Gender differences in spine surgery for degenerative lumbar disease: prospective cohort study.

OBJECTIVE: Despite efforts toward achieving gender-based equality in clinical trial enrollment, females are frequently underrepresented and gender-specific data analysis is lacking. Identifying and addressing gender bias in medical decision-making and outcome reporting may facilitate more equitable healthcare delivery. This study aimed to determine if gender differences exist in the clinical evaluation and surgical management of patients with degenerative lumbar conditions. METHODS: Consecutive adult patients undergoing spinal surgery for degenerative lumbar conditions (disc herniation [DH], spinal canal stenosis [SCS], and degenerative spondylolisthesis [DS]) were prospectively enrolled across 16 tertiary academic centers. Outcome domains included pain, disability, health-related quality of life (HRQOL), expectations of surgery, and satisfaction with surgical outcome. Covariates pertaining to the preoperative use of healthcare resources, diagnostic testing, and visits to healthcare providers were compared between genders before and after propensity score matching for 13 baseline demographic and procedural variables. RESULTS: Data were analyzed for 5038 patients (2396 female, 2642 male) with degenerative spinal pathologies including SCS (40.2%), DS (33.2%), and DH (26.6%). Surgical treatment effect was similar for both genders. For all conditions, female patients had worse pre- and postoperative pain, disability, and HRQOL. Significant gender differences were identified for marital status, education, employment status, exercise activities, and disability claims. Female patients were more likely to use select medications, diagnostic imaging tests, and nonsurgical therapeutic interventions, and access various healthcare providers. Findings were similar following post hoc propensity score matching. CONCLUSIONS: In this multicenter, prospective, observational cohort study, male and female patients benefitted similarly from surgery for degenerative lumbar spine disease. However, female patients had worse preoperative clinical assessment scores and were more likely to use select healthcare resources.

Outcome prediction following lumbar disc surgery: a longitudinal study of outcome trajectories, prognostic factors, and risk models.

OBJECTIVE: This study aimed to 1) describe the 2-year postoperative trajectories of leg pain and overall clinical outcome after surgery for radiculopathy, 2) identify the preoperative prognostic factors that predict trajectories representing poor clinical outcomes, and 3) develop and internally validate multivariable prognostic models to assist with clinical decision-making. METHODS: This retrospective cohort study included patients enrolled in the Canadian Spine Outcomes and Research Network who were diagnosed with lumbar disc pathology and radiculopathy and had undergone lumbar discectomy at one of 18 spine centers. Potential outcome predictors included preoperative demographic, health-related, and clinical prognostic factors. Clinical outcomes were 1) 2-year univariable latent trajectories of leg pain intensity (numeric pain rating scale) and 2) overall outcomes comprising multivariable trajectories showing the combined postoperative courses of leg and back pain intensity (numeric pain rating scale) together with pain-related disability (Oswestry Disability Index). Each outcome model identified a subgroup of patients classified as experiencing a poor outcome based on minimal change in their clinical status after surgery. Multivariable risk model performance and internal validity were evaluated with discrimination and calibration statistics based on bootstrap shrinkage with 500 resamplings. RESULTS: The authors included data from 1142 patients (47.6% female). The trajectory models identified 3 subgroups based on the patients' postoperative courses of pain or disability: 88.6% of patients in the leg pain model and 71.9% in the overall outcome model experienced a good-to-excellent outcome. The models classified 11.4% (leg pain outcome) and 28.2% (overall outcome) of patients as experiencing a poor clinical outcome, which was defined as minimal improvement in pain or disability after surgery. Eleven individual demographic, health, and clinical factors predicted patients' poor leg pain and overall outcomes. The performance of the multivariable risk model for leg pain was inadequate, while the overall outcome model had acceptable discrimination, calibration, and internal validity for predicting a poor surgical outcome. CONCLUSIONS: Patients with lumbar radiculopathy experience heterogeneous postoperative trajectories of pain and disability after lumbar discectomy. Individual preoperative factors are associated with postoperative outcomes and can be combined within a multivariable risk model to predict overall patient outcome. These results may inform clinical practice but require external validation before confident clinical implementation.

The Influence of Wait Time on Surgical Outcomes in Elective Lumbar Degenerative Spine Conditions: A Retrospective Multicentre Cohort Study.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: The impact of delayed access to operative treatment on patient reported outcomes (PROs) for lumbar degenerative conditions remains unclear. The goal of this study is to evaluate the association between wait times for elective lumbar spine surgery and post-operative PROs. METHODS: This study is a retrospective analysis of patients surgically treated for a degenerative lumbar conditions. Wait times were calculated from primary care referral to surgery, termed the cumulative wait time (CWT). CWT benchmarks were created at 3, 6 and 12 months. A multivariable logistic regression model was used to measure the associations between CWT and meeting the minimally clinically important difference (MCID) for the Oswestry Disability Index (ODI) score at 12 months post-operatively. RESULTS: A total of 2281 patients were included in the study cohort. The average age was 59.4 years (SD 14.8). The median CWT was 43.1 weeks (IQR 17.8 - 60.6) and only 30.9% had treatment within 6 months. Patients were more likely achieve the MCID for the ODI at 12 months post-operatively if they had surgery within 6 months of referral from primary care (OR 1.22; 95% CI 1.11 - 1.34). This relationship was also found at a benchmark CWT time of 3 months (OR 1.33; 95% CI 1.15 - 1.54) though not at 12 months (OR 1.08; 95% CI 0.97 - 1.20). CONCLUSIONS: Patients who received operative treatment within a 3- and 6-month benchmark between referral and surgery were more likely to experience noticeable improvement in post-operative function.

Satisfaction in surgically treated patients with degenerative cervical myelopathy: an observational study from the canadian spine outcomes and research network.

BACKGROUND CONTEXT: Healthcare reimbursement is evolving towards a value-based model, entwined and emphasizing patient satisfaction. Factors associated with satisfaction after degenerative cervical myelopathy (DCM) surgery have not been previously established. PURPOSE: Our primary objective was to ascertain satisfaction rates and satisfaction predictors at 3 and 12 months following surgical treatment for DCM. DESIGN: This is a prospective cohort study within Canadian Spine Outcomes and Research Network (CSORN). PATIENT SAMPLE: Patients in the study were surgically treated for DCM patients who completed 3-month and 12-month follow-ups within CSORN between 2015 and 2021. OUTCOME MEASURES: Data analyzed included patient demographic, surgical variables, patient-reported outcomes (NDI, NRS-NP, NRS-AP, SF-12-MCS, SF-12-PCS, ED-5Q, PHQ-8), MJOA and self-reported satisfaction on a Likert scale. METHODS: Multivariable regression analysis was conducted to identify significant factors associated with satisfaction, address multicollinearity and ensure predictive accuracy. This process was conducted separately for the 3-month and 12-month follow-ups. RESULTS: Six hundred and sixty-three patients were included, with an average age of 60, and an even distribution across MJOA scores (mild, moderate, severe). At 3-month and 12-month follow-up, satisfaction rates were 86% and 82%, respectively. At 12 months, logistic regression showed the odds of being satisfied varied by +24%, -3%, -10%, -14%, +3%, and +12% for each 1-point change between baseline and 12 months in MJOA, NDI, NRS-NP, NRS-AP, SF-12-MCS, SF-12-PCS. Satisfaction increased 11-fold for each 0.1-point increased in ED-5Q from baseline to 12 months. At baseline, for every 1-point increase in SF-12-MCS, the odds of being satisfied increased by 7%. At 3 months, all PROs (except for NRS-AP change and baseline SF-12-MCS) predicted satisfaction. All logistic regression analyses demonstrated excellent predictive accuracy, with the highest 12-month AUC of 0.86 (95%CI = 0.81-0.90). No patient demographic or surgical factors influenced satisfaction. CONCLUSION: Improvement in Patient Reported Outcomes and MJOA are strongly associated with patient satisfaction after surgery for DCM. The only baseline PRO associated with 12-months satisfaction was SF-12-MCS. No modifiable patient baseline characteristic or surgical variables were associated with satisfaction.

Clinical Impact of Community-Acquired Respiratory Viruses in Patients With Solid Organ Transplants.

BACKGROUND: Community-acquired respiratory viruses (CARVs) are associated with poor outcome in solid organ transplant recipients. We reviewed some of these outcomes such as respiratory support, length of stay, admission to the intensive care unit, steroid use, and 30-day all-cause mortality. METHODS: Multihospital, single center, retrospective review of electronic health records from January 1, 2014, to December 31, 2019. RESULTS: Twenty-three solid organ transplant recipients (20 male and 3 female) who tested positive for CARVs were identified. The mean age at admission was 60 years, average length of stay was 8 days with 2 patients needing >2 weeks. Six patients required intensive care unit and 8 required supplemental oxygen support. CARV distribution was rhinovirus in 48%, parainfluenza in 29%, metapneumovirus in 12%, respiratory syncytial virus in 0.03%, adenovirus in 0.03%, and non-novel coronavirus in 0.06%. All patients were immunosuppressed, intravenous immunoglobulins were used in 3 patients, antivirals in 7 patients (ribavirin in 6 and oseltamivir in 1), and steroids in 10 patients. Twelve patients had transplant organ biopsy with 5 showing acute cellular rejection. Thirty-five percent of patients died within 1 year (2 during the same admission). CONCLUSION: Transplant recipients are at a high risk of infections, especially CARVs, which may increase morbidity and mortality. In our observational study, we assessed patients with solid organ transplants who were admitted and tested positive for CARVs, and the associated impact on their clinical course. Careful analysis of the results will help us to emphasize the importance of timely diagnosis and treatment in specific populations.

Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial.

PURPOSE: To determine whether postoperative neck pain in the first 4 weeks following multi-level posterior cervical fusion (PCF) with orthosis is equivalent to multi-level PCF without orthosis. METHODS: Patients were randomly assigned in a 1:1 ratio to postoperative orthosis (CO) for 6 weeks or no orthosis (NO). Randomization was stratified by indication (traumatic vs. degenerative), and preoperative opioid use. A model of longitudinal regression for repeated measures was used. The two-sided 95% confidence interval (CI) was used to test equivalence. If the CI lay between the pre-determined margin of equivalence (-2.0 to + 2.0 pain score) the two groups were considered equivalent. A multiple imputation procedure was used to replace missing data. RESULTS: Thirty-one patients were enrolled in each group. At baseline, the CO group had more neck pain (5.3 vs. 3.2, p = 0.013). The Four week post-operative neck pain intensity score was 4.6 ± 0.3 for the CO group vs. 4.9 ± 0.3 for the NO group. The 95% confidence interval (-1.2 to 0.6) was within the pre-determined equivalence margin. Neck Disability Index, quality-of-life scores, and arm pain were similar. Eleven patients in the CO group and 12 patients in the NO group had an adverse event. The CO group had reduced range of motion at 6 weeks. CONCLUSION: Pain scores over the first 4 weeks after surgery were equivalent for patients undergoing multi-level PCF treated with or without a cervical orthosis. Our findings do not support the routine use of a postoperative cervical orthosis for postoperative pain control. Clinical Trials Registration Number NCT04308122, April 22, 2020.

Quality by design-based development and in vitro evaluation of dual release tablet of etoricoxib and thiocolchicoside: A novel chronotherapeutic approach for arthritis pain management.

OBJECTIVE: The traditional drug delivery system is not much effective when treating chronopathological diseases like arthritis. Consequently, there is a gap in the market for a delivery system that can provide an explicit treatment following the chronopharmacology of this disorder. The present study is based on the objective to develop Eudragit coated dual release bilayer tablet designed by the quality by design (QbD) and based on the chronotherapeutic approach. The dual release tablet contained an immediate release layer of etoricoxib and a sustained release layer of thiocolchicoside. MATERIAL AND METHOD: The quality target product profile (QTTP) of the formulation was established along with critical quality attributes (CQA). The optimization of the dual release layer was done using a three-level, three-factor Box-Behnken design. A total of thirteen formulations of etoricoxib (ET1-ET13) and thiocolchicoside (TH1-TH13) were developed based on the design composition of etoricoxib, sodium starch glycolate and sodium bicarbonate for the immediate release (IR) layer and thiocolchicoside, HPMC E5 LV and magnesium stearate for the sustained release (SR) layer respectively. The developed dual release layers were compressed to form a bilayer tablet. The bilayer tablets were further coated with pH-dependent polymer Eudragit S-100 to avoid drug release in upper GIT. The initial characterization and drug-excipient interaction studies were performed initially using infra-red (IR) spectroscopy and X-ray diffraction studies (XRD). Formulations showing good micrometric properties, disintegration and drug release were selected for final compression of bilayer tablets. RESULT: Formulation ET13 showed the fastest drug release (88%) at 15minutes and quick disintegration time (21s). The sustained release thiocolchicoside tablet layer (TH1-TH13) had a hardness that varied from 4.01 to 4.45kg/cm2. Formulation TH12 had the highest hardness, whereas TH6 showed the lowest hardness. The sustained release layer showing 97.63% of drug release after 8hours was selected for the compression to bilayer tablet. The developed dual layer tablets were investigated for quality parameters like hardness, percentage friability, weight variation, disintegration and dissolution. CONCLUSION: A high level of patient compliance is ensured through the current design as the patient does not need to get out of bed at night to take the medication.

Unanswered Questions in the Guidelines for Antibiotic Prescription in Critically Ill Patients.

How to cite this article: Nath SS, Nachimuthu N, Bhagyashree, Singh S. Unanswered Questions in the Guidelines for Antibiotic Prescription in Critically Ill Patients. Indian J Crit Care Med 2024;28(7):715-716.

Factors associated with increased length of stay in degenerative cervical spine surgery: a cohort analysis from the Canadian Spine Outcomes and Research Network.

OBJECTIVE: Postoperative length of stay (LOS) significantly contributes to healthcare costs and resource utilization. The primary goal of this study was to identify patient, clinical, surgical, and institutional variables that influence LOS after elective surgery for degenerative conditions of the cervical spine. The secondary objectives were to examine the variability in LOS and institutional practices used to decrease LOS. METHODS: This was a multicenter observational retrospective cohort study of patients enrolled in the Canadian Spine Outcomes and Research Network (CSORN) between January 2015 and October 2020 who underwent elective anterior cervical discectomy and fusion (ACDF) (1-3 levels) or posterior cervical fusion (PCF) (between C2 and T2) with/without decompression for degenerative conditions of the cervical spine. Prolonged LOS was defined as LOS greater than the median for the ACDF and PCF populations. The principal investigators at each participating CSORN healthcare institution completed a survey to capture institutional practices implemented to reduce postoperative LOS. RESULTS: In total, 1228 patients were included (729 ACDF and 499 PCF patients). The median (IQR) LOS for ACDF and PCF were 1.0 (1.0) day and 5.0 (4.0) days, respectively. Predictors of prolonged LOS after ACDF were female sex, myelopathy diagnosis, lower baseline SF-12 mental component summary score, multilevel ACDF, and perioperative adverse events (AEs) (p < 0.05). Predictors of prolonged LOS after PCF were nonsmoking status, education less than high school, lower baseline numeric rating scale score for neck pain and EQ5D score, higher baseline Neck Disability Index score, and perioperative AEs (p < 0.05). Myelopathy did not significantly predict prolonged LOS within the PCF cohort after multivariate analysis. Of the 8 institutions (57.1%) with an enhanced recovery after surgery (ERAS) protocol or standardized protocol, only 3 reported using an ERAS protocol specific to patients undergoing ACDF or PCF. CONCLUSIONS: Patient and clinical factors predictive of prolonged LOS after ACDF and PCF are highly variable, warranting individual consideration for possible mitigation. Perioperative AEs remained a consistent independent predictor of prolonged LOS in both cohorts, highlighting the importance of preventing intra- and postoperative complications.

Differences in the surgical management of degenerative lumbar spondylolisthesis based on self-reported sex: analysis of the CSORN prospective DLS study.

OBJECTIVE: Surgical treatment of degenerative lumbar spondylolisthesis (DLS) reliably improves patient-reported quality of life; however, patient population heterogeneity, in addition to other factors, ensures ongoing equipoise in choosing the ideal surgical treatment. Surgeon preference for fusion or decompression alone influences surgical treatment decision-making. Meanwhile, at presentation, patient-reported outcome measures (PROMs) differ considerably between females and males. The aims of this study were to determine whether there exists a difference in the rates of decompression and fusion versus decompression alone based on patient-reported sex, and to determine if widely accepted indications for fusion justify any observed differences or if surgeon preference plays a role. METHODS: This study is a retrospective cohort analysis of patients enrolled in the Canadian Spine Outcomes Research Network (CSORN) DLS study, a multicentered Canadian prospective study, investigating the surgical management and outcome of DLS. Decompression and fusion rates, patient characteristics, preoperative PROMs, and radiographic measures were compared between males and females before and after propensity score matching. RESULTS: In the unmatched cohort, female patients were more likely to undergo decompression and fusion than male patients. Females were more likely to have the recognized indications for fusion, including kyphotic disc angle, higher spondylolisthesis grade and slip percentage, and patient-reported back pain. Other radiographic findings associated with the decision to fuse, including facet effusion, facet distraction, or facet angle, were not more prevalent in females. After propensity score matching for demographic and radiographic characteristics, similar proportions of male and female patients underwent decompression and fusion and decompression alone. CONCLUSIONS: Although it remains unclear who should or should not undergo fusion, in addition to surgical decompression of DLS, female patients undergo fusion at a higher rate than their male counterparts. After matching baseline radiographic factors indicating fusion, this analysis showed that the decision to fuse was not biased by sex differences. Rather, the higher proportion of females undergoing fusion is largely explained by the radiographic and clinical indications for fusion, suggesting that specific clinical and anatomical features of this condition are indeed different between sexes.

Precision Genome Editing Techniques in Gene Therapy: Current State and Future Prospects.

Precision genome editing is a rapidly evolving field in gene therapy, allowing for the precise modification of genetic material. The CRISPR and Cas systems, particularly the CRISPRCas9 system, have revolutionized genetic research and therapeutic development by enabling precise changes like single-nucleotide substitutions, insertions, and deletions. This technology has the potential to correct disease-causing mutations at their source, allowing for the treatment of various genetic diseases. Programmable nucleases like CRISPR-Cas9, transcription activator-like effector nucleases (TALENs), and zinc finger nucleases (ZFNs) can be used to restore normal gene function, paving the way for novel therapeutic interventions. However, challenges, such as off-target effects, unintended modifications, and ethical concerns surrounding germline editing, require careful consideration and mitigation strategies. Researchers are exploring innovative solutions, such as enhanced nucleases, refined delivery methods, and improved bioinformatics tools for predicting and minimizing off-target effects. The prospects of precision genome editing in gene therapy are promising, with continued research and innovation expected to refine existing techniques and uncover new therapeutic applications.

Sagittal alignment in operative degenerative lumbar spondylolisthesis: a scoping review.

Background: The benefit of surgical intervention over conservative treatment for degenerative lumbar spondylolisthesis (DLS) patients with neurologic symptoms is well-established. However, it is currently unclear what breadth of available evidence exists on regional and global sagittal alignment in DLS surgery. As such, the purpose of the current study is to conduct a scoping review to map and synthesize the DLS literature regarding the current radiographic assessment of sagittal spinal alignment in DLS surgery. Methods: A comprehensive search of the MEDLINE, EMBASE and Cochrane databases from January 1971 to January 2023 was performed for all DLS studies examining sagittal spinal alignment parameters with DLS surgery according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review (PRISMA-ScR) protocol. Results: From 2,222 studies, a total of 109 studies were included, representing 10,730 patients with an average age of 63.0 years old and average follow-up of 35.1 months postoperatively. Among included studies, 93 (85%), were largely published in the last decade and predominantly represented retrospective cohorts 70 (64%) or case series 22 (20%). A common theme among the reporting of radiographic parameters in the included investigations was the assessment of the magnitude and/or maintenance of a radiographic change postoperatively, with 92 (84%) studies reporting these findings. The majority of studies focused on index DLS level [33 (30%) studies] or lumbar spine radiographic imaging [33 (30%) studies] only. Thirty-seven (34%) studies reported spinopelvic parameters, with only 13 (12%) of included studies assessing 36-inch standing lateral radiographs and overall alignment. Conclusions: There is increasing prevalence of investigations assessing sagittal spinal alignment parameters in DLS surgery. Although, there is an increasing prevalence of studies investigating sagittal spinal alignment parameters in DLS surgery the quality of the currently available literature on this topic is of overall low evidence and largely retrospective in nature. Additionally, there is limited analysis of global sagittal spinal alignment in DLS suggesting that future investigational emphasis should prioritize longitudinally followed large prospective cohorts or multi-centre randomized controlled trials. Attempts at standardizing the radiographic and functional outcome reporting techniques across multi-centre investigations and prospective cohorts will allow for more robust, reproducible analyses of significance to be conducted on DLS patients.

Multivariate Statistical 2D QSAR Analysis of Indenoisoquinoline-based Topoisomerase- I Inhibitors as Anti-lung Cancer Agents.

BACKGROUND: Indenoisoquinoline-based compounds have shown promise as topoisomerase-I inhibitors, presenting an attractive avenue for rational anticancer drug design. However, a detailed QSAR study on these derivatives has not been performed till date. OBJECTIVE: This study aimed to identify crucial molecular features and structural requirements for potent topoisomerase- 1 inhibition. METHODS: A comprehensive two-dimensional (2D) QSAR analysis was performed on a series of 49 indenoisoquinoline derivatives using TSAR3.3 software. A robust QSAR model based on a training set of 33 compounds was developed achieving favorable statistical values: r2 = 0.790, r2CV = 0.722, f = 36.461, and s = 0.461. Validation was conducted using a test set of nine compounds, confirming the predictive capability of the model (r2 = 0.624). Additionally, artificial neural network (ANN) analysis was employed to further validate the significance of the derived descriptors. RESULTS: The optimized QSAR model revealed the importance of specific descriptors, including molecular volume, Verloop B2, and Weiner topological index, providing essential insights into effective topoisomerase-1 inhibition. We also obtained a robust partial least-square (PLS) analysis model with high predictive ability (r2 = 0.788, r2CV = 0.743). The ANN results further reinforced the significance of the derived descriptors, with strong r2 values for both the training set (r2 = 0.798) and the test set (r2 = 0.669). CONCLUSION: The present 2D QSAR analysis offered valuable molecular insights into indenoisoquinoline-based topoisomerase- I inhibitors, supporting their potential as anti-lung cancer agents. These findings contribute to the rational design of more effective derivatives, advancing the development of targeted therapies for lung cancer treatment.

Effect of Mycetoma in Lung Transplant Patients - a Single Center Experience.

BACKGROUND: Mycetomas are uncommon in lung transplant recipients. Prior studies have shown increased mortality associated with mycetoma in lung transplant recipients (LTR). We reviewed our center's experience in outcome of LTRs with pre -or post-transplant mycetoma. METHODS: We retrospectively reviewed electronic health records of LTRs performed at our institute between January 1, 2013 to December 31, 2020. RESULTS: Mycetoma was present in less than 1 percent of LTR patients (7/1086). Mean age at the time of the transplant was 65 years. Idiopathic pulmonary fibrosis (5/7), interstitial lung disease (1/7), and sarcoidosis (1/7) were underlying pulmonary diagnoses. Seventy-one percent (5/7) received single lung transplant and 29% received double lung transplant. Seventy-one percent had negative serum galactomannan vs 29% (2/7) of patients who had positive serum galactomannan (one post and one pre). Fifty-seven percent had positive bronchoalveolar aspergillus galactomannan (23% had negative). A total of 42% (3/7) were found to have mycetoma before transplant and 58% (4/7) had mycetoma post transplant. Chest computed tomography findings in all patients were consistent with mycetoma. CONCLUSIONS: In our cohort of patients, mycetoma was not found to be the primary cause of death if diagnosed pre transplant. Transplant recipients with mycetoma pre transplant did not develop invasive fungal infection or mycetoma post transplant. Careful evaluation of lung transplant candidates with mycetoma is critical. Further studies are needed to determine optimal duration of antifungal therapy and to determine if surgical resection may be needed to manage post-lung transplant mycetoma.

Determining minimal clinically important difference estimates following surgery for degenerative conditions of the lumbar spine: analysis of the Canadian Spine Outcomes and Research Network (CSORN) registry.

BACKGROUND CONTEXT: There is significant variability in minimal clinically important difference (MCID) criteria for lumbar spine surgery that suggests population and primary pathology specific thresholds may be required to help determine surgical success when using patient reported outcome measures (PROMs). PURPOSE: The purpose of this study was to estimate MCID thresholds for 3 commonly used PROMs after surgical intervention for each of 4 common lumbar spine pathologies. STUDY DESIGN/SETTING: Observational longitudinal study of patients from the Canadian Spine Outcomes and Research Network (CSORN) national registry. PATIENT SAMPLE: Patients undergoing surgery from 2015 to 2018 for lumbar spinal stenosis (LSS; n = 856), degenerative spondylolisthesis (DS; n = 591), disc herniation (DH; n = 520) or degenerative disc disease (DDD n = 185) were included. OUTCOME MEASURES: PROMs were collected presurgery and 1-year postsurgery: the Oswestry Disability Index (ODI), and back and leg Numeric Pain Rating Scales (NPRS). At 1-year, patients reported whether they were 'Much better'/'Better'/'Same'/'Worse'/'Much worse' compared to before their surgery. Responses to this item were used as the anchor in analyses to determine surgical MCIDs for benefit ('Much better'/'Better') and substantial benefit ('Much better'). METHODS: MCIDs for absolute and percentage change for each of the 3 PROMs were estimated using a receiving operating curve (ROC) approach, with maximization of Youden's index as primary criterion. Area under the curve (AUC) estimates, sensitivity, specificity and correct classification rates were determined. All analyses were conducted separately by pathology group. RESULTS: MCIDs for ODI change ranged from -10.0 (DDD) to -16.9 (DH) for benefit, and -13.8 (LSS) to -22.0 (DS,DH) for substantial benefit. MCID for back and leg NPRS change were -2 to -3 for each group for benefit and -4.0 for substantial benefit for all groups on back NPRS. MCID estimates for percentage change varied by PROM and pathology group, ranging from -11.1% (ODI for DDD) to -50.0% (leg NPRS for DH) for benefit and from -40.0% (ODI for DDD) to -66.6% (leg NPRS for DH) for substantial benefit. Correct classification rates for all MCID thresholds ranged from 71% to 89% and were relatively lower for absolute vs percent change for those with high or low presurgical scores. CONCLUSIONS: Our findings suggest that the use of generic MCID thresholds across pathologies in lumbar spine surgery is not recommended. For patients with relatively low or high presurgery PROM scores, MCIDs based on percentage change, rather than absolute change, appear generally preferable. These findings have applicability in clinical and research settings, and are important for future surgical prognostic work.

The Role of Frailty and Sarcopenia in Predicting Major Adverse Events, Length of Stay and Reoperation Following En Bloc Resection of Primary Tumours of the Spine.

STUDY DESIGN: Retrospective observational cohort study. OBJECTIVE: En bloc resection for primary tumours of the spine is associated with a high rate of adverse events (AEs). The objective was to explore the relationship between frailty/sarcopenia and major perioperative AEs, length of stay (LOS), and unplanned reoperation following en bloc resection of primary spinal tumours. METHODS: This is a unicentre study consisting of adult patients undergoing en bloc resection for a primary spine tumor. Frailty was calculated with the modified frailty index (mFI) and spine tumour frailty index (STFI). Sarcopenia was quantified with the total psoas area/vertebral body area ratio (TPA/VB) at L3 and L4. Univariable regression analysis was used to quantify the association between frailty/sarcopenia and major perioperative AEs, LOS and unplanned reoperation. RESULTS: 95 patients met the inclusion criteria. The mFI and STFI identified a frailty prevalence of 3% and 18%. Mean CT TPA/VB ratios were 1.47 (SD ± .05) and 1.83 (SD ± .06) at L3 and L4. Inter-observer reliability was .93 and .99 for CT and MRI L3 and L4 TPA/VB ratios. Unadjusted analysis demonstrated sarcopenia and mFI did not predict perioperative AEs, LOS or unplanned reoperation. Frailty defined by an STFI score ≥2 predicted unplanned reoperation for surgical site infection (SSI) (P < .05). CONCLUSIONS: The STFI was only associated with unplanned reoperation for SSI on unadjusted analysis, while the mFI and sarcopenia were not predictive of any outcome. Further studies are needed to investigate the relationship between frailty, sarcopenia and perioperative outcomes following en bloc resection of primary spinal tumors.

Cost consequence analysis of waiting for lumbar disc herniation surgery.

The economic repercussions of waiting for lumbar disc surgery have not been well studied. The primary goal of this study was to perform a cost-consequence analysis of patients receiving early vs late surgery for symptomatic disc herniation from a societal perspective. Secondarily, we compared patient factors and patient-reported outcomes. This is a retrospective analysis of prospectively collected data from the CSORN registry. A cost-consequence analysis was performed where direct and indirect costs were compared, and different outcomes were listed separately. Comparisons were made on an observational cohort of patients receiving surgery less than 60 days after consent (short wait) or 60 days or more after consent (long wait). This study included 493 patients with surgery between January 2015 and October 2021 with 272 patients (55.2%) in the short wait group and 221 patients (44.8%) classified as long wait. There was no difference in proportions of patients who returned to work at 3 and 12-months. Time from surgery to return to work was similar between both groups (34.0 vs 34.9 days, p = 0.804). Time from consent to return to work was longer in the longer wait group corresponding to an additional $11,753.10 mean indirect cost per patient. The short wait group showed increased healthcare usage at 3 months with more emergency department visits (52.6% vs 25.0%, p < 0.032), more physiotherapy (84.6% vs 72.0%, p < 0.001) and more MRI (65.2% vs 41.4%, p < 0.043). This corresponded to an additional direct cost of $518.21 per patient. Secondarily, the short wait group had higher baseline NRS leg, ODI, and lower EQ5D and PCS. The long wait group had more patients with symptoms over 2 years duration (57.6% vs 34.1%, p < 0.001). A higher proportion of patients reached MCID in terms of NRS leg pain at 3-month follow up in the short wait group (84.0% vs 75.9%, p < 0.040). This cost-consequence analysis of an observational cohort showed decreased costs associated with early surgery of $11,234.89 per patient when compared to late surgery for lumbar disc herniation. The early surgery group had more severe symptoms with higher healthcare utilization. This is counterbalanced by the additional productivity loss in the long wait group, which likely have a more chronic disease. From a societal economic perspective, early surgery seems beneficial and should be promoted.

Deterioration After Surgery for Degenerative Cervical Myelopathy: An Observational Study From the Canadian Spine Outcomes and Research Network.

STUDY DESIGN: A Prospective cohort study. OBJECTIVE: To investigate the incidence, etiology, and outcomes of patients who experience neurological deterioration after surgery for Degenerative Cervical Myelopathy (DCM). SUMMARY OF BACKGROUND DATA: Postoperative neurological deterioration is one of the most undesirable complications that can occur after surgery for DCM. METHODS: We analyzed data from the Canadian Spine Outcomes and Research Network DCM prospective cohort study. We defined postoperative neurological deterioration as any decrease in modified Japanese Orthopaedic Association (mJOA) score by at least one point from baseline to three months after surgery. Adverse events were collected using the Spinal Adverse Events Severity protocol. Secondary outcomes included patient-reported pain, disability, and health-related quality of life. RESULTS: Among a study cohort of 428 patients, 50 (12%) deteriorated by at least one mJOA point after surgery for DCM (21 by one point, 15 by two points, and 14 by three points or more). Significant risk factors included older age, female sex, and milder disease. Among those who deteriorated, 13 experienced contributing intraoperative or postoperative adverse events, six had alternative non-DCM diagnoses, and 31 did not have an identifiable reason for deterioration. Patients who deteriorated had significantly lower mJOA scores at one year after surgery [13.5 (SD 2.7) vs. 15.2 (SD 2.2), P <0.01 and those with larger deteriorations were less likely to recover their mJOA to at least their preoperative baseline, but most secondary measures of pain, disability, and health-related quality of life were unaffected. CONCLUSIONS: The incidence of deterioration of mJOA scores after surgery for DCM was approximately one in 10, but some deteriorations were unrelated to actual spinal cord impairment and most secondary outcomes were unaffected. These findings can inform patient and surgeon expectations during shared decision-making, and they demonstrate that the interpretation of mJOA scores without clinical context can sometimes be misleading.

Effects of Workload on Return to Work After Elective Lumbar Spine Surgery.

STUDY DESIGN: Retrospective analysis was performed of a multi-center Canadian Spine Outcomes and Research Network (CSORN) surgical database. OBJECTIVE: To determine the rate and time to return to work (RTW) based on workload intensity after elective degenerative lumbar spine surgery. METHODS: Patients working pre-operatively, aged greater than 18, who underwent a primary one- or two-level elective lumbar spine surgery for degenerative conditions between January 2015 and October 2020 were evaluated. The percentage of patients who returned to work at 1 year and the time to RTW post-operatively were analyzed based on workload intensity. RESULTS: Of the 1290 patients included in the analysis, the overall rate of RTW was 82% at 1 year. Based on workload there was no significant difference in time to RTW after a fusion procedure, with median time to RTW being 10 weeks. For non-fusion procedure, the sedentary group had a statistically significantly quicker time to RTW than the light-moderate (P < .005) and heavy-very heavy (<.027) groups. CONCLUSIONS: The rate of RTW ranged between 84% for patients with sedentary work to 77% for patient with a heavy-very heavy workload. Median time to resumption of work was about 10 weeks following a fusion regardless of work intensity. There was more variability following non-fusion surgeries such as laminectomy and discectomy reflecting the patient's job demands.