Current methods for measuring goals in prosthetic fitting and training fail to account for the variables.

Measuring prosthetic device outcomes is certainly not an easily defined and concise science. This is evidenced by the absence of effective outcome measurement tools. The chief problem lies in two distinct areas: the sheer scope and variety of variables surrounding each case, and the instruments used to gather the data.

Perhaps our most endearing quality as human beings is our diversity. Whether it manifests itself physically, psychologically, psychosocially, or some combination of all three, this diversity defines the essence of what it means to be human. Diversity is precisely the problem when assessing the reliability of outcome measurement tools in prosthetic fitting and training.

No one can argue that patients possess a multitude of issues seemingly unrelated to limb involvement that bears some impact on outcomes. What is rarely considered, however, are the myriad issues surrounding those individuals involved in caring for or socially interacting with the patient. Functional status, quality of life, and service and/or prosthetic device satisfaction cannot be accurately assessed in a vacuum.

Patient Variables

Certain variables may affect the patient’s interpretation of and answers to subjective questions. These variables may affect the patient’s own assessment of the prosthetic device or service in question.

Numerous studies have compared the functional performance of one prosthetic device to another, excluding functional determinants such as therapist experience and device applicability. Unfortunately, there are so many variables that impact outcomes that it is impossible to address them all.

Questionnaires that pertain to rehabilitation strategies are rarely comprehensive and are often ignored altogether. Details concerning assessment methodology, component selection, interface design, and alignment issues are typically missed by outcome measurement tools.

Additional variables that are often overlooked include fitting schedules, postprovisional assessment schedules, rehabilitation team synergy and involvement, support group interaction, and questions about possible conversions from one class of device to another. All these factors play a tremendous role in determining functional outcomes and patient perceptions of rehabilitation.

Psychological Factors

Perhaps one of the most crucial determinants of outcomes is the difference between patient expectations and reality. Individuals who undergo amputation must not only cope with tremendous psychological challenges, but they must also deal with the limitations of current prosthetic technology. Assessment methodologies should reflect this. If a detailed psychological assessment is not possible, then, at a minimum, some form of psychological preparation should be given.

Psychological impact is rarely measured by outcome measurement tools. If measured, often the questions to determine outcome are too general and may not accurately pinpoint differences between device satisfaction, for example, and individual reactions to the trauma and the subsequent surgery.

Team Approach

The experience of the other team members, such as the orthotist, prosthetist, and surgeon, should also be taken into account. Experience is vital to developing patient confidence and building the rapport so important to positive outcomes. The patient benefits from the experienced clinician’s ability to effectively disseminate information and to better empathize with the patient’s psychological, physical, and psychosocial needs.

The experienced clinician is better able to determine the applicability of rehabilitative or restorative devices, and is more apt to correctly diagnose problems during postprosthetic assessment, for example. All of these variables are the tip of the iceberg, and any outcome measurement tool that considers them through targeted questioning, while moving in the right direction, is touching on a mere fraction of the significant issues involved.

Allen Heinemann, PhD, and his associates are currently gathering data for their outcome measurement tool at the Rehabilitation Institute of Chicago’s Rehabilitation Evaluation Services Unit (RESU). The project’s objectives are to develop a database that describes outcomes of therapeutic training from the beginning to community re-entry. Allen and his team looked at demographic and impairment characteristics, activity level, quality of life, and satisfaction with services and equipment.

So far, the team has concluded that functional status, quality of life, and service items are reliable measures. They also concluded that additional device-evaluation items are needed. I applaud the team’s efforts, and look forward to their progress, yet they too are hampered by our inability to address all the outcome variables. 

Opinion and Fact

Given our current state of rehabilitation methodology, we are left with the question of what to measure and what will provide us with the best information to assess prosthetic device outcomes. When we ask questions such as “Does your prosthesis fit well?” or “Is your prosthesis easy to use?”, we rely on a subjective response that may hinge on a thousand or more factors. When we ask questions that require opinionated versus factual answers, we will always be a little unsure about the relevance of the individual’s response when taken in the context of device assessment.

So what exactly can we ask about prosthetic devices that will provide us with an improved measure that truly reflects performance? One question that elicits a response that leaves little room for misinterpretation is, “Are you still wearing your prosthesis?” (Many orthoses are intended to be worn temporarily.) While this question does not delve into the myriad reasons why patients are or are not wearing their prosthetic devices, it does tell us whether or not the device is satisfying enough to be worn.

With most prostheses, because there is effort in donning or doffing (or discomfort from added weight or heat buildup), the benefits must outweigh these and the many other challenges to ensure continued use. Many individuals choose to wear a prosthesis for cosmetic reasons, or for self-esteem and body image, even if they are not using it for what it was intended. In cases such as these, it is still providing a benefit.

Another question is, “Is there some function your prosthesis or orthosis provides that you can’t perform without the device?” While again, this question does not provide a great amount of detail, it is a fact-based question that does not illicit subjectivity.

Practitioners in the field determine the quality of information by ensuring quality of care in its entirety, from assessment through delivery and beyond. It is the clinician who must follow a script, approved by the AOPA, so that quantification of the rehabilitation strategy can be achieved. This consistency eliminates a host of variables that significantly affect outcomes previously unrecognized or underappreciated.

Veering From the Script

The difficulty lies in the fact that although there are many similarities, variables are numerous and significant enough that assessment and rehabilitation must reflect these differences while operating within the parameters of standardization.

To develop a script that can be applied uniformly, yet allow enough variance to properly address issues specific to each individual, a set of universals needs to be defined. For example, it is universally agreed that the assessment must be comprehensive. It is, of course, important to define just what a comprehensive assessment entails and to outline all of its components. A comprehensive assessment should be administered using psychological, physical, and psychosocial perspectives. It should include patient, family, friends, and clinician education in terms of component options, advantages, and limitations of prosthetic devices and control systems.

Basically, it should be a detailed discussion of the entire process so that everyone can understand exactly what is involved. Finally, a well-defined rehabilitation strategy should be established and agreed on by all members of the rehabilitation team, so that everyone knows their role. Standardization in a field where science still struggles to gain the upper hand over craftsmanship may seem controversial, but device evaluations will continue to suffer under scientific scrutiny unless clinicians follow a set of approved standards and guidelines.

This is not about restricting practitioners from injecting their own philosophies, methods, and personalities, but rather finding common ground, removing at least some of the barriers to measuring device effectiveness. Hopefully, we will continue to account for more variables in our ongoing efforts to accurately measure outcomes.

Randall D. Alley, CP, is chairman of the AOPA’s Upper Limb Prosthetic Society and can be reached via email: ralleyone@hotmail.com.