PMID- 23158968
OWN - NLM
STAT- MEDLINE
DCOM- 20130621
LR  - 20220309
IS  - 1878-1632 (Electronic)
IS  - 1529-9430 (Linking)
VI  - 12
IP  - 12
DP  - 2012 Dec
TI  - Determination of minimum clinically important difference (MCID) in pain, 
      disability, and quality of life after revision fusion for symptomatic 
      pseudoarthrosis.
PG  - 1122-8
LID - S1529-9430(12)01282-X [pii]
LID - 10.1016/j.spinee.2012.10.006 [doi]
AB  - BACKGROUND CONTEXT: Spinal surgical outcome studies rely on patient reported 
      outcome (PRO) measurements to assess the effect of treatment. A shortcoming of 
      these questionnaires is that the extent of improvement in their numerical scores 
      lacks a direct clinical meaning. As a result, the concept of minimum clinically 
      important difference (MCID) has been used to measure the critical threshold 
      needed to achieve clinically relevant treatment effectiveness. Post hoc 
      anchor-based MCID methods have not been applied to the surgical treatment for 
      pseudoarthrosis. PURPOSE: To determine the most appropriate MCID values for 
      visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 
      physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) 
      in patients undergoing revision lumbar arthrodesis for symptomatic 
      pseudoarthrosis. STUDY DESIGN/ SETTING: Retrospective cohort study. METHODS: In 
      47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, 
      PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), 
      and general health utility (EQ-5D) were assessed preoperatively and 2 years 
      postoperatively. Four subjective post hoc anchor-based MCID calculation methods 
      were used to calculate MCID (average change; minimum detectable change; change 
      difference; and receiver operating characteristic curve analysis) for two 
      separate anchors (health transition index (HTI) of SF-36 and satisfaction index). 
      RESULTS: All patients were available for a 2-year PRO assessment. Two years after 
      surgery, a significant improvement was observed for all PROs; Mean change score: 
      BP-VAS (2.3+/-2.6; p<.001), ODI (8.6%+/-13.2%; p<.001), SF-12 PCS (4.0+/-6.1; p=.01), 
      and EQ-5D (0.18+/-0.19; p<.001). The four MCID calculation methods generated a wide 
      range of MCID values for each of the PROs (BP-VAS: 2.0-3.2; ODI: 4.0%-16.6%; 
      SF-12 PCS: 3.2-6.1; and EQ-5D: 0.14-0.24). There was no difference in response 
      between anchors for any patient, suggesting that HTI and satisfaction anchors are 
      equivalent in this patient population. The wide variations in calculated MCID 
      values between methods precluded any ability to reliably determine what the true 
      value is for meaningful change in this disease state. CONCLUSIONS: Using 
      subjective post hoc anchor-based methods of MCID calculation, MCID after revision 
      fusion for pseudoarthrosis varies by as much as 400% per PRO based on the 
      calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 
      points for SF-12. These wide variations and low values of MCID question the face 
      validity of such calculation techniques, especially when applied to heterogeneous 
      disease and patient groups with a multitude of psychosocial confounders such as 
      failed back syndromes. The variability of MCID thresholds observed in our study 
      of patients undergoing revision lumbar fusion for pseudoarthrosis raises further 
      questions to whether ante hoc or Delphi methods may be a more valid and 
      consistent technique to define clinically meaningful, patient-centered changes in 
      PRO measurements.
CI  - Copyright (c) 2012 Elsevier Inc. All rights reserved.
FAU - Parker, Scott L
AU  - Parker SL
AD  - Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, TN 
      37232-8618, USA.
FAU - Adogwa, Owoicho
AU  - Adogwa O
FAU - Mendenhall, Stephen K
AU  - Mendenhall SK
FAU - Shau, David N
AU  - Shau DN
FAU - Anderson, William N
AU  - Anderson WN
FAU - Cheng, Joseph S
AU  - Cheng JS
FAU - Devin, Clinton J
AU  - Devin CJ
FAU - McGirt, Matthew J
AU  - McGirt MJ
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20121114
PL  - United States
TA  - Spine J
JT  - The spine journal : official journal of the North American Spine Society
JID - 101130732
SB  - IM
CIN - Spine J. 2012 Dec;12(12):1129-31. PMID: 23312139
MH  - Adult
MH  - Aged
MH  - Back Pain/etiology/*surgery
MH  - Disability Evaluation
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement/*methods
MH  - *Patient Satisfaction
MH  - Pseudarthrosis/complications/*surgery
MH  - *Quality of Life
MH  - Reoperation
MH  - Retrospective Studies
MH  - *Spinal Fusion
MH  - Treatment Outcome
EDAT- 2012/11/20 06:00
MHDA- 2013/06/25 06:00
CRDT- 2012/11/20 06:00
PHST- 2011/03/23 00:00 [received]
PHST- 2012/09/24 00:00 [revised]
PHST- 2012/10/09 00:00 [accepted]
PHST- 2012/11/20 06:00 [entrez]
PHST- 2012/11/20 06:00 [pubmed]
PHST- 2013/06/25 06:00 [medline]
AID - S1529-9430(12)01282-X [pii]
AID - 10.1016/j.spinee.2012.10.006 [doi]
PST - ppublish
SO  - Spine J. 2012 Dec;12(12):1122-8. doi: 10.1016/j.spinee.2012.10.006. Epub 2012 Nov 
      14.