Why India Must Differentiate Between Normal And High-Risk TB Patients

He was underweight, had a high white blood cell count indicating severe infection, and a higher than normal pulse rate. Ramesh is also diabetic, and his blood sugar level was above normal.

The comprehensive evaluation confirmed that Ramesh had severe tuberculosis, for which he was prescribed nutritional supplements and medicine. A week’s stay in the hospital helped get his diabetes in check and bring back his appetite. Close to two months later, when IndiaSpend spoke with Ramesh, he had gained 2 kg and was feeling much better.

We asked Ramesh what might have happened if he hadn’t been admitted to a hospital, but instead, as is usually done across India, he had been administered the first dose of medicine by the tuberculosis field supervisor and sent back home with a promise to handhold him through the following doses?

“I may not have made it,” said Ramesh.

Ramesh’s prediction is spot on. While the timing of tuberculosis mortality has not been extensively documented in India, this 2022 study conducted in Karnataka found that half of the early TB fatalities (that is, TB patients who succumbed within two months of diagnosis) occurred in the first fortnight after diagnosis. Another 2011 study conducted in Andhra Pradesh concluded that 28% of TB patients succumbed in the first two months of treatment.

Extrapolating the AP study’s conclusions to India would mean that around 138,000 deaths of the 493,000 yearly estimated toll of TB would have occurred soon after those patients were diagnosed, simply because they weren’t offered more than free medicine.

Why is differentiated TB care essential

Globally, diagnostic delays, the progression of TB to severe disease and delayed care-seeking have been recognised as the key reasons for early (within two months) TB deaths. Ramesh was fortunate to have been a beneficiary of a differentiated TB care initiative of the state government of Tamil Nadu. Tamil Nadu Kasanoi Erappila Thittam (TN-KET, meaning TB death-free project in Tamil), a non-funded state-wide (excluding Chennai) initiative implemented in routine operational settings using the available health workforce, is India’s first such project, and began in April 2022.

Conceptually, differentiated TB care means “identifying high-risk patients and linking them to additional care to improve their treatment outcomes”, Venkatesh Roddawar, from JSI (John Snow, Inc.), a health consulting firm, and Project Director, Tuberculosis Implementation Framework Agreement (TIFA) in India, a five-year cooperative agreement funded by the U.S. Agency for International Development (USAID) to help countries build capacity to treat TB, told IndiaSpend.

During the January-March 2023 quarter, that is, after a year’s implementation of TN-KET in Tamil Nadu, nine out of 30 TB districts showed at least 20-30% TB death rate reduction among patients diagnosed when compared to the baseline, said Hemant Deepak Shewade, Scientist E, ICMR-National Institute of Epidemiology (ICMR-NIE), which is helping the state implement TN-KET.

It’s high time we offer differentiated TB care to every TB patient, said Anurag Bhargava, a professor at the Department of Medicine, Yenepoya Medical College. “If a patient with fever and cough is routinely evaluated for indicators of severity like breathlessness, low oxygen saturation, and low blood pressure, and advised hospitalisation if those are present, why shouldn’t similar screening for indicators of severity be done in patients with TB, which is causing lakhs of death every year in India? Differentiated care should always have been part of the TB programme because TB deaths are predictable as well as preventable.”

IndiaSpend reached out to R.P. Joshi, the deputy director general of tuberculosis, who heads the National TB Elimination Programme, for comment on the implementation of differentiated TB care in India. We will update this story when we receive a response.

Who are high-risk TB patients?

A demonstration by a resource person from JHPIEGO to community health officers, incharges of community health & wellness centres, of measuring the mid-upper arm circumference, which is an indicator of malnutrition, and helps detect high risk TB patients. This took place in October 2022 in Odisha.

In India, indicators of the severity of illness and criteria for hospitalisation of TB patients first found mention in a 2017 policy document that was drafted by a team led by Bhargava: Nutritional care and support for patients with tuberculosis in India. The document identified the criteria for hospitalising a TB patient as: “a body mass index less than 14 kg/sq m, haemoglobin less than 7 g/dl, oxygen saturation less than 94%, respiratory rate more than 24 per minute, systolic blood pressure less than 100 mm Hg, inability to stand without support, uncontrolled diabetes,” enumerated Bhargava.

These simplified criteria were used to triage patients in a large trial, the results of which were published in August 2023, and showed reduced mortality in TB patients who received nutritional support.

In the conventional sense, differentiated TB care involves providing medical services to high-risk patients in healthcare settings. However, an early pilot study on the concept, conducted in 2018, by the Karnataka Health Promotion Trust (KHPT), a not-for-profit working in the health sector, delivered a tailored package of outreach care and support in community settings, to high-risk groups in Karnataka and Andhra Pradesh.

The KHPT’s Differentiated Care Model defined high-risk patients as those with drug-resistant strains, those with HIV, those who had relapsed, those with diabetes, those living alone, those consuming alcohol and those of an advanced age.

“Community health workers were assigned the task of assessing patients, and to follow up with those meeting one or more of the criteria until their treatment outcome was clear,” explained K. Karthikeyan, Thematic Lead, Tuberculosis, KHPT.

By the time the programme concluded, we inferred that diabetes and living alone didn’t increase a patient’s chances of death/unfavourable outcomes, like the other presupposed factors, said Karthikeyan. “Also, we identified undernutrition as an independent risk factor for death and/or unfavourable outcomes.”

Piloting differentiated TB care in 11 districts

The Union government circulated guidelines for differentiated TB care in 2021, but has not published them with the other guidelines on the website of the Central TB Division. “In many states, the lack of a model to follow came in the way of implementing those guidelines”, says Roddawar. “The government (the National Tuberculosis Elimination Programme or NTEP) was aware of the situation on the ground and of the need to infuse confidence in those responsible for the delivery of services.”

So, on the request of the NTEP, JSI Research & Training Institute Inc.--through the USAID-funded TIFA project--is funding three organisations (Jhpiego, World Health Partners, and the William J Clinton Foundation India) that are, in turn, demonstrating differentiated TB care models across eight states identified as the neediest.

“TB diagnosis happens in primary, secondary as well as tertiary health facilities, albeit with a difference,” observed Roddawar, who heads this USAID TIFA project in India. “While the patient assessment forms that underlie differentiated treatment can easily be made available in all of these settings, not every facility has access to advanced investigations.”

At the outset, the three organisations assessed the availability of essential diagnostics, therapeutics, and human resources for providing differentiated TB care, continued Roddawar. “Thereafter, they plugged the gaps in diagnostic and therapeutic capacity. They also built risk assessment and referral systems for diagnostics and services, and trained those interacting with TB suspects and patients in risk assessment and in conducting investigations to identify high-risk patients.”

In six months of implementing differentiated TB care in three (of 16) blocks in Muzaffarpur (Bihar), the district TB officer Chandrajit Kumar Das told IndiaSpend that the death rate had fallen from 3.5% in the previous year to less than 1% now.

“Measuring all 16 health parameters (11 symptoms and five biochemical investigations) of tuberculosis patients at the time that they are diagnosed (baseline) helps treat them accordingly and manage their comorbidities through follow-up visits to the clinic, this pushes down the death rate and ensures very few patients need to be hospitalised,” said Das.

Anil Shukla, district TB officer for Chhattisgarh’s Durg, another district where differentiated TB care is being demonstrated, feels that the close follow-up needed to reduce the death rate mandates more trained workers on the ground than are presently available under the TIFA project.

“Assessing the 16 parameters of patients is easily doable especially now that our workers are trained, but active case finding, monitoring positive cases and counselling are human-resource-intensive tasks,” he said. “Doubling the workers assigned to the task would definitely help deliver the desired result.”

Role of technology in differentiated TB care

If the assessment process is too cumbersome, it is unlikely to be easily assimilated in the existing modus operandi of the TB programme, our reporting showed. While Tamil Nadu’s differentiated TB care initiative relied on paper forms, the 11 districts being supported under the TIFA project are being supported with technology tools, Roddawar said. One district each in Madhya Pradesh, Meghalaya and Odisha is using a mobile application (TB Triage) to record patient data, identify high risk cases and suggest appropriate referrals. In four districts in Uttar Pradesh, high risk patients are being followed-up and counselled by a team operating a call centre, he explained.

In districts Jagatsinghpur in Odisha, Ri Bhoi in Meghalaya and Bhopal in Madhya Pradesh, telemedicine and tele-consultations using eSanjeevani platforms--a telemedicine facility developed by the government--are enabling remote consultations between healthcare providers and TB patients, reducing the need for physical visits to healthcare facilities.

The use of digital tools is in line with the NTEP’s Ni-kshay system, which enables the digital capture of health records and facilitates looking-up patient data.

Challenges in implementing differentiated TB care in Tamil Nadu

Tamil Nadu’s top challenges in implementing differentiated TB care have been training, a heavy load on medical colleges and introducing special feeds for very severely malnourished TB patients who are now being systematically detected as a result of triaging.

“We had set districts a 90-90-90-7 target, that is, at least 90% of adults with TB diagnosed from public hospitals should be triaged, at least 90% triage-positive must be comprehensively assessed and confirmed as severely ill in the nodal inpatient facility and at least 90% of confirmed severely ill patients should be admitted for at least median seven days,” said Shewade of ICMR-NIE, which is helping the state implement TN-KET.

While the state met the 90-90-90-7 target in March 2023 and also saw a reduction in the TB death rate in some districts, many districts achieved the target but have yet to see a reduction in the TB death rate. Shewade attributes this to deficiencies in the quality of triaging and comprehensive assessment.

“Training is the cornerstone of quality triaging among adults with TB and of comprehensive assessment among triage-positive cases,” he said. “So, we conduct quarterly orientation/reorientation calls with the districts, supportive supervision visits to the districts and routine state level reviews. It is an ongoing effort. If we focus and improve the quality over time, we are hopeful to reduce the TB death rate at the state level soon.”

Under TN-KET, triage-positive patients with a higher total score after comprehensive assessment, those with very severe undernutrition and those requiring high dependency unit /ICU care support were mandated to be admitted in medical colleges.

Other patients were mandated to be admitted to the nearest nodal inpatient care facility--the medical college in the district, the district headquarters hospital or a sub-district hospital with a chest specialist or medicine specialist.

So far, 60% admissions under TN-KET have been to medical colleges, which is “undesirable because it affects the quality of care and reduces the duration of hospitalisation” because of the load on medical colleges, said Shewade. “We’d like to spread out the admissions more evenly across every available facility.”

Tamil Nadu’s experience has been that of 100 adults with TB, 13-15 are triage-positive and of those, five-six have very severe undernutrition, said Dr Shewade. Essentially, half of the admitted patients have very severe undernutrition. Such patients have very poor appetite, don’t tolerate a solid diet and must be stabilised with therapeutic nutrition (liquid formula feed) during their first week in hospital before they can be put on a high protein TB diet, he said.

Therapeutic nutrition costs about Rs 400 per patient per week and can be easily prepared in hospital kitchens using commonly available ingredients. “So far 12 districts are providing therapeutic nutrition in at least one of the district’s hospitals,” said Shewade. “We need to expand this to all the districts.”

On a broader level, India must accept that no two TB cases are similar and hence, differentiated TB care is vital to reduce TB mortality. Hopefully, the experience of pioneering districts and states will pave the way to that ideal, experts say.

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