PMID- 29095407
OWN - NLM
STAT- MEDLINE
DCOM- 20181105
LR  - 20221005
IS  - 1528-1159 (Electronic)
IS  - 0362-2436 (Print)
IS  - 0362-2436 (Linking)
VI  - 43
IP  - 11
DP  - 2018 Jun 1
TI  - Serious Adverse Events Significantly Reduce Patient-Reported Outcomes at 2-Year 
      Follow-up: Nonoperative, Multicenter, Prospective NIH Study of 105 Patients.
PG  - 747-753
LID - 10.1097/BRS.0000000000002479 [doi]
AB  - 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.
FAU - Pugely, Andrew J
AU  - Pugely AJ
AD  - Washington University in St. Louis School of Medicine; St. Louis, MO.
FAU - Kelly, Michael P
AU  - Kelly MP
AD  - Washington University in St. Louis School of Medicine; St. Louis, MO.
FAU - Baldus, Christine R
AU  - Baldus CR
AD  - Washington University in St. Louis School of Medicine; St. Louis, MO.
FAU - Gao, Yubo
AU  - Gao Y
AD  - Washington University in St. Louis School of Medicine; St. Louis, MO.
FAU - Zebala, Lukas
AU  - Zebala L
AD  - Washington University in St. Louis School of Medicine; St. Louis, MO.
FAU - Shaffrey, Christopher
AU  - Shaffrey C
AD  - University of Virginia; Charlottesville, VA.
FAU - Glassman, Steven
AU  - Glassman S
AD  - University of Louisville; Louisville, KY.
FAU - Boachie-Adjei, Oheneba
AU  - Boachie-Adjei O
AD  - Hospital for Special Surgery; New York, NY.
FAU - Parent, Stefan
AU  - Parent S
AD  - Sainte-Justine University Hospital; Montreal, Quebec, Canada.
FAU - Lewis, Stephen
AU  - Lewis S
AD  - UHN Orthopaedics-Toronto Western Hospital; Toronto, Ontario, Canada.
FAU - Koski, Tyler
AU  - Koski T
AD  - Northwestern University; Chicago, IL.
FAU - Edwards, Charles 2nd
AU  - Edwards C 2nd
AD  - Maryland Spine Center; Baltimore, MD.
FAU - Schwab, Frank
AU  - Schwab F
AD  - Brooklyn Spine Center; New York, NY.
FAU - Bridwell, Keith H
AU  - Bridwell KH
AD  - Washington University in St. Louis School of Medicine; St. Louis, MO.
LA  - eng
GR  - R01 AR055176/AR/NIAMS NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Spine (Phila Pa 1976)
JT  - Spine
JID - 7610646
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Conservative Treatment
MH  - Disability Evaluation
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Reported Outcome Measures
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Scoliosis/*therapy
PMC - PMC5930151
MID - NIHMS915706
EDAT- 2017/11/03 06:00
MHDA- 2018/11/06 06:00
PMCR- 2019/06/01
CRDT- 2017/11/03 06:00
PHST- 2017/11/03 06:00 [pubmed]
PHST- 2018/11/06 06:00 [medline]
PHST- 2017/11/03 06:00 [entrez]
PHST- 2019/06/01 00:00 [pmc-release]
AID - 00007632-201806010-00004 [pii]
AID - 10.1097/BRS.0000000000002479 [doi]
PST - ppublish
SO  - Spine (Phila Pa 1976). 2018 Jun 1;43(11):747-753. doi: 
      10.1097/BRS.0000000000002479.