By Becky Kesner

“Evidence-based practice.” “Outcomes studies.” More and more, medical policies are demanding that your patient care is based on these two things. Yet while these phrases are familiar to practitioners, if asked, most would have a hard time proving that their patient care was based on one or the other.

It’s important to understand these terms. Combining outcomes-based research with evidence-based care creates a cycle of improvement within O&P.

More outcomes-based research will give scientists and university researchers clear direction, and the results will either confirm that practitioners have found good options for care or direct practitioners’ efforts away from techniques that do not work. Practitioners can then focus on developing new or improving proven techniques.

This month’s “Policy and Your Practice” explains what these terms mean, examines the growing trend, and outlines what’s going on to make sure this aspect of medical policy starts benefiting O&P practices.

What are outcomes studies?
“Outcomes studies” is a straightforward term. It is research into what types of treatment bring favorable outcomes for patients.

While every practitioner evaluates what works and what doesn’t for a particular patient, conducting an outcomes study is more formal. It must be done on a statistically significant sample, and it must be done according to a specific, repeatable, scientifically sound procedure.

While an outcomes study is more formal, its hallmark is that it can be done outside of a lab. For example, one practitioner suggests that facilities conduct research based on something as simple as measuring walking velocity. (See “Letters to the Editor,” March 2007 O&P Almanac.)

Often, laboratory (clinical) research then explores those findings further. But clinical research can also spur outcomes studies. Researchers or manufacturers may develop a product or technique that produces good results in the lab. It will take outcomes studies, however, to test what happens under actual conditions.

What is evidence-based practice?
Evidence-based practice, on the other hand, is what eventually will result once enough outcomes studies and clinical research are performed. This concept, too, is fairly straightforward: once enough research, including controlled laboratory research, is performed, the techniques and treatments O&P uses can be said to be based on solid scientific evidence.

For example, a larger body of outcomes-based research will start to reveal practices and techniques that work. Once a large enough body of evidence is collected, researchers at universities can conduct controlled trials to explore these findings further and confirm that the treatment itself produces these positive outcomes. Whether controlled trials agree with or contradict earlier findings, the confirmed scientific results will influence practice.

Why do it?
Besides the benefit to O&P practice, there is a need for this kind of research because of pressures on the healthcare community. The need for evidence to support the choice of types of care and the need for clinical guidelines for the field mean that O&P would gain from working to prove the benefits of what it does.

For example, various payers, including Blue Cross and Blue Shield and Medicare, have evidence requirements that emphasize the need for a sound clinical basis for approving coverage. Kimberly Walsh, director of clinical research at Otto Bock HealthCare, recently presented information on this at the meeting of the O&P Outcomes Initiative Steering Committee, held Feb. 1-2 in Las Vegas.

For example, Blue Cross and Blue Shield’s policy states that it “uses five criteria…to assess whether a technology improves health outcomes” and lists one of the criteria as “The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.” In the policy, the description of the criteria clearly describes “scientific evidence” as matching outcomes-based research:

Medicare does not publish its criteria, but it also mentions peer-reviewed research as one of the factors it considers when reviewing national coverage determinations.

While these criteria have been in place for years, the advent of higher technology and more expensive O&P devices have spurred payers to apply the criteria to O&P. And what one payer decides, others often adopt. For example, Blue Cross and Blue Shield’s technology assessments (based on the criteria mentioned above) are for sale to other companies.

What’s happening now?
On Feb. 1–2, AOPA sponsored a meeting in Las Vegas, Nev., where practitioners, doctors, professors, AOPA staff and business leaders involved with O&P all got together to discuss the growing push for
evidence-based practice.

The group was formed not to conduct research, but to help the O&P community carry it out. It established five objectives:

This year, the group expects to work on the first objective by reviewing the existing literature to determine what areas have been covered well and what areas still need work. By the end of 2007, the group plans to finish the preparatory work, including publishing white papers, and have funding in place to turn over to a primary investigator.

Research can seem far removed from trying to fit a brace or make a socket more comfortable. But healthcare policies are, rightly, requiring some proof that what O&P practices are doing helps patients. And people from across the industry, including AOPA, are working to make it happen.

Becky Kesner is the managing editor of the O&P Almanac. Contact her at (571) 431-0815 or bkesner@AOPAnet.org.