AWARDNUMBER:W81XWH0130100396! TITLE: …AWARDNUMBER:W81XWH0130100396! TITLE:The Impact of Surgical...
Transcript of AWARDNUMBER:W81XWH0130100396! TITLE: …AWARDNUMBER:W81XWH0130100396! TITLE:The Impact of Surgical...
AWARD NUMBER: W81XWH-‐13-‐1-‐0396
TITLE: The Impact of Surgical Timing in Acute Traumatic Spinal Cord Injury
PRINCIPAL INVESTIGATOR: Jean-‐Marc Mac-‐Thiong, MD, PhD
CONTRACTING ORGANIZATION: Hopital du Sacre-Coeur de Montreal, Montreal H4J 1C5
REPORT DATE: October 2016
TYPE OF REPORT: Annual
PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-‐5012
DISTRIBUTION STATEMENT: Approved for Public Release; Distribution Unlimited
The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.
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2. REPORT TYPE
Annual 3. DATES COVERED
30 Sep 2015 - 29 Sep 2016 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER
5b. GRANT NUMBER
W81XWH-‐13-‐1-‐0396 5c. PROGRAM ELEMENT NUMBER
6. AUTHOR(S)Cynthia Thompson, PhD ([email protected])
5d. PROJECT NUMBER
Jean-‐Marc Mac-‐Thiong, MD, PhD ([email protected]) 5e. TASK NUMBER
5f. WORK UNIT NUMBER
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AND ADDRESS(ES)
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Hopital du Sacre-‐Coeur de Montreal, Montreal, Qc, Canada, H4J 1C5
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U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-‐5012 11. SPONSOR/MONITOR’S REPORT
NUMBER(S)
12. DISTRIBUTION / AVAILABILITY STATEMENT
Approved for Public Release; Distribution Unlimited
13. SUPPLEMENTARY NOTES
14. ABSTRACT
The optimal surgical timing following a traumatic spinal cord injury (SCI) remains controversial although some studies suggest improved neurological recovery with early surgery. Consequently, there is wide variability in clinical practice and institutional guidelines regarding optimal surgical timing after a SCI. Our study will help guide clinicians in their practice and health administrators in the distribution of resources, by determining the optimal surgical delay after a traumatic spinal cord injury. The global objective of our study is to determine the impact of surgical delay on costs, length of stay, complications, and outcomes (neurological recovery, functional status and quality of life) in patients with a traumatic SCI. Results obtained in the last reporting period show that early surgery improves neurological recovery in patients with a complete cervical lesion. Moreover, modifiable, extrinsic factors contribute to surgical delay while the patients health status does not affect this delay. 15. SUBJECT TERMS Spinal cord injury; surgery; delay; recovery; trauma; complications; length of stay; costs
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Standard Form 298 (Rev. 8-98)Prescribed by ANSI Std. Z39.18
The Impact of Surgical Timing in Acute Traumatic Spinal Cord Injury
TABLE OF CONTENTS
TABLE OF CONTENTS...................................................................................................................................... 3 1. INTRODUCTION............................................................................................................................................ 52. KEYWORDS.................................................................................................................................................... 53. ACCOMPLISHMENTS................................................................................................................................... 5What were the major goals of the project? ............................................................................................. 5 a) Recruitment of patients ........................................................................................................................................... 5b) Follow-‐up of patients................................................................................................................................................ 5c) Data collection.............................................................................................................................................................. 5d) Data analysis................................................................................................................................................................. 6e) Publications and conferences................................................................................................................................ 6
What was accomplished under these goals? .......................................................................................... 6 a) Recruitment of patients ........................................................................................................................................... 6b) Follow-‐up of patients................................................................................................................................................ 6c) Data collection.............................................................................................................................................................. 6d) Data analysis................................................................................................................................................................. 7e) Publications and conferences................................................................................................................................ 7
What opportunities for training and professional development has the project provided?..............................................................................................................................................................................20 How were the results disseminated to communities of interest? .................................................20 What do you plan to do during the next reporting period to accomplish the goals?..............20 4. IMPACT .........................................................................................................................................................20What was the impact on the development of the principal discipline(s) of the project?......20 What was the impact on other disciplines? ..........................................................................................20 What was the impact on technology transfer?.....................................................................................21 What was the impact on society beyond science and technology? ...............................................21 5. CHANGES / PROBLEMS ............................................................................................................................21Changes in approach and reasons for change......................................................................................21 Actual or anticipated problems or delays and actions or plans to resolve them.....................21 Changes that had a significant impact on expenditures ...................................................................21 Significant changes in use or care of human subjects, vertebrate animals, biohazards, and / or select agents ...............................................................................................................................................21 Significant changes in use or care of human subjects .......................................................................21 Significant changes in use or care of vertebrate animals.................................................................21 Significant changes in use of biohazards and / or select agents....................................................21 6. PRODUCTS ...................................................................................................................................................22Publications, conference papers, and presentations ........................................................................22 Journal publications..................................................................................................................................................... 22 Conference papers and presentations ................................................................................................................. 22
Website(s) or other Internet site(s)........................................................................................................23 Technologies or techniques .......................................................................................................................23 Inventions, patent applications, and/or licenses ...............................................................................23 Other products................................................................................................................................................23 7. PARTICIPANTS AND OTHER COLLABORATING ORGANIZATIONS.............................................24What individuals have worked on the project?...................................................................................24 Has there been a change in the active other support of the PD / PI or senior / key personnel since the last reporting period?...........................................................................................25 What other organizations were involved as partners?.....................................................................25 8. SPECIAL REPORTING REQUIREMENTS...............................................................................................259. Appendix 1: Manuscript published in Journal of Neurotrauma................................................26
10. Appendix 2: Manuscript published in Journal of Spinal Cord Medicine ..............................3211. Appendix 3: Manuscript accepted in American Journal of Physical Medicine andRehabilitation .................................................................................................................................................40 12. Appendix 4: Manuscript submitted to Journal of Spinal Cord Medicine..............................7213. Appendix 5: Manuscript submitted to Journal of Spinal Cord Medicine........................... 102
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1. INTRODUCTION
The optimal surgical timing following a traumatic spinal cord injury (SCI) remains controversial although some studies suggest improved neurological recovery with early surgery. Consequently, there is a wide variability in clinical practice and institutional guidelines regarding optimal surgical timing after a SCI. Our study will help guide clinicians in their practice and health administrators in the distribution of resources, by determining the optimal surgical delay after a traumatic spinal cord injury. The global objective of our prospective research is to determine the impact of surgical delay on costs, length of stay, complications, and outcomes (neurological recovery, functional status and quality of life) in a cohort of patients with a traumatic SCI. By defining the optimal surgical timing after a SCI, this study has the potential to improve the neurological and functional outcome of patients, while decreasing the costs, length of stay and complications for the acute care after a SCI. This study might ultimately modify existing guidelines for pre-‐hospital, en route care, and early hospital management of SCI patients in order to comply with the optimal surgical timing, and will also determine the optimal surgical timing that will minimize the rate of complications such as pressure ulcers and pneumonia.
2. KEYWORDS
Spinal cord; trauma; complications; costs; length of stay; recovery; quality of life; timing; surgery; rehabilitation; function; fracture; acute hospitalization; ASIA grade
3. ACCOMPLISHMENTS
What were the major goals of the project? Listed below are the major goals of this project, according to the approved statement of work.
a) Recruitment of patientsRecruitment of patients was completed in September 2014.
b) Follow-up of patientsFollow-‐up of patients is still in progress. Fifty-‐seven patients have completed their 2-‐year follow-‐up and have thus terminated their participation to this study.
c) Data collectionSocio-‐demographic, clinical, surgical and radiological data have been collected for all 138 patients enrolled in this study. All patients enrolled had their trauma prior to September 2014; thus, their 2-‐year follow-‐up and the outcome data collection should be completed.
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d) Data analysisData analysis is ongoing and results obtained so far will be detailed in the next section.
e) Publications and conferencesTo date, we have presented 3 abstracts at the 4th ASIA and ISCoS Joint Scientific Meeting held in Montreal (Canada) in May 2015, and 5 abstracts at the ASIA 2016 Annual Scientific Meeting in April 2016. One manuscript related to neurological recovery was published in Journal of Neurotrauma, and another manuscript on the barriers to early surgery was published in Journal of Spinal Cord Medicine. A third manuscript on the costs and hospitalization duration is in press in American Journal of Physical Medicine and Rehabilitation.
What was accomplished under these goals? For the third year of funding, the major goals were to pursue and complete the 1-‐year and 2-‐year follow-‐up of enrolled patients. As well, we planned to pursue analysis of the data pertaining to the acute hospitalization period and outcome measures.
The statement of work approved by USAMRMC was based on the hypothesis that funding would have begun on April 1, 2013. In fact, we received HRPO approval on February 21, 2014, and thus initiated the study at that time. Therefore, all activities reported in the approved statement of work are delayed by approximately 11 months (April 1, 2013 – February 21, 2014). We have obtained a 1-‐year no-‐cost extension, so funding end date is now September 29, 2017.
a) Recruitment of patientsRecruitment is completed since September 2014. Information related to this goal was provided in previous Annual reports.
b) Follow-up of patientsWith respect to patients’ follow-‐up, as of September 30, 2016, 84 patients had their 6-‐month follow-‐up completed, 87 patients came for their 1-‐year follow-‐up and 57 have done their 2-‐year follow-‐up. For these 57 patients, the participation to this study is terminated.
c) Data collectionWith respect to data, we have collected the information pertaining to the socio-‐demographic, clinical, surgical and radiological characteristics for all patients. Since all enrolled patients had their trauma before September 2014, all information pertaining to outcomes during the follow-‐up visits has been collected (functional recovery – SCIM; quality of life – SF-‐36 and WHO-‐QoL; ASIA).
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d) Data analysisData analyzed in the last year led to the presentation of five abstracts at the 2016 ASIA Annual Scientific Meeting, as well as to two published manuscripts. Three papers using data collected under this study were produced; one is in press in American Journal of Physical Medicine and Rehabilitation and two are submitted to Journal of Spinal Cord Medicine. The main results obtained so far are presented in the “Publications and conferences” section below.
e) Publications and conferences
We have presented abstracts at the 2016 ASIA Annual Scientific Meeting in Philadephia, PA (April 2016). Two papers were published (1 and 2), one is in press (3), and two are under review (4, 5).
Paper 1: Étienne Bourassa-Moreau, Jean-Marc Mac-Thiong, Ang Li, Debbie Ehrmann Feldman, Dany H. Gagnon, Cynthia Thompson, Stefan Parent. Do patients with complete spinal cord injury benefit from early surgical decompression? Analysis of neurological recovery in a prospective cohort study. J Neurotrauma 2016; 33(3): 301-6. (see Appendix 1)
The prognosis for neurological improvement (NI) in complete traumatic spinal cord injury is generally poor. It is unknown whether early surgical timing improves NI in the complete traumatic SCI population. The objectives of this study were: 1) to compare the effect of early and late surgical decompression on NI of complete traumatic SCI 2) to assess if surgical timing differently impacts on cervical or thoracolumbar SCI. A prospective cohort study was performed in a single Level 1 trauma center specialized in SCI care. All consecutive cases of traumatic SCI referred between 2010 and 2013 were screened for eligibility. Neurological status was assessed systematically using the ASIA grading system at first arrival to the trauma center and the NI was assessed at rehabilitation discharge. Patients operated within 24h of the trauma were compared with patients operated later than 24h after the trauma. Potential confounders were recorded such as the age, Injury Severity Score (ISS), smoking, body mass index (BMI), the Glascow Coma Scale (GCS) and duration of follow-‐up.
Fifty-‐three complete SCI were included in the study with 33 thoracic SCI and 20 cervical SCI. The 38 patients operated <24h were generally younger than the 15 patients operated after 24h although no other potential confounder were statistically different (Table 1). Overall, 28% (15/53) of complete SCI had some NI with 34% (13/38) of patients operated <24h and 13%(2/15) of patients operated ≥24h (p=0.182; Figure 1). Sixty-‐four percent (9/14) of cervical complete SCI operated <24h had some NI whereas none of the 6 complete cervical SCI operated ≥24h improved (p=0.008; Figure 2; Table 2). There was no difference in the proportion of patients with a thoracolumbar lesion who had NI based on the surgical delay (Table 2). This study suggests that surgical decompression earlier than 24h in complete SCI may promote improvement in neurological status, especially at the cervical level.
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Table 1: Demographic and clinical data of all ASIA A SCI patients
Figure 1: The percentage of ASIA grade at last follow-‐up of all patients with an initial complete SCI. Patients operated <24h post-‐trauma (38 patients) are compared to patients with operated ≥24h post-‐trauma (15 patients).
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Figure 2: The percentage of ASIA grade at last follow-‐up of initially complete cervical SCI. Patients operated <24h post-‐trauma <24h (14 patients) is compared to patients operated ≥24h post-‐trauma (6 patients).
Table 2: Conversion of ASIA grade in complete SCI operated <24h and ≥ 24h
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Paper 2: Cynthia Thompson, Debbie E. Feldman, Jean-Marc Mac-Thiong. Surgical management of patients following traumatic spinal cord injury: identifying barriers to early surgery in specialized SCI care centers . J Spinal Cord Med 2016; Apr 8: 1-7. (see Appendix 2)
Background: Early surgery in individuals with traumatic spinal cord injury (T-‐SCI) can improve neurological recovery and reduce complications, costs and hospitalization. Non-‐modifiable patient-‐related and modifiable healthcare-‐related factors could influence surgical delay. This study aimed at determining factors contributing to surgical delay in individuals with T-‐SCI.
Methods: Socio-‐demographic and clinic-‐administrative data were collected during the pre-‐operative period among a prospective cohort including 144 consecutive, eligible individuals with T-‐SCI admitted in a single Level I trauma centre. The cohort was stratified in two subgroups: early (<24h; N=93) and late (≥24h; N=51) surgery. A multivariate logistic regression analysis using patient-‐ and healthcare-‐related factors was carried out to identify the main predictors of surgical delay.
Results: The early surgical subgroup underwent surgery 15.6±4.7h post-‐trauma, which is roughly 32h earlier than the late surgery subgroup (46.9±30.9h; p<10-‐3; Table 3). For the early surgical subgroup, the transfer delay from trauma site to the SCI Level I trauma center was on average 8h shorter (5.0±3.0h vs 13.6±17.0; p<10-‐3) and the surgical team finalized the surgical plan 17h faster (6.0±4.0h vs 23.3±23.6h; p<10-‐3) than the late surgery subgroup (Figure 3). The occurrence of late surgery was predicted by three modifiable factors, mostly the transfer delay to the SCI-‐center, the delay before surgical plan completion, and the waiting time for the operating room after surgical plan completion. A one-‐hour increase in one of these factors doubles the odds of patients undergoing late surgery (Table 4). No patient-‐related factors predicted surgical delay.
Conclusions: A dedicated team for surgical treatment of individuals with T-‐SCI, involving direct transfer to the SCI-‐center and faster surgery planning and prompter access to the operating in hospitals dealing with emergencies from all subspecialties could greatly improve surgical delay and increase the rate of patients undergoing early surgery.
Table 3: Average delays (±SD) encountered by patients operated within 24h post-‐trauma (early surgery) and 24h or more following the trauma (late surgery).
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Table 4: Factors from a multiple logistic regression analysis predicting late surgery
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Paper 3: Andréane Richard-Denis, Cynthia Thompson, Jean-Marc Mac-Thiong. Costs and length of stay for the acute care of patients with motor-complete spinal cord injury (SCI) following cervical trauma: the impact of early transfer to specialized acute SCI center. Am J Phys Med Rehabil 2016; in press (also presented in abstract form at the 2016 ASIA Annual Scientific Meeting, April 2016; see appendix 3). Objective: Acute spinal cord injury (SCI) centers aim to optimize outcome following SCI. However, there is no timeframe to transfer patients from regional to SCI centers in order to promote cost-‐efficiency of acute care. Our objective was to compare costs and length of stay (LOS) following early and late transfer to SCI-‐center. Design: A retrospective cohort study involving 116 individuals was conducted. Group 1 (N=87) were managed in a SCI-‐center promptly after the trauma, whereas Group (N=29) was transfer to SCI-‐center only after surgery. Direct comparison and multivariate linear regression analyses were used to assess the relationship between costs, LOS and timing to transfer to the SCI-‐center. Results: LOS was significantly longer for Group 2 (median of 93,0 days) as compared to Group 1 (median of 40,0 days, p<10-‐3), and average costs ($CAN) were also higher (median of 17 920$ vs 10 560$; p=0.004) for Group 2, despite similar characteristics. Late transfer to the SCI-‐center was the main predictive factor of longer LOS and increased costs. Conclusions: Early admission to SCI-‐center was associated with shorter LOS and lower costs for patients sustaining tetraplegia. Early referral to a SCI-‐center before surgery could lower the financial costs for the healthcare system. Table 5: Demographic and clinical characteristics of patients early and lately transferred to a SCI-‐center following a motor-‐complete cervical SCI.
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Table 6: Hospitalization length of stay (LOS) in patients with a motor-‐complete cervical spine injury early and lately transferred to the SCI-‐center (Group 1 and Group 2) Table 7: Costs related to the hospitalization in the SCI-‐center for patients with a motor-‐complete cervical spine injury based on the timing of admission to the SCI-‐center.
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Paper 4: Andréane Richard-Denis, Debbie E. Feldman, Cynthia Thompson, Jean-Marc Mac-Thiong. Prediction of functional recovery six months following traumatic spinal cord injury during acute care hospitalization. Submitted to J Spinal Cord Injury. May 5, 2016. (see Appendix 4) Objectives: To determine factors associated with functional status six months following a traumatic cervical and thoracic spinal cord injury (SCI), with a particular interest in factors related to the acute care hospitalization stay. Design: This prospective cohort study was conducted on 159 patients hospitalized in a single specialized Level I trauma center for an acute traumatic SCI between January 2010 and February 2015. Fifteen potential predictive variables were studied. Univariate regression analyses were first performed to determine the strength of association of each variable independently with the total SCIM score. Significant ones were then included in a General linear model in order to determine the most relevant predictive factors among them. Analyses were carried out separately for tetraplegia and paraplegia. Main outcome measure: Spinal Cord Independence Measure (SCIM III) score. Results: Motor-‐complete SCI (AIS-‐A,B) was the main predictive factor associated with decreased total SCIM score in tetraplegia and paraplegia. Longer acute care length of stay and the occurrence of acute medical complications were predictors of decreased functional outcome following tetraplegia, while increased body mass index and higher trauma severity were predictive of decreased functional outcome following paraplegia. Conclusions: This study supports previous work while adding information regarding the importance of optimizing acute care hospitalization as it may influence chronic functional status following traumatic SCI.
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Table 8: Socio-‐demographic and clinical characteristics at hospital admission for individuals with tetraplegia and paraplegia (total cohort N=88)
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Table 9: Factors associated with the total SCIM score six-‐months post injury for patients with acute traumatic tetraplegia (N=43) Table 10 : Factors associated with the total SCIM score six-‐months post-‐injury for patients with acute traumatic paraplegia (N=45)
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Paper 5: Andréane Richard-Denis, Debbie E. Feldman, Cynthia Thompson, Jean-Marc Mac-Thiong. The impact of acute management in a specialized spinal cord injury center on the occurrence of medical complications following motor-complete cervical spinal cord injury. Submitted to J Spinal Cord Injury. May 17, 2016. (see Appendix 5) Context/Objective: Determine the impact of early admission and complete perioperative management in a specialized spinal cord injury (SCI) trauma center (SCI-‐center) on the occurrence of medical complications following tetraplegia. Design: A retrospective comparative cohort study of prospectively collected data involving 116 individuals was conducted. Group 1 (N=87) was early managed in a SCI-‐center promptly after the trauma, whereas Group 2 (N=29) was surgically and preoperatively managed in a non-‐specialized (NS) center before being transferred to the SCI-‐center. Bivariate comparisons and multivariate logistic regression analyses were used to assess the relationship between the type of acute care facility and the occurrence of medical complications. Length of stay (LOS) in acute care was also compared. Setting: Single Level-‐1 trauma center. Participants: Individuals with acute traumatic motor-‐complete cervical SCI. Interventions: Not applicable Outcome measures: The occurrence of complications during the SCI-‐center stay. Results: There was a similar rate of complications between the two groups. However, the LOS was greater in Group 2 (p=0.004). High cervical injuries (C1-‐C4) showed an important tendency to increase the likelihood of developing a complication, while high cervical injuries and increased trauma severity increased the odds of developing respiratory complications. Conclusion: Management in a SCI-‐center even at a later stage during the acute hospitalization will limit the rate of complications to a level similar to that observed in patients managed exclusively in a SCI-‐center, but at the expense of a longer LOS. Prompt transfer to a SCI-‐center for complete perioperative management is recommended for motor-‐complete cervical SCI.
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Table 11: Demographic and clinical characteristics of patients early and lately transferred to a SCI-‐center following a motor-‐complete cervical SCI
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Table 12: Comparison of medical complications and length of stay according to the type of perioperative acute care facility following a motor-‐complete cervical traumatic SCI
Table 13: Factors associated with the occurrence of medical complications during the acute care hospitalization using multivariate logistic regression analyses
Table 14: Factors associated with the occurrence of respiratory complications during the acute care hospitalization using multivariate logistic regression analyses
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What opportunities for training and professional development has the project provided? Nothing to report
How were the results disseminated to communities of interest? Nothing to report for this period
What do you plan to do during the next reporting period to accomplish the goals? We plan on analyzing data related to the impact of surgical delay on functional outcomes and quality of life. The results should be submitted in abstract form to upcoming international conferences interested in spinal cord injuries. We also intend to submit manuscripts derived from the abstracts and presentations to peer-‐reviewed journals in the field of neurotrauma and SCI.
4. IMPACT
What was the impact on the development of the principal discipline(s) of the project? Results from paper #1 emphasize the importance of performing early surgery even in SCI patients with a complete injury, in whom the potential for recovery is usually thought to be very poor. Results from paper #2 show that the delay between trauma and surgery does not depend on the patient’s health status but on logistical factors that could potentially be modified to decrease that delay. Results from papers #3 and #5 show that early referral to a specialized SCI-‐center for perioperative management following a traumatic SCI is beneficial in reducing hospitalization duration and costs on the healthcare system (paper #3) as well as by requiring less resources for preventing / managing medical complications (paper #5). Results from paper #4 show that clinical factors related to the acute hospitalization period are associated with the chronic functional outcome in tetraplegic and paraplegic patients. Some factors are non-‐modifiable but other could be modified by optimizing the acute care following a traumatic spinal cord injury.
What was the impact on other disciplines? Nothing to report
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What was the impact on technology transfer? Nothing to report
What was the impact on society beyond science and technology? Nothing to report
5. CHANGES / PROBLEMS
Changes in approach and reasons for change Nothing to report
Actual or anticipated problems or delays and actions or plans to resolve them The main issue in this study was with respect to the compliance of patients to come to their follow-‐up appointments. We do not anticipate problems or delays in the next year.
Changes that had a significant impact on expenditures Nothing to report
Significant changes in use or care of human subjects, vertebrate animals, biohazards, and / or select agents Nothing to report
Significant changes in use or care of human subjects Nothing to report
Significant changes in use or care of vertebrate animals Nothing to report
Significant changes in use of biohazards and / or select agents Nothing to report
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6. PRODUCTS
Publications, conference papers, and presentations
Journal publications Étienne Bourassa-‐Moreau, Jean-‐Marc Mac-‐Thiong, Ang Li, Debbie Ehrmann Feldman, Dany H. Gagnon, Cynthia Thompson, Stefan Parent. Do patients with complete spinal cord injury benefit from early surgical decompression? Analysis of neurological recovery in a prospective cohort study. J Neurotrauma 2016; 33(3): 301-‐6. (see Appendix 1) Cynthia Thompson, Debbie E. Feldman, Jean-‐Marc Mac-‐Thiong. Surgical management of patients following traumatic spinal cord injury: identifying barriers to early surgery in specialized SCI care centers . J Spinal Cord Med 2016; Apr 8: 1-‐7. (see Appendix 2) Andréane Richard-‐Denis, Cynthia Thompson, Jean-‐Marc Mac-‐Thiong. Costs and length of stay for the acute care of patients with motor-‐complete spinal cord injury (SCI) following cervical trauma: the impact of early transfer to specialized acute SCI center. Am J Phys Med Rehabil 2016; in press (see Appendix 3) Andréane Richard-‐Denis, Debbie E. Feldman, Cynthia Thompson, Jean-‐Marc Mac-‐Thiong. Prediction of functional recovery six months following traumatic spinal cord injury during acute care hospitalization. Submitted to J Spinal Cord Injury. May 5, 2016. (see Appendix 4) Andréane Richard-‐Denis, Debbie E. Feldman, Cynthia Thompson, Jean-‐Marc Mac-‐Thiong. The impact of acute management in a specialized spinal cord injury center on the occurrence of medical complications following motor-‐complete cervical spinal cord injury. Submitted to J Spinal Cord Injury. May 17, 2016. (see Appendix 5)
Conference papers and presentations Cynthia Thompson, Stefan Parent, Debbie Ehrmann Feldman, Jean-‐Marc Mac-‐Thiong. Factors predicting the delay between trauma and surgery in a prospective cohort admitted with a traumatic spinal cord injury; Oral presentation at the Montreal Interprofessional Trauma Conference (Montreal, Canada, September 2016); Oral presentation at the 2016 ASIA Annual Scientific Meeting (international conference; Philadelphia, April 2016) * Andréane Richard-‐Denis, Cynthia Thompson, Debbie Ehrmann Feldman, Étienne Bourassa-‐Moreau, Jean-‐Marc Mac-‐Thiong. Costs and length of stay for the acute care of patients with motor-‐complete spinal cord injury following cervical trauma: the impact of early peri-‐operative management in a specialized acute SCI center.Oral presentation at the 2016 ASIA Annual Scientific Meeting (international conference; Philadelphia, April 2016) *
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Cynthia Thompson, Andréane Richard-‐Denis, Debbie E. Feldman, Stefan Parent, Jean-‐Marc Mac-‐Thiong. Factors predicting functional outcome one year after a traumatic spinal cord injury: results from a prospective study; Poster presentation at the 2016 ASIA Annual Scientific Meeting (international conférence; Philadelphia, April 2016) *
Andréane Richard-‐Denis, Cynthia Thompson, Debbie Ehrmann Feldman, Jean-‐Marc Mac-‐Thiong. The impact of acute management in a specialized spinal cord injury center on the occurrence of medical complications following motor-‐complete cervical spinal cord injury. Oral presentation at the 2016 ASIA Annual Scientific Meeting (international conférence; Philadelphia, April 2016) Andréane Richard-‐Denis, Cynthia Thompson, Debbie Ehrmann Feldman, Jean-‐Marc Mac-‐Thiong. Requirement for tracheostomy and duration of mechanical ventilation support in patients with a complete cervical traumatic spinal cord injury: the influence of early management in a SCI-‐specialized center; Oral présentation at the 2016 ASIA Annual Scientific Meeting (international conférence; Philadelphia, April 2016)
Website(s) or other Internet site(s) Nothing to report
Technologies or techniques Nothing to report
Inventions, patent applications, and/or licenses Nothing to report
Other products Nothing to report
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7. PARTICIPANTS AND OTHER COLLABORATING ORGANIZATIONS
What individuals have worked on the project? Please note that at our institution, a regular workday is 7 hours and the schedule is based on 35 hours of work per week. We however calculated the number of “person month” worked based on 160 hours of effort as indicated in the USAMRMC report guidelines. Name Project role Researcher identifier Nearest person month worked Contribution to project Funding support
Dr Jean-‐Marc Mac-‐Thiong Principal investigator / director N/A 0.5 Supervision of staff and data collection; revision of documents No funding other than USAMRMC
Name Project role Researcher identifier Nearest person month worked Contribution to project Funding support
Cynthia Thompson Research assistant N/A 5 Data collection, reduction and analysis; communication with USAMRMC No funding other than USAMRMC
Name Project role Researcher identifier Nearest person month worked Contribution to project Funding support
Geneviève Leblanc Research assistant N/A 1 Recruitment and enrollment of patients No funding other than USAMRMC
Name Project role Researcher identifier Nearest person month worked Contribution to project Funding support
Louisane Dupré (until December 23, 2015) Research nurse N/A 2 Follow-‐up of patients, data collection No funding other than USAMRMC
Name Project role Researcher identifier Nearest person month worked Contribution to project Funding support
Sophie Bruneau (since December 23, 2015) Research nurse N/A 2 Follow-‐up of patients, data collection No funding other than USAMRMC
Name Project role Researcher identifier Nearest person month worked Contribution to project Funding support
Nathalie Ouellet Medical archivist N/A 1 Data collection No funding other than USAMRMC
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Has there been a change in the active other support of the PD / PI or senior / key personnel since the last reporting period? Nothing to report
What other organizations were involved as partners? Nothing to report
8. SPECIAL REPORTING REQUIREMENTS Nothing to report
9. Appendix 1: Manuscript published in Journal of Neurotrauma
Do Patients with Complete Spinal Cord Injury Benefitfrom Early Surgical Decompression? Analysis of Neurological
Improvement in a Prospective Cohort Study
Etienne Bourassa-Moreau,1.2 Jean-Marc Mac-Thiong,1–3 Ang Li,1,2 Debbie Ehrmann Feldman,1
Dany H. Gagnon,1 Cynthia Thompson,2 and Stefan Parent1–3
Abstract
The prognosis for patients with a complete traumatic spinal cord injury (SCI) is generally poor. It is unclear whether somesubgroups of patients with a complete traumatic SCI could benefit from early surgical decompression of the spinal cord.The objectives of this study were: (1) to compare the effect of early and late surgical decompression on neurologicalrecovery in complete traumatic SCI and (2) to assess whether the impact of surgical timing is different in patients withcervical or thoracolumbar SCI. A prospective cohort study was followed in a single Level 1 Trauma Center specializing inSCI care. All consecutive patients who sustained a traumatic SCI and were referred between 2010 and 2013 were screenedfor eligibility. Neurological status was assessed systematically using the American Spinal Injury Association impairmentscale (AIS) at arrival to the trauma center and at rehabilitation discharge. Patients operated within 24 h of the trauma werecompared with patients operated later than 24 h after the trauma. Potential confounders such as age, Injury Severity Score(ISS), smoking history, body mass index (BMI), Glasgow Coma Scale (GCS) score, and duration of follow-up wererecorded. Fifty-three patients with complete SCI were included in the study: 33 thoracolumbar and 20 cervical SCIs. The38 patients operated <24 h were generally younger than the 15 patients operated ‡24 h ( p = 0.049). Overall, 28% (15/53) ofcomplete SCI had improvement in AIS: 34% (13/38) who were operated <24 h and 13% (2/15) who were operated ‡24 h( p = 0.182). Sixty-four percent (9/14) of cervical complete SCI operated <24 h had improvement in AIS as opposed tonone in the subgroup of six complete cervical SCI operated ‡24 h ( p = 0.008). Surgical decompression within 24 h incomplete SCI may optimize neurological recovery, especially in patients with cervical SCI.
Key words: ASIA impairment scale; fracture; spinal cord; spinal cord injury; spine; surgery; surgical timing; trauma
Introduction
The effect of surgical timing on neurological recovery aftera traumatic spinal cord injury (SCI) has been extensively
studied in the last few decades. Studies have shown that earlysurgery is usually associated with improved neurological recov-ery.1–8 The effect of early surgery for complete traumatic SCI (i.e.,where no motor or sensory function is preserved at the most caudallevel below the lesion) is generally believed to be poor, however.Animal studies suggest that more severe SCI responds poorly tosurgical decompression even if surgery is performed within hoursof the trauma.9–11
A recent survey of spine surgeons showed a trend toward de-laying surgical decompression in complete SCI compared withincomplete SCI.12 Moreover, the clinical decision-making tool,
Thoracolumbar Injury Classifications and Severity System, mini-mizes the importance of surgery for complete SCI comparatively toincomplete SCI.13 Some authors even suggest that surgical de-compression in complete SCI is futile.1 The review of Fawcett andassociates,14 however, on the natural history of traumatic SCIshows that 80% of complete American Spinal Injury Association(ASIA) impairment scale (AIS) A remains AIS A, 10% regaining tosome sensory function (AIS B and about 10% of the initial AIS Apatients regaining some motor function (AIS C).
Whether cervical and thoracolumbar patients classified as hav-ing an AIS A SCI carry the same prognosis for neurological re-covery remains unclear. Local anatomical factors render thethoracic area more susceptible to severe traumatic SCI comparedwith the cervical area.15 The thoracic spinal cord is well protectedby the rib cage, which leads to a much higher amount of energy
1Faculty of Medicine, University of Montreal, Montreal, Quebec, Canada.2Hopital du Sacre-Coeur, Montreal, Quebec, Canada.3CHU Sainte-Justine, Montreal, Quebec, Canada.
JOURNAL OF NEUROTRAUMA 33:301-306 (February 1, 2016)ª Mary Ann Liebert, Inc.DOI: 10.1089/neu.2015.3957
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necessary to traumatize the spinal cord than in the cervical region.The thoracic spinal cord has limited vascularity and a smallervertebral canal compared with the cervical spinal cord. Therefore,it may be important to distinguish between thoracic and cervicalSCI, when referring to the prognosis for recovery.
So far, no prospective studies compared the neurological re-covery in complete traumatic SCI in patients who underwent earlyand late surgical timing.
The objectives of this study were:
1. To evaluate the impact of early surgical decompression onneurological recovery in complete SCI.
2. To compare the neurological recovery between thor-acolumbar and cervical complete SCI.
We hypothesized that the subgroup of cervical complete SCIwould respond better to early surgical decompression than thor-acolumbar SCI in terms of neurological recovery.
Methods
A prospective cohort study was performed in a Level I TraumaCenter specializing in SCI care. All consecutive patients admittedwith a traumatic SCI from April 2010 to April 2013 were screenedfor eligibility.
Inclusion criteria were:
! Minimal age of 16! AIS A traumatic SCI at initial presentation before surgery! Vertebral fracture and/or luxation from C1 to L2
Exclusion criteria were:
! Neurological or cognitive impairment precluding reliableneurological evaluation
! Surgical intervention performed >3 days after the trauma! Surgical decompression and fusion performed in anothercenter
The study protocol was approved by the Institutional ReviewBoard, and all patients signed informed consent for their partici-pation in the study.
Management of SCI
Immediately after arriving at the hospital, all patients wereevaluated by the emergency specialist, the trauma team, and thespine surgeon. If no other neurological or medical condition pre-cluded neurological evaluation, the first AIS assessment was madeat that time point. Complete radiological evaluation includingstandard radiographs, computed tomography, and/or magneticresonance imaging were performed to assess the compression andinjury to the spinal cord.
Cervical traction was applied in the presence of cervical dislo-cation or significant cervical misalignment causing spinal cordcompression. Cervical traction was not used if neurological eval-uation was unreliable or if surgery was to be performed within 1 hof the diagnosis. Administration of high dose corticosteroids wasnot used in our institution during the study period.
The surgical approach and the indication for decompressionwere selected by the spine surgeon according to the neurologicaland radiological evaluations. After the acute hospitalization phase,all patients were transferred to a SCI intensive specialized inpatientrehabilitation program at a rehabilitation facility where they stayeduntil their physical and functional status reached a plateau in AIS.
Independent variable. Surgical timing (in hours) was de-fined as the time elapsed between the trauma and the surgical in-cision and constitutes the independent variable for the study.
Various points of discrimination for early surgical timing are usedin the literature ranging from 8 h to 4 days.5–8,12,16 A 24 h cutoffwas selected, however, because it is often recognized as the mostrealistic timing for early surgery that is achievable in the clinicalsetting and consistent with the biology of secondary injury in SCI.12
Dependent variable. The neurological recovery consisting ofimprovement in the AIS between the preoperative state and dis-charge from the rehabilitation center was defined as the dependentvariable for this study. ASIA assessment was performed preopera-tively by a physician member of the surgical team and at rehabili-tation discharge by a physician specialized in SCI rehabilitation.
Confounding variables studied. Possible prognostic factorsfor neurological recovery were recorded: severity of traumatic in-juries assessed by Injury Severity Score (ISS), age, pre-existingcomorbidities, smoking, body mass index (BMI), Glasgow ComaScale (GCS) score, and duration of follow-up. The level of neu-rological lesion was divided into cervical (C1–T1) and thor-acolumbar (T2–L5) lesions.
Statistics
All statistical analyses were performed using the IBM SPSSStatistics 19 (Chicago, IL). The chi-square test was used for cate-gorical variables. For continuous variables, either Student t tests (ifKolmogorov-Smirnov test confirmed a normal distribution of thevariable), or Mann-Whitney U tests were used. The level of sta-tistical significance was selected to be alpha = 0.05.
Descriptive statistics and bivariate analyses were used to char-acterize our cohort and to compare those who were operated within24 h to those operated ‡24 h. We constructed a regression model toassess whether time of surgery was associated with the outcomes,adjusting for potential confounders. To address our second objective,we compared the proportions of neurological recovery (improve-ment in AIS) between thoracolumbar and cervical complete SCI.
Results
Fifty-five consecutive patients with a complete SCI (AIS A)injury were included in our study. Two patients, however, wereexcluded, because they had surgery performed >3 days after thetrauma, leaving 53 patients for statistical analyses. There were 33thoracolumbar and 20 cervical cases with complete SCI.
Seventy-two percent of patients (38/53 patients) were operated<24 h post-trauma whereas 28% (15/53) were operated ‡24 h post-trauma. Patients operated within 24 h were on average 10 yearsyounger ( p = 0.049). The proportion of females and patients whohad comorbidities tended to be smaller in the early surgery group,although the differences were not statistically significant. The twogroups were not different in terms of ISS, BMI, smoking status, andGCS score (Table 1).
Cervical traction was used in 7 (35%) of the 20 cases of cervicaltrauma. Six (86%) of these patients were operated within 24 h. Four(57%) of these seven patients had some neurological recovery.Figure 1 depicts the percentage of patients with their AIS at lastfollow-up in groups having surgery <24 h and ‡24 h for all patients.
Altogether, 15/53 patients with complete SCI improved neuro-logically after surgery (28% of sample). At last follow-up, six pa-tients improved to AIS B, three to AIS C, and six to AIS D (Fig. 1).A greater proportion of patients who had surgery within the first24 h post-trauma had some neurological improvement at dischargefrom rehabilitation compared with patients operated later. Indeed,34% (13/38) of patients in the early surgery group improved from acomplete (AIS A) to an incomplete spine injury (AIS B, C, or D),
302 BOURASSA-MOREAU ET AL.
compared with only 13% of patients operated more than 24 h aftertrauma. This difference in favor of early surgery did not reachstatistical significance ( p= 0.18).
Analysis of cervical and thoracolumbar complete SCI
Patients with a complete SCI were separated based on the levelof their injury. Table 2 presents demographic and clinical data ofpatients with SCI with a complete injury at the thoracolumbar level,and Table 3 shows the characteristics of patients with a completecervical injury.
There were no statistically significant differences in the clinicaland demographic characteristics in patients with a thoracolumbarinjury who had early or late surgery, although they tended to be 10years younger ( p = 0.09). The follow-up duration was longer inpatients operated more than 24 h post-trauma (163.6 days vs. 139.1days), but this difference was not statistically significant. Similarresults were obtained for patients with a cervical lesion (Table 3),where patients operated within 24 h post-trauma were a decadeyounger, although this difference was not significant ( p= 0.20).The follow-up delay tended to be longer for patients who had earlysurgery (170 vs. 147 days), but once again, this did not reach sta-tistical significance.
A total of six (18%) patients with a thoracolumbar injury had someneurological improvement at discharge from rehabilitation. Thesurgical delay did not impact on the proportion of patients whoimproved on the AIS, where 4/24 (17%) had early surgery and 2/9(22%) were operated later (Table 4) ( p= 0.99). Of the four patientswho improved in the early surgery thoracolumbar group, two im-proved to AIS B and two improved to AIS D at rehabilitation dis-charge. One thoracolumbar patient operated later than 24h improvedto AIS C while the other improved to an AIS D level (Fig. 2).
Contrary to patients with a thoracolumbar injury, whose recoverywas not linked to the surgical delay, Table 4 shows that 9/14 (64%)patients with cervical SCI operated within 24h showed AIS im-provement whereas none of the six patients with cervical SCI op-erated ‡24 h improved ( p= 0.008). Five patients improved from AISA to AIS B, one recovered to AIS C, and the remaining three patientswere graded AIS D at discharge from rehabilitation (Fig. 3).
In an effort to detect the presence of bias, we stratified ouranalysis of neurological recovery with possible confounding fac-tors. Our population was stratified in thoracic (T2–T9) and
Table 1. Demographic and Clinical Data of All 53American Spinal Injury Association Impairment
Scale A Spinal Cord Injury
<24 h ‡24 h TotalMean – SD Mean – SD Mean – SD p value
N 38 15 53Age (years) 39.6 – 16.6 49.6– 15.4 42.4– 16.8 0.049Sex (female) 11% (4/38) 27% (4/15) 15% (8/53) 0.202BMI (kg/m2) 26.3 – 3.9 26.0– 4.0 26.2– 3.9 0.953Comorbidity 26% (10/38) 40% (6/15) 30% (16/53) 0.342Nonsmoker 76% (29/38) 67% (10/15) 74% (39/53) 0.729GCS 13.8 – 2.5 13.7– 2.4 13.8– 2.4 0.770ISS 32.1 – 10.8 34.4– 14.1 32.8– 11.7 0.252Surgical
timing (h)16.1 – 4.9 39.1– 16.3 22.6– 14.1 <0.001
Follow-up (days) 150.6 – 39.7 156.9– 31.2 152.4– 37.3 0.580
SD, standard deviation; BMI, body mass index; GCS, Glasgow ComaScale; ISS, Injury Severity Score.
FIG. 1. The percentage of American Spinal Injury Association(ASIA) grade at last follow-up (FU) of all initially complete spinalcord injury (SCI). Patients with surgical timing <24 h (38 patients)are compared with patients with surgical timing ‡24h (15 patients).
Table 2. Demographic and Clinical Data of 33 Patientswith American Spinal Injury Association Impairment
Scale A Thoracolumbar Lesions
Thoracolumbarcomplete SCI
<24 h ‡24 h TotalMean – SD Mean – SD Mean – SD p value
N 24 9 33Age (years) 40.9– 18.7 51.2– 16.5 43.7 – 18.5 0.091Sex (female) 8% (2/24) 11% (1/9) 9% (3/33) 0.999BMI (kg/m2) 25.8 – 3.6 26.5– 3.8 26.0 – 3.6 0.239Comorbidity 25% (6/24) 22% (2/9) 24% (8/33) 0.999Nonsmoker 83% (20/24) 67% (6/9) 79% (26/33) 0.625GCS 14.7 – 0.9 14.3– 1.3 14.6 – 1.0 0.993ISS 30.9 – 7.1 33.3– 3.3 31.5 – 6.3 0.381Surgical
timing (h)16.9 – 4.5 40.1– 19.7 23.2 – 14.9 <0.001
Follow-up (days) 139.1– 40.5 163.6– 20.9 145.8 – 37.6 0.166
SD, standard deviation; BMI, body mass index; GCS, Glasgow ComaScale; ISS, Injury Severity Score.
Table 3. Demographic and Clinical Data of 20 Patientswith American Spinal Injury Association Impairment
Scale A Cervical Lesions
Cervicalcomplete SCI
<24 h ‡24 h TotalMean – SD Mean – SD Mean – SD p value
N 14 6 20Age (years) 37.3– 12.5 47.1– 14.7 40.3 – 13.6 0.199Sex (female) 14% (2/14) 50% (3/6) 25% (5/20) 0.131BMI (kg/m2) 27.1 – 4.4 25.2– 4.4 26.6 – 4.4 0.739Comorbidity 29% (4/14) 67% (4/6) 40% (8/20) 0.161Nonsmoker 64% (9/14) 67% (4/6) 65% (11/20) 0.999GCS 12.3 – 3.5 12.8– 3.4 12.5 – 3.3 0.998ISS 34.6 – 16.0 36.0– 22.2 35.1 – 17.7 0.999Surgical
timing (h)14.8 – 5.5 37.5– 10.9 21.7 – 12.8
Follow-up (days) 170.1– 30.3 147.0– 42.7 163.2 – 35.1 0.353
SD, standard deviation; BMI, body mass index; GCS, Glasgow ComaScale; ISS, Injury Severity Score.
COMPLETE SCI: SURGICAL TIMING AND IMPROVEMENT 303
thoracolumbar lesions (T10–L2), age >40 years, and ISS >30. Ourcohort comprised 17 patients with thoracic neurological lesion and16 patients with thoracolumbar lesions. Two of 17 patients withthoracic lesions improved their AIS whereas 4 of 16 with thor-acolumbar lesions improved their AIS ( p= 0.593).
Stratification analysis for agewas performed to assess the effect ofyounger age in the early surgery group. Patients <40 and ‡40 yearsold had similar recovery rate when operated <24 h (Table 4). ISS >30was also studied as stratification analysis and was not associated withworse neurological prognosis ( p= 0.999).
Discussion
This study suggests that surgical decompression and stabiliza-tion earlier than 24 h after a traumatic complete SCI may improveneurological recovery and particularly for those with cervical le-sions. Previous retrospective cohort studies that examined patientswith incomplete and complete SCI suggested a potential for neu-rological recovery with early surgical intervention.17–19 This is thefirst study examine this hypothesis in a population of solely com-plete SCI.
The neurological benefit of early surgery in complete cervicallesions is in agreement with the observations from the SurgicalTiming in Acute Spinal Cord Injury Study (STASCIS) projectconducted recently.8 The STASCIS showed a conversion rate of
43% (19 of 44 patients) in the early surgery group (<24 h) comparedwith 37% (10 of 17 patients) in the late surgery group (‡24 h).
Cengiz and colleagues7 suggest a tendency toward better neu-rological improvement in patients having surgery within 8 h afteran acute thoracolumbar SCI. It is possible that a very short surgicaldelay such as that proposed by Cenzig and colleagues7 (<8 h vs.>72 h) is necessary to obtain a significant improvement in neuro-logical recovery in patients with thoracolumbar injuries.
We did not find improvement in patients with thoracolumbarSCI who underwent surgery <24 h compared with the later group.The average surgical timing in our early and late surgery groups,however, were, respectively, 16.9 and 40.1 h. While the level of thelesions included in the study from Cenzig and colleagues7 is pre-dominantly at the thoracolumbar junction, it is also possible thatour results differ because of the higher proportion of high- ormidthoracic SCI in our cohort. Subanalysis of our cohort showed nostatistical difference between thoracic and thoracolumbar neuro-logical improvement.
Wilson and coworkers20 analyzed the effect of surgical timing ina prospective cohort of traumatic SCI. A multivariate analysis onpredictors of ASIA motor score (AMS) at rehabilitation dischargewas performedwith the data of 55 patients with SCI with ASIAA toD impairment. Similar to the findings of our study, early surgicaldecompression, incomplete SCI, and cervical trauma (rather thanthoracic or thoracolumbar) were associated with AMS improve-ment at rehabilitation discharge.
Fractures at high- or midthoracic levels (T2–T9) may behavedifferently compared with thoracolumbar lesions because of poorervascularity, smaller vertebral canal, and the higher energy neededto cause a vertebral trauma associated with SCI. Accordingly,Zariffa and associates21 reported that the AIS conversion rate inpatients with lower (T10–T12) complete thoracic lesions weremore likely to improve their motor score compared with those withhigher T6–T9 and T2–T5 lesions. This may support the opinion ofPetitjean and coworkers1 that there is no indication for early sur-gical decompression in complete thoracic SCI. Although ourstratified analysis revealed a similar trend toward better neurolog-ical recovery for thoracolumbar compete SCI, it did not show anysignificant difference.
Study limitations
The small size of our cohort is a limitation of this study; how-ever, to our knowledge, this is the first study to assess this question
Table 4. Conversion of American Spinal InjuryAssociation Grade in Complete Spinal Cord
Injury Operated <24h and ‡24h
<24 h ‡24 h Totalp
value*
All patients 34% (13/38) 13% (2/15) 28% (15/53) 0.182
Stratification for lesion levelThoracolumbar
SCI17% (4/20) 22% (2/9) 18% (6/33) 0.999
Cervical SCI 64% (9/14) 0% (0/6) 45% (9/20) 0.008
Stratification for ageAge <40 36% (8/22){ 33% (1/3)* 36% (9/25) 0.999Age ‡40 31% (5/16){ 8% (1/12)* 21% (6/28) 0.196
SCI, spinal cord injury.Improvement rate was not statistically different between the two age
groups ({, p = 0.9999; *, p = 0.370).
FIG. 2. The percentage of American Spinal Injury Association(ASIA) grade at last follow-up (FU) of initially complete cervicalSCI. Patients with surgical timing <24 h (14 patients) are com-pared with patients with surgical timing ‡24 h (6 patients).
FIG. 3. The percentage of American Spinal Injury Association(ASIA) grade at last follow-up (FU) of all initially complete thor-acolumbar SCI. Patients with surgical timing <24 h (24 patients) arecompared with patients with surgical timing ‡24h (9 patients).
304 BOURASSA-MOREAU ET AL.
in persons with complete SCI. It also must be noted that completeSCI represents only 45–50% of the total SCI population.22–24 Thisstudy focused on a specific subgroup of complete SCI that werefurther subdivided in thoracolumbar and cervical lesions. Our co-hort of cervical SCI comprised 20 cervical SCI and 33 thor-acolumbar SCI recruited over a 2-year period. The STASCIS studyrecruited 71 patients with complete cervical SCI over 5 years in sixcenters.8 Because our study was a single center study and recruit-ment occurred over a shorter period, this may reduce the impact ofvariability in management associated with different centers and indifferent periods.
Another limitation relates to the varying and relatively shortduration of follow-up to assess the neurological recovery. The timeelapsed between trauma and discharge from rehabilitation variedfrom 74 days to 208 days. The duration of follow-up, however, wassimilar between the cohorts having early versus late surgery, aswell as for cervical and thoracolumbar lesions taken separately. Inaddition, previous data suggest that 80% of conversion of AIShappens within the first 98 days after SCI, and only five patients inour cohort had a follow-up less than 98 days.
Although precise timing data for surgical decompression wascollected, timing of utilization of cervical traction and of neurologicalevaluation were not prospectively collected. These two factors mayimpact on the measured neurological recovery. Timing of neurolog-ical assessment very early after trauma may render harder the detec-tion of subtle incomplete neurological injury because of the clinicalsetting. This phenomenon may create bias toward the hypothesis ofour study. Less reliable early neurological assessment, however, is anunavoidable issue in acute care of patients with traumatic SCI. Theexclusion criteria of patients with unreliable neurological assessmentmay limit the impact of this bias in this study.
In the case of cervical traction, its early use may improve neu-rological recovery. Its use in the late surgery group may be a biasagainst our main hypothesis. Only one of the seven patients withcervical traction, however, had surgical decompression >4 h. Be-cause patients who had decompression with cervical traction weremostly operated early anyway, this bias may have very limitedimpact on the measured outcome.
A fourth limitation relates to our study design, which was ob-servational. In a modern healthcare setting, it is considered un-ethical to randomize surgical timing in SCI. Therefore the variationin surgical timing is the result of time needed for patient transfer,radiological assessment, delays related to stabilization of a medicalcondition and associated injuries, and restricted access to the op-erating room. This may introduce a healthcare access bias, becauseolder and severely injured patients with more comorbidities tend tohave their surgery delayed.
Conclusions and Recommendations
Some may consider complete SCI with fatalism, because itcarries a poor neurological prognosis. Neurological improvement,however, is proven possible in this population. The findings of thisstudy suggests that early surgical intervention within 24 h after atraumatic complete SCI may promote neurological recovery, es-pecially for those with cervical level lesions. Therefore, we rec-ommend keeping surgical timing at least lower than 24 h to promoteneurological recovery.
Acknowledgments
The authors acknowledge the support of Fonds de Recherche enSante du Quebec, the MENTOR program: the Canadian Institutes
of Health Research program on mobility and posture and the USArmy Medical Research and Material Command.
Author Disclosure Statement
No competing financial interests exist.
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Address correspondence to:Jean-Marc Mac-Thiong, MD, PhD
Department of SurgeryHopital du Sacre-Coeur de Montreal
5400 Boulevard Gouin OuestMontreal, QuebecCanada H4J 1C5
E-mail: [email protected]
306 BOURASSA-MOREAU ET AL.
10. Appendix 2: Manuscript published in Journal of Spinal Cord Medicine
Research article
Surgical management of patients followingtraumatic spinal cord injury: identifyingbarriers to early surgery in a specialized spinalcord injury centerCynthia Thompson*1, Debbie E. Feldman2, Jean-Marc Mac-Thiong1,3,4
1Research Center, Hôpital Sacré-Cœur de Montréal, Montréal, Québec, Canada, 2School of Rehabilitation,University of Montréal, Montréal, Québec, Canada, 3Department of Surgery, Université de Montréal, Montréal,Québec, Canada, 4Department of Surgery, Hôpital Ste-Justine, Montréal, Québec, Canada
Context/Objective: Early surgery in individuals with traumatic spinal cord injury (T-SCI) can improveneurological recovery and reduce complications, costs and hospitalization. Patient-related and healthcare-related factors could influence surgical delay. This study aimed at determining factors contributing to surgicaldelay in individuals with T-SCI.Design: Prospective cohort study.Setting: Single Level I trauma center in Québec, Canada.Participants: One hundred and forty-four patients who sustained a T-SCI.Interventions: None.Outcome measures: Socio-demographic and clinical administrative data were collected during the pre-operative period. The cohort was stratified in early surgery, or ES (<24 hours post-trauma) and late surgery,or LS (! 24 hours post-trauma) groups. A multivariate logistic regression analysis using patient- andhealthcare-related factors was carried out to identify the main predictors of LS.Results: 93 patients had ES (15.6 ± 4.7 hours post-trauma), which is 31 hours earlier than the 51 patients in theLS group (46.9 ± 30.9 hours; P < 10"3). The transfer delay from trauma site to the SCI center was 8 hoursshorter (5.0 ± 3.0 hours vs 13.6 ± 17.0; P < 10"3) for the ES group, and the surgical plan was completed 17hours faster (6.0 ± 4.0 hours vs 23.3 ± 23.6 hours; P < 10"3) than for the LS group. The occurrence of LSwas predicted by modifiable factors, such as the transfer delay to the SCI center, the delay before surgicalplan completion, and the waiting time for the operating room.Conclusions: A dedicated team for surgical treatment of individuals with T-SCI, involving direct transfer to theSCI center, faster surgery planning and access to the operating room in hospitals dealing with emergenciesfrom all subspecialties could improve surgical delay and increase the rate of patients undergoing ES.
Keywords: Delay, Pre-operative management, Prospective study, Spinal cord injury, Surgery
IntroductionAlthough relatively rare, traumatic spinal cord injuries(T-SCI) have a devastating impact on the physical andpsychological status of patients by decreasing qualityof life, social participation and productivity.1,2 Theworldwide estimated incidence of T-SCI varies from10.4 to 83 cases per million3 due to several regionaldifferences4 and trends over time. In Canada, the age-
adjusted incidence of T-SCI is 51.4 cases per millionin persons older than 64 years and 42.4 cases permillion among those 15–64 years of age.5
T-SCI involve a significant financial burden onpatients and the healthcare system. Costs of T-SCI tosociety were estimated in 2006 at 9.7 billion USD peryear in the United States,9 In Canada, costs in the firstyear after T-SCI were estimated between 43 400 and122 900 Canadian Dollars (CAD) (in 2002;27,637–78,262 USD) depending on the severity of theneurological deficit.10
*Corresponding to: Cynthia Thompson, Research Center, Hôpital Sacré-Coeur de Montréal, 5400 Gouin Ouest, Montréal, Québec, Canada, H4J1C5. E-mail: [email protected].
© The Academy of Spinal Cord Injury Professionals, Inc. 2016DOI 10.1080/10790268.2016.1165448 The Journal of Spinal Cord Medicine 2016 1
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While the majority of patients with an acute T-SCIwill undergo surgery for stabilization and/or decom-pression of the spine, recent studies suggest performingearly surgery, ideally within 24 hours of theinjury.11–16 Early surgery reduces costs and length ofhospital stay11 and decreases complication rate.12,13
Santos et al.14 developed a simulation model in aCanadian SCI center showing that surgery within 24hours post-trauma has indirect benefits on quality oflife, life expectancy, neurological recovery and occur-rence of complications in patients with tetraplegia.Our team showed that early surgery is associated withbetter neurological status and improvement in AISgrade among patients admitted for a complete cervicalT-SCI.15 Early surgery may be considered as best prac-tice for cervical T-SCI.16
Many factors can contribute to the surgical delayonce the patient is admitted to a specialized SCIcenter. These include patient-related factors such as acontraindication to early surgery due to, among otherreasons, severe traumatic brain injury with intracranialhypertension or concomitant life-threatening injuryrequiring emergent intervention prior to spine surgery(e.g. severe intra-abdominal or pelvic bleeding, aorticor cardiac injury), as well as healthcare-related factorsdue to the limited access to the operating roombecause of a high load of emergent cases. Potentiallymodifiable factors are transportation delays from thesite of trauma, evaluation by the emergency traumaand spine teams, and availability of the operatingroom. Accordingly, Furlan et al.17 have shown thatextrinsic factors, unrelated to the patient’s healthstatus, are mostly accountable for the delay betweentrauma and surgery. However, their study was con-ducted with a small sample of 63 patients and only cer-vical T-SCI, and did not account for other possiblefactors that could influence and delay surgery.Therefore, the objective of this study is to determinethe factors contributing to surgical delay in individualswith T-SCI in a single Level-I trauma center specializedin the care of SCI. A secondary objective was to verify ifthe time intervals were different based on the severity ofthe neurological deficit of patients with T-SCI.
Materials and methodsPatientsA prospective cohort of 175 consecutive patients with aT-SCI admitted to a single Level I SCI-specializedtrauma center between April 2010 and May 2015 wasincluded in this study (138 males and 37 females;46.4 ± 19.7 years old). Patients entered the cohort atthe time of admission and were followed until discharge
from the acute care center. They were included if theysustained a spine trauma that involved a SCI and hadsurgery performed in our institution. Patients wereexcluded if the spine injury was below the L1–L2 inter-vertebral disc or if they were diagnosed with a pre-exist-ing spinal stenosis without overt spine instability. Thestudy was approved by the institutional review boardand all patients were enrolled on a voluntary basis.
In the presence of a T-SCI associated with overt spinalinstability and/or spinal cord compression, surgeons atour institution will usually proceed with surgery in anattempt to limit the secondary injury to the spinalcord, unless there is a medical contraindication tosurgery. A multidisciplinary team composed of thetrauma, spine surgery, and physical medicine and reha-bilitation teams ensures the acute care of the patient.When the diagnosis is established and surgical treatmentis indicated, the surgical unit is informed and the patientis placed on the waiting list, which also includes all sur-gical emergencies from other subspecialties.Prioritization of all surgical emergencies is under theresponsibility of a coordinator.
Data collection and outcomesSocio-demographic, clinical and administrative datapertaining to the pre-operative period were collectedon a daily basis through a prospective database(Quebec Trauma Registry) for all patients admitted atour institution following a traumatic event.
The main healthcare related factor was delay tosurgery which was broken down into specific intervals:
I. Only for patients transferred to a community hospital(CH) prior to arrival at SCI center:
a. Delay between trauma and arrival at the CH;b. Delay between arrival at the CH and the emergency
room of SCI center;II. For all patients:c. Delay between trauma and arrival at the emergency
room of SCI center (corresponds to the sum ofdelays a. and b. for patients transferred from a CH);
d. Delay between arrival at SCI center and first medicalassessment in the emergency room (ER);
e. Delay between first medical assessment in the ER andfinalization of surgical plan, corresponding to themoment when the surgical request form is receivedby the operating room;
f. Delay between finalization of surgical plan and begin-ning of surgery;
g. Overall time spent in the emergency room.Other healthcare-related factors were collected, such asthe day patients were transferred to the SCI center, theday for finalization of surgical plan, the subspecialtyof the physician performing the first assessment in the
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ER of the SCI center, and the distance between the CHand the SCI center for patients not directly admitted tothe SCI center.Patient-related factors consisted of socio-demo-
graphic (age, sex) and clinical data: level of spineinjury (cervical or thoracolumbar), severity of traumaas measured by the Injury Severity Score (ISS), theCharlson comorbidity index (CCI) providing a weightedscore of patients comorbidities, and pre-operative sever-ity of neurological deficit assessed from the AmericanSpinal Injury Association scale (complete – ASIA A vsincomplete – ASIA B, C or D).
Data analysisWe stratified our cohort into two subgroups based onthe surgical delay, i.e. time elapsed between thetrauma and surgical incision. The early surgery (ES)subgroup included patients who had spine surgerywithin 24 hours post-trauma, and the late surgery (LS)group had surgery 24 hours or more post-trauma.Continuous data were compared between subgroupsusing Mann-Whitney U tests, while categorical datawere compared using !2 tests. Continuous data werereported as means ± one standard deviation, and categ-orical data were reported as proportions andpercentages.We determined predictors of having LS rather than
ES, by investigating 16 factors in a multivariate logisticregression. The patient-related factors were: 1) age; 2)sex; 3) pre-operative severity of neurological deficit(complete – ASIA A vs incomplete – ASIA B, C orD); 4) injury level (cervical vs thoracolumbar); 5) ISS;6) CCI. The healthcare-related factors were: 7) transferto a CH or direct admission to the SCI center; 8)delay in arrival at the CH; 9) delay of transfer from
CH to SCI center; 10) distance between CH and SCIcenter; 11) time in the ER of the SCI center; 12) delayin arrival at SCI center/first medical assessment; 13)subspecialty of physician performing first medicalassessment in SCI center; 14) delay between firstmedical assessment and finalization of surgical plan;15) delay between finalization of surgical plan andbeginning of surgery; 16) day of the week (weekday orweekend day) surgical plan is completed and surgicalrequest form is received by the operating room. All stat-istical analyses were performed using the IBM SPSSStatistics 21 software (IBM Corp, Armonk, NY, USA).
ResultsAmong the 175 patients who agreed to participate in thestudy, 15 were directly admitted from a CH to thespecialized spine center without going through the ER,and 16 had surgery more than 7 days post-injury.These 31 patients were excluded from the analysis(leaving 144 patients) because of the potential bias dueto the injury occurring outside the province of Quebecand urgent medical conditions that needed to betreated prior to the spine injury. Table 1 details thedemographic and clinical characteristics of the 93patients in the ES and 51 in the LS subgroups.Patients in the ES group were on average 8 yearsyounger than those in the LS group (P = 0.02) andhad a complete T-SCI in a greater proportion than theLS group (P = 0.01), which is consistent with epidemio-logical studies reporting a greater proportion of incom-plete lesions in older patients.2,8 The proportion ofmales and females was the same in both groups, aswell as the severity of trauma (ISS) and the comorbiditylevel (CCI).
Table 1 Demographic and clinical characteristics of patients with T-SCI operated within 24 hours and 24 hours or more post-trauma
ES (<24 h) LS (!24 h) P
N 93 51Surgical delay (mean ± SD) 15.6 ± 4.7 46.9 ± 30.9 <10!3
Age (mean ± SD) 41.2 ± 18.5 48.9 ± 20.1 0.02Sex
Male 78.5% 84.3% 0.40Female 21.5% 15.7%
CCI (mean ± SD) 0.25 ± 0.69 0.25 ± 0.64 0.82ISS (mean ± SD) 27.1 ± 9.7 25.8 ± 12.4 0.14Level of injury
Cervical 46.2% 60.8% 0.10Thoracolumbar 53.8% 39.2%
Severity of neurological deficitComplete (ASIA A) 64.1% 42.0% 0.01Incomplete (ASIA B-C-D) 35.9% 58.0%
ES: early surgery; LS: late surgery; SD: standard deviation; ISS: Injury Severity Score; CCI: Charlson Comorbidity Index
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The Journal of Spinal Cord Medicine 2016 3
Comparison between early and late surgerysubgroupsInterval between occurrence of trauma and arrival atSCI centerA minority of patients with T-SCI (14/144 or 9.7%) wasdirectly transported from the site of trauma to the SCIcenter without prior transfer in a CH. This proportionwas similar between the ES and LS subgroups (!2 test:11% vs 8% of patients with T-SCI, respectively; P =0.57). Not surprisingly, persons who had shorter timesfrom trauma to SCI center were more likely to haveES (P < 10!3; Table 2). The delay between traumaand arrival at the SCI center was longer for patientstransported to a CH prior to the SCI center (CH: 8.6hours ± 11.3 hours; SCI center: 2.4 hours ± 6.4 hours;P < 10!3), which affected the total delay betweentrauma and surgery, although not significantly (CH:27.3 hours ± 24.5 hours; SCI center: 21.0 hours ±17.4 hours; P = 0.09). The distance between the CHand the SCI center was not different between patientswho had ES or LS (ES: 83 ± 98 km; LS: 128 ±159 km; P = 0.26). Only 6 patients (3 ES, 3 LS) weretransferred to the SCI center by air transportation,from a distance ranging between 503 km and 647 km.All other patients were transferred by road transpor-tation (ambulance, private vehicles, etc.).
The interval between trauma and arrival at the SCIcenter differed based on the severity of the neurological
deficit (Table 3). Patients with a complete T-SCI weretransferred 4 hours faster to the SCI center (P < 10!3),which was however not related to whether patientstransit to a CH or are directly admitted to the SCIcenter. There were no differences in the transfer delayfrom the site of trauma to the SCI center whetherpatients had a cervical or thoracic/thoracolumbarlesion.
Intervals between arrival at SCI center and beginningof surgeryThe delay between arrival at the SCI center and begin-ning of surgery was three times longer for T-SCI patientswho had LS (P < 10!3). It can be broken down intothree major phases: delay between arrival at SCIcenter and first medical assessment in the ER; delaybetween the first medical assessment in the ER and sur-gical plan completion; and delay between surgical plancompletion and beginning of surgery (Table 2). Theonly significant difference between ES and LS sub-groups was for the time between the first medical assess-ment and completion of surgical plan, which was 4times shorter and represented 56% of the waiting timefor the ES group as compared to 70% of the waitingdelay for the LS group (P < 10!3; Table 2). There wasno significant difference in the time waiting for thefirst medical assessment and in the delay between surgi-cal plan completion and beginning of surgery between
Table 2 Average delays (±SD) encountered by patients operated within 24 hours post-trauma (early surgery) and 24 hours or morefollowing trauma (late surgery)
Time interval (h) ES (<24 h) LS (!24 h) P
Trauma—Arrival SCI center 5.0 ± 3.0 13.6 ± 17.0 <10!3
Trauma—Arrival other CH 1.2 ± 1.1 3.3 ± 4.9 0.002Arrival at other CH—Arrival SCI center 3.8 ± 2.7 10.3 ± 15.6 <10!3
Arrival SCI center—Surgery 10.6 ± 4.3 33.3 ± 26.5 <10!3
Arrival SCI center—First assessment by MD 2.0 ± 1.6 3.1 ± 3.8 0.18First assessment by MD—Surgical plan completion 6.0 ± 4.0 23.3 ± 23.6 <10!3
Surgical plan completion—Surgery 2.6 ± 2.2 7.0 ± 12.4 0.31Trauma—Surgery 15.6 ± 4.7 46.9 ± 30.9 <10!3
ES: early surgery; LS: late surgery
Table 3 Average delays (±SD) encountered by patients with a complete SCI and an incomplete SCI
Time interval (h) Complete SCI Incomplete SCI P
Trauma—Arrival SCI center 6.4 ± 12.0 10.2 ± 9.7 <10!3
Trauma—Arrival other CH 1.6 ± 2.8 2.4 ± 3.7 0.006Arrival at other CH—Arrival SCI center 4.8 ± 10.8 7.8 ± 8.8 0.001
Arrival SCI center—Surgery 16.2 ± 17.9 21.7 ± 21.1 0.049Arrival SCI center—First assessment by MD 2.0 ± 2.2 2.8 ± 3.1 0.021First assessment by MD—Surgical plan completion 11.6 ± 17.2 13.0 ± 16.0 0.56Surgical plan completion—Surgery 2.6 ± 2.7 5.9 ± 11.1 0.28
Trauma—Surgery 22.6 ± 22.6 31.9 ± 25.0 <10!3
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the ES and LS subgroups. Only one patient was oper-ated for another medical emergency before undergoingspine surgery. This patient required the placement of acerebral shunt, which resulted in a delayed spinesurgery that finally took place 96 hours post-trauma.Seventy-four percent of patients with a complete T-
SCI had ES, as compared to 53% of patients with anincomplete T-SCI (!2 = 6.450; P = 0.011). The waitingtime upon arrival at the SCI center was 5 hoursshorter for patients with a complete T-SCI (P = 0.049)which contributed, along with the prompter transferfrom the site of trauma to the SCI center, to the 9-hour shorter delay trauma-surgery as compared toincomplete patients with T-SCI (P < 10!3; Table 3).There were no differences in the duration of each stepof patient management once admitted at the SCIcenter based on the level of injury (cervical or thor-acic/thoracolumbar).
Other healthcare-related factors affecting surgicaldelayThe proportion of patients who had ES or LS was differ-ent depending on the day of surgical plan completionand reception of the request form by the OR (!2 =4.916; P = 0.027), but not on the day patients with T-SCI were transferred to the SCI center. When the surgi-cal plan was completed and the request form sent to theOR at the end of the week, i.e. between Friday andSunday, 75% of patients underwent ES. This proportiondropped to 50% when decisions were made during week-days, i.e. between Monday and Thursday.There was also a relationship, although not signifi-
cant, between the subspecialty of the first physicianassessing patients upon arrival at the SCI center ERand whether patients were operated within 24 hours orlater. Fifty-nine percent of patients who were examinedby a spine surgeon had ES, whereas this proportionreached 81% when first assessed by the trauma team(!2 = 5.197; P = 0.07). There was no relationshipbetween the number of medical assessments received atthe ER of the SCI center and the delay betweentrauma and surgery.
Using a multivariate logistic regression model, wedetermined that only healthcare-related factors wereassociated with being in the LS group. These factorswere: transfer time between the community hospitaland the SCI center, time between first medical assess-ment and surgical plan completion, and time betweensurgical plan completion and actual surgery (Table 4).
DiscussionThe results of this study show that healthcare-related,modifiable factors are mainly responsible for the delaybetween trauma and surgery. The most important con-tributors are the time of transfer from the site oftrauma to the SCI center, the interval between the firstmedical assessment and surgical plan completion, andthe delay between surgical plan completion and begin-ning of surgery. Interestingly, no patient-related factorssuch as severity of trauma, severity of injury or agewere related to surgical delay. This goes along thesame lines as what Furlan et al.17 reported, whileSamuel et al.18 observed that injury characteristics andpre-existing comorbidities were associated with longersurgical delays in patients with cervical T-SCI.Our center is a Level-I trauma center serving as the
tertiary referral center for T-SCI in western Quebecand as the single referral center for all ventilation-assisted T-SCI in Quebec. Therefore, patients with aT-SCI should systematically be transferred at ourcenter for acute care management. However, ourresults showed that only 10% of them were directlytransferred from the site of trauma to our SCI center.This might be due to the long distance between thetrauma site and the SCI center in some patients, consid-ering that hemodynamic instability can occur frequentlyand would be difficult to manage during transportationon long distances. Nevertheless, patients started beingmanaged by the SCI specialized team within less than2.5 hours post-trauma, which was 6 hours faster thanfor patients transported to another CH. Our 2.5-hourdelay was also well below what was observed byHarrop et al.,19 where patients sustaining a T-SCIwere transported to a Level I or II hospital within 5.2
Table 4 Logistic regression models for prediction of late surgery (! 24 hours post-trauma)
B SE-B Wald P Odds (95% CI)
Delay of transfer from CH to SCI center 0.907 0.264 11.770 0.001 2.476(1.475–4.157)
Delay surgical plan completion—surgery 0.906 0.279 10.541 0.001 2.474(1.432–4.275)
Delay first medical assessment—surgical plan completion 1.036 0.275 14.242 0.000 2.819(1.646–4.829)
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The Journal of Spinal Cord Medicine 2016 5
hours in Pennsylvania. Finally, whether patients weretransferred from a CH located at a long distance fromthe SCI center by air or road transportation did notseem to affect the surgical delay, since 3 out of the 6patients transferred by air transport had LS surgery,with delays ranging between 28 hours and 96 hours.This goes along the same lines as what was reportedby Harrop et al.,19 where long delays from trauma toarrival at the trauma center were observed in patientstransferred by helicopter transportation.
The other step in management resulting in the greatestdelay was the time between first medical assessment inthe ER and surgical plan completion, which is consistentwith what was already reported.17,18 It was unlikelyrelated to the severity of trauma, since the ISS wassimilar between ES and LS patients. This interval was4 times larger for patients who had LS, and was alsoone of the main predictors of undergoing LS. It rep-resented 56% of the total waiting time for the ES groupand 70% for the LS group. This is a smaller proportionof time than what was reported by Samuel et al.,18
where the inpatient waiting time represented approxi-mately 90% of the total surgical delay. As well, Furlanet al.17 reported a 14-hour interval waiting for surgicaldecision in patients who had LS. This is more than 9hours shorter than in our study, where patients whohad LS waited approximately 23 hours between thefirst medical assessment and surgical plan completion.Need for medical stabilisation and treatment of moreurgent injuries could have an impact on this delay,although the ISS was similar in both groups. This high-lights the importance of the dedicated trauma team com-posed of general surgeons also trained in intensive care,which tend to decrease the waiting time for surgery.
Difficulty in access to specialized imaging (especiallyMRI) could also be involved, as well as the fact thatmost of the late surgeries were performed during week-days. Indeed, it is possible that on some occasions, man-agement of trauma patients arriving during weekdaysand requiring surgery will depend upon the availabilityof the operating rooms and of the spine surgeons, con-sidering the high number of elective cases being per-formed simultaneously. Also, some patients can beassessed more than once by doctors from different sub-specialties while in the ER, such as neurosurgeons,intensivists, trauma specialists, etc., before the spinesurgeon who will be establishing the surgical treatmentplan. Although our analyses did not show differencesin the proportion of ES and LS patients who had mul-tiple medical assessments, this is a factor that mostlikely affects the time interval before surgical plancompletion.
Samuel et al.18 have shown that only 44% of patientswith a cervical T-SCI had surgery within 24 hourspost-trauma, despite the growing body of evidence sup-porting the benefits of ES. This rate is below what wasobtained in our study, where 64% of patients had ES.They also reported that the majority of patients with acomplete cervical T-SCI, i.e. 57%, had ES, as comparedto 49% of patients with an incomplete injury. This is con-sistent with our data, where the proportion of patientswith a complete T-SCI undergoing ES was muchlarger than the proportion of patients with an incom-plete T-SCI (74% vs 53%). Shorter waiting time in allsteps of management was responsible for the smaller sur-gical delay for patients with a complete T-SCI.
Could the rate of patients operated within 24hours post-injury be increased?In our study, 64% of patients with T-SCI had ES whilethe remaining 36% had LS, with an average delay ofnearly 46 hours. Based on the Canadian studies byNoonan et al.20 and Furlan et al.,19 we calculated thenumber of patients enrolled in our study that couldhave been operated within 24 hours, had our delaysbeen the same as reported in those studies. We con-sidered the time of transfer from the CH to the SCIcenter, the delay between the first medical assessmentand surgical plan completion, and the delay waitingfor the operating room, which were the three main pre-dictors of having LS.
Noonan et al.20 demonstrated that direct transport ofpatients with T-SCI injured within a 20-minute drive ofa SCI center significantly increases the number ofpatients directly admitted to the SCI center. Amongpatients previously transported to a CH in our study,54 went to a CH located within 40 km of the SCIcenter. We can assume that these patients were mostlikely injured within a 20- to 30-minute drive from ourSCI center. Had they been directly admitted to theSCI center, this would have resulted in a 42% rate ofdirect admissions, most likely resulting in a reduced sur-gical delay. If we consider that direct admission to theSCI center results in a 4-hour decrease in surgicaldelay,20 5 patients transported to a CH within 40 kmof the SCI center would have been operated within 24hours, which represents a 4% increase in ES rate.
With regards to the time waiting for surgical plancompletion, Furlan et al.17 reported delays of 4 hoursfor patients who had ES and 14 hours for those operatedlater. This is much shorter than the delays obtained inour study, which were 6 hours and 23 hours for the ESand LS groups, respectively. Had this delay been 9hours shorter for our LS patients, to be consistent with
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Furlan’s data, 17 additional patients would have hadsurgery within 24 hours post-trauma, resulting in a12% increased ES rate. Finally, the other main predictorof LS was the delay between surgical plan completionand beginning of surgery, which was 4 hours longer forpatients who had LS. This variable was not consideredby Furlan et al.17 and Samuel et al.18 However, if wehypothesize that the average delay between surgicalplan completion and beginning of surgery in the LSgroup was the same as the ES group, i.e. approximately3 hours, there are 4 patients that would have ended upbeing operated within 24 hours post-injury.Based on the growing clinical evidence that prompt
surgery in patients with T-SCI is beneficial andfavours better outcomes,12,13,15,16 changes in logisticsto prioritize spine surgeries for T-SCI should be made.The time interval between T-SCI and beginning ofsurgery could further be reduced by avoiding transport-ing the patients to a CH when the trauma occurs in ashort distance from a specialized SCI center, and bydecreasing the waiting time for a surgical decision andthe time for access to the operating room. Althoughthis study was conducted in a single SCI center, resultscould certainly be generalized to other centers.Considering that the care delivery model used at ourfacility is comparable to what is observed in Canada,where SCI centers are high-volume patient flow LevelI trauma centers in nearly all cases (14/15 acutecenters; Noonan et al. 2012), the main challenge for pro-viding timely care to patients with SCI resides in opti-mizing the transition delays between and withindifferent phases of patient with SCI management,especially the pre-hospital and SCI center acute carephases. Instituting policies to ensure swift transfer andsurgery post-injury for those with T-SCI can ultimatelyimprove outcomes for these patients.
AcknowledgmentsThe authors acknowledge Anny-Jacques Bernier,medical archivist, for her help with data collection.Data was partially collected through the Rick HansenSpinal Cord Injury Registry.
Disclaimer statementsContributors None.
Funding This work was supported by the US ArmyMedical Department, Medical Research and MaterialCommand [grant number W81WHX-13-1-0396].
Conflict of interest None.
Ethics approval None.
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16 Fehlings MG, Vaccaro A, Wilson JR, Singh A, Cadotte D, HarropJS, et al. Early versus delayed decompression for traumatic cervicalspinal cord injury: results of the surgical timing in acute spinal cordinjury study (STASCIS). PLoS One 2012;7(2):e32037.
17 Furlan JC, Tung K, Fehlings MG. Process benchmarking apprai-sal of surgical decompression of spinal cord following traumaticcervical spinal cord injury: opportunities to reduce delays in surgi-cal management. J Neurotrauma 2013;30(6):487–91.
18 Samuel AM, Bohl DD, Basques BA, Diaz-Collado PJ,Lukasiewicz AM, Webb ML, et al. Analysis of Delays toSurgery for Cervical Spinal Cord Injuries. Spine (Phila Pa 1976)2015;40(13):992–1000.
19 Harrop JS, Ghobrial GM, Chitale R, Krespan K, Odorizzi L,Fried T, et al. Evaluating initial spine trauma response: injurytime to trauma center in PA, USA. J Clin Neurosci 2014;21(10):1725–9.
20 Noonan VK, Soril L, Atkins D, Lewis R, Santos A, Fehlings MG,et al. The application of operations research methodologies to thedelivery of care model for traumatic spinal cord injury: the accessto care and timing project. J Neurotrauma 2012;29(13):2272–82.
Thompson et al. Predictors of delayed surgery in traumatic SCI
The Journal of Spinal Cord Medicine 2016 7
11. Appendix 3: Manuscript accepted in American Journal of Physical Medicineand Rehabilitation
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The organization of SCI care may vary from one province and one country to other. In Quebec, ##!
Canada, all patients sustaining a traumatic spinal cord injury should be directed to one of the two #"!
designated acute care centers (SCI-center) according to its location: one center serving the eastern, #'!
while the other serves the western part of the province. This system was established in the late "(!
")!
are no specific requirements to define these centers in Canada, they are all based on similar "*!
characteristics in terms of medical management and rehabilitation resources. Also, in our "+!
province, many patients are first transported to non-specialized centers following their SCI in "$!
order to stabilized patients and confirm the diagnosis of a SCI. Even if our provincial government "%!
strongly encourage prompt transfer to the SCI-center in the pre-operative phase, some non-"&!
specialized centers may choose to transfer patients only after surgical management. It is "#!
important to note that all patients were transported by ambulance. No helijet or else were used. ""!
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importance in the current political context in Canada, where health costs have greatly increased $'(!
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center following a TSCI, but may also add that transfer prior to surgical management is beneficial #$$!
on acute care resources utilization, even if medical stabilization was first performed in a regional %**!
non-specialized center. Many factors could be beneficial to SCI-centers, such as &'#! #+02,!%*+!
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has mainly evaluated costs of care based on the length of stay (by the exclusion of fees that may %*&!
vary from one system to another, such as physician and surgical fees). And, all patients sustaining %*'!
cervical TSCI generally require long acute care hospitalization. Therefore, its optimization by %*(!
prompt admission to a SCI-center prior to surgical management may by an efficient way, %*)!
applicable to any healthcare system, to decrease resources utilization that may be an important %*$!
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Page 0
13. Appendix 5: Manuscript submitted to Journal of Spinal Cord Medicine
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