Negative serology not a reliable indicator of mucosal healing in celiac disease

Dr KK Aggarwal

Do not use negative serology as a reliable indicator of mucosal healing in patients with celiac disease who have persistent symptoms. Instead perform endoscopic biopsies to evaluate healing, recommends the American Gastroenterological Association (AGA) in a clinical practice update on the role of serology and histology in monitoring celiac disease.

The key recommendations are:

·         Serology is a crucial component of the detection and diagnosis of CD, particularly tissue transglutaminase-immunoglobulin A (TG2-IgA), IgA testing, and less frequently, endomysial IgA testing.

·         Thorough histological analysis of duodenal biopsies with Marsh classification, counting of lymphocytes per high-power field, and morphometry is important for diagnosis and for differential diagnosis. A strongly positive TG2-IgA combined with a positive endomysial antibody in a second blood sample increases the positive predictive value for CD to virtually 100%.

·         Negative IgA isotype testing despite strong suspicion may be explained by IgA deficiency. Measuring total IgA levels, IgG deamidated gliadin antibody tests, and TG2-IgG testing in such cases.

·         IgG isotype testing for TG2 antibody is not specific in the absence of IgA deficiency.

·         In patients found to have CD first by intestinal biopsies, confirm by celiac-specific serology before starting gluten-free diet (GFD).

·         In patients with strong suspicion of CD but negative biopsies, TG2-IgA should still be performed and, if positive, repeat biopsies might be considered either at that time or sometime in the future.

·         Reduction or avoidance of gluten before diagnostic testing is discouraged, as it may reduce the sensitivity of both serology and biopsy testing.

·         When patients have already started on a GFD before diagnosis, the patient are suggested to go back on a normal diet with 3 slices of wheat bread daily preferably for 1 to 3 months before repeat determination of TG2-IgA.

·         HLA-DQ2/DQ8 has a limited role in diagnosis. Its value is largely related to its negative predictive value to rule out CD in patients who are seronegative in the face of histologic changes, in patients who did not have serologic confirmation at the time of diagnosis, and in those patients with a historic diagnosis of CD; especially as very young children before the introduction of celiac-specific serology.

·         Celiac serology has a guarded role in the detection of continued intestinal injury, in particular as to sensitivity, as negative serology in a treated patient does not guarantee that the intestinal mucosa has healed. Persistently positive serology usually indicates ongoing intestinal damage and gluten exposure. Follow-up serology should be performed 6 and 12 months after diagnosis, and then every year.

·         Patients with persistent or relapsing symptoms, without other obvious explanations for those symptoms, should undergo endoscopic biopsies to determine healing even in the presence of negative TG2-IgA.

(Source: Husby S, et al. AGA Clinical Practice Update on diagnosis and monitoring of celiac disease-changing utility of serology and histologic measures: expert review. Gastroenterology. 2019;156(4):885-89).

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

Inquiry ordered after pregnant woman dies in south Kashmir: Where can be the error?

Dr KK Aggarwal

Authorities have ordered an inquiry after a pregnant woman died at Maternity and Children Hospital Sherbagh in south Kashmir’s Anantnag district, even as the police took cognisance of the case. Shobi Jan (25) wife of Mohd Hussain Bhat of Sarnal Anantnag died on Tuesday (June 25). She walked into the hospital on the morning of June 25 (Tuesday). She was asked to take tea and snacks before her delivery which according to the family was fixed at 2 p.m. by the doctors. However, no doctor turned up at the scheduled time.

A female attendant observed that there was no movement of foetus inside the womb and she rushed to inform the doctors. There was no response from the doctors ill 11 pm when she was taken to labour room where no one from the family was allowed to enter. She was taken to operating theater at around 3 a.m.

It was at around 6: 30 a.m. that the operating theater was opened and that too when the police team reached the hospital. The case has been booked under 174 CrPc.

Applicable Laws

1. Section 174 in The Code Of Criminal Procedure, 1973

174. Police to enquire and report on suicide, etc.

(1) When the officer in charge of a police station or some other police officer specially empowered by the State Government in that behalf receives information that a person has committed suicide, or has been killed by another or by an animal or by machinery or by an accident, or has died under circumstances raising a reasonable suspicion that some other person has committed an offence, he shall immediately give intimation thereof to the nearest Executive Magistrate empowered to hold inquests, and, unless otherwise directed by any rule prescribed by the State Government, or by any general or special order of the District or Sub- divisional Magistrate, shall proceed to the place where the body of such deceased person is, and there, in the presence of two' or more respectable inhabitants of the neighbourhood, shall make an investigation, and draw up a report of the apparent cause of death, describing such wounds, fractures, bruises, and other marks of injury as may be found on the body, and stating in what manner, or by what weapon or instrument (if any); such marks appear to have been inflicted.

(2) The report shall be signed by such police officer and other persons, or by so many of them as concur therein, and shall be forthwith forwarded to the District Magistrate or the Sub- divisional Magistrate.

(3) When-

(i) the case involves suicide by a woman within seven years of her marriage; or

(ii) the case relates to the death of a woman within seven years of her marriage in any circumstances raising a reasonable suspicion that some other person committed an offence in relation to such woman; or

(iii) the case relates to the death of a woman within seven years of her marriage and any relative of the woman has made a request in this behalf; or

(iv) there is any doubt regarding the cause of death; or

(v) the police officer for any other reason considers it expedient so to do, he shall. subject to such rules as the State Government may prescribe in this behalf, forward the body, with a view to its being examined, to the nearest Civil Surgeon, or other qualified medical man appointed in this behalf by the State Government, if the state of the weather and the distance admit of its being so forwarded without risk of such putrefaction on the road as would render such examination useless.

(4) The following Magistrates are empowered to hold inquests, namely, any District Magistrate or Sub- divisional Magistrate and any other Executive Magistrate specially empowered in this behalf by the State Government or the District Magistrate.

MCI Ethics Regulations

3.3 Punctuality in Consultation: Utmost punctuality should be observed by a physician in making themselves available for consultations.

2.4 The Patient must not be neglected: A physician is free to choose whom he will serve. He should, however, respond to any request for his assistance in an emergency. Once having undertaken a case, the physician should not neglect the patient, nor should he withdraw from the case without giving adequate notice to the patient and his family. Provisionally or fully registered medical practitioner shall not wilfully commit an act of negligence that may deprive his patient or patients from necessary medical care.

Lessons

·         Internationally, husbands are allowed in labour rooms. The same should become a routine transparent practice in India too.

·         Punctuality must be observed. Even if the doctor is not available, the sister or the resident on duty, should introduce themselves to the patient and convey their credentials to them.

·         Every nursing home should use e-consultation and make the patient and relations talk through video chat within minutes of admission.

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

Should ivermectin-based mass drug administration for scabies be combined with albendazole in affected areas?

Dr KK Aggarwal

When I was a student at MGIMS, scabies was rampant in the society. It was among the most prevalent condition in OPDs. Ascabiol ointment was our standard treatment.

Scabies is an infestation of the skin caused by the itch mite Sarcoptes scabiei var. hominis.

In 2017, the World Health Organization (WHO) added scabies to its list of neglected tropical disease

Today Scabies is amenable to mass drug administration, as shown by the Skin Health Intervention Fiji Trial (SHIFT). The trial demonstrated that the mass administration of an ivermectin-based regimen decreased the prevalence of scabies 24 months after ivermectin-based mass drug administration, with an additional effect on impetigo.

In the trial, three island communities in Fiji were randomized to one of three scabies intervention strategies:

·         standard care involving the administration of topical permethrin to persons with scabies and their contacts (standard-care group)

·         mass administration of topical permethrin (permethrin group), or

·         mass administration of an oral ivermectin-based regimen (ivermectin group)

In the ivermectin group, a single dose of ivermectin-based treatment was provided to all participants, with a second treatment provided 7 days later to those with scabies. The participants ranged in age from infants to the elderly.

At 12 months, the ivermectin-based regimen was the most effective, with a 94% relative reduction from baseline in the prevalence of scabies (from 32.1% at baseline to 1.9%) and a 67% relative reduction in impetigo.

At 24 months, the prevalence of scabies was 3.6% in the ivermectin group, 13.5% in the permethrin group, and 15.2% in the standard-care group.

The prevalence of scabies was lower at 24 months than at 12 months in the permethrin and standard-care groups and slightly higher in the ivermectin group.

The prevalence of impetigo at 24 months was 2.6% in the ivermectin group, 8.9% in the permethrin group, and 13.0% in the standard-care group. The relative reduction from baseline in the prevalence of impetigo was greatest in the ivermectin group at 90%.

Evaluation of effectiveness in larger, less isolated populations over a longer period is required to extend these findings.

In scabies affected areas in the country, in addition to albendazole being mass-administered on 10th February and 10th August every year (National Deworming Day), why not give a combination of  ivermectin-albendazole ( It is available in the country)?

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

Left hand fractured, plaster cast on right: Is it a never event or gross negligence?

 Dr KK Aggarwal

Earlier this week, a case of gross medical error from Darbhanga Medical College Hospital was reported where an orthopedic doctor plastered the wrong hand of the boy who fell from a mango tree. The 7-year-old boy had fractured his left hand, but the plaster cast was put on his right hand.

When I read this story, few questions arose in my mind.

·         Is this an error?

·         Is it gross error or a never event?

·         Should the patient be given compensation?

·         Should the doctor be suspended?

My opinion: It is a never event but has not damaged the limb in question. It’s a never event and a fit case of compensation to the patient. We have professional indemnity insurance to cover for such mishaps. If it goes to medical council, it is not a fit case for suspension of license.

Applicable laws

This is a medical error and can be classified as a ‘never event’ i.e. event that should never occur under any circumstance. Never events are defined as adverse events that are serious, largely preventable, and of concern to both the public and health care providers for the purpose of public accountability. They are usually a direct result of a negligent action and no trial of expert’s evidence is necessary

The US National Quality Forum has defined 29 never events segregated into seven categories: surgical, product or device, patient protection, care management, environmental, radiologic, and criminal.

In M/S. Spring Meadows Hospital & Anr vs Harjol Ahluwalia 25 March, 1998, the Supreme Court said “Gross medical mistake will always result in a finding of negligence. Use of wrong drug or wrong gas during the course of anaesthetic will frequently lead to the imposition of liability and in some situations even the principle of Res ipsa loquitur can be applied.”

The apex court in Martin F. D' Souza vs Mohd. Ishfaq on 17 February, 2009 said “For instance, he would be liable if he leaves a surgical gauze inside the patient after an operation vide Achutrao Haribhau Khodwa & others vs. State of Maharashtra & others, AIR 1996 SC 2377 or operates on the wrong part of the body, and he would be also criminally liable if he operates on someone for removing an organ for illegitimate trade.”

In Indian Medical Association vs. V.P. Shantha 1995(6) SCC 651 (vide para 37) it has been held that the following acts are clearly due to negligence:   (i) Removal of the wrong limb; (ii) Performance of an operation on the wrong patient; (iii) Giving injection of a drug to which the patient is allergic without looking into the out-patient card containing the warning; (iv) Use of wrong gas during the course of an anaesthetic, etc.

This is not gross negligence. “In Dr. Suresh Gupta vs. Government of N.C.T. of Delhi and another AIR 2004 SC 4091, the appellant was a doctor accused under Section 304A IPC for causing death of his patient. The operation performed by him was for removing his nasal deformity. The Magistrate who charged the appellant stated in his judgment that the appellant while conducting the operation for removal of the nasal deformity gave incision in a wrong part and due to that blood seeped into the respiratory passage and because of that the patient collapsed and died. The High Court upheld the order of the Magistrate observing that adequate care was not taken to prevent seepage of blood resulting in asphyxia. The Supreme Court held that from the medical opinions adduced by the prosecution the cause of death was stated to be `not introducing a cuffed endotracheal tube of proper size as to prevent aspiration of blood from the wound in the respiratory passage.' The Supreme Court held that this act attributed to the doctor, even if accepted to be true, can be described as a negligent act as there was a lack of care and precaution. For this act of negligence he was held liable in a civil case but it cannot be described to be so reckless or grossly negligent as to make him liable in a criminal case. For conviction in a criminal case the negligence and rashness should be of such a high degree which can be described as totally apathetic towards the patient…” (Martin F. D' Souza vs Mohd. Ishfaq on 17 February, 2009)

In Nizam’s Institute of Medical Sciences vs Prasanth S.Dhananka & Ors on 14 May, 2009, the Apex court said, “30. Mr. Tandale has, however, relied on Indian Medical Assn. vs. V.P.Shantha & Ors. (1995) 6 SCC 651, and in particular on the following observations:

It has been urged that proceedings involving negligence in the matter of rendering services by a medical practitioner would raise complicated questions requiring evidence of experts to be recorded and that the procedure which is followed for determination of consumer disputes under the Act is summary in nature involving trial on the basis of affidavits and is not suitable for determination of complicated questions.

It is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency in rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the outpatient card containing the warning (as in Chinkeow v. Government of Malaysia (1967) 1 WLR 813 P.C.) or use of wrong gas during the course of an anesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. One often reads about such incidents in the newspapers. The issues arising in the complaints in such cases can be speedily disposed of by the procedure that is being followed by the Consumer Disputes Redressal Agencies and there is no reason why complaints regarding deficiency in service in such cases should not be adjudicated by the Agencies under the Act. In complaints involving complicated issues requiring recording of evidence of experts, the complainant can be asked to approach the Civil Court for appropriate relief. Section 3 of the Act which prescribes that the provisions of the Act shall be in addition to and not in derogation of the provisions of any other law for the time being in force, preserves the right of the consumer to approach the Civil Court for necessary relief. We are, therefore, unable to hold that on the ground of composition of the Consumer Disputes Redressal Agencies or on the ground of the procedure which is followed by the said Agencies for determining the issues arising before them, the service rendered by the medical practitioners are not intended to be included in the expression 'service' as defined in Section 2(1)(o) of the Act.”

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

Lok Sabha to discuss the issue of “unauthorized pathological labs and diagnostic centers” today

Dr KK Aggarwal

The Lok Sabha admitted unstarred question no.1274 regarding “unauthorized pathological labs and diagnostic centers” asked by Shri Manoj Kotak. 

This question will be answered by the Minister of Health & Family Welfare today.

The questions that have been raised are:

·         Whether government is aware about the mushrooming of diagnostic centers in country including Mumbai, which are functioning without having requisite infrastructure and qualified staff

·         If so, the details thereof, and

·         The action government has taken or proposes to take against such diagnostic centers in the country?

Let’s see what comes out of the discussion on this question. It would be interesting to hear the reply of the Health Minister on this

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

Non-Profit Hospitals & CEOs make the main profits

I was sent an important piece of information by one of my senior colleagues and when I went through it, it made sense. Even in India, in the so-called trust “not for profit” hospitals, the main take away is by the top ranking two or three non-medical executives including the marketing team distributing pay offs.

Can’t doctors run hospitals? They had been running them all these years.

Why do we need marketing departments in established hospitals to entice patients? If hospitals deliver the best care, patients will come of their own. A word-of-mouth referral from your current patients is the most effective marketing tool for hospitals and doctors. Why do branded hospitals need to market themselves?

A retrospective observational study published in JAMA Internal Medicine in January 2014 had characterized the compensation of Chief Executive Officers (CEOs) at nonprofit US Hospitals and examine its association with quality metrics. The study concluded that CEO compensation at nonprofit US hospitals varies widely and CEOs of hospitals who had greater use of advanced technology and higher patient satisfaction had more compensation (pay). But no association was found between the CEO compensation and the quality of care delivered, patient outcomes, or community benefit.

The rising cost of healthcare in India is a concern.

As per a recently published research paper based on cross-sectional analysis of National Sample Survey Office (NSSO) data, 55 million Indians were pushed into poverty in a single year because of having to fund their own healthcare, and out of this, 38 million fell below the poverty line due to spending on medicines alone (Press Information Bureau, July 31, 2018)

Even in the US, families who are working hard to get ahead now pay nearly $20,000 per year in insurance premiums, deductibles and out-of-pocket costs for healthcare.

But these so-called “non-profit” hospitals and their CEOs are getting richer while the people are getting healthcare poorer.

Affordable care can become more affordable, if the cost of marketing and managing the hospitals can be passed on to the patients.

A new report “Investigating the Top 82 U.S. Non-Profit Hospitals, Quantifying Government Payments and Financial Assets” specifically looked at large non-profits organized as charities under IRS Section 501(c)3 with the mission of delivering affordable healthcare to their communities. They found that these hospitals add billions of dollars annually to their bottom line, lavishly compensate their CEOs, and spend millions of dollars, which are generated by patient fees, lobbying government to defend the status quo.

The executive compensation showed that 13 organizations paid their top earner between $5 million and $21.6 million; 61 organizations paid their top executive between $1 million and $5 million and only 8 organizations paid their top earner less than $1 million (which proves it’s possible).

Collectively, $297.5 million in cash compensation flowed to the top paid executive at each of the 82 hospitals.  They found pay outs as high as $10 million, $18 million and even $21.6 million per CEO or other top-paid employee.

Banner Health paid out $34 million to just two executives. The president of Banner made $21.6 million and an executive vice-president made $12.4 million.

Consider Former CEO at Memorial Hermann in Houston, Texas made $18.6 million. In St. Louis, Missouri, the chief at Ascension Health made $13.6 million; the CEO at the Kaiser Foundation in Oakland, California made $10.7 million; and $10.6 million went to the top paid executive of Northwestern Memorial HealthCare in Chicago, Illinois.

When summing the last four years of pay (2013-2017), each of these highly compensated executives - who made more than $10 million in 2017 alone -  earned an extraordinary amount of compensation: Ascension CEO ($59.1 million); Kaiser CEO ($29.8 million); Banner CEO ($29.6 million); Advocate Health CEO, based in Downers Grove, Illinois ($27.8 million); Memorial Hermann Special Advisor/CEO ($27.3 million); and Northwestern Memorial COO ($15.3 million).

Even after paying lavish salaries, these non-profit hospitals had enough left over to add nearly $40 billion to their bottom-line.

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

FDA cautions about mortality risk with fecal transplant

As per FDA two patients received donated stool that had not been screened for drug-resistant germs, leading it to halt clinical trials until researchers prove proper testing procedures are in place.

Both transplants came from the same donor’s fecal matter. The report does not state whether the fecal material was given in liquid form as an infusion into the digestive tract or swallowed as pills.

Other samples from the same donor were tested after the patients got sick. The samples were found to harbor the same dangerous germs found in the patients, known as multi-drug-resistant organisms. They were E. coli bacteria that produced an enzyme called extended-spectrum beta-lactamase, which makes them resistant to multiple antibiotics. The stool had not been tested for the germs before being given to the patients.

Fecal transplants have come into increasing use to treat severe intestinal disorders, particularly an infection caused by a bacterium called Clostridium difficile, which can be deadly and tends to occur in hospitalized patients who have been heavily treated with antibiotics. The idea behind the transplants is to use stool from a healthy donor to restore the normal balance of bacteria and other organisms in the intestine, the microbiome.

The FDA on Thursday issued a warning to researchers that stool from donors in studies of fecal transplantation should be screened for drug-resistant microbes, and not used if those were present. It is also warning patients that the procedure can be risky, is not approved by the agency and should be used only as a last resort when C. difficile does not respond to standard treatments.

This is especially pertinent for countries like India, where the patient may be exposed to infection with drug-resistant bacteria and the source of infection cannot be found. Efforts should be made to trace the source of infection in all cases of sepsis. This will help in better management of patients.

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