Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study
Background: Patients with palpitations and pre-syncope commonly present to Emergency Departments (EDs) but underlying rhythm diagnosis is often not possible during the initial presentation. This trial compares the symptomatic rhythm detection rate of a smartphone-based event recorder (AliveCor) alon...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2019-02-01
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| Series: | EClinicalMedicine |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537019300264 |
| _version_ | 1818909603733176320 |
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| author | Matthew J. Reed Neil R. Grubb Christopher C. Lang Rachel O'Brien Kirsty Simpson Mia Padarenga Alison Grant Sharon Tuck Liza Keating Frank Coffey Lucy Jones Tim Harris Gavin Lloyd James Gagg Jason E. Smith Tim Coats |
| author_facet | Matthew J. Reed Neil R. Grubb Christopher C. Lang Rachel O'Brien Kirsty Simpson Mia Padarenga Alison Grant Sharon Tuck Liza Keating Frank Coffey Lucy Jones Tim Harris Gavin Lloyd James Gagg Jason E. Smith Tim Coats |
| author_sort | Matthew J. Reed |
| collection | DOAJ |
| description | Background: Patients with palpitations and pre-syncope commonly present to Emergency Departments (EDs) but underlying rhythm diagnosis is often not possible during the initial presentation. This trial compares the symptomatic rhythm detection rate of a smartphone-based event recorder (AliveCor) alongside standard care versus standard care alone, for participants presenting to the ED with palpitations and pre-syncope with no obvious cause evident at initial consultation. Methods: Multi-centre open label, randomised controlled trial. Participants ≥16 years old presenting to 10 UK hospital EDs were included. Participants were randomised to either (a) intervention group; standard care plus the use of a smartphone-based event recorder or (b) control group; standard care alone. Primary endpoint was symptomatic rhythm detection rate at 90 days. Trial registration number NCT02783898 (ClinicalTrials.gov). Findings: Two hundred forty-three participants were recruited over an 18-month period. A symptomatic rhythm was detected at 90 days in 69 (n = 124; 55.6%; 95% CI 46.9–64.4%) participants in the intervention group versus 11 (n = 116; 9.5%; 95% CI 4.2–14.8) in the control group (RR 5.9, 95% CI 3.3–10.5; p < 0.0001). Mean time to symptomatic rhythm detection in the intervention group was 9.5 days (SD 16.1, range 0–83) versus 42.9 days (SD 16.0, range 12–66; p < 0.0001) in the control group. The commonest symptomatic rhythms detected were sinus rhythm, sinus tachycardia and ectopic beats. A symptomatic cardiac arrhythmia was detected at 90 days in 11 (n = 124; 8.9%; 95% CI 3.9–13.9%) participants in the intervention group versus 1 (n = 116; 0.9%; 95% CI 0.0–2.5%) in the control group (RR 10.3, 95% CI 1.3–78.5; p = 0.006). Interpretation: Use of a smartphone-based event recorder increased the number of patients in whom an ECG was captured during symptoms over five-fold to more than 55% at 90 days. This safe, non-invasive and easy to use device should be considered part of on-going care to all patients presenting acutely with unexplained palpitations or pre-syncope. Funding: This study was funded by research awards from Chest, Heart and Stroke Scotland (CHSS) and British Heart Foundation (BHF) which included funding for purchasing the devices. MR was supported by an NHS Research Scotland Career Researcher Clinician award. Keywords: Ambulatory electrocardiography monitoring, Cardiac arrhythmias, Palpitations, Pre-syncope |
| first_indexed | 2024-12-19T22:29:32Z |
| format | Article |
| id | doaj.art-08861aa74a7642c29fcced7b35e7ce7b |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-12-19T22:29:32Z |
| publishDate | 2019-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj.art-08861aa74a7642c29fcced7b35e7ce7b2022-12-21T20:03:22ZengElsevierEClinicalMedicine2589-53702019-02-0183746Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) studyMatthew J. Reed0Neil R. Grubb1Christopher C. Lang2Rachel O'Brien3Kirsty Simpson4Mia Padarenga5Alison Grant6Sharon Tuck7Liza Keating8Frank Coffey9Lucy Jones10Tim Harris11Gavin Lloyd12James Gagg13Jason E. Smith14Tim Coats15Emergency Medicine Research Group Edinburgh (EMERGE), Department of Emergency Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UK; Edinburgh Acute Care, Usher Institute of Population Health Sciences and Informatics, College of Medicine and Veterinary Medicine, University of Edinburgh, The Chancellor's Building, 49 Little France Crescent, Edinburgh EH16 4SB, UK; Corresponding author at: Emergency Medicine Research Group Edinburgh (EMERGE), Department of Emergency Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, UK.Department of Cardiology, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, UKDepartment of Cardiology, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, UKEmergency Medicine Research Group Edinburgh (EMERGE), Department of Emergency Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UKEmergency Medicine Research Group Edinburgh (EMERGE), Department of Emergency Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UKEmergency Medicine Research Group Edinburgh (EMERGE), Department of Emergency Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UKEmergency Medicine Research Group Edinburgh (EMERGE), Department of Emergency Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UKEdinburgh Clinical Research Facility, Epidemiology and Statistics Core, University of Edinburgh, Western General Hospital, Crewe Road South, Edinburgh EH4 2XU, UKEmergency Department, Royal Berkshire NHS Foundation Trust, Reading RG1 5AN, UKDREEAM - Department of Research and Education in Emergency medicine, Acute medicine and Major trauma, Nottingham University Hospitals NHS Trust, Queen's Medical Centre Derby Road, Nottingham, NG7 2UH, UKChesterfield Royal Hospital NHS Foundation Trust, Chesterfield Rd, Calow, Chesterfield S44 5BL, UKBarts Health NHS Trust, Whitechapel, London E1 1BB, UKRoyal Devon and Exeter Hospital, Barrack Rd, Exeter EX2 5DW, UKDepartment of Emergency Medicine, Musgrove Park Hospital, Taunton & Somerset NHS Foundation Trust, Taunton TA1 5DA, UKEmergency Department, University Hospitals Plymouth NHS Trust, Plymouth PL6 8DH, UKEmergency Medicine Academic Group, Department of Cardiovascular Sciences, University of Leicester, University Road, Leicester LE1 7RH, UKBackground: Patients with palpitations and pre-syncope commonly present to Emergency Departments (EDs) but underlying rhythm diagnosis is often not possible during the initial presentation. This trial compares the symptomatic rhythm detection rate of a smartphone-based event recorder (AliveCor) alongside standard care versus standard care alone, for participants presenting to the ED with palpitations and pre-syncope with no obvious cause evident at initial consultation. Methods: Multi-centre open label, randomised controlled trial. Participants ≥16 years old presenting to 10 UK hospital EDs were included. Participants were randomised to either (a) intervention group; standard care plus the use of a smartphone-based event recorder or (b) control group; standard care alone. Primary endpoint was symptomatic rhythm detection rate at 90 days. Trial registration number NCT02783898 (ClinicalTrials.gov). Findings: Two hundred forty-three participants were recruited over an 18-month period. A symptomatic rhythm was detected at 90 days in 69 (n = 124; 55.6%; 95% CI 46.9–64.4%) participants in the intervention group versus 11 (n = 116; 9.5%; 95% CI 4.2–14.8) in the control group (RR 5.9, 95% CI 3.3–10.5; p < 0.0001). Mean time to symptomatic rhythm detection in the intervention group was 9.5 days (SD 16.1, range 0–83) versus 42.9 days (SD 16.0, range 12–66; p < 0.0001) in the control group. The commonest symptomatic rhythms detected were sinus rhythm, sinus tachycardia and ectopic beats. A symptomatic cardiac arrhythmia was detected at 90 days in 11 (n = 124; 8.9%; 95% CI 3.9–13.9%) participants in the intervention group versus 1 (n = 116; 0.9%; 95% CI 0.0–2.5%) in the control group (RR 10.3, 95% CI 1.3–78.5; p = 0.006). Interpretation: Use of a smartphone-based event recorder increased the number of patients in whom an ECG was captured during symptoms over five-fold to more than 55% at 90 days. This safe, non-invasive and easy to use device should be considered part of on-going care to all patients presenting acutely with unexplained palpitations or pre-syncope. Funding: This study was funded by research awards from Chest, Heart and Stroke Scotland (CHSS) and British Heart Foundation (BHF) which included funding for purchasing the devices. MR was supported by an NHS Research Scotland Career Researcher Clinician award. Keywords: Ambulatory electrocardiography monitoring, Cardiac arrhythmias, Palpitations, Pre-syncopehttp://www.sciencedirect.com/science/article/pii/S2589537019300264 |
| spellingShingle | Matthew J. Reed Neil R. Grubb Christopher C. Lang Rachel O'Brien Kirsty Simpson Mia Padarenga Alison Grant Sharon Tuck Liza Keating Frank Coffey Lucy Jones Tim Harris Gavin Lloyd James Gagg Jason E. Smith Tim Coats Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study EClinicalMedicine |
| title | Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study |
| title_full | Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study |
| title_fullStr | Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study |
| title_full_unstemmed | Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study |
| title_short | Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study |
| title_sort | multi centre randomised controlled trial of a smartphone based event recorder alongside standard care versus standard care for patients presenting to the emergency department with palpitations and pre syncope the iped investigation of palpitations in the ed study |
| url | http://www.sciencedirect.com/science/article/pii/S2589537019300264 |
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