The Lancet. Global health · 2026
Enhanced patient counselling and SMS reminder messages to improve access to community-based eye care services in Meru, Kenya: an embedded, pragmatic, individual-level, randomised, controlled, adaptive platform trial.
СтатьяРандомизированное исследованиеPragmatic Clinical TrialНазвание и аннотация: Перевод в очереди
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Allen Luke N, Kim Min Jung, Gichangi Michael, Macleod David, Carpenter James, Tlhajoane Malebogo, Karanja Sarah, Bolster Nigel, Bunywera Cosmas, Rono Hilary, Merletti Francesco, Tadesse Demissie, Odero Kennedy, Munyendo David, Njeru Aphiud, Murira Solomon, Omoga Thadeus, Mutunga Amos, Burton Matthew, Bastawrous Andrew
Аннотация
BACKGROUND: In Meru county, Kenya, only 46% of people identified with an eye problem during screening go on to access eye care services at local clinics, with younger adults (aged 18-44 years) being the least likely to receive eye care. This study aimed to test whether provision of additional information was associated with better access to eye services, compared with standard care.
METHODS: We developed enhanced counselling and SMS reminders with lay input and tested this bundled intervention against standard care using a pragmatic, two-arm, open-label, randomised controlled trial, embedded within Meru's ongoing eye screening programme. All consenting referred adults were enrolled. The primary outcome was the proportion of referred younger adults who accessed their local clinic following referral. We used Bayesian methods and Monte Carlo simulations to generate the posterior probability distribution of the effect difference between the groups every 7 days. Participants were continually recruited until one of two stopping rules were met: there was a greater than 95% probability that either one group was more effective (stopping for superiority), or that the difference between the groups was less than 1% (stopping for equivalence). This completed trial was registered with ISRCTN (11329596).
FINDINGS: The trial ran from May 21 to June 20, 2024. A total of 7356 individuals had been screened and referred. Of these, 2321 consented to participate and were randomly assigned to a group (1140 in the control group and 1181 in the intervention group). All 2321 participants had complete follow-up data (ie, 14 days had elapsed since their appointment date). Our testing algorithm stopped the trial after 30 days based on analysis of outcome data from 879 younger adults. 147 (32·1%) of 458 younger adults in the control group had accessed care versus 164 (39·0%) of 421 younger adults in the intervention group, resulting in a 98·6% posterior probability that the intervention group was superior among younger adults.
INTERPRETATION: This trial found evidence that an intervention bundle with enhanced counselling and SMS reminders, as suggested by an underserved population, increased access to care. This embedded, adaptive, equity-focused approach has broad applications, aligned with the principle of proportionate universalism.
FUNDING: National Institute for Health Research (NIHR; using the UK's Official Development Assistance funding) and NIHR-Wellcome Partnership for Global Health Research.
TRANSLATION: For the Swahili translation of the abstract see Supplementary Materials section.
METHODS: We developed enhanced counselling and SMS reminders with lay input and tested this bundled intervention against standard care using a pragmatic, two-arm, open-label, randomised controlled trial, embedded within Meru's ongoing eye screening programme. All consenting referred adults were enrolled. The primary outcome was the proportion of referred younger adults who accessed their local clinic following referral. We used Bayesian methods and Monte Carlo simulations to generate the posterior probability distribution of the effect difference between the groups every 7 days. Participants were continually recruited until one of two stopping rules were met: there was a greater than 95% probability that either one group was more effective (stopping for superiority), or that the difference between the groups was less than 1% (stopping for equivalence). This completed trial was registered with ISRCTN (11329596).
FINDINGS: The trial ran from May 21 to June 20, 2024. A total of 7356 individuals had been screened and referred. Of these, 2321 consented to participate and were randomly assigned to a group (1140 in the control group and 1181 in the intervention group). All 2321 participants had complete follow-up data (ie, 14 days had elapsed since their appointment date). Our testing algorithm stopped the trial after 30 days based on analysis of outcome data from 879 younger adults. 147 (32·1%) of 458 younger adults in the control group had accessed care versus 164 (39·0%) of 421 younger adults in the intervention group, resulting in a 98·6% posterior probability that the intervention group was superior among younger adults.
INTERPRETATION: This trial found evidence that an intervention bundle with enhanced counselling and SMS reminders, as suggested by an underserved population, increased access to care. This embedded, adaptive, equity-focused approach has broad applications, aligned with the principle of proportionate universalism.
FUNDING: National Institute for Health Research (NIHR; using the UK's Official Development Assistance funding) and NIHR-Wellcome Partnership for Global Health Research.
TRANSLATION: For the Swahili translation of the abstract see Supplementary Materials section.