Effect of a Complex Intervention to Improve Post-Vision Screening Referral Compliance Among Pre-School Children in China: A Cluster Randomized Clinical Trial

Background: We investigated whether specific appointments for quality-assured care could increase referral uptake, often low in China, in children's vision screening. Methods: We randomized children aged 4-7 years in Yudu, Jiangxi, China, by school to Control (free school-based eye screening, parents of children failing screening recommended for further examination [usual practice]) or Intervention (identical examinations, with parents additionally provided with specific appointments for further examinations by quality-assured doctors at a designated local hospital). Both groups could select any hospital for referral exams, which were not free. Six months after screening, parents were interviewed on referral compliance and potential determinants. Findings: Among 9936 children at 63 schools randomized to Intervention (32 schools, 5053 [50·9%] children) or Control (31 schools, 4883 [49·1%] children), 1114 children (11·2%) failed screening. Among 513 referred Intervention children (46·1%, 32 schools, mean age 5·36 years, 53·0% boys) and 601 referred Control children (53·9%, 31 schools, mean age 5·30 years, 57·7 % boys), 104 (20·3%) and 135 (22·5%) were lost to follow-up respectively. Under Intention to Treat analysis, assuming children lost to follow-up were non-compliant, Intervention children had significantly higher compliance than Controls (308/513=60·0 % vs. 225/601=37·4%, P<0·001). In regression models, Intervention group membership (Relative risk [RR] 1·53, 95% confidence interval, 1·36-1·72), travel time to hospital (RR: 0·97, 0·95-0·999), baseline glasses wear (RR: 1·37, 1·17-1·60), strabismus (RR: 1·17, 1·01-1·36) and worse uncorrected vision (RR: 1·41, 1·03-1·92) were associated with compliance. Interpretation: Providing specific appointments for quality-assured eye care improved referral compliance in this setting. Funding: This study was funded by the National Natural Science Foundation of China (81530028; 81721003), Local Innovative and Research Teams Project of Guangdong Pearl River Talents Program; the State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University. Prof. Congdon is supported by the Ulverscroft Foundation (UK). Declaration of Interest: No conflicting relationship exists for any author. Ethical Approval: The study was approved by the Ethical Review Committee of the Zhongshan Ophthalmic Center (ZOC), Sun Yat-sen University, Guangzhou, China, and was conducted in accordance with the tenets of the Declaration of Helsinki.