Interventions for helping people adhere to compression treatments for venous leg ulceration.

BACKGROUND: Chronic venous ulcer healing is a complex clinical problem that requires intervention from skilled, costly, multidisciplinary wound-care teams. Compression therapy has been shown to help heal venous ulcers and to reduce the risk of recurrence. It is not known which interventions help people adhere to compression treatments.

OBJECTIVES: To assess the benefits and harms of interventions designed to help people adhere to venous leg ulcer compression therapy, and thus improve healing of venous leg ulcers and prevent their recurrence after healing.

SEARCH METHODS: In May 2013 we searched The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; EBSCO CINAHL; trial registries, and reference lists of relevant publications for published and ongoing trials. There were no language or publication date restrictions.

SELECTION CRITERIA: We included randomised controlled trials (RCTs) of interventions that help people with venous leg ulcers adhere to compression treatments compared with usual care, or no intervention, or another active intervention. Our main outcomes were number of people with ulcers healed, recurrence, time to complete healing, quality of life, pain, adherence to compression therapy and number of people with adverse events.

DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data, assessed the risk of bias of each included trial, and assessed overall quality of evidence for the main outcomes in 'Summary of findings' tables.

MAIN RESULTS: Low quality evidence from one trial (67 participants) indicates that, compared with home-based care, a community-based Leg Club® clinic that provided mechanisms for peer-support, assistance with goal setting and social interaction did not result in superior healing rates at three months (12/28 people healed in Leg Club clinic group versus 7/28 in home-based care group; risk ratio (RR) 1.71, 95% confidence interval (CI) 0.79 to 3.71); or six months (15/33 healed in Leg Club group versus 10/34 in home-based care group; RR 1.55, 95% CI 0.81 to 2.93); or in improved quality of life outcomes at six months (MD 0.85 points, 95% CI -0.13 to 1.83; 0 to 10 point scale). However, the Leg Club resulted in a statistically significant reduction in pain at six months (MD -12.75 points, 95% CI -24.79, -0.71; 0 to 100 point scale), although this was not considered a clinically important difference. Time to complete healing, recurrence of ulcers, adherence and adverse events were not reported.Low quality evidence from another trial (184 participants) indicates that, compared with usual care in a wound clinic, a community-based and nurse-led self-management programme of six months' duration promoting physical activity (walking and leg exercises) and adherence to compression therapy via counselling and behaviour modification (Lively Legs®) may not result in superior healing rates at 18 months (51/92 healed in Lively Legs group versus 41/92 in usual care group; RR 1.24 (95% CI 0.93 to 1.67)); may not result in reduced rates of recurrence of venous leg ulcers at 18 months (32/69 with recurrence in Lively Legs group versus 38/67 in usual care group; RR 0.82 (95% CI 0.59 to 1.14)); and may not result in superior adherence to compression therapy at 18 months (42/92 people fully adherent in Lively Legs group versus 41/92 in usual care group; RR 1.02 (95% CI 0.74 to 1.41)). Time to complete healing, quality of life, pain and adverse events were not reported. We found no studies that investigated other interventions to promote adherence to compression therapy.

AUTHORS' CONCLUSIONS: There is a paucity of trials of interventions that promote adherence to compression therapy for venous ulcers. Low quality evidence from two trials was identified: one promoting adherence via socialisation and support (Leg Club®), and the other promoting adherence to compression, leg exercises and walking via counselling and behaviour modification (Lively Legs®).These trials did not reveal a benefit of community-based clinics over usual care in terms of healing rates, prevention of recurrence of venous leg ulcers, or quality of life. One trial indicated a small, but possibly clinically unimportant, reduction in pain, while adverse events were not reported. The small number of participants may have a hidden real benefit, or an increase in harm. Due to the lack of reliable evidence, at present it is not possible either to recommend or discourage nurse clinic care interventions over standard care.