Background Lassa fever is a viral haemorrhagic fever endemic in parts of west Africa. New treatments are needed to decrease mortality, but pretrial reference data on the disease characteristics are scarce. We aimed to document baseline characteristics and outcomes for patients hospitalised with Lassa fever in Nigeria.
MethodsWe did a prospective cohort study (LASCOPE) at the Federal Medical Centre in Owo, Nigeria. All patients admitted with confirmed Lassa fever were invited to participate and asked to give informed consent. Patients of all ages, including newborn infants, were eligible for inclusion, as were pregnant women. All participants received standard supportive care and intravenous ribavirin according to Nigeria Centre for Disease Control guidelines and underwent systematic biological monitoring for 30 days. Patients' characteristics, care received, mortality, and associated factors were recorded using standard WHO forms. We used univariable and multivariable logistic regression models to investigate an association between baseline characteristics and mortality at day 30.
To compare the pre-surgical ability of a multivariate predictive algorithm combining CA 125, HE4 and menopausal status (ROMA) vs. ultrasound (US) imaging performed by an experienced examiner, for estimation of the risk of malignancy in patients with adnexal masses. Methods: Prospective multi-center, double blind, clinical trial enrolling patients presenting with adnexal masses and candidate for surgical treatment. Blood samples for HE4 and CA 125 measurements and US were performed within 30 days prior to surgery. Masses were classified by US according to IOTA criteria: the examiner classified each mass as certainly or probably benign, difficult to classify, or probably or certainly malignant. A separate self impression of presumed histological diagnosis was given. Separate logistic regression algorithms for pre-and post-menopausal women were utilized to categorize patients into low and high risk group for ovarian cancer (ROMA). Outcome measures were sensitivity (Sens), specificity (Spec), positive predictive value (PPV) and negative predictive value (NPV) of ROMA, CA 125 and HE4 and US in discriminating adnexal masses. Results: To date 51 patients entered in the study. At final pathology there were 23 malignancies, 3 borderline tumors and 25 benign diseases. The different tests performed as follow: US (Sens 100%,
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