Macran Susan, Wileman Samantha, Barton Garry, Russell Ian
Outcomes Research Group, Centre for Health Economics, University of York, Heslington, York, YO10 5DD, United Kingdom.
Qual Life Res. 2007 Mar;16(2):331-43. doi: 10.1007/s11136-006-9005-3. Epub 2006 Oct 11.
This paper reports on the development of a new measure of health-related quality of life for use among patients with gastro-oesophageal reflux disease (GORD), funded as part of the REFLUX trial. This is a large UK multi centre trial that aims to compare the clinical and cost effectiveness of minimal access surgery with best medical treatment for patients with GORD within the NHS.
Potential items were identified via a series of interviews and focus groups carried out with patients who were receiving/had received medical or surgical treatment for GORD. The final measure consisted of 31 items covering 7 categories (Heartburn; Acid reflux; Wind; Eating and swallowing; Bowel movements; Sleep; Work, physical and social activities). The measure produced two outputs: a quality of life score (RQLS) and five Reflux symptom scores. Reliability (internal consistency), criterion validity with the SF-36 and, sensitivity to change in terms of relationship with reported change in prescribed medication were assessed amongst a sample of 794 patients recruited into the trial.
The measure was shown to be internally consistent, to show criterion validity with the SF-36 and sensitive to changes in patients use of prescribed medication at baseline and 3 month follow-up.
The Reflux questionnaire is a new self-administered questionnaire for use amongst patients with GORD. Initial findings suggest that the new measure is valid, reliable, acceptable to respondents and simple to administer in both a clinical and research context.
本文报告了一种用于胃食管反流病（GORD）患者的健康相关生活质量新测量方法的开发情况，该项目由反流试验资助。这是一项英国大型多中心试验，旨在比较在国民健康服务体系（NHS）内，微创手术与最佳药物治疗对GORD患者的临床效果和成本效益。
通过对接受过/正在接受GORD药物或手术治疗的患者进行一系列访谈和焦点小组讨论，确定潜在项目。最终测量方法由31个项目组成，涵盖7个类别（烧心；反酸；嗳气；进食与吞咽；排便；睡眠；工作、身体和社交活动）。该测量方法产生两个结果：生活质量评分（RQLS）和五个反流症状评分。在纳入试验的794名患者样本中，评估了该测量方法的信度（内部一致性）、与SF - 36的效标效度以及在与所报告的处方药变化关系方面对变化的敏感性。
该测量方法显示出内部一致性，与SF - 36具有效标效度，并且在基线和3个月随访时对患者使用处方药的变化敏感。
反流问卷是一种新的用于GORD患者的自填式问卷。初步结果表明，这种新测量方法有效、可靠，受访者可接受，并且在临床和研究环境中都易于实施。
