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BACKGROUND: Additional diagnostic means could be of added value when evaluating possible acute coronary syndrome (ACS) in primary care. AIM: To determine whether heart-type fatty acid-binding protein (H-FABP)-based point-of-care (POC) biomarker testing, embedded in a clinical decision rule (CDR), is helpful to the GP when evaluating possible ACS. DESIGN & SETTING: A prospective, non-randomised, double-blinded, diagnostic derivation study was undertaken, with a delayed-type cross-sectional diagnostic model among GPs in the Netherlands and Belgium. METHOD: Signs and symptoms predicting acute myocardial infarction (AMI) or ACS were identified using both logistic regression analysis, and classification and regression trees (CART). Diagnostic values of the POC H-FABP test (cut-off value 4 ng/ml) alone and as part of a CDR were determined. RESULTS: A total of 303 participants (48.8% male) with chest pain or discomfort who had consulted a GP were enrolled. ACS was found in 32 (10.6%) of these 303 patients. For ACS, sensitivity and negative predictive value (NPV) of the POC H-FABP test was 25.8% (95% confidence interval [CI] = 12.5 to 44.9) and 91.6% (95% CI = 87.6% to 94.5%), respectively. The area under the receiver operating curve of the optimal CDR was 0.78 for ACS. CONCLUSION: Sensitivity of the current H-FABP POC test (cut-off value 4 ng/ml) as a stand-alone test is poor, either owing to limitations of the marker or of the test device. Usability of a CDR derived from these results is doubtful: the number of ACS cases missed by the GP is reduced but, as a consequence, disproportionally more ACS-negative patients are referred.
RESUMEN
OBJECTIVE: Observational study of patients with chest pain in primary care: determination of incidence, referral rate, diagnostic tests and (agreement between) working and final diagnoses. METHODS: 118 general practitioners (GPs) in the Netherlands and Belgium recorded all patient contacts during 2weeks. Furthermore, patients presenting with chest pain were registered extensively. A follow-up form was filled in after 30 days. RESULTS: 22 294 patient contacts were registered. In 281 (1.26%), chest pain was a reason for consulting the GP (mean age for men 54.4/women 53 years). In this cohort of 281 patients, in 38.1% of patients, acute coronary syndrome (ACS) was suspected at least temporarily during consultation, 40.2% of patients were referred to secondary care and 512 diagnostic tests were performed by GPs and consulted specialists. Musculoskeletal pain was the most frequent working (26.1%) and final diagnoses (33.1%). Potentially life-threatening diseases as final diagnosis (such as myocardial infarction) accounted for 8.4% of all chest pain cases. In 23.1% of cases, a major difference between working and final diagnoses was found, in 0.7% a severe disease was initially missed by the GP. CONCLUSION: Chest pain was present in 281 patients (1.26% of all consultations). Final diagnoses were mostly non-life-threatening. Nevertheless, in 8.4% of patients with chest pain, life-threatening underlying causes were identified. This seems reflected in the magnitude and wide variety of diagnostic tests performed in these patients by GPs and specialists, in the (safe) overestimation of life-threatening diseases by GPs at initial assessment and in the high referral rate we found.