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Outcomes Meeting: Laying a Foundation for Outcome Measures

A 6 minute walk test is a 6 minute walk test, right?
Well, maybe not.

It turns out, there can be many variations of the same test. For example, is it done on carpet? On linoleum? On concrete? Shoes on? Shoes off? Socks on? Socks off? Do you start when the therapist says, “go!” or when the child takes the first step? If there’s a “false start” do you get a “do over?” Are you allowed to chase your dad, or have your dad chase you? What if you want to carry your pet dino, is that ok? And when is it over – when the child’s knee goes across the finish line? Or the toe? Or the heel??

 

Each of these variations may not make a difference individually, but together, they can affect a timed test in very significant ways. Therapists have long discussed these concerns amongst themselves. The Outcomes Meeting gave both therapists and industry a forum for discussing the standardization of the physical therapy evaluation of a child with Duchenne.

Discussions 

Led by Claudia Senesac, PT, PhD who is part of the Imaging DMD group in Gainesville, Florida, a group of therapists and industry representatives met to discuss the importance of standardizing outcome measures. After 2 days of discussion, it was decided that the group would first concentrate on reducing variability in lower limb evaluations.


These evaluations include:

  • six minute timed walk test
  • 10 meter fast walk/run
  • supine to stand
  • 4 stair climb
  • North Star Assessment


This standardization process will include the use of a Delphi survey. The first round survey will define each outcome measure with a brief description. Variations in procedures for each tool identified at the meeting will be presented to participants. The Delphi allows all participants to voice their opinion on equal ground with anonymity. Areas of consensus can be quickly identified and comments collated to form a second round survey. Up to 4 surveys are done further narrowing the scope of variables until there is 80% consensus on a standard method of using the outcome measure. After measures of lower limb strength and function are standardized, measures of upper limb strength and function will be evaluated.

 

Industry agreed that this process is both necessary and useful. While this standardization will not affect ongoing studies, future studies will require inclusion of these standardized evaluations.

 

Looking ahead

The surveys are projected to be complete by the end of September 2014, or sooner. The standardized measures will be submitted to industry for evaluation. After discussion and approval, the measures will be universally implemented in future studies. Laying a foundation for outcome measures in all areas will increase the strength of evaluation measures, increasing the strength of research outcomes, and clinical trial results gathered from multiple clinical trial sites. The goal of this meetingstandardization of outcome measures that will speed clinical trials and strengthen results, getting therapies into the community as quickly as possible. We think this is a wonderful first step.

Learn more

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