Surgeon equipoise as an inclusion criterion for the evaluation of nonoperative versus operative treatment of thoracolumbar spinal injuries.

BACKGROUND CONTEXT: Prospective studies have failed to demonstrate the superiority of either operative or nonoperative treatment of thoracolumbar fractures. Similar to other surgical fields, research has been limited by the variability in surgical interventions, difficult recruitment, infrequent pathology, and the urgency of interventions. PURPOSE: To outline factors precluding randomized controlled trials in spinal fractures research, and describe a novel methodology that seeks to improve on the design of observational studies. STUDY DESIGN/SETTING: A preliminary report describing an observational study design with clinical equipoise as an inclusion criterion. The proposed methodology is a cohort study with head-to-head comparison of operative and nonoperative treatment regimens in an expertise-based trial fashion. Patients are selected retrospectively by an expert panel and clinical outcomes are assessed to compare competing treatment regimens. Surgeon equipoise served as an inclusion criterion. PATIENT SAMPLE: Patients with closed or open thoracolumbar spinal fracture with or without neurological impairment, presenting to one of two different trauma centers between 1991 and 2005 (N = 760). OUTCOME MEASURES: Homogeneity of baseline clinical and demographic data and distribution of prognostic risk factors between the operative and the nonoperative cohort. METHODS: Patients treated for spine fractures at two University hospitals practicing opposing methods of fracture intervention were identified by medical diagnosis code searches (n = 760). A panel of spine treatment experts, blinded to the treatment received clinically has assessed each case retrospectively. Patients were included in the study when there was disagreement on the preferred treatment, that is, operative or nonoperative treatment of the injury. Baseline and initial data of a study evaluating nonoperative versus operative spinal fracture treatment are presented. RESULTS: One hundred and ninety patients were included in the study accounting for a panel discordance rate of 29%. The distribution of baseline characteristics and demographics of the study populations were equal across the parallel cohorts enrolled in the study, that is, no differences in prognostic factors were observed. CONCLUSIONS: The use of clinical equipoise as an inclusion criterion in comparative studies may be used to avoid selection bias. Using multivariate analysis of retrospectively assembled parallel cohorts, a valid comparison of operative and nonoperative spine fracture treatment strategies and their outcomes is possible.

Does the disabilities of the arm, shoulder and hand (DASH) scoring system only measure disability due to injuries to the upper limb?

Although the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was designed, and has been validated, as a measure of disability in patients with disorders of the upper limb, the influence of those of the lower limb on disability as measured by the DASH score has not been assessed. The aim of this study was to investigate whether it exclusively measures disability associated with injuries to the upper limb. The Short Musculoskeletal Functional Assessment, a general musculoskeletal assessment instrument, was also completed by participants. Disability was compared in 206 participants, 84 with an injury to the upper limb, 73 with injury to the lower limb and 49 controls. We found that the DASH score also measured disability in patients with injuries to the lower limb. Care must therefore be taken when attributing disability measured by the DASH score to injuries of the upper limb when problems are also present in the lower limb. Its inability to discriminate clearly between disability due to problems at these separate sites must be taken into account when using this instrument in clinical practice or research.

Characterisation of orthopaedic trauma admitted to adult level 1 trauma centres.

BACKGROUND: Despite the vast number of traumatic injuries that are orthopaedic in nature, comprehensive epidemiological data that characterise orthopaedic trauma are limited. The aim of this study was to investigate the nature of orthopaedic trauma admitted to adult Level 1 Trauma Centres. METHODS: Data were obtained from the Victorian Orthopaedic Trauma Outcomes Registry (VOTOR), which includes all patients with orthopaedic trauma admitted to the two adult Level 1 Trauma Centres in Victoria (Australia). Information was collected from the medical record and hospital databases on patients' demographics and injury event, diagnoses and management. RESULTS: Data were analysed on 784 patients recruited between August 2003 and March 2004. Patients were mainly young (<65 years) (70.7%), male (59.1%) and injured in a transport collision (51.3%). Fractures of the femur (23.7%) and spine (23.5%) were the most common injuries and were predominately managed with operative (87.6%) and conservative (78.8%) methods, respectively. Differences in most parameters were evident between younger (<65 years) and older (> or =65 years) patients. CONCLUSIONS: This study presents epidemiological data on patients with orthopaedic trauma who were admitted to adult Level 1 Trauma Centres. This information is critical for the future monitoring and evaluation of the outcomes of orthopaedic trauma.

Incidence of serious injury and death during sport and recreation activities in Victoria, Australia.

BACKGROUND: Participation in sport and recreation is widely encouraged for general good health and the prevention of some non-communicable diseases. However, injury is a significant barrier to participation, and safety concerns are a factor in the decision to participate. An understanding of the sport/recreation activities associated with serious injury is useful for informing physical activity choices and for setting priorities for the targeting of injury prevention efforts. OBJECTIVES: To describe the epidemiology of serious injuries sustained in sport/recreation activities by adults in Victoria, Australia. METHODS: The Victorian State Trauma Registry and the National Coroner's Information Service were used to identify and describe sport/recreation related serious injuries, including deaths, occurring during the period July 2001 to June 2003. Age adjusted rates of serious injury and death were calculated using participation figures for each sport and general population data. RESULTS: There were 150 cases of serious injury and 48 deaths. The rates of serious injury and death were 1.8 and 0.6 per 100,000 participants per year respectively. Motor, power boat, and equestrian sports had the highest rates of serious injury. Most deaths were due to drowning. CONCLUSION: Although the risk of serious injury through sport/recreation participation is low, motor, power boat, and equestrian sports should be priorities for further research into injury prevention. Most sport/recreation related deaths are due to drowning, highlighting this area for prevention efforts.

Catabolism of aggrecan by explant cultures of human articular cartilage in the presence of retinoic acid.

The N-terminal amino acid sequence of human aggrecan was determined and it was shown that two sequences were present. The major sequence, AVTVE-, accounted for 60% of the aggrecan and started at alanine residue 17 of the human aggrecan core protein cDNA sequence (K. Doege et al. (1991) J. Biol. Chem. 266, 894-920). The other N-terminal sequence, VETX-, started at valine residue 20. Characterization of aggrecan core protein peptides present in the matrix of adult human articular cartilage showed that at least 11 aggrecan core proteins were present with approximate M(r) between 300,000 and 43,000. All these core proteins were found to have the same N-terminal sequences as that observed in human aggrecan. When articular cartilage was placed in explant culture in medium containing 10(-6) M retinoic acid there was a 3.5-fold increase in the loss of aggrecan into the culture medium compared to tissue maintained in medium alone or medium containing 20% (v/v) newborn calf serum. Analysis of the aggrecan core protein fragments that were released to the culture medium containing 10(-6) M retinoic acid showed the presence of 13 core protein peptides of M(r) between 300,000 and 43,000. The 11 smaller peptides of M(r) 230,000 to 43,000 were shown to have the N-terminal sequence ARGS-. This sequence which starts at residue 393 of the human aggrecan core protein is located within the interglobular region between the G1 and G2 domains and is the site of aggrecan catabolism by the putative protease aggrecanase. The presence of core proteins of varying sizes but with the same N-terminal sequence reflects proteolytic processing from the C-terminal end of the core protein that was also observed in the aggrecan macromolecules extracted from the matrix of human articular cartilage. This proteolytic processing was also evident but to a lesser extent in newly synthesized 35S-labeled aggrecan macromolecules.