Ardestani Samaneh Khanpour, Robinson Joan L, Jou Hsing, Dieleman Levinus A, Huynh Hien Q, Vohra Sunita
Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Department of Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.
PLoS One. 2025 Jun 4;20(6):e0325436. doi: 10.1371/journal.pone.0325436. eCollection 2025.
To develop and validate a patient/proxy-reported measure of the incidence and severity of pediatric antibiotic-associated diarrhea (PAAD) in inpatient and outpatient settings.
A patient advisory group, consisting of five parents and two children, was engaged as a research partner. Instrument items were developed from three sources: relevant items from two previously validated instruments; relevant constructs from a newly developed core outcome measurement set; and outcomes identified by parents and clinicians as being the most important. In a prospective observational study, children (birth to 17 years old) newly prescribed antibiotics or on antibiotics for ≤ 7 days, were included and assessed at the time of presentation and daily thereafter until two weeks after antibiotic therapy was completed. Internal consistency and convergent validity of the instrument were examined.
Of 78 patients who agreed to participate and met the eligibility criteria, 30(38%) were lost to follow-up; Data from the remaining 48 were analyzed. By applying four different definitions of diarrhea, we found a broad range of incidence risks of PAAD (27%-83%). PAAD was more likely to develop in younger age groups (≤ 3 years old). Cronbach's α for the severity scale was less than 0.7. A high correlation was found between the PAAD severity score and numerical rating score of diarrhea severity reported by parents (r > 0.5).
The PAAD instrument is the first designed to measure the incidence and severity of PAAD. The instrument has content and construct validity. For reliability analyses of the severity scale, larger studies are required.
开发并验证一种由患者/代理人报告的、用于衡量住院和门诊环境下儿童抗生素相关性腹泻（PAAD）发生率及严重程度的指标。
一个由五名家长和两名儿童组成的患者咨询小组作为研究伙伴参与其中。指标项目来自三个来源：两种先前已验证工具中的相关项目；一个新开发的核心结局测量集中的相关结构；以及家长和临床医生确定为最重要的结局。在一项前瞻性观察研究中，纳入新开具抗生素处方或使用抗生素≤7天的儿童（出生至17岁），在就诊时进行评估，此后每天评估，直至抗生素治疗结束后两周。检验该指标的内部一致性和收敛效度。
78名同意参与并符合纳入标准的患者中，30名（38%）失访；对其余48名患者的数据进行了分析。通过应用四种不同的腹泻定义，我们发现PAAD的发生率风险范围很广（27%-83%）。PAAD在较年轻年龄组（≤3岁）中更易发生。严重程度量表的Cronbach's α小于0.7。PAAD严重程度评分与家长报告的腹泻严重程度数字评分之间存在高度相关性（r>0.5）。
PAAD指标是首个旨在测量PAAD发生率和严重程度的指标。该指标具有内容效度和结构效度。对于严重程度量表的信度分析，需要更大规模的研究。
