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LLMs Improve Patient Understanding of Ultrasound Reports

perjantai 12. kesäkuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

660

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

    • Sichuan
      • Chengdu, Sichuan, Kiina, 610041
        • Sichuan Cancer Hospital

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: 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
Kokeellinen: 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

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Text comprehension composite score
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Cognitive workload composite score
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 1. kesäkuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Lauantai 20. kesäkuuta 2026

Opintojen valmistuminen (Arvioitu)

Tiistai 30. kesäkuuta 2026

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 9. kesäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 12. kesäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 15. kesäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 15. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 12. kesäkuuta 2026

Viimeksi vahvistettu

Maanantai 1. kesäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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