Suicide and traumatic spinal cord injury-a cohort study.

STUDY DESIGN: Retrospective and prospective observational. OBJECTIVE: The main objective of this study was to analyse suicide attempt as a cause of traumatic spinal cord injury (tSCI) and suicide as a cause of death after tSCI. SETTING: This study was conducted at two British spinal centres, Stoke Mandeville and Southport. METHODS: Long-term survival of patients who were newly admitted between 1991 and 2010, had survived the first post-injury year and had neurological deficit on discharge. Follow-up was discontinued on 31 December 2014. RESULTS: Among the 2304 newly admitted cases of tSCI, suicide attempt was the cause of injury in 63 cases (2.7%). By the end of 2014 there were 533 deaths of which 4.2% deaths were by suicide, with 91% of suicides happening in the first 10 years post injury. Multiple logistic regression analyses showed a higher mortality odds ratio (OR=4.32, P<0.001) and a much higher suicide OR (9.46, P<0.001) for persons injured in suicide attempts when compared with all other SCI aetiologies. The overall age-standardised suicide mortality rate was 62.5 per 100 000 persons per year (95% confidence interval=36.4-88.6), five times higher than the general population suicide rate for England and Wales in 2014 (12.2 per 100 000). CONCLUSIONS: Suicide attempt was the cause of tSCI in 2.7% of the sample and suicide was the cause of death in 4.2% of all deaths. The overall mortality and death by suicide were significantly higher in persons whose tSCI was caused by an attempted suicide when compared with the rest of the sample. Continued psychological attention following SCI, especially to those who were injured by suicide attempt, is warranted.

Causes of death after traumatic spinal cord injury-a 70-year British study.

DESIGN: Retrospective and prospective observational. OBJECTIVE: Analyse causes of death after traumatic spinal cord injury (tSCI) in persons surviving the first year post injury, and establish any trend over time. SETTING: Two spinal centres in Great Britain. METHODS: The sample consisted of 5483 patients with tSCI admitted to Stoke Mandeville and Southport spinal centres who were injured between 1943 and 2010, survived first year post injury, had residual neurological deficit on discharge and were British residents. Mortality information, including causes of death, was collected up to 31 December 2014. Age-standardised cause-specific mortality rates were calculated for selected causes of death, and included trends over time and comparison with the general population. RESULTS: In total, 2322 persons (42.3% of the sample) died, with 2170 (93.5%) having a reliable cause of death established. The most frequent causes of death were respiratory (29.3% of all certified causes), circulatory, including cardiovascular and cerebrovascular diseases (26.7%), neoplasms (13.9%), urogenital (11.5%), digestive (5.3%) and external causes, including suicides (4.5%). Compared to the general population, age-standardised cause-specific mortality rates were higher for all causes, especially skin, urogenital and respiratory; rates showed improvement over time for suicides, circulatory and urogenital causes, no significant change for neoplasms, and increase for skin and respiratory causes. CONCLUSIONS: Leading causes of death after tSCI in persons surviving the first year post injury were respiratory, circulatory, neoplasms and urogenital. Cause-specific mortality rates showed improvement over time for most causes, but were still higher than the general population rates, especially for skin, urinary and respiratory causes.

International Spinal Cord Injury Core Data Set (version 2.0)-including standardization of reporting.

STUDY DESIGN: The study design includes expert opinion, feedback, revisions and final consensus. OBJECTIVES: The objective of the study was to present the new knowledge obtained since the International Spinal Cord Injury (SCI) Core Data Set (Version 1.0) published in 2006, and describe the adjustments made in Version 2.0, including standardization of data reporting. SETTING: International. METHODS: Comments received from the SCI community were discussed in a working group (WG); suggestions from the WG were reviewed and revisions were made. All suggested revisions were considered, and a final version was circulated for final approval. RESULTS: The International SCI Core Data Set (Version 2.0) consists of 25 variables. Changes made to this version include the deletion of one variable 'Total Days Hospitalized' and addition of two variables 'Date of Rehabilitation Admission' and 'Date of Death.' The variable 'Injury Etiology' was extended with six non-traumatic categories, and corresponding 'Date of Injury' for non-traumatic cases, was defined as the date of first physician visit for symptoms related to spinal cord dysfunction. A category reflecting transgender was added. A response category was added to the variable on utilization of ventilatory assistance to document the use of continuous positive airway pressure for sleep apnea. Other clarifications were made to the text. The reporting of the pediatric SCI population was updated as age groups 0-5, 6-12, 13-14, 15-17 and 18-21. CONCLUSION: Collection of the core data set should be a basic requirement of all studies of SCI to facilitate accurate descriptions of patient populations and comparison of results across published studies from around the world.

Long-term survival after traumatic spinal cord injury: a 70-year British study.

STUDY DESIGN: Retrospective and prospective observational. OBJECTIVES: Analyse long-term survival after traumatic spinal cord injury (SCI) in Great Britain over the 70-year study period, identify mortality risk factors and estimate current life expectancy. SETTING: Two spinal centres in Great Britain. METHODS: The sample consisted of patients with traumatic SCI injured 1943-2010 who survived the first year post-injury, had residual neurological deficit on discharge and were British residents. Life expectancy and trends over time were estimated by neurological grouping, age and gender, using logistic regression of person-years of follow-up combined with standard life table calculations. RESULTS: For the 5483 cases of traumatic SCI the mean age at injury was 35.1 years, 79.7% were male, 31.1% had tetraplegia AIS/Frankel ABC, 41.2% paraplegia ABC,and 27.7% functionally incomplete lesion (all Ds). On 31 December 2014, 54% were still alive, 42.3% had died and 3.7% were lost to follow-up. Estimated life expectancies improved significantly between the 1950s and 1980s, plateaued during the next two decades, before slightly improving again since 2010. The estimated current life expectancy, compared with the general British population, ranged from 18.1 to 88.4% depending on the ventilator dependency, level and completeness of injury, age and gender. CONCLUSIONS: Life expectancy after SCI improved significantly between the 1950s and 1980s, plateaued during the 1990s and 2000s, before slightly improving again since 2010, but still remains well below that of the general British population. SPONSORSHIP: Buckinghamshire Healthcare NHS Trust Charitable Spinal Fund and Ann Masson Legacy for Spinal Research Fund, UK.

Family caregivers of individuals with spinal cord injury: exploring the stresses and benefits.

STUDY DESIGN: Cross-sectional, focus group. OBJECTIVES: To explore positive and negative issues reported by family caregivers of people with spinal cord injury (SCI) to develop a relevant and valid tool to assess caregiver distress and benefit for this unique population. METHODS: Seventy-three family caregivers of people with SCI participated in 16 focus groups. We audio-recorded all focus group discussions and transcribed the recordings verbatim. Qualitative analysis of the transcripts was performed to identify major themes and subthemes relating to family caregiving activities. RESULTS: Positive themes were disproportionately limited in comparison with negative themes. Positives included changes in self-awareness, enhanced family cohesiveness and feeling appreciated. Negative themes included physical and emotional strain, dissatisfaction with hired carers and strain on family relationships. Health-related themes included fatigue and lack of sleep. Caregivers identified sources of strength that helped them manage stresses including faith and support from friends and co-workers. CONCLUSION: The numerous themes help lay the groundwork to develop a valid and reliable assessment tool to assist health-care providers in treatment planning and the provision of long-term assistance to people with SCI by enhancing areas of strengths and addressing factors that contribute to burden and distress for family caregivers.

A comparison of high vs standard tidal volumes in ventilator weaning for individuals with sub-acute spinal cord injuries: a site-specific randomized clinical trial.

STUDY DESIGN: Prospective, randomized, controlled parallel group trial with single-blinded data analysis. OBJECTIVES: To determine the safety and efficacy of higher (20 ml kg(-1) ideal body weight (IBW)) vs standard (10 ml kg(-1) IBW) tidal volumes (Vt) for patients with sub-acute traumatic tetraplegia during ventilator weaning using a 14-day (minimum) weaning protocol. SETTING: United States regional spinal cord injury treatment center. METHODS: Thirty-three ventilator requiring inpatients were randomized to either the higher (Group 1) or the standard (Group 2) Vt protocol. Initially, all patients were ventilated at 10 ml kg(-1) IBW Vt and 5 cm H(2)O [corrected] of PEEP for 72 h. For Group 1, Vt was raised 100 ml kg(-1) until reaching target Vt of 20 ml kg(-1) IBW. Group 2 was maintained at Vt of 10 ml kg(-1) IBW. Plateau pressures were kept at or below 30 cm H(2)O. [corrected]. Safety outcomes included incidence of adverse events. RESULTS: Because of smaller than expected enrollment, evaluation of efficacy was not possible. Therefore, we report the safety outcomes of 33 study participants. The 16 patients in Group 1 and 17 patients in Group 2 were demographically similar at baseline, except for age. The average age was 39.3 years in Group 1 and 27.2 years in Group 2, (P=0.002). There was no difference in median days to wean: 14.5 days in Group 1 and 14 days in Group 2. The incidence of adverse pulmonary events was similar between groups. CONCLUSION: Higher tidal volumes can be safely utilized during weaning of patients with tetraplegia from mechanical ventilation using a 14-day weaning protocol.

Development of the International Spinal Cord Injury Activities and Participation Basic Data Set.

STUDY DESIGN: Consensus decision-making process. OBJECTIVES: The objective of this study was to develop an International Spinal Cord Injury (SCI) Activities and Participation (A&P) Basic Data Set. SETTING: International working group. METHODS: A committee of experts was established to select and define A&P data elements to be included in this data set. A draft data set was developed and posted on the International Spinal Cord Society (ISCoS) and American Spinal Injury Association websites and was also disseminated among appropriate organizations for review. Suggested revisions were considered, and a final version of the A&P Data Set was completed. RESULTS: Consensus was reached to define A&P and to incorporate both performance and satisfaction ratings. Items that were considered core to each A&P domain were selected from two existing questionnaires. Four items measuring activities were selected from the Spinal Cord Independence Measure III to provide basic data on task execution in activities of daily living. Eight items were selected from the Craig Handicap Assessment and Reporting Technique to provide basic data on the frequency of participation. An additional rating of satisfaction on a three-point scale for each item completes the total of 24 A&P variables. CONCLUSION: Collection of the International SCI A&P Basic Data Set variables in all future research on SCI outcomes is advised to facilitate comparison of results across published studies from around the world. Additional standardised instruments to assess activities of daily living or participation can be administered, depending on the purpose of a particular study.

Good validity of the international spinal cord injury quality of life basic data set.

STUDY DESIGN: Cross-sectional validation study. OBJECTIVES: To examine the construct and concurrent validity of the International Spinal Cord Injury (SCI) Quality of Life (QoL) Basic Data Set. SETTING: Dutch community. PARTICIPANTS: People 28-65 years of age, who obtained their SCI between 18 and 35 years of age, were at least 10 years post SCI and were wheelchair users in daily life. MEASURE(S): The International SCI QoL Basic Data Set consists of three single items on satisfaction with life as a whole, physical health and psychological health (0=complete dissatisfaction; 10=complete satisfaction). Reference measures were the Mental Health Inventory-5 and three items of the World Health Organization Quality of Life measure. RESULTS: Data of 261 participants were available. Mean time after SCI was 24.1 years (s.d. 9.1); 90.4% had a traumatic SCI, 81.5% a motor complete SCI and 40% had tetraplegia. Mean age was 47.9 years (s.d. 8.8) and 73.2% were male. Mean scores were 6.9 (s.d. 1.9) for general QoL, 5.8 (s.d. 2.2) for physical health and 7.1 (s.d. 1.9) for psychological health. No floor or ceiling effects were found. Strong inter-correlations (0.48-0.71) were found between the items, and Cronbach's alpha of the scale was good (0.81). Correlations with the reference measures showed the strongest correlations between the WHOQOL general satisfaction item and general QoL (0.64), the WHOQOL health and daily activities items and physical health (0.69 and 0.60) and the Mental Health Inventory-5 and psychological health (0.70). CONCLUSIONS: This first validity study of the International SCI QoL Basic Data Set shows that it appears valid for persons with SCI.

Common data elements for spinal cord injury clinical research: a National Institute for Neurological Disorders and Stroke project.

OBJECTIVES: To develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in spinal cord injury (SCI) clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health. SETTING: International Working Groups. METHODS: Nine working groups composed of international experts reviewed existing CDEs and instruments, created new elements when needed and provided recommendations for SCI clinical research. The project was carried out in collaboration with and cross-referenced to development of the International Spinal Cord Society (ISCoS) International SCI Data Sets. The recommendations were compiled, subjected to internal review and posted online for external public comment. The final version was reviewed by all working groups and the NINDS CDE team before release. RESULTS: The NINDS SCI CDEs and supporting documents are publically available on the NINDS CDE website and the ISCoS website. The CDEs span the continuum of SCI care and the full range of domains of the International Classification of Functioning, Disability and Health. CONCLUSION: Widespread use of CDEs can facilitate SCI clinical research and trial design, data sharing and retrospective analyses. Continued international collaboration will enable consistent data collection and reporting, and will help ensure that the data elements are updated, reviewed and broadcast as additional evidence is obtained.

Using Rasch motor FIM individual growth curves to inform clinical decisions for persons with paraplegia.

STUDY DESIGN: A longitudinal retrospective study. OBJECTIVE: To better understand individual-level temporal change in functional status for participants with paraplegia in the National Spinal Cord Injury Database (NSCID), as measured by Rasch Transformed Motor Functional Indepedence Measure (FIM) scores. SETTING: Multicenter/Multistate longitudinal study across the United States. METHODS: Non-linear random effects modeling, that is, individual growth curve analysis of retrospective data obtained from the National Institute on Disability and Rehabilitation Research (NIDRR) NSCID. RESULTS: We generated non-linear individual level trajectories of recovery for Rasch Transformed Motor FIM scores that rise rapidly from inpatient rehabilitation admission to a plateau. Trajectories are based on relationships between growth parameters and patient and injury factors: race, gender, level of education at admission, age at injury, neurological level at discharge, American Spinal Injury Association Impairment Scale (AIS) at discharge, days from injury to first system inpatient rehabilitation admission, rehabilitation length of stay, marital status and etiology. On the basis of study results, an interactive tool was developed to represent individual level longitudinal outcomes as trajectories based upon an individual's given baseline characteristics, that is, information supplied by the covariates and provides a robust description of temporal change for those with paraplegia within the NSCID. CONCLUSIONS: This methodology allows researchers and clinicians to generate and better understand patient-specific trajectories through the use of an automated interactive tool where a nearly countless number of longitudinal paths of recovery can be explored. Projected trajectories holds promise in facilitating planning for inpatient and outpatient services, which could positively impact long term outcomes.

www.elearnSCI.org: a global educational initiative of ISCoS.

OBJECTIVE: To develop a web-based educational resource for health professionals responsible for the management of spinal cord injury (SCI). The resource:www.elearnSCI.org is comprised of seven learning modules, each subdivided into various submodules. Six of the seven modules address the educational needs of all disciplines involved in comprehensive SCI management. The seventh module addresses prevention of SCI. Each submodule includes an overview, activities, self-assessment questions and references. DEVELOPMENT OF THE RESOURCE: Three hundred and thirty-two experts from The International Spinal Cord Society (ISCoS) and various affiliated societies from 36 countries were involved in developing the resource through 28 subcommittees. The content of each submodule was reviewed and approved by the Education and Scientific Committees of ISCoS and finally by an Editorial Committee of 23 experts. KEY FEATURES: The content of the learning modules is relevant to students and to new as well as experienced SCI healthcare professionals. The content is applicable globally, has received consumer input and is available at no cost. The material is presented on a website underpinned by a sophisticated content-management system, which allows easy maintenance and ready update of all the content. The resource conforms to key principles of e-learning, including appropriateness of curriculum, engagement of learners, innovative approaches, effective learning, ease of use, inclusion, assessment, coherence, consistency, transparency, cost effectiveness and feedback. CONCLUSION: www.elearnSCI.org provides a cost effective way of training healthcare professionals that goes beyond the textbook and traditional face-to-face teaching.

Quality of life after spinal cord injury: a comparison across six countries.

STUDY DESIGN: An international cross-sectional study. OBJECTIVE: To examine the quality of life (QoL) of people with spinal cord injury (SCI) across six countries worldwide, controlling for socio-demographic and lesion-related sample characteristics and using a cross-culturally valid assessment. METHODS: Data from 243 persons with SCI from Australia, Brazil, Canada, Israel, South Africa and the United States were analyzed. QoL was measured using five satisfaction items from the World Health Organization Quality of Life Assessment. Cross-culturally valid, Rasch-transformed scores were used for comparison. RESULTS: Analysis of variance showed a significant difference in QoL between countries (F=3.938; df=5; P=0.002). Shorter time since injury, no paid employment and living in Brazil were significant predictors of lower QoL, explaining 13% of variance in linear regression. Using multilevel regression with country as higher-order variable, time since injury and paid employment remained significant predictors and explained 18% of variance in QoL. The intraclass correlation coefficient (0.05) indicates that 5% of the variability can be accounted for by country. CONCLUSION: This study showed QoL differences between countries that could not be explained by differences in demographic and lesion-related characteristics. Results point to the relevance of reintegration of people with SCI into the workforce. Further international comparative research using larger samples is recommended.

Autologous incubated macrophage therapy in acute, complete spinal cord injury: results of the phase 2 randomized controlled multicenter trial.

STUDY DESIGN: Randomized controlled trial with single-blinded primary outcome assessment. OBJECTIVES: To determine the efficacy and safety of autologous incubated macrophage treatment for improving neurological outcome in patients with acute, complete spinal cord injury (SCI). SETTING: Six SCI treatment centers in the United States and Israel. METHODS: Participants with traumatic complete SCI between C5 motor and T11 neurological levels who could receive macrophage therapy within 14 days of injury were randomly assigned in a 2:1 ratio to the treatment (autologous incubated macrophages) or control (standard of care) groups. Treatment group participants underwent macrophage injection into the caudal boundary of the SCI. The primary outcome measure was American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-B or better at ≥6 months. Safety was assessed by analysis of adverse events (AEs). RESULTS: Of 43 participants (26 treatment, 17 control) having sufficient data for efficacy analysis, AIS A to B or better conversion was experienced by 7 treatment and 10 control participants; AIS A to C conversion was experienced by 2 treatment and 2 control participants. The primary outcome analysis for subjects with at least 6 months follow-up showed a trend favoring the control group that did not achieve statistical significance (P=0.053). The mean number of AEs reported per participant was not significantly different between the groups (P=0.942). CONCLUSION: The analysis failed to show a significant difference in primary outcome between the two groups. The study results do not support treatment of acute complete SCI with autologous incubated macrophage therapy as specified in this protocol.

International Spinal Cord Injury Quality of Life Basic Data Set.

STUDY DESIGN: Survey of expert opinion, feedback, and development of final consensus. OBJECTIVE: Present the background, purpose, development process and results for the International Spinal Cord Injury (SCI) Quality of Life (QoL) Basic Data Set. SETTING: International. METHODS: A committee of experts was established to select and define data elements to be included in an International SCI QoL Basic Data Set. A draft data set was developed and disseminated to appropriate organizations for comment. All suggested revisions were considered, and a final version of the QoL data set was completed. RESULTS: The QoL data set consists of 3 variables: ratings of satisfaction with general quality of life, satisfaction with physical health, and satisfaction with psychological health. All variables are rated on a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied). CONCLUSION: Collection of the International SCI QoL Basic Data Set variables should be a part of all future studies of SCI QoL to facilitate comparison of results across published studies from around the world. Additional standardized instruments to assess other aspects of QoL can be administered based on the purpose of a particular study.

Secondary health conditions in individuals aging with SCI: terminology, concepts and analytic approaches.

STUDY DESIGN: Literature review. OBJECTIVES: Utilizing individuals with spinal cord injury (SCI) as a representative population for physical disability, this paper: (1) reviews the history of the concept of secondary conditions as it applies to the health of individuals aging with long-term disabilities; (2) proposes a definition of secondary health conditions (SHCs) and a conceptual model for understanding the factors that are related to SHCs as individuals age with a disability; and (3) discusses the implications of the model for the assessment of SHCs and for developing interventions that minimize their frequency, severity and negative effects on the quality of life of individuals aging with SCI and other disabilities. METHODS: Key findings from research articles, reviews and book chapters addressing the concept of SHCs in individuals with SCI and other disabilities were summarized to inform the development of a conceptual approach for measuring SCI-related SHCs. CONCLUSIONS: Terms used to describe health conditions secondary to SCI and other physical disabilities are used inconsistently throughout the literature. This inconsistency represents a barrier to improvement, measurement and for the development of effective interventions to reduce or prevent these health conditions and mitigate their effects on participation and quality of life. A working definition of the term SHCs is proposed for use in research with individuals aging with SCI, with the goal of facilitating stronger evidence and increased knowledge upon which policy and practice can improve the health and well-being of individuals aging with a disability.

Incorporation of the International Spinal Cord Injury Data Set elements into the National Institute of Neurological Disorders and Stroke Common Data Elements.

OBJECTIVES: To develop consistent variable names and a common database structure for the data elements in the International Spinal Cord Injury (SCI) Data Sets. SETTING: National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDE) Project and The Executive Committee of the International SCI Standards and Data Sets committees (ECSCI). METHODS: The NINDS CDE team creates a variable name for each defined data element in the various International SCI Data Sets. Members of the ECSCI review these in an iterative process to make the variable names logical and consistent across the data sets. Following this process, the working group for the particular data set reviews the variable names, and further revisions and adjustments may be made. In addition, a database structure for each data set is developed allowing data to be stored in a uniform way in databases to promote sharing data from different studies. RESULTS: The International SCI Data Sets variable names and database specifications will be available through the web sites of the International Spinal Cord Society (http://www.iscos.org.uk), the American Spinal Injury Association (http://www.asia-spinalinjury.org) and the NINDS CDE project web site (http://www.CommonDataElements.ninds.nih.gov). CONCLUSION: This process will continue as additional International SCI Data Sets fulfill the requirements of the development and approval process and are ready for implementation.

Recommendations for translation and reliability testing of International Spinal Cord Injury Data Sets.

OBJECTIVE: To provide recommendations regarding translation and reliability testing of International Spinal Cord Injury (SCI) Data Sets. SETTING: The Executive Committee for the International SCI Standards and Data Sets. RECOMMENDATIONS: Translations of any specific International SCI Data Set can be accomplished by translation from the English version into the target language, and be followed by a back-translation into English, to confirm that the original meaning has been preserved. Another approach is to have the initial translation performed by translators who have knowledge of SCI, and afterwards controlled by other person(s) with the same kind of knowledge. The translation process includes both language translation and cultural adaptation, and therefore shall not be made word for word, but will strive to include conceptual equivalence. At a minimum, the inter-rater reliability should be tested by no less than two independent observers, and preferably in multiple countries. Translations must include information on the name, role and background of everyone involved in the translation process, and shall be dated and noted with a version number. CONCLUSION: By following the proposed guidelines, translated data sets should assure comparability of data acquisition across countries and cultures. If the translation process identifies irregularities or misrepresentation in either the original English version or the target language, the working group for the particular International SCI Data Set shall revise the data set accordingly, which may include re-wording of the original English version in order to accomplish a compromise in the content of the data set.

A phase 2 autologous cellular therapy trial in patients with acute, complete spinal cord injury: pragmatics, recruitment, and demographics.

STUDY DESIGN: Post hoc analysis from a randomized controlled cellular therapy trial in acute, complete spinal cord injury (SCI). OBJECTIVES: Description and quantitative review of study logistics, referral patterns, current practice patterns and subject demographics. SETTING: Subjects were recruited to one of six international study centers. METHODS: Data are presented from 1816 patients pre-screened, 75 participants screened and 50 randomized. RESULTS: Of the 1816 patients pre-screened, 53.7% did not meet initial study criteria, primarily due to an injury outside the time window (14 days) or failure to meet neurological criteria (complete SCI between C5 motor/C4 sensory and T11). MRIs were obtained on 339 patients; 51.0% were ineligible based on imaging criteria. Of the 75 participants enrolled, 25 failed screening (SF), leaving 50 randomized. The primary reason for SF was based on the neurological exam (51.9%), followed by failure to meet MRI criteria (22.2%). Of the 50 randomized subjects, there were no significant differences in demographics in the active versus control arms. In those participants for whom data was available, 93.8% (45 of 48) of randomized participants received steroids before study entry, whereas 94.0% (47 of 50) had spine surgery before study enrollment. CONCLUSION: The 'funnel effect' (large numbers of potentially eligible participants with a small number enrolled) impacts all trials, but was particularly challenging in this trial due to eligibility criteria and logistics. Data collected may provide information on current practice patterns and the issues encountered and addressed may facilitate design of future trials.