CHOC-UCI origami mask project gets some national attention

Back in the early days of the COVID-19 pandemic, in late March 2020, Jonathan Realmuto, a visiting scientist at CHOC and a postdoctoral researcher at UC Irvine, got a call from his lab leader, Dr. Terence Sanger.

Dr. Sanger, a physician, engineer, and computational neuroscientist who joined CHOC in January 2020 as its vice president of research and first chief scientific officer, was concerned about the possibility of CHOC running out of masks for its frontline healthcare workers.

“Could you please think about this problem and see if you can come up with a solution just in case the supply runs out?” Dr. Sanger asked Realmuto, who has a Ph.D. in mechanical engineering and whose expertise is wearable robotics, which help people regain and strengthen their movements.

Dr. Terence Sanger, chief scientific officer at CHOC

Since September 2017, the two had been working together after Realmuto earned his doctorate degree from the University of Washington.

Thus began the UCI Face Mask Project, a collaboration between Dr. Sanger and Realmuto that grew to a team of five that includes two other UCI professors, aerosol chemist Jim Smith and environmental toxologist Michael Kleinman, and Michael Lawler, an atmospheric chemist and assistant project scientist who works in Smith’s lab.

The work of the UCI Face Mask Project ultimately led to the creation of what experts call a mask for the masses — an inexpensive face covering that takes its cues from origami, the art of paper folding closely associated with Japanese culture.

No sewing is needed to make the origami mask – just a filter material that can be purchased at a craft or hardware store, a stapler, two elastic straps, and a nose clip fashioned from a metal wire such as a twist tie.

Illustrated directions for creating the origami mask

Realmuto was among several origami mask experts recently featured in a National Geographic story that highlights the inexpensive (less than $1 of materials per mask), disposal masks that can be made by anyone after a little practice. The story details how origami pleats and interlocking folds can result in better-fitting, more comfortable, and more stylish face coverings.

Dr. Sanger, who served in an advisory capacity on the UCI Face Mask Project, played a “very critical role” in developing the mask, which has not been mass produced but was designed in case there is a shortage of face coverings such as N95 masks, the gold standard at preventing expelled air leakage during coughing.

“CHOC and UCI were one of the first out of the gate to work on this,” says Realmuto, who with his colleagues has written a paper, “A Sew-Free Origami Mask for Improvised Respiratory Protection,” that details the research that went into the project.

The team put several masks through rigorous testing using a custom-made mannequin head equipped with a breathing tube and mounted inside a chamber.

The team concluded, in the paper they plan to get reviewed by peers and published, that origami masks combine high filtration efficiency with ease of breathing, minimal leakage that can dramatically reduce overall mask performance, and greater comfort compared to some commercial alternatives.

Because of this, origami face coverings are “likely to promote greater mask-wearing tolerance and acceptance,” the researchers concluded in their paper.

Says Realmuto: “Origami presents this really nice solution where you can use the folds as a way to make seams that won’t leak.”

The team produced a how-to video starring Realmuto, who shows how to construct the single-use masks. They tested a variety of materials that have an inner layer of non-woven polypropylene that can be easily and rapidly sourced locally from a hardware or craft store, in addition to a material made by Filti that can be purchased through the manufacturer.

“For a novice without prior experience,” they write, “construction takes approximately 10 minutes. In our experience, practice decreases assembly time to under five minutes.”

Dr. Sanger and Realmuto have collaborated on another unrelated project that earned them accolades. That project involved developing a non-rigid forearm orthosis – a brace to correct alignment or provide support – to help make it easier for people with movement disorders such as cerebral palsy to feed themselves, open doors, and complete other daily tasks. Their work made them finalists in the Best Paper category at the 2019 Institute of Electrical and Electronics Engineers (IEEE) Conference on Soft Robotics.

In July 2021, Realmuto will become a full-time assistant professor in the Department of Mechanical Engineering at UC Riverside. He says he hopes to maintain his collaboration with Dr. Sanger and CHOC on future projects.

“It’s been a great partnership,”Realmuto says.

For more information about the UCI Face Mask Project, click here.

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CHOC studies child maltreatment during COVID-19, adopts new tools to better recognize signs of abuse

With COVID-19 restrictions keeping more families at home, a critical question has emerged:

Are children suffering more physical and emotional maltreatment because they’re spending more time with parents who are dealing with extra stress in their lives?

A recently completed study by clinicians in the Julia and George Argyros Emergency Department at CHOC Hospital sheds some light on whether child abuse cases are rising because of stay-at-home orders. The study comes as CHOC ED personnel are using two new screening tools to help clinicians better recognize signs of abuse as well as victims of human sex trafficking.

COVID’s effect on child maltreatment

CHOC ED personnel studied whether the incidence of child maltreatment – which includes physical, sexual and emotional abuse, plus neglect – among patients being admitted to the emergency department has risen since the pandemic began in mid-March 2020.

They reviewed records of ED visits of patients up to 18 years old during a 3 ½-month period from March to July 2020 and reviewed the Child Protective Services database, then compared that period to the same time frame in 2019, 2018 and 2017.

Result: More reports of child mistreatment – 215 – were filed during the COVID-19 pandemic, compared to 204 during the same period in 2019, 199 in 2018 and 158 in 2017.

This is especially significant because CHOC’s ED has experienced a significantly lower ED patient census during the pandemic compared to pre-COVID days, says Dr. Mary Jane Piroutek, a CHOC ED attending physician.

Dr. Mary Jane Piroutek, CHOC ED attending physician

While sexual and physical abuse cases were down in the 3 ½-month period in 2020, cases of general neglect and medical neglect, as well as emotional abuse, were higher during COVID compared to the previous years.

Erika Jewell, manager of Case Management and Social Services at CHOC, put some of these numbers in context. In 2017, she reports, the rate of children in Orange County suffering abuse or neglect was 43.8 per 1,000, compared to 33.5 in 2012.

Of the 4,451 substantiated case of child abuse and neglect in Orange County in 2017, the vast majority – 3,204 – were cases of general neglect. Sexual abuse cases, in comparison, totaled 191.

“Our findings suggest the incidence of child neglect increased during the implementation of the stay-at-home guidelines,” says Dr. Piroutek, who spoke with Jewell and others on a panel on Research Day on Nov. 18, 2020.

Knowledge of such a trend, Dr. Piroutek explains, could help providers identify children at risk for maltreatment and, ultimately, provide an impetus to shape public policy and to improve the effectiveness with which resources are allocated to address the COVID-19 public health crisis.

Two new screening tools

Beginning in October 2019, the CHOC ED rolled out the first of two new screening tools aimed at making it easier for nurses and doctors to better identify patients at risk of abuse.

The first new screening tool being used in CHOC’s ED is TRAIN, for Timely Recognition of Abusive Injuries Collaborative. It is used to screen patients 6 months and younger.

The second screening tool, launched in July 2020, is CA-CDS, for Child Abuse – Clinical Decision Support. It is used to screen patients 11 years or younger. Components include a triage screen where nurses or doctors answer five questions, a pop-up computer alert that flags which patients may be at risk for physical abuse, a link to order sets and CHOC’s computerized suspected child abuse form.

With these two new tools, the CHOC ED estimates it can detect 50 percent more sentinel injuries than before. A sentinel injury is a seemingly trivial one that can be viewed as a “sentinel event” for much worse injuries in the future. Research shows that one-quarter of abused children had previous sentinel injuries.

The ED is collecting data through December 2021 to evaluate how well the new screening tools are helping healthcare workers detect cases of maltreatment, Dr. Piroutek says.

“It’s a more data-based and methodical approach; you have a computer that’s looking at data and flagging concerning patterns for you: ‘Hey, there’s something that might be abuse here,’” Dr. Piroutek explains.

The new screening tools will help CHOC better comply with treatment guidelines set forth by the American Academy of Pediatrics (AAP), Dr. Piroutek notes.

“CHOC is committed to research for the betterment of our patients and children,” Dr. Piroutek says. “With the implementation of these new screening tools I am confident we can provide the best care for our patients.”

Screening for human sex trafficking has also become an important part of CHOC nursing care.

Sheryl Riccardi, Emergency Department manager at CHOC, says a steering group of about 20 associates has been established to help healthcare workers better identify, intervene and advocate for these victims, many of whom are minors and most of whom come from the Unites States.

Santa Ana is the largest hub of human sex trafficking in the state, she notes. The ED has begun screening 12- to 18-year-olds – regardless of their chief complaint for possible further evaluation – if a child reports a complaint indicating a high risk of abuse, Riccardi says.

CHOC, she adds, recently became a partner with the Orange County Human Trafficking Task Force, a law enforcement-led coalition that is committed to combating all forms of human trafficking through the rescue and long-term support of victims, prosecution of offenders, training of fellow law enforcement professionals, community awareness and effective public/private partnerships.

According to Waymakers and the Salvation Army, in 2019 there were 415 identified victims of human trafficking in Orange County, with sex trafficking victims totaling 359. The other victims were trafficked for labor.

CHOC is determined to do what it can to find and help these victims.

“We’ve very passionate about this,” Riccardi says.

Learn more about how to identify child abuse.

Seminal study of COVID-19 infections at Orange County schools nears completion

Two doctors – one a rising star in infectious disease research, the other a nationally known pediatric pulmonologist – are nearing completion of a seminal study on COVID-19 transmission at four Orange County schools and how closely students and staff are following mitigation procedures such as wearing face coverings.

The doctors believe the study is the first of its kind in the country, and that it could shed light on such critical issues such as the role that kids play in the spread of SARS-CoV-2, the novel coronavirus that has led to the deaths of some 300,000 Americans and counting.

“We’ll never understand COVID-19 disease until we understand it in children,” says Dr. Dan Cooper, who treats kids with lung conditions at CHOC and who serves as director of UC Irvine’s Institute for Clinical & Translational Science.

Dr. Cooper was reiterating a comment made by UCI colleague Dr. Donald Forthal, chief of the Division of Infectious Diseases at the university, in the early stages of the pandemic.

Dr. Cooper is a multiple principal investigator of the O.C. school study along with Dr. E.R. Chulie Ulloa, a CHOC infectious disease specialist and an assistant professor in the Department of Pediatrics at the UCI School of Medicine.

Drs. Coopers and Ulloa provided an update on their novel study of four O.C. middle and high schools during a recent presentation on Research Day. The study, a partnership of CHOC, UCI Health and the Orange County Health Care Agency, began at the end of October and will conclude before Christmas.

Results are expected during the first quarter of 2021.

“We understand little about the immune responses to COVID-19 in children, but hopefully we’ll be able to shed some light with this study,” Dr. Ulloa says.

Vaccinations in adult U.S. healthcare workers began in mid-December at a time when the country remains in the grips of a terrible increase in COVID-19 infections and deaths – the dreaded “second surge” healthcare experts predicted would happen this winter.

“We’re just beginning to understand and accumulate the knowledge we need to eventually make definitive statements about SARS-CoV-2 transmission in children,” Dr. Cooper says. “This information will ultimately inform decisions around vaccinations in the pediatric population.”

PRELIMINARY RESULTS

Although the numbers continue to increase as the study nears completion, as of mid-November — when Drs. Cooper and Ulloa provided their update on Research Day — 187 students and 100 staff members at four demographically diverse schools had undergone nasal-swab tests, with none testing positive for COVID-19, Dr. Ulloa reported.

Additionally, nearly 90 percent of those students agreed to have their blood drawn to check for antibodies that showed they had been exposed to the novel coronavirus. The positivity rate for those tests came back at 8.5 percent.

This number is encouraging, Dr. Ulloa says. She explains that nearly all these COVID-19 antibody-positive students were completely asymptomatic or mildly symptomatic.

“We’re not sure yet if this positivity rate shows that children do indeed have protection (against COVID-19), but it’s certainly a positive sign,” Dr. Ulloa says. “We will conduct more research in the lab to see if those antibodies are able to neutralize or inhibit the replication of the virus.”

The preliminary results of the study – which involves students from a charter school and a public school in Santa Ana, a charter school in another city that primarily serves students with special needs and a private school elsewhere whose students come from middle- to upper-class families – suggests that children likely are not super-spreaders of COVID-19, Dr. Cooper says.

“We still don’t know why that appears to be the case,” he says.

In addition to testing for COVID-19 with the nasal swabs, the school project team – which includes a total of nearly two-dozen people – also is testing for 21 other respiratory infections, such as the common cold, in the students. The thinking is that these additional tests will help determine how well students are following COVID-19 mitigation measures such as social distancing and frequent washing of hands – which should help prevent them from catching many viral diseases.

“We hope to be able to see if there’s a relationship between how well the school is able to put into place mitigation procedures and the degree of viral infection,” Dr. Cooper notes.

The pool of students involved in the research project has expanded to kids ages 7 to 17, from ages 10-15 at the onset. Dr. Cooper points out although data are accumulating through public health agencies on SARS-CoV-2 in school-aged children, there are few, if any studies like this one that involves students and school staff as research volunteers and who must consent to participate. These types of studies can often add to our knowledge of disease to a much greater extent than simple descriptions of ongoing data, he says.

“In addition, we’re capturing data from an age group that hasn’t been involved in vaccine clinical trials before,” Dr. Ulloa adds, “and these data may shed light on efforts to test COVID-19 vaccines in the future.”

Drs. Cooper and Ulloa both praised the cooperation of school officials and students in allowing them to carry out this seminal study, in which participants also receive free of charge a complete blood count to check for anemia and a full lipid screening to check the amount of cholesterol and triglycerides in their blood.

“In order to pull this off,” Dr. Cooper says, “we had to have very close relationships with the schools, with the parents, and with the kids.”

Dr. Ulloa’s fluency in Spanish and leadership has helped a lot, he says. So has her serving as a strong pediatrician-scientist role model for the children.

“We’ve really been active in the community for a while, which has helped establish trust,” Dr. Ulloa says.

Dr. Cooper notes that the school research team already is talking to the National Institutes of Health about putting together a project to follow middle- and high-school kids who are infected with the coronavirus over the next five years to determine the long-term effects on such things as cognitive development and the role of exercise in keeping the disease in check.

Pandemic has provided lessons on continuing research during a crisis

COVID-19 has been a tragic wrecking ball on several fronts, but something that isn’t mentioned much is clinical research.

Long a linchpin at CHOC and, moving forward, poised to become even more central as CHOC evolves into a leading pediatric health system, clinical research has had to quickly readjust under the strain of the pandemic.

But out of these dark days have emerged several lessons on not only how to continue research during a crisis, but how to keep it thriving.

That was a key message delivered by Phuong Dao, director of Research Operations at CHOC, during a recent webinar beamed around the country.

Phuong Dao, director of research operations at CHOC

“There’s a renewed sense of energy and purpose to use science to solve problems that are important to our patients and the public,” Phuong said during a panel discussion that was part of a two-week summit on rare diseases hosted by Global Genes, an Aliso Viejo-based non-profit that advocates for the rare disease community.

“I think we can really harness and leverage this shared renewed energy and translate that to the conducting of rare-disease trials,” Phuong said.

The panel, speaking on “Proactive Planning for Continuity of Research During a Crisis,” also featured moderator Nina Wachsman, founder and president of Augur Health, a New York-based clinical research recruitment firm, and Gerald Mosely, founder and principal of CP&P Development, a Sacramento-based specialty consulting firm focused on pharmaceutical sales and operations.

Wachsman laid out some realities hospitals face during COVID-19:

  • Less access to doctors and inpatient visits
  • Less interest in research into rare diseases
  • An explosion in telehealth visits
  • E-signatures for informed consent
  • Nurse home visits
  • Lab tests done remotely

As for clinical research, Wachsman said, challenges include a lack of available capital, a lack of access to enough clinical trial participants and the ability to retain them, and getting the attention of the FDA at a time when COVID-related studies dominate.

And in a world of virtual meetings, Mosely noted, effective teamwork can be a challenge.

“The people aspect is what can make or break things,” Mosely said. “Successful outcomes can be affected more by interpersonal than technical skills.”

But bright spots abound, Phuong said.

COVID-19 studies can serve as a template for clinical research well beyond the end of the pandemic. “We have seen study teams form quickly and multi-disciplinary teams mobilize,” she said.

The contracting and budgeting processes for COVID-19 studies have accelerated and teams involved in “master trial protocol” studies involving multiple hospitals have readily shared resources, when in the past there were more hurdles.

“This focus on leaner and faster clinical trials can be leveraged in the rare disease space as well,” Phuong said.

Other positive changes introduced during the pandemic that can affect all clinical trials moving forward include:

  • Fast tracking by the Institutional Review Board (IRB)
  • The acceptability, and patient popularity, of telehealth
  • Home-based testing and monitoring technologies
  • Curbside/courier pick-up and delivery of participant samples and investigational products
  • Digital data collecting tools
  • Remote Site Initiation Visits (SIVs) and monitoring
  • Less reliance of participants having to be on site

Phuong noted that clinical trials involving kids impact entire families, one of the things that makes pediatric research different from studies involving adults.

The consenting process is unique, she added, and some teenagers who still are minors sometimes have a different opinion from their parents when it comes to treatment plans.

Moving forward with telehealth, Phuong said, clinicians need to think about how to engage with study participants in the languages they understand best.

And there are other questions that need to be addressed, including:

  • How research should be structured to adapt to new realities
  • How to keep motivation high to conduct clinical studies into rare diseases
  • How virtual meetings and healthcare visits affect productivity

“I hope that we sustain the gains we have made to move toward more efficiently and that we are able to approach clinical research in ways that are more streamlined and modernized,” Phuong said.

To learn more about CHOC’s Research Institute, click here.

Virtual pediatric lecture series: COVID-19 in children

The CHOC virtual pediatric lecture series continues with a session on COVID-19 in children.

This online discussion will be held Thursday, Oct. 15 from 12:30 p.m. to 1:30 p.m. and is designed for general practitioners, family practitioners and other healthcare providers.

Dr. Antonio Arrieta, medical director of pediatric infectious disease at CHOC, and Dr. Jasjit Singh, assistant medical director and medical director of infection prevention and control, will present information on COVID-19 in children and the world of infectious disease. Particular focus will be given to counseling patients about the importance of influenza and other routine vaccines this fall. Given the current pandemic and concerns that flu season may exacerbate it, this timely lecture is ideal for providers looking to address preventative matters with patients.

This virtual lecture is part of a series provided by CHOC that aims to bring the latest, most relevant news to community providers. You can register here.

CHOC is accredited by the California Medical Association (CMA) to provide continuing medical education for physicians and has designated this live activity for a maximum of one AMA PRA Category 1 Credit™.

Please contact CHOC Business Development at 714-509-4291 or BDINFO@choc.org with any questions.