Faculty of Science, School of Psychology, The University of Sydney, Sydney, New South Wales, Australia.
Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.
Wound Repair Regen. 2019 Jul;27(4):396-405. doi: 10.1111/wrr.12716. Epub 2019 Mar 30.
Patient-reported outcomes can be included as end points in pressure ulcer (PU) intervention trials to provide information to inform decision-making and improve the lives of patients. However, the challenge for researchers and clinicians is identifying and choosing an appropriate instrument for each particular application that suits their research questions and clinical context. To provide researchers and clinicians with the information needed to inform choice of patient-reported outcome measures, we compared a generic and disease-specific measures' ability to discriminate between clinical groups known to differ, and determined their responsiveness to change. We performed analyses on a subset of patients recruited to the PRESSURE 2 trial that completed the pressure ulcer quality of life instrument-prevention version (PU-QOL-P) and Short Form 12 Questionnaire (SF12) measures at baseline and 30-day posttreatment. Known-group validity and responsiveness-to-change analyses were conducted. The analysis sample consisted of 617 patients that completed both measures at baseline. Known-group validity revealed that some PU-QOL-P symptoms and function scales differentiated between people with category 2 PUs and those without PUs. A less meaningful pattern of results was observed for the SF12 scales, suggesting that the PU-QOL-P is more sensitive to differences between PU and non-PU populations. Responsiveness analysis revealed that the PU-QOL-P was more responsive in detecting disease severity than the SF12. The PU-QOL-P provides a standardized method for assessing PU-specific symptoms and functioning outcomes and is suitable for quantifying the benefits of PU interventions from the patient's perspective. Generic measures are useful for group comparisons of global quality of life domains. Choice of measure for each particular application should be determined by the purpose of the measurement and the information required.
患者报告的结局可以作为压力性溃疡（PU）干预试验的终点纳入，以提供信息来辅助决策并改善患者的生活。然而，研究人员和临床医生面临的挑战是确定并选择适合特定应用的合适工具，以满足其研究问题和临床背景的需求。为了为研究人员和临床医生提供选择患者报告结局测量工具所需的信息，我们比较了通用和疾病特异性测量工具区分已知不同临床分组的能力，并确定了它们对变化的反应能力。我们对参加 PRESSURE 2 试验的部分患者进行了分析，这些患者在基线和治疗后 30 天完成了压力性溃疡生活质量工具-预防版（PU-QOL-P）和 12 项简短健康调查量表（SF12）测量。进行了已知组有效性和变化反应性分析。分析样本由 617 名同时完成这两项测量的患者组成。已知组有效性结果显示，PU-QOL-P 的一些症状和功能量表可区分 2 期压力性溃疡患者和无压力性溃疡患者。SF12 量表则呈现出意义不大的结果模式，这表明 PU-QOL-P 更能敏感地检测出 PU 与非 PU 人群之间的差异。反应性分析显示，PU-QOL-P 在检测疾病严重程度方面比 SF12 更敏感。PU-QOL-P 提供了一种评估 PU 特定症状和功能结局的标准化方法，适合从患者角度量化 PU 干预的效果。通用测量工具对于全球生活质量领域的组间比较很有用。对于每种特定应用的测量工具选择应根据测量的目的和所需的信息来确定。
