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Cited by 58Cardiovascular Syncope and Autonomic DisordersCardiac electrophysiology and arrhythmiasCardiac Arrhythmias and Treatments

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

Open access
Reed, Matthew J., Grubb, Neil R., Lang, Christopher C., O'Brien, Rachel, Simpson, Kirsty, Padarenga, Mia, Grant, Alison, Tuck, Sharon +8 more·2019·EClinicalMedicine
DOI 10.1016/j.eclinm.2019.02.005PMC PMC6537555
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Abstract

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.

AI snapshot

Written from the paper’s full text.

TL;DR

In ED patients with unexplained palpitations or pre-syncope, adding a smartphone-based AliveCor event recorder to standard care increased symptomatic rhythm detection at 90 days from 9.5% to 55.6% and symptomatic cardiac arrhythmia detection from 0.9% to 8.9%. The device was safe and easy to use, but the trial was open-label and used a central ECG reading service not available in routine practice.

Key findings

  • Symptomatic rhythm was detected at 90 days in 69/124 (55.6%; 95% CI 46.9–64.4%) intervention participants versus 11/116 (9.5%; 95% CI 4.2–14.8) control participants (RR 5.9, 95% CI 3.3–10.5; p < 0.0001).
  • Symptomatic cardiac arrhythmia was detected at 90 days in 11/124 (8.9%; 95% CI 3.9–13.9%) intervention participants versus 1/116 (0.9%; 95% CI 0.0–2.5%) control participants (RR 10.3, 95% CI 1.3–78.5; p = 0.006).
  • Mean time to symptomatic rhythm detection was 9.5 days (SD 16.1, range 0–83) in the intervention group versus 42.9 days (SD 16.0, range 12–66) in the control group (p < 0.0001); commonest symptomatic rhythms were sinus rhythm (53; 66.3%), sinus tachycardia (19; 23.8%) and ectopic beats (13; 16.3%).
  • Eighty of 92 (87.0%) participants found the AliveCor monitor easy to use; median overall healthcare utilisation cost was £108 in the intervention group versus £0 in standard care (p = 0.0001), and cost per symptomatic rhythm diagnosis was £474 versus £1395.

Methods

  • Multi-centre open label randomised controlled trial in EDs and Acute Medical Units of 10 UK hospitals; 243 participants were recruited, with 126 allocated to intervention and 117 to control, leaving 124 and 116 available for analysis after one loss to follow-up in each group.
  • Participants were aged ≥16 years presenting with palpitations or pre-syncope and an underlying ECG rhythm that remained undiagnosed after ED assessment; intervention participants received standard care plus the AliveCor smartphone-based event recorder, while control participants received standard care alone, with 90-day follow-up via hospital records, GP records, telephone and questionnaire.
  • Primary endpoint was symptomatic rhythm detection at 90 days; analysis was intention-to-treat using comparison of proportions, Fisher/χ² tests, Kaplan–Meier curves and log-rank tests, with p < 0.05; sample size was powered for 25% versus 10% detection (110 per group plus 10% dropout).

Limitations

  • The paper states that a large proportion of recruitment occurred in office hours largely by research staff in research-active hospitals, and that the central ECG reading service used is not available in routine practice.
  • The paper states that only one device was studied, that patients volunteering for a study of new technology may be more motivated to use the device, and that performance may not be as good in a non-study setting; it also notes that lack of smartphone ownership was the commonest reason for non-participation and that age of non-participants was not recorded.
  • Evident from the text: the trial was open-label and the primary outcome was assessed by each local study team, which could introduce detection or reporting bias; the intervention group also had more subsequent ED presentations for palpitations/pre-syncope (12/124, 9.7% vs 3/116, 2.6%; p = 0.031), which the authors discuss as possibly reflecting lack of immediate reassurance.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1016/j.eclinm.2019.02.005

Cites

33 of 33 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 21 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    Mean time to symptomatic rhythm detection was 9.5 days (SD 16.1) in the intervention group versus 42.9 days (SD 16.0) in the control group (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.”
    Quote in the paperSubstantial claim
  • Findingown data

    At 90 days, a symptomatic rhythm was detected in 55.6% (69/124) of intervention participants versus 9.5% (11/116) of control participants (RR 5.9, 95% CI 3.3-10.5; p < 0.0001).

    “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).”
    • Also stated in: § Interpretation · plain
      “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.”
    • Also stated in: § Results · plain
      “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).”
    Quote in the paperSubstantial claim
  • Findingown data

    At 90 days, a symptomatic cardiac arrhythmia was detected in 8.9% (11/124) of intervention participants versus 0.9% (1/116) of control participants (RR 10.3, 95% CI 1.3-78.5; p = 0.006).

    “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).”
    • Also stated in: § Funding · plain
      “The smartphone-based event recorder also increased the number of patients diagnosed with cardiac arrhythmia.”
    • Also stated in: § Results · plain
      “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).”
    Quote in the paperSubstantial claim
  • Findingnone given

    The only adverse events recorded were those directly related to the use of the smartphone-based event recorder and application.

    “The only adverse events recorded were those directly related to the use of the smartphone-based event recorder and application.”
    Quote in the paperSubstantial claim
  • Findingown data

    The mean time to symptomatic rhythm detection was 9.5 days (SD 16.1) in the intervention group versus 42.9 days (SD 16.0) in the standard care group (p < 0.0001).

    “The 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) in the standard care group (p < 0.0001).”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 22
  • May combine two claims. 20

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The commonest symptomatic rhythms detected were sinus rhythm, sinus tachycardia and ectopic beats.

    “The commonest symptomatic rhythms detected were sinus rhythm, sinus tachycardia and ectopic beats.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Symptomatic cardiac arrhythmias detected were atrial fibrillation (8 intervention, 0 control), SVT (3 intervention, 0 control), sinus bradycardia (0 intervention, 1 control) and atrial flutter (1 intervention, 0 control).

    “Symptomatic cardiac arrhythmias were AF (8 intervention, 0 standard care), SVT (3 intervention, 0 standard care), sinus bradycardia (0 intervention, 1 standard care) and atrial flutter (1 intervention, 0 standard care).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Eighty of 92 (87.0%) participants found the AliveCor monitor easy to use.

    “Eighty of 92 (87.0%) participants found the AliveCor monitor easy to use.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Among 80 participants with a symptomatic rhythm detected, 12 had a symptomatic cardiac arrhythmia and 68 had sinus rhythm, sinus tachycardia or ectopics.

    “Eighty participants had a symptomatic rhythm detected with 12 of these having a symptomatic cardiac arrhythmia (atrial fibrillation or flutter, SVT and sinus bradycardia) and 68 having sinus rhythm, sinus tachycardia or ectopics [Table 4].”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The only death in the study was in the intervention group in a participant known to have treated congenital structural heart disease, and the death was thought unrelated to his initial presentation to the ED.

    “The only death in the study was in the intervention group in a participant known to have treated congenital structural heart disease whose death was thought unrelated to his initial presentation to the ED.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    If patients are referred to cardiology services, investigation usually starts with a Holter monitor but non-compliance and lack of extended monitoring reduces diagnostic yield to less than 20%.

    “If patients are referred to cardiology services for assessment, investigation usually starts with a Holter monitor but non-compliance and lack of extended monitoring reduces diagnostic yield to less than 20% [11].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [11] Cheung CC1, Kerr CR, Krahn AD. Comparing 14-day adhesive patch with 24-h Holter monitoring. Future Cardiol. 2014; 10(3): 319–22. 24976467 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The AliveCor device is supported for clinical use by a NICE technology appraisal.

    “The device is supported for clinical use by a National Institute for Health and Care Excellence (NICE) technology appraisal [14]”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [14] National Institute for Health and Care Excellence. AliveCor heart monitor and AliveECG app (Kardia Mobile) for detecting atrial fibrillation. NICE advice MIB35. London: NICE, 2015. https://www.nice.org.uk/advice/mib35/chapter/technology-overview (accessed 16th August 2018).

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    The AliveCor automatic diagnostic algorithm has a sensitivity of 96.6% and specificity of 94% for correctly interpreting AF versus normal sinus rhythm.

    “the automatic diagnostic algorithm has excellent sensitivity (96.6%) and specificity (94%) for correctly interpreting AF versus normal sinus rhythm [15].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [15] William A.D. Kanbour M. Callahan T. Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: the iREAD study Heart Rhythm 2018 30143448 source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data

    Use of a smartphone-based event recorder increases the symptom-rhythm correlation rate over five-fold at 90 days with a reduced cost per diagnosis.

    “Use of a smartphone-based event recorder increases the symptom–rhythm correlation rate over five-fold at 90 days with a reduced cost per diagnosis.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    The trial was registered at ClinicalTrials.gov (NCT02783898) and the protocol was published.

    “This trial was registered at ClinicalTrials.gov (trial registration number NCT02783898), and the protocol published in Trials [26].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [26] Reed MJ, Grubb NR, Lang CC, et al. Multi-centre randomised controlled trial of a smart phone 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: Study protocol for a randomised controlled trial. Trials 2018; 19: 711. nndoi: 10.1186/s13063-018-3098-1 PMC6311046 30594256 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    One participant in each group was lost to follow-up, leaving 124 participants in the intervention group and 116 in the control group available for analysis.

    “One participant in each group was lost to follow-up leaving 124 participants available for analysis in the study group and 116 in the control group.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    ECGs were reviewed by the duty Consultant Emergency Physician and a trial team Emergency Physician, with central cardiology opinion in cases of disagreement.

    “The duty Consultant Emergency Physician at the coordinating Edinburgh centre along with a trial team Emergency Physician reviewed the ECG.”
    • Also stated in: § Procedures · plain
      “In cases of disagreement, the central cardiology team were contacted for further opinion.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    In previous work in ED patients, 74% found it acceptable to use a smartphone to monitor their health, 79% to use a medical device connecting to a smartphone to monitor their health, and 77% reported that they would feel confident to use such technology.

    “This reinforces data from previous work in ED patients which showed that 74% found it acceptable to use a smartphone to monitor their health, 79% to use a medical device connecting to a smartphone to monitor their health, and 77% reported that they would feel confident to use such technology [27].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [27] Summers A. Reed M.J. An evaluation of patient ownership and use and acceptability of smartphone technology within the emergency department Eur J Emerg Med 25 3 2018 224 225 29683883 source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductown data

    Secondary outcomes were not considered in the power calculation, increasing the risk of type I error.

    “Statistical significance was determined as p < 0.05 for all outcomes with an acknowledgment of increased type I error risk in the secondary outcomes not considered in the power calculation.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Allocation was concealed using sealed opaque envelopes prepared by a central administrator not involved in the study.

    “Sealed opaque envelopes containing either ‘Standard Care plus Device’ or ‘Standard Care’ cards were prepared by a central administrator not involved in the study.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    One participant was removed from the study after randomisation because they did not meet the inclusion criteria.

    “One participant was removed from the study by the local study team after being randomised, as they did not meet the inclusion criteria.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    Randomisation was by permuted block randomisation by site, with blocks randomly labelled using random number generation.

    “randomisation was by permuted block randomisation by site.”
    • Also stated in: § Randomisation · plain
      “Blocks were randomly labelled using random number generation with site-specific study participation numbers and sent to each local study team.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    The sponsor deemed that a data monitoring committee was not required.

    “The sponsor deemed that a data monitoring committee was not required.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    All participants were analysed on an intention-to-treat basis.

    “All participants were analysed on an intention to treat basis.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    In the Arrhythmia Alliance study, older people were noted to be regular users of mobile technology and gave positive feedback about the system.

    “in the Arrhythmia Alliance study, older people were noted to be regular users of mobile technology and gave positive feedback about the system [14].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [14] National Institute for Health and Care Excellence. AliveCor heart monitor and AliveECG app (Kardia Mobile) for detecting atrial fibrillation. NICE advice MIB35. London: NICE, 2015. https://www.nice.org.uk/advice/mib35/chapter/technology-overview (accessed 16th August 2018).

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Previously unexplained symptoms can cause anxiety and have a significant impact on quality of life even in the absence of underlying arrhythmia.

    “Even in the absence of underlying arrhythmia, previously unexplained symptoms can cause anxiety and can have a significant impact on quality of life [29].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [29] Barsky A.J. Cleary P.D. Coeytaux R.R. The clinical course of palpitations in medical outpatients Arch Intern Med 155 1995 1782 1788 7654112 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The study used a central ECG reading service not available in routine practice.

    “and the use of a central ECG reading service not available in routine practice.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Interpretationnone given

    Patients choosing to take part in a study of new technology may be more motivated to use the device, and the device may not perform as well in a non-study setting.

    “It is also possible that patients choosing to take part in a study of new technology may be more motivated to use the device, and it may not perform as well in a non-study setting.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    A large proportion of recruitment occurred in office hours largely by research staff in research active hospitals.

    “Potential limitations of our study include a large proportion of recruitment occurring in office hours largely by research staff in research active hospitals”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

    Interpretationnone given

    The results of this study will be generalisable across many forms of patient-activated, symptom-based home ECG recording devices.

    “We think that the results of this study will be generalisable across many forms of patient-activated, symptom-based home ECG recording devices.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable).

    Study design and conductnone given

    The study's randomised, prospective design with systematic data collection is a key strength.

    “The randomised, prospective design with systematic data collection is a key strength of the study.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Previous research shows 64% of those aged 50-75 and 30% over 75 years of age own a smartphone.

    “our previous research shows 64% of those aged 50–75 and 30% over 75 years of age own a smartphone [27]”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [27] Summers A. Reed M.J. An evaluation of patient ownership and use and acceptability of smartphone technology within the emergency department Eur J Emerg Med 25 3 2018 224 225 29683883 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

    Interpretationnone given

    Subtle differences in design or incorporation into clinical workflow may influence the effectiveness of patient-activated home ECG recording devices.

    “Subtle differences in design or incorporation into clinical workflow may have an influence on effectiveness”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    The AliveCor technology performs effectively and safely.

    “This study suggests that the AliveCor technology performs effectively and safely.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationnone given

    The pragmatic design with potential variation in standard care between sites ensures the findings are generalisable across all types of standard care in the UK National Health Service without compromising validity.

    “Whilst there was a potential variation in standard care between sites, this element of pragmatic design ensures our findings are generalisable across all types of standard care in the UK National Health Service without compromising validity.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    A smartphone-based event recorder is safe, non-invasive and easy to use.

    “A safe, non-invasive and easy to use smartphone-based event recorder should be considered part of on-going care of all patients presenting acutely with unexplained palpitations or pre-syncope.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationown data

    This study demonstrates the ability of a smartphone-based event recorder to improve clinical care and patient experience for those suffering undiagnosed palpitations and pre-syncope.

    “In summary, this study demonstrates the ability of a smartphone-based event recorder to improve clinical care and patient experience for those suffering undiagnosed palpitations and pre-syncope.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    These conditions account for up to one-fifth of all referrals to cardiology clinics.

    “where currently these conditions account for up to one-fifth of all referrals) [30], [31], [32], [33]”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [30] Abbott A.V. Diagnostic approach to palpitations Am Fam Physician 71 2005 743 750 15742913

      Not checked in the free run.

    • cites [31] Messineo F.C. Ventricular ectopic activity: prevalence and risk Am J Cardiol 64 1989 53J 56J 2480710 source

      Not checked in the free run.

    • cites [32] Kroenke K. Arrington M.E. Mangelsdorff A.D. The prevalence of symptoms in medical outpatients and the adequacy of therapy Arch Intern Med 150 1990 1685 1689 2383163 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Only one type of device was studied.

    “Only one type of device was studied”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

    Interpretationnone given

    These findings are likely to be generalisable from Emergency Medicine to General/Internal/Acute Medicine and General (Family) Practice in a broad range of developed healthcare systems.

    “These findings are likely to be generalisable from Emergency Medicine to General/Internal/Acute Medicine and General (Family) Practice in a broad range of developed healthcare systems.”
    Quote in the paperNot a substantial claim
35 of 35

  • The paper relies on this without support.

    Diagnosis of the underlying rhythm is difficult because many patients are fully recovered by the time they are seen in the ED, and examination and presenting ECG are commonly normal.

    “Diagnosis of the underlying rhythm is difficult as many patients are fully recovered by the time that they are seen in the ED. Examination and presenting electrocardiogram (ECG) are commonly normal.”

  • The paper relies on this without support.

    The only way to establish the underlying heart rhythm is to capture an ECG whilst the patient has symptoms.

    “The only way to establish the underlying heart rhythm is to capture an ECG whilst the patient has symptoms.”

  • The paper relies on this without support.

    Many patients go for years without diagnosis due to the difficulty in capturing the underlying heart rhythm.

    “Many patients go for years without diagnosis due to the difficulty in capturing the underlying heart rhythm.”

  • The paper relies on this without support.

    Traditional event recorders, external continuous loop recorders and implantable loop recorders are expensive and not recommended for a patient group who rarely have malignant arrhythmias and may have prolonged periods between episodes.

    “Traditional event recorders, external continuous loop recorders and implantable loop recorders are expensive and not recommended for a patient group who rarely have malignant arrhythmias and may have prolonged periods between episodes.”

  • The paper relies on this without support.

    The healthcare system studied does not serve this patient group well.

    “which in the healthcare system studied does not serve this patient group well.”

  • The paper relies on this without support.

    The smartphone-based event recorder is easy to use.

    “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.”

  • The paper relies on this without support.

    The AliveCor app rhythm analysis algorithm automatically reports any ECG recorded as normal, atrial fibrillation or unclassified with excellent sensitivity and specificity.

    “The AliveCor app rhythm analysis algorithm automatically reports any ECG recorded as normal, atrial fibrillation or unclassified with excellent sensitivity and specificity.”

  • The paper relies on this without support.

    The normalisation of cardiac rhythm by the time the patient undergoes clinical assessment is a major cause of current difficulties in diagnosis.

    “may overcome some of the current difficulties in diagnosis caused by the normalisation of cardiac rhythm by the time the patient undergoes a clinical assessment.”
8 of 8

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The IPED trial showed that a single-lead ECG monitor can improve outpatient arrhythmia detection in patients who present to the emergency room with palpitations or presyncope and no clear aetiology.

    “The IPED trial58 showed that a single-lead ECG monitor can improve outpatient arrhythmia detection in patients who present to the emergency room with palpitations or presyncope and no clear aetiology”

    From Smart wearable devices in cardiovascular care: Where we are and how to move forward (2021) · cites this paper as [58]

  • In the IPED study, the mean time to symptomatic rhythm detection was 9.5 days in the intervention group compared with 42.9 days in the control group.

    “The mean time to symptomatic rhythm detection in the intervention group was 9.5 days compared with 42.9 days in the control group58.”

    From Smart wearable devices in cardiovascular care: Where we are and how to move forward (2021) · cites this paper as [58]

  • In the IPED study, at 90 days a symptomatic rhythm was detected in 55.6% of participants in the intervention group compared with 9.5% in the control group.

    “At 90 days, a symptomatic rhythm was detected in 55.6% of participants in the intervention group compared with only 9.5% in the control group.”

    From Smart wearable devices in cardiovascular care: Where we are and how to move forward (2021) · cites this paper as [58]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • The study death is assigned to opposite groups

    Major

    Table 4 places the only death in the control group, while the results text says it occurred in the intervention group. This reverses the group assignment of a serious safety outcome.

  • Life-threatening arrhythmia total does not equal the group counts

    Minor

    Table 4 reports zero life-threatening arrhythmias in each group but one in total.

    Reported 1 · recomputed 0

  • Two clinician-rating percentages are overstated

    Minor

    For both ratings 4 and 5, the total is 32 of 237, or approximately 13.5%, rather than the reported 13.9%.

    Reported 13.9 · recomputed 13.50211

3 of 3

Cites

Flagged first, then by citations

1 of the 34 references couldn’t be matched to a known paper.

Research works printed but not linked: 1

  1. Blomstrom-Lundqvist, 2003, ACC/AHA/ESC guidelines for the management of patients with supraventricular arrhythmias – executive summary, J Am Coll Cardiol, 42, 1493

Cited by

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Authors
Reed, M. J., Grubb, N. R., Lang, C. C., O'Brien, R., Simpson, K., Padarenga, M., Grant, A., Tuck, S., Keating, L., Coffey, F., Jones, L., Harris, T., Lloyd, G., Gagg, J., Smith, J. E., & Coats, T.
Affiliations
  • Edinburgh Royal Infirmary (GB)
  • Western General Hospital (GB)
  • Royal Berkshire Hospital (GB)
  • Nottingham University Hospitals NHS Trust (GB)
  • Chesterfield Royal Hospital NHS Foundation Trust (GB)
  • Barts Health NHS Trust (GB)
  • Royal Devon and Exeter Hospital (GB)
  • Musgrove Park Hospital (GB)
  • University Hospitals Plymouth NHS Trust (GB)
  • University of Leicester (GB)
Corresponding author
  • Reed, Matthew J.
  • Grubb, Neil R.
  • Lang, Christopher C.
  • Simpson, Kirsty
  • Padarenga, Mia
  • Grant, Alison
  • Tuck, Sharon
  • Keating, Liza
  • Coffey, Frank
  • Jones, Lucy
  • Harris, Tim
  • Lloyd, Gavin
  • Gagg, James
  • Smith, Jason E.
  • Coats, Tim
ORCID
Venue
EClinicalMedicine
Publisher
Elsevier BV
Published
2019-02
Volume
8
Pages
37-46
ISSN
2589-5370 (ISSN-L)
DOI
10.1016/j.eclinm.2019.02.005
PMC
PMC6537555
OpenAlex
W2920512760
Semantic Scholar
0d529dcbe3f3cabefeac4fc7646452b71ab3cb18
Cited by
57
References
34
Citations by year
2026: 4 · 2025: 4 · 2024: 6 · 2023: 11 · 2022: 8 · 2021: 21 · 2020: 1 · 2019: 2
FWCI
7.64
Type
journal article
Language
en
Open access
Licence
Locations
  • EClinicalMedicine (publishedVersion, cc-by-nc-nd)
  • SSRN Electronic Journal (acceptedVersion)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
  • Figshare (submittedVersion, cc-by-nc-nd)
  • Leicester Research Archive (University of Leicester) (submittedVersion, cc-by-nc-nd)
  • Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by-nc-nd)
  • Royal Devon and Exeter Research Repository (Royal Devon and Exeter) (submittedVersion, cc-by-nc-nd)
Funders
  • Chest, Heart and Stroke Association Scotland (23,056, R15/A164)
  • British Heart Foundation
Topics
  • Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
Keywords
palpitations, presyncope, AliveCor, emergency department, arrhythmia detection, rhythm detection, cardiac implantable electronic devices, implantable cardioverter-defibrillator, cardiac resynchronization therapy, arrhythmic risk stratification

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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-09.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-09.

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