Development and implementation of clinical practice guidelines: An update and synthesis of the literature with a focus in application to spinal conditions

Study Design:Review.Objectives:The objectives of this review are to (a) summarize the role of clinical practice guidelines (CPGs), (b) outline the methodology involved in formulating CPGs, (c) provide an illustration of these principles using a CPG developed for degenerative cervical myelopathy, and (d) highlight the importance of knowledge translation.Methods:A review of the literature was conducted to summarize current standards in CPG development and implementation.Results:CPGs are systematically developed statements intended to affect decisions made by health care providers, policy makers, and patients. The main objectives of CPGs are to synthesize and translate evidence into recommendations, optimize patient outcomes, standardize care, and facilitate shared decision making among physicians, patients, and their caregivers. The main steps involved in the development of CPGs include defining the clinical problem, assembling a multidisciplinary guideline development group and systematic review team, conducting a systematic review of the literature, translating the evidence to recommendations, critically appraising the CPG and updating the document when new studies arise. The final step in developing a CPG is to implement it into clinical practice; this step requires an assessment of the barriers to implementation and the formulation of effective dissemination strategies.Conclusion:CPGs are an important component in the teaching and practice of medicine and are available for a wide spectrum of diseases. CPGs, however, can only be used to influence clinical practice if the recommendations are informed by a systematic review of the literature and developed using rigorous methodology. The opportunity to transform clinical management of spinal conditions is an attractive outcome of the application of high-quality CPGs

Management of Acute Traumatic Central Cord Syndrome: A Narrative Review.

Study Design Narrative review. Objectives To provide an updated overview of the management of acute traumatic central cord syndrome (ATCCS). Methods A comprehensive narrative review of the literature was done to identify evidence-based treatment strategies for patients diagnosed with ATCCS. Results ATCCS is the most commonly encountered subtype of incomplete spinal cord injury and is characterized by worse sensory and motor function in the upper extremities compared with the lower extremities. It is most commonly seen in the setting of trauma such as motor vehicles or falls in elderly patients. The operative management of this injury has been historically variable as it can be seen in the setting of mechanical instability or preexisting cervical stenosis alone. While each patient should be evaluated on an individual basis, based on the current literature, the authors' preferred treatment is to perform early decompression and stabilization in patients that have any instability or significant neurologic deficit. Surgical intervention, in the appropriate patient, is associated with an earlier improvement in neurologic status, shorter hospital stay, and shorter intensive care unit stay. Conclusions While there is limited evidence regarding management of ATCCS, in the presence of mechanical instability or ongoing cord compression, surgical management is the treatment of choice. Further research needs to be conducted regarding treatment strategies and patient outcomes

Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial

IMPORTANCE: The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery. OBJECTIVE: To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM. DESIGN, SETTING, AND PARTICIPANTS: This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023. INTERVENTION: Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery. MAIN OUTCOMES AND MEASURES: The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE). RESULTS: Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007). CONCLUSIONS AND RELEVANCE: In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes

DNA methylation profiling to predict recurrence risk in meningioma: development and validation of a nomogram to optimize clinical management

Abstract Background Variability in standard-of-care classifications precludes accurate predictions of early tumor recurrence for individual patients with meningioma, limiting the appropriate selection of patients who would benefit from adjuvant radiotherapy to delay recurrence. We aimed to develop an individualized prediction model of early recurrence risk combining clinical and molecular factors in meningioma. Methods DNA methylation profiles of clinically annotated tumor samples across multiple institutions were used to develop a methylome model of 5-year recurrence-free survival (RFS). Subsequently, a 5-year meningioma recurrence score was generated using a nomogram that integrated the methylome model with established prognostic clinical factors. Performance of both models was evaluated and compared with standard-of-care models using multiple independent cohorts. Results The methylome-based predictor of 5-year RFS performed favorably compared with a grade-based predictor when tested using the 3 validation cohorts (ΔAUC = 0.10, 95% CI: 0.03–0.018) and was independently associated with RFS after adjusting for histopathologic grade, extent of resection, and burden of copy number alterations (hazard ratio 3.6, 95% CI: 1.8–7.2, P &lt; 0.001). A nomogram combining the methylome predictor with clinical factors demonstrated greater discrimination than a nomogram using clinical factors alone in 2 independent validation cohorts (ΔAUC = 0.25, 95% CI: 0.22–0.27) and resulted in 2 groups with distinct recurrence patterns (hazard ratio 7.7, 95% CI: 5.3–11.1, P &lt; 0.001) with clinical implications. Conclusions The models developed and validated in this study provide important prognostic information not captured by previously established clinical and molecular factors which could be used to individualize decisions regarding postoperative therapeutic interventions, in particular whether to treat patients with adjuvant radiotherapy versus observation alone. </jats:sec

Degenerative Cervical Myelopathy; A Review of the Latest Advances and Future Directions in Management

The assessment, diagnosis, operative and nonoperative management of degenerative cervical myelopathy (DCM) have evolved rapidly over the last 20 years. A clearer understanding of the pathobiology of DCM has led to attempts to develop objective measurements of the severity of myelopathy, including technology such as multiparametric magnetic resonance imaging, biomarkers, and ancillary clinical testing. New pharmacological treatments have the potential to alter the course of surgical outcomes, and greater innovation in surgical techniques have made surgery safer, more effective and less invasive. Future developments for the treatment of DCM will seek to improve the diagnostic accuracy of imaging, improve the objectivity of clinical assessment, and increase the use of surgical technology to ensure the best outcome is achieved for each individual patient

Degenerative Cervical Myelopathy; A Review of the Latest Advances and Future Directions in Management.

The assessment, diagnosis, operative and nonoperative management of degenerative cervical myelopathy (DCM) have evolved rapidly over the last 20 years. A clearer understanding of the pathobiology of DCM has led to attempts to develop objective measurements of the severity of myelopathy, including technology such as multiparametric magnetic resonance imaging, biomarkers, and ancillary clinical testing. New pharmacological treatments have the potential to alter the course of surgical outcomes, and greater innovation in surgical techniques have made surgery safer, more effective and less invasive. Future developments for the treatment of DCM will seek to improve the diagnostic accuracy of imaging, improve the objectivity of clinical assessment, and increase the use of surgical technology to ensure the best outcome is achieved for each individual patient

Using a machine learning approach to predict outcome after surgery for degenerative cervical myelopathy.

Degenerative cervical myelopathy (DCM) is a spinal cord condition that results in progressive non-traumatic compression of the cervical spinal cord. Spine surgeons must consider a large quantity of information relating to disease presentation, imaging features, and patient characteristics to determine if a patient will benefit from surgery for DCM. We applied a supervised machine learning approach to develop a classification model to predict individual patient outcome after surgery for DCM. Patients undergoing surgery for DCM as a part of the AOSpine CSM-NA or CSM-I prospective, multi-centre studies were included in the analysis. Out of 757 patients 605, 583, and 539 patients had complete follow-up information at 6, 12, and 24 months respectively and were included in the analysis. The primary outcome was improvement in the SF-6D quality of life indicator score by the minimum clinically important difference (MCID). The secondary outcome was improvement in the modified Japanese Orthopedic Association (mJOA) score by the MCID. Predictor variables reflected information about pre-operative disease severity, disease presentation, patient demographics, and comorbidities. A machine learning approach of feature engineering, data pre-processing, and model optimization was used to create the most accurate predictive model of outcome after surgery for DCM. Following data pre-processing 48, 108, and 101 features were chosen for model training at 6, 12, and 24 months respectively. The best performing predictive model used a random forest structure and had an average area under the curve (AUC) of 0.70, classification accuracy of 77%, and sensitivity of 78% when evaluated on a testing cohort that was not used for model training. Worse pre-operative disease severity, longer duration of DCM symptoms, older age, higher body weight, and current smoking status were associated with worse surgical outcomes. We developed a model that predicted positive surgical outcome for DCM with good accuracy at the individual patient level on an independent testing cohort. Our analysis demonstrates the applicability of machine-learning to predictive modeling in spine surgery

Frailty Is a Better Predictor than Age of Mortality and Perioperative Complications after Surgery for Degenerative Cervical Myelopathy: An Analysis of 41,369 Patients from the NSQIP Database 2010–2018

Background: The ability of frailty compared to age alone to predict adverse events in the surgical management of Degenerative Cervical Myelopathy (DCM) has not been defined in the literature. Methods: 41,369 patients with a diagnosis of DCM undergoing surgery were collected from the National Surgical Quality Improvement Program (NSQIP) Database 2010&ndash;2018. Univariate analysis for each measure of frailty (modified frailty index 11- and 5-point; MFI-11, MFI-5), modified Charlson Co-morbidity index and ASA grade) were calculated for the following outcomes: mortality, major complication, unplanned reoperation, unplanned readmission, length of hospital stay, and discharge to a non-home destination. Multivariable modeling of age and frailty with a base model was performed to define the discriminative ability of each measure. Results: Age and frailty have a significant effect on all outcomes, but the MFI-5 has the largest effect size. Increasing frailty correlated significantly with the risk of perioperative adverse events, longer hospital stay, and risk of a non-home discharge destination. Multivariable modeling incorporating MFI-5 with age and the base model had a robust predictive value (0.85). MFI-5 had a high categorical assessment correlation with a MFI-11 of 0.988 (p &lt; 0.001). Conclusions and Relevance: Measures of frailty have a greater effect size and a higher discriminative value to predict adverse events than age alone. MFI-5 categorical assessment is essentially equivalent to the MFI-11 score for DCM patients. A multivariable model using MFI-5 provides an accurate predictive tool that has important clinical applications

Predictive Modeling of Outcomes After Traumatic and Nontraumatic Spinal Cord Injury Using Machine Learning: Review of Current Progress and Future Directions.

Machine learning represents a promising frontier in epidemiological research on spine surgery. It consists of a series of algorithms that determines relationships between data. Machine learning maintains numerous advantages over conventional regression techniques, such as a reduced requirement for a priori knowledge on predictors and better ability to manage large datasets. Current studies have made extensive strides in employing machine learning to a greater capacity in spinal cord injury (SCI). Analyses using machine learning algorithms have been done on both traumatic SCI and nontraumatic SCI, the latter of which typically represents degenerative spine disease resulting in spinal cord compression, such as degenerative cervical myelopathy. This article is a literature review of current studies published in traumatic and nontraumatic SCI that employ machine learning for the prediction of a host of outcomes. The studies described utilize machine learning in a variety of capacities, including imaging analysis and prediction in large epidemiological data sets. We discuss the performance of these machine learning-based clinical prognostic models relative to conventional statistical prediction models. Finally, we detail the future steps needed for machine learning to become a more common modality for statistical analysis in SCI