Development and Validation of a simple score for diagnosis of Leptospirosis at outpatient departments

Abstract

BACKGROUND: Leptospirosis is an important zoonotic disease within the tropics. Diagnosing leptospirosis is a clinical obstacle, as clinical presentations are similar to other tropical infectious diseases. Available serological tests are often insensitive and not cost-effective. Many clinical diagnostic scorings had been developed but most were based on hospitalized patients, and wound not be suitable for use in suspected patients in setting of ambulatory care. OBJECTIVES: To develop and internal validate multivariable diagnostic prediction score of leptospirosis in patients suspicious of leptospirosis at out-patient clinics of community hospitals. MATERIALS AND METHODS: We performed a prospective, multisite diagnostic prediction research with development of a diagnostic score. The development cohort was based on patients suspicious of leptospirosis who visited five community hospitals in Si Sa Ket province, Thailand during December 2017 to November 2018. Leptospirosis confirmed cases were defined when one of the three standard confirmatory tests was positive. Multivariable logistic regression was used for score derivation. Test of AuROC equality was done to compare diagnostic performance of the newly derived score and conventional WHO score. RESULTS: A total of 262 leptospirosis suspicious patients were enrolled. Eighty-two patients (31.5%) were leptospirosis confirmed cases. Five final predictors remained within the reduced logistic model which were history of exposure to wet ground at workplace, history of contact water reservoir used by animal, urine protein and urine blood positive from dipstick test, and neutrophil count from CBC ≥80%. The OPD score diagnostic performance was AuROC 0.72 (95%CI 0.65-0.79). Test of equality revealed significant differences of AuROC between the OPD and WHO score (0.72 vs 0.62, p-value 0.014). Patients were categorized into low and high probability of having leptospirosis at score point of 3.5 with sensitivity 72.4% and specificity 61.7%. CONCLUSIONS: This study developed and internal validated the OPD score. This clinical risk score could be one of the important tools for diagnosis of leptospirosis at the outpatient clinic.