Guest Julian F, Singh Heenal, Rana Karan, Vowden Peter
Catalyst Health Economics Consultants, Rickmansworth, Hertfordshire, UK, Faculty of Life Sciences and Medicine, King's College, London, UK.
Catalyst Health Economics Consultants, Rickmansworth, Hertfordshire.
J Wound Care. 2018 Apr 2;27(4):230-243. doi: 10.12968/jowc.2018.27.4.230.
To estimate the cost-effectiveness of an externally applied electroceutical (EAE) device, Accel-Heal, in treating non-healing venous leg ulcers (VLUs) in the UK.
This was a prospective, randomised, double-blind, placebo-controlled, multi-centre study of patients aged ≥18 years with a non-healing VLU. Patients were randomised in the ratio of 1:1 to receive six units of the EAE (consisting of a self-contained, programmed electric microcurrent generator and two skin contact pads) or an identical-looking placebo device over 12 consecutive days. Patients were followed-up for 24 weeks from randomisation, during which time patients received wound care according to the local standard care pathway, completed health-related quality of life (HRQoL) instruments, and health-care resource use was measured. The cost-effectiveness of the EAE device was estimated at 2015/16 prices in those patients who fulfilled the study's inclusion and exclusion criteria (economic analysis population).
At 24 weeks after randomisation, 34% and 30% of VLUs in the EAE and placebo groups in the economic analysis population, respectively, had healed. The time-to-healing was a mean of 2.6 and 3.5 months in the EAE and placebo groups, respectively. The area of the wounds that healed in the EAE group was nearly twice that of those in the placebo group (mean: 13.3 versus 7.7cm per VLU). Additionally, the pre-randomised duration of the wounds that healed in the EAE group was double that of those in the placebo group (mean: 2.6 versus 1.2 years per VLU). By the end of the study, EAE-treated patients reported less pain, more social functioning and greater overall wellbeing/satisfaction than placebo-treated patients. None of these differences reached statistical significance, but they may be important to patients. There were no significant differences in health-care resource use between the two groups. The incremental cost per quality-adjusted life year (QALY) gained with the EAE device was £4480 at eight weeks, decreasing to £2265 at 16 weeks and -£2388 (dominant) at 24 weeks. The study was confounded by unwarranted variation in patient management between centres and between individual clinicians within each centre.
Despite the unwarranted variation in the provision of wound care observed in this study, the use of the EAE device resulted in some improved clinical outcomes and patient-reported outcomes, for the same or less cost as standard care, by 24 weeks. Clinicians managing VLUs may wish to consider the findings from this study when making treatment decisions.
评估一种外用电子治疗（EAE）设备Accel-Heal在英国治疗难愈性下肢静脉溃疡（VLU）的成本效益。
这是一项针对年龄≥18岁的难愈性VLU患者的前瞻性、随机、双盲、安慰剂对照、多中心研究。患者按1:1的比例随机分组，连续12天接受6个单位的EAE（由一个独立的、可编程的微电流发生器和两个皮肤接触垫组成）或外观相同的安慰剂设备。自随机分组起对患者进行24周的随访，在此期间，患者按照当地标准护理路径接受伤口护理，完成与健康相关的生活质量（HRQoL）评估工具，并测量医疗资源使用情况。以2015/16年的价格估算符合研究纳入和排除标准的患者（经济分析人群）中EAE设备的成本效益。
在随机分组24周后，经济分析人群中EAE组和安慰剂组分别有34%和30%的VLU愈合。EAE组和安慰剂组的愈合时间平均分别为2.6个月和3.5个月。EAE组愈合伤口的面积几乎是安慰剂组的两倍（平均：每个VLU为13.3平方厘米对7.7平方厘米）。此外，EAE组愈合伤口的随机分组前持续时间是安慰剂组的两倍（平均：每个VLU为2.6年对1.2年）。到研究结束时，接受EAE治疗的患者比接受安慰剂治疗的患者报告的疼痛更少、社交功能更好、总体幸福感/满意度更高。这些差异均未达到统计学意义，但对患者可能很重要。两组在医疗资源使用方面没有显著差异。使用EAE设备每获得一个质量调整生命年（QALY）的增量成本在8周时为4480英镑，在16周时降至2265英镑，在24周时为-2388英镑（占优）。该研究受到各中心之间以及每个中心内个体临床医生之间患者管理不必要差异的干扰。
尽管本研究中观察到伤口护理提供方面存在不必要的差异，但到24周时，使用EAE设备导致了一些临床结果和患者报告结果的改善，成本与标准护理相同或更低。治疗VLU的临床医生在做出治疗决策时可能希望考虑本研究的结果。
