How to conduct trauma research with patients who can’t say yes – News


Social media has been a useful tool to inform a community about research studies that are exempt from informed consent protocols.

Written by: Allie Hulcher
Media Contact: Bob Shepard

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

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

But you are bleeding profusely. You may be unconscious. First responders attended to you at the scene. The doctors are working on you in the emergency department. You’re a good candidate for their trauma study. But you are unable and cannot give your consent to participate in the trial.

So how do researchers advance the fields of trauma and emergency medicine when dealing with a population who cannot give consent, such as those who suffer a traumatic injury, accident stroke or cardiac arrest?

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

EFIC trials are used in cases of a life-threatening illness or injury when the patient population being studied is unconscious or too ill to provide written or verbal informed consent for enrollment in a trial.

Federal rules for EFIC trials were developed in 1996. EFIC studies are held to the highest ethical standards and are subject to scrutiny by multiple agencies. Researchers must demonstrate that there is reasonable evidence that the study has the potential to provide real and direct benefit to the patient. The study should assume that the new treatment is better than what is currently available.

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


EFIC inside 2Previous EFIC trials have led to the placement of defibrillators in public places. One of the first EFIC trials 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 spaces would affect patient survival rates cardiac arrest victims outside the hospital. Prior to this trial, which began in 2000, this specific patient population had not been researched.

“For 30 years, we’ve never seen an increase in out-of-hospital cardiac arrest survival rates,” said Shannon Stephens, executive director of UAB’s Center for Injury Science, which conducts multiple EFIC trials. . “Because we were able to study the use of CPR and AED through EFIC, we saw a nearly doubling of the survival rate. Without EFIC trials, advancing clinical care in trauma and trauma medicine emergency would not be possible.

Today, AEDs are widespread and readily available in public spaces like offices, schools, airports, and stores.

Innovating to inform the community: from town halls to social networks

Before an EFIC trial begins, the United States government requires participating institutions to conduct a “community consultation and public disclosure” process. The goals are to educate community members, invite them to ask questions and provide feedback, and give them the opportunity to “opt out” of trauma research. The opt-out is to wear a bracelet on the wrist in case the patient sustains a traumatic injury.

“We take our obligation to engage community members for feedback and feedback very seriously,” Stephens said. “It’s a partnership between the community and the institution, and with any type of partnership, you have to hear from both sides.”

Researchers must meet the burden of proof, determined at UAB by the UAB Institutional Review Board, that they have sufficiently informed the potentially affected population. UAB, as the only American College of Surgeons Verified Level I Trauma Center in Alabama, has a catchment area large enough to cover at least 16 counties and even other states, should the injury is serious enough.

Previously, such community consultations were labor intensive and unprofitable, according to Stephens. He says many other trauma centers nationwide will not pursue EFIC trials because of the expensive and laborious work of community outreach.

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

UAB has done this work and invested hours and thousands of dollars to reach the community. Stephens has seen firsthand the poor return on investment in many cases: attending town forums and scout meetings, and setting up booths in malls for virtually no contact time with community members. Spending thousands of dollars buying billboards and advertisements on television, radio and newspapers with no way of knowing exactly how many people had seen the information.

But with a method pioneered by Stephens, community consultations and public discourse can now take place online through targeted social media ads and web pages. Specific populations may be affected – such as people at higher risk of car crashes who live in commuting areas, people who live in areas with high levels of gun violence, and older people who may be on blood thinners and therefore more likely to bleed after a fall.

And it works

The resulting data is ultra-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 disaggregated by age and gender.

Early EFIC trials at UAB using social media for community consultation focused on a trial studying continuous chest compressions for out-of-hospital cardiac arrest and another on fluid crystalloid resuscitation for hemorrhagic shock.

Effective inside 3EFIC trials are permitted in situations where a patient is incapable and cannot give consent.Stephens determined 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 IRB at UAB has been very receptive to this quantifiable data.”

Compared to a previous in-person campaign, which cost $8,000 and reached 465 participants, the social media campaigns generated over 1,000 webpage views for just $1,000 each. Ads for social media campaigns garnered millions of views.

Stephens published his findings in 2016 and made UAB a leader in this innovative type of community consultation. UAB has since served as the primary center for a number of multicenter EFIC trials and created the other centers’ advertisements and web pages. This will include the upcoming TAP trial, which will be the second largest trauma trial ever.

“We found a way to streamline the process, make it better, and make it easier to run these types of clinical trials,” Stephens said. “That’s what really excites us.”

“No stone is left behind”

The therapies used in trauma clinical trials are already well approved by the FDA and proven to work – in certain situations and populations. EFIC trials examine whether the same intervention or medication will work in another subset of patients. For example, the TAP trial will focus on whether a drug currently approved for use in reversing the effects of blood thinners will benefit a wider traumatized population by stopping severe bleeding.

Another example: Stephens says that tranexamic acid was previously not used in the prehospital setting, but has been shown to help treat patients with hemorrhagic shock and traumatic brain injury once patients arrived at the hospital. After favorable results from an EFIC trial, TXA is now available on most ambulances in Alabama.

UAB Hospital currently holds a 96% survival rate for trauma patients, and Stephens says UAB is always striving to improve the care it provides.

“If it was a family member or a loved one going through a trauma situation, I wouldn’t want to overlook anything,” Stephens said. “I would like 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 rewarding.

“Instead of providing care one patient at a time, I see an opportunity to really advance the delivery of 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. The mission of CIS is to promote injury prevention and improve injury outcomes at all stages of care, from prehospital to resuscitation, acute care and rehabilitation. Clinicians from many specialties – including trauma surgeons, emergency physicians, anesthesiologists, intensivists and rehabilitation specialists – work closely with epidemiologists, basic scientists, biostatisticians, health economists, psychologists health and methodologists. Learn more about the ongoing EFIC trials at UAB here. Disable trauma research here.


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