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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.
J Neurosurg Spine. 2012 May; 16(5):471-8.JN

Abstract

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.

Authors+Show Affiliations

Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, TN 37232-8618, USA. scott.parker@vanderbilt.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22324801

Citation

Parker, Scott L., et al. "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." Journal of Neurosurgery. Spine, vol. 16, no. 5, 2012, pp. 471-8.
Parker SL, Mendenhall SK, Shau DN, et al. 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. J Neurosurg Spine. 2012;16(5):471-8.
Parker, S. L., Mendenhall, S. K., Shau, D. N., Adogwa, O., Anderson, W. N., Devin, C. J., & McGirt, M. J. (2012). 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. Journal of Neurosurgery. Spine, 16(5), 471-8. https://doi.org/10.3171/2012.1.SPINE11842
Parker SL, et al. 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. J Neurosurg Spine. 2012;16(5):471-8. PubMed PMID: 22324801.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Parker,Scott L, AU - Mendenhall,Stephen K, AU - Shau,David N, AU - Adogwa,Owoicho, AU - Anderson,William N, AU - Devin,Clinton J, AU - McGirt,Matthew J, Y1 - 2012/02/10/ PY - 2012/2/14/entrez PY - 2012/2/14/pubmed PY - 2012/7/20/medline SP - 471 EP - 8 JF - Journal of neurosurgery. Spine JO - J Neurosurg Spine VL - 16 IS - 5 N2 - 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. SN - 1547-5646 UR - https://www.unboundmedicine.com/medline/citation/22324801/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_ L2 - https://thejns.org/doi/10.3171/2012.1.SPINE11842 DB - PRIME DP - Unbound Medicine ER -