Over 80% of pregnant women iron deficient by third trimester, finds study

When a woman becomes pregnant, her iron requirements increase almost tenfold to support fetal development as well as her own increased iron needs. Her ability to meet these increased iron needs depends on her iron stores at the beginning of the pregnancy as well as the physiological adaptations that enhance iron absorption as pregnancy progresses. These physiological adaptations, however, are not always enough to support a pregnant woman’s iron needs, especially among the estimated 50% of women who begin pregnancy with depleted iron stores. While often thought of as a problem in low-resource settings, recent studies have documented iron deficiency rates of 33-42% among pregnant women in high-resource settings.

Iron deficiency can lead to anemia, a condition in which the body can’t produce sufficient hemoglobin, which, in turn, limits the red blood cells’ ability to carry oxygenated blood throughout the body. Anemia during pregnancy is associated with a higher risk of both adverse maternal outcomes and adverse infant outcomes, including postpartum depression, postpartum hemorrhage, preterm birth, low birth weight, and small-for-gestational age birth. Even without the presence of anemia, maternal iron deficiency can result in long-term neurodevelopmental challenges for the child.

At the moment, screening for iron deficiency during pregnancy is not universally routine. Moreover, there is no generally agreed upon diagnostic criteria for iron deficiency during pregnancy. The most recent draft recommendation from the US Preventive Services Task Force, for example, states that “the current evidence is insufficient to assess the balance of benefits and harms of screening for iron deficiency anemia in pregnant women.” In contrast, the International Federation of Gynecology and Obstetrics and European Hematology Society recommend all pregnant women in their first trimester irrespective of the presence or absence of anemia be screened for iron deficiency. Moreover, they also recommend that all women of reproductive age irrespective of the presence or absence of anemia be screened for iron deficiency.

Even when screening is conducted, it may be insufficient to detect iron deficiency. In clinical practice, for example, hemoglobin is frequently the only benchmark used to evaluate iron status among pregnant women. Hemoglobin, however only provides an indication of anemia. As a result, poor maternal and infant health outcomes that may develop before iron deficiency advances to anemia may arise undetected.

Unfortunately, well-designed studies of the changes in iron status during the course of pregnancy are limited. In response, the authors of “Longitudinal Evaluation of Iron Status during Pregnancy: A Prospective Cohort Study in a High-Resource Setting” evaluated the changes in iron biomarkers throughout pregnancy, established the prevalence of iron deficiency, and proposed iron status benchmarks in early pregnancy that predict iron deficiency in the third trimester. The authors, Elaine K. McCarthy et al., also sought to determine how common risk factors for iron deficiency such as obesity and smoking affected iron status throughout pregnancy. The results of the study, one of the largest studies ever to document the changes in iron status during pregnancy, were published in The American Journal of Clinical Nutrition, a publication of the American Society for Nutrition.

To conduct their research, the authors worked with data collected from 641 women in Ireland who were pregnant and had a successful delivery for the first time and who participated in the IMproved PRegnancy Outcomes via Early Detection (IMPROvED) consortium project. Samples were taken from the women at 15 weeks, 20 weeks and 33 weeks of pregnancy to determine iron status. Within 72 hours following delivery, information about the pregnancy, delivery, and the baby were obtained from the mother via an interview with a research midwife. Information pertaining to clinical outcomes and complications during pregnancy and delivery were confirmed by reviewing medical records.

“In this high-resource setting,” the authors found that “iron deficiency defined by a variety of biomarkers and thresholds, was very common during pregnancy, despite the cohort profile as generally healthy.” Interestingly, none of the study participants were anemic in the first trimester, yet more than 80% of the women were iron deficient by the third trimester. In particular, the authors noted that “our cohort had higher rates of deficiency in the third trimester than even some low-resource settings.”

In this study, almost three-quarters of the participants took an iron-containing supplement that contained the Irish/European recommended daily iron allowance of 15-17mg. The authors did note that “iron-containing supplements (mainly multivitamins) taken pre/early pregnancy were associated with a reduced risk of deficiency throughout pregnancy, including the third trimester.”

According to the authors, these findings draw attention to “the benefit of screening for iron deficiency with hemoglobin and ferritin in defined low-risk populations.” Moreover, based on their findings, the authors proposed a threshold for ferritin, a protein that stores iron, of 60µg per liter or less at 15 weeks of pregnancy that predicted the presence of iron deficiency at 33 weeks of pregnancy, defined as 15µg of ferritin per liter or less. The authors noted that “this has previously been identified as the inflection point at which fetal iron accretion is compromised, leading to poorer neurocognitive function and earlier onset of postnatal iron deficiency in the offspring.”

In an accompanying editorial to this study, “Finally, a Quality Prospective Study to Support a Proactive Paradigm in Anemia of Pregnancy,” also published in The American Journal of Clinical Nutrition, authors Michael Auerbach and Helain Landy bluntly labeled the medical community’s approach to women, including the lack of screening and treating iron deficiency and anemia among pregnant women, as “misogyny.” Given the study’s findings, the editorial calls upon the American College of Obstetricians and Gynecologists and the United States Preventive Services Taskforce to “change their approach to diagnosis to screen all pregnant women for iron deficiency, irrespective of the presence or absence of anemia, and recommend supplementation when present for the most frequent nutrient deficiency disorder that we encounter.”

Looking to the future, the authors of “Longitudinal Evaluation of Iron Status during Pregnancy: A Prospective Cohort Study in a High-Resource Setting” believe that “further good-quality, large-scale longitudinal studies of iron status, with concurrent inflammatory status, are needed to provide the evidence base to help establish much-needed consensus. Moreover, the use of early pregnancy iron biomarkers and thresholds should be instituted in better alignment with clinically meaningful health outcomes.”

Reference:

Elaine K McCarthy, David Schneck, Saonli Basu, Annette Xenopoulos-Oddsson, Fergus P McCarthy, Mairead E Kiely, Michael K Georgieff, Longitudinal evaluation of iron status during pregnancy: a prospective cohort study in a high-resource setting, The American Journal of Clinical Nutrition, 2024, https://doi.org/10.1016/j.ajcnut.2024.08.010.

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‘Weekend warrior’ physical activity may help protect against more than 200 diseases, suggests study

Busy with work and other obligations, some people concentrate their moderate-to-vigorous exercise in one or two days of the week or weekend. A study led by investigators at Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system, has found that this “weekend warrior” pattern of exercise is associated with lower risk of developing 264 future diseases and was just as effective at decreasing risk as more evenly distributed exercise activity. Results are published in Circulation.

“Physical activity is known to affect risk of many diseases,” said co-senior author Shaan Khurshid, MD, MPH, a faculty member in the Demoulas Center for Cardiac Arrhythmias at Massachusetts General Hospital. “Here, we show the potential benefits of weekend warrior activity for risk not only of cardiovascular diseases, as we’ve shown in the past, but also future diseases spanning the whole spectrum, ranging from conditions like chronic kidney disease to mood disorders and beyond.”

Guidelines recommend at least 150 minutes of moderate-to-vigorous physical activity per week for overall health. Among people who meet these recommendations, however, do those who exercise 20–30 minutes most days of the week experience benefits over those who go 5 or 6 days between longer exercise sessions?

Khurshid, along with co-senior author Patrick Ellinor, MD, PhD, the acting chief of Cardiology and the co-director of the Corrigan Minehan Heart Center at Massachusetts General Hospital, and their colleagues analyzed information on 89,573 individuals in the prospective UK Biobank study who wore wrist accelerometers that recorded their total physical activity and time spent at different exercise intensities over one week. Participants’ physical activity patterns were categorized as weekend warrior, regular, or inactive, using the guideline-based threshold of 150 minutes per week of moderate-to-vigorous physical activity.

The team then looked for associations between physical activity patterns and incidence of 678 conditions across 16 types of diseases, including mental health, digestive, neurological, and other categories.

The investigators’ analyses revealed that weekend warrior and regular physical activity patterns were each associated with substantially lower risks of over 200 diseases compared with inactivity. Associations were strongest for cardiometabolic conditions such as hypertension (23% and 28% lower risks over a median of 6 years with weekend warrior and regular exercise, respectively) and diabetes (43% and 46% lower risks, respectively). However, associations also spanned all disease categories tested.

“Our findings were consistent across many different definitions of weekend warrior activity, as well as other thresholds used to categorize people as active,” said Khurshid.

The results suggest that physical activity is broadly beneficial for lowering the risk of future diseases, especially cardiometabolic conditions. “Because there appears to be similar benefits for weekend warrior versus regular activity, it may be the total volume of activity, rather than the pattern, that matters most,” said Khurshid. “Future interventions testing the effectiveness of concentrated activity to improve public health are warranted, and patients should be encouraged to engage in guideline-adherent physical activity using any pattern that may work best for them.”

Reference:

Shinwan Kany, Mostafa A. Al-Alusi, Joel T. Rämö, James P. Pirruccello, Timothy W. Churchill, Steven A. Lubitz, Associations of “Weekend Warrior” Physical Activity With Incident Disease and Cardiometabolic Health, Circulation, https://doi.org/10.1161/CIRCULATIONAHA.124.068669

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Apremilast Significantly Improves Genital Psoriasis Symptoms and QoL, reveals study

According to researchers, apremilast is the only oral phosphodiesterase 4 inhibitor that significantly improves symptoms of genital psoriasis and enhances quality of life in patients with moderate-to-severe disease. In a phase 3, randomized, placebo-controlled trial, the drug showed statistically and clinically meaningful benefits, hence depicting a promising treatment for this most challenging and stigmatizing condition. The research was published by Joseph F. Merola and colleagues in the Journal of the American Academy of Dermatology.

Genital psoriasis is an ultra-common and distressing presentation of psoriasis that affects patients’ quality of life and frequently brings significant social stigma. It has limited treatment options, especially with oral systemic agents. Apremilast is indicated for treating psoriasis, but this is the first study examining its effectiveness for treating genital psoriasis.

The DISCREET trial was a phase 3, randomized, double-blind, placebo-controlled study, NCT03777436, to determine the efficacy and safety of apremilast 30 mg twice daily in patients with moderate-to-severe genital psoriasis. This study consisted of a 16-week treatment period with an extension phase. Patients were stratified according to <10% and ≥10% affected body surface area to ensure balanced groups.

289 patients were randomized to apremilast, n=143, or placebo, n=146; the primary endpoint was the proportion of patients achieving a modified static Physician Global Assessment of Genitalia sPGA-G) score of 0 or 1 at Week 16 with at least a 2-point reduction from baseline. Secondary endpoints included improvements in genital signs and symptoms, overall skin involvement, and patient-reported quality of life outcomes.

Key Findings

  1. At week 16, 39.6% of patients treated with apremilast achieved the primary endpoint, as compared with 19.5% of patients receiving placebo, which corresponded to a difference of 20.1% between groups, statistically significant with P = .0003, thus confirming the efficacy of apremilast in the management of genital psoriasis.

  2. Treatment with apremilast was associated with dramatic improvements in genital signs and symptoms; significant reductions in itching, discomfort, and other psoriasis-related symptoms were reported. Besides genital area improvement, there were overall betterments of psoriasis symptoms in patients at other body areas.

  3. The researchers also showed that among individuals treated with apremilast, there was a significant improvement in quality-of-life measures, supporting the suggestion of better functioning in everyday life and reduced encumbrances related to emotional factors specific to genital psoriasis.

  4. The most frequently emergent adverse events in the apremilast group were diarrhea, headache, nausea, and nasopharyngitis. These adverse effects were of mild or moderate intensity, as would be consistent with a generally expected safety profile.

These results bring to the forefront an oral treatment option with apremilast in patients with genital psoriasis, where therapeutic choices have been few in this population. The significant improvement in symptoms of genital psoriasis, in combination with overall improvements in skin condition and quality of life, underlines the clinical relevance of apremilast in the management of this condition.

In this first randomized controlled study of an oral systemic treatment specifically for genital psoriasis, apremilast showed significant clinical efficacy and quality-of-life improvements. At Week 16, almost 40% of patients achieved a meaningful decrease in the symptoms of genital psoriasis, underscoring apremilast as another valid treatment option for this frequently stigmatizing condition. The results confirm apremilast’s part as an important addition to the treatment landscape for genital psoriasis, offering patients a much-needed therapeutic alternative.

Reference:

Merola, J. F., Parish, L. C., Guenther, L., Lynde, C., Lacour, J.-P., Staubach, P., Cheng, S., Paris, M., Picard, H., Deignan, C., Jardon, S., Chen, M., & Papp, K. A. (2024). Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis: Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial. Journal of the American Academy of Dermatology, 90(3), 485–493. https://doi.org/10.1016/j.jaad.2023.10.020

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Children under continuous kidney replacement therapy have higher risk of vitamin D deficiency, finds research

A new study by Peace Dorothy Imani and team found that children who need continuous kidney replacement therapy (CKRT) are more likely to have osteopenia, fractures, and/or vitamin D deficiency. The findings of this study were published in the journal of BMC Nephrology. A typical feature of chronic kidney disease (CKD) is altered calcium and phosphate balance. The dysregulation of phosphate metabolism, parathyroid hormone (PTH), fibroblast growth factor (FGF)-23, expression of Klotho, and 1,25-dihydroxyvitamin D (1, 25 di-(OH)2D) causes this. The ensuing metabolic abnormalities are linked to both mineral bone disease (MBD) and an elevated risk of cardiovascular disease, which is a primary cause of morbidity and death in people with chronic kidney disease (CKD).

In critically unwell children with acute kidney injury (AKI), continuous kidney replacement therapy is used to manage hemodynamics and gradually remove fluid while permitting nutritional assistance. Recent consensus from the Acute Disease Quality Initiative (ADQI) defines acute kidney disease (AKD) as AKI lasting more than 7 days but less than 90 days. This study was to characterize the bone and metabolic results of juvenile AKD patients who needed more than 28 days of CKRT combined with localized citrate anticoagulation.

In this prospective observational research conducted at a single site, the study included 37 patients who needed regional citrate anticoagulation and CKRT for at least 28 days. The duration of CKRT was the exposure, and the results included osteopenia and/or fractures, as well as 25-hydroxy vitamin D. Vitamin D insufficiency and deficiency were prevalent in 17.2% and 69.0% of people, respectively. The radiographic evidence of osteopenia and/or fractures were present in 29.7% of the patients. Also, age or ethnicity did not appear to have any impact on vitamin D deficit or insufficiency. Vitamin D levels were not predicted by duration on CKRT or intact PTH levels. After correcting for age and length of CKRT, children with chronic liver illness had an odds ratio higher than children with other main diagnoses for osteopenia and/or fractures.

Overall, vitamin D insufficiency and inadequacy are common in juvenile AKD patients undergoing CKRT and may deteriorate despite conventional supplementation. The patients who require extended CKRT may require higher doses of vitamin D supplementation to maintain adequate levels and avoid MBD.

Source:

Imani, P. D., Vega, M., Pekkucuksen, N. T., Srivaths, P., & Arikan, A. A. (2024). Vitamin D and metabolic bone disease in prolonged continuous kidney replacement therapy: a prospective observational study. In BMC Nephrology (Vol. 25, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s12882-024-03705-9

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Maternal depression during early pregnancy associated with impaired child executive functioning at 4 to 5 years of age: AJOG

Maternal depression is a serious condition that affects up
to 1 in 7 pregnancies. Despite evidence linking maternal depression to
pregnancy complications and adverse fetal outcomes, there remain large gaps in
its identification and treatment. More work is needed to define the specific
timing and severity of depression that most urgently requires intervention,
where feasible, to protect maternal health and the developing fetus.

A study by Levitan RD et al aimed to examine whether the
timing and severity of maternal depression and/or anxiety during pregnancy
affect child executive functioning at age 4.5 years. Executive functioning in
the preschool years is a strong predictor of both school readiness and longterm
quality of life.

This longitudinal observational pregnancy cohort study
included a sample of 323 mother-child dyads taking part in the Ontario Birth
Study, an open pregnancy cohort in Toronto, Ontario, Canada. Maternal symptoms
of depression and anxiety were assessed at 12 to 16 and 28 to 32 weeks of
gestation and at the time of child testing at age 4.5 years using the 4-item
Patient Health Questionnaire. Child executive functioning was measured during a
home visit using standardized computerized administration of the Flanker test
(a measure of attention) and the Dimensional Change Card Sort (a measure of
cognitive flexibility). Posthoc general linear models were used to assess
whether maternal depression severity categories (no symptom, mild symptoms, or
probable major depressive disorder) were helpful in identifying children at
risk.

Across all children, after controlling for potential
confounds, greater maternal depressive symptoms at weeks 12 to 16 weeks of
gestation predicted worse performance on both the Flanker test (DR2 ¼0.058; P<
.001) and the Dimensional Change Card Sort (P=.018). Posthoc general linear
modeling further demonstrated that the children of mothers meeting the
screening criteria for major depression in early pregnancy scored 11.3% lower
on the Flanker test and 9.8% lower on the Dimensional Change Card Sort than the
children of mothers without maternal depressive symptoms in early pregnancy.
Mild depressive symptoms had no significant effect on executive function
scores. There was no significant effect of anxiety symptoms or maternal
antidepressant use in early pregnancy or pandemic conditions or maternal
symptoms in later pregnancy or at the time of child testing on either the
Flanker or Dimensional Change Card Sort results.

This study demonstrated that fetal exposure to maternal
major depression, but not milder forms of depression, at 12 to 16 weeks of
gestation is associated with impaired executive functioning in the preschool
years.

The current findings suggest that maternal major depression
during early pregnancy may have a particularly deleterious effect on the fetal
brain circuitry necessary for child executive functioning. This emphasizes an
urgent need to improve the recognition and treatment of major depression,
particularly in early pregnancy, to limit its negative effects on child
cognitive development. Possible treatments include both antidepressant
medications and cognitive behavior therapy, which now has proven efficacy for
antenatal depression per se.

This study demonstrated that fetal exposure to maternal
major depression, but not milder forms of depression, at 12 to 16 weeks of
gestation is associated with impaired executive functioning in the preschool
years. Child executive functioning is crucial for school readiness and predicts
long-term quality of life. This emphasizes an urgent need to improve the
recognition and treatment of maternal major depression, particularly in early
pregnancy, to limit its negative effects on the patient and on child cognitive
development.

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Study Finds No Long-Term Benefits of Lung Recruitment Before Surfactant in Extremely Preterm Neonates

Italy: In a significant advancement for neonatal care, researchers have published the results of a randomized clinical trial investigating the effects of lung recruitment maneuvers before surfactant administration in extremely preterm neonates.

The trial, published in JAMA Network Open, compared a group of neonates who underwent lung recruitment maneuvers before receiving surfactant to a control group that received standard care. There were no notable differences between the two groups regarding mortality, neurodevelopmental outcomes, growth measurements, or rates of recurrent respiratory infections at the two-year follow-up.

“These findings can assist clinicians in determining the most effective approach to surfactant administration by taking long-term outcomes into account,” the researchers wrote.

A multicenter randomized clinical trial (RCT) demonstrated that employing a lung recruitment maneuver with high-frequency oscillatory ventilation just before surfactant administration—referred to as intubate-recruit-surfactant-extubate (IN-REC-SUR-E)—enhanced treatment efficacy compared to the standard intubate-surfactant-extubate (IN-SUR-E) method, without raising the risk of negative neonatal outcomes. Francesca Gallini, Neonatology Unit, Ospedale Isola Tiberina, Gemelli Isola, Rome, Italy, and colleagues aimed to evaluate follow-up outcomes at a corrected postnatal age (cPNA) of two years for preterm infants who were previously enrolled in an RCT and received either the IN-REC-SUR-E or IN-SUR-E treatment across 35 tertiary neonatal intensive care units.

For this purpose, the researchers conducted a follow-up study on infants recruited from 2015 to 2018 at 35 tertiary neonatal intensive care units (NICUs) in Italy. The study assessed neurodevelopmental, growth, and respiratory outcomes at a corrected postnatal age (cPNA) of two years for extremely preterm neonates (24 0/7 to 27 6/7 weeks’ gestation) who met failure criteria for continuous positive airway pressure within the first 24 hours of life. Participants were randomly assigned to either the IN-REC-SUR-E or IN-SUR-E intervention.

The primary outcome measured was the incidence of death after discharge or major disability at cPNA for two years. Secondary outcomes included neurodevelopmental issues (such as major disability, cerebral palsy, cognitive impairment, and sensory deficits), anthropometric data (weight, length, and head circumference), and rates of recurrent respiratory infections and hospitalizations due to respiratory causes at two years cPNA. Data analysis occurred between April 2023 and January 2024.

Based on the study, the researchers revealed the following findings:

  • One hundred thirty-seven extremely preterm infants (median gestational age, 26.5 weeks and 54.7% female), initially enrolled in the original RCT, were followed up at cPNA two years, including 64 infants in the IN-SUR-E group and 73 infants in the IN-REC-SUR-E group.
  • There were no significant differences in death occurrence after discharge or major disability at cPNA two years (IN-SUR-E: 20.3% children versus IN-REC-SUR-E: 13.7% children).
  • There were no significant differences in the incidence of disability, cerebral palsy, or cognitive impairment in the IN-REC-SUR-E group compared with the IN-SUR-E group.
  • There were no significant differences in anthropometric measurements (weight, length, and head circumference) between groups.
  • There were no significant differences between groups in the incidence of recurrent respiratory infections or hospitalizations because of respiratory causes.

The findings indicate that the intubate-recruit-surfactant-extubate technique is a safe approach for the outcomes assessed.

However, the researchers noted that their findings cannot yet be compared with data from other cohorts. They emphasized the need for further multicenter studies to confirm their results better.

“Additionally, neurodevelopmental outcomes, including growth and respiratory health, for all patients treated with this new procedure should be evaluated prospectively to further validate the safety and efficacy of the IN-REC-SUR-E technique compared to the standard IN-SUR-E method,” they concluded.

Reference:

Gallini F, De Rose DU, Iuliano R, et al. Lung Recruitment Before Surfactant Administration in Extremely Preterm Neonates: 2-Year Follow-Up of a Randomized Clinical Trial. JAMA Netw Open. 2024;7(9):e2435347. doi:10.1001/jamanetworkopen.2024.35347

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Vision loss due to negligence in surgery: Eye Hospital, ophthalmologists slapped Rs 15 lakh Compensation

Visakhapatnam: Holding a private eye institute, its director and two ophthalmologists guilty of medical negligence, the District Consumer Disputes Redressal Commission-II, Visakhapatnam directed them to pay Rs 15 lakh to the patient who lost vision in one eye.

The history of the case goes back to February 2019 when the patient was chatting with his friend while another friend was playing with an air rifle. One of the pellets from the air rifle touched the complainant’s left eye and due to this, he sustained bleeding injury. 

Although he was shifted to Visakha Eye Hospital, Visakhapatnam at first, the doctors expressed their inability to treat the patient and advised him to shift to the treating hospital i.e. L.V. Prasad Eye Institute.

Accordingly, the patient was admitted to the treating hospital, where Dr. Ballala, the on-duty ophthalmologist, checked the patient and instructed the optometrist to check the injury. Later, after observation, the complainant was sent to Dr Annapoorna, who diagnosed that the complainant’s left eye was having ‘Open Globe Injury-Zone 1’. Therefore, Slit Lamp Photography was conducted for the injury and it was found that the complainant had defective vision following the injury with a gun pellet (Aluminimum Pellet) and found subconjunctival hemorrhage + full thickness corneal tear from 12 o’clock limbus towards inferiority in Y shape- indo dialysis and iris prolapse through the wound – vitreous prolapsed along with lens prolapsed noted through the wound-vitreous hemorrhage. 

Following this, the doctor shielded the complainant’s eye and medicines were also prescribed. The complainant was advised of surgery- primary globe integrity and was explained the risk of Endophthalmitis, Sympathetic Ophthalmitis and Retinal detachment. After explaining his condition, the doctor advised for a management operation for a corneal tear.

Accordingly, the surgery was conducted on 20.02.2019. It was alleged that the B Scan was conducted only on the next day of operation and was not conducted before the operation or on the date of operation. However, there was no improvement in the injured eye and thereafter the complainant visited Aravind Eye Hospital in Coimbatore. A CT scan was conducted and it revealed that the pellet was still there in the left eye.

Consequently, the complainant moved to several eye hospitals and underwent another surgery for removal of the remaining pellet part and the patient also underwent Oculoplasty but his vision was not restored. 

Thereafter, the complainant filed a consumer complaint before the District Consumer Disputes Redressal Commission, Visakhapatnam and asked the eye hospital, its director and two doctors to pay compensation for their medical negligence leading to the loss of the complainant’s vision.

On the other hand, the hospital and its doctors denied any medical negligence on their part and submitted that the surgery was performed as per internationally accepted practice with due care and concern and the bleeding from the complainant’s eye was successfully stopped on the day of surgery.

They further submitted that the treatment post-procedure was duly prescribed and explained to the complainant. According to the hospital and its doctors, the complainant did not follow up as advised and therefore the complainant having not followed the advice cannot now attribute negligence on the part of the hospital and its doctors.

While considering the matter, the District Consumer Court noted,

“Irrespective of the recovery of vision, the Exhibits placed on the file of this Commission and the treatment report filed by the opposite parties prima facie speak that the present case is `res ipsa loquitur.’ The first instance of decision making to proceed for the surgery without proper investigations and tests proves negligence on part of the opposite parties-1 to 4 which falls within the guidelines of the above quoted precedents, rather the opposite parties-1 to 4 failed to abide by their duties as per the guidelines set by the Honourable Supreme Court. Therefore the opposite parties-1 to 4 (the hospital’s directors and doctors) are at liability for medical negligence, thereby deficiency of service and the complainant is entitled for compensation for mental agony, and sufferance.”

“…such a part of the body/ an eye should be attended with utmost care. The Complainant had to roam around pillar to post searching for a specialist/expert who was not referred by the Opposite Parties-1 to 4 which was their duty to do so and spend a lot of money with a hope of recovery of vision and ultimately had to go for oculoplasty and incur lots of financial loss and sufferance which could have been avoided if the treatment at 2nd opposite party hospital was done in an right manner at the right time,” observed the Commission.

Therefore, holding the hospital and its doctors guilty of medical negligence, the Commission directed them to pay Rs 15 lakh compensation. “The opposite parties-1 to 4 are jointly and severally directed to pay an amount of Rs.15,00,000/- (Rupees fifteen lakhs only) towards compensation for medical negligence which includes compensation for pain and sufferance,” ordered the Commission. The hospital and its doctors have also been directed to pay rs 10,000 as legal cost.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/visakhapatnam-dcdrc-254067.pdf

Also Read: Doctors Need to be Protected from Frivolous Prosecution for Unjust Compensation: Bombay HC

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Eris Lifscience Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC

New Delhi: Reviewing the bioequivalence (BE) study report of the fixed-dose combination (FDC) antidiabetic drug Dapagliflozin Propanediol Monohydrate plus Gliclazide plus Metformin Hydrochloride film-coated bilayer tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Eris Lifesciences to manufacture and market the proposed antidiabetic drug.

However, this approval is subject to the condition of conducting the Phase IV clinical trial of the proposed FDC.

This nod came after the firm presented a BE study report of Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg/10mg + Gliclazide IP (SR) 30mg/60mg + Metformin Hydrochloride IP (SR) 500mg/500mg film-coated bilayered tablet before the committee.

Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. Dapagliflozin is indicated as an adjunct treatment, alongside diet and exercise, to improve glycemic control in patients ≥10 years of age with type 2 diabetes mellitus.

For patients with chronic kidney disease at risk of progression, dapagliflozin is used to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure.

Dapagliflozin is also indicated to either reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. Combination products with dapagliflozin also exist, either as a dapagliflozin-saxagliptin or dapagliflozin-metformin hydrochloride formulation.

Gliclazide is a sulfonylurea used to treat hyperglycemia in patients with type 2 diabetes mellitus. Gliclazide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM).

Gliclazide binds to the β cell sulfonylurea receptor (SUR1). This binding subsequently blocks the ATP-sensitive potassium channels. The binding results in the closure of the channels and leads to a decrease in potassium efflux, which leads to depolarization of the β cells.

Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in your blood. It decreases the amount of glucose you absorb from your food and the amount of glucose made by the liver.

Metformin’s mechanism of action is the alteration of the energy metabolism of the cell. Metformin exerts its prevailing, glucose-lowering effect by inhibiting hepatic gluconeogenesis and opposing the action of glucagon.

At the recent SEC meeting for Endocrinology and Metabolism held on September 19, 2024, the expert panel reviewed the BE study of the FDC antidiabetic drug Dapagliflozin Propanediol Monohydrate plus Gliclazide plus Metformin Hydrochloride film-coated bilayered tablet

After detailed deliberation, the committee considered the BE study report and recommended the grant of permission to manufacture and market the FDC with the condition of conducting the Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months from approval of the FDC, for further review by the SEC.

Also Read: Conduct Active Surveillance Study: CDSCO Panel Tells Pfizer on Abrocitinib tablets

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NBE notifies on Completion of Joining formalities, Self-Appraisal for Registration by trainees, details

New Delhi: Through a recent notice, NBE (National Board of Examination) has informed FNB trainees for the 2023 Admission Session and concerned training institutions regarding the Completion of Joining formalities and Self-Appraisal for Registration with NBEMS at the Online Portal for Joining & Registration (OPJR).

NBEMS introduced a Self-Appraisal by candidates for seeking registration with NBEMS as NBEMS trainees to pursue NBEMS courses, the 2023 admission session onwards.

This self-appraisal is meant to determine the eligibility of candidates for registration with NBEMS as trainees subsequent to their joining at the NBEMS-accredited institutions allotted through centralized merit-based counseling.

The eligibility of candidates for said NBEMS programme is determined on the basis of prescribed criteria in the information bulletin for respective entrance examinations. On successfully meeting the criteria and submission of self-appraisal with prescribed documents to NBEMS through the training institutions, candidates get registered with NBEMS as trainees. A letter to this effect in form of a “Letter of Provisional Registration” shall be available for download on a real time basis on successful completion of self-appraisal by the trainee & respective training institution.

Following 4 steps shall be required to be completed by FNB trainees of 2023 admission session for getting registration with NBEMS, in sequence as mentioned below:

a. Submission of Joining formalities at OPJR by candidate

b. Verification of Joining status at OPJR by training institution

c. Submission of Self-Appraisal at OPJR by candidate

d. Verification of Self-Appraisal at OPJR by training institution

Timelines for opening of Self-appraisal window for FNB courses of 2023 admission session:

Process 

Timelines of online window 

Submission of joining status and self-appraisal

forms by candidates to their training institutions

26th September 2024 to

22nd October 2024 (till 11:55PM)

Confirmation of joining status and Verification

of the self-appraisal forms & documents of the

candidates by NBEMS Accredited institutes

26th September 2024 to

31st October 2024

No extension of the online window shall be admissible. Candidates who would fail to complete their self-appraisal during the prescribed window shall NOT be registered as NBEMS trainees.

Candidates shall be required to go through the information bulletin for FET 2023 before they proceed to complete the joining formalities and the self-appraisal. They shall be further required to go through the detailed guidelines available at Online Portal for Joining & Registration (OPJR) before they proceed with the Joining and Self-appraisal at OPJR. It is strongly advised to carefully go through the declaration which they shall be agreeing to after completing the joining & self-appraisal proforma.

It shall be the complete responsibility of the candidate for the accuracy and authenticity of the information provided at OPJR and the documents submitted. Any discrepancies or misrepresentations found in the information provided shall lead to the termination of the candidature to pursue the course without any prior notice or an opportunity being given by NBEMS.

The training institutions shall verify the joining details and self-appraisal submitted by the candidate before approving the same. The training institutions approving/ forwarding any false or fabricated records/information/documents for the purpose of seeking registration of the candidate as a trainee shall be liable for action as may be appropriate in terms and conditions of the accreditation agreement.

The joining of FNB trainees is subject to successful completion of joining formalities & self-appraisal within prescribed timelines and its subsequent verification by the training institutions

The registration so granted on submission of self-appraisal form and its subsequent verification by the training institution shall be purely provisional and has been granted only for the specific purpose of undertaking the FNB course. The provisional registration shall be subject to verification of the information and documents furnished by the trainee at OPJR and mere grant of this registration will not create any rights/equity in favour of the trainee, whatsoever, to undertake the FNB course or appear in FNB Exit Examination or award of FNB Qualification.

To view the official Notice, Click here : https://medicaldialogues.in/pdf_upload/nbems20241723844169jpg-254380.pdf

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Dr NTRUHS begins registrations for NEET PG Counselling Under Management Quota 2024, Know admission details here

Andhra Pradesh- Dr NTR University of Health Sciences (DR NTRUHS) is inviting online applications for admission into the Post Graduate Medical Degree and Diploma Courses in private un-aided non-minority and minority medical colleges under management quota in the state of Andhra Pradesh for the academic year 2024-25. On this, NTRUHS has released a prospectus detailing the eligibility, fee structure, registration and processing fee, procedure to fill out applications online, documents, and other details.

The online application form for determining Merit Positions in respective categories – Category – B (S1) & Category-C- NRI (S2)/ Institutional Quota(S3) is already been made live on the official website of NTRUHS which will be active till 09.00 PM on 04 October 2024 without the late fee candidates. For candidates with late fees, the application will be available from 09.00 AM on 05 October 2024 to 09.00 PM on 07 October 2024.

Also Read: Dr NTRUHS Invites Applications for NEET PG Counselling 2024, Know Eligibility, Fee, Application Process, all details here

CERTIFICATES REQUIRED BEFORE FILLING THE APPLICATION FORM ONLINE

The following Certificates are required at the time of Online Registration-

1 NEET-2024 – SCORE CARD.

2 Copy of Original Degree/Provisional certificate of MBBS.

3 Copy of MBBS study certificate.

4 Copy of the Compulsory Rotatory Internship certificate.

5 6th to Inter/10+2 study certificates for the candidates who have completed MBBS from Govt. Siddhartha Medical College, Vijayawada.

6 Copies of Temporary/Permanent Medical Registration from the respective State Medical Council.

7 Sponsorship Letter from Institute/College for claiming Institutional Quota-S3.

8 Caste Category Certificate.

9 Minority Certificate.

10 Aadhar Card, PAN Card etc.

11 Candidate’s latest passport-size Photo.

12 Specimen Signature of the Candidate.

13 Candidates claiming NRI Quota Should submit the following documents-

i Green Card (OR) Citizenship Card (OR) Pass-port issued by the respective Country and,

ii Copy of NRI’s Bank Statement for the last 6 months (OR) Latest Electricity Bill (OR) Gas Bill (OR) Water Bill in the name of NRI.

iii Visa / Driving license will NOT be accepted.

THE REGISTRATION & PROCESSING FEE (WITHOUT LATE FEE)

S.NO

CATEGORY

REGISTRATION & PROCESSING FEE INCLUDING 18% GST

IN ADDITION TO REGISTRATION & PROCESSING FEE, VERIFICATION FEE INCLUDING 18% GST

TOTAL AMOUNT

MBBS COMPETED WITHIN AP

1

OC/BC

₹.7080/- (6,000/- + 1,080/- GST 18%)

—

₹.7,080/-

MBBS COMPETED OUTSIDE AP

2

OC/BC

₹.7080/- (6,000/- + 1,080/- GST 18%)

₹.3,540/- (3,000/-+540/- (GST 18%)

₹.10,620/-

MBBS COMPETED OUTSIDE COUNTRY

3

OC/BC

₹.7080/- (6,000/- + 1,080/- GST 18%)

8,260/- (7,000/-+1,260/- (GST 18%)

₹.15,340/-

THE REGISTRATION & PROCESSING FEE (WITHOUT LATE FEE)

S.NO

CATEGORY

FEE IN RS

LATE FEE RS

TOTAL AMOUNT

1

OC/BC

₹.7080/- (6,000/- + 1,080/- GST 18%)

₹.20,000/- (FEE RS.16,950 + GST @ 18% = 3,050/-)

₹.27,080/-

MBBS COMPETED OUTSIDE AP

2

OC/BC

₹.7080/-+3540/-=10,620/-

₹.20,000/- (FEE RS.16,950 + GST @ 18% = 3,050/-)

₹.30,620/-

MBBS COMPETED OUTSIDE COUNTRY

3

OC/BC

₹.7080/-+8260/- =15,340/-

₹.20,000/- (FEE RS.16,950 + GST @ 18% = 3,050/-)

₹.35,340/-

It is to be noted that the application Meanwhile, the application and processing fees including the late fee once paid will not be refunded or adjusted to a future date under any circumstances. The fee can be paid through a Debit card, Credit card or Net Banking.

ELIGIBILITY

1 The candidates who fulfil the following criteria are eligible for admission into Post Graduate Medical Degree/Diploma courses.

2 Candidates should have completed the internship latest by 15-08-2024.

3 The candidates should secure the following cut-off scores in NEET PG-2024 conducted by the National Board of Examinations.

S.NO

CATEGORY

MINIMUM QUALIFYING/ELIGIBILITY CRITERIA

1

General/EWS.

50th percentile

2

General-PwBD.

45th percentile

3

SC/ST/OBC (Including PwBD of SC/ST/OBC)

40th percentile

ADMISSION RULES

1 The last date for reporting by the selected candidates at the allotted college will be communicated in the allotment order.

2 All the candidates including In-service candidates joining the Post Graduate Degree, and Diploma courses should execute a bond on a stamped paper of ₹. 100/- value to the effect that he/she will complete the prescribed period of training or in default to pay ₹.3,00,000/- + 18% GST to the University and should refund the amount received as stipend up to that date to the Government as notified by the University from time to time.

3 Candidates have to pay the discontinuation penalty of ₹ 3,00,000/- + 18% GST and they will be debarred for three years for admission into Post Graduate Medical Degree/Diploma courses at the colleges in the State of Andhra Pradesh.

BREAK OF STUDY AND RE-ADMISSION

If a student is absent continuously for 91 days or more and seeks permission to attend the course, his / her application by paying the requisite fee in favour of the Registrar, Dr NTR University of Health Sciences payable at Vijayawada will be forwarded to the Registrar, Dr NTR University of Health Sciences with the recommendation of the Dean/Principal. The candidates are advised to refer to the regulations before submitting the application and paying the fee. If they fulfil the conditions, they may submit applications through the Dean/Principal of the College by paying the fee. A maximum of two spells of break of study is allowed during the entire period of the course. A candidate has to complete the course including passing the final University examination within twice the duration of the course i.e., 6 years from the date of admission to the course. Re-admission is not permitted if the candidate cannot complete the course within twice the duration of the course.

MERIT LISTS

1 The Merit Position of the candidates who have applied online in response to the notification issued by Dr NTR University of Health Sciences for Management Quota Seats should be determined by NEET PG–2024 Rank and as per their eligibility criteria, applicable regulations, and guidelines.

2 The University will release the final merit position of eligible candidates for exercising web options after verification of uploaded scanned certificates by Dr.NTR UHS, Vijayawada.

To view the prospectus, click the link below

https://medicaldialogues.in/pdf_upload/pg-medical-mq-prospectus-2024-25-ntr-254641.pdf


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