Browsing by Subject "patient-reported outcomes"
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Item Open Access A Multicenter Study of the Presentation, Treatment, and Outcomes of Cervical Dural Tears.(Global spine journal, 2017-04) O'Neill, Kevin R; Fehlings, Michael G; Mroz, Thomas E; Smith, Zachary A; Hsu, Wellington K; Kanter, Adam S; Steinmetz, Michael P; Arnold, Paul M; Mummaneni, Praveen V; Chou, Dean; Nassr, Ahmad; Qureshi, Sheeraz A; Cho, Samuel K; Baird, Evan O; Smith, Justin S; Shaffrey, Christopher; Tannoury, Chadi A; Tannoury, Tony; Gokaslan, Ziya L; Gum, Jeffrey L; Hart, Robert A; Isaacs, Robert E; Sasso, Rick C; Bumpass, David B; Bydon, Mohamad; Corriveau, Mark; De Giacomo, Anthony F; Derakhshan, Adeeb; Jobse, Bruce C; Lubelski, Daniel; Lee, Sungho; Massicotte, Eric M; Pace, Jonathan R; Smith, Gabriel A; Than, Khoi D; Riew, K DanielStudy design
Retrospective multicenter case series study.Objective
Because cervical dural tears are rare, most surgeons have limited experience with this complication. A multicenter study was performed to better understand the presentation, treatment, and outcomes following cervical dural tears.Methods
Multiple surgeons from 23 institutions retrospectively identified 21 rare complications that occurred between 2005 and 2011, including unintentional cervical dural tears. Demographic data and surgical history were obtained. Clinical outcomes following surgery were assessed, and any reoperations were recorded. Neck Disability Index (NDI), modified Japanese Orthopaedic Association (mJOA), Nurick classification (NuC), and Short-Form 36 (SF36) scores were recorded at baseline and final follow-up at certain centers. All data were collected, collated, and analyzed by a private research organization.Results
There were 109 cases of cervical dural tears among 18 463 surgeries performed. In 101 cases (93%) there was no clinical sequelae following successful dural tear repair. There were statistical improvements (P < .05) in mJOA and NuC scores, but not NDI or SF36 scores. No specific baseline or operative factors were found to be associated with the occurrence of dural tears. In most cases, no further postoperative treatments of the dural tear were required, while there were 13 patients (12%) that required subsequent treatment of cerebrospinal fluid drainage. Analysis of those requiring further treatments did not identify an optimum treatment strategy for cervical dural tears.Conclusions
In this multicenter study, we report our findings on the largest reported series (n = 109) of cervical dural tears. In a vast majority of cases, no subsequent interventions were required and no clinical sequelae were observed.Item Open Access Cervical laminoplasty versus laminectomy and posterior cervical fusion for cervical myelopathy: propensity-matched analysis of 24-month outcomes from the Quality Outcomes Database.(Journal of neurosurgery. Spine, 2023-08) Yang, Eunice; Mummaneni, Praveen V; Chou, Dean; Bydon, Mohamad; Bisson, Erica F; Shaffrey, Christopher I; Gottfried, Oren N; Asher, Anthony L; Coric, Domagoj; Potts, Eric A; Foley, Kevin T; Wang, Michael Y; Fu, Kai-Ming; Virk, Michael S; Knightly, John J; Meyer, Scott; Park, Paul; Upadhyaya, Cheerag D; Shaffrey, Mark E; Buchholz, Avery L; Tumialán, Luis M; Turner, Jay D; Michalopoulos, Giorgos D; Sherrod, Brandon A; Agarwal, Nitin; Haid, Regis W; Chan, Andrew KObjective
Compared with laminectomy with posterior cervical fusion (PCF), cervical laminoplasty (CL) may result in different outcomes for those operated on for cervical spondylotic myelopathy (CSM). The aim of this study was to compare 24-month patient-reported outcomes (PROs) for laminoplasty versus PCF by using the Quality Outcomes Database (QOD) CSM data set.Methods
This was a retrospective study using an augmented data set from the prospectively collected QOD Registry Cervical Module. Patients undergoing laminoplasty or PCF for CSM were included. Using the nearest-neighbor method, the authors performed 1:1 propensity matching based on age, operated levels, and baseline modified Japanese Orthopaedic Association (mJOA) and visual analog scale (VAS) neck pain scores. The 24-month PROs, i.e., mJOA, Neck Disability Index (NDI), VAS neck pain, VAS arm pain, EQ-5D, EQ-VAS, and North American Spine Society (NASS) satisfaction scores, were compared. Only cases in the subaxial cervical region were included; those that crossed the cervicothoracic junction were excluded.Results
From the 1141 patients included in the QOD CSM data set who underwent anterior or posterior surgery for cervical myelopathy, 946 (82.9%) had 24 months of follow-up. Of these, 43 patients who underwent laminoplasty and 191 who underwent PCF met the inclusion criteria. After matching, the groups were similar for baseline characteristics, including operative levels (CL group: 4.0 ± 0.9 vs PCF group: 4.2 ± 1.1, p = 0.337) and baseline PROs (p > 0.05), except for a higher percentage involved in activities outside the home in the CL group (95.3% vs 81.4%, p = 0.044). The 24-month follow-up for the matched cohorts was similar (CL group: 88.4% vs PCF group: 83.7%, p = 0.534). Patients undergoing laminoplasty had significantly lower estimated blood loss (99.3 ± 91.7 mL vs 186.7 ± 142.7 mL, p = 0.003), decreased length of stay (3.0 ± 1.6 days vs 4.5 ± 3.3 days, p = 0.012), and a higher rate of routine discharge (88.4% vs 62.8%, p = 0.006). The CL cohort also demonstrated a higher rate of return to activities (47.2% vs 21.2%, p = 0.023) after 3 months. Laminoplasty was associated with a larger improvement in 24-month NDI score (-19.6 ± 18.9 vs -9.1 ± 21.9, p = 0.031). Otherwise, there were no 3- or 24-month differences in mJOA, mean NDI, VAS neck pain, VAS arm pain, EQ-5D, EQ-VAS, and distribution of NASS satisfaction scores (p > 0.05) between the cohorts.Conclusions
Compared with PCF, laminoplasty was associated with decreased blood loss, decreased length of hospitalization, and higher rates of home discharge. At 3 months, laminoplasty was associated with a higher rate of return to baseline activities. At 24 months, laminoplasty was associated with greater improvements in neck disability. Otherwise, laminoplasty and PCF shared similar outcomes for functional status, pain, quality of life, and satisfaction. Laminoplasty and PCF achieved similar neck pain scores, suggesting that moderate preoperative neck pain may not necessarily be a contraindication for laminoplasty.Item Open Access Coming full circle in the measurement of medication adherence: opportunities and implications for health care.(Patient preference and adherence, 2017-01) Whalley Buono, Elizabeth; Vrijens, Bernard; Bosworth, Hayden B; Liu, Larry Z; Zullig, Leah L; Granger, Bradi BThere is little debate that medication nonadherence is a major public health issue and that measuring nonadherence is a crucial step toward improving it. Moreover, while measuring adherence is becoming both more feasible and more common in the era of electronic information, the reliability and usefulness of various measurements of adherence have not been well established. This paper outlines the most commonly used measures of adherence and discusses the advantages and disadvantages of each that depend on the purpose for which the measure will be used. International consensus statements on definitions and guidelines for selection and use of medication adherence measures were reviewed. The quality of recommended measures was evaluated in selected publications from 2009 to 2014. The most robust medication adherence measures are often ill suited for large-scale use. Less robust measures were found to be commonly misapplied and subsequently misinterpreted in population-level analyses. Adherence assessment and measurement were rarely integrated into standard patient care practice patterns. Successful scalable and impactful strategies to improve medication adherence will depend on understanding how to efficiently and effectively measure adherence.Item Open Access Differences in postoperative quality of life in young, early elderly, and late elderly patients undergoing surgical treatment for degenerative cervical myelopathy.(Journal of neurosurgery. Spine, 2022-03) Croci, Davide M; Sherrod, Brandon; Alvi, Mohammed Ali; Mummaneni, Praveen V; Chan, Andrew K; Bydon, Mohamad; Glassman, Steven D; Foley, Kevin T; Potts, Eric A; Shaffrey, Mark E; Coric, Domagoj; Knightly, John J; Park, Paul; Wang, Michael Y; Fu, Kai-Ming; Slotkin, Jonathan R; Asher, Anthony L; Than, Khoi D; Gottfried, Oren N; Shaffrey, Christopher I; Virk, Michael S; Bisson, Erica FObjective
Cervical spondylotic myelopathy (CSM) is a common progressive spine disorder affecting predominantly middle-aged and elderly populations. With increasing life expectancy, the incidence of CSM is expected to rise further. The outcomes of elderly patients undergoing CSM surgery and especially their quality of life (QOL) postoperatively remain undetermined. This study retrospectively reviewed patients to identify baseline differences and validated postoperative patient-reported outcome (PRO) measures in elderly patients undergoing CSM surgery.Methods
The multi-institutional, neurosurgery-specific NeuroPoint Quality Outcomes Database was queried to identify CSM patients treated surgically at the 14 highest-volume sites from January 2016 to December 2018. Patients were divided into three groups: young (< 65 years), early elderly (65-74 years), and late elderly (≥ 75 years). Demographic and PRO measures (Neck Disability Index [NDI] score, modified Japanese Orthopaedic Association [mJOA] score, EQ-5D score, EQ-5D visual analog scale [VAS] score, arm pain VAS, and neck pain VAS) were compared among the groups at baseline and 3 and 12 months postoperatively.Results
A total of 1151 patients were identified: 691 patients (60%) in the young, 331 patients (28.7%) in the early elderly, and 129 patients (11.2%) in the late elderly groups. At baseline, younger patients presented with worse NDI scores (p < 0.001) and lower EQ-5D VAS (p = 0.004) and EQ-5D (p < 0.001) scores compared with early and late elderly patients. No differences among age groups were found in the mJOA score. An improvement of all QOL scores was noted in all age groups. On unadjusted analysis at 3 months, younger patients had greater improvement in arm pain VAS, NDI, and EQ-5D VAS compared with early and late elderly patients. At 12 months, the same changes were seen, but on adjusted analysis, there were no differences in PROs between the age groups.Conclusions
The authors' results indicate that elderly patients undergoing CSM surgery achieved QOL outcomes that were equivalent to those of younger patients at the 12-month follow-up.Item Open Access Do comorbid self-reported depression and anxiety influence outcomes following surgery for cervical spondylotic myelopathy?(Journal of neurosurgery. Spine, 2023-03) Chan, Andrew K; Shaffrey, Christopher I; Park, Christine; Gottfried, Oren N; Than, Khoi D; Bisson, Erica F; Bydon, Mohamad; Asher, Anthony L; Coric, Domagoj; Potts, Eric A; Foley, Kevin T; Wang, Michael Y; Fu, Kai-Ming; Virk, Michael S; Knightly, John J; Meyer, Scott; Park, Paul; Upadhyaya, Cheerag D; Shaffrey, Mark E; Buchholz, Avery L; Tumialán, Luis M; Turner, Jay D; Michalopoulos, Giorgos D; Sherrod, Brandon A; Agarwal, Nitin; Chou, Dean; Haid, Regis W; Mummaneni, Praveen VObjective
Depression and anxiety are associated with inferior outcomes following spine surgery. In this study, the authors examined whether patients with cervical spondylotic myelopathy (CSM) who have both self-reported depression (SRD) and self-reported anxiety (SRA) have worse postoperative patient-reported outcomes (PROs) compared with patients who have only one or none of these comorbidities.Methods
This study is a retrospective analysis of prospectively collected data from the Quality Outcomes Database CSM cohort. Comparisons were made among patients who reported the following: 1) either SRD or SRA, 2) both SRD and SRA, or 3) neither comorbidity at baseline. PROs at 3, 12, and 24 months (scores for the visual analog scale [VAS] for neck pain and arm pain, Neck Disability Index [NDI], modified Japanese Orthopaedic Association [mJOA] scale, EQ-5D, EuroQol VAS [EQ-VAS], and North American Spine Society [NASS] patient satisfaction index) and achievement of respective PRO minimal clinically important differences (MCIDs) were compared.Results
Of the 1141 included patients, 199 (17.4%) had either SRD or SRA alone, 132 (11.6%) had both SRD and SRA, and 810 (71.0%) had neither. Preoperatively, patients with either SRD or SRA alone had worse scores for VAS neck pain (5.6 ± 3.1 vs 5.1 ± 3.3, p = 0.03), NDI (41.0 ± 19.3 vs 36.8 ± 20.8, p = 0.007), EQ-VAS (57.0 ± 21.0 vs 60.7 ± 21.7, p = 0.03), and EQ-5D (0.53 ± 0.23 vs 0.58 ± 0.21, p = 0.008) than patients without such disorders. Postoperatively, in multivariable adjusted analyses, baseline SRD or SRA alone was associated with inferior improvement in the VAS neck pain score and a lower rate of achieving the MCID for VAS neck pain score at 3 and 12 months, but not at 24 months. At 24 months, patients with SRD or SRA alone experienced less change in EQ-5D scores and were less likely to meet the MCID for EQ-5D than patients without SRD or SRA. Furthermore, patient self-reporting of both psychological comorbidities did not impact PROs at all measured time points compared with self-reporting of only one psychological comorbidity alone. Each cohort (SRD or SRA alone, both SRD and SRA, and neither SRD nor SRA) experienced significant improvements in mean PROs at all measured time points compared with baseline (p < 0.05).Conclusions
Approximately 12% of patients who underwent surgery for CSM presented with both SRD and SRA, and 29% presented with at least one symptom. The presence of either SRD or SRA was independently associated with inferior scores for 3- and 12-month neck pain following surgery, but this difference was not significant at 24 months. However, at long-term follow-up, patients with SRD or SRA experienced lower quality of life than patients without SRD or SRA. The comorbid presence of both depression and anxiety was not associated with worse patient outcomes than either diagnosis alone.Item Open Access Does diabetes affect outcome or reoperation rate after lumbar decompression or arthrodesis? A matched analysis of the Quality Outcomes Database data set.(Journal of neurosurgery. Spine, 2023-12) Mooney, James; Nathani, Karim Rizwan; Zeitouni, Daniel; Michalopoulos, Giorgos D; Wang, Michael Y; Coric, Domagoj; Chan, Andrew K; Lu, Daniel C; Sherrod, Brandon A; Gottfried, Oren N; Shaffrey, Christopher I; Than, Khoi D; Goldberg, Jacob L; Hussain, Ibrahim; Virk, Michael S; Agarwal, Nitin; Glassman, Steven D; Shaffrey, Mark E; Park, Paul; Foley, Kevin T; Chou, Dean; Slotkin, Jonathan R; Tumialán, Luis M; Upadhyaya, Cheerag D; Potts, Eric A; Fu, Kai-Ming G; Haid, Regis W; Knightly, John J; Mummaneni, Praveen V; Bisson, Erica F; Asher, Anthony L; Bydon, MohamadObjective
Diabetes mellitus (DM) is a known risk factor for postsurgical and systemic complications after lumbar spinal surgery. Smaller studies have also demonstrated diminished improvements in patient-reported outcomes (PROs), with increased reoperation and readmission rates after lumbar surgery in patients with DM. The authors aimed to examine longer-term PROs in patients with DM undergoing lumbar decompression and/or arthrodesis for degenerative pathology.Methods
The Quality Outcomes Database was queried for patients undergoing elective lumbar decompression and/or arthrodesis for degenerative pathology. Patients were grouped into DM and non-DM groups and optimally matched in a 1:1 ratio on 31 baseline variables, including the number of operated levels. Outcomes of interest were readmissions and reoperations at 30 and 90 days after surgery in addition to improvements in Oswestry Disability Index, back pain, and leg pain scores and quality-adjusted life-years at 90 days after surgery.Results
The matched decompression cohort comprised 7836 patients (3236 [41.3] females) with a mean age of 63.5 ± 12.6 years, and the matched arthrodesis cohort comprised 7336 patients (3907 [53.3%] females) with a mean age of 64.8 ± 10.3 years. In patients undergoing lumbar decompression, no significant differences in nonroutine discharge, length of stay (LOS), readmissions, reoperations, and PROs were observed. In patients undergoing lumbar arthrodesis, nonroutine discharge (15.7% vs 13.4%, p < 0.01), LOS (3.2 ± 2.0 vs 3.0 ± 3.5 days, p < 0.01), 30-day (6.5% vs 4.4%, p < 0.01) and 90-day (9.1% vs 7.0%, p < 0.01) readmission rates, and the 90-day reoperation rate (4.3% vs 3.2%, p = 0.01) were all significantly higher in the DM group. For DM patients undergoing lumbar arthrodesis, subgroup analyses demonstrated a significantly higher risk of poor surgical outcomes with the open approach.Conclusions
Patients with and without DM undergoing lumbar spinal decompression alone have comparable readmission and reoperation rates, while those undergoing arthrodesis procedures have a higher risk of poor surgical outcomes up to 90 days after surgery. Surgeons should target optimal DM control preoperatively, particularly for patients undergoing elective lumbar arthrodesis.Item Open Access Does reduction of the Meyerding grade correlate with outcomes in patients undergoing decompression and fusion for grade I degenerative lumbar spondylolisthesis?(Journal of neurosurgery. Spine, 2021-09) Chan, Andrew K; Mummaneni, Praveen V; Burke, John F; Mayer, Rory R; Bisson, Erica F; Rivera, Joshua; Pennicooke, Brenton; Fu, Kai-Ming; Park, Paul; Bydon, Mohamad; Glassman, Steven D; Foley, Kevin T; Shaffrey, Christopher I; Potts, Eric A; Shaffrey, Mark E; Coric, Domagoj; Knightly, John J; Wang, Michael Y; Slotkin, Jonathan R; Asher, Anthony L; Virk, Michael S; Kerezoudis, Panagiotis; Alvi, Mohammed A; Guan, Jian; Haid, Regis W; Chou, DeanObjective
Reduction of Meyerding grade is often performed during fusion for spondylolisthesis. Although radiographic appearance may improve, correlation with patient-reported outcomes (PROs) is rarely reported. In this study, the authors' aim was to assess the impact of spondylolisthesis reduction on 24-month PRO measures after decompression and fusion surgery for Meyerding grade I degenerative lumbar spondylolisthesis.Methods
The Quality Outcomes Database (QOD) was queried for patients undergoing posterior lumbar fusion for spondylolisthesis with a minimum 24-month follow-up, and quantitative correlation between Meyerding slippage reduction and PROs was performed. Baseline and 24-month PROs, including the Oswestry Disability Index (ODI), EQ-5D, Numeric Rating Scale (NRS)-back pain (NRS-BP), NRS-leg pain (NRS-LP), and satisfaction (North American Spine Society patient satisfaction questionnaire) scores were noted. Multivariable regression models were fitted for 24-month PROs and complications after adjusting for an array of preoperative and surgical variables. Data were analyzed for magnitude of slippage reduction and correlated with PROs. Patients were divided into two groups: < 3 mm reduction and ≥ 3 mm reduction.Results
Of 608 patients from 12 participating sites, 206 patients with complete data were identified in the QOD and included in this study. Baseline patient demographics, comorbidities, and clinical characteristics were similarly distributed between the cohorts except for depression, listhesis magnitude, and the proportion with dynamic listhesis (which were accounted for in the multivariable analysis). One hundred four (50.5%) patients underwent lumbar decompression and fusion with slippage reduction ≥ 3 mm (mean 5.19, range 3 to 11), and 102 (49.5%) patients underwent lumbar decompression and fusion with slippage reduction < 3 mm (mean 0.41, range 2 to -2). Patients in both groups (slippage reduction ≥ 3 mm, and slippage reduction < 3 mm) reported significant improvement in all primary patient reported outcomes (all p < 0.001). There was no significant difference with regard to the PROs between patients with or without intraoperative reduction of listhesis on univariate and multivariable analyses (ODI, EQ-5D, NRS-BP, NRS-LP, or satisfaction). There was no significant difference in complications between cohorts.Conclusions
Significant improvement was found in terms of all PROs in patients undergoing decompression and fusion for lumbar spondylolisthesis. There was no correlation with clinical outcomes and magnitude of Meyerding slippage reduction.Item Open Access Does the number of social factors affect long-term patient-reported outcomes and satisfaction in those with cervical myelopathy? A QOD study.(Journal of neurosurgery. Spine, 2024-01) Park, Christine; Shaffrey, Christopher I; Than, Khoi D; Bisson, Erica F; Sherrod, Brandon A; Asher, Anthony L; Coric, Domagoj; Potts, Eric A; Foley, Kevin T; Wang, Michael Y; Fu, Kai-Ming; Virk, Michael S; Knightly, John J; Meyer, Scott; Park, Paul; Upadhyaya, Cheerag; Shaffrey, Mark E; Buchholz, Avery L; Tumialán, Luis M; Turner, Jay D; Agarwal, Nitin; Chan, Andrew K; Chou, Dean; Chaudhry, Nauman S; Haid, Regis W; Mummaneni, Praveen V; Michalopoulos, Georgios D; Bydon, Mohamad; Gottfried, Oren NIt is not clear whether there is an additive effect of social factors in keeping patients with cervical spondylotic myelopathy (CSM) from achieving both a minimum clinically important difference (MCID) in outcomes and satisfaction after surgery. The aim of this study was to explore the effect of multiple social factors on postoperative outcomes and satisfaction. This was a multiinstitutional, retrospective study of the prospective Quality Outcomes Database (QOD) CSM cohort, which included patients aged 18 years or older who were diagnosed with primary CSM and underwent operative management. Social factors included race (White vs non-White), education (high school or below vs above), employment (employed vs not), and insurance (private vs nonprivate). Patients were considered to have improved from surgery if the following criteria were met: 1) they reported a score of 1 or 2 on the North American Spine Society index, and 2) they met the MCID in patient-reported outcomes (i.e., visual analog scale [VAS] neck and arm pain, Neck Disability Index [NDI], and EuroQol-5D [EQ-5D]). Of the 1141 patients included in the study, 205 (18.0%) had 0, 347 (30.4%) had 1, 334 (29.3%) had 2, and 255 (22.3%) had 3 social factors. The 24-month follow-up rate was > 80% for all patient-reported outcomes. After adjusting for all relevant covariates (p < 0.02), patients with 1 or more social factors were less likely to improve from surgery in all measured outcomes including VAS neck pain (OR 0.90, 95% CI 0.83-0.99) and arm pain (OR 0.88, 95% CI 0.80-0.96); NDI (OR 0.90, 95% CI 0.83-0.98); and EQ-5D (OR 0.90, 95% CI 0.83-0.97) (all p < 0.05) compared to those without any social factors. Patients with 2 social factors (outcomes: neck pain OR 0.86, arm pain OR 0.81, NDI OR 0.84, EQ-5D OR 0.81; all p < 0.05) or 3 social factors (outcomes: neck pain OR 0.84, arm pain OR 0.84, NDI OR 0.84, EQ-5D OR 0.84; all p < 0.05) were more likely to fare worse in all outcomes compared to those with only 1 social factor. Compared to those without any social factors, patients who had at least 1 social factor were less likely to achieve MCID and feel satisfied after surgery. The effect of social factors is additive in that patients with a higher number of factors are less likely to improve compared to those with only 1 social factor.Item Open Access Effect modifiers for patient-reported outcomes in operatively and nonoperatively treated patients with adult symptomatic lumbar scoliosis: a combined analysis of randomized and observational cohorts.(Journal of neurosurgery. Spine, 2020-03) Yanik, Elizabeth L; Kelly, Michael P; Lurie, Jon D; Baldus, Christine R; Shaffrey, Christopher I; Schwab, Frank J; Bess, Shay; Lenke, Lawrence G; LaBore, Adam; Bridwell, Keith HOBJECTIVE:Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS. METHODS:Patients 40-80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7). RESULTS:Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence-lumbar lordosis (PI-LL) match (≤ 11°). Male patients and patients with more (> 11°) PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes. CONCLUSIONS:Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI-LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.Item Open Access Long-term impact of obesity on patient-reported outcomes and patient satisfaction after lumbar spine surgery: an observational study.(Journal of neurosurgery. Spine, 2020-09) Park, Christine; Garcia, Alessandra N; Cook, Chad; Shaffrey, Christopher I; Gottfried, Oren NObjective
Obese body habitus is a challenging issue to address in lumbar spine surgery. There is a lack of consensus on the long-term influence of BMI on patient-reported outcomes and satisfaction. This study aimed to examine the differences in patient-reported outcomes over the course of 12 and 24 months among BMI classifications of patients who underwent lumbar surgery.Methods
A search was performed using the Quality Outcomes Database (QOD) Spine Registry from 2012 to 2018 to identify patients who underwent lumbar surgery and had either a 12- or 24-month follow-up. Patients were categorized based on their BMI as normal weight (≤ 25 kg/m2), overweight (25-30 kg/m2), obese (30-40 kg/m2), and morbidly obese (> 40 kg/m2). Outcomes included the Oswestry Disability Index (ODI) and the visual analog scale (VAS) for back pain (BP) and leg pain (LP), and patient satisfaction was measured at 12 and 24 months postoperatively.Results
A total of 31,765 patients were included. At both the 12- and 24-month follow-ups, those who were obese and morbidly obese had worse ODI, VAS-BP, and VAS-LP scores (all p < 0.01) and more frequently rated their satisfaction as "I am the same or worse than before treatment" (all p < 0.01) compared with those who were normal weight. Receiver operating characteristic curve analysis revealed that the BMI cutoffs for predicting worsening disability and surgery dissatisfaction were 30.1 kg/m2 and 29.9 kg/m2 for the 12- and 24-month follow-ups, respectively.Conclusions
Higher BMI was associated with poorer patient-reported outcomes and satisfaction at both the 12- and 24-month follow-ups. BMI of 30 kg/m2 is the cutoff for predicting worse patient outcomes after lumbar surgery.Item Open Access Patient-reported outcome measure clustering after surgery for adult symptomatic lumbar scoliosis.(Journal of neurosurgery. Spine, 2022-01) Wondra, James P; Kelly, Michael P; Yanik, Elizabeth L; Greenberg, Jacob K; Smith, Justin S; Bess, Shay; Shaffrey, Christopher I; Lenke, Lawrence G; Bridwell, KeithObjective
Adult symptomatic lumbar scoliosis (ASLS) is a widespread and debilitating subset of adult spinal deformity. Although many patients benefit from operative treatment, surgery entails substantial cost and risk for adverse events. Patient-reported outcome measures (PROMs) are patient-centered tools used to evaluate the appropriateness of surgery and to assist in the shared decision-making process. Framing realistic patient expectations should include the possible functional limitation to improvement inherent in surgical intervention, such as multilevel fusion to the sacrum. The authors' objective was to predict postoperative ASLS PROMs by using clustering analysis, generalized longitudinal regression models, percentile analysis, and clinical improvement analysis of preoperative health-related quality-of-life scores for use in surgical counseling.Methods
Operative results from the combined ASLS cohorts were examined. PROM score clustering after surgery investigated limits of surgical improvement. Patients were categorized by baseline disability (mild, moderate, moderate to severe, or severe) according to preoperative Scoliosis Research Society (SRS)-22 and Oswestry Disability Index (ODI) scores. Responder analysis for patients achieving improvement meeting the minimum clinically important difference (MCID) and substantial clinical benefit (SCB) standards was performed using both fixed-threshold and patient-specific values (MCID = 30% of remaining scale, SCB = 50%). Best (top 5%), worst (bottom 5%), and median scores were calculated across disability categories.Results
A total of 171/187 (91%) of patients with ASLS achieved 2-year follow-up. Patients rarely achieved a PROM ceiling for any measure, with 33%-43% of individuals clustering near 4.0 for SRS domains. Patients with severe baseline disability (< 2.0) SRS-pain and SRS-function scores were often left with moderate to severe disability (2.0-2.9), unlike patients with higher (≥ 3.0) initial PROM values. Patients with mild disability according to baseline SRS-function score were unlikely to improve. Crippling baseline ODI disability (> 60) commonly left patients with moderate disability (median ODI = 32). As baseline ODI disability increased, patients were more likely to achieve MCID and SCB (p < 0.001). Compared to fixed threshold values for MCID and SCB, patient-specific values were more sensitive to change for patients with minimal ODI baseline disability (p = 0.008) and less sensitive to change for patients with moderate to severe SRS subscore disability (p = 0.01).Conclusions
These findings suggest that ASLS surgeries have a limit to possible improvement, probably due to both baseline disability and the effects of surgery. The most disabled patients often had moderate to severe disability (SRS < 3, ODI > 30) at 2 years, emphasizing the importance of patient counseling and expectation management.Item Open Access Patients' Experiences With Staphylococcus aureus and Gram-Negative Bacterial Bloodstream Infections: Results From Cognitive Interviews to Inform Assessment of Health-Related Quality of Life.(Open forum infectious diseases, 2022-02) King, Heather A; Doernberg, Sarah B; Grover, Kiran; Miller, Julie; Oakes, Megan; Wang, Tsai-Wei; McFatrich, Molly; Ruffin, Felicia; Staman, Karen; Lane, Hannah G; Rader, Abigail; Sund, Zoë; Bosworth, Hayden B; Reeve, Bryce B; Fowler, Vance G; Holland, Thomas LBackground
We previously conducted a concept elicitation study on the impact of Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) on health-related quality of life (HRQoL) from the patient's perspective and found significant impacts on HRQoL, particularly in the physical and functional domains. Using this information and following guidance on the development of patient-reported outcome (PRO) measures, we determined which combination of measures and items (ie, specific questions) would be most appropriate in a survey assessing HRQoL in bloodstream infections.Methods
We selected a variety of measures/items from the Patient-Reported Outcomes Measurement Information System (PROMIS) representing different domains. We purposefully sampled patients ~6-12 weeks post-SAB/GNB and conducted 2 rounds of cognitive interviews to refine the survey by exploring patients' understanding of items and answer selection as well as relevance for capturing HRQoL.Results
We interviewed 17 SAB/GNB patients. Based on the first round of cognitive interviews (n = 10), we revised the survey. After round 2 of cognitive interviewing (n = 7), we finalized the survey to include 10 different PROMIS short forms/measures of the most salient HRQoL domains and 2 adapted questions (41 items total) that were found to adequately capture HRQoL.Conclusions
We developed a survey from well-established PRO measures that captures what matters most to SAB/GNB patients as they recover. This survey, uniquely tailored to bloodstream infections, can be used to assess these meaningful, important HRQoL outcomes in clinical trials and in patient care. Engaging patients is crucial to developing treatments for bloodstream infections.Item Open Access Stronger association of objective physical metrics with baseline patient-reported outcome measures than preoperative standing sagittal parameters for adult spinal deformity patients.(Journal of neurosurgery. Spine, 2024-03) Azad, Tej D; Schwab, Frank J; Lafage, Virginie; Soroceanu, Alex; Eastlack, Robert K; Lafage, Renaud; Kebaish, Khaled M; Hart, Robert A; Diebo, Bassel; Kelly, Michael P; Smith, Justin S; Daniels, Alan H; Hamilton, D Kojo; Gupta, Munish; Klineberg, Eric O; Protopsaltis, Themistocles S; Passias, Peter G; Bess, Shay; Gum, Jeffrey L; Hostin, Richard; Lewis, Stephen J; Shaffrey, Christopher I; Burton, Douglas; Lenke, Lawrence G; Ames, Christopher P; Scheer, Justin KObjective
Sagittal alignment measured on standing radiography remains a fundamental component of surgical planning for adult spinal deformity (ASD). However, the relationship between classic sagittal alignment parameters and objective metrics, such as walking time (WT) and grip strength (GS), remains unknown. The objective of this work was to determine if ASD patients with worse baseline sagittal malalignment have worse objective physical metrics and if those metrics have a stronger relationship to patient-reported outcome metrics (PROMs) than standing alignment.Methods
The authors conducted a retrospective review of a multicenter ASD cohort. ASD patients underwent baseline testing with the timed up-and-go 6-m walk test (seconds) and for GS (pounds). Baseline PROMs were surveyed, including Oswestry Disability Index (ODI), Patient-Reported Outcomes Measurement Information System (PROMIS), Scoliosis Research Society (SRS)-22r, and Veterans RAND 12 (VR-12) scores. Standard spinopelvic measurements were obtained (sagittal vertical axis [SVA], pelvic tilt [PT], and mismatch between pelvic incidence and lumbar lordosis [PI-LL], and SRS-Schwab ASD classification). Univariate and multivariable linear regression modeling was performed to interrogate associations between objective physical metrics, sagittal parameters, and PROMs.Results
In total, 494 patients were included, with mean ± SD age 61 ± 14 years, and 68% were female. Average WT was 11.2 ± 6.1 seconds and average GS was 56.6 ± 24.9 lbs. With increasing PT, PI-LL, and SVA quartiles, WT significantly increased (p < 0.05). SRS-Schwab type N patients demonstrated a significantly longer average WT (12.5 ± 6.2 seconds), and type T patients had a significantly shorter WT time (7.9 ± 2.7 seconds, p = 0.03). With increasing PT quartiles, GS significantly decreased (p < 0.05). SRS-Schwab type T patients had a significantly higher average GS (68.8 ± 27.8 lbs), and type L patients had a significantly lower average GS (51.6 ± 20.4 lbs, p = 0.03). In the frailty-adjusted multivariable linear regression analyses, WT was more strongly associated with PROMs than sagittal parameters. GS was more strongly associated with ODI and PROMIS Physical Function scores.Conclusions
The authors observed that increasing baseline sagittal malalignment is associated with slower WT, and possibly weaker GS, in ASD patients. WT has a stronger relationship to PROMs than standing alignment parameters. Objective physical metrics likely offer added value to standard spinopelvic measurements in ASD evaluation and surgical planning.Item Open Access Two-Year Clinical and Radiographic Outcomes for Percutaneous Lumbar Interbody Fusion With an Expandable Titanium Cage Through Kambin's Triangle Without Facetectomy.(International journal of spine surgery, 2023-12) Tabarestani, Troy Q; Wang, Timothy Y; Sykes, David AW; Mehta, Vikram A; Yang, Lexie Z; Chow, Shein-Chung; Shaffrey, Christopher I; Wiggins, Walter F; Chi, John H; Abd-El-Barr, Muhammad MBackground
There has been heightened interest in performing percutaneous lumbar interbody fusions (percLIFs) through Kambin's triangle, an anatomic corridor allowing entrance into the disc space. However, due to its novelty, there are limited data regarding the long-term benefits of this procedure. Our objective was to determine the long-term efficacy and durability of the percutaneous insertion of an expandable titanium cage through Kambin's triangle without facetectomy.Methods
A retrospective review of patients undergoing percLIF via Kambin's triangle using an expandable titanium cage was performed. Demographics, visual analog scale (VAS) scores, Oswestry Disability Index (ODI), radiographic measurements, perioperative variables, and complications were recorded. VAS, ODI, and radiographic measurements were compared with baseline using the generalized estimating equations assuming normally distributed data. Fusion was assessed with computed tomography (CT) at 1 and 2 years after the procedure.Results
A total of 49 patients were included. Spondylolisthesis, lumbar lordosis (LL), sacral slope, pelvic tilt, and anterior/posterior disc space height were all significantly improved postoperatively at each time point of 3, 6, 12, and 24 months (P < 0.001). Pelvic incidence-LL mismatch decreased significantly at each follow-up (P < 0.001) with a mean reduction of 4° by 24 months. VAS back scores reduced by >2 points at the 6, 12, and 24 month follow-ups. ODI scores reduced by >15 points at the 12- and 24-month follow-ups. Of the patients who had 1- and 2-year CT images, fusion rates at those time points were 94.4% (17/18) and 87.5% (7/8), respectively. The mean annual rate of surgically significant adjacent segment disease was 2.74% through an average follow-up of 2.74 years.Conclusion
These results highlight that percLIF, a procedure done without an endoscope or facetectomy, can be performed using an expandable titanium cage through Kambin's triangle with excellent radiographic and clinical results.Clinical relevance
percLIF via Kambin's triangle is a safe and succesful procedure with long-term improvements in both clinical and radiographic outcomes.Level of evidence: 3
Item Open Access What factors influence surgical decision-making in anterior versus posterior surgery for cervical myelopathy? A QOD analysis.(Journal of neurosurgery. Spine, 2023-11) Park, Christine; Shaffrey, Christopher I; Than, Khoi D; Michalopoulos, Giorgos D; El Sammak, Sally; Chan, Andrew K; Bisson, Erica F; Sherrod, Brandon A; Asher, Anthony L; Coric, Domagoj; Potts, Eric A; Foley, Kevin T; Wang, Michael Y; Fu, Kai-Ming; Virk, Michael S; Knightly, John J; Meyer, Scott; Park, Paul; Upadhyaya, Cheerag; Shaffrey, Mark E; Buchholz, Avery L; Tumialán, Luis M; Turner, Jay; Agarwal, Nitin; Chou, Dean; Chaudhry, Nauman S; Haid, Regis W; Mummaneni, Praveen V; Bydon, Mohamad; Gottfried, Oren NObjective
The aim of this study was to explore the preoperative patient characteristics that affect surgical decision-making when selecting an anterior or posterior operative approach in patients diagnosed with cervical spondylotic myelopathy (CSM).Methods
This was a multi-institutional, retrospective study of the prospective Quality Outcomes Database (QOD) Cervical Spondylotic Myelopathy module. Patients aged 18 years or older diagnosed with primary CSM who underwent multilevel (≥ 2-level) elective surgery were included. Demographics and baseline clinical characteristics were collected.Results
Of the 841 patients with CSM in the database, 492 (58.5%) underwent multilevel anterior surgery and 349 (41.5%) underwent multilevel posterior surgery. Surgeons more often performed a posterior surgical approach in older patients (mean 64.8 ± 10.6 vs 58.5 ± 11.1 years, p < 0.001) and those with a higher American Society of Anesthesiologists class (class III or IV: 52.4% vs 46.3%, p = 0.003), a higher rate of motor deficit (67.0% vs 58.7%, p = 0.014), worse myelopathy (mean modified Japanese Orthopaedic Association score 11.4 ± 3.1 vs 12.4 ± 2.6, p < 0.001), and more levels treated (4.3 ± 1.3 vs 2.4 ± 0.6, p < 0.001). On the other hand, surgeons more frequently performed an anterior surgical approach when patients were employed (47.2% vs 23.2%, p < 0.001) and had intervertebral disc herniation as an underlying pathology (30.7% vs 9.2%, p < 0.001).Conclusions
The selection of approach for patients with CSM depends on patient demographics and symptomology. Posterior surgery was performed in patients who were older and had worse systemic disease, increased myelopathy, and greater levels of stenosis. Anterior surgery was more often performed in patients who were employed and had intervertebral disc herniation.Item Open Access What predicts the best 24-month outcomes following surgery for cervical spondylotic myelopathy? A QOD prospective registry study(JOURNAL OF NEUROSURGERY-SPINE, 2024) Chan, Andrew K; Park, Christine; Shaffrey, Christopher I; Gottfried, Oren N; Than, Khoi D; Bisson, Erica F; Bydon, Mohamad; Asher, Anthony L; Coric, Domagoj; Potts, Eric A; Foley, Kevin T; Wang, Michael Y; Fu, Kai-Ming; Virk, Michael S; Knightly, John J; Meyer, Scott; Park, Paul; Upadhyaya, Cheerag D; Shaffrey, Mark E; Buchholz, Avery L; Tumialan, Luis M; Turner, Jay D; Michalopoulos, Giorgos; Sherrod, Brandon A; Agarwal, Nitin; Chou, Dean; Haid, Regis W; Mummaneni, Praveen VItem Open Access What predicts the best 24-month outcomes following surgery for cervical spondylotic myelopathy? A QOD prospective registry study.(Journal of neurosurgery. Spine, 2024-01) Chan, Andrew K; Park, Christine; Shaffrey, Christopher I; Gottfried, Oren N; Than, Khoi D; Bisson, Erica F; Bydon, Mohamad; Asher, Anthony L; Coric, Domagoj; Potts, Eric A; Foley, Kevin T; Wang, Michael Y; Fu, Kai-Ming; Virk, Michael S; Knightly, John J; Meyer, Scott; Park, Paul; Upadhyaya, Cheerag D; Shaffrey, Mark E; Buchholz, Avery L; Tumialán, Luis M; Turner, Jay D; Michalopoulos, Giorgos; Sherrod, Brandon A; Agarwal, Nitin; Chou, Dean; Haid, Regis W; Mummaneni, Praveen VThe aim of this study was to identify predictors of the best 24-month improvements in patients undergoing surgery for cervical spondylotic myelopathy (CSM). For this purpose, the authors leveraged a large prospective cohort of surgically treated patients with CSM to identify factors predicting the best outcomes for disability, quality of life, and functional status following surgery. This was a retrospective analysis of prospectively collected data. The Quality Outcomes Database (QOD) CSM dataset (1141 patients) at 14 top enrolling sites was used. Baseline and surgical characteristics were compared for those reporting the top and bottom 20th percentile 24-month Neck Disability Index (NDI), EuroQol-5D (EQ-5D), and modified Japanese Orthopaedic Association (mJOA) change scores. A multivariable logistic model was constructed and included candidate variables reaching p ≤ 0.20 on univariate analyses. Least important variables were removed in a stepwise manner to determine the significant predictors of the best outcomes (top 20th percentile) for 24-month NDI, EQ-5D, and mJOA change. A total of 948 (83.1%) patients with 24-month follow-up were included in this study. For NDI, 204 (17.9%) had the best NDI outcome and 200 (17.5%) had the worst NDI outcome. Factors predicting the best NDI outcomes included symptom duration less than 12 months (OR 1.5, 95% CI 1.1-1.9; p = 0.01); procedure other than posterior fusion (OR 1.5, 95% CI 1.03-2.1; p = 0.03); higher preoperative visual analog scale neck pain score (OR 1.2, 95% CI 1.1-1.3; p < 0.001); and higher baseline NDI (OR 1.06, 95% CI 1.05-1.07; p < 0.001). For EQ-5D, 163 (14.3%) had the best EQ-5D outcome and 169 (14.8%) had the worst EQ-5D outcome. Factors predicting the best EQ-5D outcomes included arm pain-only complaints (compared to neck pain) (OR 1.9, 95% CI 1.3-2.9; p = 0.002) and lower baseline EQ-5D (OR 167.7 per unit lower, 95% CI 85.0-339.4; p < 0.001). For mJOA, 222 (19.5%) had the best mJOA outcome and 238 (20.9%) had the worst mJOA outcome. Factors predicting the best mJOA outcomes included lower BMI (OR 1.03 per unit lower, 95% CI 1.004-1.05; p = 0.02; cutoff value of ≤ 29.5 kg/m2); arm pain-only complaints (compared to neck pain) (OR 1.7, 95% CI 1.1-2.5; p = 0.02); and lower baseline mJOA (OR 1.6 per unit lower, 95% CI 1.5-1.7; p < 0.001). Compared to the worst outcomes for EQ-5D, the best outcomes were associated with patients with arm pain-only complaints. For mJOA, lower BMI and arm pain-only complaints portended the best outcomes. For NDI, those with the best outcomes had shorter symptom durations, higher preoperative neck pain scores, and less often underwent posterior spinal fusions. Given the positive impact of shorter symptom duration on outcomes, these data suggest that early surgery may be beneficial for patients with CSM.Item Open Access Which supervised machine learning algorithm can best predict achievement of minimum clinically important difference in neck pain after surgery in patients with cervical myelopathy? A QOD study.(Neurosurgical focus, 2023-06) Park, Christine; Mummaneni, Praveen V; Gottfried, Oren N; Shaffrey, Christopher I; Tang, Anthony J; Bisson, Erica F; Asher, Anthony L; Coric, Domagoj; Potts, Eric A; Foley, Kevin T; Wang, Michael Y; Fu, Kai-Ming; Virk, Michael S; Knightly, John J; Meyer, Scott; Park, Paul; Upadhyaya, Cheerag; Shaffrey, Mark E; Buchholz, Avery L; Tumialán, Luis M; Turner, Jay D; Sherrod, Brandon A; Agarwal, Nitin; Chou, Dean; Haid, Regis W; Bydon, Mohamad; Chan, Andrew KObjective
The purpose of this study was to evaluate the performance of different supervised machine learning algorithms to predict achievement of minimum clinically important difference (MCID) in neck pain after surgery in patients with cervical spondylotic myelopathy (CSM).Methods
This was a retrospective analysis of the prospective Quality Outcomes Database CSM cohort. The data set was divided into an 80% training and a 20% test set. Various supervised learning algorithms (including logistic regression, support vector machine, decision tree, random forest, extra trees, gaussian naïve Bayes, k-nearest neighbors, multilayer perceptron, and extreme gradient boosted trees) were evaluated on their performance to predict achievement of MCID in neck pain at 3 and 24 months after surgery, given a set of predicting baseline features. Model performance was assessed with accuracy, F1 score, area under the receiver operating characteristic curve, precision, recall/sensitivity, and specificity.Results
In total, 535 patients (46.9%) achieved MCID for neck pain at 3 months and 569 patients (49.9%) achieved it at 24 months. In each follow-up cohort, 501 patients (93.6%) were satisfied at 3 months after surgery and 569 patients (100%) were satisfied at 24 months after surgery. Of the supervised machine learning algorithms tested, logistic regression demonstrated the best accuracy (3 months: 0.76 ± 0.031, 24 months: 0.773 ± 0.044), followed by F1 score (3 months: 0.759 ± 0.019, 24 months: 0.777 ± 0.039) and area under the receiver operating characteristic curve (3 months: 0.762 ± 0.027, 24 months: 0.773 ± 0.043) at predicting achievement of MCID for neck pain at both follow-up time points, with fair performance. The best precision was also demonstrated by logistic regression at 3 (0.724 ± 0.058) and 24 (0.780 ± 0.097) months. The best recall/sensitivity was demonstrated by multilayer perceptron at 3 months (0.841 ± 0.094) and by extra trees at 24 months (0.817 ± 0.115). Highest specificity was shown by support vector machine at 3 months (0.952 ± 0.013) and by logistic regression at 24 months (0.747 ± 0.18).Conclusions
Appropriate selection of models for studies should be based on the strengths of each model and the aims of the studies. For maximally predicting true achievement of MCID in neck pain, of all the predictions in this balanced data set the appropriate metric for the authors' study was precision. For both short- and long-term follow-ups, logistic regression demonstrated the highest precision of all models tested. Logistic regression performed consistently the best of all models tested and remains a powerful model for clinical classification tasks.