Thursday, September 21, 2023

University of Pittsburgh launches trial tackling leading cause of death in kids

UNIVERSITY OF PITTSBURGH

Philip Spinella, M.D. — IMAGE: PHILIP SPINELLA, M.D., CO-DIRECTOR OF THE TRAUMA AND TRANSFUSION MEDICINE RESEARCH CENTER (TTMRC) IN THE DEPARTMENT OF SURGERY AT THE UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE AND AND PROFESSOR OF SURGERY AND CRITICAL CARE MEDICINE AT THE UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE. view more
CREDIT: UNIVERSITY OF PITTSBURGH

The No. 1 cause of death in children is trauma. There are an estimated 2,000 pediatric deaths from traumatic bleeding in the U.S. each year that are preventable with optimal care, yet there have been no large-scale clinical trials to guide the best way to resuscitate children with life-threatening bleeding from traumatic injury.

Until now.

The Trauma and Transfusion Medicine Research Center (TTMRC) in the Department of Surgery at the University of Pittsburgh School of Medicine is launching a clinical trial to simultaneously test multiple interventions for life-threatening bleeding in at least 1,000 traumatically injured children across 20 U.S. pediatric trauma centers. Funded by the Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health & Human Service, the trial has a budget of $34 million for the first five years, with the possibility to increase to more than $81 million.

“This trial will be transformative when it comes to trauma care for children,” said trial co-principal investigator Philip Spinella, M.D., co-director of the TTMRC and professor of surgery and critical care medicine at Pitt. “Not only is trauma the leading cause of death in kids, their mortality rate with life-threatening bleeding is almost twice that of adults. And we think that’s because of delay in recognition and treatment, not that children are less resilient.”

The Massive Transfusion in Children-II (MATIC-II) is the first randomized trial to use an approach known as a “platform trial” in traumatically injured children or adults. Typical trials compare only one intervention to standard care, but, in practice, doctors give multiple therapies and drugs at the same time. Platform trials test multiple therapies at once against standard of care, which allows scientists to determine which bundle of care is most effective and safe. Platform trials also allow scientists to change the study interventions based on data collected during the trial. A platform trial can adapt to either add or remove treatments to determine the bundle of care that best improves outcomes.

“Pediatric trauma research is decades behind trauma research in adults,” said trial co-principal investigator Christine Leeper, M.D., assistant professor of surgery and critical care medicine at Pitt and trauma surgeon and intensivist at UPMC. “In the time it takes to run a traditional trial, new therapies are introduced while others fall out of favor, so the platform design of MATIC-II will ensure the newest and best therapies are put into practice quickly in order to save lives and help close this knowledge gap.”

When blood is donated, it is typically divided into three parts: red blood cells, platelets and plasma. Patients experiencing massive bleeding usually need all of those components, so clinicians have to put the blood back together – and that reassembly can dilute the products and make them less effective. Research is increasingly indicating that “whole blood” – blood that was never divided into components after donation – may improve survival and reduce the total amount of blood needed in patients with life-threatening traumatic bleeding.

MATIC-II will study the efficacy and safety of whole blood, individual blood components and tranexamic acid, which promotes clotting to stop bleeding, compared with a placebo in newborns up to 18-year-olds with trauma and life-threatening bleeding. Four combinations – tranexamic acid with whole blood, whole blood with a placebo, component blood with a placebo and component blood with tranexamic acid – will be tested, with each of the 20 participating children’s hospitals rotating through the combinations throughout the trial. Each of these therapies are used clinically in children with trauma and life-threatening bleeding, but they haven’t been tested either in isolation or as combination therapy.

The trial will compare all the combinations to determine which one results in the best patient survival after 24 hours and 28 days. The scientists also will do additional studies to better understand a condition known as trauma-induced coagulopathy, which occurs when the blood fails to properly clot. With Angelo D’Alessandro, Ph.D., professor of biochemistry and molecular genetics at the University of Colorado, the team will determine if there are differences in how the children respond to the interventions. This will form the basis for developing a precision transfusion medicine approach to hemorrhagic shock in children.

“I’m particularly excited about the studies we have planned with Dr. D’Alessandro,” said Spinella. “Just like all cancers aren’t the same, all traumas aren’t the same. Different people and types of trauma respond differently to treatments due to biological factors that we could potentially address to improve outcomes.”

Because emergency trauma care cannot be paused for parents to consent for their children to be in the trial, MATIC-II will have an exception from informed consent protocol that has been approved by an ethics board and the U.S. Food & Drug Administration. Patients will be given the trial treatment, and, once the child is stabilized, the parents will be informed about the trial and their questions will be answered. Parents can then decide whether to give permission for continued participation or remove their child from the trial. Parents can also opt out of having their child in the trial by requesting a special bracelet that will alert emergency clinicians not to use the trial protocol. More information on that will be made available to the public by the investigators before the trial starts.

This project has been funded in whole with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00047.

The Massive Transfusion in Children-II (MATIC-II) is the first randomized trial to use an approach known as a “platform trial” in traumatically injured children or adults.
CREDIT
University of Pittsburgh

Christine Leeper, M.D., assistant professor of surgery and critical care medicine at the University of Pittsburgh School of Medicine and trauma surgeon and intensivist at UPMC
CREDIT
UPMC

Study shows simulator, combined with app, helps teachers correct mistakes before entering classroom

Results show with data, future educators improve practices before leading students on own

Peer-Reviewed Publication

UNIVERSITY OF KANSAS

LAWRENCE — When pilots, surgeons or others with high-stakes professions are learning their craft, they have simulators with which to practice. Now, a new study shows that a simulator, when combined with software to provide data on performance, can help teachers learn what mistakes to avoid before working with working in a real classroom.

A new study co-written by a researcher from the University of Kansas examined TeachLivE, or TLE, a simulator that allows pre-service teachers to deliver lessons in front of a virtual classroom of avatars. The avatars represent a diverse background of students with various personalities and academic skill levels. The simulator was combined with SeeMeTeach, or SMT, a recently developed web-based teacher observation app that provides real-time data on teacher performance. The results showed the simulation experience combined with personalized feedback data can support teachers’ practice of skills of their profession free of judgment while improving their performance.

The study, co-written with researchers Craig Berg and Raymond Scolavino from the University of Wisconsin-Milwaukee, was published in the journal Education Sciences. Co-author Lisa Dieker, Williamson Family Distinguished Professor in Special Education at KU, said the use of a teaching simulator can help future educators learn from their mistakes before leading a classroom of their own.

“We humans make mistakes, especially the first time we do things, and unfortunately for teachers, those mistakes are made on children,” Dieker said. “We want to ask, ‘How can we use this combined technology for developing targeted skills and helping teachers make the changes necessary?’ If you’re going to have a crash landing, let’s have it in front of an avatar.”

The mixed-reality technology features avatars that operate via AI combined with a human-in-the-loop as a user practices delivering lessons, calling on students, detecting inappropriate behavior and more. That is combined with a human user who can provide responses from students, based on the nuance of the situation and the users’ performance. SMT gathers real-time data on the teacher such as how many times they call on a certain student, how long they provide wait time for an answer and what section of the classroom draws the most attention.

Study results showed that users of the combined simulator and teaching data app used the data and feedback they gained to avoid repeating mistakes and even showed “teaching fingerprints,” or bodies of data on what they did right, and their strengths that indicated a unique teaching style.

Teacher training has traditionally relied on observation and written and verbal feedback. That method has stood the test of time, but the authors said it can be supplemented with technology that provides specific data about their performance.

“When teachers get specific information in the simulator, it not only helps them change their behaviors but to understand why they should,” Dieker said. “This work allows a lot of empowerment of the individual without being judgmental.”

The study found that teachers offering even a 15-minute lesson to avatars in TLE showed enough variation in how they interacted with student avatars to provide practice opportunities in a low-risk setting. And the data provided by the SMT app showed to be effective in helping them avoid repeating mistakes and taking lessons learned into practice. That can help all teacher educators achieve their goal of preparing great teachers who can provide students their best possible experiences from the beginnings of their careers, researchers said.

Dieker plans to continue researching ways teaching simulators and technology can help educators hone their craft before entering classrooms. That can prove especially important to students with novice teachers.

“A teacher can make or break your future,” Dieker said. “All other simulators take a logical, linear pathway. This simulator can do things you can’t through methods like role play or classroom observation. I want to help make a first-year teacher look like a third-year. Our most vulnerable students often have new teachers. I am confident emerging technology in simulation, artificial intelligence, biometrics and neurophysiological data collection can help us understand the differences between expert and novice teachers to better prepare and support all teachers.”

JOURNAL

Education Sciences

DOI

10.3390/educsci13070744

METHOD OF RESEARCH

Data/statistical analysis

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Using a Virtual Avatar Teaching Simulation and an Evidence-Based Teacher Observation Tool: A Synergistic Combination for Teacher Preparation

The secret to good schools: Try, try again

Justin Reich’s new book, “Iterate,” explains how education gets better through incremental improvements

Book Announcement

MASSACHUSETTS INSTITUTE OF TECHNOLOGY

Iterate Book — IMAGE: IN HIS NEW BOOK “ITERATE,” MIT ASSOCIATE PROFESSOR JUSTIN REICH CONTENDS THE KEY TO IMPROVEMENT IN SCHOOLS IS MODEST-SIZED, INCREMENTAL CHANGES THAT CAN BE REPEATEDLY REFINED. view more
CREDIT: PHOTO: ROBIN HENSON

With a new academic year under way in the U.S., imagine you have been named superintendent of your local public school district. What changes would you make? How would you make them?

That second question matters greatly. Despite supposedly stark differences among people, data show that most U.S. parents like their local public schools. At issue is not so much a shared vision — students pursuing excellence in a good environment — but how to enact it in busy, complex school districts.

To MIT Associate Professor Justin Reich, an expert on educational innovation, there are right and wrong approaches to improving schools. It is best, Reich believes, to pursue tightly focused sets of classroom changes, see how they work, refine them, and then refine them some more.

“There’s not usually one blockbuster idea that makes schools better,” says Reich, director of MIT’s Teaching Systems Lab. “When schools do get better, it’s because they do 100 things a little more right each time.”

Reich, also a faculty member in MIT’s Program in Comparative Media Studies/Writing, has made this insight the focus of a new book, “Iterate: The Secret to Innovation in Schools,” published by Jossey-Bass. In it, he sets out a series of principles educators can use to make changes, focused on relatively shorter-term, repeatable experiments.

Reich’s perspective is akin to that of software firms who keep upgrading their products, or Toyota’s famous practice of “continuous improvement.” To be sure, schools are not writing code or making Corollas, but by being open to input and working constructively with teachers, Reich thinks educational leaders can effectively keep their schools moving forward.

“We can make schools better by bringing an iterative, design-oriented mindset to them, while also thinking about the particular challenges educators face,” Reich says.

Try short cycles of improvement — then try them again

“Iterate” draws on the roughly two decades of experience Reich has accumulated, not only as a scholar but as a high school teacher, consultant, and founder of the firm EdTechTeacher. Making innovation iterative, it happens, meshes with the fact that most parents believe their kids are in good schools. It’s likely your district needs less a complete overhaul and more a sustained effort at continuous, incremental improvements.

“The vast majority of parents are shockingly, overwhelmingly, satisfied with their local public schools — they are happy, and believe the instruction aligns with their family’s values,” Reich observes.

Still, things can always get better, and Reich suggests some core ideas for academic innovation. Educators should “think in cycles and spirals,” he writes in the book, which “let us regularly return to the framing of our problems as we design and test new solutions.” Relatedly, Reich writes that schools should “act in short design spirals,” to provide more chances to improve. That also means testing concrete plans, not overly broad goals such as giving “21st-century skills” to students.

“That’s too much to think about,” Reich says. Instead, schools can implement focused programs about, for instance, better executive functioning for students, or improved ways of analyzing evidence. Or they can test new curricula or learning methods.

The key, Reich says, is that “Everybody on the faculty can see themselves doing it, and you can work on it for two to five years and get better at it.”

And yes, developing those plans should occur in concert with the teaching faculty. A core point in “Iterate” is, Reich says, “if you ask teachers who has the most influence on their practice, the number one influence is other teachers. If you want a new practice to be adopted in a school setting, you have to create the conditions for peer learning [among teachers].” In other words, don’t impose ideas upon teachers; work with them.

Of course, in a community of teachers, parents, and students, not everyone will agree with every proposed change. But smaller, iterative changes may seem more palatable and can allow for more people’s ideas to be tested.

“If you can set up approaches to design that feel small and light and doable, then it’s not that painful to test these things,” Reich says. “It makes experimentation easiser to swallow.”

And, Reich adds, citing an idea he credits to MIT Senior Lecturer Peter Senge: “We don’t have to come to consensus to keep moving forward. If you watch a really good basketball team or a set of dancers, they may not all agree about everything, but they have alignment. In communities we can have that too. The way to resolve disagreements is to not spend forever talking about them, it’s to design and test so that some resolutions to those disagreements emerge.”

Because they work

In that vein, to help schools succeed, administrators, teachers, and even librarians must sometimes not only focus on internal plans, but engage with external voices, often related to larger culture wars. Despite the broad public satisfaction with public education, Reich notes, “We are in a moment where a minority of parents, and nonparents, are attacking schools in various ways and making their day-to-day operations harder.”

To deal with this, he says, “When you get people into the details of what’s going on, it tends to defuse disagreements. People disagree more in the abstract.” Still, Reich adds, “Schools can’t solve all of these problems on their own. The majority of parents who are happy with the performance of their public schools need to spend more time in active support to prevent their schools from getting damaged. People have to stand up and get engaged.”

Other educational experts have praised “Iterate.” Sam Seidel, the K12 Lab Director of Strategy and Research at Stanford University’s d.school, has said the book is “packed with thoughtful perspectives, real stories, and actionable approaches for how we can create the conditions for positive change in schools.”

For his part, Reich emphasizes that the ideas in “Iterate” are not merely drawn from his own experiences, but borne out in the research of the MIT Teaching Systems Lab, where many researchers and students have studied the evolution of schools and the best mechanisms for helping educators to adapt.

“We’re advocating for these practices not because we’re looking for random things for schools to do, but because they work,” Reich says. “I hope for educators it will help give them confidence that these are good things to try, because they’re well-established, and from a place that’s pretty good at imagining the future.”

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Written by Peter Dizikes, MIT News

Book: “Iterate: The Secret to Innovation in Schools”

https://iteratebook.com/

AI helps bring clarity to LASIK patients facing cataract surgery

Scientists develop computer models of patients’ eyes to identify the ideal intraocular lenses and visual simulators for patients to experience how they will see with them

Peer-Reviewed Publication

UNIVERSITY OF ROCHESTER

Susana Marcos Lab — IMAGE: SUSANA MARCOS, THE DAVID R. WILLIAMS DIRECTOR OF THE CENTER FOR VISUAL SCIENCE AND THE NICHOLAS GEORGE PROFESSOR OF OPTICS AND OF OPHTHALMOLOGY, SAYS THE COMPUTATIONAL SIMULATIONS DEVELOPED BY ROCHESTER RESEARCHERS PROVIDE SURGEONS WITH IMPORTANT GUIDANCE ON THE EXPECTED OPTICAL QUALITY FOR LASIK PATIENTS AFTER CATARACT SURGERY. view more
CREDIT: UNIVERSITY OF ROCHESTER PHOTO / J. ADAM FENSTER

While millions of people have undergone LASIK eye surgery since it became commercially available in 1989, patients sometimes develop cataracts later in life and require new corrective lenses to be implanted in their eyes. With an increasing number of intraocular lens options becoming available, scientists have developed computational simulations to help patients and surgeons see the best options.

In a study in the Journal of Cataracts & Refractive Surgery, researchers from the University of Rochester created computational eye models that included the corneas of post-LASIK surgery patients and studied how standard intraocular lenses and lenses designed to increase depth of focus performed in operated eyes. Susana Marcos, the David R. Williams Director of the Center for Visual Science and the Nicholas George Professor of Optics and of Ophthalmology at Rochester, says the computational models that use anatomical information of the patient’s eye provide surgeons with important guidance on the expected optical quality post-operatively.

“Currently the only pre-operative data used to select the lens is essentially the length and curvature of the cornea,” says Marcos, a coauthor of the study. “This new technology allows us to reconstruct the eye in three dimensions, providing us the entire topography of the cornea and crystalline lens, where the intraocular lens is implanted. When you have all this three-dimensional information, you’re in a much better position to select the lens that will produce the best image at the retinal plane.”

The future of optical coherence tomography

Marcos and her collaborators from the Center for Visual Science, as well as Rochester’s Flaum Eye Institute and Goergen Institute for Data Science, are conducting a larger study to quantify in three dimensions the eye images using the optical coherence tomography quantification tools they’ve developed to find broader trends. They are using machine-learning algorithms to find relationships between pre- and post-operation data, providing parameters that can inform the best outcomes.

Additionally, they have developed technology that can help patients see for themselves what different lens options will look like.

“What we see is not strictly the image that is project on the retina,” says Marcos. “There is all the visual processing and perception that comes in. When surgeons are planning the surgery, it is very difficult for them to convey to the patients how they are going to see. A computational, personalized eye model tells which lens is the best fit for the patient’s eye anatomy, but patients want to see for themselves.”

With an optical bench, the researchers use technology originally developed for astronomy, such as adaptive optics mirrors and spatial light modulators, to manipulate the optics of the eye as an intraocular lens would. The approach allows Marcos and her collaborators to perform fundamental experiments and collaborate with industry partners to test new products. Marcos also helped develop a commercial headset version of the instrumentation called SimVis Gekko that allows patients to see the world around them as if they had had the surgery.

In addition to studying techniques to help treat cataracts, the researchers are applying their methods to study other major eye conditions, including presbyopia and myopia.

With an optical bench, researchers from the University of Rochester's Center for Visual Science use technology originally developed for astronomy, such as adaptive optics mirrors and spatial light modulators, to manipulate the optics of the eye as an intraocular lens would.

Susana Marcos, the David R. Williams Director of the Center for Visual Science and the Nicholas George Professor of Optics and of Ophthalmology, working in her lab with postdoctoral researcher Sara El Aissati. At computer is Aina Turull, visiting optical engineering student from Universitat Politècnica de Catalunya.

CREDIT

University of Rochester photo / J. Adam Fenster