Reducing Communication Delays and Improving Quality of Care with a Tuberculosis Laboratory Information System in Resource Poor Environments: A Cluster Randomized Controlled Trial

<div><p>Background</p><p>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).</p><p>Methods</p><p>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.</p><p>Results</p><p>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).</p><p>Conclusions</p><p>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.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="http://clinicaltrials.gov/show/NCT01201941" target="_blank">NCT01201941</a></p></div

Flow of samples, results, and MDR treatment requests and plans within the Peruvian National TB Program.

<p>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.</p

Primary and secondary outcomes.

<p>Figures are median number of days and IQR in parentheses except for DST laboratory TAT >60 days, which is percentage and absolute value in parentheses.</p

Characteristics, outcome measures, and sample sizes for all study health centers (HCs) and participants.

<p>For characteristics, values are mean (SD) unless stated otherwise. The sample sizes are shown for both the control/intervention, as well as for before and after the implementation of e-Chasqui.</p

Flow of participants, cultures and DSTs through trial.

<p>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.</p

Univariate, time-varying Cox proportional hazards analysis of aggressive regimen and time to death.

1<p>Continuous variable, mean (standard deviation) presented.</p>2<p><18.5 in women; <20 in men; or malnutrition established clinically.</p>3<p>≤30% in women; ≤36% in men; when missing, also used hemoglobin ≤10 in women and ≤12 in men.</p>4<p>Dyspnea; resting respiratory rate greater than 26/minute.</p>5<p>Resistance to the following 12 drugs or drug classes was tested: capreomycin, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin or amikacin, PAS, pyrazinamide, rifampicin, streptomycin, first-generation fluoroquinolones (ciprofloxacin, ofloxacin), and later-generation fluoroquinolones (gatifloxacin, levofloxacin, moxifloxacin).</p>6<p>Isolate resistant to at least isoniazid, rifampin, fluoroquinolone, and injectable (kanamycin, capreomycin, or amikacin).</p>7<p>This includes the following comorbidities: cardiovascular disease (12), diabetes mellitus (18), hepatitis or cirrhosis (10), epilepsy/seizures (11), renal insufficiency (7), psychiatric disorder (116), ever smoked (66), ever used/abused alcohol or other substance (52).</p

Distribution of covariates at initiation of ITR.

1<p>Continuous variable, mean (standard deviation) presented.</p>2<p><18.5 in women; <20 in men; or malnutrition established clinically.</p>3<p>≤30% in women; ≤36% in men; when missing, also used hemoglobin ≤10 in women and ≤12 in men.</p>4<p>Dyspnea; resting respiratory rate greater than 26/minute.</p>5<p>Resistance to the following 12 drugs or drug classes was tested: capreomycin, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin or amikacin, PAS, pyrazinamide, rifampicin, streptomycin, first-generation fluoroquinolones (ciprofloxacin, ofloxacin), and later-generation fluoroquinolones (gatifloxacin, levofloxacin, moxifloxacin).</p>6<p>Isolate resistant to at least isoniazid, rifampin, fluoroquinolone, and injectable (kanamycin, capreomycin, or amikacin).</p>7<p>This includes the following comorbidities: cardiovascular disease (12), diabetes mellitus (18), hepatitis or cirrhosis (10), epilepsy/seizures (11), renal insufficiency (7), psychiatric disorder (116), ever smoked (66), ever used/abused alcohol or other substance (52).</p

Multivariable, time-varying Cox proportional hazards analysis of aggressive regimen and time to death.

<p>Multivariable, time-varying Cox proportional hazards analysis of aggressive regimen and time to death.</p

Treatment outcomes of 669 patients enrolled in individualized treatment for MDR-TB in Peru between February 1999 and July 2002. (Adapted from Mitnick et al., 2008) [20].

<p>Treatment outcomes of 669 patients enrolled in individualized treatment for MDR-TB in Peru between February 1999 and July 2002. (Adapted from Mitnick et al., 2008) <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0058664#pone.0058664-Mitnick2" target="_blank">[20]</a>.</p