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-22 (SRS-22), 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 were collected prospectively from 2010 to 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: One hundred five 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-22 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-22 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-22 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-22 Mental Health (14.8% vs. 43.6%; P = 0.01). CONCLUSION: 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: 2.
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-22 (SRS-22), 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 were collected prospectively from 2010 to 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: One hundred five 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-22 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-22 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-22 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-22 Mental Health (14.8% vs. 43.6%; P = 0.01). CONCLUSION: 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: 2.
Authors: Alexandra Soroceanu; Bassel G Diebo; Douglas Burton; Justin S Smith; Vedat Deviren; Christopher Shaffrey; Han Jo Kim; Gregory Mundis; Christopher Ames; Thomas Errico; Shay Bess; Richard Hostin; Robert Hart; Frank Schwab; Virginie Lafage Journal: Spine (Phila Pa 1976) Date: 2015-09-15 Impact factor: 3.468
Authors: Keith H Bridwell; Christine Baldus; Sigurd Berven; Charles Edwards; Steven Glassman; Christopher Hamill; William Horton; Lawrence G Lenke; Stephen Ondra; Frank Schwab; Christopher Shaffrey; David Wootten Journal: Spine (Phila Pa 1976) Date: 2010-09-15 Impact factor: 3.468
Authors: Justin S Smith; Christopher I Shaffrey; Sigurd Berven; Steven Glassman; Christopher Hamill; William Horton; Stephen Ondra; Frank Schwab; Michael Shainline; Kai-Ming Fu; Keith Bridwell Journal: Neurosurgery Date: 2009-07 Impact factor: 4.654
Authors: Alex Soroceanu; Douglas C Burton; Bassel Georges Diebo; Justin S Smith; Richard Hostin; Christopher I Shaffrey; Oheneba Boachie-Adjei; Gregory M Mundis; Christopher Ames; Thomas J Errico; Shay Bess; Munish C Gupta; Robert A Hart; Frank J Schwab; Virginie Lafage Journal: J Neurosurg Spine Date: 2015-07-31
Authors: Shian Liu; Bassel G Diebo; Jensen K Henry; Justin S Smith; Richard Hostin; Matthew E Cunningham; Gregory Mundis; Christopher P Ames; Douglas Burton; Shay Bess; Behrooz Akbarnia; Robert Hart; Peter G Passias; Frank J Schwab; Virginie Lafage Journal: Spine J Date: 2015-10-31 Impact factor: 4.166
Authors: Justin S Smith; Christopher I Shaffrey; Michael P Kelly; Elizabeth L Yanik; Jon D Lurie; Christine R Baldus; Charles Edwards; Steven D Glassman; Lawrence G Lenke; Oheneba Boachie-Adjei; Jacob M Buchowski; Leah Y Carreon; Charles H Crawford; Thomas J Errico; Stephen J Lewis; Tyler Koski; Stefan Parent; Han Jo Kim; Christopher P Ames; Shay Bess; Frank J Schwab; Keith H Bridwell Journal: Spine (Phila Pa 1976) Date: 2019-09-01 Impact factor: 3.241