Effects of preoperative obesity and psychiatric comorbidities on minimum clinically important differences for lumbar fusion in grade 1 degenerative spondylolisthesis: analysis from the prospective Quality Outcomes Database registry

2020 ◽  
Vol 33 (5) ◽  
pp. 635-642
Author(s):  
Joseph Laratta ◽  
Leah Y. Carreon ◽  
Avery L. Buchholz ◽  
Andrew Y. Yew ◽  
Erica F. Bisson ◽  
...  

OBJECTIVEMedical comorbidities, particularly preoperatively diagnosed anxiety, depression, and obesity, may influence how patients perceive and measure clinical benefit after a surgical intervention. The current study was performed to define and compare the minimum clinically important difference (MCID) thresholds in patients with and without preoperative diagnoses of anxiety or depression and obesity who underwent spinal fusion for grade 1 degenerative spondylolisthesis.METHODSThe Quality Outcomes Database (QOD) was queried for patients who underwent lumbar fusion for grade 1 degenerative spondylolisthesis during the period from January 2014 to August 2017. Collected patient-reported outcomes (PROs) included the Oswestry Disability Index (ODI), health status (EQ-5D), and numeric rating scale (NRS) scores for back pain (NRS-BP) and leg pain (NRS-LP). Both anchor-based and distribution-based methods for MCID calculation were employed.RESULTSOf 462 patients included in the prospective registry who underwent a decompression and fusion procedure, 356 patients (77.1%) had complete baseline and 12-month PRO data and were included in the study. The MCID values for ODI scores did not significantly differ in patients with and those without a preoperative diagnosis of obesity (20.58 and 20.69, respectively). In addition, the MCID values for ODI scores did not differ in patients with and without a preoperative diagnosis of anxiety or depression (24.72 and 22.56, respectively). Similarly, the threshold MCID values for NRS-BP, NRS-LP, and EQ-5D scores were not statistically different between all groups. Based on both anchor-based and distribution-based methods for determination of MCID thresholds, there were no statistically significant differences between all cohorts.CONCLUSIONSMCID thresholds were similar for ODI, EQ-5D, NRS-BP, and NRS-LP in patients with and without preoperative diagnoses of anxiety or depression and obesity undergoing spinal fusion for grade 1 degenerative spondylolisthesis. Preoperative clinical and shared decision-making may be improved by understanding that preoperative medical comorbidities may not affect the way patients experience and assess important clinical changes postoperatively.

2018 ◽  
Vol 44 (1) ◽  
pp. E2 ◽  
Author(s):  
Anthony L. Asher ◽  
Panagiotis Kerezoudis ◽  
Praveen V. Mummaneni ◽  
Erica F. Bisson ◽  
Steven D. Glassman ◽  
...  

OBJECTIVEPatient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis.METHODSThe authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen’s effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO.RESULTSA total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 ± 17.4 points for ODI, 0.24 ± 0.23 for EQ-5D, 4.1 ± 3.5 for NRS-LP, and 3.7 ± 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3–26.5 points for ODI, 0.04–0.3 points for EQ-5D, 0.6–4.5 points for NRS-LP, and 0.5–4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort.CONCLUSIONSThe MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.


2018 ◽  
Vol 44 (1) ◽  
pp. E3 ◽  
Author(s):  
Andrew K. Chan ◽  
Erica F. Bisson ◽  
Mohamad Bydon ◽  
Steven D. Glassman ◽  
Kevin T. Foley ◽  
...  

OBJECTIVEThe American Association of Neurological Surgeons launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data, to measure the safety and quality of neurosurgical procedures, including spinal surgery. Differing results from recent randomized controlled trials have established a need to clarify the groups that would most benefit from surgery for degenerative lumbar spondylolisthesis. In the present study, the authors compared patients who were the most and the least satisfied following surgery for degenerative lumbar spondylolisthesis.METHODSThis was a retrospective analysis of a prospective, national longitudinal registry including patients who had undergone surgery for grade 1 degenerative lumbar spondylolisthesis. The most and least satisfied patients were identified based on an answer of “1” and “4,” respectively, on the North American Spine Society (NASS) Satisfaction Questionnaire 12 months postoperatively. Baseline demographics, clinical variables, surgical parameters, and outcomes were collected. Patient-reported outcome measures, including the Numeric Rating Scale (NRS) for back pain, NRS for leg pain, Oswestry Disability Index (ODI), and EQ-5D (the EuroQol health survey), were administered at baseline and 3 and 12 months after treatment.RESULTSFour hundred seventy-seven patients underwent surgery for grade 1 degenerative lumbar spondylolisthesis in the period from July 2014 through December 2015. Two hundred fifty-five patients (53.5%) were the most satisfied and 26 (5.5%) were the least satisfied. Compared with the most satisfied patients, the least satisfied ones more often had coronary artery disease (CAD; 26.9% vs 12.2%, p = 0.04) and had higher body mass indices (32.9 ± 6.5 vs 30.0 ± 6.0 kg/m2, p = 0.02). In the multivariate analysis, female sex (OR 2.9, p = 0.02) was associated with the most satisfaction. Notably, the American Society of Anesthesiologists (ASA) class, smoking, psychiatric comorbidity, and employment status were not significantly associated with satisfaction. Although there were no significant differences at baseline, the most satisfied patients had significantly lower NRS back and leg pain and ODI scores and a greater EQ-5D score at 3 and 12 months postoperatively (p < 0.001 for all).CONCLUSIONSThis study revealed that some patient factors differ between those who report the most and those who report the least satisfaction after surgery for degenerative lumbar spondylolisthesis. Patients reporting the least satisfaction tended to have CAD or were obese. Female sex was associated with the most satisfaction when adjusting for potential covariates. These findings highlight several key factors that could aid in setting expectations for outcomes following surgery for degenerative lumbar spondylolisthesis.


2020 ◽  
Vol 33 (5) ◽  
pp. 643-651
Author(s):  
Erica F. Bisson ◽  
Praveen V. Mummaneni ◽  
John Knightly ◽  
Mohammed Ali Alvi ◽  
Anshit Goyal ◽  
...  

OBJECTIVELoss to follow-up has been shown to bias outcomes assessment among studies utilizing clinical registries. Here, the authors analyzed patients enrolled in a national surgical registry and compared the baseline characteristics of patients captured with those lost to follow-up at 2 years.METHODSThe authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis undergoing a surgical intervention between July 2014 and June 2016. Only those patients enrolled in a multisite study investigating the impact of fusion on clinical and patient-reported outcomes (PROs) among patients with grade I spondylolisthesis were evaluated.RESULTSOf the 608 patients enrolled in the study undergoing 1- or 2-level decompression (23.0%, n = 140) or 1-level fusion (77.0%, n = 468), 14.5% (n = 88) were lost to follow-up at 2 years. Patients who were lost to follow-up were more likely to be younger (59.6 ± 13.5 vs 62.6 ± 11.7 years, p = 0.031), be employed (unemployment rate: 53.3% [n = 277] for successful follow-up vs 40.9% [n = 36] for those lost to follow-up, p = 0.017), have anxiety (26.1% [n = 23] vs 16.3% [n = 85], p = 0.026), have higher back pain scores (7.4 ± 2.9 vs 6.6 ± 2.8, p = 0.010), have higher leg pain scores (7.4 ± 2.5 vs 6.4 ± 2.9, p = 0.003), have higher Oswestry Disability Index scores (50.8 ± 18.7 vs 46 ± 16.8, p = 0.018), and have lower EQ-5D scores (0.481 ± 0.2 vs 0.547 ± 0.2, p = 0.012) at baseline.CONCLUSIONSTo execute future, high-quality studies, it is important to identify patients undergoing surgery for spondylolisthesis who might be lost to follow-up. In a large, prospective registry, the authors found that those lost to follow-up were more likely to be younger, be employed, have anxiety disorder, and have worse PRO scores.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Jian Guan ◽  
Erica F Bisson ◽  
Mohamad Bydon ◽  
Mohammed A Alvi ◽  
Steven D Glassman ◽  
...  

Abstract INTRODUCTION Extensive investigation has not ascertained the ideal surgical management of grade 1 lumbar spondylolisthesis. Using the large, multicenter, prospectively collected Quality Outcomes Database (QOD), we compared 24-mo outcomes for patients undergoing decompression alone vs decompression and fusion. METHODS Patients undergoing single-level surgery from 7/1/2014 to 6/30/2016 were identified. The primary outcome measure, 24-mo Oswestry Disability Index (ODI) change, was analyzed with univariate and multivariable linear regression. EQ-5D scores, numerical rating scale (NRS) back and leg pain scores, and North American Spine Society patient satisfaction scores were also analyzed. RESULTS Of the 608 patients (85.5% with at least 24-mo follow-up) who met the inclusion criteria, 140 (23.0%) underwent decompression alone and 468 (77.0%) underwent decompression and fusion. The 24-mo change in ODI was significantly greater in the fusion group than the decompression-only group (−25.8 ± 20.0 vs −15.2 ± 19.8, P < .001). Fusion remained independently associated with 24-mo ODI change in our multivariable model (B = −7.05, 95% CI 10.70-3.39, P = < .001). Patients in the fusion group were significantly more likely to reach minimal clinically important difference (MCID, 12.8 points) in ODI at 24 mo (73.3% vs 56.0%, P = < .001), and to experience significantly greater NRS back pain improvement at 24-mo follow-up (3.8 ± 3.1 vs −1.8 ± 3.9, P < .001). Fusion was also independently associated with achieving MCID for ODI at 24 mo in our logistic regression model (OR 1.767, 95% CI 1.058-2.944, P = .029). CONCLUSION The results of our study suggest that decompression plus fusion may offer superior outcomes to decompression alone in patients with grade 1 lumbar spondylolisthesis at 24 mo. Longer-term follow-up is warranted to assess whether this effect is sustained.


2019 ◽  
Vol 10 (3) ◽  
pp. 286-293
Author(s):  
Jannat M. Khan ◽  
Joseph Michalski ◽  
Bryce A. Basques ◽  
Philip K. Louie ◽  
Oscar Chen ◽  
...  

Study Design: Retrospective cohort study. Objective: To assess the effect of diabetes mellitus (DM) on clinical and radiographic outcomes in patient with degenerative spondylolisthesis undergoing posterior lumbar spinal fusion. Methods: Analysis of patients who underwent open posterior lumbar spinal fusion from 2011 to 2018. Patients being medically treated for DM were identified and separated from nondiabetic patients. Visual analogue scale Back/Leg pain and Oswestry Disability Index (ODI) were collected, and achievement of minimal clinically important difference was evaluated. Lumbar lordosis (LL), pelvic tilt (PT), pelvic incidence (PI), and PI-LL difference were measured on radiographs. Rates of postoperative complications were also collected. Results: A total of 850 patients were included; 78 (9.20%) diabetic patients and 772 (90.80%) nondiabetic patients. Final PI-LL difference was significantly larger ( P = .032) for patients with diabetes compared to no diabetes, but there were no other significant differences between radiographic measurements, operative time, or postoperative length of stay. There were no differences in clinical outcomes between the 2 groups. Diabetic patients were found to have a higher rate of discharge to a facility following surgery ( P = .018). No differences were observed in reoperation or postoperative complication. Conclusions: While diabetic patients had more associated comorbidities compared with nondiabetic patients, they had similar patient-reported and radiographic outcomes. Similarly, there are no differences in rates of reoperation or postoperative complications. This study indicates that diabetic patients who have undergone thorough preoperative screening of related comorbidities and appropriate selection should be considered for lumbar spinal fusion.


2021 ◽  
pp. 219256822098547
Author(s):  
Nabeel Alnaghmoosh ◽  
Jennifer Urquhart ◽  
Ruheksh Raj ◽  
Edward Abraham ◽  
Bradley Jacobs ◽  
...  

Study Design: Retrospective Cohort Study. Objectives: This study aimed to determine how the surgeon-determined and patient-rated location of predominant pain influences patient-rated outcomes at 1-year after posterior lumbar fusion in adult isthmic spondylolisthesis. Methods: We retrospectively reviewed consecutive patients prospectively enrolled in the Canadian Spine Outcomes and Research Network national registry between 2009 and 2017 that underwent posterior lumbar fusion for isthmic spondylolisthesis. Using longitudinal mixed-model repeated-measures analysis the change from baseline in patient-reported outcome measures (PROMs) at 1 year after surgery was compared between surgeon-determined groups (back vs. radicular) and between patient-rated pain groups (back, leg, and equal) derived from preoperative pain scores on the numerical rating scale (NRS). Results: 83/252 (33%) patients had a surgeon-determined chief complaint of back pain, while 103 (41%) patients rated their back pain as the predominant pain location, and 78 (31%) rated their back and leg pain to be equal. At baseline patients in the surgeon-determined radicular group had worse NRS-leg pain than those in the back-pain group but equal NRS-back pain. At baseline patients in the patient-rated equal pain group had similar back pain compared to the patient-rated back pain group and similar leg pain compared to the patient-rated leg pain group. All PROMs improved post-operatively and were not different between the 2 groups at 1 year. Conclusions: Our study found no difference in outcome, irrespective of whether a surgeon determines the patient’s primary pain complaint back or radicular dominant, or the patient rates pain in one location greater than another.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Mohamad Bydon ◽  
Praveen V Mummaneni ◽  
Panagiotis Kerezoudis ◽  
Andrew Kai-Hong Chan ◽  
Steven D Glassman ◽  
...  

Abstract INTRODUCTION Return to work (RTW) has become an increasingly important metric of spinal surgery success. Lumbar spondylolisthesis is a relatively common spinal pathology that may manifest as low back pain and/or leg pain, causing functional disability and hindering patients from working and performing activities of daily living. Currently, there is a lack of nationwide data evaluating RTW in lumbar spondylolisthesis. METHODS We queried the Quality Outcomes Database for employed patients that underwent single-level posterior spinal fusion for Meyerding grade I degenerative lumbar spondylolisthesis. We compared cases who returned to work within 12 mo with regard to baseline demographics, comorbidities, clinical characteristics, and patient reported outcomes. A multivariable logistic regression model was fitted for 12-mo RTW adjusting for an array of pre- and intraoperative variables. RESULTS A total of 163 patients with available 12-mo follow-up data (84%) were analyzed. Median age was 57 yr (interquartile range: 51-60 yr) and 57% were females (n = 93). On multivariable analysis, patients that were working at the time of surgery were significantly more likely to RTW compared to those that were not working (OR 4.62, 95% CI 1.42-15.07, P < .001). In addition, college education (OR 3.30, 95% CI 1.18-9.24, P = .02) was associated with significantly higher odds of returning to work compared to high-school or less education. The effect of postcollege education (OR 5.27, 95% CI 1.46-19.05, P = .01), baseline ODI score (OR 0.64, 95% CI 0.34 - 1.21, P = .17) and smoking status (OR 0.45, 95% CI 0.13-1.54, P = .20) were not found to be significant. Model c-statistic was 0.76. CONCLUSION Analysis of data from a national spinal registry revealed that employment status at the time of surgery and education level were the most significant predictors of 12-moh RTW for patients undergoing single-level posterior lumbar fusion for degenerative spondylolisthesis. The findings of the present study may assist surgeons and patients with setting realistic treatment expectations during preoperative discussions.


2021 ◽  
pp. 1-14
Author(s):  
James Mooney ◽  
Giorgos D. Michalopoulos ◽  
Mohammed Ali Alvi ◽  
Daniel Zeitouni ◽  
Andrew K. Chan ◽  
...  

OBJECTIVE With the expanding indications for and increasing popularity of minimally invasive surgery (MIS) for lumbar spinal fusion, large-scale outcomes analysis to compare MIS approaches with open procedures is warranted. METHODS The authors queried the Quality Outcomes Database for patients who underwent elective lumbar fusion for degenerative spine disease. They performed optimal matching, at a 1:2 ratio between patients who underwent MIS and those who underwent open lumbar fusion, to create two highly homogeneous groups in terms of 33 baseline variables (including demographic characteristics, comorbidities, symptoms, patient-reported scores, indications, and operative details). The outcomes of interest were overall satisfaction, decrease in Oswestry Disability Index (ODI), and back and leg pain, as well as hospital length of stay (LOS), operative time, reoperations, and incidental durotomy rate. Satisfaction was defined as a score of 1 or 2 on the North American Spine Society scale. Minimal clinically important difference (MCID) in ODI was defined as ≥ 30% decrease from baseline. Outcomes were assessed at the 3- and 12-month follow-up evaluations. RESULTS After the groups were matched, the MIS and open groups consisted of 1483 and 2966 patients, respectively. Patients who underwent MIS fusion had higher odds of satisfaction at 3 months (OR 1.4, p = 0.004); no difference was demonstrated at 12 months (OR 1.04, p = 0.67). Lumbar stenosis, single-level fusion, higher American Society of Anesthesiologists Physical Status Classification System grade, and absence of spondylolisthesis were most prominently associated with higher odds of satisfaction with MIS compared with open surgery. Patients in the MIS group had slightly lower ODI scores at 3 months (mean difference 1.61, p = 0.006; MCID OR 1.14, p = 0.0495) and 12 months (mean difference 2.35, p < 0.001; MCID OR 1.29, p < 0.001). MIS was also associated with a greater decrease in leg and back pain at both follow-up time points. The two groups did not differ in operative time and incidental durotomy rate; however, LOS was shorter for the MIS group. Revision surgery at 12 months was less likely for patients who underwent MIS (4.1% vs 5.6%, p = 0.032). CONCLUSIONS In patients who underwent lumbar fusion for degenerative spinal disease, MIS was associated with higher odds of satisfaction at 3 months postoperatively. No difference was demonstrated at the 12-month follow-up. MIS maintained a small, yet consistent, superiority in decreasing ODI and back and leg pain, and MIS was associated with a lower reoperation rate.


2020 ◽  
Vol 32 (2) ◽  
pp. 160-167 ◽  
Author(s):  
Alessandro Siccoli ◽  
Victor E. Staartjes ◽  
Marlies P. de Wispelaere ◽  
Marc L. Schröder

OBJECTIVEWhile it has been established that lumbar discectomy should only be performed after a certain waiting period unless neurological deficits are present, little is known about the association of late surgery with outcome. Using data from a prospective registry, the authors aimed to quantify the association of time to surgery (TTS) with leg pain outcome after lumbar discectomy and to identify a maximum TTS cutoff anchored to the minimum clinically important difference (MCID).METHODSTTS was defined as the time from the onset of leg pain caused by radiculopathy to the time of surgery in weeks. MCID was defined as a minimum 30% reduction in the numeric rating scale score for leg pain from baseline to 12 months. A Cox proportional hazards model was utilized to quantify the association of TTS with MCID. Maximum TTS cutoffs were derived both quantitatively, anchored to the area under the curve (AUC), and qualitatively, based on cutoff-specific MCID rates.RESULTSFrom a prospective registry, 372 patients who had undergone first-time tubular microdiscectomy were identified; 308 of these patients (83%) obtained an MCID. Attaining an MCID was associated with a shorter TTS (HR 0.718, 95% CI 0.546–0.945, p = 0.018). Effect size was preserved after adjustment for potential confounders. The optimal maximum TTS was estimated at 23.5 weeks based on the AUC, while the cutoff-specific method suggested 24 weeks. Discectomy after this cutoff starts to yield MCID rates under 80%. The 24-week cutoff also coincided with the time point after which the specificity for MCID first drops below 50% and after which the negative predictive value for nonattainment of MCID first surpasses ≥ 20%.CONCLUSIONSThe study findings suggest that late lumbar discectomy is linked with poorer patient-reported outcomes and that—in accordance with the literature—a maximum TTS of 6 months should be aimed for.


2014 ◽  
Vol 21 (1) ◽  
pp. 7-13 ◽  
Author(s):  
Zoher Ghogawala ◽  
Daniel K. Resnick ◽  
William C. Watters ◽  
Praveen V. Mummaneni ◽  
Andrew T. Dailey ◽  
...  

Assessment of functional patient-reported outcome following lumbar spinal fusion continues to be essential for comparing the effectiveness of different treatments for patients presenting with degenerative disease of the lumbar spine. When assessing functional outcome in patients being treated with lumbar spinal fusion, a reliable, valid, and responsive outcomes instrument such as the Oswestry Disability Index should be used. The SF-36 and the SF-12 have emerged as dominant measures of general health-related quality of life. Research has established the minimum clinically important difference for major functional outcomes measures, and this should be considered when assessing clinical outcome. The results of recent studies suggest that a patient's pretreatment psychological state is a major independent variable that affects the ability to detect change in functional outcome.


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