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

IMPORTANCE: Older adults and those with low back pain (LBP) are at increased risk of research-related adverse events (AEs); yet, Cochrane reviews show AE under-reporting in rehabilitation trials. OBJECTIVE: To inform AE practices in future rehabilitation trials, details are provided on novel AE surveillance and reporting practices used in the Manual Therapy and Strengthening for the Hip (MASH) trial. DESIGN: The study design was a secondary analysis of a multisite, single-masked, randomized controlled trial comparing 2 exercise-inclusive interventions. SETTING: The study was conducted at research-based physical therapist sites. PARTICIPANTS: Participants were older adults with moderate-intensity, chronic LBP with hip pain and muscle weakness. INTERVENTIONS OR EXPOSURES: Participants were randomly assigned to receive 16 sessions of hip-focused or spine-focused physical therapy over 8 weeks. Active AE monitoring was facilitated with standardized interviews during each treatment session and at 8-week, 3-, 4-, 5-, and 6-months. Common terminology criteria for AEs classification was used. AEs were adjudicated by a site investigator and reviewed at multisite meetings. MAIN OUTCOMES AND MEASURES: AE classification, relatedness, expectedness, severity, timing, recurrence, duration, and intervention impact were evaluated between interventions. RESULTS: Among 184 participants, there were 243 AEs (n = 128 hip-focused group, n = 115 spine-focused group) in 112 participants; 38.3% were unexpected, with 47 occurring in the hip-focused and 46 in the spine-focused group. AE relatedness, expectedness, and severity were similar between groups. Of the 243 AEs, 157 were mild, 71 were moderate, and 15 were severe/life threatening. Most AEs (80.2%) occurred early and were classified as musculoskeletal and connective tissue disorders (MSKCT), with shorter MSKCT AE duration in the hip-focused group. Within each group, 15 MSKCT AEs resulted in study modification. CONCLUSIONS AND RELEVANCE: This analysis describes a framework to improve upon active AE surveillance during rehabilitation trials to better inform risk-to-benefit analyses. Data can also be used to inform clinical decision-making related to risks from MASH trial interventions.

Duke Scholars

Author Steven Zachary George Orthopaedic Surgery

Author Corey B. Simon Orthopaedic Surgery, Physical Therapy