The role of bioinformatics in developing clinical practice guidelines: principles and opportunities

Clinical practice guidelines were developed by the professional organizations to provide standards of safe, effective, appropriate, equitable, affordable diagnostic and therapeutic care to promote the best yield at the least cost; to the patient, payers, health care professionals as well as to the healthcare system. One major objective of these guidelines is to prevent serious and/or harmful events in the course of disease. From a process analysis standpoint, such events are considered “errors” and should be investigated in accordance with the guidelines and tools for accident investigation. These tools include Process Mapping, Root-Cause Analysis, Influence Diagrams and Predictive Modeling methodology. The underlying principle is that all biologic environments are complex environments, involving a multitude of individual processes following multiple pathways and under the influence of numerous factors at multiple levels; as opposed to a single-axis main process line of the Ishikawa diagram. Process mapping mandates a thorough understanding of the multi-linear, inter-dependent and overlapping pathways involved in the genesis and maintenance of disease. Through this approach, the impact of various factors on the end-result can be more adequately assessed. More robust utilization of registry data is essential for comprehensive and complete data collection and organization. A probability-based predictive model may be best suited to incorporate all relevant factors, including others recognized in the future.