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LLMs Improve Patient Understanding of Ultrasound Reports

12. juni 2026 opdateret af: Lu Wang

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

660

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Sichuan Cancer Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard ultrasound report
Participants or legal guardians viewed the standard ultrasound report generated through routine clinical reporting processes
Presentation of the completed routine ultrasound report to the participant or legal guardian
Eksperimentel: 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
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Text comprehension composite score
Tidsramme: Immediately after reading the assigned report
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.
Immediately after reading the assigned report

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive workload composite score
Tidsramme: Immediately after reading the assigned report
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.
Immediately after reading the assigned report
Report perception composite score
Tidsramme: Immediately after reading the assigned report
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.
Immediately after reading the assigned report
Reading time
Tidsramme: Immediately after reading the assigned report
Participant- or guardian-reported approximate time spent reading the assigned ultrasound report format.
Immediately after reading the assigned report

Samarbejdspartnere og efterforskere

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Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2026

Primær færdiggørelse (Anslået)

20. juni 2026

Studieafslutning (Anslået)

30. juni 2026

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because the study involves sensitive patient-level clinical data, and the current informed consent and ethics approval do not include permission for external IPD sharing. Study results will be reported in aggregate form.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Patient Understanding of Ultrasound Reports

Kliniske forsøg med Standard ultrasound report presentation

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