- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07568444
Enhancing Readability of Lay Abstracts and Summaries for Medical Knowledge Using Generative Artificial Intelligence (BRIDGE AI 3)
Enhancing Readability of Lay Abstracts and Summaries for Medical Knowledge Using Generative Artificial Intelligence: A Randomized Controlled Trial (BRIDGE AI 3)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study evaluates whether a generative artificial intelligence (AI) tool can improve the readability and accessibility of lay summaries derived from scientific medical abstracts. Many patients encounter difficulty understanding medical literature due to technical language and complexity, which can limit informed decision-making and engagement with healthcare information.
The BRIDGE-AI (Provider Perspective) initiative aims to address this gap by enabling healthcare professionals and researchers to generate patient-friendly summaries of scientific content using AI-assisted tools. The intervention leverages a generative AI framework (pub2people) designed to translate complex medical terminology into language that is understandable to a general audience.
In this randomized controlled study, participants with experience in scientific publishing will be assigned to either an AI-assisted group or a control group using conventional methods. Participants will be asked to transform scientific abstracts into layperson-friendly summaries. The study compares AI-assisted and manually generated outputs in terms of readability, accuracy, and efficiency.
The primary objective is to determine whether AI-assisted generation improves the readability of lay summaries compared to standard approaches. Secondary objectives include evaluating the accuracy of AI-generated summaries relative to source material and assessing potential time savings associated with AI use.
This study contributes to ongoing efforts to improve health communication by evaluating scalable tools that may enhance the translation of complex medical information into patient-accessible formats.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 91100
- University of Southern California
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Provider Participants
Inclusion:
- Corresponding authors who have been published in the top 10 journals of urology and medicine
- All genders
- Any profession
- 18+ years of age
Exclusion:
- Anyone under the age of 18
- Participants that have not published in the top 10 journals of urology and medicine
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Gold Standard
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Sperimentale: Pub2Post
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Pub2Post, a generative artificial intelligence agent which helps in drafting the layperson abstracts and summaries
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Readability Change
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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Flesch Reading Ease Score Description: Measures text readability based on sentence length and word syllables. Scale: 0 to 100 Interpretation: Higher scores indicate easier readability (better outcome). |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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Readability Change
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
Flesch-Kincaid Grade Level Description: Estimates U.S. school grade level required to understand the text.
Scale: Typically ranges from ~0 to 18+ Interpretation: Lower scores indicate easier readability (better outcome).
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The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
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Readability Change
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
Gunning Fog Index Description: Estimates years of formal education needed to understand the text on first reading. Scale: Typically 0 to 20+ Interpretation: Lower scores indicate easier readability (better outcome). |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
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Readability Change
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
SMOG Index (Simple Measure of Gobbledygook) Description: Estimates years of education required to comprehend the text.
Scale: Typically 0 to 20+ Interpretation: Lower scores indicate easier readability (better outcome).
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The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
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Readability Change
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
Coleman-Liau Index Description: Readability formula based on characters per word and sentence length. Scale: Typically 0 to 18+ (grade level equivalent) Interpretation: Lower scores indicate easier readability (better outcome). |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
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Readability Change
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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Automated Readability Index (ARI) Description: Estimates grade level required for comprehension using characters and word counts. Scale: Typically 0 to 14+ Interpretation: Lower scores indicate easier readability (better outcome). |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time Saving
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
To evaluate the time savings achieved by using generative AI compared to traditional methods for generating layperson abstracts and summaries. Time will be recorded in hours, minutes, and seconds. We will collect and compare the total time spent drafting the complete layperson abstract and summaries, as well as the time spent on each individual section - background, methods, results, conclusion, and short summaries. The comparison will be made between summaries created by humans alone versus those created with GAI assistance. Time will be reported in minutes |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
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Correctness and meaning retention
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
Accuracy Score of Layperson Abstract Sections Description: Degree to which each section (Background, Methods, Results, Conclusion, Short Summary) reflects key information from the original scientific abstract. Scale: 5-point Likert scale (1 = very inaccurate, 5 = highly accurate) Assessment Method: Two independent reviewers score each section Interpretation: Higher scores indicate better accuracy (better outcome). |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
|
Correctness and meaning retention
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
Completeness Score of Layperson Abstract Sections Description: Extent to which essential information from the original abstract is included in each section. Scale: 5-point Likert scale (1 = very incomplete, 5 = fully complete) Assessment Method: Two independent reviewers evaluate each section. Interpretation: Higher scores indicate greater completeness (better outcome). |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
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Correctness and meaning retention
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
Clarity Score for Layperson Readability Description: Evaluates simplicity, avoidance of jargon, and coherence for lay audiences. Scale: 5-point Likert scale (1 = very unclear, 5 = very clear and understandable) Assessment Method: Two independent reviewers evaluate each section. Interpretation: Higher scores indicate better clarity (better outcome). |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
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Correctness and meaning retention
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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Section-Level Correctness Rate Description: Proportion of sections rated as "correct," defined as receiving scores ≥4 from both reviewers on accuracy, completeness, and clarity simultaneously. Scale: 0 to 1 (proportion) or 0% to 100% Interpretation: Higher values indicate better overall section quality. |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
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Correctness and meaning retention
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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Hallucination Rate Description: Frequency of false or misleading content in generated layperson abstracts, defined as information not supported by the original abstract. Scale: Proportion of sections or documents containing hallucinations (0 to 1 or %) Assessment Method: Evaluated separately by reviewers using predefined criteria. Interpretation: Lower values indicate better performance (fewer hallucinations). |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
|
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Perceived Task Difficulty
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
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Description: Participant-reported difficulty of completing the lay abstract summarization task. Scale: 5-point Likert scale (1 = very easy, 5 = very difficult) (adjust anchors if different in your instrument) Assessment Timing: Immediately after task completion Interpretation: Lower scores indicate less perceived difficulty (better outcome) |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
|
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Perceived Task Duration
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
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Description: Participant perception of time required to complete the task.
Scale: 5-point Likert scale (1 = very short, 5 = very long) Assessment Timing: Post-task Interpretation: Lower scores indicate shorter perceived duration (better outcome)
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The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
|
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Perceived Helpfulness of the intervention
Lasso di tempo: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
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Description: Participant-reported usefulness of the generative AI tool in assisting lay abstract creation. Scale: 5-point Likert scale (1 = not helpful at all, 5 = extremely helpful) Assessment Timing: Post-task Interpretation: Higher scores indicate greater perceived helpfulness (better outcome) |
The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
|
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System Usability Scale (SUS) Score
Lasso di tempo: Immediately after completing the system/task (post-use assessment)
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Description: Standardized assessment of system usability using the System Usability Scale. Scale: 0 to 100 Interpretation: Higher scores indicate better usability
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Immediately after completing the system/task (post-use assessment)
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Perceived Usefulness (Technology Acceptance Model)
Lasso di tempo: Immediately after completing the system/task (post-use assessment)
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Description: Degree to which participants believe the GAI tool enhances task performance. Scale: Likert scale (typically 1-5 or 1-7; specify exact instrument version) Interpretation: Higher scores indicate greater perceived usefulness (better outcome) |
Immediately after completing the system/task (post-use assessment)
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Perceived Ease of Use (Technology Acceptance Model)
Lasso di tempo: Immediately after completing the system/task (post-use assessment)
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Description: Degree to which participants find the GAI tool easy to use.
Scale: Likert scale (typically 1-5 or 1-7; must match instrument used) Interpretation: Higher scores indicate greater ease of use (better outcome)
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Immediately after completing the system/task (post-use assessment)
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Collaboratori e investigatori
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema endocrino
- Neoplasie genitali, maschio
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie genitali, maschio
- Malattie della prostata
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Neoplasie per tipo istologico
- Neoplasie delle ghiandole endocrine
- Neoplasie, ghiandolari ed epiteliali
- Disturbi gonadici
- Neoplasie urologiche
- Carcinoma
- Malattie della vescica urinaria
- Malattie testicolari
- Neoplasie prostatiche
- Adenocarcinoma
- Neoplasie della vescica urinaria
- Neoplasie renali
- Neoplasie testicolari
Altri numeri di identificazione dello studio
- UP-24-01142
Piano per i dati dei singoli partecipanti (IPD)
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Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .