PMID- 19296136
OWN - NLM
STAT- MEDLINE
DCOM- 20091113
LR  - 20220410
IS  - 1432-0932 (Electronic)
IS  - 0940-6719 (Print)
IS  - 0940-6719 (Linking)
VI  - 18 Suppl 3
IP  - Suppl 3
DP  - 2009 Aug
TI  - The quality of spine surgery from the patient's perspective: part 2. Minimal 
      clinically important difference for improvement and deterioration as measured 
      with the Core Outcome Measures Index.
PG  - 374-9
LID - 10.1007/s00586-009-0931-y [doi]
AB  - The Core Outcome Measures Index (COMI) is a reliable and valid instrument for 
      assessing multidimensional outcome in spine surgery. The minimal clinically 
      important score-difference (MCID) for improvement (MCID(imp)) was determined in 
      one of the original research studies validating the instrument, but has never 
      been confirmed in routine clinical practice. Further, the MCID for deterioration 
      (MCID(det)) has never been investigated; indeed, this needs very large sample 
      sizes to obtain sufficient cases with worsening. This study examined the MCIDs of 
      the COMI in routine clinical practice. All patients undergoing surgery in our 
      Spine Center since February 2004 were asked to complete the COMI before and 12 
      months after surgery. The COMI has one question each on back (neck) pain 
      intensity, leg/buttock (arm/shoulder) pain intensity, function, symptom-specific 
      well-being, general quality of life, work disability, and social disability, 
      scored as a 0-10 index. At follow-up, patients also rated the global 
      effectiveness of surgery, on a 5-point Likert scale. This was used as the 
      external criterion ("anchor") in receiver operating characteristics (ROC) 
      analyses to derive cut-off scores for individual improvement and deterioration. 
      Twelve-month follow-up questionnaires were returned by 3,056 (92%) patients. The 
      group mean COMI score change for patients declaring that the "operation helped" 
      was a reduction of 3.1 points; the corresponding value for those whom it "did not 
      help" was a reduction of 0.5 points. The group MCID(imp) was hence 2.6 points 
      reduction; the corresponding group MCID(det) was 1.2 points increase (0.5 minus 
      -0.7). The area under the ROC curve was 0.88 for MCID(imp) and 0.89 for MCID(det) 
      (both P < 0.0001), indicating that the COMI had good discriminative ability. The 
      cut-offs for individual improvement and deterioration, respectively, were > or 
      =2.2 points decrease (sensitivity 81%, specificity 83%) and > or =0.3 points 
      increase (sensitivity 83%, specificity 88%). The MCID(imp) score of 2.2 points 
      was similar to that reported in the original study (2-3 points, depending on 
      external criterion used). The MCID(det) suggested that the COMI is less 
      responsive to deterioration than to improvement, a phenomenon also reported for 
      other spine outcome instruments. This needs further investigation in even larger 
      patient groups. The MCIDs provide essential information for both the planning 
      (sample size) and interpretation of the results (clinical relevance) of future 
      clinical studies using the COMI.
FAU - Mannion, A F
AU  - Mannion AF
AD  - Spine Center Division, Department of Research and Development, Schulthess Klinik, 
      Lengghalde 2, 8008 Zurich, Switzerland. anne.mannion@kws.ch
FAU - Porchet, F
AU  - Porchet F
FAU - Kleinstuck, F S
AU  - Kleinstuck FS
FAU - Lattig, F
AU  - Lattig F
FAU - Jeszenszky, D
AU  - Jeszenszky D
FAU - Bartanusz, V
AU  - Bartanusz V
FAU - Dvorak, J
AU  - Dvorak J
FAU - Grob, D
AU  - Grob D
LA  - eng
PT  - Journal Article
DEP - 20090319
PL  - Germany
TA  - Eur Spine J
JT  - European spine journal : official publication of the European Spine Society, the 
      European Spinal Deformity Society, and the European Section of the Cervical Spine 
      Research Society
JID - 9301980
SB  - IM
MH  - Activities of Daily Living
MH  - *Disability Evaluation
MH  - Humans
MH  - Neurosurgical Procedures/*standards/statistics & numerical data
MH  - Outcome Assessment, Health Care/*methods
MH  - Pain Measurement/methods
MH  - Pain, Postoperative/epidemiology
MH  - Patient Compliance
MH  - Patient Satisfaction/*statistics & numerical data
MH  - Quality Assurance, Health Care/methods
MH  - Quality Control
MH  - Quality of Health Care/*statistics & numerical data
MH  - Quality of Life
MH  - Spinal Diseases/*surgery
MH  - Surveys and Questionnaires
PMC - PMC2899314
EDAT- 2009/03/20 09:00
MHDA- 2009/11/17 06:00
PMCR- 2010/08/01
CRDT- 2009/03/20 09:00
PHST- 2008/12/22 00:00 [received]
PHST- 2009/03/01 00:00 [accepted]
PHST- 2009/02/17 00:00 [revised]
PHST- 2009/03/20 09:00 [entrez]
PHST- 2009/03/20 09:00 [pubmed]
PHST- 2009/11/17 06:00 [medline]
PHST- 2010/08/01 00:00 [pmc-release]
AID - 931 [pii]
AID - 10.1007/s00586-009-0931-y [doi]
PST - ppublish
SO  - Eur Spine J. 2009 Aug;18 Suppl 3(Suppl 3):374-9. doi: 10.1007/s00586-009-0931-y. 
      Epub 2009 Mar 19.