 May 4.

Department of Vascular Surgery, Northern Vascular Centre, Freeman Hospital, Newcastle Upon Tyne, UK.

Background: The objective of this project was to create a model capable of training endovascular skills using a freshly frozen human cadaver (HC). We present the results of our experience creating a cadaveric model for endovascular skills training. We undertook a unique cadaver laboratory-based research project.

Methods: We favor a minimally invasive surgical technique with inflow into the right common carotid artery and outflow through the left common femoral and right superficial femoral arteries. Endovascular access was through the right common femoral artery.

Results: Through this technique, the arch, thoracic, abdominal, and iliac vessels are all accessible. We perfuse the model through an open pulsatile flow circuit at varying rates to maximize angiographic image capture while minimizing cadaveric edema thus expanding the models longevity.

Conclusions: A fresh frozen pulsatile human cadaver training model is a feasible and credible training model that has exciting potential for endovascular skills training.
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http://dx.doi.org/10.1016/j.avsg.2017.01.024DOI Listing
October 2017

Pharmacological treatment of vascular risk factors for reducing mortality and cardiovascular events in patients with abdominal aortic aneurysm.

Cochrane Database Syst Rev 2017 01 12;1:CD010447. Epub 2017 Jan 12.

Northern Vascular Centre, Freeman Hospital, Newcastle upon Tyne, UK, NE7 7DN.

Background: Pharmacological prophylaxis has been proven to reduce the risk of cardiovascular events in individuals with atherosclerotic occlusive arterial disease. However, the role of prophylaxis in individuals with abdominal aortic aneurysm (AAA) remains unclear. Several studies have shown that despite successful repair, those people with AAA have a poorer rate of survival than healthy controls. People with AAA have an increased prevalence of coronary heart disease and risk of cardiovascular events. Despite this association, little is known about the effectiveness of pharmacological prophylaxis in reducing cardiovascular risk in people with AAA. This is an update of a Cochrane review first published in 2014.

Objectives: To determine the long-term effectiveness of antiplatelet, antihypertensive or lipid-lowering medication in reducing mortality and cardiovascular events in people with abdominal aortic aneurysm (AAA).

Search Methods: For this update the Cochrane Vascular Information Specialist (CIS) searched the Cochrane Vascular Specialised Register (14 April 2016). In addition, the CIS searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 3) and trials registries (14 April 2016) and We also searched the reference lists of relevant articles.

Selection Criteria: Randomised controlled trials in which people with AAA were randomly allocated to one prophylactic treatment versus another, a different regimen of the same treatment, a placebo, or no treatment were eligible for inclusion in this review. Primary outcomes included all-cause mortality and cardiovascular mortality.

Data Collection And Analysis: Two review authors independently selected studies for inclusion, and completed quality assessment and data extraction. We resolved any disagreements by discussion. Only one study met the inclusion criteria of the review, therefore we were unable to perform meta-analysis.

Main Results: No new studies met the inclusion criteria for this update. We included one randomised controlled trial in the review. A subgroup of 227 participants with AAA received either metoprolol (N = 111) or placebo (N = 116). There was no clear evidence that metoprolol reduced all-cause mortality (odds ratio (OR) 0.17, 95% confidence interval (CI) 0.02 to 1.41), cardiovascular death (OR 0.20, 95% CI 0.02 to 1.76), AAA-related death (OR 1.05, 95% CI 0.06 to 16.92) or increased nonfatal cardiovascular events (OR 1.44, 95% CI 0.58 to 3.57) 30 days postoperatively. Furthermore, at six months postoperatively, estimated effects were compatible with benefit and harm for all-cause mortality (OR 0.71, 95% CI 0.26 to 1.95), cardiovascular death (OR 0.73, 95% CI 0.23 to 2.39) and nonfatal cardiovascular events (OR 1.41, 95% CI 0.59 to 3.35). Adverse drug effects were reported for the whole study population and were not available for the subgroup of participants with AAA. We considered the study to be at a generally low risk of bias. We downgraded the quality of the evidence for all outcomes to low. We downgraded the quality of evidence for imprecision as only one study with a small number of participants was available, the number of events was small and the result was consistent with benefit and harm.

Authors' Conclusions: Due to the limited number of included trials, there is insufficient evidence to draw any conclusions about the effectiveness of cardiovascular prophylaxis in reducing mortality and cardiovascular events in people with AAA. Further good-quality randomised controlled trials that examine many types of prophylaxis with long-term follow-up are required before firm conclusions can be made.
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http://dx.doi.org/10.1002/14651858.CD010447.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464734PMC
January 2017