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  • 1
    In: Family Practice, Oxford University Press (OUP), Vol. 38, No. 2 ( 2021-03-29), p. 70-75
    Abstract: Handheld single-lead electrocardiograms (1L-ECG) present a welcome addition to the diagnostic arsenal of general practitioners (GPs). However, little is known about GPs’ 1L-ECG interpretation skills, and thus its reliability in real-world practice. Objective To determine the diagnostic accuracy of GPs in diagnosing atrial fibrillation or flutter (AF/Afl) based on 1L-ECGs, with and without the aid of automatic algorithm interpretation, as well as other relevant ECG abnormalities. Methods We invited 2239 Dutch GPs for an online case-vignette study. GPs were asked to interpret four 1L-ECGs, randomly drawn from a pool of 80 case-vignettes. These vignettes were obtained from a primary care study that used smartphone-operated 1L-ECG recordings using the AliveCor KardiaMobile. Interpretation of all 1L-ECGs by a panel of cardiologists was used as reference standard. Results A total of 457 (20.4%) GPs responded and interpreted a total of 1613 1L-ECGs. Sensitivity and specificity for AF/Afl (prevalence 13%) were 92.5% (95% CI: 82.5–97.0%) and 89.8% (95% CI: 85.5–92.9%), respectively. PPV and NPV for AF/Afl were 45.7% (95% CI: 22.4–70.9%) and 98.8% (95% CI: 97.1–99.5%), respectively. GP interpretation skills did not improve in case-vignettes where the outcome of automatic AF-detection algorithm was provided. In detecting any relevant ECG abnormality (prevalence 22%), sensitivity, specificity, PPV and NPV were 96.3% (95% CI: 92.8–98.2%), 68.8% (95% CI: 62.4–74.6%), 43.9% (95% CI: 27.7–61.5%) and 97.9% (95% CI: 94.9–99.1%), respectively. Conclusions GPs can safely rule out cardiac arrhythmias with 1L-ECGs. However, whenever an abnormality is suspected, confirmation by an expert-reader is warranted.
    Type of Medium: Online Resource
    ISSN: 1460-2229
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 1484852-1
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  • 2
    In: BMJ, BMJ
    Abstract: To investigate whether opportunistic screening in primary care increases the detection of atrial fibrillation compared with usual care. Design Cluster randomised controlled trial. Setting 47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018. Participants In each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected. In the intention-to-screen group, 9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years. In the usual care group, 9526 patients were eligible for screening, 54.3% women, mean age 75.0 years. Interventions Opportunistic screening (that is, screening in patients visiting their general practice) consisted of three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device. The reference standard was 12 lead ECG, performed in patients with at least one positive index test and in a sample of patients (10%) with three negative tests. If 12 lead ECG showed no atrial fibrillation, patients were invited for more screening by continuous monitoring with a Holter electrocardiograph for two weeks. Main outcome measures Difference in the detection rate of newly diagnosed atrial fibrillation over one year in intention-to-screen versus usual care practices. Results Follow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices. 144 (1.62%) new diagnoses of atrial fibrillation in the intention-to-screen group versus 139 (1.53%) in the usual care group were found (adjusted odds ratio 1.06 (95% confidence interval 0.84 to 1.35)). Of 9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol. In these patients, 12 lead ECG detected newly diagnosed atrial fibrillation in 26 patients (0.63%). In the 266 patients who continued with Holter monitoring, four more diagnoses of atrial fibrillation were found. Conclusions Opportunistic screening for atrial fibrillation in primary care patients, aged 65 and over, did not increase the detection rate of atrial fibrillation, which implies that opportunistic screening for atrial fibrillation is not useful in this setting. Trial registration Netherlands Trial Register No NL4776 (old NTR4914).
    Type of Medium: Online Resource
    ISSN: 1756-1833
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1479799-9
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  • 3
    In: BMJ, BMJ
    Type of Medium: Online Resource
    ISSN: 1756-1833
    Language: English
    Publisher: BMJ
    Publication Date: 2015
    detail.hit.zdb_id: 1479799-9
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  • 4
    In: BMJ Open Respiratory Research, BMJ, Vol. 8, No. 1 ( 2021-09), p. e000939-
    Abstract: To evaluate the performance of direct-to-consumer pulse oximeters under clinical conditions, with arterial blood gas measurement (SaO 2 ) as reference standard. Design Cross-sectional, validation study. Setting Intensive care. Participants Adult patients requiring SaO 2 -monitoring. Interventions The studied oximeters are top-selling in Europe/USA (AFAC FS10D, AGPTEK FS10C, ANAPULSE ANP 100, Cocobear, Contec CMS50D1, HYLOGY MD-H37, Mommed YM101, PRCMISEMED F4PRO, PULOX PO-200 and Zacurate Pro Series 500 DL). Directly after collection of a SaO 2 blood sample, we obtained pulse oximeter readings (SpO 2 ). SpO 2 -readings were performed in rotating order, blinded for SaO 2 and completed 〈 10 min after blood sample collection. Outcome measures Bias (SpO 2 –SaO 2 ) mean, root mean square difference (A RMS ), mean absolute error (MAE) and accuracy in identifying hypoxaemia (SaO 2 ≤90%). As a clinical index test, we included a hospital-grade SpO 2 -monitor (Philips). Results In 35 consecutive patients, we obtained 2258 SpO 2 -readings and 234 SaO 2 -samples. Mean bias ranged from −0.6 to −4.8. None of the pulse oximeters met A RMS ≤3%, the requirement set by International Organisation for Standardisation (ISO)-standards and required for Food and Drug Administration (FDA) 501(k)-clearance. The MAE ranged from 2.3 to 5.1, and five out of ten pulse oximeters met the requirement of ≤3%. For hypoxaemia, negative predictive values were 98%–99%. Positive predictive values ranged from 11% to 30%. Highest accuracy (95% CI) was found for Contec CMS50D1; 91% (86–94) and Zacurate Pro Series 500 DL; 90% (85–94). The hospital-grade SpO 2 -monitor had an A RMS of 3.0% and MAE of 1.9, and an accuracy of 95% (91%–97%). Conclusion Top-selling, direct-to-consumer pulse oximeters can accurately rule out hypoxaemia, but do not meet ISO-standards required for FDA-clearance
    Type of Medium: Online Resource
    ISSN: 2052-4439
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2736454-9
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  • 5
    In: EP Europace, Oxford University Press (OUP), Vol. 22, No. 5 ( 2020-05-01), p. 684-694
    Abstract: Atrial fibrillation (AF) is a common arrhythmia associated with an increased stroke risk. The use of multivariable prediction models could result in more efficient primary AF screening by selecting at-risk individuals. We aimed to determine which model may be best suitable for increasing efficiency of future primary AF screening efforts. Methods and results We performed a systematic review on multivariable models derived, validated, and/or augmented for AF prediction in community cohorts using Pubmed, Embase, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) through 1 August 2019. We performed meta-analysis of model discrimination with the summary C-statistic as the primary expression of associations using a random effects model. In case of high heterogeneity, we calculated a 95% prediction interval. We used the CHARMS (Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies) checklist for risk of bias assessment. We included 27 studies with a total of 2 978 659 unique participants among 20 cohorts with mean age ranging from 42 to 76 years. We identified 21 risk models used for incident AF risk in community cohorts. Three models showed significant summary discrimination despite high heterogeneity: CHARGE-AF (Cohorts for Heart and Aging Research in Genomic Epidemiology) [summary C-statistic 0.71; 95% confidence interval (95% CI) 0.66–0.76], FHS-AF (Framingham Heart Study risk score for AF) (summary C-statistic 0.70; 95% CI 0.64–0.76), and CHA2DS2-VASc (summary C-statistic 0.69; 95% CI 0.64–0.74). Of these, CHARGE-AF and FHS-AF had originally been derived for AF incidence prediction. Only CHARGE-AF, which comprises easily obtainable measurements and medical history elements, showed significant summary discrimination among cohorts that had applied a uniform (5-year) risk prediction window. Conclusion CHARGE-AF appeared most suitable for primary screening purposes in terms of performance and applicability in older community cohorts of predominantly European descent.
    Type of Medium: Online Resource
    ISSN: 1099-5129 , 1532-2092
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2002579-8
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  • 6
    In: BMJ Open, BMJ, Vol. 11, No. 11 ( 2021-11), p. e055072-
    Abstract: To determine the accuracy of QT measurement in a smartphone-operated, single-lead ECG (1L-ECG) device (AliveCor KardiaMobile 1L). Design Cross-sectional, within-patient diagnostic validation study. Setting/participants Patients underwent a 12-lead ECG (12L-ECG) for any non-acute indication in primary care, April 2017–July 2018. Intervention Simultaneous recording of 1L-ECGs and 12L-ECGs with blinded manual QT assessment. Outcomes of interest (1) Difference in QT interval in milliseconds (ms) between the devices; (2) measurement agreement between the devices (excellent agreement 〈 20 ms and clinically acceptable agreement 〈 40 ms absolute difference); (3) sensitivity and specificity for detection of extreme QTc (short (≤340 ms) or long (≥480 ms)), on 1L-ECGs versus 12L-ECGs as reference standard. In case of significant discrepancy between lead I/II of 12L-ECGs and 1L-ECGs, we developed a correction tool by adding the difference between QT measurements of 12L-ECG and 1L-ECGs. Results 250 ECGs of 125 patients were included. The mean QTc interval, using Bazett’s formula (QTcB), was 393±25 ms (mean±SD) in 1L-ECGs and 392±27 ms in lead I of 12L-ECGs, a mean difference of 1±21 ms, which was not statistically different (paired t-test (p=0.51) and Bland Altman method (p=0.23)). In terms of agreement between 1L-ECGs and lead I, QTcB had excellent agreement in 66.9% and clinically acceptable agreement in 93.4% of observations. The sensitivity and specificity of detecting extreme QTc were 0% and 99.2%, respectively. The comparison of 1L-ECG QTcB with lead II of 12L-ECGs showed a significant difference (p= 〈 0.01), but when using a correction factor (+9 ms) this difference was cancelled (paired t-test (p=0.43) or Bland Altman test (p=0.57)). Moreover, it led to improved rates of excellent (71.3%) and clinically acceptable (94.3%) agreement. Conclusion Smartphone-operated 1L-ECGs can be used to accurately measure the QTc interval compared with simultaneously obtained 12L-ECGs in a primary care population. This may provide an opportunity for monitoring the effects of potential QTc-prolonging medications.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2599832-8
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  • 7
    In: Cardiovascular Drugs and Therapy, Springer Science and Business Media LLC, Vol. 33, No. 5 ( 2019-10), p. 615-623
    Abstract: To study whether polypharmacy or drug–drug interactions have differential effect on safety and efficacy in patients treated with direct oral anticoagulants (DOACs) versus warfarin. Methods We performed a systematic review and meta-analysis of studies that randomized patients with atrial fibrillation to DOACs or warfarin stratified by the number of concomitant drugs. Outcomes included stroke or systemic embolism (SE), all-cause mortality, major bleeding, and intracranial hemorrhage. Risk ratios (RR) were calculated and Mantel-Haenszel random effects were applied. Results Two high-quality studies were eligible, including 32,465 participants who received apixaban, rivaroxaban, or warfarin, with a median follow-up of 1.9 years. Of participants, 29% used 〈  5 drugs, 55% used 5–9 drugs, and 16% used ≥ 10 drugs. Drugs interacting with DOACs (P-glycoprotein/CYP3A4) were used by 6460 (20%) of patients. Patients with higher number of drugs (0–4 vs 5–9 vs ≥ 10) had higher rates of mortality (5.8%, 7.9%, 10.0%) and major bleeding (3.4%, 4.8%, 7.7%). Comparative efficacy or safety of DOACs versus warfarin was not affected by polypharmacy status or P-glycoprotein/CYP3A4 inhibitor use. However, the presence of polypharmacy ( p  = 0.001) or glycoprotein/CYP3A4-modulating drugs ( p  = 0.03) was correlated with increased risk of major bleeding when compared with warfarin. Overall, DOAC use was associated with a lower risk of stroke/SE (RR, 0.84; 95%CI, 0.74–0.94), all-cause mortality (RR, 0.91; 95%CI, 0.84–0.98), and intracranial hemorrhage (RR, 0.51; 95%CI, 0.38–0.70) compared with warfarin. Conclusions DOACs were more effective than warfarin, and at least as safe. Polypharmacy was associated with adverse outcomes and attenuated the advantage in risk of major bleeding among rivaroxaban users, particularly in the presence of P-glycoprotein/CYP3A4-modulating drugs.
    Type of Medium: Online Resource
    ISSN: 0920-3206 , 1573-7241
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2019
    detail.hit.zdb_id: 2003553-6
    SSG: 15,3
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  • 8
    In: EP Europace, Oxford University Press (OUP), Vol. 21, No. 5 ( 2019-05-01), p. 698-707
    Type of Medium: Online Resource
    ISSN: 1099-5129 , 1532-2092
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
    detail.hit.zdb_id: 2002579-8
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  • 9
    In: BMJ Open, BMJ, Vol. 9, No. 2 ( 2019-02), p. e027081-
    Abstract: To identify and assess the performance of clinical decision rules (CDR) for chest pain in general practice. Design Systematic review of diagnostic studies. Data sources Medline/Pubmed, Embase/Ovid, CINAHL/EBSCO and Google Scholar up to October 2018. Study selection Studies that assessed CDRs for intermittent-type chest pain and for rule out of acute coronary syndrome (ACS) applicable in general practice, thus not relying on advanced laboratory, computer or diagnostic testing. Review methods Reviewers identified studies, extracted data and assessed the quality of the evidence (using Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2)), independently and in duplicate. Results Eight studies comprising five CDRs met the inclusion criteria. Three CDRs are designed for rule out of coronary disease in intermittent-type chest pain (Gencer rule, Marburg Heart Score, INTERCHEST), and two for rule out of ACS (Grijseels rule, Bruins Slot rule). Studies that examined the Marburg Heart Score had the highest methodological quality with consistent sensitivity (86%–91%), specificity (61%–81%) and positive (23%–35%) and negative (97%–98%) predictive values (PPV and NPV). The diagnostic performance of Gencer (PPV: 20%–34%, NPV: 95%–99%) and INTERCHEST (PPV: 35%–43%, NPV: 96%–98%) appear comparable, but requires further validation. The Marburg Heart Score was more sensitive in detecting coronary disease than the clinical judgement of the general practitioner. The performance of CDRs that focused on rule out of ACS were: Grijseels rule (sensitivity: 91%, specificity: 37%, PPV: 57%, NPV: 82%) and Bruins Slot (sensitivity: 97%, specificity: 10%, PPV: 23%, NPV: 92%). Compared with clinical judgement, the Bruins Slot rule appeared to be safer than clinical judgement alone, but the study was limited in sample size. Conclusions In general practice, there is currently no clinical decision aid that can safely rule out ACS. For intermittent chest pain, several rules exist, of which the Marburg Heart Score has been most extensively tested and appears to outperform clinical judgement alone.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 2599832-8
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  • 10
    In: Open Heart, BMJ, Vol. 8, No. 1 ( 2021-01), p. e001459-
    Abstract: To validate a multivariable risk prediction model (Cohorts for Heart and Aging Research in Genomic Epidemiology model for atrial fibrillation (CHARGE-AF)) for 5-year risk of atrial fibrillation (AF) in routinely collected primary care data and to assess CHARGE-AF’s potential for automated, low-cost selection of patients at high risk for AF based on routine primary care data. Methods We included patients aged ≥40 years, free of AF and with complete CHARGE-AF variables at baseline, 1 January 2014, in a representative, nationwide routine primary care database in the Netherlands (Nivel-PCD). We validated CHARGE-AF for 5-year observed AF incidence using the C-statistic for discrimination, and calibration plot and stratified Kaplan-Meier plot for calibration. We compared CHARGE-AF with other predictors and assessed implications of using different CHARGE-AF cut-offs to select high-risk patients. Results Among 111 475 patients free of AF and with complete CHARGE-AF variables at baseline (17.2% of all patients aged ≥40 years and free of AF), mean age was 65.5 years, and 53% were female. Complete CHARGE-AF cases were older and had higher AF incidence and cardiovascular comorbidity rate than incomplete cases. There were 5264 (4.7%) new AF cases during 5-year follow-up among complete cases. CHARGE-AF’s C-statistic for new AF was 0.74 (95% CI 0.73 to 0.74). The calibration plot showed slight risk underestimation in low-risk deciles and overestimation of absolute AF risk in those with highest predicted risk. The Kaplan-Meier plot with categories 〈 2.5%, 2.5%–5% and 〉 5% predicted 5-year risk was highly accurate. CHARGE-AF outperformed CHA 2 DS 2 -VASc (Cardiac failure or dysfunction, Hypertension, Age 〉 =75 [Doubled], Diabetes, Stroke [Doubled] -Vascular disease, Age 65-74, and Sex category [Female]) and age alone as predictors for AF. Dichotomisation at cut-offs of 2.5%, 5% and 10% baseline CHARGE-AF risk all showed merits for patient selection in AF screening efforts. Conclusion In patients with complete baseline CHARGE-AF data through routine Dutch primary care, CHARGE-AF accurately assessed AF risk among older primary care patients, outperformed both CHA 2 DS 2 -VASc and age alone as predictors for AF and showed potential for automated, low-cost patient selection in AF screening.
    Type of Medium: Online Resource
    ISSN: 2053-3624
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2747269-3
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