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

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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.

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Notes

  1. The Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group, which is an international collaboration dedicated to developing dermatologic core outcome sets [16, 17].

Abbreviations

COMET:

Core outcome measures in effectiveness trials

COS:

Core outcome set

CS-COUSIN:

Cochrane Skin—Core Outcome Set Initiative

HOME:

Harmonizing outcome measures for eczema

IMPROVED:

Measurement of Priority Outcome Variables in Dermatologic Surgery group

GRADE:

Grading of recommendations assessment, development and evaluation

FDA:

US Food and Drug Administration

EMA:

European Medicines Agency

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Funding

This publication was supported by Merz Center for Quality and Outcomes Research in Dermatologic Surgery and the IMPROVED (Measurement of Priority Outcome Variables in Dermatologic Surgery) Group.

Author information

Authors and Affiliations

  1. Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N Saint Clair Street, Suite 1600, Chicago, IL, 60611, USA

    Bianca Y. Kang, Sarah A. Ibrahim, Divya Shokeen, Emily Poon & Murad Alam

  2. Division of Dermatology, Department of Internal Medicine, Washington University in St. Louis, St. Louis, MO, USA

    Daniel I. Schlessinger

  3. Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK

    Jamie J. Kirkham

  4. Centre for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany

    Jochen Schmitt

  5. Department of Dermatology, University of Minnesota, Minneapolis, MN, USA

    Ian A. Maher

  6. Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA

    Joseph F. Sobanko

  7. Division of Dermatologic Surgery, University of Pennsylvania, Philadelphia, PA, USA

    Joseph F. Sobanko

  8. Department of Dermatology, Penn State Health, Hershey, PA, USA

    Todd V. Cartee

  9. Department of Otolaryngology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Murad Alam

  10. Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Murad Alam

Authors
  1. Bianca Y. Kang
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  2. Sarah A. Ibrahim
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  3. Divya Shokeen
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  4. Daniel I. Schlessinger
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  5. Jamie J. Kirkham
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  6. Jochen Schmitt
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  7. Emily Poon
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  8. Ian A. Maher
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  9. Joseph F. Sobanko
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  10. Todd V. Cartee
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  11. Murad Alam
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Contributions

Study concept and design: BYK, SAI, DS, DIS, JS, JJK, IAM, JFS, TVC, EP, and MA. Drafting of the manuscript: BYK, SAI, EP, and MA. Critical revision of the manuscript for important intellectual content: BYK, SAI, JJK, EP, and MA obtained funding: MA. Study supervision: MA. All the authors read and approved the final manuscript.

Corresponding author

Correspondence to Murad Alam.

Ethics declarations

Conflict of interest

None of the authors has personal or financial relationships with other people or organizations that may influence their interpretation of data or presentation of information. Several of the authors (JFS, TVC, IAN, JJK, KS, and MA) have been involved also in the development of other core outcome sets, and several (JK, JS, and MA) are members of the CS-COUSIN Methods group.

Ethical approval

Ethics approval has been given from the Northwestern University Institutional Review Board (IRB) protocol ID: STU00201637.

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Informed consent will be obtained from all participants prior to enrollment.

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Kang, B.Y., Ibrahim, S.A., Shokeen, D. et al. Postinflammatory hyperpigmentation: protocol for development of a core outcome set for clinical trials. Arch Dermatol Res 314, 357–361 (2022). https://doi.org/10.1007/s00403-021-02239-6

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  • DOI: https://doi.org/10.1007/s00403-021-02239-6

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