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Importance: Identifying disparities in health outcomes related to modifiable patient factors can improve patient care. Objective: To compare likelihood of withdrawal of life-supporting treatment (WLST) and mortality in patients with complete cervical spinal cord injury (SCI) with different types of insurance. Design, Setting, and Participants: This retrospective cohort study collected data between 2013 and 2020 from 498 trauma centers participating in the Trauma Quality Improvement Program. Participants included adult patients (older than 16 years) with complete cervical SCI. Data were analyzed from November 1, 2023, through May 18, 2024. Exposure: Uninsured or public insurance compared with private insurance. Main Outcomes and Measures: Coprimary outcomes were WLST and mortality. The adjusted odds ratio (aOR) of each outcome was estimated using hierarchical logistic regression. Propensity score matching was used as an alternative analysis to compare public and privately insured patients. Process of care outcomes, including the occurrence of a hospital complication and length of stay, were compared between matched patients. Results: The study included 8421 patients with complete cervical SCI treated across 498 trauma centers (mean [SD] age, 49.1 [20.2] years; 6742 male [80.1%]). Among the 3524 patients with private insurance, 503 had WLST (14.3%) and 756 died (21.5%). Among the 3957 patients with public insurance, 906 had WLST (22.2%) and 1209 died (30.6%). Among the 940 uninsured patients, 156 had WLST (16.6%) and 318 died (33.8%). A significant difference was found between uninsured and privately insured patients in the adjusted odds of WLST (aOR, 1.49; 95% CI, 1.11-2.01) and mortality (aOR, 1.98; 95% CI, 1.50-2.60). Similar results were found in subgroup analyses. Matched public compared with private insurance patients were found to have significantly greater odds of hospital complications (odds ratio, 1.27; 95% CI, 1.14-1.42) and longer hospital stay (mean difference 5.90 days; 95% CI, 4.64-7.20), which was redemonstrated on subgroup analyses. Conclusions and Relevance: Health insurance type was associated with significant differences in the odds of WLST, mortality, hospital complications, and days in hospital among patients with complete cervical SCI in this study. Future work is needed to incorporate patient perspectives and identify strategies to close the quality gap for the large number of patients without private insurance.
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BACKGROUND: Degenerative cervical myelopathy (DCM) is a progressive chronic spinal cord injury estimated to affect 1 in 50 adults. Without standardised guidance, clinical research studies have selected outcomes at their discretion, often underrepresenting the disease and limiting comparability between studies. Utilising a standard minimum data set formed via multi-stakeholder consensus can address these issues. This combines processes to define a core outcome set (COS)-a list of key outcomes-and core data elements (CDEs), a list of key sampling characteristics required to interpret the outcomes. Further "how" these outcomes should be measured and/or reported is then defined in a core measurement set (CMS). This can include a recommendation of a standardised time point at which outcome data should be reported. This study defines a COS, CDE, and CMS for DCM research. METHODS AND FINDINGS: A minimum data set was developed using a series of modified Delphi processes. Phase 1 involved the setup of an international DCM stakeholder group. Phase 2 involved the development of a longlist of outcomes, data elements, and formation into domains. Phase 3 prioritised the outcomes and CDEs using a two-stage Delphi process. Phase 4 determined the final DCM minimal data set using a consensus meeting. Using the COS, Phase 5 finalised definitions of the measurement construct for each outcome. In Phase 6, a systematic review of the literature was performed, to scope and define the psychometric properties of measurement tools. Phase 7 used a modified Delphi process to inform the short-listing of candidate measurement tools. The final measurement set was then formed through a consensus meeting (Phase 8). To support implementation, the data set was then integrated into template clinical research forms (CRFs) for use in future clinical trials (Phase 9). In total, 28 outcomes and 6 domains (Pain, Neurological Function, Life Impact, Radiology, Economic Impact, and Adverse Events) were entered into the final COS. Thirty two outcomes and 4 domains (Individual, Disease, Investigation, and Intervention) were entered into the final CDE. Finally, 4 outcome instruments (mJOA, NDI, SF-36v2, and SAVES2) were identified for the CMS, with a recommendation for trials evaluating outcomes after surgery, to include baseline measurement and at 6 months from surgery. CONCLUSIONS: The AO Spine RECODE-DCM has produced a minimum data set for use in DCM clinical trials today. These are available at https://myelopathy.org/minimum-dataset/. While it is anticipated the CDE and COS have strong and durable relevance, it is acknowledged that new measurement tools, alongside an increasing transition to study patients not undergoing surgery, may necessitate updates and adaptation, particularly with respect to the CMS.
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BACKGROUND: Healthcare inequities for patients with traumatic brain injury (TBI) represent a major priority area for trauma quality improvement. We hypothesized a relationship between health insurance status and timing of withdrawal of life sustaining treatment (WLST) for adults with severe TBI. METHODS: This multicenter retrospective observational cohort study utilized data collected between 2017 and 2020. We identified adult (age ≥ 16) patients with isolated severe TBI admitted participating Trauma Quality Improvement Program centers. We determined the relationship between insurance status (public, private, and uninsured) and the timing of WLST using a competing risk survival analysis framework adjusting for baseline, clinical, injury and trauma center characteristics. Multivariable cause-specific Cox regressions were used to compute adjusted hazard ratios (HR) reflecting timing of WLST, accounting for mortality events. We also quantified the between-center residual variability in WLST using the median odds ratio (MOR) and measured insurance status association with access to rehabilitation at discharge. RESULTS: We identified 42,111 adults with isolated severe TBI treated across 509 trauma centers across North America. There were 10,771 (25.6%) WLST events in the cohort and a higher unadjusted incidence of WLST events was evident in public insurance patients compared to private or uninsured groups. After adjustment, WLST occurred earlier for publicly insured (HR 1.07, 95% CI 1.02-1.12) and uninsured patients (HR 1.29, 95% CI 1.18-1.41) compared to privately insured patients. Access to rehabilitation was lower for both publicly insured and uninsured patients compared to patients with private insurance. Accounting for case-mix, the MOR was 1.49 (95% CI 1.43-1.55), reflecting significant residual between-center variation in WLST decision-making. CONCLUSIONS: Our findings highlight the presence of disparate WLST practices independently associated with health insurance status. Additionally, these results emphasize between-center variability in WLST, persisting despite adjustments for measurable patient and trauma center characteristics.
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Lesiones Traumáticas del Encéfalo , Seguro de Salud , Privación de Tratamiento , Humanos , Estudios Retrospectivos , Lesiones Traumáticas del Encéfalo/terapia , Masculino , Femenino , Adulto , Persona de Mediana Edad , Seguro de Salud/estadística & datos numéricos , Estudios de Cohortes , Privación de Tratamiento/estadística & datos numéricos , Privación de Tratamiento/tendencias , Cobertura del Seguro/estadística & datos numéricos , Cobertura del Seguro/normas , AncianoRESUMEN
Importance: Spinal cord injury (SCI) causes drastic changes to an individual's physical health that may be associated with the ability to work. Objective: To estimate the association of SCI with individual earnings and employment status using national administrative health databases linked to income tax data. Design, Setting, and Participants: This was a retrospective, national, population-based cohort study of adults who were hospitalized with cervical SCI in Canada between January 2005 and December 2017. All acute care hospitalizations for SCI of adults ages 18 to 64 years were included. A comparison group was constructed by sampling from individuals in the injured cohort. Fiscal information from their preinjury years was used for comparison. The injured cohort was matched with the comparison group based on age, sex, marital status, province of residence, self-employment status, earnings, and employment status in the year prior to injury. Data were analyzed from August 2022 to January 2023. Main outcomes and Measures: The first outcome was the change in individual annual earnings up to 5 years after injury. The change in mean yearly earnings was assessed using a linear mixed-effects differences-in-differences regression. Income values are reported in 2022 Canadian dollars (CAD $1.00 = US $0.73). The second outcome was the change in employment status up to 5 years after injury. A multivariable probit regression model was used to compare proportions of individuals employed among those who had experienced SCI and the paired comparison group of participants. Results: A total of 1630 patients with SCI (mean [SD] age, 47 [13] years; 1304 male [80.0%]) were matched to patients in a preinjury comparison group (resampled from the same 1630 patients in the SCI group). The mean (SD) of preinjury wage earnings was CAD $46â¯000 ($48â¯252). The annual decline in individual earnings was CAD $20â¯275 (95% CI, -$24â¯455 to -$16â¯095) in the first year after injury and CAD $20â¯348 (95% CI, -$24â¯710 to -$15â¯985) in the fifth year after injury. At 5 years after injury, 52% of individuals who had an injury were working compared with 79% individuals in the preinjury comparison group. SCI survivors had a decrease in employment of 17.1 percentage points (95% CI, 14.5 to 19.7 percentage points) in the first year after injury and 17.8 percentage points (14.5 to 21.1 percentage points) in the fifth year after injury. Conclusions and Relevance: In this study, SCI was associated with a decline in earnings and employment up to 5 years after injury for adults aged 18 to 64 years in Canada.
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Empleo , Renta , Traumatismos de la Médula Espinal , Humanos , Traumatismos de la Médula Espinal/economía , Traumatismos de la Médula Espinal/epidemiología , Masculino , Femenino , Adulto , Empleo/estadística & datos numéricos , Persona de Mediana Edad , Renta/estadística & datos numéricos , Estudios Retrospectivos , Canadá/epidemiología , Adulto Joven , Adolescente , Médula Cervical/lesionesRESUMEN
BACKGROUND: Despite an abundance of literature on degenerative cervical myelopathy (DCM), little is known about preoperative expectations of these patients. PURPOSE: The primary objective was to describe patient preoperative expectations. Secondary objectives included identifying patient characteristics associated with high preoperative expectations and to determine if expectations varied depending on myelopathy severity. STUDY DESIGN: This was a retrospective study of a prospective multicenter, observational cohort of patients with DCM. PATIENT SAMPLE: Patients who consented to undergo surgical treatment between January 2019 and September 2022 were included. OUTCOMES MEASURES: An 11-domain expectation questionnaire was completed preoperatively whereby patients quantified the expected change in each domain. METHODS: The most important expected change was captured. A standardized expectation score was calculated as the sum of each expectation divided by the maximal possible score. The high expectation group was defined by patients who had an expectation score above the 75th percentile. Predictors of patients with high expectations were determined using multivariable logistic regression models. RESULTS: There were 262 patients included. The most important patient expectation was preventing neurological worsening (40.8%) followed by improving balance when standing or walking (14.5%), improving independence in everyday activities (10.3%), and relieving arm tingling, burning and numbness (10%). Patients with mild myelopathy were more likely to select no worsening as the most important expected change compared to patients with severe myelopathy (p<.01). Predictors of high patient expectations were: having fewer comorbidities (OR -0.30 for every added comorbidity, 95% CI -0.59 to -0.10, p=.01), a shorter duration of symptoms (OR 0.92, 95% CI 0.35-1.19, p=.02), no contribution from "failure of other treatments" on the decision to undergo surgery (OR 1.49, 95% CI 0.56-2.71, p=.02) and more severe neck pain (OR 0.19 for 1 point increase, 95% CI 0.05-0.37, p=.01). CONCLUSIONS: Most patients undergoing surgery for DCM expect prevention of neurological decline, better functional status, and improvement in their myelopathic symptoms. Stopping neurological deterioration is the most important expected outcomes by patients.
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Vértebras Cervicales , Enfermedades de la Médula Espinal , Humanos , Masculino , Femenino , Persona de Mediana Edad , Enfermedades de la Médula Espinal/cirugía , Enfermedades de la Médula Espinal/psicología , Vértebras Cervicales/cirugía , Anciano , Canadá , Estudios Retrospectivos , Estudios Prospectivos , Periodo Preoperatorio , Encuestas y CuestionariosRESUMEN
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.
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Vértebras Cervicales , Discectomía , Tiempo de Internación , Fusión Vertebral , Humanos , Femenino , Masculino , Vértebras Cervicales/cirugía , Persona de Mediana Edad , Fusión Vertebral/métodos , Canadá , Discectomía/métodos , Estudios Retrospectivos , Anciano , Adulto , Descompresión Quirúrgica , Degeneración del Disco Intervertebral/cirugía , Procedimientos Quirúrgicos Electivos , Complicaciones Posoperatorias/epidemiología , Estudios de CohortesRESUMEN
Background: Spinal metastases are a significant complication of advanced cancer. In this study, we assess temporal trends in the incidence and timing of spinal metastases and examine underlying patient demographics and primary cancer associations. Methods: In this population-based retrospective cohort study, health data from 2007 to 2019 in Ontario, Canada were analyzed (nâ =â 37, 375 patients identified with spine metastases). Primary outcomes were annual incidence of spinal metastasis, and time to metastasis after primary diagnosis. Results: The age-standardized incidence of spinal metastases increased from 229 to 302 cases per million over the 13-year study period. The average annual percent change (AAPC) in incidence was 2.2% (95% CI: 1.4% to 3.0%) with patients aged ≥85 years demonstrating the largest increase (AAPC 5.2%; 95% CI: 2.3% to 8.3%). Lung cancer had the greatest annual incidence, while prostate cancer had the greatest increase in annual incidence (AAPC 6.5; 95% CI: 4.1% to 9.0%). Lung cancer patients were found to have the highest risk of spine metastasis with 10.3% (95% CI: 10.1% to 10.5%) of patients being diagnosed at 10 years. Gastrointestinal cancer patients were found to have the lowest risk of spine metastasis with 1.0% (95% CI: 0.9% to 1.0%) of patients being diagnosed at 10 years. Conclusions: The incidence of spinal metastases has increased in recent years, particularly among older patients. The incidence and timing vary substantially among different primary cancer types. These findings contribute to the understanding of disease trends and emphasize a growing population of patients who require subspecialty care.
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BACKGROUND AND OBJECTIVES: Recent evidence suggests earlier tracheostomy is associated with fewer complications in patients with complete cervical spinal cord injury (SCI). This study aims to evaluate the influence of spine surgical approach on the association between tracheostomy timing and in-hospital adverse events treating patients with complete cervical SCI. METHODS: This retrospective cohort study was performed using Trauma Quality Improvement Program data from 2017 to 2020. All patients with acute complete (American Spinal Injury Association-A) cervical SCI who underwent tracheostomy and spine surgery were included. Tracheostomy timing was dichotomized to early (within 1 week after surgery) and delayed (more than 1 week after surgery). Primary outcome was the occurrence of major in-hospital complications. Secondary outcomes included occurrences of immobility-related complications, surgical-site infection, hospital and intensive care unit length of stay, and time on mechanical ventilation. RESULTS: The study included 1592 patients across 358 trauma centers. Mean time to tracheostomy from surgery was 8.6 days. A total of 495 patients underwent anterior approach, 670 underwent posterior approach, and 427 underwent combined anterior and posterior approach. Patients who underwent anterior approach were significantly more likely to have delayed tracheostomy compared with posterior approach (53% vs 40%, P < .001). Early tracheotomy significantly reduced major in-hospital complications (odds ratio 0.67, 95% CI 0.53-0.84) and immobility complications (odds ratio = 0.78, 95% CI 0.6-1.0). Those undergoing early tracheostomy spent 6.0 (95% CI -8.47 to -3.43) fewer days in hospital, 5.7 (95% CI -7.8 to -3.7) fewer days in the intensive care unit, and 5.9 (95% CI -8.2 to -3.7) fewer days ventilated. Surgical approach had no significant negative effect on the association between tracheostomy timing and the outcomes of interest. CONCLUSION: Earlier tracheostomy for patients with cervical SCI is associated with reduced complications, length of stay, and ventilation time. This relationship appears independent of the surgical approach. These findings emphasize that tracheostomy need not be delayed because of the SCI treatment approach.
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Vértebras Cervicales , Traumatismos de la Médula Espinal , Traqueostomía , Humanos , Traumatismos de la Médula Espinal/cirugía , Traqueostomía/métodos , Traqueostomía/efectos adversos , Traqueostomía/estadística & datos numéricos , Masculino , Femenino , Persona de Mediana Edad , Adulto , Estudios Retrospectivos , Vértebras Cervicales/cirugía , Factores de Tiempo , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Tiempo de Internación/estadística & datos numéricos , Anciano , Médula Cervical/lesiones , Médula Cervical/cirugía , Estudios de Cohortes , Respiración Artificial/estadística & datos numéricos , Respiración Artificial/métodos , Tiempo de Tratamiento/estadística & datos numéricosRESUMEN
BACKGROUND AND OBJECTIVES: There is a lack of data examining the effects of perioperative adverse events (AEs) on long-term outcomes for patients undergoing surgery for degenerative cervical myelopathy. We aimed to investigate associations between the occurrence of perioperative AEs and coprimary outcomes: (1) modified Japanese Orthopaedic Association (mJOA) score and (2) Neck Disability Index (NDI) score. METHODS: We analyzed data from 800 patients prospectively enrolled in the Canadian Spine Outcomes and Research Network multicenter observational study. The Spine AEs Severity system was used to collect intraoperative and postoperative AEs. Patients were assessed at up to 2 years after surgery using the NDI and the mJOA scale. We used a linear mixed-effect regression to assess the influence of AEs on longitudinal outcome measures as well as multivariable logistic regression to assess factors associated with meeting minimal clinically important difference (MCID) thresholds at 1 year. RESULTS: There were 167 (20.9%) patients with minor AEs and 36 (4.5%) patients with major AEs. The occurrence of major AEs was associated with an average increase in NDI of 6.8 points (95% CI: 1.1-12.4, P = .019) and reduction of 1.5 points for mJOA scores (95% CI: -2.3 to -0.8, P < .001) up to 2 years after surgery. Occurrence of major AEs reduced the odds of patients achieving MCID targets at 1 year after surgery for mJOA (odds ratio 0.23, 95% CI: 0.086-0.53, P = .001) and for NDI (odds ratio 0.34, 95% CI: 0.11-0.84, P = .032). CONCLUSION: Major AEs were associated with reduced functional gains and worse recovery trajectories for patients undergoing surgery for degenerative cervical myelopathy. Occurrence of major AEs reduced the probability of achieving mJOA and NDI MCID thresholds at 1 year. Both minor and major AEs significantly increased health resource utilization by reducing the proportion of discharges home and increasing length of stay.
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Vértebras Cervicales , Medición de Resultados Informados por el Paciente , Complicaciones Posoperatorias , Enfermedades de la Médula Espinal , Humanos , Masculino , Femenino , Persona de Mediana Edad , Canadá/epidemiología , Anciano , Vértebras Cervicales/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Enfermedades de la Médula Espinal/cirugía , Estudios de Cohortes , Resultado del Tratamiento , Estudios ProspectivosRESUMEN
STUDY DESIGN: Clinical practice guideline development. OBJECTIVES: Acute spinal cord injury (SCI) can result in devastating motor, sensory, and autonomic impairment; loss of independence; and reduced quality of life. Preclinical evidence suggests that early decompression of the spinal cord may help to limit secondary injury, reduce damage to the neural tissue, and improve functional outcomes. Emerging evidence indicates that "early" surgical decompression completed within 24 hours of injury also improves neurological recovery in patients with acute SCI. The objective of this clinical practice guideline (CPG) is to update the 2017 recommendations on the timing of surgical decompression and to evaluate the evidence with respect to ultra-early surgery (in particular, but not limited to, <12 hours after acute SCI). METHODS: A multidisciplinary, international, guideline development group (GDG) was formed that consisted of spine surgeons, neurologists, critical care specialists, emergency medicine doctors, physical medicine and rehabilitation professionals, as well as individuals living with SCI. A systematic review was conducted based on accepted methodological standards to evaluate the impact of early (within 24 hours of acute SCI) or ultra-early (in particular, but not limited to, within 12 hours of acute SCI) surgery on neurological recovery, functional outcomes, administrative outcomes, safety, and cost-effectiveness. The GRADE approach was used to rate the overall strength of evidence across studies for each primary outcome. Using the "evidence-to-recommendation" framework, recommendations were then developed that considered the balance of benefits and harms, financial impact, patient values, acceptability, and feasibility. The guideline was internally appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool. RESULTS: The GDG recommended that early surgery (≤24 hours after injury) be offered as the preferred option for adult patients with acute SCI regardless of level. This recommendation was based on moderate evidence suggesting that patients were 2 times more likely to recover by ≥ 2 ASIA Impairment Score (AIS) grades at 6 months (RR: 2.76, 95% CI 1.60 to 4.98) and 12 months (RR: 1.95, 95% CI 1.26 to 3.18) if they were decompressed within 24 hours compared to after 24 hours. Furthermore, patients undergoing early surgery improved by an additional 4.50 (95% 1.70 to 7.29) points on the ASIA Motor Score compared to patients undergoing surgery after 24 hours post-injury. The GDG also agreed that a recommendation for ultra-early surgery could not be made on the basis of the current evidence because of the small sample sizes, variable definitions of what constituted ultra-early in the literature, and the inconsistency of the evidence. CONCLUSIONS: It is recommended that patients with an acute SCI, regardless of level, undergo surgery within 24 hours after injury when medically feasible. Future research is required to determine the differential effectiveness of early surgery in different subpopulations and the impact of ultra-early surgery on neurological recovery. Moreover, further work is required to define what constitutes effective spinal cord decompression and to individualize care. It is also recognized that a concerted international effort will be required to translate these recommendations into policy.
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STUDY DESIGN: Clinical practice guideline development following the GRADE process. OBJECTIVES: Hemodynamic management is one of the only available treatment options that likely improves neurologic outcomes in patients with acute traumatic spinal cord injury (SCI). Augmenting mean arterial pressure (MAP) aims to improve blood perfusion and oxygen delivery to the injured spinal cord in order to minimize secondary ischemic damage to neural tissue. The objective of this guideline was to update the 2013 AANS/CNS recommendations on the hemodynamic management of patients with acute traumatic SCI, acknowledging that much has been published in this area since its publication. Specifically, we sought to make recommendations on 1. The range of mean arterial pressure (MAP) to be maintained by identifying an upper and lower MAP limit; 2. The duration of such MAP augmentation; and 3. The choice of vasopressor. Additionally, we sought to make a recommendation on spinal cord perfusion pressure (SCPP) targets. METHODS: A multidisciplinary guideline development group (GDG) was formed that included health care professionals from a wide range of clinical specialities, patient advocates, and individuals living with SCI. The GDG reviewed the 2013 AANS/CNS guidelines and voted on whether each recommendation should be endorsed or updated. A systematic review of the literature, following PRISMA standards and registered in PROSPERO, was conducted to inform the guideline development process and address the following key questions: (i) what are the effects of goal-directed interventions to optimize spinal cord perfusion on extent of neurological recovery and rates of adverse events at any time point of follow-up? and (ii) what are the effects of particular monitoring techniques, perfusion ranges, pharmacological agents, and durations of treatment on extent of neurological recovery and rates of adverse events at any time point of follow-up? The GDG combined the information from this systematic review with their clinical expertise in order to develop recommendations on a MAP target range (specifically an upper and lower limit to target), the optimal duration for MAP augmentation, and the use of vasopressors or inotropes. Using methods outlined by the GRADE working group, recommendations were formulated that considered the balance of benefits and harms, financial impact, acceptability, feasibility and patient preferences. RESULTS: The GDG suggested that MAP should be augmented to at least 75-80 mmHg as the "lower limit," but not actively augmented beyond an "upper limit" of 90-95 mmHg in order to optimize spinal cord perfusion in acute traumatic SCI. The quality of the evidence around the "target MAP" was very low, and thus the strength of this recommendation is weak. For duration of hemodynamic management, the GDG "suggested" that MAP be augmented for a duration of 3-7 days. Again, the quality of the evidence around the duration of MAP support was very low, and thus the strength of this recommendation is also weak. The GDG felt that a recommendation on the choice of vasopressor or the use of SCPP targets was not warranted, given the dearth of available evidence. CONCLUSION: We provide new recommendations for blood pressure management after acute SCI that acknowledge the limitations of the current evidence on the relationship between MAP and neurologic recovery. It was felt that the low quality of existing evidence and uncertainty around the relationship between MAP and neurologic recovery justified a greater range of MAP to target, and for a broader range of days post-injury than recommended in previous guidelines. While important knowledge gaps still remain regarding hemodynamic management, these recommendations represent current perspectives on the role of MAP augmentation for acute SCI.
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BACKGROUND AND OBJECTIVES: The advantages and disadvantages of anterior vs posterior surgical approaches for patients with progressive degenerative cervical myelopathy (DCM) remain uncertain. Our primary objective was to evaluate patient-reported disability at 1 year after surgery. Our secondary objectives were to evaluate differences in patient profiles selected for each approach in routine clinical practice and to compare neurological function, neck and arm pain, health-related quality of life, adverse events, and rates of reoperations. METHODS: We analyzed data from patients with DCM who were enrolled in an ongoing multicenter prospective observational cohort study. We controlled for differences in baseline characteristics and numbers of spinal levels treated using multivariable logistic regression. Adverse events were collected according to the Spinal Adverse Events Severity protocol. RESULTS: Among 559 patients, 261 (47%) underwent anterior surgery while 298 (53%) underwent posterior surgery. Patients treated posteriorly had significantly worse DCM severity and a greater number of vertebral levels involved. After adjusting for confounders, there was no significant difference between approaches for odds of achieving the minimum clinically important difference for the Neck Disability Index (odds ratio 1.23, 95% CI 0.82 to 1.86, P = .31). There was also no significant difference for change in modified Japanese Orthopedic Association scores, and differences in neck and arm pain and health-related quality of life did not exceed minimum clinically important differences. Patients treated anteriorly experienced greater rates of dysphagia, whereas patients treated posteriorly experienced greater rates of wound complications, neurological complications, and reoperations. CONCLUSION: Patients selected for posterior surgery had worse DCM and a greater number of vertebral levels involved. Despite this, anterior and posterior surgeries were associated with similar improvements in disability, neurological function, pain, and quality of life. Anterior surgery had a more favorable profile of adverse events, which suggests it might be a preferred option when feasible.
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In spite of an exponential increase in the volume of medical data produced globally, much of these data are inaccessible to those who might best use them to develop improved health care solutions through the application of advanced analytics such as artificial intelligence. Data liberation and crowdsourcing represent two distinct but interrelated approaches to bridging existing data silos and accelerating the pace of innovation internationally. In this article, we examine these concepts in the context of medical artificial intelligence research, summarizing their potential benefits, identifying potential pitfalls, and ultimately making a case for their expanded use going forward. A practical example of a crowdsourced competition using an international medical imaging dataset is provided. Keywords: Artificial Intelligence, Data Liberation, Crowdsourcing © RSNA, 2023.
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Investigación Biomédica , Colaboración de las Masas , Holometabola , Animales , Inteligencia Artificial , Instituciones de SaludRESUMEN
BACKGROUND AND OBJECTIVES: Withdrawal of life-sustaining treatment (WLST) in severe traumatic brain injury (TBI) is complex, with a paucity of standardized guidelines. We aimed to assess the variability in WLST practices between trauma centers in North America. METHODS: This retrospective study used data from trauma centers through the American College of Surgeons Trauma Quality Improvement Program between 2017 and 2020. We included adult patients (>16 years) with severe TBI and a documented decision for WLST. We constructed a series of hierarchical logistic regression models to adjust for patient, injury, and hospital attributes influencing WLST; residual between-center variability was characterized using the median odds ratio. The impact of disparate WLST practices was further assessed by ranking centers by their conditional random intercept and assessing mortality, length of stay, and WLST between quartiles. RESULTS: We identified a total of 85 511 subjects with severe TBI treated across 510 trauma centers, of whom 20 300 (24%) had WLST. Patient-level factors associated with increased likelihood of WLST were advanced age, White race, self-pay, or Medicare insurance status (compared with private insurance). Black race was associated with reduced tendency for WLST. Treatment in nonprofit centers and higher-severity intracranial and extracranial injuries, midline shift, and pupil asymmetry also increased the likelihood for WLST. After adjustment for patient and hospital attributes, the median odds ratio was 1.45 (1.41-1.49 95% CI), suggesting residual variation in WLST between centers. When centers were grouped into quartiles by their propensity for WLST, there was increased adjusted mortality and shorter length of stay in fourth compared with first quartile centers. CONCLUSION: We highlighted the presence of contextual phenomena associated with disparate WLST practice patterns between trauma centers after adjustment for case-mix and hospital attributes. These findings highlight a need for standardized WLST guidelines to improve equity of care provision for patients with severe TBI.
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Purpose To develop an automated triage tool to predict neurosurgical intervention for patients with traumatic brain injury (TBI). Materials and Methods A provincial trauma registry was reviewed to retrospectively identify patients with TBI from 2005 to 2022 treated at a specialized Canadian trauma center. Model training, validation, and testing were performed using head CT scans with binary reference standard patient-level labels corresponding to whether the patient received neurosurgical intervention. Performance and accuracy of the model, the Automated Surgical Intervention Support Tool for TBI (ASIST-TBI), were also assessed using a held-out consecutive test set of all patients with TBI presenting to the center between March 2021 and September 2022. Results Head CT scans from 2806 patients with TBI (mean age, 57 years ± 22 [SD]; 1955 [70%] men) were acquired between 2005 and 2021 and used for training, validation, and testing. Consecutive scans from an additional 612 patients (mean age, 61 years ± 22; 443 [72%] men) were used to assess the performance of ASIST-TBI. There was accurate prediction of neurosurgical intervention with an area under the receiver operating characteristic curve (AUC) of 0.92 (95% CI: 0.88, 0.94), accuracy of 87% (491 of 562), sensitivity of 87% (196 of 225), and specificity of 88% (295 of 337) on the test dataset. Performance on the held-out test dataset remained robust with an AUC of 0.89 (95% CI: 0.85, 0.91), accuracy of 84% (517 of 612), sensitivity of 85% (199 of 235), and specificity of 84% (318 of 377). Conclusion A novel deep learning model was developed that could accurately predict the requirement for neurosurgical intervention using acute TBI CT scans. Keywords: CT, Brain/Brain Stem, Surgery, Trauma, Prognosis, Classification, Application Domain, Traumatic Brain Injury, Triage, Machine Learning, Decision Support Supplemental material is available for this article. © RSNA, 2024 See also commentary by Haller in this issue.
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Lesiones Traumáticas del Encéfalo , Lesiones Encefálicas , Masculino , Humanos , Persona de Mediana Edad , Femenino , Estudios Retrospectivos , Canadá , Lesiones Traumáticas del Encéfalo/diagnóstico por imagen , Procedimientos NeuroquirúrgicosRESUMEN
BACKGROUND CONTEXT: Degenerative cervical myelopathy (DCM) is a form of acquired spinal cord compression and contributes to reduced quality of life secondary to neurological dysfunction and pain. There remains uncertainty regarding optimal management for individuals with mild myelopathy. Specifically, owing to lacking long-term natural history studies in this population, we do not know whether these individuals should be treated with initial surgery or observation. PURPOSE: We sought to perform a cost-utility analysis to examine early surgery for mild degenerative cervical myelopathy from the healthcare payer perspective. STUDY DESIGN/SETTING: We utilized data from the prospective observational cohorts included in the Cervical Spondylotic Myelopathy AO Spine International and North America studies to determine health related quality of life estimates and clinical myelopathy outcomes. PATIENT SAMPLE: We recruited all patients that underwent surgery for DCM enrolled in the Cervical Spondylotic Myelopathy AO Spine International and North America studies between December 2005 and January 2011. OUTCOME MEASURES: Clinical assessment measures were obtained using the Modified Japanese Orthopedic Association scale and health-related quality of life measures were obtained using the Short Form-6D utility score at baseline (preoperative), 6 months, 12 months and 24 months postsurgery. Cost measures inflated to January 2015 values were obtained using pooled estimates from the hospital payer perspective for surgical patients. METHODS: We employed a Markov state transition model with Monte Carlo microsimulation using a lifetime horizon to obtain an incremental cost utility ratio associated with early surgery for mild myelopathy. Parameter uncertainty was assessed through deterministic means using one-way and two-way sensitivity analyses and probabilistically using parameter estimate distributions with microsimulation (10,000 trials). Costs and utilities were discounted at 3% per annum. RESULTS: Initial surgery for mild degenerative cervical myelopathy was associated with an incremental lifetime increase of 1.26 quality-adjusted life years (QALY) compared to observation. The associated cost incurred to the healthcare payer over a lifetime horizon was $12,894.56, resulting in a lifetime incremental cost-utility ratio of $10,250.71/QALY. Utilizing a willingness to pay threshold in keeping with the World Health Organization definition of "very cost-effective" ($54,000 CDN), the probabilistic sensitivity analysis demonstrated that 100% of cases were cost-effective. CONCLUSIONS: Surgery compared to initial observation for mild degenerative cervical myelopathy was cost-effective from the Canadian healthcare payer perspective and was associated with lifetime gains in health-related quality of life.
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Compresión de la Médula Espinal , Enfermedades de la Médula Espinal , Humanos , Canadá , Vértebras Cervicales/cirugía , Análisis Costo-Beneficio , Calidad de Vida , Compresión de la Médula Espinal/etiología , Compresión de la Médula Espinal/cirugía , Enfermedades de la Médula Espinal/cirugía , Estudios ProspectivosRESUMEN
BACKGROUND CONTEXT: Existing degenerative cervical myelopathy (DCM) severity scales have significant shortcomings, creating a strong impetus for the development of a practical measurement tool with sound psychometric properties. PURPOSE: This work reports the item generation and reduction of the Cervical Myelopathy Severity Index (CMSI), a new DCM patient-reported outcome measure of symptoms and functional limitations. DESIGN: Prospective observational study. PATIENT SAMPLE: Adult DCM patients belonging to one of three distinct treatment groups: (1) observation cohort, (2) preoperative surgical cohort, (3) 6 to 12 months postoperative cohort. OUTCOME MEASURES: Patient-reported outcome measure of symptoms and functional limitations. METHODS: Item generation was performed using semi-structured patient focus groups emphasizing symptoms experienced and functional limitations. Readability was assessed through think-aloud patient interviews. Item reduction involved surveys of DCM patients with a spectrum of disease severity and board-certified spine surgeons experienced in the treatment of DCM. A priori criteria for item removal included: patient median importance/severity <2 (of 4), 30% or more no severity (response of zero), item severity correlations ≤ 0.80 (Spearman), item severity reliability (weighted kappa <0.60) based on a 2-week interval and clinician median importance <2 with retention of items with very high clinical importance. RESULTS: There were 42 items generated from a combination of specialist input and patient focus groups. Items captured sensorimotor symptoms and limitations related to upper and lower extremities as well as sphincter dysfunction. Ninety-eight patients (43, 30, 25 observation, pre- and postsurgery respectively) and 51 surgeons completed the assessment. Twenty-three items remained after application of median importance and severity thresholds and weighted kappa cutoffs. After elimination of highly correlated (>0.80) items and combining two similar items, the final CMSI questionnaire list included 14 items. CONCLUSIONS: The CMSI is a new DCM patient-reported clinical measurement tool developed using patient and clinician input to inform item generation and reduction. Future work will evaluate the reliability, validity, and responsiveness of the CMSI in relation to existing myelopathy measurement indices.
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Enfermedades de la Médula Espinal , Adulto , Humanos , Reproducibilidad de los Resultados , Enfermedades de la Médula Espinal/diagnóstico , Enfermedades de la Médula Espinal/cirugía , Psicometría , Medición de Resultados Informados por el Paciente , Estudios Prospectivos , Vértebras Cervicales/cirugíaRESUMEN
BACKGROUND AND OBJECTIVES: Central cord syndrome (CCS) is expected to become the most common traumatic spinal cord injury, yet its optimal management remains unclear. This study aimed to evaluate variability in nonoperative vs operative treatment for CCS between trauma centers in the American College of Surgeons Trauma Quality Improvement Program, identify patient- and hospital-level factors associated with treatment, and determine the association of treatment with outcomes. METHODS: Adults with CCS were identified from the Trauma Quality Improvement Program database (2014-2016). Mixed-effects modeling with a random intercept for trauma centers was used to examine the adjusted association of patient- and hospital-level variables with nonoperative treatment. The random-effects output of the model assessed the risk-adjusted variability in nonoperative treatment across centers. Outlier hospitals were identified, and the median odds ratio was calculated. The adjusted effect of nonoperative treatment on mortality, morbidity, and hospital length of stay (LOS) was examined at the patient and hospital level by mixed-effects regression. RESULTS: Three thousand, nine hundred twenty-eight patients across 255 centers were eligible; of these, 1523 (38.8%) were treated nonoperatively. Older age, noncommercial insurance (odds ratio [OR] 1.26, 95% CI 1.08-1.48, P = .004), absence of fracture (OR 0.58, 95% CI 0.49-0.68, P < .001), severe head injury (OR 1.41, 95% CI 1.09-1.82, P = .008), and comatose presentation (1.82, 95% CI 1.15-2.89, P = .011) were associated with nonoperative treatment. Twenty-eight hospitals were outliers, and the median odds ratio was 2.02. Patients receiving nonoperative treatment had shorter LOS (mean difference -4.65 days). Nonoperative treatment was associated with lesser in-hospital morbidity (OR 0.49, 95% CI 0.37-0.63, P < .001) at the patient level. There was no difference in mortality. CONCLUSION: Operative decision-making for CCS is influenced by patient factors. There remains substantial variability between trauma centers not explained by case-mix differences. Nonoperative treatment was associated with shorter hospital LOS and lesser inpatient morbidity.
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Síndrome del Cordón Central , Traumatismos Vertebrales , Adulto , Humanos , Síndrome del Cordón Central/epidemiología , Síndrome del Cordón Central/terapia , Centros Traumatológicos , Traumatismos Vertebrales/cirugía , Tiempo de Internación , América del Norte , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
STUDY DESIGN: Literature Review. OBJECTIVE: Myelopathy affecting the thoracic spinal cord can arise secondary to several aetiologies which have similar presentation and management. Consequently, there are many uncertainties in this area, including optimal terminology and definitions. Recent collaborative cervical spinal research has led to the proposal and subsequent community adoption of the name degenerative cervical myelopathy(DCM), which has facilitated the establishment of internationally-agreed research priorities for DCM. We put forward the case for the introduction of the term degenerative thoracic myelopathy(DTM) and degenerative spinal myelopathy(DSM) as an umbrella term for both DCM and DTM. METHODS: Following PRISMA guidelines, a systematic literature search was performed to identify degenerative thoracic myelopathy literature in Embase and MEDLINE. RESULTS: Conditions encompassed within DTM include thoracic spondylotic myelopathy, ossification of the posterior longitudinal ligament, ossification of the ligamentum flavum, calcification of ligaments, hypertrophy of ligaments, degenerative disc disease, thoracic osteoarthritis, intervertebral disc herniation, and posterior osteophytosis. The classic presentation includes girdle pain, gait disturbance, leg weakness, sensory disturbance, and bladder or bowel dysfunction, often with associated back pain. Surgical management is typically favoured with post-surgical outcomes dependent on many factors, including the causative pathology, and presence of additional stenosis. CONCLUSION: The clinical entities encompassed by the term DTM are interrelated, can manifest concurrently, and present similarly. Building on the consensus adoption of DCM in the cervical spine and the recent proposal of degenerative cervical radiculopathy(DCR), extending this common nomenclature framework to the terms degenerative spinal myelopathy and degenerative thoracic myelopathy will help improve recognition and communication.
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Importance: The decision to withdraw life-sustaining treatment for pediatric patients with severe traumatic brain injury (TBI) is challenging for clinicians and families with limited evidence quantifying existing practices. Given the lack of standardized clinical guidelines, variable practice patterns across trauma centers seem likely. Objective: To evaluate the factors influencing decisions to withdraw life-sustaining treatment across North American trauma centers for pediatric patients with severe TBI and to quantify any existing between-center variability in withdrawal of life-sustaining treatment practices. Design, Setting, and Participants: This retrospective cohort study used data collected from 515 trauma centers through the American College of Surgeons Trauma Quality Improvement Program between 2017 and 2020. Pediatric patients younger than 19 years with severe TBI and a documented decision for withdrawal of life-sustaining treatment were included. Data were analyzed from January to May 2023. Main Outcomes and Measures: A random intercept multilevel logistic regression model was used to quantify patient, injury, and hospital characteristics associated with the decision to withdraw life-sustaining treatment; the median odds ratio was used to characterize residual between-center variability. Centers were ranked by their conditional random intercepts and quartile-specific adjusted mortalities were computed. Results: A total of 9803 children (mean [SD] age, 12.6 [5.7]; 2920 [29.8%] female) with severe TBI were identified, 1003 of whom (10.2%) had a documented decision to withdraw life-sustaining treatment. Patient-level factors associated with an increase in likelihood of withdrawal of life-sustaining treatment were young age (younger than 3 years), higher severity intracranial and extracranial injuries, and mechanism of injury related to firearms. Following adjustment for patient and hospital attributes, the median odds ratio was 1.54 (95% CI, 1.46-1.62), suggesting residual variation in withdrawal of life-sustaining treatment between centers. When centers were grouped into quartiles by their propensity for withdrawal of life-sustaining treatment, adjusted mortality was higher for fourth-quartile compared to first-quartile centers (odds ratio, 1.66; 95% CI, 1.45-1.88). Conclusions and Relevance: Several patient and injury factors were associated with withdrawal of life-sustaining treatment decision-making for pediatric patients with severe TBI in this study. Variation in withdrawal of life-sustaining treatment practices between trauma centers was observed after adjustment for case mix; this variation was associated with differences in risk-adjusted mortality rates. Taken together, these findings highlight the presence of inconsistent approaches to withdrawal of life-sustaining treatment in children, which speaks to the need for guidelines to address this significant practice pattern variation.