一项针对用于成人踝关节骨折患者的患者报告结局测量指标测量属性的系统评价。
A systematic review of the measurement properties of patient reported outcome measures used for adults with an ankle fracture.
作者信息
McKeown Rebecca, Ellard David R, Rabiu Abdul-Rasheed, Karasouli Eleni, Kearney Rebecca S
机构信息
Warwick Clinical Trials Unit, Warwick Medical School, Clinical Sciences Research Laboratories, University of Warwick, University Hospitals Coventry and Warwickshire, Coventry, CV2 2DX, UK.
Trauma and Orthopaedics Department, King's College Hospital, Denmark Hill, London, SE5 9RS, UK.
出版信息
J Patient Rep Outcomes. 2019 Dec 17;3(1):70. doi: 10.1186/s41687-019-0159-5.
BACKGROUND
Ankle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Patient reported outcome measures (PROMs) are commonly used outcome measures in clinical trials of interventions for ankle fracture but there is little evidence on their validity and reliability. This systematic review aims to identify and appraise evidence for the measurement properties of ankle specific PROMs used in adults with an ankle fracture using Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology.
METHODS
We searched MEDLINE, Embase and CINAHL online databases for evidence of measurement properties of ankle specific PROMs. Articles were included if they assessed or described the development of the PROM in adults with ankle fracture. Articles were ineligible if they used the PROM to assess the measurement properties of another instrument. Abstracts without full articles and conference proceedings were ineligible, as were articles that adapted the PROM under evaluation without any formal justification of the changes as part of a cross-cultural validation or translation process. Two reviewers completed the screening. To assess methodological quality we used COSMIN risk of bias checklist and summarised evidence using COSMIN quality criteria and a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two reviewers assessed the methodological quality and extracted the data for a sample of articles.
RESULTS
The searches returned a total of 377 articles. From these, six articles were included after application of eligibility criteria. These articles evaluated three PROMs: A-FORM, OMAS and AAOS. The A-FORM had evidence of a robust development process within the patient population, however lacks post-formulation testing. The OMAS showed sufficient levels of reliability, internal consistency and construct validity. The AAOS showed low quality evidence of sufficient construct validity.
CONCLUSIONS
There is insufficient evidence to support the recommendation of a particular PROM for use in adult ankle fracture research based on COSMIN methodology. Further validation of these outcome measures is required in order to ensure PROMs used in this area are sufficiently valid and reliable to assess treatment effects. This would enable high quality, evidenced-based management of adults with ankle fracture.
背景
踝关节骨折是疼痛且使人衰弱的损伤，给社会和医疗保健系统带来了重大负担。患者报告结局指标（PROMs）是踝关节骨折干预措施临床试验中常用的结局指标，但关于其有效性和可靠性的证据很少。本系统评价旨在使用基于共识的健康测量工具选择标准（COSMIN）方法，识别和评估用于成人踝关节骨折的特定踝关节PROMs测量属性的证据。
方法
我们在MEDLINE、Embase和CINAHL在线数据库中搜索特定踝关节PROMs测量属性的证据。如果文章评估或描述了成人踝关节骨折患者PROMs的开发，则纳入该文章。如果文章使用PROMs评估另一工具的测量属性，则不符合纳入标准。没有全文的摘要和会议论文不符合要求，在跨文化验证或翻译过程中对所评估的PROMs进行修改但未对更改进行任何正式说明的文章也不符合要求。两名评审员完成筛选。为评估方法学质量，我们使用COSMIN偏倚风险清单，并使用COSMIN质量标准和改良的推荐分级评估、制定和评价（GRADE）方法总结证据。两名评审员评估方法学质量并提取部分文章的数据。
结果
检索共返回377篇文章。应用纳入标准后，纳入了6篇文章。这些文章评估了三种PROMs：A-FORM、OMAS和AAOS。A-FORM在患者群体中有稳健的开发过程的证据，但缺乏制定后测试。OMAS显示出足够的信度、内部一致性和结构效度水平。AAOS显示出结构效度足够的低质量证据。
结论
根据COSMIN方法，没有足够的证据支持推荐在成人踝关节骨折研究中使用特定的PROMs。需要对这些结局指标进行进一步验证，以确保该领域使用的PROMs足够有效和可靠，以评估治疗效果。这将有助于对成人踝关节骨折进行高质量的循证管理。
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