Protocol for developing an evidence-based expert consensus on efficacy evaluation and comorbidity management of integrated Chinese and Western medicine for pediatric tic disorders: a GRADE-based modified Delphi study.

چکیده اصلی

BACKGROUND: Pediatric tic disorders (TD) are common neurodevelopmental conditions frequently complicated by attention-deficit/hyperactivity disorder, obsessive-compulsive disorder, anxiety, and depression. Integrated Chinese and Western medicine is widely used in China, but its efficacy evaluation and comorbidity management lack standardized, evidence-anchored consensus methodologies. OBJECTIVE: To describe the protocol for developing an evidence-based expert consensus on efficacy evaluation and comorbidity management of integrated Chinese-Western medicine for pediatric TD, using a GRADE-informed modified Delphi process. METHODS: The consensus will be developed in six phases: (1) setup and scoping, including a multidisciplinary, cross-regional Development Panel and identification of core clinical questions; (2) systematic literature search, quality appraisal (AMSTAR 2, RoB 2, ROBINS-I, QUADAS-2, AGREE II, and JBI checklists), and GRADE certainty assessment; (3) a three-round modified Delphi survey with ≥75% consensus threshold, anonymous voting, and controlled feedback; (4) a planned hybrid consensus meeting to adjudicate unresolved items, with two-stage voting (adoption then strength) and predefined decision rules; (5) drafting, external review, and final endorsement; and (6) dissemination and updating. Good Practice Statements (GPS) will be distinguished from evidence-based recommendations. EXPECTED OUTCOMES: This protocol seeks to generate: (1) core recommendation statements; (2) an integrated efficacy evaluation framework spanning tic severity, TCM syndromes, and functional status; (3) targeted management pathways for prevalent comorbidities (ADHD, OCD, anxiety/depression); and (4) standardized safety monitoring principles. CONCLUSION: This protocol presents a transparent, reproducible, and GRADE-aligned methodology for developing an integrative consensus in pediatric TD. It may serve as a methodological reference for future integrative guideline development.

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