Chronic cough is a common and burdensome condition in children, with complex and overlapping etiologies that often lead to delayed diagnosis, misdiagnosis, and inappropriate treatment. This prospective, controlled, observational study aims to develop and clinically validate a Wenjuanxing-based, parent-reported, multidimensional etiologic screening questionnaire for pediatric chronic cough. Children aged 3-18 years presenting with cough lasting ≥2 weeks will be enrolled in a tertiary pediatric respiratory clinic and allocated to either a routine-care group or a questionnaire-assisted group. All caregivers will complete the standardized electronic questionnaire, which generates an automated preliminary etiologic suggestion based on symptom patterns, triggers, and associated features. Diagnostic accuracy, treatment effectiveness, and symptom resolution will be evaluated through structured follow-up at two weeks. The primary outcome is the difference in diagnostic accuracy between physicians using routine assessment alone and those supported by the questionnaire. Secondary outcomes include treatment response and prevention of cough chronicity. This study seeks to provide evidence for a scalable, digital, and standardized screening tool to improve early etiologic identification and clinical decision-making in pediatric chronic cough.
Children aged 3 to 18 years, any sex.
Presenting for medical care due to cough lasting ≥2 weeks.
No fever within the past 2 weeks.
Caregiver is willing to complete the Wenjuanxing questionnaire and agree to follow-up.
Presence of congenital airway malformations, chronic lung disease, or severe immunodeficiency.
Recent participation in other interventional clinical research.
Unable to complete follow-up as required.
Children aged 3 to 18 years presenting to the pediatric respiratory outpatient clinic of Shanghai Children's Medical Center with cough lasting at least 2 weeks will be eligible for enrollment. The study population consists of symptomatic pediatric patients without fever in the preceding two weeks, whose caregivers are willing to complete an electronic questionnaire and participate in follow-up assessments. Participants will receive routine clinical evaluation and management according to standard practice, with or without access to questionnaire-generated etiologic suggestions, depending on study group assignment.
Cohort
Prospective
No intervention (observational study)
Other interventionNo intervention (observational study)
Diagnostic Accuracy of Initial Etiologic Assessment for Pediatric Chronic Cough
Diagnostic accuracy is defined as the concordance between the initial etiologic diagnosis made at the first outpatient visit and the post hoc clinical validation based on symptom response during follow-up. Caregivers will be contacted approximately two weeks after the initial visit and asked to report changes in cough symptoms using a standardized follow-up protocol. An initial diagnosis will be considered correct if the prescribed treatment results in marked improvement or resolution of cough symptoms, as assessed by caregiver-reported symptom improvement and overall treatment effectiveness. The diagnostic accuracy will be compared between the routine-care group and the questionnaire-assisted group.
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