Pre-hospital and in-hospital first aid programs and specifications for spine and spinal cord injury in Beijing, China: study protocol for a prospective, multicenter, nonrandomized controlled trial
Feng Xue, Jian Xiong, Pei-xun Zhang, Yu-hui Kou, Shuai Han, Tian-bing Wang, Dian-ying Zhang, Bao-guo Jiang
Department of Orthopedics, Peking University People's Hospital, Beijing, China
|Date of Web Publication||28-Apr-2017|
Department of Orthopedics, Peking University People's Hospital, Beijing
Source of Support: This study was supported by the Beijing Science and Technology Plan Project in China, No. D161100002816001., Conflict of Interest: None
Background: The optimal time to rescue spinal cord function after spinal cord injury is within 24 hours, especially within 3 to 8 hours, after the injury. Timely and proper pre-hospital first aid, hospital admission, patient assessment, and surgery are essential for the rescue of spinal cord function. A sound and rapid treatment system is the basis for improving the level of injury treatment and recovery of spinal cord function. China currently lacks a systematic and standardized treatment system.
Methods/Design: We herein propose our study protocol for a prospective, multicenter, nonrandomized controlled trial. We will recruit 200 patients with acute spinal cord injury undergoing pre-hospital treatment at Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center and receiving in-hospital treatment at Peking University People's Hospital, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital, China. This study will comprise two parts: (1) establishment of a database of patients with spinal cord injury in the Beijing area; and (2) formulation of the pre-hospital and in-hospital process and establishment of a standardized treatment protocol for acute spinal cord injury. The primary outcome will be the American Spinal Injury Association impairment scale score for spinal nerve function. The secondary outcomes will be spinal X-ray, three-dimensional computed tomography, and magnetic resonance imaging findings and the incidence of complications due to improper pre-hospital and in-hospital treatment of acute spinal cord injury.
Discussion: The aims of this study are as follows: (1) We will establish a spine and spinal cord injury treatment database in the Beijing area. (2) We will assess the complete pre-hospital and in-hospital evaluation of spine and spinal cord injury, develop and optimize first aid procedures, and create a pre-hospital and in-hospital standardized training program for the treatment of spine and spinal cord injury. (3) We will build a pre-hospital and in-hospital first aid “green channel” for acute spine and spinal cord injury after completion of the study. (4) We will develop first aid guidelines and establish an evaluation and treatment system for early surgery to save spinal cord function and reduce the degree of disability to the greatest extent as possible. (5) We anticipate that our results will be used in expert consensuses on acute spinal cord injury and that “green channel” patterns will be promoted in hospitals in Beijing and other cities of China to improve the level of first aid treatment of acute spine and spinal cord injury in Chinese cities and reduce the occurrence of secondary injury and severe dysfunction due to improper treatment. This trial will begin in May 2017. Patient recruitment will be finished in August 2019. Analysis of all data and results will be completed in December 2020.
Trial registration: ClinicalTrials.gov identifier: NCT03103516.
Ethics: All protocols will be in accordance with Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki (2013), formulated by the World Medical Association. The study protocol has been approved by the Medical Ethics Committee of Peking University People's Hospital, China (approval number: 2016PHB136-01).
Informed consent: Written informed consent will be provided by legal representative of participants.
Keywords: clinical trial; spinal cord injury; first aid; standards; nonrandomized controlled study
|How to cite this article:|
Xue F, Xiong J, Zhang Px, Kou Yh, Han S, Wang Tb, Zhang Dy, Jiang Bg. Pre-hospital and in-hospital first aid programs and specifications for spine and spinal cord injury in Beijing, China: study protocol for a prospective, multicenter, nonrandomized controlled trial. Asia Pac J Clin Trials Nerv Syst Dis 2017;2:58-65
|How to cite this URL:|
Xue F, Xiong J, Zhang Px, Kou Yh, Han S, Wang Tb, Zhang Dy, Jiang Bg. Pre-hospital and in-hospital first aid programs and specifications for spine and spinal cord injury in Beijing, China: study protocol for a prospective, multicenter, nonrandomized controlled trial. Asia Pac J Clin Trials Nerv Syst Dis [serial online] 2017 [cited 2017 Jun 27];2:58-65. Available from: http://www.actnjournal.com/text.asp?2017/2/2/58/205195
| Introduction|| |
History and related studies
Acute spinal cord injury (SCI) is a common clinical condition and frequently occurs in young adults. Clinical treatment is often difficult. The incidence of acute SCI is 30–40 per million people in Europe and the United States but 60.2 per million people in Beijing, China (Sekhon and Fehlings, 2001; Pickett et al., 2006; Cortez and Levi, 2007; Li et al., 2011; Lee et al., 2014). Complete SCI is very dangerous, and no effective medical therapy is available. At present, the most effective treatment for acute SCI is first aid and advanced rehabilitation (Waters et al., 1991).
The optimal time period in which to rescue the spinal cord function after SCI is within the first 24 hours after injury; in particular, the first 3 to 8 hours after injury is considered the golden opportunity (Bracken et al., 1997). Aggressive hormone therapy in the first 3 to 8 hours after injury can reduce secondary injury, thereby reducing the degree of SCI (Short et al., 2000; Evaniew et al., 2016). Within 24 hours after injury, early surgery to relieve spinal cord compression can significantly improve the recovery of spinal cord function (Dvorak et al., 2015; Grassner et al., 2016). Timely and proper pre-hospital first aid, hospital admission, patient assessment, and surgery are essential for the rescue of spinal cord function (Battistuzzo et al., 2016; Fransen et al., 2016). Patients with incomplete SCI can lose the possibility of recovery of spinal cord function because of improper first aid or untimely treatment. More severe injuries resulting from complete SCI, if improperly treated, make recovery from surgery more difficult. A sound and rapid treatment system is the basis for improving the treatment level of SCI, but such a system is lacking in China.
In Beijing, pre-hospital treatment can be performed at Beijing Emergency Medical Center (120 first aid system) and Beijing Red Cross Hospital (999 first aid system). Although these institutions cooperate with each other, they utilize different mechanisms and treatment patterns and have overlapping treatment regions. With respect to in-hospital treatment, Beijing has a large number of high-level hospitals, but these hospitals are overcrowded. No SCI treatment specialists or professional hospitals are present in Beijing, so treatment basically relies on the various general hospitals in the area. The medical information transfer process during pre-hospital first aid and in-hospital treatment in Beijing is not smooth; there lacks smooth link and standardization between pre-hospital care and in-hospital treatment. The abilities and skill levels of medical personnel are not consistent, the technology is not always up-to-date, and professional training is lacking. Thus, the vast majority of patients with SCI cannot be treated within the optimal time after injury. These factors are important causes of the higher mortality and disability rates among patients with SCI in China than in developed countries.
In 2006, Professor Bao-guo Jiang, director of the Department of Orthopedics at Peking University People's Hospital, led the establishment of the Traffic Medicine Center of Peking University. This collaboration includes Peking University People's Hospital, the School of Public Health of Peking University, Peking UniversityFirst Hospital, Peking University Third Hospital, the Beijing Traffic Management Bureau, and Beijing Emergency Medical Center in China. After a review by the Health and Family Planning Commission, the National Center for Severe Trauma Training was established in 2015, and Bao-guo Jiang served as the director of the center. The Traffic Medicine Center and two emergency centers in Beijing have cooperated for many years, and they established an epidemiological database for the treatment of severe trauma and a pre-hospital and in-hospital linkage mechanism. The treatment of spine injury and SCI is an important component of treating severe trauma. With this center as a platform, the database of patients with SCI can be specialized; a unified standardized and rapid treatment protocol can be carried out in many participating medical units using the emergency center linkage mechanism; a high level of scientific research can be carried out; and research in SCI epidemiology, treatment procedures, and improvements in treatment effects can be performed. Simultaneously, standardized training for pre-hospital and in-hospital first aid care personnel can be completed in each research center and hospital.
The herein-described study was prompted by the nonstandard treatment processes and paths, poor information exchange, incoherent pre-hospital care and in-hospital treatment, lack of professional training for treatment personnel, and uneven comprehensive hospital treatment capacity among medical centers in Beijing. The aim of this multicenter study is to formulate standards for the treatment of spine injury and SCI to thus improve the level of SCI treatment and reduce the mortality and disability of patients with SCI in Beijing, China.
We aim to: (1) establish a spine injury and SCI treatment database; (2) complete pre-hospital and in-hospital evaluations of spine injury and SCI, develop and optimize first aid procedures, and create a pre-hospital and in-hospital standardized training program for the treatment of spine injury and SCI; (3) develop first aid guidelines and establish an evaluation and treatment system for early surgery to save the spinal cord function and reduce the degree of disability to the greatest extent possible; and (4) use our results in expert consensuses on acute SCI and “green channel” patterns in hospitals in Beijing and other cities of China to improve the level of first aid treatment of acute spine injury and SCI in Chinese cities and reduce the occurrence of secondary injury and severe dysfunction caused by improper treatment.
Distinguishing features from related studies
We will: (1) standardize procedures and techniques to improve the medical staff's efficiency and effectiveness when treating patients with acute SCI in Beijing, effectively reducing mortality and disability; (2) establish a pre-hospital care model and “green channel” model for acute SCI, forming a high standard to benefit the majority of patients through a large-sample multicenter prospective study; and (3) develop a pre-hospital and in-hospital information platform and realize information transfer and standardized management to improve the level of treatment through the establishment of an acute spine injury and SCI treatment database.
| Methods/design|| |
This will be a prospective, multicenter, nonrandomized controlled trial.
(1) Peking University People's Hospital will be responsible for the overall implementation. This trial will be carried out with the cooperation of Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital.
(2) Peking University People's Hospital will be responsible for the overall management, design, project bidding, implementation, quality control, and data collection and analysis; it will guide the other hospitals to complete standardized training for spine injury and SCI and organize experts to demonstrate and evaluate the research contents of the participating hospitals.
(3) Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center will be responsible for 100 cases of spine injury and SCI, separately, for pre-hospital treatment, trans-shipment, information communication, case handover, and pre-hospital first aid training.
(4) Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, and Chaoyang Hospital Affiliated to Capital Medical University will be responsible for 40 cases, separately; Chinese PLA General Hospital will be responsible for 30 cases. These hospitals will mainly perform in-hospital treatment, follow-up, data entry, and in-hospital standardized training in some patients and will help Peking University People's Hospital to complete group assignment, data provision, staffing, and equipment management. At least 200 patients will be enrolled in this trial.
We will recruit patients with acute SCI undergoing pre-hospital treatment at Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center and receiving in-hospital at Peking University People's Hospital, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital, China.
Patients presenting with all of the following criteria will be considered for study inclusion:
- Spinal cord injury patients will be evaluated as complete or incomplete (contusion) after admission using rectal examination, in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000)
- Final diagnosis by spine computed tomography (CT) and/or magnetic resonance imaging (MRI)
- Cervical, thoracic and thoracolumbar fracture dislocation or without fracture dislocation but combined with spinal cord injury
- No other injury involving life, injury severity score < 16 (Vaccaro et al., 2005)
- No anesthesia contraindication
- No local skin infection, no severe soft tissue contusion, soft tissue condition of the operation area met the operation requirements
- Age: 16–85 years old, irrespective of sex
Patients with one or more of the following conditions will be excluded from this study:
- Active or recent severe infection
- Severe infectious diseases that need to be treated in infectious disease hospital
- History of mental illness
- History of metal allergy
- Long-term alcohol abuse and drug abuse
- Do not agree to participate in this trial; the legal representative of the patient refuses to sign informed consent
- Poor compliance, cannot be followed up as required
Establishment of a database of patients with SCI in Beijing, China
Data will be collected from patients with SCI using information gathered from an SCI questionnaire.
(1) The questionnaire will contain information on age, sex, degree of injury, first aid condition, in-hospital treatment, and clinical results.
(2) We will then perform data collection and statistical analysis, sort the relevant data, and review the incidence of SCI and prognosis of patients in Beijing during the past 3 to 5 years.
(3) Information of patients with SCI in Beijing from 2017 to 2019 will be statistically analyzed and compared with previous data to validate the effectiveness of the pre-hospital and in-hospital first aid.
Establishment of standardized pre-hospital and in-hospital treatment procedure and scheme for treating SCI
(1) We will establish a professional SCI training team and develop a standardized training course for first aid personnel in line with China's national conditions based on the first aid treatment experience of worldwide experts. We will conduct pre-hospital and in-hospital first aid training, first aid training, SCI assessment and training, database entry, and maintenance training for all people involved in the trial. We will also establish a professional SCI treatment team and implement a 24-hour responsibility system.
(2) We will establish pre-hospital and in-hospital emergency procedures for spine injury and SCI.
- The emergency center will receive an alarm, and emer gency personnel will rush to the scene
- Pre-hospital disease assessment will be performed
- History of injury, e.g., serious traffic accident, falling from height, heavy rolling, impact, or firearm injury
- Injury evaluation
- Airway, breathing, and circulation
- Signs of SCI
- Neck or back pain
- Pain upon motion of the neck or back
- Pain in the neck or back midline after palpation
- Spinal deformity
- Stiffness or spasm of the neck or back
- Paralysis, paresis, numbness, or tingling in the leg or arm after the accident
- Continuous penile erection (male patients)
(3) On-site first aid treatment will be performed. Braking and handling: If patients with suspected cervical spine injury need to be turned over, the hand flip method will be used for “log rolling,” and a neck support will be used to fix the head and neck. The patient will be moved using the horizontal lifting method. Moreover, a spade-type stretcher or other hard stretcher and body-fixing measures will be applied.
(4) The pre-hospital and in-hospital information exchange system will be utilized. The patient will be transfer to a designated hospital. After receiving a pre-hospital warning signal, the designated hospital will inform the SCI emergency team to complete first aid preparation. In-hospital staff will be in place.
(5) In-hospital evaluation and treatment will be performed.
- Maintain airway patency and avoid unnecessary head and neck movement
- Oxygen inhalation
- Arterial blood gas testing
- Ventilation function testing
- If necessary, oropharyngeal intubation or intercricothyrotomy intubation will be performed to assist ventilation
- Continuous monitoring of blood pressure
- If hypotension is present, the presence of hypovolemic shock (decreased blood pressure, elevated heart rate) or neurogenic shock (decreased blood pressure, decreased heart rate) will be clarified.
- If hypovolemic shock is present, blood transfusion and replenishment with a colloidal solution will be conducted based on the patient's blood test results.
- Due to SCI-induced sympathetic signal blockade (T1–L2) and vagal dysfunction, neurogenic shock occurs due to the combined effect of hypotension and bradycardia. Early treatment mainly involves supplementation of blood volume. Vasopressors can be used to promote vasoconstriction, and atropine can be used to control the heart rate. Lower limb elevation can reduce venous filling and increase the returned blood volume.
- For patients with neurogenic shock, central venous pressure will be monitored during fluid administration to prevent fatal pulmonary edema.
- Glasgow coma scale (Rowley and Fielding)
The lowest possible Glasgow coma scale (the sum) is 3 (deep coma or death), while the highest is 15 (fully awake). A score of ≤ 8 indicates a severe injury.
- Evaluation of spinal cord function
- American Spinal Injury Association (ASIA) scores and grades will be recorded.
- Tendon reflex detection: If spinal shock is present, all reflexes will disappear; 24 hours later, tendon reflexes and various pathological signs can occur.
- The urinary canal will be detained for urethral catheterization. When inserting a catheter, sensation and urinary retention will be observed.
- Recording of neurological findings: A pen will be used to mark the sensation plane on the body. The body examination will be repeated. Changes in neurological function will be dynamically observed.
- Complete SCI: Anal examination results.
- Imaging evaluation: Spinal X-ray films, CT, and MRI
- Types of spinal fractures: AO classification: A = compression, B = distraction, and C = rotation
- Spine protection and resetting: Neck support, skull traction, horizontal movement, and axial turn-over
- For patients with SCI exhibiting paraplegia, high-dose methylprednisolone therapy will be used within 8 hours after injury.
- According to the patient's injury and time point at which first aid is begun, the patient will undergo either early or delayed spinal cord decompression surgery.
(6) All data will be recorded in the spine injury and SCI treatment database, arranged, and analyzed by our team and third-party statisticians.
Primary outcome measure
ASIA impairment scale: The ASIA impairment scale will be used to assess spinal nerve function at 1 week and 1 and 3 months postoperatively (Hastings et al., 2003).
Grade A (Complete): Loss of motor and sensory function is preserved in sacral segments S4 and S5.
Grade B (Incomplete): Sensory but not motor function is preserved below the neurological level and includes sacral segments S4 and S5.
Grade C (Incomplete): Motor function is preserved below the neurological level, and more than half of the key muscles below the neurological level have a muscle grade of < 3.
Grade D (Incomplete): Motor function is preserved below the neurological level, and at least half of the key muscles below the neurological level have a muscle grade of ≥ 3.
Grade E (Normal): Motor and sensory function are normal.
Secondary outcome measures
Spinal X-ray, CT, and MRI: Spinal X-ray, CT, and MRI will be utilized to assess the spine injury and SCI and repair preoperatively and at 1 week and 1 and 3 months postoperatively.
Incidence of complications: Complications will be evaluated at 1 week and 1 and 3 months postoperatively to calculate the percentage of patients with complications among the total number of patients.
Other outcome measures
Respirator off-line time, intensive care unit stay, total length of stay, and hospitalization costs will also be evaluated.
Statistical analysis will be performed using SPSS 19.0 software (IBM Inc., Armonk, NY, USA).
Measurement data will be expressed as the case number (missing number), mean, median, standard deviation, first quartile, third quartile, maximum, and minimum. The 95% confidence interval of the rate will be calculated. Count data will be expressed as the frequency and relative number. The 95% confidence interval of the rate will be calculated.
Normally or non-normally distributed measurement data will be analyzed using a paired t-test or Wilcoxon's signed rank test. Count data will be analyzed using the chi-square test or Fisher's exact test. Ranked data will be analyzed using Wilcoxon's signed rank test.
Sample size calculation
In accordance with previous SCI treatment conditions in participating units, we will recruit 200 patients.
The database will be constructed and maintained by Peking University People's Hospital. According to the data characteristics of the research program, the main researcher will draft detailed data management and statistical plans; this will include data quality auditing, construction of a corresponding electronic database, and complete and accurate input of all expected data.
Each participating unit will be responsible for filling in their patient database.
The computer program combined with the manual method will be used to check the consistency and logicality of the data.
Any questions will be answered by the person in charge of the project and the main staff. This information will then be returned to the data management center, and the data manager will modify and update the database. All inspection procedures will be repeated several times until there is no doubt regarding the accuracy of the data. All changes and updates must be recorded and filed. The use of correction fluid or correction tape will be strictly forbidden.
All researchers will be required to ensure that the data recorded in the case report forms are authentic.
Peking University People's Hospital will organize training sessions before the study and conduct unified training for all participants. One person will act as coordinator of the whole research project by preparing a research brief, regularly announcing the progress of the study, and solving problems that arise during in the study.
The coordinator will hold regular meetings, summarize the work, communicate, correct problems, and make a request.
To ensure that the Guidelines for Good Clinical Practice are followed, we will set up a regular visit to each center to ensure compliance with the research program, Good Clinical Practice, and related laws.
Quality control and management
A project launch meeting involving the heads of the participating units will be held to ensure that unified training is carried out for implementation of the project plan and for recording and assessment.
The heads of the participating units will train specific operators on programs, procedures, and instructions and will develop training programs and manuals to ensure that the team members are familiar with and grasp the relevant contents before the trial.
The inspector is responsible for ensuring smooth progression of the trial, controlling the whole process, and dealing with emergencies.
Each participating unit will perform its duties, strictly follow the clinical trial program, and adopt standard operating procedures. Quality control teams will be set up; teams of different grades will be responsible for different team tasks which will be inspected by the superior staff to ensure that the data is input into the database system within 24 hours after the incident and to ensure the authenticity and validity of the data. All new team members will be trained regarding the project plan and process, and retraining will be performed in a timely manner when the content/process is updated or content needs to be re-emphasized.
The standard operation procedure will ensure smooth handover if necessary.
An arbitrator will guarantee the rights of each participating unit; ensure that true, accurate, complete, and correct data are recorded and reported; and ensure that the research follows the relevant laws and regulations. The number of visits by the arbitrator will meet the needs of quality control. After each visit, the arbitrator will inform the project leader of the inspection results.
The quality controller of each region will carry out an internal inspection weekly according to the requirements.
According to the training program, the leader of each region will submit the results, statements, and a summary report to the research group on a quarterly basis. The research group will adjust the protocol according to the report in a timely manner.
All Protocols Will Be Performed in Accordance With the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki (2013), Formulated by the World Medical Association. the Study Protocol Has Been Approved by the Medical Ethics Committee of Peking University People's Hospital, China (Approval Number: 2016phb136-01). the Writing and Editing of the Article Will Be Performed in Accordance With the Standard Protocol Items: Recommendations for Interventional Trials (Spirit) (Additional File 1 [Additional file 1]). Written Informed Consent Will Be Provided by a Legal Representative of Each Patient After They Have Indicated That They Fully Understand the Treatment Plan.
| Results|| |
Patient recruitment will begin in May 2017. The primary outcome analysis will be finished in August 2019. All tests will be completed in December 2020.
The goals and expected results of this study are as follows:
(1) To establish a spine injury and SCI treatment database by collecting, recording, and submitting the data of at least 200 patients with spine injury and SCI to the Beijing Biobank of Clinical Resources for open access;
(2) To develop a pre-hospital and in-hospital linkage information platform, achieve pre-hospital and in-hospital information connection, and complete one analysis report;
(3) To establish one evaluation scheme and process of pre-hospital and in-hospital treatment for spine injury and SCI;
(4) To create one set of standardized training programs and teaching materials for pre-hospital and in-hospital treatment for spine injury and SCI;
(5) To formulate one expert consensus on standardized treatment of spine injury and SCI;
(6) To publish the study results in an international peer-reviewed journal.
| Discussion|| |
Significance of this study
This overall aims of this study are to establish a spine injury and SCI treatment database; carry out data collection; develop a pre-hospital and in-hospital evaluation protocol for spine injury and SCI; formulate, optimize, and standardize the first aid procedure; and formulate a pre-hospital and in-hospital standardized training program for spine injury and SCI.
The results of this study will enable us to establish a pre-hospital and in-hospital first aid “green channel” for treating acute spine injury and SCI, formulate first aid specifications, and establish an evaluation and treatment system for early surgery to save the spinal cord function and reduce the degree of disability. The formulated expert consensus and “green channel” mode can be promoted to hospitals throughout Beijing and other cities of China, allowing them to improve their level of emergency treatment of acute spine injury and SCI and reduce the occurrence of serious complications and secondary injury due to improper treatment.
Advantages of this study and evidence for contribution to future studies
Establishment of a spine injury and SCI treatment database: Based on our previous data on treatment of periprosthetic fractures combined with the clinical treatment characteristics of spine injury and SCI, we will establish a treatment database network and carry out data collection.
Formulation of standardized process and treatment program: Based on our previous studies of spine injury and SCI and in accordance with international advanced treatment concepts and experience, we will finally formulate a scientific and standardized process and treatment program for spine injury and SCI by combining our data with Chinese experts' recommendations regarding revision and optimization. This program will be conducted in the participating units.
Research and development of a spine injury and SCI pre-hospital and in-hospital information platform: Based on our previously developed trauma warning linkage system, we will research and develop a spine injury and SCI pre-hospital and in-hospital information platform, which will be used in the participating units. This platform will change the status of hospitals lacking preparation, will be conducive to rapid and standardized treatment, and will reduce the mortality and disability rates.
We will formulate rescue personnel training programs and teaching materials, develop standardized personnel training programs for spine injury and SCI, and improve the efficiency and effectiveness of the medical staff.
We will start a multicenter prospective study on standardized treatment of spine injury and SCI and finish the standardized treatment of at least 200 patients during this trial. We will collect the patients' information, perform follow-up, and input their data into the database. The standardized process and treatment programs, personnel training, and overall effect of the information platform will be verified in the clinic.
Additional file 1: SPIRIT checklist (PDF 48.0 kb).
| References|| |
Battistuzzo CR, Armstrong A, Clark J, Worley L, Sharwood L, Lin P, Rooke G, Skeers P, Nolan S, Geraghty T, Nunn A, Brown DJ, Hill S, Alexander J, Millard M, Cox SF, Rao S, Watts A, Goods L, Allison GT, et al. (2016) Early Decompression following Cervical Spinal Cord Injury: Examining the Process of Care from Accident Scene to Surgery. J Neurotrauma 33:1161-1169.
Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Aldrich EF, Fazl M, Fehlings M, Herr DL, Hitchon PW, Marshall LF, Nockels RP, Pascale V, Perot PL Jr, Piepmeier J, Sonntag VK, Wagner F, Wilberger JE, Winn HR, Young W (1997) Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury. Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. National Acute Spinal Cord Injury Study. JAMA 277:1597-1604.
Cortez R, Levi AD (2007) Acute spinal cord injury. Curr Treat Options Neurol 9:115-125.
Dvorak MF, Noonan VK, Fallah N, Fisher CG, Finkelstein J, Kwon BK, Rivers CS, Ahn H, Paquet J, Tsai EC, Townson A, Attabib N, Bailey CS, Christie SD, Drew B, Fourney DR, Fox R, Hurlbert RJ, Johnson MG, Linassi AG, Parent S, Fehlings MG; RHSCIR Network (2015) The influence of time from injury to surgery on motor recovery and length of hospital stay in acute traumatic spinal cord injury: an observational Canadian cohort study. J Neurotrauma 32:645-654.
Evaniew N, Belley-Côté EP, Fallah N, Noonan VK, Rivers CS, Dvorak MF (2016) Methylprednisolone for the Treatment of Patients with Acute Spinal Cord Injuries: A Systematic Review and Meta-Analysis. J Neurotrauma 33:468-481.
Fransen BL, Hosman AJ, van Middendorp JJ, Edwards M, van Grunsven PM, van de Meent H (2016) Pre-hospital and acute management of traumatic spinal cord injury in the Netherlands: survey results urge the need for standardisation. Spinal Cord 54:34-38.
Grassner L, Wutte C, Klein B, Mach O, Riesner S, Panzer S, Vogel M, Bühren V, Strowitzki M, Vastmans J, Maier D (2016) Early Decompression (< 8 h) after Traumatic Cervical Spinal Cord Injury Improves Functional Outcome as Assessed by Spinal Cord Independence Measure after One Year. J Neurotrauma 33:1658-1666.
Hastings J D, Fanucchi ER, Burns SP (2003) Wheelchair configuration and postural alignment in persons with spinal cord injury. Arch Phys Med Rehabil 84:528-534.
Lee BB, Cripps RA, Fitzharris M, Wing PC (2014) The global map for traumatic spinal cord injury epidemiology: update 2011, global incidence rate. Spinal Cord 52:110-116.
Li J, Liu G, Zheng Y, Hao C, Zhang Y, Wei B, Zhou H, Wang D (2011) The epidemiological survey of acute traumatic spinal cord injury (ATSCI) of 2002 in Beijing municipality. Spinal Cord 49:777-782.
Pickett GE, Campos-Benitez M, Keller JL, Duggal N
(2006) Epidemiology of traumatic spinal cord injury in Canada. Spine (Phila Pa 1976) 31:799-805.
Rowley G, Fielding K (1991) Reliability and accuracy of the Glasgow Coma Scale with experienced and inexperienced users. Lancet 337:535-538.
Sekhon LH, Fehlings MG (2001) Epidemiology, demographics, and pathophysiology of acute spinal cord injury. Spine 26(24S):S2-12.
Short DJ, El Masry WS, Jones PW (2000) High dose methylprednisolone in the management of acute spinal cord injury-a systematic review from a clinical perspective. Spinal Cord 38:273.
Vaccaro AR, Zeiller SC, Hulbert RJ, Anderson PA, Harris M, Hedlund R, Harrop J, Dvorak M, Wood K, Fehlings MG, Fisher C, Lehman RA Jr, Anderson DG, Bono CM, Kuklo T, Oner FC (2005) The thoracolumbar injury severity score: a proposed treatment algorithm. J Spinal Disord Tech 18:209-215.
Waters RL, Adkins RH, Yakura JS (1991) Definition of complete spinal cord injury. Spinal Cord 29:573-581.
Declaration of patient consent
The authors certify that they will obtain all appropriate patient consent forms. In the form the patients will give their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
BGJ developed the study. FX drafted the manuscript. BGJ will act as the principal trial investigator. JX, PXZ, SH and TBW will participate in patient inclusion and outcome assessment. YHK and DYZ will perform statistical analysis of the study data. All authors have read and approved the final manuscript.
Conflicts of interest
This paper was screened twice using CrossCheck to verify originality before publication.
This paper was double-blinded and stringently reviewed by international expert reviewers.