Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause)...

Area of Science:

• Menopause research
• Clinical trial methodology
• Patient-reported outcomes

Background:

• Vasomotor symptoms are a key concern for women during menopause.
• The COMMA (Core Outcomes in Menopause) project identified six core outcomes for evaluating these symptoms.
• Standardized measurement of these outcomes is crucial for clinical research and practice.

Purpose of the Study:

• To identify appropriate definitions and patient-reported outcome measures (PROMs) for six core menopause vasomotor symptom outcomes.
• To establish consensus on the best methods for measuring symptom frequency, severity, distress, sleep impact, treatment satisfaction, and side effects.

Main Methods:

• A systematic literature review identified definitions and PROMs.
• A global consensus process involving 36 experts from 16 countries reviewed and recommended measures.
• PROMs were evaluated for their relevance to core outcomes and measurement properties.

Main Results:

• 40 PROMs were identified, but only four met the criteria for two core outcomes.
• The Hot Flash Related Daily Interference Scale is recommended for measuring distress/bother/interference and sleep impact.
• Six definitions for 'side effects' were reviewed; reporting adverse events is recommended.

Conclusions:

• Suitable PROMs were identified for only three of the six core outcomes.
• No validated PROMs were found for symptom frequency, severity, or treatment satisfaction.
• Development and validation of new PROMs are needed for the remaining core outcomes.