Thursday, February 21, 2019

A new protocol to diagnose life-threatening bacterial infections in infants: Will this change medical practice?

A new protocol, which measures the levels of bacteria in urine, serum procalcitonin and absolute neutrophil count may help to rule out life-threatening bacterial infections among infants up to 2 months of age who have fevers, potentially eliminating the need for spinal taps, unnecessary antibiotic treatments or expensive hospital stays, according to new research published online Feb. 18, 2019 in JAMA Pediatrics. 

Researchers from the Pediatric Emergency Care Applied Research Network (PECARN) developed the protocol from a prospective, observational study of 1821 infants seen at 26 emergency departments across the US.

The researchers ruled out a serious bacterial infection if tests showed low levels of bacteria and procalcitonin and a normal neutrophil count.

They were able to accurately rule out all but three of the 170 cases of serious bacterial infection ultimately detected, including all cases of meningitis. The rule sensitivity was 97.7%, specificity was 60.0% and negative predictive value was 99.6%. However, the authors note that their findings need to be verified in a larger sample before they can be applied to medical practice.

Previous studies suggest that 8 to 13 percent of infants up to 2 months of age who have a fever may have a serious bacterial infection (SBI). These include urinary tract infections, bacteremia (bacteria in the blood) and bacterial meningitis (bacterial infection of the membrane housing the brain and spinal cord). Often, a physician will need to confirm a diagnosis with a spinal tap (lumbar puncture), in which a small amount of fluid is extracted from the spinal canal. Although complications of the procedure are rare, they include inflammation of the spinal canal, bleeding and headache. In addition, an infant may be given antibiotics when a bacterial infection is suspected and may be admitted to a hospital for observation.

(Source: NIH; JAMA Pediatr. Published online February 18, 2019)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Dial 112 in any emergency

Is it really a Pan-India single emergency helpline number?

Sixteen states and Union territories have joined a pan-India network of the single emergency helpline number “112” on which immediate assistance can be sought by people.

The 16 states and UTs are Andhra Pradesh, Uttarakhand, Punjab, Kerala, Madhya Pradesh, Rajasthan, Uttar Pradesh, Telangana, Tamil Nadu, Gujarat, Puducherry, Lakshadweep, Andaman, Dadar Nagar Haveli, Daman and Diu, Jammu and Kashmir, a home ministry statement said.

The ERSS is an integration of police (100), fire (101), health (108) and women (1090) helpline numbers to provide emergency services through the single number “112”.

To access the emergency services, a person can dial 112 on a phone or press the power button of a smart phone three times quickly to send a panic call to the Emergency Response Centre. In case of a normal phone, a long press of the “5” or “9” key will activate the panic call function.

To ensure safety of women, a SHOUT feature has been introduced in ‘112 India’ mobile app to seek immediate assistance from registered volunteers in the vicinity apart from the immediate assistance from Emergency Response Centre. The SHOUT feature is exclusively available to women.

People can also log onto the ERSS website for the state and lodge emergency Email or send SOS alert to state ERC; they can use “112”' India mobile app, which is available free on Google Playstore and Apple store.

The single number for various emergency services is similar to the emergency number “911” in the US.

The question arises why only 16 states? Why can’t the government come out with an ordinance and make it an All-India number? 

There should be no politics when it comes to emergencies. 

Health care should be above politics as it is a matter of life and death.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Wednesday, February 20, 2019

Beware of fluoroquinolone antibiotics if your patient has high BP or

Avoid using fluoroquinolones (ciprofloxacin and levofloxacin) in patients with hypertension, Marfan syndrome and Ehlers-Danlos syndrome or a history of arterial blockages or aneurysms.

A US Food and Drug Administration (FDA) review found that fluoroquinolones can increase the occurrence of rare but serious events of ruptures or tears in the aorta, which can cause serious, sometimes fatal bleeding. Aortic dissections or ruptures of an aortic aneurysm can occur in people taking these antibiotics orally or by injection.

Because of this risk, the US FDA is advising doctors to try to avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with hypertension or peripheral atherosclerotic vascular diseases or certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome and elderly patients. Fluoroquinolones should be prescribed to these patients only when no other treatment options are available.

Patients are also advised to seek immediate medical care if they develop sudden, severe, and constant pain in the stomach, chest or back. 

The FDA issued a separate warning in July 2018, alerting people that fluoroquinolones could increase the risk of rapid fall in blood sugar (hypoglycemia) and certain mental health side effects such as disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.

In July 2016, the FDA had issued safety information about disabling side effects of the tendons, muscles, joints, nerves and central nervous system associated with fluoroquinolones; peripheral neuropathy in August 2013 and tendinitis and tendon rupture in July 2008.

In May 2016, the FDA restricted the use of fluoroquinolones in patients with acute sinusitis, acute bronchitis and uncomplicated urinary tract infections who have other treatment options.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Nida, a success story: Addressing social determinants of health to improve health equity

Nida came to us, at Samir Malik Heart Care Foundation Fund, in 2014, with complaints of breathlessness on exertion. She was born with an atrial septal defect (ASD), which had been diagnosed four years back during a routine health checkup in school. Her parents took her to a hospital, where she was advised open heart surgery to correct the condition at an estimated cost of around Rs 1.5 lakh. Her father, a welder, was the sole earning member of his family, which had six dependent family members. He had no insurance cover, ESI or CGHS. So, clearly, he could not afford the surgery.

He was then referred to us by the doctor who had first diagnosed the child.

When Nida came to us in 2014, she was 9 years old; after reviewing her condition, the Samir Malik Heart Care Foundation Fund decided to adopt her. In September 2014, she underwent ASD device closure by Dr Smita Mishra through the fund. An open heart surgery was avoided. 

Since then, Nida has been regularly coming to us for follow up care.

She is now 14 years old and a student of class 9. She has friends and participates enthusiastically in all school extracurricular activities – drawing, poem recitations etc.; she enjoys sports like Kho Kho, Kabaddi and above all, she is doing very well academically.

Nida is another success story of the Samir Malik Heart Care Foundation Fund.

Using the device closure method avoided the trauma of open heart surgery, a more invasive procedure, to correct the congenital heart defect. It also meant a shorter hospital stay, quicker recovery. Undergoing the device closure also helped to remove the social stigma of living with a scar on the chest. 

Social gradient has been identified as one of the 10 social determinants of health. The others are: Stress, early life, social exclusion, work, unemployment, social support, addiction, food and transport. Social gradient means “people who are less advantaged in terms of socioeconomic position have worse health (and shorter lives) than those who are more advantaged”. 

Social gradient needs to be addressed to eliminate the inequalities in health in the society.

To see Nida as a healthy and active child today only helps us to stay committed to our cause, which is to provide assistance to needy heart patients, young and old, so that they can live a healthy and productive life – “no person should die of a heart disease just because he/she cannot afford treatment”. 

Since it was first established in 2014, the Fund has successfully sponsored 279 heart surgeries such as valvular heart surgery, pacemaker implantation, surgeries for congenital heart diseases, bypass surgery and stents. It has also helped more than 1788 patients, both children and adults.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Tuesday, February 19, 2019

No loudspeaker, children’s studies more important than rallies, says Hon’ble SC

On 11th Feb the Hon’ble Bench of Chief Justice Ranjan Gogoi and Hon’ble Mr. Justice Sanjiv Khanna, dismissed a petition filed by West Bengal BJP challenging order of the State Pollution Control Board banning the use of loudspeakers in the residential areas and near educational institutions.

The court while dismissing the challenge asked “You are challenging an order of 2013?”. He also pointed out “the children are writing their exams around this time”.

The petitioner said it violates the party’s right to garner public support and is an infringement on the right to free speech.

The petitioner said that checking noise pollution especially at the time when exams are to be held in the state appears to be within legitimate purpose however a blanket ban on the use of microphones near residential areas or educational institutions virtually results in a complete ban.


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Dengue death: Error of judgment or medical negligence

 Arun Kumar Manglik versus Chirayu Health and Medicare Private Ltd. & Anr. Civil Appeal Nos. 227-228 of 2019 (@SLP (C) Nos. 30119-30120 of 2016 dated January 9, 2019

Chronology of events

On 14th November, 2009, Madhu Manglik (spouse of the appellant “Arun Kumar Manglik”; hereby referred to as “patient”), aged 56 years, was diagnosed with dengue fever. Lab report findings were:  “RBC- 4.21 million/cmm, Hb-12.1 gm/dL, TLC-1900/Cmm, Platelet Count 1.79 lakh/cmm, Dengue NS1 Antigen - Positive”.

The patient was admitted to Chirayu Health & Medicare hospital at Bhopal (Respondent) to ICU on 15th November, 2009. She was afebrile but reported accompanying signs of dengue fever including headache, body ache and a general sense of restlessness. Her past medical history was suggestive of cardiac complications (catheter ablation and paroxysmal supra ventricular tachycardia).

On the day of admission, investigations carried out at 7.30 am revealed the following:

·         Hb 13.4
·         TLC 3000/Cumm
·         Platelet count 97000/cumm
·         PS for MP no malarial parasite seen
·         Blood urea 21 mg%
·         Serum bilirubin 1mg%
·         SGPT 521 U/L, SGOT 105 mg/dl
·         Sodium 140 meq/L Potasium 4.0 meq/L Ex R4
·         Urine test normal Ex R6
·         10.00 am – Pulse-88/min, Bp. 130/88 mm Hg
·         Temp. Afebrile c/o Pain in abdomen, hence ultrasonography of the abdomen was carried out

At 2.00 pm:  Pulse 128/min, mildly febrile, BP 110/70 mm Hg

By 6 pm, the BP was non-recordable, extremities were cold and the pulse was non-palpable. The patient was administered IV fluids. She developed bradycardia and cardiac arrest; 1.5 litres of extra fluids and colloids were administered. Inotropes (dopamine and nor adrenaline) were given to improve BP.

At 6.45 pm, she suffered a cardiac arrest

At 6.55 pm, she was examined by Dr CC Chaubey.

At 7.15 pm, another blood sample was taken; the results were as follows:

·         Hb 8.1
·         TLC 7,400/Cumm
·         Platelet count 19000/cmm
·         Total protein- 3.9 gms%
·         A/G Ratio – 2
·         SGOT 169 IU/L

At 8 pm, the patient had a cardiac arrest.

At 8.50 pm: Patient was declared dead.

Subsequent course of events

·         A complaint of medical negligence was filed before the Medical Council of India (MCI). According to the Ethics Committee, while treatment given was as per established medical guidelines, it was not administered timely. In its order, dated 20th February, 2015, the Ethics Committee observed:

“…..After perusing the statements given by both the parties and documents on record in the case, the Ethics Committee discussed the matter in detailed and noted that the patient admitted in Chirayu Health & Medicare Pvt. Ltd., Malipura, Bhopal on the advice of Dr. A. Goenka but he never visited in hospital to see the patient. The committee further noted that treatment administered to the deceased in the hospital was correct as per the medical guidelines but not given timely. Although, Dr. Goenka did not went (sic)to hospital to see the patient as the patient admitted there as per his assurance and advice, therefore, the Ethics committee prima facie found that there is a professional misconduct on the part of both the doctors and decided to issue a warning to Dr. A. Goenka and Dr. Abhay Tyagi with the directions to be more careful in future while treating such type of patients/cases”

·         The Appellant filed a complaint before the State Consumer Disputes Redressal Commission (SCDRC) seeking compensation of Rs. 48 lakhs due to untimely death of his spouse due to the medical negligence of the treating doctors at the hospital. The SCDRC found a case of medical negligence and awarded a compensation of Rs 6 lakh together with interest at the rate of 9% per annum (judgement dated 27th April, 2015).

·         The National Consumer Disputes Redressal Commission (NCDRC) reversed the observations of SCDRC and dismissed the claims.

·         The Appellant appealed before the Supreme Court of India

Arguments of the Appellant’s Counsel

·         “…The hospital and the treating doctors failed to follow the established protocol in treating a case of dengue;
·         The line of treatment was contrary to established guidelines, formulated by the World Health Organisation, titled “Dengue Guidelines for Diagnosis, Treatment, Prevention and Control”;
·         Except for the blood sample which was taken at about 7.30 am, no further effort was made to determine the hematocrit levels (HCT) during the course of the day and it was only when the patient suffered a cardiac arrest after 6 pm that blood investigations were done at about 7.15 pm;
·         Admittedly, fluids were administered to the patient as a part of the treatment protocol;
·         The administration of fluids ought to have been accompanied by regular monitoring of blood levels which would have indicated that there was a precipitous decline in the platelet counts and in the HCT levels;
·         In the absence of regular monitoring, the treating doctors were guilty of medical negligence. As a result of their negligence, the doctors precluded themselves from receiving information in regard to the status or progression of the disease;…”

Arguments of the Respondent’s Counsel

·         “The patient had been suffering from fever from several days prior to her admission to the hospital. She was stable at the time of admission
·         The patient did not go into a situation of a dengue shock syndrome or hemorrhagic fever during the course of the day when she was admitted to the hospital;
·         In such a situation, no requirement of regular monitoring of HCT was warranted in accordance with the guidelines which have been prescribed by the Directorate of National Vector Borne Diseases Control Programme (DNVBDCP);
·         The above guidelines, which have been prescribed by the Union of India under the National Rural Health Mission, would indicate that it is only in a situation involving dengue hemorrhagic fever or dengue shock syndrome that further steps would be necessary;
·         The fluids which were administered to the patient did not require a monitoring of the blood more than twice a day and it was only in the evening that the HCT levels were required to be evaluated;
·         The patient had prior cardiac complications for which she had been on an aspirin regime prior to admission to the hospital. She was carefully monitored by a team of four doctors at the hospital;
·         The treatment protocol which was followed was consistent with the guidelines which have been prescribed both by WHO as well as by the National Vector Borne Diseases Control Programme;”

Observations of the Supreme Court

·         “…Between 14 January 2009 when the blood report of the patient was obtained from Glaze Pathology Lab and the morning of the following day on which she was admitted to the hospital, the platelet count had recorded a precipitous decline from 1,79,000 to 97,000. This undoubtedly, as the hospital urges in the present case, is a consequence of dengue. The patient had tested positive in the Dengue Antigen test. At 7.30 am, on 15 January 2009, her Hemoglobin was reported to be 13.4. The patient was thereafter placed on a treatment protocol involving the administration of intravenous fluids.

·         The condition of the patient was serious enough to require her admission to the Intensive Care Unit of the hospital. The hospital has justified the administration of about 1200 ml of fluid between 7 am and 6 pm when she developed bradycardia and cardiac arrest.

·         The real bone of contention in the present case is not the decision which was taken by the doctors to place the patient on a regime of intravenous fluids which, for the purposes of the present appeals, the Court ought to proceed as being on the basis of an established protocol.

·         The essential aspect of the case, which bears out the charge of medical negligence, is that between 7.30 am when the patient was admitted to hospital and 6 pm when she developed cardiac arrest, the course of treatment which has been disclosed in the counter affidavit does not indicate any further monitoring of essential parameters particularly those which could be detected by a laboratory analysis of blood samples.

·         Since her admission and through the day, the patient was administered intravenous fluids. The fluids were enhanced at 6 pm by 1.5 litres after she developed cardiac arrest. The record before the Court indicates that even thereafter, it was only at 7.15 pm that her blood levels were monitored. The lab report indicated a hemoglobin level of 8.1 and platelet count at 19,000. By then, the patient had developed acute signs of cardiac distress and she eventually died within a couple of hours thereafter.

·         The requirement of carefully monitoring a patient in such a situation is stipulated both by the guidelines of the World Health Organisation (Clause on which the appellant has placed reliance as well as in those incorporated by the Directorate of the National Vector Borne Diseases Control Programme in 2008 (Clause 7.1)…”

The Hon’ble Apex Court further observed:

 “The issue is not whether the patient had already entered a situation involving haemorrhagic fever or a dengue shock syndrome when she was admitted on the morning of 15 November 2009. The real charge of medical negligence stems from the failure of the hospital to regularly monitor the blood parameters of the patient during the course of the day. Had this been done, there can be no manner of doubt that the hospital would have been alive to a situation that there was a decline progressively in the patient’s condition which eventually led to cardiac arrest”.

This Court has consistently held in its decisions that “the standard of care which is expected of a medical professional is the treatment which is expected of one with a reasonable degree of skill and knowledge. A medical practitioner would be liable only where the conduct falls below the standards of a reasonably competent practitioner in the field.”

In several of its judgements (as below), the Supreme Court has elucidated on the standards of care expected of medical practitioners.

·         Bolam v Friern Hospital Management Committee
·         Dr Laxman Balkrishna Joshi v Dr Trimbak Bapu Godbole
·         Jacob Mathew v State of Punjab
·         Indian Medical Association v VP Shantha
·         Nizam’s Institute of Medical Sciences v Prasanth S Dhananka
·         Kusum Sharma v Batra Hospital and Medical Research Centre

Conclusions of the Apex Court

In the practice of medicine, there could be varying approaches to treatment. There can be a genuine difference of opinion. However, while adopting a course of treatment, the medical professional must ensure that it is not unreasonable. The threshold to prove unreasonableness is set with due regard to the risks associated with medical treatment and the conditions under which medical professionals function. This is to avoid a situation where doctors resort to ‘defensive medicine’ to avoid claims of negligence, often to the detriment of the patient. Hence, in a specific case where unreasonableness in professional conduct has been proven with regard to the circumstances of that case, a professional cannot escape liability for medical evidence merely by relying on a body of professional opinion.

In the present case, the record which stares in the face of the adjudicating authority establishes that between 7.30 am and 7 pm, the critical parameters of the patient were not evaluated. The simple expedient of monitoring blood parameters was not undergone. This was in contravention of WHO guidelines as well as the guidelines prescribed by the Directorate of National Vector Borne Diseases Control Programme. It was the finding of the Medical Council of India that while treatment was administered to the patient according to these guidelines, the patient did not receive timely treatment. It had accordingly administered a warning to the respondents to be more careful in the future. In failing to provide medical treatment in accordance with medical guidelines, the respondents failed to satisfy the standard of reasonable care as laid down in the Bolam case and adopted by Indian Courts.”

The Court found the judgement of NCDRC to be “unsustainable” and held that “There was no basis or justification to reverse the finding of medical negligence which was arrived at by the SCDRC.” It did not find the Director of the hospital to be personally liable for the medical negligence, although it found the hospital to be liable for medical negligence. “…Hence, while the finding of medical negligence against the hospital would stand confirmed, the second respondent would not be personally liable.”

Compensation awarded

The Supreme Court observed that “While quantifying the compensation, the SCDRC was in error in holding that since the son and daughter of the appellant are “highly educated and working” and had not joined as complainants, the complainant himself would be entitled to receive compensation only in the amount of Rs. 6 lakhs.”

“…it is now well settled by a catena of decisions of this Court that the contribution made by a non-working spouse to the welfare of the family has an economic equivalent. In Malay Kumar Ganguly v Sukumar Mukherjee, Justice S B Sinha held thus:

“172. Loss of wife to a husband may always be truly compensated by way of mandatory compensation. How one would do it has been baffling the court for a long time. For compensating a husband for loss of his wife, therefore, the courts consider the loss of income to the family. It may not be difficult to do when she had been earning. Even otherwise a wife's contribution to the family in terms of money can always be worked out. Every housewife makes a contribution to his family. It is capable of being measured on monetary terms although emotional aspect of it cannot be. It depends upon her educational qualification, her own upbringing, status, husband's income, etc.”

Thus, in computing compensation payable on the death of a home-maker spouse who is not employed, the Court must bear in mind that the contribution is significant and capable of being measured in monetary terms.

We accordingly, direct that the appellant shall be entitled to receive an amount of Rs. 15 lakhs by way of compensation from the first respondent. The compensation, as awarded, shall carry interest at the rate of 9 per cent per annum from the date of the institution of the complaint before the SCDRC until payment or realisation. Payment should be effected within two months.”

Discussion on the case

In dengue, people do not die of low platelets but of capillary leakage. In this case, capillary leakage occurred around 2 PM as evident by inappropriate tachycardia. Missing this is a common mistake in a clinical situation even in the best of the centers. In this setting, one will find low pulse pressure (the difference between SBO and DBP will be < 20 mm Hg). Without wasting time, one should infuse 20 ml / kg of fluids bolus at this juncture and then go on infusing fluids ( 150 ml per hour) till the patient passes urine ( adequate hydration)

With leakage, the hematocrit will rise rapidly and will fluids it will normalize. One may not waste time in getting the investigations done; simple pulse pressure and tachycardia monitoring may be sufficient in smaller setups.

·         Is it criminal negligence? No; no intention, no knowledge 
·         Is it a difference of opinion? No, line of treatment is standard
·         Is it an error of Judgment? Yes, one often misses tachycardia in presence of fever
·         Did this patient die of low platelets? No clear cut evidence
·         Did this patient die of leakage? Looks like
·         Was the death preventable? Once leakage has occurred the mortality is high
·         How to prevent? Make sure that a patient with dengue passes urine every few hours (adequate hydration)
·         What are the clinical signs of leakage? Sudden onset of weakness with high heart rate
·         Is the compensation justified? Will depend on the arguments
·         Is the amount of compensation justified? Yes, if compensation is awarded

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA