September 2008 • Vol. 4, No. 4
	Advancing Orthotic and Prosthetic Care Through Knowledge

Lower Limb Prosthetics Outcome Measures: An Academy State-of-the-Science Conference

With the expanded attention being placed on evidence-based practice, especially by insurers, there is a greater need to find effective ways to show efficacy of treatment and care. This State-of-the-Science Conference (SSC) was convened to examine the body of scientific knowledge related to lower-limb prosthetic (LLP) outcome measures. The meeting was held September 7–9, 2005, in Chicago, Illinois, and funding for this conference was provided by the American Academy of Orthotists and Prosthetists (the Academy) through a grant from the U.S. Department of Education (H235J040017). Experts in the field were invited to offer their insight and expertise in summarizing the evidence and identifying key areas for future research. It was the goal of the conference to examine, debate, and answer the following key questions.

1. What validated instruments are available in English to measure global lower-limb prosthetic outcomes?

2. What do these instruments attempt to measure?

3. What are the relative strengths and weaknesses of current instruments?

4. What are the barriers to clinical application of these tools?

5. In light of the literature review and the panel's discussion, what are the primary future research priorities?

Conference participants contributed the following topics of focus for the SSC:

• Measurement of Health Outcomes: Reliability, Validity and Responsiveness, Kathryn E. Roach, PhD, PT

• Lower Limb Prosthetic Outcome Measures: A Review of the Literature 1995 to 2005, Elizabeth Condie, Grad Dip Phys, FCSP

• Improving Health Care Quality with Outcomes Management, Allen W. Heinemann, PhD

• Predictive Outcome Measures Versus Functional Outcome Measures in the Lower Limb Amputee, Robert S. Gailey, PhD, PT

• Tools to Measure Outcome of People with a Lower Limb Amputation:Update on the PPA and LCI, Christiane Gauthier-Gagnon, MSc

• Use of the Prosthesis Evaluation Questionnaire (PEQ), David Alan Boone, BS, CP, MPH, PhD

• Development and Application of the Orthotics and Prosthetics User Survey: Applications and Opportunities for Health Care Quality Improvement, Allen W. Heinemann, PhD

• Use of a Step Activity Monitor in Determining Outcomes, David Alan Boone, BS, CP, MPH, PhD

• Use of Quantitative Gait Analysis for the Evaluation of Prosthetic Walking Performance, Steven A. Gard, PhD

• Overview of Outcome Measures for the Assessment of Prosthetic Foot and Ankle Components, Brian J. Hafner, PhD

• Outcomes from the Surgeon's Perspective, Michael S. Pinzur, MD

• Special Challenges in Outcome Studies for Amputation Surgery and Prosthetic Rehabilitation, Douglas G. Smith, MD

• The Walter Reed Experience: Current Issues in the Care of the Traumatic Amputee, LTC Paul F. Pasquina, MD

• Barriers to Clinical Application: A Prosthetist's View, Jack E. Uellendahl, CPO

• The Development of Coverage Policy for Lower- Extremity Prosthetics: The Influence of the Payer on Prosthetic Prescription, Deanna Fish, MS, CPO

The discussion was facilitated by an extremely thorough and comprehensive written review of the literature that was completed by Elizabeth Condie, PT, FCSP, and colleagues, and which was provided to the participants prior to the meeting and is included in the final proceedings.

Outcome measurement tools can evaluate either the actual level of performance or perceived performance and can also be generic or population specific (e.g. for lower-limb amputees). Although there was a general preference for population-specific outcome measurement tools, which may be more responsive, one primary conclusion that emerged from the discussion regarding the strengths and weaknesses of outcome measures in LLP was that although there are many tools that have been validated in one situation, this does not mean they can be used in any situation. The tool must be validated for the specific application (that is, for the question to be answered and population to be studied). Other than the outcome measurement tools summarized by Condie, there were also presentations and discussion about the use of gait analysis and about the findings of the Academy SSC on the evaluation of prosthetic foot/ankle mechanisms.

In addition to discussing the tools themselves, there was an assessment of the general challenges to the use of outcome measures in a clinical setting. One of these challenges was the general selection of the tool and whether it should evaluate overall function or the patient's subjective perception of this function, which may not always coincide. Additional discussion included the challenges of administering these outcome measurements in a clinical setting where time is already limited.

However, there was no question that there is a need to continue the implementation of these tools in the tightening healthcare market. To better justify new components, it is important to show not only how this technology can improve function or quality of life, but also how optimal care can reduce the need for more expensive healthcare overall. However, to show an "improvement," it is necessary to have a well-defined and well-designed study that accurately identifies which changes in function and/or quality of life are expected and clearly chooses an appropriate outcome-measurement tool based on this hypothesis.

Overall, five research priorities and their order of importance were agreed on by the participants. The primary future research questions were then categorized into these five priority areas: (1) healthcare economic impact; (2) rehabilitation guidance tools; (3) activity limitation/performance measures; (4) pain and comfort; and (5) quality of life.

Healthcare economic impact was agreed to be the most important category, with rehabilitation guidance tools second. After determining the list of five research priorities, the group discussed the current outcome measurement tools and categorized them according to priority. Specific topic areas of research in each of the priority areas were recommended.

This group, with experience and training in many areas, brought a rich contribution to the areas of discussion. Given the breadth of the topic, final conclusions on the "best" outcome measure were not found, but recommendations for the use of certain existing tools were made, as were recommendations for future research. These recommendations are summarized in the State of the Science Conference Findings on Lower Limb Prosthetics Outcome Measures, published in 2006.

The Academy continues to share and update the results through certificate programming and an online course that was recently released.