Postinflammatory hyperpigmentation: protocol for development of a core outcome set for clinical trials

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Bianca Y Kang - , Feinberg School of Medicine (Author)
  • Sarah A Ibrahim - , Feinberg School of Medicine (Author)
  • Divya Shokeen - , Feinberg School of Medicine (Author)
  • Daniel I Schlessinger - , Washington University St. Louis (Author)
  • Jamie J Kirkham - , University of Manchester (Author)
  • Jochen Schmitt - , Center for Evidence-Based Healthcare (Author)
  • Emily Poon - , Feinberg School of Medicine (Author)
  • Ian A Maher - , University of Minnesota System (Author)
  • Joseph F Sobanko - , University of Pennsylvania (Author)
  • Todd V Cartee - , Pennsylvania State College of Medicine (PSCOM) (Author)
  • Murad Alam - , Feinberg School of Medicine (Author)

Abstract

Postinflammatory hyperpigmentation (PIH) is a disorder of pigmentation that is a common presenting complaint, especially in individuals with skin of color. It is associated with a significant psychological burden and decrement of quality of life. Management options include photoprotection, topical lightening agents, and lasers and energy devices. Clinical trials of melasma report a diversity of outcomes, which often impedes synthesis of results across trials, or comparison of results associated with different treatment modalities. This protocol describes the design of a consensus process that would culminate in the development of a core set of outcomes to be assessed in all clinical trials for PIH. A long list of candidate outcomes will be developed through a systematic review, combined with semi-structured interviews with various stakeholders, including patients, scientists, regulators, and health care professionals. This long list of outcomes will be reviewed and refined by a steering committee. Then two rounds of Delphi surveys of patient and physician groups, respectively, will be used to cull the list, with provisional inclusion of those items deemed "important" by 70% of the respondents. A consensus meeting will be held virtually or in person to vote on these items, and also to consider any changes necessary before acceptance of a final core outcome set. Development of a core outcome set for PIH is expected to improve and standardize outcomes reporting in current and future clinical trials. This, in turn, may facilitate aggregation of research results and permit comparison of outcomes across multiple studies.

Details

Original languageEnglish
Pages (from-to)357-361
Number of pages5
JournalArchives of dermatological research
Volume314
Issue number4
Publication statusPublished - May 2022
Peer-reviewedYes

External IDs

Scopus 85106406706

Keywords

Keywords

  • Clinical Trials as Topic, Delphi Technique, Humans, Melanosis, Outcome Assessment, Health Care/methods, Quality of Life, Research Design, Treatment Outcome

Library keywords