McKenna S P, Doughty N, Meads D M, Doward L C, Pepke-Zaba J
Galen Research, Enterprise House, Manchester Science Park, Lloyd Street North, Manchester M15 6SE, UK.
Qual Life Res. 2006 Feb;15(1):103-15. doi: 10.1007/s11136-005-3513-4.
No outcome measures specific to pulmonary hypertension (PH) currently exist. The aim of the study was to develop health-related quality of life (symptoms and functioning) scales and a quality of life scale that would allow comprehensive, accurate and valid patient-reported outcome assessment in clinical studies.
The content of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) was derived from qualitative interviews conducted with 35 patients. Item reduction was based on the analysis of responses to a postal survey (n=75) and patient interviews (n=15) designed to determine face and content validity. A final postal validation study (n=91) was performed to determine reproducibility and construct validity.
The questionnaire was well received by participants who found it to be relevant, comprehensible and quick and easy to complete. Rasch and factor analyses were conducted to ensure unidimensionality of the final CAMPHOR scales; Overall symptoms (made up of Energy, Breathlessness and Mood subscales), Functioning and Quality of life. The CAMPHOR scales had good internal consistency (alpha=0.90-0.92) and reproducibility (test-retest correlations=0.86-0.92). They also exhibited convergent, divergent and known groups validity.
The CAMPHOR is a valuable new instrument for assessing patient-reported outcome in PH clinical trials and routine practice.
目前尚无专门针对肺动脉高压（PH）的结局指标。本研究的目的是开发与健康相关的生活质量（症状和功能）量表以及生活质量量表，以便在临床研究中进行全面、准确且有效的患者报告结局评估。
剑桥肺动脉高压结局评估（CAMPHOR）的内容源自对35名患者进行的定性访谈。基于对旨在确定表面效度和内容效度的邮寄调查问卷（n = 75）及患者访谈（n = 15）的回答分析进行项目精简。开展了一项最终的邮寄验证研究（n = 91）以确定可重复性和结构效度。
参与者对该问卷评价良好，认为其相关、易懂且填写快速简便。进行了拉施分析和因子分析以确保最终的CAMPHOR量表具有单维性；总体症状（由精力、呼吸困难和情绪子量表组成）、功能和生活质量。CAMPHOR量表具有良好的内部一致性（α = 0.90 - 0.92）和可重复性（重测相关性 = 0.86 - 0.92）。它们还表现出收敛效度、区分效度和已知群组效度。
CAMPHOR是一种有价值的新工具，可用于评估PH临床试验和常规实践中的患者报告结局。
