PMID- 22324801
OWN - NLM
STAT- MEDLINE
DCOM- 20120719
LR  - 20220409
IS  - 1547-5646 (Electronic)
IS  - 1547-5646 (Linking)
VI  - 16
IP  - 5
DP  - 2012 May
TI  - Minimum clinically important difference in pain, disability, and quality of life 
      after neural decompression and fusion for same-level recurrent lumbar stenosis: 
      understanding clinical versus statistical significance.
PG  - 471-8
LID - 10.3171/2012.1.SPINE11842 [doi]
AB  - OBJECT: Spine surgery outcome studies rely on patient-reported outcome (PRO) 
      measurements to assess treatment effect, but the extent of improvement in the 
      numerical scores of these questionnaires lacks a direct clinical meaning. Because 
      of this, the concept of a minimum clinically important difference (MCID) has been 
      used to measure the critical threshold needed to achieve clinically relevant 
      treatment effectiveness. As utilization of spinal fusion has increased over the 
      past decade, so has the incidence of same-level recurrent stenosis following 
      index lumbar fusion, which commonly requires revision decompression and fusion. 
      The MCID remains uninvestigated for any PROs in the setting of revision lumbar 
      surgery for this pathology. METHODS: In 53 consecutive patients undergoing 
      revision surgery for same-level recurrent lumbar stenosis-associated back and leg 
      pain, PRO measures of back and leg pain were assessed preoperatively and 2 years 
      postoperatively, using the visual analog scale for back pain (VAS-BP) and leg 
      pain (VAS-LP), Oswestry Disability Index (ODI), Physical and Mental Component 
      Summary categories of the 12-Item Short Form Health Survey (SF-12 PCS and MCS) 
      for quality of life, Zung Depression Scale (ZDS), and EuroQol-5D health survey 
      (EQ-5D). Four established anchor-based MCID calculation methods were used to 
      calculate MCID (average change; minimum detectable change; change difference; and 
      receiver operating characteristic curve analysis) for 2 separate anchors (health 
      transition index of the SF-36 and the satisfaction index). RESULTS: All patients 
      were available for 2-year PRO assessment. Two years after surgery, a significant 
      improvement was observed for all PROs assessed. The 4 MCID calculation methods 
      generated a range of MCID values for each of the PROs (VAS-BP 2.2-6.0, VAS-LP 
      3.9-7.5, ODI 8.2-19.9, SF-12 PCS 2.5-12.1, SF-12 MCS 7.0-15.9, ZDS 3.0-18.6, and 
      EQ-5D 0.29-0.52). Each patient answered synchronously for the 2 anchors, 
      suggesting both of these anchors are equally appropriate and valid for this 
      patient population. CONCLUSIONS: The same-level recurrent stenosis 
      surgery-specific MCID is highly variable based on calculation technique. The 
      "minimum detectable change" approach is the most appropriate method for 
      calculation of MCIDs in this population because it was the only method to 
      reliably provide a threshold above the 95% confidence interval of the unimproved 
      cohort (greater than the measurement error). Based on this method, the MCID 
      thresholds following neural decompression and fusion for symptomatic same-level 
      recurrent stenosis are 2.2 points for VAS-BP, 5.0 points for VAS-LP, 8.2 points 
      for ODI, 2.5 points for SF-12 PCS, 10.1 points for SF-12 MCS, 4.9 points for ZDS, 
      and 0.39 QALYs for EQ-5D.
FAU - Parker, Scott L
AU  - Parker SL
AD  - Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, TN 
      37232-8618, USA. scott.parker@vanderbilt.edu
FAU - Mendenhall, Stephen K
AU  - Mendenhall SK
FAU - Shau, David N
AU  - Shau DN
FAU - Adogwa, Owoicho
AU  - Adogwa O
FAU - Anderson, William N
AU  - Anderson WN
FAU - Devin, Clinton J
AU  - Devin CJ
FAU - McGirt, Matthew J
AU  - McGirt MJ
LA  - eng
PT  - Journal Article
DEP - 20120210
PL  - United States
TA  - J Neurosurg Spine
JT  - Journal of neurosurgery. Spine
JID - 101223545
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cohort Studies
MH  - *Decompression, Surgical
MH  - *Disability Evaluation
MH  - Female
MH  - Health Surveys
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain/etiology/*prevention & control
MH  - Pain Measurement
MH  - *Quality of Life
MH  - Recurrence
MH  - Reoperation
MH  - Reproducibility of Results
MH  - *Spinal Fusion
MH  - Spinal Stenosis/complications/*surgery
MH  - Treatment Outcome
EDAT- 2012/02/14 06:00
MHDA- 2012/07/20 06:00
CRDT- 2012/02/14 06:00
PHST- 2012/02/14 06:00 [entrez]
PHST- 2012/02/14 06:00 [pubmed]
PHST- 2012/07/20 06:00 [medline]
AID - 10.3171/2012.1.SPINE11842 [doi]
PST - ppublish
SO  - J Neurosurg Spine. 2012 May;16(5):471-8. doi: 10.3171/2012.1.SPINE11842. Epub 
      2012 Feb 10.