PMID- 20362248
OWN - NLM
STAT- MEDLINE
DCOM- 20100618
LR  - 20191210
IS  - 1878-1632 (Electronic)
IS  - 1529-9430 (Linking)
VI  - 10
IP  - 4
DP  - 2010 Apr
TI  - Testing minimal clinically important difference: consensus or conundrum?
PG  - 321-7
LID - 10.1016/j.spinee.2009.10.015 [doi]
AB  - BACKGROUND CONTEXT: Various methodologies have been used in attempting to 
      elucidate a standard method for calculating minimal clinically important 
      difference (MCID). A consensus-based decision (Initiative on Methods, 
      Measurement, and Pain Assessment in Clinical Trials [IMMPACT] group) suggested a 
      30% reduction from baseline as a means to define the MCID of self-report back 
      pain measures. Additionally, important psychometric issues need to be addressed 
      regarding use of an independent measure of the same construct as an external 
      criterion, instead of simply using another self-report measure, when using an 
      anchor-based approach to MCID. PURPOSE: The purpose was to test the validity of 
      recently published guidelines regarding MCID using self-report back pain measures 
      and objective socioeconomic outcomes. STUDY DESIGN/SETTING: This is a prospective 
      study assessing change scores on commonly used spinal pain assessment measures in 
      patients with chronic disabling occupational spinal disorders (CDOSDs) treated in 
      a regional referral rehabilitation center performing interdisciplinary functional 
      restoration. PATIENT SAMPLE: The study consisted of consecutive cohort of 
      patients (N=1,180) with CDOSDs completing a functional restoration program. 
      OUTCOMES MEASURES: Self-report measures including the Oswestry Disability Index 
      (ODI) and the physical component summary (PCS) and mental component summary (MCS) 
      of the Short Form-36 (SF-36) obtained before and after treatment, were compared 
      with objective socioeconomically relevant outcomes obtained 1 year after 
      treatment (ie, work status and additional health-care utilization), that were the 
      external criteria for evaluating MCID. METHODS: Pre- to posttreatment improvement 
      was calculated separately for each measure, and subjects were divided into two 
      groups based on the change in scores relative to baseline: 30% or greater versus 
      less than 30% improvement. One-year posttreatment objective socioeconomic 
      outcomes were used as independent external criteria relevant to the CDOSD 
      population. This population is often studied as the most costly and problematic 
      cohort in spine care. RESULTS: The ODI and SF-36 MCS were not associated with any 
      of the objective 1-year outcomes used as external criteria. Reduced 
      post-rehabilitation health-care utilization (based on the percentage of patients 
      pursuing health care from a new provider) was weakly associated with 30% or 
      greater improvement on the SF-36 PCS, relative to patients whose scores changed 
      by less than 30% relative to baseline (17.0% vs. 21.1%). The same was true for 
      the ODI and return-to-work. CONCLUSIONS: When objective and independent criteria 
      are used (socioeconomic outcomes) in a CDOSD cohort, the 30% improvement in the 
      ODI and SF-36 may not be a valid MCID index. This replicates similar conclusions 
      made by an independent research group using a distribution-based approach to 
      MCID. The validity of the MCID concept rests on future research using objective 
      external criteria. Moreover, there remains a question whether the term 
      "important" in MCID can be unequivocally and operationally defined as a reliable 
      construct.
FAU - Gatchel, Robert J
AU  - Gatchel RJ
AD  - Department of Psychology, College of Science, The University of Texas, Arlington, 
      TX 76019, USA.
FAU - Mayer, Tom G
AU  - Mayer TG
LA  - eng
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, Non-P.H.S.
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. 2010 Apr;10(4):328-9. PMID: 20362249
MH  - Adult
MH  - Back Pain/epidemiology/therapy
MH  - Cohort Studies
MH  - Consensus
MH  - Data Interpretation, Statistical
MH  - *Disability Evaluation
MH  - Female
MH  - *Health Status
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Outcome Assessment, Health Care
MH  - Patient Satisfaction
MH  - Physical Therapy Modalities
MH  - Risk Factors
MH  - Social Support
MH  - Socioeconomic Factors
MH  - Spinal Diseases/*epidemiology/*therapy
MH  - Surveys and Questionnaires
EDAT- 2010/04/07 06:00
MHDA- 2010/06/19 06:00
CRDT- 2010/04/06 06:00
PHST- 2009/02/04 00:00 [received]
PHST- 2009/09/23 00:00 [revised]
PHST- 2009/10/20 00:00 [accepted]
PHST- 2010/04/06 06:00 [entrez]
PHST- 2010/04/07 06:00 [pubmed]
PHST- 2010/06/19 06:00 [medline]
AID - S1529-9430(09)01057-2 [pii]
AID - 10.1016/j.spinee.2009.10.015 [doi]
PST - ppublish
SO  - Spine J. 2010 Apr;10(4):321-7. doi: 10.1016/j.spinee.2009.10.015.