Outcomes Studies: A Very Sharp, Two-Edged Sword

As readers of this Corner know, I have been advocating an increase in objective research about prosthetic and orthotic care for many years. I believe that sound research results would validate many of the fundamental assumptions we now hold, and also debunk some invalid beliefs, settling many ongoing clinical debates and enabling us to improve the effectiveness of the care we provide. In the past year or so, U.S. insurance companies have begun using the mantra "lack of outcomes research" to deny technically sophisticated prostheses and orthoses, even when patients have successfully and happily used the technology to improve the quality of their lives for many years. This perversion of science to increase insurance profits is a very disturbing trend, but one that is likely to continue to accelerate.

The British Medical Journal recently published the results of a randomized controlled trial involving 286 patients at 7 different institutions who were prospectively assigned to one of two study groups. [ BMJ . 2004;329:694-695, 708-711] All patients had low back pain of at least 6 weeks duration. One group received only one PT visit, which consisted of an evaluation and the recommendation to "stay active". The other group received the same evaluation and advice to stay active, plus routine physical therapy treatments for low back pain for one year. The primary outcome measurement was the Oswestry Disability Index after twelve months, which demonstrated no significant difference between the two groups even though those patients who received a year of PT subjectively perceived significant improvement in their condition.

In the United States, such a finding would give private insurers an immediate reason to deny coverage for physical therapy, a knee-jerk reaction that increases insurance company profits but clouds the scientific issues and politicizes research results. To their credit, the authors of the BMJ did not advocate such rash actions. Instead, they concluded that, "Patients' perception of treatment benefit was, however, in conflict with the validated outcome measures, and the clinical importance of this finding needs further investigation."

The authors then noted a number of limitations and potential reasons for these findings, including the fact that 76 different therapists, with varying treatment philosophies and skill levels, treated the patients. I was struck by how similar the confounding variables in this study would be to a similar study on the effectiveness of orthoses for this condition. This study is an excellent illustration of the difficulties in designing a "bullet proof" and clinically relevant outcomes study, providing some insight into the magnitude of the challenges we in P&O will be facing in the coming years.

I still believe that good outcomes studies are in important element in the maturation of our field, but acknowledge that starting to develop such information carries the risk of premature denial of coverage in the US. If insurers continue to exploit the acknowledged lack of objective evidence regarding P&O care, which has rarely been studied in any systematic manner, this will actively discourage clinicians from participating in this important work.

Interested readers can read a more extensive article about this study by the folks at WebMD, or access the entire BMJ article, and the related editorial and commentary at the BMJ website.

Reader Comments: Read all user comments Expanding O&P borders Thank you for clarifying this misunderstanding. I thought Mr. Shreter had originated this idea, since I had not seen this style of lanyard suspunsion system until he demonstrated the application of this TF suspension system on one of his C... read more - Sewpersaud Madho   11/29/2004 Re: Expanding O&P borders Glad to clarify the distinction between a lanyard technique and the KISS approach. I do try hard to keep the contents of this Corner accurate, so I'm glad readers are so alert and raise appropriate concerns from time to time. You raised t... read more - John Michael   11/29/2004 Security The security issues that are often raised around the ultra light materials and modular components that are incorporated in the design of a prosthesis is over classified. From a historical perspective the contributions of Van Phillips, and ... read more - S.M.   11/30/2004 Re: Security Frankly, no, I wouldn't agree. It seems to me that both carbon fiber composite structures and titanium were originally ultra high cost aerospace materials, and at one time they probably did have some strategic significance. But, they were... read more - John Michael   11/30/2004 Expanding O&P borders What about the technology security agreement? And why are we not offering these opportunities to American citizens first. Also the KISS Suspension system is a Jon Shreter idea that he has been implementing since 2002. Give credit where... read more - Sewpersaud Madho   11/28/2004 Re: Expanding O&P borders Thanks for your comments, Mr. Madho. The implications of the technology security agreement are not clear to me, so please feel free to explain your concerns in more detail. I contacted Jon Shreter in response to your concerns, and he has ... read more - John Michael   11/29/2004