Browsing by Author "Pellise, Ferran"

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    Development and Validation of a Multidomain Surgical Complication Classification System for Adult Spinal Deformity.
    (Spine, 2021-02) Klineberg, Eric O; Wick, Joseph B; Lafage, Renaud; Lafage, Virginie; Pellise, Ferran; Haddad, Sleiman; Yilgor, Caglar; Núñez-Pereira, Susana; Gupta, Munish; Smith, Justin S; Shaffrey, Christopher; Schwab, Frank; Ames, Christopher; Bess, Shay; Lewis, Stephen; Lenke, Lawrence G; Berven, Sigurd; International Spine Study Group

    Study design

    Prospective analysis of example cases.

    Objective

    The aim of this study was to analyze the accuracy and repeatability of a new comprehensive classification system for capturing complications data in adult spinal deformity.

    Summary of background data

    Complications are common in adult spinal deformity surgery. However, no consensus exists on the definition or classification of complications in adult spinal deformity surgery. The lack of consensus significantly limits understanding of complications' effects on outcomes in surgery for adult spinal deformity.

    Methods

    Using a Delphi method, members of the International Spine Study Group, AO Spine, and the European Spine Study Group collaborated to develop an adult spinal deformity classification system. The multidomain classification system accounts for medical complications (cancer, cardiopulmonary, central nervous system, gastrointestinal, infectious, musculoskeletal, renal) and surgical complications (implant complications, radiographic complications, neurologic events, intraoperative events, and wound complications). Seventeen individuals ("event readers"), including spine surgeons, trainees, and research coordinators, used the new classification system two separate times to analyze complications in ten example cases. The accuracy and repeatability of the classification system were subsequently calculated based on the providers' responses for the example cases.

    Results

    The 10 example cases included 22 complications. Nearly 95% of complications were captured by >95% of the event readers. The system demonstrated good repeatability of 86.9% between the first and second set of responses provided by event readers.

    Conclusion

    The ISSG-AO Multi-Domain Spinal Deformity Complication Classification System for Adult Spinal Deformity demonstrated good accuracy and repeatability among both surgeons and research coordinators in capturing complications in adult spinal deformity surgery. The ISSG-AO system may be applied to help better understand the impact of complications on outcomes and costs in adult spinal deformity surgery.Level of Evidence: 5.
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    Independent Prognostic Factors Associated With Improved Patient-Reported Outcomes in the Prospective Evaluation of Elderly Deformity Surgery (PEEDS) Study.
    (Global spine journal, 2023-05) Hassan, Fthimnir M; Lenke, Lawrence G; Berven, Sigurd H; Kelly, Michael P; Smith, Justin S; Shaffrey, Christopher I; Dahl, Benny T; de Kleuver, Marinus; Spruit, Maarten; Pellise, Ferran; Cheung, Kenneth MC; Alanay, Ahmet; Polly, David W; Sembrano, Jonathan; Matsuyama, Yukihiro; Qiu, Yong; Lewis, Stephen J; AO Spine Knowledge Forum Deformity

    Study design

    Prospective, multicenter, international, observational study.

    Objective

    Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery.

    Methods

    Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively.

    Results

    171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) - OR: .01 [.00-.12]; (2)- OR: .00 [.00-.07]) and number of severe adverse events (AEs) ((1) - OR: .48 [.28-.82]; (2)- OR: .39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) - OR: 1.05 [1.02-1.07]) and number of severe AEs (OR: .58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR: .44 [.25-.77]) and baseline PROMs (OR: .01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR: .50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches.

    Conclusion

    In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID.
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    Retrospective analysis underestimates neurological deficits in complex spinal deformity surgery: a Scoli-RISK-1 Study.
    (Journal of neurosurgery. Spine, 2017-07) Kelly, Michael P; Lenke, Lawrence G; Godzik, Jakub; Pellise, Ferran; Shaffrey, Christopher I; Smith, Justin S; Lewis, Stephen J; Ames, Christopher P; Carreon, Leah Y; Fehlings, Michael G; Schwab, Frank; Shimer, Adam L
    OBJECTIVE The authors conducted a study to compare neurological deficit rates associated with complex adult spinal deformity (ASD) surgery when recorded in retrospective and prospective studies. Retrospective studies may underreport neurological deficits due to selection, detection, and recall biases. Prospective studies are expensive and more difficult to perform, but they likely provide more accurate estimates of new neurological deficit rates. METHODS New neurological deficits were recorded in a prospective study of complex ASD surgeries (pSR1) with a defined outcomes measure (decrement in American Spinal Injury Association lower-extremity motor score) for neurological deficits. Using identical inclusion criteria and a subset of participating surgeons, a retrospective study was created (rSR1) and neurological deficit rates were collected. Continuous variables were compared with the Student t-test, with correction for multiple comparisons. Neurological deficit rates were compared using the Mantel-Haenszel method for standardized risks. Statistical significance for the primary outcome measure was p < 0.05. RESULTS Overall, 272 patients were enrolled in pSR1 and 207 patients were enrolled in rSR1. Inclusion criteria, defining complex spinal deformities, and exclusion criteria were identical. Sagittal Cobb measurements were higher in pSR1, although sagittal alignment was similar. Preoperative neurological deficit rates were similar in the groups. Three-column osteotomies were more common in pSR1, particularly vertebral column resection. New neurological deficits were more common in pSR1 (pSR1 17.3% [95% CI 12.6-22.2] and rSR1 9.0% [95% CI 5.0-13.0]; p = 0.01). The majority of deficits in both studies were at the nerve root level, and the distribution of level of injury was similar. CONCLUSIONS New neurological deficit rates were nearly twice as high in the prospective study than the retrospective study with identical inclusion criteria. These findings validate concerns regarding retrospective cohort studies and confirm the need for and value of carefully designed prospective, observational cohort studies in ASD.
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    Validation of Adult Spinal Deformity Surgical Outcome Prediction Tools in Adult Symptomatic Lumbar Scoliosis.
    (Spine, 2023-01) Wondra, James P; Kelly, Michael P; Greenberg, Jacob; Yanik, Elizabeth L; Ames, Christopher P; Pellise, Ferran; Vila-Casademunt, Alba; Smith, Justin S; Bess, Shay; Shaffrey, Christopher I; Lenke, Lawrence G; Serra-Burriel, Miquel; Bridwell, Keith H

    Study design

    A post hoc analysis.

    Objective

    Advances in machine learning (ML) have led to tools offering individualized outcome predictions for adult spinal deformity (ASD). Our objective is to examine the properties of these ASD models in a cohort of adult symptomatic lumbar scoliosis (ASLS) patients.

    Summary of background data

    ML algorithms produce patient-specific probabilities of outcomes, including major complication (MC), reoperation (RO), and readmission (RA) in ASD. External validation of these models is needed.

    Methods

    Thirty-nine predictive factors (12 demographic, 9 radiographic, 4 health-related quality of life, 14 surgical) were retrieved and entered into web-based prediction models for MC, unplanned RO, and hospital RA. Calculated probabilities were compared with actual event rates. Discrimination and calibration were analyzed using receiver operative characteristic area under the curve (where 0.5=chance, 1=perfect) and calibration curves (Brier scores, where 0.25=chance, 0=perfect). Ninety-five percent confidence intervals are reported.

    Results

    A total of 169 of 187 (90%) surgical patients completed 2-year follow up. The observed rate of MCs was 41.4% with model predictions ranging from 13% to 68% (mean: 38.7%). RO was 20.7% with model predictions ranging from 9% to 54% (mean: 30.1%). Hospital RA was 17.2% with model predictions ranging from 13% to 50% (mean: 28.5%). Model classification for all three outcome measures was better than chance for all [area under the curve=MC 0.6 (0.5-0.7), RA 0.6 (0.5-0.7), RO 0.6 (0.5-0.7)]. Calibration was better than chance for all, though best for RA and RO (Brier Score=MC 0.22, RA 0.16, RO 0.17).

    Conclusions

    ASD prediction models for MC, RA, and RO performed better than chance in a cohort of adult lumbar scoliosis patients, though the homogeneity of ASLS affected calibration and accuracy. Optimization of models require samples with the breadth of outcomes (0%-100%), supporting the need for continued data collection as personalized prediction models may improve decision-making for the patient and surgeon alike.