Serious Adverse Events Significantly Reduce Patient-Reported Outcomes at 2-Year Follow-up: Nonoperative Multicenter Prospective NIH Study of 105 Patients.

Serious Adverse Events Significantly Reduce Patient-Reported Outcomes at 2-Year Follow-up: Nonoperative Multicenter Prospective NIH Study of 105 Patients.

Spine (Phila Pa 1976). 2017 Oct 31;:

Authors: Pugely AJ, Kelly MP, Baldus CR, Gao Y, Zebala L, Shaffrey C, Glassman S, Boachie-Adjei O, Parent S, Lewis S, Koski T, Edwards C, Schwab F, Bridwell KH

Abstract
STUDY DESIGN: This is an analysis of a prospective 2-year study on nonoperative patients enrolled in the Adult Symptomatic Lumbar Scoliosis (ASLS) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) trial.
OBJECTIVE: The purpose was to evaluate the impact of serious adverse events (SAEs) on patient-reported outcomes (PROs) in nonoperative management of ASLS as measured by Scoliosis Research Society-22r (SRS-22r), Oswestry Disability Index (ODI) and Short Form-12 (SF-12) at 2-year follow-up.
SUMMARY OF BACKGROUND DATA: Little is known about PROs in the nonoperative management of ASLS or the prevalence and impact of SAEs on PROs.
METHODS: The ASLS trial dataset was analyzed to identify adult lumbar scoliosis patients electively choosing or randomly assigned to nonoperative treatment with minimum 2-year follow-up. Patient data was collected prospectively from 2010-2015 as part of NIAMS R01-AR055176-01A2 "A Multi-Centered Prospective Study of Quality of Life in Adult Scoliosis". SAEs were defined as life threatening medical events, new significant or permanent disability, new or prolonged hospitalization or death.
RESULTS: 105 nonoperative patients were studied to 2-year follow-up. Twenty-seven patients (25.7%) had 42 SAEs; 15 (14.3%) had a SAE during the first year. The SAE group had higher body mass index (29.4 vs 25.2; p=0.008) and reported worse SRS-22r Function scores than the non-SAE group at baseline (3.3 vs 3.6; p=0.024). At 2-year follow-up, SAE patients experienced less improvement (change) in SRS-22r Self-Image (-0.07 vs 0.26; p=0.018) and Mental Health domains (-0.19 vs 0.25; p=0.002) than non-SAE patients and had lower SRS-22r Function, Self-Image, Subscore and SF-12 Mental and Physical component scores (MCS/PCS). Fewer SAE patients reached Minimal Clinically Important Difference (MCID) threshold in SRS-22r Mental Health (14.8% vs 43.6%; p=0.01).
CONCLUSIONS: A high percentage (25.7%) of ASLS patients managed nonoperatively experienced SAEs. Those patients who sustained a SAE had less improvement in reported outcomes.
LEVEL OF EVIDENCE: Level 2.

PMID: 29095407 [PubMed - as supplied by publisher]

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