Development of a pain education resource for people with spinal cord injury.

Many people with spinal cord injury (SCI) develop chronic pain, including neuropathic pain. Unfortunately, current treatments for this condition are often inadequate because SCI-associated neuropathic pain is complex and depends on various underlying mechanisms and contributing factors. Multimodal treatment strategies including but not limited to pharmacological treatments, physical rehabilitation, cognitive training, and pain education may be best suited to manage pain in this population. In this study, we developed an educational resource named the SeePain based on published pain literature, and direct stakeholder input, including people living with SCI and chronic pain, their significant others, and healthcare providers with expertise in SCI. The SeePain was then 1) systematically evaluated by stakeholders regarding its content, comprehensibility, and format using qualitative interviews and thematic analysis, and 2) modified based on their perspectives. The final resource is a comprehensive guide for people with SCI and their significant others or family members that is intended to increase health literacy and facilitate communication between SCI consumers and their healthcare providers. Future work will quantitatively validate the SeePain in a large SCI sample.

Neuroprosthesis for individuals with spinal cord injury.

OBJECTIVE: Individuals who sustain a traumatic spinal cord injury (SCI) often have a loss of multiple body systems. Significant functional improvement can be gained by individual SCI through the use of neuroprostheses based on electrical stimulation. The most common actions produced are grasp, overhead reach, trunk posture, standing, stepping, bladder/bowel/sexual function, and respiratory functions. METHODS: We review the fundamental principles of electrical stimulation, which are established, allowing stimulation to be safely delivered through implanted devices for many decades. We review four common clinical applications for SCI, including grasp/reach, standing/stepping, bladder/bowel function, and respiratory functions. Systems used to implement these functions have many common features, but are also customized based on the functional goals of each approach. Further, neuroprosthetic systems are customized based on the needs of each user. RESULTS & CONCLUSION: The results to date show that implanted neuroprostheses can have a significant impact on the health, function, and quality of life for individuals with SCI. A key focus for the future is to make implanted neuroprostheses broadly available to the SCI population.

The Interdisciplinary Stem Cell Institute's Use of Food and Drug Administration-Expanded Access Guidelines to Provide Experimental Cell Therapy to Patients With Rare Serious Diseases.

The U.S. Food and Drug Administration (FDA) provides guidance for expanded access to experimental therapies, which in turn plays an important role in the Twenty-first Century Cures Act mandate to advance cell-based therapy. In cases of incurable diseases where there is a lack of alternative treatment options, many patients seek access to cell-based therapies for the possibility of treatment responses demonstrated in clinical trials. Here, we describe the use of the FDA's expanded access to investigational new drug (IND) to address rare and emergency conditions that include stiff-person syndrome, spinal cord injury, traumatic brain stem injury, complex congenital heart disease, ischemic stroke, and peripheral nerve injury. We have administered both allogeneic bone marrow-derived mesenchymal stem cell (MSC) and autologous Schwann cell (SC) therapy to patients upon emergency request using Single Patient Expanded Access (SPEA) INDs approved by the FDA. In this report, we present our experience with 10 completed SPEA protocols.

Development and deployment of an at-home strength and conditioning program to support a phase I trial in persons with chronic spinal cord injury.

STUDY DESIGN: Nonrandomized clinical trial (NCT02354625). OBJECTIVES: As a part of a Phase I clinical trial to assess the safety of autologous human Schwann cells (ahSC) in persons with chronic spinal cord injury (SCI), participants engaged in a multimodal conditioning program pre- and post-ahSC transplantation. The program included a home-based strength and endurance training program to prevent lack of fitness and posttransplantation detraining from confounding potential ahSC therapeutic effects. This paper describes development, deployment, outcomes, and challenges of the home-based training program. SETTING: University-based laboratory. METHODS: Development phase: two men with paraplegia completed an 8-week laboratory-based 'test' of the home-based program. Deployment phase: the first four (two males, two females) participant cohort of the ahSC trial completed the program at home for 12 weeks pre and 20 weeks post ahSC transplant. RESULTS: Development phase: both participants improved their peak aerobic capacity (VO2peak) (≥17%), peak power output (POpeak) (≥8%), and time to exhaustion (TTE) (≥7%). Deployment phase: pretransplant training minimally increased fitness in the two male participants (≥6% POpeak and ≥9% TTE). The two women had no POpeak changes and slight TTE changes (+2.6 and -1.2%, respectively.) All four participants detrained during the posttransplant recovery period. After posttransplant retraining, all four participants increased TTE (4-24%), three increased VO2peak (≥11%), and two increased POpeak (≥7%). CONCLUSIONS: Home-based strength and condition programs can be effective and successfully included in therapeutic SCI trials. However, development of these programs requires substantial content knowledge and experience.

Neurophysiological Changes in the First Year After Cell Transplantation in Sub-acute Complete Paraplegia.

Neurophysiological testing can provide quantitative information about motor, sensory, and autonomic system connectivity following spinal cord injury (SCI). The clinical examination may be insufficiently sensitive and specific to reveal evolving changes in neural circuits after severe injury. Neurophysiologic data may provide otherwise imperceptible circuit information that has rarely been acquired in biologics clinical trials in SCI. We reported a Phase 1 study of autologous purified Schwann cell suspension transplantation into the injury epicenter of participants with complete subacute thoracic SCI, observing no clinical improvements. Here, we report longitudinal electrophysiological assessments conducted during the trial. Six participants underwent neurophysiology screening pre-transplantation with three post-transplantation neurophysiological assessments, focused on the thoracoabdominal region and lower limbs, including MEPs, SSEPs, voluntarily triggered EMG, and changes in GSR. We found several notable signals not detectable by clinical exam. In all six participants, thoracoabdominal motor connectivity was detected below the clinically assigned neurological level defined by sensory preservation. Additionally, small voluntary activations of leg and foot muscles or positive lower extremity MEPs were detected in all participants. Voluntary EMG was most sensitive to detect leg motor function. The recorded MEP amplitudes and latencies indicated a more caudal thoracic level above which amplitude recovery over time was observed. In contrast, further below, amplitudes showed less improvement, and latencies were increased. Intercostal spasms observed with EMG may also indicate this thoracic "motor level." Galvanic skin testing revealed autonomic dysfunction in the hands above the injury levels. As an open-label study, we can establish no clear link between these observations and cell transplantation. This neurophysiological characterization may be of value to detect therapeutic effects in future controlled studies.

Body System Effects of a Multi-Modal Training Program Targeting Chronic, Motor Complete Thoracic Spinal Cord Injury.

The safety and efficacy of pharmacological and cellular transplantation strategies are currently being evaluated in people with spinal cord injury (SCI). In studies of people with chronic SCIs, it is thought that functional recovery will be best achieved when drug or cell therapies are combined with rehabilitation protocols. However, any functional recovery attributed to the therapy may be confounded by the conditioned state of the body and by training-induced effects on neuroplasticity. For this reason, we sought to investigate the effects of a multi-modal training program on several body systems. The training program included body-weight-supported treadmill training for locomotion, circuit resistance training for upper body conditioning, functional electrical stimulation for activation of sublesional muscles, and wheelchair skills training for overall mobility. Eight participants with chronic, thoracic-level, motor-complete SCI completed the 12-week training program. After 12 weeks, upper extremity muscular strength improved significantly for all participants, and some participants experienced improvements in function, which may be explained by increased strength. Neurological function did not change. Changes in pain and spasticity were highly variable between participants. This is the first demonstration of the effect of this combination of four training modalities. However, balancing participant and study-site burden with capturing meaningful outcome measures is also an important consideration.

Living With Chronic Pain After Spinal Cord Injury: A Mixed-Methods Study.

OBJECTIVE: To identify the relative importance of positive (facilitators) and negative (barriers) contributors to living with chronic pain after spinal cord injury (SCI). DESIGN: Mixed-methods: (1) Qualitative (n=35): individual, semistructured, open-ended interviews identifying facilitator/barrier themes; (2) Quantitative (n=491): converting the most common themes into statements and quantifying agreement with these in an online survey to determine relative importance, underlying dimensions, and their associations with perceived difficulty in dealing with pain. SETTING: University-based research setting and general community. PARTICIPANTS: Volunteers (N=526) with SCI experiencing moderate to severe chronic pain. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Interview guides, facilitator/barrier statements, and pain inventories. RESULTS: Exploratory factor analyses reduced agreement ratings into 4 facilitators (information regarding pain and treatments, resilience, coping, medication use) and 5 barriers (poor health care communication, pain impact and limitations, poor communication about pain, difficult nature of pain, treatment concerns). Greater "pain impact and limitations," "difficult nature of pain," "poor communication from provider," lower "resilience," greater "medication use," and younger age predicted greater difficulty in dealing with pain (r=.75; F=69.02; P<.001). CONCLUSIONS: This study revealed multiple facilitators and barriers to living with chronic pain after SCI. The principal barrier, "poor health care communication," indicated that consumers do not receive adequate information from their health care providers regarding pain. "Information regarding pain and treatments" had greater agreement scores and factor loadings than all other facilitators, indicating that most participants view provider-patient communication and educational efforts regarding pain and pain management as priorities and critical needs. Further initiatives in these areas are important for improving pain management post-SCI.

Educational scholarship as a route to academic promotion: a depiction of surgical education scholars.

BACKGROUND: Education is the central component of academic medicine. Historically, academic promotion has favored clinician-investigators over clinician-educators. However, there are increasing numbers of individuals pursuing education scholarship as their academic focus. This study sought to describe these individuals and their experiences with academic promotion. METHODS: A cross-sectional survey of surgical educators was undertaken, eliciting demographic data and attitudes toward educational efforts and promotion. RESULTS: Advanced academic rank was associated with male gender, age, publication on education topics, funding for research in education, recipient of teaching awards, and status as officer in an education association. CONCLUSIONS: Educational scholarship is a viable pathway for academic promotion when sentinel components are included.

How surgical faculty and residents assess the first year of the Accreditation Council for Graduate Medical Education duty-hour restrictions: results of a multi-institutional study.

BACKGROUND: This study examined how surgical residents and faculty assessed the first year of the Accreditation Council for Graduate Medical Education duty-hour restrictions. METHODS: Questionnaires were administered in 9 general-surgery programs during the summer of 2004; response rates were 63% for faculty and 58% for residents (N = 259). Questions probed patient care, the residency program, quality of life, and overall assessments of the duty-hour restrictions. Results include the means, mean deviations, percentage who agree or strongly agree with the hour restrictions, and significance tests. RESULTS: Although most support the restrictions, few maintain that they improved surgical training or patient care. Faculty and residents differed (P < or = .05) on 16 of 21 items. Every difference shows that residents view the restrictions more favorably than faculty. The sex of the resident shaped the magnitude of the gap for 11 of 21 items. CONCLUSIONS: Few believe that duty-hour restrictions improve patient care or resident training. Residents, especially female residents, view the restrictions more favorably than faculty.

Duty-hour restrictions and the work of surgical faculty: results of a multi-institutional study.

PURPOSE: To examine whether duty-hour restrictions have been consequential for various aspects of the work of surgical faculty and if those consequences differ for faculty in academic and nonacademic general surgery residency programs. METHOD: Questionnaires were distributed in 2004 to 233 faculty members in five academic and four nonacademic U.S. residency programs in general surgery. Participation was restricted to those who had been faculty for at least one year. Ten items on the questionnaire probed faculty work experiences. Results include means, percentages, and t-tests on mean differences. Of the 146 faculty members (63%) who completed the questionnaire, 101 volunteered to be interviewed. Of these, 28 were randomly chosen for follow-up interviews that probed experiences and rationales underlying items on the questionnaire. Interview transcripts (187 single-spaced pages) were analyzed for main themes. RESULTS: Questionnaire respondents and interviewees associated duty-hour restrictions with lowered faculty expectations and standards for residents, little change in the supervision of residents, a loss of time for teaching, increased work and stress, and less satisfaction. No significant differences in these perceptions (p < or = .05) were found for faculty in academic and nonacademic programs. Main themes from the interviews included a shift of routine work from residents to faculty, a transfer of responsibility to faculty, more frequent skill gaps at night, a loss of time for research, and the challenges of controlling residents' hours. CONCLUSIONS: Duty-hour restrictions have been consequential for the work of surgical faculty. Faculty should not be overlooked in future studies of duty-hour restrictions.

Gender differences among spouses of surgeons.

BACKGROUND: The goal of this study was to identify whether gender differences exist regarding the degree of spousal support for, satisfaction with, and perception of surgeons' careers. METHODS: A survey was performed of spouses of academic surgeons in the United States and Canada. RESULTS: Female respondents were significantly less likely to work outside of the home and were significantly more likely to be the major decision-makers at home. They were less likely to credit their surgeon spouses with contributing to household duties and childcare. If both spouses worked outside of the home, the female spouse was still more likely to be the major decision maker. Overall, male and female respondents rated their role in and their satisfaction with their spouses' career choices similarly. CONCLUSIONS: Male and female spouses contribute equally to the career choices of their surgeon spouses. However, female spouses, both surgeon and nonsurgeon, are more likely to make the majority of the decisions at home and contributions to household care.

Perceptions and predictors of surgeon satisfaction: a survey of spouses of academic surgeons.

BACKGROUND: Although several studies have addressed the role of spouses in physicians' career choices, there is limited data about spousal perception of surgeons' careers after training. This study examined satisfaction with surgeons' careers and potential contributing factors from a spousal standpoint. STUDY DESIGN: A survey of spouses of academic surgeons in 38 participating departments was conducted. Questions included demographic information and perceptions of career satisfaction and contributing factors. Data were analyzed using descriptive statistics, Student's t-test or Mann-Whitney U test, and chi-square or Fisher's exact test. RESULTS: Three hundred seventy-nine surveys (27%) were returned, with the majority (81%) perceiving their surgeon spouses to be satisfied. Contributing factors to surgeon dissatisfaction included: work hours/call (42%); practice limitations (18%); reimbursement/income (12%); and malpractice/insurance (7%). Dissatisfied surgeons, as perceived by their spouses, did not differ from satisfied surgeons in terms of work hours, income expectations, geographic desirability, or home involvement. On the other hand, predictors of dissatisfied spouses included lack of input into career decisions, less satisfaction with location, and lack of their surgeon spouses' participation in household and child-care activities. CONCLUSIONS: There are many positive and negative aspects to being an academic surgeon. Yet, despite the time commitment, work hours per se do not appear to contribute to either surgeon or spousal satisfaction. Spousal satisfaction is dependent on surgeon contribution to household and childcare activities. Despite the multiple potential detractors from an academic surgical career, most surgeons, as perceived by their spouses, would not have chosen differently and are satisfied with their career choices.

Preclinical students: who are surgeons?

BACKGROUND: The purpose of the present study was to determine how preclinical medical students formulate their career choice and to determine the origin of negative perceptions regarding surgery as a career. MATERIALS AND METHODS: A qualitative study was performed with second-year medical students voluntarily participating in focus group study. Students with and without an interest in surgery attended. Topics discussed included factors influencing career choice, priorities, perceptions, exposure, and interactions with surgeons. Three investigators conducted independent content analysis. RESULTS: Career choices for students interested in surgery originated primarily from premedical school experiences/interactions with surgeons. In contrast, students not interested in surgery made career choices during medical school and choices were shaped primarily by second-year preceptors. The main priority for students interested in surgery was personal happiness that was perceived as being significantly dependent upon career satisfaction. Students not interested in surgery tended to separate happiness derived from career versus family. Negative perceptions toward surgery were developed and reinforced by media, preceptors, and classmates. All students had minimal exposure to surgeons during preclinical years and generally agreed that increased involvement with surgeons would be beneficial, particularly through preclinical preceptorships. CONCLUSIONS: Career choices of preclinical students interested in surgery were made prior to entering medical school, suggesting that outreach programs to high schools and colleges may beneficial. Negative perceptions about surgery develop through a variety of sources, including fellow classmates, preceptors, and the media. Surgeons need to take responsibility for these perceptions.