Iron deficiency may increase risk of severe HF and adverse events among children with dilated cardiomyopathy

Australia: A recent study published in The Journal of Heart and Lung Transplantation has revealed a high prevalence of iron deficiency (ID) in children with dilated cardiomyopathy (DCM).

The study showed that in clinical practice, iron studies are under-measured, but iron deficiency is associated with severe heart failure and an increased risk of composite adverse events (CAE). The researchers suggested considering the need for iron replacement therapy in children who present with heart failure with DCM.”

“The study is the largest to date to evaluate iron status in pediatric DCM,” the researchers reported. “Almost two-thirds of patients who had iron studies measured were iron deficient, and this conferred an increased risk of the composite occurrence of mechanical circulatory support (MCS), death, or transplantation over time.”

They added, “Those who were iron deficient had a longer hospital stay and were more likely to be microcytic, anaemic, and hypochromic, with a higher NT-proBNP.”

Jack C. Luxford from Children’s Hospital at Westmead, Sydney, Australia, and colleagues aimed to determine the prevalence and impact of iron deficiency in children with dilated cardiomyopathy by conducting a retrospective single-centre cohort study.

For this purpose, the researchers conducted a retrospective single-centre review of all children between 2010 and 2020 with a DCM diagnosis and complete iron studies. Iron deficiency was defined as ≥2 of ferritin <20 μg/litre, transferrin >3 g/liter, iron <9 μmol/litre, or transferrin saturation (TSat) <15%. Laboratory and clinical and freedom from a composite adverse event of MCS, death, or transplant were compared between children with and without ID.

The study led to the following findings:

  • Of 138 patients with DCM, 47 had available iron studies. 62% of patients were iron deficient.
  • Children with ID were more likely to be receiving inotropes (17, 59%) or invasive/noninvasive ventilation (13, 45%) than those who were iron-replete.
  • They had a higher incidence of anaemia (22, 76%) and higher NT-proBNP (1,590 pmol/litre).
  • Children with ID had significantly less freedom from the CAE at 1 year (54% ± 10%), 2 years (45 ± 10), and 5 years (37% ± 11%) than those without.
  • Iron deficiency and anaemia were the only significant predictors of the CAE on univariate Cox regression.

The findings revealed a high prevalence of ID in children with DCM.

“Iron studies are undermeasured in clinical practice, but ID is associated with severe heart failure and an increased CAE risk,” the researchers concluded. “The need for iron replacement therapy should be considered in children who present in HF with DCM.”

Reference:

Luxford, J. C., Casey, C. E., Roberts, P. A., & Irving, C. A. (2023). Iron deficiency and anemia in pediatric dilated cardiomyopathy are associated with clinical, biochemical, and hematological markers of severe disease and adverse outcomes. The Journal of Heart and Lung Transplantation. https://doi.org/10.1016/j.healun.2023.11.014

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Lowest and highest levels of fasting stress hyperglycemia may increase contrast-induced AKI among patients undergoing PCI

China: A recent study has revealed a significant association between both the highest and lowest levels of fasting stress hyperglycemia ratio (SHR) and an increased occurrence of contrast-induced acute kidney injury (CI-AKI) in patients undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI).

The findings published in Frontiers in Endocrinology showed that the correlation was observed regardless of whether the patients had diabetes or HbA1c > 6%.

Coronary artery disease (CAD) imposes a significant global disease burden and is a prominent contributor to human mortality on a global scale. Recently, there has been a significant improvement in the clinical prognosis of CAD patients with the widespread application of intervention techniques such as percutaneous coronary intervention and coronary angiography in the diagnosis and treatment of CAD. However, the use of these interventions is tied to a series of related complications that cannot be overlooked due to their effect on patient health.

Stress hyperglycemia ratio is an emerging indicator of critical illness, and exhibits a significant association with adverse cardiovascular outcomes. Yu Shan, Zhejiang University, Hangzhou, Zhejiang, China, and colleagues aimed to evaluate the association between fasting SHR and contrast-induced AKI in a cross-sectional study comprising 3,137 patients who underwent CAG or PCI.

Fasting SHR was calculated by dividing the admission of fasting blood glucose by the estimated mean glucose obtained from glycosylated haemoglobin. Contrast-induced acute kidney injury was evaluated based on elevated serum creatinine (Scr) levels.

The relationship between fasting SHR and the proportion of serum creatinine elevation was investigated using piecewise linear regression analysis. The correlation between fasting SHR and CI-AKI was evaluated through Modified Poisson’s regression analysis. Sensitivity analysis and subgroup analysis were conducted to explore result stability.

The researchers reported the following findings:

  • Among the total population, 15.4% of patients experienced CI-AKI.
  • Piecewise linear regression analysis revealed significant associations between the proportion of SCr elevation and fasting SHR on both sides (≤ 0.8 and > 0.8) [β = -12.651, β = 8.274].
  • The Modified Poisson’s regression analysis demonstrated a statistically significant correlation between both the lowest and highest levels of fasting SHR and an increased incidence of CI-AKI [(SHR < 0.7 versus 0.7 ≤ SHR < 0.9) β = 1.828 (SHR ≥ 1.3 versus 0.7 ≤ SHR < 0.9) β = 2.896], which was validated further through subgroup and sensitivity analyses.

“In populations undergoing PCI or CAG, both the lowest and highest levels of fasting SHR were significantly associated with an increased occurrence of CI-AKI,” the researchers concluded.

The researchers emphasized that this study solely encompassed the Chinese population, thus requiring further investigation to ascertain the generalizability of these findings to other populations in different countries.

Reference:

Shan, Y., Lin, M., Gu, F., Ying, S., Bao, X., Zhu, Q., Tao, Y., Chen, Z., Li, D., Zhang, W., Fu, G., & Wang, M. (2023). Association between fasting stress hyperglycemia ratio and contrast-induced acute kidney injury in coronary angiography patients: A cross-sectional study. Frontiers in Endocrinology, 14, 1300373. https://doi.org/10.3389/fendo.2023.1300373

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Mindfulness therapy reduces depression anxiety and increases sleep quality of university students

Anxiety and depression are the most common mental disorders, with a significant impact on work capability and performance. College students face stressors such as leaving home, assuming new responsibilities, and academic challenges, leading to increased stress and difficulty coping with stressors. As a result, many students sacrifice their sleep quality. Early psychological interventions can help prevent mental disorders, and the prevalence of mental health disorders varies widely among university students.

A study published in Frontiers in Public Health concluded that mindfulness therapy may reduce depression, anxiety, and stress in university students. Additionally, it may improve their sleep quality but not their mindfulness rating scores significantly. These findings emphasize mindfulness therapy’s effects on students’ moods.

This study estimated the effect of mindfulness therapy on mental health.

Two researchers conducted a meta-analysis of 12 databases to determine how mindfulness therapy impact depression. They searched relevant trials ( January 2018 to May 2023) and measured depression using different scales and scoring systems like Beck Depression Inventory (BDI), Patient Health Questionnaire-9 (PHQ-9), Quick Inventory of Depressive Symptomatology (QIDS), Patient-Reported Outcomes Measurement Information System (PROMIS), Hospital Anxiety and Depression Scale (HADS), and Depression Anxiety Stress Scales (DASS) and others. After screening, they included 11 randomized controlled trials involving 1,824 participants.

Key findings are:

  • Studies demonstrated positive effects of mindfulness therapy on depression, anxiety, stress and sleep quality with SMD,−0.33, −0.35, −0.39, and −0.81, respectively.
  • There was no significant difference in mindfulness between the mindfulness therapy and control groups, with an SMD of -0.12.

They added that future studies should evaluate the effectiveness of strategies to enhance mindfulness therapy adherence and fidelity in improving mental health outcomes.

It is crucial to develop a simple, economical, and effective intervention to address mental health issues among university students.

Study strengths include inclusion of studies from 12 global databases, representative sample, large sample size all of which lead to subgroup and sensitivity analysis.

Reference:

Zuo X et al.The efficacy of mindfulness-based interventions on mental health among university students: a systematic review and meta-analysis. Front Public Health. 2023 Nov 30;11:1259250. doi: 10.3389/fpubh.2023.1259250.

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JAMA: Increased Risk of Vitiligo Observed in Transplant Recipients

Vitiligo is characterized by the selective loss of melanocytes, but the large-scale studies assessing its occurrence in transplant recipients specially those with graft-vs-host disease (GVHD), have been rarely studied so far. In a recent cohort study by Chul Hwan Bang and colleagues, a significant correlation between solid organ and hematopoietic stem cell transplant (SOT and HSCT) recipients and an heightened risk of vitiligo was explored. The findings were published in JAMA Dermatology.

The study utilized data from the National Health Insurance Service database of Korea and included patients of 20 years or older. These participants underwent transplantation from January 2010 to December 2017, with follow-up until December 2019. A total of 119,145 individuals were grouped as age- and sex-matched controls who provided the benchmark for comparison.

The analysis was conducted from July to December 2021 revealed that the 23,829 transplant patients studied exhibited a higher risk of vitiligo compared to their non-transplant counterparts (adjusted hazard ratio [AHR] of 1.73; 95% CI, 1.35-2.22). Also, kidney and liver transplant recipients showed a slightly increased risk, but the most important findings were observed in HSCT recipients by indicating an AHR of 12.69 (95% CI, 5.11-31.50).

Further stratification revealed that those who had received allogeneic grafts, autologous grafts, patients with comorbid GVHD, and those without GVHD all demonstrated higher vitiligo risks compared to the control group.

The key findings of this research emphasize the imperative for clinicians to be cognizant of the increased risk of vitiligo in transplant recipients, specially in the context of HSCT, GVHD, and the type of graft received. This understanding urges a multidisciplinary approach in monitoring patients to bridge dermatology and transplantation medicine. With this outcome, clinicians can customize their strategies to offer more vigilant care to those at high risk, ultimately improving the management of transplant recipients.

Source:

Bang, C. H., Park, H. E., Kim, Y. H., Jung, J.-H., Lee, J. H., Park, Y. M., & Han, J. H. (2023). Risk of subsequent vitiligo in transplant recipients with comorbid graft-vs-host disease. JAMA Dermatology (Chicago, Ill.). https://doi.org/10.1001/jamadermatol.2023.4933

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Urethral stenosis post-radiation therapy has magnitude of side effects with poor patient reported QoL

Canada: A recent study published in Urology has shed light on health-related quality of life (QoL) in patients with urethral stenosis after radiation treatment for prostate cancer.

The researchers revealed urethral stenosis after radiotherapy to be a clinically complex entity with a broad scope of associated symptoms, including high rates of patient-reported incontinence, pain, sexual dysfunction, depression, and bowel dysfunction.

“This multi-focal nature combined with patient unawareness and often insidious presentation creates a uniquely challenging condition to treat,” the researchers wrote.

Patients with localized prostate cancer typically have a choice of curative options, either surgery (radical prostatectomy) or radiotherapy (external beam or brachytherapy). There is no clarity on which treatment provides superior outcomes for both preserved genitourinary (GU) function and cancer control.

Kennedy Dirk and Keith Rourke from the University of Alberta, Edmonton, Alberta, Canada, aimed to evaluate patient-reported QoL (PRQoL) in patients presenting with membranous urethral stenosis after prostate radiotherapy. Urethral stenosis is an under-reported complication following prostate radiotherapy with a particular deficiency in PRQoL.

For this purpose, the researchers retrospectively reviewed patients presenting with urethral stenosis after radiotherapy from 2004-2022. Patient-reported quality of life was evaluated via patient survey using the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP). The researchers identified 230 patients at a mean age of 67.7 years and a mean time to stricture diagnosis of 63.6 months post-radiotherapy.

The study led to the following findings:

  • Of 87 patients completing the survey, 29.9% recalled being aware of urethral stenosis as a potential complication, and 51.7% had documentation of urethral stenosis as a potential complication.
  • 33.5% of patients underwent urethroplasty, 59.6% repeat endoscopic treatment and 6.1% an indwelling catheter. 64.4% of patients reported urinary dysfunction as a “moderate” or “big” problem, 66.7% reported frequent or total incontinence, 64.4% required daily pad use and 50.6% reported incontinence as either a “moderate” or “big” problem.
  • 85.0% reported poor or absent orgasmic dysfunction and 88.5% reported erections insufficient for sexual activity.
  • 47.1% of patients reported rectal pain and 31.0% reported dysuria.
  • Fatigue and depressive symptoms were reported by 60.9% and 41.4% of patients, respectively.

“The findings from this cohort of patients presenting with urethral stenosis after radiotherapy for localized prostate cancer showed the magnitude of side effects and global impact on PRQoL which has previously not been reported,” the researchers wrote.

“There is a broad scope of patient-reported symptoms spanning lower urinary tract symptoms, incontinence, bowel dysfunction, sexual dysfunction, and systemic effects,” they concluded.

Reference:

Dirk, K., & Rourke, K. (2023). Health-Related Quality of Life in Patients with Urethral Stenosis after Radiation Treatment for Prostate Cancer. Urology. https://doi.org/10.1016/j.urology.2023.10.041

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Women with history of bariatric surgery had lower pregnancy weight gain than matched controls: JAMA

In a groundbreaking nationwide study conducted in Sweden from 2014 to 2021, researchers delved into the intricate relationship between pregnancy weight gain and the history of bariatric surgery. The study found that women who underwent bariatric surgery had lower weight gain in pregnancy than women who did not undergo surgery. The study results were published in the journal JAMA Network Open. 

The increasing global prevalence of obesity in reproductive-age women poses maternal and fetal health risks. Bariatric surgery, notably gastric bypass and sleeve gastrectomy, is a primary treatment. Previous studies indicate reduced risks for certain complications, but concerns remain about postoperative pregnancy weight gain. This Swedish nationwide study aims to compare pregnancy weight gain among women with a history of bariatric surgery against those without. The investigation delves into potential variations based on surgical procedure, surgery-to-conception interval, and surgery-to-conception weight loss, addressing existing gaps in understanding.

Also Read:  Hypoalbuminemia increase complications associated with bariatric surgery

The nationwide, population-based matched cohort study encompassing 12,776 pregnancies, aimed to shed light on how bariatric surgery influences pregnancy outcomes and whether factors such as surgical procedure, surgery-to-conception interval, and weight loss play crucial roles. This population-based study in Sweden (2014–2021) matched singleton pregnancies with a history of bariatric surgery to those without, employing a 1:1 propensity score matching based on various factors. Data analysis spanned from November 2022 to May 2023. The main outcome was to measure pregnancy weight gain was standardized by gestational age into early-pregnancy BMI-specific z scores.

Findings: 

  • The findings, unveiled through meticulous analysis, revealed a compelling connection between a woman’s history of bariatric surgery and her pregnancy weight gain. 
  • Notably, across all early-pregnancy BMI categories, women with a history of bariatric surgery exhibited lower pregnancy weight gain compared to their counterparts without such surgical history.
  • The study categorized BMI into normal weight, overweight, and various obesity classes, highlighting that the disparities in pregnancy weight gain were consistently evident.
  • One of the key revelations was that the choice of surgical procedure did not significantly alter the observed patterns of pregnancy weight gain. Whether individuals underwent gastric bypass or sleeve gastrectomy, the impact on pregnancy weight gain remained consistent. 
  • The study also explored the temporal aspect, investigating the influence of the surgery-to-conception interval. Intriguingly, a shorter surgery-to-conception interval, particularly within the first year, was associated with lower pregnancy weight gain. This temporal factor emerged as a crucial variable, suggesting that the timing of conception relative to bariatric surgery plays a pivotal role in shaping pregnancy outcomes.
  • Furthermore, the study highlighted the correlation between surgery-to-conception weight loss and pregnancy weight gain. Notably, a lower surgery-to-conception weight loss was linked to reduced pregnancy weight gain, contributing another layer to the intricate relationship between bariatric surgery history and maternal weight dynamics during pregnancy. 
Also Read: Bariatric surgery associated with Lower risk of haematological cancer among women: Lancet

In essence, this nationwide matched cohort study provides comprehensive insights into the nuanced association between bariatric surgery and pregnancy weight gain. The research not only challenges prevailing assumptions but also emphasizes the multifaceted nature of this relationship, encouraging a more nuanced approach to understanding the impact of bariatric surgery on pregnancy outcomes. As medical science continues to unravel the complexities of these interactions, this study marks a significant step forward in bridging gaps in knowledge and guiding future research and clinical practices.

Further reading: Xu H, Holowko N, Näslund I, et al. Pregnancy Weight Gain After Gastric Bypass or Sleeve Gastrectomy. JAMA Netw Open. 2023;6(12):e2346228. doi:10.1001/jamanetworkopen.2023.46228

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Higher Omega-3 levels intake may lower risk of total and ischemic stroke

A 2021 global study revealed that 1 in 4 adults will experience a stroke in their lifetime, making it the second-leading cause of death and third-leading cause of death and disability combined. Traditionally, diets low in sodium, saturated fat, and cholesterol (high-fibre diets) are the nutritional-based approach to preventing these conditions. Marine omega-3 PUFAs have also shown potential in preventing CVD.

According to a recent study published in STROKE, Higher omega-3 levels are linked to a lower risk of total and ischemic stroke; there is no association with hemorrhagic stroke.

The effect of marine omega-3 PUFAs on the risk of stroke remains unclear. This study investigated the associations between circulating and tissue omega-3 PUFA levels and incident stroke (total, ischemic, and hemorrhagic). The study design included 29 international prospective cohorts with 183,291 participants. Each site conducted de novo individual-level analyses. Harmonized data is centrally pooled and analyzed.

Key findings from the study are:

  • Out of 183,291 participants, 10,561 strokes were observed, including 8,220 ischemic and 1,142 hemorrhagic strokes, during a median follow-up of 14.3 years.
  • For eicosapentaenoic acid, comparing quintile 5 with quintile 1, total stroke incidence was 17% lower and ischemic stroke was 18% lower with HR 0.83 and 0.82, respectively.
  • For docosahexaenoic acid, comparing Q5 with Q1, there was a 12% lower incidence of total stroke and a 14% lower incidence of ischemic stroke with HR, 0.88 and 0.86, respectively.
  • Neither eicosapentaenoic acid nor docosahexaenoic acid was associated with a risk for hemorrhagic stroke.
  • These associations were not modified by baseline AF history or prevalent CVD.

James H. O’Keefe said This analysis of prospective studies found that long-chain omega-3 PUFA levels were inversely associated with f total and ischemic stroke risk, but not with hemorrhagic stroke risk. Therefore, higher DHA and EPA intakes may lower the stroke risk.

Reference:

O’Keefe et al. Omega-3 blood levels and stroke risk: A pooled and harmonized analysis of 183 291 participants from 29 prospective studies. Stroke, 55(1), 50–58. https://doi.org/10.1161/strokeaha.123.044281

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Maternal folic acid supplementation during pregnancy tied to reduced Kawasaki disease risk during infancy in offspring: JAMA

Japan: A recent study published in JAMA Network Open has suggested a reduced risk of Kawasaki disease (KD) during infancy among offspring with increasing maternal folic acid levels via maternal folic acid supplementation during pregnancy.

The Japanese nationwide birth cohort study of 87,702 children revealed that the frequency of maternal folic acid supplementation and maternal serum folic acid levels during pregnancy were significantly associated with a reduced risk of Kawasaki disease in offspring during infancy.

Kawasaki disease is an acute systemic vasculitis that majorly affects young children and infants. A previous study has reported a possible association between maternal folic acid supplementation and Kawasaki disease, but no reproducible risk factors have been identified yet. Sayaka Fukuda, Yokohama City University, Yokohama, Japan, and colleagues investigate the associations of exposure to maternal serum folic acid levels and maternal folic acid supplementation with the onset of KD during infancy among offspring.

In the cohort study, the researchers used data from a nationwide birth cohort, the Japan Environment and Children’s Study, which enrolled children since 2011.

Maternal serum folic acid levels (≥10 ng/mL classified as exposed) were determined during the second and third trimesters and the frequency of maternal folic acid supplementation during the first trimester and during the pregnancy’s second and third trimesters (once a week or more was classified as exposed).

The primary outcome of the study was the onset of Kawasaki disease in offspring up to 12 months of age. Odds ratios (ORs) for each exposure were estimated, and propensity score–adjusted logistic regression was conducted based on the sets of variables.

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

  • The study population consisted of 87,702 children who were followed up for 12 months. Of these, 336 children developed Kawasaki disease.
  • Mothers who took folic acid supplements (35.7% of mothers; mean age, 32 years) had higher serum folic acid levels than those who did not take supplements.
  • Higher maternal serum folic acid levels were associated with a significantly lower risk of Kawasaki disease in offspring than lower levels (folic acid ≥10 vs <10 ng/mL, 0.27% children vs 0.41% children; OR, 0.68).
  • Children whose mothers took folic acid supplementation during the first trimester had a lower prevalence of Kawasaki disease than children whose mothers did not take folic acid (0.34% of children versus 0.42% of children), although the difference was not statistically significant (OR, 0.83).
  • Supplementation during the second and third trimesters was associated with a significantly lower risk of Kawasaki disease compared with no supplementation (94 of 0.30% children versus 0.43% children; OR, 0.73).

“Findings showed that higher serum folic acid levels (≥10 ng/mL) and maternal folic acid supplementation more than once a week during the second and third trimesters were tied to a reduced risk of Kawasaki disease in offspring during infancy” they concluded.

Reference:

Fukuda S, Tanaka S, Kawakami C, Kobayashi T, Ito S, Japan Environment and Children’s Study Group. Maternal Serum Folic Acid Levels and Onset of Kawasaki Disease in Offspring During Infancy. JAMA Netw Open. 2023;6(12):e2349942. doi:10.1001/jamanetworkopen.2023.49942

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Fascia iliaca and pericapsular nerve group blocks may bring pain relief in patients undergoing Hip replacement

Patients who receive hip arthroplasty may have moderate to severe pain after surgery, which might negatively impact their long-term prognosis and increase their risk of perioperative complications. Treatments for regional anaesthesia, such as fascia iliaca compartment block (FICB) and pericapsular nerve group block (PENG), improve functional ability and quality of life.

However, there is now little data to refute the analgesic benefits of these techniques. Twelve randomised controlled trials (RCTs) were included in this recently published systematic review and meta-analysis to evaluate the relative efficacy of pericapsular nerve group block (PENG) and fascia iliaca compartment block (FICB) for patients undergoing hip replacement surgery. The primary outcome was the pain score (1–10) using the visual analogue scale (VAS) or numeric rating scale (NRS) at rest and during movement after a 24-hour period. The GRADE method was used to evaluate the data, and it was found that there was intermediate quality evidence for pain ratings at rest and during movement over a period of 30 to 24 hours. PENG block indicated improved analgesia in 30 minutes during movement and during rest, and a 24 hour decrease in postoperative opioid consumption, with a fair degree of confidence in the findings. The study found that PENG block was more effective than suprainguinal or infrainguinal FICB at rest and during movement within 30 minutes. Peripheral nerve blocks are preferred over regular intravenous opioids in the better recovery after surgery protocol because they may decrease pain, speed up the mobility and usage of opioids, and lower the risk of side effects in the early postoperative phase.

Reference –

Prakash, Jay; Rochwerg, Bram1; Saran, Khushboo2; Yadav, Arun K.3; Bhattacharya, Pradip Kumar; Kumar, Amit4; Chaudhuri, Dipayan1; Priye, Shio5. Comparison of analgesic effects of pericapsular nerve group block and fascia iliaca compartment block during hip arthroplasty: A systematic review and meta-analysis of randomised controlled trials. Indian Journal of Anaesthesia 67(11):p 962-972, November 2023. | DOI: 10.4103/ija.ija_672_23.

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Thyroid test not done before IVF Procedure: AIIMS Delhi held negligent, slapped compensation

New Delhi: The State Consumer Disputes Redressal Commission, Delhi recently held the All India Institute of Medical Sciences (AIIMS) guilty of medical negligence while providing In Vitro Fertilization (IVF) treatment to a patient.

Despite undergoing the IVF procedure twice, the complainant could not conceive. She alleged that the treating doctors at the hospital failed to prescribe the necessary Thyroid test before undergoing the procedure.

AIIMS has been directed by the Commission to pay Rs 2.5 lakh compensation (including the cost of treatment spent for IVF) to the Complainant for the suffering, mental pain and agony caused.

The Commission opined that there was sheer negligence on the part of the hospital as the patient was not treated with due care and caution by the hospital and the treatment was not done in accordance with the medical practice followed by the doctors while treating the patient of similar condition and age.

The matter goes back to 2008 when the complainant approached AIIMS hospital to undergo the necessary treatment to overcome infertility and to have a child. After the preliminary tests and examinations under the guidance of the HOD Gynae, the complainant was advised to opt for In Vitro Fertilization (IVF) and accordingly, she got admitted to the hospital on 07.01.2008 and a team of doctors was engaged to start laparoscopy and a mandatory process before the IVF i.e. Mock ET on 26.03.2008. Consequently, the IVF process was conducted by the operating doctor on 01.12.2008.

Following this, the patient was discharged on the same day after charging an amount of Rs 60,000 for the said process. However, allegedly, the Thyroid-test, which is necessary in cases of fertility was not done or advised by the operating doctor before commencement of the treatment.

The second plan for IVF was adopted beginning on 20.05.2010 with the help of frozen embryo. However, the doctors failed to advise the Thyroid Test before undergoing the method adopted and therefore, no positive result came out from the second IVF process, alleged the complainant.

Thereafter, the third IVF process was proposed to be carried out on 21.04.2011. However, as the patient was putting on weight, she decided to go for the Thyroid Test through a pathology, from where she got to know that she was suffering from thyroid and therefore she consulted Dr. Ganpati, a specialist, who prescribed some medicines for the treatment of thyroid.

Once again the complainant approached AIIMS, where the operating doctor advised the Thyroid test and based on the report dated 27.06.2011. However, no such test was prescribed by them prior to such date, alleged the complainant. Losing all her faith in the hospital, the complainant deferred to go for the third IVF process.

It was alleged by the complainant that when she was admitted to AIIMS, the operating doctor should have, at the first instance, advised for the Thyroid-Test since it is crucial to know about the success rate of the IVF and the process should run accordingly. She alleged that there was clear negligence on the part of the hospital as the operating doctors also failed to conduct the required test during the second phase of IVF.

In her complaint, she pointed out that the success rate in the case of IVF is 25 to 30%. However, in the case when the patient is suffering from Thyroid, the success rate falls to 15%. However, no efforts were made by the hospital to advice for the Thyroid Test, alleged the complainant. 

Therefore, on these grounds mentioned above, the complainant alleged utter Medical Negligence on the part of the hospital and approached the State Consumer Court, Delhi. 

While considering the matter, the consumer court heard the complainant’s counsel and also perused the material available on record including the written arguments filed on behalf of the complainant and the hospital. In order to discuss in detail the scope and extent of Negligence with respect of Medical Professionals, the consumer court referred to the order in the case of Seema Garg & Anr. vs. Superintendent, Ram Manohar Lohia Hospital & Anr. decided on 31.01.2022.

In the concerned judgment, it was mentioned that in cases where the allegations are levelled against the Medical Professionals, negligence is an essential ingredient for the offence, which is basically the breach of a duty exercised by omission to do something which a reasonable man would do or would abstain from doing. However, negligence cannot be attributed to a doctor so long as he performs his duties with reasonable skill and competence and they are entitled to protection so long as they follow the same.

Referring to this order, the consumer court noted,

“In the present case also, it will have to be ascertained whether there was any lack of skill and competence on the part of the operating doctor and/or any omission to do what was actually required in the present facts and circumstances.”

The Commission observed that the complainant did not allege that the operating doctors did not have the requisite skill or competence or they were not qualified to operate on the complainant. The main complaint was that the treating doctors at AIIMS failed to do the thyroid test before doing the IVF procedure, noted the Commission.

At this outset, the Commission perused the discharge summary and noted,

“Therefore, in order to check whether there was an deficiency on the part of treating doctor, we have carefully perused the medical records filed by the Complainant and found that the treating doctor have prescribed certain tests before doing the first process of IVF and they were done before doing IVF, however, no Thyroid-test was done and prescribed by the treating doctors which can be clearly seen from the discharge summary available before us…”

Additionally, the consumer court found that the treating doctors while mentioning the history of patient have mentioned about the Thyroid-Test which was undertaken by the Complainant in the year 2004 and mentioned the readings as: T3-119.0, T4 – 6.54 and TSH – 4.38 which was normal.

Besides, the Commission also took note of the fact that the “…Thyroid function may indeed affect the process and success of in vitro fertilization (IVF) as the thyroid gland plays a crucial role in regulating metabolism and hormone production, and thyroid disorders can impact fertility in the patient. Additionally, Thyroid hormones, specifically thyroxine (T4) and triiodothyronine (T3), plays a role in regulating the menstrual cycle and ovulation. An underactive thyroid (hypothyroidism) or an overactive thyroid (hyperthyroidism) can disrupt the normal hormonal balance required for ovulation and the preparation of the uterine lining for embryo implantation and due to these reasons, it is important for individuals undergoing IVF to have their thyroid function evaluated and, if necessary, treated or managed before and during the IVF process. Further, if a thyroid disorder is diagnosed, appropriate treatment or medication may be recommended to bring thyroid function into the normal range.”

However, the Commission observed that the treating doctors have failed to diagnose the Thyroid function at the primary stage and it came to the knowledge of the treating doctor in the year 2011, when the Complainant opted to get herself checked for the Thyroid test. “Additionally, considering the age of the Complainant in the present case, it was clear to the treating doctor that the chances of getting the IVF successful in the present case is very low,” noted the Commission.

“Moreover, it is a well laid down principle that the doctor diagnosing upon a patient is the best judge of the treatment which is to be undertaken for that specific patient. There may be multiple approaches with which the patient may be treated upon, however, the doctor is expected to choose the most appropriate one in the given facts and circumstances. Hence, a higher degree of reliance is placed upon the concerned doctor, that whatever option he/she exercises will be for the benefit and interest of the patient. However, failure on the part of doctor in diagnosing the Thyroid function at the primitive stage has mentally and physically harassed the Complainant and her family,” it further added.

Finally, relying upon the Supreme Court order in the case of Jacob Mathew v. State of Punjab and Anr, Martin F. D’Souza v. Mohd. Ishfaq, and Kusum Sharma and Ors. (supra), the Commission opined that the approach in medical negligence cases should be “what was actually done by the doctor was not acceptable or generally used in the medical practices at the given point of time.”

Taking all these factors into account, the Commission opined that there was sheer negligence on the part of the hospital i.e. AIIMS

“as the patient (Complainant) was not treated with due care and caution by the Opposite Party no. 1 and the treatment was not done in accordance with the medical practice followed by the doctors while treating the patient of similar condition and age.”

Therefore, holding AIIMS negligent in providing its services to the Complainant and keeping in view the principles detailed above and the facts and circumstances of the case, the age of the patient, and other necessary and essential factors, the Commission opined it to be just and reasonable to award compensation of Rs. 2,50,000 (including the cost of treatment spent by the Complainant for IVF) to the Complainant for the suffering, mental pain and agony caused.

“The amount so awarded … be paid by the Opposite Party no. 1 being liable, within a period of three months from the date of present judgment i.e. on or before 29.02.2024, failing which, the Opposite Party no. 1 would be liable to pay the said amount alongwith the interest at the rate of 9% p.a. from 01.12.2008 (when the Complainant has undergone for the first IVF process) till the actual realization of said amount,” the Commission mentioned in its order.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/aiims-negligence-229143.pdf

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