Minimizing errors in acute traumatic spinal cord injury trials by acknowledging the heterogeneity of spinal cord anatomy and injury severity: an observational Canadian cohort analysis.

Clinical trials of therapies for acute traumatic spinal cord injury (tSCI) have failed to convincingly demonstrate efficacy in improving neurologic function. Failing to acknowledge the heterogeneity of these injuries and under-appreciating the impact of the most important baseline prognostic variables likely contributes to this translational failure. Our hypothesis was that neurological level and severity of initial injury (measured by the American Spinal Injury Association Impairment Scale [AIS]) act jointly and are the major determinants of motor recovery. Our objective was to quantify the influence of these variables when considered together on early motor score recovery following acute tSCI. Eight hundred thirty-six participants from the Rick Hansen Spinal Cord Injury Registry were analyzed for motor score improvement from baseline to follow-up. In AIS A, B, and C patients, cervical and thoracic injuries displayed significantly different motor score recovery. AIS A patients with thoracic (T2-T10) and thoracolumbar (T11-L2) injuries had significantly different motor improvement. High (C1-C4) and low (C5-T1) cervical injuries demonstrated differences in upper extremity motor recovery in AIS B, C, and D. A hypothetical clinical trial example demonstrated the benefits of stratifying on neurological level and severity of injury. Clinically meaningful motor score recovery is predictably related to the neurological level of injury and the severity of the baseline neurological impairment. Stratifying clinical trial cohorts using a joint distribution of these two variables will enhance a study's chance of identifying a true treatment effect and minimize the risk of misattributed treatment effects. Clinical studies should stratify participants based on these factors and record the number of participants and their mean baseline motor scores for each category of this joint distribution as part of the reporting of participant characteristics. Improved clinical trial design is a high priority as new therapies and interventions for tSCI emerge.

Meeting the privacy requirements for the development of a multi-centre patient registry in Canada: the Rick Hansen Spinal Cord Injury Registry.

Privacy legislation addresses concerns regarding the privacy of personal information; however, its interpretation by research ethics boards has resulted in significant challenges to the collection, management, use and disclosure of personal health information for multi-centre research studies. This paper describes the strategy used to develop the national Rick Hansen Spinal Cord Injury Registry (RHSCIR) in accordance with privacy statutes and benchmarked against best practices. An analysis of the regional and national privacy legislation was conducted to determine the requirements for each of the 31 local RHSCIR sites and the national RHSCIR office. A national privacy and security framework was created for RHSCIR that includes a governance structure, standard operating procedures, training processes, physical and technical security and privacy impact assessments. The framework meets a high-water mark in ensuring privacy and security of personal health information nationally and may assist in the development of other national or international research initiatives.

Effectiveness of hand therapy interventions in primary management of carpal tunnel syndrome: a systematic review.

The purpose of this study was to determine the effectiveness of hand therapy interventions for carpal tunnel syndrome (CTS) based on the best available evidence. A qualitative systematic review was conducted. A literature search using 40 key terms was conducted from the earliest available date to January 2003 using seven databases. Articles were randomly assigned to two of five reviewers and evaluated according to predetermined criteria for inclusion at each of the title, abstract, and article levels. Included studies were independently scored by two reviewers using a structured effectiveness quality evaluation scale and also graded according to Sackett's Levels of Evidence. There were 2027 articles identified from the literature search, of which 345 met the inclusion criteria. Twenty-four studies were used to formulate 30 recommendations. Current evidence demonstrates a significant benefit (grade B recommendations) from splinting, ultrasound, nerve gliding exercises, carpal bone mobilization, magnetic therapy, and yoga for people with CTS.