Yield of screening for atrial fibrillation in primary care with a hand-held, single-lead electrocardiogram device during influenza vaccination

Aims To assess the yield of screening for atrial fibrillation (AF) with a hand-held single-lead electrocardiogram (ECG) device during influenza vaccination in primary care in the Netherlands. Methods and results We used the MyDiagnostick to screen for AF in persons who participated in influenza vaccination sessions of ten Dutch primary care practices. In case of suspected AF detection by the stick, the recorded 1-min ECG registrations were analysed by a cardiologist. We scrutinized electronic medical files of the general practitioners to obtain information about the cases screened. Multivariable logistic regression analysis was performed to predict the relation between patient characteristics and a new screen-detected diagnosis of AF. In total, 3269 persons were screened for AF during the influenza vaccination sessions of 10 general practitioner practices. As a result, 37 (1.1%) new cases of AF were detected. Prior transient ischeamic attack or stroke (OR 6.05; 95%CI 1.93-19.0), and age (OR 1.09 per year; 95% CI 1.05-1.14) were independent predictors for such newly screen-detected AF. Of the 37 screen-detected AF cases, 2.7% had a CHA2DS2-VASc of 0, 18.9% a score of 1, and 78.4% a score of 2 or more. The majority needed oral anticoagulant therapy. Conclusions Screening seems feasible with an easy to use single-lead, hand-held ECG device with automatic AF detection during influenza vaccination in primary care and results in a '1-day' yield of 1.1% new cases of AF. Trial registration clinicaltrials.gov NCT02006524

Drug Registries and Approval of Drugs:Promises, Placebo, or a Real Success?

Purpose: As part of the approval process, regulatory authorities often require postauthorization studies that involve patient registries; it is unknown, however, whether such registry studies are adequately completed. We investigated whether registry studies for new drugs were performed as agreed at time of approval. Methods: This study reviewed protocols and follow-up reports for 73 registry studies that were proposed for 43 drugs approved by the Committee for Medicinal Products for Human Use in Europe in the period 2007 to 2010. Results: The data lock point of January 1, 2016, was taken to allow a 5-year follow-up period for each drug after approval. At that time, 2 studies (3%) in registries had been finalized, 19 registries (26%) had not enrolled any patients, and 52 studies (71%) were ongoing. The median enrollment was 31% (interquartile range [IQR], 6–104) of the required number of patients for 41 registry studies that had a predefined sample size, 30% (IQR, 2–101) for nonimposed registries, and 61% (IQR, 18–144) for imposed registries. Implications: Enrollment of patients into postapproval registries is poor, although the results for imposed registries seem better. Currently, registries only have a limited impact on resolving gaps in the knowledge of a drug's benefits and risks at time of marketing authorization

Diagnostic Accuracy of the Explicit Diagnostic Criteria for Transient Ischemic Attack:A Validation Study

Background and Purpose-The clinical diagnosis of a transient ischemic attack (TIA) can be difficult. Evidence-based criteria hardly exist. We evaluated if the recently proposed Explicit Diagnostic Criteria for TIA (EDCT), an easy to perform clinical tool focusing on type, duration, and mode of onset of clinical features, would facilitate the clinical diagnosis of TIA. Methods-We used data from patients suspected of a TIA by a general practitioner and referred to a TIA service in the region of Utrecht, the Netherlands, who participated in the MIND-TIA (Markers in the Diagnosis of TIA) study. Information about the clinical features was collected with a standardized questionnaire within 72 hours after onset. A panel of 3 experienced neurologists ultimately determined the definite diagnosis based on all available diagnostic information including a 6-month follow-up period. Two researchers scored the EDCT. Sensitivity, specificity, and predictive values of the EDCT were assessed using the panel diagnosis as reference. A secondary analysis was performed with modified subcriteria of the EDCT. Results-Of the 206 patients, 126 (61%) had a TIA (n=104) or minor stroke (n=22), and 80 (39%) an alternative diagnosis. Most common alternative diagnoses were migraine with aura (n=24; 30.0%), stress related or somatoform symptoms (n=16; 20.0%), and syncope (n=9; 11.3%). The original EDCT had a sensitivity of 98.4% (95% CI, 94.4-99.8) and a specificity of 61.3% (49.7-71.9). Negative and positive predictive values were 96.1% (86.0-99.0) and 80.0% (75.2-84.1), respectively. The modified EDCT showed a higher specificity of 73.8% (62.7-83.0) with the same sensitivity and a similar negative predictive value of 96.7%, but a higher positive predictive value of 85.5% (80.3-89.5). Conclusions-The EDCT has excellent sensitivity and negative predictive value and could be a valuable diagnostic tool for the diagnosis of TIA

Diagnostic value of a heart-type fatty acid-binding protein (H-FABP) bedside test in suspected acute coronary syndrome in primary care

AbstractBackgroundTo determine the diagnostic accuracy of a rapid heart-type fatty acid-binding protein (H-FABP) test in patients suspected of acute coronary syndrome (ACS) in primary care.MethodsGeneral practitioners included 298 patients suspected of ACS. In all patients, whether referred to hospital or not, ECG and cardiac biomarker testing was performed. ACS was determined in accordance with international guidelines. Multivariate analysis was used to determine the value of H-FABP in addition to clinical findings.ResultsMean patient age was 66years (SD 14), 52% was female and 66 patients (22%) were diagnosed with ACS. The H-FABP bedside test was performed within 24h (median 3.1, IQR 1.5 to 7.1) after symptom onset. The positive predictive value (PPV) of H-FABP was 65% (95% confidence interval (CI) 50–78). The negative predictive value (NPV) was 85% (95% CI 80–88). Sensitivity was 39% (29–51%) and specificity 94% (90–96%). Within 6h after symptom onset, the PPV was 72% (55–84) and the NPV was 83% (77–88), sensitivity 43% (31–57%) and specificity 94% (89–97%). Adding the H-FABP test to a diagnostic model for ACS led to an increase in the area under the receiver operating curve from 0.66 (95% CI 0.58–0.73) to 0.75 (95% CI 0.68–0.82).ConclusionThe H-FABP rapid test provides modest additional diagnostic certainty in primary care. It cannot be used to safely exclude rule out ACS. The test can only be used safely in patients otherwise NOT referred to hospital by the GP, as an extra precaution not to miss ACS (‘rule in’)

Towards tailoring of self-management for patients with chronic heart failure or chronic obstructive pulmonary disease: a protocol for an individual patient data meta-analysis

Introduction Self-management interventions in patients with chronic conditions have received increasing attention over the past few years, yet the meta-analyses encountered considerable heterogeneity in results. This suggests that the effectiveness of self-management interventions must be assessed in the context of which components are responsible for eliciting the effect and in which subgroups of patients the intervention works best. The aim of the present study is to identify condition-transcending determinants of success of self-management interventions in two parallel individual patient data meta-analyses of self-management trials in patients with congestive heart failure (CHF) and in patients with chronic obstructive pulmonary disease (COPD). Methods and analysis Investigators of 53 randomised trials (32 in CHF and 21 in COPD) will be requested to share their de-identified individual patient data. Data will be analysed using random effects models, taking clustering within studies into account. Effect modification by age, sex, disease severity, symptom status, comorbid conditions and level of education will be assessed. Sensitivity analyses will be conducted to assess the robustness of the findings. Ethics and dissemination The de-identified individual patient data are used only for the purpose for which they were originally collected and for which ethical approval has been obtained by the original investigators. Knowledge on the effective ingredients of self-management programmes and identification of subgroups of patients in which those interventions are most effective will guide the development of evidence-based personalised self-management interventions for patients with CHF and COPD as well as with other chronic diseases

The importance of cardiovascular disease for mortality in patients with COPD: a prognostic cohort study

Background. Cardiovascular diseases are the major cause of mortality in patients with chronic obstructive pulmonary disease (COPD), however, are rarely considered in prediction models in patients with COPD. Objective. To quantify the effect of cardiovascular determinants on mortality in patients with a GP's diagnosis of COPD. Methods. Four hundred and five patients aged >65 years with a diagnosis of COPD (244 with COPD by spirometry) were followed up for an average period of 4.2 (SD 1.4) years. Cox proportional hazard regression analyses with bootstrapping techniques were performed to identify independent predictors of all-cause mortality. Results. In multivariable analysis, all-cause mortality was best predicted by age [hazard ratio Conclusions. Physicians should consider ischaemic heart disease in the clinical evaluation of any patient with a GP's diagnosis of COPD. Angina pectoris on history taking is a strong predictor of all-cause mortality in these patients and should be treated adequately to improve prognosis

Contemporary use of devices in chronic heart failure in the Netherlands

Aims: Despite previous surveys regarding device implantation rates in heart failure (HF), insight into the real-world management with devices is scarce. Therefore, we investigated device implantation rates in HF with reduced left ventricular ejection fraction (LVEF) in 34 Dutch centres. Methods and results: A cross-sectional outpatient registry was conducted in 6666 patients with LVEF < 50% and with information about device implantation available [74 (66–81) years of age; 64% male]. Patients were classified into conventional pacemakers (PM, n = 562), implantable cardioverter defibrillato

Integrated management of atrial fibrillation in primary care:results of the ALL-IN cluster randomized trial

Aims To evaluate whether integrated care for atrial. fibrillation (AF) can be safely orchestrated in primary care. Methods and results The ALL-IN trial was a cluster randomized, open-label, pragmatic non-inferiority trial performed in primary care practices in the Netherlands. We randomized 26 practices: 15 to the integrated care intervention and 11 to usual care. The integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics. The primary endpoint was all-cause mortality during 2 years of follow-up. In the intervention arm, 527 out of 941 eligible AF patients aged >65 years provided informed consent to undergo the intervention. These 527 patients were compared with 713 AF patients in the control arm receiving usual care. Median age was 77 (interquartile range 72-83) years. The all-cause mortality rate was 3.5 per 100 patient-years in the intervention arm vs. 6.7 per 100 patient-years in the control arm [adjusted hazard ratio (HR) 0.55; 95% confidence interval (CI) 0.37-0.82]. For non cardiovascular mortality, the adjusted HR was 0.47 (95% CI 0.27-0.82). For other adverse events, no statistically significant differences were observed. Conclusion In this cluster randomized trial, integrated care for elderly AF patients in primary care showed a 45% reduction in all-cause mortality when compared with usual care