Heart Valve Disease
Conditions
Keywords
clinical decision support system, artificial intelligence, cdss
Brief summary
The study aims to validate naevia medical, a knowledge-based clinical decision support system (CDSS), for clinical benefit and safety in cases of cardiac valvulopathies. Using a series of retrospective clinical cases of heart valve disease, the research will evaluate the number of appropriate and inappropriate recommendations during baseline measurement (conventional management) and after CDSS activation.
Detailed description
The objective of this study is to validate both the clinical benefit and safety of a knowledge-based clinical decision support system (CDSS), naevia medical, applied to clinical cases of cardiac valvulopathies. naevia medical aims to bridge the gap between scientific evidence and medical practice by improving adherence to scientific recommendations. The research aims to establish and verify that the naevia medical product is suitable for its intended purposes and provides the specified intended functionality as outlined by its manufacturer under normal conditions of use. It seeks to verify the clinical benefits of the product compared to conventional management by enhancing healthcare professionals' ability to provide a greater number of scientifically based recommendations tailored to each patient's specific situation. Additionally, the study aims to establish the clinical safety of the product by identifying potential undesirable side effects under normal usage conditions and evaluating whether these effects constitute acceptable risks in relation to the benefits provided. To achieve these objectives, a clinical research study will be conducted to assess naevia medical's capacity to increase appropriate recommendations and decrease inappropriate recommendations received by patients with valvulopathy, compared to conventional management without support. The study proposes a pre-test-post-test design with a randomly assigned group, utilizing a longitudinal approach with repeated measures and retrospective validation. Evaluation criteria will focus on the number of appropriate and inappropriate recommendations during baseline measurement (conventional management) and after CDSS activation, using a series of retrospective clinical cases of heart valve disease.
Interventions
DEVICEClinical decision support system (software)
Use of a clinical decision support system. Naevia Medical is clinical decision support software (CDSS) that, based on clinical input data (patient history, symptoms, complementary test data, etc.) from adult patients with heart disease, provides healthcare professionals with prioritized, justified, and referenced recommendations and knowledge-related suggestions related to diagnosis, prognosis, and/or treatment (recommended tests, medications, alerts, etc.)
Sponsors
Dilemma Solutions S.L.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Inclusion criteria
* Patients randomly selected from those presented during the year 2022 in medical-surgical sessions, with a primary diagnosis of: * aortic valve stenosis * aortic insufficiency * mitral valve stenosis * mitral insufficiency (greater than moderate severity).. * Patients randomly selected from valvulopathy clinic records attended during the year 2022, with a primary diagnosis of * aortic valve stenosis * aortic insufficiency * mitral valve stenosis * mitral insufficiency (greater than moderate severity)
Exclusion criteria
* Subjects under 18 years old. * Inability to anonymize the case. * Clinical cases of valvulopathies in which a complex congenital heart disease coexists. * Clinical cases that do not meet the minimum data set necessary for decision-making. * Clinical cases with a primary diagnosis other than valvulopathy. * Presence of bacterial endocarditis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Relevant Appropriate Recommendations | 1 week | Number of relevant appropriate recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study. |
| Number of Inappropriate Recommendations | 1 week | Number of inappropriate recommendations (that do not apply to the specific case) |
| Number of Relevant Missing Recommendations | 1 week | Number of relevant missing recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study. |
Countries
Spain
Participant flow
Pre-assignment details
The same group of 106 cases was evaluated before and after the CDSS activation.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Heart Valve Disease The same group of patients is evaluated with a pre-test-post-test design with a randomly assigned group, utilizing a longitudinal approach with repeated measures and retrospective validation. | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | Patients With Heart Valve Disease | — |
|---|---|---|
| Age, Continuous | 73.35 Years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 42 Participants | — |
| Sex: Female, Male Male | 64 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Inappropriate Recommendations
Number of inappropriate recommendations (that do not apply to the specific case)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients with heart valve disease (pre-test) | Number of Inappropriate Recommendations | 0.29 Recommendations | Standard Deviation 0.6 |
| Patients with heart valve disease (post-test) | Number of Inappropriate Recommendations | 0.07 Recommendations | Standard Deviation 0.29 |
Primary
Number of Relevant Appropriate Recommendations
Number of relevant appropriate recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients with heart valve disease (pre-test) | Number of Relevant Appropriate Recommendations | 2.35 Recommendations | Standard Deviation 1.97 |
| Patients with heart valve disease (post-test) | Number of Relevant Appropriate Recommendations | 6.20 Recommendations | Standard Deviation 2.57 |
Primary
Number of Relevant Missing Recommendations
Number of relevant missing recommendations. Only high-level recommendations (class I and IIa) were included and evaluated in the study.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients with heart valve disease (pre-test) | Number of Relevant Missing Recommendations | 3.80 Recommendations | Standard Deviation 2.27 |
| Patients with heart valve disease (post-test) | Number of Relevant Missing Recommendations | 0.49 Recommendations | Standard Deviation 0.67 |