Allen Luke, Kim Min, Tlhajoane Malebogo, Macleod David, Nkomazana Oathokwa, Gichangi Michael, Mishra Sailesh, Sabherwal Shalinder, Carpenter James R, Karanja Sarah, Ho-Foster Ari, Ratshaa Bakgaki, Bolster Nigel, Ramke Jacqueline, Burton Matthew J, Bastawrous Andrew
London School of Hygiene & Tropical Medicine, London, UK
London School of Hygiene & Tropical Medicine, London, UK.
BMJ Open. 2025 Feb 2;15(1):e085353. doi: 10.1136/bmjopen-2024-085353.
Only 30%-50% of people referred to clinics during community-based eye screening are able to access care in Botswana, India, Kenya and Nepal. The access rate is even lower for certain population groups. This platform trial aims to test multiple, iterative, low-risk public health interventions and simple service modifications with a series of individual randomised controlled trials (RCT) conducted in each country, with the aim of increasing the proportion of people attending.
We will set up a platform trial in each country to govern the running of a series of pragmatic, adaptive, embedded, parallel, multiarm, superiority RCTs to test a series of service modifications suggested by intended service users. The aim is to identify serial marginal gains that cumulatively result in large improvements to equity and access. The primary outcome will be the probability of accessing treatment among the population group with the worst access at baseline. We will calculate Bayesian posterior probabilities of clinic attendance in each arm every 72 hours. Each RCT will continually recruit participants until the following default stopping rules have been met: >95% probability that one arm is best; >95% probability that the difference between the best arm and the arms remaining in the trial is <1%; or 10 000 people have been recruited. Lower thresholds may be used for RCTs testing interventions with very low risks and costs. The specific design of cluster RCTs will be determined by our research team once the intervention is known, but the population and outcome will be the same across all trials.This adaptive platform trial will be used to identify effective service modifications, driving continuous improvements in access.
This trial has been approved by the research ethics committee at the London School of Hygiene & Tropical Medicine (ref: 29549). Approvals for individual interventions will be sought from UK and local ethics committees. Results will be shared via local workshops, social media and peer-reviewed publications.
ISRCTN53970958.
在博茨瓦纳、印度、肯尼亚和尼泊尔，参加社区眼部筛查并被转诊至诊所的人群中，只有30%-50%的人能够获得医疗服务。某些人群的就诊率甚至更低。本平台试验旨在通过在每个国家开展一系列个体随机对照试验（RCT），测试多种迭代式低风险公共卫生干预措施和简单的服务改进措施，以提高就诊人数的比例。
我们将在每个国家设立一个平台试验，以管理一系列实用、适应性、嵌入式、平行、多组、优效性RCT的运行，测试目标服务使用者提出的一系列服务改进措施。目的是确定一系列边际收益，这些收益累计起来会大幅改善公平性和可及性。主要结局将是基线时就诊最难的人群获得治疗的概率。我们将每72小时计算每组就诊的贝叶斯后验概率。每个RCT将持续招募参与者，直到满足以下默认停止规则：某一组最佳的概率>95%；最佳组与试验中其余组之间的差异<1%的概率>95%；或已招募10000人。对于测试风险和成本极低的干预措施的RCT，可使用更低的阈值。一旦确定干预措施，整群RCT的具体设计将由我们的研究团队确定，但所有试验的人群和结局将相同。这个适应性平台试验将用于确定有效的服务改进措施，推动可及性的持续改善。
本试验已获得伦敦卫生与热带医学院研究伦理委员会的批准（参考编号：29549）。将寻求英国和当地伦理委员会对个体干预措施的批准。结果将通过当地研讨会、社交媒体和同行评审出版物分享。
ISRCTN53970958。
