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  • 1
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    Performance of popular pulse oximeters compared with simultaneous arterial oxygen saturation or clinical-grade pulse oximetry: a cross-sectional validation study in intensive care patients
    BMJ ; 2021
    In:  BMJ Open Respiratory Research Vol. 8, No. 1 ( 2021-09), p. e000939-
    Details
    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
    URL: Article
    DOI: 10.1136/bmjresp-2021-000939
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 2
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    Evaluation of general practitioners’ single-lead electrocardiogram interpretation skills: a case-vignette study
    Oxford University Press (OUP) ; 2021
    In:  Family Practice Vol. 38, No. 2 ( 2021-03-29), p. 70-75
    Details
    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
    URL: Article
    DOI: 10.1093/fampra/cmaa076
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 3
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    Prediction models for atrial fibrillation applicable in the community: a systematic review and meta-analysis
    Oxford University Press (OUP) ; 2020
    In:  EP Europace Vol. 22, No. 5 ( 2020-05-01), p. 684-694
    Details
    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
    URL: Article
    DOI: 10.1093/europace/euaa005
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 4
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    Manual QT interval measurement with a smartphone-operated single-lead ECG versus 12-lead ECG: a within-patient diagnostic validation study in primary care
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 11 ( 2021-11), p. e055072-
    Details
    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
    URL: Article
    DOI: 10.1136/bmjopen-2021-055072
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2599832-8
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  • 5
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    Performance of risk scores for coronary artery disease: a retrospective cohort study of patients with chest pain in urgent primary care
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 12 ( 2021-12), p. e045387-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 12 ( 2021-12), p. e045387-
    Abstract: To evaluate the diagnostic performance of the Marburg Heart Score (MHS), INTERCHEST, Gencer rule, Bruins Slot rule and compare these with unaided clinical judgement in patients with chest pain in urgent primary care. Design Retrospective, cohort study. Setting Regional primary care facility responsible for out-of-hours primary care for a quarter-million people in the Netherlands. Participants Consecutive patients aged ≥18 years who were evaluated for chest pain. Main outcome measures Discriminatory ability (C-statistic), sensitivity, specificity, positive and negative predictive values (PPV/NPV). The reference standard involved a composite endpoint of the occurrence of death, acute coronary syndrome or coronary revascularisation (=major adverse cardiac events; MACE) up to 6 weeks after initial contact. Results A total of 664 patients were included, of whom 4.8% (n=32) had a MACE event. C-statistics for MHS, INTERCHEST, Gencer and Bruins Slot rule were: 0.77 (95% CI 0.69 to 0.84), 0.85 (95% CI 0.78 to 0.92), 0.72 (95% CI 0.63 to 0.81) and 0.72 (95% CI 0.63 to 0.81), respectively. Optimal diagnostic accuracy was found for MHS ≥2 (sensitivity=81.3%, specificity=67.1%, PPV=11.1%, NPV=98.6%), INTERCHEST ≥2 (sensitivity=87.5%, specificity=78.8%, PPV=17.3%, NPV=99.1%), Gencer ≥2 (sensitivity=84.4%, specificity=37.8%, PPV=6.4%, NPV=98.0%) and Bruins Slot≥2 (sensitivity=90.6%, specificity=40.8%, PPV=7.2%, NPV=98.9%). Physicians referred 157 patients (23.6%) and missed 6 out of 32 MACEs (sensitivity=81.3%, specificity=79.3%, PPV=16.6%, NPV=98.8%). Using INTERCHEST with a referral threshold of ≥2 points, 4 MACEs would have been missed and 162 patients (24.4%) referred. The other risk scores resulted in far higher referral rates. Conclusion While available risk scores have reasonable to good discriminatory properties, they do not outperform unaided clinical judgment for evaluating chest pain in urgent primary care. Only the INTERCHEST score may slightly improve risk stratification.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2020-045387
    DOI: 10.1136/bmjopen-2020-045387.supp1
    DOI: 10.1136/bmjopen-2020-045387.supp2
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 6
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    Validating risk models versus age alone for atrial fibrillation in a young Dutch population cohort: should atrial fibrillation risk prediction be expanded to younger community members?
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 2 ( 2022-02), p. e057476-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 2 ( 2022-02), p. e057476-
    Abstract: Advancing age is the primary selection criterion for community screening for atrial fibrillation (AF), with selection often restricted to those aged ≥65 years. If multivariable models were shown to have considerable additional value over age alone in predicting AF risk among younger individuals, AF screening could be expanded to patients with lower age, but with high AF risk as per a validated risk model. Methods We validated risk models CHARGE-AF (Cohorts for Heart and Aging Research in Genomic Epidemiology model for AF) and FHS-AF (Framingham Heart Study model for AF), and risk scores CHA 2 DS 2 -VASc and CHA 2 DS 2 -VA, and presented their predictive abilities for 5-year and 10-year AF risk versus that of age alone in a young Dutch population cohort (PREVEND) free from AF at baseline. We assessed discrimination by the C-statistic and calibration by the calibration plot and stratified Kaplan-Meier plot using survey-weighted Cox models. Results During 5-year and 10-year follow-up there were n=98 (2.46/1000 person-years) and n=249 (3.29/1000 person-years) new AF cases, respectively, among 8265 participants with mean age 49±13 years. CHARGE-AF and FHS-AF both showed good discrimination for 5-year and 10-year AF (C-statistic range 0.83–0.86) with accurate calibration for 5-year AF, but overestimation of 10-year AF risk in highest-risk individuals. CHA 2 DS 2 -VASc and CHA 2 DS 2 -VA relatively underperformed. Age alone showed similar discrimination to that of CHARGE-AF and FHS-AF both in the overall, young PREVEND cohort and in subgroups for lower age and lower stroke risk. Conclusion Multivariable models accurately discriminate for 5-year and 10-year AF risk among young European community-dwelling individuals. However, their additional discriminatory value over age alone was limited. Selection strategies for primary AF screening using multivariable models should not be expanded to younger individuals.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2021-057476
    Language: English
    Publisher: BMJ
    Publication Date: 2022
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  • 7
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    Chest pain in general practice: a systematic review of prediction rules
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 2 ( 2019-02), p. e027081-
    Details
    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
    URL: Article
    DOI: 10.1136/bmjopen-2018-027081
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 8
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    Evaluation of telephone triage among chest pain patients in out-of-hours primary care in the Netherlands (TRACE)
    Oxford University Press (OUP) ; 2023
    In:  Family Practice Vol. 40, No. 1 ( 2023-02-09), p. 23-29
    Details
    In: Family Practice, Oxford University Press (OUP), Vol. 40, No. 1 ( 2023-02-09), p. 23-29
    Abstract: Telephone triage is fully integrated in Dutch out-of-hours primary care (OOH-PC). Patients presenting with chest pain are initially assessed according to a standardized protocol (“Netherlands Triage Standard” [NTS]). Nevertheless, little is known about its (diagnostic) performance, nor on the impact of subsequent clinical judgements made by triage assistants and general practitioners (GPs). Objective To evaluate the performance of the current NTS chest pain protocol. Methods Observational, retrospective cohort study of adult patients with chest pain who contacted a regional OOH-PC facility in the Netherlands, in 2017. The clinical outcome measure involved the occurrence of a “major event,” which is a composite of all-cause mortality and urgent cardiovascular and noncardiovascular conditions, occurring ≤6 weeks of initial contact. We assessed the performance using diagnostic and discriminatory properties. Results In total, 1,803 patients were included, median age was 54.0 and 57.5% were female. Major events occurred in 16.2% of patients with complete follow-up, including 99 (6.7%) cases of acute coronary syndrome and 22 (1.5%) fatal events. NTS urgency assessment showed moderate discriminatory abilities for predicting major events (c-statistic 0.66). Overall, NTS performance showed a sensitivity and specificity of 83.0% and 42.4% with a 17.0% underestimated major event rate. Triage assistants’ revisions hardly improved urgency allocation. Further consideration of the clinical course following OOH-PC contact did generate a more pronounced improvement with a sensitivity of 89.4% and specificity of 61.9%. Conclusion Performance of telephone triage of chest pain appears moderate at best, with acceptable safety yet limited efficiency, even after including further work-up by GPs.
    Type of Medium: Online Resource
    ISSN: 1460-2229
    URL: Article
    DOI: 10.1093/fampra/cmac077
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 9
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    CHARGE-AF in a national routine primary care electronic health records database in the Netherlands: validation for 5-year risk of atrial fibrillation and implications for patient selection in atrial fibrillation screening
    BMJ ; 2021
    In:  Open Heart Vol. 8, No. 1 ( 2021-01), p. e001459-
    Details
    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
    URL: Article
    DOI: 10.1136/openhrt-2020-001459
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 10
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    Frequent premature atrial contractions are associated with atrial fibrillation, brain ischaemia, and mortality: a systematic review and meta-analysis
    Oxford University Press (OUP) ; 2019
    In:  EP Europace Vol. 21, No. 5 ( 2019-05-01), p. 698-707
    Details
    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
    URL: Article
    DOI: 10.1093/europace/euy276
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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