Demographic and clinical characteristics of patients with hereditary angioedema in Canada.

BACKGROUND: Data on the clinical and demographic features of Canadian patients with hereditary angioedema (HAE) are lacking. OBJECTIVE: To describe the clinical and demographic features in a large Canadian HAE cohort and compare them with patients with HAE in other countries. METHODS: An online questionnaire was distributed to the members of 2 Canadian HAE patient groups to collect information on demographics and HAE clinical characteristics. All participants 18 years of age or older with HAE type I or II were eligible. Frequency, location, prodromes, and triggers of HAE attacks, including types of HAE treatment, were characterized. RESULTS: Among the 90 participants who completed the online survey, 57% self-identified as having HAE type 1 and 26% HAE type II. The average diagnostic delay was 11 years. In the preceding 6 months, 24% of the participants had no attacks and 35% experienced greater than 5 attacks. The most frequently affected regions of the body were the abdomen (83%), arms orlegs (63%), face (41%), and larynx or throat (41%). Approximately 87% of the participants reported having access to C1 inhibitor at home, and 69% reported using it for long-term prophylaxis. CONCLUSION: Canadian patients with HAE share common clinical characteristics with patients with HAE in other countries. They had a delay in HAE diagnosis and a high burden of disease, as indicated by the high frequency of attacks in the preceding 6 months. This study provides a better understanding of the demographic and clinical characteristics of Canadian patients with HAE.

Quality of life in patients with hereditary angioedema in Canada.

BACKGROUND: Hereditary angioedema (HAE) is associated with decreased quality of life (QoL), which has typically been measured using a generic non-disease-specific questionnaire. OBJECTIVE: We aimed to assess the QoL in patients with HAE type I and II in Canada using a previously validated HAE-specific questionnaire. METHODS: An online questionnaire was sent to the members of two Canadian HAE patient groups to collect data on demographics, HAE clinical course, and QoL scores. All patients 18 years of age or older with HAE type I or II were eligible. The impact of the available clinical factors on the QoL scores was evaluated. Multiple linear regression was performed using clinically relevant factors to predict HAE QoL outcome. RESULTS: Among the 72 patients in the study, the mean total HAE QoL score was 102 (±23) (SD) on a scale of 25 to 135, with higher scores indicating better QoL. Although the total QoL scores correlated positively with patients' level of satisfaction and perceived control (P < .001 for both), it correlated negatively with the number of acute attacks (P = .03). Yet, the types of treatment did not have an impact on the QoL. Predictors, including sex, comorbidities, and the number of attacks, only explained 12% of the variance in the total QoL scores. CONCLUSION: HAE continues to impair QoL in Canadian patients despite receiving recommended treatment. Although the frequency of attacks affects QoL, patients' experience with their HAE care also affects QoL substantially. The study highlights the importance of considering patients' experience with their HAE care as physicians develop an appropriate management plan.

Clinical trials and tribulations: lessons from spinal cord injury studies registered on ClinicalTrials.gov.

STUDY DESIGN: Article. OBJECTIVE: ClinicalTrials.gov is an online trial registry that provides public access to information on past, present, and future clinical trials. While increasing transparency in research, the quality of the information provided in trial registrations is highly variable. The objective of this study is to assess key areas of information on ClinicalTrials.gov in interventional trials involving people with spinal cord injuries. SETTING: Interventional trials on ClinicalTrials.gov involving people with spinal cord injuries. METHODS: A subset of data on interventional spinal cord injury trials was downloaded from ClinicalTrials.gov. Reviewers extracted information pertaining to study type, injury etiology, spinal cord injury characteristics, timing, study status, and results. RESULTS: Of the interventional trial registrations reviewed, 62.5%, 58.6%, and 24.3% reported injury level, severity, and etiology, respectively. The timing of intervention relative to injury was reported in 72.8% of registrations. Most trials identified a valid study status (89.2%), but only 23.5% of those completed studies had posted results. CONCLUSIONS: Our review provides a snapshot of interventional clinical trials conducted in the field of spinal cord injury and registered in ClinicalTrials.gov. Areas for improvement were identified with regards to reporting injury characteristics, as well as posting results.

The challenge of recruitment for neurotherapeutic clinical trials in spinal cord injury.

STUDY DESIGN: Narrative review by individuals experienced in the recruitment of participants to neurotherapeutic clinical trials in spinal cord injury (SCI). OBJECTIVES: To identify key problems of recruitment and explore potential approaches to overcoming them. METHODS: Published quantitative experience with recruitment of large-scale, experimental neurotherapeutic clinical studies targeting central nervous system and using primary outcome assessments validated for SCI over the last 3 decades was summarized. Based on this experience, potential approaches to improving recruitment were elicited from the authors. RESULTS: The rate of recruitment has varied between studies, depending on protocol design and other factors, but particularly inclusion/exclusion criteria. The recruitment rate also ranged over an order of magnitude between individual centers in a given study. In older multicenter studies, average recruitment rate was approximately one person per study center per month. More recent trials experienced lower rates of recruitment and potential reasons for this trend were examined. The current roles and potential of various stakeholder organizations in addressing problems of recruitment were explored. In addition, recent developments in methodology may help reduce the number of subjects required for well-powered studies. CONCLUSIONS: Several approaches are emerging to improve clinical trial design, efficacy outcome measures, and quantifiable surrogate markers, all of which should reduce the number of participants required for adequate statistical power. There is a growing sense of cooperation between various stakeholders but more should be done to bring together consumer and provider groups to improve recruitment and the effectiveness and relevance of neurotherapeutic clinical trials.

Nurses' perceptions of e-portfolio use for on-the-job training in Taiwan.

Electronic portfolios can be used to record user performance and achievements. Currently, clinical learning systems and in-service education systems lack integration of nurses' clinical performance records with their education or training outcomes. For nurses with less than 2 years' work experience (nursing postgraduate year), use of an electronic portfolio is essential. This study aimed to assess the requirements of using electronic portfolios in continuing nursing education for clinical practices. Fifteen nurses were recruited using a qualitative purposive sampling approach between April 2013 and May 2013. After obtaining participants' consent, data were collected in a conference room of the study hospital by one-on-one semistructured in-depth interviews. Through data analyses, the following five main themes related to electronic learning portfolios were identified: instant access to in-service education information, computerized nursing postgraduate year training manual, diversity of system functions and interface designs, need for sufficient computers, and protection of personal documents. Because electronic portfolios are beginning to be used in clinical settings, a well-designed education information system not only can meet the needs of nurses but also can facilitate their learning progress.

[Reflection on Nurse Preceptor Training Courses: The Experiences of Nurse Preceptors and Preceptees].

BACKGROUND: The Taiwan Joint Commission on Hospital Accreditation established a nurse preceptor training program in 2012. However, there has been minimal assessment of the nurse preceptor training program from the respective perspectives of nurse preceptors and preceptees. PURPOSES: This study explores the teaching experiences of nurse preceptors and the learning experiences of new nurses, and reflects on the nurse preceptor training program. METHODS: Investigators used a qualitative method to conduct 5 focus group interviews with 15 nurse preceptors and 14 new nurses in a medical center in northern Taiwan. Interview data was analyzed using content analysis. RESULTS: Eight themes were categorized from the teaching experiences of preceptors and two themes were categorized from the learning experiences of preceptees. The analysis of the data shows that this nurse preceptor training program focused on enhancing teaching skills and assessment skills and lacked instruction in teaching affection, guidance skills, and emotion management. CONCLUSIONS / IMPLICATIONS FOR PRACTICE: This study may be used as a reference for developing training courses for nurse preceptors in Taiwan.

[Constructing indicators of competence for nurse preceptor instruction skills].

BACKGROUND: The professional teaching competence of nurse preceptors must be monitored regularly. However, the existing instruments that are designed to measure nurse preceptor professional teaching competency seldom examine updated indicators such as inter-professional practice (IPP) and evidence-based practice. PURPOSE: This study constructs indicators for assessing the teaching competence of nurse preceptor. METHODS: Phase I used a literature review to identify appropriate indicators of nurse preceptor teaching competence. Phase II conducted focus-group interviews with 10 nurse preceptors and 6 new nurses from a teaching hospital in southern Taiwan. Content analysis was used to construct a preliminary framework of indicators. Phase III invited 15 experts to evaluate the content validity of the preliminary indicators in two rounds using the Delphi method. RESULTS: The teaching-related competence of nurse comprises 36 items in the five dimensions of passionate commitment to teaching, harmonious learning atmosphere, inductive teaching skills, objective feedback and evaluation, and inter-professional practice. CONCLUSIONS / IMPLICATIONS FOR PRACTICE: The indicators developed in this study may be used by nurse preceptors to examine their teaching abilities and by healthcare institutions to design preceptor training curricula.

Examining the effectiveness of intrathecal baclofen on spasticity in individuals with chronic spinal cord injury: a systematic review.

OBJECTIVE: To review the available evidence on the effectiveness of intrathecal baclofen in the treatment of spasticity in individuals with spinal cord injuries (SCIs) at least 6 months post-injury or diagnosis. DATA SOURCES: A literature search of multiple databases (Pub Med, CINAHL, EMBASE) was conducted to identify articles published in the English language. STUDY SELECTION: Studies were included for review if: (1) more than 50% of the sample size had suffered a traumatic or non-traumatic SCI; (2) there were more than three subjects; (3) subjects received continuous intrathecal baclofen via an implantable pump aimed at improving spasticity; and (4) all subjects were ≥6 months post-SCI, at the time of the intervention. DATA EXTRACTION: Data extracted from the studies included patient and treatment characteristics, study design, method of assessment, and outcomes of the intervention. DATA SYNTHESIS: Methodological quality was assessed using the PEDro for randomized-controlled trials (RCTs) and the Downs and Black (D&B) tool for non-RCTs. A level of evidence was assigned to each intervention using a modified Sackett scale. CONCLUSION: The literature search resulted in 677 articles. No RCTs and eight non-RCTs (D&B scores 13-24) met criteria for inclusion, providing a pooled sample size of 162 individuals. There was substantial level 4 evidence that intrathecal baclofen is effective in reducing spasticity. Mean Ashworth scores reduced from 3.1-4.5 at baseline to 1.0-2.0 (P < 0.005) at follow-up (range 2-41 months). Average dosing increased from 57-187 µg/day at baseline to 218.7-535.9 µg/day at follow-up. Several complications from the use of intrathecal baclofen or pump and catheter malfunction were reported.

Using the ADDIE model to develop online continuing education courses on caring for nurses in Taiwan.

BACKGROUND: A hospital in Taiwan committed to implementing a framework of caring in clinical practice. This study was conducted to develop online courses on caring for the hospital's nurses. METHOD: The ADDIE (Analysis, Design, Development, Implementation, and Evaluation) model was applied to develop and evaluate this caring curriculum. Concrete caring and uncaring behaviors were identified through patient and nurse interviews. These were used to make 72 instructional videos and five live-action movies. Evaluation tools included quizzes, self-evaluations, focus group interviews, and a measurement of caring behavior. Patients used the same instrument to evaluate the nurses. RESULTS: Nurses' self-evaluations showed positive results. No significant difference was found between pre- and postcourse patient evaluations. CONCLUSION: This study shows the usefulness of ADDIE and provides a model for how research data and results can be used to inform administratively mandated organizational change. It also provides evidence on the effects of caring education.

Nurse preceptor training needs assessment: views of preceptors and new graduate nurses.

BACKGROUND: In Taiwan, regulatory bodies mandate that preceptor training programs comprise six mandatory topics used by all teaching hospitals. These programs have little empirical justification. This study explores the training needs of preceptors from the viewpoints of both preceptors and preceptees. METHOD: Investigators used qualitative methods to conduct 17 focus group interviews with 63 preceptors and 24 preceptees from five hospitals in Taiwan. A constant comparative method was used to analyze the data and extract themes and subthemes from participants' experiences. RESULTS: Seven themes were extracted from both preceptor teaching experiences and preceptee learning experiences. Analysis of the empirical data showed that the six mandated topics do not meet the needs of preceptors. This study also documented the concept of "nurses eating their young" for the first time in Taiwan. CONCLUSION: The findings of this study may serve as a reference for redesigning preceptor training programs in Taiwan.

Data Safety Monitoring Boards: Overview of Structure and Role in Spinal Cord Injury Studies.

This paper provides an overview of the history, composition, organization, responsibilities, and regulatory requirements of Data Safety Monitoring Boards (DSMB), with particular reference to the context of clinical trials in spinal cord injury. It is intended to help potential members of such boards and those undertaking the design of new clinical trials to understand the important role of the DSMB in safeguarding the integrity of complex trials, promoting safety, and countering potential bias. An independent DSMB helps to protect research subjects by providing study oversight and serves as an additional step to assure that clinical trials are performed to existing and appropriate standards. The DSMB must meet on a regular schedule, diligently evaluate all the information it receives, and report in a timely and decisive manner. Members must be free of significant conflicts of interest throughout the study and be adequately trained and experienced to serve their roles within the group. DSMB service can be a valuable learning experience and a gratifying opportunity to participate in advancing medicine and helping to maintain and improve the standards of research.

Meta-analysis of botulinum toxin A detrusor injections in the treatment of neurogenic detrusor overactivity after spinal cord injury.

OBJECTIVE: To examine the effectiveness of botulinum toxin type A (BTX-A) on neurogenic detrusor overactivity (NDO) in individuals with spinal cord injury (SCI). DATA SOURCES: MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for all relevant articles published from 1980 to June 2012. STUDY SELECTION: Trials examining the use of BTX-A injections into the detrusor wall in the treatment of NDO after SCI were included if (1) ≥ 50% of study sample comprised subjects post-SCI; (2) outcomes of interest were assessed before and after treatment with a single injection of BTX-A; and (3) the sample size was ≥ 3. DATA EXTRACTION: A standardized mean difference ± SE (95% confidence interval) was calculated for at least 1 of the following outcomes in every study: postvoid residual urine volume, reflex detrusor volume, bladder capacity, bladder compliance, catheterization frequency, and maximum flow rate. Results from all studies were then pooled using a random-effects model. Treatment effect sizes were interpreted as small, >0.2; moderate, >0.5; or large, >0.8. DATA SYNTHESIS: Fourteen studies representing data from 734 subjects were included. After BTX-A injection, large treatment effects were observed in postvoid residual urine volume, reflex detrusor volume, bladder capacity, bladder compliance, and catheterization frequency (P<.01). Rate of incontinence episodes was reduced from 23% to 1.31% after BTX-A treatment. No significant decrease in max flow rate was observed (P=.403). CONCLUSIONS: Results of the meta-analysis indicate BTX-A is effective in treating NDO after SCI. The use of BTX-A was associated with a decrease in incontinence episodes, catheter use, and bladder pressures.

Developing online continuing education content for enhancing caring among Taiwan nurses.

BACKGROUND: To promote the quality of nursing care, a hospital in Taiwan committed to implementing its SHARE framework for clinical practice. This study was conducted to develop caring content for the SHARE framework in the form of online continuing education videos. METHODS: Five focus group interviews were conducted with 19 exemplary nurses. A constant comparative method was used to extract caring themes that were integrated into the five components of SHARE: S: Sense patient's needs; H: Help patient out; A: Acknowledge patient's feelings; R: Respect patient's dignity and privacy; E: Explain what is happening. RESULTS: Concrete caring behaviors consistent with SHARE were identified. Real-world scenarios were used to produce five videos demonstrating the components of SHARE for use in online caring education. CONCLUSION: This project offers a new strategy for strengthening caring behavior in nurse-patient interactions and may help to establish a model for caring in nursing continuing education in Taiwan.

Neuropathic pain post spinal cord injury part 1: systematic review of physical and behavioral treatment.

BACKGROUND: Neuropathic pain has various physiologic and psychosocial aspects. Hence, there is a growing use of adjunct nonpharmacological therapy with traditional pharmacotherapy to reduce neuropathic pain post spinal cord injury (SCI). OBJECTIVE: The purpose of this study was to conduct a systematic review of published research on nonpharmacological treatment of neuropathic pain after SCI. METHODS: MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for articles addressing nonpharmacological treatment of pain post SCI. Articles were restricted to the English language. Article selection was conducted by 2 independent reviewers with the following inclusion criteria: the subjects participated in a treatment or intervention for neuropathic pain; at least 50% of the subjects had an SCI; at least 3 subjects had an SCI; and a definable intervention was being studied. Data extracted included study design, study type, subject demographics, inclusion and exclusion criteria, sample size, outcome measures, and study results. Randomized controlled trials (RCTs) were assessed for quality using the Physiotherapy Evidence Database (PEDro) assessment scale. Levels of evidence were assigned to each intervention using a modified Sackett scale. RESULTS: The 16 articles selected for this review fell into 1 of 2 categories of nonpharmacological management of pain after SCI: physical and behavioral treatments. The pooled sample size of all studies included 433 participants. Of the 16 studies included, 7 were level 1, 3 were level 2, and 6 were level 4 studies. CONCLUSIONS: Physical interventions demonstrated the strongest evidence based on quality of studies and numbers of RCTs in the nonpharmacological treatment of post-SCI pain. Of these interventions, transcranial electrical stimulation had the strongest evidence of reducing pain. Despite a growing body of literature, there is still a significant lack of research on the use of nonpharmacological therapies for SCI pain.

Neuropathic pain post spinal cord injury part 2: systematic review of dorsal root entry zone procedure.

BACKGROUND: Pharmacotherapy may not sufficiently reduce neuropathic pain in many individuals post spinal cord injury (SCI). The use of alternative therapies such as surgery may be effective in reducing neuropathic pain in these individuals. However, because of the invasive nature of surgery, it is important to examine the evidence for use of this treatment. OBJECTIVE: The purpose of this study was to conduct a systematic review of published literature on the surgical treatment of neuropathic pain after SCI. METHODS: MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for articles in which surgical treatment of pain after SCI was examined. Articles were restricted to the English language. Article selection was conducted by 2 independent reviewers with the following inclusion criteria: the subjects participated in a surgical intervention for neuropathic pain; at least 50% of the subjects had an SCI; at least 3 subjects had an SCI; and a definable intervention involving the dorsal root entry zone (DREZ) procedure was used to reduce pain. Data extracted included study design, study type, subject demographics, inclusion and exclusion criteria, sample size, outcome measures, and study results. Randomized controlled trials (RCTs) were assessed for quality using the Physiotherapy Evidence Database (PEDro) assessment scale. Levels of evidence were assigned to each intervention using a modified Sackett scale. RESULTS: Eleven studies met the inclusion criteria. One study provided level 2 evidence, and the rest provided level 4 evidence. The DREZ procedure was shown to be more effective for segmental pain than for diffuse pain after SCI. Further, individuals with conus medullaris level injury were found to have a higher level of neuropathic pain relief than those with cervical, thoracic, or cauda equina injury. CONCLUSIONS: The studies demonstrated that the DREZ procedure may be effective in reducing segmental pain. Hence, DREZ may be important in treatment of neuropathic pain in individuals resistant to less invasive treatments. Because the studies lacked control conditions and examination of long-term effects, there is a need for larger trials with more stringent conditions.

A meta-analysis of botulinum toxin sphincteric injections in the treatment of incomplete voiding after spinal cord injury.

OBJECTIVE: To conduct a systematic review and meta-analysis to examine the effect of injecting botulinum toxin A (BTX-A) into the detrusor sphincter on improving bladder emptying in individuals with spinal cord injury (SCI). DATA SOURCES: MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched for all relevant articles published from 1980 to September 2011. DATA SELECTION: All trials examining the use of BTX-A injections into the detrusor sphincter for the treatment for incomplete bladder emptying after SCI were included if at least 50% of the study sample comprised subjects with SCI, and if the SCI sample size was 3 or greater. DATA EXTRACTION: A standardized mean difference (SMD) ± SE and 95% confidence interval (CI) were calculated for each outcome of interest, and the results were pooled using a fixed or random effects model, as appropriate. Outcomes assessed included postvoid residual urine volume (PRV), detrusor pressure (PDet), and urethral pressure (UP). Effect sizes were interpreted as small, 0.2; moderate, 0.5; and large, 0.8. DATA SYNTHESIS: A relatively limited number of studies (2 randomized controlled trials, 6 uncontrolled trials) were identified. The 8 studies included results from 129 subjects. There was a statistically significant decrease in PRV at 1 month (SMD=1.119±.140; 95% CI, .844-1.394; P<.001), with a pooled mean PRV decrease from 251.8 to 153.0 mL. There was a moderate statistical effect on PDet (SMD=.570±.217; 95% CI, .145-.995; P=.009); pooled PDet decreased from 88.7 to 20.5 cmH(2)O. A large statistical effect size on UP (SMD=.896±.291; 95% CI, .327-1.466; P=.002) and an improvement from 119.7 to 102.3 cmH(2)O were seen. The systematic review also indicated a 50% reduction in urinary tract infections based on 3 studies. Discontinuation or reduction in catheter usage was reported in 4 studies after BTX-A. CONCLUSIONS: Results of the meta-analysis indicate that BTX-A is effective in reducing PRV and demonstrating a statistically significant reduction in PDet and UP 1 month postinjection. However, the clinical utility of BTX-A is yet to be determined.

Using scoping review methods to describe current capacity and prescribe change in Canadian SCI rehabilitation service delivery.

OBJECTIVE: To describe the methodology used to conduct a scoping review of spinal cord injury (SCI) rehabilitation service delivery in Canada, and to explain the reporting process intended to advance future service delivery. EVIDENCE ACQUISITION: A SCI rehabilitation framework derived from the International Classification of Function, Disability and Health was developed to describe the goals and interprofessional processes of rehabilitation. An adapted Arksey and O'Malley (2005) methodological framework was used to conduct a scoping review of SCI rehabilitation services in Canada. Data were obtained from multiple relevant sources via survey (N = 3572 data fields) from 13 of 15 Canadian tertiary SCI rehabilitation sites, systematic reviews, white papers, literature reviews, clinical practice resources, and clinicians. Multidisciplinary teams of content experts (N = 17), assisted with data interpretation and validation by articulating practice trends, gaps, and priorities. EVIDENCE SYNTHESIS: The findings will be presented in an atlas, which includes aggregate national data regarding impairment and demographic characteristics, service utilization, available resources (staff and capital equipment), specialized services, local expertise, and current best practice indicators, outcome measures, and clinical guidelines. Data were collated and synthesized relative to specific rehabilitation goals. The current state of SCI rehabilitation service delivery (specific to each rehabilitation goal) is summarized in a report card within three domains, knowledge generation, clinical application, and policy change, and specifies key 2020 priorities. CONCLUSION: These findings should prompt critical evaluation of current Canadian SCI rehabilitation service delivery while specifying enhancements in knowledge generation, clinical application and policy change domains likely to assist with achievement of best practices by 2020.

[Clinical nursing education].

Nursing is a clinical profession influenced by social and environmental change. Facing the continuing evolution of the medical practice environment, nursing educators should take into account both current issues and future trends. As nursing clinical education undergoes radical reform, it must address both current and future healthcare demands. Relevant articles in the literature indicate that students continue to face significant difficulties applying classroom knowledge to clinical practice. This article describes the meanings, purposes, elements and models of nursing clinical education as well as relevant factors of influence. We also offer suggestions for meeting future societal demands.

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations.

Accurate safety information in published clinical trials guides the assessment of risk-benefit, as well as the design of future clinical trials. Comprehensive reporting of adverse events, toxicity, and discontinuations from acute spinal cord injury clinical trials is an essential step in this process. Here, we sought to assess the degree of "satisfactoriness" of reporting in past clinical trials in spinal cord injury. A review of citations from MEDLINE and EMBASE identified eligible clinical trials in acute (within 30 days) spinal cord injury. English language studies, published between 1980 and 2020, with sensory, motor, or autonomic neurological assessments as the primary outcome measure were eligible for inclusion. Criteria were then established to qualify the safety reporting as satisfactory (i.e., distinguished severe/life-threatening events), partially satisfactory, or unsatisfactory (i.e., only mentioned in general statements, or reported but without distinguishing severe events). A total of 40 trials were included. Satisfactory reporting for clinical adverse events was observed in 30% of trials; partially satisfactory was achieved by 10% of the trials, and the remaining 60% were unsatisfactory. The majority of trials were determined to be unsatisfactory for the reporting of laboratory-defined toxicity (82.5%); only 17.5% were satisfactory. Discontinuations were satisfactorily reported for the majority of trials (80%), with the remaining partially satisfactory (5%) or unsatisfactory (15%). Reporting of safety in clinical trials for acute spinal cord injury is suboptimal. Due to the complexities of acute spinal cord injury (e.g., polytrauma, multiple systems affected), tailored and specific standards for tracking adverse events and safety reporting should be established.