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TB diagnosis in India: how a diagnosis is delayed

By Madhukar Pai | 19 Jul, 2016

By R Prasad, The Hindu

URL http://www.thehindu.com/opinion/op-ed/tuberculosis-in-india-how-a-diagnosis-i...

Studies suggest an urgent need for the TB programme to engage with private doctors and change their empirical approach in dealing with the disease.

Tuberculosis (TB) patients in India who seek care in the private sector face a delay of as long as two months before they are diagnosed correctly — if at all — according to systematic reviews of Indian studies. This is alarming, as TB patients begin their pathway to care in the private sector before they get treated in the public sector. But despite the huge challenges posed by the private sector in TB diagnosis and treatment, only anecdotal evidence is available to explain the delay. Two studies published recently by Andrew McDowell, a medical anthropologist, and Madhukar Pai, a TB expert, from the McGill International TB Centre, McGill University, Canada, provide the much-needed insights into the cause of delay.

Besides interviewing private practitioners holding MBBS degrees and those practising alternative medicine such as Ayurveda, Unani and homeopathy, Dr. McDowell also conducted observations in the clinics of some of the doctors who were earlier interviewed, to understand the nuances of doctor-patient interactions including diagnostic or referral recommendations, prescriptions, and final diagnosis.

Experimenting with antibiotics
One study of 175 practitioners of Indian medicine published in the Transactions of the Royal Society of Tropical Medicine and Hygiene in March 2016 involved 400 interviews and 208 hours of observation, and 2,000 observed patient interactions in 10 clinics in Mumbai. One of the highlights of this study was that none of the 175 practitioners exclusively practised their system of training. While allopathic medicines, including antibiotics, were prescribed for acute conditions, the physicians generally prescribed their system of medicine for chronic conditions.

Though all the physicians reported seeing at least one patient with typical TB symptoms for more than two weeks in the preceding year, the patient had to visit a doctor several times before he or she was suspected of having TB. The patients were treated with broad-spectrum antibiotics and other symptomatic drugs during the first few visits. Different antibiotics were prescribed during each visit. This process of experimentation using antibiotics usually lasted 10-14 days.

Though fever is common and not very specific to TB, and more than two weeks of cough is one of the main symptoms of TB, no physician ever asked for lab investigation on the first visit. Instead the focus was in managing symptoms using non-specific therapies.

Though an X-ray should be used as a screening tool and sputum smear or GeneXpert as confirmatory tests, only 31 practitioners asked for sputum smear and only after conducting blood tests and a chest X-ray.

The good news is that 164 of the 175 AYUSH practitioners preferred to refer the TB patients to the public sector or to a chest physician and not treat the patients themselves. “Not treating TB patients could be due to a number of factors including uncertainty about treatment protocol, fear of MDR-TB, stronger messaging by RNTCP, fear of being exposed to TB themselves, and a desire to protect other patients in the waiting room from TB exposure,” Dr. McDowell says.

However, some AYUSH practitioners did treat the TB patients who left the public sector. What is alarming is that about 5 per cent (nine AYUSH practitioners) used at least one second-line TB drug when treating drug-susceptible TB. “The key problem is that testing for resistance is very low. It would be unfair, however, to say that this issue is limited to AYUSH practitioners,” Dr. McDowell says. Adds Dr. Pai: “AYUSH doctors should not be treating any form of TB, and definitely not be using second-line anti-TB drugs.”

Lack of diagnostic tests
The second study was published in April 2016 in the International Journal of Tuberculosis and Lung Disease. It found private doctors using fever as a diagnostic criterion for TB due to “ubiquity of cough and paucity of sputum production by patients”. This study of 110 private doctors (MBBS and AYUSH) in Mumbai and Patna involving 143 interviews and 150 clinical observations in seven clinics found doctors from all systems of medicine treating patients symptomatically based on patient history and clinical observation without asking for diagnostic tests.

Patients were asked for a chest X-ray and other lab tests when some doctors suspected TB, but “often after months of fever”. Even when patients had a history of cough, none of the practitioners of alternative medicine suspected TB on the first visit. “I will not think TB unless the problem persists for some time despite treatment,” one practitioner told the authors.

This empirical approach not only leads to delay in diagnosis and increase in the spread of TB but also exposes the patients to a broad-spectrum of needless antibiotics. Using drugs, particularly quinolones and amoxicillin-clavulanate, as diagnostic tools adds to the delay in diagnosing TB as they tend to temporarily mask symptoms such as cough, fever, or sputum production. As the patients are poor and need immediate relief, the only way to reduce experimentation with antibiotics is to work to reduce the cost of TB diagnostic tests.

The study reveals that the uptake of sputum smear testing is low in the private sector because it only confirms what the X-ray already suggests. Moreover, an X-ray presents a broader set of information about what is happening in the patients’ lungs.

The study found three reasons why doctors choose the ‘treat with antibiotics and wait’ approach while dealing with TB patients. First, there is a compulsion to provide rapid symptom relief; there is a risk of losing patients, especially when diagnostic tests are asked for during the first visit; there is the factor of financial capability of patients; and there is an easy availability of antibiotics. Second, there is a lack of clear and unique TB symptoms besides TB’s slow onset and progression. Finally, doctors perceive that many TB patients come without a cough or do not produce sputum.

These studies suggest the urgent need for the Indian TB programme to engage with private providers (allopathic and AYUSH) and change their traditional, empirical approach to dealing with TB. Ordering a chest X-ray early, a greater use of sputum TB tests (especially GeneXpert), and greater linkages and referrals to the public sector would be key issues for behaviour change management.

Replies

 

Nathan Chimbatata Replied at 9:23 PM, 19 Jul 2016

Thanks for such a great resource from India on TB diagnosis delay. I also conducted a cross sectional study in the northern part of Malawi recently on TB diagnosis delay. The preliminary findings show patient delay as a result of long queues in the public sector health care facilities and the patients rush to private sector which in most cases do not have the diagnostic capacity for TB. Besides this, practitioners take history of cough in many patients as just mere cough and subject patients to long courses of antibiotic treatment without requesting for further diagnostic investigation. This delays TB diagnosis in the process.

Nathan Chimbatata,
Fudan University,
PR China.

Dr Shanta Ghatak Replied at 2:35 AM, 20 Jul 2016

Nice and kind of you to share .

Mahesh Gautam Replied at 1:46 AM, 23 Jul 2016

Thank you for such an insightful article. Coming to a diagnosis of tuberculosis in pediatric age group is much more delayed in our setup.

Madhukar Pai Replied at 9:35 AM, 23 Jul 2016

Thank you for the responses. This problem of empirical antibiotic therapy and delayed diagnosis is not unique to India. Please see this systematic review which included studies from all over the word:

http://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-8-15

In this review, the authors conclude:

"The core problem in delay of diagnosis and treatment seemed to be a vicious cycle of repeated visits at the same healthcare level, resulting in nonspecific antibiotic treatment and failure to access specialized TB services. Once generation of a specific diagnosis was in reach, TB treatment was initiated within a reasonable period of time."

Our work in India using simulated or standardized patients (http://www.letstalktb.org/wp-content/uploads/2015/11/Das-Lancet-ID-2015.pdf) shows that providers often know that they should be testing for TB, but still prefer to try multiple rounds of non-specific therapies and wait it out, before testing for TB. So, shortening this long pathway to diagnosis should be a key priority for TB control, since the transmission consequences are worrisome.

Gurpal Bindra Replied at 9:57 AM, 23 Jul 2016

gr8 discussion. what are the logistics of gene sputum test in terms of
sample collection transportation,accuracy of test performance and delivery
to patient of test result.
what is the feasibility of mass screenings in communities with epidemic
overlay using sputum test?

Gurpal Bindra Replied at 10:03 AM, 23 Jul 2016

could there be a system where a pt could get a test without a visit to md
in conjuction with public health awareness rollout to avoid stigmatization
with the illness. if positive be directed to appropriate care to expediate
the process as the healthcare system is already overstreched. some ques
from how the hiv epidemic was controlled?

Madhukar Pai Replied at 10:12 AM, 23 Jul 2016

Mass screening: no data to support that, and cost-effectiveness is a big issue.

But there is definitely a need for a simple, low-cost, triage test that can be done at the community level. All those who are positive can then be referred to the next level for confirmatory TB testing.

A target product profile for such a triage test is published: http://www.who.int/tb/publications/tpp_report/en/

For now, a chest x-ray is the best triage test we have and should be used early in the pathway, where available, to then refer those with abnormal CXR for GeneXpert. Unfortunately, x-ray hardware is expensive and access is limited outside of urban areas and district level centers. But, where available, CXR is a great screening option. See WHO fact sheet on this: http://www.who.int/tb/publications/Radiography_TB_factsheet.pdf

SHAMEER KM Replied at 10:16 AM, 23 Jul 2016

Hi Sir,
The problem with delay in diagnosing TB in India is related to practitioners mind set. Most of the practitioners,if the condition of patient is beyond the control of their practice, still they are trying to give various medications to patients.
Benefits to practitioners
1. Prescription profit from pharmacy
2. Patient is a long term customer if it is chest diseas, they all happy.
Expectations of patient.
1. They expecting a Medicine from a practitioner, before actual diagnosis made.

Minimise the pathway means, patient - physician must compromise many things..
I am not sure, that will happen or not.
These are my observational view's from the Rural Reality in India.

Gurpal Bindra Replied at 10:32 AM, 23 Jul 2016

Dr. Pai you are spot on but for a cxr to be positive the disease has
progressed significantly. what are the costs involved with gene sputum test
and are you aware of any testing where testing can be ported to at risk
population.like the stool guiac test

Ariful Basher Replied at 2:19 PM, 23 Jul 2016

I am not totally agree with the findings . One problem is our patient knowledge and treatment seeking behaviour. I have seen many patients had taken antibiotics days after days from public hospital out door services. Our problem is our policy . In Bangladesh any antibiotics can sell by pharmacist without any registered doctor prescription. Village pharmacist or quack or traditional doctors who had no qualification except some experience can prescribe any drugs . Interestingly they are more intimate to local people then registered doctor. pharmaceutical company also give some honorium for promoting their drugs. We should break this chain other use misuse and delayed can not be prevented.

Now came to the point , why some times really delay in confirmation because we have had a lot of patients associated with sequelae who
need medical treatment for many symptoms. We also have a lot of patients diagnosed as an extra pulmonary tuberculosis where diagnosed is usually based on histological findings and treatment duration was based on expert opinion. Gen Xpert is not a good test for follow up. I have seen many patients no clinical improvement but Rif is still sensitive. some patients presented with extensive tuberculosis or with so many complications that predict nonresponsive to CAT-1 tuberculosis drugs. Many PTB patients prescribing anti TB later diagnosed bronchial ca. . Many CAT-1 non responsive patients presented with so many chest complication like fibrosis, bronchectasis, collapse,cavity etc that was difficult to consider whether patients still have tuberculosis especially when existing facilities failed to identify. Lymph node or wound infection tuberculosis generally difficult to identify the bacilli are many times non responsive to usual tuberculosis treatment regimen. Unjustified or misuse of tuberculosis drugs are not uncommon
especially when clinician failed to correlate the patients situation and guideline suggestions. Many bone or spine tuberculosis patients had history taking anti tuberculous drugs more than two years with little improvement. I pointed out the problems of complicated presentation of tuberculosis where extensive investigations and judicious chosen of regimen are needed.

Tom Yates Replied at 3:21 AM, 24 Jul 2016

Dear Madhu,

Great article. I wonder if we need both a short term and a long term plan.
In the short term, clearly small private sector providers are going to be a
large part of the Indian healthcare sector. I know lots of smart people are
thinking about how best to work with the private sector to address the
issues you describe in your article.

However, in the long term, the solution probably lies in free universal
healthcare provided by a single provider (the government). We know such
systems are more efficient, more equitable, and easier to regulate. There
is clearly some (inevitable) conflict between supporting the private sector
in the short term and wishing that it ceases to exist in the long term.

I have heard a lot less about how people see the Indian healthcare system
evolving over the next 10-20 years. What we probably need is serious
investment to make public hospitals places doctors wish to work and
patients wish to attend. What we see is Harsh Vardhan spouting empty
platitudes from the podium at the 2014 Union Conference then returning home
to cut the health budget by 20%. I'd be interested to hear of any advocacy
being undertaken on these longer term issues.

Kunjan Acharya Replied at 5:13 AM, 24 Jul 2016

Good one

Madhukar Pai Replied at 10:01 AM, 24 Jul 2016

Thanks for the vibrant discussion.

Yes, lack of regulation of private sector, and poor regulation of antibiotics definitely contributes to the private sector provider practices we find. India has an astounding number of practitioners who have little or no medical qualifications. This new report on the healthcare work force is getting a lot of attention: http://www.who.int/hrh/resources/16058health_workforce_India.pdf?ua=1 In addition, it is so easy to get antibiotics over-the-counter, and pharmacists also serve as de facto healthcare providers. They also contribute to TB diagnostic delay by dispensing non-specific therapies.

Re Tom's point, there is no question that the public health system needs to be strengthened. But I do not see this as public versus private - regardless of where patients go, they need quality TB care (see
http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(14)70198-6/ful...). On paper, India does offer free TB (and general) healthcare, but the system is weak, and patients are making deliberate choices re seeking private or informal care.

I fully agree about the need for greater advocacy for country governments to invest more in TB care, and in healthcare as such. Here is our piece around Prime Minister Modi's visit to the US Congress, where we made the point about the critical need for India to increase their investment in health and TB control: http://www.huffingtonpost.in/dr-madhukar-pai/tb-elimination-india-can-_b_1033...

Frederick Dun-Dery Replied at 12:54 PM, 24 Jul 2016

This a great article and an invaluable revelation into the slacking progress in controlling and preventing infectious diseases, especially in many developing countries. I believe this situation is not just typical to India but perhaps even worst in other countries, and even possibly in some public hospitals as well.

The promptness and accuracy in diagnosing and treating many antibiotic-related infections could be suffering this same fate in many health facilities across the globe. More of such work needs to be done to save the situation.

Thank you for sharing.
Fred

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