lncreased fetal catecholamines associated with postnatal hypoglycemic episodes: JAMA

Neonatal hypoglycemia, a condition marked by low blood sugar levels in newborns, poses significant risks and can be particularly concerning for infants with perinatal stress or fetal growth restriction. Understanding the underlying mechanisms of this condition is crucial for effective management and prevention.

Perinatal stress and fetal growth restriction are known risk factors for neonatal hypoglycemia, but the precise pathomechanism remains unclear. In a recent study, researchers investigated whether elevated catecholamine concentrations in umbilical cord blood (UCB) and amniotic fluid (AF) are associated with neonatal hypoglycemia and whether they correlate with postnatal glycemic levels. This study was published in the JAMA Pediatrics. The study was conducted by Henrike H. and colleagues.

The key findings of the study were:

• The study involved 328 neonates, with 234 in the risk group and 94 in the control group.

• Growth-restricted neonates showed increased umbilical cord blood (UCB) concentrations of norepinephrine (21.10 vs 10.88 nmol/L), metanephrine (0.37 vs 0.12 nmol/L), and 3-methoxytyramine (0.149 vs 0.091 nmol/L) compared to controls.

• Neonates with perinatal stress had increased UCB concentrations of norepinephrine (22.55 vs 10.88 nmol/L), normetanephrine (1.75 vs 1.25 nmol/L), and 3-methoxytyramine (0.120 vs 0.091 nmol/L).

• UCB norepinephrine, metanephrine, and 3-methoxytyramine concentrations were positively correlated with the number of hypoglycemic episodes (rs = 0.146, p = 0.01; rs = 0.151, p = 0.009; and rs = 0.180, p = 0.002, respectively).

• These concentrations were also negatively correlated with the lowest measured blood glucose levels (rs = -0.149, p = 0.01; and rs = -0.153, p = 0.008).

• UCB catecholamine concentrations were negatively correlated with amniotic fluid C-peptide concentration (rs = -0.212, p = 0.005; rs = -0.182, p = 0.016; and rs = -0.183, p = 0.016).

• A p-value of less than 0.0083 was considered statistically significant due to multiple comparisons.

Neonates at risk for hypoglycemia exhibited elevated catecholamine concentrations in UCB, which correlated with postnatal hypoglycemic episodes and lower blood glucose levels. These findings suggest a link between perinatal stress, fetal growth restriction, and neonatal hyperinsulinemic hypoglycemia. Understanding these mechanisms could improve the management of newborns at risk for hypoglycemia.

Reference:

Hoermann, H., van Faassen, M., Roeper, M., Hagenbeck, C., Herebian, D., Muller Kobold, A. C., Dukart, J., Kema, I. P., Mayatepek, E., Meissner, T., & Kummer, S. (2024). Association of fetal catecholamines with neonatal hypoglycemia. JAMA Pediatrics. https://doi.org/10.1001/jamapediatrics.2024.0304

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Study finds high prevalence of hidden brain changes in people with heart disease

A new analysis involving over 13,000 people has found changes to blood vessels in the brain that can increase the risk of stroke and dementia are common in people with a range of heart conditions, regardless of whether they have experienced a stroke.

The new research, published today in Neurology®, the medical journal of the American Academy of Neurology, is the most comprehensive systematic review of ‘hidden’ brain changes in people with a range of heart conditions to date.

Lead author Dr Zien Zhou from The George Institute for Global Health said that identifying these changes could play an important role in choosing treatments for these patients.

“Although people with heart disease are two to three times more likely than the general population to have changes in their brain’s vascular system, they’re often overlooked, because these patients don’t routinely undergo brain imaging unless they have suffered a stroke,” he said.

“But it can make them more susceptible to the risk of brain bleeds from medications commonly used to treat or prevent blood clots – intracranial hemorrhage is a life-threatening complication with no proven treatment and a survival rate of less than 50 percent.”

Changes to blood vessels in the brain that can only be detected by brain imaging such as silent brain infarction (SBI) and cerebral small vessel disease (CSVD) are known to occur more commonly in older people or those who have hypertension. While not sufficient to cause obvious neurological symptoms, they can result in subtle neurological deficits and increase the longer-term risk of stroke or dementia.

To determine the prevalence of these hidden or covert cerebrovascular changes in adults with atrial fibrillation, coronary artery disease, heart failure or cardiomyopathy, heart valve disease, and patent foramen ovale (a hole in the heart), George Institute researchers conducted a meta-analysis of 221 observational studies published between 1988 and 2022.

The findings showed that in people with heart disease:

  • approximately one third had any form of SBI
  • a quarter had lacune (small cavities where neural tissue has died after a previous blockage or leakage from small arteries)
  • two-thirds had white matter lesions (damage to the protective coating around nerve fibres)
  • a quarter had evidence of asymptomatic microbleeds in the brain tissue, and
  • over one half had brain atrophy (a shrinking of the brain due to loss of neurons or connections between neurons).

The prevalence of these brain changes was generally the same between those with and without a recent stroke and there were no apparent sex differences in the results.

Dr Zhou said the study also confirmed that heart disease is one of the main causes of these changes that reflect brain ‘frailty’.

“While several potential mechanisms of the association between heart disease and hidden cerebrovascular injury have been proposed, the two conditions share common risk factors such as ageing, hypertension, type 2 diabetes, hyperlipidaemia, and smoking,” said Dr Zhou.

“It’s possible that a gradual decline in cardiac output in some patients with heart disease might affect how much blood is reaching the brain tissue, contributing to vascular changes and cognitive dysfunction in these patients,” he added.

“It’s also possible that hidden brain changes and cognitive dysfunction are a consequence of tiny blood clots traveling to the brain through the arterial circulation after forming in the heart.”

Dr Zhou said that more research was needed to look at the exact causes of these brain changes and the implications for managing these patients.

“We need to know whether performing an additional MRI in those considered for anticoagulation therapy – which is required for most people with heart disease – would be cost-effective in terms of preventing unwanted side effects,” he said.

“But refining the risks of brain clots and bleeds from anticoagulants and using this information to make the best treatment choice could improve treatment safety for people with heart disease.”

Reference:

Zien Zhou, Shoujiang You, Yuki Sakamoto, Ying Xu, Song Ding,  Wenyi Xu, Wenjie Li, Covert Cerebrovascular Changes in People With Heart Disease, Neurology, https://doi.org/10.1212/WNL.000000000020920

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Heart health declines rapidly after menopause, claims study

A woman’s cardiovascular risk can rise sharply after she goes through menopause, quickly catching up to men of a similar age and health profile, according to new findings presented at the American College of Cardiology’s Annual Scientific Session. Researchers said the study underscores the importance of recognizing and addressing early warning signs of heart disease risk in women as they lose the protective effects of estrogen after menopause.

“This is a unique study cohort of only post-menopausal statin users that signals that post-menopausal women may have risk of heart disease that is on par with males,” said Ella Ishaaya, MD, an internal medicine physician at Harbor-UCLA Medical Center in Torrance, California, and the study’s lead author. “Women are underscreened and undertreated, especially post-menopausal women, who have a barrage of new risk factors that many are not aware of. This study raises awareness of what those risk factors are and opens the door to indicating the importance of increased screening for coronary artery calcium (CAC).”

In the study, post-menopausal women underwent heart scans to assess their CAC score, a measure of plaque buildup-fat, calcium and other substances-in the heart’s arteries. CAC levels are assessed with a quick, non-invasive scan similar to an X-ray. A higher CAC score indicates a higher risk of a heart attack or other cardiac events.

Researchers analyzed data from 579 post-menopausal women who were taking statins to control their cholesterol and had undergone two CAC scans at least one year apart. Participants did not have heart disease at the time of the first scan. To compare CAC changes in men and women, each female participant was matched with a male of a similar profile in terms of age, race, statin use, blood pressure and diabetes status.

Researchers divided the participants into three groups with CAC levels of 1–99, 100–399, and 400 or higher at baseline. Between their first and second heart scan, women with baseline CAC of 1–99 saw their CAC rise by a median of eight points, double the median of four seen in their male counterparts. Similarly, women with baseline CAC of 100–399 saw their CAC rise by a median of 31 points, about double the median of 16 seen in males. There was no significant difference between sexes for those with baseline CAC of 400 or higher.

The findings suggest plaque buildup is accelerated in post-menopausal women compared to men, indicating that many women experience a steep rise in the risk of heart problems. Ishaaya said this is likely related to the drop in estrogen that women experience during menopause. Estrogen has long been known to have a protective effect on heart health, but researchers said many women and even many clinicians are not aware of what it means to lose that protection during menopause.

“After menopause, women have much less estrogen and shift to a more testosterone-heavy profile,” Ishaaya said. “This affects the way your body stores fat, where it stores fat and the way it processes fat; it even affects the way your blood clots. And all of those [changes] increase your risk for developing heart disease.”

Heart disease is the leading cause of death in both men and women, but women’s cardiovascular risk has traditionally been undertreated because women tend to develop heart disease at an older age than men and may experience different and sometimes more subtle symptoms.

Based on these results, researchers suggested post-menopausal women should talk to their doctor about heart disease risk factors and follow up on any recommended tests or monitoring. More women may benefit from heart scans when compared to the number of women currently receiving them, Ishaaya said.

Since all the women in the study were taking statins but many still saw a substantial rise in CAC, the results may also indicate that statins are not sufficient to keep plaque buildup in check for this population, Ishaaya said. Future studies could investigate the effectiveness of statins or other therapies in reducing plaque burden in post-menopausal women, she said.

ACC/American Heart Association guidelines recommend considering a heart scan to assess CAC when a person’s risk level is ambiguous or borderline based on standard risk factors. In the U.S. and many other countries, CAC scoring is most used to determine recommendations for statins for intermediate-risk and asymptomatic patients.

Reference:

Heart health declines rapidly after menopause, American College of Cardiology, Meeting: American College of Cardiology’s Annual Scientific Session.

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High Altitude Climbing Increases Risk of Cardiac Arrhythmia, reveals JAMA study

Exposure to high altitudes presents physiological challenges such as arterial hypoxemia, electrolyte imbalances, and periodic breathing, which can increase vulnerability to cardiac arrhythmias. Cardiac arrhythmias, including tachyarrhythmias and bradyarrhythmias, pose serious health risks, particularly in challenging environments such as high altitudes.

However, the incidence and characteristics of arrhythmias in individuals undertaking extreme altitude climbs like Mount Everest remain understudied. A recent study was published in the journal JAMA Cardiology. The study was conducted by Sherpa K. and colleagues. This prospective cohort study aimed to explore the incidence of tachyarrhythmias and bradyarrhythmias in healthy individuals during a high-altitude expedition to Mount Everest.

Healthy individuals participating in the expedition underwent baseline cardiac evaluations, including electrocardiogram and echocardiography, before ascending Mount Everest. Ambulatory rhythm recording was conducted both before and during the climb. The primary outcome was the incidence of a composite of supraventricular and ventricular tachyarrhythmias, as well as bradyarrhythmias.

The key findings of the study were:

  • 41 male individuals, with a mean age of 33.6 years, participated in the study.

  • 38.2% of participants experienced cardiac arrhythmias during the climb, with 45 primary endpoint-relevant events recorded.

  • Bradyarrhythmic events were more common, with 43 events documented in 13 individuals, compared to 2 ventricular tachycardias in 2 individuals.

  • Arrhythmias occurred more frequently at lower altitudes without supplemental oxygen, with 80% of events occurring in this setting.

  • The proportion of individuals with arrhythmias remained stable across altitudes, while event rates numerically increased between 5300 m and 7300 m before decreasing again at higher altitudes.

The study confirms a significant association between high-altitude exposure and the incidence of cardiac arrhythmias, with over one-third of healthy climbers experiencing arrhythmias during the ascent of Mount Everest. These findings underscore the importance of further research to explore the implications and management of cardiac rhythm disturbances in extreme altitude environments.

Understanding the prevalence and characteristics of cardiac arrhythmias in high-altitude climbers can inform risk assessment and management strategies for individuals undertaking similar expeditions. Additionally, these findings emphasize the need for medical interventions and monitoring to mitigate the risks associated with cardiac arrhythmias during high-altitude climbs.

Reference:

Sherpa, K., Sherpa, P. P., Sherpa, T., Rothenbühler, M., Ryffel, C., Sherpa, D., Sherpa, D. R., Sherchand, O., Galuszka, O., Dernektsi, C., Reichlin, T., & Pilgrim, T. (2024). Risk of cardiac arrhythmias among climbers on Mount Everest. JAMA Cardiology. https://doi.org/10.1001/jamacardio.2024.0364

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Insulin resistance before diabetes onset may increase risk of albuminuria after diabetes onset: Study

USA: A prospective cohort study has revealed an association between lower insulin sensitivity and albuminuria development, suggesting a role for insulin signaling in the pathogenesis of proteinuria.

The findings, published in Diabetes, Obesity and Metabolism on February 28, 2024, highlight the potential of improving insulin signaling as a therapeutic strategy.

The study implies that maintaining good insulin action is important for preventing albuminuria onset and reducing the risk of kidney and cardiovascular diseases, particularly in nondiabetic individuals.

Albuminuria is a risk factor for cardiovascular (CV) events and mortality in the general population and among patients with diabetes mellitus. Understanding the pathophysiology of albuminuria is critical for targeting interventions to reduce albuminuria and accompanying outcomes. Reduced renal insulin signaling is implicated in the albuminuria pathogenesis.

Longitudinal studies linking insulin action and subsequent albuminuria risk are limited. Therefore, Douglas C. Chang, National Institutes of Health, Phoenix, Arizona, USA, and colleagues aimed to investigate whether insulin secretion and action, measured before diabetes onset, are associated with albuminuria development after diabetes onset.

For this purpose, the researchers measured Baseline body composition, insulin sensitivity by a hyperinsulinaemic-euglycaemic clamp at submaximal and maximal insulin stimulation (240 and 2400 pmol/m2/min; M-low and M-high), and insulin secretion by intravenous glucose tolerance test [acute insulin response (AIR)] in 170 Southwestern Indigenous American adults who subsequently developed diabetes.

After diabetes onset and during the median follow-up of 13.6 years, 81 participants developed albuminuria (urine albumin-to-creatinine ratio ≥30 mg/g). Separate associations of M-low, M-high, and AIR (per 1-SD change) with albuminuria risk were assessed by Cox regression models adjusted for sex, age, and body fat (%).

The researchers reported the following findings:

  • Participants who developed albuminuria were of similar age (26.4 ± 5.4 vs. 27.5 ± 6.1 years), sex (46% vs. 48% male), body fat (36.4 ± 7.5 vs. 35.7 ± 7.9%) and AIR [2.3 ± 0.3 vs. 2.3 ± 0.3, pmol/L (log)] as those who did not develop albuminuria but had lower insulin sensitivity [M-low: 0.33 ± 0.08 vs. 0.36 ± 0.12; M-high: 0.87 ± 0.11 vs. 0.91 ± 0.12, p = .02; mg/kg-metabolic body size/min (log)].
  • In separate adjusted models, lower M-low and M-high were both associated with an increased risk for albuminuria [hazard ratio (HR) 1.51, HR 1.31), whereas AIR was not (HR 1.15).

In conclusion, lower insulin action in Indigenous Americans without diabetes is a risk factor in albuminuria development after diabetes onset.

“These findings indicate insulin signaling as a possible therapeutic target for preventing cardiovascular and kidney disease,” the researchers wrote.

Reference:

Willig MR, Stinson EJ, Looker HC, et al. Insulin resistance before type 2 diabetes onset is associated with increased risk of albuminuria after diabetes onset: A prospective cohort study. Diabetes Obes Metab. 2024;1‐9. doi:10.1111/dom.15505

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Maternal intake of fish oil during pregnancy may increase risk of obesity in kids: Study

Denmark: Findings from a randomized clinical trial have suggested potential adverse health effects from n–3 (ω–3) long-chain polyunsaturated fatty acid (n–3 LCPUFA) supplementation during pregnancy. The study was published online in The American Journal of Clinical Nutrition in its April 2024 issue.

The researchers revealed that children of mothers receiving n–3 LCPUFA supplementation had an increased risk of being overweight and a tendency to increase fat percentage, increased body mass index (BMI) at age 10 years, and higher metabolic syndrome score.

There has been an increase in the prevalence of obesity and overweight in childhood and adolescence during the past 40 years, and environmental exposures during fetal life have long been suspected of playing a role. One exposure of interest is the intake of n–3 long-chained polyunsaturated fatty acids during pregnancy, mainly derived from fatty fish.

Rebecca K Vinding, University of Copenhagen, Copenhagen, Denmark, and colleagues had previously reported that children of mothers who received fish oil supplementation during pregnancy had higher BMI at 6 y of age as well as a concomitant increase in muscle-, fat, and bone mass, but no difference in fat percentage.

In the study, Dr. Vinding, and the team reported follow-up at the age of 10 years, including an assessment of metabolic health.

The study is a follow-up analysis of a randomized clinical trial conducted among 736 pregnant females and their offspring participating in the Copenhagen Prospective Studies on Asthma in Childhood Mother-child cohort.

The intervention was 2.4 g n–3 LCPUFA or control daily from pregnancy week 24 until 1 week after birth. Outcomes included body composition from Bioelectrical Impedance Analysis, anthropometric measurements, concentrations of triglycerides, blood pressure, glucose, cholesterol, and C-peptide from fasting blood samples, and a metabolic syndrome score was calculated.

Body composition and anthropometric measurements were prespecified secondary endpoints of the n–3 LCPUFA trial, and others were exploratory.

The study revealed the following findings:

  • Children in the n–3 LCPUFA group had a higher mean BMI at age 10 years compared to the control group: 17.4 compared with 16.9 and a higher odds ratio of being overweight (odds ratio: 1.53). This corresponded to differences in body composition in terms of increased lean mass (0.49 kg), fat percent (0.74%), and fat mass (0.49 kg) compared to the control group.
  • Children in the n–3 LCPUFA group had a higher metabolic syndrome score compared to the control (mean difference: 0.19).

In conclusion, the researchers revealed that children of mothers who received n–3 LCPUFA supplementation during pregnancy showed an increased risk of being overweight, increased BMI at age 10, and a tendency to display both an increased fat percentage and a higher metabolic syndrome score.

“These findings suggest potential adverse health effects from n–3 LCPUFA supplementation during pregnancy and need to be replicated in future independent studies,” the researchers wrote.

Reference:

Vinding, R. K., Sevelsted, A., Horner, D., Vahman, N., Lauritzen, L., Hagen, C. P., Chawes, B., Stokholm, J., & Bønnelykke, K. (2024). Fish oil supplementation during pregnancy, anthropometrics, and metabolic health at age ten: A randomized clinical trial. The American Journal of Clinical Nutrition, 119(4), 960-968. https://doi.org/10.1016/j.ajcnut.2023.12.015

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COVID-19 vaccination as effective for adults with common mental disorders as for those without: Study

A large multi-state electronic health record-based study from the Centers for Disease Control and Prevention’s (CDC’s) VISION Network has found that COVID-19 vaccines are as effective for adults with anxiety or depression or mood disorders as for individuals without these common diagnoses. This is one of the first studies to evaluate COVID-19 mRNA vaccine effectiveness for those living with mental illness.

While vaccination provided similar protection regardless of psychiatric diagnosis (none, one or multiple conditions), in contrast, unvaccinated adults with any of these conditions had a higher rate of hospitalization for COVID-19-a marker for severe disease-than did those without a psychiatric diagnosis.

Both these findings held true whether two, three or four vaccinations were received and for ages 18-49, 50-64 and 65 and older.

“Although mental health conditions can tax the immune system, putting stress on the body, we saw similar COVID-19 vaccine effectiveness in people with psychiatric diagnoses compared with those without. That’s encouraging,” said study co-author Shaun Grannis, M.D., M.S., Regenstrief Institute vice president for data and analytics.

“But we also found that the risk of COVID-19 associated hospitalization is higher among unvaccinated patients with a psychiatric diagnosis,” added Dr. Grannis. “For patients with a diagnosis of depression, anxiety, or mood disorders who are wondering if the COVID vaccine would be valuable, this paper gives us evidence that the vaccine maintains its effectiveness even in the face of mental illness. So, I would encourage vaccination because it reduces the risk of hospitalization significantly.”

Psychiatric disorders have been associated with lower antibody positivity and reduced immune response to other vaccines. Prior to this study, it was not known whether anxiety, depression, or mood disorders influence COVID-19 vaccine effectiveness.

“While the evidence on vaccine effectiveness for the overall population is well-established, many people still have questions about whether someone like them should get the vaccine or whether people like them benefit from the vaccine,” said study co-author Brian Dixon, PhD, MPA, interim director of Regenstrief Institute’s Clem McDonald Center for Bioinformatics. “Studies like this one help answer those questions for large segments of society. Our network will continue to pursue rigorous studies on important, vulnerable populations. That is, after all, the work we do in public health.”

“Risk of COVID-19 hospitalization and protection associated with mRNA vaccination among US adults with psychiatric disorders” is published in the peer-reviewed journal Influenza and Other Respiratory Viruses. 

Reference:

Matthew E. Levy, Duck-Hye Yang, Margaret M. Dunne, Kathleen Miley, Stephanie A. Irving, Shaun J. Grannis, Zachary A. Weber, Eric P. Griggs, Talia L. Spark, Elizabeth Bassett, Peter J. Embi, Manjusha Gaglani, Nicola P. Klein, Ruth Link-Gelles, Malini B. DeSilva, Anupam B. Kharbanda, Risk of COVID-19 Hospitalization and Protection Associated With mRNA Vaccination Among US Adults With Psychiatric Disorders, Influenza and Other Respiratory Viruses, https://doi.org/10.1111/irv.13269.

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Diclofenac transbuccal mucoadhesive patch effective,safe for pain control after third molar surgery: Study

India: A recent study in the Journal of Oral and Maxillofacial Surgery revealed effective pain control with a transbuccal mucoadhesive patch of diclofenac sodium with fewer side effects and quicker analgesia than oral tablets.

Swelling, pain, and trismus are the most common sequelae after surgical removal of mandibular third molars. They pose significant challenges for clinicians, prompting the exploration of efficacious management approaches. Therefore, Zenish Bhatti, AMC Dental College and Hospital, Khokhara, Ahmedabad, Gujarat, India, and colleagues aimed to assess the efficacy of transbuccal mucoadhesive patch of diclofenac sodium versus oral tablet in controlling sequelae after a third molar surgery.

For this purpose, they conducted a prospective split-mouth, single-blinded study in the Department of Oral and Maxillofacial Surgery at AMC Dental College and Hospital, Ahmedabad. The study sample comprised patients of either sex, aged 18-45 years, needing surgical removal of bilaterally symmetrical mandibular third molars under local anesthesia. It excluded patients who had consumed analgesics within 24 hours before the procedure.

The primary predictor variable was the route of non-steroidal anti-inflammatory drugs administration. The study group received transbuccal mucoadhesive patches of 20 mg diclofenac sodium; the control group received 50 mg oral tablets.

The primary outcome variable was postoperative pain measured with a visual analog scale (VAS); mouth opening, swelling, adverse events, and onset of analgesic effect were assessed as secondary outcome variables.

Two categories of covariates were considered. First, demographic – gender and age. Second, peri-operative – the pattern of impaction.

Paired sample t-test and independent sample t-test were used for intergroup comparison, and intragroup differences were assessed with One-way ANOVA and paired t-test.

The study led to the following findings:

· Out of 146 patients screened initially, the final study sample included 37 subjects with a mean age of 26.08±5.09 years (56.75% males).

· The study group exhibited significantly lower postoperative pain scores than the control group on day 0, 1st, 2nd, and 3rd days postoperatively.

· No statistically significant difference was observed in the reduction of facial swelling and improvement in mouth opening on the 1st, 2nd, and 3rd days, postoperatively between both the groups.

· The mean onset of analgesia was statistically significant in the study group (19.96 ± 5.40 minutes) compared to the control group (52.56 ± 6.33 minutes).

“Diclofenac transbuccal mucoadhesive patch is superior to oral diclofenac for management of postoperative sequelae after third molar surgery with effective pain control, fewer side effects, and quicker analgesia,” the researchers concluded.

Reference:

DOI: https://doi.org/10.1016/j.joms.2024.03.019

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Interferon-γ Release Assays Outperform Tuberculin Skin Test in Predicting Tuberculosis: JAMA

The elimination of tuberculosis (TB) in the US relies on effective tests to detect individual risk of developing the disease, aiding in preventive interventions. However, the comparative performance of available TB tests—specifically, the tuberculin skin test (TST) and two interferon-γ release assays (IGRAs)—in predicting TB disease development remains uncertain. In high-risk populations, accurate prediction of TB disease development is crucial for timely intervention and prevention strategies.

While the TST and IGRAs are commonly used diagnostic tools, their relative performance in predicting incident TB in the US has not been well-established. A recent study was published in the journal JAMA Network Open. The study was conducted by Traycy A. and colleagues. This prospective diagnostic study aimed to compare the performance of the TST with two IGRAs, QuantiFERON-TB Gold In-Tube (QFT-GIT) and SPOT.TB (TSPOT), in predicting TB disease in high-risk populations.

The study enrolled participants at 10 US sites between 2012 and 2020 who were at high risk of TB infection or progression to disease. Participants underwent concurrent testing with the TST and two IGRAs at enrollment. Incident TB cases were diagnosed more than 30 days after enrollment. Data analysis was performed in June 2023.

The key findings of the study were as follows:

  • A total of 22,020 eligible participants were included, with a median follow-up of 6.4 years.

  • Tuberculosis disease was identified in 129 case patients, with 42 having incident TB and 87 prevalent TB.

  • Both IGRAs, TSPOT and QFT-GIT, performed significantly better than the TST in predicting incident TB, with positive predictive value (PPV) ratios of 1.65 and 1.47, respectively.

  • There was a statistically significant incremental gain in PPV when a positive TST result was known, with positive QFT-GIT and TSPOT results.

The study concluded that IGRAs demonstrated superior performance for predicting incident TB compared to the TST. Additionally, IGRAs provided a statistically significant incremental improvement in PPV when combined with a positive TST result. These findings suggest that IGRAs may enhance decisions to treat TB infection and prevent TB disease.

The results underscore the importance of utilizing IGRAs in high-risk populations for accurate prediction of TB disease development, thereby enabling timely interventions to prevent TB transmission and improve patient outcomes.

Reference:

Ayers, T., Hill, A. N., Raykin, J., Mohanty, S., Belknap, R. W., Brostrom, R., Khurana, R., Lauzardo, M., Miller, T. L., Narita, M., Pettit, A. C., Pyan, A., Salcedo, K. L., Polony, A., Flood, J., Pascopella, L., Ahmed, A., Aiona, K., Lovato, J., … CDC Tuberculosis Epidemiologic Studies Consortium. (2024). Comparison of tuberculin skin testing and interferon-γ release assays in predicting tuberculosis disease. JAMA Network Open, 7(4), e244769. https://doi.org/10.1001/jamanetworkopen.2024.4769

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Failure in Handling pregnancy case: Hospital, Head IVF, 2 Gynaecologists told to pay compensation for negligence in treatment

New Delhi: The District Consumer Court, Delhi recently directed an IVF facility, an IVF Head, and 2 Gynaecologists to pay Rs 7,48,230 to a pregnant patient, who underwent treatment at the facility. After admitting the patient for the delivery of her children, the hospital and its doctors failed to handle the case and referred her to another hospital stating that there was a lack of ICU and blood bank facility.

While considering the case, the consumer court noted that the doctors and the IVF hospital failed in their ‘duty of care in deciding what treatment is to be given to the patient complainant’ and ‘duty of care in administration of that treatment’ at the final and crucial stage of delivery.

They were directed to pay jointly and severally Rs.5,83,230, the amount spent by the patient in her treatment, Rs.1,00,000 as specific personal compensation towards physical pains and trauma and Rs 50,000 as damages. Further, the Commission also granted Rs 15,000 as legal cost to the complainant.

The history of the case goes back to 2020 when the patient  and her husband approached Indira IVF Hospital. After approaching the Head of IVF Dr. Kumar, the patient underwent tests and they were advised to undergo In Virto Fertilization treatment. They were informed that the cost of treatment including the medicines was Rs 1,80,000. However, in case of miscarriage, an additional Rs 1,75,000 would have to be paid. After an initial miscarriage, the complainant conceived again and remained under treatment at the treating hospital. During the course of treatment, she was informed that there were twins in her womb.

The patient was informed about the chances of pre-mature delivery and was advised to meet Dr. Monica, the Gynecologist. The expected due date of delivery was given in or about September 2021. The complainant’s husband deposited delivery charges of Rs. 60,000/- on 26.08.2021 on the instructions of the hospital.

When the patient developed severe pain, the doctor advised her to go to the hospital. It was alleged the signatures of the complainant’s husband were taken on blank papers without discussing any eventuality. The treatment started, however, after a few hours, the Gynecologist and her team came out of the OT and asked the husband of the complainant to arrange for some other hospital as the condition of the patient was critical.

After persuasion by the patient’s husband, the doctor gave in writing stating “Pt. is referred to higher centre for emergency in u/o nonavailability blood bank ICU facility”. Allegedly, an ambulance lifesaver facility was also not provided by the hospital.

Initially, the patient was taken in critical condition to a Government Hospital. However, after not getting admission there, the complainant’s husband requested the Gynecologiost at the first hospital, who suggested taking the patient to Maharaja Agrasen Hospital, Delhi.

It was alleged that when the bed sheet underneath the patient was removed by a doctor in Maharaja Agrasen Hospital, Delhi, it was found that half the body of the newborn was inside the uterus and half was outside. 

Claiming that the treating hospital failed to discharge its duties, the patient filed a complaint alleging medical negligence and demanded Rs 50 lakhs as compensation for severe pain, suffering of harassment, humiliation, mental torture, financial losses, malpractice and agony.

On the other hand, the treating hospital and doctors denied all allegations and submitted that when the patient reached the hospital on 24.09.2021, she was examined clinically in detail and was found to be in early labour with a chest infection and altered coagulation profile. Her condition was discussed with the attending anaesthetist at the Centre. Consequently, the complainant’s husband was explained about the urgent need for medical ICU and was advised to take the complainant to Maharaja Agrasen Hospital. 

They alleged that the husband took more than one hour to decide and ultimately decided to take the patient to some Government Hospital. Thereafter, the treating Gynaecologist prepared a referral note immediately for admission to some higher medical centre in view of the non-availability of ICU and blood bank facility at its centre, further a medical team in such circumstances arranged an ambulance also and the treating hospital did not charge anything for the same.

After being refused admission at the Government Hospital, the patient was admitted to Maharaja Agrasen Hospital with the efforts and cooperation of the treating Gynecologist, they claimed. Ultimately, the complainant safely delivered two baby girls. It was emphasized by the treating hospital and doctors that the patient was informed and advised from the beginning to make arrangements in some government/private hospitals having ICU and blood bank facilities. However, such advice was allegedly ignored by the patient and her husband.

While considering the question “whether the OPs had taken proper care to undertake the case of complainant”, the District Consumer Court noted that the patient was diagnosed with infertility. It also noted that the treating facility renders medical services for infertility treatment, all kinds of ART including procedure and technique of IVF through its qualified and competent doctors.

“Therefore, the OP1 and its doctors have taken care in taking the case of complainant for diagnosis and treatment of infertility. To that extent, there is no medical negligence on the part of OPs,” noted the Commission.

The consumer court also considered the issue ‘of duty of care in deciding what treatment is to be given to the patient/ complainant’ and ‘duty of care in administration of that treatment’ to the patient.

At this outset, the consumer court took note of the two discharge summaries issued to the patient  and her babies by Maharaja Agrasen Hospital. The discharge summary depicted diagnosis that the patient was diagnosed with ‘prime with IVF conception at 35 weeks 2 days, dichorionic diamniotic twin with preeclampsia with cervical cerclage with BTM covered with spasmodic bronchitis; post LSCS; leptospirosis (IgM positive); sepsis with thrombocytopenia; dyselectrolytemia. The complainant was operated on in emergency LSCS done under spinal anaesthesia on 24.09.2021; indication- severe PIH, twin in labour.’

Further, the Discharge Summary also mentioned that “the patient was admitted with 9 months amenorrhea, bleeding per vagina, leaking per vagina since morning” and on examination it was found uterus was overdistended, fetal heart sounds present, per vagina OS7-8 cephalic cervix 80% effaced vertex 2 cm.

The Commission also noted that before bringing the patient to the second hospital, the treating Gynaecologist at the first treating hospital issued a referral note remarking that “patient is referred to higher centre for emergency LSCS in V/O non- availability of blood bank and ICU facility.”

While the treating hospital argued that the patient was advised to make arrangements in advance at a government/private hospital having ICU and blood bank facilities, the Commission noted that there was no such record that would prove that such advice was given to the complainant.

Meanwhile, the complainant filed a record of discharge card in respect of another patient of the same hospital, who was admitted on 23.02.2021 and discharged on 25.02.2021 since surgery was done as LSCS under spinal anaesthesia. Taking note of this, the Commission observed, “This shows that OP1 and its doctors perform surgeries in the hospital of OP1. But it was not done so in the case of complainant.”

“The discharge summary issued by Maharaja Agrasen Hospital in respect of complainant (at page 122-126 of replication) does not depict that the complainant was administered blood by the said hospital, which corroborates complainant’s plea that she was not given blood during treatment at Maharaja Agrasen Hospital,” it further noted.

Referring to the referral note issued on 24.09.2021, the Commission noted that the hospital and its doctors are projecting that as if the referral was immediately issued after examining the complainant. However, in reality, the complainant’s husband was asked to purchase a surgery kit and it was handed over to the doctors at the operation theatre. Later, a part amount of Rs 12,000 was refunded to the complainant since some of the articles in the kit were used after opening the same by the hospital and the doctors.

“It proves that the complainant was taken into operation theatre in the morning of 24.09.2021, the surgery kit was also arranged [and delivery charges were already got deposited on 26.08.2021] but later on around noon hours the OP3 (gynaecologist) the OP2 (IVF Head), OP4 (gynaecologist) of doctors team after coming out of OT asked the husband of complainant to take complainant to some other hospital for want of ICU facility and blood bank in OP1 Hospital. It also proves that in the phase of delivery process, it was abandoned and complainant’s husband was asked to take the complainant to some other hospital. Had the complainant not been in the OT/Labour Room, there was no occasion for opening of the surgery kit and use of some of its articles. The OP3, the OP2, OP1 and other had started the procedure of delivery but it was not performed,” noted the Commission.

The Commission clarified that when a patient is taken to the OT/labour room, it could be after admitting the patient as inpatient and after delivery or subsequently after the patient is discharged. “Whereas, in this case the same procedure would have been affected that the complainant was taken to labour room/OT and then she was relieved without preparing the discharge summary instead referral note (page 42 of the paper book of complainant) was prepared. The circumstances on record are crystal clear. OT/Labour room is not an OPD,” noted the Commission.

It was observed by the Commission that even though the complainant was examined from time to time and tests, investigations were performed accordingly, after admitting the patient on 24.09.2021, the “…OPs could not handle the case of complainant because of its omissions and commissions, then at very crucial moments when complainant was about to deliver children, there was an impasse by the OPs and the complainant was referred to other hospital by stating want of ICU and blood bank facility.”

“Would it be acceptable that a patient/complainant would request the OPs in the night to perform delivery on next date and OPs acceded to such request of the complainant without accessing medical requirement? The answer it in ‘negative’,” the Commission opined.

Therefore, the Commission observed that there was partly breach of ‘duty of care in deciding what treatment is to be given to the patient complainant’ and also a breach of ‘duty of care in administration of that treatment’ at the final and crucial stage of delivery, for which the OPs were required to be prepared in advance but they failed.

“Hence it is held that OPs (hospital, IVF head, 2 gynaecologists) are jointly and severally negligent on their part in this regard,” the Commission noted.

Taking note of the amount spent by the complainant, the consumer court directed the hospital and the doctors to pay back the extra amount of Rs 2,04,710 spent by the complainant and also the extra medical expenses of Rs. 3,78,520/- for her treatment of delivery in Maharaja Agrasen Hospital.

“Accordingly, the complaint is allowed in favour of complainant and against the OPs to pay jointly and/or severally amount of Rs.5,83,230/- [i.e. Rs.2,04,710+Rs.3,78,520/-] alongwith interest at the rate of 4%pa from the date of complaint till realization of amount besides specific personal compensation of Rs.1,00,000/-[towards physical pains and trauma suffered by the complainant during crucial phase she was referred to other hospital and till she delivered babies], damages of Rs.50,000/- for harassment, inconvenience and mental agony suffered by the complainant and others with her, besides costs of Rs.15,000/- to complainant. OPs are also directed to pay the amount within 45 days from the date of this order,” ordered the Commission.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/delhi-consumer-court-ivf-235628.pdf

Also Read: Failure to diagnose, Delayed Treatment for Ruptured Ectopic Pregnancy: Gynecologist directed Rs 5 lakh Compensation

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