Lower extremity peripheral artery disease is a chronic illness that has a significant effect
on the quality of life of the patients in short- as well as long-term.
Generic Instruments, such as widely used Medical Outcomes Study Short Form 36 questionnaire
(SF-36) might be too insensitive to specific problems and associated comorbidities of
vascular surgery patients as well as too complicated for routine use in a busy clinical
setting. Therefore, the Vascular Quality of life questionnaire (VascuQoL-25) has been
developed for use in the UK in 2001 at the Vascular Surgical Unit of King's College Hospital
in London. To further simplify the use of the questionnaire, a lighter Version, that reduced
the amount of asked questions from 25 to 6 (VascQuol-6) has been presented and found to be
both valid and relevant. VascuQoL- 6 is a disease-specific questionnaire, developed to assess
health-related quality of life (HRQoL) in patients with peripheral artery disease. It has
been translated to 8 languages including German, and successfully validated for the use to
assess in patients with peripheral artery disease in Sweden, Netherlands, Norway, Brazil and
Poland.
In opinion of the investigators, a unified means to obtain relevant data concerning
patient-related outcomes following treatment (endovascular or surgical) for PAD as part of
existing aftercare schemes currently lacks in Switzerland. A simple tool such as VascuQoL-6
would allow collecting and objectively assessing, as well as comparing this kind of
information after such procedures.
The main objective of the project is to validate the electronic version of the VascuQoL-6 for
assessment of patient-related outcomes after a revascularization procedure (either surgical
or interventional) for peripheral artery disease in the German-speaking part of Switzerland
preoperatively, during the routine 30 days and a one-year follow-up.
Furthermore, upon the successful validation of the electronic VascuQoL-6, the investigators
seek to implement the use of this easy to use, straight-forward tool in the follow-up scheme
of the Swiss Vascular Registry (SwissVasc).
This project is of Risk A (minimum risk) according to art. 7 (HRO), because the
patient-related quality of life will be evaluated after vascular surgery or intervention and
will not have an influence on treatment modality.
Hypothesis and primary objective Assessment of quality regarding invasive treatment
(endovascular or surgical), outcomes and patients satisfaction becomes a more and more
powerful instrument to influence and guide decisions in the Swiss healthcare system. However,
no unified means are currently being applied as part of the existing follow-up schema after
revascularization for PAD in the German-speaking part of Switzerland. Therefore, the
possibility to provide, assess, compare and use the information about short- mid- and
long-term patient-related outcomes and improved/decreased disease- related quality of life in
the decision-making process is limited.
Validation of a comprehensible and easy-to-use electronic Version of the VascuQoL-6 will
allow obtaining such information in patients that underwent vascular/ endovascular surgery in
the German-speaking part of Switzerland.
SwissVasc (i.e. Adjumed.net) is a nation-wide database to register vascular interventions and
associated outcomes. Registration of individual data in SwissVasc (i.e. 30-day mortality,
complication rate) is mandatory in Kanton Zurich and will become mandatory in Kanton Basel-
Stadt and Basel-Landschaft in 2020. Moreover, this register will soon be part of the statutes
of the Swiss Society of Vascular Surgery to evaluate the quality of training in each
institution.
The Evaluation of VascuQoL-6 is part of this ambitious project. The goal is to implement the
use of this questionnaire into the SwissVasc registry follow-up schema, to provide a
uniformly used tool to collect and investigate the above-said information.