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Patient-reported outcomes put definition of success in new hands

Just when dermatologists have become adept at patient satisfaction surveys, they are being asked to incorporate patient-reported outcomes (PROs) into their clinical practice to optimize the patient experience. After all, ample parking space and comfortable seating in the waiting room may make the doctor’s visit more pleasant, but they don’t necessarily lead to better outcomes.

“Ultimately people come to us because they have a problem. The appointment itself is not the deliverable; it’s a means to an end,” said Robert A. Swerlick, MD, the Alicia Leizman Stonecipher chair of dermatology at Emory University School of Medicine. The endpoint is not that the parking was easy and the seating was comfortable, he said, it is that the patients’ problems are addressed and their needs met.

“There is growing interest in patient-reported outcomes because the value of medical care is not based on what the doctor thinks. It’s based on what the patient thinks,” added Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and public health sciences at Wake Forest University School of Medicine. “Whether doctors like it or not, they’re in the service industry where the value of a product is determined by the consumer, not by the provider.” 

Defining PROs

According to the Food and Drug Administration (FDA), PROs are “any report of the status of the patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” They address symptoms and symptom burden, functional status, quality of life, and health behaviors.

In contrast, patient surveys probe satisfaction that is mostly independent of patient health status, noted Joshua C. Nyirenda, MPA, PhD, manager of performance measurement at the American Academy of Dermatology (AAD). That explains why such data may show satisfied patients even when their symptoms did not change substantially from clinical presentation, he said. Questions on instruments used to capture patient satisfaction with regard to health outcomes may ask how much better patients can function at work and in their social life as a result of their treatment. [pagebreak]

Still, patient satisfaction and PROs are interrelated. “When patients have a better overall experience, they become more adherent to their therapeutic regimen,” said Charles Ellis, MD, the William B. Taylor professor and associate chair in the dermatology department at the University of Michigan Medical School. Better adherence to treatment leads to better outcomes and greater patient satisfaction.

Seeing the bigger picture

Patient-reported outcomes are not new to dermatology. Indeed, many dermatologists are familiar with the various instruments used to measure and collect specialty-specific PROs such as the ItchyQOL, Skindex, and the Dermatology Life Quality Index, or DLQI.

Additionally, PROs have been used for clinical research for decades. In 2004, the Patient Reported Outcomes Measurement Information System (PROMIS) was established to house such measures. Data collected with PRO measures provide clinicians with an understanding of how various treatments might affect patients’ symptoms and their ability to function. This information is used to test drug therapies, design treatment plans, improve patient-physician communication, and manage chronic disease.

The growing interest in PROs has been spurred by national health policy that is increasingly focused on patient-centeredness. For instance, the Affordable Care Act mandated that clinical care and research incorporate the patient’s perspective. It called for the creation of the Patient-Centered Outcomes Research Institute (PCORI), which is charged with emphasizing study designs and results that are more meaningful to decisions faced by real patients and is guided largely by their input. To date, PCORI has approved 279 awards totaling more than $464 million to fund patient-centered comparative clinical effectiveness research projects. Last year, the National Quality Forum developed a pathway for creating what it calls “PRO performance measures,” assessments that go beyond the patient experience to measures based on PRO data. Stage 2 of Medicare’s Meaningful Use incentive program for electronic health records requires physicians to engage patients in their health care decision making. Recognizing the importance of PRO measures, some vendors have started to incorporate them into EHR systems. [pagebreak]

More recently, PROs are beginning to show up in routine care settings. Several medical centers across the country looking to improve health outcomes across-the-board are using PRO tools to do so. Once PRO data is collected in the clinical environment, the data can be aggregated to assess organization- and/or provider-level performance. Eventually, PROs will be aggregated to measure performance much the same way that largely process-related and some outcomes-related measures are used today.

Measuring outcomes differently

Physicians have traditionally focused on objective clinical and physician-centered measures, such as disease severity in the case of psoriasis as determined, for example, by looking at body surface area involvement, said Junko Takeshita, MD, PhD, a postdoctoral fellow and clinical instructor in the department of dermatology at the University of Pennsylvania. However, studies have shown that disease severity as reported objectively by dermatologists doesn’t always correlate with the subjective patient report, nor does therapeutic effectiveness. “In comparative effectiveness research evaluating psoriasis therapies, we have found that there are significant differences among the therapies examined when evaluated by physician-reported outcome measures but not when we use patient-reported outcome measures,” she said.

“If physicians and patients can’t agree on objective measures, how can they agree on subjective ones?” Dr. Ellis asked. He also noted the range in which patients perceive their own illnesses. Every dermatologist is familiar with the patient with psoriasis who has a small spot on his or her arm, and is distraught and can’t go out. Then there is the patient who is scaling profusely and engaging in normal daily activities. “That’s why patient-reported outcomes are important,” Dr. Ellis said. “There is great value in understanding the patient’s situation with regard to both quality of life and perception of their disorder.” [pagebreak]

Added Dr. Feldman, who is the founder of the patient satisfaction/physician rating website DrScore.com, “You can get a patient with psoriasis 90 percent clear, but the patient could be zero percent happy because he or she wants to be 100 percent clear.” While the dermatologist may consider the therapy a success, the patient considers it a failure — and it’s the patient’s opinion that counts.

By focusing on objective criteria, physicians might miss the impact of the disease that only the patient can provide, Dr. Swerlick noted. Clinicians tend to report the most severe aspects of a condition and under-report those that are potentially impactful because the latter doesn’t reach their threshold of severity. But even nominal disease can have a significant impact on a patient’s functioning in some domains. “We tend to be impressed by what we can see, not by what we don’t see,” he continued. “Itching is the number-one example in our world.” Other physical symptoms not obvious to observation include fatigue, headache, and psychological symptoms such as depression and anxiety, Nyirenda noted. Some symptoms, such as sleep disturbances, occur in the absence of the observer. When these symptoms are severe, they significantly interfere with quality of life. Measures in the PROMIS, however, readily categorize various patient experience domains, capturing a wide array of symptoms while adapting the domains to different population needs.

“Patients are better at identifying what’s important to them than physicians are,” said Dr. Swerlick, who was reminded of a six-month study in which he was involved. During 2011, 150 patients at a handful of dermatology offices throughout the Atlanta area, including his, filled out questionnaires about what their goals were for the visit and whether or not they were met. Physicians were asked the same questions. “The alignment with regard to the goals was less than perfect,” he said; he is working on publication of data from the study. [pagebreak]

Optimizing patient experience

Moving forward, PROs will play an increasingly important role as an indicator of quality care, Nyirenda noted. “All fields of medicine, not just dermatology, will be increasingly incorporating patient-reported outcomes,” Dr. Takeshita echoed. As the population ages and lives with diseases that were once terminal and are now manageable chronic conditions, quality of life will become an even more important factor in health outcomes. That’s why it is important that dermatologists optimize patient experience, especially quality of life, she stressed.

Patient-reported outcomes may hold the key to optimizing patient experience by engaging patients in their health care. Patients who are actively engaged in their health care tend to experience better outcomes and lower costs, according to several studies published in the February 2013 issue of Health Affairs, the entire issue of which was devoted to this topic. Conversely, evidence suggests that patients dissatisfied with any aspect of their medical care, including their physician or a treatment, are less likely to be compliant or continue with their therapies, which ultimately results in them not being adequately treated, Dr. Takeshita said.

In addition, there is “the halo effect” in which the overall impression of the experience influences how one feels about specific aspects of it. If patients have an excellent experience with the staff and feel that they’re being well-cared-for, their clinical reported outcomes will likely be better, as well, Dr. Ellis explained. As an example, through the satisfaction survey distributed to patients at the University of Michigan’s dermatology department, “We found out that our parking is better and our restrooms cleaner than those of the other departments despite the fact that they are the exact same parking lot and restrooms,” he said. Patients who are happy with their doctors will find that they like everything better. [pagebreak]

From the patient perspective, PROs can enhance physician-patient communications, which the literature suggests strengthens the doctor-patient relationship and optimizes treatment, noted Andrew D. Robertson, PhD, chief scientific and medical officer at the National Psoriasis Foundation. In a study published in the October 2013 issue of JAMA Dermatology, 52 percent of patients with psoriasis and 45 percent of patients with psoriatic arthritis were dissatisfied with their treatment. Patients with severe disease experienced a lot of discomfort, bleeding, itching, and poor quality of life, said Robertson, who was a study co-author. If these providers were assessing their patients’ health outcomes with PRO measures, they would have realized that approximately half of them found their treatments ineffective. “The communication would have improved and patients would have received better treatment resulting in improved outcomes,” he said.

On a broader scale, with the establishment of the PCORI, patients will be able to drive research that has not been done previously due to a lack of incentives, Robertson added; in some cases they will be in the room in ways they weren’t before as research is planned. One of the first questions patients with a chronic condition ask is what they can do to manage it. Trials may now begin studying nutritional and lifestyle options to inform patients about those that are effective, he said.

Introducing PROs into clinical practice

Integrating PROs into daily practice may be as easy as asking a simple question. Before every visit, Dr. Swerlick now asks his patients what their goals are for their visit. “You don’t know if you’ve met the patient’s goals unless you know what they are,” he said. Next, Dr. Swerlick may ask if they are concerned about symptom control, appearance, their ability to function, or something else. “Sometimes, patients just need reassurance.” [pagebreak]

Additionally, Dr. Swerlick is involved in a pilot project in which he is providing the ItchyQOL on a computer tablet for patients to fill out while they are in the exam room. Ideally, patients will be able to use the PRO tool at home and import the data directly in the future. The project is trying to determine if the data can be collected easily and aggregated.

For its part, the AAD is exploring the feasibility of applying PROs, specifically PROMIS tools, to dermatology, Nyirenda said. The Council of Science and Research recently established a Data Collection Workgroup chaired by Dr. Swerlick. Since clinical application of the PROMIS is a generally new concept, Nyirenda explained, the workgroup’s task will start with a feasibility analysis. Next, the workgroup would have to determine if the tool needs to be adapted to dermatologic settings.

Twenty years ago, the physician assessed the patient and prescribed a treatment that he or she thought was best, Dr. Ellis said. “Today, we’re trying to capture information from the patient about that treatment and its impact on medical outcomes in a way that we can use it.” The more specific and standardized the information, the more valuable it becomes. And not just to physicians, but to payers who want to know not only that the doctor is using effective therapies, but that the patient thinks their treatment is going well. “Thus, medicine is becoming a more patient-focused field, as it should be.”



Questions that integrate PROs
IDEOM looks to patients for PROs