Compression therapies for the treatment of venous leg ulcers: a mixed method process evaluation in a randomised controlled trial, VenUS6

BACKGROUND: Strong compression treatment is an evidence-based first-line treatment that helps reduce the healing time of venous leg ulcers. VenUS 6 is a three-arm RCT conducted in the UK that aimed to compare 4-layer bandages and 2-layer hosiery with compression wraps and 2-layer bandages. The study found that compression wraps are unlikely to reduce time to venous leg ulcer healing compared to the other treatments evaluate, although there was some uncertainty with this estimate. We nested a mixed-methods process evaluation within VenUS 6 to gain a more in-depth understanding of trial participant and nursing staff views on and experiences of various compression therapies, and to consider how these insights may explain VenUS 6 outcomes. METHODS: We conducted individual, in-depth interviews with 11 trial participants and focus group discussions with 19 relevant health professionals based at seven participating primary, secondary and community care NHS Trust sites. We also used data collected during the trial from patients about their experience of compression use. We conducted a separate UK-wide survey with nurses to learn more about availability of the trial compression treatment options in clinics and their views on the ease of use of the compression treatments in scope. Qualitative data were analysed using framework analysis and quantitative data were analysed descriptively. Data were integrated with the help of the Pillar Integration Process. RESULTS: There was high satisfaction with compression wraps and limited discomfort among trial participants, who appreciated the wraps could be adjusted and taken off to allow them to take showers. Staff mentioned, however, that trial participants were prone to loosen the wraps. Whilst 2-layer hosiery allowed for self-application and could be taken off, trial participants said the hosiery was very tight and difficult to apply. Bandages, on the other hand, whilst bulky and sometimes uncomfortable, would often not be removed by trial participants, leading to greater exposure to effective compression. CONCLUSION: We have identified that people with venous ulcers wearing compression wraps are more likely to report loosening them and removal at night, than people wearing other types of compression treatment which was confirmed by staff. These reported behaviours could explain longer healing times for compression wraps, compared to other treatments delivered in our RCT. Despite longer times to healing, compression wraps may still be an appropriate compression treatment option for some people, and it is important for nursing staff to have conversations with service users and share decisions about suitable treatment options.