| 1. |
- Etminani, Farzaneh, 1984-, et al.
(författare)
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Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged ≥ 65 years : CONSIDERING-AF study design
- 2024
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Ingår i: BMJ Open. - London : BMJ Publishing Group Ltd. - 2044-6055. ; 14:1
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Atrial fibrillation (AF) is the most common arrhythmia and confers an increased risk of mortality, stroke, heart failure and cognitive decline. There is growing interest in AF screening; however, the most suitable population and device for AF detection remains to be elucidated. Here, we present the design of the CONSIDERING-AF (deteCtiON and Stroke preventIon by moDEl scRreenING for Atrial Fibrillation) study. METHODS AND ANALYSIS: CONSIDERING-AF is a randomised, controlled, siteless, non-blinded diagnostic superiority trial with four parallel groups and a primary endpoint of identifying AF during a 6-month study period set in Region Halland, Sweden. In each group, 740 individuals aged≥65 years will be included. The primary objective is to compare the intervention of AF screening enrichment using a risk prediction model (RPM), followed by 14 days of a continuous ECG patch, with no intervention (standard care). Primary outcome is defined as the incident AF recorded in the Region Halland Information Database after 6 months as compared with standard care. Secondary endpoints include the difference in incident AF between groups enriched or not by the RPM, with and without an invitation to 14 days of continuous ECG recording, and the proportions of oral anticoagulation treatment in the four groups. ETHICS AND DISSEMINATION: This study has ethical approval from the Swedish Ethical Review Authority. Results will be published in peer-reviewed international journals. TRIAL REGISTRATION NUMBER: NCT05838781. © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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| 2. |
- Magnusson, Peter, et al.
(författare)
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A protocol for a prospective observational study using chest and thumb ECG : transient ECG assessment in stroke evaluation (TEASE) in Sweden
- 2018
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 8:4
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Tidskriftsartikel (refereegranskat)abstract
- Atrial fibrillation (AF) causes ischaemic stroke and based on risk factor evaluation warrants anticoagulation therapy. In stroke survivors, AF is typically detected with short-term ECG monitoring in the stroke unit. Prolonged continuous ECG monitoring requires substantial resources while insertable cardiac monitors are invasive and costly. Chest and thumb ECG could provide an alternative for AF detection poststroke. The primary objective of our study is to assess the incidence of newly diagnosed AF during 28 days of chest and thumb ECG monitoring in cryptogenic stroke. Secondary objectives are to assess health-related quality of life (HRQoL) using short-form health survey (SF-36) and the feasibility of the Coala Heart Monitor in patients who had a stroke.Methods: Stroke survivors in Region Gavleborg, Sweden, will be eligible for the study from October 2017. Patients with a history of ischaemic stroke without documented AF before or during ECG evaluation in the stroke unit will be evaluated by the chest and thumb ECG system Coala Heart Monitor. The monitoring system is connected to a smartphone application which allows for remote monitoring and prompt advice on clinical management. Over a period of 28 days, patients will be monitored two times a day and may activate the ECG recording at symptoms. On completion, the system is returned by mail. This system offers a possibility to evaluate the presence of AF poststroke, but the feasibility of this system in patients who recently suffered from a stroke is unknown. In addition, HRQoL using SF-36 in comparison to Swedish population norms will be assessed. The feasibility of the Coala Heart Monitor will be assessed by a self-developed questionnaire.Ethics and dissemination: The study was approved by The Regional Ethical Committee in Uppsala (2017/321). The database will be closed after the last follow-up, followed by statistical analyses, interpretation of results and dissemination to a scientific journal.
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| 3. |
- Magnusson, Peter, et al.
(författare)
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Diagnostic yield of chest and thumb ECG after cryptogenic stroke, Transient ECG Assessment in Stroke Evaluation (TEASE) : an observational trial
- 2020
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 10:9
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Tidskriftsartikel (refereegranskat)abstract
- Objective In stroke survivors, atrial fibrillation (AF) is typically evaluated solely by short-term ECG monitoring in the stroke unit. Prolonged continuous ECG monitoring or insertable cardiac monitors require substantial resources. Chest and thumb ECG could provide an alternative means of AF detection, which in turn could allow prompt anticoagulation to prevent recurrent stroke. The objective of this study was to assess the yield of newly diagnosed AF during 28 days of chest and thumb ECG monitoring two times per day in cryptogenic stroke.Methods This study, Transient ECG Assessment in Stroke Evaluation, included patients who had a stroke from Region Gävleborg, Sweden, between 2017 and 2019. Patients with a recent ischaemic stroke without documented AF (or other reasons for anticoagulation) before or during ECG evaluation in the stroke unit were evaluated using the Coala Heart Monitor connected to a smartphone application for remote monitoring.Results The prespecified number of 100 patients (mean age 67.6±10.8 years; 60% men) was analysed. In nine patients (9%, number needed to screen 11) AF but no other significant atrial arrhythmias (>30 s) was diagnosed. The mean CHA2DS2-VASc score was similar among patients with AF and no AF (4.9±1.1 vs 4.3±1.3; p=0.224) and patients with AF were older (74.3±9.0 vs 66.9±10.8; p=0.049). Patients performed on average 90.1%±15.0% of scheduled transmissions.Conclusion In evaluation of cryptogenic stroke, 9% of patients had AF detected using chest and thumb ECG two times per day during 1 month. In many stroke survivors, this is a feasible approach and they will be potentially protected from recurrent stroke by anticoagulation treatment.
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| 4. |
- Magnusson, Peter, et al.
(författare)
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EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic Cardiomyopathy (ELUCIDATE HCM)-rationale and design : a prospective observational study on incidence of arrhythmias in Sweden
- 2017
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 7:12
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Hypertrophic cardiomyopathy (HCM) is a heterogeneous disease associated with sudden cardiac death (SCD) mainly due to ventricular tachycardia (VT) or fibrillation even though life-threatening bradycardia occurs. Risk stratification takes several variables into consideration including non-sustained VT (NSVT). An implantable cardioverter defibrillator effectively prevents SCD. Atrial fibrillation (AF) is common among patients with HCM and warrants anticoagulation even without conventional risk factors according to European guidelines. Routinely, the evaluation of arrhythmias using a 48-hour ambulatory external monitor takes place every 6–24 months if patients do not report palpitations. The remaining time the potential burden arrhythmia is unknown. Therefore, the aim of the present study is to assess NSVT and AF incidence during 18 months by an insertable cardiac monitor (ICM).Methods: Adult patients, aged 18–65 years, with a validated diagnosis of HCM are eligible for the study. The study sample is planned to include 30 patients. A Confirm Rx is implanted at the level of the fourth rib on the left side subcutaneously after local anaesthesia. The application for monitoring is installed in the patients’ smartphone and symptoms registered by the patient activation and VT detection programmed as 160 bpm during ≥8 intervals. An AF episode is recorded based on ≥2 min duration. Bradycardia is recorded at ≤40 bpm or pause ≥3.0 s. The patients are followed during 18 months before explant.Ethics and dissemination: The study was approved by The Regional Ethical Committee in Umeå (protocol number 2017/13–31). The study protocol, including variables and prespecified research questions, the study was registered at Clinical Trial Registration NCT03259113. Each patient is informed about the study in both oral and written form by a physician and included after written consent.
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| 5. |
- Magnusson, Peter, et al.
(författare)
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Health-related quality of life in patients with implantable cardioverter defibrillators in Sweden : a cross-sectional observational trial
- 2021
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Ingår i: BMJ Open. - : BMJ Journals. - 2044-6055. ; 11:7
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: Decisions regarding implantable cardioverter defibrillators (ICDs) must consider information about presumed health-related quality of life (HRQL). The purpose of the study was to assess HRQL in patients with ICD and compare it to a Swedish age-matched and sex-matched population.DESIGN: Cross-sectional observational trial.SETTING: Swedish ICD cohort.INTERVENTIONS: Short form 36 (SF-36) questionnaires from ICD recipients implanted 2007-2017 (response rate 77.2%) were analysed using Mann-Whitney U test and effect size (ES).RESULTS: In total, 223 patients (mean age 71.1±9.7 years, 82.1% men) were included. In most SF-36 domains (physical functioning (PF), role physical, general health (GH), vitality, social functioning and mental health), the score for patients with ICD was significantly lower (ES range 0.23-0.41, ie, small difference) than norms, except for bodily pain and role emotional. Both the physical component summary (PCS) and the mental component summary (MCS) scores had ES=0.31. Men and women had similar scores. Primary and secondary prevention patients scored similarly, except for worse GH in primary prevention (p=0.016, ES=0.35). Atrial fibrillation was associated with worse PF (ES=0.41) and PCS (ES=0.38). Appropriate therapy, inappropriate shock or complications requiring surgery were not associated with lower scores in any domain. In primary prevention due to ischaemic versus non-ischaemic cardiomyopathy, no domain was significantly different. PCS decreased with higher age strata (p=0.002) in contrast to MCS (p=0.986).CONCLUSIONS: Patients with ICDs have lower physical and mental HRQL than age-matched and sex-matched norms; however, the ESs are small. HRQL is similar regardless of sex, primary/secondary prevention indication, appropriate therapy, inappropriate shock or complications, but decreases with advancing age.
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| 6. |
- Magnusson, Peter, et al.
(författare)
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Patient-reported feasibility of chest and thumb ECG after cryptogenic stroke in Sweden : an observational study
- 2020
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Ingår i: BMJ Open. - : BMJ PUBLISHING GROUP. - 2044-6055. ; 10:10
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The aim of this study was to assess the feasibility, based on a questionnaire, of the chest and thumb ECG system Coala Heart Monitor in patients who recently had a stroke.Design: Observational study.Setting: Two stroke units, Region Gavleborg, Sweden.Participants and interventions: This study, Transient ECG Assessment in Stroke Evaluation (TEASE), included patients who had a stroke between 2017 and 2019. Patients eligible for anticoagulation in the presence of atrial fibrillation were scheduled for 28 days monitoring.Primary and secondary outcome measures: The questionnaire regarding feasibility of monitoring included seven questions, using a 100 mm Visual Analogue Scale which covered overall satisfaction, technical feasibility, remember to monitor, physical application, feeling of security, help from others and recommendation to others. A lower score indicated better outcome.Results: The prespecified number of 100 patients underwent the monitoring and 83 out of the 97 alive patients returned the questionnaire (response rate 85.6%). The median age was 69.5 years, mean CHA(2)DS(2)-VASc score was 4.4 +/- 1.3 points and 59.0% were men (n=49). The median time from index stroke to start of monitoring was 7.0 days. Patients performed on average 90.1%+/- 15.0% of scheduled ECG-transmissions. In all seven questions, the median score ranged from 4 to 8. The vast majority reported acceptable outcomes, that is, the 95th percentile ranged from 30 to 54. There was no significant difference between men and women with regard to any of the seven questions (p values ranging from 0.117 to 0.849). Two of the seven outcome scores correlated significantly to patient age (Spearman's r=-0.238 and r=-0.308, and p values 0.031 and 0.005 for 'overall satisfaction' and 'remember to monitor', respectively).Conclusion: In stroke survivors, chest and thumb ECG two times per day over a period of 4 weeks is feasible from a patient's perspective. The Coala Heart Monitor provides a valuable and convenient tool for monitoring after stroke.
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| 7. |
- Strömbom, Ylva, 1959-, et al.
(författare)
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Health-related quality of life among frequent attenders in Swedish primary care : a cross-sectional observational study
- 2019
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 9:7
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: The aim was to examine health-related quality of life (HRQoL), patient characteristics and reasons for visits to general practitioners (GPs) by frequent attenders (FAs) and a comparison group (CG) in primary care.METHODS: Patients aged 18-64 years were eligible for the study. Medical records were scrutinised concerning reasons for visits. Questionnaires including short-form health survey (SF-36) were mailed to 331 FAs (≥5 visits at GPs during 2000) and 371 patients in a CG randomly selected from two healthcare centres and returned by 49% and 57%, respectively. FAs' SF-36 health profiles were compared both to CG and general Swedish population norms.RESULTS: FAs report lower HRQoL than CG and below the general Swedish population norms in all eight SF-36 domains including both mental and physical component summary scores (MCS and PCS). Effect sizes (ESs) for differences between FAs and norms ranged from 0.79 to 1.08 for specific domains and was 0.94 for PCS and 0.71 for MCS. ESs of FAs versus CG ranged between 0.60 and 0.95 for the domains and was 0.76 for PCS and 0.49 for MCS. There were no significant differences between the FAs and CG with regard to sex, being married or cohabiting, number of children in household or educational level. FAs were more often unemployed, obese, slightly older and used complementary medicine more frequently. Except for injuries, all health complaints as classified in 10 categories were more common among FAs than CG, particularly musculoskeletal pain and psychosocial distress related to compromised HRQoL.CONCLUSION: The HRQoL is compromised in FAs, both when compared with patients who do not often seek care and to general Swedish population norms. Commonly reported reasons for visiting GPs among FAs were musculoskeletal pain and psychosocial distress. Thus, perceived ill health, particularly pain and distress, seems important for high utilisation of healthcare resources.
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