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Background and purpose <p>Radiation dermatitis (RD) is often experienced by cancer patients undergoing radiation therapy (RT) and can negatively impact the quality of life of patients. The Skindex-16 questionnaire is an instrument that measures the impact of skin conditions on patient quality of life. The Skindex-16 has been validated for use in assessing many benign conditions, however it has not yet been validated for the assessment of patient-reported outcomes (PROs) for patients experiencing RD.</p> Materials and methods <p>A group of 42 breast cancer patients enrolled in a StrataXRT study for RD were analyzed. Increases in Skindex-16 scores indicate worsening symptoms. To validate the Skindex-16, scores were compared at baseline, 2&#xa0;weeks, and 3&#xa0;months post-RT. Skindex-16 scores were also compared to scores from the Common Terminology Criteria of Adverse Events (CTCAE) for RD and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS) using various statistical analyses at baseline, 2&#xa0;weeks, and 3&#xa0;months post-RT.</p> Results <p>Skindex-16 scores were found to be low at baseline and 3&#xa0;months post-RT but peaked at 2&#xa0;weeks post-RT. Significant worsening scores from baseline to 2&#xa0;weeks post-RT were found in a longitudinal assessment of Skindex-16 items for several items on the patient portion of the RISRAS, but only two items on the healthcare professional RISRAS component. Skindex-16 scores showed no significant relationship to CTCAE scores.</p> Conclusion <p>This validation of the Skindex-16 questionnaire indicates that it is reliable to be used for the assessment of PROs for cancer patients experiencing RD. However, the PROs assessed by Skindex-16 do not correlate with clinician-reported outcomes.</p>

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Validation of the Skindex-16 questionnaire for assessing patient-reported outcomes in radiation dermatitis among breast cancer patients

  • 期刊论文

  • 发表日期：

    2025年2月14日

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  • Marley Day,
  • Olivia Kuszaj,
  • Liying Zhang,
  • Henry Wong,
  • S. F. Lee,
  • Jennifer Kwan,
  • Alyssa Wang,
  • Sarah Bayrakdarian,
  • Irene Karam,
  • William Tran,
  • Edward Chow

摘要

Background and purpose

Radiation dermatitis (RD) is often experienced by cancer patients undergoing radiation therapy (RT) and can negatively impact the quality of life of patients. The Skindex-16 questionnaire is an instrument that measures the impact of skin conditions on patient quality of life. The Skindex-16 has been validated for use in assessing many benign conditions, however it has not yet been validated for the assessment of patient-reported outcomes (PROs) for patients experiencing RD.

Materials and methods

A group of 42 breast cancer patients enrolled in a StrataXRT study for RD were analyzed. Increases in Skindex-16 scores indicate worsening symptoms. To validate the Skindex-16, scores were compared at baseline, 2 weeks, and 3 months post-RT. Skindex-16 scores were also compared to scores from the Common Terminology Criteria of Adverse Events (CTCAE) for RD and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS) using various statistical analyses at baseline, 2 weeks, and 3 months post-RT.

Results

Skindex-16 scores were found to be low at baseline and 3 months post-RT but peaked at 2 weeks post-RT. Significant worsening scores from baseline to 2 weeks post-RT were found in a longitudinal assessment of Skindex-16 items for several items on the patient portion of the RISRAS, but only two items on the healthcare professional RISRAS component. Skindex-16 scores showed no significant relationship to CTCAE scores.

Conclusion

This validation of the Skindex-16 questionnaire indicates that it is reliable to be used for the assessment of PROs for cancer patients experiencing RD. However, the PROs assessed by Skindex-16 do not correlate with clinician-reported outcomes.