Pyoderma gangrenosum (PG) is a rare neutrophilic dermatosis that affects approximately 6 out of every 100,000 people. Presently, there are no FDA-approved treatments and patient outcomes are varied. There is growing interest in using newer and more targeted therapeutics to achieve disease remission. However, there are no standardized instruments to measure outcomes in pyoderma gangrenosum and therefore future clinical trials are hampered by the absence of an established and accurate means of assessment and comparison.
Scope of the intended COS
- Study types: RCTs
- Region: Global
A systematic review (Br J Dermatol. 2020 Nov;183(5):821-828) of prior studies on pyoderma gangrenosum instruments and their respective domains has been completed and will inform subsequent steps. We plan to survey physicians taking care of patients with PG, wound care nurses, patients, scientists, and pharmaceutical representatives on what factors in PG they think will be most useful in measuring and reporting in clinical trials. We will then use the Delphi collaborative technique (2-3 rounds) and two virtual consensus meetings to establish the core outcome set domains.
Involvement of stakeholders
- Physicians, scientists, patients, wound care specialists, and industry representatives
- Establishing Core Outcome Domains
- 16 Countries across 4 continents
Date of updates
- Alex G Ortega-Loayza, M.D, M.C.R.
Project team members
- Jonathan Rick, M.D.
- Afsaneh Alavi, M.D., M.Sc.
- Toshiyuki Yamamoto, M.D. Ph.D.
- Angelo Valerio Marzano, M.D.
- Joachim Dissemond, M.D.
- Lisa J Gould, M.D., Ph.D.
- Hans Herfarth, M.D., Ph.D.
- Joel Pekow, M.D.
- Marcia A. Friedman, M.D.
- Amit Garg, M.D.
- Kim Thomas, Ph.D.
Responsible member of Methods group (as assigned by CS-COUSIN)
- Kim Thomas, Ph.D.
- Hobbs, M. M., Byler, R., Latour, E., Bonomo, L., Hennessy, K., Cruz-Diaz, C. N., Shinohara, M. M., Seminario-Vidal, L., Shinkai, K., & Ortega-Loayza, A. G. (2021). Treatment of pyoderma gangrenosum: A multicenter survey-based study assessing satisfaction and quality of life. Dermatologic Therapy, 34(2). https://doi.org/ARTN e1473610.1111/dth.14736
- Ighani, A., Al-Mutairi, D., Rahmani, A., Weizman, A. V., Piguet, V., & Alavi, A. (2019). Pyoderma gangrenosum and its impact on quality of life: a multicentre, prospective study. British Journal of Dermatology, 180(3), 672-673. https://doi.org/10.1111/bjd.17347
- Lu, J. D., Hobbs, M. M., Huang, W. W., Ortega-Loayza, A. G., & Alavi, A. (2020). Identification and evaluation of outcome measurement instruments in pyoderma gangrenosum: a systematic review. British Journal of Dermatology, 183(5), 821-828. https://doi.org/10.1111/bjd.19027