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This prospective, randomized controlled trial evaluated the efficacy of adding Large Language model (LLM)-generated Plain Language Summaries (PLSs) to Standard Ophthalmology Notes (SONs) in enhancing comprehension among non-ophthalmology providers. The study utilized surveys to assess non-ophthalmology providers' comprehension and satisfaction with the notes and ophthalmologists' evaluation of PLS accuracy, safety, and time burden. An objective semantic and linguistic analysis of the PLSs was also conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants receive standard ophthalmology notes without any additions. | |
| Intervention | Experimental | Participants receive standard ophthalmology notes with an appended LLM-generated plain language summary, reviewed and edited by the ophthalmologist. The plain language summary is clearly marked as generated as part of a Quality Improvement initiative. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Large Language Model-generated Plain Language Summary of Ophthalmology notes | Other | Prospective, randomized Quality Improvement study with real-world implementation of Large Language Model-generated Plain Language Summaries of Ophthalmology notes. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-Ophthalmologist Note Comprehension and Satisfaction | Assessed via survey responses evaluating understanding of the patient's ophthalmology diagnosis, satisfaction with the note, and overall preference between Standard Ophthalmology Note and Standard Ophthalmology Note + Plain Language Summary. Degree of understanding was assessed on the following Likert scale: Not at all Neutral Moderately A great deal Satisfaction was graded on the following Likert scale: Not satisfied at all Somewhat unsatisfied Neutral Somewhat satisfied Satisfied Preference between note types was assessed on the following Likert scale: Standard Note, a great deal Standard Note, somewhat Neutral Plain Language Summary, somewhat Plain Language Summary, a great deal | From enrollment to 8 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Ophthalmologist Evaluation of Summary Accuracy and Time burden | Assessed via survey responses regarding Plain Language Summary accuracy in reflecting the Standard Ophthalmology Note findings, time spent reviewing/editing, and perceived burden. Accuracy in reflecting findings was graded on the following Likert scale: Not at all Neutral A little A great deal Time spent reviewing/editing was reported using the following options: <1 minute
Perceived burden was graded on the following Likert scale: Not at all Neutral A little A great deal |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Errors, Type of Errors, and Potential Harm of Errors | Presence of any incorrect or missing information in the Plain Language Summary, error rates, types of errors, and potential harm rating. Types of errors were reported as: HPI Exam findings Diagnosis Plan Explanation of the patient&amp;#39;s overall eye health Other N/A Likelihood of harm was graded on the following scale: Low risk Medium risk High risk N/A Potential harm rating was graded on the following scale: Mild or moderate harm Death or severe harm |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John J Chen, MD, PhD | Mayo Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
All collected IPD.
Beginning after publication with no end date
The underlying data supporting the findings of this study can be made available to clinical investigators and researchers upon request. Written requests for data sharing including an analysis plan will be required before approval. These requests will be individually assessed in consultation with the study team leads and co-investigators as appropriate. If other investigators are interested in performing additional analyses, these requests can be made to the corresponding author (PDT) and analyses will be performed in collaboration with the Mayo Clinic. In all cases, any data and materials to be shared will be released via a Material Transfer Agreement. Individual-level data will be available and data sharing will ensure that the rights and privacy of individuals participating in the research always remains protected. The anticipated time frame to respond to initial data requests is 1 month.
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Randomized study assessing the efficacy of Large Language Model-generated Plain Language Summaries of Ophthalmology notes in increasing non-ophthalmologist note understanding. Notes were randomized to intervention (Summary + Original Note) or control (Original note only) arms. Non-ophthalmology providers were sent surveys assessing note comprehension for both control and treatment arm notes, and Ophthalmologists were sent surveys for intervention arm notes regarding Summary accuracy and other attributes. Conducted as a Quality Improvement initiative.
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| Assessed at a single time point <24 hr after enrollment |
| Semantic and Linguistic Quality of Plain Language Summaries | Flesch Reading Ease Scale: 0 (poor) to 100 (good) | Assessed at a single time point &lt;24 hr following enrollment |
| Semantic and Linguistic Quality of Plain Language Summaries | Flesch-Kincaid Grade Level Scale: 0 (most difficult to read, highest grade level) to 80 (easiest to read, lowest grade level) | Assessed at a single time point &lt;24 hr following enrollment |
| Semantic and Linguistic Quality of Plain Language Summaries | Semantic Measure of Gobbledygook (SMOG) Index Scale: 0 (easiest to read) to 11 (most difficult to read) | Assessed at a single time point &lt;24 hr following enrollment |
| Semantic and Linguistic Quality of Plain Language Summaries | BERTScore Measure of Linguistic Similarity Scale: -1 (least similar) to +1 (most similar) | Assessed at a single time point &amp;lt;24 hr following enrollment |
| Semantic and Linguistic Quality of Plain Language Summaries | SBERT Cosine Similarity Measure of Linguistic Similarity Scale: -1 (least similar) to +1 (most similar) | Assessed at a single time point &amp;lt;24 hr following enrollment |
| Assessed at a single time point &amp;amp;amp;amp;lt;24 hr following enrollment and again at a single time point 8 weeks after enrollment |
| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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