PMID- 20171937
OWN - NLM
STAT- MEDLINE
DCOM- 20100618
LR  - 20220317
IS  - 1878-1632 (Electronic)
IS  - 1529-9430 (Linking)
VI  - 10
IP  - 4
DP  - 2010 Apr
TI  - Assessment of spine surgery outcomes: inconsistency of change amongst outcome 
      measurements.
PG  - 291-6
LID - 10.1016/j.spinee.2009.12.027 [doi]
AB  - BACKGROUND CONTEXT: Outcomes of spinal treatments are evaluated by clinical 
      relevance: the proportion of patients who reach a minimum clinically important 
      outcome change. Outcomes are evaluated through multiple measurements, and the 
      inconsistency of outcome change across measurements is not known. PURPOSE: The 
      primary purpose of this study was to illustrate outcome inconsistencies after 
      spinal surgery. Secondary goals of this study were to develop an index of overall 
      change that incorporates outcome inconsistencies, to relate the index of overall 
      change to patients' global assessment and satisfaction with treatment, to relate 
      the index of global change to an intuitively understandable outcome: the level of 
      tolerable pain. STUDY DESIGN: This study is a review of prospectively collected 
      patient-reported outcomes data. PATIENT SAMPLE: Four hundred sixty patients from 
      a large multicenter database were chosen. Those patients were included in the 
      sample because they had undergone lumbar surgery and had baseline and 1-year 
      follow-up scores. Baseline and 1-year follow-up scores for Oswestry Disability 
      Index (ODI), physical component summary (PCS) of the Medical Outcome Study Short 
      Form-36 (SF-36), numerical back and leg pain scales, and 1-year scores for 
      satisfaction with results were included in the study. OUTCOME MEASURES: The 
      outcome measures of the study were preoperative and 1-year postoperative scores 
      for ODI, PCS, back pain scale, leg pain scale, health transition item of the 
      SF-36, and satisfaction with results scales. METHODS: Oswestry Disability Index, 
      SF-36, and pain scales were administered before and 1 year after spinal surgery. 
      Satisfaction with results questionnaires were administered 1 year after surgery. 
      The following threshold values were previously established and were used to 
      evaluate outcome changes: minimum clinically important difference (MCID), 
      substantial clinical benefit (SCB), and standard error of the mean. The following 
      proportions of patients were determined according to outcome changes: 
      "deteriorated," "no change," "below MCID," "above MCID," and "above SCB." The 
      consistency of outcome change was determined amongst the four outcome measures. 
      An index of overall change was developed and related to patients' answers to the 
      health transition item of the SF-36 and to the satisfaction with results scale. 
      The overall change index was also compared with the tolerable pain level. 
      RESULTS: Only 40.5% of patients report consistent outcome changes on all four 
      measures. The overall change index was significantly correlated to the global 
      change and satisfaction scale (rho=.67, p less than .001). The overall change 
      index was clearly associated with the tolerable pain level. CONCLUSIONS: Efforts 
      should be made to take into account the inconsistency of outcomes and to make 
      clinical relevance more readily understandable by patients and clinicians.
FAU - Copay, Anne G
AU  - Copay AG
AD  - The Spinal Research Foundation, Reston, VA 20190, USA. acopay@spinemd.com
FAU - Martin, Marcus M
AU  - Martin MM
FAU - Subach, Brian R
AU  - Subach BR
FAU - Carreon, Leah Y
AU  - Carreon LY
FAU - Glassman, Steven D
AU  - Glassman SD
FAU - Schuler, Thomas C
AU  - Schuler TC
FAU - Berven, Sigurd
AU  - Berven S
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100219
PL  - United States
TA  - Spine J
JT  - The spine journal : official journal of the North American Spine Society
JID - 101130732
SB  - IM
MH  - Back Pain/*surgery
MH  - Data Interpretation, Statistical
MH  - Databases, Factual
MH  - Disability Evaluation
MH  - Female
MH  - Health Status
MH  - Humans
MH  - Lumbar Vertebrae/surgery
MH  - Male
MH  - Middle Aged
MH  - *Outcome Assessment, Health Care
MH  - Pain Measurement
MH  - Pain, Postoperative
MH  - *Patient Satisfaction
MH  - Quality of Life
MH  - Spinal Diseases/*surgery
MH  - *Spinal Fusion
MH  - Treatment Outcome
EDAT- 2010/02/23 06:00
MHDA- 2010/06/19 06:00
CRDT- 2010/02/23 06:00
PHST- 2009/10/09 00:00 [received]
PHST- 2009/12/27 00:00 [accepted]
PHST- 2010/02/23 06:00 [entrez]
PHST- 2010/02/23 06:00 [pubmed]
PHST- 2010/06/19 06:00 [medline]
AID - S1529-9430(10)00011-2 [pii]
AID - 10.1016/j.spinee.2009.12.027 [doi]
PST - ppublish
SO  - Spine J. 2010 Apr;10(4):291-6. doi: 10.1016/j.spinee.2009.12.027. Epub 2010 Feb 
      19.