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Accuracy and repeatability of the Dopplex Ability.

Rebecca N Millen1, Kate N Thomas1, Arunesh Majumder1

  • 1a Department of Surgical Sciences , University of Otago , Dunedin , New Zealand.

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|January 23, 2018
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Summary

The Dopplex Ability device showed poor accuracy and repeatability for diagnosing peripheral arterial disease (PAD) using ankle-brachial index (ABI) and pulse volume recordings (PVR). It was found unsuitable for clinical use in community settings.

Keywords:
Dopplexaccuracyankle-brachial indexpulse volume recordingrepeatability

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Area of Science:

  • Vascular Medicine
  • Diagnostic Imaging
  • Medical Device Evaluation

Background:

  • Peripheral arterial disease (PAD) diagnosis relies on non-invasive tests like ankle-brachial index (ABI) and pulse volume recordings (PVR).
  • The Dopplex Ability is an automated device for rapid PAD diagnosis using air plethysmography.
  • This study evaluated the accuracy and repeatability of the Dopplex device against a established system.

Purpose of the Study:

  • To assess the accuracy of the Dopplex Ability device in measuring ABI and PVR.
  • To evaluate the repeatability of ABI and PVR measurements obtained with the Dopplex device.
  • To compare the performance of the Dopplex Ability with the Parks Flo-Lab system.

Main Methods:

  • Sixty-six patients (129 lower limbs) underwent assessment using both Dopplex and Parks systems.
  • Accuracy criteria: Dopplex ABI within ±10% of Parks ABI; PVR grade (1-4) equality.
  • Repeatability assessed via coefficient of variation (CV) from three repeat ABI/PVR readings.

Main Results:

  • Poor correlation between Dopplex and Parks for ABI (R² = 0.17).
  • Only 43% of ABIs and 69% of PVRs met accuracy criteria.
  • Dopplex demonstrated significantly higher CV for both ABI and PVR, indicating lower repeatability.

Conclusions:

  • The Dopplex Ability device exhibited suboptimal accuracy and repeatability for ABI/PVR assessment.
  • The device was deemed unsuitable for use in community-based PAD diagnosis.
  • Further validation of automated PAD diagnostic devices is warranted.