How to conduct trauma research with patients who cannot say yes – News

Written by Allie Hulcher
Media contact: Bob Shepard

UAB pioneered the use of social media to inform the public about an EFIC study. Imagine you become a trauma patient. It can happen to anyone. You could get into a car accident on your way to work. You could be hit by a stray bullet at a gas station. You could fall off a ladder while working on your house.

Next, imagine that local medical researchers are conducting a trauma research study and your injury entitles you. The study focuses on an intervention that could increase your chances of survival. The study could ultimately determine whether the intervention should become the standard of care for trauma patients like you, and thousands of lives could be saved.

But you’re bleeding profusely. You may be unconscious. First responders took care of you on site. Doctors work on you in the emergency room. You’re a good candidate for her trauma study. But you are incapacitated and cannot agree to participate in the study.

So how do researchers advance the fields of trauma and emergency medicine when dealing with a non-consenting population such as the United States? B. People suffering from traumatic injuries, stroke or cardiac arrest?

Enter a special type of study: the Exception from Informed Consent or EFIC study.

EFIC studies are used in cases of life-threatening illness or injury when the patient population being studied is unconscious or too ill to provide written or oral informed consent to participate in a study.

The federal rules for EFIC studies were developed in 1996. EFIC studies are conducted to the highest ethical standards and are reviewed by multiple agencies. Researchers must demonstrate that there is sufficient evidence that the study has the potential to bring real and direct benefit to the patient. The study must include the premise that the new treatment is better than the one currently available.

Patients will receive standard treatment in addition to research treatment, and research treatment must have shown promise in previous or smaller studies.

EFIC at UAB

Previous EFIC studies resulted in the placement of defibrillators in public facilities. One of the first EFIC studies, conducted at the University of Alabama at Birmingham, examined whether training volunteers in CPR and the availability of automated external defibrillators or AEDs in public areas would affect survival rates of patients with out-of-hospital cardiac arrest. Prior to this study, which began in 2000, this particular patient population was not the focus of research.

“For 30 years, we have not seen an increase in survival from out-of-hospital cardiac arrest,” said Shannon Stephens, executive director of the UAB Center for Injury Science, which conducts multiple EFIC studies. “Because we were able to study CPR and AED use through EFIC, we saw a nearly doubling of survival rates. Without EFIC studies, further development of clinical care in trauma and emergency medicine would not be possible.”

Today, AEDs are widely available and easily accessible in public spaces such as offices, schools, airports, and shops.

Innovation in community information: from town halls to social media

Before starting an EFIC study, the United States government requires participating institutions to complete a “community consultation and disclosure” process. The goals are to educate community members, invite them to ask questions and give their feedback, and give them the opportunity to opt-out of trauma research. Signing out includes wearing a bracelet in case the patient suffers a trauma injury.

“We take very seriously our commitment to engaging with community members for their feedback and input,” said Stephens. “This is a partnership between the community and the institution, and with any type of partnership, you need to hear from both sides.”

Researchers must meet a burden of proof, set at UAB by the UAB’s Institutional Review Board, that they have been adequately informed of the potentially affected population. As the only American College of Surgeons-verified Level I trauma center in Alabama, UAB has a service area large enough to include at least 16 counties and even other states if the injury is severe enough.

According to Stephens, these community consultations used to be associated with high effort and low payouts. He says many other trauma centers across the country will not conduct EFIC studies because of the costly and labor-intensive work of informing the community.

“That’s one of the reasons we haven’t seen the advances in trauma care that we need, because more sites aren’t willing to do that kind of research,” Stephens said.

UAB has done this work and invested hours and thousands of dollars to reach out to the community. Stephens has seen the poor returns firsthand in many cases: he attended community forums and Boy Scout meetings, and set up stalls in malls to spend little time with community members. Spend thousands of dollars buying billboards and TV, radio and newspaper ads without the ability to track exactly how many people viewed the information.

But using a method pioneered by Stephens, community consultation and public discourse can now take place online via targeted social media ads and websites. Certain population groups can be reached — such as people at higher risk of car accidents who live in commuter areas, people who live in areas with high gun violence, and older people who are likely to be on an anticoagulant and are therefore more likely to bleed after a fall.

And it works

The resulting data is extremely specific – how many people saw the ad, how many people clicked on the ad, how many people read the informational web pages, and for how long. And these people can be broken down by age and gender.

The first EFIC studies at the UAB, which used social media for community consultation, focused on one study examining continuous chest compressions for out-of-hospital cardiac arrest and another looking at crystalloid resuscitation for hemorrhagic shock concerned.

EFIC studies are permitted in situations where a patient is incapacitated and unable to consent.Stephens identified the areas and demographics he wanted to reach and created the Facebook ads and websites.

“We were blown away by the results,” Stephens said. “The UAB IRB was very receptive to this quantifiable data.”

Compared to a previous in-person campaign that cost $8,000 and reached 465 participants, the social media campaigns drove more than 1,000 webpage views for just $1,000 each. The ads for the social media campaigns were viewed millions of times.

Stephens published his findings in 2016, establishing UAB as a leader in this innovative type of community consulting. UAB has since been the lead center for a number of multi-center EFIC trials and has created the advertisements and websites for the other centers. This includes the upcoming TAP study, which will be the second largest trauma study ever conducted.

“We found a way to streamline the process, improve it, and make it easier to conduct these types of clinical trials,” Stephens said. “We’re really looking forward to that.”

“No stone is left unturned”

The therapies used in trauma clinical trials are already well-vetted by the FDA and have been shown to be effective—in specific settings and populations. EFIC studies examine whether the same intervention or drug works in a different subset of patients. For example, the TAP study will focus on whether a drug currently approved to reverse the effects of anticoagulants will benefit a broader trauma population by stopping major bleeding.

As another example, Stephens says tranexamic acid has not previously been used in the prehospital setting, but has been shown to help treat patients with hemorrhagic shock and traumatic brain injuries once the patients arrive at the hospital. Following positive results from an EFIC study, TXA is now available on most Alabama ambulances.

UAB Hospital currently has a 96 percent survival rate for trauma patients, and Stephens said UAB is always striving to improve the care it provides.

“If it were my family member or loved one in a trauma situation, I would want no stone unturned,” Stephens said. “I would want to give them every chance to survive.”

Stephens was a paramedic for 30 years. He says he’s “still a paramedic at heart,” but he finds the research fulfilling.

“Rather than treating one patient at a time, I see an opportunity to really advance trauma care in a way that can impact thousands or tens of thousands of lives a year,” Stephens said.

The Center for Injury Science was founded in 1999 and conducts research to improve trauma care. CIS’s mission is to advance injury prevention and improve injury outcomes at all stages of care, from the prehospital setting through resuscitation, acute care and rehabilitation. Clinicians of many specialties—including trauma surgeons, emergency physicians, anesthesiologists, critical care physicians, and rehabilitation specialists—work closely with epidemiologists, basic scientists, biostatisticians, health economists, health psychologists, and methodologists. Find out more about current EFIC studies taking place at UAB here. Unsubscribe from trauma research here.