Jenkinson Crispin, Kennedy Stephen, Jones Georgina
Health Services Research Unit, Department of Public Health and Harris Manchester College, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Qual Life Res. 2008 Nov;17(9):1147-52. doi: 10.1007/s11136-008-9403-9. Epub 2008 Oct 10.
Health status instruments, which measure the subjective functioning and well-being of respondents, are increasingly being used in international, multi-centre trials of new treatments. If the results of such trials in different countries are to be pooled, it is vitally important for researchers to know how comparable the instruments are across cultures. In this study, we evaluated the response rate, data quality, score reliability and scaling assumptions of the 30-item Endometriosis Health Profile (EHP-30) in the USA.
Data were obtained from a multi-centre study which recruited 225 patients from 43 clinic sites in the United States of America. It was a randomised, evaluator-blinded, Phase III study. In the evaluation of the EHP-30 reported here, the two groups (Depot Medroxyprogesterone Acetate [DMPA] and Leuprolide Acetate [LA]) are combined, and analyses are based on the data gained at baseline. Questionnaires were self-completed by patients when they visited the clinics.
Data completeness was very high, with 97.33% of respondents completing all of the items on the EHP-30. Furthermore, there were no more than a maximum of two missing responses for any given item. No floor and ceiling effects were found for any of the dimensions of the questionnaire. Internal consistency reliability was high for all dimensions (alpha ranged from 0.84 to 0.91). The psychometric properties of the instrument, outlined in the development of the UK version, are supported in the American context.
The data presented here suggest that the EHP-30 is a valid and reliable measure that can be appropriately and meaningfully used in studies that include respondents from the USA.
健康状况测评工具用于衡量受访者的主观功能和幸福感，在新治疗方法的国际多中心试验中使用得越来越频繁。如果要汇总不同国家此类试验的结果，研究人员了解这些测评工具在不同文化间的可比性至关重要。在本研究中，我们评估了美国版30项子宫内膜异位症健康量表（EHP - 30）的应答率、数据质量、评分信度和量表假设。
数据来自一项多中心研究，该研究从美国43个临床站点招募了225名患者。这是一项随机、评估者盲法的III期研究。在本文报告的EHP - 30评估中，将两组（醋酸甲羟孕酮长效注射剂[DMPA]和醋酸亮丙瑞林[LA]）合并，并基于基线时获得的数据进行分析。患者在就诊时自行填写问卷。
数据完整性非常高，97.33%的受访者完成了EHP - 30上的所有项目。此外，任何给定项目的缺失回答最多不超过两个。问卷的任何维度均未发现地板效应和天花板效应。所有维度的内部一致性信度都很高（α范围为0.84至0.91）。英国版开发中概述的该测评工具的心理测量特性在美国背景下得到了支持。
此处呈现的数据表明，EHP - 30是一种有效且可靠的测评工具，可适当地且有意义地用于包含美国受访者的研究中。
