Juniper E F, Howland W C, Roberts N B, Thompson A K, King D R
Department of Clinical Epidemiology and Biostatistics, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.
J Allergy Clin Immunol. 1998 Feb;101(2 Pt 1):163-70. doi: 10.1016/s0091-6749(98)70380-x.
The objective of this study was to develop, pretest, and validate a questionnaire to measure quality of life in children with seasonal allergic rhinoconjunctivitis (SAR).
METHODS (DEVELOPMENT STUDY): Thirty-four children with SAR were enrolled from summer camps, notices in the media, and an allergy clinic (Southern Ontario). After generating a pool of 48 potentially important quality of life items, the children identified the ones that they experienced with their SAR and scored each for bother (1 = a little bothered to 4 = extremely bothered). Items identified most frequently and with the highest bother score were included in the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ). The PRQLQ was pretested for ease completion and accuracy of understanding.
RESULTS (DEVELOPMENT STUDY): The PRQLQ has 23 items in five domains (nose symptoms, eye symptoms, practical problems, other symptoms, and activities). Responses are given on a seven-point scale, and children are asked to score their experiences during the previous 7 days.
METHODS (VALIDATION STUDY): Seventy-five children with symptomatic SAR were enrolled from notices in the media and a pediatric allergy clinic (Austin, Tex.). A single cohort design was used, with children assessed at 0, 1, and 3 weeks. The PRQLQ was administered to the children by a trained interviewer at 1 and 3 weeks. A conventional nasal symptom daily diary was completed for 1 week before each of these clinic visits. Global ratings were completed at the final visit.
RESULTS (VALIDATION STUDY): In patients who were stable between clinic visits, the PRQLQ demonstrated good reliability (intraclass correlation coefficient = 0.93). The questionnaire was very responsive to change (p < 0.001) and was able to differentiate between patients who were in a stable clinical state and those whose clinical state changed between visits (p = 0.005). Correlations between the PRQLQ and diary scores were close to predicted and supported both the cross-sectional and longitudinal validity of the PRQLQ.
The PRQLQ measures the quality of life impairments important to children with SAR. Children provide reliable and accurate responses, the measurement properties are strong, and the questionnaire can be used with confidence in clinical trials, clinical practice, and surveys.
本研究的目的是开发、预测试并验证一份用于测量季节性变应性鼻结膜炎(SAR)患儿生活质量的问卷。
方法(开发研究):从夏令营、媒体公告以及一家过敏诊所(安大略省南部)招募了34名SAR患儿。在生成了48个可能对生活质量重要的项目库后,让患儿们确定他们在患SAR时所经历的项目,并对每个项目的困扰程度进行评分(1 = 有点困扰至4 = 极度困扰)。最常被提及且困扰评分最高的项目被纳入儿童鼻结膜炎生活质量问卷(PRQLQ)。对PRQLQ进行了预测试,以评估其填写的 ease 程度和理解的准确性。
结果(开发研究):PRQLQ在五个领域(鼻部症状、眼部症状、实际问题、其他症状和活动)有23个项目。回答采用七点量表,要求患儿对前7天的经历进行评分。
方法(验证研究):从媒体公告和一家儿科过敏诊所(德克萨斯州奥斯汀)招募了75名有症状的SAR患儿。采用单队列设计,在0、1和3周时对患儿进行评估。在1周和3周时,由经过培训的访谈者向患儿发放PRQLQ。在每次诊所就诊前1周完成一份常规的每日鼻部症状日记。在最后一次就诊时完成总体评分。
结果(验证研究):在诊所就诊期间病情稳定的患者中,PRQLQ显示出良好的信度(组内相关系数 = 0.93)。该问卷对变化非常敏感(p < 0.001),并且能够区分临床状态稳定的患者和就诊期间临床状态发生变化的患者(p = 0.005)。PRQLQ与日记评分之间的相关性接近预测值,支持了PRQLQ的横断面和纵向效度。
PRQLQ能够测量对SAR患儿重要的生活质量损害。患儿能够提供可靠且准确的回答,测量特性良好,该问卷可放心用于临床试验、临床实践和调查。