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.
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
- Conditions the study is for
- Patient Understanding of Ultrasound Reports
- 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.
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 group | Role | What they receive |
|---|---|---|
| Standard ultrasound report | Active comparator | Participants 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 report | Experimental | 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 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.
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)
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
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
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.
- First posted15 Jun 2026
- Study start1 Jun 2026
- Primary completion20 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Understanding of Ultrasound ReportsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lu Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Wang, Sichuan Cancer Hospital and Research Institute
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Language Model Simplification of Ultrasound Reports Improves Patient Understanding
- ClinicalTrials.gov ID
- NCT07647536
- Acronym / sponsor ID
- 2026-AI-US-report
- Keywords
- Artificial intelligence, Ultrasound reports, Plain language, Patient communication, Health literacy, Report comprehension, Large language model
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Lu WangUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard ultrasound report | Active comparator | Other: Standard ultrasound report presentationParticipants or legal guardians viewed the standard ultrasound report generated through routine clinical reporting processes |
| Expert-reviewed AI-simplified ultrasound report | Experimental | Other: Expert-reviewed AI-simplified ultrasound report presentationParticipants 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ultrasound report presentationPresentation of the completed routine ultrasound report to the participant or legal guardian | Other | Standard ultrasound report |
| Expert-reviewed AI-simplified ultrasound report presentationPresentation 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 | Other | Expert-reviewed AI-simplified ultrasound report |
Primary outcome
Text comprehension composite score
Time frame: 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.
3 secondary outcomes
Cognitive workload composite score
Time frame: Immediately after reading the assigned report
Report perception composite score
Time frame: Immediately after reading the assigned report
Reading time
Time frame: Immediately after reading the assigned report
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.