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Determination of minimum clinically important difference in pain, disability, and quality of life after extension of fusion for adjacent-segment disease.
J Neurosurg Spine. 2012 Jan; 16(1):61-7.JN

Abstract

OBJECT

Spinal surgical outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lack a direct clinical meaning. As a result, the concept of minimum clinical 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 adjacent-segment degeneration following index lumbar fusion, which commonly requires revision laminectomy and extension of fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for adjacent-segment disease (ASD).

METHODS

In 50 consecutive patients undergoing revision surgery for ASD-associated back and leg pain, PRO measures of back and leg pain on a visual analog scale (BP-VAS and LP-VAS, respectively), Oswestry Disability Index (ODI), 12-Item Short Form Health Survey Physical and Mental Component Summaries (SF-12 PCS and MCS, respectively), and EuroQol-5D health survey (EQ-5D) were assessed preoperatively and 2 years postoperatively. The following 4 well-established anchor-based MCID calculation methods were used to calculate MCID: average change; minimum detectable change (MDC); change difference; and receiver operating characteristic curve (ROC) analysis for the following 2 separate anchors: health transition item (HTI) of the SF-36 and satisfaction index.

RESULTS

All patients were available for 2-year PRO assessment. Two years after surgery, a statistically significant improvement was observed for all PROs (mean changes: BP-VAS score [4.80 ± 3.25], LP-VAS score [3.28 ± 3.25], ODI [10.24 ± 13.49], SF-12 PCS [8.69 ± 12.55] and MCS [8.49 ± 11.45] scores, and EQ-5D [0.38 ± 0.45]; all p < 0.001). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS score, 2.3-6.5; LP-VAS score, 1.7-4.3; ODI, 6.8-16.9; SF-12 PCS, 6.1-12.6; SF-12 MCS, 2.4-10.8; and EQ-5D, 0.27-0.54). The area under the ROC curve was consistently greater for the HTI anchor than the satisfaction anchor, suggesting this as a more accurate anchor for MCID.

CONCLUSIONS

Adjacent-segment disease revision surgery-specific MCID is highly variable based on calculation technique. The MDC approach with HTI anchor appears to be most appropriate for calculation of MCID after revision lumbar fusion for ASD because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was not significantly affected by choice of anchor. Based on this method, MCID following ASD revision lumbar surgery is 3.8 points for BP-VAS score, 2.4 points for LP-VAS score, 6.8 points for ODI, 8.8 points for SF-12 PCS, 9.3 points for SF-12 MCS, and 0.35 quality-adjusted life-years for EQ-5D.

Authors+Show Affiliations

Departments of Neurosurgery and Orthopedic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.No affiliation info availableNo 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

21962034

Citation

Parker, Scott L., et al. "Determination of Minimum Clinically Important Difference in Pain, Disability, and Quality of Life After Extension of Fusion for Adjacent-segment Disease." Journal of Neurosurgery. Spine, vol. 16, no. 1, 2012, pp. 61-7.
Parker SL, Mendenhall SK, Shau D, et al. Determination of minimum clinically important difference in pain, disability, and quality of life after extension of fusion for adjacent-segment disease. J Neurosurg Spine. 2012;16(1):61-7.
Parker, S. L., Mendenhall, S. K., Shau, D., Adogwa, O., Cheng, J. S., Anderson, W. N., Devin, C. J., & McGirt, M. J. (2012). Determination of minimum clinically important difference in pain, disability, and quality of life after extension of fusion for adjacent-segment disease. Journal of Neurosurgery. Spine, 16(1), 61-7. https://doi.org/10.3171/2011.8.SPINE1194
Parker SL, et al. Determination of Minimum Clinically Important Difference in Pain, Disability, and Quality of Life After Extension of Fusion for Adjacent-segment Disease. J Neurosurg Spine. 2012;16(1):61-7. PubMed PMID: 21962034.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of minimum clinically important difference in pain, disability, and quality of life after extension of fusion for adjacent-segment disease. AU - Parker,Scott L, AU - Mendenhall,Stephen K, AU - Shau,David, AU - Adogwa,Owoicho, AU - Cheng,Joseph S, AU - Anderson,William N, AU - Devin,Clinton J, AU - McGirt,Matthew J, Y1 - 2011/09/30/ PY - 2011/10/4/entrez PY - 2011/10/4/pubmed PY - 2012/2/18/medline SP - 61 EP - 7 JF - Journal of neurosurgery. Spine JO - J Neurosurg Spine VL - 16 IS - 1 N2 - OBJECT: Spinal surgical outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lack a direct clinical meaning. As a result, the concept of minimum clinical 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 adjacent-segment degeneration following index lumbar fusion, which commonly requires revision laminectomy and extension of fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for adjacent-segment disease (ASD). METHODS: In 50 consecutive patients undergoing revision surgery for ASD-associated back and leg pain, PRO measures of back and leg pain on a visual analog scale (BP-VAS and LP-VAS, respectively), Oswestry Disability Index (ODI), 12-Item Short Form Health Survey Physical and Mental Component Summaries (SF-12 PCS and MCS, respectively), and EuroQol-5D health survey (EQ-5D) were assessed preoperatively and 2 years postoperatively. The following 4 well-established anchor-based MCID calculation methods were used to calculate MCID: average change; minimum detectable change (MDC); change difference; and receiver operating characteristic curve (ROC) analysis for the following 2 separate anchors: health transition item (HTI) of the SF-36 and satisfaction index. RESULTS: All patients were available for 2-year PRO assessment. Two years after surgery, a statistically significant improvement was observed for all PROs (mean changes: BP-VAS score [4.80 ± 3.25], LP-VAS score [3.28 ± 3.25], ODI [10.24 ± 13.49], SF-12 PCS [8.69 ± 12.55] and MCS [8.49 ± 11.45] scores, and EQ-5D [0.38 ± 0.45]; all p < 0.001). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS score, 2.3-6.5; LP-VAS score, 1.7-4.3; ODI, 6.8-16.9; SF-12 PCS, 6.1-12.6; SF-12 MCS, 2.4-10.8; and EQ-5D, 0.27-0.54). The area under the ROC curve was consistently greater for the HTI anchor than the satisfaction anchor, suggesting this as a more accurate anchor for MCID. CONCLUSIONS: Adjacent-segment disease revision surgery-specific MCID is highly variable based on calculation technique. The MDC approach with HTI anchor appears to be most appropriate for calculation of MCID after revision lumbar fusion for ASD because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was not significantly affected by choice of anchor. Based on this method, MCID following ASD revision lumbar surgery is 3.8 points for BP-VAS score, 2.4 points for LP-VAS score, 6.8 points for ODI, 8.8 points for SF-12 PCS, 9.3 points for SF-12 MCS, and 0.35 quality-adjusted life-years for EQ-5D. SN - 1547-5646 UR - https://www.unboundmedicine.com/medline/citation/21962034/Determination_of_minimum_clinically_important_difference_in_pain_disability_and_quality_of_life_after_extension_of_fusion_for_adjacent_segment_disease_ DB - PRIME DP - Unbound Medicine ER -