• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Johns Hopkins Rheumatology

Show Search
Hide Search
  • About Us
    • Our History
    • Our Faculty
    • Rheumatology Fellowship
    • Administrative Core
    • Contact Us
    • eNews Signup
  • Make an Appointment
    • Clinic Information
    • Specialty Clinics
  • Our Research
    • Current Research Studies
    • Andrade Lab
    • Antiochos Lab
    • Casciola-Rosen Lab
    • Darrah Lab
    • Konig Lab
    • RDRCC
    • Bayview Immunomics Core (BIC)
  • Charitable Giving
    • Dr. John Welton Fellowship in Rheumatology
    • Dr. Ira T. Fine Discovery Fund
    • Dr. Nadia D. Morgan Memorial Fund
  • News
    • LEAP Magazine
  • Education
    • Advances in the Diagnosis and Treatment of the Rheumatic Diseases Course
    • RheumTV – Patient Education Video Library
Home / News / Research / Patients and doctors decide what to measure in clinical trials for Psoriatic Arthritis

Patients and doctors decide what to measure in clinical trials for Psoriatic Arthritis

October 12, 2016 By Erika Darrah

Summary

In an international effort including Dr. Ana-Maria Orbai, M.D., M.H.S. from the Johns Hopkins Division of Rheumatology, patients and physicians came together to agree on what characteristics are critical to be measured in psoriatic arthritis clinical trials. The characteristics that are measured in clinical trials tells us how effective a drug is in treating psoriatic arthritis. For example, we currently record the number of tender and swollen joints in psoriatic arthritis, and an effective drug will reduce this number after treatment. But while joint inflammation is important to measure, it is not the only important outcome to monitor in psoriatic arthritis clinical trials, especially from the patients’ point of view. This project was critical in defining what outcomes are important for both patients and their doctors.

Why was this study done?

The impact of psoriatic arthritis on the lives of patients living with this disease is not fully measured in current clinical trials. This study was important to include the perspective of patients living with psoriatic arthritis, in addition to doctors’, in deciding how to tell that a therapy is effective for treating psoriatic arthritis. This is extremely important if we want patients to be truly involved in medical decisions about their health and treatments.

How was this study done?

The study consisted of multiple steps. Step 1: international focus groups with patients in 6 countries who told us how psoriatic arthritis affects their life. Step 2: systematic literature review of what has been measured to date in psoriatic arthritis clinical trials. Step 3: results from the first two steps were assembled in a list of outcomes (example fatigue, swollen joints, etc) which was sent to patients and physicians separately to vote on how important each outcome on the list is to them. Step 4: results from step 3 were discussed in a face-to-face meeting of 12 patients and physicians with a neutral moderator who used the “nominal group technique” to ensure that the voice of each participant was taken into consideration. At the end of this phase, 10 critical outcomes were agreed on by both patients and physicians and a few additional outcomes were considered important but not mandatory to measure. Step 5: The 10 outcomes were sent for voting again separately to patients and physicians. At the end of this phase, results were presented at the international conference Outcome Measures in Rheumatology for voting and endorsement.

What were the major findings?

PsA-Core-Domains-Figure-3

As shown on the right, this study identified eight outcomes that were voted as critical to be measured in every clinical trial (inner core), four voted important but not mandatory for every clinical trial (middle core), and four others that were deemed important but require further study (research agenda).  From this, we learned that the perspectives of patients and physicians are different when considering the importance of outcomes in psoriatic arthritis. Both perspectives are important to consider in order to select a truly relevant set of outcomes which best measures the impact of a therapy.  In addition, we learned that patients value improvements in fatigue, social participation, and emotional well-being in addition to improvements valued by both patients and physicians including pain, joint swelling, skin disease, inflammation, physical function and damage.

What is the impact of this work?

Clinical trials measuring these outcomes will include these results in the description of drug effectiveness for treating the symptoms of psoriatic arthritis that are important to patients as well as physicians. This will allow a better discussion of therapy options between patients and their physicians and enable personalized treatment decisions.

This research was supported by:

The Rheumatic Disease Research Core Center at the Johns Hopkins Division of Rheumatology and the P30 award sponsored by the National Institutes of Health.

Link to original research article:

International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Orbai AM, de Wit M, Mease P, Shea JA, Gossec L, Leung YY, Tillett W, Elmamoun M, Callis Duffin K, Campbell W, Christensen R, Coates L, Dures E, Eder L, FitzGerald O, Gladman D, Goel N, Grieb SD, Hewlett S, Hoejgaard P, Kalyoncu U, Lindsay C, McHugh N, Shea B, Steinkoenig I, Strand V, Ogdie A. Ann Rheum Dis. 2016 Sep 9.

Receive the Latest News from Johns Hopkins Rheumatology

Receive the Latest News from Johns Hopkins Rheumatology

Join our mailing list to receive the latest news and updates from Johns Hopkins Rheumatology.

Interested In

You have Successfully Subscribed!

Filed Under: Research Tagged With: Featured 2

Erika Darrah

Erika Darrah, Ph.D. is an Assistant Professor of Medicine in the Johns Hopkins University Division of Rheumatology with an interest understanding the mechanisms that drive the development of rheumatic diseases.

Use of this Site

All information contained within the Johns Hopkins Division of Rheumatology website is intended for educational purposes only. Physicians and other health care professionals are encouraged to consult other sources and confirm the information contained within this site. Consumers should never disregard medical advice or delay in seeking it because of something they may have read on this website.

Primary Sidebar

  • Our History
  • Our Faculty
  • Administrative Core
  • Contact Us
  • eNews Signup

Rheumatology News

RheumTV Logo

Rheum.TV is an educational platform created to help patients living with a rheumatic disease. With over 100 disease education videos produced by the team at Johns Hopkins Rheumatology.

Visit RheumTV

Footer

Rheumatology Specialty Care Centers

  • Johns Hopkins Arthritis Center
  • Johns Hopkins Lupus Center
  • Johns Hopkins Lyme Disease Research Center
  • Johns Hopkins Myositis Center
  • Johns Hopkins Scleroderma Center
  • Johns Hopkins Sjögren’s Syndrome Center
  • Johns Hopkins Vasculitis Center

Connect with Us

  • Facebook
  • Twitter
  • YouTube
U.S. News and World Report Rankings Badge

Johns Hopkins Medicine

© 2025 Johns Hopkins Rheumatology - Patient Privacy