For weight loss calorie restriction more important than Time-restricted eating, claims Study

A randomized controlled trial comprised of adults with obesity and prediabetes found that both time-restricted eating and a usual eating pattern resulted in weight loss when calories were held constant in both groups. It did not seem to matter whether participants consumed most of their calories early in the day or in the evening, suggesting that overall calories may be more important than meal timing when it comes to weight loss. The findings were presented at the inaugural scientific plenary session “New in Annals of Internal Medicine: Hear it First from the Authors” held at the Boston Convention and Exhibition Center during the American College of Physician’s (ACP) Internal Medicine Meeting 2024. The paper also is published in Annals of Internal Medicine.

Time-restricted eating (TRE) is a diet approach where patients limit their eating to a window of time during the day and then fast for the remaining hours. During the eating window, patients are not required to count calories or monitor food intake and during the fasting window, patients are limited to water and calorie-free beverages. Evidence shows that when adults with obesity limit their eating window to 4 to 10 hours, they naturally reduce caloric intake by approximately 200-550 calories per day and lose weight over 2-12 months. Whether TRE induces weight loss independent of reductions in calorie intake, as seen in rodent studies, is unknown.

Researchers from Johns Hopkins University randomly assigned 41 adults with obesity and prediabetes to either TRE with a 10-hour eating window or a regular eating pattern for 12 weeks (about 3 months) to compare weight loss and other measures of metabolic health. At the beginning of the study, the researchers assessed participants’ history and activity level to estimate baseline caloric needs, and participants ate the same number of calories daily throughout the study. Participants in both arms received prepared meals with identical macronutrient and micronutrient compositions and instructions on when to consume the meals. The time restricted eating group was instructed to eat only between the hours of 8am to 6pm and consumed most of their calories before 1pm each day. The usual eating pattern group ate between 8am and midnight and consumed most of their calories after 5pm each day. After 12 weeks, both groups lost about the same amount of weight and there were no real differences in fasting glucose, waist circumference, blood pressure, or lipid levels. According to the authors, these findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in calories, and, therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake.

According to the authors of an accompanying editorial from the University of Illinois Chicago, these results have important clinical implications. While TRE was not found to be more effective for weight loss, it may be easier for patients to follow because it allows them to continue consuming familiar foods. This simplified approach to treating obesity could help patients who don’t do well counting calories.

Reference:

 Nisa M. Maruthur, Scott J. Pilla, Karen White, MS,  Beiwen Wu, May Thu Thu Maw, Daisy Duan, Ruth-Alma Turkson-Ocran, Effect of Isocaloric, Time-Restricted Eating on Body Weight in Adults With Obesity: A Randomized Controlled Trial, Annals of Internal Medicine, https://doi.org/10.7326/M23-3132.

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Diets with high glycaemic index and high glycaemic load linked to incident diabetes: PURE trial

In a landmark study spanning five continents, researchers have uncovered a significant association between dietary carbohydrate quality and the risk of developing type 2 diabetes. The findings, published in the renowned scientific journal, underscore the critical role of diet in preventing this increasingly prevalent metabolic disorder. individuals who consumed diets characterized by elevated glycemic index (GI) and glycemic load (GL) faced an increased likelihood of developing type 2 diabetes within a diverse multinational cohort representing five continents. 

The study results were published in the journal The Lancet: Diabetes & Endocrinology. 

The relationship between glycemic index (GI) and glycemic load (GL) and the onset of type 2 diabetes is subject to debate. Hence, researchers conducted a study with to assess this connection within a multinational cohort characterized by varying levels of GI and GL in their diets. The study, known as the Prospective Urban Rural Epidemiology (PURE) study, involved a vast cohort of 127,594 adults aged 35-70 from 20 countries across diverse economic backgrounds. Led by an international team of scientists, the research aimed to evaluate the impact of dietary glycemic index (GI) and glycemic load (GL) on the incidence of type 2 diabetes. Using validated food frequency questionnaires, the researchers assessed participants’ diets at the outset of the study, estimating GI and GL based on the intake of seven categories of carbohydrate-containing foods. Over a median follow-up period of 11.8 years, 7326 cases of incident type 2 diabetes were recorded, providing a robust dataset for analysis.

Findings:

  • The results revealed a clear correlation between carbohydrate quality and diabetes risk.
  • Participants consuming diets with a higher GI were found to have a significantly elevated risk of developing type 2 diabetes.
  • Specifically, those in the highest quintile of GI faced a 15% greater risk compared to their counterparts in the lowest quintile.
  • Similarly, individuals with diets characterized by higher GL also exhibited an increased risk of type 2 diabetes.
  • Those in the highest quintile of GL experienced a 21% higher risk compared to those in the lowest quintile, highlighting the detrimental impact of high GL foods on metabolic health.
  • Interestingly, the study identified an interaction between GI and body mass index (BMI), with the association between GI and diabetes risk being more pronounced among individuals with higher BMIs.
  • This suggests that the quality of carbohydrates consumed may have a greater impact on diabetes risk in those who are overweight or obese.

The study findings emphasize the importance of making informed dietary choices, particularly regarding the quality of carbohydrates consumed, in reducing the risk of type 2 diabetes. Diets characterized by low GI and GL may offer protective benefits against the development of this chronic condition, offering a potential avenue for preventive interventions on a global scale. As the global burden of type 2 diabetes continues to escalate, these findings provide valuable insights for healthcare professionals, policymakers, and individuals alike. By prioritizing the consumption of low GI and GL foods, individuals can take proactive steps towards safeguarding their metabolic health and reducing their risk of developing type 2 diabetes.

Further reading: Miller V, Jenkins DA, Dehghan M, et al. Associations of the glycaemic index and the glycaemic load with risk of type 2 diabetes in 127 594 people from 20 countries (PURE): a prospective cohort study. Lancet Diabetes Endocrinol. Published online April 5, 2024. doi:10.1016/S2213-8587(24)00069-X

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Uttar Pradesh Introduces Virtual Evidence Recording System for Doctors to Expedite Court Cases

Lucknow: The Prosecution Department of
Uttar Pradesh is planning to implement a new virtual evidence recording system
for doctors to expedite court cases and reduce case backlog in the
state. This initiative will allow government officials, including police
officers and doctors, to provide testimony virtually in pending legal
matters.

The state government is
building a centralized computer system in various districts where police
officers and medical professionals can record evidence from the office of the
Joint Director of the Prosecution Department. This measure aims to streamline court
proceedings and address the substantial number of pending cases in district
courts.

Currently, police officers and
doctors who act as investigating officers and provide medico-legal testimony
must regularly travel to district courts to present evidence. However, due to
frequent transfers and the expansive geographic size of Uttar Pradesh, this
process can be cumbersome and time-consuming. The virtual system will alleviate
these challenges, enabling officers and doctors to record evidence remotely,
saving time and resources.

Commenting on the issue, UP Additional Director of Police (Prosecution) Dipesh Juneja told The Indian Express, “Now, because of the geographic size of Uttar Pradesh, it becomes difficult for these officers to physically go to district courts. For example, one officer who was posted in West UP and investigated a case there gets transferred to East UP. Now that officer has to take leave and travel all the way to the district where he was posted in the past. This results in loss of manpower and also requires huge amounts of funds for travel, lodging etc. The same is true for government doctors. We plan to have a centralized system where the officer or doctor can go and do it virtually through a computerized system. This will help us ensure speedy trials in cases, and also, save money.”

By early June, the Prosecution Department plans to roll out the initiative in five districts: Lucknow, Prayagraj, Varanasi, Noida, and Barabanki. Once an officer retires, they will be able to record evidence from their current location, eliminating the need to travel to different districts. This system is expected to improve the efficiency of legal proceedings in Uttar Pradesh and provide more convenience for government officers and doctors involved in court cases.

Explaining the need for the new system, Joint Director (Prosecution) Atul Kumar Ojha said, “We routinely come across cases which have been pending for close to a decade because of delays due to these issues. We hope to reduce the pendency of cases with this new system. This will also reduce the financial burden of the police department and government. We plan to appoint one coordinating officer at the Joint Director’s office in each district who will be in charge of this system.” 

Also Read: Poor Infrastructure at Govt Hospitals: HC orders implementation of immediate measures suggested by expert panel

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New study reveals E-cigarette use poses elevated risk of heart failure

USA: People using e-cigarettes are significantly more likely to develop heart failure (HF) compared with those who have never used them. The findings from one of the largest prospective studies to date investigating possible links between vaping and heart failure were presented at the Annual Scientific Session of the American College of Cardiology.

According to the study, E-cigarette use was associated with increased risk for incident heart failure compared with never use. The association was significant even after adjustment for concomitant substance use and other risk factors.

Heart failure is a condition that affects more than 6 million US 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 vape pens, e-cigarettes, personal vaporizers and mods, hookah pens, e-cigars, e-pipes, and e-hookahs, deliver nicotine in aerosol form without combustion.

Since their first introduction in the US in the late 2000s, electronic nicotine products have often been portrayed as a safer alternative to smoking, but a growing body of research has suggested increased concern about potential adverse health effects.

Surveys indicate that about 5% to 10% of US teens and adults use e-cigarettes. In 2018, the US Surgeon General called youth e-cigarette use an epidemic and warned about the health risks associated with nicotine addiction.

“More and more studies are linking e-cigarettes to harmful effects and finding that it might not be as safe as previously thought,” Yakubu Bene-Alhasan, a resident physician at MedStar Health in Baltimore and the study’s lead author, said in a press release.

“The difference we saw was substantial. It’s worth considering the consequences to your health, especially about heart health.”

For the study, the researchers aimed 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). For this purpose, they used data from surveys and electronic health records in All of Us, a large national study of US adults run by the National Institutes of Health.

Following were the study’s key findings:

  • Of this sample, 3,242 participants developed heart failure within a median follow-up time of 45 months.
  • 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, a variety of demographic and socioeconomic factors, other heart disease risk factors, and participants’ past and current use of substances, including alcohol and tobacco products, were accounted for.
  • There was no evidence that participants’ age, sex, or smoking status modified the relationship between e-cigarettes and 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 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.

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 smaller sample sizes, cross-sectional study designs, 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.

“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 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.

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Fire acupuncture may control symptoms and prevent recurrence in patients with psoriasis: Study

Fire acupuncture may significantly control symptoms and prevent recurrence in patients with psoriasis suggests a study published in the Medicine.

A study was done to investigate the clinical efficacy of fire acupuncture (FA) on plaque psoriasis (PP), exploring its suitable syndrome types, to achieve better therapeutic effects, accelerate the possibility of psoriasis skin lesion recovery, and provide assistance for clinical treatment. A total of 8 patients with plaque psoriasis aged between 18 and 60 years were recruited and treated with fire acupuncture once a week, and the lesion area and severity index (PASI), visual analog scale and pruritus were measured before, 2, 4 and 8 weeks after treatment and at the follow-up period (week 12), respectively. Visual analog scale, and dermoscopy were used for assessment. Results: All patients showed improvement in pruritus after 1 Fire acupuncture treatment, and lesions were reduced to varying degrees after 2 weeks.

Except for patients 5 and 8, who only achieved effective results due to severe disease, all other patients with psoriasis achieved significant results at 8 weeks after treatment. Fire acupuncture can significantly control the development of lesions, reduce the symptoms of plaque psoriasis lesions and pruritus, and help prevent psoriasis recurrence.

Reference:

Chen, Rui-Ming MMa; Shi, Guo-Ao MMa; Xiong, Yong-Qin MMb; Li, Zhong-Xian MDa; Ji, Xiang MMa; Feng, Yan-Yan MDa; Yan, Luda MDa; Zhou, Xia-Yun MDa; Xu, Hai-Yan MMa; Wu, Ting MMa; Chen, Shi-Yun MDa; Gan, Hai-Fang MDa; Zhou, Yi-Fu MMa; Peng, Min MMa; Zhou, Peng MDa; Zeng, Jing-Chun MDc; Li, Jing-Jing MDa,*. Fire acupuncture for plaque psoriasis case series. Medicine 103(16):p e37848, April 19, 2024. | DOI: 10.1097/MD.0000000000037848

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Mandibular Advancement Device Matches CPAP for BP Reduction in OSA Patients: Study

Researchers have found in a new study that the mandibular advancement device (MAD) is non-inferior to continuous positive airway pressure (CPAP) therapy for reducing 24-hour mean arterial blood pressure in patients with hypertension and increased cardiovascular risk. This finding is based on a randomized, non-inferiority trial comparing the two treatments for patients with moderate-to-severe obstructive sleep apnea (OSA). This study was published in the Journal Of The American College Of Cardiology. The study was conducted by Yi-Hui and colleagues.

Hypertension guidelines recommend diagnosing and treating obstructive sleep apnea in patients with hypertension. MAD is an oral appliance therapy option for patients who decline or cannot tolerate CPAP. The effectiveness of MAD versus CPAP in reducing 24-hour ambulatory blood pressure (BP) was the focus of the study.

In an investigator-initiated, randomized, non-inferiority trial, researchers enrolled 321 participants aged over 40 with hypertension and increased cardiovascular risk from three public hospitals. A total of 220 participants with moderate-to-severe OSA (apnea–hypopnea index ≥15 events/hour) were randomized to either MAD or CPAP (1:1 ratio). The primary outcome was the difference between the 24-hour mean arterial BP at baseline and six months.

The key findings of the studu were:

• In the MAD group, the 24-hour mean arterial BP decreased by 2.5 mmHg (P = 0.003) at six months compared to baseline.

• In the CPAP group, no significant change was observed (P = 0.374).

• The between-group difference in 24-hour mean arterial BP was -1.6 mmHg (95% confidence interval: -3.51 to 0.24), indicating non-inferiority (P < 0.001).

• The MAD group showed a larger reduction in all secondary ambulatory BP parameters compared to the CPAP group, with the most pronounced effects observed in asleep BP parameters.

• Both treatments improved daytime sleepiness, with similar between-group differences (P = 0.384).

• There were no significant between-group differences in cardiovascular biomarkers.

The study concludes that MAD is non-inferior to CPAP for reducing 24-hour mean arterial BP in patients with hypertension and increased cardiovascular risk. Given its effectiveness, MAD may provide an alternative treatment option for patients who cannot tolerate CPAP.

Reference:

Ou, Y.-H., Colpani, J. T., Cheong, C. S., Loke, W., Thant, A. T., Shih, E. C., Lee, F., Chan, S.-P., Sia, C.-H., Koo, C.-Y., Wong, S., Chua, A., Khoo, C.-M., Kong, W., Chin, C. W., Kojodjojo, P., Wong, P. E., Chan, M. Y., Richards, A. M., … Lee, C.-H. (2024). Mandibular advancement vs CPAP for blood pressure reduction in patients with obstructive sleep apnea. Journal of the American College of Cardiology. https://doi.org/10.1016/j.jacc.2024.03.359

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Visual Impairment Among Adolescents Increase Risk of Suicidal Behavior: JAMA

A recent comprehensive study published in the Journal of American Medical Association found a significant association between visual impairment and an increased risk of suicide by highlighting the mental health challenges faced by individuals with sensory impairments. This extensive review drew data until February 8, 2024 to analyze the connection between visual impairments and various aspects of suicidal behavior, including the ideation and attempts.

The study involved a meta-analysis of 31 population-based studies and encompassed over 5.6 million individuals. This research employed robust statistical methods to assess the risk by revealing the substantially higher likelihood of suicidal behavior expressed in visually impaired individuals when compared to the individuals without such impairments. Also, the odds of attempting suicide or engaging in suicidal behavior were found to be more than double among those with visual impairments.

The detailed analysis reported a pooled odds ratio (OR) of 2.49 for suicidal behavior and 2.01 for suicidal ideation among the individuals with visual impairment. The risk of actual suicide death was also increased, with a pooled OR of 1.89. The findings underlined the severe impact visual impairment can have on mental health, beyond the direct effects on physical capabilities.

This study revealed the increased risk associated with visual impairment that varied by age, where adolescents experienced the most pronounced risk. This demographic emerged as particularly vulnerable by necessitating targeted interventions and support systems to address their unique challenges.

The meta-regression analyses found age as a significant factor in the risk of suicide among the visually impaired by suggesting that younger individuals experience higher psychological impacts from the loss or lack of vision. These findings indicate a major need for specialized mental health services and support structures tailored to younger populations with visual impairments.

The outcomes of this study emphasize the importance of recognizing visual impairment as a significant factor in mental health assessments and suicide prevention strategies. Given the high risk among adolescents, the findings call for immediate attention to this group which advocates for enhanced screening, preventive measures and supportive interventions to reduce the increased suicide risk identified in this population. Overall, this study helps in ensuring that individuals with visual impairments receive the comprehensive care and support they require to safeguard their mental and emotional well-being.

Reference:

Kim, C. Y., Ha, A., Shim, S. R., Hong, I. H., Chang, I. B., & Kim, Y. K. (2024). Visual Impairment and Suicide Risk. In JAMA Network Open (Vol. 7, Issue 4, p. e247026). American Medical Association (AMA). https://doi.org/10.1001/jamanetworkopen.2024.7026

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AI effectively detects interval breast cancer in subsequent two years post-screening by mammograms: Study

Turkey: A recent study published in Clinical Radiology has shown the potential of artificial intelligence (AI) in detecting interval cancers (ICs) in the initial mammograms and lowering errors and undetected cancers.

“Artificial intelligence can detect interval breast cancer that may often be overlooked,” the researchers from Turkey wrote in their study.

Prof. Levent Çelik, MD, from Maltepe University Hospital and Erkin Aribal, MD, from Acibadem University, both in Istanbul, Turkey, found that AI was implemented into breast cancer screening in a middle-income country, it achieved high specificity and sensitivity in detecting interval cancers that were labeled initially as BI-RADS 1 or 2.

Previous studies have shown the efficacy of AI in reducing interval cancers, identifying between 12% and 50% of these cancers. The level of success depends on the thresholds chosen for the technology’s implementation.

Middle-income countries comprise 108 countries with a gross national income per capita ranging from $1,136 to $13,845. These countries contribute about 30% to the global gross domestic product (GDP) and constitute about 75% of the world’s population.

Against the above background, the study was conducted to investigate the accuracy and efficiency of an AI algorithm (Transpara v1.6, ScreenPoint Medical) in detecting interval cancers in a middle-income country national screening program.

The study included data from 2,129,486 mammograms reported as BI-RADS 1 or 2. These were matched with the national cancer registry for interval cancers. The interval group comprised 406, while a control group comprised 446 women with two negative consequent mammograms, defined as time-proven normal.

The cancer risk scores were issued on a one-to-10 scale, with 10 indicating extremely elevated risk. The researchers also employed specificity thresholds of 90% and 95% for the system.

The study led to the following findings:

· AI labeled 53% of ICs with the highest score of 10. The sensitivity of AI in detecting ICs was 53.7% and 38.5% at specificities of 90% and 95%, respectively.

· AUC of AI in detecting major signs was 0.93 with a sensitivity of 81.6% and 72.4% at specificities of 90% and 95%, respectively and minor signs were 0.87 with a sensitivity of 70% and 53% at a specificity of 90% and 95%, respectively.

· In subgroup analysis for time to diagnosis, the AUC value of the AI system was higher in the 0-6 month period than in later periods.

In conclusion, AI has the potential to enhance screening mammogram outcomes, specifically in countries with limited resources, by reducing human errors and detecting more undepictable cancers with the expense of a possible higher recall rate.

“It is necessary to conduct additional real-life studies to determine the appropriate approach for using suitable AI algorithms in national screening programs,” the researchers wrote. “Such studies can help optimize strategies utilizing AI and human readers.”

Reference:

DOI: https://doi.org/10.1016/j.crad.2024.03.012

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Prior pneumococcal vaccination reduces mortality in elderly patients with community-acquired pneumonia: Study

Korea: Prior pneumococcal vaccination in elderly patients hospitalized for community-acquired pneumonia (CAP) is associated with improved in-hospital mortality and 30-day mortality, a recent study published in BMC Pulmonary Medicine has shown.

“Prior pneumococcal vaccination resulted in higher in-hospital improvement (97.6% vs. 95.0%) and lower 30-day mortality rates (2.6% vs. 5.3%) versus the unvaccinated group,” the researchers reported.

Further analyses confirmed a significant reduction in in-hospital mortality (HR 0.53) and 30-day mortality (HR 0.58) among the vaccinated.

Community-acquired pneumonia (CAP) remains a significant cause of morbidity and mortality, particularly among the elderly population. However, recent research suggests that prior pneumococcal vaccination could significantly reduce the risk of in-hospital mortality for these vulnerable individuals. However, there is a lack of real-world data on the efficacy of the pneumococcal vaccine in reducing mortality, especially in elderly patients.

To fill this knowledge gap, Jeong Uk Lim, The Catholic University of Korea, Seoul, Korea, and colleagues aimed to assess the effects of prior pneumococcal vaccination in elderly pneumonia patients.

For this purpose, the researchers procured data from the Health Insurance Review and Assessment and Quality Assessment database. It included hospitalized patients who met the community-acquired pneumonia criteria and were grouped according to vaccination state. Patients were aged ≥ 65 years and treated with quinolone, beta-lactam, or macrolide. Patients were excluded when treatment outcomes were unknown.

The researchers evaluated a total of 4515 patients, and 35.6% of them were vaccinated before hospitalization. The mean age was 77.0, 54.2% were male, and the mean Charlson comorbidity index (CCI) was 3.0.

The study led to the following findings:

  • The patients in the vaccinated group were younger than those in the unvaccinated group (76.0 vs. 78.0 years) and showed higher in-hospital improvement (97.6 vs. 95.0%) and lower 30-day mortality (2.6 vs. 5.3%).
  • After adjusting confounding factors such as age, gender, CURB score, and CCI score, the vaccinated group demonstrated a significant reduction in 30-day mortality (hazard ratio [HR] 0.58) and in-hospital mortality (HR 0.53) compared to the unvaccinated group in multivariate analysis.
  • The vaccinated group showed better 30-day survival than those in the non-vaccinated group (log-rank test < 0.05).

In conclusion, the study showed the effectiveness of prior pneumococcal vaccination in elderly populations for improving in-hospital and 30-day mortalities among those hospitalized for pneumonia, however, it does not affect the length of admission duration.

“Emphasizing the importance of vaccination as part of comprehensive pneumonia prevention efforts could lead to improved outcomes and reduced healthcare costs associated with CAP in this vulnerable population,” the researchers wrote.

Reference:

Kim, S., Kim, M.J., Myong, JP. et al. Prior pneumococcal vaccination improves in-hospital mortality among the elderly population hospitalized due to community-acquired pneumonia. BMC Pulm Med 24, 168 (2024). https://doi.org/10.1186/s12890-024-02928-8

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Innovative shoe technology may help reduce risk of diabetic foot ulcers: Study

Researchers have developed a new shoe insole technology that helps reduce the risk of diabetic foot ulcers, a dangerous open sore that can lead to hospitalization and leg, foot or toe amputations.

“The goal of this innovative insole technology is to mitigate the risk of diabetic foot ulcers by addressing one of their most significant causes: skin and soft tissue breakdown due to repetitive stress on the foot during walking,” said Muthu B.J. Wijesundara, principal research scientist at The University of Texas at Arlington Research Institute (UTARI).

Affecting about 39 million people in the U.S., diabetes can damage the small blood vessels that supply blood to the nerves, leading to poor circulation and foot sores, also called ulcers. About one-third of people with diabetes develop foot ulcers during their lifetime. In the U.S., more than 160,000 lower extremity amputations are performed annually due to complications from diabetic foot ulcers, costing the American health system about $30 billion a year. Those who have foot ulcers often die at younger ages than those without ulcers.

“Although many shoe insoles have been created over the years to try to alleviate the problem of foot ulcers, studies have shown that their success in preventing them is marginal,” Wijesundara said. “We took the research a step further by creating a pressure-alternating shoe insole that works by cyclically relieving pressure from different areas of the foot, thereby providing periods of rest to the soft tissues and improving blood flow. This approach aims to maintain the health of the skin and tissues, thereby reducing the risk of diabetic foot ulcers.”

In an article in the peer-reviewed International Journal of Lower Extremity Wounds, Wijesundara and UTA colleagues Veysel Erel, Aida Nasirian and Yixin Gu, along with Larry Lavery of UT Southwestern Medical Center, described their innovative insole technology. After this successful pilot project, the next step for the research team will be refining the technology to make it more accessible for users with varying weights and shoe sizes.

“Considering the impact of foot ulcers, it’s exciting that we may be able to make a real difference in the lives of so many people,” Wijesundara said.

Reference:

Veysel Erel, Aida Nasirian, Yixin Gu, Larry Lavery, Muthu B. J. Wijesundara. Development of Cyclic Pressure Offloading Insole for Diabetic Foot Ulcer Prevention. The International Journal of Lower Extremity Wounds, 2024; DOI: 10.1177/15347346241234825.

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