STUDY OBJECTIVE: To observe changes in perceived health in patients during a clinical trial of treatments for venous leg ulceration. DESIGN: Randomised prospective factorial trial in patients with venous ulceration. Each patient randomised to a bandage, dressing and a drug. Perceived health assessed at entry and after 24 weeks. SETTING: Outpatient departments and patient's home. PATIENTS: Two hundred patients presenting to two vascular services in Falkirk and Edinburgh with chronic (duration > 2 months) non-healing venous ulceration. STATISTICAL ANALYSIS AND MAIN RESULTS: Analysis using the Nottingham Health Profile revealed that after 24 weeks there were significant improvements in all subscores (p < 0.01) with the exception of social isolation (p = 0.081). Patients with healed ulceration had improved in energy, pain, emotion, sleep and mobility compared with those whose ulceration failed to heal (p < 0.05). Patients randomised to four layer bandaging had significantly better energy (diff = 7.9, 95% CI 0.2, 15.6, p = 0.04) and mobility (diff = 4.5, 95% CI 0.0, 9.0, p = 0.046). This difference could be explained largely by the improved healing of patients randomised to this bandage system (67/97 vs. 50/103, OR = 2.37, 95% CI 1.31, 4.27). CONCLUSIONS: Improvements in perceived health were significantly greater in patients whose ulcers had completely healed. Methods of treatment which offer improved healing for patients with venous leg ulceration are likely to improve patients' perceived health status.
RCT Entities:
STUDY OBJECTIVE: To observe changes in perceived health in patients during a clinical trial of treatments for venous leg ulceration. DESIGN: Randomised prospective factorial trial in patients with venous ulceration. Each patient randomised to a bandage, dressing and a drug. Perceived health assessed at entry and after 24 weeks. SETTING:Outpatient departments and patient's home. PATIENTS: Two hundred patients presenting to two vascular services in Falkirk and Edinburgh with chronic (duration > 2 months) non-healing venous ulceration. STATISTICAL ANALYSIS AND MAIN RESULTS: Analysis using the Nottingham Health Profile revealed that after 24 weeks there were significant improvements in all subscores (p < 0.01) with the exception of social isolation (p = 0.081). Patients with healed ulceration had improved in energy, pain, emotion, sleep and mobility compared with those whose ulceration failed to heal (p < 0.05). Patients randomised to four layer bandaging had significantly better energy (diff = 7.9, 95% CI 0.2, 15.6, p = 0.04) and mobility (diff = 4.5, 95% CI 0.0, 9.0, p = 0.046). This difference could be explained largely by the improved healing of patients randomised to this bandage system (67/97 vs. 50/103, OR = 2.37, 95% CI 1.31, 4.27). CONCLUSIONS: Improvements in perceived health were significantly greater in patients whose ulcers had completely healed. Methods of treatment which offer improved healing for patients with venous leg ulceration are likely to improve patients' perceived health status.
Authors: Gill Norman; Maggie J Westby; Amber D Rithalia; Nikki Stubbs; Marta O Soares; Jo C Dumville Journal: Cochrane Database Syst Rev Date: 2018-06-15