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Establishing the Minimum Clinically Important Difference in NDI and mJOA for Adult Cervical Deformity
NASS 32nd Annual Meeting Proceedings / The Spine Journal 17 (2017) S41–S88 OUTCOME MEASURES: One-year radiographic correction, one-year HRQL measures (NDI, NSR Neck, EQ5D, mJOA). METHODS: A prospective database of operative CD patients was analyzed. Inclusion criteria were cervical kyphosis (CK)>10°, cervical scoliosis (CS)>10°, C2-7 SVA >4 cm or CBVA >25°. Patients with horizontal gaze disruption (high McGS >10°) were compared to those without on the basis of demographic, surgical and radiographic parameters. Visibility of horizontal gaze parameters was assessed. The subset of patients with preop cSVA >4 cm was analyzed. Statistical analysis was performed using Chi Square, t-tests where appropriate. RESULTS: 115 CD patients (mean age 62 years, 56% female, 41% revisions) were included. CBVA was visible in 17% of CD patient X ray images vs 90% for McGS. High McGS patients had worse baseline alignment by cSVA (58.6 vs 33.0 cm, p<.001) and TS-CL (58.2 vs 31.8°, p<.001), more consecutive kyphotic levels in the cervical spine (64% vs 37%, p<.001) and more consecutive kyphotic levels below C5 (68% vs 26%, p=.012). There were no significant differences in baseline HRQL (NDI, mJOA, EQ5D) or demographics (age, gender, CCI and BMI). Both groups improved at 1 year postop in NDI, NSR neck, EQ5D (all p<.01). Higher preop McGS correlated with worse 1-year NSR neck (r=.27, p=.03). High McGS patients had worse McGS at 1 year (4.79 vs −1.36°, p=.017). Higher McGS at 1 year correlated with worse NDI (r=.302, p=.012). CONCLUSIONS: In patients with severe CD, better alignment correlated with less disability with respect to NDI, EQ5D and neck pain, emphasizing the importance of optimal correction. Cervical deformity patients with loss of horizontal gaze have worse subaxial cervical alignment driven by more consecutive kyphotic levels below C5. CBVA is not visible on most CD patient X ray images but a useful surrogate is McGS. Cervical deformity patients with loss of horizontal gaze have improved their HRQL with correction but worse 1-year McGS correlated with worse NDI. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.023 13. Establishing the Minimum Clinically Important Difference in NDI and mJOA for Adult Cervical Deformity Alexandra Soroceanu, MD, MPH1, Jeffrey L. Gum, MD2, Michael P. Kelly, MD3, Peter G. Passias, MD4, Justin S. Smith, MD, PhD5, Themistocles S. Protopsaltis, MD6, Virginie Lafage, PhD7, Han Jo Kim, MD7, Justin K. Scheer, BS8, Munish C. Gupta, MD9, Gregory M. Mundis Jr., MD10, Eric O. Klineberg, MD11, Douglas C. Burton, MD12, Shay Bess, MD13, Christopher P. Ames, MD14, International Spine Study Group15; 1University of Calgary, Calgary, Canada; 2Norton Leatherman Spine Center, Louisville, KY, USA; 3 Washington University, Saint Louis, MO, USA; 4NY Spine Institute, NYU Medical Center Hospital for Joint Diseases, New York, NY, USA; 5UVA Health System, Charlottesville, VA, USA; 6Hospital for Joint Diseases at NYU Langone Medical Center, New York, NY, USA; 7Hospital for Special Surgery, New York, NY, USA; 8University of California, San Diego, San Diego, CA, USA; 9Washington University School of Medicine, St. Louis, MO, USA; 10Scripps Clinic Medical Group, Department of Orthopedics, La Jolla, CA, USA; 11UC Davis School of Medicine, Sacramento, CA, USA; 12University of Kansas Medical Center, Kansas City, KS, USA; 13 Denver, CO, USA; 14University of California, San Francisco, San Francisco, CA, USA; 15Brighton, CO, USA BACKGROUND CONTEXT: Patient-reported outcome (PRO) questionnaires are commonly used to measure the effectiveness of surgical intervention. The minimum clinically important difference (MCID) represents the smallest change in PRO corresponding to meaningful improvement, and can vary according to specific disease. Adult cervical deformity (ACD) patients have characteristics that are unique when compared to the degenerative cervical conditions used in the development of the cervical-specific PRO questionnaires. No MCID thresholds are currently established in the ACD population for the NDI and mJOA .
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PURPOSE: The purpose of this study was to establish MCID thresholds for the NDI and mJOA in the adult cervical deformity population. STUDY DESIGN/SETTING: Multicenter prospective cohort study. PATIENT SAMPLE: Adult cervical deformity patients undergoing surgical intervention. OUTCOME MEASURES: Outcome measures included the Neck Disability Index (NDI), and modified Japanese Orthopaedic Association (mJOA) questionnaires administered preoperatively and one year postoperatively. METHODS: Surgically treated ACD patients who completed one-year follow up were included. PROs (NDI, mJOA, and EQ-5D) were administered preand 1 year postoperatively. The minimally detectable measurement difference (MDMD) was calculated. The EQ-VAS was used as an anchor and anchor-based MCID thresholds were computed. Distribution-based MCID calculations (SEM method) were also performed. RESULTS: Of 122 patients eligible for 1-year follow-up, 73 (60%) patients met inclusion criteria; 42 (57.5%) were female with a mean age of 62.23 years, and average BMI of 29.28. Preoperative NDI score was 46.49, vs 37.04 postoperatively (p=.0001). Preoperative mJOA score was 13.17 vs 13.71 postoperatively (p=.12). The MDMD was 6.41 for the NDI, and 1.82 for the mJOA. Distribution-based MCID values were 7.48 for the NDI, and 1.85 for the mJOA. Anchor-based MCID values were 7.0 for the NDI (AUC 0.72), and 1.0 for the mJOA (AUC 0.61). We recommend using an MCID threshold of 1.8 for the mJOA and of 7.0 for the NDI in adult cervical deformity patients. CONCLUSIONS: This study established adult cervical deformity specific MCID thresholds for the NDI and mJOA. These new thresholds will be useful in future studies evaluating the success of surgery for adult cervical deformity patients undergoing deformity correction. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.024 14. Identifying Sources of Improvement of Axial Pain in Corrective Cervical Deformity Surgery Peter G. Passias, MD1, Gregory W. Poorman2, Samantha R. Horn, BA2, Eric O. Klineberg, MD3, Christopher I. Shaffrey, MD4, Virginie Lafage, PhD5, Themistocles S. Protopsaltis, MD2, Christopher P. Ames, MD6, Justin S. Smith, MD, PhD7, Gregory M. Mundis Jr., MD8, Brian J. Neuman, MD9, Robert A. Hart, MD10, Douglas C. Burton, MD11, International Spine Study Group12; 1NY Spine Institute, NYU Medical Center Hospital for Joint Diseases, New York, NY, USA; 2Hospital for Joint Diseases at NYU Langone Medical Center, New York, NY, USA; 3UC Davis School of Medicine, Sacramento, CA, USA; 4University of Virginia, Charlottesville, VA, USA; 5Hospital for Special Surgery, New York, NY, USA; 6University of California, San Francisco, San Francisco, CA, USA; 7UVA Health System, Charlottesville, VA, USA; 8Scripps Clinic Medical Group, Department of Orthopedics, La Jolla, CA, USA; 9Baltimore, MD, USA; 10 Oregon Health & Science University, Portland, OR, USA; 11University of Kansas Medical Center, Kansas City, KS, USA; 12Brighton, CO, USA BACKGROUND CONTEXT: Cervical deformity (CD) patients are frequently older with numerous comorbidities and an uncertain ability to heal, making it difficult to justify total scoliosis correction. Neck pain, radiculopathy, and deformity are the primary complaints of CD patients. Identifying factors most likely to improve symptomology is key to patient selection and improving surgical outcomes. PURPOSE: To identify key prognostic variables associated with improvements in neck pain after cervical deformity surgery. STUDY DESIGN/SETTING: Retrospective review of a prospective multicenter database. PATIENT SAMPLE: Patients over 18 years old meeting one of the following CD criteria: cervical kyphosis (C2-7 Cobb angle >10°), cervical scoliosis (coronal Cobb angle >10°), positive cervical sagittal imbalance (C2-C7 sagittal vertical axis >4 cm or T1-C6 >10°), or horizontal gaze impairment (chin-brow vertical angle >25°).
Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.
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PURPOSE: The purpose of this study was to establish MCID thresholds for the NDI and mJOA in the adult cervical deformity population. STUDY DESIGN/SETTING: Multicenter prospective cohort study. PATIENT SAMPLE: Adult cervical deformity patients undergoing surgical intervention. OUTCOME MEASURES: Outcome measures included the Neck Disability Index (NDI), and modified Japanese Orthopaedic Association (mJOA) questionnaires administered preoperatively and one year postoperatively. METHODS: Surgically treated ACD patients who completed one-year follow up were included. PROs (NDI, mJOA, and EQ-5D) were administered preand 1 year postoperatively. The minimally detectable measurement difference (MDMD) was calculated. The EQ-VAS was used as an anchor and anchor-based MCID thresholds were computed. Distribution-based MCID calculations (SEM method) were also performed. RESULTS: Of 122 patients eligible for 1-year follow-up, 73 (60%) patients met inclusion criteria; 42 (57.5%) were female with a mean age of 62.23 years, and average BMI of 29.28. Preoperative NDI score was 46.49, vs 37.04 postoperatively (p=.0001). Preoperative mJOA score was 13.17 vs 13.71 postoperatively (p=.12). The MDMD was 6.41 for the NDI, and 1.82 for the mJOA. Distribution-based MCID values were 7.48 for the NDI, and 1.85 for the mJOA. Anchor-based MCID values were 7.0 for the NDI (AUC 0.72), and 1.0 for the mJOA (AUC 0.61). We recommend using an MCID threshold of 1.8 for the mJOA and of 7.0 for the NDI in adult cervical deformity patients. CONCLUSIONS: This study established adult cervical deformity specific MCID thresholds for the NDI and mJOA. These new thresholds will be useful in future studies evaluating the success of surgery for adult cervical deformity patients undergoing deformity correction. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2017.07.024 14. Identifying Sources of Improvement of Axial Pain in Corrective Cervical Deformity Surgery Peter G. Passias, MD1, Gregory W. Poorman2, Samantha R. Horn, BA2, Eric O. Klineberg, MD3, Christopher I. Shaffrey, MD4, Virginie Lafage, PhD5, Themistocles S. Protopsaltis, MD2, Christopher P. Ames, MD6, Justin S. Smith, MD, PhD7, Gregory M. Mundis Jr., MD8, Brian J. Neuman, MD9, Robert A. Hart, MD10, Douglas C. Burton, MD11, International Spine Study Group12; 1NY Spine Institute, NYU Medical Center Hospital for Joint Diseases, New York, NY, USA; 2Hospital for Joint Diseases at NYU Langone Medical Center, New York, NY, USA; 3UC Davis School of Medicine, Sacramento, CA, USA; 4University of Virginia, Charlottesville, VA, USA; 5Hospital for Special Surgery, New York, NY, USA; 6University of California, San Francisco, San Francisco, CA, USA; 7UVA Health System, Charlottesville, VA, USA; 8Scripps Clinic Medical Group, Department of Orthopedics, La Jolla, CA, USA; 9Baltimore, MD, USA; 10 Oregon Health & Science University, Portland, OR, USA; 11University of Kansas Medical Center, Kansas City, KS, USA; 12Brighton, CO, USA BACKGROUND CONTEXT: Cervical deformity (CD) patients are frequently older with numerous comorbidities and an uncertain ability to heal, making it difficult to justify total scoliosis correction. Neck pain, radiculopathy, and deformity are the primary complaints of CD patients. Identifying factors most likely to improve symptomology is key to patient selection and improving surgical outcomes. PURPOSE: To identify key prognostic variables associated with improvements in neck pain after cervical deformity surgery. STUDY DESIGN/SETTING: Retrospective review of a prospective multicenter database. PATIENT SAMPLE: Patients over 18 years old meeting one of the following CD criteria: cervical kyphosis (C2-7 Cobb angle >10°), cervical scoliosis (coronal Cobb angle >10°), positive cervical sagittal imbalance (C2-C7 sagittal vertical axis >4 cm or T1-C6 >10°), or horizontal gaze impairment (chin-brow vertical angle >25°).
Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.