Students holding OCI cards to be treated on par with Indian citizens for MBBS, BDS admissions: Karnataka HC

Granting interim relief to a student, the Karnataka High Court bench recently held that students holding Overseas Citizens of India (OCI) cards are to be treated on par with Indian citizens while participating in Online counselling for admission to undergraduate medical and dental courses for 2024-2025.

“…we are of the opinion that this submission can be recorded that the OCI cardholders are to be permitted to participate in Online counseling for admission to undergraduate courses in Medical, Dental and Engineering for the Academic Year 2024-2025 for both Government and Private seats, on par with Indian citizens,” the HC bench of Justices Anu Sivaraman and Anant Ramanath Hegde ordered on April 02, 2024.

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Delhi’s Health infrastructure: Here are 10 Key takeaways from Panel’s recommendations

New Delhi: Taking note of problems affecting the healthcare services at the Government-run hospitals in Delhi, a committee constituted by the Delhi High Court recently submitted its interim report listing the immediate, short term and long-term measures required to be implemented for the betterment of the system.

Medical Dialogues had previously reported that earlier this year, expressing displeasure over the “misleading” information provided to it on the functioning of medical equipment in GTB hospital, the Delhi High Court had advised the State to constitute a committee of doctors to examine the hospitals run by the city government to come up with a solution. These directions were issued by the Court while considering a PIL initiated by it on its own in 2017 concerning the issue of the non-availability of ICU beds and ventilator facilities in government hospitals in Delhi.

Consequently, the Delhi HC on February 13 formed a six-member committee of experts to evaluate and improve the medical facilities run by the State Government and Municipal Corporation of Delhi. Last week, the Committee submitted its Interim Report identifying the measures to improve the healthcare system in Delhi.

Here are the key takeaways from the Interim Report of the panel, which was submitted to the High Court:

The panel has identified the lack of manpower including the inadequate number of specialist doctors, GDMOs, Senior and Junior Residents and other staff in 38 government-run hospitals in Delhi. As per the report, among the 1700 sanctioned posts of specialists in these hospitals, a total number of 818 posts (around 50%) are still lying vacant. Further, it noted that 189 out of 741 sanctioned posts of GDMOs are lying vacant and 762 out of 2953 posts of senior residents are also unfilled. In the case of Junior Residents, 542 posts out of 2250 sanctioned posts are vacant. There is a huge vacancy in respect of Nursing and Para-medical staff as well. 

1. Give Autonomy to Hospitals for Contractual Employment:

To fill up these vacant posts of Specialists, GDMOs, and resident doctors immediately, the panel has recommended giving autonomy to the respective hospitals to fill up the vacant posts on adhoc/contractual basis. 

It has been recommended by the committee that emoluments and other benefits for the contractual employees should be at par with the regular appointments to attract candidates for such contractual employment.

“Filling these posts will be easier if the salary is 25% more than that of a regular employee,” recommended the panel.

2. Hire Visiting Consultants on Hour-based Remuneration: 

Noting around 50% vacancies of specialists in the Delhi-based hospitals, the panel suggested paying remuneration based on working hours to the visiting consultants to deal with the shortage of specialists. In its interim report, the panel recommended that such visiting consultants should be paid Rs 1.5 lakh plus incentives for 4 hours, Rs 3 lakh plus incentives for 8 hours, Rs 4 lakh plus incentives for 12 hours and Rs 2 lakh plus incentives or on-call basis for night calls.

As a long-time measure to tackle the scarcity of specialists in Delhi government hospitals, the committee has suggested creating a panel of consultants comprising private practitioners who can cater to government hospitals on a part-time basis. However, the committee recommended ensuring that such specialists were receiving at least 1.5 times more salary or fees than that of a regular employee on weekdays and double on holidays and weekends.

3. Compulsory One-year Residentship at Parent Institutes: 

Taking note of the huge vacancies in the posts of Senior and Junior Residents, the committee, constituted by the Delhi High Court, has recommended making one-year residentship (JRs/SRs) compulsory at the parent institutes where the doctors pursued their MBBS or MD courses.

“Compulsory one year of SR ship in the institution from where MD is done (like being followed in some states/Institution),” the panel recommended in respect of the vacant posts of Senior Residents.

Similarly, for the vacant posts of Junior Residents as well, the panel suggested introducing “compulsory one year of JR ship in the institution from where MBBS is done like being followed in some states/Institution.”

Also Read: Shortage of Resident doctors! Panel suggests Compulsory 1-yr JRship at medical college from Where MBBS is Done

4. Implement PPP Model to Deal with Shortage of Equipment: 

In its report, the panel highlighted the huge numbers of non-functional medical equipment in the Delhi hospitals and suggested implementing a Public-Private Partnership (PPP) model for CT scan and MRI services by identifying successful bidder for this purpose. It also suggested that PPP model or leasing models could be implemented for procuring various equipment like ultrasound machines, dialysis machines, ventilators, lab diagnostic machines, ICU and cardiac monitors, ABG machines, etc.

Currently, at the Janakpuri Super-Specialty Hospital {JSSH) and PGI Rohtak a PPP model is running successfully. In all hospitals where CT/MRI scan or radiologist is not available, the aforesaid model can be adopted and implemented, especially in level 3 & 4 hospitals, highlighted the panel.

5. Requirement of Additional ICU Beds: 

Referring to the recommendations of the World Health Organization (WHO) of having 3 hospital beds for a population of 1000 people, the panel noted in its report that for around 3 crore population in Delhi, 90000 hospital beds are required. It also highlighted that as a general rule, it is suggested that there should be 5-10 percent of hospital beds as ICU beds. This number can be more in a tertiary care or a super-specialty hospital. Some of the Delhi hospitals have up to 25% of hospital beds as ICU beds.

As per the report, currently, Delhi government hospitals have 1058 ICU beds. However, according to the committee, these beds should be enhanced to 2028 beds by adding 1046 additional beds in the existing hospitals, but eventually Delhi will require 4500 beds out of which Delhi government hospitals should contribute at least 2400 ICU beds.

6. Centralised Command and Control Room, Referral Coordinator in Every Hospital: 

Considering the issue of providing real-time information concerning the availability of ICU/HDU beds in various hospitals and their timely availability for patients, the panel suggested setting up a centralized command and control room (CCR) by the IT department of GNTCD which should be manned by adequately trained executives and medical professionals round the clock.

“This control room should at least have a live screen showing the location of available emergency and ICU hospital beds and medical services (like CT I MRI, OT facility, etc.) in the near vicinity of the patient and the promptness and availability of an ambulance service. There should be a screen showing region-wise Gee-mapping of all the Delhi hospitals with dynamic details of available facilities,” recommended the panel.

Further, the panel recommended that every hospital shall designate a referral coordinator, who shall update the information on the dashboard linked to the Centralised Command and Control Room (CCR).

7. Reverse Referral Policy: 

To ensure that healthcare resources are utilized optimally, the panel constituted by the Delhi High Court suggested implementing a reverse referral policy to streamline patient transfers from higher-level to lower-level facilities when appropriate.

8. Convert large service hospitals into medical colleges: 

The committee recommended in its report that spending money on large service hospitals results in suboptimal outcomes as the staff of such hospitals is not updated to the recent developments of rapidly evolving medical science. Therefore, they are inclined to refer difficult patients to medical colleges or tertiary care institutions.

As per the panel, by increasing the budget of such hospitals by around 20-25%, these institutes can be converted into teaching institutions. This will ensure that the specialists of such institutes will become teachers and they will remain updated and in return will produce medical graduates.

9. Proposal to create the “Delhi State Health Authority”: 

The panel has recommended setting up a High-Power Delhi Health Authority directly under the control of the Principal Secretary of Health, Department of Health and Family Welfare, Government of NCT of Delhi. It suggested that there should be a Central Authority named “Delhi State Health Authority” (DESHA) and further “District Health Authority” in the districts.

As per the panel, DESHA should be chaired by the Principal Secretary of Health and also comprise the Director of OSHA. It should have a 24×7 working office and should be manned by the CMOs around the clock. DGHS (Govt of India), DGHS (Delhi), Director, Lok Nayak Hospital, Director, GTB Hospital, Director, Hindu Rao Hospital, and Director IBHAS should be other members of the committee. 

The committee recommended that the Authority will have the District Level Dm/DC as In-charge & responsible for implementation & execution. Their responsibility will be to ensure any healthcare emergency in their respective districts will be attended through Central Control room and appropriate action is taken. It will enable timely action as desired.

Subsequently, it will conduct arrangement and audit of hospitals in terms of service provided, outcome and other infrastructure-related issues. Such an authority will also have a grievance redressal mechanism, recommended the panel.

10. CGHS Rates at Private Hospitals: 

The report highlighted that the Delhi Government currently has the Delhi Arogya Kosh (DAK) scheme which allows the patient to avail the services of private hospitals at CGHS rates.

Such facility can be extended to emergency services (E-DAK) as well, recommended the panel, adding that this will ensure that any patient in an emergency can be transferred to the nearest private hospital and avail the services at CGHS rates and have online approval within 4 hours.

“Every citizen should with a Delhi Aadhar card should be entitled to receive emergency health care at any nearby private hospital by producing the Adhar card. Some mechanism for the migrant population should also be worked out in this regard,” the panel recommended.

“Aadhar card holders should be permitted to avail such facilities and the government should sign MOUs with select private players who can provide care at CGHS rates,” it further added.

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Empagliflozin fails to reduce HF hospitalizations, deaths after acute MI: EMPACT-MI

USA: Treatment with empagliflozin did not lead to a significantly reduced risk of first hospitalization for heart failure (HF) or death from any cause than placebo among patients at increased risk for HF after acute myocardial infarction (MI), according to the EMPACT-HF trial. The findings were published online in the New England Journal of Medicine on April 6, 2024. 

Between empagliflozin and placebo groups, the researchers found no difference in the time-to-first-event analysis of hospitalizations for HF or deaths from any cause over approximately 18 months (8.2% vs 9.1%), which came out to 5.9 and 6.6 events per 100 patient-years, respectively (HR 0.90).

Mortality alone appeared unchanged with empagliflozin (5.2% versus 5.5%), but there was a 22% reduction in first hospitalizations for HF (3.6% versus 4.7%, HR 0.77).

The SGLT2 inhibitor empagliflozin (Jardiance) improves cardiovascular (CV) outcomes in patients with heart failure, patients with type 2 diabetes who are at high CV risk, and patients with chronic kidney disease. The efficacy and safety of empagliflozin in patients who have had acute myocardial infarction are unknown. To fill this knowledge gap, Javed Butler, Baylor Scott and White Research Institute, Live Oak St., Dallas, TX, and colleagues conducted an event-driven, double-blind, randomized, placebo-controlled trial.

Patients who had been hospitalized for acute myocardial infarction and were at risk for heart failure were assigned in a 1:1 ratio to receive empagliflozin (n=3260) at a dose of 10 mg daily or placebo (n=3262) in addition to standard care within 14 days after admission. The primary endpoint was a composite of hospitalization for HF or death from any cause as assessed in a time-to-first-event analysis.

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

  • During a median follow-up of 17.9 months, first hospitalization for heart failure or death from any cause occurred in 8.2% of patients in the empagliflozin group and 9.1% of patients in the placebo group, with incidence rates of 5.9 and 6.6 events, respectively, per 100 patient-years (hazard ratio, 0.90).
  • For the individual components of the primary endpoint, a first hospitalization for heart failure occurred in 3.6% of patients in the empagliflozin group and 4.7% of patients in the placebo group (hazard ratio, 0.77), and death from any cause occurred in 5.2% and 5.5% patients, respectively (hazard ratio, 0.96).
  • Adverse events were consistent with the known safety profile of empagliflozin and were similar in the two trial groups.

In conclusion, the SGLT2 inhibitor empagliflozin did not exactly prevent deaths and heart failure events when initiated atop other standard therapies for acute myocardial infarction, but the cumulative risk did go down.

Reference:

Butler J, et al “Empagliflozin after acute myocardial infarction” N Engl J Med 2024; DOI: 10.1056/NEJMoa23104051.

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SGLT2 inhibitors may protect T2D patients with AF from HF and renal complications: Study

A recent study found a significant discovery in the treatment of patients with from type 2 diabetes (T2D) with concurrent atrial fibrillation (AF) which is a combination that markedly increases the risk of adverse cardiovascular events. The major outcomes of this study were published in The Journal of Clinical Endocrinology and Metabolism.

This comprehensive nationwide retrospective cohort study utilized data from the Taiwan National Health Insurance Research Database and the findings highlight the comparative effects of sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) on the patients with and without AF.

The study spanned from May 1, 2016 to December 31, 2019 and observed a total of 344,392 T2D patients without AF and a total of 31,351 with AF treated with SGLT2i, along with 11,462 and 816 T2D patients with and without AF, respectively with GLP-1RA administration. The participants were monitored up to December 31, 2020 for various cardiovascular outcomes after employing propensity score stabilized weighting to ensure the equitable comparison between the two medication groups.

The results unveiled a striking distinction in treatment outcomes, specially for the patients with concomitant AF. The individuals treated with SGLT2i experienced a significantly reduced risk of hospitalization for heart failure when compared to their counterparts on GLP-1RA with an incidence rate of 2.32 versus 4.74 events per 100 person-years. SGLT2i was associated with a lower risk of composite kidney outcomes in both groups that highlights its benefits beyond heart health.

This study observed no significant difference between the two drugs in terms of major adverse cardiovascular events and all-cause mortality, regardless of AF status. This neutrality illuminates the complexity of T2D management along with cardiovascular conditions and highlights the need for personalized treatment strategies.

The positive effects of these findings are significant in diabetic patients with the high prevalence and risk of heart failure. This evidence strongly suggests that SGLT2i may offer superior protection against heart failure and renal complications for the T2D patients with AF which elevated the risk for these debilitating conditions. However, this study warrants further investigation to conclusively determine whether SGLT2i should be the preferred treatment option over GLP-1RA for this high-risk demographic.

Source:

Chan, Y.-H., Chao, T.-F., Chen, S.-W., Lee, H.-F., Li, P.-R., Yeh, Y.-H., Kuo, C.-T., See, L.-C., & Lip, G. Y. H. (2024). SGLT2 inhibitors vs. GLP-1 receptor agonists and clinical outcomes in patients with diabetes with/without atrial fibrillation. In The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. https://doi.org/10.1210/clinem/dgae157

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RCT may reduce cumulative inflammatory burden in T2DM and improve glycaemic control, suggests study

Root canal treatment (RCT) may reduce cumulative inflammatory burden in T2DM and contribute to the improvement of glycaemic control, suggests a new study published in the International Endodontic Journal.

This prospective cohort study was undertaken to evaluate the success rate of root canal treatment (RCT) in type 2 diabetes mellitus (T2DM) patients with targeted level and unachieved targeted level of glycaemic control as well as the impact of RCT on the glucose blood level in T2DM patients. Patients needing RCT were divided into three groups: these without T2DM, that is, the control group (CG), those with targeted level of glycated haemoglobin HbA1c < 7% (TL A1c) and the third ones with unachieved targeted level (UTL A1c), that is, with HbA1c ≥ 7%. Before RCT, HbA1c and the periapical index (PAI) score were assessed, as well as 1 year later.

RESULTS: The results showed less favourable treatment results of RCT such as a reduction of radiographic lesions in T2DM patients, particularly in subjects with UTL A1c. The intergroup analysis of PAI score at the 12-month follow-up revealed a significant difference in TL A1C (p = .022) and CG (p = .001) with respect to UTL A1c. Total number of healed teeth (PAI≤2) at the 12-month after RCT in UTL A1c was significantly lower in comparison to CG (p = .008). Contrariwise, RCT may improve the glycaemic control in diabetic patients with UTL A1c after 12 months of posttreatment. Regression analysis showed that UTL A1c patients were more likely to have AP persistence after endodontic treatment (OR = 4.788; CI: 1.157-19.816; p = .031). T2DM retards the AP healing and conversely AP contributes to increasing the inflammatory burden in T2DM. RCT reduces the cumulative inflammatory burden in T2DM and thus may contribute to improvement of glycaemic control particularly in patients with UTL A1c.

Reference:

Davidović, Brankica, et al. “Effects of Apical Periodontitis Treatment On Hyperglycaemia in Diabetes: a Prospective Cohort Study.” International Endodontic Journal, 2024.

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Medicover Cancer Institute performs minimal access surgery to treat lung cancer

Hyderabad: In the field of lung cancer treatment, Medicover Cancer Institute, under the expert guidance of Dr Pavan Kumar Jonmada is introducing a pioneering approach known as minimal access surgery. 

Mr Rao, a resident of Khammam, sought medical attention at Medicover Cancer Institute due to persistent cough and breathlessness. Following a thorough examination by Dr Pavan Kumar Jonmada tests revealed the presence of a lung cancer tumor.

Traditionally, treating such tumors involved extensive surgery, which often required the removal of a lung lobe through thoracic incisions. This approach resulted in prolonged hospital stays and significant post-operative weakness. However, Dr Pavan Kumar Jonmada recognized the potential for improved patient outcomes and proposed an innovative alternative: minimal access surgery.

Also Read:Medicover sees India’s healthcare market will triple in size in coming 10 years

Explaining this innovative technique, Dr Pavan Kumar Jonmada stated, “For patients with this type of cancer tumor, traditional thoracic surgery meant longer hospital stays and increased weakness after the operation. However, with minimal access surgery, we can achieve remarkable results with just two stitches and a mere two days of hospitalization.”

This transformative approach not only reduces physical trauma but also accelerates the recovery process, allowing patients to resume their normal lives with minimal interruption. Dr Pavan Kumar Jonmada’s dedication to patient welfare and medical advancement highlights the Medicover Cancer Institute’s commitment to pushing the boundaries of cancer treatment.

Dr Pavan Kumar Jonmada emphasized, “Minimal access surgery represents a significant advancement in lung cancer treatment. By utilizing advanced techniques and technology, we provide patients with a faster and less invasive path to recovery. With just two stitches and a brief hospital stay of two days, we achieve remarkable outcomes while prioritizing patient comfort and well-being. This approach reflects our dedication to medical innovation and compassionate patient care.”

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Snoring Associated with Increased Risk of Hypertension and Diabetes, claims study

Snoring, a common sleep disorder, has been associated with various health risks, including hypertension and type 2 diabetes mellitus (T2DM). However, data on snoring prevalence and its association with hypertension and T2DM in African countries, particularly in Sudan, are limited. A recent study aimed to assess the prevalence of snoring and its relationship with hypertension and T2DM in northern Sudan. This study was published in the journal BMC Public Health. The study was conducted by Bashir AO and colleagues.

Snoring, often dismissed as a harmless nuisance, can indicate underlying health issues. Hypertension and T2DM are major public health concerns globally, contributing significantly to morbidity and mortality. Understanding the relationship between snoring and these conditions is crucial for preventive strategies.

A community-based cross-sectional study was conducted in four villages in the River Nile state of northern Sudan from July to September 2021. A total of 384 adults participated, with sociodemographic data collected via questionnaire. Body mass index (BMI) was measured, and multivariate analysis was performed using SPSS version 22.0.

The key findings of the study were as follows:

Among the participants, 27.6% were snorers.

Factors positively associated with snoring included increasing age, increasing BMI, obesity, and alcohol consumption.

Hypertension was prevalent in 56.0% of adults, with increasing age, increasing BMI, female sex, and snoring positively associated with hypertension.

T2DM affected 27.6% of adults, with increasing age and snoring positively associated with T2DM.

The study reveals a significant prevalence of snoring among adults in northern Sudan, with notable associations with obesity, hypertension, and T2DM. These findings underscore the importance of addressing snoring as a potential risk factor for these chronic conditions.

Snoring appears to be a common issue in northern Sudan, with implications for hypertension and T2DM. Healthcare providers should consider screening for snoring in routine assessments, especially in individuals with obesity, to mitigate the risk of hypertension and T2DM development. Early intervention and lifestyle modifications may help prevent adverse health outcomes associated with snoring.

Reference:

Bashir, A. O., Elimam, M. A., Elimam, M. A., & Adam, I. (2024). Snoring is associated with hypertension and diabetes mellitus among adults in north Sudan: a cross-sectional study. BMC Public Health, 24(1), 1–9. https://doi.org/10.1186/s12889-024-18505-x

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Study links e-cigarette use with higher risk of heart failure

People who use e-cigarettes are significantly more likely to develop heart failure compared with those who have never used them, according to one of the largest prospective studies to date investigating possible links between vaping and heart failure. The findings are being presented at the American College of Cardiology’s Annual Scientific Session.

Heart failure is a condition affecting more than 6 million U.S. adults in which the heart becomes too stiff or too weak to pump blood as effectively as it should. It can often lead to debilitating symptoms and frequent hospitalizations as people age. Electronic nicotine products, which include e-cigarettes, vape pens, hookah pens, personal vaporizers and mods, e-cigars, e-pipes and e-hookahs, deliver nicotine in aerosol form without combustion. Since they were first introduced in the U.S. in the late 2000s, electronic nicotine products have often been portrayed as a safer alternative to smoking, but a growing body of research has led to increased concern about potential negative health effects.

“More and more studies are linking e-cigarettes to harmful effects and finding that it might not be as safe as previously thought,” said Yakubu Bene-Alhasan, MD, a resident physician at MedStar Health in Baltimore and the study’s lead author. “The difference we saw was substantial. It’s worth considering the consequences to your health, especially with regard to heart health.”

For the study, researchers used data from surveys and electronic health records in All of Us, a large national study of U.S. adults run by the National Institutes of Health, to analyze associations between e-cigarette use and new diagnoses of heart failure in 175,667 study participants (an average age of 52 years and 60.5% female). Of this sample, 3,242 participants developed heart failure within a median follow-up time of 45 months.

The results showed that people who used e-cigarettes at any point were 19% more likely to develop heart failure compared with people who had never used e-cigarettes. In calculating this difference, researchers accounted for a variety of demographic and socioeconomic factors, other heart disease risk factors and participants’ past and current use of other substances, including alcohol and tobacco products. The researchers also found no evidence that participants’ age, sex or smoking status modified the relationship between e-cigarettes and heart failure.

Breaking the data down by type of heart failure, the increased risk associated with e-cigarette use was statistically significant for heart failure with preserved ejection fraction (HFpEF)-in which the heart muscle becomes stiff and does not properly fill with blood between contractions. However, this association was not significant for heart failure with reduced ejection fraction (HFrEF)-in which the heart muscle becomes weak and the left ventricle does not squeeze as hard as it should during contractions. Rates of HFpEF have risen in recent decades, which has led to an increased focus on determining risk factors and improving treatment options for this type of heart failure.

The findings align with previous studies conducted in animals, which signaled e-cigarette use can affect the heart in ways that are relevant to the heart changes involved in heart failure. Other studies in humans have also shown links between e-cigarette use and some risk factors associated with developing heart failure. However, previous studies attempting to assess the direct connection between e-cigarette use and heart failure have been inconclusive, which Bene-Alhasan said is due to the inherent limitations of the cross-sectional study designs, smaller sample sizes and the smaller number of heart failure events seen in previous research.

Researchers said the new study findings point to a need for additional investigations of the potential impacts of vaping on heart health, especially considering the prevalence of e-cigarette use among younger people. Surveys indicate that about 5% to 10% of U.S. teens and adults use e-cigarettes. In 2018, the U.S. Surgeon General called youth e-cigarette use an epidemic and warned about the health risks associated with nicotine addiction.

“I think this research is long overdue, especially considering how much e-cigarettes have gained traction,” Bene-Alhasan said. “We don’t want to wait too long to find out eventually that it might be harmful, and by that time a lot of harm might already have been done. With more research, we will get to uncover a lot more about the potential health consequences and improve the information out to the public.”

Bene-Alhasan also said e-cigarettes are not recommended as a tool to quit smoking, since many people may continue vaping long after they quit smoking. The U.S. Centers for Disease Control and Prevention recommends a combination of counseling and medications as the best strategy for quitting smoking.

Researchers said that the study’s prospective observational design allows them to infer, but not conclusively determine, a causal relationship between e-cigarette use and heart failure. However, with its large sample size and detailed data on substance use and health information, Bene-Alhasan said the study is one of the most comprehensive studies to assess this relationship to date.

Reference:

Study links e-cigarette use with higher risk of heart failure, American College of Cardiology, Meeting: American College of Cardiology’s Annual Scientific Session.

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Non insertion of Prophylactic abdominal drain not tied to increased morbidity after distal pancreatectomy: Lancet

Non-insertion of Prophylactic abdominal drain is not tied to increased morbidity after distal pancreatectomy suggests a study published in the Lancet.

Researchers have found in a randomized non-inferiority PANDORINA trial that non insertion of a drain did not increase rates of major morbidity and tied to reduced detection of grade B or C postoperative pancreatic fistula (POPF), compared with insertion of a passive abdominal drain after distal pancreatectomy, which has been standard practice. Prophylactic passive abdominal drainage is standard practice after distal pancreatectomy. This approach aims to mitigate the consequences of postoperative pancreatic fistula (POPF) but its added value, especially in patients at low risk of POPF, is currently being debated. We aimed to assess the non-inferiority of a no-drain policy in patients after distal pancreatectomy. In this international, multicentre, open-label, randomised controlled, non-inferiority trial, we recruited patients aged 18 years or older undergoing open or minimally invasive elective distal pancreatectomy for all indications in 12 centres in the Netherlands and Italy. We excluded patients with an American Society of Anesthesiology (ASA) physical status of 4–5 or WHO performance status of 3–4, added by amendment following the death of a patient with ASA 4 due to a pre-existing cardiac condition.

Patients were randomly assigned (1:1) intraoperatively by permuted blocks (size four to eight) to either no drain or prophylactic passive drain placement, stratified by annual centre volume (<40 or ≥40 distal pancreatectomies) and low risk or high risk of grade B or C POPF. High-risk was defined as a pancreatic duct of more than 3 mm in diameter, a pancreatic thickness at the neck of more than 19 mm, or both, based on the Distal Pancreatectomy Fistula Risk Score. Other patients were considered low-risk. The primary outcome was the rate of major morbidity (Clavien–Dindo score ≥III), and the most relevant secondary outcome was grade B or C POPF, grading per the International Study Group for Pancreatic Surgery. Outcomes were assessed up to 90 days postoperatively and analysed in the intention-to-treat population and per-protocol population, which only included patients who received the allocated treatment. A prespecified non-inferiority margin of 8% was compared with the upper limit of the two-sided 95% CI (Wald) of unadjusted risk difference to assess non-inferiority. This trial is closed and registered in the Netherlands Trial Registry, NL9116.

Findings: Between Oct 3, 2020, and April 28, 2023, 376 patients were screened for eligibility and 282 patients were randomly assigned to the no-drain group (n=138; 75 [54%] women and 63 [46%] men) or the drain group (n=144; 73 [51%] women and 71 [49%] men). Seven patients in the no-drain group received a drain intraoperatively; consequently, the per-protocol population included 131 patients in the no-drain group and 144 patients in the drain group. The rate of major morbidity was non-inferior in the no-drain group compared with the drain group in the intention-to-treat analysis (21 [15%] vs 29 [20%]; risk difference –4·9 percentage points [95% CI –13·8 to 4·0]; pnon-inferiority=0·0022) and the per-protocol analysis (21 [16%] vs 29 [20%]; risk difference –4·1 percentage points [–13·2 to 5·0]; pnon-inferiority=0·0045). Grade B or C POPF was observed in 16 (12%) patients in the no-drain group and in 39 (27%) patients in the drain group (risk difference –15·5 percentage points [95% CI –24·5 to –6·5]; pnon-inferiority<0·0001) in the intention-to-treat analysis. Three patients in the no-drain group died within 90 days; the cause of death in two was not considered related to the trial. The third death was a patient with an ASA score of 4 who died after sepsis and a watershed cerebral infarction at second admission, leading to multiple organ failure. No patients in the drain group died within 90 days. A no-drain policy is safe in terms of major morbidity and reduced the detection of grade B or C POPF, and should be the new standard approach in eligible patients undergoing distal pancreatectomy.

Reference:

van Bodegraven EA, Balduzzi A, van Ramshorst TME, Malleo G, Vissers FL, van Hilst J, Festen S, Abu Hilal M, Asbun HJ, Michiels N, Koerkamp BG, Busch ORC, Daams F, Luyer MDP, Ramera M, Marchegiani G, Klaase JM, Molenaar IQ, de Pastena M, Lionetto G, Vacca PG, van Santvoort HC, Stommel MWJ, Lips DJ, Coolsen MME, Mieog JSD, Salvia R, van Eijck CHJ, Besselink MG; Dutch Pancreatic Cancer Group. Prophylactic abdominal drainage after distal pancreatectomy (PANDORINA): an international, multicentre, open-label, randomised controlled, non-inferiority trial. Lancet Gastroenterol Hepatol. 2024 Mar 15:S2468-1253(24)00037-2. doi: 10.1016/S2468-1253(24)00037-2. Epub ahead of print. PMID: 38499019.

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Omadacycline Equally Effective as Linezolid to Treat Complex Skin Infections: Study

A recent study published in the BMC Infectious Diseases discovered that Omadacycline (OMC) which is a newer antibiotic, is just as effective and safe as the more traditionally used Linezolid (LZD) for treating complicated skin and soft tissue infections (cSSTIs) in adults. This findings could significantly impact the approach that healthcare professionals take in managing these challenging infections.

This complicated skin and soft tissue infections represent a substantial burden to the healthcare systems over the world due to their often difficult-to-treat nature. These infections require antibiotics that can treat the infection effectively and minimize the risk of resistance. The search for such antibiotics led Wenxin Liang and team to compare Omadacycline with Linezolid for treating complicated skin and soft tissue infections.

The study synthesizes data from four randomized controlled trials (RCTs) and included a total of 1,757 patients to assess the clinical efficacy, microbiological response and safety profiles of OMC when compared to LZD. The findings indicated that OMC is not inferior to LZD by showing comparable success rates in both the modified intent-to-treat (MITT) and clinically evaluable (CE) populations. Also, the odds ratio (OR) for clinical efficacy in the MITT population was 1.24 (95% CI: [0.93, 1.66], P = 0.15) and in the CE population, it was 1.92 (95% CI: [0.94, 3.92], P = 0.07) that indicated no significant difference between the two drugs.

Also, the study looked into the microbiological response of OMC against LZD and found that OMC had a numerically higher response rate, though not statistically significant. The mortality and adverse event rates were similar for both treatments which suggests a comparable safety profile of OMC to LZD.

These results are significant and this suggest that healthcare providers may have an additional tool to treat cSSTIs that potentially offers a new antibiotic option which is just as effective and safe as the current standard of care. Also, the similarity in efficacy and safety profiles between OMC and LZD brought out that patients who cannot tolerate one medication might have another viable alternative. Th findings of this study could possibly pave the way for Omadacycline to become a more widely used option in treating complicated skin and soft tissue infections.

Reference:

Liang, W., Yin, H., Chen, H., Xu, J., & Cai, Y. (2024). Efficacy and safety of omadacycline for treating complicated skin and soft tissue infections: a meta-analysis of randomized controlled trials. In BMC Infectious Diseases (Vol. 24, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s12879-024-09097-3

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