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Abstract
Introduction Among lower extremity artery disease (LEAD), symptomatic carotid stenosis (SCS) and abdominal aortic aneurysm (AAA), the disease burden is insufficiently illuminated from a patient and societal perspective. Such knowledge is central to identifying patients at risk of poorer outcomes. Therefore, the Danish Vascular (DanVasc) survey aims to describe self-reported health status, health literacy, medication adherence and loneliness, including changes over time, and investigate characteristics associated with worse self-reported health at baseline and their associations with poorer outcomes within 1 year (healthcare utilisation and mortality) in patients with LEAD, SCS and AAA.
Methods and analysis The DanVasc survey, a national prospective cohort study combining survey data measured at several time points with register-based data, includes validated patient-reported outcome measures (PROMs) and ancillary questions developed with patient representatives. Our baseline survey (T0) follows the index contact in vascular outpatient clinics with follow-up surveys determined by the patient’s trajectory: (1) newly referred patients in conservative treatment trajectories; the date for the outpatient visit activates 1-month (T1), 3-month (T2) and 12-month (T3) follow-ups. (2) Patients referred for vascular surgery; the surgery date activates 1-month (T1), 3-month (T2) and 12-month (T3) follow-ups. The included PROMs assess health-related quality of life (HRQoL), anxiety and depression, sleep, frailty status, health literacy, medication adherence and loneliness. For LEAD, a disease-specific PROM evaluates HRQoL. For AAA, disease-specific ancillary questions are added. Additionally, the DanVasc survey includes questions on health behaviour, preventive measures and sexual life. The DanVasc survey will be linked to national registries to obtain socio-demographic information and data on redeemed prescriptions, clinical information, healthcare utilisation, comorbidities and mortality. From December 2023 to December 2024, we aim to recruit approximately 5500 patients from all seven DanVasc surgery departments. Patient characteristics will be reported using descriptive statistics. Changes over time and factors associated with poorer health outcomes will be analysed using linear, logistic and Cox proportional hazard models, presented as univariate and multivariate regressions.
Ethics and dissemination Approval for the collection of medical record data was granted by the Central Denmark Region, acting on behalf of all Danish regions (record 1-45-70-94-22). Consent to participate is obtained prior to answering the survey. Results will be disseminated through peer-reviewed scientific publications and conference presentations, and findings will be shared with patients and relevant stakeholders via public and social media.
- VASCULAR SURGERY
- Adolescent
- EPIDEMIOLOGY
- Health Literacy
- MENTAL HEALTH
- Observational Study
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STRENGTHS AND LIMITATIONS OF THIS STUDY
The Danish Vascular survey is a national and interdisciplinary survey targeting patients with lower extremity artery disease, symptomatic carotid stenosis and abdominal aortic aneurysm.
Conducted in a country with free and tax-financed public healthcare, prompting broad and equitable participation.
Includes validated patient-reported outcome measures, registry data and clinical data that provide comprehensive insights.
The survey has been developed in collaboration with patient representatives.
Expected challenges include varying response rates, but comparisons of responders and non-responders will be facilitated through complete follow-up ensured by linkage to national registries.
Introduction
Vascular diseases entail a considerable disease burden that affects the overall life and well-being of patients,1–3 including lower extremity artery disease (LEAD), symptomatic carotid stenosis (SCS) and abdominal aortic aneurysm (AAA). Beyond disrupting daily activities due to physical, mental and social implications, suffering from a vascular disease commonly impacts patients’ quality of life and their self-care ability.4–6 LEAD is the most prevalent vascular disease, affecting slightly less than 6% of the global population, equivalent to 237 million individuals, with the European Region bearing the highest prevalence at around 8%.7 Carotid stenosis, a condition in which the arteries narrow by 50% or more, affects 1.5% of the global population, corresponding to 58 million individuals.8 Similarly, AAA, with an approximate 1% prevalence, affects 32 million individuals globally.9
Recognising the multifaceted nature of disease burden and its subjective experience, patient-reported outcome measures (PROMs) emerge as a tool for capturing the nuances of the patient perspective.10 By allowing patients to directly report their symptoms, functional status, health and overall well-being, PROMs offer a holistic view of the impact of vascular diseases on individuals' lives. Thus, PROMs offer insights that traditional clinical assessments may not fully capture. In patients with vascular diseases, emerging studies have reported associations between PROMs and conventional clinical endpoints, such as prolonged hospital stays, elevated healthcare costs, non-home discharges and increased readmission rates. These trends are particularly evident following procedures such as LEAD revascularisation, carotid artery surgery and AAA repair.11–13 Such findings underscore the value of PROMs in capturing the full spectrum of the disease burden, identifying significant health concerns and monitoring treatment effectiveness, all aimed at enhancing vascular care and improving patients’ quality of life.
Notably, the most recent guidelines on managing vascular disease highlight the importance of improved quality of life as a treatment goal.14–16 However, no consensus or specific guidance exists on the use of PROMs across the major vascular diseases. The choice between generic-specific, disease-specific and domain-specific questionnaires is essential for understanding the patient perspective comprehensively.17 While generic questionnaires offer broad insights into overall health status and quality of life, allowing for comparison across different populations, disease-specific questionnaires provide more targeted assessments tailored to specific vascular conditions' unique symptoms and challenges.18 19 Additionally, domain-specific questionnaires offer knowledge about the population’s mental health or health literacy.18 19 Thus, combining several types of PROMs may provide a comprehensive evaluation of the impact of vascular diseases on patients' lives and how this affects their future pathways. The Danish Vascular (DanVasc) survey includes these perspectives in vascular care by combining validated PROMs and ancillary questions with registry data, allowing exploration of the disease burden, while investigating factors associated with poorer health outcomes in patients with LEAD, SCS and AAA.
Aims
The DanVasc survey aims to describe self-reported health status, health literacy, medication adherence and loneliness (1), including changes over time (2), and to investigate characteristics associated with worse self-reported health at baseline (3) and their associations with poorer outcomes within 1 year (healthcare utilisation including readmissions and mortality) (4) in patients with LEAD, SCS and AAA.
Methods and analysis
Study design
The DanVasc survey is a nationwide prospective cohort study combinding repeated survey data collection with clinical data and register-based follow-up. The survey includes validated PROMs and ancillary questions sent to patients at baseline, 1-month (T1), 3-month (T2) and 12-month (T3) follow-up, according to their trajectories.
Setting and participants
The seven DanVasc surgery departments (Aalborg, Aarhus, Copenhagen, Kolding, Odense, Roskilde and Viborg, figure 1) consecutively include patients from their outpatient clinics. Patients within the three diagnostic groups (LEAD, SCS and AAA) are included. Specifically, we include newly referred patients with LEAD and AAA treated conservatively as well as patients referred for vascular surgery due to LEAD, SCS and AAA within a 1-year period (December 2023 to December 2024) (figure 2). Table 1 presents the predefined inclusion and exclusion criteria.
Participating Danish Vascular departments.
Study flow chart. 1Conservative treatment trajectory refers to non-surgical disease management in accordance with guideline recommendations, including medical treatment and risk factor modification. For patients with lower extremity artery disease (LEAD), physical activity particularly focuses on walking exercise. 2Surgical trajectory refers to disease management including vascular intervention in combination with medical treatment and risk factor modification in accordance with guidelines. For patients with LEAD, physical activity particularly focuses on walking exercise. AAA, abdominal aortic aneurysm; SCS, symptomatic carotid stenosis.
Inclusion and exclusion criteria
Data collection
Patients within the three diagnostic groups who meet the inclusion criteria are identified from patient lists. Diagnoses are verified by electronic patient journals.
The first part, the baseline survey (T0), is sent to patients after their index contact. The subsequent measurements depend on the patient’s trajectory, as follows: for newly referred patients in conservative treatment, the date of the outpatient visit activates 1-month (T1), 3-month (T2) and 12-month (T3) follow-ups. For patients referred for vascular surgery, the date of surgery activates 1-month (T1), 3-month (T2) and 12-month (T3) follow-ups.
All Danish citizens hold a unique identification number (ID). The patients’ ID will be entered into the Research Electronic Data Capture (REDCap) system hosted by the Open Patient data Explorative Network (OPEN), Odense University Hospital, Denmark. The REDCap system then invites participants via a personalised nationwide digital mail account (coined e-boks) provided to all Danish citizens by the Danish Authorities. Non-responders are sent reminders after 5 days by e-boks and 10 days by surface mail, including a prestamped envelope for their reply. Overall, 93.3% of the Danish population above 15 years of age are active e-boks users.20 Patients who do not use e-boks receive a paper-based version of the survey by surface mail, including a prestamped envelope for their response (no reminders are sent).21 Along with the survey, all participants receive a participant information sheet about its aim, how data are used and how to fill in the questionnaire.
To optimise the response rate,22 we have adopted various approaches, including electronic and paper response options, reminders (as described above), personalised invitations using the patients' first and last names, and including institutional and survey logos. Moreover, we have employed a range of advertising strategies (table 2).22 In REDCap, only unique ID is entered to prevent multiple participation. As suggested by patient representatives and collaborators, a telephone hotline was set up for patients and site staff with support from national DanVasc coordinators.
Advertising strategies to facilitate recruitment
Development of the DanVasc survey
The selection of PROMs was led by the DanVasc Scientific Advisory Board, followed by patient and public involvement (PPI) meetings. Patients representing all diseases covered by the DanVasc participated in the development phases to identify relevant issues and prioritise PROMs. Furthermore, ancillary questions were integrated based on suggestions from PPI representatives and the Scientific Advisory Board, and were further PPI tested for acceptability and face validity. In addition, PPI representatives assessed the extent of the overall DanVasc survey as acceptable.
Data sources and variables
Self-reported variables
Self-reported variables include socio-demographic and personal characteristics data, PROMs and ancillary questions. Table 3 provides an overview of the time points at which the specific self-reported variables are collected.
Data collection timelines
Socio-demographic and personal data
Socio-demographic and personal data include gender (male, female, other), employment status (working full-time, working part time, retirement age, sick leave or early retirement), height (cm) and weight (kg), data related to risk factors (smoking, alcohol consumption and exercise) and sexual life. Smoking is categorised into never, former and current. Alcohol consumption ranges from never to almost daily. Three questions elaborate on the physical activity level: (1) “How often are you physically active?” (from never to almost daily), (2) “When you are physically active, how long do you exercise at a time?” (from <15 min to >60 min) and (3) “When you are physically active, how hard do you exercise on average?” (from easy to exhaustion).
Questions related to sexual life include (1) “Have you been worried about your sexual life because of your vascular disease?” (2) “Have you experienced a lack or reduced desire for sex?” (3) “Have you experienced physical problems with sex?” (4) “If the opportunity existed, would you have wanted to talk with a healthcare professional about your sexual life?” and for a patient undergoing vascular surgery (5) “Have you experienced that your sexual health/sexuality has changed after undergoing vascular surgery?” The response options indicate the severity levels in questions 1 to 3, with a ”not relevant” option. Question 4 offers the options of yes, no, don't know. Finally, question 5 offers the following response categories: no change, more sexually active than before, less sexually active than before or not relevant/don’t know. Information related to sexual life is included as suggested in the recent AAA guideline.15
Patient-reported outcome measures
The EuroQol Five-Dimension Five-Level (EQ-5D-5L) is a generic measure of HRQoL yielding two scores: an index score and a visual analogue scale (VAS).23 The index score comprises five health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a five-level response scale ranging from no problems to extreme problems/being unable. The index score is summarised using specific population norms.24 The VAS score ranges from 0 to 100. Higher scores indicate better health status on both scores.23 The EQ-5D-5L was chosen for this study as it is a well-validated instrument widely used in general populations, facilitating comparisons and allowing for potential calculation of quality-adjusted life-years.24
The LEAD disease-specific Vascular Quality of Life Questionnaire (VascuQoL-6) consists of six items regarding limitation in activities, tiredness in legs, walking ability, concerns about poor leg circulation, ability to participate in social activities and discomforts due to pain in the leg.25 Each question has a four-point response scale from pronounced difficulty to no problems. The instrument is scored by summarising the item responses from 6 (worst) to 24 (best). Based on a recent Delphi Consensus, the VascuQol-6 has been recommended as a core outcome in registries and trials focusing on patients with LEAD.26
The Hospital Anxiety and Depression Scale (HADS) is a domain-specific measure of symptoms of anxiety and depression.27 The scale consists of 14 items, divided into two subscores: anxiety (HADS-A) and depression (HADS-D). The scales are summarised from 0 to 21 (higher score, more symptoms), with a cut-off score≥8 representing symptoms of anxiety (HADS-A≥8) or depression (HADS-D≥8).27 28 The domains are associated with adverse health outcomes after LEAD revascularisation, carotid artery surgery and AAA repair.11–13 29 HADS is commonly used in clinical settings in Denmark.
Sleep quality is measured using two brief questionnaires developed based on the Uppsala Sleep Inventory-25.30 The first short part, the Sleep Sufficient Index (SSI), comprises two items related to actual and desired sleep based on average hours. The index is calculated as a ratio of the two items, with persistent insufficient sleep defined as an SSI below 80%.31 The second part, the Minimal Insomnia Symptom Scale (MISS), assesses major features of insomnia. It consists of three items: difficulties initiating sleep, waking at night and not feeling refreshed by sleep.32 MISS is scored on a five-point scale ranging from no problems to very severe problems, with a cut-off of ≥6 indicating insomnia in younger patients,33 and a suggested cut-off of ≥7 in elderly populations.32 Sleep quality is a fundamental aspect of overall health. Poor sleep can exacerbate health conditions, including cardiovascular diseases.34 Currently, self-reported sleep status using standardised PROMs has not been reported in vascular populations. Thus, with the DanVasc survey, critical data on sleep quality will be captured.
The Study of Osteoporosis Fractures Frailty Index (SOF) is a frailty instrument comprising three components: unintentional weight loss, the ability to rise from a chair five times without using the arms and energy level. Frailty status is defined as robust (0 components), prefrail (1 component) and frail (2–3 components).35–37 Frailty is common in vascular surgery populations; frail versus robust patients have a higher risk for non-home discharge and mortality.38 A consensus on frailty instruments is lacking for vascular patients.39 However, SOF offers a short and self-reported frailty index.
The Health Literacy Questionnaire (HLQ) measures health literacy from a broad perspective.40 The DanVasc survey includes two HLQ domains: “understanding health information well enough to know what to do” and “ability to actively engage with healthcare providers”. Each domain has five items with a five-point difficulty scale (lower score, lower ability).40 These two domains encompass distinct health literacy dimensions that are central to self-care among patients with cardiovascular disease and diabetes.41 42
The eHealth Literacy Scale (eHEALS) comprises eight items assessing patients’ combined knowledge, comfort and perceived skills at finding, evaluating and applying electronic health information, ranging each score on a five-point level of disagreement—agreement scale (from 8 to 40, with a higher score reflecting higher perceived skills). Furthermore, two items assess patients’ interest in using eHealth in general, with a higher score indicating eHealth as very important or useful on a five-point response scale.43 The eHEALS was selected to provide insights into patients’ electronic skills, a contributing factor when assessing health literacy and comprehending health information.
The Medication Adherence Report Scale (MARS-5) is a self-reported adherence scale assessing intentional and unintentional medication non-adherence based on five items.44 The MARS-5 is a short version of MARS-10.45 Each item is scored on a five-point scale, with higher scores indicating better adherence.44 MARS-5 was chosen to support registry-based prescription adherence.
TIL-S is a short, validated scale measuring loneliness by three items with a three-point scale ranging from rarely to often. The score is the sum of all items (3–9), with a higher score indicating loneliness.46 Furthermore, two items were adopted from the Danish Nationwide Survey assessing social relations: “Does it ever happen that you are alone, even though you most want to be together with others?” and “Do you have someone to talk to if you have problems or need support?", with four-point response options ranging from often/always to no.47 Loneliness and lack of social support are associated with poorer health outcomes and adherence to modifiable risk factors and medical treatment.48–51 The selected items enable comparisons of the DanVasc cohort and the general Danish population participating in the Danish Nationwide Survey.
Figure 3 provides an overview of all included domains and PROMs.
Overview of domains and specific patient-reported outcome measures in the Danish Vascular survey. EHEALS, the eHealth Literacy Scale; EQ-5D-5L, the EuroQol Five-Dimension Five Level; HADS, the Hospital Anxiety and Depression Scale; HLQ, the Health Literacy Questionnaire; HRQOL, health-related quality of life; MARS-5, the Medication Adherence Report Scale; MISS, the Minimal Insomnia Symptom Scale; SOF, the Study of Osteoporosis Fractures Frailty Index; TIL-S, the Three-Item Loneliness Scale; SSI, the Sleep Sufficient Index; VASCUQOL-6, the Vascular Quality of Life Questionnaire.
Ancillary questions
Previous qualitative research on patients with AAA2 gave rise to selected ancillary disease-specific questions. As existing AAA-specific PROMs52 53 exceeded the DanVasc survey’s desired length, the DanVasc Scientific Advisory Board drafted ancillary questions. These questions were discussed and worded in collaboration with patients with AAA and vascular nursing experts, focusing on the patients’ perspective. The derived ancillary questions encompass various dimensions of the patient experience with AAA, including (1) physical limitations and frailty status attributable to AAA, (2) abdominal discomfort, (3) withdrawing into oneself, (4) concerns regarding the aneurysm, (5) worrying about the AAA during physical activities, (6) reduced engagement in physical activities, (7) perception that the AAA is self-inflicted, (8) preference for being unaware of the AAA diagnosis and (9) the desire for more information about the condition. Questions 1–8 use a five-point response scale ranging from ‘always’ to ‘never’. Item 9 on information is binary (yes or no). If respondents answer that more information is needed, a text box allows them to elaborate on their specific information needs.
The PPI representative further suggested ancillary questions, illuminating the healthcare services offered (eg, smoking cessation, diet and physical training) and their needs and preferences for support (eg, phone calls, virtual follow-up and patient group). These questions included supplementary textboxes and were co-designed with patients.
A single question is included to capture the patient’s perspective of the overall outcome after 1 year (an anchor-based approach): “Do you feel better than before?” with the possible answers: “Yes, feeling better”, “No, feeling worse” or “No change.” The simple anchor-based approach is used to compare performance with standardised PROMs.
Data enrichment from Danish registries
The survey data will be enriched by registry data achieved by linking to national registries using the unique ID. We will retrieve data from national registries as follows:
The Danish Civil Registration System54; vital status, age and marital status.
Population: country of origin/ethnicity.
The Danish Education Register55: highest obtained educational level.
The Danish Register for Evaluation of Marginalisation56 57 : employment status.
The National Prescription Registry: medicine use up to 1 year after the index date.
The Danish Vascular Registry58: treatment indications, clinical data and laboratory results (data only available for patients admitted to a vascular department and undergoing a vascular procedure).
The Danish National Health Service Register59: contacts with general practitioners before and after the index date (during regular opening hours and in out-of-hours consultations).
The Danish National Patient Register60: discharge diagnosis, comorbidities (10 years back), procedures, length of hospital stay, type of hospitalisation and readmission, up to one after the index date.
Non-response and missing data
To allow for comparisons between survey respondents and non-respondents, registry data will be used, including data on baseline characteristics and outcomes. Furthermore, the impact of non-response bias on estimates among responders will be investigated through a weighting approach that incorporates information such as sex, age, socio-demographic and socio-economic status and healthcare utilisation.61 This will be done as missing data at the response level is not expected to follow the ‘missing completely at random’ assumption.62
Item non-response will be handled based on the specific guidelines provided by the developers of each instrument during the scoring process, including instructions on when to include or exclude specific responses in the analyses. At a minimum, descriptive information on item-level reporting and total score calculation will be reported to ensure transparency and allow for a thorough understanding of the extent and impact of item non-response.
Data handling and record-keeping
The survey is listed in the record of processing activities for research in the Central Denmark Region (record 1-16-02-370-22) and the Region of Southern Denmark (record 22/58298) following the General Data Protection Regulation (Article 30) of the EU. An agreement licence has been made with the OPEN, Odense University Hospital, Denmark (22/58909) to secure data storage in REDCap and later link these data with national registries. Postal surveys are entered into REDCap sequentially.
Outcomes
In addition to self-reported outcomes, the analyses will include the health outcomes: healthcare utilisation, including readmission rates, vascular procedures, visits to general practitioners/primary care and emergency care, major adverse cardiovascular events, major adverse limb events, employment status, medication use and mortality. As previously described, data on these health outcomes will be obtained from national registries, with individuals followed until death or 1 year of follow-up, whichever comes first. The association between PROMs and outcomes within 1 year will be investigated.
Statistics
Patient demographics and patient-reported data (1) will be reported using descriptive statistics. Continuous variables will be presented as either means and SD or medians and IQR (the 25th and the 75th percentile), as appropriate. Categorical variables will be expressed as the number of patients and percentages and compared using the χ2 test/Fisher’s exact test. To compare potential descriptive differences among the three diagnostic groups, one-way ANOVA and Kruskal-Wallis tests will be used to assess group differences.
Changes in self-reported outcomes from baseline to follow-up (2) will be investigated by linear mixed modelling for longitudinal data, presented as unadjusted and adjusted analyses expressed as regression coefficients with 95% CIs. The analyses will include random effects on the individual patient, and a random slope, if this proves to significantly improve the model.
The association between characteristics and poorer self-reported health status at baseline (3) will be analysed by linear or logistic regression to estimate coefficients or ORs with 95% CIs. Poorer health status will be described as either the poorest quartile of the scores or a validated cut-off for the instrument (depending on each instrument).
The association between self-reported health status and poorer outcomes (healthcare utilisation including readmissions and mortality) within 1 year (4) will be analysed by Cox proportional hazards regression models, reported as HR with 95% CI.
In adjusted models, covariates will be included if between-group imbalance reaches a p-value<0.1. However, adjustments will include as a minimum inclusion diagnosis, sex and age.
All assumptions behind the statistical tests will be checked before analysis. A p-value<0.05 is considered statistically significant.
Sample size considerations
The survey involves consecutive data collection of all patients during 1 year. Thus, the sample size is not derived statistically. Furthermore, the survey seeks to identify the most significant self-reported health concerns and challenges using PROMs, along with other pertinent outcomes, which can later be used for statistical purposes.
Based on the DanVasc pilot test, we expect to include approximately 5500 patients with an estimated response rate of 49%. Consequently, we expect an effective sample size of 2695 responses. Due to the high morbidity and mortality rates within the patient populations, we anticipate a 20–25% dropout rate across the survey time points (from baseline to the 1 year follow-up).
Patient and public involvement
We apply a combination of methods to engage patients in the research process. PPI representatives from all three diagnosis groups were involved in the planning, design and implementation of the survey. Patient information accompanying the survey and study dissemination is co-designed with patient representatives to improve the readability of survey information and enhance the relevance of the research and, thus, the uptake.63–65 DanVasc-specific ancillary questions have been suggested and developed in collaboration with patients. Patient representatives have been involved in the evaluation process, including assessment of the time required to complete the DanVasc survey (ranging from 7 to 19 min). Furthermore, patient representatives will be involved in disseminating the study results to relevant stakeholders and the public through public and social media.
Ethics and dissemination
Ethics
This survey is conducted in accordance with the Declaration of Helsinki.66 In Denmark, a survey does not require ethical approval in pursuance of the Danish Healthcare Act. The Central Denmark Region has approved data transfer from the study participants’ medical journals to the DanVasc database without patient consent on behalf of all five Danish regions until December 2024 as per §46, sub-section 2 of the Danish Healthcare Act (record 1-45-70-94-22). Each department management provides further approval to contact patients, and approval for medical chart review is provided differently in the various Danish Regions, either by the Hospital Management Boards (Copenhagen, Roskilde, Kolding, Odense and Aalborg) or by the Central Denmark Region (Aarhus and Viborg) (record 1-16-5-72-719-23).
Consent to participate is obtained via REDCap before answering the survey. For the paper-based version of the DanVasc survey, written consent is returned with the survey. By consenting, participants agree to take part in T0–T3 and allow their medical charts to be reviewed for additional vascular clinical data from their medical records for up to 1 year.
Dissemination
Results will be disseminated to researchers through peer-reviewed scientific publications and conference presentations and to patients and relevant stakeholders through public media and the DanVasc webpage (danvasc.dk). A dissemination strategy will be prepared during the data collection period.
Discussion
As the first large national study, Danvasc-a nationwide Danish survey-seeks to further understand the disease burden of the three major vascular diseases (LEAD, SCS and AAA) by combining multiple data types obtained from prospective self-reported outcomes, clinical data and national registry data.
The results from the DanVasc survey will be used to identify the most noticeable health concerns across vascular diseases. Self-reported outcomes have the potential to identify targets for national quality improvements, enhancing person-centred care and providing benchmarks of vascular care, all with the overarching goal of improving patients’ quality of life.
The selected PROMs encompass generic and domain-specific instruments, including outcomes related to mental health, a topic that has gained increasing international attention among patients with vascular disease.6 67 68 Furthermore, psychological care has been suggested to be integrated into managing the population.69 In Denmark, the rehabilitation guidelines of several cardiac diseases advise screening for anxiety and depression, conditions known to be associated with poorer health outcomes,70 increased healthcare utilisation71 and non-adherence to guideline recommendations.72 In patients with ischaemic heart disease, depression alone adds an extra 33% costs compared with patients without depression.73 American studies comparing patients with LEAD with and without depressive symptoms showed that depressive symptoms increased the risk of a major amputation after endovascular and surgical revascularisation.29 In contrast, a recent Norwegian study described how depressive symptoms had no prognostic impact on mortality in patients with AAA.74 When it comes to the psychological consequences of living with vascular disease in Denmark, the evidence is remarkably insufficient. An interview study among Danish patients under AAA surveillance highlighted the importance of addressing the mental impact of living with AAA, including the need for changes in the AAA trajectories.2 The DanVasc survey will contribute with evidence providing the rationale for changes in the organisation of vascular trajectories, while also encompassing the mental well-being of patients.
PROMs have been adopted in vascular research and are moving towards application in clinical practice.75 However, the clarity of applicable PROMs for clinical practice and best practice for interpretation remains unknown.76 In clinical practice, awareness of the pros and cons of PROMs from the users’ perspectives is essential. In a review and synthesis of qualitative research on healthcare professionals’ perceptions, PROMs were experienced to enhance their knowledge of the individual patient, give a ‘voice’ to patients in their care, and facilitate dialogue and interaction with patients.77 Similarly, a review and synthesis of patient-perceived advantages of PROMs were related to being an ‘icebreaker’, facilitating communication and building relationships with their care providers, including mutual understanding and shared decision-making. PROMs can potentially prepare patients for consultations and promote an enhanced understanding of their disease.78
As stated above, the DanVasc survey combines domain-specific, generic-specific and disease-specific PROMs. From a patient perspective, disease-specific instruments are commonly perceived as more relevant than generic instruments.78 However, generic PROMs enable us to compare disease burden across LEAD, SCS and AAA—and to compare disease burdens with those of other populations and reference populations. Thus, combining different PROMs allows us to identify common denominators of needs and inequality across vascular diseases and, thereby, build a broader basis for vascular treatment.
The potential benefits of PROMs are rooted in their relevance and validation.79 Ideally, all PROMs in the DanVasc survey should have undergone psychometric evaluation on the minimal clinically important differences. Currently, such evidence is lacking across vascular diseases, particularly for Danish patients. Before implementing any PROMs in clinical settings, sufficient psychometric evaluation is mandatory. The DanVasc survey provides the basis for such analyses.
The DanVasc survey builds on a prospective design with serially repeated surveys, which is particularly useful for evaluating factors associated with disease progression and poorer outcomes.80 Nevertheless, challenges are expected due to non-responders. In the recruitment phase, non-responders may compromise the population representativeness. Inspired by Shiyab and colleagues, we implemented several steps to minimise self-selection bias.22 Another challenge is the risk of incomplete follow-up, constituting a threat to the representative nature of the dynamic sample.80 However, national registries provide complete and comprehensive information for all study participants, enabling us to report the characteristics of survey respondents and non-respondents and their outcomes. In addition, the success of the survey hinges on a well-planned setup and long-term engagement from the sites involved. Therefore, representatives from all sites—including researchers, clinical staff and managers—are involved in the survey.
Ethics statements
Patient consent for publication
Acknowledgments
We take this opportunity to express their gratitude to the clinical nurse directors of the Vascular Departments: Gitte Bekker, Odense; Jytte Hykkelbjerg Bruhn, Roskilde; Anne Marie Kaa Hansen, Kolding; Margit Roed Heman, Copenhagen; Henriette Vadsbach Lie, Aalborg; Marianne Mikkelsen, Aarhus; and Helle Skytte, Viborg. We appreciate the enthusiastic engagement of all site staff. We are also indebted to the national DanVasc coordinators, Cecilia Serup Christensen and Bibi Damsgaard, for their invaluable contribution in launching the survey and supporting the sites and patients. Thanks are extended to Anna Mejdal affiliated with the Open Patient data Explorative Network (OPEN) for statistical advice.
References
Footnotes
Contributors MD is the principal investigator of the DanVasc survey. MD and JSL are DanVasc initiators and defined the overall aims in collaboration with BB. Each site is represented by at least one researcher in the DanVasc Scientific Advisory Board, which contributed to the design and organisation of the DanVasc survey to secure its feasibility at all involved sites (all authors). MD and BB drafted this protocol. All authors critically revised the manuscript and approved the final version. MD is the guarantor.
Funding DanVasc presents independent research supported by the Clinical Academic Group Task Force on Cross-Sectoral and Interdisciplinary Programs, Viborg Regional Hospital, Denmark, the Research Fund of the Central Denmark Region Hospital and in-house grants from participating sites.
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Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.