Standard Operating Procedures for the Clinical Management of Patients Enrolled in a Prospective Study of Inflammation and the Host Response to Thermal Injury

Abstract

As part of the National Institutes of General Medical Sciences (NIGMS)-funded Inflammation and the Host Response to Injury study, participating investigators created a database, a clinical data collection protocol, and web-based case report form. To obtain high-quality clinical endpoints for correlation with genomic data, a uniform approach to patient management between centers was required. Standard operating procedures (SOPs) were generated to minimize variability and promote a uniform standard of patient care. The SOPs are necessary to enable validation of the clinical endpoints to be used for comparison with genomic and proteomic information derived from samples of blood and tissue obtained from thermally injured patients. Participating investigators identified areas of potential practice variation and developed a set of SOPs based on available data and sound clinical principles. In the absence of sufficient clinical data to identify a single management strategy, SOPs were designed to apply the best approach to management without interfering with local standards of care. The data- collection instrument, or case report form, was constructed concurrently with the SOPs. Wherever possible, the case report form was modified to collect data that might resolve controversial management issues. Modifications in management strategies that were necessary for children are delineated as needed. Data queries and site visits were conducted to audit compliance. SOPs for 10 areas of clinical care were developed. The institution of the SOPs required minor changes in clinical practice patterns and personnel training but did not require participating centers to procure new technology or alter the utilization of clinical resources significantly. The SOPs represent current management strategies applied to the study population to reduce variation in patient management. The SOPs are easily adaptable to other burn-related clinical protocols as well as to the routine daily management burn patients.