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OHSU starts clinical study - without your consent

PHOTO COURTESY: NEUROLOGICAL EMERGENCIES TREATMENT TRIALS NETWORK - One box with one of three experimental medications and an iPod for enrollment and data gathering are being given to hospitals participating in a new Portland-area study. The study will test the different medications used to help emergency patients in seizure.Forgive Dr. Mohamud Daya if he’s starting to think about the Hawthorne Effect — again.

Daya is a professor of emergency medicine at Oregon Health & Science University with a long involvement in a unique sort of life and death clinical trial — the kind in which subjects haven’t agreed to participate.

OHSU last week announced that it is undertaking the 10th Portland-area clinical study under a research mechanism titled Exception from Informed Consent. The latest study will look at three medicines that are commonly given to unconscious emergency patients suffering prolonged epileptic seizures.

According to Dr. Craig Warden, a pediatric emergency physician and OHSU's lead investigator in the trial, physicians have virtually no idea which of the three drugs works best to save the lives of epileptic patients who have developed resistance to anti-seizure drugs. Some physicians use one drug, others another in the approximately 50,000 episodes of persistent epileptic seizures that occur each year. These seizures can cause irreversible brain damage and death.

But those patients in seizure are in no position to consent to participate in a clinical trial when the paramedics arrive. That’s the crux of the Exception studies. The federal Food & Drug Administration allows such studies citywide as long as researchers first make an effort to allow people to opt out. So OHSU is tasked with informing the public about the studies, and those who wish to opt out need to be wearing “No Study” bracelets should the ambulance arrive at their door .

FDA rules allow the Exception studies only if a life-threatening situation exists and data shows that patients might actually benefit from either of the therapies being tested.

Previous Portland Exception studies looked at different strategies for airway management during cardiac arrest and different drugs administered by paramedics to accident victims who have suffered severe brain injuries. A third looked at different devices to revive trauma victims whose hearts had stopped.

Unlike previous Exception studies which could have enrolled anybody involved in a major car crash, this latest study only needed to inform epileptics that they might participate. So, according to Warden, much of the required pubic information process involved speaking to groups of people who suffer from epilepsy. None of those residents requested opt-out bracelets, Warden says.

It took Warden five years to design and get approval for this study, which will take place in 40 cities around the country. For the study to work here, Warden needs one or two cases a month brought in to OHSU. It’s an expensive process, but necessary, according to Daya.

“This is the only way we can truly understand what we’re doing,” says Daya about the Exception studies. And community voices who don’t like the idea of participating in trials without having consented are all part of the process, he adds.

“We’ve learned there will always be a group of people who will object to this kind of work,” Daya says.

Another thing Daya says researchers have learned is that informing the community about upcoming trials isn’t easy, and can require different tactics in different cities. The first few Exception studies generated controversy, in Portland and in other cities. But that concern has mostly faded. Only 84 Portland-area residents requested “No Study” bracelets for the most recent experiment last year. Early studies had more than 600 requesting the bracelets.

“We don’t know if people being reached truly understand what the project is all about,” Daya says.

But what some of those people who object to the idea of Exception studies don’t take into account is the Hawthorne Effect, Daya surmises. The Hawthorne Effect is a phenomenon in which people change their behavior because they know they are being closely watched. In the case of the Exception studies, those people are the paramedics, physicians and nurses caring for the study patients.

Most of the previous trials, Daya says, showed little difference in outcomes between the different drugs or therapies being studied. But survival of the patients across the board increased. That’s may be the Hawthorne Effect at work.

“Whenever you study something the whole process tends to get better because you’re highlighting the entire system and you’re looking for flaws in the system,” Daya says.