Clinical standards for the diagnosis, treatment and prevention of TB infection

Abstract

BACKGROUND: Tuberculosis (TB) preventive therapy (TPT) decreases the risk of developing TB disease and its associated morbidity and mortality. The aim of these clinical standards is to guide the assessment, management of TB infection (TBI) and implementation of TPT.METHODS: A panel of global experts in the field of TB care was identified; 41 participated in a Delphi process. A 5-point Likert scale was used to score the initial standards. After rounds of revision, the document was approved with 100% agreement.RESULTS: Eight clinical standards were defined: Standard 1, all individuals belonging to at-risk groups for TB should undergo testing for TBI; Standard 2, all individual candidates for TPT (including caregivers of children) should undergo a counselling/health education session; Standard 3, testing for TBI: timing and test of choice should be optimised; Standard 4, TB disease should be excluded prior to initiation of TPT; Standard 5, all candidates for TPT should undergo a set of baseline examinations; Standard 6, all individuals initiating TPT should receive one of the recommended regimens; Standard 7, all individuals who have started TPT should be monitored; Standard 8, a TBI screening and testing register should be kept to inform the cascade of care.CONCLUSION: This is the first consensus-based set of Clinical Standards for TBI. This document guides clinicians, programme managers and public health officers in planning and implementing adequate measures to assess and manage TBI.

Figure 1

Algorithm to exclude TB disease before initiating TPT. *For adults and adolescents, including PLHA, a four-symptom screening of cough, fever, weight loss or night sweats is recommended. For infants and children living with HIV/AIDS and/or in contact with a person with infectious TB disease, screening for poor weight gain/loss of weight, fever, cough, decreased playfulness, symptoms of extrapulmonary TB (e.g., mass in neck, lethargy/sleepiness, vomiting) is recommended. ^†CXR should be performed but lack of CXR should not be a barrier to initiating TPT in resource-limited settings. ^‡TST or IGRA if available is ideal to identify PLHA who might benefit most from TPT. ^§Patients should also be investigated for other diseases such as malignancies which have similar constitutional symptoms with TB disease. If clinical suspicion for TB disease is high but investigations are negative, a specialist may be consulted to determine if the patient should be empirically started on anti-TB treatment. In the event that TB disease is excluded, PLHA and household contacts ≤5 years old should be considered for TST/IGRA screening and TPT. TPT = TB preventive therapy; PLHA = patients living HIV/AIDS; TST = tuberculin skin test; IGRA = interferon-γ release assay; CXR = chest X-ray.

Figure 2

Cascade of care for TB prevention. TPT = TB preventive therapy. Created using Biorender (BioRender.com).

Figure 3

Indicators for TBI screening and elements of the TBI register. Children under 5 years of age and PLHA may not have had a test before TBI treatment initiation. The TBI treatment uptake here would be number of persons who initiated TPTover persons eligible for TBI in this age group. *Patients eligible for TBI testing can opt-out of the TBI register; ^†Patients who reactivate TB disease after or during TBI treatment should be linked to the national TB surveillance. TBI = TB infection; TPT = TB preventive therapy; PLHA = patients living HIV/AIDS.