Abstract

BackgroundLost, delayed or incorrect laboratory results are associated with delays in initiating treatment. Delays in treatment for Multi-Drug Resistant Tuberculosis (MDR-TB) can worsen patient outcomes and increase transmission. The objective of this study was to evaluate the impact of a laboratory information system in reducing delays and the time for MDR-TB patients to culture convert (stop transmitting).MethodsSetting: 78 primary Health Centers (HCs) in Lima, Peru. Participants lived within the catchment area of participating HCs and had at least one MDR-TB risk factor. The study design was a cluster randomized controlled trial with baseline data. The intervention was the e-Chasqui web-based laboratory information system. Main outcome measures were: times to communicate a result; to start or change a patient's treatment; and for that patient to culture convert.Results1671 patients were enrolled. Intervention HCs took significantly less time to receive drug susceptibility test (DST) (median 11 vs. 17 days, Hazard Ratio 0.67 [0.62–0.72]) and culture (5 vs. 8 days, 0.68 [0.65–0.72]) results. The time to treatment was not significantly different, but patients in intervention HCs took 16 days (20%) less time to culture convert (p = 0.047).ConclusionsThe eChasqui system reduced the time to communicate results between laboratories and HCs and time to culture conversion. It is now used in over 259 HCs covering 4.1 million people. This is the first randomized controlled trial of a laboratory information system in a developing country for any disease and the only study worldwide to show clinical impact of such a system.Trial RegistrationClinicalTrials.gov NCT01201941

Highlights

  • Diagnosis and management of many diseases requires prompt, reliable access to laboratory investigations

  • Multi drug resistant Tuberculosis (MDR-TB) is an increasingly common, dangerous and highly infectious disease where diagnosis and management is critically dependent on laboratory testing

  • In 2010 the World Health Organization (WHO) and the Global Fund for AIDS, Tuberculosis and Malaria planned to expand the number of patients on drug resistant tuberculosis treatment annually from 30,000 to 450,000 by 2015

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Summary

Introduction

Diagnosis and management of many diseases requires prompt, reliable access to laboratory investigations. Inaccurate or lost data can put patients at risk and lead to increased costs through duplicate testing [1] and late stage management of disease. This is important in infectious diseases where untreated patients can pose a risk to family and community. In 2010 the World Health Organization (WHO) and the Global Fund for AIDS, Tuberculosis and Malaria planned to expand the number of patients on drug resistant tuberculosis treatment annually from 30,000 to 450,000 by 2015 This expansion will require over US$15 billion. The objective of this study was to evaluate the impact of a laboratory information system in reducing delays and the time for MDR-TB patients to culture convert (stop transmitting)

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