Development of a risk assessment and risk management tool for an academic research organization.

BACKGROUND: In the past decade, regulatory agencies have released guidance around risk-based management with the goal of focusing on risks to critical aspects of a research study. Several tools have been developed aimed at implementing these guidelines. We designed a risk management tool to meet the demands of our academic data coordinating center. METHODS: We developed the Risk Assessment and Risk Management (RARM) tool on three fundamental criteria of our risk/quality program: (1) Quality by Design concepts applies to all employees, regardless of the employee's role; (2) the RARM process must be economically feasible and dynamically flexible during the study startup and implementation process; and (3) responsibility of the RARM lay with the entire study team as opposed to a single quality expert. RESULTS: The RARM tool has 20 elements for both risk assessment and risk management. The incorporation of both aspects of risk management allow for a seamless transition from identifying risks to actively monitoring risks throughout enrollment. CONCLUSION: The RARM tool achieves a simplified, seamless approach to risk assessment and risk management. The tool incorporates the concept of Quality by Design into daily work by having every team member contribute to the RARM tool. It also combines the risk assessment and risk management processes into a single tool which allows for a seamless transition from identifying risks to managing the risks throughout the life of the study. The instructions facilitate documentation of de-risking protocols early in development and the tool can be implemented in any platform and organization.

Clinical Presentations and Outcomes of Children With Basilar Skull Fractures After Blunt Head Trauma.

STUDY OBJECTIVE: We describe presentations and outcomes of children with basilar skull fractures in the emergency department (ED) after blunt head trauma. METHODS: This was a secondary analysis of an observational cohort of children with blunt head trauma. Basilar skull fracture was defined as physical examination signs of basilar skull fracture without basilar skull fracture on computed tomography (CT), or basilar skull fracture on CT regardless of physical examination signs of basilar skull fracture. Other definitions included isolated basilar skull fracture (physical examination signs of basilar skull fracture or basilar skull fracture on CT with no other intracranial injuries on CT) and acute adverse outcomes (death, neurosurgery, intubation for >24 hours, and hospitalization for ≥2 nights with intracranial injury on CT). RESULTS: Of 42,958 patients, 558 (1.3%) had physical examination signs of basilar skull fracture, basilar skull fractures on CT, or both. Of the 525 (94.1%) CT-imaged patients, 162 (30.9%) had basilar skull fracture on CT alone, and 104 (19.8%) had both physical examination signs of basilar skull fracture and basilar skull fracture on CT; 269 patients (51.2%) had intracranial injuries other than basilar skull fracture on CT. Of the 363 (91.7%) CT-imaged patients with physical examination signs of basilar skull fracture, 104 (28.7%) had basilar skull fracture on CT. Of 266 patients with basilar skull fracture on CT, 104 (39.1%) also had physical examination signs of basilar skull fracture. Of the 256 CT-imaged patients who had isolated basilar skull fracture, none had acute adverse outcomes (0%; 95% confidence interval 0% to 1.4%), including none (0%; 95% confidence interval 0% to 6.1%) of 59 with isolated basilar skull fractures on CT. CONCLUSION: Approximately 1% of children with blunt head trauma have physical examination signs of basilar skull fracture or basilar skull fracture on CT. The latter increases the risk of acute adverse outcomes more than physical examination signs of basilar skull fracture. A CT scan is needed to adequately stratify the risk of acute adverse outcomes for these children. Children with isolated basilar skull fractures are at low risk for acute adverse outcomes and, if neurologically normal after CT and observation, are candidates for ED discharge.

Intracranial hemorrhage after blunt head trauma in children with bleeding disorders.

OBJECTIVE: To determine computerized tomography (CT) use and prevalence of traumatic intracranial hemorrhage (ICH) in children with and without congenital and acquired bleeding disorders. STUDY DESIGN: We compared CT use and ICH prevalence in children with and without bleeding disorders in a multicenter cohort study of 43 904 children <18 years old with blunt head trauma evaluated in 25 emergency departments. RESULTS: A total of 230 children had bleeding disorders; all had Glasgow Coma Scale (GCS) scores of 14 to 15. These children had higher CT rates than children without bleeding disorders and GCS scores of 14 to 15 (risk ratio, 2.29; 95% CI, 2.15 to 2.44). Of the children who underwent imaging with CT, 2 of 186 children with bleeding disorders had ICH (1.1%; 95% CI, 0.1 to 3.8) , compared with 655 of 14 969 children without bleeding disorders (4.4%; 95% CI, 4.1-4.7; rate ratio, 0.25; 95% CI, 0.06 to 0.98). Both children with bleeding disorders and ICHs had symptoms; none of the children required neurosurgery. CONCLUSION: In children with head trauma, CTs are obtained twice as often in children with bleeding disorders, although ICHs occurred in only 1.1%, and these patients had symptoms. Routine CT imaging after head trauma may not be required in children without symptoms who have congenital and acquired bleeding disorders.

Development and implementation of a performance measure tool in an academic pediatric research network.

BACKGROUND: The Pediatric Emergency Care Applied Research Network (PECARN) is a federally funded multi-center research network. To promote high quality research within the network, it is important to establish evaluation tools to measure performance of the research sites. PURPOSE: To describe the collaborative development of a site performance measure tool "report card" in an academic pediatric research network. To display report card template information and discuss the successes and challenges of the report cards. DEVELOPMENT AND IMPLEMENTATION OF THE NETWORK PERFORMANCE MEASURE TOOL: The PECARN Quality Assurance Subcommittee and the PECARN data center were responsible for the development and implementation of the report cards. Using a Balanced Scorecard format, four key metrics were identified to align with PECARN's research goals. Performance indicators were defined for each of these metrics. After two years of development, the final report cards have been implemented annually since 2005. Protocol submission time to the Institutional Review Board (IRB) improved between 2005 and 2007. Mean overall report card scores for site report cards increased during this period with less variance between highest and lowest performing sites indicating overall improvement. CONCLUSIONS: Report cards have helped PECARN sites and investigators focus on performance improvement and may have contributed to improved operations and efficiencies within the network.

Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study.

BACKGROUND: CT imaging of head-injured children has risks of radiation-induced malignancy. Our aim was to identify children at very low risk of clinically-important traumatic brain injuries (ciTBI) for whom CT might be unnecessary. METHODS: We enrolled patients younger than 18 years presenting within 24 h of head trauma with Glasgow Coma Scale scores of 14-15 in 25 North American emergency departments. We derived and validated age-specific prediction rules for ciTBI (death from traumatic brain injury, neurosurgery, intubation >24 h, or hospital admission >or=2 nights). FINDINGS: We enrolled and analysed 42 412 children (derivation and validation populations: 8502 and 2216 younger than 2 years, and 25 283 and 6411 aged 2 years and older). We obtained CT scans on 14 969 (35.3%); ciTBIs occurred in 376 (0.9%), and 60 (0.1%) underwent neurosurgery. In the validation population, the prediction rule for children younger than 2 years (normal mental status, no scalp haematoma except frontal, no loss of consciousness or loss of consciousness for less than 5 s, non-severe injury mechanism, no palpable skull fracture, and acting normally according to the parents) had a negative predictive value for ciTBI of 1176/1176 (100.0%, 95% CI 99.7-100 0) and sensitivity of 25/25 (100%, 86.3-100.0). 167 (24.1%) of 694 CT-imaged patients younger than 2 years were in this low-risk group. The prediction rule for children aged 2 years and older (normal mental status, no loss of consciousness, no vomiting, non-severe injury mechanism, no signs of basilar skull fracture, and no severe headache) had a negative predictive value of 3798/3800 (99.95%, 99.81-99.99) and sensitivity of 61/63 (96.8%, 89.0-99.6). 446 (20.1%) of 2223 CT-imaged patients aged 2 years and older were in this low-risk group. Neither rule missed neurosurgery in validation populations. INTERPRETATION: These validated prediction rules identified children at very low risk of ciTBIs for whom CT can routinely be obviated. FUNDING: The Emergency Medical Services for Children Programme of the Maternal and Child Health Bureau, and the Maternal and Child Health Bureau Research Programme, Health Resources and Services Administration, US Department of Health and Human Services.