Adverse Events in the MASH Randomized Controlled Trial With Detailed Reporting of Musculoskeletal and Connective...

Area of Science:

• Rehabilitation Medicine
• Clinical Trial Methodology
• Patient Safety

Background:

• Older adults and individuals with low back pain (LBP) face higher risks of adverse events (AEs) during research.
• Existing Cochrane reviews indicate under-reporting of AEs in rehabilitation trials.
• Effective AE surveillance is crucial for patient safety and accurate risk-benefit analysis in clinical research.

Purpose of the Study:

• To present and evaluate novel AE surveillance and reporting practices implemented in the Manual Therapy and Strengthening for the Hip (MASH) trial.
• To provide a framework for enhancing AE monitoring in future rehabilitation studies.
• To inform clinical decision-making regarding potential risks associated with hip-focused and spine-focused physical therapy interventions.

Main Methods:

• Secondary analysis of a multisite, single-masked, randomized controlled trial comparing two exercise-inclusive interventions.
• Active AE monitoring through standardized interviews during sessions and at multiple follow-up points (8 weeks to 6 months).
• Classification of AEs using common terminology criteria, with adjudication by investigators and multisite review.

Main Results:

• 243 AEs were reported in 112 out of 184 participants; 38.3% were unexpected.
• AE relatedness, expectedness, and severity were comparable between the hip-focused and spine-focused physical therapy groups.
• Most AEs (80.2%) were mild and occurred early, primarily classified as musculoskeletal and connective tissue disorders (MSKCT), with shorter duration in the hip-focused group.

Conclusions:

• The study outlines a framework for improved active AE surveillance in rehabilitation trials, enhancing risk-to-benefit assessments.
• The findings contribute to better understanding and management of AEs in physical therapy interventions for chronic LBP and hip pain.
• The developed framework can inform clinical practice and guide future research protocols for AE monitoring.