Research Results

“The measures work, they give us new information, and they tell us that a lot of things are affected by rheumatoid arthritis that we’re not currently appreciating with standard measures,” says Clifton Bingham, MD, of Johns Hopkins University, who is one of the principal investigators.

As one indication of the reliability of the electronic questionnaire, Bingham, co-principal investigator Susan Bartlett, and their team recently reported in the journal PLOS ONE that the patients with more severe rheumatoid arthritis described more significant impacts on their lives. The study also demonstrated that patients reported more pain, fatigue, depression, and other problems than the general US population.

What’s more, the electronic questionnaire called PROMIS, which was originally developed by the National Institutes of Health, revealed more impairment than do standard rheumatoid arthritis measures that doctors use in clinics. “Doctors may be fooling themselves in understanding how well the patients are doing,” Bingham says.

A Practical Tool

Just as important, the team reported that neither doctors nor patients found the electronic questionnaire burdensome. In fact, they said it was useful for providing, and receiving, health information. Both groups told the team that the patient-reported outcomes collected through the questionnaire facilitated useful discussion between doctor and patient.

Bingham reports that patients typically said, “You’re finally asking me about the things that actually matter.” More than one patient told Bingham that the questionnaire led to a better understanding of the full effects of their arthritis, such as impacts on sleep.  Meanwhile, doctors said the questionnaire helped them identify problems, such as depression, that they might not otherwise have asked about.

Enthusiasm for the research by potential participants led to enrollment of 177 participants, rather than the 120 originally planned, without adding recruitment time or cost.

Moving Forward

Both doctors and patients wanted more information about the meaning of the questionnaire’s outputs. The researchers have embarked on another PCORI-funded study to evaluate more closely how the questionnaire’s measures relate to patients’ severity of symptoms and potential benefits of changing treatments.

Bingham hopes the results of his first study will encourage clinical researchers to use patient-reported outcomes. The team is filming patients and doctors talking about their experiences in the study. These videos and more information concerning the study are available on the Johns Hopkins Arthritis Center website.

“We think we can improve quality of care and make it more patient centered,” he says. “If you don't ask patients about—and measure accurately—those things that are most important to them, you are not treating the whole patient.”

ORIGINAL FEATURE (APRIL 2014)

When patients sit in a physician’s waiting room, a parade of symptoms, questions, and concerns may march through their minds, ripe for discussion with their clinicians. But once in the exam room, patients often find they don’t make it through their full list, perhaps leaving out the issues most troubling them. The communication failure leaves both the patient and doctor incompletely informed.

Clifton Bingham, MD, who treats patients with rheumatoid arthritis at The Johns Hopkins University in Baltimore, Maryland, says he hates to see their concerns fail to make it out of the waiting room. “The current measures that we use in practice really do not incorporate these perspectives at all,” he says.

So with support from PCORI, Bingham, Susan Bartlett, PhD, and their team are measuring the value of an increased focus on the day-to-day struggles faced by a patient with a chronic condition. The idea is to improve patient-clinician communication, shared decision making, and outcomes that matter most to patients.

Physicians, nurses, and other clinicians usually give the most weight to visible symptoms and clinical measurements, such as lab and imaging results. However, patients with rheumatoid arthritis face a complex disease experience. Critical outcomes can include pain levels, sleep quality, and mood.

Patient Reports by the Numbers

"We patients have to deal with a lot of pain, a lot of ups and downs:  such as, yesterday I was fine, today I can barely walk,” says Amye Leong of Santa Barbara, California, one of the patient partners on the study, a PCORI Pilot Project. “PCORI-funded projects help clinicians understand the need to consider their patients’ emotional handling of the disease, social support, functional capabilities—whether we can use our hands, feet, knees, or shoulders in everyday life."

Leong was diagnosed with rheumatoid arthritis at age 18 and spent five years in a wheelchair. After a series of surgeries and medication adjustments, she began to walk again. Now, she travels around the world in her work as a motivational speaker, health educator and advocate, and director of strategic relations for the global Bone and Joint Decade initiative.

In the Baltimore study, 120 patients with rheumatoid arthritis were handed an iPad when they sat down in their doctors’ waiting rooms. The tablet displays a questionnaire that asks about the patient’s physical, mental, and social health. The National Institutes of Health developed the questionnaire as part of its Patient Reported Outcome Measurement Information System, or PROMIS.

Patients may be asked to rate their levels of pain, fatigue, or depression on a 1-to-10 scale. The questionnaire adapts according to the answers, so patients see different follow-up questions. The result: a customized, numerical description of how patients view their current health.

At the end of a patient’s appointment, the doctor reviews and discusses the PROMIS report. “We may find that things come up that the patient hadn’t thought were important or that the doctor hadn’t asked about,” Bingham says. “The report can identify a new problem that needs to be addressed.”

The research team is now conducting interviews with patients, providers, and staff to explore the value of the patient’s iPad input and the feasibility of using this measurement system in busy practices.

Better Health Outcomes for Chronic Conditions

Bingham says initial feedback from patients is very positive. “We have had instances where it made a difference in identifying a problem,” he adds. “Sometimes, it has changed the treatment decisions.”

Clinicians say they feel comfortable incorporating patients’ numerical evaluations of patient-centered outcomes into their medical practices. “We think this can fundamentally change the way we take care of patients,” Bingham says.

The potential impact of integrating patients’ health assessments into the treatment of chronic conditions is huge. In the United States, an estimated 1.5 million adults have rheumatoid arthritis, and about 133 million Americans—nearly half of all adults—live with at least one chronic illness, according to the Centers for Disease Control and Prevention.

Meaningful improvement in treating such conditions can help millions of patients achieve the health outcomes they want. “Because rheumatoid arthritis has a lot of variability, it’s a perfect choice for putting PROMIS to a real-world test,” Leong says.

Advisory Group Spans the Spectrum

To advise the Hopkins project, Bingham says, “We have brought together patients; healthcare providers; patient organizations; outcomes researchers; psychometricians; industry, regulatory, and government representatives; and professional organizations of physicians and nurses to provide ongoing guidance, ensure project progress, evaluate interim data, and develop plans for dissemination and expansion.”

Leong says, “What we patient advocates bring to the project is the face of reality. Is the PROMIS questionnaire practical for people like me? I can tap into my personal experience as a research team member that then complements the expertise of our researcher leaders.”

The diverse advisory group has encountered challenges. Early on, a survey revealed that the patient members didn’t really feel part of the teleconference discussions. Bingham’s team responded to patients’ hesitancy by coaching them via additional phone calls and educational materials, including a glossary of research terms, so that they could become more active participants. Now, all the partners feel comfortable participating in the teleconferences.

“Everything comes back to the patient,” Bingham says. “We ask, ‘Is this making sense to you? Are we on the right track?’ And sometimes we find that we’re off the mark and need to make corrections as we go along.”

During the development of the iPad app, the patient partners put it to the practical test. For example, the researchers thought that it would be easy for patients to use their fingers to tap. Leong says, “Like me, many patients have almost no hand strength, so tapping can be very painful.  We patient team members suggested that they give patients a stylus with a little rubber tip to make it easier.”

“The beauty of this research project is that it’s very interactive,” Leong concludes. “There’s a lot of respect and a lot of acknowledgement of the patient experience, with all its diversity.”

Posted: April 22, 2014; Updated: February 22, 2016