Browsing by Subject "Minimal Clinically Important Difference"
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Item Open Access Development of Deployable Predictive Models for Minimal Clinically Important Difference Achievement Across the Commonly Used Health-related Quality of Life Instruments in Adult Spinal Deformity Surgery.(Spine, 2019-08) Ames, Christopher P; Smith, Justin S; Pellisé, Ferran; Kelly, Michael P; Gum, Jeffrey L; Alanay, Ahmet; Acaroğlu, Emre; Pérez-Grueso, Francisco Javier Sánchez; Kleinstück, Frank S; Obeid, Ibrahim; Vila-Casademunt, Alba; Burton, Douglas C; Lafage, Virginie; Schwab, Frank J; Shaffrey, Christopher I; Bess, Shay; Serra-Burriel, Miquel; European Spine Study Group, International Spine Study GroupStudy design
Retrospective analysis of prospectively-collected, multicenter adult spinal deformity (ASD) databases.Objective
To predict the likelihood of reaching minimum clinically important differences in patient-reported outcomes after ASD surgery.Summary of background data
ASD surgeries are costly procedures that do not always provide the desired benefit. In some series only 50% of patients achieve minimum clinically important differences in patient-reported outcomes (PROs). Predictive modeling may be useful in shared-decision making and surgical planning processes. The goal of this study was to model the probability of achieving minimum clinically important differences change in PROs at 1 and 2 years after surgery.Methods
Two prospective observational ASD cohorts were queried. Patients with Scoliosis Research Society-22, Oswestry Disability Index , and Short Form-36 data at preoperative baseline and at 1 and 2 years after surgery were included. Seventy-five variables were used in the training of the models including demographics, baseline PROs, and modifiable surgical parameters. Eight predictive algorithms were trained at four-time horizons: preoperative or postoperative baseline to 1 year and preoperative or postoperative baseline to 2 years. External validation was accomplished via an 80%/20% random split. Five-fold cross validation within the training sample was performed. Precision was measured as the mean average error (MAE) and R values.Results
Five hundred seventy patients were included in the analysis. Models with the lowest MAE were selected; R values ranged from 20% to 45% and MAE ranged from 8% to 15% depending upon the predicted outcome. Patients with worse preoperative baseline PROs achieved the greatest mean improvements. Surgeon and site were not important components of the models, explaining little variance in the predicted 1- and 2-year PROs.Conclusion
We present an accurate and consistent way of predicting the probability for achieving clinically relevant improvement after ASD surgery in the largest-to-date prospective operative multicenter cohort with 2-year follow-up. This study has significant clinical implications for shared decision making, surgical planning, and postoperative counseling.Level of evidence
4.Item Open Access Improvement in some Ames-ISSG cervical deformity classification modifier grades may correlate with clinical improvement.(Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia, 2021-07) Horn, Samantha R; Passias, Peter G; Passfall, Lara; Lafage, Renaud; Smith, Justin S; Poorman, Gregory W; Steinmetz, Leah M; Bortz, Cole A; Segreto, Frank A; Diebo, Bassel; Hart, Robert; Burton, Douglas; Shaffrey, Christopher I; Sciubba, Daniel M; Klineberg, Eric O; Protopsaltis, Themistocles S; Schwab, Frank J; Bess, Shay; Lafage, Virginie; Ames, Christopher; International Spine Study Group (ISSG)This retrospective cohort study describes adult cervical deformity(ACD) patients with Ames-ACD classification at baseline(BL) and 1-year post-operatively and assesses the relationship of improvement in Ames modifiers with clinical outcomes. Patients ≥ 18yrs with BL and post-op(1-year) radiographs were included. Patients were categorized with Ames classification by primary deformity descriptors (C = cervical; CT = cervicothoracic junction; T = thoracic; S = coronal) and alignment/myelopathy modifiers(C2-C7 Sagittal Vertical Axis[cSVA], T1 Slope-Cervical Lordosis[TS-CL], Horizontal Gaze[Horiz], mJOA). Univariate analysis evaluated demographics, clinical intervention, and Ames deformity descriptor. Patients were evaluated for radiographic improvement by Ames classification and reaching Minimal Clinically Important Differences(MCID) for mJOA, Neck Disability Index(NDI), and EuroQuol-5D(EQ5D). A total of 73 patients were categorized: C = 41(56.2%), CT = 18(24.7%), T = 9(12.3%), S = 5(6.8%). By Ames modifier 1-year improvement, 13(17.8%) improved in mJOA, 26(35.6%) in cSVA grade, 19(26.0%) in Horiz, and 15(20.5%) in TS-CL. The overall proportion of patients without severe Ames modifier grades at 1-year was as follows: 100% cSVA, 27.4% TS-CL, 67.1% Horiz, 69.9% mJOA. 1-year post-operatively, severe myelopathy(mJOA = 3) prevalence differed between Ames-ACD descriptors (C = 26.3%, CT = 15.4%, T = 0.0%, S = 0.0%, p = 0.033). Improvement in mJOA modifier correlated with reaching 1-year NDI MCID in the overall cohort (r = 0.354,p = 0.002). For C descriptors, cSVA improvement correlated with reaching 1-year NDI MCID (r = 0.387,p = 0.016). Improvement in more than one radiographic Ames modifier correlated with reaching 1-year mJOA MCID (r = 0.344,p = 0.003) and with reaching more than one MCID for mJOA, NDI, and EQ-5D (r = 0.272,p = 0.020). In conclusion, improvements in radiographic Ames modifier grades correlated with improvement in 1-year postoperative clinical outcomes. Although limited in scope, this analysis suggests the Ames-ACD classification may describe cervical deformity patients' alignment and outcomes at 1-year.Item Open Access SRS-22R Minimum Clinically Important Difference and Substantial Clinical Benefit After Adult Lumbar Scoliosis Surgery.(Spine deformity, 2018-01) Carreon, Leah Y; Kelly, Michael P; Crawford, Charles H; Baldus, Christine R; Glassman, Steven D; Shaffrey, Christopher I; Bridwell, Keith HSTUDY DESIGN:Longitudinal cohort. OBJECTIVES:To determine if the minimum clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for the Scoliosis Research Society-22R (SRS22R) domains in patients with degenerative lumbar scoliosis are similar to those in patients with adult spinal deformity (ASD) with fusions extending into the thoracic spine. SUMMARY OF BACKGROUND DATA:The MCID and SCB thresholds for the SRS22R domains in patients with ASD and adolescent idiopathic scoliosis have been reported. METHODS:Patients enrolled in the NIH-sponsored Adult Symptomatic Lumbar Scoliosis (ASLS) trial who underwent surgery and completed the SRS22R preoperative and the SRS30 one-year postoperative were identified. One-year postoperative answers to the last eight questions of the SRS30 were used as anchors to determine the MCID and SCB for the Pain, Appearance, and Activity domains, and the Subscore and Total score using receiver operating characteristic (ROC) curve analysis. RESULTS:The sample population consisted of 147 patients. A total of 132 (89%) were females with a mean age of 59.4 years. There was a statistically significant improvement in all SRS22R scores from preoperative to one-year postoperative. There was also a statistically significant difference in domain scores among the different responses to the anchors. According to the ROC analysis, MCID was 1.17 for Appearance, 0.40 for Activity, 0.60 for Pain, 0.53 for Subscore, and 0.77 for Total; and SCB was 1.67 for Appearance, 0.60 for Activity, 0.62 for Subscore, and 1.11 for Total score. These are similar to previous reports of MCID and SCB thresholds for ASD patients who underwent fusion to the thoracic spine. CONCLUSION:The MCID and SCB thresholds for the SRS22R domains in patients with adult symptomatic lumbar scoliosis are very similar to the threshold values previously reported for adult deformity patients. LEVEL OF EVIDENCE:Level II.