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24 result(s) for "Appelboam, Andrew"
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Postural modification to the standard Valsalva manoeuvre for emergency treatment of supraventricular tachycardias (REVERT): a randomised controlled trial
The Valsalva manoeuvre is an internationally recommended treatment for supraventricular tachycardia, but cardioversion is rare in practice (5–20%), necessitating the use of other treatments including adenosine, which patients often find unpleasant. We assessed whether a postural modification to the Valsalva manoeuvre could improve its effectiveness. We did a randomised controlled, parallel-group trial at emergency departments in England. We randomly allocated adults presenting with supraventricular tachycardia (excluding atrial fibrillation and flutter) in a 1:1 ratio to undergo a modified Valsalva manoeuvre (done semi-recumbent with supine repositioning and passive leg raise immediately after the Valsalva strain), or a standard semi-recumbent Valsalva manoeuvre. A 40 mm Hg pressure, 15 s standardised strain was used in both groups. Randomisation, stratified by centre, was done centrally and independently, with allocation with serially numbered, opaque, sealed, tamper-evident envelopes. Patients and treating clinicians were not masked to allocation. The primary outcome was return to sinus rhythm at 1 min after intervention, determined by the treating clinician and electrocardiogram and confirmed by an investigator masked to treatment allocation. This study is registered with Current Controlled Trials (ISRCTN67937027). We enrolled 433 participants between Jan 11, 2013, and Dec 29, 2014. Excluding second attendance by five participants, 214 participants in each group were included in the intention-to-treat analysis. 37 (17%) of 214 participants assigned to standard Valsalva manoeuvre achieved sinus rhythm compared with 93 (43%) of 214 in the modified Valsalva manoeuvre group (adjusted odds ratio 3·7 (95% CI 2·3–5·8; p<0·0001). We recorded no serious adverse events. In patients with supraventricular tachycardia, a modified Valsalva manoeuvre with leg elevation and supine positioning at the end of the strain should be considered as a routine first treatment, and can be taught to patients. National Institute for Health Research.
Geometric semi-automatic analysis of radiographs of Colles’ fractures
Fractures of the wrist are common in Emergency Departments, where some patients are treated with a procedure called Manipulation under Anaesthesia. In some cases, this procedure is unsuccessful and patients need to revisit the hospital where they undergo surgery to treat the fracture. This work describes a geometric semi-automatic image analysis algorithm to analyse and compare the x-rays of healthy controls and patients with dorsally displaced wrist fractures (Colles' fractures) who were treated with Manipulation under Anaesthesia. A series of 161 posterior-anterior radiographs from healthy controls and patients with Colles' fractures were acquired and analysed. The patients' group was further subdivided according to the outcome of the procedure (successful/unsuccessful) and pre- or post-intervention creating five groups in total (healthy, pre-successful, pre-unsuccessful, post-successful, post-unsuccessful). The semi-automatic analysis consisted of manual location of three landmarks (finger, lunate and radial styloid) and automatic processing to generate 32 geometric and texture measurements, which may be related to conditions such as osteoporosis and swelling of the wrist. Statistical differences were found between patients and controls, as well as between pre- and post-intervention, but not between the procedures. The most distinct measurements were those of texture. Although the study includes a relatively low number of cases and measurements, the statistical differences are encouraging.
Evaluation of pre-hospital use of a valsalva assist device in the emergency treatment of supraventricular tachycardia EVADE: a randomised controlled feasibility trial
Background The valsalva manoeuvre is an internationally recommended initial treatment for supraventricular tachycardia (SVT). The pre-hospital use of a valsalva assist device, to help deliver this manoeuvre, could improve cardioversion rates and reduce the need for patients to attend hospital. Methods We conducted a randomised controlled feasibility trial comparing ambulance clinician use of a valsalva assist device versus standard care to treat adult patients presenting to an ambulance service in the south west of England. Eligible consenting participants were randomised 1:1 to device or standard care with trial procedures mirroring a proposed definitive trial. Feasibility was assessed upon ambulance clinician and participant recruitment rates and feedback, data completeness and potential future primary outcome rates. Results Over a 6 months period (1 July to 31 December 2018), 276 (23%) of 1183 eligible ambulance clinicians were trained and they recruited 34 participants; approximately 10% of patients presenting with suspected SVT during that time. Seventeen participants were randomised to each arm and all underwent their allocated valsalva strain method. All trial data and 63/68 (93%) of pre and post-valsalva ECGs were available. Seven (21%) participants had ineligible initial rhythms on retrospective expert ECG review. Valsalva assist device use was associated with cardioversion and non-conveyance in 4 (24%) and 2 (12%) participants respectively. No participants assigned to standard care were cardioverted and all were conveyed. Participant feedback highlighted the challenges of retaining trial information during an SVT attack. Conclusions The trial achieved efficient clinician training, randomisation and data collection, and there was an encouraging effect signal associated with device use. However, trial design changes should be considered to address the relatively small proportion of eligible patients recruited and challenges identified with consent and confirmation of cardioversion as a primary outcome. Trial registration The trial was registered with ClinicalTrials.gov ( NCT03514628 ) on 2 May 2018.
Ultrasound-directed reduction of distal radius fractures in adults: a systematic review
ObjectiveTo conduct a systematic review of the clinical literature to determine whether ultrasound can be used to improve the reduction of distal radius fractures in adults in the ED.MethodologyA study protocol was registered on PROSPERO. EMBASE, PubMed/MEDLINE, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov of the US National Library of Medicine were searched for studies evaluating ultrasound-assisted distal radial fracture reductions in comparison with standard care. The primary outcome of interest was manipulation success rates, defined as the proportion of fracture manipulations resulting in acceptable anatomical alignment, with secondary outcome being subsequent surgical intervention rates in ultrasound and standard care group of patients.Results248 were screened at title and abstract, and 10 studies were included for a narrative synthesis. The quality of this evidence is limited but suggests ultrasound is accurate in determining distal radius fracture reduction and may improve the quality of reduction compared with standard care. However, there is insufficient evidence to determine whether this affects the rate of subsequent surgical intervention or functional outcome.ConclusionThere is a lack of evidence that using ultrasound in the closed reduction of distal radius fractures benefits patients. Properly conducted randomised controlled trials with patient-orientated outcomes are crucial to investigate this technology.
Colles’ type distal radial fractures undergoing manipulation in the ED: a multicentre observational cohort study
BackgroundColles’ type fractures of the distal radius are one of the most commonly manipulated fractures in the ED. Local audit data suggest that a high proportion of these injuries undergo subsequent surgical fixation. If widespread, this could represent a potential burden on patients and the NHS worthy of further research. The aims of this study were to estimate the rate of surgical fixation of Colles’ type distal radial fractures after ED fracture manipulation and explore variations in their management in UK EDs.MethodsWe conducted a multicentre observational study in 16 EDs in the UK from 4 February 2019 to 31 March 2019. All adult patients with a Colles’ fracture who underwent fracture manipulation in the ED were included. Patients who could not be followed up and those with volar displaced fractures were excluded. We measured the rate of wrist fracture surgery at 6 weeks, patient demographics and variations in anaesthetic technique used.ResultsDuring the study period, 328 adult patients attended the participating EDs with a distal radial fracture. Of these, 83 patients underwent fracture manipulation in the ED and were eligible for the study. Their mean age (SD) was 65.3 (17.0) years, 84.3% were female and the most common method of anaesthesia used was haematoma block (38.6%). 34 (41.0%, 95 % CI 30.3 to 52.3) patients had subsequent surgical fixation of their fracture. Younger age was associated with higher rates of surgical fixation but ED anaesthetic technique did not affect the subsequent need for surgery in this sample.ConclusionSubsequent surgical fixation was carried out in 41% of patients who underwent manipulation of Colles’ type wrist fractures in this cohort. This merits further research and represents a potential target to rationalise repeat procedures.
Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK
The most common fractures in children are torus (buckle) fractures of the wrist. Controversy exists over treatment, which ranges from splint immobilisation and discharge to cast immobilisation, follow-up, and repeat imaging. This study compared pain and function in affected children offered a soft bandage and immediate discharge with those receiving rigid immobilisation and follow-up as per treating centre protocol. In this randomised controlled equivalence trial we included 965 children (aged 4–15 years) with a distal radius torus fracture from 23 hospitals in the UK. Children were randomly allocated in a 1:1 ratio to the offer of bandage group or rigid immobilisation group using bespoke web-based randomisation software. Treating clinicians, participants, and their families could not be masked to treatment allocation. Exclusion criteria included multiple injuries, diagnosis at more than 36 h after injury, and inability to complete follow-up. The primary outcome was pain at 3-days post-randomisation measured using Wong-Baker FACES Pain Rating Scale. We performed a modified intention-to-treat and per protocol analysis. The trial was registered with ISRCTN registry, ISRCTN13955395. Between Jan 16, 2019, and July 13, 2020, 965 children were randomly allocated to a group, 489 to the offer of a bandage group and 476 to the rigid immobilisation group, 379 (39%) were girls and 586 (61%) were boys. Primary outcome data was collected for 908 (94%) of participants, all of whom were included in the modified intention-to-treat analysis. Pain was equivalent at 3 days with 3·21 points (SD 2·08) in the offer of bandage group versus 3·14 points (2·11) in the rigid immobilisation group. With reference to a prespecified equivalence margin of 1·0, the adjusted difference in the intention-to-treat population was –0·10 (95% CI –0·37 to 0·17) and–0·06 (95% CI –0·34 to 0·21) in the per-protocol population. This trial found equivalence in pain at 3 days in children with a torus fracture of the distal radius assigned to the offer of a bandage group or the rigid immobilisation group, with no between-group differences in pain or function during the 6 weeks of follow-up. UK National Institute for Health and Care Research.
02 The evaluation of the pre-hospital use of a valsalva assist device in the emergency treatment of supraventricular tachycardia EVADE SVT study – surviving a cyber-attack
BackgroundThe modified Valsalva Manoeuvre (VM) is a recommended first line treatment of supraventricular tachycardia (SVT) used by emergency medical services globally. In practice, effective manoeuvres may be difficult to perform, and most patients require conveyance to hospital. A simple Valsalva Assist Device (VAD) was evaluated to establish whether it could improve pre-hospital treatment and conveyance rates.MethodsWe conducted a stepped wedge cluster randomised trial of the VAD versus standard VM to treat SVT within South Western Ambulance Service NHS Foundation Trust (SWASFT). We used routinely collected electronic clinical data and opt out consent. Sample size target was 800 patients, across 80 ambulance station clusters, over 5 activation phases (4 months each). Totalling 20 months recruitment, to detect a 10%-point difference between VAD and standard VM conveyance rates.ResultsIn July 2023, during the fourth period of recruitment, SWASFTs electronic record system was affected by a cyber-attack. This resulted in the encryption of 19 million clinical records, quarantine of active records, and a return to hand-written clinical notes, lasting 3 months. Successful completion of the trial required labour-intensive hand-searching of 240,000 paper clinical records to identify potential recruits. Final recruitment, despite the challenges, was 865 participants who had undergone a SWASFT delivered VM.ConclusionAmbulance services see and treat a large number of suspected SVT patients with a VM. Routine electronic clinical data systems can be used to efficiently identify participants and collect trial data but are at risk from cyber-attack. Contingency plans should be considered in such trials. The main study results and implications for practice will be published in due course.This study is funded by the NIHR Research for Patient Benefit Programme (NIHR202185). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Diagnostic accuracy of the T-MACS decision aid with a contemporary point-of-care troponin assay
ObjectivesThe rapid turnaround time of point-of-care (POC) cardiac troponin (cTn) assays is highly attractive for crowded emergency departments (EDs). We evaluated the diagnostic accuracy of the Troponin-only Manchester Acute Coronary Syndromes (T-MACS) decision aid with a POC cTn assay.MethodsIn a prospective diagnostic accuracy study at eight EDs, we included patients with suspected acute coronary syndromes (ACS). Blood drawn on arrival and 3 hours later was analysed for POC cTnI (i-Stat, Abbott Point of Care). The primary outcome was a diagnosis of ACS, which included both an adjudicated diagnosis of acute myocardial infarction (AMI) based on serial laboratory cTn testing and major adverse cardiac events (death, AMI or coronary revascularisation) within 30 days.ResultsOf 716 patients included, 105 (14.7%) had ACS. Using serial POC cTnI concentrations over 3 hours could have ‘ruled out’ ACS in 198 (31.2%) patients with a sensitivity of 99.0% (95% CI 94.4% to 100.0%) and negative predictive value 99.5% (95% CI 96.5% to 99.9%). No AMIs were missed. T-MACS ‘ruled in’ ACS for 65 (10.4%) patients with a positive predictive value of 91.2% (95% CI 82.1% to 95.9%) and specificity 98.9% (97.6% to 99.6%).ConclusionWith a POC cTnI assay, T-MACS could ‘rule out’ ACS for approximately one-third of patients within 3 hours while ‘ruling in’ ACS for another 10%. The rapid turnaround time and portability of the POC assay make this an attractive pathway for use in crowded EDs or urgent care centres. Future work should also evaluate use in the prehospital environment.
71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial
Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.
Ultrasound Directed Reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomised controlled trial
BackgroundThere is a high rate of surgical fixation of displaced Colles’ type distal radial wrist fractures despite fracture manipulation in the ED. Point-of-care ultrasound has been used to guide ED manipulations but its effect on the quality of fracture reduction or subsequent need for surgical fixation is unknown. This study aims to assess the feasibility of conducting a definitive randomised controlled trial to assess the use of ultrasound to guide these fracture manipulations.MethodsWe conducted a pragmatic randomised controlled feasibility trial in two EDs in England over a 6-month period (7 October 2019 to 6 April 2020). Adult patients with wrist fractures undergoing manipulation in the ED were randomised 1:1 to ultrasound-guided distal radial fracture manipulation or manipulation with sham ultrasound. The primary outcome for this study was trial recruitment rate. Other measures were recorded to assess potential future definitive trial outcomes and feasibility.ResultsOf 120 patients meeting inclusion criteria, 48 (40%) were recruited and randomised in the two centres, giving overall recruitment rates of 0.3 and 1.8 participants per week at each site, respectively, and 1 participant per week overall. The most common reason that patients were not included was research staff availability. After 6 weeks, six patients in each group (26% intervention, 24% control) had undergone surgical fixation, with 98% data completeness for this potential definitive trial primary outcome. Randomisation, blinding and data collection processes were effective but there were data limitations in the X-ray assessment of fracture positions.ConclusionA definitive study of a similar design would be feasible within UK ED practice but organisational factors and research staff availability should be considered when estimating the predicted recruitment rate and required sites. 6-week surgical fixation rate was the most reliable outcome measure.Trial registrationClinicalTrials.gov (NCT03868696).