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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
| The First Hospital of Hebei Medical University | OTHER |
| Qianfoshan Hospital | OTHER |
| Qingdao Municipal Hospital |
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This study will validate the effectiveness of a multimodal large language model to screen for heart failure with preserved ejection fraction (HFpEF), comparing it with the traditional clinical standardized assessment process.
Heart failure is a major complication of various heart diseases and is the leading lethal cause of cardiovascular death worldwide. Based on the left ventricular ejection fraction (LVEF), heart failure can be divided into heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF). Heart failure rehospitalization rates and in-hospital complications did not differ between HFrEF and HFpEF. However, over the past two decades, the survival rate of HFrEF has improved significantly, whereas HFpEF has remained stagnant. One of the major reasons for this is that the diagnostic process of HFpEF is complicated, and it is easy to cause missed diagnosis in the clinic, resulting in delayed treatment.
Multimodal large language models are capable of integrating and analyzing medical data from different sources, including textual data (e.g., medical records, medical literature), image data (e.g., electrocardiograms, CT scan images), and audio data (e.g., symptoms narrated by patients). This multimodal data integration capability is crucial for understanding complex medical scenarios, as it provides a more comprehensive view of the condition than a single data source.
The diagnosis of HFpEF faces many challenges and requires clinicians to make judgments on multi-dimensional data, which can easily lead to the underdiagnosis and misdiagnosis of the disease. As a generative artificial intelligence tool, a large language model is able to integrate and analyze data from different sources and has the ability to learn and evolve from existing clinical evidence. Based on this, this study intends to evaluate the effectiveness of multimodal large language model for screening for heart failure with preserved ejection fraction (HFpEF), comparing it with the traditional clinical standard assessment process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single group | The routine consultation process was performed first: according to the process recommended by the 2023 edition of the Chinese Expert Consensus on the Diagnosis and Treatment of Heart Failure with Preserved Ejection Fraction, the attending cardiologist completed the subject's clinical criteria assessment and performed the HFpEF diagnosis (yes/no). During the attending physician's checkup visit, the multimodal large language model screening system (MedGuide-72B) collected routine visit data, recorded relevant data and indicators during the patient's communication with MedGuide-72B and made the diagnosis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal Large Language Model Diagnosis | Diagnostic Test | Diagnosis for heart failure with preserved ejection fraction (HFpEF) using the multimodal large language model MedGuide-72B. |
| Measure | Description | Time Frame |
|---|---|---|
| dignostic specificity | dianostic specificity comparison between routine diagnosis and therapy and large language model diagnosis | through study completion, an average of 8 months |
| dignostic sensitivity | dianostic sensitivity comparison between routine diagnosis and therapy and large language model diagnosis | through study completion, an average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| consistency rate | consistency rate between routine diagnosis and therapy and large language model diagnosis | through study completion, an average of 8 months |
| time spent on diagnosis | comparison of time spent on diagnosis between routine diagnosis and therapy and large language model diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from patients routinely hospitalized in the cardiology department who also met the needs of this trial and are not recruited separately.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangbin Meng | Contact | 17600220171 | 15896850171@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking UniversityThird Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37137593 | Background | Kittleson MM, Panjrath GS, Amancherla K, Davis LL, Deswal A, Dixon DL, Januzzi JL Jr, Yancy CW. 2023 ACC Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2023 May 9;81(18):1835-1878. doi: 10.1016/j.jacc.2023.03.393. Epub 2023 Apr 19. No abstract available. | |
| 35789069 |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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| Routine diagnostic and therapeutic procedure | Diagnostic Test | Routine diagnostic and therapeutic procedure |
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| through study completion, an average of 8 months |
| patient satisfaction | comparison of patient satisfaction between routine diagnosis and therapy and large language model diagnosis by questionnaire | through study completion, an average of 8 months |
| economic cost analysis | comparison of economic cost between routine diagnosis and therapy and large language model diagnosis by the total cost of treatment | through study completion, an average of 8 months |
| false discovery rate | comparison of false discovery rate between routine diagnosis and therapy and large language model diagnosis | through study completion, an average of 8 months |
| physician workload assessment | comparison of physician workload between routine diagnosis and therapy and large language model diagnosis according to counting the number of participants with treatment-related | through study completion, an average of 8 months |
| diagnosis efficiency | The probability of accuracy compared to the final diagnosis of the patient's visit | through study completion, an average of 8 months |
| Background |
| Wang X, Cunningham JW. Restoring balance in heart failure with preserved ejection fraction. Eur J Heart Fail. 2022 Aug;24(8):1415-1417. doi: 10.1002/ejhf.2599. Epub 2022 Jul 18. No abstract available. |
| 35262693 | Background | Sicari R. Phenotyping heart failure with preserved ejection fraction with exercise stress echocardiography. Eur Heart J Cardiovasc Imaging. 2022 Jul 21;23(8):1053-1054. doi: 10.1093/ehjci/jeac053. No abstract available. |
| 34379445 | Background | Omote K, Verbrugge FH, Borlaug BA. Heart Failure with Preserved Ejection Fraction: Mechanisms and Treatment Strategies. Annu Rev Med. 2022 Jan 27;73:321-337. doi: 10.1146/annurev-med-042220-022745. Epub 2021 Aug 11. |
| 36027566 | Background | Margulies KB. DELIVERing Progress in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1138-1140. doi: 10.1056/NEJMe2210177. Epub 2022 Aug 27. No abstract available. |
| 31976862 | Background | Ventura HO, Lavie CJ, Mehra MR. Heart Failure With Preserved Ejection Fraction: Separating the Wheat From the Chaff. J Am Coll Cardiol. 2020 Jan 28;75(3):255-257. doi: 10.1016/j.jacc.2019.11.027. No abstract available. |
| 32247333 | Background | Reddy YNV, Borlaug BA. Heart Failure With Preserved Ejection Fraction: Where Do We Stand? Mayo Clin Proc. 2020 Apr;95(4):629-631. doi: 10.1016/j.mayocp.2020.02.015. No abstract available. |
| 32956811 | Background | Donal E, L'official G, Kosmala W. Heart Failure With Preserved Ejection Fraction: Defining Phenotypes. J Card Fail. 2020 Nov;26(11):929-931. doi: 10.1016/j.cardfail.2020.09.013. Epub 2020 Sep 19. No abstract available. |
| 31926855 | Background | Ahmad T, Desai NR, Januzzi JL. Heart Failure With Preserved Ejection Fraction: Many Emperors With Many Clothes. JACC Heart Fail. 2020 Mar;8(3):185-187. doi: 10.1016/j.jchf.2019.11.004. Epub 2020 Jan 8. No abstract available. |