Use of diffusion optics technology spectacle lenses may prevent juvenile myopia progression

Researchers have found in a new study that Use of diffusion optics technology spectacle lenses may prevent juvenile myopia progression. 

The findings of the new study have been published in the British Journal of Ophthalmology.

Mutations in the L/M cone opsin gene array cause abnormally high perceived retinal contrast and the development of myopia. Environmental factors may also lead to high visual contrast and cause myopia. Diffusion optics technology (DOT) lenses are designed to reduce contrast signalling in the retina and slow myopia progression.

The Control of Myopia Using Peripheral Diffusion Lenses Efficacy and Safety Study (CYPRESS, NCT03623074) is a 36-month, multicentre, randomised, controlled, double-masked trial evaluating two investigational spectacle lenses versus control lenses in myopic children aged 6–10, with a planned interim analysis at 12 months. The primary endpoints are change from baseline in axial length (AL) and spherical equivalent refraction (SER).

Results

In all 256 children (58% female; mean age at screening, 8.1 years) were dispensed spectacles. Across all groups, baseline averages were AL 24.02 mm (SD±0.77 mm), SER −2.01 D (SD±0.9 D) using manifest refraction, and SER −1.94 D (SD±1.0 D) using cycloplegic autorefraction. At 12 months, mean difference in SER progression for test 1 versus control was −0.40 D (p<0.0001), representing a 74% reduction and −0.32 D for Test 2 (p<0.0001), representing a 59% reduction. The difference in AL progression for test 1 versus control was 0.15 mm (p<0.0001) and test 2 versus control was 0.10 mm (p=0.0018).

Reseachers concluded that 12-month results from this ongoing trial demonstrate the safety and effectiveness of Diffusion optics technology (DOT) spectacles for reducing myopic progression.

Reference:

Rappon J, Chung C, Young G, et alControl of myopia using diffusion optics spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS) British Journal of Ophthalmology 2023;107:1709-1715.

Keywords:

Use, diffusion, optics, technology, spectacle, lenses, may, prevent, juvenile, myopia, progression, British Journal of Ophthalmology

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Valproate Use Linked to Brain Volume Reduction in Epilepsy Patients

Recent study unveiled important findings about the impact of valproate (VPA) use on the brain volume of individuals with idiopathic generalized epilepsy. The crucial results of the extensive study were published in Epilepsia Journal.

The study employed voxel-based morphometry on magnetic resonance imaging (MRI) and focused on 112 patients currently using VPA (VPA+ group), 81 not using VPA (VPA– group), and 120 healthy subjects for comparison.

The findings indicated significant gray matter (GM) volume reduction in the VPA+ group in various brain regions, including the bilateral cerebellum, hippocampus, insula, caudate nucleus, medial frontal cortex/anterior cingulate cortex, primary motor/premotor cortex, medial occipital cortex, and anteromedial thalamus. When compared to the control group, the VPA– group also exhibited GM volume reduction in the anteromedial thalamus and right hippocampus/temporal cortex.

The study found distinctive differences the VPA+ group, when compared to the VPA– group which showed more extensive GM volume reduction in the bilateral cerebellum, primary motor/premotor cortex, and medial frontal cortex/anterior cingulate cortex.

These findings found the potential adverse effects of VPA on brain structure, particularly in the frontal cortex and cerebellum. The study suggests that the use of VPA may contribute to cortical thinning and GM volume reduction, urging caution while interpreting morphometric MRI studies involving individuals taking VPA.

The study emphasizes the importance of considering VPA use as a potential confounding factor in studies exploring brain morphometry. Understanding these associations is crucial not only for clinicians prescribing VPA but also for researchers aiming to accurately interpret MRI data in epilepsy studies. Further investigations are imperative to validate the clinical implications and long-term effects of these structural changes that were observed in epilepsy patients using VPA.

Source:

Shin, J. H., Song, M. J., & Kim, J. H. (2023). Valproate use associated with frontal and cerebellar gray matter volume reductions: A voxel‐based morphometry study. In Epilepsia. Wiley. https://doi.org/10.1111/epi.17825

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Point-of-care PCR may help guide antibiotic choice and improve pneumonia treatment

Community-acquired pneumonia (CAP) is a leading cause of hospitalization and death. Timely antibiotic treatment is crucial to prevent complications like bacteremia, sepsis, organ failure, and death. Initial treatment is often empiric, and an uncertain or delayed diagnosis can lead to broad-spectrum antibiotic use. This contributes to adverse effects, such as Clostridioides difficile infection and super-infections with resistant bacteria, and can worsen patient outcomes and contribute to antibiotic resistance.

A study published in PLOS ONE has concluded that using respiratory POC does not appear to be effective in reducing antibiotic use in a setting with low antimicrobial resistance and already prudent antibiotic use. However, it may help ensure targeted and appropriate treatment in a restrictive antibiotic setting and support a restrictive strategy. The COVID-19 pandemic and low transmission of common respiratory viruses during the study period may have impacted the results.

We need rapid and accurate detection of pathogens in community-acquired pneumonia (CAP) to use appropriate antibiotics and slow down antibiotic resistance development. The study aimed to compare the effect of adding point-of-care (POC) polymerase chain reaction (PCR) detection of respiratory pathogens to standard care with standard care only (SCO) on antibiotic prescriptions after acute hospital admission.

They conducted an open-label, multicenter, parallel-group, superiority RCT at three Danish medical emergency departments from March 2021 to February 2022. Adults with suspected CAP during daytime weekdays were included and randomly assigned (1:1) to POC-PCR or SCO analysis of respiratory samples. Two hundred ninety-four patients with collected samples were randomly assigned to POC-PCR (n = 148, 50.4%) or SCO (n = 146, 49.6%). The study used logistic regression and Huber–White clustered standard errors for the prescription of antibiotic treatment. The study included intention-to-treat and per-protocol analysis.

Key findings from the study are:

  • Loss to follow-up comprises three patients in the POC-PCR and none in the SCO group.
  • There was no difference in the primary outcome of prescriptions of no or narrow-spectrum antibiotics four hours after admission for the POC-PCR and SCO.
  • The prescriptions were more targeted at four h (OR 5.68) and 48 h (OR 4.20)and more adequate at 48 h (OR 2.11) and on day 5 in the POC-PCR group (OR 1.40).
  • There was no difference between the groups about intensive care unit (ICU) admissions, readmission within 30 days, length of stay, 30-day mortality and in-hospital mortality.

· The POC-group patients showed a non-statistically significant shortening of hospital stay by approximately one day.

· The POC group treated more patients with targeted antibiotics within 48 hours and five days after admission.

Antimicrobial resistance is low in Denmark, and most Haemophilus influenzae and Streptococcus pneumoniae are susceptible to benzylpenicillin. Danish guidelines recommend narrow-spectrum penicillin for milder CAP cases and broad-spectrum antibiotics for severe cases. CAP diagnosis is based on clinical symptoms and unspecific diagnostic tools like auscultation, chest radiography, blood tests, and microbiological analysis of sputum samples.

They said that in a setting with limited antibiotic use, point-of-care – polymerase chain reaction (POC-PCR) did not increase the number of patients treated with narrow-spectrum or without antibiotics. However, it showed potential for more targeted and appropriate antibiotic use. A study limitation was the COVID-19 pandemic, which led to low respiratory virus transmission.

Reference:

: Cartuliares MB et al. Evaluation of point-of-care multiplex polymerase chain reaction in guiding antibiotic treatment of patients acutely admitted with suspected community-acquired pneumonia in Denmark: A multicentre randomized controlled trial. PLoS Med 20(11): e1004314. https://doi.org/10.1371/journal.pmed.1004314

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Statin Initiation Linked to Reduced Mortality in Chronic Kidney Disease among Older Veterans

In a breakthrough study focusing on older veterans with chronic kidney disease (CKD), researchers have discovered a potential game-changer in the form of statin initiation. The study, employing a target trial emulation design, aimed to investigate the impact of statin use on all-cause mortality and major adverse cardiovascular events (MACE) in veterans aged over 65 with CKD stages 3 to 4. The study found that Statin initiation in US veterans over 65 with CKD stages 3 to 4 and no prior atherosclerotic cardiovascular disease (ASCVD) was associated with a lower risk of all-cause mortality but did not significantly impact the occurrence of MACE

The study results were published in the journal JAMA Network Open. 

Atherosclerotic cardiovascular disease is the leading cause of death among adults with chronic kidney disease. Some evidence supports the use of statins for the primary prevention of ASCVD in older patients with CKD. While statins are widely known for their efficacy in preventing cardiovascular events, their utility in individuals with CKD has been a subject of limited data and exploration. Due to uncertainty in the evidence researchers from Massachusetts conducted a study to evaluate the association of statin use with all-cause mortality and major adverse cardiovascular events (MACE) among US veterans older than 65 years with CKD stages 3 to 4

The study was conducted as a cohort study, by utilizing a target trial emulation design and involving veterans diagnosed with moderate CKD between 2005 and 2015. Participants were aged over 65, within 5 years of CKD diagnosis, without prior atherosclerotic cardiovascular disease (ASCVD) or statin use, and had at least 1 clinical visit in the year before the trial baseline. Propensity weighting was applied for a meticulous analysis of the outcomes.

Findings:

  • The comprehensive analysis included 14,828 veterans, with a mean age of 76.9 years at CKD diagnosis.
  • The results, after propensity score adjustment, were striking.
  • Statin initiators exhibited a significantly lower risk of all-cause mortality (hazard ratio 0.91, 95% CI 0.85-0.97) compared to noninitiators.
  • This finding suggests a noteworthy association between statin initiation and a reduced risk of mortality in this specific population.
  • However, the study did not find a significant impact on the occurrence of major adverse cardiovascular events (MACE) with statin use.
  • The hazard ratio for MACE was 0.96 (95% CI 0.91-1.02), indicating that statin initiation did not result in a statistically significant reduction in MACE.

These findings carry significant implications for the management of CKD in older veterans. While statin initiation demonstrated a clear association with lower all-cause mortality, the lack of a substantial impact on MACE suggests a need for further research.

The study underscores the importance of considering statin therapy in the care plan for older veterans with CKD, emphasizing the potential for mortality reduction. However, the researchers emphasize the necessity for confirmation through randomized clinical trials to establish a robust evidence base and inform clinical guidelines.

Further reading: Barayev O, Hawley CE, Wellman H, et al. Statins, Mortality, and Major Adverse Cardiovascular Events Among US Veterans With Chronic Kidney Disease. JAMA Netw Open. 2023;6(12):e2346373. doi:10.1001/jamanetworkopen.2023.46373

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Aspirin use may significantly delay progression of Abdominal Aortic Aneurysm with favorable safety profile.

The preclinical research indicates that aspirin may play a role in slowing the progression of abdominal aortic aneurysms (AAAs) and averting their rupture. However, human studies are scarce to demonstrate the clinical advantages of aspirin in treating AAA.

In a recent retrospective study of a clinical cohort of 3435 patients with objectively measured changes in aortic aneurysm progression, aspirin usage slowed the progression of abdominal aortic aneurysm (AAA) with a favorable safety profile.

This original Investigation on Cardiology was published in JAMA Network Open.

This retrospective study included adult patients with at least two vascular ultrasounds available at the Cleveland Clinic. Patients with a history of aneurysm repair, dissection, or rupture were excluded. All patients were followed for ten years, and clinical outcomes were analyzed from May 2022 to July 2023. The primary outcomes were the time-to-first occurrence of all-cause mortality, major bleeding, or a composite of dissection, rupture, and repair. Multivariable-adjusted Cox proportional-hazard regression and Fine and Gray proportional subhazard regression were used.

Key summary points of this investigation are:

  • There were 2672 male patients with a mean age of 73 years.
  • The median follow-up duration was 4.9 years.
  • Two thousand one hundred fifty patients were verified to be taking aspirin by prescription.
  • Patients taking aspirin had a slower mean annualized change in aneurysm diameter (2.8 vs 3.8 mm per year ) and lower odds of having rapid aneurysm progression compared to patients who were not taking aspirin.
  • The adjusted odds ratio was 0.64.
  • There was no association between aspirin use and risk of all-cause mortality, major bleeding and composite outcome with aHR of 0.92, 0.88 and 1.16, respectively.

They said that in this study, aspirin use slowed the progression of abdominal aortic aneurysms, especially in men and nonsmokers. Aspirin use was not associated with all-cause mortality, major bleeding, or the risk of aneurysm dissection, rupture, or repair after ten years.

Reference:

Hariri E, Matta M, Layoun H, et al. Antiplatelet Therapy, Abdominal Aortic Aneurysm Progression, and Clinical Outcomes. JAMA Netw Open. 2023;6(12):e2347296

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High resting heart rate may be risk factor for end-stage renal disease

High resting heart rate may independent risk factor for end-stage renal disease suggests a new study published in the Journal of the American Heart Association. 

The relationship between resting heart rate (RHR) and the risk of end‐stage renal disease (ESRD) among those without cardiovascular disease remains unclear. We aim to establish temporal consistency and elucidate the independent relationship between RHR and the risk of ESRD.

This cohort enrolled participants from 476 347 individuals who had taken part in a screening program from 1996 to 2017. We identified 2504 participants who had ESRD, and the median follow‐up was 13 years. RHR was extracted from electrocardiography results, and the study assessed the relationship between RHR and the risk of ESRD using the Cox proportional hazards model. Of the participants, 32.6% had an RHR of 60 to 69 beats per minute (bpm), and 22.2% had an RHR of ≥80 bpm. Participants with an RHR of ≥80 bpm had a higher stage of chronic kidney disease, lower estimated glomerular filtration rate, and more proteinuria than those with an RHR of 60 to 69 bpm. Participants with an RHR of 80 to 89 and ≥90 bpm had a 24% (hazard ratio [HR], 1.24 [95% CI, 1.09–1.42]) and 64% (HR, 1.64 [95% CI, 1.42–1.90]) higher risk of ESRD, respectively. The risk of ESRD remained significantly elevated (HR, 1.32 [95% CI, 1.10–1.58] per 10‐beat increase from 60 bpm) after excluding participants who smoked; had hypertension, diabetes, or hyperlipidemia; or were overweight.

An RHR of ≥80 bpm is significantly associated with an increased risk of ESRD. These results suggest that RHR may serve as a risk factor for kidney disease in individuals without established cardiovascular disease risk factors.

Reference:

Resting Heart Rate Independent of Cardiovascular Disease Risk Factors Is Associated With End‐Stage Renal Disease: A Cohort Study Based on 476 347 Adults

Min‐Kuang Tsai, Wayne Gao, Kuo‐Liong Chien, Thu Win Kyaw, Chin‐Kun Baw, Chih‐Cheng Hsu and Chi‐Pang Wen. Originally published1 Dec 2023https://doi.org/10.1161/JAHA.123.030559Journal of the American Heart Association. 2023;12:e030559

Keywords:

High, resting, heart, rate, may, independent, risk, factor, for, end-stage, renal, disease, Journal of the American Heart Association, Min‐Kuang Tsai, Wayne Gao, Kuo‐Liong Chien, Thu Win Kyaw, Chin‐Kun Baw, Chih‐Cheng Hsu and Chi‐Pang We

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Elagolix monotherapy Safe Against Heavy Menstrual Bleeding associated with Uterine Leiomyomas

A new phase 4 study published in The Journal of Obstetrics and Gynecology found elagolix 150 mg monotherapy taken once-daily to solve heavy menstrual bleeding associated with uterine leiomyomas were the safe and effective. This offers promise to premenopausal patients aged 18–51 years.

This randomized, double-blind, placebo-controlled study assessed  a total of 82 patients, with 54 receiving elagolix 150 mg and 28 receiving a placebo. The primary endpoint was a reduction in menstrual blood loss volume to less than 80 mL at the final month, coupled with at least a 50% reduction from baseline to the final month.

The results found 49.4% of patients in the elagolix group who met the primary endpoint, compared with 23.3% in the placebo group (P=.035). The differences in mean reduction of menstrual blood loss were significant as early as month 1 (P<.05 for months 1–3 and 5).

Moreover, elagolix demonstrated its effectiveness in suppressing bleeding (P=.036). The patients on elagolix experienced greater improvements in the proportion of those with amenorrhea, hemoglobin concentrations, and health-related quality of life.

Elagolix treatment was well-tolerated. There were no serious or severe adverse events reported, in stark contrast to the 7.1% of participants in the placebo group facing serious adverse events, including coronavirus disease 2019 (COVID-19) and an enlarged uvula. Only 5.6% of patients discontinued elagolix due to adverse events.

This study brings out a significant improvement in addressing heavy menstrual bleeding associated with uterine leiomyomas in premenopausal patients. The positive outcomes of elagolix 150 mg once-daily monotherapy, coupled with its favorable safety profile, underscore its potential as a transformative treatment option.

Source:

Brown, E., Kroll, R., Li, H., Ng, J., Pinsky, B., Rodriguez, J. W., Thomas, J., & Snabes, M. C. (2023). Low-dose elagolix for the treatment of heavy menstrual bleeding in patients with uterine leiomyomas: A randomized controlled trial. Obstetrics and Gynecology, 142(5), 1068–1076. https://doi.org/10.1097/aog.0000000000005380

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Delay in treatment of cancer patient leading to death: GTB Hospital, doctors held negligent, slapped Rs 5 lakh compensation

New Delhi: Noting that the apathetic approach of the hospital and its doctors towards the gravity of the ailment raises a presumption as regards to the failure of treating doctors in clinical judgment and choosing the right course of action in time, the Delhi State Consumer Disputes Redressal Commission has upheld the District Forum’s order that found GTB Hospital and its two doctors guilty of negligence and delay in treating a cancer patient who eventually succumbed to the disease.

The District Commission had directed the facility and the doctors to jointly pay a lump sum compensation of Rs 5 lakhs to the heirs (complainants) of the deceased patient.

The State Commission’s bench comprising of Justice Sangita Dhingra Sehgal, President, and Pinki, Member (judicial) dismissed the appeal filed by GTB Hospital and its doctors challenging the District Commission’s order, and crucially remarked that courts are not experts in the field of medical science and are required to be assisted by experts to form opinion, in order to decide as to whether negligence was committed or not.

The case concerns a man named Singh, who held the role of a senior Mali in the PWD Department under the Government of NCT of Delhi. His work was stationed at G.T.B Hospital in Dilshad Garden, Shahdra. Singh was enrolled in the Delhi Govt. Employees Health Scheme (DGEHS), an initiative for the healthcare of Delhi Government employees. A nominal deduction of Rs 30 per month from his salary was regularly allocated for his subscription to this scheme. Consequently, he was identified as a consumer, a status inherited by his heirs following his death.

In April 2005, Singh noticed an unusual growth in his mouth, reminiscent in size and shape of a pea. Concerned, he sought assistance at GTB Hospital, where he was officially registered for medical treatment. Here, a Central ID No. was assigned to him, guiding him to the ENT Department of the Hospital.

A tissue sample was procured from his mouth for a biopsy by the Hospital. However, despite this step, an accurate diagnosis was delayed by an entire month, ultimately confirming that he was grappling with “Squamous Cell Carcinoma (Oral Cavity Cancer)” on the left side of his mouth. The initial tumor size was a mere square centimeter, but alleged negligent and careless treatment by the hospital led to a worrying increase to 3 square centimeters by July 2005.

In the following months, the patient made multiple visits to the hospital, seeking treatment. However, he alleged to receive no medicine or proper treatment during these visits. The situation escalated to the point where a surgical intervention was planned for the tumor in May 2005. He underwent a pre-operative P.A.C. test, a prerequisite for anesthesia preparation, at the Anesthesia Department of the hospital and was instructed to arrange a unit of blood for the operation, which he promptly organized. However, the operation did not proceed as scheduled, leaving the much-needed treatment elusive.

Amidst this medical uncertainty, the patient revisited, this time guided to a doctor in the Dental Department of the hospital. Despite this referral, the operation failed to materialize. Subsequently, in July 2005, he was referred to L.N.J.P Hospital, Delhi by GTB Hospital for further treatment. Despite subsequent visits to LNJP and other hospitals, the negligence and lack of proper treatment persisted, eventually leading to the death of the patient in February 2007.

In the aftermath, the deceased’s legal heirs (the complainants), filed a consumer complaint with the District Commission alleging negligence and delays in treatment by various medical practitioners, ultimately leading to the patient’s death; and sought a claim amount of Rs. 13 lakhs, Rs 40,000 as compensation for the mental and physical distress, along with litigation costs of Rs. 11,000.

The District Commission reviewed the evidence and passed an order. They considered whether the deceased, a government employee and member of DGEHS, qualified as a consumer under section 2(1)(d) of the Act. They affirmed the deceased’s consumer status based on previous legal interpretations.

The Commission further addressed another critical issue if the deceased’s death resulted from doctors’ negligence. It went through the medical experts’ reports from R.M.L hospital and evidence that indicated that GTB Hospital and the doctor did not provide adequate care and precaution during the deceased’s treatment. Despite the detection of cancer, they pursued tests and treatments for tuberculosis instead of addressing the actual disease. The delay in surgery allowed the tumor to grow, ultimately contributing to the patient’s death. Subsequently, the hospital and the doctor were found negligent.

The Commission awarded a lump sum compensation of Rs 5 lakhs to the complainants, along with additional amounts for mental pain, agony, and litigation costs. The compensation was to be paid by the hospital and the doctors jointly and severally within one month of receiving the order. Failure to comply would incur 6% p.a. interest from the complaint filing date till realization.

Displeased with the District Commission’s verdict, GTB Hospital and the doctors lodged an appeal with the State Commission asserting that the District Commission overlooked the patient’s lackadaisical attitude towards his condition and his disinclination for surgery. They argue that there was no undue delay or any negligence or deficiency on their part. Moreover, they emphasize that the patient was advised to schedule surgery, but he did not. Finally, they contend that the District Commission erred in dismissing the report from the medical expert committee of Safdarjung Hospital and relying solely on the report from RML Hospital, which they claim did not encompass the complete medical history of the deceased.

In response, the complainants asserted that the deceased patient eagerly anticipated his surgery and meticulously adhered to every directive, prescription, and advice provided by the doctors from the hospital. They argue that the doctors at the hospital never advised the patient to ‘schedule’ the surgery; instead, it was the responsibility of the treating doctors at GTB hospital to ‘arrange’ the surgery date for the deceased. Additionally, they claim that the hospital and the doctors unnecessarily prolonged the surgery date without valid justification, allowing the disease to advance to an incurable stage. They further argued that during the 106-day period the patient spent at the Hospital, no cancer-specific treatment was administered, and the patient only developed purulent discharge in his mouth after the hospital’s treating doctors took a biopsy sample (muscle piece) from the patient’s mouth, causing a wound.

After hearing the arguments, the State Commission remarked that the discussion and available records demonstrate the patient’s full compliance with the hospital and the doctor’s instructions. The patient efficiently completed all necessary steps, from PAC to dental extraction and arranging blood, indicating a clear willingness to undergo the operation. There is no doubt about the patient’s readiness for the surgery. It further observed;

“In our opinion, it is highly improbable that any patient suffering from a life-usurping disease like cancer shall assume a casual attitude towards his own treatment. Therefore, the contention of the Appellants (GTB Hospital and the doctors) that the patient was reluctant to undergo surgery and didn’t take his treatment seriously holds no water in light of the material on record.”

The Commission found it baffling why the doctor continuously delayed the surgery without valid reasons. Over the 2-month period, the tumor size increased significantly from 1 sq.cm to 3 sq.cm. Notably, the hospital and the doctors did not administer any cancer-specific treatment, despite knowing cancer is a progressive disease. The prolonged wait for surgery is perplexing, especially when the patient needed radiotherapy, indicating a lack of urgency and clinical judgment. Additionally, the failure to refer the patient to LNJP, if the hospital lacked the necessary resources or expertise, raises questions about appropriate action. It observed;

“We fail to understand as to why the patient was made to wait for an extended period of time for performing surgery in the first place when ultimately the patient was to be referred to another hospital for a completely different modality of treatment i.e. radiotherapy. Such conduct clearly indicates the Appellant’s’ apathetic approach towards the gravity of the ailment and raises a presumption as regards to the failure of treating doctors in clinical judgment and choosing the right course of action in time. We fail to understand that if the Appellant-hospital didn’t have the required facilities or specialized doctors to treat the patient, then why was the patient not referred to LNJP in the first instance.”

The Commission further strengthened its opinion based on the expert medical report of RML Hospital, which concluded as:

“The Committee Members have concluded that the patient was advised surgery and was fit from anaesthesia department on 27/05/05. However, he was not operated upon and referred to LNJP Hospital for Radiotherapy on 18/07/2005. There was definite delay in referring him and crucial time was lost in his repeated visits to oncology clinic GTB Hospital.”

The Commission noted;

“In the present case, the expert medical board constituted at RML hospital clearly opines that the patient was not operated upon in time and there was definite delay in referring, thereby crucial time was wasted in his repeated visits to the Oncology Clinic at the Appellant No.1-hospital. The patient was PAC fit and surgery was planned on 13.05.2005 which means he was fit for surgery, yet inexplicable delays were caused and he was not operated upon. Therefore, it is established beyond doubt that the Appellants have clearly failed to act in a case where time was the essence and made delays which rendered the disease incurable, ultimately resulting in the patient’s death.”

The consumer body also emphasized that the medical record does not indicate any consultation with an Oncologist or Cancer Specialist. This observation is reinforced by reviewing the Directory of officers and employees of GTB Hospital, which confirms the absence of an Oncologist or Cancer Specialist in the hospital.

The Commission focused on the final aspect to consider, whether the District Commission erred in disregarding the Safdarjung Hospital Medical Board’s opinion. The board, led by Dr. J.S. Bhatia, stated that from April 6, 2005, to June 16, 2005, the patient underwent diagnosis, staging, and obtained PAC clearance after ruling out co-morbid conditions. However, from June 20, 2005, to July 15, 2005 (25 days), the patient did not report to doctors. Cancer being a progressive disease, by July 18, 2005, the disease had progressed, leading to a change in the treatment approach from surgery to radiotherapy. The board affirmed that there was no negligence at any stage in the management of the case.

However, the State Commission disagreed with the same, and observed that;

“On a combined analysis of the abovementioned shortcomings during the treatment and the negligence culled out by the District Commission through the impugned judgment, we are of the opinion that such recurrent negligent conduct is against medical ethics and is intolerable in light of the casual attitude of the treating doctors towards the patient. Also, the members of the Expert Panel of Safdarjung Hospital have ostensibly turned a blind eye towards such conduct of the Appellants (GTB Hospital and its doctors) and have remarked “no medical negligence” in their report, which is not tenable in the eyes of law. Such opinion prima facie appears to be baseless and biased in as much as no details pertaining to the aforementioned misconduct have been taken into consideration nor any thoughtful deliberations have been recorded in this regard. As such, we find no reason as to why would the District Commission not be perturbed by such glaring irregularity that reeks of connivance on part of the expert panel and treating doctors, at the time when the District Commission required medical expertise in the form of valuable inputs for deciding the present case.”

“It is pertinent to remark that Courts are not experts in the field of medical science and are required to be assisted by experts to form opinion, in order to decide as to whether negligence was committed or not. Therefore, expert opinion is crucial for the adjudicating court to decide the matter, but in the present case, the opinion of the experts was an attempt to mislead the court and therefore, reliance upon the same could have resulted into gross injustice towards the Respondents (the heirs/complainants).”

Subsequently, the State Commission affirmed the District Commission’s decision and found no fault in the impugned order. Therefore, dismissing the appeal filed by GTB Hospital and its doctors with no costs awarded.

To view the original order, click on the link below:

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PFAS exposure tied to reduced bone health in adolescents and young adults

USA: Exposure to per- and polyfluoroalkyl substances (PFAS) is associated with lower bone mineral density (BMD) in adolescence and young adulthood, critical periods for bone development, which may have implications on future bone health and osteoporosis risk in adulthood, a recent study has found. 

PFAS manufactured chemicals used in products such as food packaging and cosmetics, can lead to reproductive problems, increased cancer risk and other health issues. A growing body of research has also linked the chemicals to lower bone mineral density, which can lead to osteoporosis and other bone diseases. But most of those studies have focused on older, non-Hispanic white participants and only collected data at a single point in time.

Now, researchers from the Keck School of Medicine of USC have replicated those results in a longitudinal study of two groups of young participants, primarily Hispanics, a group that faces a heightened risk of bone disease in adulthood.

“This is a population completely understudied in this area of research, despite having an increased risk for bone disease and osteoporosis,” said Vaia Lida Chatzi, MD, PhD, a professor of population and public health sciences at the Keck School of Medicine and the study’s senior author.

In a group of 304 adolescents, exposure to PFAS was linked to a decrease in bone mineral density over time. In a group of 137 young adults, PFAS exposure was also linked to lower baseline bone density, but no differences were observed over time. The results were just published in the journal Environmental Research.

“Many existing studies haven’t included participants this young, but we’re now able to see that this association is already happening at a time when bones are supposed to be developing,” said Emily Beglarian, MPH, a doctoral student in the Keck School of Medicine’s Department of Population and Public Health Sciences and lead author of the study.

The researchers say the findings highlight the need for stricter regulation of PFAS, which have contaminated public drinking water, food and soil across the United States.

“PFAS are ubiquitous-we are all exposed to them,” Chatzi said. “We need to eliminate that exposure to allow our youth to reach their full potential in terms of bone development to help them avoid osteoporosis later in life.”

Implications across the lifespan

Bone mineral density increases during adolescence, peaks between the ages of 20 and 30, then slowly decreases throughout adulthood. Peak bone mineral density helps predict whether a person will get osteoporosis later in life, prompting the researchers to investigate how PFAS can affect young people.

“We want to make sure we’re not exposing ourselves to things that harm our bone development, because it has implications over the rest of our lives,” Beglarian said.

The researchers studied 304 Hispanic adolescents, with an average age of 11 years, from the Study of Latino Adolescents at Risk of Type 2 Diabetes. They collected blood samples to measure PFAS levels and a special kind of x-ray known as a dual x-ray absorptiometry (DXA) scan to measure bone density, then followed up after about one and a half years to check for a change over time. For each doubling of baseline perfluorooctanesulfonic acid (PFOS), one type of PFAS, participants had an average decrease in bone mineral density of .003 g/cm2 per year at follow-up.

They also studied 137 young adults, who were 58.4% Hispanic and had an average age of 19 years, from the Southern California Children’s Health Study. They collected blood samples and DXA scans at baseline, then followed up about four years later. When baseline levels of PFOS doubled, participants had an average of .032 g/cm2 lower baseline bone mineral density, though no significant change was observed over time.

Limiting exposure to PFAS

The researchers say stricter regulations are needed for PFAS, especially to protect high-risk communities such as Hispanics who also face increased exposures to other types of pollutants.

“It’s important to regulate PFAS as a class because we are not just exposed to one chemical, we are exposed to thousands of chemicals,” Chatzi said.

While the burden of reducing PFAS should not fall to individuals, the researchers are planning outreach efforts to help people learn how to limit their exposure. Tips include avoiding nonstick pans and personal care products known to include PFAS.

Chatzi, Beglarian and their colleagues are also expanding their research to confirm the findings across the lifespan and in other communities throughout the U.S., with a continued focus on Hispanics. They also plan to study the biological mechanisms behind the effects of PFAS on bone health, including looking for biomarkers that could indicate bone health is at risk before osteoporosis sets in.

Reference:

Emily Beglarian, Elizabeth Costello, Douglas I. Walker, Hongxu Wang, Tanya L. Alderete, Zhanghua Chen, Damaskini Valvi, Brittney O. Baumert, Sarah Rock, Bruna Rubbo, Max T. Aung, Frank D. Gilliland, Michael I. Goran, Dean P. Jones, Rob McConnell, Sandrah P. Eckel, David V. Conti, Jesse A. Goodrich, Lida Chatzi, Exposure to perfluoroalkyl substances and longitudinal changes in bone mineral density in adolescents and young adults: A multi-cohort study, Environmental Research, 2023, https://doi.org/10.1016/j.envres.2023.117611.

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Glucocorticoid effective option for preventing delirium after major surgeries

Glucocorticoid effective option for preventing Postoperative delirium among patients undergoing major non-cardiac surgery suggests a new study published in the BMC Anesthesiology.

The effects of intravenous glucocorticoids on postoperative delirium (POD) in adult patients undergoing major surgery remain controversial. Therefore, we conducted this meta-analysis to assess whether intravenous glucocorticoids can decrease POD incidence in the entire adult population undergoing major surgery and its association with patients age, type of surgery, and type of glucocorticoid.

They searched the relevant literature published before November 3, 2023, through Cochrane Library, PubMed, Embase, and Web of Science. The primary outcome was POD incidence. The risk ratio for the primary outcome was calculated using the Mantel–Haenszel method. The secondary outcomes included 30-day mortality, length of hospital stay, ICU duration, mechanical ventilation duration, and occurrence of glucocorticoid-related adverse effects (e.g., infection and hyperglycemia). This meta-analysis was registered in PROSPERO: CRD42022345997.

Results

They included eight randomized controlled studies involving 8972 patients. For the entire adult population undergoing major surgery, intravenous glucocorticoids reduced the POD incidence (risk ratio = 0.704, 95% confidence interval, 0.519–0.955; P = 0.024). However, subgroups defined by type of surgery showed differential effects of glucocorticoids on POD. Intravenous glucocorticoids can not reduce POD incidence in adult patients undergoing cardiac surgery (risk ratio = 0.961, 95% confidence interval, 0.769–1.202; P = 0.728), with firm evidence from trial sequential analysis. However, in major non-cardiac surgery, perioperative intravenous glucocorticoid reduced the incidence of POD (risk ratio = 0.491, 95% confidence interval, 0.338–0.714; P < 0.001), which warrants further studies due to inconclusive evidence by trial sequence analysis. In addition, the use of glucocorticoids may reduce the mechanical ventilation time (weighted mean difference, -1.350; 95% confidence interval, -1.846 to -0.854; P < 0.001) and ICU duration (weighted mean difference = -7.866; 95% confidence interval, -15.620 to -0.112; P = 0.047).

For the entire adult population undergoing major surgery, glucocorticoids reduced the POD incidence. However, the effects of glucocorticoids on POD appear to vary according to the type of surgery. In patients receiving major non-cardiac surgery, glucocorticoid may be an attractive drug in the prevention of POD, and further studies are needed to draw a definitive conclusion. In cardiac surgery, intravenous glucocorticoids have no such effect.

Reference:

Li, C., Zhang, Z., Xu, L. et al. Effects of intravenous glucocorticoids on postoperative delirium in adult patients undergoing major surgery: a systematic review and meta-analysis with trial sequential analysis. BMC Anesthesiol 23, 399 (2023). https://doi.org/10.1186/s12871-023-02359-8

Keywords:

Glucocorticoid, effective, option, preventing, Postoperative, delirium, among, patients, undergoing, major, non-cardiac surgery, BMC Anesthesiology, Li, C., Zhang, Z., Xu, L

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