scholarly journals 120. Impact of a Molecular Point-of-care ‘test and Treat’ Strategy for Influenza in Hospitalised adults: A Multi-centre, Randomised Controlled Trial (FluPOC)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S188-S188
Author(s):  
Tristan William Clark ◽  
Kate Beard ◽  
Nathan J Brendish ◽  
Ahalya Malachira ◽  
Samuel Mills ◽  
...  
Keyword(s):  
Relative Risk ◽  
Point Of Care ◽  
Controlled Trial ◽  
Clinical Care ◽  
Group Versus ◽  
Control Group ◽  
Material Support ◽  
Point Of Care Test ◽  
Randomised Controlled ◽  
Isolation Facility

Abstract Background The diagnosis of Influenza in hospitalised patients is delayed due to long turnaround times of laboratory testing, leading to inappropriate and late antiviral and isolation facility use. Molecular point-of-care test (mPOCT) are highly accurate, easy to use and generate results in under 1 hour but high quality evidence for their clinical impact is lacking. Methods In this multicentre, randomised controlled trial we enrolled adults hospitalised with acute respiratory illness during influenza seasons. Patients were randomised (1:1) to receive mPOCT for influenza or routine clinical care. The primary outcome was the proportion of influenza-infected patients who received antivirals. Secondary outcomes included time to antivirals, isolation facility use, and clinical outcome. This study is registered with ISRCTN, number:17197293, and has completed. Results Between December 2017 and May 2019, 613 patients were enrolled (307 assigned to mPOCT and 306 to routine care) and all were analysed. 100 (33%) of 307 patients in the mPOCT group and 102 (33%) of 306 in the control group had influenza. 100 (100%) of 100 influenza-infected patients were diagnosed in the mPOCT group and 60 (59%) of 102 were diagnosed though routine clinical care (relative risk 1·7, 95%CI 1·7 to 1·7;p< 0·0001). 99 (99%) of 100 influenza-infected patients received antivirals in the mPOCT group versus 63 (62%) 102 in the control group (relative risk 1·6, 95%CI 1·4 to 1·9;p< 0·0001). Median time to antivirals was 1·0 hour in the mPOCT group versus 6·0 hours in the control group (difference of 5·0 hours, 95%CI 0 to 6·0;p=0·004). 70 (70%) of 100 influenza-infected patients in the mPOCT group were nursed in single room accommodation versus 39 (38%) of 102 in the control group (relative risk 1·8, 95%CI 1·4 to 2·4;p< 0·0001). Median hospital recovery scale score (an ordinal 6 point scale used to assess patient outcome) at 7 days was lower in the mPOCT group verses the control group (p=0·045). Figure 1a: Time-to-event curve showing antiviral use over time in influenza-infected patients. Figure 1b: Time-to-event curve showing isolation facility use over time in influenza-infected patients. Conclusion Routine mPOCT for influenza was associated with enhanced influenza detection, improvements in appropriate and timely antiviral and isolation facility use, and more rapid clinical recovery. Disclosures Tristan William. Clark, BM MRCP DTM&H MD, BioFire Diagnostics (Other Financial or Material Support, Equiptment and consumables for the purposes of research)BioMerieux (Other Financial or Material Support, Equipment and consumables for the purposes of research)Qiagen (Other Financial or Material Support, Discounted Equipment and consumables for the purposes of research)

scholarly journals 1717. The Impact of Routine Molecular Point-of-care Testing for Gastrointestinal Pathogens in Adults Hospitalized With Suspected Gastroenteritis: Results of a Pragmatic Randomized Controlled Trial (GastroPOC)

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S51-S51
Author(s):  
Ahalya Malachira ◽  
Kate Beard ◽  
Nathan Brendish ◽  
Tristan Clark
Keyword(s):  
Infection Control ◽  
Point Of Care ◽  
Controlled Trial ◽  
Clinical Care ◽  
Infection Control Measure ◽  
Group Versus ◽  
Antibiotic Use ◽  
Turnaround Time ◽  
Control Group ◽  
The Impact

Abstract Background Adults hospitalised with diarrhoea are routinely isolated as an infection control measure, but many have non-infectious etiology. Side room facilities are a limited resource in hospitals. Routine laboratory testing takes several days to generate results but rapid molecular platforms can test comprehensively for GI pathogens and generate a result in 1 hour, making them deployable as point-of-care tests (POCT). POCT could reduce unnecessary isolation facility use in addition to other benefits. Methods In this pragmatic, pilot randomised controlled trial, adults hospitalised with suspected gastroenteritis were recruited and randomised 1:1 to receive either POCT (using the FilmArray GI panel) or routine clinical care. Results of POCT were communicated directly to clinical and infection control teams. The primary outcome was duration of time in a side room and secondary outcomes included turnaround time, proportion of patients with a pathogen detected, proportion of patients correctly de-isolated, time to de-isolation, antibiotic use and length of hospital stay. Results 140 patients were recruited. Groups (n = 70) were well matched in terms of baseline characteristics. The median [IQR] turnaround time for results was 1.7 [1.6–2.3] hours in the POCT group and 61 [49–84] hours in the control group, P < 0.0001. Pathogens were detected in 44% of patients in the POCT group and 23% in the control group; P = 0.012. Overall the duration of side room isolation was 1.9 [1.0–2.9] days in the POCT group compared with 2.7 [1.8–5.1] days in the control group; P = 0.001. For those testing negative for pathogens this was 1.3 [0.8–2.5] days in the POCT group versus 2.7 [1.8–5.0] days in the control group, P < 0.0001. 63% of pathogen-negative patients were correctly de-isolated in the POCT group versus 28% in the control group, P = 0.0012. Antibiotic use and length of stay data will be available subsequently. Conclusion POCT using the FilmArray GI panel resulted in a substantially reduced turnaround time for results and an increase in the proportion of patients with pathogens correctly detected. POCT was associated with a reduction in the duration of unnecessary side room use. If these benefits are confirmed in further studies and cost effectiveness is demonstrated, molecular POCT for GI pathogens should replace current diagnostic pathways. Disclosures T. Clark, BioFire LLC: Collaborator, Research support and Speaker honorarium. NIHR: Grant Investigator, Grant recipient.

scholarly journals Music to prevent deliriUm during neuroSurgerY (MUSYC) Clinical trial: a study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e048270
Author(s):  
Pablo Kappen ◽  
Johannes Jeekel ◽  
Clemens M F Dirven ◽  
M Klimek ◽  
Steven Kushner ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Randomised Controlled Trial ◽  
Medical Center ◽  
Controlled Trial ◽  
Clinical Care ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Neurosurgical Procedures ◽  
Depth Of Anaesthesia ◽  
Randomised Controlled

IntroductionDelirium is a neurocognitive disorder characterised by an acute and temporary decline of mental status affecting attention, awareness, cognition, language and visuospatial ability. The underlying pathophysiology is driven by neuroinflammation and cellular oxidative stress.Delirium is a serious complication following neurosurgical procedures with a reported incidence varying between 4% and 44% and has been associated with increased length of hospital stay, increased amount of reoperations, increased costs and mortality.Perioperative music has been reported to reduce preoperative anxiety, postoperative pain and opioid usage, and attenuates stress response caused by surgery. We hypothesize that this beneficial effect of music on a combination of delirium eliciting factors might reduce delirium incidence following neurosurgery and subsequently improve clinical outcomes.MethodsThis protocol concerns a single-centred prospective randomised controlled trial with 6 months follow-up. All adult patients undergoing a craniotomy at the Erasmus Medical Center in Rotterdam are eligible. The music group will receive recorded music through an overear headphone before, during and after surgery until postoperative day 3. Patients can choose from music playlists, offered based on music importance questionnaires administered at baseline. The control group will receive standard of clinical careDelirium is assessed by the Delirium Observation Scale and confirmed by a delirium-expert psychiatrist according to the DSM-5 criteria. Risk factors correlated with the onset of delirium, such as cognitive function at baseline, preoperative anxiety, perioperative medication use, depth of anaesthesia and postoperative pain, and delirium-related health outcomes such as length of stay, daily function, quality of life (ie, EQ-5D, EORTC questionnaires), costs and cost-effectiveness are collected.Ethics and disseminationThis study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Center Rotterdam, The Netherlands, approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.Trial registration numbersNL8503 and NCT04649450.

Use of point-of-care test in identification of patients who can benefit from desmopressin during cardiac surgery: a randomised controlled trial

The Lancet ◽  
1999 ◽  
Vol 354 (9173) ◽  
pp. 106-110 ◽  
Author(s):  
George J Despotis ◽  
Vladimir Levine ◽  
Rao Saleem ◽  
Edward Spitznagel ◽  
J Heinrich Joist
Keyword(s):  
Cardiac Surgery ◽  
Randomised Controlled Trial ◽  
Point Of Care ◽  
Controlled Trial ◽  
Point Of Care Test ◽  
Randomised Controlled

scholarly journals Pragmatic multicentre randomised controlled trial evaluating the impact of a routine molecular point-of-care ‘test-and-treat’ strategy for influenza in adults hospitalised with acute respiratory illness (FluPOC): trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031674 ◽  
Author(s):  
Kate Beard ◽  
Nathan Brendish ◽  
Ahalya Malachira ◽  
Samuel Mills ◽  
Cathleen Chan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Point Of Care ◽  
Controlled Trial ◽  
Clinical Care ◽  
Respiratory Illness ◽  
Acute Respiratory Illness ◽  
National Guidelines ◽  
South Central ◽  
Randomised Controlled ◽  
The Impact

BackgroundInfluenza infections often remain undiagnosed in patients admitted to hospital due to lack of routine testing. When tested for, the diagnosis and treatment of influenza are often delayed due to the slow turnaround times of centralised laboratory PCR testing. Newer molecular systems, have comparable accuracy to laboratory PCR testing, and can generate a result in under 1 hour, making them potentially deployable as point-of-care tests (POCTs). High-quality evidence for the impact of routine POCT for influenza on clinical outcomes is, however, currently lacking. This large pragmatic multicentre randomised controlled trial aims to address this evidence gap.Methods and analysisThe FluPOC trial is a pragmatic, multicentre, randomised controlled trial evaluating adults admitted to a large teaching hospital and a district general hospital with an acute respiratory illness, during influenza season and defined by Public Health England. Up to 840 patients will be recruited over up to three influenza seasons, and randomised (1:1) to receive either POCT using the FilmArray respiratory panel, or routine clinical care. Clinical and infection control teams will be informed of the results in real time and where influenza is detected clinical teams will be encouraged to offer neuraminidase inhibitor (NAI) treatment in accordance with national guidelines. Those allocated to standard clinical care will have a swab taken for later analysis to allow assessment of missed diagnoses. The outcomes assessment will be by retrospective case note analysis. The outcome measures include the proportion of influenza-positive patients detected and appropriately treated with NAIs, isolation facility use, antibiotic use, length of hospital stay, complications and mortality.Ethics and disseminationPrior to commencing the study, approval was obtained from the South Central Hampshire A Ethics Committee (reference 17/SC/0368, granted 7 September 2017). Results generated from this protocol will be published in peer-reviewed scientific journals and presented at national and international conferences.Trial registration numberISRCTN17197293

scholarly journals Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016590 ◽  
Author(s):  
Alexandre Dumont ◽  
Cécile Bodin ◽  
Benjamin Hounkpatin ◽  
Thomas Popowski ◽  
Mamadou Traoré ◽  
...  
Keyword(s):  
Relative Risk ◽  
Randomised Controlled Trial ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Case Fatality ◽  
Control Group ◽  
Total Blood ◽  
Balloon Tamponade ◽  
Uterine Balloon Tamponade ◽  
Randomised Controlled

ObjectiveTo assess the effectiveness of low-cost uterine tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage (PPH) in low-resource settings.DesignRandomised controlled trial.SettingSeven healthcare facilities in Cotonou, Benin and Bamako, Mali.PopulationWomen delivering vaginally who had clinically diagnosed PPH that was suspected to be due to uterine atony, who were unresponsive to oxytocin and who needed additional uterotonics.MethodsWomen were randomly assigned to receive uterine balloon tamponade with a condom-catheter device or no tamponade; both groups were also given intrarectal or sublingual misoprostol.Main outcome measureProportion of women with invasive surgery or who died before hospital discharge.ResultsThe proportion of primary composite outcome did not differ significantly between the tamponade arm (16%; 9/57) and the standard second line treatment arm (7%; 4/59): relative risk 2.33 (95% CI 0.76 to 7.14, p=0.238). A significantly increased proportion of women with tamponade and misoprostol versus misoprostol alone had total blood loss more than 1000 mL: relative risk 1.52 (95% CI 1.15 to 2.00, p=0.01). Case fatality rate was higher in the tamponade group (10%; 6/57) than in the control group (2%; 1/59) (p=0.059).Trial registration numberISRCT Registry Number 01202389; Post-results.

scholarly journals A feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients

2021 ◽  
pp. 175114372110100
Author(s):  
Daniel S Martin ◽  
Margaret McNeil ◽  
Chris Brew-Graves ◽  
Helder Filipe ◽  
Ronan O’Driscoll ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Group Versus ◽  
Weighted Average ◽  
Control Group ◽  
Mechanically Ventilated ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Background Despite oxygen being the commonest drug administered to critically ill patients we do not know which oxygen saturation (SpO2) target results in optimal survival outcomes in those receiving mechanical ventilation. We therefore conducted a feasibility randomised controlled trial in the United Kingdom (UK) to assess whether it would be possible to host a larger national multi-centre trial to evaluate oxygenation targets in mechanically ventilated patients. Methods We set out to recruit 60 participants across two sites into a trial in which they were randomised to receive conservative oxygenation (SpO2 88–92%) or usual care (control – SpO2 ≥96%). The primary outcome was feasibility; factors related to safety and clinical outcomes were also assessed. Results A total of 34 patients were recruited into the study until it was stopped due to time constraints. A number of key barriers to success were identified during the course of the study. The conservative oxygenation intervention was feasible and appeared to be safe in this small patient cohort and it achieved wide separation of the median time-weighted average (IQR) SpO2 at 91% (90–92%) in conservative oxygenation group versus 97% (96–97%) in control group. Conclusion Whilst conservative oxygenation was a feasible and safe intervention which achieved clear group separation in oxygenation levels, the model used in this trial will require alterations to improve future participant recruitment rates in the UK.

scholarly journals A multicentre, pragmatic, cluster randomised, controlled feasibility trial of the POD system of care

2020 ◽  
Vol 49 (4) ◽  
pp. 640-647
Author(s):  
John Young ◽  
John Green ◽  
Amanda Farrin ◽  
Michelle Collinson ◽  
Suzanne Hartley ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Assessment Method ◽  
System Of Care ◽  
Feasibility Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
New Onset

Abstract Objective to provide a preliminary estimate of the effectiveness of the prevention of delirium (POD) system of care in reducing incident delirium in acute hospital wards and gather data for a future definitive randomised controlled trial. Design cluster randomised and controlled feasibility trial. Setting sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales. Participants patients 65 years and over admitted to participating wards during the trial period. Interventions participating wards were randomly assigned to either the POD programme or usual care, determined by existing local policies and practices. The POD programme is a manualised multicomponent delirium prevention intervention that targets 10 risk factors for delirium. The intervention wards underwent a 6-month implementation period before trial recruitment commenced. Main outcome measure incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10 days post consent. Results out of 4449, 3274 patients admitted to the wards were eligible. In total, 714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew. Adherence to the intervention was classified as at least medium for seven wards. Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37–1.26); P = 0.2225). Conclusions based on these findings, a definitive trial is achievable and would need to recruit 5220 patients in 26 two-ward hospital clusters. Trial registration: ISRCTN01187372. Registered 13 March 2014.

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