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Developing a Core Outcome Set for Netherton Syndrome: An International Multi-Stakeholder e-Delphi Consensus Study.

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Summary
This summary is machine-generated.

Netherton syndrome (NS) patients need a standardized way to measure treatment success. This study developed a core outcome set (COS) of 21 outcomes across 10 domains to improve clinical care and research for NS.

Keywords:
Core outcome setNetherton syndromeOutcomeSPINK5e-Delphi

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Area of Science:

  • Dermatology and Genetics
  • Rare Disease Research
  • Clinical Trial Methodology

Background:

  • Netherton syndrome (NS) is a severe genetic disorder affecting skin maturation due to SPINK5 gene variants.
  • NS causes significant skin barrier impairment, necessitating effective treatment strategies.
  • Current treatment outcome reporting lacks standardization, hindering guideline development.

Purpose of the Study:

  • To establish a consensus-based Core Outcome Set (COS) for Netherton syndrome.
  • To standardize outcome measurement in NS clinical care and research.
  • To facilitate the development of evidence-based treatment guidelines for NS.

Main Methods:

  • Literature search and classification of potential outcomes.
  • Expert group discussions at the 2nd International Netherton Congress.
  • Two-round e-Delphi survey with 41 international stakeholders.
  • Online consensus meeting to finalize the COS.

Main Results:

  • A Core Outcome Set (COS) comprising 21 outcomes across 10 domains was established.
  • Domains include skin, sensation, treatment side-effects, vitality, emotional functioning, physical development, nutrition, infections, allergies, and assessment results.
  • The COS reflects the multifaceted impact of NS beyond skin manifestations.

Conclusions:

  • Consensus on 21 outcomes provides a standardized framework for NS research and clinical practice.
  • The COS emphasizes the need for a multidisciplinary approach to managing NS.
  • Implementation of the COS will enable comparable study results and guide future treatment recommendations.