Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal
Introduction 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 interven...
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BMJ Publishing Group
2025-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e085353.full |
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| author | Min Kim David Macleod Michael Gichangi Andrew Bastawrous Matthew J Burton Jacqueline Ramke Oathokwa Nkomazana James R Carpenter Sailesh Mishra Shalinder Sabherwal Luke Allen Sarah Karanja Ari Ho-Foster Nigel Bolster Malebogo Tlhajoane Bakgaki Ratshaa |
| author_facet | Min Kim David Macleod Michael Gichangi Andrew Bastawrous Matthew J Burton Jacqueline Ramke Oathokwa Nkomazana James R Carpenter Sailesh Mishra Shalinder Sabherwal Luke Allen Sarah Karanja Ari Ho-Foster Nigel Bolster Malebogo Tlhajoane Bakgaki Ratshaa |
| author_sort | Min Kim |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ISRCTN53970958. |
| format | Article |
| id | doaj-art-677998163d0144399dcccad7a3fce2fc |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-677998163d0144399dcccad7a3fce2fc2025-02-03T04:20:09ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115110.1136/bmjopen-2024-085353Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and NepalMin Kim0David Macleod1Michael Gichangi2Andrew Bastawrous3Matthew J Burton4Jacqueline Ramke5Oathokwa Nkomazana6James R Carpenter7Sailesh Mishra8Shalinder Sabherwal9Luke Allen10Sarah Karanja11Ari Ho-Foster12Nigel Bolster13Malebogo Tlhajoane14Bakgaki Ratshaa15London School of Hygiene & Tropical Medicine, London, UKLondon School of Hygiene & Tropical Medicine, London, UKMinistry of Public Health and Sanitation, Division of Preventive Ophthalmic Services, Nairobi, KenyaLondon School of Hygiene & Tropical Medicine, London, UKLondon School of Hygiene & Tropical Medicine, London, UKLondon School of Hygiene & Tropical Medicine, London, UKDepartment of Surgery, Faculty of Medicine, University of Botswana, Gaborone, BotswanaLondon School of Hygiene & Tropical Medicine, London, UKNepal Netra Jyoti Sangh, Kathmandu, NepalDr Shroff`s Charity Eye Hospital Delhi, Delhi, New Delhi, IndiaLondon School of Hygiene & Tropical Medicine, London, UKPopulation Health and Primary Care, Kenya Medical Research Institute, Nairobi, KenyaDepartment of Health Sciences, Faculty of Medicine, University of Botswana, Gaborone, BotswanaLondon School of Hygiene & Tropical Medicine, London, UKLondon School of Hygiene & Tropical Medicine, London, UKDepartment of Health Sciences, Faculty of Medicine, University of Botswana, Gaborone, BotswanaIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number ISRCTN53970958.https://bmjopen.bmj.com/content/15/1/e085353.full |
| spellingShingle | Min Kim David Macleod Michael Gichangi Andrew Bastawrous Matthew J Burton Jacqueline Ramke Oathokwa Nkomazana James R Carpenter Sailesh Mishra Shalinder Sabherwal Luke Allen Sarah Karanja Ari Ho-Foster Nigel Bolster Malebogo Tlhajoane Bakgaki Ratshaa Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal BMJ Open |
| title | Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal |
| title_full | Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal |
| title_fullStr | Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal |
| title_full_unstemmed | Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal |
| title_short | Protocol for an adaptive platform trial of intended service user-derived interventions to equitably reduce non-attendance in eye screening programmes in Botswana, India, Kenya and Nepal |
| title_sort | protocol for an adaptive platform trial of intended service user derived interventions to equitably reduce non attendance in eye screening programmes in botswana india kenya and nepal |
| url | https://bmjopen.bmj.com/content/15/1/e085353.full |
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