School of Nursing and Midwifery, NUI Galway, Galway, Ireland.
Alliance for Research and Innovation in Wounds, NUI Galway, Galway, Ireland.
Wound Repair Regen. 2019 Nov;27(6):702-710. doi: 10.1111/wrr.12756. Epub 2019 Aug 19.
We set out to evaluate quality of reporting of data related to external validity from randomized controlled trials (RCTs) assessing treatment interventions for active venous leg ulcers. Using a systematic review study design, we identified 144 full-text RCTs of treatment interventions, where the wound was assessed and published in English from 1998 to 2018. We found that the median study sample size was 75.5. Weighted mean wound size was 13.22 cm and weighted mean wound duration was 22.20 months. Forty-six (32%) reported numbers screened for eligibility and 27 (19%) reported the number who declined to participate; 19 (13%) reported on patient ethnicity; 60 (42%) reported comorbidities; and 5 (4%) reported current medication use. When reported, 60/102 (59%) excluded patients with an ankle-brachial pressure index <0.8; 68/135 (50%) were conducted in Europe, 6/135 (4%) in Asia, and 74/104 (71%) were conducted in outpatient facilities; 3 (2%) reported socioeconomic factors and 88 (61%) reported on adverse events. We concluded that there is inadequate reporting of data related to external validity in reports of RCTs assessing venous leg ulcers treatment interventions. Significant variability exists in the ankle-brachial pressure index cutoff point for inclusion or exclusion, making generalizability difficult to assess.
我们着手评估评估主动静脉性腿部溃疡治疗干预的随机对照试验（RCT）中与外部有效性相关的数据报告质量。使用系统评价研究设计，我们确定了 144 项评估治疗干预的英文全文 RCT，其中伤口得到了评估并发表。我们发现，研究样本中位数为 75.5。加权平均伤口大小为 13.22cm，加权平均伤口持续时间为 22.20 个月。46（32%）报告了筛选合格患者的人数，27（19%）报告了拒绝参与的人数；19（13%）报告了患者的种族；60（42%）报告了合并症；5（4%）报告了当前的药物使用情况。在报告中，60/102（59%）排除了踝肱指数<0.8 的患者；68/135（50%）在欧洲进行，6/135（4%）在亚洲进行，74/104（71%）在门诊进行；3（2%）报告了社会经济因素，88（61%）报告了不良事件。我们得出结论，在评估静脉性腿部溃疡治疗干预的 RCT 报告中，与外部有效性相关的数据报告不足。纳入或排除的踝肱指数截止值存在显著差异，使得难以评估普遍性。
