Improving venous leg ulcer management

This thesis reports several different methods to develop and evaluate complex interventions designed to improve venous leg ulcer management. Chronic venous leg ulcers (VLU) are the most common chronic wound problem in the community. Its health and economic burden is predicted to increase due to ageing of the community and increase in prevalence of diabetes and obesity. Although many patients seek health care for VLU, most do not receive the most effective management. Patients with this condition are mainly treated in general practice, outpatient settings or the community with variability in treatment and referral practices. A recent Cochrane review reported the main treatment for VLU is firm compression bandage and that multi-layered bandage systems are more effective than single-layered systems. It noted a paucity of research in the area and a lack of attention to the contribution to outcomes of patient adherence to treatment and practitioner compliance with guidelines. The review further noted that economic evaluations should be undertaken in association with randomised control trials (RCT). The work reported in this thesis seeks to address these shortfalls and hence improve venous ulcer healing. A systematic review of the literature was undertaken to evaluate which interventions help people adhere to compression bandage therapy. Only one small trial of low quality evidence was identified. Another reviewed which RCTs reported cost effectiveness in conjunction with clinical effectiveness of different types of compression bandaging therapies. It found a lack of clear reporting of cost effectiveness in these RCTs. To test practitioner compliance with bandaging guidelines a cross-sectional survey of Practice Nurses (PN) in General Practice, where most VLU bandaging takes place, demonstrated that PN knowledge of venous ulcer management is sub-optimal and current practice does not adequately comply with evidence based venous leg ulcer guidelines. At the core of this thesis is a RCT undertaken to evaluate a graduated three layer straight tubular bandaging system (the intervention bandage) compared to standard short stretch compression bandaging system. A CONSORT statement was used to design the RCT. As a prelude to this study the sub-bandage pressure (SBP) of the intervention bandage was compared to the standard bandage in a group of healthy volunteers. It was found that the SBP of the intervention bandage was consistently 15 mmHg less than the control bandage. While the literature espouses that higher compression is linked to higher healing rates our RCT showed that a lower SBP did not appear to affect adherence or healing. The RCT showed the intervention bandage increased healing rates and costs were substantially less. Strategies are needed to improve appropriate and early intervention within collaborative and integrated health services for people with VLU. Future research should explore the complexities of patient adherence to compression therapy using accepted uniform terminology by the wound research community. In addition to developing and testing the effect of VLU interventions using CONSORT in future RCTs, there is a need to facilitate better reporting of patient adherence and economic evaluations of VLU interventions.