Shaikh Nader, Martin Judith M, Casey Janet R, Pichichero Michael E, Wald Ellen R, Colborn D Kathleen, Gerber Michael A, Kearney Diana H, Balentine Tracy L, Haralam Mary Ann, Hoberman Alejandro
Division of General Academic Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Pediatrics. 2009 Oct;124(4):e557-63. doi: 10.1542/peds.2009-0331. Epub 2009 Sep 28.
The objective of this study was to develop a patient-reported outcome measure (Strep-PRO) for assessing symptoms of group A Streptococcus (GAS) pharyngitis from the child's point of view and to present preliminary data on its internal reliability, construct validity, and responsiveness.
We selected 8 symptoms for inclusion in the Strep-PRO. We used the Strep-PRO to assess improvement in children who were aged 5 to 15 years and had confirmed GAS pharyngitis. Children completed the scale at study visits and as a diary at home. To evaluate internal reliability, we examined correlations between the items on the scale. To evaluate construct validity, we examined the correlation at entry between Strep-PRO scores and scores on other, previously validated measures of pain and functional status. To evaluate responsiveness, we examined the change in score from enrollment to follow-up. The correlation between the Strep-PRO score and parental assessment of symptoms was also evaluated.
A total of 131 children were enrolled; 113 returned completed diaries. The internal reliability of the scale was high. The magnitude of correlations between Strep-PRO scores and other measures of pain and functional status ranged from 0.39 to 0.63. The responsiveness of the Strep-PRO was very good. The overall level of agreement between child Strep-PRO scores and parental assessment of symptoms was 0.57.
The scale seems to measure effectively both pain and overall functional status in children with GAS pharyngitis. These data support the use of Strep-PRO as a measure of outcome in future clinical trials.
本研究的目的是开发一种患者报告结局测量工具（Strep-PRO），从儿童的角度评估A组链球菌（GAS）咽炎的症状，并提供关于其内部信度、结构效度和反应度的初步数据。
我们选择了8种症状纳入Strep-PRO。我们使用Strep-PRO评估5至15岁确诊为GAS咽炎的儿童的改善情况。儿童在研究访视时完成该量表，并在家中作为日记记录。为了评估内部信度，我们检查了量表项目之间的相关性。为了评估结构效度，我们检查了入组时Strep-PRO得分与其他先前验证的疼痛和功能状态测量得分之间的相关性。为了评估反应度，我们检查了从入组到随访的得分变化。还评估了Strep-PRO得分与父母对症状评估之间的相关性。
共招募了131名儿童；113名儿童返回了完整的日记。该量表的内部信度较高。Strep-PRO得分与其他疼痛和功能状态测量得分之间的相关程度在0.39至0.63之间。Strep-PRO的反应度非常好。儿童Strep-PRO得分与父母对症状评估之间的总体一致性水平为0.57。
该量表似乎能有效测量GAS咽炎患儿的疼痛和整体功能状态。这些数据支持在未来的临床试验中使用Strep-PRO作为结局测量工具。
