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Health-related quality of life measures in adult spinal deformity: can we replace the SRS-22 with PROMIS?

Passias, Peter G; Pierce, Katherine E; Krol, Oscar; Williamson, Tyler; Naessig, Sara; Ahmad, Waleed; Passfall, Lara; Tretiakov, Peter; Imbo, Bailey; Joujon-Roche, Rachel; Lebovic, Jordan; Owusu-Sarpong, Stephane; Moattari, Kevin; Kummer, Nicholas A; Maglaras, Constance; O'Connell, Brooke K; Diebo, Bassel G; Vira, Shaleen; Lafage, Renaud; Lafage, Virginie; Buckland, Aaron J; Protopsaltis, Themistocles
PURPOSE/OBJECTIVE:To determine the validity and responsiveness of PROMIS metrics versus the SRS-22r questionnaire in adult spinal deformity (ASD). METHODS:Surgical ASD patients undergoing ≥ 4 levels fused with complete baseline PROMIS and SRS-22r data were included. Internal consistency (Cronbach's alpha) and test-retest reliability [intraclass correlation coefficient (ICC)] were compared. Cronbach's alpha and ICC values ≥ 0.70 were predefined as satisfactory. Convergent validity was evaluated via Spearman's correlations. Responsiveness was assessed via paired samples t tests with Cohen's d to assess measure of effect (baseline to 3 months). RESULTS:One hundred and ten pts are included. Mean baseline SRS-22r score was 2.62 ± 0.67 (domains = Function: 2.6, Pain: 2.5, Self-image: 2.2, Mental Health: 3.0). Mean PROMIS domains = Physical Function (PF): 12.4, Pain Intensity (PI): 91.7, Pain Interference (Int): 55.9. Cronbach's alpha, and ICC were not satisfactory for any SRS-22 and PROMIS domains. PROMIS-Int reliability was low for all SRS-22 domains (0.037-0.225). Convergent validity demonstrated strong correlation via Spearman's rho between PROMIS-PI and overall SRS-22r (- 0.61), SRS-22 Function (- 0.781), and SRS-22 Pain (- 0.735). PROMIS-PF had strong correlation with SRS-22 Function (0.643), while PROMIS-Int had moderate correlation with SRS-22 Pain (- 0.507). Effect size via Cohen's d showed that PROMIS had superior responsiveness across all domains except for self-image. CONCLUSIONS:PROMIS is a valid measure compared to SRS-22r in terms of convergent validity, and has greater measure of effect in terms of responsiveness, but failed in reliability and internal consistency. Surgeons should consider the lack of reliability and internal consistency (despite validity and responsiveness) of the PROMIS to SRS-22r before replacing the traditional questionnaire with the computer-adaptive testing.
PMID: 35013830
ISSN: 1432-0932
CID: 5118562

Examination of the Economic Burden of Frailty in Patients With Adult Spinal Deformity Undergoing Surgical Intervention

Passias, Peter G; Ahmad, Waleed; Kummer, Nicholas; Lafage, Renaud; Lafage, Virginie; Kebaish, Khaled; Daniels, Alan; Klineberg, Eric; Soroceanu, Alex; Gum, Jeffrey; Line, Breton; Hart, Robert; Burton, Douglas; Eastlack, Robert; Jain, Amit; Smith, Justin S; Ames, Christopher P; Shaffrey, Christopher; Schwab, Frank; Hostin, Richard; Bess, Shay
BACKGROUND:With increasing interest in cost optimization, costs of adult spinal deformity (ASD) surgery intersections with frailty merit investigation. OBJECTIVE:To investigate costs associated with ASD and frailty. METHODS:Patients with ASD (scoliosis ≥20°, sagittal vertical axis [SVA] ≥5 cm, pelvic tilt ≥ 25°, or thoracic kyphosis ≥ 60°) with baseline and 2-yr radiographic data were included. Patients were severely frail (SF), frail (F), or not frail (NF). Utility data were converted from Oswestry Disability Index to Short-Form Six-Dimension. Quality-adjusted life years (QALYs) used 3% rate for decline to life expectancy. Costs were calculated using PearlDiver. Loss of work costs were based on SRS-22rQ9 and US Bureau of Labor Statistics. Accounting for complications, length of stay, revisions, and death, cost per QALY at 2 yr and life expectancy were calculated. RESULTS:Five hundred ninety-two patients with ASD were included (59.8 ± 14.0 yr, 80% F, body mass index: 27.7 ± 6.0 kg/m2, Adult Spinal Deformity-Frailty Index: 3.3 ± 1.6, and Charlson Comorbidity Index: 1.8 ± 1.7). The average blood loss was 1569.3 mL, and the operative time was 376.6 min, with 63% undergoing osteotomy and 54% decompression. 69.3% had a posterior-only approach, 30% combined, and 0.7% anterior-only. 4.7% were SF, 22.3% F, and 73.0% NF. At baseline, 104 were unemployed losing $971.38 weekly. After 1 yr, 62 remained unemployed losing $50 508.64 yearly. With propensity score matching for baseline SVA, cost of ASD surgery at 2 yr for F/SF was greater than that for NF ($81 347 vs $69 722). Cost per QALY was higher for F/SF at 2 yr than that for NF ($436 473 vs $430 437). At life expectancy, cost per QALY differences became comparable ($58 965 vs $58 149). CONCLUSION/CONCLUSIONS:Despite greater initial cost, F and SF patients show greater improvement. Cost per QALY for NF and F patients becomes similar at life expectancy.
PMID: 34982882
ISSN: 1524-4040
CID: 5107022

Treatment Outcomes in American Football Players After Intervertebral Disk Herniation: Systematic Review and Meta-Analysis

Abola, Matthew V; Lin, Charles C; Colasanti, Christopher A; Schreiber-Stainthorp, William; Passias, Peter G
BACKGROUND:American football players are at increased risk for many forms of spinal injury. Intervertebral disk herniations are particularly concerning as they are the leading cause of days lost to injury and can have long-term effects on player careers. Disk herniation management plays a major role in the likelihood and success of return-to-play (RTP). OBJECTIVE:To assess the incidence, demographic variables, treatment approaches, outcomes, and RTP rates of disk herniations in American football players. METHODS:A systematic review of the literature investigating disk herniations in American football players using PubMed, Cochrane Library, and Embase was performed. RTP estimates were calculated by pooling study-specific data using a random-effects model. RESULTS:Four hundred twenty-two studies were identified, with 18 meeting inclusion criteria. Offensive and defensive linemen were the 2 most commonly injured positions. Players undergoing operations were on average younger, with higher body mass indexes, fewer seasons played, and longer post-treatment careers than nonsurgical counterparts. Postsurgical recovery periods lasted an average 106 d, with a mean RTP duration of 33 games over 2.7 yr and an 8.45% reoperation rate. Operative treatment offered a nonsignificant increase in the likelihood of return-to-play compared with nonoperative treatment (odds ratio = 2.81, 95% CI 0.83-9.51). CONCLUSION/CONCLUSIONS:Disk herniations are a common injury, with surgery potentially improving post-treatment outcomes. The literature suffers from heterogeneous definitions of RTP and varying performance metrics, making it difficult to draw clear conclusions. To better understand the impact of disk herniation and treatment on player health and performance, more studies should be performed prospectively and with standardized metrics.
PMID: 34982870
ISSN: 1524-4040
CID: 5107012

Surgical Factors and Treatment Severity for Perioperative Complications Predict Hospital Length of Stay in Adult Spinal Deformity Surgery

Le, Hai V; Wick, Joseph B; Lafage, Renaud; Kelly, Michael P; Kim, Han Jo; Gupta, Munish C; Bess, Shay; Burton, Douglas C; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank J; Passias, Peter G; Protopsaltis, Themistocles S; Lafage, Virginie; Klineberg, Eric O
STUDY DESIGN/METHODS:Retrospective review of prospectively collected multicenter registry data. OBJECTIVE:The aim of this study was to determine whether surgical variables and complications as graded by treatment severity impact postoperative hospital length of stay (LOS). SUMMARY OF BACKGROUND DATA/BACKGROUND:Surgical treatment can substantially improve quality of life for patients with adult spinal deformity (ASD). However, surgical treatment is associated with high complication rates, which may impact hospital LOS. Classifying complications by severity of subsequent treatment may allow surgeons to better understand complications and predict their impact on important outcome metrics, including LOS. METHODS:Patients enrolled in a multicenter, prospectively enrolled database for ASD were assessed for study inclusion. Complications were graded based on intervention severity. Associations between LOS, complication intervention severity, and surgical variables (fusion length, use of interbody fusion, use of major osteotomy, primary versus revision surgery, same day vs. staged surgery, and surgical approach), were assessed. Two multivariate regression models were constructed to assess for independent associations with LOS. RESULTS:Of 1183 patients meeting inclusion criteria, 708 did not and 475 did experience a perioperative complication during their index hospitalization, with 660 and 436 included in the final cohorts, respectively. Among those with complications, intervention severities included 14.9% with no intervention, 68.6% with minor, 8.9% with moderate, and 7.6% with severe interventions. Multivariate regression modeling demonstrated that length of posterior fusion, use of major osteotomy, staged surgery, and severity of intervention for complications were significantly associated with LOS. CONCLUSION/CONCLUSIONS:Careful selection of surgical factors may help reduce hospital LOS following surgery for ASD. Classification of complications by treatment severity can help surgeons better understand and predict the implications of complications, in turn assisting with surgical planning and patient counseling.Level of Evidence: 4.
PMID: 34889884
ISSN: 1528-1159
CID: 5105852

Characterizing Health-Related Quality of Life by Ambulatory Status in Patients with Spinal Metastases

Schoenfeld, Andrew J; Yeung, Caleb M; Tobert, Daniel G; Nguyen, Lananh; Passias, Peter G; Shin, John H; Kang, James D; Ferrone, Marco L
STUDY DESIGN/METHODS:Retrospective review of prospective longitudinal data. OBJECTIVE:To determine health-related quality of life (HRQL) utilities associated with specific ambulatory states in patients with spinal metastases: independent, ambulatory with assistance, and nonambulatory. SUMMARY OF BACKGROUND DATA/BACKGROUND:It is assumed that HRQL is aligned with ambulatory ability in patients with spinal metastases. Few studies have effectively considered these parameters while also accounting for clinical confounders. METHODS:We used prospective longitudinal data from patients treated at one of three tertiary medical centers (2017-2019). HRQL was characterized using the Euroquol-5-dimension (EQ5D) inventory. We performed standardized estimations of HRQL stratified by ambulatory state using generalized linear modeling that accounted for patient age at presentation, biologic sex, follow-up duration, operative or nonoperative management, and repeated measures within the same participant. RESULTS:We evaluated 675 completed EQ5D assessments, with 430 for independent ambulators, 205 for ambulators with assistance, and 40 for nonambulators. The average age of the cohort was 61.5. The most common primary cancer was lung (20%), followed by breast (18%). Forty-one percent of assessments were performed for participants treated surgically. Mortality occurred in 51% of the cohort. The standardized EQ5D utility for patients with spinal metastases and independent ambulatory function was 0.76 (95% confidence interval [CI] 0.74, 0.78). Among those ambulatory with assistance, the standardized EQ5D utility was 0.59 (95% CI 0.57, 0.61). For nonambulators, the standardized EQ5D utility was 0.14 (95% CI 0.09, 0.19). CONCLUSION/CONCLUSIONS:Patients with spinal metastases and independent ambulatory function have an HRQL similar to patients with primary cancers and no spinal involvement. Loss of ambulatory ability leads to a 22% decrease in HRQL for ambulation with assistance and an 82% reduction among nonambulators. Given prior studies demonstrate superior maintenance of ambulatory function with surgery for spinal metastases, our results support surgical consideration to the extent that it is clinically warranted.Level of Evidence: 3.
PMCID:8651806
PMID: 34107526
ISSN: 1528-1159
CID: 5103582

Increasing Cost Efficiency in Adult Spinal Deformity Surgery: Identifying Predictors of Lower Total Costs

Passias, Peter G; Brown, Avery E; Bortz, Cole; Alas, Haddy; Pierce, Katherine; Ahmad, Waleed; Naessig, Sara; Lafage, Renaud; Lafage, Virginie; Hassanzadeh, Hamid; Labaran, Lawal A; Ames, Christopher; Burton, Douglas C; Gum, Jeffrey; Hart, Robert; Hostin, Richard; Kebaish, Khaled M; Neuman, Brian J; Bess, Shay; Line, Breton; Shaffrey, Christopher; Smith, Justin; Schwab, Frank; Klineberg, Eric
STUDY DESIGN/METHODS:Retrospective study of a prospective multicenter database. OBJECTIVE:The purpose of this study was to identify predictors of lower total surgery costs at 3 years for adult spinal deformity (ASD) patients. SUMMARY OF BACKGROUND DATA/BACKGROUND:ASD surgery involves complex deformity correction. METHODS:Inclusion criteria: surgical ASD (scoliosis ≥20°, sagittal vertical axis [SVA] ≥5 cm, pelvic tilt ≥25°, or thoracic kyphosis ≥60°) patients >18 years. Total costs for surgery were calculated using the PearlDiver database. Cost per quality-adjusted life year was assessed. A Conditional Variable Importance Table used nonreplacement sampling set of 20,000 Conditional Inference trees to identify top factors associated with lower cost surgery for low (LSVA), moderate (MSVA), and high (HSVA) SRS Schwab SVA grades. RESULTS:Three hundred sixtee of 322 ASD patients met inclusion criteria. At 3-year follow up, the potential cost of ASD surgery ranged from $57,606.88 to $116,312.54. The average costs of surgery at 3 years was found to be $72,947.87, with no significant difference in costs between deformity groups (P > 0.05). There were 152 LSVA patients, 53 MSVA patients, and 111 HSVA patients. For all patients, the top predictors of lower costs were frailty scores <0.19, baseline (BL) SRS Activity >1.5, BL Oswestry Disability Index <50 (all P < 0.05). For LSVA patients, no history of osteoporosis, SRS Activity scores >1.5, age <64, were the top predictors of lower costs (all P < 0.05). Among MSVA patients, ASD invasiveness scores <94.16, no past history of cancer, and frailty scores <0.3 trended toward lower total costs (P = 0.071, P = 0.210). For HSVA, no history of smoking and body mass index <27.8 trended toward lower costs (both P = 0.060). CONCLUSION/CONCLUSIONS:ASD surgery has the potential for improved cost efficiency, as costs ranged from $57,606.88 to $116,312.54. Predictors of lower costs included higher BL SRS activity, decreased frailty, and not having depression. Additionally, predictors of lower costs were identified for different BL deformity profiles, allowing for the optimization of cost efficiency for all patients.Level of Evidence: 3.
PMID: 34392276
ISSN: 1528-1159
CID: 5103662

A predictive model of perioperative myocardial infarction following elective spine surgery

Passias, Peter G; Pierce, Katherine E; Alas, Haddy; Bortz, Cole; Brown, Avery E; Vasquez-Montes, Dennis; Oh, Cheongeun; Wang, Erik; Jain, Deeptee; O'Connell, Brooke K; Raad, Micheal; Diebo, Bassel G; Soroceanu, Alexandra; Gerling, Michael C
Myocardial infarction (MI), and its predictive factors, has been an understudied complication following spine operations. The objective was to assess the risk factors for perioperative MI in elective spine surgery patients as a retrospective case control study. Elective spine surgery patients with a perioperative MI were isolated in the NSQIP. The relationship between MI and non-MI spine patients was assessed using chi-squared and independent samples t-tests. Univariate/multivariate analyses assessed predictive factors of MI. Logistic regression with stepwise model selection was employed to create a model to predict MI occurrence. The study included 196,523 elective spine surgery patients (57.1 yrs, 48%F, 30.4 kg/m2), and 436 patients with acute MI (Spine-MI). Incidence of MI did not change from 2010 to 2016 (0.2%-0.3%, p = 0.298). Spine-MI patients underwent more fusions than patients without MI (73.6% vs 58.4%, p < 0.001), with an average of 1.03 levels fused. Spine-MI patients also had significantly more SPO (5.0% vs 1.8%, p < 0.001) and 3CO (0.9% vs 0.2%, p < 0.001), but less decompression-only procedures (26.4% vs 41.6%, p < 0.001). Spine-MI underwent more revisions (5.3% vs 2.9%, p = 0.003), had greater invasiveness scores (3.41 vs 2.73, p < 0.001) and longer operative times (211.6 vs 147.3 min, p < 0.001). Mortality rate for Spine-MI patients was 4.6% versus 0.05% (p < 0.001). Multivariate modeling for Spine-MI predictors yielded an AUC of 83.7%, and included history of diabetes, cardiac arrest and PVD, past blood transfusion, dialysis-dependence, low preoperative platelet count, superficial SSI and days from operation to discharge. A model with good predictive capacity for MI after spine surgery now exists and can aid in risk-stratification of patients, consequently improving preoperative patient counseling and optimization in the peri-operative period.
PMID: 34929633
ISSN: 1532-2653
CID: 5099612

Percutaneous image-guided cryoablation of spinal metastases: A systematic review

Sagoo, Navraj S; Haider, Ali S; Ozair, Ahmad; Vannabouathong, Christopher; Rahman, Masum; Haider, Maryam; Sharma, Neha; Raj, Karuna M; Raj, Sean D; Paul, Justin C; Steinmetz, Michael P; Adogwa, Owoicho; Aoun, Salah G; Passias, Peter G; Vira, Shaleen
Percutaneous cryoablation (PCA) is a minimally invasive technique that has been recently used to treat spinal metastases with a paucity of data currently available in the literature. A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Prospective or retrospective studies concerning metastatic spinal neoplasms treated with current generation PCA systems and with available data on safety and clinical outcomes were included. In the 8 included studies (7 retrospective, 1 prospective), a total of 148 patients (females = 63%) underwent spinal PCA. Tumors were located in the cervical (3/109 [2.8%], thoracic (74/109 [68.8%], lumbar (37/109 [33.9%], and sacrococcygeal (17/109 [15.6%] regions. Overall, 187 metastatic spinal lesions were treated. Thermo-protective measures (e.g., carbo-/hydro-dissection, thermocouples) were used in 115/187 [61.5%] procedures. For metastatic spinal tumors, the pooled mean difference (MD) in pain scores from baseline on the 0-10 numeric rating scale was 5.03 (95% confidence interval [CI]: 4.24 to 5.82) at a 1-month follow-up and 4.61 (95% CI: 3.27 to 5.95) at the last reported follow-up (range 24-40 weeks in 3/4 studies). Local tumor control rates ranged widely from 60% to 100% at varying follow-ups. Grade I-II complications were reported in 9/148 [6.1%] patients and grade III-V complications were reported in 3/148 [2.0%]) patients. PCA, as a stand-alone or adjunct modality, may be a viable therapy in appropriately selected patients with painful spinal metastases who were traditionally managed with open surgery and/or radiation therapy.
PMID: 34840092
ISSN: 1532-2653
CID: 5065342

Assessment of Adult Spinal Deformity Complication Timing and Impact on Two-Year Outcomes Using a Comprehensive Adult Spinal Deformity Classification System

Wick, Joseph B; Le, Hai V; Lafage, Renaud; Gupta, Munish C; Hart, Robert A; Mundis, Gregory M; Bess, Shay; Burton, Douglas C; Ames, Christopher P; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank J; Passias, Peter G; Protopsaltis, Themistocles S; Lafage, Virginie; Klineberg, Eric O
STUDY DESIGN/METHODS:Retrospective review of prospectively collected multicenter registry data. OBJECTIVE:To identify rates and timing of postoperative complications in adult spinal deformity (ASD) patients, the impact of complication type and timing on health related quality of life (HRQoL) outcomes, and the impact of complication timing on readmission and reoperation rates. Better understanding of complication timing and impact on HRQoL may improve patient selection, preoperative counseling, and postoperative complication surveillance. SUMMARY OF BACKGROUND DATA/BACKGROUND:ASD is common and associated with significant disability. Surgical correction is often pursued, but is associated with high complication rates. The International Spine Study Group, AO Spinal Deformity Forum, and European Spine Study Group have developed a new complication classification system for ASD (ISSG-AO spine complications classification system). METHODS:The ISSG-AO spine complications classification system was utilized to assess complications occurring over the 2-year postoperative time period amongst a multicenter, prospectively enrolled cohort of patients who underwent surgery for ASD. Kaplan-Meier survival curves were established for each complication type. Propensity score matching was performed to adjust for baseline disability and comorbidities. Associations between each complication type and HRQoL, and reoperation/readmission and complication timing, were assessed. RESULTS:Of 584 patients meeting inclusion criteria, cardiopulmonary, gastrointestinal, infection, early adverse events, and operative complications contributed to a rapid initial decrease in complication-free survival. Implant-related, radiographic, and neurologic complications substantially decreased long-term complication-free survival. Only radiographic and implant-related complications were significantly associated with worse 2-year HRQoL outcomes. Need for readmission and/or reoperation was most frequent among those experiencing complications after postoperative day 90. CONCLUSION/CONCLUSIONS:Surgeons should recognize that long-term complications have a substantial negative impact on HRQoL, and should carefully monitor for implant-related and radiographic complications over long-term follow-up.Level of Evidence: 4.
PMID: 34812199
ISSN: 1528-1159
CID: 5063502

Comparing and Contrasting the Clinical Utility of Sagittal Spine Alignment Classification Frameworks: Roussouly vs. SRS-Schwab

Passias, Peter G; Bortz, Cole; Pierce, Katherine E; Passfall, Lara; Kummer, Nicholas A; Krol, Oscar; Lafage, Renaud; Diebo, Bassel G; Lafage, Virginie; Ames, Christopher P; Burton, Douglas C; Gupta, Munish C; Sciubba, Daniel M; Schoenfeld, Andrew J; Bess, Shay; Hostin, Richard; Shaffrey, Christopher I; Line, Breton G; Klineberg, Eric O; Smith, Justin S; Schwab, Frank J
STUDY DESIGN/METHODS:Retrospective cohort study of a prospectively collected database. OBJECTIVE:To compare clinical utility of two common classification systems for ASD and determine whether both should be considered in surgical planning to improve patient outcomes. SUMMARY OF BACKGROUND DATA/BACKGROUND:Surgical restoration of appropriate Roussouly classification shape or SRS-Schwab adult spinal deformity (ASD) classification may improve outcomes. METHODS:ASD patients with pre- and 2-year postop (2Y) radiographic/HRQL data were grouped by "theoretical" and "current" Roussouly type. Univariate analyses assessed outcomes of patients who mismatched Roussouly types at both pre- and 2Y intervals (Mismatched) and those of preoperative mismatched patients who matched at 2-years (Matched). Subanalysis assessed outcomes of patients who improved in Schwab modifiers, and patients who both improved in both Schwab modifiers and matched Roussouly type by 2Y. RESULTS:Included: 515 ASD patients (59 ± 14yrs, 80%F). Preoperative breakdown of "current" Roussouly types: Type 1 (10%), 2 (54%), 3 (24%), and 4 (12%). Matched and Mismatched groups did not differ in rates of reaching MCID for any HRQL metrics by 2Y (all p > 0.10). Reoperation, PJK, and complications did not differ between Matched and Mismatched (all p > 0.10), but Roussouly Matched patients had toward lower rates of instrumentation failure (17.2% vs 24.8%, p=0.038). By 2Y, 28% of patients improved in PT Schwab modifier, 37% in SVA, and 46% in PI-LL. Patients who both Matched Roussouly at 2Y and improved in all Schwab modifiers met MCID for ODI and SRS Activity at higher rates than patients who did not. CONCLUSIONS:Isolated restoration per the Roussouly system was not associated with superior outcomes. Patients who both matched Roussouly type and improved in Schwab modifiers had superior patient-reported outcomes at 2-years. Concurrent consideration of both systems may offer utility in establishing optimal realignment goals.Level of Evidence: 3.
PMID: 34812196
ISSN: 1528-1159
CID: 5063492