Original Title: Evalueringsrapport vedrørende superviseret gangtræning til patienter med claudicatio intermittens

Authors' objectives: In Denmark, intermittent claudication (IC) is managed with standard treatment which includes both pharmacological and non-pharmacological approaches, including unsupervised walking exercise, and, in severe cases, surgical procedures. The Danish Society for Vascular Surgery has endorsed the recommendations from the European Society for Vascular Surgery, which advocates that supervised walking therapy (SET) should be the first-line treatment for all patients with IC as part of a stepwise treatment strategy, aimed at prioritizing the least invasive options. In Denmark, SET is provided by the municipalities, but there is no standardized, cross-municipal training program specifically targeting IC. As a result, patients with IC face unequal access to SET across the country. This evaluation aims to answer whether patients with IC should be offered SET as first-line treatment rather than standard treatment alone and surgery. The evaluation reviews the current evidence on the use of SET, using a treadmill, in addition to standard treatment compared to 1) standard treatment alone and 2) standard treatment, incl. surgery for patients with IC, Fontaines classification IIa and IIb. The evaluation includes four areas of interest: Clinical effectiveness and safety, the Patient perspective, Organizational implications, and Health Economics. The Danish Healthcare Quality Institute based their recommendation on the use of SET for IC on the findings in the evaluation report.

Authors' results and conclusions: Clinical effect and safety: The clinical effectiveness and safety of SET were evaluated based on a systematic review of the scientific literature identifying eight randomized controlled trials (three comparing SET with surgery, and six comparing it with standard care alone). Findings suggest a clinically relevant advantage of SET over surgery regarding the effect measure “adverse events”. No clinically relevant differences were found between the SET and surgery in terms of health-related quality of life, walking distance, mortality, cardiovascular events, or amputations. However, the results are marked by substantial uncertainty due to limited data and small sample sizes. The evidence quality ranges from very low to moderate when assessed using GRADE. In the comparison between SET and standard treatment alone, no clinically relevant differences were identified across all measured outcomes. The evidence quality, assessed using GRADE, likewise, ranged from very low to moderate. Based on the reviewed literature, the expert committee considers SET to be superior to surgery, primarily supported by the findings concerning adverse events. In the comparison of SET and standard treatment, the evidence base did not show superiority for neither treatment alternative. Overall, the expert committee expresses significant reservations about the evidence base, citing limited data, the associated uncertainty, the lack of evidence for key effectiveness and safety outcomes, and the overall low quality of the evidence. The expert committee highlights that the current evaluation focuses solely on SET using a treadmill. The expert committee emphasizes that further evidence is available, though not included in this evaluation, if the intervention under investigation were broadened to encompass “supervised exercise” or “supervised walking exercise” without the specification of the use of a treadmill. Patient perspective: The patients’ perspective of SET was evaluated based on a systematic literature review, expert opinions, and professional articles. Investigated themes included preferences for treatment among individuals with IC, experiences with SET and reasons for potential dropout. Patients’ treatment choices are influenced by their understanding of IC, symptom severity, psychosocial factors, and practical concerns such as time and transportation. Severe symptoms often lead to a preference for surgical relief, while milder cases favor non-invasive options. A recurring issue is patients’ limited knowledge of IC and its treatment alternatives, which can reduce willingness to engage in SET – especially when healthcare professionals fail to provide adequate information about this treatment alternative. SET is often not perceived as an actual treatment, and patients may feel dismissed when it is recommended. The managing surgeon plays a key role in informing patients about all options, emphasizing the benefits of exercise in improving function and reducing symptoms. Patients who participate in SET report improved mobility, reduced pain, better physical fitness, and enhanced quality of life. The social support from group training and physiotherapists boosts motivation, with tools like step counters and goal-setting further encouraging adherence. The expert committee emphasizes that group training is crucial for many patients’ engagement and progress, as it fosters a sense of community and mutual support. Maintaining new habits post-program is challenging due to lack of continued support and logistical barriers like cost and time. The expert committee considers SET a viable treatment alternative, but success depends on individualized support and thorough patient education to foster long-term engagement and health benefits. Organizational implications: The investigated organizational implications include an assessment of the typical care pathways associated with SET, surgery, or standard treatment alone, potential task shifting, and infrastructure and competence needs among health care professionals and patients, if SET is to be implemented nationally. The assessment was based on a systematic review of the scientific literature (zero hits), grey literature and expert opinions. Currently, SET is primarily offered by municipalities, while surgery and standard care are managed by regional hospitals. Due to the fundamental differences between these therapeutic approaches, the care pathways vary significantly. Furthermore, the expert committee notes significant variation in the availability and content of SET programs across Denmark. The referral structure affects patient rights, program quality, and logistics leading to unequal access to treatment across Denmark. The expert committee does not anticipate a formal shift in responsibilities between regions and municipalities in the case of a national implementation of SET, as SET is already established as a municipal responsibility. A national rollout of SET may reduce surgical procedures and increase demand for municipal SET programs, leading to the need for resource reallocation and potential cost increases for municipalities. Successful implementation of SET requires adequate facilities (e.g., treadmills, space) and upskilling of healthcare professionals. Providers must understand IC, its symptoms, and comorbidities, and possess pedagogical skills to guide patients through pain thresholds and lifestyle changes. Patients must have physical and motor abilities, as well as health literacy, to engage and sustain SET. Health economics: The assessment includes a cost-utility analysis (CUA) and a cost-consequence analysis (CCA) for the comparison of SET versus surgery, a CCA for the comparison of SET versus standard treatment, and a budget impact analysis (BIA) investigating the budgetary consequences for the Danish regions if SET is further implemented as first-line treatment. The CUA and CCA of SET versus surgery indicate that SET is associated with lower estimated costs (- DKK 44,211 per patient) and greater effectiveness (0.19 QALYs per patient) over a lifetime horizon, making it dominant. Consistent with the findings on the clinical effectiveness and safety of SET versus surgery, no clinically relevant differences between SET and surgery were included in the CCA. For the CUA, sensitivity analyses reveal considerable uncertainty, especially regarding mortality and the accumulated QALYs. The expert committee cautions that the clinical evidence base is scarce and suspect an underreporting of mortality in the applied clinical studies that may affect the health economic results. Based on the included uncertainty, there’s a 54% probability that SET dominates surgery, but also a 41% chance it’s less costly, yet also less effective and a 4% probability of surgery dominating SET. In the CCA of SET versus standard care, SET is estimated to be more costly compared to standard care (DKK 22,588 per patient), with no clinically relevant differences in the investigated outcomes. Due to very limited evidence, the expert committee consider that no firm conclusions can be drawn about the comparative cost-effectiveness of SET and standard treatment. The projected regional budget impact of a recommendation and further implementation of SET is a saving of approximately DKK 110 million over five years, mainly due to a reduction in surgical procedures. The expert committee emphasizes that municipal costs, i.e. effectively all costs associated with providing SET, are not included in the analysis. If supervised walking is recommended for further national implementation, municipalities—especially those not currently offering the program—may face significant additional expenses.

Project Status: Completed

Year Published: 2025

URL for published report: https://www.sundk.dk/media/xumbwlmq/anbefaling_superviseret-gangtraening_sundk.pdf

English language abstract: There is no English language summary available

Publication Type: Not Assigned

Country: Denmark

Organisation Name: The Danish Health Technology Council

Contact Address: Niels Jernes Vej 6a, 9220 Aalborg