Measuring surgical outcomes in cervical spondylotic myelopathy patients undergoing anterior cervical discectomy and fusion: assessment of minimum clinically important difference

PLoS One. 2013 Jun 24;8(6):e67408. doi: 10.1371/journal.pone.0067408. Print 2013.

Abstract

Object: The concept of minimum clinically important difference (MCID) has been used to measure the threshold by which the effect of a specific treatment can be considered clinically meaningful. MCID has previously been studied in surgical patients, however few studies have assessed its role in spinal surgery. The goal of this study was to assess the role of MCID in patients undergoing anterior cervical discectomy and fusion (ACDF) for cervical spondylotic myelopathy (CSM).

Methods: Data was collected on 30 patients who underwent ACDF for CSM between 2007 and 2012. Preoperative and 1-year postoperative Neck Disability Index (NDI), Visual-Analog Scale (VAS), and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary PRO scores were collected. Five distribution- and anchor-based approaches were used to calculate MCID threshold values average change, change difference, receiver operating characteristic curve (ROC), minimum detectable change (MDC) and standard error of measurement (SEM). The Health Transition Item of the SF-36 (HTI) was used as an external anchor.

Results: Patients had a significant improvement in all mean physical PRO scores postoperatively (p<0.01) NDI (29.24 to 14.82), VAS (5.06 to 1.72), and PCS (36.98 to 44.22). The five MCID approaches yielded a range of values for each PRO: 2.00-8.78 for PCS, 2.06-5.73 for MCS, 4.83-13.39 for NDI, and 0.36-3.11 for VAS. PCS was the most representative PRO measure, presenting the greatest area under the ROC curve (0.94). MDC values were not affected by the choice of anchor and their threshold of improvement was statistically greater than the chance of error from unimproved patients.

Conclusion: SF-36 PCS was the most representative PRO measure. MDC appears to be the most appropriate MCID method. When MDC was applied together with HTI anchor, the MCID thresholds were: 13.39 for NDI, 3.11 for VAS, 5.56 for PCS and 5.73 for MCS.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cervical Vertebrae / surgery*
  • Diskectomy / methods*
  • Female
  • Humans
  • Male
  • Middle Aged
  • ROC Curve
  • Spinal Fusion / methods*
  • Spondylosis / surgery*
  • Treatment Outcome
  • Visual Analog Scale

Grants and funding

RF receives educational grant support for research on spinal techniques from Medtronic Inc. However, he has no direct compensatory financial disclosures. The remaining authors have no direct compensatory financial disclosures. These funders had no role in study design, data collection and analysis, decision to publish, or preparation of this manuscript.