Clinical Trials Research Unit (CTRU), University of Leeds, Leeds LS2 9JT, UK.
Health Qual Life Outcomes. 2013 Jun 13;11:95. doi: 10.1186/1477-7525-11-95.
Patient-reported outcome (PRO) data are integral to patient care, policy decision making and healthcare delivery. PRO assessment in pressure ulcers is in its infancy, with few studies including PROs as study outcomes. Further, there are no pressure ulcer PRO instruments available.
We used gold-standard methods to develop and evaluate a new PRO instrument for people with pressure ulcers (the PU-QOL instrument). Firstly a conceptual framework was developed forming the basis of PU-QOL scales. Next an exhaustive item pool was used to produce a draft instrument that was pretested using mixed methods (cognitive interviews and Rasch Measurement Theory). Finally, we undertook psychometric evaluation in two parts. This first part was item reduction, using PU-QOL data from 227 patients. The second part was reliability and validity evaluation of the item-reduced version using both Traditional and Rasch methods, on PU-QOL data from 229 patients.
The final PU-QOL contains 10 scales for measuring symptoms, physical functioning, psychological well-being and social participation specific to pressure ulcers. It is intended for administration and patients rate the amount of "bother" attributed during the past week on a 3-point response scale. Scale scores are generated by summing items, with lower scores indicating better outcome. The PU-QOL instrument was found to be acceptable, reliable (Cronbach's alpha values ranging 0.89-0.97) and valid (hypothesised correlations between PU-QOL and SF-12 scores (r>0.30) and PU-QOL scales and sociodemographic variables (r<0.30) were consistent with predictions).
The PU-QOL instrument provides a standardised method for assessing PROs, reflecting the domains in a pressure ulcer-specific conceptual framework. It is intended for evaluating patient orientated differences between interventions and in particular the impact from the perspective of patients.
患者报告的结局（PRO）数据是患者护理、政策决策和医疗保健提供的重要组成部分。压疮的 PRO 评估仍处于起步阶段，很少有研究将 PRO 作为研究结果。此外，目前还没有压疮 PRO 仪器。
我们使用金标准方法开发和评估了一种新的压疮患者 PRO 仪器（PU-QOL 仪器）。首先，制定了一个概念框架，作为 PU-QOL 量表的基础。接下来，使用详尽的项目池生成一份草案仪器，然后使用混合方法（认知访谈和 Rasch 测量理论）进行预测试。最后，我们分两部分进行心理测量评估。第一部分是使用来自 227 名患者的 PU-QOL 数据进行项目缩减。第二部分是使用传统和 Rasch 方法对项目缩减版本进行可靠性和有效性评估，使用来自 229 名患者的 PU-QOL 数据。
最终的 PU-QOL 包含 10 个量表，用于测量压疮特有的症状、身体功能、心理幸福感和社会参与。它旨在通过患者在过去一周内的“困扰”程度进行 3 点反应量表进行管理和评分。量表得分通过对项目进行求和生成，得分越低表示结果越好。PU-QOL 仪器被认为是可接受的，具有可靠性（Cronbach's alpha 值范围为 0.89-0.97）和有效性（PU-QOL 与 SF-12 评分之间的假设相关性（r>0.30）和 PU-QOL 量表与社会人口统计学变量之间的相关性（r<0.30）与预测一致）。
PU-QOL 仪器提供了一种评估 PRO 的标准化方法，反映了压疮特定概念框架中的领域。它旨在评估干预措施之间的患者导向差异，特别是从患者角度的影响。
