PMID- 20195203
OWN - NLM
STAT- MEDLINE
DCOM- 20100709
LR  - 20191210
IS  - 1528-1159 (Electronic)
IS  - 0362-2436 (Linking)
VI  - 35
IP  - 7
DP  - 2010 Apr 1
TI  - Spine adverse events severity system: content validation and interobserver 
      reliability assessment.
PG  - 790-5
LID - 10.1097/BRS.0b013e3181bf25a3 [doi]
AB  - STUDY DESIGN: A prospective validation study, preliminary single-center report. 
      OBJECTIVE: The purpose of this study was to assess the content validity and 
      interobserver reliability of a simple severity classification system for adverse 
      events (AEs) associated with spinal surgery. SUMMARY OF BACKGROUND DATA: In the 
      surgical literature what is defined as an AE, the severity of an AE, and the 
      reporting of AEs are variable. Consequently, valid comparison of AEs within or 
      among specialties or surgical centers for the same or different procedures is 
      often impossible. METHODS: Since 2002, a Spine Adverse Events Severity system 
      (SAVES) has been locally developed and prospectively used. AEs were graded as I 
      (requires none/minimal treatment, minimal effect [<1-2 days] on length of stay 
      [LOS]), II (requires treatment and/or increases LOS [3-7 days] with no long-term 
      sequelae), III (requires treatment and/or increased LOS [>7 days] with long-term 
      sequelae [>6 months]), and IV (death). Content validity of the grading system was 
      assessed using the hospital chart abstraction (current defacto gold standard) 
      compared with the SAVES from 200 randomly selected patients. Interobserver 
      reliability was assessed in consecutive operative cases for 1 spine surgeon 
      during a 1-year period (2006) using 3 raters (staff surgeon, fellow, and/or 
      resident). RESULTS: The prospectively administered form reported a higher number 
      of surgical AEs (n = 43 vs. n = 30) and a similar number of medical AEs (n = 31 
      vs. n = 27). Compared with the chart, the AE form displayed substantial agreement 
      for number (70%; weighted Kappa [wK] = 0.60) and type (75%; wK = 0.67) of AE. The 
      interobserver reliability was near perfect (kappa = 0.8) for the actual grade of 
      AE and moderate (kappa = 0.5) for the criteria behind the grading (i.e., clinical 
      effect of the AE or the effect of the AE on LOS or both). CONCLUSION: The result 
      of this study demonstrates improved capture of surgical AEs using SAVES. 
      Excellent interobserver reliability between surgeons at different level of 
      training was demonstrated with minimal education or training regarding the use of 
      SAVES.
FAU - Rampersaud, Yoga Raja
AU  - Rampersaud YR
AD  - Division of Orthopaedic and Neurosurgery, Department of Surgery, University of 
      Toronto, Toronto, Ontario, Canada. raja.rampersaud@uhn.on.ca
FAU - Neary, Mary Ann
AU  - Neary MA
FAU - White, Kevin
AU  - White K
LA  - eng
PT  - Journal Article
PT  - Validation Study
PL  - United States
TA  - Spine (Phila Pa 1976)
JT  - Spine
JID - 7610646
SB  - IM
MH  - Humans
MH  - Medical Records
MH  - Observer Variation
MH  - Orthopedic Procedures/*adverse effects
MH  - Outcome Assessment, Health Care/*standards
MH  - Prospective Studies
MH  - Reproducibility of Results
MH  - Spine/*surgery
EDAT- 2010/03/03 06:00
MHDA- 2010/07/10 06:00
CRDT- 2010/03/03 06:00
PHST- 2010/03/03 06:00 [entrez]
PHST- 2010/03/03 06:00 [pubmed]
PHST- 2010/07/10 06:00 [medline]
AID - 10.1097/BRS.0b013e3181bf25a3 [doi]
PST - ppublish
SO  - Spine (Phila Pa 1976). 2010 Apr 1;35(7):790-5. doi: 10.1097/BRS.0b013e3181bf25a3.