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Multicenter Study
. 2017 Jul 1;21(7):746-752.
doi: 10.5588/ijtld.16.0699.

Feasibility of a streamlined tuberculosis diagnosis and treatment initiation strategy

P B Shete  1 , T Nalugwa  2 , K Farr  1 , C Ojok  2 , M Nantale  2 , P Howlett  3 , P Haguma  2 , E Ochom  2 , F Mugabe  4 , M Joloba  5 , L H Chaisson  6 , D W Dowdy  6 , D Moore  3 , J L Davis  7 , A Katamba  2 , A Cattamanchi  1
Affiliations
Multicenter Study

Feasibility of a streamlined tuberculosis diagnosis and treatment initiation strategy

P B Shete et al. Int J Tuberc Lung Dis. .

Abstract
in English, French, Undetermined language

Objective: To assess the feasibility of a streamlined strategy for improving tuberculosis (TB) diagnostic evaluation and treatment initiation among patients with presumed TB.

Design: Single-arm interventional pilot study at five primary care health centers of a streamlined, SIngle-saMPLE (SIMPLE) TB diagnostic evaluation strategy: 1) examination of two smear results from a single spot sputum specimen using light-emitting diode fluorescence microscopy, and 2) daily transportation of smear-negative sputum samples to Xpert® MTB/RIF testing sites.

Results: Of 1212 adults who underwent sputum testing for TB, 99.6% had two smears examined from the spot sputum specimen. Sputum was transported for Xpert testing within 1 clinic day for 83% (907/1091) of the smear-negative patients. Of 157 (13%) patients with bacteriologically positive TB, 116 (74%) were identified using sputum smear microscopy and 41 (26%) using Xpert testing of smear-negative samples. Anti-tuberculosis treatment was initiated in 142 (90%) patients with bacteriologically positive TB, with a median time to treatment of 1 day for smear-positive patients and 6 days for smear-negative, Xpert-positive patients.

Conclusion: The SIMPLE TB strategy led to successful incorporation of Xpert testing and rapid treatment initiation in the majority of patients with bacteriologically confirmed TB in a resource-limited setting.

OBJECTIF:: Evaluer la faisabilité d'une stratégie simplifiée pour améliorer l'évaluation du diagnostic et la mise en route du traitement de la tuberculose (TB) parmi les patients avec une présomption de TB.

SCHÉMA:: Étude pilote d'intervention à un seul bras dans cinq centres de soins de santé primaires d'une stratégie simplifiée, l'évaluation du diagnostic de TB sur un seul échantillon, SIngle-saMPLE (SIMPLE) : 1) examen de deux résultats de frottis d'un seul échantillon de crachats grâce à un microscope en fluorescence à LED, et 2) transport quotidien d'échantillons de crachats à frottis négatif vers les sites de test Xpert® MTB/RIF.

RÉSULTATS:: Sur 1212 adultes qui ont eu un recueil de crachats pour un test de TB, 99,6% ont bénéficié de deux frottis de l'échantillon de crachats examiné. Les crachats ont été transportés pour le test Xpert en moins d'un jour pour 83% (907/1091) des patients à frottis négatif. Sur 157 (13%) patients avec une TB à bactériologie positive, 116 (74%) ont été identifiés par microscopie de frottis de crachats et 41 (26%) par un test Xpert sur des échantillons à frottis négatif. Le traitement de TB a été initié chez 142 (90%) patients atteints de TB à bactériologie positive, avec un délai médian de traitement d'un jour pour les patients à frottis positif et de 6 jours pour les patients à frottis négatif, Xpert positif.

CONCLUSION:: La stratégie TB SIMPLE a abouti à une incorporation réussie du test Xpert et à une mise en route rapide du traitement chez la majorité des patients atteints de TB confirmée par bactériologie dans un contexte aux ressources limitées.

OBJETIVO:: Evaluar la factibilidad de dinamizar la estrategia de diagnóstico, evaluación e iniciación del tratamiento de los pacientes con presunción clínica de la tuberculosis (TB).

MÉTODO:: Se llevó a cabo un estudio preliminar de intervención con un solo grupo experimental en cinco centros de atención primaria, sobre la dinamización de la estrategia SIngle-saMPLE (SIMPLE) de evaluación y diagnóstico de la TB, que comportaba: 1) el examen con microscopio LED de fluorescencia de los resultados de dos baciloscopias a partir de una muestra inmediata única; y 2) el transporte diario de las muestras con baciloscopia negativa a otro centro con el fin de practicar la prueba Xpert® MTB/RIF.

RESULTADOS:: De los 1212 adultos en quienes se recogieron muestras de esputo para la investigación de la TB, en el 99,6% se examinaron dos frotis de una muestra inmediata. Las muestras se transportaron en el día de la consulta con el fin de practicar la prueba Xpert en el 83% de los pacientes con baciloscopia negativa (907/1091). De los 157 pacientes con TB confirmada bacteriológicamente (13%), 116 se detectaron mediante el examen microscópico del frotis (74%) y 41 mediante la prueba Xpert en las muestras con baciloscopia negativa (26%). El tratamiento de la TB en 142 pacientes con confirmación bacteriológica (90%) se inició en un lapso mediano de un día en los pacientes con baciloscopia positiva y 6 días en los pacientes con baciloscopia negativa y prueba Xpert positiva.

CONCLUSIÓN:: La estrategia SIMPLE de detección de la TB facilitó la incorporación eficaz de la prueba Xpert y la rápida iniciación del tratamiento en la mayoría de los pacientes con TB confirmada bacteriológicamente, en un entorno de escasos recursos.

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Conflict of interest statement

Conflicts of interest: none declared.

Figures

Figure 1.
Figure 1.
SIMPLE TB diagnostic algorithm. The SIMPLE TB algorithm calls for two smears from the spot sputum sample to be prepared and examined. Patients with a positive sputum smear should be initiated on treatment during their initial visit to the health center. Patients with two negative smears or with HIV infection should have the remainder of the spot sputum sample sent for Xpert testing. Patients with positive Xpert results should be started on treatment at their next visit to the health center. TB = tuberculosis; HIV = human immunodeficiency virus; SIMPLE = SIngle-saMPLE.
Figure 2.
Figure 2.
Overall tuberculosis diagnosis and treatment. The diagram describes the study flow and outcomes for patients using the SIMPLE strategy. Of 1212 patients evaluated for TB using the SIMPLE approach, 157 (13%) were microbiologically diagnosed. The majority of patients with bacteriological diagnosis were started on treatment (90%); however, same-day treatment was initiated in less than half of patients. *Treated for TB in the absence of a positive smear or Xpert result. TB = tuberculosis; SIMPLE = SIngle-saMPLE.
Figure 3.
Figure 3.
Adherence to the SIMPLE TB diagnostic algorithm. The diagram describes the flow of patients through the SIMPLE algorithm. Almost all patients referred for testing had two spot sputum smears examined, with results. Same-day treatment initiation for smear-positive patients and Xpert referral for HIV-positive patients had moderate fidelity of implementation (43%). The majority of smear-negative patients (83%) were referred for Xpert testing in 1 day. These results suggest that a facilitated TB diagnostic approach is feasible, particularly for smear-negative patients. TB = tuberculosis; HIV = human immunodeficiency virus; RIF = rifampin; MDR-TB = multidrug-resistant TB; SIMPLE = SIngle-saMPLE.
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References

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