The main goal of clinical registries is to collect information about patients to better understand disease conditions and treatment options and to improve quality of care. At least three registries in otolaryngology have played important roles in steering treatment decisions and bolstering outcomes. ENTtoday spoke with three founders of these registries to discuss their journeys, successes, and barriers.
Explore This IssueNovember 2019
Recurrent Respiratory Papillomatosis
One of the longest running registries in otolaryngology has been the recurrent respiratory papillomatosis (RRP) registry, which was established in 1995.
Because RRP is a rare disorder—affecting four out of 100,000 children, with approximately 1,000 new pediatric cases in the United States back in 1995—it has been designated as an orphan disease, making it a good candidate for a registry, according to Craig Derkay, MD, Fine Endowed Professor and vice chairman in the department of otolaryngology at Eastern Virginia Medical School in Norfolk.
With orphan diseases, clinicians often have experience with only a small number of patients, which may not provide enough information to change the way the disorder is managed. “But if you aggregate everybody’s small experience together, then you may have enough information to really learn enough to change the treatment,” Dr. Derkay told ENTtoday.
With the help of the Centers for Disease Control and Prevention (CDC), Dr. Derkay created the national registry of approximately 700 patients with RRP. Based on the information gathered, Dr. Derkay and his colleagues were able to confirm that the majority of the children were firstborn, that their mothers were young and had a prolonged labor, and that the mothers had previously had multiple sexual partners and abnormal Pap smears or warts in their genital region. “We were able to use the registry to much better describe the disease than what we had previously been able to do just based on everybody taking care of five or 10 of these children,” he added.
Once the registry had this information, Dr. Derkay and his colleagues were able to design clinical trials to evaluate treatment options. They conducted trials looking at a heat shock protein (HSPE7), and gathered expert opinions on the use of cidofovir. Based on the findings, “we were able to come up with clinical practice guidelines for use of cidofovir, addressing which children are most likely to benefit, along with ideal dosing and intervals to use, as well as what side effects warranted monitoring.”
“Within the papilloma community, we were able to get both the US and international experts to agree upon these guidelines, and we all signed off on them as part of an organized effort to try and help our fellow otolaryngologists. The guidelines are widely quoted and widely utilized,” Dr. Derkay said (Laryngoscope. 2013;123:705–712).
Since the introduction of the human papillomavirus vaccine (Gardasil, Merck) in 2006, the RRP registry was revived to look at the effect of the vaccine on the number of new cases of RRP in the United States. “We’ve now gone back to most of the same 30 academic centers used in the original registry. We now have a second registry built out of 22 sites that have contributed their retrospective data and 26 sites that have prospective data,” Dr. Derkay said. “What we are seeing is a dramatic decrease in new cases, which mirrors the Canadian registry experience led by Paolo Campisi, MD, from Hospital for Sick Children at the University of Toronto.”
When clinicians come up with good ideas about treatment, they can go back to the registry, and contributing members can test their theories on treatment and look further at treatment trends, new instruments, and new medicines. It’s not the registry itself that does all of this, but it’s the trickle-down effect of the registry that allows the science to move forward. We’ve really made a difference in the lives of these children and their families. —Craig Derkay, MD
The benefit of having an RRP registry is that it identifies the location of affected patients. “When clinicians come up with good ideas about treatment, they can go back to the registry, and contributing members can test their theories on treatment and look further at treatment trends, new instruments, and new medicines. So it’s not the registry itself that does all of this, but it’s the trickle-down effect of the registry that allows the science to move forward. We’ve really made a difference in the lives of these children and their families.” Dr. Derkay added.
Auditory Implant Initiative
The idea for a cochlear implant registry started in 2012. “It took us a while to get the idea and to build it, but we have been collecting data since 2015, and right now we have about 8,000 patients in our database,” said Jed Grisel, MD, of Texoma Hearing Institute in Wichita Falls, Texas, founder of the Auditory Implant Initiative (Aii).
The Aii focuses on clinical research and quality improvement. “We developed our own software application [HERMES] to allow cochlear implant centers to track their patients’ progress, providing clinical value that clinicians can use in their practices,” said Dr. Grisel.
In order to access the software, the clinics have to agree to allow the deidentified data to be used for research. “We give feedback to the clinics of how they’re doing, but also we use that data to conduct research studies that can help push the cochlear implant industry forward,” he said. For example, the Aii team was able to show that older adults, those 75 years and older, do as well with a cochlear implant as their younger counterparts (Otol Neurotol. 2017;38:e405–e412). “If the patient is healthy enough to undergo surgery, age is not an indicator of worse success with a cochlear implant, which is meaningful,” Dr. Grisel added.
Dr. Grisel and his colleagues are also conducting a study to determine whether type of insurance predicts outcomes with cochlear implants. “Private insurers, like Blue/Cross Blue Shield, have different criteria for cochlear implants than Medicare, which is more stringent and waits until the patients has worse hearing. We found that Medicare is a risk factor for doing worse with a cochlear implant,” he said.
“Because the type of data that we collect is very unique and specific, it cannot be extracted from electronic health records [EHRs]. We had to create our own forms, and people have to manually put the data in, which is good because we can get more robust and detailed data and answer more specific questions. The downside is convincing clinics to use the database; that has been a challenge,” Dr. Grisel said.
The registry is funded by a combination of industry support and private funding. “This has been a big barrier to creating registries. We all think the idea of registries is really great, but the important question is, ‘If you build it, who is going to pay for it and how is it going to be sustainable?’” he noted.
Global Tracheostomy Collaborative
Perhaps the most ambitious registry is the Global Tracheostomy Collaborative (GTC), which was founded by David Roberson, MD, MBA, of Bayhealth Delaware in Dover. In 2011, when Dr. Roberson was a co-chair of the American Academy of Otolaryngology–Head and Neck Surgery (AAO–HNS) Patient Safety and Quality Improvement Committee, the committee conducted a survey of the academy members. “We asked, ‘Has something bad ever happened with a trach?’ and we collected a lot of reports of completely preventable terrible events,” he said. At the same time, the AAO–HNS Airway and Swallowing Committee was publishing a giant multi-institutional study of tracheostomies, likewise demonstrating major opportunities for improvement (Laryngoscope. 2012;122:38–45).
At around the same time, Dr. Roberson read work from two institutions, St. Mary’s Hospital in the UK and Austin Health in Australia, that had independently developed tracheostomy programs that had reduced such important outcomes as length of stay and adverse events by 50% to 90% (Crit Care Resusc. 2009;11(1):14–19; Clin. Otolaryngol. 2011;36:482–488).
“In the world of quality improvement, one of the big challenges is disseminating information about improved treatments,” said Dr. Roberson. “One of the solutions is the idea of a quality improvement collaborative. Here are two hospitals that have published data with phenomenal improvements, but it’s not being widely adopted. It shouldn’t be that way.”
So, in July of 2012, Dr. Roberson invited tracheostomy experts from around the world to meet in Glasgow. “Twenty or so experts came, and we spent a day together and talked about tracheostomy care and agreed to form a collaborative. We had representatives from Australia, the UK, India, and America. Because tracheostomy care is multidisciplinary, we included representatives from nursing, respiratory care, speech pathology, otolaryngology, ICU, pulmonary care, [and] anesthesia, and a tracheostomy patient’s parent. We began enrolling hospitals in 2014 and currently have about 40 hospitals enrolled around the world,” he said.
Dr. Roberson acknowledged that there have been some barriers to enrollment. One is money. “We charge an annual fee of $7,500, which is extremely cheap for a QI collaborative,” he said. “However, in the UK and Australia, there is no discretionary funding, and GTC payment has to go through the national health service budget and approval process, which is slow, tedious, and sometimes not rational,” he said.
Another barrier to implementation has been getting different departments to work together. “To make this work, every department in the hospital has to get on board. For example, if the otolaryngology surgeons and general surgeons disagree about postoperative care and aren’t willing to work through that together, it can be a nonstarter,” he said. Often bedside caregivers—nursing, respiratory therapy, and speech—are well aware that care in a hospital is fragmented and confusing, but physicians may not realize it. “The otolaryngology and pulmonary departments often don’t understand how difficult and confusing it is for the patients and front line staff if every practitioner has a different set of postop orders. But if you can get all the disciplines in a room at the same time, and they listen to each other, then all of a sudden you can make decisions.”
A group of UK hospitals have published data demonstrating that GTC membership led to substantial and statistically significant reduction in adverse events, severity of events, and length of stay (BMJ Qual Improv Rep. 2017 May 23;6(1)). One AAO-HNS member, Joshua Bedwell, MD, a pediatric otolaryngologist at Children’s National Medical Center in Washington, D.C., has also published on the Center’s experience using the GTC database (Int J Pediatr Otorhinolaryngol. 2016;80:106–108).
Despite difficulty in enrolling hospitals, Dr. Roberson and colleagues have created the largest database of tracheostomy patients in existence—including more than 6,000 unique admissions. A manuscript describing outcomes across that entire dataset will be submitted in the next couple of months. “I can’t share this data in advance of peer review,” he said, “but I really look forward to seeing them in print.”
Nikki Kean is a freelance medical writer based in New Jersey.