Dataset Information

Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT).

ABSTRACT:

Objective

Many patients presenting with suspected acute coronary syndrome (ACS) have high-sensitivity cardiac troponin (hs-cTn) concentrations between rule-in and rule-out thresholds and hence need serial testing, which is time consuming. The Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT) assessed the utility of coronary CT angiography (CCTA) in patients with suspected ACS, non-ischaemic ECG and intermediate initial hs-cTn concentration.

Methods

Patients were randomised to CCTA-guided management versus standard of care (SOC). The primary outcome was hospital length of stay (LOS). Secondary outcomes included cost of in-hospital stay and major adverse cardiac events (MACE) at 12 months of follow-up. Data are mean (SD); for LOS harmonic means, IQRs are shown.

Results

250 (aged 55 (14) years, 25% women) patients were randomised. Harmonic mean (IQR) LOS was 7.53 (6.0-9.6) hours in the CCTA arm and 8.14 (6.3-9.8) hours in the SOC arm (p=0.13). Inpatient cost was £1285 (£2216) and £1108 (£3573), respectively, p=0.68. LOS was shorter in the CCTA group in patients with <25% stenosis, compared with SOC; 6.6 (5.6-7.8) hours vs 7.5 (6.1-9.4) hours, respectively; p=0.021. More referrals for cardiology outpatient clinic review and cardiac CT-related outpatient referrals occurred in the SOC arm (p=0.01). 12-month MACE rates were similar between the two arms (7 (5.6%) in the CCTA arm and 8 (6.5%) in the SOC arm-log-rank p=0.78).

Conclusions

CCTA did not lead to reduced hospital LOS or cost, largely because these outcomes were influenced by the detection of ≥25% grade stenosis in a proportion of patients.

Trial registration number

NCT03583320.

SUBMITTER: Aziz W

PROVIDER: S-EPMC9726962 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT).

Aziz Waqar W Morgan Holly H Demir Ozan M OM Sinha Aish A Rua Tiago T Rajani Ronak R Chang Ai-Lee AL Woo Eric E Mak Sze Mun SM Benedetti Giulia G Villa Adriana A Preston Rebecca R Navin Roshan R O'Kane Kevin K Hunter Laura L Ismail Tevfik T Carr-White Gerry G Beckley-Hoelscher Nick N Peacock Janet J Marber Michael M Razavi Reza R Perera Divaka D

Heart (British Cardiac Society) 20221124 24

<h4>Objective</h4>Many patients presenting with suspected acute coronary syndrome (ACS) have high-sensitivity cardiac troponin (hs-cTn) concentrations between rule-in and rule-out thresholds and hence need serial testing, which is time consuming. The Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT) assessed the utility of coronary CT angiography (CCTA) in patients with suspected ACS, non-ischaemic ECG and intermediate initial hs-cTn concentration.<h4>Methods</ ...[more]

PMID: 36288924

Similar Datasets

Project description:BackgroundRobotic-arm assisted surgery aims to reduce manual errors and improve the accuracy of implant positioning during total hip arthroplasty. The objective of this study is to compare the accuracy of implant positioning, restoration of hip biomechanics, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in conventional manual total hip arthroplasty (CO THA) versus robotic-arm assisted total hip arthroplasty (RO THA). Preoperative pelvic computerised tomography (CT) scans will be used to create patient-specific, virtual, three-dimensional reconstructions for surgical planning in both treatment groups.Methods and analysisThis prospective randomised controlled trial will include 60 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to CO THA (control group) or RO THA (investigation group) at a ratio of 1:1 using an online random number generator. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to the accuracy of implant positioning, hip biomechanics, postoperative rehabilitation, clinical progress, functional outcomes, cost-effectiveness, and complications. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. Intention to treat relates to the allocated treatment (CO THA or RO THA), and per-protocol refers to the actual treatment received by the patient. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Bromley Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CT-planned CO THA versus CT-planned RO THA. The findings of this study will enable an improved understanding of the differences in CO THA versus RO THA with respect to patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.Trial registrationClinicalTrials.gov NCT04095845 . Registered on 19 September 2019.

Project description:ObjectiveTo evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS) for paramedics attending older people who fall.DesignCluster trial randomised by paramedic; modelling.Setting13 ambulance stations in two UK emergency ambulance services.Participants42 of 409 eligible paramedics, who attended 779 older patients for a reported fall.InterventionsIntervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture.Main outcome measuresEffectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care.SafetyFurther emergency contacts or death within one month.Cost-effectivenessCosts and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness.Results17 intervention paramedics used CCDS for 54 (12.4%) of 436 participants. They referred 42 (9.6%) to falls services, compared with 17 (5.0%) of 343 participants seen by 19 control paramedics [Odds ratio (OR) 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72); quality of life (mean SF12 differences: MCS -0.74, 95% CI -2.83 to +1.28; PCS -0.13, 95% CI -1.65 to +1.39) and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52). However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3). Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without.ConclusionsIntervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture.Trial registrationISRCTN Register ISRCTN10538608.

Project description:BackgroundCognitive impairments, including delirium, are common after coronary artery bypass grafting (CABG). Improving cognition pre- and post-operatively using computerised cognitive training (CCT) may be an effective approach to improve cognitive outcomes in CABG patients.ObjectivesInvestigate the effect of remotely supervised CCT on cognitive outcomes, including delirium, in older adults undergoing CABG surgery.MethodsThirty-six participants, were analysed in a single-blinded randomised controlled trial (CCT Intervention: n = 18, Control: n = 18). CCT was completed by the intervention group pre-operatively (every other day, 45-60-minute sessions until surgery) and post-operatively, beginning 1-month post-CABG (3 x 45-60-minute sessions/week for 12-weeks), while the control group maintained usual care plus weekly phone calls. Cognitive assessments were conducted pre- and post-operatively at multiple follow-ups (discharge, 4-months and 6-months). Post-operative delirium incidence was assessed daily until discharge. Cognitive change data were calculated at each follow-up for each cognitive test (Addenbrooke's Cognitive Examination III and CANTAB; z-scored).ResultsAdherence to the CCT intervention (completion of three pre-operative or 66% of post-operative sessions) was achieved in 68% of pre-CABG and 59% of post-CABG participants. There were no statistically significant effects of CCT on any cognitive outcome, including delirium incidence.ConclusionAdherence to the CCT program was comparatively higher than previous feasibility studies, possibly due to the level of supervision and support provided (blend of face-to-face and home-based training, with support phone calls). Implementing CCT interventions both pre- and post-operatively is feasible in those undergoing CABG. No statistically significant benefits from the CCT interventions were identified for delirium or cognitive function post-CABG, likely due to the sample size available (study recruitment greatly impacted by COVID-19). It also may be the case that multimodal intervention would be more effective.

Project description:IntroductionPostoperative delirium (POD) is a common neurological complication after surgery among older patients, characterised by acute disturbances in consciousness, attention and cognition, usually occurring within 24-72 hours after surgery. POD has a significant impact on the prognosis of older patients undergoing major cardiovascular surgery, including increased length of hospital stay, hospital costs and readmission rates, with an incidence rate as high as 26%-52%. Computerised cognitive training (CCT) refers to difficulty-adaptive training in cognitive domains such as attention, memory and logical reasoning, using systematically designed tasks. Existing studies have shown that CCT has reduced the risk of delirium in non-cardiac surgery patients with at least minimal compliance. The purpose of this study is to investigate the effects of preoperative CCT on the incidence of POD in older patients undergoing elective cardiac surgery, to clarify the dose-effect relationship between different training time of preoperative CCT and POD and to explore the minimum effective time target that can significantly lower the incidence of POD.Methods and analysisThis is a prospective, single-blind, randomised controlled trial that aims to enrol 261 older patients scheduled for elective cardiac surgery at the Affiliated Hospital of Xuzhou Medical University. The patients will be randomised into three groups: group C will be the routine care group (no CCT prior to surgery); group L will be the low-dose time group (with a total of 5 hours of CCT prior to surgery) and group H will be the high-dose time group (with a total of 10 hours of CCT prior to surgery). The primary outcome is the incidence of delirium within 7 days after surgery. Secondary outcomes include postoperative mild neurocognitive disorder (NCD) and postoperative major NCD (30 days up to 1 year), time of onset and duration and severity of delirium, and all-cause mortality within 1 year after surgery. The results of this study are of significant importance for establishing effective, patient-centred and low-risk prevention strategies for POD/postoperative NCD.Ethics and disseminationThis study protocol has been approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (Ethics Number: XYFY2023-KL149-01). All participants will provide written informed consent, and the results of the study will be published in international peer-reviewed academic journals and presented at academic conferences.Trial registration numberChiCTR2300072806.

Project description:BackgroundContinuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes.MethodsIn this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland. They were randomly assigned (1:1) to decision support with the INFANT system or no decision support via a computer-generated stratified block randomisation schedule. The primary outcomes were poor neonatal outcome (intrapartum stillbirth or early neonatal death excluding lethal congenital anomalies, or neonatal encephalopathy, admission to the neonatal unit within 24 h for ≥48 h with evidence of feeding difficulties, respiratory illness, or encephalopathy with evidence of compromise at birth), and developmental assessment at age 2 years in a subset of surviving children. Analyses were done by intention to treat. This trial is completed and is registered with the ISRCTN Registry, number 98680152.FindingsBetween Jan 6, 2010, and Aug 31, 2013, 47 062 women were randomly assigned (23 515 in the decision-support group and 23 547 in the no-decision-support group) and 46 042 were analysed (22 987 in the decision-support group and 23 055 in the no-decision-support group). We noted no difference in the incidence of poor neonatal outcome between the groups-172 (0·7%) babies in the decision-support group compared with 171 (0·7%) babies in the no-decision-support group (adjusted risk ratio 1·01, 95% CI 0·82-1·25). At 2 years, no significant differences were noted in terms of developmental assessment.InterpretationUse of computerised interpretation of cardiotocographs in women who have continuous electronic fetal monitoring in labour does not improve clinical outcomes for mothers or babies.FundingNational Institute for Health Research.

Project description:IntroductionComputerised diagnostic decision support systems (CDDS) suggesting differential diagnoses to physicians aim to improve clinical reasoning and diagnostic quality. However, controlled clinical trials investigating their effectiveness and safety are absent and the consequences of its use in clinical practice are unknown. We aim to investigate the effect of CDDS use in the emergency department (ED) on diagnostic quality, workflow, resource consumption and patient outcomes.Methods and analysisThis is a multicentre, outcome assessor and patient-blinded, cluster-randomised, multiperiod crossover superiority trial. A validated differential diagnosis generator will be implemented in four EDs and randomly allocated to a sequence of six alternating intervention and control periods. During intervention periods, the treating ED physician will be asked to consult the CDDS at least once during diagnostic workup. During control periods, physicians will not have access to the CDDS and diagnostic workup will follow usual clinical care. Key inclusion criteria will be patients' presentation to the ED with either fever, abdominal pain, syncope or a non-specific complaint as chief complaint. The primary outcome is a binary diagnostic quality risk score composed of presence of an unscheduled medical care after discharge, change in diagnosis or death during time of follow-up or an unexpected upscale in care within 24 hours after hospital admission. Time of follow-up is 14 days. At least 1184 patients will be included. Secondary outcomes include length of hospital stay, diagnostics and data regarding CDDS usage, physicians' confidence calibration and diagnostic workflow. Statistical analysis will use general linear mixed modelling methods.Ethics and disseminationApproved by the cantonal ethics committee of canton Berne (2022-D0002) and Swissmedic, the Swiss national regulatory authority on medical devices. Study results will be disseminated through peer-reviewed journals, open repositories and the network of investigators and the expert and patients advisory board.Trial registration numberNCT05346523.

Project description:IntroductionThe 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT).Methods and analysisAdolescents aged 12-18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness.Ethics and disseminationThe current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).Trial registration numberISRCTN31219579.

Project description:BackgroundDecline in executive functions and related cognitive processes is associated with mobility decline, and these functions might be amenable to cognitive remediation. This study aimed to examine whether a computerised cognitive remediation programme would improve walking in adults aged 70 years and older.MethodsThis single-blind, randomised trial at one academic centre in the USA evaluated the efficacy of an 8-week computerised programme (also known as brain games) of progressive intensity and complexity to improve walking in older adults at high-risk for mobility disability. Inclusion criteria included being 70 years or older; ambulatory; and at high-risk for mobility disability, defined using a cutscore of nine or less (frail range) on the Short Physical Performance Battery and a walking speed of 100 cm/s or less. Individuals with dementia, acute or terminal medical illnesses, recent or planned surgery affecting mobility, mobility limitations solely due to musculoskeletal limitation or pain that prevented them from completing mobility tests, and those who were nursing home residents were excluded. Participants were block randomised (1:1; block size 12 and no stratification) to the intervention group or the control group (low complexity computer games and health education classes). Primary outcomes were change in walking speed at normal pace and walking while talking conditions assessed from baseline to 8 weeks post-intervention by investigators who were masked to group assignment. Groups were compared using the intention-to-treat principle with linear mixed models adjusted for confounders. This trial was registered with ClinicalTrails.gov, NCT02567227.FindingsBetween March 1, 2016, and March 12, 2020, 383 patients were enrolled and randomly assigned to the intervention or control group. After randomisation, 11 (3%) patients were diagnosed with dementia. 372 (97%; 271 [73%] women) were included in the intention-to-treat analysis. The mean age of participants was 77·0 years [SD 5·6]). 183 (49·2%) participants were Black and 62 (16·7%) were Hispanic. 314 (93%) of the target 338 completers had finished the intervention when the trial was terminated due to the COVID-19 pandemic. Although there were significant within-group improvements in both groups after the 8-week intervention, there was no significant difference in normal walking speed (-1·03 cm/s [SD 1·30]; 95% CI -3·60 to 1·54) and walking while talking conditions (0·59 cm/s [SD 1·61]; 95% CI -2·59 to 3·76) between the intervention and control groups. Similarly, within-group, but no between-group, differences were seen on executive function tests and physical function. There were no severe adverse events related to interventions.InterpretationComputerised cognitive remediation improved walking in adults aged 70 years and older at high-risk for mobility disability, but improvements were not significantly greater compared with an active control. Although our findings corroborate the within-group improvements on cognition and mobility reported in previous pilot clinical trials, future studies are required to determine the optimal dose, frequency, intensity, and content of computerised cognitive remediation programmes.FundingNational Institute on Aging.

Dataset Information

Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT).

Objective

Methods

Results

Conclusions

Trial registration number

Publications

Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets