SWISH (See Well to Stay In ScHool: Randomised trial of spectacle distribution to decrease secondary school dropout rates in rural communities)

What we want to know: Will giving free glasses to short-sighted Chinese children in poor rural areas, and working with teachers to encourage them to use the glasses in class, result in more children going on to high school?

Type of study: Called a "trial," this kind of study chooses at random (like flipping a coin) the study group that all children in a particular school will be in.

Why the study is needed: Chinese children are some of the most short-sighted in the world, but only one in five children in poor areas who needs glasses has them. Our team has already showed in other trials that giving children free glasses leads to better grades, and that free glasses have a bigger impact on grades than factors like parents' education level and the amount of money a family has. The effect on grades from glasses is greater than from other health services in school, like giving vitamins. Only about one in three children in rural western China goes on to a regular, non-vocational high school. We would like to show the Chinese government strong evidence of what glasses can do to help children continue their education, in order to help convince the government to carry out national programs to provide free glasses for children who need them.

Study Plan: We will choose 130 middle schools at random in Ningxia, western China, and all children in Years 1 and 2 (one class each) at each school will go at random into one of two groups: either a group getting free glasses, with support from teachers to push them to wear the glasses ("Intervention") or a group getting just glasses prescriptions ("Control.") The study will mainly look at the rate of children going on to high school, and is large enough to find out whether we produced at least a 10% rise in this number. We'll also look at the children's test scores, whether they wear their glasses at school, and how often they use blackboards (harder for short-sighted kids to see) or textbooks to learn from. These other things will help us to better understand whether the idea that making the vision better with glasses leads to better grades and then to higher rates of going on to high school really makes logical sense. We'll also study how much it costs to give the glasses and the teacher support to wear them, compared to how much benefit it brings to children. We will also study the thinking of students, teachers and parents about wearing glasses and staying in school, to make sure our approaches are suitable in this area.

Study Team: Dr Congdon, the head of the study, is an eye doctor and public health expert who speaks fluent Chinese. He works at both the UK (Queen's) and Chinese (Zhongshan) universities seeking this grant. Also at Queen's there are specialists in this type of study (trials), an expert data analyst who speaks Chinese, an expert to carry out the part of the study looking at costs and benefits, and also a cultural expert to help us understand local attitudes about wearing glasses and staying in school. Working with us in China are staff at Zhongshan, the top eye hospital in China and a center for doing trials such as this one, and Shaanxi Normal (teacher training) University, which has very close connections to the bureau running the schools in Ningxia where we plan to work. Another partner is an American group, REAP, at Stanford University. They are experts in doing studies to prove what changes help rural Chinese schools to improve. Our team has worked together on many trials on glasses like this one in Chinese schools.

Research question: Will providing free glasses to myopic rural Chinese students, with a teacher incentive to promote use, increase high school attendance?

Design: Cluster-randomised controlled trial

Rationale: Rural Chinese children have high myopia prevalence, but poor access to glasses. Our previous trials show giving free glasses significantly improves academic performance, with greater effect size than parental education or family income, equaling or exceeding other classroom-based medical interventions. Non-vocational high school attendance is only 30% in rural western China. Strong evidence of educational benefit from glasses is needed to spur adoption of national distribution programs.

Methods: Children in Year 1 and 2 (1 class each) at 130 randomly-selected middle schools in Ningxia, western China, will be randomized by school to receive free glasses and a trial-proven teacher-based incentive to promote wear (Intervention) or prescriptions only (Control). The main outcome 2-3 years later will be high school attendance (powered to detect 10% increase); secondary outcomes of compliance, test scores and use of near versus distance classroom learning aids will elucidate biological plausibility of a causal pathway between myopia correction and learning. Local knowledge and attitudes about myopia and spectacle use and intervention cost-effectiveness will be studied.

Team: PI Congdon, a public health ophthalmologist, is fluent in Chinese and has appointments at the UK (Queen's) and Chinese (Zhongshan) applicant institutions. The Queen's team includes a trialist, Chinese-speaking statistician, health economist and medical anthropologist. Chinese collaborating institutions are Zhongshan, China's leading eye hospital, and Shaanxi Normal, with close ties to Ningxia education authorities. Trial partners include Stanford REAP, a leader in impact evaluation in Chinese schools. This team has conducted multiple trials on glasses and learning in China.

Importance: Over 90% of vision impairment among children in China and globally is due to uncorrected refractive error, estimated to affect over 100 million Chinese children and twice this number worldwide by 2020. Among underserved populations in China's rural west and 300 million urban migrants, only 15-20% of children needing spectacles have them, reflecting similar low numbers in other low and middle-income countries. Only governments have the resources to tackle this problem, and evidence of the educational benefits of providing spectacles to school-going children is crucial to bring the issue to their attention. A recently-announced Chinese national program targeting children's refractive error involving 8 government departments specifically cited educational impact of improved vision, for which our prior trials provide the best existing evidence. Evidence that spectacle provision does not just improve grades but can keep children in school is needed to galvanise further government action in low and middle-income countries world-wide.
Direct benefits of the proposed trial will include:
*Benefits to study participants: The SWISH trial will screen 14,500 children in poor, rural areas of Ningxia, provide glasses to 5400 and refer 250 children detected with eye disease besides refractive error to collaborating local county hospitals for management, generally covered by National Health Insurance. Our previous trials have shown that these children receiving glasses will experience significant academic benefits, and if the hypothesis of the proposed trial is correct, there will be lifelong economic benefits of additional schooling.
*Strengthening of partnerships: The trial will bring together local county hospitals (who will receive refractive training from Zhongshan), the Clinical Trial Unit at Zhongshan (where PI Congdon's team and trial statistician Jin will strengthen their research capacity through interaction with Congdon and other experts at Queen's) and health economists and educationalists at Shanxi Normal University, whose capacity to carry out and exploit data from trials will be strengthened by interacting with the Queen's and REAP teams. Existing partnerships between Queen's, REAP and eye health NGO Orbis, who will assist in spectacle distribution, will also be strengthened.
A positive trial result will benefit:
*Chinese children and families: Some 30 million Chinese children with un-corrected refractive error could improve their vision and chances of attending high school by receiving good-quality glasses through expanded government programs catalysed by trial evidence of educational benefit. Children and their families would receive better career opportunities afforded by better access to education, in fulfilment of the Convention on the Rights of the Child, VISION 2020 and Sustainable Development Goals 3 (Health and well-being), 4 (Quality education) and 10 (Reduced inequality).
*Chinese Ministries of Health and Education: Success of our project will aid in achieving a major goal of the Ministry of Health's 13th 5-Year Prevention of Blindness Plan, reducing the burden of un-corrected refractive error.
*Children, families and schools outside China: If proven successful in improving educational attainment, the spectacle distribution model used in SWISH can benefit children in under-served regions of low and middle-income countries globally, reducing school dropout rates by correcting refractive error, the leading cause of vision loss among children globally. Our team is engaged in research already to leverage findings from our Chinese trials world-wide. In July 2019, we begin the national PRISSM trial in India, to define and test a school-based model for spectacle distribution to the world's largest population of children. We have recently been funded by USAID to carry out the SEEDS program in Mongolia, testing novel models to deliver children's glasses in this challenging setting of very low population density.