New ICMR guidelines on COVID-19 misleading, point out doctors

Updated: May 26, 2020, 07:41 IST | Vinod Kumar Menon | Mumbai

They tell medicos to record cause of death as COVID-19 even if test report is negative, inconclusive, or even if it is awaited

A woman being tested for COVID-19 in the premises of the KEM Hospital. Pic/Suresh Karkera
A woman being tested for COVID-19 in the premises of the KEM Hospital. Pic/Suresh Karkera

Doctors are concerned about the Indian Council of Medical Research's (ICMR) latest guidelines asking them to record underlying cause of death as COVID-19, even if the test report is negative, or inconclusive, or if test report is awaited.

The doctors arguing these guidelines have cited medical text books and other supportive medical guidelines, which have clearly stated that if viruses test positive, only then they can be stated 'as cause of death.' For instance, an HIV infected person's test report coming positive for HIV will only then be reflected in the cause of death, and a negative HIV report will never be mentioned. The experts pointed out that a person 'dying with virus' and a person 'dying of virus' have a vast difference, but they claim that ICMR guidelines have also brought this under one umbrella.

Dr Indrajit Khandekar, professor of forensic medicine and toxicology, Mahatma Gandhi Institute of Medical Sciences (MIMS), Sewagram, Wardha has already sent an email to ICMR (copy with this newspaper) raising concern about writing the cause of death in the above conditions and has sought clarity on the same.

The guidelines
Issued on May 10, ICMR guidelines tell hospitals to record "clinically diagnosed" or "probable" or "suspected" COVID as underlying cause of death even when the laboratory test is negative or inconclusive or awaited respectively. "This means that COVID-19 should be reported as a underlying cause of death where the disease caused, or is assumed to have caused, or contributed, without a confirmed laboratory test," explained Dr Khandekar.

"Thus, if no testing is done and a patient dies with an infection having symptoms close to the seasonal flu or vaguely COVID-19-like, then that person's death automatically will be attributed to COVID-19," Dr Khandekar noted.

"Doctors were never asked to follow such practices for other viral deaths, and we were mainly asked to focus on "precision and specificity," while writing the cause of death but COVID death certification guidelines run completely counter to well-established and followed dictum since long. These new guidelines are expected to result in COVID-19 being the underlying cause more often than not and the same will inflate the numbers of COVID deaths and could mislead the public about the actual number of these deaths," said Dr Khandekar.

Dr Khandekar cited a recent example of a 64-year-old resident of Wardha, who visited a private hospital with a complaint of chest pain. The doctor prescribed some medicine, but the next day, he returned with chest pain and breathlessness, and died before admission. The treating doctor, wrote a note, 'COVID-19 suspected,' and directed the relatives to travel 50 kms to MIGMS medical college, to take nasal swabs to rule it out. Asked by the medical college professor, the private practitioner stated that the deceased had no symptoms other than breathlessness, and as a precautionary measure he wanted to get the swab tested. The test was negative. "This misdiagnosis left the family stressed," said Dr Khandekar.

'Every death not COVID-19'
Mumbai-based Dr Wiqar Shaikh, senior allergy and asthma specialist, shared a similar view saying, "There are 3,500 ailments which could lead to death, in the medical text books. Every death today cannot be labelled as a COVID death. There are 27,000 deaths registered in India per day and all these deaths are due to other reasons – accidents, stroke, cardiac, heart attacks, kindey failure, HIV (AIDS), poisoning, suicides and homicides, etc."

The ICMR guidelines have also opened up a debate amongst clinical experts, as to whether the COVID-19 test is positive, with or without symptoms, and with or without comorbid health conditions such as heart ailment, diabetes, hypertension etc, then the patient's death can be labelled as 'due to COVID-19.' "However, if the test is negative, or the result is awaited or inconclusive, ICMR expects that such deaths should also be registered as a COVID death, which is a wrong practice," said Dr Shaikh.

"Already there is a lot of stigma attached to a COVID-19 suffering patient or a COVID death. So without having a conclusive positive test, it would be ethically and professionally wrong to label the victim as a COVID-19 death. The only way therefore, to confirm if the death was indeed due to COVID-19, is to have a clinical autopsy by a pathologist, and have the nasal and throat swabs examined," he added.

Dr Shaikh said, "We can presume that deaths prior to ICMR guidelines (May 10) where COVID was inconclusive, or negative, or results were awaited, doctors may not have labelled as due to COVID-19. This might have been started post the new directives, thereby bringing all India numbers of death to just over 4,021, and the real figures may not be known, unless ICMR issues modified guidelines for COVID-19 related deaths."

More confusion
A senior forensic expert from a medical college in Mumbai added, "We have come across many contradictions between ICMR and the BMC guidelines. ICMR states that a person dying at home or dying before admission at a hospital, the swab should be collected for testing, while BMC say that a dead person's swab is not be taken. But at ground level the dead person's swab is collected."

Moreover, ICMR says, that if a swab from a dead person is negative, then the body can be sent for a post-mortem to ascertain the cause of death, which again is a high-risk, as the first test may not be 100 per cent negative.

Purpose of noting the deaths

COVID-19 is a new disease. It's clinical presentation ranges from mild to severe, and fatality depends on the severity of the illness, associated co-morbid conditions and age of patients. Patterns of disease and death come from only standardised recording of clinical disease history and cause of death, and therefore epidemiological surveillance of disease and death are important. Data is needed from every district, state in India to measure public health impact of COVID-19 and plan timely health interventions and protect communities.

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