Results Summary

PCORI funded the Pilot Projects to explore how to conduct and use patient-centered outcomes research in ways that can better serve patients and the healthcare community. Learn more.

Background

When patients have swollen or irritated blood vessels, doctors call it vasculitis. Vasculitis occurs when the body’s immune system attacks blood vessels by mistake. One type of vasculitis is called ANCA-associated vasculitis, or AAV. It is named after the part of the immune system that is not working right. Even with treatment, vasculitis can last for a long time.

It’s important for doctors to learn about the overall health and well-being of patients living with a condition like vasculitis. The Patient-Reported Outcomes Measurement Information System (PROMIS®) provides surveys doctors can use to ask patients about what they are able to do in daily life and how they feel.

Project Purpose

The researchers wanted to find out what matters most to people living with AAV. They also wanted to create a survey that could help doctors to better understand how to treat patients with AAV.

This study had three main goals:

  • To see if surveys from PROMIS include questions about the things that matter most to patients with AAV
  • To create a new method for measuring how AAV affects patients’ daily lives
  • To match AAV symptoms to symptoms listed in the International Classification of Functioning, Disability and Health (ICF). The ICF is a detailed list of ways that the human body functions and how people experience life with their illnesses. It is often used to help researchers think about how to measure health and the impact of illness. The ICF can be used by doctors to choose measures and surveys that help them understand their patients better.

Methods

The researchers did interviews and held discussion groups. They also created a survey and looked at patient health information. The study took place at clinics in the United States, Canada, and the United Kingdom.

The researchers gave the PROMIS surveys to patients with AAV to see if the survey could accurately measure patients’ health outcomes and identify if AAV was still causing symptoms.

The researchers interviewed more than 30 patients with AAV individually and in groups to learn what matters most to them about AAV and to identify what health outcomes they thought were important. They also talked with a committee of experts on AAV about what they thought mattered to patients.

The researchers created a new draft survey, called the AAV-PRO, based on what they heard from the patients and input from the experts. The survey had 35 questions about how AAV affects patients’ lives. Three hundred patients with AAV filled out the AAV-PRO two times, three months apart. The researchers then looked at the patients’ survey answers to see if the survey was accurately measuring patients’ experience with AAV.

Finally, the researches asked an international group of experts who treat AAV to identify the parts of the ICF that matched what patients had said was most important to them.

Findings

The researchers reported that they made progress in

  • Learning how patients with AAV experience their illness and what health outcomes matter to them
  • Finding out if the PROMIS surveys can help doctors know whether a patient is still experiencing symptoms
  • Developing the AAV-PRO, a new survey that is specifically for patients with the condition
  • Finding out what parts of the ICF match up with patients’ experiences with AAV

The researchers believe that it will be possible to use the PROMIS approach to develop a patient-reported outcomes survey for vasculitis.

The researchers found it helpful to include patients in the research process. The researchers learned how to work together with patients and felt it made the study better.

Limitations

The patients who took part in this study spoke English. The results might be different for patients who don’t speak English.

Conclusions

PROMIS surveys worked well for patients with AAV. The new survey, AAV-PRO, was designed to capture information that is specific to AAV. It is ready to be tested. The ICF included many of the things that patients with AAV say matter to them. The ICF can be used to help doctors or researchers figure out how to better measure the impact of AAV on patients.

Sharing the Results

The researchers will provide the study results to the public through websites and newsletters. They will send the results to patients and clinicians in the VCRC Patient Contact Registry, the Vasculitis Patient-Powered Research Network, the Vasculitis Foundation, and Vasculitis United Kingdom. They will present the study to researchers and patients at conferences. The researchers will submit articles about the project to medical journals.

Project Information

Peter A. Merkel, MD, MPH
University of Pennsylvania Perelman School of Medicine
$616,839
Patient-Reported Outcomes for Vasculitis

Key Dates

June 2012
June 2015
2012
2015

Study Registration Information

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Has Results
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State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022