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Patient-Reported Outcomes Measurement Information System instruments: outperforming traditional quality of life measures in patients with back and neck pain

Tishelman, Jared C; Vasquez-Montes, Dennis; Jevotovsky, David S; Stekas, Nicholas; Moses, Michael J; Karia, Raj J; Errico, Thomas; Buckland, Aaron J; Protopsaltis, Themistocles S
OBJECTIVEThe Patient-Reported Outcomes Measurement Information System (PROMIS) has become increasingly popular due to computer adaptive testing methodology. This study aims to validate the association between PROMIS and legacy outcome metrics and compare PROMIS to legacy metrics in terms of ceiling and floor effects and questionnaire burden.METHODSA retrospective review of an outcomes database was performed at a single institution from December 2016 to April 2017. Inclusion criteria were age > 18 years and a chief complaint of back pain or neck pain. The PROMIS computer adaptive testing Pain Interference, Physical Function (PF), and Pain Intensity domains; Oswestry Disability Index (ODI); Neck Disability Index (NDI); and visual analog scale (VAS) back, VAS leg, VAS neck, and VAS arm were completed in random order. PROMIS was compared to legacy metrics in terms of the average number of questions needed to complete each questionnaire and the score distributions in the lower and higher bounds of scores.RESULTSA total of 494 patients with back pain and 130 patients with neck pain were included. For back pain, ODI showed a strong correlation with PROMIS-PF (R = -0.749, p < 0.001), Pain Intensity (R = 0.709, p < 0.001), and Pain Interference (R = 0.790, p < 0.001) domains. Additionally, the PROMIS Pain Intensity domain correlated to both VAS back and neck pain (R = 0.642, p < 0.001 for both). PROMIS-PF took significantly fewer questions to complete compared to the ODI (4.123 vs 9.906, p < 0.001). When assessing for instrument sensitivity, neither survey presented a significant ceiling and floor effect in the back pain population (ODI: 0.40% and 2.63%; PROMIS-PF: 0.60% and 1.41%). In the neck pain cohort, NDI showed a strong correlation with PROMIS-PF (R = 0.771, p < 0.001). Additionally, PROMIS Pain Intensity correlated to VAS neck (R = 0.642, p < 0.001). The mean number of questions required to complete the questionnaire was much lower for PROMIS-PF compared to NDI (4.417 vs 10, p < 0.001). There were no significant differences found in terms of ceiling and floor effects for neck complaints (NDI: 2.3% and 6.92%; PROMIS-PF: 0.00% and 5.38%) or back complaints (ODI: 0.40% and 2.63%; PROMIS-PF: 1.41% and 0.60%).CONCLUSIONSPROMIS correlates strongly with traditional disability measures in patients with back pain and neck pain. For both back and neck pain, the PROMIS-PF required patients to answer significantly fewer questions to achieve similar granularity. There were no significant differences in ceiling and floor effects for NDI or ODI when compared with the PROMIS-PF instrument.
PMID: 30717038
ISSN: 1547-5646
CID: 3683982

Use of Gabapentin in Posterior Spinal Fusion is Associated With Decreased Postoperative Pain and Opioid Use in Children and Adolescents

Trzcinski, Stacey; Rosenberg, Rebecca E; Vasquez Montes, Dennis; Sure, Akhila; Zhou, Peter; Tishelman, Jared; Mansky, Robert; McLeod, Lisa; Tracy, Joanna; Buckland, Aaron J; Errico, Thomas J
STUDY DESIGN/METHODS:Retrospective cohort study. OBJECTIVE:The objective of this study was to examine associations of gabapentin use with inpatient postoperative daily pain scores and opioid use in children undergoing PSF for AIS. SUMMARY OF BACKGROUND DATA/BACKGROUND:Gabapentin use in posterior spinal fusion (PSF) postoperative pain management for adolescent idiopathic scoliosis (AIS) is increasingly common in order to decrease opioid use and improve pain control, though there is conflicting data on dosing and effectiveness to support this practice in real world settings. METHODS:Retrospective cohort study of children aged 10 to 21 years undergoing PSF for AIS between January 2013 and June 2016 at an urban academic tertiary care center. Adjuvant gabapentin exposure was defined as at least 15 mg/kg/d by postoperative day (POD) 1 with an initial loading dose of 10 mg/kg on day of surgery. Primary outcomes were daily postoperative mean pain score and opioid use [morphine milligram equivalents/kg/day(mme/kg/d)]. Secondary outcomes were short and long-term complications. RESULTS:Among 129 subjects (mean age, 14.6 y, 74% female, mean coronal cobb, 55.2 degrees), 24 (19%) received gabapentin. Unadjusted GABA exposure was associated with significantly lower opioid use on POD1 and 2 (49% and 31%mme/kg/d, respectively) and lower pain scores (14%) on POD2. Adjusting for preexisting back pain, preoperative coronal Cobb angle, and site, GABA use was associated with significantly lower mean pain scores on POD1 through POD3 (-0.68, P=0.01; -0.86, P=0.002; -0.63, P=0.04). Gabapentin use was also associated with decreased opioid use on POD1 and POD2 (-0.39mme/kg/d, P<0.001; -0.27, P=0.02). There was no difference in complications by gabapentin exposure. CONCLUSIONS:Addition of gabapentin as adjuvant therapy for adolescent PSF, beginning on day of surgery, is associated with improved pain scores and decreased opioid use in the first 48 to 72 hours postoperatively. LEVEL OF EVIDENCE/METHODS:This is a retrospective cohort study, classified as Level III under "Therapeutic Studies Investigating the Results of a Treatment."
PMID: 30688677
ISSN: 2380-0194
CID: 3626342

Impact of presenting patient characteristics on surgical complications and morbidity in early onset scoliosis

Segreto, Frank A; Vasquez-Montes, Dennis; Bortz, Cole A; Horn, Samantha R; Diebo, Bassel G; Vira, Shaleen; Kelly, John J; Stekas, Nicholas; Ge, David H; Ihejirika, Yael U; Lafage, Renaud; Lafage, Virginie; Karamitopoulos, Mara; Delsole, Edward M; Hockley, Aaron; Petrizzo, Anthony M; Buckland, Aaron J; Errico, Thomas J; Gerling, Michael C; Passias, Peter G
This study sought to assess comorbidity profiles unique to early-onset-scoliosis (EOS) patients by employing cluster analytics and to determine the influence of isolated comorbidity clusters on perioperative complications, morbidity and mortality using a high powered administrative database. The KID database was queried for ICD-9 codes pertaining to congenital and idiopathic scoliosis from 2003, 2006, 2009, 2012. Patients <10 y/o (EOS group) were included. Demographics, incidence and comorbidity profiles were assessed. Comorbidity profiles were stratified by body systems (neurological, musculoskeletal, pulmonary, cardiovascular, renal). K-means cluster and descriptive analyses elucidated incidence and comorbidity relationships between frequently co-occurring comorbidities. Binary logistic regression models determined predictors of perioperative complication development, mortality, and extended length-of-stay (≥75th percentile). 25,747 patients were included (Age: 4.34, Female: 52.1%, CCI: 0.64). Incidence was 8.9 per 100,000 annual discharges. 55.2% presented with pulmonary comorbidities, 48.7% musculoskeletal, 43.8% neurological, 18.6% cardiovascular, and 11.9% renal; 38% had concurrent neurological and pulmonary. Top inter-bodysystem clusters: Pulmonary disease (17.2%) with epilepsy (17.8%), pulmonary failure (12.2%), restrictive lung disease (10.5%), or microcephaly and quadriplegia (2.1%). Musculoskeletal comorbidities (48.7%) with renal and cardiovascular comorbidities (8.2%, OR: 7.9 [6.6-9.4], p < 0.001). Top intra-bodysystem clusters: Epilepsy (11.7%) with quadriplegia (25.8%) or microcephaly (20.5%). Regression analysis determined neurological and pulmonary clusters to have a higher odds of perioperative complication development (OR: 1.28 [1.19-1.37], p < 0.001) and mortality (OR: 2.05 [1.65-2.54], p < 0.001). Musculoskeletal with cardiovascular and renal anomalies had higher odds of mortality (OR: 1.72 [1.28-2.29], p < 0.001) and extLOS (OR: 2.83 [2.48-3.22], p < 0.001). EOS patients with musculoskeletal conditions were 7.9x more likely to have concurrent cardiovascular and renal anomalies. Clustered neurologic and pulmonary anomalies increased mortality risk by as much as 105%. These relationships may benefit pre-operative risk assessment for concurrent anomalies and adverse outcomes. Level of Evidence: III - Retrospective Prognostic Study.
PMID: 30635164
ISSN: 1532-2653
CID: 3580042

Predicting the occurrence of complications following corrective cervical deformity surgery: Analysis of a prospective multicenter database using predictive analytics

Passias, Peter G; Oh, Cheongeun; Horn, Samantha R; Kim, Han Jo; Hamilton, D Kojo; Sciubba, Daniel M; Neuman, Brian J; Buckland, Aaron J; Poorman, Gregory W; Segreto, Frank A; Bortz, Cole A; Brown, Avery E; Protopsaltis, Themistocles S; Klineberg, Eric O; Ames, Christopher; Smith, Justin S; Lafage, Virginie
We developed a predictive model to describe risk factors for complications in cervical deformity surgeries. Cervical deformity (CD) surgical patients are growing in number, but remain under-studied in the literature. CD was defined as at least one of the following: C2-C7 Cobb >10°, CL >10°, cSVA >4 cm, CBVA >25°. Patient demographics and clinical data were assessed as risk factors for medical/surgical complications using multivariate regression models. 123 patients underwent CD surgery (60.6 yrs, 60.8% F). The most common complications were neurologic (24.4%), dysphagia (13.0%), cardiopulmonary (11.4%), infection (9.7%). 51 (41.5%) of patients experienced a medical complication and 73 (59.3%) had a surgical complication. An overall complication was predicted with high accuracy (AUC = 0.79) by the following combinations of factors: higher baseline EQ5D pain and lower baseline EQ5D anxiety/depression scores, and higher cervical and global SVA. A medical complication can be predicted by male gender, baseline mJOA score, and cervical SVA (AUC = 0.770). A surgical complication can be predicted by higher estimated blood loss, lower anxiety scores, and larger global SVA (AUC = 0.739). 64.2% of patients undergoing cervical deformity correction sustained any complication. While the most reliable predictor of the occurrence of a complication involved a cluster of risk factors, a radiographic baseline sagittal parameter of cervical SVA was the strongest isolated predictor for complications across categories. Although these findings are specific to a cervical population with moderate to severe deformities, collectively they can be utilized for pre-operative risk assessment and patient education.
PMID: 30459012
ISSN: 1532-2653
CID: 3479652

Comparative Analysis of Two Transforaminal Lumbar Interbody Fusion Techniques: Open TLIF Versus Wiltse MIS TLIF

Ge, David H; Stekas, Nicholas D; Varlotta, Christopher G; Fischer, Charla R; Petrizzo, Anthony; Protopsaltis, Themistocles S; Passias, Peter G; Errico, Thomas J; Buckland, Aaron J
STUDY DESIGN/METHODS:Retrospective cohort study at a single institution. OBJECTIVE:To analyze the perioperative and postoperative outcomes of patients who underwent open transforaminal lumbar interbody fusion (O-TLIF) and bilateral minimally invasive (MIS) Wiltse approach TLIF (Wil-TLIF). SUMMARY OF BACKGROUND DATA/BACKGROUND:Several studies have compared Open TLIF to MIS TLIF, however, comparing the techniques using a large cohort of one-level TLIFs has not been fully explored. METHODS:We reviewed the charts of patients undergoing a single-level primary posterior lumbar interbody fusion between 2012 and 2017. The cases were categorized as Open TLIF (traditional midline exposure including lateral exposure of transverse processes) or bilateral paramedian Wiltse TLIF approach. Differences between groups were assessed by t-tests. RESULTS:227 patients underwent one-level primary TLIF (116 O-TLIF, 111 Wil-TLIF). There was no difference in age, gender, ASA or BMI between groups. Wil-TLIF had the lowest EBL (197 mL vs. 499 mL O-TLIF, p =  < .001), LOS (2.7 days vs. 3.6 days O-TLIF, p =  < .001), overall complication rate (12% vs. 24% O-TLIF, p = .015), minor complication rate (7% vs. 16% O-TLIF, p = .049), and 90-day readmission rate (1% vs. 8% O-TLIF, p = .012). Wil-TLIF was associated with the higher fluoroscopy time (83 sec vs. vs. 24 sec O-TLIF, p =  < .001). There was not a significant difference in operative time, intraoperative or neurological complications, extubation time, reoperation rate, or infection rate. CONCLUSIONS:In comparing Wiltse MIS TLIF to Open TLIF, the minimally invasive paramedian Wiltse approach demonstrated the lowest EBL, LOS, readmission rates and complications, but longer fluoroscopy times when compared to the traditional open approach. LEVEL OF EVIDENCE/METHODS:3.
PMID: 30325884
ISSN: 1528-1159
CID: 3368352

Ponte Osteotomies Increase the Risk of Neuromonitoring Alerts in Adolescent Idiopathic Scoliosis Correction Surgery

Buckland, Aaron J; Moon, John Y; Betz, Randal R; Lonner, Baron S; Newton, Peter O; Shufflebarger, Harry L; Errico, Thomas J
STUDY DESIGN/METHODS:Observational cohort study of prospective database registry. OBJECTIVE:To determine the incidence of neurological complications in AIS patients undergoing surgical treatment with PO. SUMMARY OF BACKGROUND DATA/BACKGROUND:Despite the widespread use of Ponte Osteotomies (PO) in adolescent idiopathic scoliosis (AIS) correction, outcomes and complications in patients treated with this technique have not been well characterized. METHODS:A multicenter prospective registry of patients undergoing surgical correction of AIS was queried at 2-year follow up for patient demographics, surgical data, deformity characteristics and peri-operative complications. A neurological complication was defined as perioperative nerve root or spinal cord injury as identified by the surgeon. Patients were divided into those that underwent peri-apical PO and those without, and further stratified by Lenke curve classification into 3 groups (I-types 1 & 2, II- types 3, 4, 6, and III-type 5). Patients with- and without neurological complications were compared with respect to baseline demographics, surgical variables, curve types, fusion construct types (screws vs. hybrid), curve magnitude (coronal and sagittal Cobb), apical vertebral translation, and coronal- deformity angular ratios (C-DAR). RESULTS:Of 2210 patients included in the study, 1611 underwent PO. Peri-operative neurological complications occurred in 7 patients, with 6 in the PO group (0.37%) and 1 in non-PO group (0.17%) though this was not a statistically significant risk factor for peri-operative neurological injury (p = 0.45). Neuromonitoring alerts were recorded in 168 patients (7.6%: 9.3% PO group; 4.2% no-PO group (p < 0.001). Multivariate logistic regression analysis found PO and curve magnitude to be independent risk factors for intra-operative neuromonitoring alerts (p < 0.01). CONCLUSIONS:PO and curve magnitude were independent risk factors for intra-operative neuromonitoring alerts in surgical AIS correction. The effect of Ponte osteotomy on neurological complications remains unknown due to the low incidence of these complications. LEVEL OF EVIDENCE/METHODS:3.
PMID: 30005041
ISSN: 1528-1159
CID: 3200292

Comparison of Patient Reported Outcome Measurement Information System (PROMIS) with Neck Disability Index (NDI) and Visual Analog Scale (VAS) in Patients with Neck Pain

Moses, Michael J; Tishelman, Jared C; Stekas, Nicholas; Jevotovsky, David S; Vasquez-Montes, Dennis; Karia, Raj; Errico, Thomas; Buckland, Aaron; Protopsaltis, Themistocles S
STUDY DESIGN/METHODS:A retrospective analysis of a patient-reported outcomes database from a single institution from December 2016 to April 2017. OBJECTIVE:To validate the association of PROMIS with NDI in patients with neck pain and examine each instruments ability to capture concomitant arm pain and concomitant back pain. SUMMARY OF BACKGROUND DATA/BACKGROUND:PROMIS has been increasingly utilized and its computer adapted testing methodology improves assessment of pain and disability. However literature is lacking regarding how these instruments perform in neck pain patients with concomitant arm pain or back pain. METHODS:Inclusion criteria were age>18years and a primary complaint of neck pain. The NDI, VAS Back, Neck, Arm and Leg, and PROMIS Physical Function, Pain Intensity, and Pain Interference questionnaires were administered. Propensity score matching was performed to compare patients with high and low back and arm pain while controlling for neck pain. Bivariate correlations and independent samples t-tests were performed to assess linear relationships and compare back and arm pain groups with PROMIS. RESULTS:130 patients were included. NDI correlated strongly to PROMIS Physical Function (r = -0.771, p < 0.001), Pain Intensity (r = 0.605, p < 0.001), and Pain Interference (r = 0.786, p < 0.001). VAS Neck and Arm Pain also correlated to the PROMIS Pain Intensity instrument (VAS Neck: r = 0.642, p < 0.001; VAS Arm: r = 0.376, p < 0.001).Following matching for neck pain, the high and low back pain groups each included 32 patients. There were significant differences in PROMIS Physical Function when high and low back pain groups were compared (39.07 vs 43.68, p = 0.031). No significant difference was found for any outcome metric for high and low arm pain groups. CONCLUSIONS:PROMIS instruments are capable of characterizing pain and disability in patients with neck pain and are sensitive to disability in regions adjacent to the neck. LEVEL OF EVIDENCE/METHODS:3.
PMID: 30015716
ISSN: 1528-1159
CID: 3200652

The Impact of Different Intraoperative Fluid Administration Strategies on Postoperative Extubation Following Multilevel Thoracic and Lumbar Spine Surgery: A Propensity Score Matched Analysis

Ramchandran, Subaraman; Day, Louis M; Line, Breton; Buckland, Aaron J; Passias, Peter; Protopsaltis, Themistocles; Bendo, John; Huncke, Tessa; Errico, Thomas J; Bess, Shay
BACKGROUND:Patients undergoing multilevel spine surgery are at risk for delayed extubation. OBJECTIVE:To evaluate the impact of type and volume of intraoperative fluids administered during multilevel thoracic and/or lumbar spine surgery on postoperative extubation status. METHODS:Retrospective evaluation of medical records of patients ≥ 18 yr undergoing ≥ 4 levels of thoracic and/or lumbar spine fusions was performed. Patients were organized according to postoperative extubation status: immediate (IMEX; in OR/PACU) or delayed (DEX; outside OR/PACU). Propensity score matched (PSM) analysis was performed to compare IMEX and DEX groups. Volume, proportion, and ratios of intraoperative fluids administered were evaluated for the associated impact on extubation status. RESULTS:A total of 246 patients (198 IMEX, 48 DEX) were included. PSM analysis demonstrated that increased administration of non-cell saver blood products (NCSB) and increased ratio of crystalloid: colloids infused were independently associated with delayed extubation. With increasing EBL, IMEX had a proportionate reduction in crystalloid infusion (R = -0.5, P < .001), while the proportion of crystalloids infused remained relatively unchanged for DEX (R = -0.27; P = .06). Twenty-six percent of patients receiving crystalloid: colloid ratio > 3:1 had DEX compared to none of those receiving crystalloid: colloid ratio ≤ 3:1 (P = .009). DEX had greater cardiac and pulmonary complications, surgical site infections and prolonged intensive care unit and hospital stay (P < .05). CONCLUSION/CONCLUSIONS:PSM analysis of patients undergoing multilevel thoracic and/or lumbar spine fusion demonstrated that increased administration of crystalloid to colloid ratio is independently associated with delayed extubation. With increasing EBL, a proportionate reduction of crystalloids facilitates early extubation.
PMID: 29850844
ISSN: 1524-4040
CID: 3166062

Implementation and early adaptation of patient-reported outcome measures into an electronic health record: A technical report

Gold, Heather Taffet; Karia, Raj J; Link, Alissa; Lebwohl, Rachel; Zuckerman, Joseph D; Errico, Thomas J; Slover, James D; Buckland, Aaron J; Mann, Devin M; Cantor, Michael N
We integrated and optimized patient-reported outcome measures into the electronic health record to provide quantitative, objective data regarding patients' health status, which is important for patient care, payer contracts, and research. With a multidisciplinary team from information technology, clinical informatics, population health, and physician champions, we used formal human-computer interaction techniques and user-centered design to integrate several technology platforms and computerized adaptive testing for the National Institutes of Health Patient-Reported Outcomes Measurement Information System. The patient-reported outcome measure system leverages software frequently used by health systems and provides data for research and clinical care via a mobile-responsive web application using Symfony, with REDCap for configuring assessments and de-identified data storage. The system incorporates Oracle databases and Epic flowsheets. Patients complete patient-reported outcome measures, with data viewable in MyChart and Epic Synopsis Reports. Researchers can access data portals. The highly usable, successful patient-reported outcome measures platform is acceptable to patients and clinicians and achieved 73 percent overall completion rates.
PMID: 30516095
ISSN: 1741-2811
CID: 3520672

The Influence of Body Mass Index on Achieving Age-Adjusted Alignment Goals in Adult Spinal Deformity Corrective Surgery with Full-Body Analysis at 1 Year

Horn, Samantha R; Segreto, Frank A; Ramchandran, Subbu; Poorman, Gregory R; Sure, Akhila; Marascalachi, Bryan; Bortz, Cole A; Varlotta, Christopher G; Tishelman, Jared; Vasquez-Montes, Dennis; Ihejirika, Yael; Zhou, Peter; Moon, John; Lafage, Renaud; Diebo, Bassel G; Vira, Shaleen; Jalai, Cyrus M; Wang, Charles; Shenoy, Kartik; Errico, Thomas; Lafage, Virginie; Buckland, Aaron; Passias, Peter G
BACKGROUND:The impact of obesity on global spinopelvic alignment is poorly understood. This study investigated the effect of body mass index on achieving alignment targets and compensation mechanisms after corrective surgery for adult spinal deformity (ASD). METHODS:Retrospective review of a single-center database. Inclusion: patients ≥18 years with full-body stereographic images (baseline and 1 year) and who met ASD criteria (sagittal vertical axis [SVA] >5 cm, pelvic incidence minus lumbar lordosis [PI-LL] >10°, coronal curvature >20° or pelvic tilt >20°). Patients were stratified by age (<40, 40-65, and ≥65 years) and body mass index (<25, 25-30, and >30). Postoperative alignment was compared with age-adjusted ideal values. Prevalence of patients who matched ideals and unmatched (undercorrected/overcorrected) was assessed. Health-related quality of life (HRQL) scores, alignment, and compensatory mechanisms were compared across cohorts using analysis of variance and temporally with paired t tests. RESULTS:A total of 116 patients were included (average age, 62 years; 66% female). After corrective surgery, obese and overweight patients had more residual malalignment (worse PI-LL, T1 pelvic angle, pelvic tilt, and SVA) compared with normal patients (P < 0.05). In addition, obese and overweight patients recruited more pelvic shift (obese, 62.36; overweight, 49.80; normal, 31.50) and had a higher global sagittal angle (obese, 6.51; overweight, 6.35; normal, 3.40) (P < 0.05). Obese and overweight patients showed lower overcorrection rates and higher undercorrection rates (P < 0.05). Obese patients showed worse postoperative HRQL scores (Scoliosis Research Society 22 Questionnaire, Oswestry Disability Index, visual analog scale-leg) than did overweight and normal patients (P < 0.05). Obese and overweight patients who matched age-adjusted alignment targets for SVA or PI-LL showed no HRQL improvements (P > 0.05). CONCLUSIONS:After surgery, obese patients were undercorrected, showed more residual malalignment, recruited more pelvic shift, and had a greater global sagittal angle and worse HRQL scores. The benefits from age-adjusted alignment targets seem to be less substantial for obese and overweight patients.
PMID: 30165222
ISSN: 1878-8769
CID: 3500382