Attendance at ophthalmology clinic among schoolchildren identified as requiring correction of visual impairment during a vision screening programme Eye Diseases
Conditions
Interventions
This is an evaluation of an algorithm's performance. The researchers have developed lines of code that can run a pilot embedded, pragmatic, four-arm, adaptive randomised controlled trial (RCT) whereby
and then to identify when the stopping criteria have been met (one arm is found to be best with >95% probability, or there is a >95% probability that the difference between the arms is <1%). Human sta
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Parents/guardians of children identified as needing referral for refractive services in Botswanan vision screening programmes run by ‘Peek Vision’ in 2022
Exclusion criteria
Exclusion criteria: 1. Participant does not speak English or Setswana 2. Participant does not have access to a mobile phone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Differences in the timing and magnitude of allocation adjustments, dropping of arms, and closure of the trial - comparing algorithm performance against human statisticians who will perform real-time review using the same data and underlying equations and criteria: 1.1. Daily assessment of the number of participants allocated to each arm by the algorithm in comparison to the number of participants allocated to each arm by human statisticians using the same outcome data 1.2. Date at which the algorithm concluded that a stopping rule has been satisfied (this includes dropping arms and stopping the trial) vs date at which human statisticians concluded that a stopping rule has been satisfied; report difference in days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Direct costs of setting up and running the software, compared to the estimated direct costs of using human statisticians to perform the same work. Costs will be calculated at the end of the study once the embedded RCT study has closed: 1.1. The researchers will collect information on two main costs components: the staff involved and the IT hardware and software equipment used in the trial. They will register a map of interrelations between all the activities performed by all the staff included in the trial (statisticians, epidemiologists, database developer and clinical trial managers) and the resources consumed measured in working hours. Activities include, for example, team meetings to conceptualise and plan the trial or algorithm design, and testing and monitoring conducted by the statistician. Staff wages and overheads will be obtained from LSHTM and Peek Payroll services. A list of all IT hardware and software equipment used during the clinical trial will also be recorded including workstation towers, laptops, monitors and printers. IT equipment characteristics, acquisition costs and annual depreciation will be collected from Peek and the International Centre for Eye Health. 1.2. All other costs, not directly related to a specific activity, will be included in an overhead cost category estimated at 15% of the cost of all activities performed, including costs connected with infrastructures and the general operation of the organisation, such as depreciation of buildings, water/gas/electricity, maintenances, insurances, supplies and office equipment, communication and connection costs, and costs connected with general services such as administrative and financial management, human resources, training, legal advice, and documentation. 1.3. To estimate the costs associated with future amendments/adaptations, a list of all the technical requirements will be produced by the statisticians and epidemiologists. Based on these requirements the researchers will estima | — |
Countries
Botswana
Outcome results
None listed