Guidance

1 Recommendations

1 Recommendations

1.1 There is not enough evidence to recommend routine adoption of automated ankle brachial pressure index (ABPI) measurement devices to detect peripheral arterial disease in people with leg ulcers. They should only be used in the context of research for these people.

1.2 Centres already using automated ABPI measurement devices to detect peripheral arterial disease in people with leg ulcers can continue to use them, only if:

  • they collect data or do research to assess their value and how well they identify people with peripheral arterial disease (see the section on further research)

  • people using the devices have experience assessing peripheral arterial disease

  • people using the devices are aware of their limitations, particularly diagnostic accuracy and the risk of missing peripheral arterial disease, and that there are differences between devices

  • further assessment using other methods, including manual doppler, is available.

1.3 Further research is recommended on automated ABPI measurement devices (see the section on further research) to:

  • assess their ability to detect peripheral arterial disease in people with leg ulcers

  • assess how they affect time to treatment for venous leg ulcers

  • assess clinical outcomes for treatments started after ABPI assessment

  • explore the most appropriate user (specialist and non-specialist in assessing peripheral arterial disease) and the most appropriate healthcare setting for their use

  • explore whether different ABPI thresholds can improve their sensitivity for detecting peripheral arterial disease.

Why the committee made these recommendations

Treatment for leg ulcers caused by a problem with blood flow in the veins (venous) involves compression therapy with bandages or stockings. Compression therapy is not suitable for some people with peripheral arterial disease because it could disrupt blood flow to the leg. Measuring ABPI as part of a clinical assessment can help detect if someone has peripheral arterial disease and therefore should not have compression therapy.

Currently, ABPI is measured and calculated manually. The assessment takes up to 1 hour and can be uncomfortable for people with leg ulcers. Automated ABPI measurement devices may potentially be easier and faster to use than manual doppler measurement, and more comfortable for people with leg ulcers. But there is limited evidence on whether automated devices can reduce the length of time an ABPI assessment takes.

There is a lack of clinical evidence on automated ABPI measurement devices and most studies were done in people without leg ulcers. So, it is unclear how well automated devices detect peripheral arterial disease in people with leg ulcers. There is also uncertainty about which healthcare setting the devices should be used in (for example, hospital or community) and who should use them (specialist or non-specialist in assessing peripheral arterial disease). It is therefore unclear:

  • whether automated devices reduce the length of time before starting treatment for venous leg ulcers

  • how inaccurate test results impact clinical decision making and health outcomes.

Economic modelling shows that automated ABPI devices are unlikely to be cost effective compared with manual doppler measurement unless they reduce the length of time before treatment starts, which is uncertain. The results of the economic model are also uncertain because there is no evidence on how results from automated ABPI measurement devices affect clinical decision making or clinical outcomes. So, automated ABPI measurement devices are only recommended in the context of research. Centres already using the devices can continue to use them if they do research and ensure safety.