How Pragmatic Are Sarcopenia Intervention Studies? A Systematic Review

Area of Science:

• Gerontology
• Clinical Trials
• Muscle Physiology

Background:

• Sarcopenia is an age-related muscle disease impacting mobility and cognition, often limiting treatment adherence in older adults.
• While sarcopenia is reversible, many randomized controlled trials (RCTs) use explanatory designs, limiting real-world applicability.
• Pragmatic trials are crucial for reflecting clinical practice complexities and improving treatment adherence.

Purpose of the Study:

• To assess the pragmatism level of current sarcopenia RCTs.
• To identify design gaps hindering real-world applicability and clinical relevance.
• To inform future trial designs for improved feasibility and effectiveness.

Main Methods:

• A systematic review of sarcopenia RCTs published until March 2024 was conducted.
• The PRECIS-2 tool assessed trial pragmatism across 10 domains.
• Subgroup analyses examined the impact of intervention type, location, sample size, duration, and sarcopenia definition.

Main Results:

• 54 RCTs were analyzed, with a mean PRECIS-2 score of 2.93, indicating a balance between explanatory and pragmatic features.
• Organization, recruitment, and primary outcomes were most pragmatic; eligibility, adherence, and follow-up were most explanatory.
• Studies from Asia and those using Asian sarcopenia criteria demonstrated higher pragmatism.

Conclusions:

• A significant gap persists between explanatory and pragmatic designs in sarcopenia trials.
• Current trials often lack real-world applicability due to overly controlled eligibility, adherence, and follow-up.
• Enhancing trial pragmatism is essential for generating robust and clinically relevant evidence for sarcopenia management.