PROMS Can Help With Patient Outcomes And With Patient-Centered Research

Patient-Reported Outcome Measures (PROMs) were originally developed as a research and quality improvement measurement tool. They have come to reflect the evolving nature of otolaryngology from a field that relied on objective findings like radiographs and blood tests to one that’s focused on the unique patient experience, including patients’ physical, functional, and emotional concerns, noted several clinicians interviewed for this article.

PROMs are important in otolaryngology because many of the issues that patients have (e.g., hearing loss, nasal issues, snoring, swallowing, dizziness) have a big subjective component, said Jonathan Skirko, MD, MHPA, MPH, an associate professor at the University of Arizona, medical director of the Cleft and Craniofacial Program, and director of the division of pediatric otolaryngology at Banner–University Medicine Tucson. “A lot of what we treat impacts the way that our patients feel, breathe, speak, and hear. These types of problems lend themselves very well to PROMs. We can get the patient’s perspective on their experiences,” said Dr. Skirko, who developed the VELO (Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes) questionnaire (Otolaryngol Head Neck Surg. 2013. doi:10.1177/0194599813486081).

Jay Piccirillo, MD, from the department of otolaryngology–head and neck surgery at Washington University School of Medicine in St. Louis, Mo., who is a pioneer in the development of PROMs for otolaryngology, said that “people don’t come to us because their apnea-hypopnea index score is greater than 30. They come to us because they’re tired during the day or their spouse is complaining about them stopping breathing at night.

It’s a much more holistic approach than just using objective measures, and I think it’s more sensitive to what is meaningful to patients. —Jay Piccirillo, MD

“With PROMS, we’re trying to capture the things that are important to patients,” Dr. Piccirillo added. “I use them to measure the severity of a patient’s condition at presentation. For a patient with rhinosinusitis, I have them fill out the SNOT and then I score the instrument before seeing the patients. I have a measure of how bothered they are, if you will. I use PROMs to give me an idea of where the patients are on the severity spectrum at baseline. Then, on return visits, I’ll refer to their previous score and see if the patient has improved with treatment. It’s a quick and easy measure of how they’re doing. It’s a much more holistic approach than just using objective measures, and I think it’s more sensitive to what is meaningful to patients.”

One of the benefits of performing PROMs is getting a measure of how a patient is doing at that visit, as well as giving the clinician a point of focus, whether it’s a specific physical, functional, or emotional issue. “The questionnaire is a point to begin a conversation about how the patient is doing. For example, ‘I notice on the questionnaire you mentioned xyz—tell me more about that,’” Dr. Skirko said.

Dr. Piccirillo agreed. “Patients may come in with a nebulous complaint,” he said. “The PROMs help to focus them on the things that are bothering them most at that moment. Their response tells me what’s really bothering [them] and helps me focus on what they want to address at that visit. Also, I’ve never had a patient say they wouldn’t fill out the forms, so I think the patients appreciate it too.”

AAO-HNS’s Reg-ent Registry

The American Academy of Otolaryn-gology–Head and Neck Surgery is developing the Reg-ent Registry. The focus of the registry is quality improvement and patient outcomes, but it also serves as the foundation for Merit-based Incentive Payment System (MIPS) reporting, measures development and research, and will contribute to members meeting Maintenance of Certification requirements, noted the academy.

“One of the features is that it will allow physicians to automatically deliver a PROM to a patient,” said Vikas Mehta, MD, MPH, who is the current coordinator for research and quality for the AAO-HNS and the vice chair and associate professor of otorhinolaryngology–head and neck surgery at Montefiore Medical Center/Albert Einstein College of Medicine in Bronx, N.Y. “For example, if a sinus surgery is planned for a patient, a SNOT form can be sent electronically to the patient before and after surgery.” That information will be de-identified and incorporated into a database. “After a few patients, you’ll have an aggregate of SNOT scores before and after surgery, which will give you a sense of how your surgical interventions have improved patients’ quality of life and health outcomes based on your intervention. It helps give more of an objective data point in what’s largely a subjective improvement.”

This information can also be used to provide information about value-based care, something that insurance companies are doing more often. “The physician will have the ability to automatically administer those surveys, get the feedback, and submit it back to Medicare/Medicaid and third-party insurance companies or other payers, if that ends up being required in alternative payment models,” Dr. Mehta said.

According to the academy, Reg-ent benefits include:

• Safeguarding the role of otolaryngologists in defining optimal care;

• Demonstrating the value of services provided by otolaryngologists in all iterations of future payment models and providing the opportunity for participation in future private payer quality programs;

• Serving as the first national data repository of otolaryngology-specific data that can be mined for research and quality improvement purposes; and

• Helping define and develop specialty-specific quality measures.

PROMs are already used as a benchmark for surgery in Europe. In the United Kingdom, when physicians want to perform sinus surgery, the National Health Service has established a threshold value for the SNOT score. “If somebody has a value below the threshold, meaning they’re not so bothered, the NIH won’t reimburse the surgery,” Dr. Piccirillo said. “In the United States, if the patient has a high rhinosinusitis score, along with a computed tomography scan that shows opacification of the sinuses, along with a record of the patient being treated with multiple medications without improvement, that’s pretty good documentation that surgery would be the next step,” said Dr. Piccirillo.

Pediatric assessments have their unique challenges, Dr. Skirko noted. For newborns through age 3, parents complete the PROMs (proxy assessment). For young children (age 4 to 5 years) with speech issues, parents and guardians fill out the reports. With parent-filled PROMs, it’s up to the clinician to determine how much of what is reported comes from the parents’ issues and how much of it reflects the child’s experience.

“When we start transitioning to patient-filled report [at ages 7 to 9], we often have both parent and patient assessments. Capturing both is really interesting, because the patients will have experiences that the parents don’t always fully understand. This allows for open communication between the parent and patient about what the patients are experiencing,” Dr. Skirko said.

Barriers to Use in Practice

One of the biggest barriers to adopting PROMs into practice is logistics: making sure the right forms are handed to the right patients in the waiting room. “It may seem simple, but with a busy practice, this can often be the point where that process breaks down,” Dr. Piccirillo said. In larger practices and universities, clinicians can have their IT department enter the forms into their electronic health records, but in smaller practices, the experts recommend simply scanning the forms or dictating the information into the patients’ charts.

Most of the otolaryngology PROMs are available to clinicians at no charge. How often the questionnaires are being used in clinical practice is hard to estimate, but Dr. Piccirillo suspects that 80% of rhinologists use the SNOT. “For patients with snoring, the Epworth Sleepiness Scale is widely used,” he added.

One challenge for clinicians is getting patients to fill out the forms. “This is always a challenge, especially outside of a research setting,” Dr. Mehta said. He estimates that less than 10% of patient satisfaction scores are returned, for example. “We’re entering an era of more value-based care and outcomes-based reimbursement, where PROMs are going to become a standard feature. Therefore, it’s important that we have good measurements that are appropriately validated and that correlate with clinical improvement. You can ask patients questions, but unless it’s been shown to be scientifically rigorous and correlated with improvement in outcomes, then it’s just subjective information.”

We’re entering an era of more value-based care and outcomes-based reimbursement where PROMs are going to become a standard feature.

— Vikas Mehta, MD, MPH

PROMs are important in assessing the burden of disease and effectiveness of treatment, “because we can’t always rely on objective measures to show that treatments, like surgery and medications, are improving patients’ health,” Dr. Mehta said. Sometimes, he added, “it’s just whether the patient feels better or not. PROMs were created to more accurately measure those things in a standardized and validated fashion.”

As an early faculty member, Dr. Mehta received a master’s in public health at Johns Hopkins University in Baltimore, where he learned the value of PROMs. “From a science perspective, being able to better understand how treatments are impacting patients through quantitative measurements that are reliable, reproducible, and meaningful to patients requires a lot of work in developing, validating, and implementing these measures.”

Many available PROMs haven’t undergone rigorous evaluation to make sure that they correlate with clinically meaningful results. Therefore, any clinician who’s thinking about incorporating one should make sure it has been studied and validated. “We’re a small field, and those of us conducting research know how important it is to have validated research tools and clinical metrics,” Dr. Skirko said. “We want to make sure that anyone helping children and adults has the best access to these tools.”

The Future of PROMs

Dr. Piccirillo is researching the use of ecological momentary assessment (EMA) to capture patient responses more accurately in real time. “Instead of waiting to see the clinician to rate your pain score or symptoms, you could fill out a finite number of questions four times a day, which allows for real-time assessment,” he said. The future will be about how to incorporate electronic digital devices, such as the iWatch or iPhone, for regular assessment outside the physician’s office.

“My recent research has really broadened my understanding of what patient-centered research has become,” Dr. Skirko said. “Patient-centered research is transitioning into an area where not only do we include patient-reported outcomes, but we actually include patients on our research teams. Part of my research now is developing the ability to do patient-centered research in Pierre Robin Sequence,” a rare disorder that involves infant airway obstruction resulting from a small jaw. Included on the team are parents, advocacy groups, speech pathologists, and cleft coordinators. “This enables us to have a more holistic picture when designing clinical research,” Dr. Skirko said.

Electronic digital devices can also help with remote monitoring and telehealth. “Many of our patients are coming from far away, so this could also help with monitoring outcomes,” Dr. Skirko said. “We’re also building teams that are working toward multicenter studies so we can answer some of the harder questions with patient populations that have had broader experiences in a single institution.”

There’s a lot of power in creating registries, Dr. Skirko noted, but a lot of work is required to figure out what’s in the inclusion criteria and who makes the specific diagnosis. “Some conditions are easier to diagnose, but for the rare conditions, there isn’t always uniform consensus on what that diagnosis entails, which can make it really challenging. I think the academy has done a really good job of having some online resources for types of PROMs that have known value and quality.” 

Nikki Kean is a freelance medical writer based in New Jersey.