- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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California
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Los Angeles, California, Spojené státy, 91100
- University of Southern California
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Gold Standard
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Experimentální: Pub2Post
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Pub2Post, a generative artificial intelligence agent which helps in drafting the layperson abstracts and summaries
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Readability Change
Časové okno: 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
Časové okno: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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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
Časové okno: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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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
Časové okno: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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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
Časové okno: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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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
Časové okno: 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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time Saving
Časové okno: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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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
Časové okno: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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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.
|
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Correctness and meaning retention
Časové okno: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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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
Časové okno: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Onemocnění endokrinního systému
- Genitální novotvary, muži
- Urogenitální novotvary
- Novotvary podle místa
- Novotvary
- Onemocnění pohlavních orgánů, muž
- Onemocnění prostaty
- Mužská urogenitální onemocnění
- Onemocnění ledvin
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Novotvary podle histologického typu
- Novotvary endokrinních žláz
- Novotvary, žlázové a epiteliální
- Gonadální poruchy
- Urologické novotvary
- Karcinom
- Onemocnění močového měchýře
- Testikulární nemoci
- Novotvary prostaty
- Adenokarcinom
- Novotvary močového měchýře
- Novotvary ledvin
- Testikulární novotvary
Další identifikační čísla studie
- UP-24-01142
Plán pro data jednotlivých účastníků (IPD)
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- PROTOKOL STUDY
- MÍZA
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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