New AI tool predicts post-surgery mortality

USA: The researchers at the Smidt Heart Institute at Cedars-Sinai and colleagues at two other institutions have developed an artificial intelligence (AI) tool that accurately predicts how patients would fare after surgeries and procedures. The results, published in The Lancet Digital Health, include data from patients from three healthcare systems: Cedars-Sinai, Stanford University and Columbia University.

All patients in the study underwent a surgical procedure, including open heart surgery, other major surgeries, and minimally invasive procedures involving a catheter or endoscope.

Investigators trained an AI model on pre-operative electrocardiograms, discovering a new use for the 130-year-old test. Invented in the late-1800s, an electrocardiogram is a commonly deployed test that involves placing electrodes on the skin to measure the heart’s electrical activity and assess how well the heart is functioning.

“This is the first electrocardiogram-based AI algorithm that predicts post-operative mortality,” said David Ouyang, MD, a cardiologist in the Department of Cardiology in the Smidt Heart Institute at Cedars-Sinai, and a corresponding author of the study. “Previously, algorithms have been used to assess long-term mortality as well as individual disease states, but determining post-surgical outcomes helps inform the actual decision to do surgery.”

Investigators paired patients’ electrocardiograms from before the surgery or procedure, with their outcomes after the surgery or procedure, and asked the algorithm to find associations or patterns in the electrocardiogram waveforms.

While classifying most patients as low risk, those individuals the algorithm identified as high risk had nearly a 9-fold increased probability of post-operative mortality.

“As it now stands, clinicians only have a modest ability to predict how a patient is going to do after surgery,” said Ouyang, also a faculty member in the Division of Artificial Intelligence in Medicine at Cedars-Sinai. “Current clinical risk prediction tools are insufficient. This AI model could potentially be used to determine exactly which patients should undergo an intervention and which patients might be too sick.”

Every medical intervention comes with risk, and doctors currently rely on guidelines from medical societies to determine a patient’s individual risk.

“In cardiology, we’re fortunate to have many life-saving procedures, everything from catheter-based procedures to open-heart surgery, so we’re often trying to think about who are the right patients for the right procedure,” said Christine M. Albert, MD, MPH, chair of the Department of Cardiology in the Smidt Heart Institute and the other corresponding author of the study. “A better understanding of risk, particularly by using a commonly obtained diagnostic test, can inform important medical decisions.”

Investigators are currently studying how the algorithm could be translated into a web application that would be widely available for physicians and patients.

Reference:

David Ouyang, John Theurer, Nathan R Stein, J Weston Hughes, Pierre Elias, Bryan He, Electrocardiographic deep learning for predicting post-procedural mortality: a model development and validation study, DOI:https://doi.org/10.1016/S2589-7500(23)00220-0.

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Lupin gets CDSCO Panel nod for Rifapentine Dispersible Tablet 150 mg

New Delhi: Granting the local clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved drug major Lupin’s Rifapentine dispersible Tablets 150mg for already approved indication with the condition of conducting a Phase IV Clinical study.

This came after the firm presented their proposal for a grant of permission to manufacture and marketing of Rifapentine Dispersible Tablets 150mg (Additional Dosage Form) for an already approved indication along with the bioequivalence study report before the committee.

Rifapentine is an antitubercular agent and a leprostatic drug. Rifapentine is an antibacterial prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of active tuberculosis (TB) of the lungs. (Active TB is also called TB disease.) Rifapentine is also FDA-approved for the treatment of latent TB infection to prevent the infection from advancing to active TB disease.

It inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

Rifapentine is used with other medications to treat active tuberculosis (TB; a serious infection that affects the lungs and sometimes other parts of the body) in adults and children 12 years of age and older.

At the recent SEC meeting for Antimicrobial and Antiviral held on 29th November 2023, the expert panel reviewed the proposal for grant of permission to manufacture and marketing of Rifapentine Dispersible Tablets 150mg (Additional Dosage Form) for an already approved indication along with the Bioequivalence study report presented by drug major Lupin.

After detailed deliberation, the committee recommended for approval of Rifapentine Dispersible Tablets 150mg for an already approved indication with a local clinical trial waiver with a condition to conduct a Phase IV Clinical study.

Accordingly, the expert panel suggested that the firm should submit a Phase IV protocol to CDSCO within 3 months of approval for further evaluation by the committee.

In addition, the committee stated that the firm should fulfill the requirements of CMC (chemistry, manufacturing, and controls) data before approval of the product.

Also Read: AstraZeneca gets CDSCO panel Nod to study anti-cancer drug Volrustomig in women with cervical cancer

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Consumption of Fresh vegetables has potential benefit of improving eGFR among elderly

Diet rich in Fresh vegetables has potential benefit of improving eGFR among elderly suggests a new study published in the BMC Nephrology.

This study aimed to investigate the relationship between the consumption of fresh and salt-preserved vegetables and the estimated glomerular filtration rate (eGFR), which requires further research.

The prevalence of chronic kidney disease (CKD) generally increases with age owing to nephron loss and a decline in the glomerular filtration rate (GFR). The estimated GFR (eGFR) assumes a widely recognized role as a marker that plays a pivotal role in evaluating overall kidney health and diagnosing various renal disorders.

For this purpose, the data of those subjects who participated in the 2011–2012 and 2014 surveys of the Chinese Longitudinal Healthy Longevity Survey (CLHLS) and had biomarker data were selected. Fresh and salt-preserved vegetable consumptions were assessed at each wave. eGFR was assessed using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation based on plasma creatinine. Furthermore, a linear mixed model was used to evaluate associations between fresh/salt-preserved vegetables and eGFR.

Results

The results indicated that the median baseline and follow-up eGFRs were 72.47 mL/min/1.73 m² and 70.26 mL/min/1.73 m², respectively. After applying adjusted linear mixed model analysis to the data, the results revealed that compared to almost daily intake, occasional consumption of fresh vegetables was associated with a lower eGFR (β=-2.23, 95% CI: -4.23, -0.23). Moreover, rare or no consumption of salt-preserved vegetables was associated with a higher eGFR (β = 1.87, 95% CI: 0.12, 3.63) compared to individuals who consumed salt-preserved vegetables daily.

Fresh vegetable consumption was direct, whereas intake of salt-preserved vegetables was inversely associated with eGFR among the oldest subjects, supporting the potential benefits of diet-rich fresh vegetables for improving eGFR.

Reference:

Zheng, H., Li, H., Pan, L. et al. Association of fresh vegetable and salt-preserved vegetable consumptions with estimated glomerular filtration rate. BMC Nephrol 24, 369 (2023). https://doi.org/10.1186/s12882-023-03353-5

Keywords:

Diet, rich, Fresh, vegetable, potential, benefit, of, improving, eGFR, among, elderly, BMC Neph8rology, Zheng, H., Li, H., Pan, L

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Conduct BE study and clinical trial: CDSCO Panel tells Cipla on Formoterol Fumarate Dihydrate, glycopyrronium inhaler

New Delhi: Rejecting the proposal for clinical trial and bioequivalence (BE) study waiver presented by drug major Cipla, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the BE study of the fixed-dose combination Formoterol Fumarate Dihydrate plus Glycopyrronium inhaler with innovator product as a reference product.

In addition, the expert panel rejected the clinical trial waiver at this stage.

This came after the drug major Cipla presented their proposal along with justification for clinical trial and bioequivalence (BE) study waiver before the committee.

Formoterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

Formoterol is an inhaled beta2-agonist used in the management of Chronic Obstructive Pulmonary Disease (COPD) and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways and is administered as a racemic mixture of its active (R; R)- and inactive (S;S)-enantiomers.

Formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

At the recent SEC meeting for Pulmonary held on 5th December 2023, the expert panel reviewed the proposal presented by the drug major Cipla along with the justification for clinical trial (CT) and BE waiver before the committee.

After detailed deliberation, the committee recommended that the firm conduct the BE study with the innovator product as a reference product, and the clinical trial waiver was not considered at this stage.

Accordingly, the expert panel suggested that the BE protocol should be presented before the committee for review.

Also Read: Modify phase III clinical trial protocol: CDSCO panel tells Akum Pharma on antidiabetic FDC

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New guidelines released for treatment of anaphylaxis and atopic dermatitis

Two new practice parameters from the Joint Task Force for Practice Parameters (JTFPP) offer evidence-based recommendations for the diagnosis and management of anaphylaxis and atopic dermatitis (AD) in pediatric and adult patients. The Joint Task Force is a partnership between the American College of Allergy, Asthma and Immunology (ACAAI) and the American Academy of Allergy, Asthma and Immunology.

“Both anaphylaxis and atopic dermatitis are allergic conditions that affect millions of people-in the United States and around the world,” says allergist Jay Lieberman, MD, co-chair of the JTFPP Task Force. “We regularly update our practice parameters to make sure allergists and other healthcare practitioners are aware of best practices when diagnosing and managing these disorders. When physicians and their staffs are aware of updated guidance, it means patients are getting the best, most appropriate care.”

Anaphylaxis

“The 2023 JTFPP anaphylaxis practice parameter provides evidence-based recommendations to support optimal contextual care across contemporary practice settings,” says allergist David B.K. Golden, MDCM, lead author of the practice parameter. “With important new guidance related to diagnostic evaluation, anaphylaxis in infants and in community settings, epinephrine treatment, mast cell conditions, beta-blockers and ACE inhibitors, and peri-operative anaphylaxis, these guidelines translate recent advances in the understanding of severe allergic reactions to help all healthcare professionals provide individualized care to each patient at the right time, in the right place, every time.”

The practice parameter on anaphylaxis focuses on areas where new evidence has emerged, and recommendations have evolved.

Key anaphylaxis guideline highlights include:

  • Updates on recommendations regarding if a patient must go to the emergency room if they use epinephrine for anaphylaxis. Calling emergency services (EMS) after use of an epinephrine auto injector (EAI) may not be required if the patient experiences prompt, complete, and durable response to treatment and has access to additional EAIs. Situations that would warrant EMS activation include severe anaphylaxis, symptoms that do not resolve promptly, completely or nearly completely, or symptoms that return or worsen.
  • Recommendations on how, where and by whom epinephrine auto injectors should be stored.
  • Updates on the diagnosis of anaphylaxis. Revised criteria by the World Allergy Organization (WAO), Brighton, and Delphi Consensus groups aim to create more universally accepted definitions and criteria for anaphylactic reactions.
  • Updates on how to recognize and treat anaphylaxis in infants. Diagnosing anaphylaxis in infants and toddlers can be challenging, and there are no age-specific anaphylaxis diagnostic criteria. Therefore, the current National Institute of Allergy and Infectious Diseases/Food Allergy & Anaphylaxis Network or World Allergy Organization anaphylaxis criteria should be used to establish the diagnosis of anaphylaxis in infants/toddlers.
  • Updates on how to evaluate and treat anaphylaxis in relation to a surgery.
  • Updates on nuances regarding the use of beta-blockers and ACE inhibitors in patients at risk for anaphylaxis.

Atopic Dermatitis

“The 2023 JTFPP atopic dermatitis guideline represents an advancement in trustworthy allergy guidelines,” says allergist Derek Chu, M.D., Ph.D. “It is distinguished from other guidelines through systematic reviews of the evidence with multidisciplinary panelist engagement, adherence to GRADE – a rigorous guideline development process, as well as the involvement of the patient and caregiver voice from start to finish. Clear translation of evidence to clinically actionable and contextual recommendations, and novel approaches to facilitate knowledge translation were paramount. The guidelines emphasize, in addition to standards of trustworthiness, the third principle of evidence-based medicine: that evidence alone is never enough; that patient values and preferences are crucial to arriving at optimal recommendations. The new recommendations also reflect the evolution of diversity, equity and inclusion in approaching diagnosis and management of this condition.”

Key atopic dermatitis guideline highlights include:

  • Recommends the use of topical corticosteroids or topical calcineurin inhibitors in patients with uncontrolled AD, despite moisturizers.
  • Highlights the safety of the topical calcineurin inhibitors with typical usage once or twice daily.
  • Recommends proactive therapy with topical corticosteroids or topical calcineurin inhibitors for patients with a relapsing course.
  • Consideration for once daily dosing of topical medications. Recommends dupilumab for patients 6 months of age or older with moderate-severe AD refractory, intolerant, or unable to use mid-potency topical treatment, or tralokinumab for similar patients ages 12 years and older.
  • Suggests against elimination diets for AD.
  • Suggests the usage of crisaborole 2% ointment for mild to moderate atopic dermatitis.
  • Suggests against the use of topical antibiotics for AD alone with no infection.
  • Suggests bleach baths for AD patients with moderate to severe disease as an additive therapy; suggests against use for mild AD.
  • Suggests consideration of allergen immunotherapy for moderate to severe AD.
  • Suggests use of oral JAK inhibitors after careful consideration of risks and benefits in adults and adolescents with moderate-severe AD refractory, intolerant, or unable to use mid to high potency topical treatment and biologics.
  • Suggests against immunosuppressant medications such as baricitinib (a JAK inhibitor), azathioprine, methotrexate and, mycophenylate mofetil
  • Suggests consideration of cyclosporin in adults and adolescents with moderate-severe AD refractory, intolerant, or unable to use mid to high potency topical treatment and biologics.
  • Suggests against the use of systemic corticosteroids for AD.

The practice parameters are published in Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma & Immunology.

Reference:

Golden DBK, Wang J, Waserman S, Akin C, Campbell RL, Ellis AK, Greenhawt M, Lang DM, Ledford DK, Lieberman J, Oppenheimer J, Shaker MS, Wallace DV, Abrams EM, Bernstein JA, Chu DK, Horner CC, Rank MA, Stukus DR; Collaborators; Burrows AG, Cruickshank H; Workgroup Contributors; Golden DBK, Wang J, Akin C, Campbell RL, Ellis AK, Greenhawt M, Lang DM, Ledford DK, Lieberman J, Oppenheimer J, Shaker MS, Wallace DV, Waserman S; Joint Task Force on Practice Parameters Reviewers; Abrams EM, Bernstein JA, Chu DK, Ellis AK, Golden DBK, Greenhawt M, Horner CC, Ledford DK, Lieberman J, Rank MA, Shaker MS, Stukus DR, Wang J. Anaphylaxis: A 2023 practice parameter update. Ann Allergy Asthma Immunol. 2023 Dec 5:S1081-1206(23)01304-2. doi: 10.1016/j.anai.2023.09.015.

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Shweta Rai appointed as MD of Bayer Zydus Pharma

Bayer has announced that Shweta Rai will take over as Managing Director of Bayer Zydus Pharma Private Limited and Country Division Head (CDH) for Bayer’s Pharmaceuticals Business in South Asia effective, January 1, 2024. Manoj Saxena will move out of his present role to take on the role of CDH for Bayer’s Pharmaceuticals Division and Senior Bayer Representative, Bayer Group for the Australia & New Zealand (ANZ) cluster, with effect from the same date.

For more details, check out the link given below:

Shweta Rai Takes Over As MD Of Bayer Zydus Pharma

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NEET PG: In-service candidate alleges arbitrary seat allotment at RVM Medical College, HC issues notice

The Telangana High Court bench has recently issued notices in a plea challenging the arbitrary seat allotment to a postgraduate medical candidate in RVM Institute of Medical Sciences and Research Centre, Medak.

Issuing the notice, the HC bench comprising Chief Justice Alok Aradhe and Justice J. Anil Kumar has listed the matter for further hearing after two weeks.

The bench was considering a plea by an in-service PG medical candidate, who also belongs to the scheduled caste category. Approaching the HC bench, the petitioner alleged arbitrary seat allotment at the medical college.

For more details, check out the link given below:

NEET PG: In Service Candidate Alleges Arbitrary Seat Allotment At RVM Medical College, HC Issues Notice

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Tragic Accident Claims Lives of 2 Final Year RIMS Adilabad MBBS Students

Adilabad: In an unfortunate incident, two final-year MBBS students from the esteemed Rajiv Gandhi Institute of Medical Sciences (RIMS) met with a fatal accident on Sunday night in Yavatmal district, Maharashtra.

The accident happened when the motorcycles, carrying the medicos, collided with a stationary lorry in the vicinity of Pandharkawada.

The victims, identified as a 23-year-old hailing from Parkal in Hanamkonda district and a 24-year-old from Vijayawada, suffered fatal head injuries, tragically leading to their deaths at the scene of the accident. The news of this untimely loss has brought grief into the RIMS community, where both students were almost in the final year of their medical education journey.

RIMS Director, Dr. Jaisingh Rathod, expressed deep condolences and highlighted the devastating impact of the accident on the institute. The two students, along with four others, had informed institute officials that they intended to have a meal in the neighboring state of Maharashtra before the tragic turn of events. The loss of these promising young minds has left the RIMS community and their families in profound grief. The institute is extending support to the bereaved families during this challenging time. The entire medical fraternity mourns the loss of the young medicos recognizing the potential they held for contributing significantly to the field of medicine, reports  Telangana Today. 

Upon learning about the event, Rathod and the doctors of the medical college went to a government hospital in Pandharkawada where the remains were preserved. The parents of the victims were notified about the mishap. The bodies will be conveyed to the native locations of the students by evening. 

Also Read:Tragic car accident on Delhi-Dehradun highway claims life of MBBS Intern, injures second-year PG Medic

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Fake medical factory producing duplicate Betnovate-N busted, mastermind held

A fake medical factory preparing duplicate ‘Betnovate-N’ was busted by the Delhi Police’s Crime Branch and 2,200 filled tubes and 68,000 empty tubes of the skin ointment seized, an official said on Sunday, adding that they have also arrested the mastermind.

The accused was identified as Avan Monga, 45, a resident of Vishnu Garden, Delhi.

Betnovate-N’ cream, a product of Glaxo Smith Kline (GSK) Company, is used for skin problems.

For more details, check out the link given below:

Delhi: Factory Producing Duplicate Of GSK’s Betnovate-N Busted, Mastermind Held

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Ensure 75 percent faculty attendance or lose recognition: NMC warns medical colleges

New Delhi: Few days after issuing show-cause notices to over 350 medical colleges after finding a deficiency in attendance and failure to meet required faculty requirements (Minimum Standard Requirements 2020), the National Medical Commission (NMC) has now issued a warning for the institutions directing them to strictly follow UG-MSR 2023 and MSMER 2023 otherwise their applications will not be considered and they will lose on approvals/recognition.

Earlier this month, NMC issued show cause notices to around 50 percent of medical colleges for not following standards set by them. Medical Dialogues had earlier reported that 350 out of a total of 654 medical colleges were issued the show cause for violations of the Minimum Standard Requirements 2020 including a deficiency in having the required faculty numbers.

Among these 349 medical colleges, 197 colleges are government-aided and others are private medical institutes. Show cause notice was also issued to a medical college in Kerala’s Idukki after finding a deficiency in attendance and failure to meet required faculty requirements (Minimum Standard Requirements 2020)

“Your college has failed to meet the required faculty requirement (MSR 2020) for the existing MBBS Course being run in the college for 2023-24. This has been viewed seriously by the Competent Authority. Therefore, your college is hereby directed as to why the action should not be initiated against the non-compliance of the provisions contained in MSR as well as directions issued by NMC,” read the show cause notice.

Also Read:Faculty Shortage, Violation of MSR: 349 out of 654 medical colleges get NMC Show Cause Notice

Now, through a recent notice, the Undergraduate Medical Education Board (UGMEB) of the National Medical Commission (NMC) has ordered the medical colleges to strictly follow UG-MSR 2023 and MSMER 2023 and fulfil the requirements accordingly while applying for increase of seats/Renewal of permissions/Recognition of degree/continuation of Recognition for MBBS etc.

The Apex Medical Commission issued this direction after highlighting the fact that even though 75% attendance of the faculties is a must for approval or renewal, several colleges were found deficient in this regard.

NMC has, therefore, released a list of colleges with deficient faculty attendance and asked all the medical institutes to comply with UGMSR 2023 and MSMER 2023. “…failing which, appropriate action shall be taken against the college/institution,” warned the Apex Medical Body.

The Commission has clarified that in the absence of these requirements or deficiency in any of the fields, proposals for increase of seats/renewal of permissions/recognition of MBBS degree/continuation of Recognition shall not be considered and admissions for the Academic Year 2024-2025 shall not be allowed.

Earlier, NMC UGMEB notified the “Guidelines for Under Graduate Courses under Establishment of New Medical Institutions, Starting of New Medical Courses, Increase of Seats for Existing Courses & Assessment and Rating Regulations, 2023,” or the UG-MSR 2023 on August 16, 2023 in its official Gazette.

Also Read: NMC Notifies Guidelines for MBBS Course under Establishment of New Medical Institutions, Starting of New Courses, Increase of Seats, Assessment and Rating Regulations 2023

Meanwhile, the final Graduate Medical Education Regulations 2023 came into force on June 02, 2023, the date on which it was published in the official Gazette.

Referring to these, NMC mentioned in the recent notice dated 18.12.2023, “Para 3(f) of GMER-23: provide periodic and transparent assessment of medical education being imparted by Medical Institutions across the nation to meet with highest global standards. Further, in accordance with para 3.1 (i) & (ii) of UG-MSR 2023, All Medical Colleges/Institutions shall install AEBAS to be linked to Command and Control center of NMC and the daily AEBAS of the required staff (faculty, residents and supporting staff), preferably along with face linked recognition, shall be made available to NMC as well as on the Medical College Website in the form of daily attendance dashboard. Para 3.2 also provides that it shall be mandatory to have at least 75% of the total working days (excluding vacations) for all faculty and resident doctors.”

However, the Commission highlighted that while considering the applications received from the various medical colleges for increase of seats/renewal of permissions etc, it was found that there was a deficiency in respect of the attendance of the faculties. The attendance of the faculties were scrutinized by the Apex Medical Education Regulatory Body through the Aadhaar Enabled Biometric Attendance System (AEBAS), which has now been made mandatory in all the medical colleges.

“With reference to the applications received from various medical colleges for increase of seats/ renewal of permissions/ recognition of degree / continuation of Recognition for MBBS, attendance of faculties have been observed and scrutinized in accordance with the provisions contained in MSR 2020 so as to help colleges to cope up with the actual requirement as per Regulations/Guidelines, through AEBAS for the period from 19.6.2023 to 19.9.2023. 75% attendance of the faculties which is a mandatory requirement have been found deficient,” NMC mentioned in its notice.

Issuing the notice, NMC warned the medical institutes to strictly comply with the UG-MSR 2023 and MSMER 2023 (Maintenance Of Standards Of Medical Education Regulations 2023) requirements at their earliest. The Commission clarified that in case of deficiency the applications shall not be considered for the Academic Year 2024-2025.

“All the Medical Colleges are hereby informed that they must follow the UG-MSR 2023 and MSMER 2023 and fulfill the requirements accordingly, at their earliest. In the absence of these requirements or deficiency in any of the fields, proposal for increase of seats/ renewal of permissions /recognition of MBBS degree/ continuation of Recognition shall not be considered and admissions for the Academic Year 2024-25 shall not be allowed,” NMC mentioned.

Releasing a list of deficient colleges, the notice added, “All colleges/institutions which are not reflected in the list provided with the link shown at para 5 below and have students admitted at UG level shall be required to follow UGMSR 2023 and MSMER 2023 failing which, appropriate action shall be taken against the college/institution.”

Also Read: NMC releases final Graduate Medical Education Regulations 2023, check out details

Details of the attendance of these colleges may be viewed on the link mentioned in the notice :

Step 1 Open the link in Browser ( click on the link)

Step 2 Search your Medical College name

Step 3 Open the hyper link from last column ( Download from the website).

This will open PDF file in PDF viewer.

This will open the PDF file of the faculty attendance.

To read the NMC notice, click on the link below:

https://medicaldialogues.in/pdf_upload/nmc-public-notice-228200.pdf

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