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result(s) for
"Reed, Matthew J"
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Early fibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): results from a UK multi-centre, randomised, double blind, placebo-controlled pilot trial
by
Kellett, Suzanne
,
Davenport, Ross
,
Moss, Phil
in
Analysis
,
Care and treatment
,
Clinical trials
2018
Background
There is increasing interest in the timely administration of concentrated sources of fibrinogen to patients with major traumatic bleeding. Following evaluation of early cryoprecipitate in the CRYOSTAT 1 trial, we explored the use of fibrinogen concentrate, which may have advantages of more rapid administration in acute haemorrhage. The aims of this pragmatic study were to assess the feasibility of fibrinogen concentrate administration within 45 minutes of hospital admission and to quantify efficacy in maintaining fibrinogen levels ≥ 2 g/L during active haemorrhage.
Methods
We conducted a blinded, randomised, placebo-controlled trial at five UK major trauma centres with adult trauma patients with active bleeding who required activation of the major haemorrhage protocol. Participants were randomised to standard major haemorrhage therapy plus 6 g of fibrinogen concentrate or placebo.
Results
Twenty-seven of 39 participants (69%; 95% CI, 52–83%) across both arms received the study intervention within 45 minutes of admission. There was some evidence of a difference in the proportion of participants with fibrinogen levels ≥ 2 g/L between arms (
p
= 0.10). Fibrinogen levels in the fibrinogen concentrate (FgC) arm rose by a mean of 0.9 g/L (SD, 0.5) compared with a reduction of 0.2 g/L (SD, 0.5) in the placebo arm and were significantly higher in the FgC arm (
p
< 0.0001) at 2 hours. Fibrinogen levels were not different at day 7. Transfusion use and thromboembolic events were similar between arms. All-cause mortality at 28 days was 35.5% (95% CI, 23.8–50.8%) overall, with no difference between arms.
Conclusions
In this trial, early delivery of fibrinogen concentrate within 45 minutes of admission was not feasible. Although evidence points to a key role for fibrinogen in the treatment of major bleeding, researchers need to recognise the challenges of timely delivery in the emergency setting. Future studies must explore barriers to rapid fibrinogen therapy, focusing on methods to reduce time to randomisation, using ‘off-the-shelf’ fibrinogen therapies (such as extended shelf-life cryoprecipitate held in the emergency department or fibrinogen concentrates with very rapid reconstitution times) and limiting the need for coagulation test-based transfusion triggers.
Trial registration
ISRCTN67540073
. Registered on 5 August 2015.
Journal Article
Metoclopramide for analgesia in renal colic: a narrative systematic review
2024
Metoclopramide, a prokinetic antiemetic with activity at multiple receptor types, may be a useful treatment for renal colic pain. This review investigated whether metoclopramide is an effective analgesic in the management of adults with renal colic.
Eligible studies were randomised, quasi-randomised or case-control trials of metoclopramide for the management renal colic pain. Electronic database searches were performed in November 2022. Screening was performed by two authors independently; disagreement was resolved by discussion or by adjudication by a third author. The Cochrane Collaboration Risk of Bias Tool v2.0 was used to assess bias.
Two studies were included, enrolling 279 patients. Heterogeneity of primary outcome measurement and comparators rendered meta-analysis inappropriate; a narrative review is presented. Both studies showed some evidence of analgesic effect. The largest study had a low risk of bias in all assessed domains, whilst the smaller study was at a high risk of bias.
There is limited evidence that metoclopramide may be an effective analgesic in the management of renal colic, with the highest quality study demonstrating analgesic properties similar to an intravenous non-steroidal anti-inflammatory medication.
Protocol registration
Prospero (CRD42022346618).
Journal Article
Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar
by
Stoddart, Andrew
,
Niven, Angela
,
Black, Polly L
in
Activities of daily living
,
Fractures
,
Frailty
2022
IntroductionFractures of the odontoid process frequently result from low impact falls in frail or older adults. These are increasing in incidence and importance as the population ages. In the UK, odontoid fractures in older adults are usually managed in hard collars to immobilise the fracture and promote bony healing. However, bony healing does not always occur in older adults, and bony healing is not associated with quality of life, functional, or pain outcomes. Further, hard collars can cause complications such as skin pressure ulcers, swallowing difficulties and difficulties with personal care. We hypothesise that management with no immobilisation may be superior to management in a hard collar for older or frail adults with odontoid fractures.Methods and analysesThis is the protocol for the Duration of External Neck Stabilisation (DENS) trial—a non-blinded randomised controlled trial comparing management in a hard collar with management without a collar for older (≥65 years) or frail (Rockwood Clinical Frailty Scale ≥5) adults with a new odontoid fracture. 887 neurologically intact participants with any odontoid process fracture type will be randomised to continuing with a hard collar (standard care) or removal of the collar (intervention). The primary outcome is quality of life measured using the EQ-5D-5L at 12 weeks. Secondary outcomes include pain scores, neck disability index, health and social care use and costs, and mortality.Ethics and disseminationInformed consent for participation will be sought from those able to provide it. We will also include those who lack capacity to ensure representativeness of frail and acutely unwell older adults. Results will be disseminated via scientific publication, lay summary, and visual abstract. The DENS trial received a favourable ethical opinion from the Scotland A Research Ethics Committee (21/SS/0036) and the Leeds West Research Ethics Committee (21/YH/0141).Trial registration numberNCT04895644.
Journal Article
Correction: Personalized risk stratification through attribute matching for clinical decision making in clinical conditions with aspecific symptoms: The example of syncope
2021
[This corrects the article DOI: 10.1371/journal.pone.0228725.].[This corrects the article DOI: 10.1371/journal.pone.0228725.].
Journal Article
Prevalence and non-invasive predictors of left main or three-vessel coronary disease: evidence from a collaborative international meta-analysis including 22 740 patients
by
Kosuge, Masami
,
Biondi-Zoccai, Giuseppe
,
Modena, Maria Grazia
in
Acute coronary syndromes
,
Angina pectoris
,
aorta
2012
BackgroundLeft main disease (LMD) and three-vessel disease (3VD) have important prognostic value in patients with coronary artery disease. However, uncertainties still exist about their prevalence and predictors in patients with acute coronary syndrome (ACS) and also in patients with stable coronary disease. Thus the aim of this study was to perform an international collaborative systematic review and meta-analysis to appraise the prevalence and predictors of LMD and 3VD.MethodsMedline/PubMed were systematically searched for eligible studies published up to 2010, reporting multivariate predictors of LMD or 3VD. Study features, patient characteristics, and prevalence and predictors of LMD and 3VD were abstracted and pooled with random-effect methods (95% CIs).Results17 studies (22 740 patients) were included, 11 focusing on ACS (17 896 patients) and six on stable coronary disease (4844 patients). In the ACS subgroup, LMD or 3VD occurred in 20% (95% CI 7.2% to 33.4%), LMD in 12% (95% CI 10.5% to 13.5%), and 3VD in 25% (95% CI 23.1% to 27.0%). Heart failure at admission and extent of ST-segment elevation in lead aVR on 12-lead ECG were the most powerful predictors of LMD or 3VD. In the stable disease subgroup, LMD or 3VD was found in 36% (95% CI 18.5% to 48.8%), with the most powerful predictors being transient ischaemic dilation during the imaging stress test, extent of ST-segment elevation in aVR and V1 during the stress test, and hyperlipidaemia.ConclusionsThis meta-analysis demonstrated that severe coronary disease—that is, LMD or 3VD—is more common in patients with ACS or stable coronary disease than generally perceived, and that simple and low-cost tools may help in the selection of the most appropriate therapeutic approach.
Journal Article
Personalized risk stratification through attribute matching for clinical decision making in clinical conditions with aspecific symptoms: The example of syncope
by
Ungar, Andrea
,
Dipaola, Franca
,
Reed, Matthew J.
in
Biology and Life Sciences
,
Cardiac arrhythmia
,
Clinical decision making
2020
Risk stratification is challenging in conditions, such as chest pain, shortness of breath and syncope, which can be the manifestation of many possible underlying diseases. In these cases, decision tools are unlikely to accurately identify all the different adverse events related to the possible etiologies. Attribute matching is a prediction method that matches an individual patient to a group of previously observed patients with identical characteristics and known outcome. We used syncope as a paradigm of clinical conditions presenting with aspecific symptoms to test the attribute matching method for the prediction of the personalized risk of adverse events.
We selected the 8 predictor variables common to the individual-patient dataset of 5 prospective emergency department studies enrolling 3388 syncope patients. We calculated all possible combinations and the number of patients in each combination. We compared the predictive accuracy of attribute matching and logistic regression. We then classified ten random patients according to clinical judgment and attribute matching.
Attribute matching provided 253 of the 384 possible combinations in the dataset. Twelve (4.7%), 35 (13.8%), 50 (19.8%) and 160 (63.2%) combinations had a match size ≥50, ≥30, ≥20 and <10 patients, respectively. The AUC for the attribute matching and the multivariate model were 0.59 and 0.74, respectively.
Attribute matching is a promising tool for personalized and flexible risk prediction. Large databases will need to be used in future studies to test and apply the method in different conditions.
Journal Article
Multicentre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients: the ASPIRED study
by
Goodacre, Steve
,
Dinsmore, Lynn
,
Weir, Christopher J
in
ACCIDENT & EMERGENCY MEDICINE
,
Adult cardiology
,
Arrhythmias, Cardiac - diagnosis
2023
IntroductionDiagnosing underlying arrhythmia in emergency department (ED) syncope patients is difficult. There is a evidence that diagnostic yield for detecting underlying arrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit. This strategy has the potential to change current syncope management from low diagnostic yield Holter to higher yield ambulatory monitoring, reduce episodes of syncope, reduce risk of recurrence and its potential serious consequences, reduce hospital admissions, reduce overall health costs and increase quality of life by allowing earlier diagnosis, treatment and exclusion of clinically important arrhythmias.Methods and analysesThis is a UK open prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor vs standard care in 2234 patients presenting acutely with unexplained syncope. Our patient focused primary endpoint will be number of episodes of syncope at 1 year. Health economic evaluation will estimate the incremental cost per syncope episode avoided and quality-adjusted life year gained.Ethics and disseminationInformed consent for participation will be sought. The ASPIRED trial received a favourable ethical opinion from South East Scotland Research Ethics Committee 01 (21/SS/0073). Results will be disseminated via scientific publication, lay summary and visual abstract.Trial registration numberISRCTN 10278811.
Journal Article
Multimorbidity and adverse outcomes following emergency department attendance: population based cohort study
2024
ObjectivesTo describe the effect of multimorbidity on adverse patient centred outcomes in people attending emergency department.DesignPopulation based cohort study.SettingEmergency departments in NHS Lothian in Scotland, from 1 January 2012 to 31 December 2019.ParticipantsAdults (≥18 years) attending emergency departments.Data sourcesLinked data from emergency departments, hospital discharges, and cancer registries, and national mortality data.Main outcome measuresMultimorbidity was defined as at least two conditions from the Elixhauser comorbidity index. Multivariable logistic or linear regression was used to assess associations of multimorbidity with 30 day mortality (primary outcome), hospital admission, reattendance at the emergency department within seven days, and time spent in emergency department (secondary outcomes). Primary analysis was stratified by age (<65 v ≥65 years).Results451 291 people had 1 273 937 attendances to emergency departments during the study period. 43 504 (9.6%) had multimorbidity, and people with multimorbidity were older (median 73 v 43 years), more likely to arrive by emergency ambulance (57.8% v 23.7%), and more likely to be triaged as very urgent (23.5% v 9.2%) than people who do not have multimorbidity. After adjusting for other prognostic covariates, multimorbidity, compared with no multimorbidity, was associated with higher 30 day mortality (8.2% v 1.2%, adjusted odds ratio 1.81 (95% confidence interval (CI) 1.72 to 1.91)), higher rate of hospital admission (60.1% v 20.5%, 1.81 (1.76 to 1.86)), higher reattendance to an emergency department within seven days (7.8% v 3.5%, 1.41 (1.32 to 1.50)), and longer time spent in the department (adjusted coefficient 0.27 h (95% CI 0.26 to 0.27)). The size of associations between multimorbidity and all outcomes were larger in younger patients: for example, the adjusted odds ratio of 30 day mortality was 3.03 (95% CI 2.68 to 3.42) in people younger than 65 years versus 1.61 (95% CI 1.53 to 1.71) in those 65 years or older.ConclusionsAlmost one in ten patients presenting to emergency department had multimorbidity using Elixhauser index conditions. Multimorbidity was strongly associated with adverse outcomes and these associations were stronger in younger people. The increasing prevalence of multimorbidity in the population is likely to exacerbate strain on emergency departments unless practice and policy evolve to meet the growing demand.
Journal Article
Authors’ response to Comments on “Why do emergency department clinicians miss acute aortic syndrome? A case series and descriptive analysis”
2023
Dear Editor,We thank Vercelli et al.1 for their comments on our paper: Why do emergency department clinicians miss acute aortic syndrome? A case series and descriptive analysis.We fully agree with the authors, that investigating the heart and aorta using POCUS may allow for an earlier diagnosis and therefore more expedient treatment of a patient with acute aortic syndrome (AAS). We would also agree with the authors that POCUS is a point of care test with good specificity for the detection of AAS (i.e., it may be good at ruling in the diagnosis) but has poor sensitivity for the detection of AAS (i.e., it is not good at ruling out the diagnosis).[...]
Journal Article
A Digital Health Intervention for Concussion: Development and Clinical Feasibility Study
by
Grant, Alison
,
Carson, Alan
,
Ng, Xin Yi
in
Behavior modification
,
Brain research
,
Clinical outcomes
2023
Concussion is a common condition that can lead to a constellation of symptoms that affect quality of life, social integration, and return to work. There are several evidence-based behavioral and psychological interventions that have been found to improve postconcussion symptom burden. However, these are not routinely delivered, and individuals receive limited support during their concussion recovery.
This study aimed to develop and test the feasibility of a digital health intervention using a systematic evidence-, theory-, and person-based approach.
This was a mixed methodology study involving a scoping review (n=21), behavioral analysis, and logic model to inform the intervention design and content. During development, the intervention was optimized with feedback from individuals who had experienced concussions (n=12) and health care professionals (n=11). The intervention was then offered to patients presenting to the emergency department with a concussion (n=50). Participants used the intervention freely and input symptom data as part of the program. A number of outcome measures were obtained, including participant engagement with the intervention, postconcussion symptom burden, and attitudes toward the intervention. A selection of participants (n=15) took part in in-depth qualitative interviews to understand their attitudes toward the intervention and how to improve it.
Engagement with the intervention functionality was 90% (45/50) for the symptom diary, 62% (31/50) for sleep time setting, 56% (28/50) for the alcohol tracker, 48% (24/50) for exercise day setting, 34% (17/50) for the thought diary, and 32% (16/50) for the goal setter. Metrics indicated high levels of early engagement that trailed off throughout the course of the intervention, with an average daily completion rate of the symptom diary of 28.23% (494/1750). A quarter of the study participants (13/50, 26%) were classified as high engagers who interacted with all the functionalities within the intervention. Quantitative and qualitative feedback indicated a high level of usability and positive perception of the intervention. Daily symptom diaries (n=494) demonstrated a wide variation in individual participant symptom burden but a decline in average burden over time. For participants with Rivermead scores on completion of HeadOn, there was a strong positive correlation (r=0.86; P<.001) between their average daily HeadOn symptom diary score and their end-of-program Rivermead score. Insights from the interviews were then fed back into development to optimize the intervention and facilitate engagement.
Using this systematic approach, we developed a digital health intervention for individuals who have experienced a concussion that is designed to facilitate positive behavior change. Symptom data input as part of the intervention provided insights into postconcussion symptom burden and recovery trajectories.
ClinicalTrials.gov NCT05069948; https://clinicaltrials.gov/ct2/show/NCT05069948.
Journal Article