Trauma patients, community say they support exception from informed consent research

February 1, 2013

Traumatic injury – including car accidents, gunshot wounds, and stabbings – is the leading cause of death for people younger than 40 years old in the United States, but despite the toll of these injuries, few emergency medical interventions considered to be the standard of care for these injuries have been rigorously studied in clinical trials, because patients and their families are typically unable to consent to participate in research. A new study from the Perelman School of Medicine at the University of Pennsylvania sought to examine peoples' willingness to be enrolled in these types of studies under the federal provisions that allow patients with time-sensitive illnesses and injuries to be part of clinical trials without their express consent. The study revealed that those surveyed expressed high levels of approval and willingness to be part of these types of trials, both for themselves and their family members and friends. The findings provide important clues for increasing the number of studies aimed at improving care for this patient population.

The study is published this month in the and Surgery.

"We're trying to advance care and really change the associated with these injuries, but we will never really be able to do that until we can apply the scientific method," says the study's lead author, Carrie A. Sims, MD, MS, an assistant professor and the director of Research in Penn Medicine's division of Traumatology, Acute Care Surgery, and Surgical Critical Care. "We don't have all the answers, but we can get closer by conducting more of the same rigorous studies that have led to improvements in care for diseases from cancer to cardiovascular disease."

Since many trauma patients are unconscious and unable to consent to be part of a clinical trial, this research must be conducted under the 's Exception from Informed Consent (EFIC) regulations, which were established in 1996. These stipulations, designed to protect patients, govern how physicians can ethically study time-sensitive conditions like traumatic injuries and illnesses including cardiac arrest and stroke. All of these scenarios require instant medical intervention, without the typical discussion of the risks and benefits associated with participation in a study which would typically comprise the informed consent process.

Instead, the EFIC guidelines call for a community consultation and notification process to make the target community aware that the research will be taking place, including information on how to opt out of the study. But progress in trauma and other disciplines has been hampered by the difficulties of conducting research under these regulations, partly because it can be difficult to define the intended patient population and engage with them during the consultation process. While research on a condition such as epilepsy would call for meeting with patient advocacy groups dedicated to that particular illness, EFIC research for traumatic injuries – which, in the case of things such as , can strike anyone at anytime – presents more challenges.

To obtain more insights about how EFIC research may be perceived by prospective patients and the community at large, the Penn Medicine team studied the community consultation process associated with an upcoming Penn trial known as AVERT Shock, which will investigate the effect of using the hormone vasopressin during resuscitation of patients who have lost a large amount of blood. The team conducted interviews with 309 Hospital of the University of Pennsylvania trauma patients and their families, as well as members of community organizations and churches in the neighborhood surrounding the hospital, in West Philadelphia.

The overwhelming majority of the participants – more than 95 percent – supported the need for more trauma research, and indicated that the AVERT Shock Trial was an important study to perform. When queried on the appropriateness of enrolling patients if neither they nor a legally authorized representative could provide consent, 67 percent of participants agreed it would be acceptable to enroll a family member, 77 percent said it would be OK to enroll them personally, and 84 percent said it would be acceptable to enroll a member of their community. These results are in contrast to previous studies that show much lower support for research conducted under EFIC regulations. Only 63 percent of those interviewed, however, agreed that it was important to involve the community in making decisions on behalf of potential patients.

"We see the community consultation process required for EFIC research as serving an important educational need in our trauma community – by engaging with members of the public on these issues, we are able to provide information about these injuries as well as the specific trials we are planning, which helps to improve support for our research efforts," Sims said. "We recognize that our patients are especially vulnerable, having been injured with no warning or knowledge of the medical care they will require, and we are eager to find ways to provide comfort and information that can help people during these frightening experiences."

The AVERT Shock Trial is designed to improve the standard of care for the 10 percent or so of whose tremendous blood loss puts them at the highest risk of dying as a result of their injuries. The study, slated to begin this spring, will compare the use of normal saline – the standard practice during resuscitation of trauma victims who have lost a substantial amount of blood – with infusions of vasopressin, a hormone that's necessary to maintain blood pressure. Sims and her team will explore whether using vasopressin during resuscitations improves patient outcomes, by cutting complications, requiring less blood products during recovery, or boosting survival rates. The findings may also provide a way to preserve the blood supply, which is often a limited resource, especially for certain blood types.

Explore further: Injured children may not be getting best possible care

Related Stories

Injured children may not be getting best possible care

May 2, 2011
Most injured children are not being treated at pediatric trauma centers, arguably the most appropriate location of care for young patients, according to a study to be presented Monday, May 2, at the Pediatric Academic Societies ...

Car crash victims more likely to survive if taken directly to a trauma centre

June 8, 2012
People who are seriously injured in a car accident are more than 30 per cent more likely to survive at least 48 hours if they are taken directly to a trauma centre than those who are taken first to a non-trauma centre, new ...

Advancing the treatment of trauma

September 21, 2012
(Medical Xpress)—With traumatic injuries claiming almost six million lives a year, improvements in care, including in the challenging areas of brain and bone injuries, and haemorrhage, are urgently needed.

Penn-developed online informed consent tool could boost number of patients in cancer clinical trials

October 3, 2011
A new multimedia informed consent tool accessed via the Internet may make it easier for cancer patients to understand and feel comfortable enrolling in clinical trials, according a study conducted by researchers in the Perelman ...

First-of-its-kind program improves outcomes for seniors admitted for trauma

November 13, 2012
A first-of-its-kind program at St. Michael's Hospital lowers risk of delirium in elderly patients admitted for trauma and decreases the likelihood they will be discharged to a long-term care facility.

Recommended for you

World's first child hand transplant a 'success'

July 19, 2017
The first child in the world to undergo a double hand transplant is now able to write, feed and dress himself, doctors said Tuesday, declaring the ground-breaking operation a success after 18 months.

Knee surgery—have we been doing it wrong?

July 18, 2017
A team of University at Buffalo medical doctors have published a study that challenges a surgical practice used for decades during arthroscopic knee surgery.

New tools help surgeons find liver tumors, not nick blood vessels

July 17, 2017
The liver is a particularly squishy, slippery organ, prone to shifting both deadly tumors and life-preserving blood vessels by inches between the time they're discovered on a CT scan and when the patient is lying on an operating ...

Researchers discover indicator of lung transplant rejection

July 13, 2017
Research by scientists at Dignity Health St. Joseph's Hospital and Medical Center's Norton Thoracic Institute was published in the July 12, 2017 issue of Science Translational Medicine titled "Zbtb7a induction in alveolar ...

New device could make closing surgical incisions a cinch

July 7, 2017
Like many surgeons, Dr. Jason Spector is often faced with the challenge of securely closing the abdominal wall without injuring the intestines. If the process goes awry, there can be serious consequences for patients, including ...

Success with first 20 patients undergoing minimally invasive pancreatic transplant surgery

June 29, 2017
Surgeons at Johns Hopkins Medicine report that their first series of a minimally invasive procedure to treat chronic pancreas disease, known as severe pancreatitis, resulted in shorter hospital stays, less need for opioids ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.