Kelleher Maeve M, Hourihane Jonathan O'B, Dunngalvin Audrey, Cullinane Claire, Fitzsimons John, Sheikh Aziz
Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.
BMJ Open. 2012 Aug 13;2(4). doi: 10.1136/bmjopen-2012-001282. Print 2012.
Anaphylaxis is an important, potentially life-threatening paediatric emergency. It is responsible for considerable morbidity and, in some cases, death. Poor outcomes may be associated with an inability to differentiate between milder and potentially more severe reactions and an associated reluctance to administer self-injectable adrenaline. This study aims to assess the effectiveness of a 24-h telephone access to specialist paediatric allergy expert advice in improving the quality of life of children and their families with potentially life-threatening food allergy (ie, anaphylaxis) compared with usual clinical care.
Children aged less than 16 years with food allergy and who carry an adrenaline autoinjector will be recruited from the Paediatric Allergy Clinic at Cork University Hospital, Ireland and baseline disease-specific quality of life will be ascertained using the validated Food Allergy Quality of Life Questionnaire (FAQLQ). Participants will be randomised for a period of 6 months to the 24-h telephone specialist support line or usual care. The primary outcome measure of interest is a change in FAQLQ scores, which will be assessed at 0, 1 and 6 months postrandomisation. Analysis will be on an intention-to-treat basis using a 2×3 repeated measures within-between analysis of variance. Although lacking power, we will in addition assess the impact of the intervention on a range of relevant process and clinical endpoints.
This trial protocol has been approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. The findings will be presented at international scientific conferences and will be reported on in the peer-reviewed literature in early 2013.
过敏反应是一种重要的、可能危及生命的儿科急症。它会导致相当高的发病率，在某些情况下还会导致死亡。不良后果可能与无法区分较轻和潜在更严重的反应以及不愿使用自动注射肾上腺素有关。本研究旨在评估与常规临床护理相比，通过24小时电话获得儿科过敏专科专家建议对患有潜在危及生命的食物过敏（即过敏反应）的儿童及其家庭生活质量的改善效果。
将从爱尔兰科克大学医院儿科过敏诊所招募年龄小于16岁、患有食物过敏且携带肾上腺素自动注射器的儿童，并使用经过验证的食物过敏生活质量问卷（FAQLQ）确定疾病特异性生活质量基线。参与者将被随机分配接受为期6个月的24小时电话专科支持热线或常规护理。感兴趣的主要结局指标是FAQLQ评分的变化，将在随机分组后的0、1和6个月进行评估。分析将采用意向性分析方法，使用2×3重复测量的组内-组间方差分析。尽管效力不足，但我们还将评估干预措施对一系列相关过程和临床终点的影响。
本试验方案已获得科克教学医院临床研究伦理委员会的批准。研究结果将在国际科学会议上展示，并将于2013年初在同行评审的文献中报道。
