Kulich Károly R, Madisch Ahmed, Pacini Franco, Piqué Jose M, Regula Jaroslaw, Van Rensburg Christo J, Ujszászy László, Carlsson Jonas, Halling Katarina, Wiklund Ingela K
AstraZeneca R&D, Medical Science, Mölndal, S-431 86, Sweden.
Health Qual Life Outcomes. 2008 Jan 31;6:12. doi: 10.1186/1477-7525-6-12.
Symptoms of dyspepsia significantly disrupt patients' lives and reliable methods of assessing symptom status are important for patient management. The aim of the current study was to document the psychometric characteristics of the Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) in Afrikaans, German, Hungarian, Italian, Polish and Spanish patients with dyspepsia.
853 patients with symptoms of dyspepsia completed the GSRS, the QOLRAD, the 36-item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression scale.
The internal consistency reliability of the GSRS was 0.43-0.87 and of the QOLRAD 0.79-0.95. Test-retest reliability of the GSRS was 0.36-0.75 and of the QOLRAD 0.41-0.82. GSRS Abdominal pain domain correlated significantly with all QOLRAD domains in most language versions, and with SF-36 Bodily pain in all versions. QOLRAD domains correlated significantly with the majority of SF-36 domains in most versions. Both questionnaires were able to differentiate between patients whose health status differed according to symptom frequency and severity.
The psychometric characteristics of the different language versions of the GSRS and QOLRAD were found to be good, with acceptable reliability and validity. The GSRS and QOLRAD were found to be useful for evaluating dyspeptic symptoms and their impact on patients' daily lives in multinational clinical trials.
消化不良症状严重影响患者生活,可靠的症状评估方法对患者管理至关重要。本研究旨在记录胃肠道症状评定量表(GSRS)和反流与消化不良生活质量问卷(QOLRAD)在南非荷兰语、德语、匈牙利语、意大利语、波兰语和西班牙语消化不良患者中的心理测量特征。
853例有消化不良症状的患者完成了GSRS、QOLRAD、36项简短健康调查(SF - 36)和医院焦虑抑郁量表。
GSRS的内部一致性信度为0.43 - 0.87,QOLRAD为0.79 - 0.95。GSRS的重测信度为0.36 - 0.75,QOLRAD为0.41 - 0.82。在大多数语言版本中,GSRS腹痛领域与所有QOLRAD领域显著相关,在所有版本中与SF - 36身体疼痛领域显著相关。在大多数版本中,QOLRAD领域与大多数SF - 36领域显著相关。两份问卷都能够区分健康状况因症状频率和严重程度而异的患者。
发现GSRS和QOLRAD不同语言版本的心理测量特征良好,具有可接受的信度和效度。在跨国临床试验中,GSRS和QOLRAD被发现可用于评估消化不良症状及其对患者日常生活的影响。