School of Nursing, The University of Auckland, New Zealand.
National Institute for Health Innovation, The University of Auckland, New Zealand.
J Wound Care. 2023 Oct 2;32(10):657-664. doi: 10.12968/jowc.2023.32.10.657.
To investigate whether the use of a simple baseline measurement predicts venous leg ulcer healing at 12 and 24 weeks.
This was a secondary analysis of a cohort of four randomised controlled trials (RCTs) of treatments adjuvant to compression. Self-reported ulcer duration, and measured ulcer length and width, to calculate estimated ulcer area, were used to obtain a Margolis index score. The score created three prognostic strata for likelihood to heal within 24 weeks, and the number of participants healed and time-to-healing were compared.
There were a total of 802 participants across the four RCTs-408 (50.9%) in two 12-week trials and 394 (49.1%) in two 24-week trials. The mean age of participants was 63.7±17.6 years, and 372 were female (46.4%). The Margolis index score at baseline was 0 for 320 participants (predicted normal healing); 1 for 334 participants; and 2 for 148 participants (both 1 and 2 predicted slow-to-heal). Overall, 248 (77.5%) of those participants who scored 0 at baseline healed within 24 weeks, compared with 182 (54.5%) of participants who scored 1, and 30 (20.3%) participants who scored 2. The median time-to-healing was 40 (24-62) days, 57 (35-100) days and 86.5 (56-151) days, respectively. The area under the receiver operating characteristic curve was 0.69 and 0.77, respectively, for the 12 and 24 week trials.
A simple baseline index identifies participants with normal or slow-to-heal wounds and could be used to demonstrate prognostic balance between treatment groups in trials. This approach could also be used in clinical practice to assist with managing expectations and for early identification of patients who may best benefit from adjuvant treatments.
探讨基线简单测量是否可预测静脉性腿部溃疡在 12 周和 24 周时的愈合情况。
这是对四项辅助加压治疗的随机对照试验（RCT）的队列进行的二次分析。采用自我报告的溃疡持续时间以及测量的溃疡长度和宽度，计算估计的溃疡面积，得出 Margolis 指数评分。该评分创建了三个预后分层，用于预测在 24 周内愈合的可能性，比较了愈合的参与者人数和愈合时间。
四项 RCT 共有 802 名参与者-2 项 12 周试验中有 408 名（50.9%），2 项 24 周试验中有 394 名（49.1%）。参与者的平均年龄为 63.7±17.6 岁，其中 372 名女性（46.4%）。基线时 Margolis 指数评分为 0 的有 320 名参与者（预计正常愈合）；评分为 1 的有 334 名参与者；评分为 2 的有 148 名参与者（评分 1 和 2 均预测愈合缓慢）。总体而言，基线评分 0 的 248 名参与者（77.5%）在 24 周内愈合，而评分 1 的 182 名参与者（54.5%）和评分 2 的 30 名参与者（20.3%）。中位愈合时间分别为 40（24-62）天、57（35-100）天和 86.5（56-151）天。受试者工作特征曲线下面积分别为 12 周和 24 周试验的 0.69 和 0.77。
一个简单的基线指标可以识别正常或愈合缓慢的伤口参与者，并可用于证明试验中治疗组之间的预后平衡。这种方法也可以在临床实践中用于帮助管理期望，并及早识别可能从辅助治疗中获益最大的患者。
