Decisional regret following corrective adult spinal deformity surgery: a single institution study of incidence and risk factors.

PURPOSE: To assess the characteristics and risk factors for decisional regret following corrective adult spinal deformity (ASD) surgery at our hospital. METHODS: This is a retrospective cohort study of a single-surgeon ASD database. Adult patients (> 40 years) who underwent ASD surgery from May 2016 to December 2020 with minimum 2-year follow-up were included (posterior-only, ≥ 4 levels fused to the pelvis) (n = 120). Ottawa decision regret questionnaires, a validated and reliable 5-item Likert scale, were sent to patients postoperatively. Regret scores were defined as (1) low regret: 0-39 (2) medium to high regret: 40-100. Risk factors for medium or high decisional regret were identified using multivariate models. RESULTS: Ninety patients were successfully contacted and 77 patients consented to participate. Nonparticipants were older, had a higher incidence of anxiety, and higher ASA class. There were 7 patients that reported medium or high decisional regret (9%). Ninety percentage of patients believed that surgery was the right decision, 86% believed that surgery was a wise choice, and 87% would do it again. 8% of patients regretted the surgery and 14% believed that surgery did them harm. 88% of patients felt better after surgery. On multivariate analysis, revision fusion surgery was independently associated with an increased risk of medium or high decisional regret (adjusted odds ratio: 6.000, 95% confidence interval: 1.074-33.534, p = 0.041). CONCLUSIONS: At our institution, we found a 9% incidence of decisional regret. Revision fusion was associated with increased decisional regret. Estimates for decisional regret should be based on single-institution experiences given differences in patient populations.

Counseling Guidelines for Anticipated Postsurgical Improvements in Pain, Function, Mental Health, and Self-image for Different Types of Adult Spinal Deformity.

STUDY DESIGN: Retrospective analysis of a multicenter prospective adult spinal deformity (ASD) database. OBJECTIVE: Quantify postoperative improvements in pain, function, mental health, and self-image for different ASD types. SUMMARY OF BACKGROUND DATA: Medical providers are commonly requested to counsel patients on anticipated improvements in specific health domains including pain, function, and self-image following surgery. ASD is a heterogeneous condition; therefore, health domain improvements may vary according to deformity type. Few studies have quantified outcomes for specific ASD types. METHODS: Surgically treated ASD patients (≥4 levels fused) prospectively enrolled into a multicenter database, minimum 2-year follow-up, were categorized into ASD types according to Scoliosis Research Society-Schwab ASD classification (THORACIC, LUMBAR, DOUBLE, SAGITTAL, MIXED). Demographic, radiographic, operative, and patient reported outcome measures (NRS back and leg pain, SRS-22r, SF-36) data were evaluated. Preoperative and last postoperative values for pain, physical and social function, mental health, and self-image were evaluated, improvements in each domain were quantified, and domain scores compared to generational normative values. Postoperative improvements were also calculated for three age cohorts (<45 yr, 45-65 yr, and >65 yr) within each deformity type. RESULTS: 359 of 564 patients eligible for study (mean age 57.9 yr, mean scoliosis 43.4°, mean SVA 63.3 mm, mean 11.7 levels fused) had ≥2 yr follow-up. Domain improvements for the entire ASD population were 45.1% for back pain, 41.3% for leg pain, 27.1% for physical function, 35.9% for social function, 62.0% for self-image, and 22.6% for mental health (P < 0.05). LUMBAR, SAGITTAL, and MIXED had greatest improvements in pain and function, while THORACIC and DOUBLE had greatest improvements in self-image. Self-image was the most impacted preoperative domain and demonstrated the greatest postoperative improvement for all ASD types. CONCLUSION: ASD patients demonstrated quantifiable postoperative improvements in pain, self-image, physical and social function, and mental health; however, improvements differed between ASD types. Further research is needed to understand specific patient expectations for ASD treatment. LEVEL OF EVIDENCE: 3.

Helping spine surgeons detect pre-surgical psychological distress in complex spine patients: an observational pilot study.

STUDY DESIGN: Retrospective analysis. OBJECTIVE: Analysis of a standardized, pre-surgical psychological evaluation program for complex spine surgery. Adult spinal deformity (ASD) patients have a high rate of comorbid mental health conditions. Although there is a body of literature demonstrating the impact of psychological factors, including anxiety and depression, on spine surgery outcome, it is estimated that spine surgeons utilize a psychological assessment only about one third of the time prior to a patient's spine surgery. At this time, there is not a widely reported pre-surgical psychological evaluation program for ASD patients. METHODS: 129 consecutive complex spine surgery candidates receiving a pre-surgical psychological evaluation were analyzed between January 1st 2014 and December 31st 2018. Based on the available literature and professional experience in our facility, a color code for patients was developed from Green (low psychological or psychosocial co-morbidity) to Red (high psychological or psychosocial co-morbidity). Univariate analysis was used to evaluate between color grades and demographics, mental health disorders and outcomes. RESULTS: 83% of complex spine patients had at least one psychological disorder or psychosocial barrier. Only 17% had a combination of realistic expectations for surgery, a good support plan, and were without a history of mental illness. The pre-surgical psychological color criteria were validated in showing higher rates of major depression, anxiety disorder, and bipolar disorder in moderate to severe color grades (p < .001) in addition to higher PHQ-9 and GAD-7 scores (p < .001). Patients having a more severe color grade had lower rates of a discharge home and were taking higher morphine equivalent dosages (MEDs) at their six-month follow-up, though both did not reach statistical significance (p = .07 and p = .08; respectively). CONCLUSION: A comprehensive pre-surgical psychological evaluation may be beneficial to risk stratify and counsel patients being evaluated for surgical reconstruction of adult spinal deformities. LEVEL OF EVIDENCE: 3.

Effect of Perioperative Mental Status on Health-related Quality of Life in Patients With Adult Spinal Deformities.

STUDY DESIGN: A retrospective study. OBJECTIVE: We aimed to evaluate the impact of mental status on the clinical outcomes of patients with adult spinal deformity (ASD). SUMMARY OF BACKGROUND DATA: Limited information is currently available on how preoperative mental status affects postoperative health-related quality of life (HRQOL) in patients with ASD. METHODS: We enrolled 165 patients with ASD who underwent corrective surgery at a single university hospital between March 2010 and September 2015. We compared Scoliosis Research Society-22r (SRS-22r) and Oswestry Disability Index (ODI) scores using various x-ray parameters at these time points: preoperative period and postoperative 2 years. Additionally, to determine the associations between perioperative complications and mental health disorders, we examined these x-ray parameters: lumbar lordosis, thoracic kyphosis, sacral slope, pelvic incidence, pelvic tilt, sagittal vertical axis (SVA), and T1 pelvic angle (TPA). RESULTS: We found correlations between the preoperative SRS-22r total score and preoperative ODI (r = -0.692, P < 0.01) and postoperative ODI (r = -0.443, P < 0.01). Preoperative SRS-22r mental domain correlated with preoperative ODI (r = -0.561, P ≤ 0.01) and postoperative ODI (r = -0.315, P ≤ 0.01). Perioperative (preoperative and postoperative) SRS-22r mental domain did not correlate with the postoperative x-ray parameters except for SVA and TPA. Postoperative mental health correlated with early infection (P < 0.05), hematoma (P < 0.05), deep vein thrombosis (P < 0.05), and delirium (P < 0.05). Regression analysis revealed that preoperative SRS-22r mental health score correlated with preoperative ODI (P < 0.001) and postoperative ODI (P < 0.001). The regression coefficient number between preoperative SRS-22r mental health score and perioperative (preoperative and postoperative) ODI improved from -17.3 to -10.2 from preoperative to postoperative periods. CONCLUSION: Diminished preoperative mental health worsened postoperative HRQOL. Perioperative complications influence postoperative mental status and HRQOL; hence, screening preoperative mental health is important. LEVEL OF EVIDENCE: 3.

Mental health status and sagittal spinopelvic alignment correlate with self-image in patients with adult spinal deformity before and after corrective surgery.

PURPOSE: Preoperative patient self-image (SI) in adult spinal deformity (ASD) is the most relevant factor for surgical decision-making. Postoperative SI has an important role in a patient's satisfaction with surgery. However, few studies are available to describe these variables. The aim was to investigate the factors that correlate with SI before and 2 years after ASD surgery. METHODS: This study was a retrospective review of prospectively collected multicentric data. Patients who underwent ASD surgery with a minimum follow-up of 2 years were enrolled (n = 391). They were divided into high-SI and low-SI groups, both preoperatively and postoperatively, according to SRS-22R SI/appearance subdomain scores at baseline and at 2 years, respectively. Independently related factors for SI were determined using logistic regression analysis. RESULTS: Crucial factors for SI at baseline were the scores on the SRS-22R function/activity (OR: 2.61), SRS-22R mental health (OR: 2.63) subdomains, and relative spinopelvic alignment (RSA, OR: 0.95). SF-36 MCS (OR: 1.07) at baseline as well as sagittal vertical axis (SVA, OR: 0.99) at 2 years, and complications (OR: 0.44) were independent predictive factors for SI at 2 years. The patients who transitioned from the preoperative low-SI group to the postoperative high-SI group achieved larger global sagittal alignment restoration and had lesser complications than those who did not. CONCLUSIONS: Mental status and sagittal spinopelvic alignment are key determinants of SI. The results indicate that considering mental status, preventing complications, and global sagittal alignment, restoration is crucial for achieving substantial SI scores after ASD surgery. These slides can be retrieved under Electronic Supplementary Material.

Adult spinal deformity.

Adult spinal deformity affects the thoracic or thoracolumbar spine throughout the ageing process. Although adolescent spinal deformities taken into adulthood are not uncommon, the most usual causes of spinal deformity in adults are iatrogenic flatback and degenerative scoliosis. Given its prevalence in the expanding portion of the global population aged older than 65 years, the disorder is of growing interest in health care. Physical examination, with a focus on gait and posture, along with radiographical assessment are primarily used and integrated with risk stratification indices to establish optimal treatment planning. Although non-operative treatment is regarded as the first-line response, surgical outcomes are considerably favourable. Global disparities exist in both the assessment and treatment of adults with spinal deformity across countries of varying incomes, which represents an area requiring further investigation. This Seminar presents evidence and knowledge that represent the evolution of data related to spinal deformity in adults over the past several decades.

Living with Chronic Pain: A Qualitative Study of the Daily Life of Older People with Chronic Pain in Chile.

One of the main causes of chronic pain in older people is spine deformity, an abnormal curvature of the spine. The purpose of this study is to improve understanding of the experience of chronic pain produced by spinal deformity in older people and understand how cultural factors may affect this experience. A qualitative study was performed with 10 older people. Participants were encouraged to describe a typical day in their life, including the factors that affect their pain and how their quality of life had been affected since experiencing chronic pain. The semistructured interviews were transcribed and analyzed using open coding. Pain caused by spine deformity produces disability, affecting how older people perform their daily activities, causing them to adapt their households and physical positions to perform these tasks, albeit slowly or incompletely. Chronic pain also affects emotional states and social relationships because older people become unable to undertake physical activities that they performed in the past. The close relationship with adult children and friends, typical in Latin cultures, is a source of comfort and support. At a community level, adaptation of public services (such as public transportation) must be improved.

Activities of daily living and patient satisfaction after long fusion for adult spinal deformity: a retrospective study.

PURPOSE: Spinal instrumented arthrodesis improves health-related quality of life (HRQOL), although mobility is impaired. This study evaluates activities of daily livings after thoracolumbosacroiliac arthrodesis for adult spinal deformity and patient satisfaction. METHODS: Fifty patients who underwent surgery filled self-administered questionnaires (1-year preoperative and postoperative conditions), and 36 patients (3 men and 33 women; mean age 71.4 years) participated in the study. Twenty-five activities, including weeding, snow shoveling, toilet activities, and sleeping postures, were examined. Spinal alignment with Scoliosis Research Society (SRS)-Schwab classification, HRQOL with SRS-22, complications, and patient satisfaction were evaluated. Pre- and postoperative conditions were statistically compared. RESULTS: Spinal alignment improved postoperatively. Comparison data revealed that strenuous activities, such as weeding and farm work, significantly deteriorated postoperatively in 42.1-87.5% patients. Other basic activities, excluding Western toilet usage, sleeping supine, laundry and kitchen chores, and changing jacket/pants, also significantly deteriorated in 21-88% patients. Only activities such as sleeping supine, standing upright, vacuuming, doing laundry, and reaching for objects placed at heights became possible with significant difference postoperatively among activities that could not be performed preoperatively. Light activities were continued, but strenuous activities were restricted. Nevertheless, the patient satisfaction rate was 70%. Six patients exhibited complications; however, none were dissatisfied with surgery outcomes. Instrumentation or proximal junctional failures were associated with at least one strenuous work activity. CONCLUSIONS: Thoracolumbosacroiliac arthrodesis does not always improve activities postoperatively. Therefore, surgical indication for patients who continue activities preoperatively should be carefully decided. LEVEL OF EVIDENCE: Level 3. These slides can be retrieved under Electronic Supplementary Material.

Cervical Versus Thoracolumbar Spinal Deformities: A Comparison of Baseline Quality-of-Life Burden.

STUDY DESIGN: Retrospective analysis of 2 prospectively collected multicenter databases, one for cervical deformity (CD) and the other for general adult spinal deformity. OBJECTIVE: To investigate the relative quality-of-life and disability burden in patients with uncompensated cervical, thoracolumbar, or cervical and thoracolumbar deformities. SUMMARY OF BACKGROUND DATA: The relative quality-of-life burden of cervical and thoracolumbar deformities have never been compared with each other. This may have significant implications when deciding on the appropriate treatment intervention for patients with combined thoracolumbar and cervical deformities. METHODS: When defining CD C2-C7 sagittal vertical axis (SVA)>4 cm was used while a C7-S1 SVA>5 cm was used to defined thoracolumbar deformity. Patients with both SVA criteria were defined as "combined." Primary analysis compared patients in the different groups by demographic, comorbidity data, and quality-of-life scores [EuroQOL 5 dimensions questionnaire (EQ-5D)] using t tests. Secondary analysis matched deformity groups with propensity scores matching based on baseline EQ-5D scores. Differences in disease-specific metrics [the Oswestry Disability Index, Neck Disability Index, modified Japanese Orthopaedic Association questionnaire (mJOA)] were analyzed using analysis of variance tests and post hoc analysis. RESULTS: In total, 212 patients were included in our analysis. Patients with CD only had less neurological deficits (mJOA: 14.6) and better EQ-5D (0.746) scores compared with patients with combined deformities (11.9, 0.716), all P<0.05. Regarding propensity score-matched deformity cohorts, 99 patients were matched with similar quality-of-life burden, 33 per deformity cohort. CD only patients had fewer comorbidities (1.03 vs. 2.12 vs. 2.70; P<0.001), whereas patients with combined deformity had more baseline neurological impairment compared with CD only patients (mJOA: 12.00 vs. 14.25; P=0.050). CONCLUSIONS: Combined deformity patients were associated with the lowest quality-of-life and highest disability. Furthermore, regarding deformity cohorts matched by similar baseline quality-of-life status (EQ-5D), patients with combined deformities were associated with significantly worse neurological impairments. This finding implies that quality of life may not be a direct reflection of a patient's disability status, especially in patients with combined cervical and thoracolumbar deformities. LEVEL OF EVIDENCE: Level III.

Development of a Preoperative Predictive Model for Reaching the Oswestry Disability Index Minimal Clinically Important Difference for Adult Spinal Deformity Patients.

STUDY DESIGN: Retrospective review of prospective multicenter adult spinal deformity (ASD) database. OBJECTIVE: To create a model based on baseline demographic, radiographic, health-related quality of life (HRQOL), and surgical factors that can predict patients meeting the Oswestry Disability Index (ODI) minimal clinically important difference (MCID) at the two-year postoperative follow-up. SUMMARY OF BACKGROUND DATA: Surgical correction of ASD can result in significant improvement in disability as measured by ODI, with the goal of reaching at least one MCID. However, a predictive model for reaching MCID following ASD correction does not exist. METHODS: ASD patients ≥18 years and baseline ODI ≥ 30 were included. Initial training of the model comprised forty-three variables including demographic data, comorbidities, modifiable surgical variables, baseline HRQOL, and coronal/sagittal radiographic parameters. Patients were grouped by whether or not they reached at least one ODI MCID at two-year follow-up. Decision trees were constructed using the C5.0 algorithm with five different bootstrapped models. Internal validation was accomplished via a 70:30 data split for training and testing each model, respectively. Final predictions from the models were chosen by voting with random selection for tied votes. Overall accuracy, and the area under a receiver operating characteristic curve (AUC) were calculated. RESULTS: 198 patients were included (MCID: 109, No-MCID: 89). Overall model accuracy was 86.0%, with an AUC of 0.94. The top 11 predictors of reaching MCID were gender, Scoliosis Research Society (SRS) activity subscore, back pain, sagittal vertical axis (SVA), pelvic incidence-lumbar lordosis mismatch (PI-LL), primary version revision, T1 spinopelvic inclination angle (T1SPI), American Society of Anesthesiologists (ASA) grade, T1 pelvic angle (T1PA), SRS pain, SRS total. CONCLUSIONS: A successful model was built predicting ODI MCID. Most important predictors were not modifiable surgical parameters, indicating that baseline clinical and radiographic status is a critical factor for reaching ODI MCID. LEVEL OF EVIDENCE: Level II.

Análisis de la calidad de vida en los pacientes afectos de escoliosis vertebral / Analysis of the quality of life in patients affected by scoliosis

Objetivos: Analizar la calidad de vida mediante el test SRS 22 en los pacientes con escoliosis de 20 o más grados Cobb. Material y método: Estudio descriptivo prospectivo realizado a pacientes con escoliosis de al menos 20 grados Cobb y con edad comprendida entre 10 y 20 años. Fue realizado entre abril y mayo de 2016.Se les registró peso, talla, índice de masa corporal y cuestionario SR 22, que es un cuestionario específico de calidad de vida para pacientes con escoliosis. Los pacientes se dividieron en 2 grupos para su análisis: a) escoliosis entre 20 y 29 grados Cobb (n=44); y b) escoliosis de 30 grados Cobb o superior (n=32). Resultados: Existen diferencias significativas en las dimensiones que evalúan el dolor, la autopercepción de la imagen y la satisfacción del tratamiento, siendo peor valoradas cuando el grado de escoliosis es de 30 grados Cobb o superior. No hay diferencias significativas en la función/actividad ni en la salud mental. La puntuación global del cuestionario también fue peor en el grupo con mayor grado de escoliosis. El peso, talla e índice de masa corporal no han mostrado diferencias significativas según el mayor o menor grado de escoliosis. Conclusiones: La escoliosis afecta de forma importante a la calidad de vida de las personas que la padecen, existiendo una correlación negativa entre la gravedad de la escoliosis medida mediante grados Cobb y la calidad de vida

Objectives: To assess the quality of life using the SRS 22 test in patients with scoliosis of 20 or more degrees Cobb. Material and methods: A prospective descriptive study was conducted between April and May 2016 on patients with scoliosis of at least 20 degrees Cobb and aged between 10 and 20 years. A record was made of weight, height, body mass index, and the SR 22 specific quality of life questionnaire for patients with scoliosis was completed. Patients were divided into two groups for analysis: a) scoliosis between 20 and 29 degrees Cobb (n=44); and b) scoliosis with a Cobb of 30 degrees or greater (n=32). Results: There were significant differences in the dimensions that assess pain, image self-perception, and satisfaction with treatment, being valued worse when the degree of scoliosis Cobb is 30 degrees or higher. There were no significant differences in function/activity or mental health. The overall score of the questionnaire was also worse in the group with the highest degree of scoliosis. The weight, height, and BMI showed no significant differences due to the varying degrees of scoliosis. Conclusions: Scoliosis significantly affects the quality of life of people who suffer it, and there is a negative correlation between the severity of scoliosis measured by degrees Cobb and quality of life

Analysis of factors affecting baseline SF-36 Mental Component Summary in Adult Spinal Deformity and its impact on surgical outcomes.

OBJECTIVES: To identify the factors that affect SF-36 mental component summary (MCS) in patients with adult spinal deformity (ASD) at the time of presentation, and to analyse the effect of SF-36 MCS on clinical outcomes in surgically treated patients. METHODS: Prospectively collected data from a multicentric ASD database was analysed for baseline parameters. Then, the same database for surgically treated patients with a minimum of 1-year follow-up was analysed to see the effect of baseline SF-36 MCS on treatment results. A clinically useful SF-36 MCS was determined by ROC Curve analysis. RESULTS: A total of 229 patients with the baseline parameters were analysed. A strong correlation between SF-36 MCS and SRS-22, ODI, gender, and diagnosis were found (p < 0.05). For the second part of the study, a total of 186 surgically treated patients were analysed. Only for SF-36 PCS, the un-improved cohort based on minimum clinically important differences had significantly lower mean baseline SF-36 MCS (p < 0.001). SF-36 MCS was found to have an odds ratio of 0.914 in improving SF-36 PCS score (unit by unit) (p < 0.001). A cut-off point of 43.97 for SF-36 MCS was found to be predictive of SF-36 PCS (AUC = 0.631; p < 0.001). CONCLUSIONS: The factors effective on the baseline SF-36 MCS in an ASD population are other HRQOL parameters such as SRS-22 and ODI as well as the baseline thoracic kyphosis and gender. This study has also demonstrated that baseline SF-36 MCS does not necessarily have any effect on the treatment results by surgery as assessed by SRS-22 or ODI. LEVEL OF EVIDENCE: Level III, prognostic study.

Adult Spinal Deformity Knowledge in Orthopedic Spine Surgeons: Impact of Fellowship Training, Experience, and Practice Characteristics.

STUDY DESIGN: Survey study. OBJECTIVE: The purpose of this paper was to assess the level of adult spine deformity (ASD) knowledge among orthopedic spine surgeons and identify areas for improvement in spine surgery training. SUMMARY OF BACKGROUND DATA: ASD is increasingly encountered in spine surgery practice. While ASD knowledge among neurosurgeons has been evaluated, ASD knowledge among orthopedic spine surgeons has not previously been reported. METHODS: A survey of orthopedic spine surgeon members of North American Spine Society (NASS) was conducted to assess level of spine surgery training, practice experience, and spinal deformity knowledge base. The survey used was previously completed by a group of neurologic surgeons with published results. The survey used 11 questions developed and agreed upon by experienced spinal deformity surgeons. RESULTS: Complete responses were received from 413 orthopedic spine surgeons. The overall correct-answer rate was 69.0%. Surgeons in practice for less than 10 years had a higher correct-answer rate compared to those who have practiced for 10 years or more (74% vs. 67%; p = .000003). Surgeons with 75% or more of their practice dedicated to spine had a higher overall correct rate compared to surgeons whose practice is less than 75% spine (71% vs. 63%; p = .000029). Completion of spine fellowship was associated with a higher overall correct-answer rate compared to respondents who did not complete a spine fellowship (71% vs. 59%; p < .00001). CONCLUSIONS: Completion of spine fellowship and having a dedicated spine surgery practice were significantly associated with improved performance on this ASD knowledge survey. Unlike neurosurgeons, orthopedic spine surgeons who have practiced for less than 10 years performed better than those who have practiced for more than 10 years. Ongoing emphasis on spine deformity education should be emphasized to improve adult spinal deformity knowledge base.

Health-related quality of life outcomes in complex adult spinal deformity surgery.

OBJECTIVE Significant health-related quality of life (HRQOL) benefits have been observed for patients undergoing primary and revision adult spinal deformity (ASD) surgery. The purpose of this study was to report changes in HRQOL measures in a consecutive series of patients undergoing complex spinal reconstructive surgery, using Scoli-RISK-1 (SR-1) inclusion criteria. METHODS This was a single-center, retrospective cohort study. The SR-1 inclusion criteria were used to define patients with complex ASD treated between June 1, 2009, and June 1, 2011. Standard preoperative and perioperative data were collected, including the Scoliosis Research Society (SRS)-22r instrument. The HRQOL changes were evaluated at a minimum 2-year follow-up. Standardized forms were used to collect surgery-related complications data for all patients. Complications were defined as minor, transient major, or permanent major. Patients who achieved a minimum 2-year follow-up were included in the analysis. RESULTS Eighty-four patients meeting SR-1 criteria were identified. Baseline demographic and surgical data were available for 74/84 (88%) patients. Forty-seven of 74 (64%) patients met the additional HRQOL criteria with a minimum 2-year follow-up (mean follow-up 3.4 years, range 2-6.5 years). Twenty-one percent of patients underwent posterior fusion only, 40% of patients had a posterior column osteotomy, and 38% had a 3-column osteotomy. Seventy-five percent of patients underwent a revision procedure. Significant improvements were observed in all SRS-22r domains: Pain: +0.8 (p < 0.001); Self-Image: +1.4 (p < 0.001); Function: +0.46 (p < 0.001); Satisfaction: +1.6 (p < 0.001); and Mental Health: +0.28 (p = 0.04). With the exception of Mental Health, more than 50% of patients achieved a minimum clinically important difference (MCID) in SRS-22r domain scores (Mental Health: 20/47, 42.6%). A total of 65 complications occurred in 31 patients. This includes 29.8% (14/47) of patients who suffered a major complication and 17% (8/47) who suffered a postoperative neurological deficit, most commonly at the root level (10.6%, 5/47). Of the 8 patients who suffered a neurological deficit, 1 (13%) was able to achieve MCID in the SRS Function domain. CONCLUSIONS The majority of patients experienced clinically relevant improvement in SRS-22r HRQOL scores after complex ASD surgery. The greatest improvements were seen in the SRS Pain and SRS Self-Image domains. Although 30% of patients suffered a major or permanent complication, benefits from surgery were still attained. Patients sustaining a neurological deficit or major complication were unlikely to achieve HRQOL improvements meeting or exceeding MCID for the SRS Function domain.

Defining a core outcome set for adolescent and young adult patients with a spinal deformity.

Background and purpose - Routine outcome measurement has been shown to improve performance in several fields of healthcare. National spine surgery registries have been initiated in 5 Nordic countries. However, there is no agreement on which outcomes are essential to measure for adolescent and young adult patients with a spinal deformity. The aim of this study was to develop a core outcome set (COS) that will facilitate benchmarking within and between the 5 countries of the Nordic Spinal Deformity Society (NSDS) and other registries worldwide. Material and methods - From August 2015 to September 2016, 7 representatives (panelists) of the national spinal surgery registries from each of the NSDS countries participated in a modified Delphi study. With a systematic literature review as a basis and the International Classification of Functioning, Disability and Health framework as guidance, 4 consensus rounds were held. Consensus was defined as agreement between at least 5 of the 7 representatives. Data were analyzed qualitatively and quantitatively. Results - Consensus was reached on the inclusion of 13 core outcome domains: "satisfaction with overall outcome of surgery", "satisfaction with cosmetic result of surgery", "pain interference", physical functioning", "health-related quality of life", "recreation and leisure", "pulmonary fatigue", "change in deformity", "self-image", "pain intensity", "physical function", "complications", and "re-operation". Panelists agreed that the SRS-22r, EQ-5D, and a pulmonary fatigue questionnaire (yet to be developed) are the most appropriate set of patient-reported measurement instruments that cover these outcome domains. Interpretation - We have identified a COS for a large subgroup of spinal deformity patients for implementation and validation in the NSDS countries. This is the first study to further develop a COS in a global perspective.

Depression as an independent predictor of postoperative delirium in spine deformity patients undergoing elective spine surgery.

OBJECTIVE Depression is the most prevalent affective disorder in the US, and patients with spinal deformity are at increased risk. Postoperative delirium has been associated with inferior surgical outcomes, including morbidity and mortality. The relationship between depression and postoperative delirium in patients undergoing spine surgery is relatively unknown. The aim of this study was to determine if depression is an independent risk factor for the development of postoperative delirium in patients undergoing decompression and fusion for deformity. METHODS The medical records of 923 adult patients (age ≥ 18 years) undergoing elective spine surgery at a single major academic institution from 2005 through 2015 were reviewed. Of these patients, 255 (27.6%) patients had been diagnosed with depression by a board-certified psychiatrist and constituted the Depression group; the remaining 668 patients constituted the No-Depression group. Patient demographics, comorbidities, and intra- and postoperative complication rates were collected for each patient and compared between groups. The primary outcome investigated in this study was rate of postoperative delirium, according to DSM-V criteria, during initial hospital stay after surgery. The association between depression and postoperative delirium rate was assessed via multivariate logistic regression analysis. RESULTS Patient demographics and comorbidities other than depression were similar in the 2 groups. In the Depression group, 85.1% of the patients were taking an antidepressant prior to surgery. There were no significant between-group differences in intraoperative variables and rates of complications other than delirium. Postoperative complication rates were also similar between the cohorts, including rates of urinary tract infection, fever, deep and superficial surgical site infection, pulmonary embolism, deep vein thrombosis, urinary retention, and proportion of patients transferred to the intensive care unit. In total, 66 patients (7.15%) had an episode of postoperative delirium, with depressed patients experiencing approximately a 2-fold higher rate of delirium (10.59% vs 5.84%). In a multivariate logistic regression analysis, depression was an independent predictor of postoperative delirium after spine surgery in spinal deformity patients (p = 0.01). CONCLUSIONS The results of this study suggest that depression is an independent risk factor for postoperative delirium after elective spine surgery. Further studies are necessary to understand the effects of affective disorders on postoperative delirium, in hopes to better identify patients at risk.

ISYQOL: a Rasch-consistent questionnaire for measuring health-related quality of life in adolescents with spinal deformities.

BACKGROUND CONTEXT: Spinal deformities are commonly associated with poor health-related quality of life (HRQOL). Several questionnaires (eg, Scoliosis Research Society-24 [SRS-24] and Scoliosis Research Society-22 [SRS-22]) have been developed to evaluate HRQOL in these conditions. In adults as well as during growth, the HRQOL is considered one of the most relevant outcomes of both conservative and surgical treatments. Rasch analysis is a powerful statistical technique for developing high-quality and valid questionnaires. The SRS-24 and SRS-22 have been evaluated using the Rasch analysis but showed poor measurement properties. Thus, a proper measure of HRQOL in people with a spine condition is still missing. PURPOSE: This study aimed to develop a new questionnaire that is totally Rasch consistent for measuring the HRQOL in young people with a spine condition. STUDY DESIGN: This is a cross-sectional study for developing a new HRQOL measure. PATIENT SAMPLE: A total of 402 participants with adolescent idiopathic scoliosis or Scheuermann juvenile kyphosis were included in the study. OUTCOME MEASURE: The outcome measure used was the Italian Spine Youth Quality of Life (ISYQOL) questionnaire. MATERIALS AND METHODS: The study consisted of different stages: a conventional approach content analysis, an opinion poll among clinicians trained in spine deformities, and the Rasch analysis (partial credit model). RESULTS: The Rasch analysis showed that all items of the ISYQOL questionnaire had ordered thresholds and a good fit to the model. Differential item functioning was present for Item 1, with bracing only, and was solved with a conventional items splitting procedure. The ISYQOL item map spans an adequate range of HRQOL. The principal component analysis for Rasch residuals showed, in practical terms, the ISYQOL unidimensionality. The reliability of ISYQOL was high enough so that approximately three significantly different levels of HRQOL could be discerned. Two questionnaire versions were provided for patients with and without the brace, respectively. CONCLUSIONS: ISYQOL is the first HRQOL questionnaire developed according to the Rasch analysis. It was developed in a conservative treatment setting for all types of spinal deformities, including also patients with surgical curves. Validation in many languages is already under way.

Decision analysis to identify the ideal treatment for adult spinal deformity: What is the impact of complications on treatment outcomes?

OBJECTIVE: The aim of this study was to analyze the impact of treatment complications on outcomes in adult spinal deformity (ASD) using a decision analysis (DA) model. METHODS: The study included 535 ASD patients (371 with non-surgical (NS) and 164 with surgical (S) treatment) from an international multicentre database of ASD patients. DA was structured in two main steps; 1) Baseline analysis (Assessing the probabilities of outcomes, Assessing the values of preference -utilities-, Combining information on probability and utility and assigning the quality adjusted life expectancy (QALE) for each treatment) and 2) Sensitivity analysis. Complications were analyzed as life threatening (LT) and nonlife threatening (NLT) and their probabilities were calculated from the database as well as a thorough literature review. Outcomes were analyzed as improvement, no change and deterioration. Death/complete paralysis was considered as a separate category. RESULTS: All 535 patients were analyzed in regard to complications. Overall, there were 78 NLT and 12 LT complications and 3 death/paralysis. Surgical treatment offered significantly higher chances of clinical improvement but also was significantly more prone to complications (31.7% vs. 11.1%, p < 0.001). CONCLUSION: Surgical treatment of ASD is more likely to cause complications compared to NS treatment. On the other hand, surgery has been shown to provide a higher likelihood of improvement in HRQoL scores. So, the decision on the type of treatment in ASD needs to take both chances of improvement and burden associated with S or NS treatments and better be arrived by the active participation of patients and physicians equipped with the present information. LEVEL OF EVIDENCE: Level II, Decision analysis.

Importance of patient-reported individualized goals when assessing outcomes for adult spinal deformity (ASD): initial experience with a Patient Generated Index (PGI).

BACKGROUND CONTEXT: Current metrics to assess patients' health-related quality of life (HRQOL) may not reflect a true change in the patients' specific perception of what is most important to them. PURPOSE: This study aimed to describe the initial experience of a Patient Generated Index (PGI) in which patients create their own outcome domains. STUDY DESIGN: This is a single-center prospective study. PATIENT SAMPLE: Patients with adult spinal deformity (ASD) comprise the study sample. OUTCOME MEASURES: Oswestry Disability Index (ODI), Short Form-36 (SF-36 Physical Component Score [PCS] and Mental Component Score [MCS]), Scoliosis Research Society-22r (SRS-22r), and PGI. METHODS: Oswestry Disability Index, SF-36, SRS-22r, and PGI were administered preoperatively and postoperatively at 6 weeks, 3 months, 6 months, and 1 and 2 years. PGI correlations with ODI, SF-36, SRS total score, free-text frequency analysis of PGI exact response with text in ODI and SRS-22r questionnaires, and the responsiveness (effect size [ES]) of the HRQOL metrics were analyzed. No funding was used for this study and there are no conflicts of interest. RESULTS: A total of 59 patients with 209 clinical encounters produced 370 PGI written response topics that included affect or emotions, relationships, activities of daily life, personal care, work, and hobbies. Mean preoperative PGI score was 18.6±13.5 (0-71.7 out of 100 [best]), and mean scores significantly improved at every postoperative time point (p<.05). Preoperative PGI scores significantly correlated with preoperative ODI (r=-0.28, p=.03), MCS (r=0.48, p<.01), and SRS total (r=0.57, p<.01). Postoperative PGI scores correlated with all HRQOL measures (p<.0001): ODI (r=-0.65), PCS (r=0.50), MCS (r=0.55), and SRS total (r=0.63). PGI responses exactly matched ODI and SRS-22r text at 47.8% and 35.4%, respectively, and at 63.2% and 58.9%, respectively, for categories. Patient Generated Index ES at a minimum of 1-year follow-up was -2.39, indicating substantial responsiveness (|ES|>0.8). Effect sizes for ODI, SRS-22r total, SF-36 PCS, and SF-36 MCS were 2.16, -2.06, -2.05, and -0.80, respectively. CONCLUSIONS: The PGI is easy to administer and offers additional information about the patients' perspective not captured in standard HRQOL metrics. Patient Generated Index scores correlated with all of the standard HRQOL scores and were more responsive than ODI, SF-36, and SRS-22r, suggesting that the PGI may be a step closer to one HRQOL measure that better encompasses concerns and goals of the individual patients.

Principal Radiographic Characteristics for Cervical Spinal Deformity: A Health-related Quality-of-life Analysis.

STUDY DESIGN: Retrospective study. OBJECTIVE: The aim of this study was to propose radiographic characteristics of patients with cervical disability and to investigate the relevant parameters when assessing cervical alignment. SUMMARY OF BACKGROUND DATA: Although cervical kyphosis is traditionally recognized as presentation of cervical deformity, an increasing number of studies demonstrated that cervical kyphosis may not equal cervical deformity. Therefore, several other differentiating criteria for cervical deformity should be investigated and supported with quality of life scores. METHODS: A database of full-body radiographs was retrospectively reviewed. Patients without previous cervical surgery, with a well-aligned thoracolumbar profile (defined as T1 pelvis angle <15°), and with an available Neck Disability Index (NDI) score were reviewed in this study. Subjects were stratified into an asymptomatic (64 subjects with NDI ≤15, Visual Analogue Scale [VAS] neck ≤3, and VAS arm ≤3) and a symptomatic group (107 subjects with NDI >15, VAS neck >3, or VAS arm >3). Independent t tests were performed to investigate differences between two groups. Logistic regressions and principal component analyses were then performed. RESULTS: NDI averaged 5.43 in asymptomatic group, significantly smaller than symptomatic group (5.43 vs. 41.25). t Test revealed that C2-C7 sagittal vertical axis (SVA), McGregor slope, and the slope of line of sight (SLS) were significantly different while C2-C7 angle (cervical curvature, CC) did not show statistical difference (P = 0.09). Logistic regressions were performed using the significantly different parameters as well as CC. Results identified C2-C7 SVA and SLS as independent risk factors for low health-related quality of life. The principal component analysis leads to a new factor (0.55 × C2C7SVA + 0.34 × COC2 + 0.77 × CC) with strong correlations with NDI, VAS, and EQ5D measurements. CONCLUSION: The traditional concept of cervical kyphosis should not be regarded as a standalone criterion of cervical deformity. The most clinically relevant components of cervical analysis are the C2-C7 SVA, C0C2 angle, and C2C7 angle. In addition, the three components should be assessed together in harmony and not individually. LEVEL OF EVIDENCE: 4.