- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07647536
LLMs Improve Patient Understanding of Ultrasound Reports
Large Language Model Simplification of Ultrasound Reports Improves Patient Understanding
This multicenter, patient-blinded, controlled evaluation assessed whether expert-reviewed artificial intelligence (AI)-simplified ultrasound reports improved patient- or guardian-reported understanding and reading experience compared with standard ultrasound reports. Routine ultrasound reports were completed through existing clinical processes. After completion of the routine report, participants were assigned to view either the standard report or an expert-reviewed plain-language version generated with a large language model workflow.
The simplified report was intended only as a patient-facing communication aid. It did not replace the standard clinical report and did not alter ultrasound acquisition, diagnostic interpretation, treatment decisions, follow-up, or subsequent clinical management. Patient- or guardian-reported outcomes included cognitive workload, comprehension, report perception, and reading time. Expert review assessed whether AI-generated simplified reports preserved source meaning and identified factual errors, omissions, or unsupported additions before patient presentation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Radiology and ultrasound reports are primarily written for communication among clinicians and often contain technical terminology, compressed syntax, measurements, uncertainty statements, and diagnostic language that may be difficult for patients to interpret. Patient access to reports through electronic portals may improve transparency, but access alone does not ensure comprehension. This study evaluated a bounded AI-assisted communication workflow designed to translate completed ultrasound reports into patient-facing plain language while preserving the meaning of the original clinical report.
The study was conducted at three participating centers: Sichuan Cancer Hospital and Institute, Sichuan Provincial Hospital of Integrated Traditional Chinese and Western Medicine, and The First People's Hospital of Liangshan Yi Autonomous Prefecture. Eligible participants were patients receiving an ultrasound report at a participating center. For participants younger than 18 years, a legal guardian provided consent, read the report, and completed the questionnaire.
Routine ultrasound reports were first completed through standard clinical processes. The study workflow began only after the routine report had been finalized. A built-in random-number function determined whether the participant or guardian viewed the standard report or an expert-reviewed AI-simplified report. Participants or guardians were not informed which presentation format they received. The standard clinical report remained the authoritative diagnostic report and the sole report used for clinical communication and care.
For the AI-simplified format, the completed routine report text was submitted to a large language model workflow. The prompt instructed the model to preserve all findings, avoid new diagnoses or recommendations, explain terminology in plain language, and maintain uncertainty expressed in the source report. Before presentation to participants or guardians, the generated simplified report was reviewed against the routine report by paired ultrasound physicians at each center. Experts corrected inaccuracies, omissions, or unsupported additions before patient exposure. The workflow did not generate orders, referrals, follow-up intervals, medication instructions, or treatment recommendations, and no model output was written back into the diagnostic report.
After reading the assigned report format, participants or guardians completed a questionnaire evaluating their immediate reading experience. Patient- or guardian-reported outcomes included cognitive workload, text comprehension, report perception, and approximate reading time. Cognitive workload included mental demand, frustration, and effort, with lower scores indicating a more favorable experience. Comprehension included clarity, readability, and comprehensibility. Report perception included helpfulness, informativeness, and trust, with higher scores indicating more favorable responses.
Expert assessment of AI-generated simplified reports included factual errors, important omissions, unsupported additions, terminology simplification, clinical usefulness, and overall quality. Paired expert ratings were resolved into consensus records for report-level safety summaries. The primary purpose of expert review was to determine whether the AI-generated patient-facing explanation preserved the source meaning and to define the residual need for human oversight before such reports are shown to patients.
The prespecified analysis population included completed evaluations with recorded center and presentation format. Outcomes were analyzed using descriptive statistics, between-format comparisons, and adjusted models including presentation format, age, sex, education, and center. The study was approved by the Medical Ethics Committee of Sichuan Cancer Hospital, and written informed consent was obtained from adult participants or from legal guardians of minors.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- Sichuan Cancer Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients receiving an ultrasound report at a participating center. Adult participants able to provide written informed consent. For participants younger than 18 years, a legal guardian able to provide written informed consent, read the assigned report, and complete the questionnaire.
Participants or legal guardians able to read one assigned report presentation format and complete the study questionnaire immediately after reading.
Exclusion Criteria:
- Refusal or inability to provide written informed consent by the adult participant or legal guardian.
Inability of the participant or legal guardian to read the assigned report presentation format or complete the questionnaire.
Incomplete evaluation, including missing responses to any of the nine rating items or the reading-time item.
Missing key study information required for analysis, including participating center or assigned report presentation format.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Standard ultrasound report
Participants or legal guardians viewed the standard ultrasound report generated through routine clinical reporting processes
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Presentation of the completed routine ultrasound report to the participant or legal guardian
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Experimental: Expert-reviewed AI-simplified ultrasound report
Participants or legal guardians viewed a plain-language ultrasound report generated by an AI workflow after completion of the routine report and reviewed by ultrasound physicians before presentation
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Presentation of a patient-facing plain-language ultrasound report generated by an AI workflow and reviewed by ultrasound physicians before participant or guardian exposure.
The intervention did not alter ultrasound acquisition, diagnostic interpretation, treatment decisions, follow-up, or clinical management
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Text comprehension composite score
Periodo de tiempo: Immediately after reading the assigned report
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Participant- or guardian-reported text comprehension after reading the assigned ultrasound report format.
The composite score was calculated as the arithmetic mean of three seven-point questionnaire items assessing clarity, readability, and comprehensibility.
Higher scores indicate better comprehension.
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Immediately after reading the assigned report
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cognitive workload composite score
Periodo de tiempo: Immediately after reading the assigned report
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Participant- or guardian-reported cognitive workload after reading the assigned ultrasound report format.
The composite score was calculated as the arithmetic mean of three seven-point items assessing mental demand, frustration, and effort.
Lower scores indicate a more favorable reading experience.
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Immediately after reading the assigned report
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Report perception composite score
Periodo de tiempo: Immediately after reading the assigned report
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Participant- or guardian-reported perception of the assigned ultrasound report format.
The composite score was calculated as the arithmetic mean of three seven-point items assessing helpfulness, informativeness, and trust.
Higher scores indicate more favorable report perception.
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Immediately after reading the assigned report
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Reading time
Periodo de tiempo: Immediately after reading the assigned report
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Participant- or guardian-reported approximate time spent reading the assigned ultrasound report format.
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Immediately after reading the assigned report
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2026-AI-US-report
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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