Randomized Controlled Trials (RCTs) have long been the gold standard in clinical research representing the best of what is known of research methodology. However, improvement science is a novel field of research with requirements for advanced methodologies ranging from observational to implementation design. As the landscape of improvement research evolves, so have the methodologies needed to study vastly different types of projects. The variety of studies that can be conducted in healthcare within the scope of improvement research include topics for which random assignment may not be practical or ethical, or for which RCTs will not assure unbiased, generalizable results. The ISRN has set the course for research topics by defining national stakeholder priorities. For example, Priority A - Coordination and Transitions of Care – emphasizes strategies for care improvements in which hospital participants in these studies may not be willing to be randomly assigned to intervention or control. Or, if random assignment is possible, the number of accessible units to be randomized may be relatively small because of the nesting aspects of clinical units. In situations like these, alternatives to RCTs should be considered.
As a leading expert in the field, Alexander Young, MD, MSHS, from the UCLA Department of Psychiatry and Greater Los Angeles Veterans Healthcare Center, discusses alternative designs for evaluating interventions under routine, real-world conditions, and discusses key tradeoffs and features of alternative research approaches.
Hospital-based research spans from policy to organizational research, and potentially includes hundreds of variables. The uniqueness of improvement research within the ISRN is that is allows for multiple methodologies to be used. “Improvement research can study interventions designed to help clinicians or organizations improve the care they provide, or can study policy changes designed to improve care,” says Dr. Young. He adds, “It is critical that we understand the effect of these interventions, however, RCTs may not be able to produce this information. Alternative designs are available, and may be preferable.”
Learn more about methods that can be employed in the design of improvement research by attending the 2014 Improvement Science Summit. The Summit will be held on August 5-6, 2014 in San Antonio, TX. For details and registration information, visit www. ISRN.net.