Smart Analysis and Decision-Making for Emerging Infectious Diseases (SMART-ID)

This is a multicenter, cluster-randomized controlled trial (cRCT) with a single-blind design (blinding of statisticians). The study will be conducted across five provinces/municipalities: Guangdong, Zhejiang, Hubei, Sichuan, and Shanghai. A total of 52 district/county/city-level Centers for Disease Control and Prevention (CDCs) will be selected as study clusters and randomized 1:1 to either the intervention group (26 clusters) or the control group (26 clusters).

Randomization Procedure: For the four provinces (Zhejiang, Guangdong, Hubei, Sichuan), CDC clusters will be stratified by socioeconomic level (high, medium, low), with 2 prefecture-level CDCs randomly selected from each stratum and allocated to intervention or control. For Shanghai municipality, CDCs will be stratified by urban functional zone (central urban vs. new/suburban districts), with 2 district-level CDCs selected from each stratum and randomly allocated.

Intervention: The intervention group will use a multi-agent integrated toolkit (including data-knowledge agent, assessment agent, decision agent, and evaluation agent) to assist with epidemic risk perception, situational assessment, and emergency decision-making, in addition to routine practices. The control group will follow routine practices only.

Follow-up Plan: The intervention period is 3 months, timed to coincide with peak seasons for specific infectious diseases (winter/spring for respiratory infections; summer/autumn for vector-borne diseases like dengue). Follow-up assessments will occur every 3 months, with the endpoint defined as the conclusion of an emerging infectious disease event.

Sample Size: Using PASS software (α=0.05, Power=80%, ICC=0.05, CV=0.5, average cluster size m=15), assuming an 80% improvement in decision-making efficiency in the intervention group (response time reduced from 24 to approximately 19 hours), with a 10% attrition rate, a minimum of 28 clusters is required. This study will enroll 52 clusters (approximately 780 participants), exceeding the minimum requirement.

Data Management: Dual independent data entry will be performed. Data will be stored on Peking University's encrypted servers, with backups on the university cloud platform and offline encrypted hard drives (AES-256 encryption). All data will be physically destroyed after the retention period.

Missing Data: Analysis will follow the intention-to-treat (ITT) principle. Missing primary outcome data will be handled using the last observation carried forward (LOCF) method.

Safety Evaluation: Adverse events include headache and absenteeism, classified using a five-level attribution scale (definitely, probably, possibly, probably not, definitely not related), with the first three categories counted as adverse reaction rates. Any serious adverse event must be reported immediately to the sponsor and/or ethics committee.

Early Termination: The study may be terminated early under the following conditions: (1) identification of serious safety issues; (2) the toolkit proves ineffective or futile; (3) major protocol flaws or implementation deviations; (4) request by the applicant or administrative authority.