Day: October 9, 2024

Bridging the Gap: How Pragmatic Trials can Better Serve Healthcare Systems

Photo by Hush Naidoo Jade Photography on Unsplash

A new thought piece led by the Harvard Pilgrim Health Care Institute with collaborators from Duke University and Kaiser Permanente Washington Health Research Institute highlights the challenges facing healthcare researchers and decision makers in the quest to improve population health in a constantly evolving healthcare landscape. The authors offer strategies to enhance the effectiveness of pragmatic clinical trials and increase their impact on real-world healthcare settings.

The Viewpoint appears October 2 in JAMA.

Pragmatic clinical trials, designed to inform health care decision-makers about the comparative benefits, burdens, and risks of health interventions, have seen a significant increase in interest over the past decade. Since 2012, the NIH Pragmatic Trials Collaboratory has supported 32 such trials, addressing critical issues like suicide prevention, opioid prescribing, and infection control.

Pragmatic clinical trials are designed to bridge the gap between research and care, and we believe this bridge can be built even more efficiently.
– Richard Platt, MD, MSc

Pragmatic clinical trials compare treatments in everyday clinical settings, rather than under ideal conditions. However, the authors note that the adoption of trial findings by healthcare systems has been inconsistent.

“Our goal is to ensure that the findings from these trials are not only scientifically sound but also readily implementable in diverse healthcare settings,” says lead author Richard Platt, Harvard Medical School distinguished professor of population medicine at the Harvard Pilgrim Health Care Institute. “Pragmatic clinical trials are designed to bridge the gap between research and care, and we believe this bridge can be built even more efficiently.”

The authors identify key challenges and propose solutions to align trial goals with healthcare system needs, including:

  • Identifying relevant outcomes: Collaborate with healthcare leaders to determine the clinical or cost-saving outcomes that would motivate adoption.
  • Shortening trial duration: Designing trials to span 2-3 years to match the decision-making timelines of healthcare systems.
  • Conducting interim assessments: Utilizing interim analyses to provide timely information and potentially stop or modify trials early.
  • Considering costs: Understanding and planning for associated costs to ensuring interventions are sustainable post-trial.

“By accommodating the priorities of healthcare leaders and introducing adaptive trial designs, we can generate actionable evidence that truly improves patient care,” adds Dr Platt.

Source: Harvard Pilgrim Health Care Institute

Avo at Breakfast for Women, Oats for Men, Study Suggests

Photo by Thought Catalog on Unsplash

New research from the University of Waterloo suggests that men and women should have different kinds of food for breakfast in order to help lose weight.

The study, which employed a mathematical model of men’s and women’s metabolisms, showed that men’s metabolisms respond better on average to a meal laden with high carbohydrates like oats and grains after fasting for several hours, while women are better served by a meal with a higher percentage of fat, such as omelettes and avocados. The findings are out now in Computers in Biology and Medicine.

“Lifestyle is a big factor in our overall health,” said Stéphanie Abo, an Applied Mathematics PhD candidate and the lead author of the study. “We live busy lives, so it’s important to understand how seemingly inconsequential decisions, such as what to have for breakfast, can affect our health and energy levels. Whether attempting to lose weight, maintain weight, or just keep up your energy, understanding your diet’s impact on your metabolism is important.”

The study builds on an existing gap in research on sex differences in how men and women process fat. “We often have less research data on women’s bodies than on men’s bodies,” said Anita Layton, a professor of Applied Mathematics and Canada 150 Research Chair in Mathematical Biology and Medicine.

“By building mathematical models based on the data we do have, we can test lots of hypotheses quickly and tweak experiments in ways that would be impractical with human subjects.”

“Since women have more body fat on average than men, you would think that they would burn less fat for energy, but they don’t,” said Layton. “The results of the model suggest that women store more fat immediately after a meal but also burn more fat during a fast.”

Going forward, the researchers hope to build more complex versions of their metabolism models and extend beyond the consideration of biological sex by incorporating an individual’s weight, age, or stage in the menstrual cycle.

Source: University of Waterloo

The Brain Forces Muscles to ‘Hit the Brakes’ in Hip Osteoarthritis

Photo by Kampus Production on Pexels

Muscle activation in people suffering from hip osteoarthritis might be a case of ‘mind over matter’, new research from Edith Cowan University (ECU) has shown.

Research undertaken by ECU post-doctoral research fellow Dr Myles Murphy investigated muscle function in people with hip osteoarthritis and found that these patients were unable to activate their muscles as efficiently. The findings are published in Sports Medicine and Health Science.

“Previous research has well established that the degree to which a joint degenerates is not directly related to the amount of pain a person with arthritis will experience. In fact, the stronger your muscles are, the more protected your joint is, and the less pain you will experience.

“Our research has shown that people with hip osteoarthritis were unable to activate their muscles as efficiently, irrespective of strength.”

As part of this research, Dr Murphy and his team studied the brain function of people with hip arthritis, finding that the mind played an enormous part in this equation.

“Basically, people with hip arthritis are unable to activate their muscles properly because the brain is actively putting on the brake to stop them from using the muscle. We don’t know why that is, yet. But the brain seems to really be hampering the progress of rehabilitation and the muscles to protect the joint,” Dr Murphy said.

“We suspect that it is a short-term, protective response gone wrong. Unlike a rolled ankle or a hurt knee, chronic pain like osteoarthritis tends to hang around for a long time.  Instead of being a protective response in the short term, the brain’s protective response becomes a really problematic and maladaptive response in the long term.”

Hip osteoarthritis is more prevalent in people over the age of 45, and women are much more like to develop the condition. People who have reported previous joint damage, from a sports injury or accident, are more likely to present with hip osteoarthritis, as are those with joint abnormalities, such as developmental dysplasia of the hip.

People living with hip arthritis often presents with different walking patterns than those without and could struggle with everyday activities like getting out of a chair, or vehicle.

“The impact on their daily lives is the biggest burden of osteoarthritis. The condition also results in substantial time-loss from work, and is associated with a high economic cost,” Dr Murphy said.

“The level of disability for normal activity within our study cohort was about 25%, compared to the 0% reported in our healthy control group.”

Dr Murphy is currently investigating novel ways in which to overcome this automatic muscle inhibition to effectively rehabilitate patients.

In the meantime, those living with hip osteoarthritis have been urged to continue strength training and to work with a qualified physiotherapist or exercise physiologist.

“You will need to work quite hard to build the strength in those muscles, but it can be done. There is no quick fix. Staying strong is something that people with hip osteoarthritis will need to actively keep working on,” he said.

Source: Edith Cowan University

Managing your Mental Health at your Own Tempo

Photo by Sammy Williams on Unsplash

World Mental Health Day, celebrated internationally on 10 October, is not just another commemorative day, but in fact, a time to truly reflect on the need to break the stigma associated with seeking mental health support.

Today, many may acknowledge that mental health issues are common and can adversely affect a significant portion of the population. “In fact, according to the fourth annual Mental State of the World Report 2023, published in March 2024 by Sapien Labs, Brazil, South Africa and the United Kingdom all show the greatest proportion of respondents who are distressed or struggling with their mental health, which indicates that there is still a dire need for more open conversations about mental health in families, workplaces and communities,” says Madelein O’Connell, Executive: Marketing, Sales and Corporate Relations at Bestmed Medical Scheme.

“We already know that our mental wellbeing can affect emotions, physical health, relationships and overall quality of life,” adds O’Connell. “Beyond this, neglecting your mental health can also lead to burnout, anxiety, and an array of serious health conditions. However, prioritising your mental health can be daunting, with so many not knowing where to start. It’s important to remember that it starts with, and is built on, small, consistent steps, which can make a significant difference.”

From a medical scheme perspective, there is often a range of mental health services covered as supplementary benefits by the medical scheme, such as access to psychologists, psychiatrists, counsellors, and support for conditions like anxiety, depression, and trauma. It’s important for members to understand what their medical scheme provides.

“At Bestmed, we offer a free Tempo wellness programme for our members, which can be accessed via the Bestmed App or online Member portal. As part of the Tempo wellness programme, members have access to free Tempo Wellness Webinars, hosted by mental healthcare experts, who discuss and give advice on various relevant topics,” says O’Connell. 

“We really want to support the integration of mental, nutritional, and physical health in overall wellbeing for our members, as we recognise that mental health covers a wide array of aspects. In fact, the World Health Organisation (WHO), defines mental health as ‘a state of mental well-being that enables people to cope with the stresses of life, realise their abilities, learn well and work well, and contribute to their community’, so giving people the support and skills to navigate their life is vital, particularly those more vulnerable to mental health challenges, such as adolescents, the elderly, or individuals dealing with long-term physical illness.”

Madelein O’Connell concludes, “of course, we also recognise that limited mental health service availability, a shortage of mental health professionals and financial constraints can impact a person’s ability to find the right support they need, when they need it. However, there are also some incredible mental health support organisations, locally, that can assist. LifeLine and The South African Depression and Anxiety Group (SADAG), for example, are confidential, free, and offer a starting point for anyone in need.”

Asymmetric Placebo Effect in Response to Spicy Food

Positive expectations facilitate reward processing and negative expectations prime pain processing

Photo by Ryan Quintal on Unsplash

The expectations humans have of a pleasurable sensation asymmetrically shape neuronal responses and subjective experiences to hot sauce, according to a study published October 8th, in the open-access journal PLOS Biology by Yi Luo from East China Normal University, Kenneth Kishida from Wake Forest School of Medicine, US, and colleagues.

Expectations shape our perception, profoundly influencing how we interpret the world. Positive expectations about sensory stimuli can alleviate distress and reduce pain through what’s known as the placebo effect, while negative expectations may heighten anxiety and exacerbate pain. In the new study, Luo, Kishida, and colleagues investigated the impact of the hedonic aspect of expectations on subjective experiences.

Specifically, the researchers measured neurobehavioral responses to the taste of hot sauce among individuals with a wide range of taste preferences. In total, 47 participants completed the tasks while undergoing functional magnetic resonance imaging scanning. The researchers identified participants who liked versus those who strongly disliked spicy flavors and provided contextual cues about the spiciness of the sauce to be tasted. That way, they were able to dissociate the effects of positive and negative expectations from sensory stimuli (i.e., visual and taste stimuli), which were the same across all participants.

The results showed that positive expectations lead to modulations in the intensity of subjective experience. These modulations were accompanied by increased activity in brain regions previously linked to pleasure, information integration, and the placebo effect, including the anterior insula, dorsolateral prefrontal cortex, and dorsal anterior cingulate cortex. By contrast, negative expectations decreased hedonic experience and increased neural activity in the Neurological Pain Signature network.

Taken together, these findings demonstrate that hedonic aspects of one’s expectations asymmetrically shape how the brain processes sensory input and associated behavioral reports of one’s subjective experiences of intensity, pleasure, and pain. The results suggest a dissociable impact of hedonic information. While positive expectations facilitate higher-level information integration and reward processing, negative expectations prime lower-level processes related to pain and emotions. According to the authors, this study demonstrates the powerful role of hedonic expectations in shaping subjective reality and suggests potential avenues for consumer and therapeutic interventions targeting expectation-driven neural processes.

The authors add, “Our study highlights how hedonic expectations shape subjective experiences and neural responses, offering new insights into the mechanisms behind pain perception.”

Provided by PLOS

Younger Children at Greater Risk for a Postoperative Knee Surgery Complication

Discoid lateral meniscus and osteochondritis dissecans in adolescent patients. The black arrow represents DLM and the white arrow represents osteochondritis dissecans. Credit: Osaka Metropolitan University

New research published in Knee Surgery, Sports Traumatology, Arthroscopy has shown that younger age is associated with increased risk of osteochondritis dissecans, a serious complication arising from surgery to correct misshapen knee cartilage.

Growing pains are common in maturing children, but sometimes this growth can be irregular and cause injury. Discoid lateral meniscus (DLM), a misshapen knee cartilage, is one such occurrence that can degenerate into osteochondritis dissecans, a joint disorder where the bone and joint begin to separate from the rest of the bones. It has been reported that osteochondritis dissecans of the femoral condyle occurs in approximately 14.5% of cases of DLM, but there has been little analysis of its treatment to date.

Dr Ken Iida and Specially Appointed Professor Yusuke Hashimoto’s team at Osaka Metropolitan University’s Graduate School of Medicine analysed the incidence of post-surgery osteochondritis dissecans. This analysis consisted of two groups, a pre-osteochondritis group with DLM and osteochondritis dissecans of the outer femoral epicondyle, and a non-osteochondritis dissecans DLM group. They studied 95 cases of DLM patients under the age of 15 who underwent surgery between 2003 and 2017 and had five years of post-surgery records. There were 15 cases in the pre-osteochondritis dissecans group and 80 non-osteochondritis dissecans cases.

Their analysis found that the surgical results for osteochondritis dissecans were good in pre-osteochondritis cases, but 28.5% had a recurrence of the joint disorder. In the non-osteochondritis dissecans group, 8.8% were diagnosed with the disorder after surgery. Additionally, age was found to be a risk factor for relapse or post-surgical osteochondritis dissecans, and surgery on patients ages 9 and under was also involved in the occurrence of osteochondritis dissecans.

“Patients with DLM accompanied by osteochondritis dissecans of the femoral condyle often have difficulty in deciding on a treatment method,” Dr Iida explained. “Based on the results of this study, we believe for patients ages 9 years or younger, it is necessary to consider conservative treatment methods rather than immediate surgery.”

Source: Osaka Metropolitan University

DBS Immediately Improves Arm and Hand Function After a Brain Injury

Deep brain stimulation illustration. Credit: NIH

Deep brain stimulation (DBS) may provide immediate improvement in arm and hand strength and function weakened by traumatic brain injury or stroke, according to research from the University of Pittsburgh School of Medicine.

Encouraging results from extensive tests in monkeys and humans open a path for a new clinical application of an already widely used brain stimulation technology and offer insights into neural mechanisms underlying movement deficits caused by brain injury. The results are published in Nature Communications.

“Arm and hand paralysis significantly impacts the quality of life of millions of people worldwide,” said senior and corresponding author Elvira Pirondini, Ph.D., assistant professor of physical medicine and rehabilitation at Pitt. “Currently, we don’t have effective solutions for patients who suffered a stroke or traumatic brain injury but there is a growing interest in the use of neurotechnologies that stimulate the brain to improve upper-limb motor functions.”

Brain lesions caused by serious brain trauma or stroke can disrupt neural connections between the motor cortex, a key brain region essential for controlling voluntary movement, and the muscles. Weakening of these connections prevents effective activation of muscles and results in movement deficits, including partial or complete arm and hand paralysis.

To boost the activation of existing, but weakened, connections, researchers proposed to use deep brain stimulation (DBS), a surgical procedure that involves placing tiny electrodes in specific areas of the brain to deliver electrical impulses that regulate abnormal brain activity. Over the past several decades, DBS has revolutionised the treatment of neurological conditions such as Parkinson’s disease by providing a way to control symptoms that were once difficult to manage with medication alone. 

“DBS has been life-changing for many patients. Now, thanks to ongoing advancements in the safety and precision of these devices, DBS is being explored as a promising option for helping stroke survivors recover their motor functions,” said senior author Jorge González-Martínez, MD, PhD, neurosurgery professor at Pitt. “It offers new hope to millions of people worldwide.” 

Taking cues from another successful Pitt project that used electrical stimulation of the spinal cord to restore arm function in individuals affected by stroke, scientists hypothesised that stimulating the motor thalamus – a key relay hub of movement control – using DBS could help restore movements that are essential for tasks of daily living, such as object grasping. However, because the theory has not been tested before, they first had to test it in monkeys, which are the only animals that have the same organization of the connections between the motor cortex and the muscles as humans. 

To understand the mechanism of how DBS of the motor thalamus helps improve voluntary arm movement and to finesse the specific location of the implant and the optimal stimulation frequency, researchers implanted the FDA-approved stimulation device into monkeys that had brain lesions affecting how effectively they could use their hands. 

As soon as the stimulation was turned on, it significantly improved activation of muscles and grip force. Importantly, no involuntary movement was observed.

To verify that the procedure could benefit humans, the same stimulation parameters were used in a patient who was set to undergo DBS implantation into the motor thalamus to help with arm tremors caused by brain injury from a serious motor vehicle accident that resulted in severe paralysis in both arms.

As soon as the stimulation was turned on again, the range and strength of arm motion was immediately improved: The participant was able to lift a moderately heavy weight and reach, grasp and lift a drinking cup more efficiently and smoothly than without the stimulation.

To help bring this technology to more patients in the clinic, researchers are now working to test the long-term effects of DBS and determine whether chronic stimulation could further improve arm and hand function in individuals affected by traumatic brain injury or stroke.

Source: University of Pittsburgh