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Core Outcome Set for the Post-Inflammatory Hyperpigmentation (PIH)

Condition

post-inflammatory hyperpigmentation (PIH)

Background

The development of post-inflammatory hyperpigmentation (PIH) is a final common result that follows many inflammatory skin processes. Once the acute, inciting event is past, PIH may manifest as an independent diagnosis, and be treated similarly regardless of cause.   Treatment of PIH remains challenging, with amelioration often being slow and subtle.   Sensitive and standardized outcomes are needed to track the evolution, and regression of PIH.   In particular, a standardized outcome set is necessary to reliably and precisely compare the benefits and limitations of the many types of treatments, including topical applications and energy devices, that have been employed.

Scope of the intended COS

  • Study types: e.g. RCTs: RCTs or Controlled Clinical Trials
  • Region, e.g. global scope: Global scope

Methods

We aim to develop a core outcome set by (1) identifying all current outcomes from a systematic review of literature; (2) involving other stakeholder groups such as other clinicians, and regulators to participate in identifying additional outcomes; (3) conducting Delphi consensus exercises on the identified outcomes; (4) presenting all results from the Delphi exercises during a face-to-face (if possible) consensus meeting to vote and agree upon a core set of outcomes important for PIH research.

Involvement of stakeholders

Stakeholders, or those invested in the development of a core outcome set, will also be included in the decision process, along with patients. Dermatologists, and industry scientists associated treatments for PIH are potential members that can provide input regarding what outcomes they feel should be represented. Nurses, physician assistants, and other health care practitioners may be included as well to enhance further discussion.

Current status

Protocol development

Funding

Departmental research funds

Involved Countries

International

Date of updates

  • 10/08/2020

Lead

  • Murad Alam, MD

Project team members

Steering Committee:

  • Murad Alam, MD
  • Joseph F. Sobanko, MD
  • Ian A. Maher, MD
  • Todd V. Cartee, MD

Responsible member of Methods group (as assigned by CS-COUSIN)

  • Jamie Kirkham, PhD

Contact

Murad Alam, MD (m-alam@northwestern.edu)

Published references

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