Developing a spinal cord injury research strategy using a structured process of evidence review and stakeholder dialogue. Part II: Background to a research strategy.

STUDY DESIGN: Literature review/semi-structured interviews. OBJECTIVE: To develop a spinal cord injury (SCI) research strategy for Australia and New Zealand. SETTING: Australia. METHODS: The National Trauma Research Institute Forum approach of structured evidence review and stakeholder consultation was employed. This involved gathering from published literature and stakeholder consultation the information necessary to properly consider the challenge, and synthesising this into a briefing document. RESULTS: A research strategy 'roadmap' was developed to define the major steps and key planning questions to consider; next, evidence from published SCI research strategy initiatives was synthesised with information from four one-on-one semi-structured interviews with key SCI research stakeholders to create a research strategy framework, articulating six key themes and associated activities for consideration. These resources, combined with a review of SCI prioritisation literature, were used to generate a list of draft principles for discussion in a structured stakeholder dialogue meeting. CONCLUSION: The research strategy roadmap and framework informed discussion at a structured stakeholder dialogue meeting of 23 participants representing key SCI research constituencies, results of which are published in a companion paper. These resources could also be of value in other research strategy or planning exercises. SPONSORSHIP: This project was funded by the Victorian Transport Accident Commission and the Australian and New Zealand Spinal Cord Injury Network.

Developing a spinal cord injury research strategy using a structured process of evidence review and stakeholder dialogue. Part III: outcomes.

STUDY DESIGN: Focus Group. OBJECTIVES: To develop a unified, regional spinal cord injury (SCI) research strategy for Australia and New Zealand. SETTING: Australia. METHODS: A 1-day structured stakeholder dialogue was convened in 2013 in Melbourne, Australia, by the National Trauma Research Institute in collaboration with the SCI Network of Australia and New Zealand. Twenty-three experts participated, representing local and international research, clinical, consumer, advocacy, government policy and funding perspectives. Preparatory work synthesised evidence and articulated draft principles and options as a starting point for discussion. RESULTS: A regional SCI research strategy was proposed, whose objectives can be summarised under four themes. (1) Collaborative networks and strategic partnerships to increase efficiency, reduce duplication, build capacity and optimise research funding. (2) Research priority setting and coordination to manage competing studies. (3) Mechanisms for greater consumer engagement in research. (4) Resources and infrastructure to further develop SCI data registries, evaluate research translation and assess alignment of research strategy with stakeholder interests. These are consistent with contemporary international SCI research strategy development activities. CONCLUSION: This first step in a regional SCI research strategy has articulated objectives for further development by the wider SCI research community. The initiative has also reinforced the importance of coordinated, collective action in optimising outcomes following SCI.

Developing a spinal cord injury research strategy using a structured process of evidence review and stakeholder dialogue. Part I: rapid review of SCI prioritisation literature.

STUDY DESIGN: This is a rapid evidence review. OBJECTIVES: The objective of this study was to gain an overview of the volume, nature and findings of studies regarding priorities for spinal cord injury (SCI) research. SETTING: A worldwide literature search was conducted. METHODS: Six medical literature databases and Google Scholar were searched for reviews in which the primary aim was to identify SCI research priorities. RESULTS: Two systematic reviews were identified-one of quantitative and one of qualitative studies. The quality of the reviews was variable. Collectively, the reviews identified 31 primary studies; 24 quantitative studies totalling 5262 participants and 7 qualitative studies totalling 120 participants. Despite the difference in research paradigms, there was convergence in review findings in the areas of body impairments and relationships. The vast majority of literature within the reviews focused on the SCI patient perspective. CONCLUSION: The reviews inform specific research topics and highlight other important research considerations, most notably those pertaining to SCI patients' perspectives on quality of life, which may be of use in determining meaningful research outcome measures. The views of other SCI research stakeholders such as researchers, clinicians, policymakers, funders and carers would help shape a bigger picture of SCI research priorities, ultimately optimising research outputs and translation into clinical practice and health policy change. Review findings informed subsequent activities in developing a regional SCI research strategy, as described in two companion papers. SPONSORSHIP: This project was funded by the Victorian Transport Accident Commission and the Australian and New Zealand SCI Network.

Pressure ulcers in people with spinal cord injury in developing nations.

STUDY DESIGN: Literature review. OBJECTIVES: To explore the prevalence or incidence, risk factors, and costs of pressure ulcers among individuals with spinal cord injury (SCI), specifically in the context of the developing world. To highlight important targets for intervention and research for pressure ulcer management the world over. SETTING: World Bank 'low-income' and 'middle-income' countries with a gross national income per capita <$12 746. METHODS: PubMed search. RESULTS: SCI-associated pressure ulcers are very prevalent in developing nations; however, reported prevalence and incidence numbers are highly variable. Risk factors for pressure ulcers are similar in developed and developing countries however many of the risk factors are more prevalent in developing nations. CONCLUSION: SCI-associated pressure ulcers are common but can be prevented in the developing world. Key targets for interventions include acute care, nurse-to-patient ratios, support surfaces and education.

Outcome measures in spinal cord injury: recent assessments and recommendations for future directions.

STUDY DESIGN: Review by the spinal cord outcomes partnership endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. OBJECTIVES: Assessment of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. METHODS: a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity for human SCI. RESULTS: Imaging, neurological, functional, autonomic, sexual health, bladder/bowel, pain and psychosocial tools were evaluated. Several specific tools for human SCI studies have or are being developed to allow the more accurate determination for a clinically meaningful benefit (improvement in functional outcome or quality of life) being achieved as a result of a therapeutic intervention. CONCLUSION: Significant progress has been made, but further validation studies are required to identify the most appropriate tools for specific targets in a human SCI study or clinical trial.

International standards to document remaining autonomic function after spinal cord injury.

STUDY DESIGN: Experts opinions consensus. OBJECTIVE: To develop a common strategy to document remaining autonomic neurologic function following spinal cord injury (SCI). BACKGROUND AND RATIONALE: The impact of a specific SCI on a person's neurologic function is generally described through use of the International Standards for the Neurological Classification of SCI. These standards document the remaining motor and sensory function that a person may have; however, they do not provide information about the status of a person's autonomic function. METHODS: Based on this deficiency, the American Spinal Injury Association (ASIA) and the International Spinal Cord Society (ISCoS) commissioned a group of international experts to develop a common strategy to document the remaining autonomic neurologic function. RESULTS: Four subgroups were commissioned: bladder, bowel, sexual function and general autonomic function. On-line communication was followed by numerous face to face meetings. The information was then presented in a summary format at a course on Measurement in Spinal Cord Injury, held on June 24, 2006. Subsequent to this it was revised online by the committee members, posted on the websites of both ASIA and ISCoS for comment and re-revised through webcasts. Topics include an overview of autonomic anatomy, classification of cardiovascular, respiratory, sudomotor and thermoregulatory function, bladder, bowel and sexual function. CONCLUSION: This document describes a new system to document the impact of SCI on autonomic function. Based upon current knowledge of the neuroanatomy of autonomic function this paper provides a framework with which to communicate the effects of specific spinal cord injuries on cardiovascular, broncho-pulmonary, sudomotor, bladder, bowel and sexual function.

Implantable FES system for upright mobility and bladder and bowel function for individuals with spinal cord injury.

STUDY DESIGN: Postintervention. OBJECTIVES: To determine the effectiveness of the Praxis multifunctional implantable functional electrical stimulation (FES) system (Neopraxis Pty. Ltd, Lane Cove, NSW, Australia) to provide standing and stepping ability and bladder and bowel management for individuals with motor complete thoracic level spinal cord injuries (SCI). SETTING: Pediatric orthopedic hospital specializing in SCI. SUBJECTS: Three males, ages 17 and 21 years, with motor-complete thoracic level SCI and intact lower motor neurons to the muscles targeted for stimulation. METHODS: Each subject was successfully implanted with the Praxis FES system. All three subjects received electrodes for upright mobility and the first two subjects received additional electrodes for stimulated bladder and bowel management. Following training, subjects were evaluated in their ability to use FES for nine mobility activities. Acute and chronic experiments of the effect of stimulation on bowel and bladder function were also performed. RESULTS: All three subjects could independently stand up from the wheelchair and could walk at least 6 m using a swing through gait pattern. Two subjects were able to independently perform swing through gait for 6 min and one subject was able to independently ascend and descend stairs. Suppression of reflex bladder contractions by neuromodulation (subject 1) and stimulated contractions of the rectum (subject 2) were observed in acute experiments. When stimulation was applied over the course of several weeks, a positive effect on bowel function was measured. Stimulated bladder contractions were not achieved. CONCLUSION: The feasibility of using the Praxis FES system for upright mobility and aiding aspects of bladder and bowel function was demonstrated with three subjects with thoracic level SCI.

An implantable neuroprosthesis for restoring bladder and bowel control to patients with spinal cord injuries: a multicenter trial.

OBJECTIVE: To evaluate the safety and efficacy of an implanted neuroprosthesis for management of the neurogenic bladder and bowel in individuals with spinal cord injury (SCI). DESIGN: Prospective study comparing bladder and bowel control before and at 3, 6, and 12 months after implantation of the neuroprosthesis. SETTING: Six US hospitals specializing in treatment of SCI. PATIENTS: Twenty-three neurologically stable patients with complete suprasacral SCIs. INTERVENTION: Implantation of an externally controlled neuroprosthesis for stimulating the sacral nerves and posterior sacral rhizotomy. MAIN OUTCOME MEASURES: Ability to urinate more than 200mL on demand and a resulting postvoid residual volume of less than 50mL. RESULTS: At 1-year follow-up, 18 of 21 patients could urinate more than 200mL with the neuroprosthesis, and 15 of 21 had postvoid volumes less than 50mL (median, 15mL). Urinary tract infection, catheter use, reflex incontinence, anticholinergic drug use, and autonomic dysreflexia were substantially reduced. At 1-year follow-up, 15 of 17 patients reduced the time spent with bowel management. CONCLUSIONS: Neural stimulation and posterior rhizotomy is a safe and effective method of bladder and bowel management after suprasacral SCI.

Economic consequences of an implanted neuroprosthesis for bladder and bowel management.

OBJECTIVE: To determine whether an implanted neuroprosthesis for bladder and bowel management is less costly than conventional techniques. DESIGN: Retrospective cost-identification analysis with comparison before and after implantation of the neuroprosthesis. SETTING: Life-care planning interviews in patients' homes. PATIENTS: Twelve patients with complete suprasacral spinal cord injuries and neurogenic bladder and bowel. INTERVENTION: Implantation of a neuroprosthesis for electric stimulation of the sacral nerves and posterior sacral rhizotomy. MAIN OUTCOME MEASURES: Annual costs of bladder and bowel care with and without the neuroprosthesis, projected over 10 years. RESULTS: Bladder and bowel care costs were reduced by over 80%, from a median of 8152 dollars a year for conventional care to a median of 948 dollars a year. With the neuroprosthesis, median annual costs for bladder supplies were reduced from 3368 dollars to 58 dollars; for medications, from 1866 dollars to 108 dollars; for medical care, from 656 dollars to 96 dollars; and for bowel care supplies, from 205 dollars to 87 dollars. After 5 years, the cumulative costs of treatment with the neuroprosthesis, including the cost of the device and its implantation and maintenance, equaled those of conventional care. Thereafter, savings from the implanted neuroprosthesis are projected to increase progressively throughout the patient's life. CONCLUSION: A neuroprosthesis implant with posterior rhizotomy greatly reduces the cost of managing the neurogenic bladder and bowel.

Urethral pressure profiles in the female canine implanted with sacral anterior nerve root electrodes.

The purpose of this work was to study the pressure distribution along the urethra in female canines with and without electrical stimulation of the sacral anterior roots innervating the bladder and urethra. Urethral pressure profiles were recorded in two orientations, dorsal and ventral, with microtransducer catheters. Two pulse types were applied at 1 Hz, 500 micros quasitrapezoidal pulses to selectively activate the small axons and 100 micros rectangular pulses. Four parameters were measured from each profile; maximum urethral pressure (MUP), bladder pressure (Pv), functional urethral length (FUL), and the position of the maximum peak from the bladder neck (PMP). Two derived measures, the estimated maximum urethral closing pressure (UCP) and the position of the maximum as a percentage of the FUL (PM%) were calculated. There were highly significant differences (P<0.01) in the value and position of the estimated UCP in the two orientations of the transducers. The highest pressures were recorded in the ventral orientation near the terminal portions of the urethra. Principal sphincter activity during electrical stimulation of the ventral sacral roots was also confined to this part. Selective small fiber activation did not result in any significant increase in this peak pressure from passive values.

Reduction of costs of disability using neuroprostheses.

The lifetime costs associated with spinal cord injury are substantial. Assistive technology that reduces complications, increases independence, or decreases the need for attendant services can provide economic as well as medical or functional benefit. This study describes two approaches for estimating the economic consequences of implanted neuroprostheses utilizing functional electrical stimulation. Life care plan analysis was used to estimate the costs of bladder and bowel care with and without a device restoring bladder and bowel function and to compare these with the costs of implementing the device. For a neuroprosthesis restoring hand grasp, the costs of implementation were compared to the potential savings in attendant care costs that could be achieved by the use of the device. The results indicate that the costs of implementing the bladder and bowel system would be recovered in 5 years, primarily from reduced costs of supplies, medications, and procedures. The costs of the hand grasp neuroprosthesis would be recovered over the lifetime of the user if attendant time was reduced only 2 hours per day and in a shorter time if attendant care was further reduced. Neither analysis includes valuation of the quality of life, which is further enhanced by the neuroprostheses through restoration of greater independence and dignity. Our results demonstrate that implantable neuroprosthetic systems provide good health care value in addition to improved independence for the disabled individual.

Functional neuromuscular stimulation in spinal cord injury.

With recent advances in clinical medicine and biomedical engineering, functional neuromuscular stimulation (FNS) can now be added to the psychiatric armamentarium to decrease the debilitating effects of traumatic spinal cord injury. In this article, the components of FNS systems and their evolution in design are presented. The clinical implications of FNS are discussed with respect to upper and lower extremities and bladder applications, and perspectives on future developments and directions are reviewed.

Health promotion in motion: improving quality of life for persons with neurogenic bladder and bowel using assistive technology.

The neurogenic bladder and bowel lead to many complications in individuals with spinal cord injury (SCI). Management of these neurological complications is a multidimensional challenge for persons with SCI and their caregivers, and can affect the person medically, economically, socially, and personally. This may result in social isolation, poor self-image, and overall decreased quality of life (QOL). When facing this challenge, nurses working with persons with SCI must expand their practice to include more than traditional preventive care. A newly available technique for promoting health with a neurogenic bladder and bowel is the VOCARE Bladder and Bowel Control System. Sixteen persons with SCI who received this system were interviewed by telephone and asked for their recollections of health and QOL pre-operatively in relation to bladder and bowel care and to rate changes in their QOL post-implant. Post-operatively, the recipients reported improved health, a decrease in costs of management of their neurogenic bladder and bowel, increased independence leading to less social isolation, increased sense of control, increased feelings of self-worth, and overall improvement in QOL. These outcomes illustrate the global impact that can be made on the lives of persons with SCI by health services that go beyond prevention of complications and into the realm of health promotion.

Social and personal consequences of acquired bowel dysfunction for persons with spinal cord injury.

BACKGROUND: Traditional literature regarding acquired bowel dysfunction for persons with spinal cord injury (SCI) has focused on clinical assessments of bowel dysfunction and bowel management programs. These studies make reference to the effects of bowel dysfunction on quality of life (QOL), but none systematically study the relationship. This study develops 4 scales that measure impediment to community integration (ICI) due to bowel dysfunction and then examines the relationship between bowel dysfunction, ICI, and QOL. METHODS: A structured telephone survey was conducted with a convenience sample of 103 SCI consumers. Survey questions documented bowel dysfunction (ie, severity and number of accidents), bowel management (ie, how often bowels are evacuated), ICI, and satisfaction with 4 life domains. RESULTS: Correlation analyses showed that subjective bowel dysfunction severity and number of days per month a respondent had to stay home because of lack of bowel control were associated with barriers to personal relationships, feelings about self, and home life. Also, the number of bowel accidents per month was associated with feelings about self. ICI scales were shown to be related to lower levels of satisfaction with free time, friendships, family life, and life in general. No statistically significant relationships were found between bowel dysfunction and satisfaction with life. CONCLUSION: Bowel dysfunction is a barrier to community integration and is related to low levels of life satisfaction. Also, it is possible to quantify ICI related to bowel dysfunction. Educational programs can reduce the stigma associated with bowel dysfunction. Further research into the intricate relationships between bowel problems, barriers to participation in the community, and life satisfaction is needed.

Optimization of sacral ventral root stimulation following SCI: two case reports with six-month follow-up.

Sacral ventral root stimulation in conjunction with sacral dorsal rhizotomy has been effective in promoting voiding in individuals with upper-motor-neuron spinal cord injury. We report on two patients who had variable voiding responses to stimulation during the first six months after electrode implantation. We used videourodynamic records and daily voiding records to characterize their voiding difficulties. Different methods were used to improve voiding, including seating adjustments and changes in stimulation parameters. The first patient was unable to empty his bladder on a regular basis with stimulation using 24 pulses per sec stimulating frequency for the first two months after implantation. Voiding was substantially improved by using 35 pulses per sec. At the end of six months, he is regularly emptying his bladder with stimulation and is on an every-second-day bowel program. However, his bowel program has been irregular. The second patient had very good voiding when stimulation was applied in bed, but he had poor voiding with high residual volumes when sitting in his wheelchair. Voiding was improved when he used a wheelchair cushion that was cut out in the back or lifted his buttocks off the chair. These procedures appeared to reduce perineal pressures. This patient has bowel care on alternate days and his bowel care time has been reduced following implantation of the device. Neither of the patients experienced an erection with the device. Both patients feel positive about their implant experience.

Functional conditions of micturition induced by selective sacral anterior root stimulation: experimental results in a canine animal model.

Electrical stimulation of the sacral anterior roots using conventional rectangular current pulses results in a simultaneous contraction of the urinary bladder and the striated urethral sphincter. Using a tripolar nerve cuff electrode with quasitrapezoidal current pulses and appropriate stimulation parameters, hyperpolarization of the nerve-fiber cell membrane under the anode of the stimulating electrode can reversibly arrest action potential propagation in large myelinated nerve fibers, innervating the striated urethral sphincter, while leaving action potential propagation unaffected in small nonmyelinated nerve fibers innervating the urinary bladder smooth muscle (anodal arrest). Using this technique in 19 female mongrel dogs, we studied the effect of bladder filling, level of anesthesia, and sacral deafferentation on bladder pressure, urethral pressure, and urinary flow. Effective micturition could be induced only after complete dorsal rhizotomy, abolishing reflex contraction of the striated urethral sphincter, when blocking quasitrapezoidal current pulses were used for stimulation. Stimulation with rectangular current pulses directly induced a rise in distal urethral pressure, preventing micturition during stimulation.

Children's affective responses, cognitive appraisals, and coping strategies in response to the negative affect of parents and peers.

Although research has linked difficulties in parent mood functioning to developmental problems in children, little work has examined why such a link occurs. Following current social-cognitive perspectives on children's cognitive appraisals to negative parent affect, it was hypothesized that children would show more intense affective responses, less confidence, and less active coping strategies in response to parent, as opposed to peer, negative affect. In the current study, young children (N = 39) were read experimental vignettes portraying peers and parents in either happy, sad, or angry emotional states. Children were then interviewed about their affective responses, cognitive appraisals, and coping strategies to each vignette. Beyond experiencing more negative affective responses to parent, compared to peer negative affect, children felt they could do little to help themselves when faced with paternal distress and frequently indicated they would engage in avoidant coping strategies (e.g., hiding) to make themselves feel better when confronted with parent sadness. This study has implications for more industrious future research, as well as intervention projects that involve assisting children who live in households marked by high levels of negative adult affect.

Electrical stimulation to restore respiration.

Electrical stimulation has been used for over 25 years to restore breathing to patients with high quadriplegia causing respiratory paralysis and patients with central alveolar hypoventilation. Three groups have developed electrical pacing systems for long-term support of respiration in humans. These systems consist of electrodes implanted on the phrenic nerves, connected by leads to a stimulator implanted under the skin, and powered and controlled from a battery-powered transmitter outside the body. The systems differ principally in the electrode design and stimulation waveform. Approximately 1,000 people worldwide have received one of the three phrenic pacing devices, most with strongly positive results: reduced risk of tracheal problems and chronic infection, the ability to speak and smell more normally, reduced risk of accidental interruption of respiration, greater independence, and reduced costs and time for ventilatory care. For patients with partial lesions of the phrenic nerves, intercostal muscle stimulation may supplement respiration.