Acute spinal cord injury occurred in 2.6% of the 114,510 patients entered into the Major Trauma Outcome Study from 1982 to 1989. The most common causes of spinal cord injury were motor vehicle accidents (40%), falls (20%), and gunshot wounds (13.6%). Almost 80% of patients with spinal cord injury had multiple injuries. Cervical cord injury was seen in 65% of patients with isolated spinal cord injury, but in only 52% of patients with multiple injuries. The hospital mortality rate was 17%, with patients with multiple injuries having a significantly higher mortality rate than patients with isolated spinal cord injury (19.8% vs 6.9%). The TRISS method overpredicted the mortality rate among patients with multiple injuries (450 vs 379), but not among those with isolated injury. A program for better national surveillance and prevention of spinal cord injury is warranted.
SummaryA detailed analysis was undertaken to study the incidence of deep vein thrombosis (DVT), pulmonary embolism (PE), and death during the initial hospitalisation after traumatic spinal cord injury (SCI). The National Spinal Cord Injury Statistical Center supplied data on 1419 subjects with acute injuries hospitalised between October 1, 1986 andJune 9,1989. The incidence of PE was 4'6% (4'3% for paraplegia and 4'8% for quadriplegia) and 14·5% for DVT ( 15·9% for paraplegia and 12 ' 5% for quadriplegia). Fifty two patients (3'7%) died during their initial hospitalisation. Age, gender, and quadriplegia were not statistically significantly correlated with the development of DVT, while motor complete lesion was a better predictor of DVT than a complete lesion. The highest incidence of DVT was 22·9% in patients with motor complete paraplegia, while the lowest incidence was 9·3% in patients with motor incomplete quadriplegia. The only significant predictor for PE was age. Mortality was associated with increased age, PE, quadriplegia, and complete lesions. The highest incidence of death was /4·0% in patients :? 40 years of age with quadriplegia and the lowest incidence of death was 0'37% in patients < 40 years of age with paraplegia. This study emphasises the need for careful analysis and detailed stratification when designing or interpreting SCI research with DVT, PE, and mortality. Completeness of lesion, age, and category of impairment, whether quadriplegia or paraplegia, are appropriate strata to select.
The purpose of this article is to provide researchers and clinicians with a basic understanding of randomized clinical trials and to discuss their potential application to and limitations in the field of physical medicine and rehabilitation. A brief history of the development of randomized clinical trials, definitions of clinical trials, types of trials, and overview of methodological issues related to design are offered. Information is provided about the need to establish clear and concise study objectives and to explicitly define interventions and expected outcomes. Recommendations for developing clinical protocols and determining adequate sample size are presented, and various statistical considerations, including power, are discussed. Issues related to sampling strategies, and recruitment are reviewed. Importance of randomization and blinding is emphasized. Readers are also referred to other resources available on this topic. Finally, the authors describe shortfalls associated with the use of this design in rehabilitation research. These are further explored and discussed in terms of the actual benefits and limitations of randomized clinical trials in physical medicine and rehabilitation research. Recommendations are made regarding the use of this methodology to address relevant needs in clinical practice.
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