Browsing by Author "Alanay, Ahmet"
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Item Open Access An international consensus on the appropriate evaluation and treatment for adults with spinal deformity.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2018-03) Berven, Sigurd H; Kamper, Steven J; Germscheid, Niccole M; Dahl, Benny; Shaffrey, Christopher I; Lenke, Lawrence G; Lewis, Stephen J; Cheung, Kenneth M; Alanay, Ahmet; Ito, Manabu; Polly, David W; Qiu, Yong; de Kleuver, Marinus; AOSpine Knowledge Forum DeformityPurpose
Evaluation and surgical management for adult spinal deformity (ASD) patients varies between health care providers. The purpose of this study is to identify appropriateness of specific approaches and management strategies for the treatment of ASD.Methods
From January to July 2015, the AOSpine Knowledge Deformity Forum performed a modified Delphi survey where 53 experienced deformity surgeons from 24 countries, rated the appropriateness of management strategies for multiple ASD clinical scenarios. Four rounds were performed: three surveys and a face-to-face meeting. Consensus was achieved with ≥70% agreement.Results
Appropriate surgical goals are improvement of function, pain, and neural symptoms. Appropriate preoperative patient evaluation includes recording information on history and comorbidities, and radiographic workup, including long standing films and MRI for all patients. Preoperative pulmonary and cardiac testing and DEXA scan is appropriate for at-risk patients. Intraoperatively, appropriate surgical strategies include long fusions with deformity correction for patients with large deformity and sagittal imbalance, and pelvic fixation for multilevel fusions with large curves, sagittal imbalance, and osteoporosis. Decompression alone is inappropriate in patients with large curves, sagittal imbalance, and progressive deformity. It is inappropriate to fuse to L5 in patients with symptomatic disk degeneration at L5-S1.Conclusions
These results provide guidance for informed decision-making in the evaluation and management of ASD. Appropriate care for ASD, a very diverse spectrum of disease, must be responsive to patient preference and values, and considerations of the care provider, and the healthcare system. A monolithic approach to care should be avoided.Item Open Access Artificial Intelligence Based Hierarchical Clustering of Patient Types and Intervention Categories in Adult Spinal Deformity Surgery: Towards a New Classification Scheme that Predicts Quality and Value.(Spine, 2019-07) Ames, Christopher P; Smith, Justin S; Pellisé, Ferran; Kelly, Michael; Alanay, Ahmet; Acaroğlu, Emre; Pérez-Grueso, Francisco Javier Sánchez; Kleinstück, Frank; Obeid, Ibrahim; Vila-Casademunt, Alba; Shaffrey, Christopher I; Burton, Douglas; Lafage, Virginie; Schwab, Frank; Shaffrey, Christopher I; Bess, Shay; Serra-Burriel, Miquel; European Spine Study Group, International Spine Study GroupSTUDY DESIGN:Retrospective review of prospectively-collected, multicenter adult spinal deformity (ASD) databases. OBJECTIVE:To apply artificial intelligence (AI)-based hierarchical clustering as a step toward a classification scheme that optimizes overall quality, value, and safety for ASD surgery. SUMMARY OF BACKGROUND DATA:Prior ASD classifications have focused on radiographic parameters associated with patient reported outcomes. Recent work suggests there are many other impactful preoperative data points. However, the ability to segregate patient patterns manually based on hundreds of data points is beyond practical application for surgeons. Unsupervised machine-based clustering of patient types alongside surgical options may simplify analysis of ASD patient types, procedures, and outcomes. METHODS:Two prospective cohorts were queried for surgical ASD patients with baseline, 1-year, and 2-year SRS-22/Oswestry Disability Index/SF-36v2 data. Two dendrograms were fitted, one with surgical features and one with patient characteristics. Both were built with Ward distances and optimized with the gap method. For each possible n patient cluster by m surgery, normalized 2-year improvement and major complication rates were computed. RESULTS:Five hundred-seventy patients were included. Three optimal patient types were identified: young with coronal plane deformity (YC, n = 195), older with prior spine surgeries (ORev, n = 157), and older without prior spine surgeries (OPrim, n = 218). Osteotomy type, instrumentation and interbody fusion were combined to define four surgical clusters. The intersection of patient-based and surgery-based clusters yielded 12 subgroups, with major complication rates ranging from 0% to 51.8% and 2-year normalized improvement ranging from -0.1% for SF36v2 MCS in cluster [1,3] to 100.2% for SRS self-image score in cluster [2,1]. CONCLUSION:Unsupervised hierarchical clustering can identify data patterns that may augment preoperative decision-making through construction of a 2-year risk-benefit grid. In addition to creating a novel AI-based ASD classification, pattern identification may facilitate treatment optimization by educating surgeons on which treatment patterns yield optimal improvement with lowest risk. LEVEL OF EVIDENCE:4.Item Open Access Cost Benefit of Implementation of Risk Stratification Models for Adult Spinal Deformity Surgery.(Global Spine J, 2023-12-11) Passias, Peter G; Williamson, Tyler K; Kummer, Nicholas A; Pellisé, Ferran; Lafage, Virginie; Lafage, Renaud; Serra-Burriel, Miguel; Smith, Justin S; Line, Breton; Vira, Shaleen; Gum, Jeffrey L; Haddad, Sleiman; Sánchez Pérez-Grueso, Francisco Javier; Schoenfeld, Andrew J; Daniels, Alan H; Chou, Dean; Klineberg, Eric O; Gupta, Munish C; Kebaish, Khaled M; Kelly, Michael P; Hart, Robert A; Burton, Douglas C; Kleinstück, Frank; Obeid, Ibrahim; Shaffrey, Christopher I; Alanay, Ahmet; Ames, Christopher P; Schwab, Frank J; Hostin, Richard A; Bess, Shay; International Spine Study GroupSTUDY DESIGN/SETTING: Retrospective cohort study. OBJECTIVE: Assess the extent to which defined risk factors of adverse events are drivers of cost-utility in spinal deformity (ASD) surgery. METHODS: ASD patients with 2-year (2Y) data were included. Tertiles were used to define high degrees of frailty, sagittal deformity, blood loss, and surgical time. Cost was calculated using the Pearl Diver registry and cost-utility at 2Y was compared between cohorts based on the number of risk factors present. Statistically significant differences in cost-utility by number of baseline risk factors were determined using ANOVA, followed by a generalized linear model, adjusting for clinical site and surgeon, to assess the effects of increasing risk score on overall cost-utility. RESULTS: By 2 years, 31% experienced a major complication and 23% underwent reoperation. Patients with ≤2 risk factors had significantly less major complications. Patients with 2 risk factors improved the most from baseline to 2Y in ODI. Average cost increased by $8234 per risk factor (R2 = .981). Cost-per-QALY at 2Y increased by $122,650 per risk factor (R2 = .794). Adjusted generalized linear model demonstrated a significant trend between increasing risk score and increasing cost-utility (r2 = .408, P < .001). CONCLUSIONS: The number of defined patient-specific and surgical risk factors, especially those with greater than two, were associated with increased index surgical costs and diminished cost-utility. Efforts to optimize patient physiology and minimize surgical risk would likely reduce healthcare expenditures and improve the overall cost-utility profile for ASD interventions.Level of evidence: III.Item Open Access Development and validation of risk stratification models for adult spinal deformity surgery.(Journal of neurosurgery. Spine, 2019-06) Pellisé, Ferran; Serra-Burriel, Miquel; Smith, Justin S; Haddad, Sleiman; Kelly, Michael P; Vila-Casademunt, Alba; Sánchez Pérez-Grueso, Francisco Javier; Bess, Shay; Gum, Jeffrey L; Burton, Douglas C; Acaroğlu, Emre; Kleinstück, Frank; Lafage, Virginie; Obeid, Ibrahim; Schwab, Frank; Shaffrey, Christopher I; Alanay, Ahmet; Ames, Christopher; International Spine Study Group; European Spine Study GroupOBJECTIVE:Adult spinal deformity (ASD) surgery has a high rate of major complications (MCs). Public information about adverse outcomes is currently limited to registry average estimates. The object of this study was to assess the incidence of adverse events after ASD surgery, and to develop and validate a prognostic tool for the time-to-event risk of MC, hospital readmission (RA), and unplanned reoperation (RO). METHODS:Two models per outcome, created with a random survival forest algorithm, were trained in an 80% random split and tested in the remaining 20%. Two independent prospective multicenter ASD databases, originating from the European continent and the United States, were queried, merged, and analyzed. ASD patients surgically treated by 57 surgeons at 23 sites in 5 countries in the period from 2008 to 2016 were included in the analysis. RESULTS:The final sample consisted of 1612 ASD patients: mean (standard deviation) age 56.7 (17.4) years, 76.6% women, 10.4 (4.3) fused vertebral levels, 55.1% of patients with pelvic fixation, 2047.9 observation-years. Kaplan-Meier estimates showed that 12.1% of patients had at least one MC at 10 days after surgery; 21.5%, at 90 days; and 36%, at 2 years. Discrimination, measured as the concordance statistic, was up to 71.7% (95% CI 68%-75%) in the development sample for the postoperative complications model. Surgical invasiveness, age, magnitude of deformity, and frailty were the strongest predictors of MCs. Individual cumulative risk estimates at 2 years ranged from 3.9% to 74.1% for MCs, from 3.17% to 44.2% for RAs, and from 2.67% to 51.9% for ROs. CONCLUSIONS:The creation of accurate prognostic models for the occurrence and timing of MCs, RAs, and ROs following ASD surgery is possible. The presented variability in patient risk profiles alongside the discrimination and calibration of the models highlights the potential benefits of obtaining time-to-event risk estimates for patients and clinicians.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 Development of predictive models for all individual questions of SRS-22R after adult spinal deformity surgery: a step toward individualized medicine.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2019-09) Ames, Christopher P; Smith, Justin S; Pellisé, Ferran; Kelly, Michael; Gum, Jeffrey L; Alanay, Ahmet; Acaroğlu, Emre; Pérez-Grueso, Francisco Javier Sánchez; Kleinstück, Frank S; Obeid, Ibrahim; Vila-Casademunt, Alba; Shaffrey, Christopher I; Burton, Douglas C; Lafage, Virginie; Schwab, Frank J; Shaffrey, Christopher I; Bess, Shay; Serra-Burriel, Miquel; European Spine Study Group; International Spine Study GroupPurpose
Health-related quality of life (HRQL) instruments are essential in value-driven health care, but patients often have more specific, personal priorities when seeking surgical care. The Scoliosis Research Society-22R (SRS-22R), an HRQL instrument for spinal deformity, provides summary scores spanning several health domains, but these may be difficult for patients to utilize in planning their specific care goals. Our objective was to create preoperative predictive models for responses to individual SRS-22R questions at 1 and 2 years after adult spinal deformity (ASD) surgery to facilitate precision surgical care.Methods
Two prospective observational cohorts were queried for ASD patients with SRS-22R data at baseline and 1 and 2 years after surgery. In total, 150 covariates were used in training machine learning models, including demographics, surgical data and perioperative complications. Validation was accomplished via an 80%/20% data split for training and testing, respectively. Goodness of fit was measured using area under receiver operating characteristic (AUROC) curves.Results
In total, 561 patients met inclusion criteria. The AUROC ranged from 56.5 to 86.9%, reflecting successful fits for most questions. SRS-22R questions regarding pain, disability and social and labor function were the most accurately predicted. Models were less sensitive to questions regarding general satisfaction, depression/anxiety and appearance.Conclusions
To the best of our knowledge, this is the first study to explicitly model the prediction of individual answers to the SRS-22R questionnaire at 1 and 2 years after deformity surgery. The ability to predict individual question responses may prove useful in preoperative counseling in the age of individualized medicine. These slides can be retrieved under Electronic Supplementary Material.Item Open Access External validation of the adult spinal deformity (ASD) frailty index (ASD-FI)(European Spine Journal, 2018-09-01) Miller, Emily K; Vila-Casademunt, Alba; Neuman, Brian J; Sciubba, Daniel M; Kebaish, Khaled M; Smith, Justin S; Alanay, Ahmet; Acaroglu, Emre R; Kleinstück, Frank; Obeid, Ibrahim; Sánchez Pérez-Grueso, Francisco Javier; Carreon, Leah Y; Schwab, Frank J; Bess, Shay; Scheer, Justin K; Lafage, Virginie; Shaffrey, Christopher I; Pellisé, Ferran; Ames, Christopher P; European Spine Study Group; International Spine Study Group© 2018, Springer-Verlag GmbH Germany, part of Springer Nature. Purpose: To assess the ability of the recently developed adult spinal deformity frailty index (ASD-FI) to predict odds of perioperative complications, odds of reoperation, and length of hospital stay after adult spinal deformity (ASD) surgery using a database other than the one used to create the index. Methods: We used the ASD-FI to calculate frailty scores for 266 ASD patients who had minimum postoperative follow-up of 2 years in the European Spine Study Group (ESSG) database. Patients were enrolled from 2012 through 2013. Using ASD-FI scores, we categorized patients as not frail (NF) (< 0.3 points), frail (0.3–0.5 points), or severely frail (SF) (> 0.5 points). Multivariable logistic regression, adjusted for preoperative and surgical factors such as operative time and blood loss, was performed to determine the relationship between ASD-FI category and odds of major complications, odds of reoperation, and length of hospital stay. Results: We categorized 135 patients (51%) as NF, 90 patients (34%) as frail, and 41 patients (15%) as SF. Overall mean ASD-FI score was 0.29 (range 0–0.8). The adjusted odds of experiencing a major intraoperative or postoperative complication (OR 4.5, 95% CI 2.0–10) or having a reoperation (OR 3.9, 95% CI 1.7–8.9) were higher for SF patients compared with NF patients. Mean hospital stay was 2.1 times longer (95% CI 1.8–2.4) for SF patients compared with NF patients. Conclusions: Greater patient frailty, as measured by the ASD-FI, is associated with longer hospital stays and greater odds of major complications and reoperation. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.].Item Open Access 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 DeformityStudy 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.Item Open Access Introduction. Adult spinal deformity.(Neurosurgical focus, 2017-12) Shaffrey, Christopher I; Smith, Justin S; Ames, Christopher P; Yagi, Mitsuru; Alanay, Ahmet; Ha, YoonItem Open Access Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.(Global spine journal, 2024-06) Sardi, Juan P; Smith, Justin S; Gum, Jeffrey L; Rocos, Brett; Charalampidis, Anastasios; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Qiu, Yong; Matsuyama, Yukihiro; Pellisé, Ferran; Polly, David W; Sembrano, Jonathan N; Dahl, Benny T; Kelly, Michael P; de Kleuver, Marinus; Spruit, Maarten; Alanay, Ahmet; Berven, Sigurd H; Lewis, Stephen J; AO Spine Knowledge Forum DeformityProspective multicenter database post-hoc analysis. Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.Item Open Access Optimal surgical care for adolescent idiopathic scoliosis: an international consensus.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2014-12) de Kleuver, Marinus; Lewis, Stephen J; Germscheid, Niccole M; Kamper, Steven J; Alanay, Ahmet; Berven, Sigurd H; Cheung, Kenneth M; Ito, Manabu; Lenke, Lawrence G; Polly, David W; Qiu, Yong; van Tulder, Maurits; Shaffrey, ChristopherPurpose
The surgical management of adolescent idiopathic scoliosis (AIS) has seen many developments in the last two decades. Little high-level evidence is available to support these changes and guide treatment. This study aimed to identify optimal operative care for adolescents with AIS curves between 40° and 90° Cobb angle.Methods
From July 2012 to April 2013, the AOSpine Knowledge Forum Deformity performed a modified Delphi survey where current expert opinion from 48 experienced deformity surgeons, representing 29 diverse countries, was gathered. Four rounds were performed: three web-based surveys and a final face-to-face meeting. Consensus was achieved with ≥ 70% agreement. Data were analyzed qualitatively and quantitatively.Results
Consensus of what constitutes optimal care was reached on greater than 60 aspects including: preoperative radiographs; posterior as opposed to anterior (endoscopic) surgical approaches; use of intraoperative spinal cord monitoring; use of local autologous bone (not iliac crest) for grafts; use of thoracic and lumbar pedicle screws; use of titanium anchor points; implant density of <80% for 40°-70° curves; and aspects of postoperative care. Variability in practice patterns was found where there was no consensus. In addition, there was consensus on what does not constitute optimal care, including: routine pre- and intraoperative traction; routine anterior release; use of bone morphogenetic proteins; and routine postoperative CT scanning.Conclusions
International consensus was found on many aspects of what does and does not constitute optimal operative care for adolescents with AIS. In the absence of current high-level evidence, at present, these expert opinion findings will aid health care providers worldwide define appropriate care in their regions. Areas with no consensus provide excellent insight and priorities for future research.Item Open Access Quality metrics in adult spinal deformity surgery over the last decade: a combined analysis of the largest prospective multicenter data sets.(Journal of neurosurgery. Spine, 2021-10) Pellisé, Ferran; Serra-Burriel, Miquel; Vila-Casademunt, Alba; Gum, Jeffrey L; Obeid, Ibrahim; Smith, Justin S; Kleinstück, Frank S; Bess, Shay; Pizones, Javier; Lafage, Virginie; Pérez-Grueso, Francisco Javier S; Schwab, Frank J; Burton, Douglas C; Klineberg, Eric O; Shaffrey, Christopher I; Alanay, Ahmet; Ames, Christopher P; International Spine Study Group (ISSG) and European Spine Study Group (ESSG)Objective
The reported rate of complications and cost of adult spinal deformity (ASD) surgery, associated with an exponential increase in the number of surgeries, cause alarm among healthcare payers and providers worldwide. The authors conjointly analyzed the largest prospective available ASD data sets to define trends in quality-of-care indicators (complications, reinterventions, and health-related quality of life [HRQOL] outcomes) since 2010.Methods
This is an observational prospective longitudinal cohort study. Patients underwent surgery between January 2010 and December 2016, with > 2 years of follow-up data. Demographic, surgical, radiological, and HRQOL (i.e., Oswestry Disability Index, SF-36, Scoliosis Research Society-22r) data obtained preoperatively and at 3, 6, 12, and 24 months after surgery were evaluated. Trends and changes in indicators were analyzed using local regression (i.e., locally estimated scatterplot smoothing [LOESS]) and adjusted odds ratio (OR).Results
Of the 2286 patients included in the 2 registries, 1520 underwent surgery between 2010 and 2016. A total of 1151 (75.7%) patients who were treated surgically at 23 centers in 5 countries met inclusion criteria. Patient recruitment increased progressively (2010-2011 vs 2015-2016: OR 1.64, p < 0.01), whereas baseline clinical characteristics (age, American Society of Anesthesiologists class, HRQOL scores, sagittal deformity) did not change. Since 2010 there has been a sustained reduction in major and minor postoperative complications observed at 90 days (major: OR 0.59; minor: OR 0.65; p < 0.01); at 1 year (major: OR 0.52; minor: 0.75; p < 0.01); and at 2 years of follow-up (major: OR 0.4; minor: 0.80; p < 0.01) as well as in the 2-year reintervention rate (OR 0.41, p < 0.01). Simultaneously, there has been a slight improvement in the correction of sagittal deformity (i.e., pelvic incidence-lumbar lordosis mismatch: OR 1.11, p = 0.19) and a greater gain in quality of life (i.e., Oswestry Disability Index 26% vs 40%, p = 0.02; Scoliosis Research Society-22r, self-image domain OR 1.16, p = 0.13), and these are associated with a progressive reduction of surgical aggressiveness (number of fused segments: OR 0.81, p < 0.01; percent pelvic fixation: OR 0.66, p < 0.01; percent 3-column osteotomies: OR 0.63, p < 0.01).Conclusions
The best available data show a robust global improvement in quality metrics in ASD surgery over the last decade. Surgical complications and reoperations have been reduced by half, while improvement in disability increased and correction rates were maintained, in patients with similar baseline characteristics.Item Open Access Stratifying outcome based on the Oswestry Disability Index for operative treatment of adult spinal deformity on patients 60 years of age or older: a multicenter, multi-continental study on Prospective Evaluation of Elderly Deformity Surgery (PEEDS).(The spine journal : official journal of the North American Spine Society, 2021-11) Nielsen, Christopher J; Lewis, Stephen J; Oitment, Colby; Martin, Allan R; Lenke, Lawrence G; Qiu, Yong; Cheung, Kenneth Mc; de Kleuver, Marinus; Polly, David W; Shaffrey, Christopher I; Smith, Justin S; Spruit, Maarten; Alanay, Ahmet; Matsuyama, Yukihiro; Jentzsch, Thorsten; Rienmuller, Anna; Shear-Yashuv, Hananel; Pellisé, Ferran; Kelly, Michael P; Sembrano, Jonathan N; Dahl, Benny T; Berven, Sigurd H; Forum Deformity, Ao Spine KnowledgeBackground context
Patients with adult spinal deformity suffer from disease related disability as measured by the Oswestry Disability Index (ODI) for which surgery can result in significant improvements.Purpose
The purpose of this study was to show the change in overall and individual components of the ODI in patients aged 60 years or older following multi-level spinal deformity surgery.Study design
Prospective, multicenter, multi-continental, observational longitudinal cohort study PATIENT SAMPLE: Patients ≥60 years undergoing primary spinal fusion surgery of ≥5 levels for coronal, sagittal or combined deformity.Outcome measures
Oswestry Disability Index (ODI) METHODS: : Patients completed the ODI pre-operatively for baseline, then at 10 weeks, 12 months and 24 months post-operatively. ODI scores were grouped into deciles, and change was calculated with numerical score and improvement or worsening was further categorized from baseline as substantial (≥20%), marginal (≥10-<20%) or no change (within 10%).Results
Two-hundred nineteen patients met inclusion criteria for the study. The median number of spinal levels fused was 9 [Q1=5.0, Q3=12.0]. Two-year mean (95% CI) ODI improvement was 19.3% (16.7%; 21.9%; p<.001) for all age groups, with mean scores improved from a baseline of 46.3% (44.1%; 48.4%) to 41.1% (38.5%; 43.6%) at 10 weeks (p<.001), 28.1% (25.6%; 30.6%) at 12 months (p<.001), and 27.0% (24.4%; 29.5%) at 24 months (p<.001). At 2 years, 45.5% of patients showed 20% or greater improvement in ODI, 23.7% improved between 10% and 20%, 26.3% reported no change (defined as±10% from baseline), 4.5% of patients reported a worsening between 10% to 20%, and none reported worsening greater than 20%. 59.0% of patients were severely disabled (ODI >40%) pre-operatively, which decreased to 20.2% at 2 years. Significant improvement was observed across all 10 ODI items at 12 and 24 months. The largest improvements were seen in pain, walking, standing, sex life, social life and traveling.Conclusions
In this prospective, multicenter, multi-continental study of patients 60 years or older undergoing multi-level spinal deformity surgery, almost 70% of patients reported significant improvements in ODI without taking into account surgical indications, techniques or complications. Clear data is presented demonstrating the particular change from baseline for each decile of pre-operative ODI score, for each sub-score, and for each age group.Item Open Access Surgeons' risk perception in ASD surgery: The value of objective risk assessment on decision making and patient counselling.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2022-05) Pellisé, Ferran; Vila-Casademunt, Alba; Núñez-Pereira, Susana; Haddad, Sleiman; Smith, Justin S; Kelly, Michael P; Alanay, Ahmet; Shaffrey, Christopher; Pizones, Javier; Yilgor, Çaglar; Obeid, Ibrahim; Burton, Douglas; Kleinstück, Frank; Fekete, Tamas; Bess, Shay; Gupta, Munish; Loibl, Markus; Klineberg, Eric O; Sánchez Pérez-Grueso, Francisco J; Serra-Burriel, Miquel; Ames, Christopher P; European Spine Study Group, International Spine Study GroupBackground
Surgeons often rely on their intuition, experience and published data for surgical decision making and informed consent. Literature provides average values that do not allow for individualized assessments. Accurate validated machine learning (ML) risk calculators for adult spinal deformity (ASD) patients, based on 10 year multicentric prospective data, are currently available. The objective of this study is to assess surgeon ASD risk perception and compare it to validated risk calculator estimates.Methods
Nine ASD complete (demographics, HRQL, radiology, surgical plan) preoperative cases were distributed online to 100 surgeons from 22 countries. Surgeons were asked to determine the risk of major complications and reoperations at 72 h, 90 d and 2 years postop, using a 0-100% risk scale. The same preoperative parameters circulated to surgeons were used to obtain ML risk calculator estimates. Concordance between surgeons' responses was analyzed using intraclass correlation coefficients (ICC) (poor < 0.5/excellent > 0.85). Distance between surgeons' and risk calculator predictions was assessed using the mean index of agreement (MIA) (poor < 0.5/excellent > 0.85).Results
Thirty-nine surgeons (74.4% with > 10 years' experience), from 12 countries answered the survey. Surgeons' risk perception concordance was very low and heterogeneous. ICC ranged from 0.104 (reintervention risk at 72 h) to 0.316 (reintervention risk at 2 years). Distance between calculator and surgeon prediction was very large. MIA ranged from 0.122 to 0.416. Surgeons tended to overestimate the risk of major complications and reintervention in the first 72 h and underestimated the same risks at 2 years postop.Conclusions
This study shows that expert surgeon ASD risk perception is heterogeneous and highly discordant. Available validated ML ASD risk calculators can enable surgeons to provide more accurate and objective prognosis to adjust patient expectations, in real time, at the point of care.Item Open Access The Influence of Multilevel Spinal Deformity Surgery on the EuroQol 5 Dimensions' (EQ-5D) Questionnaire and Residential Status in the Elderly: A Prospective, Observational, Multicenter Study.(Global spine journal, 2023-03) Jentzsch, Thorsten; Lewis, Stephen J; Oitment, Colby; Rienmüller, Anna; Martin, Allan R; Nielsen, Christopher J; Shear-Yashuv, Hananel; de Kleuver, Marinus; Qiu, Yong; Matsuyama, Yukihiro; Lenke, Lawrence G; Alanay, Ahmet; Pellisé-Urquiza, Ferran; Cheung, Kenneth MC; Spruit, Maarten; Polly, David W; Sembrano, Jonathan N; Shaffrey, Christopher I; Smith, Justin S; Kelly, Michael P; Dahl, Benny; Berven, Sigurd H; AO Spine Knowledge Forum DeformityStudy design
Multicenter, international prospective study.Objective
This study investigated the clinical outcome up to 2 years after multi-level spinal deformity surgery in the elderly by reporting the minimal clinically important difference (MCID) of EuroQol 5-dimensions (EQ-5D), EQ-VAS, and residential status.Methods
As an ancillary study of 219 patients ≥60 years with spinal deformity undergoing primary instrumented fusion surgery of ≥5 levels, this study focuses on EQ-5D (3-L) as the primary outcome and EQ-VAS and residential status as secondary outcomes. Data on EQ-5D were compared between pre-operatively and postoperatively at 10 weeks, 12 months, and 24 months. An anchor-based approach was used to calculate the MCID.Results
The EQ-5D index and EQ-VAS, respectively, improved significantly at each time point compared to pre-operatively (from .53 (SD .21) and 55.6 (SD 23.0) pre-operatively to .64 (SD .18) and 65.8 (SD 18.7) at 10 weeks, .74 (SD .18) and 72.7 (SD 18.1) at 12 months, and .73 (SD .20) and 70.4 (SD 20.4) at 24 months). 217 (99.1%) patients lived at home pre-operatively, while 186 (88.6%), 184 (98.4%), and 172 (100%) did so at 10 weeks, 12 months, and 24 months, respectively. Our calculated MCID for the EQ-5D index at 1 year was .22 (95% CI .15-.29).Conclusions
The EQ-5D index significantly increased at each time point over 24 months after ≥5 level spinal deformity surgery in elderly patients. The MCID of the EQ-5D-3 L was .22. Patients living at home pre-operatively can expect to be able to live at home 2 years postoperatively.