Massive Online Open Validation and Evaluation of Large Language Models for Resource Constrained Settings - a Study of Contextual Awareness, Safety, and Accuracy (SilentMOOVE)
Healthcare settings in low and middle income countries, clinicians are frequently required to manage a wide range of acute conditions under the constraints of time pressure, limited diagnostic resources, and variable availability of up-to-date clinical guidelines. Large language models (LLMs), which can synthesize and generate medical information in a natural language, have been proposed as potential clinical decision support tools. Most evaluations of LLMs in medicine have relied on standardized benchmark examinations or hypothetical case vignettes, often derived from high-income country contexts. MOOVE (Massive online open validation and evaluation) framework was developed to address the need for rigorous and context-sensitive evaluation of LLMs through a staged approach.
Study is a non-interventional, prospective study designed to test LLMs safely in real clinical settings, evaluate their performance against human care, and explore how feasible their future implementation in healthcare might be.
Přehled studie
Detailní popis
SilentMOOVE (Silent massive online open validation and evaluation) phase of the MOOVE project, which represents the intermediate step between previous hypothetical testing study and future interventional trial. In silentMOOVE, patients are prospectively recruited during routine clinical care in participating outpatient health facilities. Clinical and demographic data collected during consultations are used to prompt LLMs retrospectively without influencing patient care. The routine diagnosis and care plan of the treating clinicians (human care plan) are also captured. LLM outputs are subsequently evaluated by a panel of independent clinical experts against the human care plan as a comparator. Patient clinical outcomes are collected on 7 and 28 days after enrolment to establish a baseline and to be used in the evaluation of LLMs.
The rationale for this study is to generate robust, prospective evidence on the safety and performance of LLMs in real-world clinical contexts, while minimizing risk to participants by fully separating model evaluation from clinical decision-making.
Study also provides the opportunity to assess the usability and gather early insights on implementation readiness of the LLM prompting interface. For this reason, besides evaluating the performance and safety of various LLMs, this study includes an implementation feasibility component. These activities are needed to better understand the context and any amelioration needed before future implementation in healthcare settings. Learnings from the implementation feasibility research will be shared among countries, especially applicable within a given use case. Implementation feasibility research will be grounded in artificial intelligence in healthcare implementation frameworks and other Implementation science frameworks Primary objectives
- To evaluate the overall performance profile of LLMs on real-world clinical scenarios using the human care plan as a comparator
- To assess whether each LLM being evaluated is not inferior to the human comparator with respect to safety on real-world clinical scenarios, based on structured retrospective assessment of model- and human-generated care plans.
Implementation feasibility research objectives
- Assess clinician experience with the LLM prompting interface: ease of use, time burden, and alignment with clinical workflow.
- Gather clinician impressions of LLM output disclosed and reviewed post-consultation: clarity, relevance, perceived safety, alignment with local clinical guidelines, and trust in LLM outputs.
- Facilitators and Barriers to Future Implementation: Identify site-level infrastructure, staff capacity, and organizational readiness factors that may support or hinder future implementation of LLM feedback in real-time
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Mary-Anne Hartley
- Telefonní číslo: +41216930828
- E-mail: mary-anne.hartley@epfl.ch
Studijní záloha kontaktů
- Jméno: Kristina Keitel
- Telefonní číslo: +41216932039
- E-mail: Kristina.keitel@epfl.ch
Studijní místa
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Nairobi County
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Nairobi, Nairobi County, Keňa, 19676
- Zatím nenabíráme
- University of Nairobi College of health sciences
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Kontakt:
- Paul Macharia
- E-mail: pmachariah@gmail.com
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Vrchní vyšetřovatel:
- Paul Macharia
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Blantyre
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Blantyre, Blantyre, Malawi, 303
- Nábor
- Malawi University of Business and Applied Sciences (MUBAS)
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Kontakt:
- Chiyembekezo Kachimanga
- Telefonní číslo: +265 887247777
- E-mail: chembekachimanga@yahoo.co.uk
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Vrchní vyšetřovatel:
- Chiyembekezo Kachimanga
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Dar es Salaam Region
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Dar es Salaam, Dar es Salaam Region, Tanzanie
- Zatím nenabíráme
- Muhimbili University of Health and Allied Sciences (MUHAS)
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Kontakt:
- Hendry R Sawe
- Telefonní číslo: +255754885658
- E-mail: hendry_sawe@yahoo.com
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Vrchní vyšetřovatel:
- Hendry R Sawe
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Dodoma
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Dodoma, Dodoma, Tanzanie
- Nábor
- Ifakara Health Institute (IHI)
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Kontakt:
- Grace Mhalu
- Telefonní číslo: +255655888891
- E-mail: gmhalu@ihi.or.tz
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Vrchní vyšetřovatel:
- Grace Mhalu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The study population consists of patients of any age presenting to participating health facilities for a distinct care-seeking episode related to a clinical condition within the defined use case (e.g. primary care, emergency care).
Both adult and pediatric patients are eligible, reflecting the real-world case mix of the participating facilities.
Popis
Inclusion Criteria:
- Presentation at a participating facility for a distinct care seeking episode related to a clinical condition.
- Use case specific inclusion criteria
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Prolonged care-seeking episode.
- Previously enrolled in the same study.
- Use case specific exclusion criteria
- Immediate life-threatening condition requiring emergency intervention precluding study procedures.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Non interventional study
Non interventional study |
Non interventional study |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Performance Scores
Časové okno: Day 0
|
Scoring is between -2 to +2 where '-2' means minimum, and '-2' means maximum. Score to be >0. Higher score means better outcome. |
Day 0
|
|
Safety performance threshold achievement
Časové okno: 'Day 7' and 'Day 28'
|
The mean safety score (minimum is -2 and maximum is +2) is formally compared between each LLM and the human comparator to assess non-inferiority within a UCA (use case appendix) dependent pre-specified margin. |
'Day 7' and 'Day 28'
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Implementation Feasibility Research
Časové okno: week 4 until study completion
|
Usability: Quantitative scoring rubric for clinicians; semi-structured interviews with clinicians; evaluation methods will be used |
week 4 until study completion
|
|
Implementation Feasibility Research
Časové okno: week 4 until study completion
|
Workflow integration feasibility: This will be evaluated using semi structured interviews and questionnaires |
week 4 until study completion
|
|
Implementation Feasibility Research
Časové okno: week 4 until study completion
|
Acceptability and perceived trust: This will be evaluated with Quantitative scoring rubric for clinicians; semi-structured interviews with clinicians |
week 4 until study completion
|
|
Implementation Feasibility Research
Časové okno: week 4 until study completion
|
Implementation facilitators and barriers: This will be evaluated using semi-structured interviews and questionnaires |
week 4 until study completion
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Mary-Anne Hartley, LIGHT
Publikace a užitečné odkazy
Obecné publikace
- 1. Arora RK, Wei J, Hicks RS, Bowman P, et al. HealthBench: Evaluating Large Language Models Towards Improved Human Health. Preprint [Under Review]. 2025. 2. Burnell R, Schellaert W, Burden J, Ullman TD, Martinez-Plumed F, Tenenbaum JB, et al. Rethink reporting of evaluation results in AI. Science. 2023;380: 136-138. doi:10.1126/SCIENCE.ADF6369. 3. Hager P, Jungmann F, Holland R, Bhagat K, Hubrecht I, Knauer M, et al. Evaluation and mitigation of the limitations of large language models in clinical decision-making. Nature Medicine 2024 30:9. 2024;30: 2613-2622. doi:10.1038/s41591-024-03097-1. 4. Singhal, K., Azizi, S., Tu, T., Mahdavi, S. S., Wei, J., Chung, H. W., et al. (2023). Large language models encode clinical knowledge. Nature, 620(7972), 172-180. https://doi.org/10.1038/s41586-023-06291-2 5. WHO. Towards the Development of guidance on ethics and governance of artificial intelligence for health. 2019. 6. Azad TD, Krumholz HM, Saria S. Principles to guide clinical AI readiness and move from benchmarks to real-world evaluation. Nature Medicine. 2026;32:802-804. doi:10.1038/s41591-025-04198-1 7. Declaration of Helsinki https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects 8. European Parliament and Council of the European Union, 2016. Regulation (EU) 2016/679 (General Data Protection Regulation). Official Journal of the European Union, L119, pp.1-88. 9. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), 2016. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Step 4, 9 November 2016. 10. U.S. Food and Drug Administration. 21 CFR Part 11-Electronic Records; Electronic Signatures. Code of Federal Regulations. Title 21, Part 11. Revised 2024.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- LiGHT-26-02
- INV-076674 (Jiné číslo grantu/financování: BILL and Melinda gates foundation)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
We will share IPD within 12 months of study completion.
Časový rámec sdílení IPD
IPD information will be shared within 12 months of study completion.
Kritéria přístupu pro sdílení IPD
Will be confirmed within 12 months of study completion
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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