Reducing communication delays and improving quality of care with a tuberculosis laboratory information system in resource poor environments: a cluster randomized controlled trial

Joaquín A Blaya, Sonya S Shin, Martin Yagui, Carmen Contreras, Peter Cegielski, Gloria Yale, Carmen Suarez, Luis Asencios, Jaime Bayona, Jihoon Kim, Hamish S F Fraser, Joaquín A Blaya, Sonya S Shin, Martin Yagui, Carmen Contreras, Peter Cegielski, Gloria Yale, Carmen Suarez, Luis Asencios, Jaime Bayona, Jihoon Kim, Hamish S F Fraser

Abstract

Background: Lost, 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).

Setting: 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.

Results: 1671 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).

Conclusions: The 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 registration: ClinicalTrials.gov NCT01201941.

Conflict of interest statement

Competing Interests: The authors have the following interests: Joaquín A. Blaya is founder and shareholder of eHealth Systems, Santiago, Chile. This company implements and provides services for open source health information systems such as OpenMRS. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Figure 1. Flow of samples, results, and…
Figure 1. Flow of samples, results, and MDR treatment requests and plans within the Peruvian National TB Program.
TB microscopy is carried out at point of care health centers, and smear positive samples are only referred for DST if there are risk factors for MDR TB.
Figure 2. Flow of participants, cultures and…
Figure 2. Flow of participants, cultures and DSTs through trial.
The Pre-intervention groups represent baseline data collection prior to the RCT which was used to correct for baseline differences between sites during the analysis. Cx is sputum culture, DST is drug sensitivity test.

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