Immediate weaning of braces benefits Adolescents with Idiopathic Scoliosis by earlier resumption of exercise and activity: JAMA

Gradual weaning did not demonstrate superiority to immediate weaning with predefined criteria of Cobb angle and truncal balance maintenance and HRQoL after brace weaning suggests a new study published in the JAMA Pediatrics.

Lack of evidence and consensus for brace weaning protocol in adolescent idiopathic scoliosis (AIS) results in clinicians prescribing gradual weaning in the hope of avoiding curve deterioration after weaning. However, gradual weaning contributes to prolonged brace wear, which can affect spinal stiffness and health-related quality of life (HRQoL). A study was done to determine whether gradual weaning results in better curve magnitude and truncal balance maintenance after brace weaning vs immediate brace removal for patients with AIS. This was an open-labeled randomized clinical trial commenced in April 2017 with 24-month follow-up completed in January 2023. Outcome assessors were masked to weaning protocol assigned. The study took place at a territory-wide tertiary scoliosis clinic serving the largest number of referrals in the local population. Patients with AIS ready to wean off of brace wear were eligible (402 were screened; 33 were excluded [15 for <18 hours/day of brace-wear compliance before weaning, 11 were treated with Milwaukee brace, and 7 declined to participate]; and 369 were included), and those who were treated with a custom molded thoracolumbosacral orthosis and had reached skeletal maturity were consecutively recruited. Patients were randomized to gradual weaning protocol (n = 176) with an additional 6 months of nighttime wear before completely stopping or immediate weaning protocol (n = 193) with immediate brace removal at recruitment. Changes in major curve Cobb angle and truncal balance from the time of weaning to 6-month, 12-month, and 24-month follow-up. HRQoL was also assessed using the refined Scoliosis Research Society 22-item and EuroQol 5-dimension questionnaires. Results: A total of 369 patients (mean [SD] age, 14.9 [1.1] years; 304 [83.4%] girls) were randomized with 284 (77.0%) completing 24-month longitudinal follow-up. Immediate and gradual weaning groups had no significant differences in change of major Cobb angle at postweaning 6-month (difference, −0.6°; 95% CI, −1.4 to 0.2; P = .17), 12-month (difference, −0.3°; 95% CI, −1.2 to 0.6; P = .47), and 24-month (difference, −0.3°; 95% CI, −1.2 to 0.7; P = .60) follow-up. The number of curve progression, nonprogression, and rebound cases were comparable (χ22 = 2.123; P = .35). Postweaning changes in truncal balance and HRQoL demonstrated no significant differences between groups. Gradual weaning did not demonstrate superiority to immediate weaning with predefined criteria of Cobb angle and truncal balance maintenance and HRQoL after brace weaning. Gradual and immediate weaning achieved very similar maintenance of brace outcomes in AIS. We therefore recommend the consideration of immediate brace weaning, which aims to benefit patients with earlier time for increased exercises and activity level.

Reference:

Cheung PWH, Chan OKO, Wu H, et al. Immediate vs Gradual Brace Weaning Protocols in Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial. JAMA Pediatr. Published online June 03, 2024. doi:10.1001/jamapediatrics.2024.1484

Keywords:

Cheung PWH, Chan OKO, Immediate, Gradual Brace, Weaning, Protocols, Adolescent, Idiopathic Scoliosis, Randomized Clinical Trial, JAMA Pediatrics

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Battle of Antisepsis Titans in new study: Povidone Iodine vs Chlorhexidine Gluconate in Alcohol to Prevent SSIs

Switzerland: In a groundbreaking study that promises to reshape preoperative protocols, researchers have conducted a randomized clinical trial comparing the efficacy of two widely used antiseptic solutions: povidone-iodine and chlorhexidine gluconate in alcohol. The findings of this trial, published in the Journal of the American Medical Association (JAMA), provide crucial insights into which solution offers superior protection against surgical site infections (SSIs), a persistent concern in surgical practice.

The randomized clinical trial that included 3360 patients revealed that povidone-iodine is noninferior to chlorhexidine gluconate as preoperative skin antisepsis in preventing SSIs after cardiac or abdominal surgery.

“Surgical site infections after abdominal or cardiac surgery were identified in 5.1% of patients in the povidone-iodine group versus 5.5% in the chlorhexidine gluconate group,” the researchers reported, “a difference of 0.4% that met the predefined noninferiority margin of an absolute difference of 2.5%.”

Surgical procedures carry inherent risks, with SSIs posing a significant threat to patient recovery and healthcare costs. Antisepsis, particularly the skin preparation before incision, plays a pivotal role in reducing these infections. Traditionally, povidone-iodine and chlorhexidine gluconate in alcohol have been mainstays in surgical settings, each with its proponents and perceived advantages. However, the choice of antiseptic agent, chlorhexidine gluconate or povidone-iodine, remains debated.

Against the above background, Andreas F. Widmer, University Hospital Basel and University of Basel, Basel, Switzerland, and colleagues aimed to determine whether povidone iodine in alcohol is noninferior to chlorhexidine gluconate in alcohol for SSIs prevention after cardiac or abdominal surgery.

For this purpose, the researchers conducted a multicenter, cluster-randomized, investigator-masked, crossover, noninferiority trial comprising 4403 patients undergoing abdominal or cardiac surgery in three tertiary care hospitals in Switzerland between 2018 and 2020; 3360 patients were enrolled (cardiac, n = 2187; abdominal, n = 1173).

Over 18 consecutive months, study sites were randomly assigned each month to either chlorhexidine gluconate or povidone-iodine, each formulated in alcohol. Disinfectants and skin application processes were standardized and followed published protocols.

1598 patients (26 cluster periods) were randomly assigned to receive povidone-iodine versus 1762 patients (26 cluster periods) to chlorhexidine gluconate. Patients’ mean age was 65.0 years in the povidone-iodine group and 65.0 years in the chlorhexidine gluconate group. Patients were 33.9% and 32.7% female in the chlorhexidine gluconate and povidone-iodine groups, respectively.

The primary outcome was SSI within 30 days following abdominal surgery and 1 year after cardiac surgery. A noninferiority margin of 2.5% was used. Secondary outcomes were SSIs stratified by type of surgery and depth of infection.

The following were the key findings of the study:

  • SSIs were identified in 5.1% of patients in the povidone-iodine group vs 5.5% in the chlorhexidine gluconate group, a difference of 0.4% with the lower limit of the CI not exceeding the predefined noninferiority margin of −2.5%; results were similar when corrected for clustering.
  • The unadjusted relative risk for povidone iodine vs chlorhexidine gluconate was 0.92.
  • Nonsignificant differences were observed following stratification by type of surgical procedure.
  • In cardiac surgery, SSIs were present in 4.2% of patients with povidone-iodine versus 3.3% with chlorhexidine gluconate (relative risk, 1.26); in abdominal surgery, SSIs were present in 6.8% with povidone-iodine vs 9.9% with chlorhexidine gluconate (relative risk, 0.69).

“The findings showed that povidone-iodine in alcohol as preoperative skin antisepsis was noninferior to chlorhexidine gluconate in alcohol in preventing SSIs after cardiac or abdominal surgery,” the researchers concluded.

Reference:

Widmer AF, Atkinson A, Kuster SP, et al. Povidone Iodine vs Chlorhexidine Gluconate in Alcohol for Preoperative Skin Antisepsis: A Randomized Clinical Trial. JAMA. Published online June 17, 2024. doi:10.1001/jama.2024.8531

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For type 1 diabetes distress, focus first on managing emotions, suggests study

Virtual, emotion-centered program cuts distress in half after one year, while also improving patients’ glucose control.

The most effective way to reduce the distress that comes with having diabetes – and improve glucose control – is to focus on managing the emotional strain of living with the condition, a new study of adults that was led by researchers at UC San Francisco has found.

Diabetes distress, or DD, refers to the fears, worries and burdens associated with living with and managing diabetes, and it affects up to 75% of adults with Type 1 diabetes. It is linked with poor self-management, such as missing medication doses, elevated glucose levels, more incidents of low blood glucose (hypoglycemia) and lower quality of life. 

The recent study, published in Diabetes Care, compared three group programs, all of which were delivered virtually. The first focused on education about and management of diabetes, the second on the emotional side of living with diabetes, and the third combined the two approaches.

All three programs yielded significant and clinically meaningful reductions in diabetes distress and hemoglobin A1C, which measures glucose control. But the emotion-focused program, called TunedIn, displayed the most consistent benefits and was far more effective at lowering DD than any other intervention that has been studied.

“Most patients with diabetes have never heard of diabetes distress or been asked about it, and don’t understand that it can be alleviated,” said first author Danielle Hessler Jones, PhD, professor and vice chair for research in the UCSF Department of Faculty and Community Medicine. “Knowing virtual group-based programs are effective presents an opportunity to change that.” 

Improving access to care

Two hundred and seventy-six adults with Type 1 diabetes and elevated diabetes distress participated in the study conducted from 2019-2022. Participants were randomly assigned to one of the three programs, each of which involved a series of virtual meetings over a 3- to 4-month period and included group workshops, group calls and a one-to-one call with the instructor.

Half the study participants no longer had diabetes distress after using TunedIn for one year, compared to 27% of those who used the education-focused program and 31% who used the combination program. TunedIn also had the highest percentage of participants (56%) whose A1C declined by 0.5% or more, which is clinically and statistically significant.

TunedIn incorporates elements and strategies of Acceptance and Commitment Therapy (ACT), which fosters awareness of how painful emotions and beliefs can drive behavior that conflicts with diabetes management. In previous research, ACT strategies have proven effective across a range of chronic diseases and other stress-related settings.  

“Providing individuals with Type 1 diabetes with opportunities to recognize and observe these processes, and to ‘stand beside them,’ may enable them to make different choices, choices that can have positive impacts on their health and wellbeing,” Jones said.  

Based on this research, the UCSF Diabetes Center has begun to integrate diabetes distress screening into its practice.

“If you don’t address the emotional part of living with the illness, you don’t do well,” said co-author Umesh Masharani, MBBS, a UCSF professor of endocrinology. “It’s important that clinicians are trained on how to have these conversations with their patients with diabetes as part of normal care.”

TunedIn could broaden access for patients nationwide, and potentially worldwide, who are unable to book treatment with clinical experts in diabetes distress, added Jones. The research team’s work has gained international attention through the leadership of co-author Lawrence Fisher, PhD, ABPP, professor emeritus at UCSF and director of the Behavioral Diabetes Research Group. Fisher is currently working with colleagues on implementing DD programs in the UK and Europe.

“With so few mental health specialists and psychologists trained in diabetes, virtual programs are really needed to be able to bring this type of evidence-based treatment to patients who can’t come to us,” Jones said.   

Reference:

Danielle M. Hessler, Lawrence Fisher; Susan Guzman; Lisa Strycker; William H. Polonsky; Andrew Ahmann; Grazia Aleppo; Nicholas B. Argento; Joseph Henske; Sarah Kim; Elizabeth Stephens; Katherine Greenberg; Umesh Masharani, EMBARK: A Randomized, Controlled Trial Comparing Three Approaches to Reducing Diabetes Distress and Improving HbA1c in Adults With Type 1 Diabetes, Diabetes Care, https://doi.org/10.2337/dc23-2452.

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CDSCO Panel Denies Pfizer Products India request for local CT waiver to market Elranatamab solution for injection

New Delhi: Noting that no new data, literature, or updates have been presented by the firm, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected the drug major Pfizer Products India’s proposal for waiver of local clinical trials for the grant of permission to import and market Elranatamab solution for injection.

This came after the proposal was redeliberated for the grant of permission to import and market Elranatamab solution for injection 44mg/1.1mL (40 mg/mL) and 76 mg/1.9 mL (40 mg/mL), along with a request for a local clinical trial waiver.

Elranatamab is a bispecific antibody used to treat adults with relapsed or refractory multiple myeloma. Elranatamab is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma. In the US, it is approved for patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Elranatamab works by bringing healthy T cells (immune cells that help kill cancer cells) and myeloma cells close together so the T cells can more effectively kill the myeloma cells. It does this by binding to a protein called CD3 on healthy T cells and a protein called BCMA on myeloma cells.

At the recent SEC meeting for oncology held on June 5 and 6, 2024, the expert panel reviewed the proposal for the grant of permission to import and market Elranatamab solution for injection 44mg/1.1mL (40mg/mL) and 76 mg/1.9mL (40 mg/mL), along with a request for a local clinical trial waiver.

The committee noted that no new data, literature, or updates have been presented by the firm.

The drug is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.

The committee noted that the drug has accelerated approval (conditional approval) in the USFDA for the proposed indication based on Phase II clinical trial data, and the trial is ongoing.

After detailed deliberation, the committee reiterated the earlier SEC recommendation dated April 3, 2024, stating:

“The committee did not consider the firm’s request for waiver of local clinical trial for grant of permission to import and market Elranatamab solution for injection.”

Also Read:CDSCO declares 5 formulations as spurious: Details

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World first brain implant fitted in UK teenager to control epilepsy seizures

A UK teenager, Oran Knowlson, has become the first person globally to receive a brain implant designed to control seizures from severe epilepsy. The neurostimulator, placed under his skull, sends electrical signals deep into his brain, reducing his daytime seizures by 80%.
Oran, 13, who resides in Somerset, suffers from Lennox-Gastaut syndrome, a severe, treatment-resistant form of epilepsy that began when he was three. Prior to the implant, he experienced daily seizures, sometimes hundreds, often losing consciousness and requiring resuscitation, necessitating constant care due to the high risk of sudden unexpected death in epilepsy (SUDEP).

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Dengue cases rise by 60 percent in Karnataka

The Karnataka Health Department has reported a nearly 60% increase in dengue cases in the first half of this year compared to 2023. Cases surged from 2,003 by June 2023 to 4,886 this year, with 1,230 cases recorded within BBMP (Bruhat Bengaluru Mahanagara Palike) limits and 30 cases in Bengaluru Rural and Urban districts. Health Commissioner Randeep D highlighted efforts to improve surveillance by deploying health staff to towns bi-monthly to reduce infection rates and educate the public.
The increase in cases is attributed to a long dry spell leading to water shortages, prompting increased water storage that has intensified mosquito breeding. Community resistance to larvicide application in stored water and intermittent rains causing outdoor breeding have also contributed to the rise in cases. Increased testing for suspected dengue fever cases has further revealed more infections.

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Telangana Junior Doctors temporarily suspend strike, Govt releases GO on demands

Hyderabad: The Telangana Junior Doctors Association (T-JUDA) have temporarily suspended their indefinite strike across all government medical colleges in the state, which started on Monday.  

Boycotting outpatient (OPD) services, elective surgeries and ward duties, the junior doctors have demanded a solution to their unresolved issues concerning the doctors, including the establishment of a green channel for timely stipend disbursement and inadequate honorarium for Super Specialty Senior Residents as primary grievances.  

Junior doctors working in government hospitals across Telangana, barring those serving in Osmania Hospital, temporarily called off their indefinite strike on Wednesday.

According to the IANS report, following talks with the Director of Medical Education and the officials of the health department late on Tuesday night, Telangana Junior Doctors Association (T-JUDA) decided to call off the strike for now.

Leaders of T-JUDA said they would wait till Wednesday evening for the government to issue orders, accepting their demands. They warned that if the government failed to issue the GOs, they would resume the strike from Thursday. 

Also Read:7000 Telangana Junior doctors on strike demanding timely stipend disbursement

The government assured T-JUDA that hostels for junior doctors will be built in Gandhi Hospital and Osmania Hospital. It also gave an assurance that funds would be released for the hostels.

However, junior doctors at Osmania Hospital opted to continue their strike due to the government’s lack of a clear commitment to construct a new building. They persisted with their protest on the hospital premises, emphasizing their stance to not end the strike until an order is issued for a new building.

The talks between T-JUDA leaders and Director of Medical Education (DME) Dr N Vani and other officials continued till late Tuesday night.

The officials gave an assurance on road repairs at Kakatiya Medical College in Warangal and the introduction of college buses, news agency IANS reported.

As per a media report in The Hindu, The G.O., issued by Health Secretary Christina Z Chongthu, allocates ₹204.85 crore to the Director of Medical Education (DME) for civil works at OMC, GMC, and KMC through the Telangana Medical Services Infrastructure Development Corporation (TGMSIDC). The sanctioned amount includes Rs 121.9 crore for Osmania Medical College, Rs 79.5 crore for Gandhi Medical College and Rs 3.45 crore for the construction of internal cement concrete roads at Kakatiya Medical College.

The junior doctors had been boycotting outpatient services, elective surgeries, and ward duties. However, they were attending emergency duties.

The government had also given assurances on the demands for the establishment of a green channel for timely stipend disbursement, honorarium for super-speciality senior residents, and deployment of police personnel to prevent violence against doctors in hospitals.

Also Read:Telangana Junior Doctors announce Indefinite Strike over delay in stipend disbursement

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Health risks associated with prolonged sitting may be reduced with coffee consumption: Study

A recent study conducted by researchers at Soochow University and published in BMC Public Health suggested that incorporating a regular cup of coffee into your daily routine might mitigate the long-term health risks associated with sedentary behaviour, such as sitting for prolonged periods.
Years of inactivity, such as sitting in an office chair or lounging on a couch, can have detrimental health effects, but coffee consumption appears to offer some protective benefits.
Reference: Zhou, H., Nie, J., Cao, Y. et al. Association of daily sitting time and coffee consumption with the risk of all-cause and cardiovascular disease mortality among US ad

Coffee consumption may reduce health risks associated with prolonged sitting: Study

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Submission of fake degrees: Internships of 3 FMGS cancelled by Rajasthan Medical Council

Taking action against three foreign medical graduates (FMGs) who submitted fake documents, the Rajasthan Medical Council (RMC) has cancelled their internships.
This came to light during the verification process conducted by the medical council in May, 2024. Confirming this development, the registrar of RMC Dr. Rajesh Kumar Sharma informed that the internship of Raj Kumar Meena, Ankur Kumar, and Himanshu Chauhan were cancelled, TOI has reported.

For more information click on the link below:

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New review analyzes impact of plant-based meat alternatives on cardiovascular disease risk factors

Even though there is substantial variability in the contents and nutritional profiles of plant-based meat alternatives (PBMAs), the nutritional profiles tend to reflect a heart-healthy dietary pattern. A review article of the available studies directly comparing the impact of plant-based and animal-based meats consistently suggests that the plant-based alternatives improve cardiovascular risk factors.

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