CVderm - German Center for Health Services Research in Dermatology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
CVderm - German Center for Health Services Research in Dermatology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Eur J Vasc Endovasc Surg. 2014 Jan;47(1):100-7. doi: 10.1016/j.ejvs.2013.10.009. Epub 2013 Oct 22.
Patient-relevant treatment benefit is traditionally measured with health-related quality of life (HRQoL) instruments. The Patient Benefit Index (PBI) methodology allows for a more direct measurement, with the patients rating both importance and achievement of treatment goals. Here, we developed and validated a PBI version specific for the assessment of benefit in lymphedema and lipedema treatment (PBI-L).
The development included five steps: (1) open item collection; (2) consensus of items in a multidisciplinary expert panel; (3) application of the German PBI-L in a cross-sectional study (n = 301); (4) translation into English; (5) application of the English PBI-L in a randomized clinical trial (n = 82). Subscales were developed using factor analysis. Construct validity was analyzed by correlating PBI-L and convergent criteria such as HRQoL and quality of care. To test for responsiveness, the association to change in HRQoL measures was computed.
Floor and ceiling effects were low. There were few missing values. Two well-interpretable subscales were found with Cronbach's alpha >0.8 each. Global and subscale scores correlated with convergent criteria and with change in disease-specific HRQoL, but not with change in generic HRQoL.
The PBI-L is an internally consistent, valid, and responsive instrument for the assessment of patient-relevant benefit of edema treatment.
传统上，患者相关的治疗获益是通过健康相关生活质量（HRQoL）工具来衡量的。患者获益指数（PBI）方法允许更直接的测量，患者对治疗目标的重要性和实现程度进行评分。在这里，我们开发并验证了一种专门用于评估淋巴水肿和脂肪水肿治疗获益的 PBI 版本（PBI-L）。
该开发包括五个步骤：（1）开放式项目收集；（2）多学科专家小组对项目达成共识；（3）在横断面研究（n=301）中应用德国 PBI-L；（4）翻译成英文；（5）在随机临床试验（n=82）中应用英文 PBI-L。使用因子分析开发子量表。通过将 PBI-L 与 HRQoL 和护理质量等趋同标准相关联，分析结构有效性。为了测试反应性，计算与 HRQoL 测量变化的关联。
地板和天花板效应较低。缺失值较少。发现了两个可解释性良好的子量表，每个子量表的克朗巴赫系数均大于 0.8。总体和子量表评分与趋同标准以及疾病特异性 HRQoL 的变化相关，但与通用 HRQoL 的变化无关。
PBI-L 是一种内部一致、有效且敏感的评估水肿治疗患者相关获益的工具。
