Core Outcome Set for Actinic Keratosis Clinical Trials.

Area of Science:

• Dermatology
• Clinical Trials Methodology
• Evidence Synthesis

Background:

• Actinic keratosis (AK) treatments show varied effectiveness in clinical trials.
• Inconsistent outcome reporting hinders cross-study comparisons and systematic reviews.
• A standardized approach is needed to evaluate AK treatments effectively.

Purpose of the Study:

• To establish an international core outcome set for clinical studies on actinic keratosis (AK) treatment.
• To facilitate consistent and comparable results across AK treatment trials.
• To improve the synthesis of treatment effectiveness in systematic reviews.

Main Methods:

• Systematic literature review of AK treatment studies (1980-2015).
• Two-round e-Delphi consensus surveys involving physician and patient stakeholders.
• Consensus criteria required at least 70% agreement and a mean score of 7.5 for outcome inclusion.

Main Results:

• Identified 516 potential outcomes, with 137 included in Delphi surveys.
• Six core outcomes reached consensus: complete clearance, percentage cleared, adverse events, patient effectiveness perspective, future treatment preference, and recurrence rate.
• Recommendations for assessment timing of treatment response and recurrence were established.

Conclusions:

• A consensus-based core outcome set for actinic keratosis (AK) treatment trials was successfully established.
• This core set will standardize outcome reporting in future AK clinical studies.
• Further research is needed to define specific outcome measures for each consensus outcome.