QI methodology, Dr. James concedes, is “inherently an observational study design in the hierarchy of evidence because of the way data is collected.” He maintains that researchers can increase the reliability of quality improvement initiatives “by incorporating prospective non-randomized controlled trials designs, or quasi-experiments, the pinnacle of observational study designs. Staggered implementation, risk adjustment, and case matching can bring a quasi-experimental study design within a hair’s breadth of the same evidence reliability of a full randomized controlled trial.”
Once routine care processes are standardized at an institution, other opportunities for controlled studies will appear. Dr. James cites work done at LDS Hospital, Salt Lake City, Utah, by Allen Morris to produce a best practices guideline for treating acute respiratory distress syndrome (ARDS). Now disseminated via ARDSnet (www.ardsnet.org/clinicalnetwork/
“There are definitely ways in which the two fields [quality improvement and rigorous scientific research] make each other better,” says Dr. Schnipper. For his study of glycemic management of diabetic patients in a non-ICU setting (at press time scheduled to publish in a forthcoming issue of the Journal of Hospital Medicine), Dr. Schnipper and his team conducted rigorous prospective data collection, identifying every diabetic on the general medicine service at the time of admission. Using the APACHE III, the team then assessed each patient’s severity of disease, a known confounder of glucose control in hospitalized diabetics. They conducted a detailed chart review to assess the quality of insulin orders for the diabetic patients. Finally, they used a novel statistical technique (marginal structural models) to remove the confounding by indication that occurs when hyperglycemia results in more intensive insulin therapy. They revealed that better quality insulin orders resulted in better glucose control.
“There’s a lot to be said for designing this research so that it is maximally useful for its consumers—hospitalists and others—who want to improve care in their own hospitals. I think we need to move toward multi-center quality improvement studies. If you can get [an intervention] to work at 10 hospitals, then you’ve gone a long way to say this works, in general. As long as you can answer that question—is there knowledge to be gained—then it’s worth doing a study well, with good methods, and it’s worth publishing.”
In Academia Alone?
Dr. Williams hopes the new emphasis on quality improvement, evidenced in such publications as the AHRQ’s August 2004 technical review, “Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies,” can become a springboard for new areas of research.4 He reports that the Journal of Hospital Medicine has already received article submissions detailing quality improvement initiatives. “We would love to see more,” he says.
It may not always be possible to clear the time for the additional duties of conducting research. Community-based hospitalists do not usually enjoy the same degree of funding and research support infrastructure found in the academic setting. SHM’s “Authoritative Source on the State of the Hospital Medicine Movement” reveals that the majority of hospitalists involved in research are affiliated with universities and medical schools.5 Dr. Williams admits that fitting in research projects can often be a challenge for other busy hospitalists.
“I don’t think it’s something you can just do on nights and weekends. The only way, honestly, that hospitalists can fit research into what they’re doing is if [research] becomes part of their job description,” says Dr. Williams. “And I think the appropriate avenue is through quality improvement initiatives.”