Introducing patient-reported outcomes into the VQI

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Vascular specialists have long recognized that there is more to the treatment of peripheral arterial disease (PAD) than the immediate procedural success and early outcomes.

The patient experience should not only be measured in clinical outcomes such as patency or mortality but subjective measures such as the impact on lifestyle. In recognition of this, the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) has launched a pilot program of patient-reported outcomes measures (PROM) for use with peripheral vascular interventions (PVI).

Beginning in April 2021, 15 sites in the United States and Canada joined the My Peripheral Arterial Disease (My PAD) pilot for PAD PROM collection.

Patients undergoing PVI for claudication or chronic limb-threatening ischemia (CLTI) will be asked to complete two health-related quality of life (QoL) surveys at three time points—pre-procedure, one-month and one year.

While there are a number of options for PROM, the VQI chose two validated QoL instruments. The EuroQol 5D-5L (EQ 5D-5L) is a general QoL survey while the VascuQol 6 (VQ-6) is a vascular disease-specific survey used for PROM in Europe and validated for English and Spanish speakers. The VQI added three additional questions from the original VQ-25 in an effort to study and improve PRO collection for CLTI.

The pilot will evaluate workflows at participating sites and aims to identify best strategies and minimize the burden of data collection.

The pilot will evaluate several methods for PROs collection, including web-based entry through personal computers, tablets and smartphones, as well as conventional, low-tech, paper forms.

Individual sites will choose their collection method and will have the option to use more than one mode of data entry. In an effort to reduce the burden of data collection at participating sites, the VQI commercial technology partner, Medstreaming/M2S, of West Lebanon, New Hampshire, will use email notifications to prompt direct patient entry of PROs after obtaining their verbal consent to participate. The pilot will set the stage for future expansion of collection to all member sites in the PVI registry and eventually for rollout to cover other vascular procedures.

In the future, VQI PROs collection will enable international study in collaboration with European registries through the International Consortium of Vascular Registries (ICVR).

We envision a time when clinicians will have access to longitudinal PROs for their individual patients to better understand the impact of their treatments on their QoL. We hope this information will increase patient engagement, support shared decision-making and improve vascular care.

Daniel J. Bertges, MD, and Jens Eldrup-Jorgensen, MD, were writing on behalf of the Vascular Quality Initiative Patient-Reported Outcomes Committee. Jorgensen is medical director of the VQI.

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