scholarly journals Assessing the differences in characteristics of patients lost to follow-up at 2 years: results from the Quality Outcomes Database study on outcomes of surgery for grade I 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.

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.


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.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Praveen V Mummaneni ◽  
Mohamad Bydon ◽  
John J Knightly ◽  
Anshit Goyal ◽  
Mohammed A Alvi ◽  
...  

Abstract INTRODUCTION Recent changes in healthcare policies implemented as per the Affordable Care Act (ACA) have resulted in providers and hospitals seeking ways to optimize resource utilization and improve patient outcomes. Length of stay (LOS) after surgery has increasingly been used as a surrogate for resource utilization. In the current study, we investigated factors associated with longer LOS after surgery for grade 1 spondylolisthesis. METHODS We queried the Quality Outcomes Database for patients with grade 1 lumbar degenerative spondylolisthesis undergoing a surgical intervention between July 2014 and June 2016. Only those patients enrolled in a multi-side study investigating the impact of fusion on clinical and patient reported outcomes (PROs) among patients with grade 1 spondylolisthesis were evaluated. A multivariable (MV) proportional odds regression model was fitted to determine factors associated with longer LOS. RESULTS A total of 608 patients undergoing surgery were identified (555 single-level, 53 2-level surgeries). Median LOS was 3 d (IQR: 2-4 d). On MV analysis, factors found to be independently predictive of longer LOS included nonroutine home discharge (home with healthcare: OR: 3.5 (1.9-6.8); postacute care: OR: 9.6 (5.2-17.7)), higher baseline ODI (interquartile OR: 1.44 (1.21-1.86)), longer operative time (OR: 1.98 (1.56-2.51), 2-level surgery (OR: 2.91 (1.37-6.21), ref = 1-level surgery); assisted ambulation (OR: 1.9 (1.1-3.3)) and higher American Society of Anesthesiologists (ASA) score (OR: 1.6 (1.1-2.3) while decompression alone (OR: 0.05 (0.03-0.09)), anterior/lateral approaches (OR: 0.25 (0.11-0.56, ref = posterior) and use of MIS (OR: 0.42 (0.30-0.59) were associated with shorter length of stay. Predictor importance analysis revealed that type of surgery (decompression vs fusion), discharge disposition, operative time, use of Minimally invasive spine surgery (MIS) and surgical approach were the top predictors determining duration of stay. CONCLUSION These results from a multi-site study of patients undergoing surgery for grade I spondylolisthesis indicate that patients undergoing fusion, discharged to nonhome, with longer operative time and posterior surgical approaches may have longer LOS. Type of surgery and discharge destination are top predictors determining length of stay.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Praveen V Mummaneni ◽  
Mohamad Bydon ◽  
John Knightly ◽  
Mohammed Ali Alvi ◽  
Anshit Goyal ◽  
...  

Abstract INTRODUCTION Discharge to an in-patient rehabilitation facility or another acute care facility not only constitutes a postoperative challenge for patients and their care team but also contributes significantly to health-care costs. In the era of changing dynamics of healthcare payment models where the risk of cost over-runs are being increasingly shifted to surgeons and hospitals, it is important to understand better outcomes such as discharge disposition. In the current manuscript, we sought to develop a predictive model for factors associated with nonroutine discharge after surgery for grade I spondylolisthesis. METHODS We queried the Quality Outcomes Database for patients with grade 1 lumbar degenerative spondylolisthesis undergoing a surgical intervention between July 2014 and June 2016. Only those patients enrolled in a multiside study investigating the impact of fusion on clinical and Patient Reported Outcomes (PROs) among patients with grade 1 spondylolisthesis were evaluated. Nonroutine discharge was defined as those that were discharged to postacute or nonacute care setting in the same hospital or transferred to another acute care facility. RESULTS Of the 605 patients eligible for inclusion, 9.4% (n = 57) had a nonroutine discharge (8.7%, n = 53 discharged to an inpatient postacute or nonacute care in the same hospital and 0.7%, n = 4 transferred to another acute care facility). On multivariable logistic regression, after adjusting for an array of demographic, socioeconomic, clinical, and operative variables, factors found to be independently associated with higher odds of nonroutine discharge included higher age (OR 10.53, 95% CI 3.8-29.2, P < .001), higher BMI (OR 2.42, 95% CI 1.45-4.05, P < .001), depression (OR 4.97, 95% CI 2.10-11.77, P < .001), and length of stay (OR 3.4, 95% CI 2.3-4.9, P < .001). CONCLUSION In this multisite study of a defined cohort of patients undergoing surgery for grade I spondylolisthesis, factors associated with higher odds of nonroutine discharge included higher age, higher BMI, presence of depression, and higher length of stay.


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.


2020 ◽  
Author(s):  
Jenna M Reps ◽  
Peter Rijnbeek ◽  
Alana Cuthbert ◽  
Patrick B Ryan ◽  
Nicole Pratt ◽  
...  

Abstract Background: Researchers developing prediction models are faced with numerous design choices that may impact model performance. One of the main decisions is how to include patients who are lost to follow-up. In this paper we perform a large-scale empirical evaluation investigating the impact of this decision. In addition, we aim to provide guidelines for how to deal with loss to follow-up. Methods: We generate a synthetic dataset with complete follow-up and simulate loss to follow-up based either on random selection or on selection based on comorbidity. We investigate four simple strategies for developing models using data containing some patients with loss to follow-up. Three strategies employ a binary classifier with data that: i) include all patients (including those lost to follow-up), ii) exclude all patients lost to follow-up or iii) only exclude patients lost to follow-up who do not have the outcome before being lost to follow-up. The fourth strategy uses a survival model with data that include all patients. In addition to our synthetic data study, we empirically evaluate the discrimination and calibration performance of these strategies across 21 prediction problems using real-world data. Results: The synthetic data study results show that excluding patients lost to follow-up can introduce bias when loss to follow-up is common and does not occur at random. However, when loss to follow-up was completely at random, the choice of addressing it had negligible impact on the model performance. Our empirical results showed that the four design choices investigated to deal with loss to follow-up resulted in comparable performance when the time-at-risk was 1-year, but demonstrated differential bias when we looking into 3-year time-at-risk. Removing patients who are lost to follow-up before the outcome but keeping patients who are loss to follow-up after the outcome can bias a model and should be avoided. Conclusion: Based on this study we therefore recommend i) developing models using data that includes patients that are lost to follow-up and ii) evaluate the discrimination and calibration of models twice: on a test set including patients lost to follow-up and a test set excluding patients lost to follow-up.


Author(s):  
Maria Teresa Ventura ◽  
Antonio Francesco Maria Giuliano ◽  
Rosalba Buquicchio ◽  
Anna Bedbrook ◽  
Wienczyslawa Czarlewski ◽  
...  

<b><i>Introduction:</i></b> MASK-air® is an app whose aim is to reduce the global burden of allergic rhinitis and asthma. A transfer of innovative practices was performed to disseminate and implement MASK-air® in European regions. The aim of the study was to examine the implementation of the MASK-air® app in older adults of the Puglia TWINNING in order to investigate (i) the rate of acceptance in this population, (ii) the reasons for refusal and (iii) the evaluation of the app after its use. <b><i>Methods:</i></b> All consecutive geriatric patients aged between 65 and 90 years were included by the outpatient clinic of the Bari Geriatric Immunoallergology Unit. After a 1-h training session, older adults used the app for 6 months. A 6-item questionnaire was developed by our unit to evaluate the impact of the app on the management of the disease and its treatment. <b><i>Results:</i></b> Among the 174 recruited patients, 102 accepted to use the app (mean age, SD: 72.4 ± 4.6 years), 6 were lost to follow-up, and 63 had a low education level. The reasons given not to use the app included lack of interest (11%), lack of access to a smartphone or tablet (53%), low computer literacy (28%), and distrust (8%). At follow-up, the overall satisfaction was high (89%), the patient considered MASK-air® “advantageous” (95%), compliance to treatment was improved (81%), and the rate of loss to follow-up had decreased to 6%. <b><i>Conclusion:</i></b> Older adults with a low level of education can use the MASK-air® app after a short training session.


2021 ◽  
pp. 1-10
Author(s):  
Erica F Bisson ◽  
Jian Guan ◽  
Mohamad Bydon ◽  
Mohammed A Alvi ◽  
Anshit Goyal ◽  
...  

OBJECTIVE The ideal surgical management of grade I lumbar spondylolisthesis has not been determined despite extensive prior investigations. In this cohort study, the authors used data from the large, multicenter, prospectively collected Quality Outcomes Database to bridge the gap between the findings in previous randomized trials and those in a more heterogeneous population treated in a typical practice. The objective was to assess the difference in patient-reported outcomes among patients undergoing decompression alone or decompression plus fusion. METHODS The primary outcome measure was change in 24-month Oswestry Disability Index (ODI) scores. The minimal clinically important difference (MCID) in ODI score change and 30% change in ODI score at 24 months were also evaluated. After adjusting for patient-specific and clinical factors, multivariable linear and logistic regressions were employed to evaluate the impact of fusion on outcomes. To account for differences in age, sex, body mass index, and baseline listhesis, a sensitivity analysis was performed using propensity score analysis to match patients undergoing decompression only with those undergoing decompression and fusion. RESULTS In total, 608 patients who had grade I lumbar spondylolisthesis were identified (85.5% with at least 24 months of follow-up); 140 (23.0%) underwent decompression alone and 468 (77.0%) underwent decompression and fusion. The 24-month change in ODI score was significantly greater in the fusion plus decompression group than in the decompression-only group (−25.8 ± 20.0 vs −15.2 ± 19.8, p < 0.001). Fusion remained independently associated with 24-month ODI score change (B = −7.05, 95% CI −10.70 to −3.39, p ≤ 0.001) in multivariable regression analysis, as well as with achieving the MCID for the ODI score (OR 1.767, 95% CI 1.058–2.944, p = 0.029) and 30% change in ODI score (OR 2.371, 95% CI 1.286–4.371, p = 0.005). Propensity score analysis resulted in 94 patients in the decompression-only group matched 1 to 1 with 94 patients in the fusion group. The addition of fusion to decompression remained a significant predictor of 24-month change in the ODI score (B = 2.796, 95% CI 2.228–13.275, p = 0.006) and of achieving the 24-month MCID ODI score (OR 2.898, 95% CI 1.214–6.914, p = 0.016) and 24-month 30% change in ODI score (OR 2.300, 95% CI 1.014–5.216, p = 0.046). CONCLUSIONS These results suggest that decompression plus fusion in patients with grade I lumbar spondylolisthesis may be associated with superior outcomes at 24 months compared with decompression alone, both in reduction of disability and in achieving clinically meaningful improvement. Longer-term follow-up is warranted to assess whether this effect is sustained.


2021 ◽  
pp. 175319342110456
Author(s):  
Paul H. C. Stirling ◽  
Paul J. Jenkins ◽  
Nathan Ng ◽  
Nicholas D. Clement ◽  
Andrew D. Duckworth ◽  
...  

The primary aim of this study was to identify factors associated with nonresponse to routinely collected patient-reported outcome measures (PROMs) after hand surgery. The secondary aim was to investigate the impact of nonresponder bias on postoperative PROMs. We identified 4357 patient episodes for which the patients received pre- and 1-year postoperative questionnaires. The response rate was 55%. Univariate and regression analyses were undertaken to determine factors predicting nonresponse. We developed a predictive model for the postoperative Quick version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores for nonresponders using imputation. Younger age, increasing deprivation, higher comorbidity, worse preoperative QuickDASH scores and unemployment predicted nonresponse. No significant difference in mean postoperative QuickDASH score was observed between the responders, and the scores for the responders combined with the predicted scores for the nonresponders. Preoperative function was the primary predictor of postoperative outcome. These results challenge the dogma that ‘loss to follow-up’ automatically invalidates the results of a study. Level of evidence: III


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