ArticlePilot and feasibility studies2026
Lessons from the Danish Vascular (DanVasc) pilot survey: patient-reported outcomes following lower extremity, carotid and aortic artery disease.
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Abstract
backgroundPatient-reported outcomes are insufficiently studied across the three predominant vascular diseases: lower extremity artery disease (LEAD), symptomatic carotid stenosis (SCS) and abdominal aortic aneurysm (AAA). To address this gap, the Danish Vascular (DanVasc) survey was developed and pilot tested before national implementation. Following the National Institutes of Health guidelines for pilot studies, we assessed survey feasibility by evaluating acceptability (response rates, retention, participant time burden), timeliness and data quality (completeness and floor/ceiling effects).
methodsThis pilot study recruited a representative cohort from two Danish vascular outpatient clinics between May and November 2023. Participants received four surveys in total, consisting of multiple patient-reported outcome measures (PROMs) and ancillary questions: a baseline survey (T0), sent after the initial outpatient visit, and three follow-up surveys at 1 (T1), 3 (T2) and 12 months (T3). Follow-up surveys were activated according to the patient's care pathway: (a) the date of outpatient visit for newly referred patients treated conservatively and (b) the date of surgery for patients undergoing a vascular procedure. Site staff and hotline staff were trained to support patient engagement and facilitate uptake.
resultsOf 468 invited patients, 231 (49.4%) consented to participate; 70.1% responded digitally and 29.9% by postal mail. Among participants, 74.9% had LEAD, 13.0% had SCS and 12.1% had AAA. Of these, 27.7%, 90.0% and 75.0%, respectively, underwent surgery, while the remaining patients received conservative treatment. All four surveys (T0-T3) were completed by 68.8% of participants. None withdrew consent. The median completion time for the digital baseline survey was 16 min (IQR 10.0). Surgical treated patients had a median response time of 5 days before surgery (IQR 43); digital respondents replied 17.5 days pre-operatively (IQR 54), whereas postal respondents 25 days post-operatively (IQR 40). Data completeness ranged from 72.3% to 98.3% across the PROMs. A floor effect was observed for the loneliness scale (61.8%) and a ceiling effect for the medication adherence scale (52.2%).
conclusionThe DanVasc pilot survey demonstrated acceptable feasibility and data quality. Feasibility depended on digital and paper response options, survey hotline support and adequate survey management resources. Timely response was challenged by delays related to postal correspondence.
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