Validity of Clinical Outcomes Assessment System Tested

Objective measurement of a patient’s functional capability is
becoming increasingly important for clinicians. With renewed focus on
identifying inaccurate billing for lower extremity devices from the federal
government, O&P practitioners need to have clear and objective measurements
of patient functionality to justify their reimbursements, according to David A.
Boone, CP, MPH, PhD, chief technology officer, Orthocare Innovations.

Boone presented a study at the 2011 American Orthotic and Prosthetic
Association National Assembly in Las Vegas, which tested the validity of a
outcomes assessment system known as the Galileo Functional
Assessment. The overarching goal of the Galileo Functional Assessment was to
validate the care practitioners provide scientifically, based on their real
world functional activity and physical activity monitoring technology.

“What we need is a fast, reliable and accurate system to
objectively document functional levels,” Boone told the audience.

Accurate description

Boone discussed the importance of the words clinicians use when
determining the K-level of a patient. Accurate descriptions are crucial,
especially when determining the difference between K-2 and K-3 levels.

“We have certain semantic descriptions about what the K-2 or K-3
is,” Boone said. “Words like ‘potential’ or ‘low
cadence’ are crucial in how we derive functional activity from our

In the study, individual raters estimated the K-levels of 65 anonymous
transtibial amputees. The K-levels of the seven raters were averaged. Those
estimates were then compared with the estimated ratings provided by the Galileo
Functional Assessment.

Patients’ activities were monitored for 1 week using physical
activity monitoring technology. This gave researchers information about how
patients use their prostheses in the real-world, how variable their cadence
was, as well as information on their endurance and potential ambulation. The
ratings were based on how well patients utilized their prostheses during
everyday activities, rather than in a laboratory or clinical setting.

“Can we have an automated, objective system that reflects the
clinical interpretation accurately?” Boone asked. “It’s not that
the clinical interpretations of K-levels are bad, it’s just that it can be
inconsistent. The point of creating a system like Galileo is to give everyone a
consistent measurement.”

Incremental change

Michael Orendurff, MS, director of Activity Monitoring and Outcomes
Services, Orthocare Innovations, and Boone determined the amount of agreement
between the automated Galileo measures vs. the patients’ actual K-level.
Galileo measures to the tenth, allowing practitioners to identify incremental
changes. This may to help practitioners determine whether a patient is a K-2
moving up to a K-3 or moving down, according to Boone.

They found that the Galileo Functional Assessment system closely matched
the ratings determined by experts.

“The raters had 68 combined years of clinical experience,
“Boone said. “We were determining how an automated measurement system
measures versus experience. The Galileo is like getting an expert second
opinion on a patient.” — by Anthony Calabro

For more information:

  • Orendurff MO, Boone DA. Validity of a clinical outcomes assessment
    system. Presented at the 2011 American Orthotic and Prosthetic Association
    National Assembly. Sept. 19-22. Las Vegas.

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