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Patient Understanding of Ultrasound ReportsNCT07647536

LLMs Improve Patient Understanding of Ultrasound Reports

A study testing Standard ultrasound report presentation and Expert-reviewed AI-simplified ultrasound report presentation in people with Patient Understanding of Ultrasound Reports, run by Lu Wang at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Standard ultrasound report presentation and Expert-reviewed AI-simplified ultrasound report presentation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
660 participants
Where
1 siteChina
Study dates
1 Jun 2026to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Sichuan cancer hospital

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Standard ultrasound report presentation, Expert-reviewed AI-simplified ultrasound report presentation
Keywords
Artificial intelligence, Ultrasound reports, Plain language, Patient communication, Health literacy, Report comprehension, Large language model

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard ultrasound report presentationOther

    Presentation of the completed routine ultrasound report to the participant or legal guardian

  • Expert-reviewed AI-simplified ultrasound report presentationOther

    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

Study groups in NCT07647536
Study groupRoleWhat they receive
Standard ultrasound reportActive comparatorParticipants or legal guardians viewed the standard ultrasound report generated through routine clinical reporting processes
Receives: Other: Standard ultrasound report presentation
Expert-reviewed AI-simplified ultrasound reportExperimentalParticipants 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
Receives: Other: Expert-reviewed AI-simplified ultrasound report presentation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Text comprehension composite score

    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.

    Measured: Immediately after reading the assigned report

Secondary outcomes (3)
  1. Cognitive workload composite score

    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.

    Measured: Immediately after reading the assigned report

  2. Report perception composite score

    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.

    Measured: Immediately after reading the assigned report

  3. Reading time

    Participant- or guardian-reported approximate time spent reading the assigned ultrasound report format.

    Measured: Immediately after reading the assigned report

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start1 Jun 2026
  3. Primary completion20 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants or legal guardians were assigned to one of two parallel report presentation formats: a standard ultrasound report or an expert-reviewed AI-simplified patient-facing ultrasound report. The workflow began only after the routine ultrasound report had been completed and did not alter ultrasound acquisition, diagnostic interpretation, treatment decisions, follow-up, or subsequent clinical management.
Masking
Single blind
Who is masked
Participant
Enrolment
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07647536
Sponsor's protocol ID
2026-AI-US-report
Status last verified
Jun 2026
First submitted
9 Jun 2026
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Standard ultrasound report presentation and Expert-reviewed AI-simplified ultrasound report presentation in people with Patient Understanding of Ultrasound Reports, run by Lu Wang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Text comprehension composite score (time frame: Immediately after reading the assigned report). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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