We hypothesize that the AI- assessment procedure will have a sensitivity of 98%.
ID
Bron
Verkorte titel
Aandoening
Asbestosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The sensitivity of the AI- assessment procedure when assessing cases for financial asbestosis compensation in The Netherlands
Achtergrond van het onderzoek
Background: Asbestosis is a rare pneumoconiosis, which emerges after extensive occupational asbestos exposure. Financial compensation is possible in The Netherland if an independent pulmonologist panel underlines the diagnosis based on: Extensive asbestos exposure, the presence of lung fibrosis and loss of lung function. Since this is a time consuming and expensive process, an automated asbestosis assessment procedure was developed in which an artificial intelligence prediction model- and lung function loss is combined with medical experts assessments.
Objectives: The primary objective of this trial is sensitivity of the asbestosis automated assessment procedure. Main secondary objectives will be diagnostic accuracy in term of specificity, positive predictive value, negative predictive value and positive- and negative likelihood ratio.
Trial design: This prospective cohort study will include all Dutch applicants for asbestosis compensation from September 2020. All applications will be assesses by the standard workup (reference test), and parallel by the automated assessment procedure (index test). The two assessment strategies will be blinded for each other. Inclusion will be stopped after 59 patients are diagnosed with asbestosis by the reference test.
Ethics and dissemination: Approval of the study by the Institutional Review Board has been obtained prior to the start of this study. The aim is to report the study findings in international peer-reviewed journals and to present the data at international meetings.
Doel van het onderzoek
We hypothesize that the AI- assessment procedure will have a sensitivity of 98%.
Onderzoeksopzet
The is a observational prospective cross-sectional study. Both the index test and the refference test will take place after registration of the application at the SAGA. Both the data for the primary and secondary outcomes will be collected at the time of reference test and the index test take place
Onderzoeksproduct en/of interventie
Observational study
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All applications for financial asbestosis compensation at the Intituut Asbest slachtoffer (IAS) which are proceeded to the Sectie Asbest-Gerelateerde Aandoeningen (SAGA) from Oktober 2020 will be included in the consecutive validation cohort. Inclusion will be stopped after 59 patients are diagnosed with asbestosis by the reference test.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
All applications presided by the IAS will be taken into account for this model. However, IAS can decide to not proceed an application to the SAGA if: Patients already received compensation for asbestosis or malignant mesothelioma in the past or if the applicant was not a Dutch citizen for more than ten years.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9064 |
| Ander register | Institutional Review Board of The Netherlands Cancer Institute : This study is not a subject to the Medical Research Involving Human Subjects Act (WMO), judged by the accredited Medical Research Ethics Committees of The Netherlands Cancer Institute (IRBd19-136 ) |