An extensive study conducted in four Indian cities to assess the diagnostic process and treatment for paediatric tuberculosis has revealed an alarming lack of uniformity in the utilisation of an innovative technology by physicians across the country.
The Xpert MTB/RIF system is a cartridge-based nucleic acid amplification test (NAAT) and automated diagnostic test that can identify mycobacterium tuberculosis (MTB) DNA and resistance to rifampicin (RIF). The high-sensitivity rapid molecular assay aides in antibiotic stewardship and reduces dependence on clinical diagnosis. However, an alarming diversity of Xpert prescription practices, despite clear guidance from Revised National Tuberculosis Control Programme (RNTCP), is a factor that demands immediate attention, say healthcare experts associated with the initiative.
The qualitative study, spearheaded by researchers from the Foundation for Innovation in New Diagnostics (FIND), the RNTCP and the World Health Organisation, was held in Delhi, Hyderabad, Chennai and Kolkata, covering a population of more than 30 million. Its results are pertinent as under-diagnosis remains a major obstacle in tackling childhood TB in the country. The details of the initiative are published in PLOS One, a peer-reviewed open access scientific journal.
The country is home to the largest number of people suffering from TB in the world and about 6 per cent of all notified cases in 2014 were children. Despite declines in the annual risk of TB infection in India, paediatric TB is a significant concern as it leads to substantial morbidity and mortality.
Xpert is a new test that is revolutionising TB control and upfront testing using the novel technology is recommended by the RNTCP for paediatric presumptive patients. The test, in one go, detects MTB and resistance to RIF in less than 2 hours. In comparison, standard cultures can take two to six weeks for MTB to grow and conventional drug resistance tests can add three more weeks.
After the WHO endorsement of Xpert in 2010, it is offered free of cost in India in the public sector and at a reduced and controlled price in parts of the private sector through various initiatives. According to RNTCP protocols, all paediatric presumptive TB cases should be offered upfront Xpert testing as it yields a high proportion of valid results and detection rates are more than three-fold higher than smear microscopy.
But the new report reveals that this is not always the case. A high-level of diversity exists in practices for diagnosis of TB in kids, even in the presence of evidence-based guidance.
“Considerable variety was observed with respect to placement for Xpert in the diagnostic process across different settings. This diversity was heavily influenced by the existing or past practices of the physicians. Many physicians continue to diagnose paediatric TB with reliance on Mantoux tuberculin skin test and radiology and used Xpert only for differential diagnosis in confusing cases. This is a notable divergence from WHO and RNTCP policies which recommend upfront Xpert testing for all paediatric presumptive TB patients,” the report pointed out.
“Diversity of practices is a matter of concern. More needs to be done to improve provider literacy and disseminate the evidence on newer diagnostics. Only when each paediatric presumptive TB patient is offered upfront Xpert testing that a more synchronised case management, same day diagnosis and access to accurate treatment can be guaranteed. Locating Xpert at the end of the diagnostic process or placing too many restrictions on the criteria of patients who can access it will limit its impact,” a medical professional associated with the initiative opined.
“The findings highlight the urgent need for concerted efforts to place Xpert early in diagnostic algorithms. A positive change may be possible with continued advocacy, time and increased access,” she added.
As part of the study, researchers conducted semi-structured interviews with as many as 55 health providers from public and private sectors. Providers were sampled from intervention data based on sector of practice, number of Xpert referrals and TB detection rates among referrals. Most providers reported that Xpert was an important tool for managing paediatric TB cases by providing upfront information on drug resistance, which is seldom suspected in children.