Hillier Bethany, Scandrett Katie, Coombe April, Hernandez-Boussard Tina, Steyerberg Ewout, Takwoingi Yemisi, Veličković Vladica M, Dinnes Jacqueline
Department of Applied Health Sciences, College of Medicine and Health, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, United Kingdom.
PLoS Med. 2025 Feb 6;22(2):e1004518. doi: 10.1371/journal.pmed.1004518. eCollection 2025 Feb.
Pressure injuries (PIs) pose a substantial healthcare burden and incur significant costs worldwide. Several risk prediction tools to allow timely implementation of preventive measures and a subsequent reduction in healthcare system burden are available and in use. The ability of risk prediction tools to correctly identify those at high risk of PI (prognostic accuracy) and to have a clinically significant impact on patient management and outcomes (effectiveness) is not clear. We aimed to evaluate the prognostic accuracy and clinical effectiveness of risk prediction tools for PI and to identify gaps in the literature.
The umbrella review was conducted according to Cochrane guidance. Systematic reviews (SRs) evaluating the accuracy or clinical effectiveness of adult PI risk prediction tools in any clinical settings were eligible. Studies on paediatric tools, sensor-only tools, or staging/diagnosis of existing PIs were excluded. MEDLINE, Embase, CINAHL, and EPISTEMONIKOS were searched (inception to June 2024) to identify relevant SRs, as well as Google Scholar (2013 to 2024) and reference lists. Methodological quality was assessed using adapted AMSTAR-2 criteria. Results were described narratively. We identified 26 SRs meeting all eligibility criteria with 19 SRs assessing prognostic accuracy and 11 assessing clinical effectiveness of risk prediction tools for PI (4 SRs assessed both aspects). The 19 SRs of prognostic accuracy evaluated 70 tools (39 scales and 31 machine learning (ML) models), with the Braden, Norton, Waterlow, Cubbin-Jackson scales (and modifications thereof) the most evaluated tools. Meta-analyses from a focused set of included SRs showed that the scales had sensitivities and specificities ranging from 53% to 97% and 46% to 84%, respectively. Only 2/19 (11%) SRs performed appropriate statistical synthesis and quality assessment. Two SRs assessing machine learning-based algorithms reported high prognostic accuracy estimates, but some of which were sourced from the same data within which the models were developed, leading to potentially overoptimistic results. Two randomised trials assessing the effect of PI risk assessment tools (within the full test-intervention-outcome pathway) on the incidence of PIs were identified from the 11 SRs of clinical effectiveness; both were included in a Cochrane SR and assessed as high risk of bias. Both trials found no evidence of an effect on PI incidence. Limitations included the use of the AMSTAR-2 criteria, which may have overly focused on reporting quality rather than methodological quality, compounded by the poor reporting quality of included SRs and that SRs were not excluded based on low AMSTAR-2 ratings (in order to provide a comprehensive overview). Additionally, diagnostic test accuracy principles, rather than prognostic modelling approaches were heavily relied upon, which do not account for the temporal nature of prediction.
Available systematic reviews suggest a lack of high-quality evidence for the accuracy of risk prediction tools for PI and limited reliable evidence for their use leading to a reduction in incidence of PI. Further research is needed to establish the clinical effectiveness of appropriately developed and validated risk prediction tools for PI.
压疮(PIs)在全球范围内构成了巨大的医疗负担并产生了高昂的费用。有几种风险预测工具可用于及时采取预防措施,进而减轻医疗系统的负担,目前这些工具正在使用中。风险预测工具正确识别压疮高风险人群的能力(预测准确性)以及对患者管理和结局产生临床显著影响的能力(有效性)尚不清楚。我们旨在评估压疮风险预测工具的预测准确性和临床有效性,并找出文献中的差距。
本系统评价按照Cochrane指南进行。纳入评估任何临床环境中成人压疮风险预测工具的准确性或临床有效性的系统评价(SRs)。排除关于儿科工具、仅传感器工具或现有压疮分期/诊断的研究。检索MEDLINE、Embase、CINAHL和EPISTEMONIKOS(从创刊到2024年6月)以识别相关的系统评价,以及谷歌学术(2013年至2024年)和参考文献列表。使用改编的AMSTAR - 2标准评估方法学质量。结果采用描述性叙述。我们识别出26项符合所有纳入标准的系统评价,其中19项评估预测准确性,1项评估压疮风险预测工具的临床有效性(4项系统评价评估了两个方面)。19项预测准确性的系统评价评估了70种工具(39个量表和31个机器学习(ML)模型),其中Braden、Norton、Waterlow、Cubbin - Jackson量表(及其修改版)是评估最多的工具。一组重点纳入的系统评价的荟萃分析表明,这些量表的敏感性和特异性分别为53%至97%和46%至84%。只有2/19(11%)的系统评价进行了适当统计综合和质量评估。两项评估基于机器学习算法的系统评价报告了较高的预测准确性估计值,但其中一些数据来自模型开发所用的相同数据,可能导致结果过于乐观。从11项临床有效性的系统评价中识别出两项评估压疮风险评估工具(在完整的测试 - 干预 - 结局路径内)对压疮发生率影响的随机试验;这两项试验均被纳入Cochrane系统评价,并被评估为高偏倚风险。两项试验均未发现对压疮发生率有影响的证据。局限性包括使用AMSTAR - 2标准,这可能过度关注报告质量而非方法学质量,再加上纳入的系统评价报告质量较差,且未基于低AMSTAR - 2评分排除系统评价(以便提供全面概述)。此外,严重依赖诊断测试准确性原则而非预后建模方法,这未考虑预测的时间性质。
现有系统评价表明,缺乏关于压疮风险预测工具准确性的高质量证据,且其使用导致压疮发生率降低的可靠证据有限。需要进一步研究以确定适当开发和验证的压疮风险预测工具的临床有效性。