Anette Arbjerg Højen

Summary: Background: Non-adherence to guideline-directed best medical therapies is prevalent in people with lower extremity peripheral arterial disease (PAD), constituting a significant challenge to effective treatment. Underlying drivers for non-adherence remain poorly understood. This study explored patients’ health-related beliefs and behaviours regarding antithrombotic and lipid-lowering therapy to identify opportunities for improvement. Patients and methods: Using a qualitative design, we conducted semi-structured interviews with patients with symptomatic PAD based on a purposeful sampling strategy. Patients were recruited from four vascular surgery departments in Denmark between December 2022 and January 2024, excluding those with cognitive impairment or terminal illness. Data were analysed using framework analysis based on the six domains of the Health Belief Model (HBM): perceived susceptibility, severity, benefits, barriers, cues to action, and self-efficacy. Results: Sixteen patients participated (median age: 69 years, 38% women); 68.8% had intermittent claudication, 18.8% had chronic limb-threatening ischemia, and 12.5% had undergone major amputation. Seven patients were adherent, and nine were non-adherent to secondary preventive therapy. Patients expressed low perceived awareness of PAD severity and its cardiovascular implications. Their perception of PAD centred around leg pain and its impact on everyday life, limiting their understanding of the benefits of secondary preventive therapies. Patients lacked knowledge about treatment goals and did not link secondary preventive therapy with PAD. Adherence barriers included inadequate understanding of PAD’s chronic progressive nature, concerns about side-effects, prescription confusion, and financial constraints. Internal adherence triggers included fear of recurring pain, complications, and early death. External cues to action included a trusting patient-provider relationship and receiving comprehensive, understandable information. Conclusions: This study highlights the multifaceted challenges hindering adherence to antithrombotic and lipid-lowering therapies. Addressing the limited disease awareness and the expressed need for patient-centred communication delivered in a trusting patient-provider relationship could serve as starting point for future strategies to improve adherence.

Objective Patient-reported outcome measures are essential for assessing health-related quality of life (HRQoL) in both research and clinical practice. The Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire is a disease-specific instrument designed to measure HRQoL in patients with pulmonary embolism (PE). This study aimed to evaluate the psychometric properties of the Danish electronic version of the PEmb-QoL questionnaire. Design Psychometric validation study. Setting Eligible patients received a digital mail 6 months after their diagnosis, with an invitation to complete an online questionnaire. A subset of patients completed a second time 7–10 days following the initial completion. Participants Adult patients diagnosed with PE in Denmark between March 2022 and May 2023 were included in the study. Main outcome measure The main outcome measure was the PEmb-QoL summary score. Validation procedures included assessments of targeting, internal reliability (IR), test–retest reliability, differential item functioning (DIF) and concurrent validity. Results The study included 1017 patients. The Danish PEmb-QoL demonstrated robust IR (IR=0.95 for the total score) and adequate test–retest reliability for most domains (relative G-coefficients>0.7). However, DIF analysis revealed subgroup differences for some items, particularly those related to daily activity limitations and pain. Targeting analysis indicated moderate alignment between latent score distributions and item response distributions, with ceiling effects noted in several domains. The PEmb-QoL exhibited strong correlations with the Post-Venous Thromboembolism Functional Status Scale (r=0.82) and EuroQol-5 Domain (r=0.73), and moderate correlations with Generalised Anxiety Disorder Questionnaire (r=0.47) and Patient Health Questionnaire (r=0.57), confirming its concurrent validity. Conclusion While some items in the PEmb-QoL instrument performed inadequately on DIF and targeting, the expected overall score and the concurrent validity did not seem to be compromised by these issues. Thus, it is likely that a reduced version of the electronic Danish PEmb-QoL will possess suitable psychometric properties for measuring HRQoL in patients with PE.

Introduction: Patients with cancer are at increased risk of thrombotic complications from both the disease and its treatments, with antithrombotic therapy (ATT) usually continued in the last phase of life where the benefit is less clear and there is high risk of harms. Physiological changes toward the end of life increase the risk that ATT will cause serious bleeding events, but discussion between clinicians and patients of ATT risks and benefits is sub-optimal. This realist synthesis explores shared decision-making (SDM) to: (a) provide insights into why prescribing continues in end-of-life care; (b) build a conceptual platform for optimizing ATT prescribing for persons living with cancer towards end-of-life. Methods and findings: We conducted a realist synthesis using context-mechanism-outcome configurations and ‘if…then’ statements. A total of 17,036 citations identified across 10 databases (Medline, EMBASE, APA PsycInfo, CINAHL Complete, CDSR, CENTRAL, EPISTEMONIKOS, Web of Science Core Collection, Assia, Google Scholar). Ninety-one papers included following reverse chronology quota record screening (from: database searches (n = 56), consortium experts (n = 35)). Included papers: quantitative (n = 40), qualitative (n = 17), mixed-methods (n = 2), evidence syntheses (n = 16), commentaries (n = 9), case reports (n = 7). Exclusion criteria: persons <18 years, non-English language, not focused on SDM or deprescribing in palliative care. An analytic appraisal journal was used with realist logic to synthesize insights from included papers (contents from 43/91 included in this paper). The concept of ‘prescribing inertia’ was used to formulate explanatory theories about clinician reluctance to deprescribe and the mechanisms underpinning SDM, including (a) the meaning medications have to end-of-life patients (e.g., ‘life preserving’ or ‘symptom management’) and public awareness of medications (e.g., high-profile chemotherapy versus low-profile ATT) are determinants of: (i) clinician motivation to engage patients around deprescribing, (ii) patient understanding, volition and participation in SDM; (b) SDM for ATT deprescribing requires sensitive engagement with patients and families without removing positivity around survival and continuing clinician interest in their welfare; (c) multi-disciplinary clinical decision-making about timing and suitability of deprescribing in end-of-life care requires specialized consensus-driven processes and evidence-based decision support tools; (d) if patients are healthy enough, empowerment interventions outside clinical encounters (e.g., health literacy apps) may increase patient and family readiness to engage in deprescribing conversations; (e) organizational investments can facilitate discussion of deprescribing (e.g., improved electronic medical record prompts, clinician communication skills training, data presentation to clinicians of actual ATT risks). Limitations: despite robust screening and selection, the sample of included papers does not reflect the entirety of eligible source material and did not include a systematic search for papers focusing on low- and middle-income country countries. Conclusion: Implementation of ATT deprescribing is enabled or constrained by (a) the meaning of medications to patients; (b) clinician engagement and understanding; (c) multi-disciplinary clinical decision-making processes (including support tools); (d) patient empowerment; (e) organizational investment. Addressing these multi-level factors, including the development of SDM tools, can address the prescribing inertia that may cause devastating impacts on patients and their families as well as moral distress amongst healthcare staff. This study was performed as part of the Horizon-Europe funded SERENITY project.

Introduction Patients with pulmonary embolism (PE) experience impaired functional ability and reduced quality of life long after discharge from the hospital. However, there are no structured follow-up programmes in Denmark for these patients, and there is considerable variation in practice patterns of post-PE management. No studies have investigated the effectiveness of structured follow-up care models in patients with PE. This study aims to investigate the effect and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE) compared with usual care. The Attend-PE model outlines a structured approach for in-hospital follow-up, involving group-based patient education, individual consultations and systematic use of patient-reported outcome measures to assess the patient’s physical and psychological well-being. Methods and analysis The study is conducted in Denmark, where the healthcare system is tax-funded and services are freely available for all citizens, with an expected inclusion of 2000 patients in total. A pre-post-intervention study design is used to compare outcomes in the post-implementation cohort with the pre-implementation cohort. The co-primary outcomes are (1) health-related quality of life (patient-reported outcome, PRO) and (2) adherence to medical treatment (register-based data). Secondary outcomes include PROs on disability, treatment satisfaction, self-management, anxiety, depression and work productivity, and register-based outcomes, including recurrent PE, bleeding, mortality and healthcare use. Register-based data will be assessed at baseline (date of PE event), 6 and 12 months, while PRO-data will be assessed at 6 and 12 months after the PE event. The health economic evaluation of the Attend-PE model will include a cost-effectiveness analysis and a cost-utility analysis. Ethics and dissemination The project will be conducted by the Declaration of Helsinki. In accordance with the Danish Act on Health Research Ethics §14, the study is exempt from approval. The use of survey responses in research (in anonymous form) is, however, contingent on participants’ consent, and the invitation letter therefore included information about the purpose of the study and participants’ rights to withdraw consent at any time, and that completion of the questionnaire is considered as consent to their survey data to be included in research. Study findings will be disseminated in scientific peer-reviewed journals, at national and international conferences, and for staff and decision-makers at participating hospitals and patients and relatives via the Danish Heart Association. Trial registration number Clinicaltrials.gov NCT06037096.