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.

Phase 2 trial of sustained-release fampridine in chronic spinal cord injury.

STUDY DESIGN: Double-blind, randomized, placebo-controlled, parallel-group clinical trial. OBJECTIVE: Assess safety and efficacy of sustained-release fampridine in subjects with chronic spinal cord injury. SETTING: A total of 11 academic rehabilitation research centers in the United States. METHODS: A total of 91 subjects with motor-incomplete spinal cord injury (SCI), randomized to three arms: fampridine, sustained release, 25 mg b.i.d. (Group I), 40 mg b.i.d. (Group II), and placebo (Group III) for 8 weeks. OUTCOME MEASURES: Patient diary questionnaire, Ashworth score, American Spinal Cord Injury Association International Standards, International Index of Erectile Function, bladder and bowel management questionnaires, and Clinician and Subject Global Impressions (Clinician Global Impression of change, Subject Global Impression (SGI)). Safety was evaluated from adverse events, physical examinations, vital signs, electrocardiograms, and laboratory tests. RESULTS: In total, 78% of the subjects completed the study. More (13/30) discontinued from Group II than Group I (4/30) and Group III (3/31). The most frequent adverse events across groups were hypertonia, generalized spasm, insomnia, dizziness, asthenia, pain, constipation, and headache. One subject in Group II experienced a seizure. SGI changed significantly in favor of Group I (P=0.02). Subgroup analysis of subjects with baseline Ashworth scores >1 showed significant improvement in spasticity in Group I versus III (P=0.02). CONCLUSIONS: Group I showed significant improvement in SGI, and potential benefit on spasticity. The drug was well tolerated. Group II showed more adverse events and discontinuations.

Obesity intervention in persons with spinal cord injury.

STUDY DESIGN: A single group uncontrolled trial. OBJECTIVES: Despite widespread emphasis on the obesity-related health risks in persons with spinal cord injury (SCI), limited research has been carried out to intervene in this problem. This study was conducted to assess the initial effectiveness of a weight loss program on various health outcomes in persons with SCI. SETTING: A rehabilitation center in Birmingham, Alabama, United States. METHODS: A total of 16 individuals with chronic SCI who were overweight or obese participated in a weight management program that consisted of 12 weekly classes, covering nutrition, exercise, and behavior modification. Various outcomes were examined over a 6-month period (baseline, week 12, and week 24), including body composition measured by dual energy X-ray absorptiometry, physiologic measures, diet behavior, and psychosocial and physical functioning. Of these, 13 participants returned for the week 24 follow-up. RESULTS: Weight loss averaged 3.5+/-3.1 kg (3.8% of the initial weight) at week 12 and 2.9+/-3.7 kg (3.0% of the initial weight) at week 24. There was a significant reduction from baseline values at weeks 12 and 24 in body mass index, anthropometric measurements, and fat mass and improvement in diet behavior and psychosocial and physical functioning, while lean mass and blood albumin and hemoglobin levels were maintained. A correlation analysis showed that a greater weight loss was importantly (r>0.4) associated with a greater reduction in total cholesterol at weeks 12 and 24 and in systolic and diastolic blood pressure at week 24. Several factors were important (r>0.4 or r<-0.4) in determining the success in weight loss, including age, race, marital and employment status, family history of overweight/obesity, level and duration of injury, and cholesterol level at baseline. CONCLUSIONS: This is the first demonstration that a carefully planned program with time-calorie displacement diet is effective for overweight/obese individuals with SCI to lose weight without compromising total lean mass and overall health. It provides foundation for a future large clinical trial for weight loss of persons with SCI or other spinal cord dysfunction.

Gynecologic and reproductive issues in women with spinal cord injury.

As the treatment of SCI and its secondary medical complications improves, women with SCI are becoming increasingly successful in re-integrating themselves into society. Part of this re-integration involves the resumption of active sexual lives and motherhood. Clinicians who care for patients with SCIs play an important role in facilitating the resumption of these roles. With appropriate follow-up and care, women with SCI should be expected to maintain good gynecologic health and deliver healthy children with minimal complications.

Recovery of upper-extremity strength in complete and incomplete tetraplegia: a multicenter study.

OBJECTIVE: To examine upper-extremity motor recovery of subjects with tetraplegia with both complete and incomplete injuries, to predict which patients and at what time they would recover a motor level. DESIGN: Prospective, multicenter clinical study of upper-extremity motor recovery in subjects with acute traumatic spinal cord injury. SETTING: Three regional spinal cord injury centers. SUBJECTS: One hundred sixty-seven individuals with acute traumatic tetraplegia (144 males [86%], and 23 females [14%]) between the ages of 15 and 75 years (mean age, 35.5 yrs). METHODS: Subjects were examined and classified using sequential manual muscle tests performed on admission, 72 hours, 1, 2, and 3 weeks, and 1, 2, 3, 6, 12, 18, and 24 months postinjury. C5 biceps, C6 extensor carpi radialis, C7 triceps, and C8 flexor digitorum profundus were evaluated using a 0-5 scale. Analyses of the right motor levels used a series of logistic regression models, and for multiple measurements on each subject, models were estimated using generalized estimating equations. RESULTS: The analysis for recovery of the biceps for the C4 group showed 70% of complete compared with 90% of incomplete injuries recovered (p < .001); of the extensor carpi radialis in the C5 group, 75% complete and 90% incomplete recovered (p < .002); and of the triceps in the C6 group, 85% of complete and 90% of incomplete injuries recovered (p < .16). CONCLUSION: Predicting future potential for upper-extremity motor recovery and for independence in self-care in groups of patients at a specific motor level is possible within the first week of injury.

Long-term medical complications after traumatic spinal cord injury: a regional model systems analysis.

OBJECTIVE: To analyze the incidence, risk factors, and trends of long-term secondary medical complications in individuals with traumatic spinal cord injury. DESIGN: Data were reviewed from the National SCI Statistical Center on annual evaluations performed at 1, 2, 5, 10, 15, and 20 years after injury on patients injured between 1973 and 1998. SETTING: Multicenter Regional SCI Model Systems. MAIN OUTCOME MEASURES: Secondary medical complications at annual follow-up years, including pneumonia/atelectasis, autonomic dysreflexia, deep venous thrombosis, pulmonary embolism, pressure ulcers, fractures, and renal calculi. RESULTS: Pressure ulcers were the most frequent secondary medical complications in all years, and individuals at significant (p < .05) risk included those with complete injuries (years 1, 2, 5, 10), younger age (year 2), concomitant pneumonia/atelectasis (year 1, 2, 5), and violent injury (years 1, 2, 5, 10). The incidence of pneumonia/atelectasis was 3.4% between rehabilitation discharge and year-1 follow-up with those most significantly at risk being older than 60 years (years 1, 2, 5, 10) and tetraplegia-complete (years 1, 2). One-year incidence of deep venous thrombosis was 2.1% with a significant decline seen at year 2 (1.2%), and individuals most significantly (p < .001) at risk were those with complete injuries (year 1). The incidence of calculi (kidney and/or ureter) was 1.5% at 1-year follow-up and 1.9% at 5 years and was more frequent in patients with complete tetraplegia. Intermittent catheterization was the most common method of bladder management among patients with paraplegia but became less common at later postinjury visits. CONCLUSIONS: Pressure ulcers, autonomic dysreflexia, and pneumonia/atelectasis were the most common long-term secondary medical complications found at annual follow-ups. Risk factors included complete injury, tetraplegia, older age, concomitant illness, and violent injury.

A multicenter study of women's self-reported reproductive health after spinal cord injury.

OBJECTIVE: Little attention has been given to women's reproductive health issues in the disabled population. This study documents the unique reproductive health conditions, complications, and behaviors in women with spinal cord injury (SCI). SUBJECTS: A total of 472 women at least 18 years of age who were at least 1 year post-SCI. Their average age at injury was 32 years. DESIGN: An extensive questionnaire regarding gynecologic, sexual, obstetric, and menopausal health issues was developed and piloted. The questionnaire was then administered by a trained woman health care clinician to women who agreed to participate in the study. SETTING: Private outpatient clinics at 10 regional model SCI systems of care. RESULTS: Women reported similar gynecologic problems in both preinjury and postinjury time periods. Exceptions were urinary tract infections and vaginal yeast infections. Sexually transmitted infections appear to be less common after injury, but the difference was not statistically significant. The number of hysterectomies was similar both before and after injury, but reasons differed greatly. Women with SCI were less likely to have routine mammograms. They reported similar preventive practices such as performing self-breast examinations and obtaining Papanicolaou smears. Almost 14% of women with SCI became pregnant after injury (101 pregnancies). Complications from pregnancy, labor, and delivery were reported to be more frequent in their postinjury than in their preinjury obstetric experiences. They tended to have babies of lower birth weight and with more complications at time of delivery. Of the sample, 87% reported having sexual intercourse before injury, with only 67% having intercourse after injury. Years postinjury and level of injury were predictive of intercourse; extent of injury was not. Experience of orgasms and methods of contraception varied among the two groups. There were significant complaints of dysreflexia and bladder incontinence with sexual function. Menopause after injury was reported by 14.6% of the women. Postinjury menopausal symptoms were of low frequency, but more than those reported by women who had undergone menopause before injury. Only 19% of women who had menopause after SCI were placed on hormone replacement therapy. Almost one third of the women who had menopause after injury reported new bone fractures. CONCLUSION: This study illustrates the unique reproductive health concerns of women with SCI. Many pregnancy, labor, and delivery experiences in these women are different. Sexual activity and function have several disability-related consequences and the effects of menopause are still unknown, but may be more problematic than for able-bodied women.

Combined medical and surgical treatment after acute spinal cord injury: results of a prospective pilot study to assess the merits of aggressive medical resuscitation and blood pressure management.

The optimal management of acute spinal cord injuries remains to be defined. The authors prospectively applied resuscitation principles of volume expansion and blood pressure maintenance to 77 patients who presented with acute neurological deficits as a result of spinal cord injuries occurring from C-1 through T-12 in an effort to maintain spinal cord blood flow and prevent secondary injury. According to the Intensive Care Unit protocol, all patients were managed by using Swan-Ganz and arterial blood pressure catheters and were treated with immobilization and fracture reduction as indicated. Intravenous fluids, colloid, and vasopressors were administered as necessary to maintain mean arterial blood pressure above 85 mm Hg. Surgery was performed for decompression and stabilization, and fusion in selected cases. Sixty-four patients have been followed at least 12 months postinjury by means of detailed neurological assessments and functional ability evaluations. Sixty percent of patients with complete cervical spinal cord injuries improved at least one Frankel or American Spinal Injury Association (ASIA) grade at the last follow-up review. Thirty percent regained the ability to walk and 20% had return of bladder function 1 year postinjury. Thirty-three percent of the patients with complete thoracic spinal cord injuries improved at least one Frankel or ASIA grade. Approximately 10% of the patients regained the ability to walk and had return of bladder function. As of the 12-month follow-up review, 92% of patients demonstrated clinical improvement after sustaining incomplete cervical spinal cord injuries compared to their initial neurological status. Ninety-two percent regained the ability to walk and 88% regained bladder function. Eighty-eight percent of patients with incomplete thoracic spinal cord injuries demonstrated significant improvements in neurological function 1 year postinjury. Eighty-eight percent were able to walk and 63% had return of bladder function. The authors conclude that the enhanced neurological outcome that was observed in patients after spinal cord injury in this study was in addition to, and/or distinct from, any potential benefit provided by surgery. Early and aggressive medical management (volume resuscitation and blood pressure augmentation) of patients with acute spinal cord injuries optimizes the potential for neurological recovery after sustaining trauma.

Incidence of respiratory complications following spinal cord injury.

From 1985 to 1990 five Model Regional Spinal Cord Injury (SCI) Care Systems participated in a collaborative effort to prospectively document the occurrence of adult respiratory distress syndrome (ARDS), aspiration, atelectasis, bronchitis, bronchospasm, lung abscess, pleural effusion, pneumonia, pneumo/hemothorax, pulmonary edema, pulmonary thromboembolism, tracheitis, upper respiratory infection, and ventilatory failure in patients admitted within 48 hours of SCI with a level of C1-T12 and Frankel Grade A, B, or C. The mean, standard deviation and range was calculated for the time of onset and duration of each complication. Of the 261 patients who entered the study, 175 (67%) experience 544 respiratory complications with atelectasis being the most common (36.4%) followed by pneumonia (31.4%) and ventilatory failure (22.6%). These complications occurred on the average of 17.7 days, 24.5 days and 4.5 days postinjury and lasted 12.8 days, 15.5 days, and 35.9 days, respectively. Twenty-two percent, 47%, and 31% had injury levels at C1-4, C5-8, T1-12, respectively with the majority being Frankel Grade A (78%). Eighty-four percent of C1-4, 60% of the C5-8, and 65% of the T1-12 had respiratory complications. Statistical analysis revealed complications to be significantly greater (p < .05) and of longer duration (p < .05) for the C1-4 group. Ventilatory failure and aspiration were the earliest to occur (at 4.5 days) for all SCI patients. Surprisingly, however, complications overall occurred significantly sooner (p < .05) in the T1-12 group. In conclusion, patients who sustain SCI have a high incidence of respiratory complications; however, some occur earlier and more frequently depending on the level of injury.

Spinal cord injury model systems of care: the legacy and the promise.

The Spinal Cord Injury Model Systems of Care have served a unique role in the provision of integrated and coordinated care for persons with spinal cord injuries (SCI), and in collaborative research efforts to advance available technologies. Although the basic mission of the model systems remains viable, contemporary issues and trends indicate that the model systems concept ought to be expanded in terms of roles and functions to meet current needs.

Intermittent catheterization in women with spinal cord injury-three decades of experience.

Removal of an indwelling catheter and the initiation of intermittent catheterization (IC) has become a standard urological goal over the past decades. While realistic for men it is more difficult for women, mainly due to their anatomical differences and lack of development of a satisfactory external collection device. Thus, the evaluation for IC as a bladder management method must involve a different approach for women with spinal cord injury (SCI) than their male counterparts. Key components of the evaluation include the woman's functional abilities, attendant care, motivation, neurological bladder type (i.e., reflexive versus areflexive) along with maintenance of social continence and stable renal function. It has been shown that women tend to have less urological complications and renal deterioration than men, no matter what method of bladder management they we. Advances in urological pharmacology, diversionary surgeries and neural blocks have greatly contributed to successful bladder manipulation for self-IC.

Urological long-term follow-up in women with spinal cord injuries.

One hundred eight women and 434 men admitted with spinal cord injuries between 1973 and 1987 were observed prospectively to determine the effects of age, sex, neurological classification, and method of bladder management method on renal function and urological complications. The primary method of bladder management for women throughout the study period was indwelling urethral catheterization as compared to condom drainage for their male counterparts. Renal function was determined by effective renal plasma flow and urological complications were determined by clinical symptoms and/or objective findings on intravenous pyelography (IVP). Analysis reveals that as in the general population advancing age and being female were significantly associated with lower ERPF (p < .05). Only in men were neurological classification (quadriplegia) and bladder management (ileoconduit) associated with significant decreases in ERPF (p < .05). Furthermore, women and men showed no significant differences in urological complication rates. From the data it can be concluded that there is no particular method of bladder management for women that necessarily leads to impaired renal function.

Neurogenic urinary tract infection.

Even though renal failure secondary to the urologic complications of chronic or recurrent urinary tract infection has decreased markedly due to advances in diagnostic, preventive, and therapeutic measures, infection and its sequelae continue to be major problems in patients with spinal cord injury regardless of the bladder emptying method employed. Although lower urinary tract complications have decreased with intermittent catheterization, the effects of increased intravesicular pressure, inflammation, and chronic bacterial colonization or invasion of the urinary tract on long-term renal function are still undetermined. Thorough evaluation of the urologic status on a regular basis in all patients with spinal cord injury is encouraged. Treatment of urinary tract infection should be guided by scientific data and drug susceptibilities of etiologic bacteria. The general consensus is that the presence of asymptomatic bacteriuria, particularly in the absence of pyuria, usually does not warrant antibiotic treatment, and that prophylaxis or suppression of infection with systemic antibiotics is not effective for any considerable length of time. Preservation of renal function is the ultimate goal of all bladder management strategies.

Urinary tract infection in spinal cord injury.

Loss of normal bladder function results in increased risk of developing urinary tract infection. Recurrent bacteriuria continues to be a problem in most spinal cord injured persons regardless of the bladder emptying method used. Lower urinary tract complications have decreased with intermittent catheterization, but the effect of increased intravesical pressure and presence of bacteriuria on renal function are still undetermined. Current methods of neurogenic bladder management are often based on professional or institutional presuppositions rather than scientific data. Although there are many unanswered questions about the role of urinary tract infection in spinal cord injury patients, treatment should be based on scientific knowledge, even though the knowledge base is still limited. Preservation of renal function is the ultimate goal of any method of neurogenic bladder management. Although a person with spinal cord injury is described, the material covered is applicable to other neurogenic bladder disturbances.