RESUMEN
BACKGROUND: In an attempt to assess the effects of the Ebola viral disease (EVD) on hospital functions in Sierra Leone, the aim of this study was to evaluate changes in provisions of surgery and non-Ebola admissions during the first year of the EVD outbreak. METHODS: All hospitals in Sierra Leone known to perform inpatient surgery were assessed for non-Ebola admissions, volume of surgery, caesarean deliveries and inguinal hernia repairs between January 2014 and May 2015, which was a total of 72 weeks. Accumulated weekly data were gathered from readily available hospital records at bi-weekly visits during the peak of the outbreak from September 2014 to May 2015. The Mann-Whitney U test was used to compare weekly median admissions during the first year of the EVD outbreak, with the 20 weeks before the outbreak, and weekly median volume of surgeries performed during the first year of the EVD outbreak with identical weeks of 2012. The manuscript is prepared according to the STROBE checklist for cross-sectional studies. RESULTS: Of the 42 hospitals identified, 40 had available data for 94% (2719/2880) of the weeks. There was a 51% decrease in weekly median non-Ebola admissions and 41% fewer weekly median surgeries performed compared with the 20 weeks before the outbreak (admission) and 2012 (volume of surgery). Governmental hospitals experienced a smaller reduction in non-Ebola admissions (45% versus 60%) and surgeries (31% versus 53%) compared to private non-profit hospitals. Governmental hospitals realized an increased volume of cesarean deliveries by 45% during the EVD outbreak, thereby absorbing the 43% reduction observed in the private non-profit hospitals. CONCLUSIONS: Both non-Ebola admissions and surgeries were severely reduced during the EVD outbreak. In addition to responding to the EVD outbreak, governmental hospitals were able to maintain certain core health systems functions. Volume of surgery is a promising indicator of hospital functions that should be further explored.
Asunto(s)
Brotes de Enfermedades/estadística & datos numéricos , Fiebre Hemorrágica Ebola/epidemiología , Hospitalización/estadística & datos numéricos , Cesárea/estadística & datos numéricos , Lista de Verificación , Estudios Transversales , Utilización de Instalaciones y Servicios/estadística & datos numéricos , Femenino , Hospitales Privados/estadística & datos numéricos , Hospitales Públicos/estadística & datos numéricos , Humanos , Pacientes Internos , Masculino , Organizaciones sin Fines de Lucro/estadística & datos numéricos , Embarazo , Utilización de Procedimientos y Técnicas , Sierra Leona/epidemiología , Estadísticas no Paramétricas , Procedimientos Quirúrgicos Operativos/estadística & datos numéricosRESUMEN
BACKGROUND: TKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated. METHODS AND FINDINGS: In this single-arm phase 2 trial, adults with laboratory-confirmed EVD received 0.3 mg/kg of TKM-130803 by intravenous infusion once daily for up to 7 d. On days when trial enrolment capacity was reached, patients were enrolled into a concurrent observational cohort. The primary outcome was survival to day 14 after admission, excluding patients who died within 48 h of admission. After 14 adults with EVD had received TKM-130803, the pre-specified futility boundary was reached, indicating a probability of survival to day 14 of ≤0.55, and enrolment was stopped. Pre-treatment geometric mean Ebola virus load in the 14 TKM-130803 recipients was 2.24 × 109 RNA copies/ml plasma (95% CI 7.52 × 108, 6.66 × 109). Two of the TKM-130803 recipients died within 48 h of admission and were therefore excluded from the primary outcome analysis. Of the remaining 12 TKM-130803 recipients, nine died and three survived. The probability that a TKM-130803 recipient who survived for 48 h will subsequently survive to day 14 was estimated to be 0.27 (95% CI 0.06, 0.58). TKM-130803 infusions were well tolerated, with 56 doses administered and only one possible infusion-related reaction observed. Three patients were enrolled in the observational cohort, of whom two died. CONCLUSIONS: Administration of TKM-130803 at a dose of 0.3 mg/kg/d by intravenous infusion to adult patients with severe EVD was not shown to improve survival when compared to historic controls. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR201501000997429.
Asunto(s)
Antivirales/uso terapéutico , Ebolavirus/genética , Fiebre Hemorrágica Ebola/tratamiento farmacológico , ARN Interferente Pequeño/uso terapéutico , ARN Viral/genética , Tratamiento con ARN de Interferencia/métodos , Adulto , Anciano , Anciano de 80 o más Años , Ebolavirus/patogenicidad , Femenino , Fiebre Hemorrágica Ebola/diagnóstico , Fiebre Hemorrágica Ebola/genética , Fiebre Hemorrágica Ebola/mortalidad , Fiebre Hemorrágica Ebola/virología , Interacciones Huésped-Patógeno , Humanos , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Nanopartículas , ARN Interferente Pequeño/administración & dosificación , ARN Viral/sangre , Tratamiento con ARN de Interferencia/efectos adversos , Sierra Leona , Análisis de Supervivencia , Factores de Tiempo , Resultado del Tratamiento , Carga Viral/efectos de los fármacos , Carga Viral/genética , Adulto JovenRESUMEN
BACKGROUND: The indirect effects of the Ebola epidemic on health service function may be significant but is not known. The aim of this study was to quantify to what extent admission rates and surgery has changed at health facilities providing such care in Sierra Leone during the time of the Ebola epidemic. METHODS: Weekly data on facility inpatient admissions and surgery from admission and surgical theatre register books were retrospectively retrieved during September and October. 21 Community Health Officers enrolled in a surgical task-shifting program personally visited the facilities. The study period was January 6 (week 2) to October 12, (week 41) 2014. RESULTS: Data was retrieved from 40 out of 55 facilities. A total of 62,257 admissions and 12,124 major surgeries were registered for the study period. Total admissions in the week of the first Ebola case were 2,006, median 40 (IQR 20-76) compared to 883, median 12 (IQR 4-30) on the last week of the study. This equals a 70% drop in median number of admissions (p=0.005) between May and October. Total number of major surgeries fell from 342, median 6 (IQR 2-14) to 231, median 3 (IQR 0-6) in the same period, equal 50% reduction in median number of major surgeries (p=0.014). CONCLUSIONS: Inpatient health services have been severely affected by the Ebola outbreak. The dramatic documented decline in facility inpatient admissions and major surgery is likely to be an underestimation. Reestablishing such care is urgent and must be a priority.