DEVELOPING A KOREAN MEDICINE CORE OUTCOME SET FOR ALLERGIC RHINITIS AND APPLYING IT IN A PRACTICE-BASED RESEARCH NETWORK: REAL-WORLD EVIDENCE FOR HERBAL MEDICINE IN PEDIATRIC PATIENTS
Author(s)
MIJU SON, Ph.D.1, Sungha Kim, Ph.D2.
1Principal researcher, Korea Institute of Oriental Medicine, Daejeon, Korea, Republic of, 2Korea Institute of Oriental Medicine, Daejeon, Korea, Republic of.
1Principal researcher, Korea Institute of Oriental Medicine, Daejeon, Korea, Republic of, 2Korea Institute of Oriental Medicine, Daejeon, Korea, Republic of.
OBJECTIVES: Heterogeneous outcome reporting limits evidence synthesis for herbal medicine (HM) in allergic rhinitis (AR). We aimed to (1) develop a Korean Medicine Core Outcome Set for AR (COS-AR-KM) to standardize outcome selection, and (2) demonstrate its application by evaluating real-world effectiveness and safety of personalized decoction HM (D-HM) for pediatric AR within a practice-based research network (PBRN).
METHODS: The COS-AR-KM was developed following COMET (COS-STAD/COS-STAR) methodology, comprising an overview of systematic reviews to generate candidate outcomes and effect modifiers, a two-round modified Delphi consensus (12 experts; content validity ratio, consensus, convergence), and a usability evaluation by 9 primary-care clinicians, with separate sets for adult and pediatric/adolescent patients. Core outcomes were then operationalized in a retrospective observational PBRN study of 30 children (aged 6-15) with AR treated with 4-week personalized D-HM across 27 Korean Medicine clinics affiliated with the Daejeon Metropolitan Association of Korean Medicine. The primary outcome was the Total Nasal Symptom Score (TNSS); secondary outcomes included quality of life (QoL-KCAR), digestion and sleep numeric rating scales, satisfaction, and adverse events (AEs).
RESULTS: The COS-AR-KM consensus process yielded core domains covering disease-specific symptom scales, patient-reported outcomes, safety (hepatic/renal laboratory tests, concomitant medication), and Korean Medicine-specific effect modifiers. In the PBRN application, mean TNSS decreased from 7.03 (95% CI 6.39-7.67) to 3.00 (95% CI 2.36-3.64), a 4.03-point (57.3%) reduction (p<0.0001), exceeding the minimal clinically important difference. QoL-KCAR improved by 12.60 points (64.2%; p<0.0001); digestion and sleep scores improved significantly (both p<0.01). Satisfaction was high (23.13/25). Only 3 (10%) patients had mild treatment-related AEs, all resolved.
CONCLUSIONS: A rigorously developed core outcome set enabled standardized real-world evaluation of herbal medicine for pediatric AR. The PBRN application showed clinically meaningful symptom and quality-of-life improvement with a favorable safety profile, supporting D-HM as a viable primary-care option and informing reimbursement and future trial design.
METHODS: The COS-AR-KM was developed following COMET (COS-STAD/COS-STAR) methodology, comprising an overview of systematic reviews to generate candidate outcomes and effect modifiers, a two-round modified Delphi consensus (12 experts; content validity ratio, consensus, convergence), and a usability evaluation by 9 primary-care clinicians, with separate sets for adult and pediatric/adolescent patients. Core outcomes were then operationalized in a retrospective observational PBRN study of 30 children (aged 6-15) with AR treated with 4-week personalized D-HM across 27 Korean Medicine clinics affiliated with the Daejeon Metropolitan Association of Korean Medicine. The primary outcome was the Total Nasal Symptom Score (TNSS); secondary outcomes included quality of life (QoL-KCAR), digestion and sleep numeric rating scales, satisfaction, and adverse events (AEs).
RESULTS: The COS-AR-KM consensus process yielded core domains covering disease-specific symptom scales, patient-reported outcomes, safety (hepatic/renal laboratory tests, concomitant medication), and Korean Medicine-specific effect modifiers. In the PBRN application, mean TNSS decreased from 7.03 (95% CI 6.39-7.67) to 3.00 (95% CI 2.36-3.64), a 4.03-point (57.3%) reduction (p<0.0001), exceeding the minimal clinically important difference. QoL-KCAR improved by 12.60 points (64.2%; p<0.0001); digestion and sleep scores improved significantly (both p<0.01). Satisfaction was high (23.13/25). Only 3 (10%) patients had mild treatment-related AEs, all resolved.
CONCLUSIONS: A rigorously developed core outcome set enabled standardized real-world evaluation of herbal medicine for pediatric AR. The PBRN application showed clinically meaningful symptom and quality-of-life improvement with a favorable safety profile, supporting D-HM as a viable primary-care option and informing reimbursement and future trial design.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
RWD2
Topic
Clinical Outcomes, Organizational Practices, Real World Data & Information Systems
Topic Subcategory
Distributed Data & Research Networks
Disease
Alternative Medicine, No Additional Disease & Conditions/Specialized Treatment Areas, Pediatrics, Personalized & Precision Medicine, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)