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The goal of treadmill testing in clinical trials is to determine the exercise performance of patients with disorders such as peripheral artery disease (PAD) and Cardiac Ischemia/Angina. The claudication onset time (COT) and the peak walking time (PWT) are two endpoint measurements often collected in order to assess the level of functional independence of the PAD patient. In patients with Angina, the total exercise time is often the endpoint. Unfortunately there are many factors that affect the variability of these endpoints. The goal of our intervention is to decrease testing variability and increase reproducibility by creating a more consistent and accurate measurement. By utilizing a combination of training and oversight CPC can help to ensure test validity by providing consistent measurement techniques.
Factors affecting the variability of the treadmill test endpoints:
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Treadmill equipment
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Pre-testing activity, consumption of alcohol, tobacco, food, and medication as mandated by the protocol
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Patient instruction and familiarization prior to testing
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Patient walking technique
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Inappropriate clothing and/or shoes
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Staff instruction and guidance during testing
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Staff collection and documentation of endpoint data
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Not pushing the patient to a maximal, symptom-limited, claudication endpoint
These, and other factors effecting variability, can be controlled in a
clinical research setting with thorough training and oversight.
CPC Interventions:
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Site Endpoint Evaluation Visit, which includes: 1) assessment of the sites’ equipment for
appropriateness for the protocol, 2) evaluation of the techniques utilized by each staff
member who will administer the treadmill tests, 3) assessment of the environment in which the test
is administered, 4) source document review to evaluate adherence to the protocol and CPC’s data
collection guidelines, and 5) a detailed report to the site noting all issues at their site
and specific recommendations for improving the procedure at their site
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A reference tool for sites to use during treadmill testing
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Hands on training to the site staff during an Investigator Meeting
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Development of source documents specific to treadmill testing
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Weekly review at Endpoint Evaluation Committee meetings of issues identified during
SEEVs; recommendations for corrective actions are forthcoming from this meeting
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Receiving phone calls or other inquiries from sites about data collection methods
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Sponsor Training on treadmill testing
CPC offers quality assurance of treadmill testing as described as
well as quality assurance for other endpoints utilized in clinical trials.
For more information on these services, please Contact Us or call 303.860.9900. |
